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1 | Installation Manual 1 | Users Manual | 1.54 MiB |
INSTALLATION MANUAL INSTRUCTIONS Labels and Symbols Important Information Please Read Before Use 1 7 ENDOSCOPE REPROCESSOR OER-Elite Chapter 1 Checking the Package Contents 17 Chapter 2 Nomenclature and Functions Chapter 3 Installation of Accessories Chapter 4 Installation of Equipment 21 37 49 Installation Work Check Points 191 For information on how to operate this equipment, please refer to Instructions - Operation Manual. Contents Contents Labels and Symbols .......................................................................................................... 1 Important Information Please Read Before Use ......................................................... 7 Intended use .......................................................................................................................... 7 Instruction manuals ............................................................................................................... 7 Terms used in these manuals ................................................................................................ 8 Ensuring the safety of reprocessing personnel .................................................................... 11 Equipment compatibility ....................................................................................................... 12 Signal words ........................................................................................................................ 12 Warnings and cautions ........................................................................................................ 12 Outline of Functions ........................................................................................................ 14 Chapter 1 Checking the Package Contents ....................................... 17 1.1 Checking the package contents ............................................................................ 17 Chapter 2 Nomenclature and Functions ............................................ 21 2.1 Front panel .............................................................................................................. 21 2.2 Top panel ................................................................................................................. 22 2.3 Inside ....................................................................................................................... 23 2.4 Rear panel ............................................................................................................... 24 2.5 Side panel ................................................................................................................ 25 2.6 Reprocessing basin ............................................................................................... 26 2.7 Control panels ........................................................................................................ 28 Touch screen Menu Screen .............................................................................................. 29 Touch screen Reprocessing standby screen .................................................................... 30 Touch screen Reprocessing process screen .................................................................... 32 2.8 Consumable accessories (Optional) .................................................................... 33 Chapter 3 Installation of Accessories ................................................ 37 Installation of accessories workflow below ......................................................... 37 Installation of the grommets ................................................................................. 38 Installation of the buckling guard ......................................................................... 39 Inspection of the mesh filters ............................................................................... 40 Inspection of the retaining rack ............................................................................ 41 Installation of the washing case (MAJ-2121) ....................................................... 42 Installation of the stylus pen holder ..................................................................... 43 Required items .................................................................................................................... 43 Installing the stylus pen holder ............................................................................................ 43 Inspecting the accessory holder .......................................................................... 44 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 OER-Elite INSTALLATION MANUAL i Contents 3.9 Storing other accessories ...................................................................................... 44 3.10 Installation of the optional accessories ............................................................... 45 Connection of the bar code reader (MAJ-2130) .................................................................. 45 Installation of the printer set (MAJ-2144) ............................................................................. 46 Chapter 4 Installation of Equipment ................................................... 49 4.1 General flow of installation of the equipment ...................................................... 49 4.2 Installation workflow .............................................................................................. 52 Installation conditions ............................................................................................ 54 4.3 Installation condition ............................................................................................................ 54 Checking the installation position ........................................................................................ 57 4.4 Connection of the water supply hose ................................................................... 58 4.5 Connection of the drain hose ................................................................................ 60 4.6 Connection of the power supply ........................................................................... 64 4.7 Confirmation of the power supply ........................................................................ 66 4.8 Inspection of the RFID function ............................................................................ 69 4.9 Setting the date and time ....................................................................................... 74 4.10 Installation of the gas filters (MAJ-822) ................................................................ 79 Required items .................................................................................................................... 79 Attachment of the gas filter case to the lid ........................................................................... 80 Attachment of the gas filter case to the disinfectant solution tank ....................................... 83 4.11 Installation of the air filter (MAJ-823) .................................................................... 90 Required items .................................................................................................................... 90 Installing the air filter ............................................................................................................ 91 4.12 Inspection of air leakage from the air filter connectors ...................................... 96 4.13 Installation of the water tray .................................................................................. 99 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) ...................................... 100 Required items .................................................................................................................. 101 Attachment of the water filter ............................................................................................. 101 4.15 Correction of equipment tilt ................................................................................ 113 Adjustment if water level is not located within even one of the three ranges ..................... 117 Correcting the tilt ................................................................................................................ 118 4.16 Inspecting the detergent/alcohol inner tray ....................................................... 121 4.17 Inspecting the alcohol tank ................................................................................. 122 4.18 Addition of alcohol ............................................................................................... 123 4.19 Installation of the detergent tank ........................................................................ 126 Required items .................................................................................................................. 127 Installing the detergent tank .............................................................................................. 127 4.20 Setup of the disinfectant solution ....................................................................... 134 Required items .................................................................................................................. 136 Setup of the disinfectant solution ....................................................................................... 136 ii OER-Elite INSTALLATION MANUAL Contents 4.21 Self disinfection and check the operation ......................................................... 145 Self-disinfection and check the operation workflow ........................................................... 146 Required items .................................................................................................................. 146 Checking the MRC level and entering the check result ..................................................... 147 Performing the self disinfection ......................................................................................... 154 When the Message 093 is displayed .............................................................................. 159 When the Message 087 is displayed .............................................................................. 160 4.22 Water line disinfection ......................................................................................... 162 Disinfection of water supply piping workflow ..................................................................... 164 Required items .................................................................................................................. 164 Checking the MRC level and entering the check result ..................................................... 164 Disinfecting the water line .................................................................................................. 172 4.23 Checking the operation of optional accessories .............................................. 180 Checking the operation of the bar code reader (MAJ-2130) ............................................. 180 Checking the operation of the printer (MAJ-1937) ............................................................. 186 Installation Work Check Points ........................................................... 191 Installation work check points ...................................................................................... 191 OER-Elite INSTALLATION MANUAL iii Contents iv OER-Elite INSTALLATION MANUAL Labels and Symbols Labels and Symbols The meaning(s) of the symbol(s) shown on the component packaging, the back cover of this instruction manual and/or this equipment are as follows:
Symbol Description Refer to instructions. Endoscope reprocessor Manufacturer Authorized representative in the European Community Lot number Serial number Safety-related labels and symbols are attached to the equipment at the locations shown below. If labels or symbols are missing or illegible, contact Olympus. OER-Elite INSTALLATION MANUAL 1 Labels and Symbols Front panel UDI label A label required by some countries regulations regarding identification of medical device also known as Unique Device Identification (UDI). RFID marking 2 OER-Elite INSTALLATION MANUAL Labels and Symbols Inner side FRA Rotation direction indicator label Indicates the rotation direction for locking and releasing gas filter case (tank). Rating plate Shows the product model, power rating, and serial number. FRA Date of manufacture OER-Elite INSTALLATION MANUAL 3 Labels and Symbols Rear panel CSA/UL MARKING 4 OER-Elite INSTALLATION MANUAL Top panel FRA Rotation direction indicator label Indicates the rotation directions for locking and releasing gas filter case (lid). Labels and Symbols FRA FRA OER-Elite INSTALLATION MANUAL 5 Labels and Symbols Reprocessing basin Fonts displayed on the touch screen Ricoh bitmap fonts designed by RICOH Company, Ltd. are used. 6 OER-Elite INSTALLATION MANUAL Important Information Please Read Before Use Important Information Please Read Before Use Intended use The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Elite. Instruction manuals The instructions for this equipment are divided into two volumes: Instructions-Installation Manual, and Instructions-Operation Manual. Instructions regarding the preparation of endoscopes prior to placing them in the OER-Elite are found in Instructions-Operation Manual. Each of these manuals contains essential information for using this equipment safely and effectively. The Instructions-Installation Manual describes how to install the equipment. The Instructions-Operation Manual describes how to operate and maintain the equipment and describes modifications to the manual endoscope cleaning process that can save the user time and inconvenience, if the endoscope is going to be subsequently reprocessed using the OER-Elite. The List of Compatible Endoscopes/Connecting Tubes <OER-Elite> identifies all Olympus model endoscopes that are compatible with the OER-Elite, plus the specific connecting tube(s) required for each of these endoscope models. The descriptions in these manuals assume that all endoscopes are reprocessed in the OER-Elite using both an Olympus-validated detergent and disinfectant. Contact Olympus to obtain the list of both Olympus-validated disinfectant solutions and detergents. Before using this reprocessor, be sure to review all of the above-mentioned manuals, the safety information provided with Olympus-validated detergents and disinfectants, and the manuals for all other equipment used in the process. Always use this equipment as instructed. It might cause unexpected danger if you do not follow the installation and operation manual. Keep these and all related instruction manuals and documents in a safe and accessible location. If you have any questions or comments about any information in these manuals, contact Olympus. OER-Elite INSTALLATION MANUAL 7 Important Information Please Read Before Use Terms used in these manuals ALT Stands for Auto Leak Test. Air purge In this operation, air is fed into an endoscope channel to blow out residual fluid. This operation is usually performed automatically during a process, but it can also be activated independently. Air purge is also used to drain cleaning fluid or disinfectant solution from inside the equipment when the operation has stopped due to an error code, etc. Alcohol 70% ethyl alcohol or 70% isopropyl alcohol. Alcohol flush To assist in drying the channels after reprocessing, alcohol is flushed through the endoscope channels followed by air. This operation can be performed as the last step of the reprocessing program or as an independent operation. Automatic processing When the equipment is stopped by the operator or due to an error, it identifies its status and executes the optimum operation automatically. For example, if the device stops in the middle of the disinfection process, it terminates the disinfection process and removes the disinfectant solution. Channel blockage monitoring This function monitors the channel blockage of endoscopes suction channel due to a foreign object, etc., during a reprocessing program. Channel connectivity monitoring This function monitors the connection status of the connecting tubes during a reprocessing program. Channel monitoring Channel monitoring will be used as a generic Channel connectivity monitoring and Channel blockage monitoring. Cleaning fluid Refers to filtered water with detergent that is used during the cleaning process. Cleaning process A series of operations programmed into the equipment that enable it to perform ultrasonic cleaning and detergent cleaning of endoscopes. 8 OER-Elite INSTALLATION MANUAL Important Information Please Read Before Use Detergent Olympus-validated detergent. Refer to Section 2.8, Consumable accessories (Optional) for details. Disinfectant solution Olympus-validated disinfectant solution. Refer to Section 2.8, Consumable accessories
(Optional) for details. Disinfection process A series of operations programmed into the equipment that enable it to perform disinfection of endoscopes. Error code A code consisting of [E] and a three-digit number. This code is displayed on the touch screen if there is a problem with the equipment. When an error code is displayed, check the troubleshooting guide. LCG Stands for Liquid Chemical Germicide. It refers to disinfectant solution displayed on GUI. Leak test A test to confirm that an endoscope is free of leaks. This equipment is capable of both the auto leak test and the manual leak test. Manual cleaning Cleaning of an endoscope by hand. Modified precleaning and manual cleaning A precleaning and manual cleaning method that simplified due to subsequent use of the OER-Elite which automates cleaning steps in the process. MRC Stands for Minimum Recommended Concentration. Patient ID Identify information specific to each patient. It can be recorded in the histories of reprocessing, etc. For the patient ID input method, refer to Section 3.6, Entering ID in Instructions-Operation manual. Physician ID Identity information specific to each endoscopist. It can be recorded in the histories of reprocessing, etc. For the physician ID input method, refer to Section 3.6, Entering ID in Instructions-Operation manual. OER-Elite INSTALLATION MANUAL 9 Important Information Please Read Before Use Portable memory A digital medium for storage. Precleaning Cleaning of an endoscope performed after each procedure at the bedside of the endoscopy room. Procedure ID Identify information specific to each procedure of the patient. It can be recorded in the histories of reprocessing, etc. For the procedure ID input method, refer to Section 3.6, Entering ID in Instructions-Operation manual. Process Generic term for any operation, including cleaning and disinfection that is performed automatically by this equipment. Reprocessing process A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush of the outer surface or channels of endoscopes that run in a specified sequence and for a specified time. Reprocessing programs [1] to [4] can be selected by the user. Programs [1] to [4] have a fixed cleaning process time and disinfection process time. They also have different patterns of auto leak test and channel monitoring respectively. Scope ID Identity information specific to each endoscope. It can be recorded in the histories of reprocessing, etc. For the scope ID input method, refer to Section 3.6, Entering ID in Instructions-Operation manual. Shelf life The date of expiration of the effectiveness of a detergent or disinfectant before it is opened. Test strip Device used to test if the concentration of disinfectant solution is effective for disinfection. Refer to Section 2.8, Consumable accessories (Optional) for details. (i.e., the minimum recommended concentration (MRC) specified by the disinfectant manufacturer) User ID Identity information specific to each reprocessing operator. It can be recorded in the histories of reprocessing, etc. For the user ID input method, refer to Section 3.6, Entering ID in Instructions-Operation manual. 10 OER-Elite INSTALLATION MANUAL Important Information Please Read Before Use Ensuring the safety of reprocessing personnel
Disinfectant solution may irritate the mucous membranes in the eyes and respiratory organs. If disinfectant solution contacts directly on the skin, it may cause irritation or damage. Therefore, before handling high-level disinfectant solution, and detergent, carefully read the instructions for use and the material safety data sheet. For further details, contact Olympus.
During reprocessing, wear appropriate personal protective equipment to prevent contact with or inhalation of infectious substances or disinfectant. Personal protective equipment includes eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged.
When using disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this equipment in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person performing the inspection or maintenance exhibits an allergic reaction or symptoms no matter how slight they should discontinue the task and vacate the room.
Before handling the detergent or disinfectant, read the MSDS (material safety data sheets) and learn what measures to take in the event of exposure.
Operators who exhibit symptoms of an allergic reaction or sensitivity to the reprocessing chemicals should not operate this equipment.
This equipment can be set up to use the RFID (Radio Frequency Identification) function. Be aware that the radio waves emitted from the RFID reader of the equipment may cause medical devices such as pacemakers to malfunction. If any interference with the equipment is observed, immediately move away from the RFID reader or set the power switch to OFF. Call your doctor if you do not begin to feel better. OER-Elite INSTALLATION MANUAL 11 Important Information Please Read Before Use Equipment compatibility Use this equipment in combination with ancillary equipment listed in System chart in Instructions-Operation Manual. Using incompatible equipment may interfere with the proper operation of this equipment and could lead to personal injury and/or equipment damage. Olympus has not tested the efficacy of cleaning and high-level disinfection on this equipment in combination with endoscopes that are not listed on the List of compatible Endoscopes/Connecting Tubes <OER-Elite>. Signal words The following signal words are used throughout these manuals:
WARNING CAUTION Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. NOTE Indicates additional helpful information. Warnings and cautions Follow the warnings and cautions given below when handling this equipment. This information is supplemented by warnings given in each chapter. WARNING
Do not insert an EndoTherapy accessory or other object through an opening including the air vent of the equipment. Also, do not allow any liquid (including water or disinfectant solution) to flow into an opening. Contact with an electrical part inside the equipment could cause an electric shock or equipment failure.
Always remove the tank from the detergent/alcohol drawer before putting detergent or alcohol in the tank. If detergent or alcohol is spilled on the detergent/alcohol drawer, it could get inside the equipment and contact an electrical part inside, causing an electric shock or fire hazard. 12 OER-Elite INSTALLATION MANUAL Important Information Please Read Before Use WARNING
Do not install this equipment in any place where any of the following are present.
High oxygen concentration
Oxidizing substance such as Nitrous Oxide (N2O)
Flammable anesthetic gas This equipment is not explosion-proof and may explode or cause a fire under these conditions.
Always use the power cord provided with this equipment. Otherwise, equipment failure or power cord burnout may result. Also, remember that the provided power cord is for use only with this equipment and should not be used with any other equipment. CAUTION
Do not press any of the switches on the control panel of this equipment with a pointed or hard object. Otherwise, the switch may be damaged.
Be sure to turn off the water faucet and the power switch of the equipment at the end of the day to avoid potential water leaks.
To avoid malfunctions, do not use this equipment in a dusty environment.
To avoid electromagnetic interference from other equipment, do not install any other electrical devices in close proximity to this equipment (aside from ancillary devices used with this equipment).
This equipment enables radio communication by RFID and emits RF (radio frequency:13.56MHz) energy to perform the said intended Functions. It may cause electromagnetic interference in nearby electronic equipment, and is labeled with the symbol below. If electromagnetic interference occurs, mitigation measures may be necessary, such as moving the electronic equipment away, reorienting or relocating this instrument, or shielding the location. An electromagnetic interference with other devices may shorten the communications distance of the designated ID tag and cause signals to become unreadable. Try to take mitigation measures such as keeping the affecting device away from this equipment. OER-Elite INSTALLATION MANUAL 13 Outline of Functions Outline of Functions Following functions are available in this device. Reprocessing A series of operations that enable the equipment to perform ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush. A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush of the outer surface and channels of endoscopes in a specified sequence and for a specified time. Reprocessing programs [1] to [4] can be selected by the user. Programs [1] to [4] have a fixed cleaning process time and disinfection process time. They also have different patterns of auto leak test and channel monitoring respectively. For details, refer to Chapter 6, Reprocessing Operations in Instructions-Operation manual. Drain LCG This function drains the disinfectant solution from the disinfectant tank. For details, refer to Section 8.2, Replacing the disinfectant solution in Instructions-Operation manual. Load LCG This function loads the disinfectant solution by setting a new disinfectant bottle. For details, refer to Section 8.2, Replacing the disinfectant solution in Instructions-Operation manual. Heat LCG A process for heating disinfectant solution until it reaches the specified temperature. This process is performed automatically during the reprocessing program. It can also be performed as an independent operation. For details, refer to Section 7.2, Heat LCG in Instructions-Operation manual. Heat LCG Timer The function for heating the disinfectant solution until the specified temperature by the specified time. For details, refer to Section 7.3, Heat LCG Timer in Instructions-Operation manual. Mix LCG This function is mixing the disinfectant solution to the appropriate concentration concentration and enables accurate concentration check. 14 OER-Elite INSTALLATION MANUAL Outline of Functions Water line disinfection This function disinfects the water supply line and other lines inside the equipment. For details, refer to Section 7.7, Water line disinfection in Instructions-Operation manual. Self disinfection and water sampling This function disinfects the basin and internal piping of the equipment. At the end of the process, sampling of rinse water can be performed for microbiological surveillance. For details, refer to Section 7.8, Self-disinfection and water sampling in Instructions-Operation manual. Detergent/Alcohol line disinfection This function disinfects the detergent line and alcohol line of the equipment. For details, refer to Section 7.9, Detergent line disinfection in Instructions-Operation manual and Section 7.10, Alcohol line disinfection in Instructions-Operation manual. Auto leak test The endoscope leak test can be executed automatically by programming it in a user-configured reprocessing process. It can also be performed as an independent operation. For details, refer to Section 7.12, Auto leak test in Instructions-Operation manual. Manual leak test Manual inspection for endoscope leakage during immersion of water can be performed as an independent operation. For details, refer to Section 7.11, Manual leak test in Instructions-Operation manual. Alcohol flush To assist in drying the channel after reprocessing, alcohol is flushed through the endoscope channels followed by air. This function performs alcohol flush into the endoscope channels. The alcohol flush can be executed automatically in a reprocessing process. It can also be performed as an independent operation. For details, refer to Section 7.14, Alcohol flush in Instructions-Operation manual. Air purge This function drains the remaining fluid from the basin after an irregularity occurs, or if the process is stopped before it completes. Air purge also eliminates residual fluid from the endoscope channels. For details, refer to Section 7.6, Air purge in Instructions-Operation manual. OER-Elite INSTALLATION MANUAL 15 Outline of Functions Rinse This function performs the rinsing process if the fluid remains in the basin or in the endoscopes after an irregularity occurs or the process is stopped midway. For details, refer to Section 7.5, Rinse in Instructions-Operation manual. Leaking scope decontamination This function decontaminates a leaking endoscope prior to repair. During the decontamination, positive pressure is applied to the leaking endoscope to avoid fluid invasion and damage to the endoscope. For details, refer to Section 7.15, Leaking scope decontamination in Instructions-Operation manual. ALT self-check This function diagnoses the auto leak test function of the device. It is performed automatically at the end of Load LCG function or as an independent operation. For details, refer to Section 7.13, Self-check of auto leak test in Instructions-Operation manual. 16 OER-Elite INSTALLATION MANUAL 1.1 Checking the package contents Chapter 1 Checking the Package Contents 1.1 Checking the package contents Ch.1 Check that the package contains all the items listed below. Inspect each item for damage. If the device is damaged, a component is missing, or there is any question regarding items, do not use the device and contact Olympus immediately. Endoscope reprocessor Accessories for use in installation Endoscope reprocessor OER-Elite Buckling guard (GT970400) Buckling guard retaining screw
(GC783700, 2 pcs) Grommet (GC784100, 4 pcs) Wrench (GC748400) Drain hose (GJ853400) Water supply hose (GC416500) Power cord (RL545000) Water supply plug (GN573800) OER-Elite INSTALLATION MANUAL 17 1.1 Checking the package contents Accessories for use in reprocessing Ch.1 Connecting tube (MAJ-2110, 2 pcs) Connecting tube (MAJ-2111, 2 pcs) Connecting tube (MAJ-2112, 2 pcs) Connecting tube (MAJ-2113, 2 pcs) Leak test air tube
(MAJ-2127, 2 pcs) Accessories to be attached to the equipment Gas filter case (GJ460700) Gas filter (2 pcs) (MAJ-822) Gas filter adapter (splash guard)
(GC949900) Washing case (MAJ-2121) Air filter (MAJ-823) Water filter (MAJ-824 or MAJ-2318) Stylus pen holder (RA016500) Hex wrench (GT804300) M4 10 mm cap bolt (2 pcs) Stylus pen (GT944200) 18 OER-Elite INSTALLATION MANUAL 1.1 Checking the package contents Accessories preattached to the equipment Alcohol tank (RU715000) Circulation port mesh filter
(GC574000 and GC693900) Ch.1 Retaining rack (GT943000) Detergent/alcohol inner tray
(GT647800) Drain port mesh filter
(GC220100) Gas filter case (GJ460700) Water tray (GT949200) Accessories for use in maintenance Syringe (GT173600) Tube (GC651300) Disinfectant collection hose
(GJ668000) Disinfectant removal tube
(GJ460200) Filter tube (GJ460500, 2 pcs) Water filter wrench (GC601300) Drain connector (GL366300) Connector jig (RU726500) Spare fuse (DB181500, 2 pcs) Water supply piping disinfection hose (RU205800) Card holder (GT271000, 2 pcs) OER-Elite INSTALLATION MANUAL 19 1.1 Checking the package contents Scope ID master card (GT970700) User ID master card (GT970600) Accessory for use in record management Ch.1 Portable memory (MAJ-1925) Manuals Instructions-Installation Manual
(this manual) Instructions-Operation Manual OER-Elite Quick Reference Guide OER-Elite Operation Guide 20 OER-Elite INSTALLATION MANUAL List of Compatible Endoscopes/Connecting Tubes
<OER-Elite>
2.1 Front panel Ch.2 Chapter 2 Nomenclature and Functions 2.1 Front panel 11 10 9 8 7 6 No. 1 2 3 Nomenclature Power switch Power indicator Disinfectant bottle drawer 4 5 Disinfectant bottle drawer check windows Casters 1 2 3 4 5 Description Press to turn the equipment ON or OFF. Lights up when the equipment is ON. Accommodates disinfectant cassette bottles. This door can be opened when the load LCG function is started. Check an inside of bottles in the disinfectant bottle drawer. The two front casters have lock mechanisms. The caster heights can be adjusted to level the equipment. Step to open the lid. It is locked during the reprocessing process. Push the area marked PUSH to open. Checks the amount of alcohol remaining. Foot pedal Front door Alcohol tank check window Detergent tank check window Checks the amount of detergent remaining. 6 7 8 9 10 Detergent/alcohol drawer Accommodates the specially designed tanks of detergent for cleaning and alcohol for alcohol flush. Insert the portable memory into this port. 11 Portable memory port OER-Elite INSTALLATION MANUAL 21 2.2 Top panel 2.2 Top panel Ch.2 7 6 5 1 2 3 4 Nomenclature No. 1 Water supply hose 2 Water supply hose Description Supplies water for use in cleaning. Connect the water supply hose. A mesh filter is built in this connector. 3 4 5 6 7 connector Lid Control panel RFID reader Gas filter case (lid) Ventilation openings on the gas filter case Step on the foot pedal to open the lid. Used for various setup and operation. Refer to Section 2.7, Control panel. Reads RFID tag for user ID, scope ID, and physician ID. Accommodates the gas filter for removing the odor and vapor of the disinfectant solution. This is the hole for taking and exhausting air into/from the reprocessing basin. Do not block the ventilation openings on the gas filter case. 22 OER-Elite INSTALLATION MANUAL 2.3 Inside Ch.2 4 2.3 Inside 11 10 9 8 7 1 2 3 6 5 No. 1 Nomenclature Gas filter case (tank) 2 3 4 5 Ventilation opening on the gas filter case Disinfectant solution tank window Accessory holder Disinfectant removal port 6 Maintenance terminal 7 Water tray 8 9 Air filter Connector below water filter housing Description Accommodates the gas filter for removing the odor and vapor of the disinfectant solution. This is the hole for taking and exhausting air into/from the disinfectant solution tank. Do not block the ventilation openings on the gas filter cases. Used to check the amount of remaining disinfectant solution. Used to store the connecting tubes, etc. Used to remove the residual disinfectant solution in the tank by using the disinfectant removal tube. It is also used to withdraw the amount of disinfectant solution by using the drain connector for detergent/alcohol piping disinfection.
(Remove the rubber cap and attach the drain connector or the disinfectant removal tube.) Used for connecting ancillary equipment (for trained service personnel only). Collects water during maintenance such as the water filter replacement. Accommodates the 0.2-micron air filter. For use in draining water from the water filter housing. 10 Water filter (housing) 11 Connector above water Accommodates the 0.2-micron internal water filter. For use in draining water and air from the water filter housing. filter housing OER-Elite INSTALLATION MANUAL 23 2.4 Rear panel 2.4 Rear panel 1 2 3 4 Ch.2 7 8 6 5 No. 1 Nomenclature Printer outlet Bar code reader port Fuse (BOX) Power cord receptacle 100BASE-TX terminal 2 3 4 5 6 7 8 Description Connect the power cord of the printer (MAJ-1937) provided with the optional printer set (MAJ-2144) to feed power to it. Do not connect any devices other than the specified printer. Connect the optional bar code reader (MAJ-2130). Do not connect any devices other than the specified bar code reader. Protects the equipment from an over-current. Connect the power cord. Used to access the Olympus-designated external devices (for trained service personnel only). Printer communication port Connects the printer (MAJ-1937) provided with the optional printer set Buckling guard attaching holes Drain hose connector
(MAJ-2144). Do not connect any devices other than the specified printer. Screw holes used to attach the buckling guard. Connect the drain hose. 24 OER-Elite INSTALLATION MANUAL 2.5 Side panel Ch.2 2.5 Side panel 1 2 3 4 5 Left Right No. 1 2 3 4 5 Nomenclature Description Bar code reader attaching holes Printer set attaching holes Used to attach the optional printer set (MAJ-2144). The connector hanger cannot Used to attach the optional bar code reader (MAJ-2130). Stylus pen holder attaching holes Connector hanger attaching holes Grommet attaching holes
(4) be attached if the printer set is already attached. Used to attach the provided stylus pen holder. Used to attach the optional connector hanger (MAJ-865). The printer set cannot be attached if the connector hanger is already attached. Used to attach the grommets. OER-Elite INSTALLATION MANUAL 25 2.6 Reprocessing basin 2.6 Reprocessing basin 1 2 3 4 Ch.2 22 19 21 20 18 17 16 15 14 13 5 6 7 8 9 10 11 12 23 26 OER-Elite INSTALLATION MANUAL 2.6 Reprocessing basin No. 1 Nomenclature Description Connector A2 (Light blue) Connect a connecting tube colored light blue. Connector B2 (Blue) Connector B1 (Blue) This connector is mainly used for second endoscope. Connect a connecting tube colored blue. This connector is mainly used for second endoscope. Connect a connecting tube colored blue. This connector is mainly used for first endoscope. Connector A1 (Light blue) Connect a connecting tube colored light blue. 2 3 4 5 6 7 8 9 Connector D2 (Orange) Connector C2 (Green) Connector C1 (Green) Connector D1 (Orange) Circulation port 10 Drain port 11 Leak test connector E2
(Purple) Leak test connector E1
(Purple) 12 13 Washing case mount 14 Temperature sensor 15 Water supply piping disinfection connector Fluid level sensor 16 17 Disinfectant solution nozzle 18 Float switch (long) 19 Detergent nozzle 20 Float switch (short) 21 Circulation nozzle 22 Water supply/circulation nozzle 23 Water level scale ( 3) Ch.2 This connector is mainly used for first endoscope. Connect a connecting tube colored orange. This connector is mainly used for second endoscope. Connect a connecting tube colored green. This connector is mainly used for second endoscope. Connect a connecting tube colored green. This connector is mainly used for first endoscope. Connect a connecting tube colored orange. This connector is mainly used for first endoscope. Aspirates the cleaning fluid or disinfectant solution for circulation during cleaning or disinfection. Drains liquid from the reprocessing basin. Connect the leak test air tube that is connected to the second endoscope here. Connect the leak test air tube that is connected to the first endoscope here. Mount for the Washing case that is used to hold the endoscope accessories including valves for reprocessing. Monitor the temperature of the fluid in the reprocessing basin. Connect the water supply piping disinfection hose here. Detects abnormal fluid level in the reprocessing basin. Supplies disinfectant solution to the reprocessing basin. Also, used to check if the disinfectant concentration meets the recommended level by the disinfectant manufacturer.(Open the cap and insert the chemical indicator (test strip).) Detects the fluid level in the reprocessing basin to control it. Supplies detergent to the reprocessing basin. Detects the fluid level in the reprocessing basin to control it. Supplies the cleaning fluid or disinfectant solution aspirated through the circulation port for circulation. Supplies water for cleaning. Also, supplies the cleaning fluid or disinfectant solution aspirated through the circulation port for circulation. Marks for confirming that the equipment is level. OER-Elite INSTALLATION MANUAL 27 2.7 Control panels 2.7 Control panels Ch.2 1 2 No. 1 Nomenclature Touch screen 2 3 4 5 Heat LCG Timer indicator Heat LCG Timer button Stop button Start button 3 4 5 Description Used to control and set the equipment. Also, the information and state of the equipment can be displayed. The indicator lights when the Heat LCG Timer is in progress. Press this button to active the Heat LCG Timer. Press this button to stop process. Press this button to start process. 28 OER-Elite INSTALLATION MANUAL 2.7 Control panels Touch screen Menu Screen The menu consists of six buttons according to the classification of the equipments Functions into six categories. Select the desired category here. 1 3 5 2 4 6 Ch.2 No. 1 Name Reprocessing 2 3 4 5 6 Log Functions Settings Replacement of Consumable Items Information NOTE Description Press this button to display the Reprocessing Standby screen. oRefer to Section 6.5, Basic operation for reprocessing in Instructions-Operation manual. Press this button to go to Log menu. oRefer to Section 11.1, Log menu in Instructions-Operation manual. Press this button to go to Function menu. oRefer to Section 7.1, Function menu in Instructions-Operation manual. Press this button to go to Setting menu. oRefer to Section 4.1, Setting menu in Instructions-Operation manual. Press this button to go to Replacement of Consumable Items menu. oRefer to Section 8.1, Replacement of consumable items menu in Instructions-Operation manual. Press this button to go to Information menu. oRefer to Chapter 12, Information Menu Screen in Instructions-Operation manual. The operational buttons are expressed by a box with gradation. Figure 2.1 OER-Elite INSTALLATION MANUAL 29 2.7 Control panels Touch screen Reprocessing standby screen Select the program by pressing the program selection buttons. 1 2 3 4 5 6 1 2 3 4 5 6 7 8 Ch.2 7 8 9 10 11 9 10 11 12 13 14 12 13 14 Description Nomenclature Scope 1 button No. 1 2 Model number of 3 6 7 8 9 Goes to the ID information screen associated with the first endoscope. Displays the model number of the first endoscope. It is blank when the Scope ID is not entered. scope 1 ID status of scope 1 Displays the input status of patient ID, physician ID, user ID, and procedure ID Scope 2 button 4 5 Model number of associated with the first scope. Goes to the ID information screen associated with the second endoscope. Displays the model number of the second endoscope. It is blank when the Scope ID is not entered. scope 2 ID status of scope 2 Displays the input status of patient ID, physician ID, user ID, and procedure ID Program selection button Program number display Process time associated with the second scope. Press these buttons to select the reprocessing program. Displays the selected reprocessing program number. For details of the reprocessing program number, refer to Reprocessing Program on the next page. Displays the process time of the selected reprocessing program. If the scope ID is inputed with one of the following four methods, the reprocessing time of programs extend 3 minutes.
The scope ID of the endoscope with forceps elevator
The scope ID master card
Input from the software keyboard
Recalling the pre-registerd ID 10 Alcohol flush indicator 11 Heat LCG indicator 12 Menu button 13 LCG Info. button Indicate that the Alcohol Flush is incorporated in the reprocessing program. Alcohol flush cannot be eliminated from the reprocessing process. Indicate that the Heat LCG is incorporated in the reprocessing program. Heat LCG cannot be eliminated from the reprocessing process. Returns to the Menu screen, Goes to the LCG info. screen. 30 OER-Elite INSTALLATION MANUAL 2.7 Control panels No. Nomenclature 14 MRC Check Result button Goes to the MRC Check Result entry screen. Description 1 3 Ch.2 2 4 No. 1 Nomenclature Program information Cln. Dis. Channel Monitor indicator Auto Leak Test indicator 2 3 4 Display LCG Info. Button LCG information LCG Cycle Count LCG Usage LCG Temp MRC Check Result Display Program Info. button Description Displays information about the selected reprocessing program. Displays the cleaning time Displays the disinfecting time. If PCM is displayed, channel monitor is executed in the cleaning and disinfection process. If FCM is displayed, channel monitor is executed in the cleaning, disinfection and rinsing process. If ALT ON is displayed, auto leak test is incorporated in the reprocessing process. If ALT OFF is displayed, auto leak test is not incorporated in the reprocessing process. Press to display the disinfectant solution information on the area of No.1. Refer to No.3. Displays information about the current disinfectant solution. Usage count of the disinfectant solution. Number of days that have elapsed since preparation of the disinfectant solution. Temperature of disinfectant solution during reprocessing process. Input result of MRC check. Press to display the information of the selected reprocessing program on the area of No.3. Refer to No.1. OER-Elite INSTALLATION MANUAL 31 2.7 Control panels Touch screen Reprocessing process screen 1 2 3 4 5 6 Ch.2 7 8 9 10 11 Nomenclature No. 1 2 Model number of scope 1 Scope 1 button type ID status of scope 1 Scope 2 button 3 4 12 13 14 15 Description Press this button to display the ID information associated with first endoscope. Displays the model number of the first endoscope. It is blank when the scope ID is not entered. Displays the input status of patient ID, physician ID, user ID, and procedure ID associated with the first endoscope. Press this button to display the ID information associated with the second endoscope. 5 Model number of scope 2 Displays the model number of the second endoscope. It is blank when the scope 6 ID status of scope 2 ID is not entered. Displays the input status of patient ID, physician ID, user ID, and procedure ID associated with the second endoscope. Displays the selected reprocessing program number. Displays the remaining time of a reprocessing process. Displays progress of the reprocessing process. Displays the process being executed. Displays the temperature of fluid in the reprocessing basin. During the reprocessing process, it cannot be operated with this button. Press this button to display the LCG Info. screen. Program number 7 Remaining time 8 9 Process progress bar 10 Current process name Temperature 11 12 Menu button 13 14 MRC Check Result button During the reprocessing process, it cannot be operated with this button. 15 Press this button to display the reprocessing program information about the selected reprocessing program. LCG Info./Program information button LCG Info. button 32 OER-Elite INSTALLATION MANUAL 2.8 Consumable accessories (Optional) 2.8 Consumable accessories (Optional) Water filter (MAJ-824 or MAJ-2318) WARNING Before using consumable items, be sure to check its expiration date instructed in the labeling of consumable items. If these items are expired, effectiveness of items may be compromised. Ch.2 Internal 0.2 micron water filter. Figure 2.2 Gas filters (MAJ-822) Figure 2.3 Incorporated in the gas filter cases to absorb disinfectant odors and vapors. OER-Elite INSTALLATION MANUAL 33 2.8 Consumable accessories (Optional) Air filter (MAJ-823) Filters microorganisms and fine particles in the air fed into the equipment. Ch.2 Figure 2.4 Olympus-validated detergent Figure 2.5 Name Type EndoQuick Alkaline detergent Manufacturer Best Sanitizers, Inc
(154 Mullen Drive, Walton, KY) Remarks 2.8 L disposable tank for use in OER-Elite Table 2.1 NOTE EndoQuick is distributed by Olympus America, Inc. To obtain EndoQuick listed above, contact Olympus. 34 OER-Elite INSTALLATION MANUAL 2.8 Consumable accessories (Optional) Olympus-validated concentrated disinfectant solution
(1,065 ml cassette bottles) Ch.2 Figure 2.6 Name Type Acecide-C Peracetic Acid
(PAA) Manufacturer Best Sanitizers, Inc. (154 Mullen Drive, Walton, KY) Remarks 1,065 ml cassette bottles For use in OER-Elite 510(k) number K091210 Table 2.2 NOTE Acecide-C is distributed by Olympus America, Inc. To obtain Acecide-C listed above, contact Olympus. OER-Elite INSTALLATION MANUAL 35 2.8 Consumable accessories (Optional) Chemical indicator (test strip) Ch.2 Figure 2.7 FDA-cleared Chemical indicator (test strip) used to determine if Olympus-validated disinfectant meets the minimum recommended concentration. Name Manufacturer 510(k) number ACECIDE test strips Best Sanitizers, Inc. (154 Mullen Drive, Walton, KY) K091210 Table 2.3 NOTE ACECIDE test strips is distributed by Olympus America, Inc. To obtain ACECIDE test strips listed above, contact Olympus. 36 OER-Elite INSTALLATION MANUAL 3.1 Installation of accessories workflow below Chapter 3 Installation of Accessories Set up the equipment and ancillary equipment as required while referring to the System chart in the Instructions-Operation Manual. Also, refer to the instruction manual for the ancillary equipment and follow the instructions below to install and connect the equipment and ancillary equipment. 3.1 Installation of accessories workflow below See the installation of accessories workflow below. Ch.3 1 Install the grommets. 2 Install the bucking guard. 3 Inspect the mesh filter. 4 Inspect the retaining rack.
Section 3.2 on page 38
Section 3.3 on page 39
Section 3.4 on page 40
Section 3.5 on page 41 5 Install the washing case (MAJ-2121).
Section 3.6 on page 42 6 Install the stylus pen holder.
Section 3.7 on page 43 7 Inspect the accessory holder.
Section 3.8 on page 44 OER-Elite INSTALLATION MANUAL 37 3.2 Installation of the grommets 8 Store other accessories.
Section 3.9 on page 44 9 Connect the optional accessories.
Install the optional bar code reader (MAJ-2130)on page 45 Install the optional printer set (MAJ-2144)on page 46 3.2 Installation of the grommets Ch.3 Insert two grommets into the grommet attaching holes on each sides of the reprocessor (four grommets in total). CAUTION Be sure to attach the grommets. Otherwise, fluid may penetrate the grommet attaching holes and cause equipment damage. Figure 3.1 38 OER-Elite INSTALLATION MANUAL 3.3 Installation of the buckling guard 3.3 Installation of the buckling guard The buckling guard helps maintain proper drainage by preventing the drain hose from being crushed if the instrument is pushed too close to a wall, etc. CAUTION Be sure to securely attach the buckling guard using the buckling guard retaining screws. If the screws are not properly attached, the buckling guard may become detached, allowing the drain hose and power cord to be pinched against the wall and causing problems such as water discharge failure. Align the holes on the buckling guard with the screw holes threaded on the rear panel and attach using the three buckling guard retaining screws. Ch.3 Bucking guard Figure 3.2 OER-Elite INSTALLATION MANUAL 39 3.4 Inspection of the mesh filters 3.4 Inspection of the mesh filters Ch.3 The mesh filters are used to prevent the penetration of debris into the equipment and endoscope channels. CAUTION
If the mesh filters have been removed, be sure to put them back in their original positions before using the equipment. If you forget to attach the mesh filters, the pump may malfunction and/or foreign objects may clog the endoscope channels including the nozzle.
After removing any of the mesh filters, be sure to reinstall them in their original locations before using the equipment. Otherwise, debris may clog the endoscope channels and nozzles or the pumps may fail. If a mesh filter is dropped or impacted in any way, ensure that it is not damaged. Damaged mesh filters may not perform adequately.
Two-type mesh filters are installed on the outer and inner sides of the circulation port. Be sure to remove, inspect, and clean both of them. 1 Step on the foot pedal to open the lid. 2 Check that the drain port mesh filter and two circulation port mesh filters are attached inside the reprocessing basin. Circulation port mesh filters Drain port mesh filter Figure 3.3 40 OER-Elite INSTALLATION MANUAL 3.5 Inspection of the retaining rack 3.5 Inspection of the retaining rack The retaining rack is used to hold the endoscopes in the specified position for reprocessing. WARNING Attach the retaining rack correctly. If the retaining rack is not attached properly, the washing case and endoscopes cannot be set properly and the endoscopes may not be adequately reprocessed. Make sure the retaining rack is attached properly to the reprocessing basin and that the ring of the retaining rack fits onto the projection on the temperature sensor. Ch.3 Temperature sensor Ring of retaining rack Figure 3.4 OER-Elite INSTALLATION MANUAL 41 3.6 Installation of the washing case (MAJ-2121) 3.6 Installation of the washing case (MAJ-2121) The washing case is used to hold the endoscope valves in the specified position for reprocessing. WARNING
Do not use the washing case if any abnormality is found with it. If an abnormal washing case is used, the reprocessing may become insufficient.
Be sure to attach the washing case properly. Otherwise, endoscope reprocessing may not be effective.
Place the washing case in the washing case holder of the retaining rack, washing case protrusion to fit on the cutout of washing case holder and ensure that it is centered on the washing case mount of the reprocessing basin. Otherwise the reprocessing may become insufficient. Ch.3 Cutout of Washing case holder Washing case holder Washing case mount Washing case mount Washing case protrusion Figure 3.5 42 OER-Elite INSTALLATION MANUAL 3.7 Installation of the stylus pen holder 3.7 Installation of the stylus pen holder The stylus pen offered is used to operate the touch screen of the OER-Elite. Required items Check Required items M4 10 mm cap bolt Hex wrench (GT804300) Stylus pen holder (RA016500) Stylus pen (GT944200) Table 3.1 Ch.3 Installing the stylus pen holder 1 Align the two holes on the stylus pen holder with the screw holes on the right side panel of the equipment and secure it with two M4 10 mm cap bolts using the provided hex wrench. 2 Place the stylus pen in to the stylus holder. Figure 3.6 OER-Elite INSTALLATION MANUAL 43 3.8 Inspecting the accessory holder 3.8 Inspecting the accessory holder Check if the accessory holder is attached securely with two screws to the inner side of the front door as shown in Figure 3.7. Check by turning the screws clockwise with your hands, and tighten them if they are loose. 3.9 Storing other accessories Ch.3 1 Accessories such as the connecting tubes can be hung on the accessory holder on the inner side of the front door. After reprocessing the accessories ensure that they are completely dry before storing them. Accessory holder Figure 3.7 2 Put the scope ID master card and user ID master card in the card holders and attach the card holder below the accessory holder on the inner side of the front door. 3 Less frequently used accessories should be dried completely and then stored together in a place not exposed to dust or direct sunlight. 44 OER-Elite INSTALLATION MANUAL 3.10 Installation of the optional accessories 3.10 Installation of the optional accessories Connection of the bar code reader (MAJ-2130) If the optional bar code reader (MAJ-2130) is connected to the equipment, the patient ID can be entered by the bar code reader. For details, refer to Entering the patient ID by the optional bar code in Section 3.6, Entering ID in Instructions-Operation Manual. To install the bar code reader (MAJ-2130), refer to Chapter 3, Installation and Connection in MAJ-2130 Instruction Manual. WARNING
Do not stare into beam. It may cause damage to the eyes.
Do not irradiate peoples eyes with beam. It may cause damage to the eyes. Ch.3 CAUTION
Do not connect any other equipment with the bar code reader port except the bar code reader itself (MAJ-2130). Otherwise, the bar codes may not be scanned correctly. Also, equipment failure or burnout may result.
The communication cable should not be sharply bent, pulled, twisted, or crushed. Cable damage can result, and bar codes may not be properly scanned. Connecting diagram Communication cable Bar code reader port Bar code reader Figure 3.8 OER-Elite INSTALLATION MANUAL 45 3.10 Installation of the optional accessories Installation of the printer set (MAJ-2144) If the optional printer set (MAJ-2144) is connected to the equipment, the history of each process can printed. For details, refer to the instruction manual Section 6.10, Printing of the reprocessing records in Instructions-Operation Manual. To install the printer set (MAJ-2144), refer to Chapter 3, Installation of the printer in MAJ-2144 Instruction Manual. WARNING Do not bend the AC power cord forcibly, or place heavy objectives on the AC power cord. Doing so may damage the AC power cord and cause a fire or an electric shock. If the AC power cord is damaged, discontinue using it and contact Olympus. Ch.3 CAUTION
Do not connect any other power cord and any equipment the printer power outlet except the printer (MAJ-1937) AC power cord. Connecting anything other than the specified power cord may result in failure or burnout of the equipment.
Do not connect any other cable to the printer communication port except the interface cable intended to be used with printer (MAJ-1937). Connecting except the specified cable may result in failure or burnout of the equipment.
The interface cable should not be sharply bent, pulled, twisted, or crushed. Cable damage can result, and printer may not be properly communicated. 46 OER-Elite INSTALLATION MANUAL 3.10 Installation of the optional accessories Connecting diagram Printer outlet AC power cord
(RU6517) attached to printer AC adapter
(RU6518) attached to printer Printer communication port Ch.3 Printer MAJ-1937 Interface cable Figure 3.9 OER-Elite INSTALLATION MANUAL 47 3.10 Installation of the optional accessories Ch.3 48 OER-Elite INSTALLATION MANUAL 4.1 General flow of installation of the equipment Chapter 4 Installation of Equipment 4.1 General flow of installation of the equipment Connect the water supply hose, drain hose and power cord to the equipment, and set up the required chemicals (disinfectant, detergent etc.). Be sure to clean the reprocessor before installation, since dust could accumulate on or in the machine under certain storage or transport conditions. Check that the external surface, bottom surface, and casters of the equipment are clean before installation. WARNING
Make sure to connect the power cord plug to the hospital-grade wall mains power outlet of your medical facility. Plug the power cord directly into a hospital-grade, wall mains power outlet and do not use a multiple outlet. This equipment must be grounded; otherwise, an electric shock or a fire may result. Ch.4
Do not allow the power cord plug to get wet. A wet plug could cause an electric shock.
To prevent an electric shock, do not touch the power cord plug or directly touch the power source with wet hands.
When using disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this equipment in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person operating the equipment exhibits an allergic reaction or symptoms no matter how slight they should discontinue the task they are performing and vacate the room. OER-Elite INSTALLATION MANUAL 49 4.1 General flow of installation of the equipment WARNING
Do not push the rear end of equipment against a wall after connecting the power cord plug. The power cord may break and result in an electric shock or a fire.
Make sure that the hospital-grade, wall mains power outlet of your medical facility meets the power specifications required by this unit. Insufficient capacity could result in a fire or activation of the facilitys circuit breakers, which will turn off the power to all other equipment connected to the same power source.
Use the power cord plug supplied with the equipment. Using a different power cord plug may result in equipment malfunction or power cord burnout. Additionally, do not use the supplied power cord plug on any other equipment as it is specified to be used only with this equipment. CAUTION
To prevent fluid leakage, do not attempt to extend the water supply hose and drain hoses.
To prevent fluid leakage or damage, do not bend the water supply hose and drain hose or apply external force to them.
To prevent discharge failure, cut off any excess drain hose and coil in such a manner as to prevent it from bending or kinking. Ch.4
To prevent discharge failure, always leave the drain hose tip open to the air inside the floor drain (the hose tip should not be immersed in liquid and the inside of the floor drain should be open to the air). If the water supply capacity drops below the minimum required flow rate and pressure levels, the equipment may stop with an error, the process time may be prolonged. When the water supply capacity pressure and flow rate is low, improve the water supply by installing a booster pump, etc. If the water supply pressure (shut-off pressure) exceeds 0.5 MPa, contact Olympus to request pressure reducing materials.
Do not supply water with a temperature over 28qC (82qF), as this can cause the equipment or endoscope to deteriorate.
Although the reprocessor incorporates a water filter, it may still fail or the water filter use life may be reduced if the water contains a large amount of debris and sediment. If this is the case, contact Olympus to have a strainer installed in the water supply piping. 50 OER-Elite INSTALLATION MANUAL 4.1 General flow of installation of the equipment CAUTION
The disinfectant solutions waste fluid should be treated in accordance with the instructions supplied with the disinfectant solution. It is recommended the waste fluid be treated and drained or disposed of according to local wastewater standards defined by law, or to temporarily collect and store the waste fluid and have it treated by a waste disposal firm.
Do not install the equipment in a place exposed to direct sunlight or where the temperature exceeds 40qC (104qF). Otherwise, the equipment may malfunction or the disinfectant solution may not last as long.
Do not place objects on or apply excessive force to the equipment. Doing so could damage or deform the lid.
Before installing the equipment, ventilate the room. Otherwise, the ancillary equipment may malfunction.
Do not install equipment in a way that would make it difficult to disconnect the power cord plug from the wall mains power outlet. Otherwise, power shutdown by disconnecting the power cord plug cannot be performed in case of malfunction or failure of the equipment. Ch.4
Before installing the equipment, be sure to check that the installation meets the conditions provided in Section 4.3, Installation conditions. If not, water leaks, malfunction, or failure of the equipment may result. OER-Elite INSTALLATION MANUAL 51 4.2 Installation workflow 4.2 Installation workflow See the installation workflow below. 1 Install the equipment.
Section 4.3 on page 54 2 Connect the water supply hose.
Section 4.4 on page 58 3 Connect the drain hose. Ch.4
Section 4.5 on page 60 4 Connect the power supply cord.
Section 4.6 on page 64 5 Confirm the power supply. 6 Inspect the RFID function. 7 Set the date and the time. 8 Install the gas filters. 9 Install the air filter.
Section 4.7 on page 66
Section 4.8 on page 69
Section 4.9 on page 74
Section 4.10 on page 79
Section 4.11 on page 90 10 Inspect air leakage from the air filter connectors.
Section 4.12 on page 96 52 OER-Elite INSTALLATION MANUAL 4.2 Installation workflow 11 Install the water filter. 12 Correct equipment tilt.
Section 4.14 on page 100
Section 4.15 on page 113 13 Inspect the detergent/alcohol inner tray.
Section 4.16 on page 121 14 Inspect the alcohol tank.
Section 4.17 on page 122 15 Addition of alcohol.
Section 4.18 on page 123 Ch.4 16 Install of the detergent tank.
Section 4.19 on page 126 17 Set up the disinfectant solution.
Section 4.20 on page 134 18 Check the functions.
Section 4.21 on page 145 19 Disinfect the water supply piping.
Section 4.22 on page 162 20 Check the functions of the optional accessories.
Section 4.23 on page 180 OER-Elite INSTALLATION MANUAL 53 4.3 Installation conditions 4.3 Installation conditions To ensure safe use of this equipment, be sure to observe the following conditions. Installation condition Installation location conditions Ch.4
The floor should be able to support a weight of 200 kg (440 lb) (50 kg per caster).
The provided water supply hose (3 m/9.8 ft) and drain hose (3 m/9.8 ft) should be able to reach the water faucet and floor drain.
The power cord (3.5 m/11.5 ft) should be able to reach the power outlet.
The equipment should not be exposed to direct sunlight.
The location should be clean and free of dirt or dust.
The ambient temperature should be between 10qC (50qF) and 40qC (104qF).
The elevation above sea level should not exceed 3,000 m (9,842 ft)
The equipment should be used indoors.
When using the disinfectant solution, and alcohol, Olympus recommends the use of gas filters and running this equipment in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person performing the inspection or maintenance exhibits an allergic reaction or symptoms no matter how slight they should discontinue the task and vacate the room. 54 OER-Elite INSTALLATION MANUAL 4.3 Installation conditions Water supply conditions
Potable water, softened water, or pure water can be used.
The water hardness should not exceed 400 ppm. The recommended water hardness is 150 ppm 1 or lower.
The water supply quantity at water supply/circulation nozzle on the reprocessing basin should be 6 liters per minute (1.6 gallon per minute) or more when the water faucet is fully open. The recommended water supply quantity is 18 liters per minute (4.8 gallons per minute) or more. NOTE The process time is extended if the water supply amount is lower than 18 liters per minute.
The water supply pressure should be between 0.1 and 0.5 MPa (Include water hammer).
The water temperature should be between 5qC (41qF) and 28qC (82qF).
The water should not contain rust, dirt, or other foreign matter. Ch.4
*1 The recommended value is in reference to AAMI TIR34: 2014 Water for the reprocessing of medical devices. Drain conditions
The top of the drain hose should be no higher than 60 cm. A floor drain is recommended.
The diameter of the drain piping of the facility should be 36 mm (1.4 in) or more (a 100 mm
(3.9 in) pipe is desirable).
The drain capacity of the floor drain should be 50 liters per minute (13.3 gallons per minute) or more (this capacity should be maintained until all of the fluids in the reprocessing basin are drained).
The floor drain should be connected to a waste fluid treatment or pooling facility.
The specification of drain above is for one unit of the equipment. When using more than one unit in your facility, a larger size of floor drain will be required. Power supply conditions
Power supply capacity should be enough for the equipment rating (120 V AC, 5.5 A, 60 Hz, voltage fluctuations within 10%, frequency fluctuations within 1 Hz).
The power outlet should be a hospital-grade, wall mains power outlet (3-conductor, grounded). OER-Elite INSTALLATION MANUAL 55 4.3 Installation conditions Equipment dimensions and minimum wall clearances Buckling guard Bar code reader Connector hanger Printer set 500 mm
(19.7 in) Top 42 mm
(1.6 in) 88 mm
(3.5 in) 156 mm
(6.2 in) Ch.4 Min. rear clearance 50 mm (1.9 in)
(Projection of buckling guard) 800 mm
(31.5 in) Max. projection 774 mm
(30.5 in) Power cord
(3.5 m) (11.5 ft) Top Drain hose
(3 m) (9.8 ft) Water supply hose
(3 m) (9.8 ft) 28 mm
(1.1 in) 273 mm
(10.7 in) Min. side clearances 30 mm (1.2 in)
(50 mm (1.9 in) when connector hanger is installed 120 mm (4.7 in) when bar code reader is installed 190 mm (7.1 in) when printer set is installed) 1423 to 1723 mm
(56.0 to 67.8 in) Connector hanger Bar code reader Lid 1582 mm
(62.2 in) Front 1172 mm
(46.1 in) 945 mm
(37.2 in) Right side Buckling guard Power cord connector 165 mm
(6.4 in) 92 mm
(3.6 in) Rear Drain hose connector 180 mm
(7.0 in) 67 mm
(2.6 in) Figure 4.1 56 OER-Elite INSTALLATION MANUAL 4.3 Installation conditions Checking the installation position 1 Place the equipment on a flat, level floor surface. NOTE The tilt of the equipment will be corrected in Section 4.15, Correction of equipment tilt. 2 Open the front door and press the foot pedal to open the lid. Make sure that the door and the cover do not come into contact with other equipment or with the walls. Ch.4 OER-Elite INSTALLATION MANUAL 57 4.4 Connection of the water supply hose 4.4 Connection of the water supply hose The water supply plug of this equipment is designed to be connected to an ordinary tap water faucet with 3/4 GHT (garden hose thread), or the Olympus Pre-Filter Assembly (MF01-0033PL). If a different type of the water faucet is used, have a plumber enable a safe and secure connection. 1 Make sure that there is a packing inside of the water supply plug. Packing Ch.4 Figure 4.2 2 Fit the water supply plug onto the water faucet and turn it clockwise to tighten with the provided wrench. The pitch of the thread of the water supply plug is 3/4 garden hose thread
(GHT). 3 While pushing a finger against the lock lever on the water supply socket, pull the sleeve down toward the hose and fit the socket onto the water supply plug. Release the lock lever ensuring that it hooks onto the outer ring of the plug as pictured in Figure 4.4. Figure 4.3
(2)
(3) Figure 4.4
(1) 58 OER-Elite INSTALLATION MANUAL 4.4 Connection of the water supply hose 4 After confirming that the lock lever is engaged, pull the hose lightly to make sure the connection is tight. CAUTION Figure 4.5 Connect the connection ring on the equipment end of the water supply hose to the water supply hose connection port by tightening securely. An insecure connection may lead to a risk of a water leak. Ch.4 5 Align the connection ring on the equipment end of the water supply hose with the water supply hose connector on the rear right of the reprocessing basin so the hose does not hinder the opening and shutting of the lid, and turn the connection ring clockwise to tighten. Connection ring on the equipment end 6 Open the water faucet slowly while checking to make sure that water does not leak from the hose connection area. If water leaks, close the water faucet and reconnect the water supply hose. Figure 4.6 OER-Elite INSTALLATION MANUAL 59 4.5 Connection of the drain hose 4.5 Connection of the drain hose WARNING
Do not bend the drain hose or position it in such a way that it kinks and obstructs access to the floor drain hole. Otherwise, discharge will be incomplete and the endoscope may not be properly cleaned and disinfected.
Connect the connection ring of the drain hose to the drain hose connection port on the rear (bottom right) of the equipment by tightening securely. An insecure connection may lead to a risk of a solution leak. CAUTION
Fix the other end of the drain hose firmly inside the facilitys floor drain hole. Otherwise, the drain hose may come out of the hole due to the discharge pressure resulting in fluid overflow. Install the drain hose so that its maximum height is 60 cm (23 in) or less. Otherwise, discharge failure may cause the equipment to malfunction.
Ch.4 1 Align the connection ring of the drain hose with the drain hose connector on the rear (bottom right) of the equipment and turn the ring clockwise to tighten it. 2 Insert the other end of the drain hose into the drain hole on the floor and secure it so that it does not come out of the drain hole during discharge. Figure 4.7 NOTE If the drain hose is too long, cut it to an appropriate length. 60 OER-Elite INSTALLATION MANUAL
1 | Installation Manual 2 | Users Manual | 2.86 MiB |
4.5 Connection of the drain hose Connection of drain hose (Supplementary information) NOTE
Cut the drain hose to an optimum length by considering the length when it is pulled out for maintenance. When pushing the equipment against the wall, make sure any excess section of the hose is laid horizontally on the floor. Example 1 No buckling. Ch.4 Figure 4.8
The recommended drain pipe diameter is 100 mm (3.9 in). As this can vary for different facilities, check with your facilities maintenance personnel or a plumber. Example 2 No buckling. H d 60 cm
(23 in) Figure 4.9 OER-Elite INSTALLATION MANUAL 61 4.5 Connection of the drain hose NOTE
The drain hose connection examples below are intended to show different draining concepts. When connecting the drain hose, be sure to check with your facilitys maintenance personnel or a plumber.
(1) Reserve tank + Submersible pump Air discharger Air vent 40 to 50 mm pipe is enough. Sealing Ch.4 100 mm (3.9 in) pipe is desirable. Submersible pump Figure 4.10
If you plan to exhaust air near the ceiling, the ceiling height should be 2 m or more or the air discharge pipe should be connected to the buildings air vent.
(2) Discharging air when discharging air from the floor drain opening is insufficient 100 mm (3.9 in) pipe is desirable. Sealing 2 m 100 mm (3.9 in) pipe is desirable. Figure 4.11 62 OER-Elite INSTALLATION MANUAL 4.5 Connection of the drain hose NOTE
If you plan to use the drainage line of a sink, check the following:
The pipe diameter should be 100 mm (3.9 in) or more.
A backflow prevention structure should be provided.
An air discharge should be provided.
(3) Using a sink Sink Sealing Ch.4 Figure 4.12 OER-Elite INSTALLATION MANUAL 63 4.6 Connection of the power supply 4.6 Connection of the power supply Ch.4 WARNING
Always connect the power cord plug into a grounded, hospital-grade, wall mains power outlet. Never use a multi-outlet tap. Always connect directly to a wall mains power outlet. The equipment must be grounded via the power cord plug. Connecting the equipment to anything but a grounded wall mains power outlet may cause an electric shock or a fire.
Do not allow the power cord plug to get wet. A wet plug can cause an electric shock.
To prevent an electric shock, do not touch the power cord plug with wet hands or touch the power source directly.
After connecting the power cord, do not to push the rear of the equipment against a wall. The power cord could break and cause an electric shock or a fire.
Make sure that the grounded wall mains power outlet meets the power specifications required by this unit. Insufficient capacity may result in a fire or activation of the facilitys circuit breakers, which will turn off the power to all other equipment connected to the same power line.
Always use the power cord provided with this equipment. Otherwise, equipment failure or power cord burnout could result. Also, remember that the provided power cord is for exclusive use with this equipment and should not be used with other equipment. 1 Check that the power switch of the equipment is set to OFF (When you press the power switch, you will feel a click when set to ON and no click when set to OFF). 2 Insert the power cord all the way into the connector on the rear (bottom left). 64 OER-Elite INSTALLATION MANUAL Figure 4.13 4.6 Connection of the power supply 3 Clip the marking on the power cord with the clamp. Clamp Marking Ferrite core Figure 4.14 CAUTION Properly attach the power cord to the clamp so that the ferrite core of the power cord does not touch the floor. Otherwise, the ferrite core may be caught between the equipment and floor and break when you move the equipment. Ch.4 4 Connect the power cord plug into a hospital-grade, wall mains power outlet that meets the input power conditions indicated on the rating plate. 5 Press the ON side of each of the two casters on the bottom front to lock them. Figure 4.15 Figure 4.16 OER-Elite INSTALLATION MANUAL 65 4.7 Confirmation of the power supply 4.7 Confirmation of the power supply 1 Press the power switch ON. Ch.4 2 Make sure that the power indicator lights up and the touch screen displays the Start screen as shown in following figure. Power switch Lamp Figure 4.17 Figure 4.18 If the touch screen displays nothing or the power indicator does not light up:
If the touch screen displays nothing or the power indicator does not light up, turn the power OFF, wait at least 5 seconds and turn it ON again. If the problem persists, turn the power OFF and contact Olympus. 66 OER-Elite INSTALLATION MANUAL 4.7 Confirmation of the power supply If the touch screen has no display and the power indicator does not light up:
If the touch screen has no display and the power indicator does not light up, inspect the equipment by following the procedure below. If the problem persists, turn the power OFF and contact Olympus. WARNING
Before removing the fuse holder, be sure to turn the power switch OFF and unplug the power cord from the equipment and power outlet. Otherwise, a fire or an electric shock may result.
To prevent an electric shock, do not replace the fuses with wet hands. 1 Ensure that the power cord is connected securely to the connector on the equipment and to a hospital-grade, wall mains power outlet. 2 Turn power OFF and unplug the power cord from the power outlet. 3 Unplug the power cord from the power cord receptacle on the equipment. 4 Push the tabs on the fuse holder in the directions shown and take out the fuses.
(1) Ch.4
(2)
(1) The numbers in the figure indicate the fuse box removal sequence. Figure 4.19 5 Visually confirm that neither of the two fuses is blown. WARNING Always use the fuses specified below. Otherwise, malfunction or failure of the equipment may cause a fire or an electric shock. Spare fuses: DB181500 OER-Elite INSTALLATION MANUAL 67 4.7 Confirmation of the power supply CAUTION If the power indicator does not light up even if neither fuse is blown or after both fuses are replaced, contact Olympus. Figure 4.20 6 Insert the fuse holder into the equipment until it clicks. Confirm that the fuse holder is properly installed, referring to Figure 4.21. Ch.4 The fuse holder is properly installed
(Both the top and bottom projections touch the surface of the fuse holder cavity) The fuse holder is not properly installed
(Both the top and bottom projections do not touch the surface of the fuse holder cavity) Figure 4.21 7 Connect the power cord, turn the power ON and make sure the power indicator lights up. 68 OER-Elite INSTALLATION MANUAL 4.8 Inspection of the RFID function WARNING If the power indicator does not illuminate even after the fuses have been replaced, be sure to unplug the power cord from the power outlet. Otherwise, an electric shock may result. 4.8 Inspection of the RFID function This equipment can store the scope ID, user ID, and physician ID entered by RFID in the log of each process. WARNING Be aware that the radio waves emitted from the RFID reader of the equipment may cause medical devices such as pacemakers to malfunction. If any interference with the equipment is observed, immediately move away from the RFID reader or set the power switch to OFF. Call your doctor if you do not begin to feel better. Ch.4 CAUTION Electromagnetic interference from other devices may shorten the communication distance of the designated ID tag and cause signals to become unreadable. Try to take mitigation measures such as keeping the affecting device far enough away from this equipment to eliminate this type of interference. NOTE
In the step 4 below, if the endoscope is not any of 180 series, 190 series, or endoscopes with the external ID tag, use the Scope ID master card (GT970700). If entering a user ID is not done by RFID in the reprocessing process or each function, skip the steps 6 and 7 below. If entering a physician ID is not done by RFID in the reprocessing process or each function, skip the steps 8 and 9 below. Perform the inspection procedure described below. Also, use the following procedure to check if the scope ID tag on each endoscope matches the actual scope information, if the user ID matches the actual user information, and if the physician ID matches the actual physician information. OER-Elite INSTALLATION MANUAL 69 4.8 Inspection of the RFID function 1 Press the Information button on the menu screen. 2 Press the RFID Information button. Figure 4.22 Ch.4 3 Check that the scope ID tag is attached to each scope as defined in the instruction manual for the scope ID tag. Figure 4.23 70 OER-Elite INSTALLATION MANUAL 4.8 Inspection of the RFID function 4 Hold the internal ID-type endoscope connector or the external ID tag to the ID reader section of the equipment and scan the tag with the reader until a short beep sounds. For internal ID-type endoscope
(For example 180 series endoscope) For external ID tag Ch.4 Scope ID mark For internal ID-type endoscope
(190 series endoscope 1) 1 190 series endoscopes may not be available in some areas. Figure 4.24 5 The information on the scope ID is displayed on the touch screen. Approach the scope ID mark on the endoscope connector of 190 series 1 to the RFID reader of the equipment. Figure 4.25 OER-Elite INSTALLATION MANUAL 71 4.8 Inspection of the RFID function 6 Next, hold a User ID card parallel to the ID reader and scan the card with the reader until the equipment generates a short beep. 7 The information on the User ID is displayed on touch screen. Figure 4.26 Ch.4 8 Next, hold a physician ID card parallel to the ID reader and scan the card with the reader until the equipment generates a short beep. Figure 4.27 9 The information on the physician ID is displayed the touch screen. Figure 4.28 Figure 4.29 72 OER-Elite INSTALLATION MANUAL 4.8 Inspection of the RFID function 10 Press the END button to finish the RFID data check. Figure 4.30 Ch.4 OER-Elite INSTALLATION MANUAL 73 4.9 Setting the date and time 4.9 Setting the date and time NOTE
The built-in clock may gain or lose some time during use. In this case, adjust the clock to the correct time using this function.
Before changing the date setting, print records of the past stored in equipment by using the print function.
Records are stored according to the date and time.
If there is the difference of date and time between that of equipment and that of other connected equipment, adjust the clock to the correct time using this function. Ch.4 Set the date and time on the built-in clock of the equipment. 1 Press the Settings button on the Menu screen. 2 Press the Date and Time button on the 3rd page of the Settings menu. Figure 4.31 Figure 4.32 74 OER-Elite INSTALLATION MANUAL 4.9 Setting the date and time 3 Select the date format and the time format, and then press the Next button. 1 2 3 4 No. 1 Item/Button Date Format 2 3 4 Time Format Cancel Next NOTE Setting options Year/Month/Day Month/Day/Year
(default) Day/Month/Year 12-hour clock
(default) 24-hour clock Sets the format of the date display on the touch screen. Description Ch.4 The hour is displayed in the 12-hour system, with AM for before noon or PM for the afternoon. The hour is displayed in the 24-hour system. Returns to the Setting menu without saving the edited information. Goes to the next setting. The selected settings are displayed with white buttons. OER-Elite INSTALLATION MANUAL 75 4.9 Setting the date and time 4 Check and correct the date, and then press the Next button. 1 2 3 4 5 6 Ch.4 Item/Button No. 1 Month Setting options 1 12 2 3 4 5 6 Day Year Cancel Back Next 1 31 2012 2087 NOTE Description Edit the figure of the current month. Pressing the + button increments the setting and pressing the button decrements it. Edit the figure of the current day. Pressing the + button increments the setting and pressing the button decrements it. Edit the figure of the current year. Pressing the + button increments the setting and pressing the button decrements it. Returns to the Setting menu without saving the edited information. Returns to the previous screen. Goes to the next setting. The order of year, month, and day displayed on the screen depends on the date format setting. 76 OER-Elite INSTALLATION MANUAL 4.9 Setting the date and time 5 Confirm or correct the time and press the Next button. 1 2 3 4 5 No. 1 Item/Button Hour 2 Minute 3 4 5 Cancel Back Next Setting options 0 11
(12-hour clock) 0 23
(24-hour clock) 0 59 Description Edit the figure of the current hour. Pressing the + button increments the setting and pressing the button decrements it. Ch.4 Edit the figure of the current minute. Pressing the + button increments the setting and pressing the button decrements it. Returns to the Setting menu without saving the edited information. Returns to the previous screen. Goes to the confirmation screen. OER-Elite INSTALLATION MANUAL 77 4.9 Setting the date and time 6 Confirm the date and time and press the Save button to save the corrected date and time. 1 2 3 Ch.4 No. Setting item/
Button Note 1 2 3 Cancel Back Save Returns to the Setting menu without saving the edited information. Return to the previous screen. Returns to the Setting menu after saving the edited information. 7 When the date and time setting is completed, the touch screen displays the completion message. The completion massage closes after a few seconds and the Setting menu is displayed. Figure 4.33 78 OER-Elite INSTALLATION MANUAL 4.10 Installation of the gas filters (MAJ-822) 4.10 Installation of the gas filters (MAJ-822) The gas filter cases are designed to be attached to the lid and gas filter case mount for the disinfectant tank. A gas filter (MAJ-822) should be placed in each of the two gas filter cases. WARNING
As individual reactions to the disinfectant solution may vary, Olympus recommends the use of gas filters and enhanced protection by following the recommendations on ventilation given in Ensuring the safety of reprocessing personnel on page 11.
Always be sure to attach the specified gas filter. Otherwise, the elimination of the odor and vapor of the disinfectant solution may become insufficient. CAUTION Ch.4 Do not block the ventilation openings on the gas filter cases with the replacement date indication sticker or any other label. Blocking the ventilation does not hinder the deodorization effect but may cause the equipment to malfunction. NOTE The lot number of the gas filter can be recorded in the gas filter replacement history. For changing the lot management of the gas filter, refer to Section 4.15, Filter lot number management in Instructions-Operation Manual. Required items Check Required items Gas filter (MAJ-822) 2 Table 4.1 OER-Elite INSTALLATION MANUAL 79 4.10 Installation of the gas filters (MAJ-822) Attachment of the gas filter case to the lid 1 Prepare the gas filter 2 Press the Replacement of Consumable Items button on the Menu Screen. Ch.4 3 Press the Replace Gas Filter on the Lid button. Figure 4.34 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). Figure 4.35 When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Figure 4.36 80 OER-Elite INSTALLATION MANUAL 4.10 Installation of the gas filters (MAJ-822) NOTE
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
5 Press the Next button. Figure 4.37 Ch.4 NOTE When the lot number management of the gas filter is activated, the lot number of the gas filter is entered after Step 5. For details, refer to When entering the lot number of the gas filter on page 87. 6 Unlock each gas filter case cover and open it. Ventilation opening Cover Lock Figure 4.38 NOTE The gas filters are not placed in the gas filter cases when the equipment is shipped from the factory. OER-Elite INSTALLATION MANUAL 81 4.10 Installation of the gas filters (MAJ-822) 7 Attach the gas filter adapter (splash guard) to the lid gas filter case as shown below so that the water droplets from the reprocessing basin do not penetrate. Gas filter adapter
(splash guard) Figure 4.39 8 Place a new gas filter in each gas filter case. Ch.4 Ventilation opening Figure 4.40 9 Close and lock the cover. Do not to catch the gas filter when closing the cover. 10 Insert the gas filter case designed for the reprocessing basin (the one with gas filter adapter (splash guard) attached to it) into the mount on the deep part of the lid, and then turn it all the way in the direction shown below until it is stopped. Gas filter case mount Figure 4.41 82 OER-Elite INSTALLATION MANUAL 4.10 Installation of the gas filters (MAJ-822) 11 Press the OK button. Figure 4.42 Attachment of the gas filter case to the disinfectant solution tank Ch.4 1 Prepare the gas filter. 2 Press the Replacement of Consumable Items button on the Menu Screen. 3 Press the Replace Gas Filter on the Tank button. Figure 4.43 Figure 4.44 OER-Elite INSTALLATION MANUAL 83 4.10 Installation of the gas filters (MAJ-822) 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Ch.4 Figure 4.45 NOTE
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
5 Press the Next button. Figure 4.46 NOTE When the Lot management of the water filter is activated, the lot number of the water filter is entered after Step 5. For details, refer to When entering the lot number of the gas filter on page 87. 84 OER-Elite INSTALLATION MANUAL 4.10 Installation of the gas filters (MAJ-822) 6 Unlock each gas filter case cover and open it. Ventilation opening Cover Lock Figure 4.47 NOTE
The gas filters are not placed in the gas filter cases when the equipment is shipped from the factory. Ch.4
Do not attach the gas filter adapter (splash guard) to the disinfectant solution tank gas filter case 7 Place a new gas filter in each gas filter case. Ventilation opening Figure 4.48 8 Close and lock the cover. Do not to catch the gas filter when closing the cover. OER-Elite INSTALLATION MANUAL 85 4.10 Installation of the gas filters (MAJ-822) 9 Insert the gas filter case designed for the disinfectant solution tank into the gas filter case mount at the top right of the inside of the front door, and then turn it all the way in the direction shown below until it is stopped. Gas filter case mount Figure 4.49 10 Press the OK button. Ch.4 Figure 4.50 86 OER-Elite INSTALLATION MANUAL 4.10 Installation of the gas filters (MAJ-822) When entering the lot number of the gas filter If the Lot management is activated, enter the Lot number according to the following procedure. NOTE The Lot number is printed on a label affixed to the package containing the gas filter. 1 If the filter lot number management of the gas filter (Lid and/or Tank) is active, the touch screen displays a screen as shown in following figure after Step 6 in Attachment of the gas filter case to the lid on page 81 or Step 5 in Attachment of the gas filter case to the disinfectant solution tank on page 84. Press the Next button. 2 Press the Edit button to display the lot entry screen. Figure 4.51 Ch.4 Figure 4.52 NOTE If the Delete button is pressed, the entered Lot No can be deleted. OER-Elite INSTALLATION MANUAL 87 4.10 Installation of the gas filters (MAJ-822) 3 Enter the lot number of the new gas filter by the software keyboard on the touch screen and press the Save button. Alphabet input Numeral input Ch.4 1 2 3 No. 1 2 3 4 5 6 7 8 4 5 6 1 2 3 4 5 6 7 8 7 8 Button Note Enter the alphabet or a numeral. Alphabet/Numeral key Uppercase/Lowerc ase button Numeric/Alphabetic button Back space button Press the Backspace button to delete the left character of a cursor. Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercases character s and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. When a cursor is on the leftmost, this button becomes gray and cannot be pressed. Press to the Space button to insert a space character. Space button Cursor move button Press to the cursor move button to move a cursor to left or right. Back button Save button Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 4 Press the Next button. 88 OER-Elite INSTALLATION MANUAL Figure 4.53 4.10 Installation of the gas filters (MAJ-822) 5 Check the displayed lot number and press the Next button. 6 Press the OK button. Figure 4.54 Ch.4 Figure 4.55 OER-Elite INSTALLATION MANUAL 89 4.11 Installation of the air filter (MAJ-823) 4.11 Installation of the air filter (MAJ-823) The air filter is used to remove miscellaneous bacteria and fine particles from the air. When the air filter is installed in the following procedure, the record of air filter replacements can be stored in memory. WARNING
Always be sure to attach the specified air filter. Otherwise, the air may contaminate the equipment piping and/or the scope and prevent effective reprocessing.
Replace the air filter at least every month. If the performance of the air filter drops, insufficient elimination of miscellaneous bacteria in air may cause contamination of the instrument and scopes and make the reprocessing insufficient. Ch.4 NOTE
When the air filter counter setting is activated, the filter replacement indicator can be displayed on the top right of the touch screen and on the Replace Air Filter button on the Replacement of Consumable Items menu when the counter setting value is reached.
The lot number of the air filter can be recorded in the air filter replacement history. For changing the lot management of the air filter, refer to Section 4.15, Filter lot number management in Instructions-Operation Manual. Required items Check Required items Air filter (MAJ-823) Table 4.2 90 OER-Elite INSTALLATION MANUAL 4.11 Installation of the air filter (MAJ-823) Installing the air filter 1 Prepare the air filter. 2 Press the Replacement of Consumable items button on the Menu screen. 3 Press the Replace Air Filter on the Lid button. Figure 4.56 Ch.4 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). Figure 4.57 When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Figure 4.58 OER-Elite INSTALLATION MANUAL 91 4.11 Installation of the air filter (MAJ-823) NOTE
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
5 Open the front door of the device. NOTE The air filter is not installed on the device when it is shipped from the factory. 6 With the FLOW indicator pointing upwards, attach a new air filter by fitting into the two connectors until they click. Ch.4 7 Press the Next button. Figure 4.59 NOTE Figure 4.60 When the lot management of the air filter is activated, the lot number of the air filter is entered after step 4. For details, refer to When entering the lot number of the air filter: on page 93. 92 OER-Elite INSTALLATION MANUAL 4.11 Installation of the air filter (MAJ-823) 8 Press the OK button to finish. Figure 4.61 When entering the lot number of the air filter:
If the Lot management is activated, enter the Lot number according to the following procedure. NOTE The Lot number is printed on a label affixed to the package containing the air filter. Ch.4 1 If the filter lot number management of the air filter is active, the touch screen displays a screen as shown in following figure after Step 7 in Installing the air filter on page 91. 2 Press the Edit button to display the lot entry screen. Figure 4.62 Figure 4.63 OER-Elite INSTALLATION MANUAL 93 4.11 Installation of the air filter (MAJ-823) NOTE If the Delete button is pressed, the entered Lot No can be deleted. 3 Enter the lot number of the new air filter by the software keyboard on the touch screen and press the Save button. Alphabet input Numeral input Ch.4 1 2 3 No. 1 2 3 4 5 6 7 8 4 5 6 1 2 3 4 5 6 7 8 7 8 Button Note Enter the alphabet or a numeral. Alphabet/Numeral key Uppercase/Lowerc ase button Numeric/Alphabetic button Back space button Press the Backspace button to delete the left character of a cursor. Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercases character s and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. When a cursor is on the leftmost, this button becomes gray and cannot be pressed. Press to the Space button to insert a space character. Space button Cursor move button Press to the cursor move button to move a cursor to left or right. Returns to the previous screen without saving the setting value. Back button Save button Returns to the previous screen and save the entered value. 94 OER-Elite INSTALLATION MANUAL 4.11 Installation of the air filter (MAJ-823) 4 Press the Next button. 5 Check the displayed lot number and press the Next button. Figure 4.64 Ch.4 6 Press the OK button. Figure 4.65 Figure 4.66 OER-Elite INSTALLATION MANUAL 95 4.12 Inspection of air leakage from the air filter connectors 4.12 Inspection of air leakage from the air filter connectors Check that air is not leaking from the air filter connectors. 1 Press the Functions button on the Menu screen. Ch.4 2 Press the Air Purge button. Figure 4.67 Figure 4.68 96 OER-Elite INSTALLATION MANUAL 4.12 Inspection of air leakage from the air filter connectors 3 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Figure 4.69 NOTE Ch.4
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
4 Press the Start button. 5 Open the front door of the equipment. Figure 4.70 OER-Elite INSTALLATION MANUAL 97 4.12 Inspection of air leakage from the air filter connectors 6 When air purge has started, touch the air filter connectors to ensure that air is not leaking out. Also, ensure that the connectors do not produce a whistling sound, which would mean there is an air leak. Figure 4.71 Connector Connector 7 Press the Stop button on the touch screen to end Air Purge. If an air Leak is detected, reinstall the air filter as described in refer to Replacing the air filter in Section 8.5, Replacing the air filter (MAJ-823) in Instructions-Operation Manual. 8 The touch screen displays the error code [E000]. Press the OK button repeatedly until the error screen is closed. Ch.4 Figure 4.72 98 OER-Elite INSTALLATION MANUAL 4.13 Installation of the water tray 4.13 Installation of the water tray The water tray is used to receive and hold water during maintenance such as water filter replacement. Push [PUSH] on the front door of the equipment to open the front door and place the water tray below the water filter. Figure 4.73 Ch.4 OER-Elite INSTALLATION MANUAL 99 Ch.4 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) The water filter is bacteria-retentive. When the water filter is installed in the following procedure, the record of water filter changes can be stored in memory. WARNING
Attach the water filter under clean conditions. Do not touch the inner side of the water filter. Otherwise, dust could get on it.
After replacing the water filter, be sure to perform the operation described in Section 4.22, Water line disinfection to prevent contaminating the water supply pipes. Failure to perform this operation could result in contamination of the equipment piping and/or the endoscope, preventing effective reprocessing.
Always be sure to attach the water filter. Otherwise, the water may contaminate the equipment piping and/or the endoscope and prevent effective reprocessing.
Always be sure to use the specified water filter. Otherwise, the water may contaminate the equipment piping and/or the endoscope and prevent effective reprocessing. CAUTION
Hold the water filter wrench at a point below the projection on the grip. If you hold it at a point closer to the water filter housing connector than the projection, you might catch your finger in the equipment.
After attaching the water filter, be sure to discharge air from the water filter housing completely. If air is left in the water filter housing, the process time may be extended. Check for air in the housing whenever the process time is extended or other irregularities are noticed.
Do not to drop the removed water filter housing. Otherwise, the water filter housing and/or the connector below the water filter housing case may be cracked or damaged and cause water leak.
Make sure that the O-ring at the head of the water filter housing is free of irregularities such as cracks, breaks, rips, scratches, or stains. Water leakage may result if the O-ring is not attached or is abnormal. 100 OER-Elite INSTALLATION MANUAL 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) NOTE The lot number of the water filter can be recorded in the water filter replacement history. For changing the lot management of the water filter, refer to Section 4.15, Filter lot number management in Instructions-Operation Manual. Required items Check Required items Water filter (MAJ-824 or MAJ-2318) Water filter wrench Filter tubes ( 2) Container with 2 L or larger capacity (wide-mouthed container such as a vat) Table 4.3 Ch.4 Attachment of the water filter 1 Make sure that the water faucet is open. 2 Press the Replacement of Consumable Items button on the Menu Screen. Figure 4.74 OER-Elite INSTALLATION MANUAL 101 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 3 Press the Replace Water Filter button. 4 Press the No button. Figure 4.75 Ch.4 Figure 4.76 NOTE The disinfection of water supply piping is performed in Section 4.21, Disinfection of the water supply piping. 5 Press the Next button repeatedly until the touch screen display changes as shown below. Figure 4.77 102 OER-Elite INSTALLATION MANUAL 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 6 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Figure 4.78 NOTE Ch.4
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
7 Press the Start button. Figure 4.79 NOTE When the Lot management of the water filter is activated, the lot number of the water filter is entered after Step 7. For details, refer to When entering the lot number of the water filter on page 111 OER-Elite INSTALLATION MANUAL 103 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 8 Press the Next button repeatedly until the touch screen display changes as shown below. Ch.4 Figure 4.80 Figure 4.81 NOTE If the Detail button is pressed, the details of work can be displayed on the touch screen. 9 Push the area marked PUSH on the front door to open it. NOTE Hold the water filter wrench at a point closer to you than to the projection on the grip. If you hold it at a point closer to the water filter housing connector than the projection, you might catch your finger in the mechanism. 104 OER-Elite INSTALLATION MANUAL 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 10 Insert the water filter wrench from below the water case and rotate the tool as shown below to loosen the water filter housing. Projection Figure 4.82 CAUTION Ch.4 After fully loosening the water filter housing with the attaching/detaching tool, hold it with both hands and remove it. If the case is not fully loosened, your hands may slip and you could be injured. 11 Hold the water filter housing with both hands and rotate it in the direction shown to remove it. 12 Open the bottom (the side without the O-ring) of the package containing the new water filter. Figure 4.83 OER-Elite INSTALLATION MANUAL 105 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 13 Hold the water filter housing and place the new water filter directly from the bag into the water filter housing so that its O-ring will be positioned upward. Figure 4.84 Ch.4 14 Attach and rotate the water filter housing in the direction shown to secure it temporarily. Figure 4.85 NOTE
To ensure smooth installation, it is recommended to moisten the O-ring at the head of the water filter with clean water or ethanol before securing it temporarily.
The rotation drag increases during temporary securing, but rotate the case all the way until it is stopped. 106 OER-Elite INSTALLATION MANUAL 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 15 Attach the water filter wrench and rotate it slowly in the direction shown to tighten. CAUTION Figure 4.86 Tighten the water filter case securely. Insecure tightening may lead to a risk of water leak. Ch.4 16 Remove the water filter wrench and place it in the space on the left of the water filter housing. 17 Press the Continue button. Figure 4.87 18 Prepare a container with a capacity of at least 2 L and place it in front of the equipment. Figure 4.88 OER-Elite INSTALLATION MANUAL 107 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) NOTE If the Detail Info button is pressed, the details of work can be displayed on the touch screen. 19 Put the tube-side end of the filter tube in the container, and insert the connector end of the filter tube into the connector above the water filter housing until it clicks. Do not connect anything to the connector below the water filter housing. Ch.4 CAUTION Figure 4.89 Be sure to drain air from the newly attached water filter. If air gets in the water filter housing, the process time may be extended. Air should also be drained from the water filter housing whenever there is an irregularity such as extension of the process time. 20 Press the Continue button. Figure 4.90 108 OER-Elite INSTALLATION MANUAL 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 21 When water starts to flow continuously from the filter tube, disconnect the tube by pushing its lock lever. Water flow should stop when the filter tube is disconnected. Figure 4.91 22 Check that no water Leaks from the water filter housing. If a Leak is detected, immediately press the STOP button to stop water supply and reinstall the water filter
(perform as described in Section 8.4, Replacing the water filter (MAJ-824 or MAJ-2318) in the Instructions-Operation Manual). Ch.4 NOTE When the Stop button is pressed to stop the process, error code [E000] is displayed and the auto processing is executed. 23 Press the Continue button. Figure 4.92 OER-Elite INSTALLATION MANUAL 109 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 24 Press the OK button. 25 Close the front door. 26 Rinse the filter tube with running water, dry it completely and store in a clean place. Figure 4.93 Ch.4 110 OER-Elite INSTALLATION MANUAL 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) When entering the lot number of the water filter If the Lot management is activated, enter the Lot number according to the following procedure. NOTE The Lot number is printed on a label affixed to the box containing the water filter. 1 If the filter lot number management of the water filter is active, the touch screen displays a screen as shown in following figure at Step 7 in Attachment of the water filter on page 101. Press the Next button. 2 Press the Edit button to display the lot entry screen. Figure 4.94 Ch.4 Figure 4.95 NOTE If the Delete button is pressed, the entered lot number can be deleted. OER-Elite INSTALLATION MANUAL 111 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) 3 Enter the lot number of the new water filter by the software keyboard on the touch screen and press the Save button. Alphabet input Numeral input Ch.4 1 2 3 No. 1 2 3 4 5 6 7 8 4 5 6 1 2 3 4 5 6 7 8 7 8 Button Note Enter the alphabet or a numeral. Alphabet/Numeral key Uppercase/Lowerc ase button Numeric/Alphabetic button Back space button Press the Backspace button to delete the left character of a cursor. Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercases character s and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. When a cursor is on the leftmost, this button becomes gray and cannot be pressed. Press to the Space button to insert a space character. Space button Cursor move button Press to the cursor move button to move a cursor to left or right. Back button Returns to the previous screen without saving the setting value. Returns to the previous screen and save the entered value. Save button 4 Press the Start button. Go to Step 8 in Attachment of the water filter on page 101. 112 OER-Elite INSTALLATION MANUAL Figure 4.96 4.15 Correction of equipment tilt 4.15 Correction of equipment tilt Make sure that the equipment is not tilted. If it is, correct the tilt as follows. CAUTION To prevent fluid leakage, do not use the equipment if it is not level. NOTE The Manual Leak Test function is performed to supply water to the reprocessing basin. The work instruction of this section may differ from the instruction displayed on the touch screen. 1 Make sure that the water faucet is open. 2 Make sure power is ON. 3 Close the lid. 4 Press the Functions button on the Menu screen. Ch.4 5 Press the Manual Leak Test button on the 2nd page of the functions menu screen. Figure 4.97 Figure 4.98 OER-Elite INSTALLATION MANUAL 113 4.15 Correction of equipment tilt 6 Hold the scope ID master card parallel to the RFID reader and scan the card with the reader until the equipment generates a short beep. Figure 4.99 7 Press the Next button. 8 Hold the User ID master card parallel to the RFID reader and scan the card with the reader until the equipment generates a short beep. Ch.4 Figure 4.100 NOTE
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
114 OER-Elite INSTALLATION MANUAL 4.15 Correction of equipment tilt 9 Press the Start button. Water supply to the reprocessing basin starts and the touch screen changes a screen. Figure 4.101 10 When the water supply completes, the equipment generates three buzzer beeps and unlock the lid. Open the lid within 10 minutes. Ch.4 11 Ensure that the water supply is stopped and then step on the foot pedal to open the lid. When the lid is opened, the touch screen displays the following screen. Figure 4.102 Figure 4.103 OER-Elite INSTALLATION MANUAL 115 4.15 Correction of equipment tilt NOTE
When the lid is opened, the remaining time displayed on the touch screen is reset
to 10 minutes and the countdown restarts. If the lid is not opened within 10 minutes, the fluid in the reprocessing basin is drained automatically and the manual leak test stops. The touch screen will then display the error code E092. 12 Check that the water level is located within the range of each of the three scale indicators inside the reprocessing basin. Water level Scale indicator Ch.4 Three scale indicators Figure 4.104 13 If the water level is located within all of the ranges of the three scale indicators, it is not required to correct the equipment tilt. If the water level is not located within even one of the ranges of the three scale indicators, adjust according to Adjustment if water level is not located within even one of the three ranges on page 117 and Correcting the tilt on page 118. 14 Press the Pass button. 15 Close the lid. Then the water inside the reprocessing basin is drained. Figure 4.105 116 OER-Elite INSTALLATION MANUAL 4.15 Correction of equipment tilt NOTE Even if the process is not completed by closing the lid, the water is drained automatically 10 minutes after the water supply stopped. The touch screen will then display error code [E092]. 16 When draining has completed, the equipment generates three buzzer beeps and the touchscreen shows the following screen. Press the OK button to finish. Figure 4.106 Ch.4 Adjustment if water level is not located within even one of the three ranges Required items Check Required items Container such as a cup Table 4.4 1 Check the water level. Using a cup, add or remove water until the water level reaches the scale indicator that had the largest deviation from the water level. Scale indicator Water level Water level Range Figure 4.107 OER-Elite INSTALLATION MANUAL 117 4.15 Correction of equipment tilt 2 Also, check the other scale indicators to ensure that the water level is within their respective ranges. 3 If the water level is still out of the range of the other scale indicators, the equipment may be tilted. Correct the tilt as described in Correcting the tilt on page 118 below. Figure 4.108 Correcting the tilt The tilt of the equipment can be adjusted by turning the nuts on the four casters. After correcting the tilt, push the caster lock levers down to stabilize the equipment. Ch.4 Required items Check Required items Provided wrench Table 4.5 118 OER-Elite INSTALLATION MANUAL 4.15 Correction of equipment tilt Raising the height WARNING The height is set to the lowest position at the factory. Therefore, the height cannot be reduced below the factory shipped height. The height can be raised by up to 10 mm (0.4 in). If it is raised higher, the casters may separate, causing equipment damage or injury. 1 Using the provided wrench, turn the lower nut on each caster in the direction shown in Figure 4.109 to set the desired height. Lower nut Ch.4 Figure 4.109 2 Turn the upper nut on each caster in the direction shown in Figure 4.110 to tighten. Upper nut Figure 4.110 OER-Elite INSTALLATION MANUAL 119 4.15 Correction of equipment tilt Lowering the height 1 Using the provided wrench, turn the upper nut of each caster in the direction shown in Figure 4.111 to loosen the current height setting. Upper nut Ch.4 Figure 4.111 2 Turn the lower nut on each caster in the direction shown in Figure 4.112 to set the desired height. Lower nut Figure 4.112 3 Turn the upper nut on each caster in the direction shown Figure 4.113 to tighten. Upper nut Figure 4.113 120 OER-Elite INSTALLATION MANUAL 4.16 Inspecting the detergent/alcohol inner tray 4.16 Inspecting the detergent/alcohol inner tray The detergent/alcohol inner tray is used to hold the detergent tank and alcohol tank in position so that they will not fall over. 1 Hold the section marked PULL on the detergent/alcohol drawer and pull it out. 2 Check if the detergent/alcohol inner tray is properly installed as shown in Figure 4.115. Ch.4 Figure 4.114 Detergent/
alcohol inner tray Figure 4.115 OER-Elite INSTALLATION MANUAL 121 4.17 Inspecting the alcohol tank 4.17 Inspecting the alcohol tank The alcohol tank is used to store alcohol for use during alcohol flush. CAUTION Do not install the alcohol tank unless the ventilation tube is properly secured to the side of the alcohol tank. 1 Place the alcohol tank on the detergent/alcohol drawer so that the ventilation tube sits on the front of the tray. 2 Insert the blue connector into the connector on the alcohol tank until it clicks. Ch.4 3 Rotate the connector and orientate the tube as shown in Figure 4.117. Alcohol tank Ventilation tube Figure 4.116 Connector 4 Close the detergent/alcohol drawer. Figure 4.117 122 OER-Elite INSTALLATION MANUAL 4.18 Addition of alcohol 4.18 Addition of alcohol WARNING
The alcohol used with the equipment must be 70% ethyl alcohol or 70% isopropyl alcohol. Using any other kind of alcohol may result in malfunction of the equipment or insufficient reprocessing of the endoscope, difficulty drying the endoscope, fire hazard, or a hazard due to toxic vapor emitted from the alcohol.
Alcohol is flammable and should be handled with extra care.
Drain the alcohol in the alcohol tank and replace it with new alcohol at least once a week. Otherwise, the alcohol in the tank may degrade.
Before handling alcohol, read the cautions carefully and use as instructed. Ch.4 NOTE
If alcohol flush is initiated without alcohol in the tank, the message screen Alcohol cannot be supplied will be displayed and the process will be stopped temporarily.
When the reprocessing process is performed with newly-installed equipment or with equipment after Section 9.9, Preparing the reprocessor for long-term storage in Instructions-Operation Manual is performed, the reprocessing process may stop temporarily with the message screen Alcohol cannot be supplied displayed even though there is enough alcohol in the tank. 1 Hold the section on the detergent/alcohol drawer marked PULL and pull it out. Figure 4.118 OER-Elite INSTALLATION MANUAL 123 4.18 Addition of alcohol 2 Push the lock lever on the connector of the tube connected to the cap on the alcohol tank to detach the tube. Lock lever Cap Alcohol tank Figure 4.119 3 Remove the alcohol tank and place it in a sink or other tub. 4 Turn the cap on the alcohol inlet in the direction shown in Figure 4.120 to remove it. Cap Ch.4 Alcohol inlet Figure 4.120 CAUTION
Do not add alcohol while the tank is in the detergent/alcohol drawer. If alcohol is spilled on the plate, it could damage the equipment.
Do not knock over the alcohol tank while there is still alcohol inside. Otherwise, the alcohol may spill. 5 Carefully pour the 70% ethyl alcohol or 70%
isopropyl alcohol into the alcohol tank until it is level with the line inside the tank. If any alcohol is spilled from the tank, wipe it with a clean cloth. Replace the cap on the alcohol tank, making sure that it is tight. Line Figure 4.121 124 OER-Elite INSTALLATION MANUAL 4.18 Addition of alcohol NOTE When the alcohol tank is filled to the line, it will hold about 1 L (33 ounces) of alcohol (enough for about 20 alcohol flushes). 6 Place the alcohol tank in the detergent/alcohol drawer so that the ventilation tube of the alcohol tank sits on the front of the tray. Ensure that the vent tube is properly attached to the side of the alcohol tank and then place the tank in the detergent alcohol drawer. CAUTION Placing the alcohol tank so that the ventilation tube sits on the deeper side of the tray could damage the alcohol tank. 7 Connect the tube that was originally connected to the cap. Ch.4 Alcohol tank Ventilation tube Figure 4.122 8 Turn the connector to orientate the tube as shown in Figure 4.123. Confirm that the tube is not bent. Connector 9 Close the detergent/alcohol drawer. Figure 4.123 OER-Elite INSTALLATION MANUAL 125 Ch.4 4.19 Installation of the detergent tank 4.19 Installation of the detergent tank Installation of the detergent tank as described below. When the detergent tank is installed in the following procedure, the record of the detergent tank replacements can be stored in memory. WARNING
Before handling the detergent, read the cautions and instructions for use carefully, get fully accustomed to the content, and use the detergent as instructed. Make sure that you fully understand what measures need to be taken if you get any detergent on your skin.
Always use an Olympus-validated detergent. Otherwise, the endoscopes may not be properly cleaned and as a result, the endoscopes may not achieve high-level disinfection.
When handling the detergent, always wear appropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged.
To prevent the detergent from leaking, do not tilt the detergent tank when there is detergent inside. NOTE
If detergent has run out and the message screen Detergent cannot be supplied is displayed, the equipment will stop the process. Refer to When the Message 093 is displayed on page 159.
For Olympus-validated detergents, Refer to Section 2.8 Consumable accessories
(Optional).
The detergent tank can hold about 2.8 L (95 ounces) of detergent (which can be used for approximately 30 reprocessing operations).
When the reprocessing process is performed with newly-installed equipment or with equipment after Section 9.9, Preparing the reprocessor for long-term storage in Instructions-Operation Manual is performed, the reprocessing process may stop temporarily with the message screen Detergent cannot be supplied displayed even though there is enough detergent in the tank.
The shelf-life and/or lot number of the detergent can be recorded in the detergent replacement history. For changing the shelf-life and lot management of the detergent, refer to Section 4.11, Detergent lot number and shelf-life management in Instructions-Operation Manual. 126 OER-Elite INSTALLATION MANUAL 4.19 Installation of the detergent tank Required items Check Required items Olympus-validated detergent Table 4.6 Installing the detergent tank 1 Close the lid. 2 Press the Replacement of Consumable Items button on the Menu screen. Ch.4 3 Press the Replace Detergent on the Replacement of Consumable Items menu. Figure 4.124 Figure 4.125 OER-Elite INSTALLATION MANUAL 127 4.19 Installation of the detergent tank 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). Figure 4.126 NOTE Ch.4
The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
5 Hold the section marked PULL on the detergent/alcohol drawer and pull it out. 6 Place the new detergent tank on the left side of the detergent/alcohol drawer. Figure 4.127 Detergent tank Figure 4.128 128 OER-Elite INSTALLATION MANUAL 4.19 Installation of the detergent tank 7 Remove the detergent tank cap. Cap 8 Remove the seal on the detergent tank. Figure 4.129 Ch.4 9 Attach the cap with connector to the detergent tank. Figure 4.130 Attachment Connector Figure 4.131 OER-Elite INSTALLATION MANUAL 129 4.19 Installation of the detergent tank 10 Insert the gray connector into the connector on the detergent tank until it clicks. 11 Turn the connector to correct the tube orientation as show in Figure 4.133. Confirm that the tube is not bent. Figure 4.132 Ch.4 12 Close the detergent/alcohol drawer. 13 Press the Next button. Connector Figure 4.133 NOTE Figure 4.134 If the shelf-life and lot management of the detergent are activated, the shelf-life or lot number of detergent can be entered after Step 13. For entering the shelf-life and/or lot number of the detergent, refer to When entering the shelf-life and/or lot number of the disinfectant solution: on page 142. 130 OER-Elite INSTALLATION MANUAL 4.19 Installation of the detergent tank 14 Press the OK button. Figure 4.135 When entering the lot number of detergent and shelf life:
If the lot number of detergent and Shelf life management is activated, enter the lot number and/or shelf life according to the following procedure. Ch.4 1 If the lot number management of the detergent is activated, the touch screen displays the screen as shown in following figure after Step 13 in Installing the detergent tank on page 127. If the lot number management of the detergent is inactivated, go to Step 5. 2 Press the Edit button to display the lot number entry screen. Figure 4.136 Figure 4.137 OER-Elite INSTALLATION MANUAL 131 4.19 Installation of the detergent tank 3 Enter the lot number of the new detergent by the software keyboard on the touch screen and press the Save button. Alphabet input Numeral input Ch.4 1 2 3 No. 1 2 3 4 5 6 7 8 4 5 6 1 2 3 4 5 6 7 8 7 8 Enter the alphabet or a numeral. Note Button Alphabet/
Numeral key Uppercase/
Lowercase button Numeric/
Alphabetic button Backspace button Press the Uppercase/Lowercase button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Press the Numeric/Alphabetic button to switch the input mode between a numeral and the alphabet. Press the Backspace button to delete the left character of a cursor. When a cursor is on the left edge, this button becomes gray and unavailable. Press the Space button to insert a space character. Space button Cursor move button Press the Cursor move button to move a cursor to left or right. Cancel button Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. Save button 4 Press the Next button. If the shelf-life management of the detergent is activated, go to Step 5. If the shelf-life management of the detergent is inactivated, go to Step 6. 132 OER-Elite INSTALLATION MANUAL Figure 4.138 4.19 Installation of the detergent tank 5 Enter the Expiration Date of the detergent. Press the Plus button to increase or the Minus button to decrease. Then press the Next button. 6 Check the displayed lot number and the expiration date, and press the Next button. Figure 4.139 Ch.4 7 Press the OK button. Figure 4.140 Figure 4.141 OER-Elite INSTALLATION MANUAL 133 4.20 Setup of the disinfectant solution 4.20 Setup of the disinfectant solution WARNING
Before handling the disinfectant solution, read the cautions carefully and use it as instructed. It is especially important to know what to do if the disinfectant solution comes in contact with your skin.
Always use disinfectant that has been validated by Olympus. High-level disinfectants that are not validated by Olympus for use in the OER-Elite may be unsafe and ineffective due to improper dilution, incorrect contact time and temperature, excessive foaming, inadequate rinse, and therefore may compromise patient safety. Use of a high-level disinfectant that has not been validated by Olympus may also damage internal OER-Elite components (e.g., seals, valves, etc.) and the endoscopes being reprocessed.
When handling the disinfectant solution, wear personal protective equipment to prevent any disinfectant from getting on your skin or being inhaled. Avoid direct physical contact and inhalation of vapors. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Ch.4 134 OER-Elite INSTALLATION MANUAL Ch.4 4.20 Setup of the disinfectant solution WARNING
When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this equipment in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person performing the inspection or maintenance exhibits an allergic reaction or symptoms no matter how slight they should discontinue the task and vacate the room.
Effective reprocessing cannot be guaranteed when a non-validated disinfectant solution is used. Equipment malfunction may also result.
Follow the disinfectant manufacturers instructions for any preparation or activation
required prior to loading into the OER-Elite. If the disinfectant solution in the cassette bottles has not completely drained after preparation of disinfectant solution, do not use the equipment and contact Olympus. Inappropriate preparation of disinfectant solution will prevent proper endoscope reprocessing.
Do not touch inside the caps of cassette bottles. Do not push or apply strong pressure to the bottle. Otherwise, disinfectant solution may leak from the bottle. CAUTION
To avoid malfunction, do not attempt to pull out the disinfectant bottle drawer while it is locked.
Do not put your hand into the disinfectant bottle drawer or near the cassette bottle cutters. Irritation of skin due to contact with concentrated disinfectant solution, injury by touching a projection, or malfunction of this equipment may result. OER-Elite INSTALLATION MANUAL 135 4.20 Setup of the disinfectant solution Required items Check Required items Acecide-C high level disinfectant solution Table 4.7 NOTE For Acecide-C high level disinfectant solution, refer to Section 2.8, Consumable accessories (Optional). Setup of the disinfectant solution Ch.4 CAUTION
To avoid malfunction, do not attempt to pull out the disinfectant bottle drawer while it is locked.
Do not put your hand into the disinfectant bottle drawer or near the cassette bottle cutters. Irritation of skin due to contact with concentrated disinfectant solution, injury by touching a projection, or malfunction of this equipment may result. NOTE For Acecide-C high level disinfectant solution, refer to Section 2.8, Consumable accessories (Optional). 1 Make sure that the water faucet is open. 2 Close the lid. 3 Press the Replacement of Consumable Items button on the Menu screen. 136 OER-Elite INSTALLATION MANUAL Figure 4.142 4.20 Setup of the disinfectant solution 4 Press the Load LCG button. 5 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). Figure 4.143 Ch.4 Figure 4.144 NOTE
The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
6 Press the Start button to unlock the disinfectant bottle drawer. Figure 4.145 OER-Elite INSTALLATION MANUAL 137 4.20 Setup of the disinfectant solution NOTE
The Load LCG cannot be started unless the disinfectant solution tank is empty.
If the shelf-life and/or lot management of the disinfectant solution are activated, the touch screen displays a screen as shown in following figure. For entering the shelf-life and/or lot number of the disinfectant solution, refer to When entering the shelf-life and/or lot number of the disinfectant solution: on page 142. Ch.4 Figure 4.146 7 Pull out the disinfectant bottle drawer. Cassette bottles Figure 4.147 8 To remove the empty cassette bottles from the disinfectant bottle drawer, position the bottle mouths upward so that residual disinfectant solution that might remain in the bottles does not come out. 9 If any disinfectant solution spills, wipe it away with a clean cloth. If the disinfectant bottle drawer is dirty, clean using a clean cloth moistened with neutral detergent solution and then wipe with a clean cloth. 138 OER-Elite INSTALLATION MANUAL 4.20 Setup of the disinfectant solution WARNING
Do not put your hand behind the disinfectant bottle drawer. Irritation of skin due to contact with concentrated disinfectant solution, injury by touching a projection, or malfunction of this equipment may result. If the cassette cutters are abnormal, do not use the equipment and contact Olympus. If the cassette cutters are abnormal, the disinfectant solution cannot be properly prepared. This will prevent effective endoscope reprocessing and may cause the equipment to malfunction.
10 Check the two cassette cutters (blades for ripping caps on disinfectant cassette bottles) placed at the back of the disinfectant bottle drawer. Compare the two blades and make sure that neither cutter is bent, cracked, or deformed. Changes in color are not a malfunction. Ch.4 Figure 4.148 11 Hold the new disinfectant cassette bottles together and place them on the disinfectant bottle drawer so that the bottle with the purple cap is on the right. Cassette cutters Purple cap Figure 4.149 OER-Elite INSTALLATION MANUAL 139 4.20 Setup of the disinfectant solution CAUTION When pushing in the disinfectant bottle drawer, hold the disinfectant drawer horizontally and push it all the way in. Otherwise, the disinfectant cassette bottle would be unable to be opened and the disinfectant solution would be unable to be prepared normally. 12 Lift the disinfectant bottle drawer slightly up, and insert it all the way. The buzzer should beep, the drawer should lock, and the disinfectant cassette bottles should open automatically. Ch.4 Figure 4.150 13 Look at the disinfectant bottle drawer and check the windows to verify that the disinfectant solution in both bottles has decreased. Disinfectant bottle drawer check windows Figure 4.151 140 OER-Elite INSTALLATION MANUAL 4.20 Setup of the disinfectant solution 14 The buzzer generates short beeps and the touch screen displays a screen indicating that the disinfectant solution is being prepared. NOTE Figure 4.152
Preparation of disinfectant solution includes single rinse process to rinse the reprocessing basin. While executing the preparation of disinfectant solution, buzzer beeps intermittently and the main control panel displays as shown in Figure 4.152. STOP button is deactivated during the process.
The required time for setup of disinfectant solution may vary depending on the Ch.4 water supply condition. 15 The touch screen displays the following screen. This screen indicates the process is completed. Press the OK button. Figure 4.153 OER-Elite INSTALLATION MANUAL 141 4.20 Setup of the disinfectant solution When entering the shelf-life and/or lot number of the disinfectant solution:
If the shelf-life and lot number management is activated, enter the shelf-life and/or lot number according to the following procedure. NOTE The lot number and shelf-life are printed on the bottle. 1 If the shelf-life and/or lot number management of the disinfectant solution are activated, the touch screen displays a screen as shown in following figure at Step 7 in Setup of the disinfectant solution on page 136. Press the Next button. If the lot number management of the disinfectant solution is activated, go to Step 2. If the lot number management of the disinfectant solution is inactivated, go to Step 5. Ch.4 2 Press the Edit button to display the lot entry screen. Figure 4.154 3 Enter the lot number of the disinfectant solution by the software keyboard on the touch screen and press the Save button. Figure 4.155 142 OER-Elite INSTALLATION MANUAL 4.20 Setup of the disinfectant solution Alphabet input Numeral input 1 2 3 No. 1 2 3 4 5 6 7 8 4 5 6 1 2 3 7 8 7 8 Button Note 4 5 6 Ch.4 Enter the alphabet or a numeral. Alphabet/Numeral key Uppercase/Lowerc ase button Numeric/Alphabetic button Back space button Press the Backspace button to delete the left character of a cursor. Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercases character s and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. When a cursor is on the leftmost, this button becomes gray and cannot be pressed. Press to the Space button to insert a space character. Space button Cursor move button Press to the cursor move button to move a cursor to left or right. Back button Save button Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 4 Press the Next button. If the shelf-life management of the disinfectant solution is activated, go to Step 5. If the shelf-life management of the disinfectant solution is inactivated, go to Step 6. Figure 4.156 OER-Elite INSTALLATION MANUAL 143 4.20 Setup of the disinfectant solution 5 Enter the Expiration Date of the disinfectant solution. Press the + button to increase or the button to decrease. And then press the Next button. 6 Check the displayed lot number and press the Start button. Go to Step 8 in Setup of the disinfectant solution on page 136. Figure 4.157 Ch.4 Figure 4.158 144 OER-Elite INSTALLATION MANUAL 4.21 Self disinfection and check the operation 4.21 Self disinfection and check the operation This process is to disinfect the internal lines of the equipment and check the operation of the equipment. Before reprocessing, be sure to check that the disinfectant solution has an effective concentration by using a test strip. (Refer to Section 3.7, Checking the MRC level and entering the check result in Instructions-Operation Manual.) Be sure to replace the disinfectant solution when it fails to meet the Minimum Recommended Concentration as specified by the manufacturer. WARNING
Before handling the disinfectant solution, read the cautions carefully and use as instructed. It is especially important to know what to do if the disinfectant solution comes into contact with your skin.
When handling the disinfectant solution, wear personal protective equipment to prevent any disinfectant from getting on your skin or being inhaled. To avoid adverse physical effects, do not to touch the disinfectant solution directly or to inhale too much vapor. If any disinfectant solution gets in your eyes, immediately Rinse with a large amount of fresh water and then consult a medical specialist. Personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. If an OER-Elite pipe is clogged or another malfunction occurs, it can prevent fluid from entering the endoscope channel and render the endoscope reprocessing process ineffective. Be sure to confirm the fluid jet from the connecting tube connector hits the dome of the lid.
Ch.4 CAUTION Before starting the self disinfection and check the operation, always confirm that there is no foreign material on the ventilation openings on the gas filter cases. Blocking the ventilation not only hinders deodorization but may also cause the device to malfunction. OER-Elite INSTALLATION MANUAL 145 4.21 Self disinfection and check the operation Self-disinfection and check the operation workflow 1 2 Check the MRC level.
If the concentration is below the minimum effective level, replace the disinfectant solution.
on page 164 Check the function of this equipment.
Check if the equipment operates properly to complete the Self-Disinfection.
on page 154 Required items Ch.4 Check Required items FDA-cleared chemical indicator (test strip) Connector jig User ID card Table 4.8 NOTE For the test strip, refer to Section 2.8, Consumable accessories (Optional) 146 OER-Elite INSTALLATION MANUAL 4.21 Self disinfection and check the operation Checking the MRC level and entering the check result CAUTION Do not collect the drained disinfectant solution from the disinfectant removal port to check the MRC. Otherwise, the disinfectant solution in the disinfectant solution tank would decrease, making it impossible to start the reprocessing. 1 Press the Functions button on the Menu screen. 2 Press the Self-Disinfection & Water Sampling button. Figure 4.159 Ch.4 Figure 4.160 OER-Elite INSTALLATION MANUAL 147 4.21 Self disinfection and check the operation NOTE When a touch screen displays a screen as shown in the following figure, perform the LCG Mixing. For details, refer to Mix LCG on page 152. Ch.4 3 Press the LCG Info. Button. Figure 4.161 4 Press the MRC Check button. Figure 4.162 5 Step on the foot pedal to open the lid. Figure 4.163 148 OER-Elite INSTALLATION MANUAL 4.21 Self disinfection and check the operation 6 Uncap the disinfectant solution nozzle of the reprocessing basin by turning the disinfectant solution nozzle cap in the direction shown right. Disinfectant solution nozzle cap Figure 4.164 7 Insert a test strip all the way into the disinfectant nozzle and check the concentration as described in the instruction manual for the test strip. If the concentration is below the minimum effective level, replace the disinfectant solution as described in Section 8.2, Replacing the disinfectant solution in Instructions-Operation Manual. Ch.4 NOTE Figure 4.165
Under high temperature and extreme temperature fluctuations, test strip may result in fail. In such cases, Olympus recommends performing mix LCG and check the MRC level again.
Depending on conditions of internal valve, there is a possibility that no disinfectant solution exist in the disinfectant solution nozzle. In the following cases, perform the mix LCG, then check the MRC level again.
No reaction is observed on the chemical indicator after checking the MRC level.
Reaction is observed only from the edge parts of the chemical indicator after checking the MRC level. If the disinfectant solution in the disinfectant solution nozzle is found insufficient for checking the MRC level on a regular basis, contact Olympus. OER-Elite INSTALLATION MANUAL 149 4.21 Self disinfection and check the operation 8 Attach the disinfectant solution nozzle cap to the original position above the disinfectant solution nozzle. Make sure that the pin backs in original position, and the projection of the disinfectant solution nozzle cap is aligned to the projection of the disinfectant solution nozzle. Pin projection NOTE Figure 4.166 Ch.4 Be sure to return the disinfectant solution nozzle cap in the original position. Otherwise, the disinfectant solution inside the nozzle may be diluted in the next process and next MRC check will be failed even if the concentration of LCG in the tank is above its MRC. In this case, perform mix LCG, then check MRC again. 9 Select the result of the MRC level. Figure 4.167 NOTE
The currently selected button is highlighted.
If you select Fail, the process cannot be started. 150 OER-Elite INSTALLATION MANUAL 4.21 Self disinfection and check the operation 10 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Figure 4.168 NOTE Ch.4
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
11 Press the Save button. The touch screen displays as shown in the following figure. Figure 4.169 OER-Elite INSTALLATION MANUAL 151 4.21 Self disinfection and check the operation 12 Press the OK button. Figure 4.170 Mix LCG Ch.4 If the touch screen displays a screen as shown in following figure, perform the LCG Mixing by using the following procedure. Figure 4.171 1 Make sure that the water faucet is open. 2 Close the lid. 3 Press the Mix LCG button to close the message. 152 OER-Elite INSTALLATION MANUAL Figure 4.172 4.21 Self disinfection and check the operation 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Figure 4.173 NOTE Ch.4
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
5 Press the Start button. The touch screen displays as shown in the following figure. Figure 4.174 OER-Elite INSTALLATION MANUAL 153 4.21 Self disinfection and check the operation 6 When the disinfectant solution mixing process completes, the equipment generates a buzzer beep and displays the following screen on the touch screen. Press the OK button to finish. Figure 4.175 Performing the self disinfection Ch.4 1 Make sure that the water faucet is open. 2 Press the Functions button on the Menu screen. 3 Press the Self-Disinfection & Water Sampling button. Figure 4.176 Figure 4.177 154 OER-Elite INSTALLATION MANUAL 4.21 Self disinfection and check the operation 4 Press the No button. Figure 4.178 5 Step on the foot pedal to open the lid. 6 Connect the connector jig to the same-colored connector at the reprocessing basin by pushing down on the connector jig until it clicks. Ch.4 7 Press the Next button repeatedly until the touch screen display changes as shown below. Figure 4.179 8 Close the lid by pushing until it clicks. 9 Make sure that the water faucet is open. Figure 4.180 OER-Elite INSTALLATION MANUAL 155 4.21 Self disinfection and check the operation 10 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Ch.4 Figure 4.181 NOTE
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
11 Press the Start button. Figure 4.182 156 OER-Elite INSTALLATION MANUAL 4.21 Self disinfection and check the operation NOTE
The cleaning, disinfection and rinse are executed in the process.
If the temperature of the disinfectant solution in the reprocessing basin is below 20qC (68qF), it will be heated to 20qC (68qF) before the disinfection process starts. During heating, the remaining time countdown and the progress bar display stop and turn gray. After the completion of heating, the remaining time countdown and progress bar display resume. Displays the remaining time Ch.4 Figure 4.183 12 Check that a jet of fluid is squirted from the water supply/circulation nozzle to the dome of lid (to check that the cleaning pump is not clogged or abnormal). 13 Confirm the following points during reprocessing:
Figure 4.184
That no water Leaks from the water supply hose connector.
That no water Leaks from the drain hose connector.
That no water Leaks from the water filter housing and the surroundings.
That no water Leaks from the lid and surroundings.
That no water Leaks from the lower part of the equipment.
That there are no abnormal noises. OER-Elite INSTALLATION MANUAL 157 4.21 Self disinfection and check the operation 14 When the self-disinfection is finished, the buzzer beeps and the touch screen displays a screen as shown in the following figure. 15 Step the foot pedal to open the lid. 16 Disconnect the connector jig and close the lid. 17 Press the OK button. Figure 4.185 Ch.4 18 Rinse the connector jig thoroughly under running water, dry them well and store them in a clean place. Figure 4.186 158 OER-Elite INSTALLATION MANUAL 4.21 Self disinfection and check the operation When the Message 093 is displayed If detergent has run out and the message screen Detergent cannot be supplied is displayed, the equipment will stop the process. In this case, you can restart the process from the cleaning process by implementing the following procedure. Figure 4.187 Ch.4 WARNING When handling the detergent, read the cautions carefully and use as instructed. It is especially important to know what measures to take if the disinfectant solution comes into contact with your skin. CAUTION When handling the detergent, always wear appropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Required items Check Required items Syringe Tube Table 4.9 Solution Refer to When the Message 093 is displayed in Section 13.2, Troubleshooting guide in Instructions-Operation Manual. OER-Elite INSTALLATION MANUAL 159 4.21 Self disinfection and check the operation When the Message 087 is displayed If the message screen Alcohol cannot be supplied is displayed and the equipment is stopped while the detergent is still present in the detergent tank, check that there is no irregularity regarding the following points.
The tube connected to the alcohol tank is not kinked.
The connector of alcohol tank is attached firmly. If any irregularity is found by inspection, correct these points and press Restart button to restart the alcohol flush process. If any irregularity is not observed during an inspection or the message screen Alcohol cannot be supplied is displayed again, internal problem with the equipment may be suspected. In this case, follow the procedure below. Ch.4 Figure 4.188 WARNING
The alcohol used with the equipment must be 70% ethyl alcohol or 70% isopropyl alcohol. Using any other kind of alcohol may result in malfunction of the equipment or the endoscope, difficulty drying the endoscope, fire hazard, or a hazard due to toxic vapor emitted from the alcohol.
Alcohol is flammable and should be handled with extra care.
Remove the alcohol in the alcohol tank and replace it with new alcohol at least once a week. Otherwise, the alcohol in the alcohol tank may degrade.
Before handling the alcohol, read the cautions carefully and use it as instructed. 160 OER-Elite INSTALLATION MANUAL 4.21 Self disinfection and check the operation Required items Check Required items Connector jig Syringe Tube Table 4.10 Solution Refer to When the message screen Message 087 is displayed in Section 13.2, Troubleshooting guide in Instructions-Operation Manual. Ch.4 OER-Elite INSTALLATION MANUAL 161 4.22 Water line disinfection 4.22 Water line disinfection Disinfection of water supply piping is required in the following cases. Immediately after replacing the water filter.
Before using this equipment for the first time (after installation of the water filter).
Whenever contamination of the water supply piping has been determined.
Before using the equipment when it has not been used for more than 14 days. NOTE Ch.4
Olympus recommends performing microbiological sampling of the OER-Elite rinse water quality immediately after performing the water supply piping disinfection if the device has not been used for more than 14 days. For details on sampling rinse water, refer to Section 7.9, Self-disinfection and water sampling in Instructions-Operation Manual.
When disinfection of water supply piping is required, Olympus recommends performing it prior to replacement of the disinfectant solution. The disinfectant solution must still meet the MRC using the test strip. After disinfection of water supply piping, drain the disinfectant solution according to the instructions in the instruction manual and the facility policy. Fill the OER-Elite with fresh disinfectant solution prior to proceeding with endoscope reprocessing.
There may be instances when the water supply lines are disinfected using fresh disinfectant for the first time. Following disinfection of the water supply piping with fresh disinfectant, the quantity of disinfectant solution might be reduced preventing use of the fresh disinfectant for endoscope reprocessing. In this case, additional fresh disinfectant can be added to the OER-Elite only when using the ready-to-use disinfectant prepared by top loading. Adding fresh disinfectant to increase the volume of the existing fresh disinfectant will achieve typical usage conditions. The disinfectant solution stored in the equipment is used for disinfection of the water supply piping. WARNING
Before disinfecting the water supply piping, check the concentration of the disinfectant solution with the Test Strip, and replace the disinfectant solution if the disinfectant efficacy has been determined to be below the required level. If this check is not applied, disinfection may be insufficient.
Disinfection of the water supply piping is required each time the water filter is replaced (at least once every month). Otherwise, the rinse water may be contaminated. 162 OER-Elite INSTALLATION MANUAL 4.22 Water line disinfection WARNING
Disconnect the connecting tubes from the connectors on the equipment before disinfecting the water supply piping. Otherwise, a jet of disinfectant solution may squirt out from the connecting tubes and leak from a connector such as the gas filter case connector.
Before handling the disinfectant solution, read the cautions carefully and use as instructed. It is especially important to know what to do if the disinfectant solution comes into contact with your skin.
When handling the disinfectant solution, wear personal protective equipment to prevent any disinfectant from getting on your skin or being inhaled. To avoid adverse physical effects, do not to touch the disinfectant solution directly or to inhale too much vapor. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Such protective equipment should include appropriate eyewear, face mask, cap, moisture-resistant clothing, shoe covers, and chemical-resistant gloves that fit properly and are long enough to prevent skin exposure. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Ch.4 NOTE
For details on replacing the disinfectant solution, refer to Section 4.20, Setup of the disinfectant solution.
Disinfecting the water supply piping also disinfects the water filter and other components in the piping. OER-Elite INSTALLATION MANUAL 163 4.22 Water line disinfection Disinfection of water supply piping workflow Check the MRC level. 1
If the concentration is below the minimum effective level, replace the disinfectant solution
on page 164 2 Disinfect the water supply piping.
on page 172 Required items Ch.4 Check Required items Chemical indicator (test strip) Container with 2 L (67 ounces) or larger capacity (wide-mouthed container such as a vat) Filter tube ( 2) Water supply piping disinfection hose Table 4.11 NOTE For details on the test strip, refer to Section 2.8, Consumable accessories
(Optional). Checking the MRC level and entering the check result CAUTION Do not collect the drained disinfectant solution from the disinfectant removal port to check the MRC. Otherwise, the disinfectant solution in the disinfectant solution tank would decrease, making it impossible to start the reprocessing. 164 OER-Elite INSTALLATION MANUAL 4.22 Water line disinfection 1 Press the Functions button on the Menu screen. 2 Press the Water Line Disinfection. Figure 4.189 Ch.4 3 Press the LCG Info. Button. Figure 4.190 Figure 4.191 OER-Elite INSTALLATION MANUAL 165 4.22 Water line disinfection 4 Press the MRC Check Result button to display the MRC Check Result entry screen. Figure 4.192 NOTE When a touch screen displays a screen as shown in the following figure, perform the LCG Mixing. For details, refer to LCG Mixing on page 169. Ch.4 Figure 4.193 5 Step on the foot pedal to open the lid. 6 Turn the disinfectant solution nozzle cap in the direction shown to remove, refer to the Figure 4.194. Disinfectant solution nozzle cap Figure 4.194 166 OER-Elite INSTALLATION MANUAL 4.22 Water line disinfection 7 Insert a test strip all the way into the disinfectant nozzle and check the MRC level according to the instructions manual of the test strip. If the concentration is below the minimum effective level, replace the disinfectant solution as described in Section 8.2, Replacing the disinfectant solution in Instructions-Operation Manual. WARNING Figure 4.195 Be sure to attach the disinfectant solution nozzle cap to the original position above the disinfectant solution nozzle. There is a risk that water penetrates in the disinfectant nozzle during the process, in which case the disinfectant concentration cannot be checked correctly. Ch.4 8 Attach the disinfectant solution nozzle cap to the original position above the disinfectant solution nozzle. Make sure that the pin backs in original position, and the projection of the disinfectant solution nozzle cap is aligned to the projection of the disinfectant solution nozzle. Pin projection 9 Select the result of the MRC level. If you select Fail, the process cannot be started. Figure 4.196 Figure 4.197 OER-Elite INSTALLATION MANUAL 167 4.22 Water line disinfection NOTE The currently selected button is highlighted. 10 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). Ch.4 When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Figure 4.198 NOTE
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
11 Press the Save button. The touch screen displays as shown in the following figure. Figure 4.199 168 OER-Elite INSTALLATION MANUAL 12 Press the OK button. 4.22 Water line disinfection Figure 4.200 LCG Mixing If the touch screen displays a screen as shown in following figure, perform the LCG Mixing by using the following procedure. Ch.4 Figure 4.201 1 Make sure the water faucet is open. 2 Close the lid. 3 Press the Mix LCG button to close the message. OER-Elite INSTALLATION MANUAL 169 Figure 4.202 4.22 Water line disinfection 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Ch.4 Figure 4.203 NOTE
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5, User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
5 Press the Start button. Disinfectant solution mixing starts. Figure 4.204 170 OER-Elite INSTALLATION MANUAL 4.22 Water line disinfection 6 When the disinfectant solution mixing process completes, the equipment generates a buzzer beep and displays the following screen on the touch screen. Press the OK button to finish. Figure 4.205 Ch.4 OER-Elite INSTALLATION MANUAL 171 4.22 Water line disinfection Disinfecting the water line 1 Make sure that the water faucet is open. 2 Close the lid. 3 Press the Next button repeatedly until the touch screen display changes as shown below. Ch.4 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID in Instructions-Operation Manual (If applicable). Figure 4.206 When the User ID entered by RFID When the User ID is entered by the software keyboard or called from registered users Figure 4.207 NOTE
The input of the User ID can be omitted by modifying the User ID input setting. For details, refer to Section 4.5 User ID Setting in Instructions-Operation Manual. If the Delete button is pressed, the entered ID can be deleted.
5 Press the Start button. 6 Push the area marked PUSH on the front door to open it. 172 OER-Elite INSTALLATION MANUAL 4.22 Water line disinfection 7 Prepare the container with a capacity of 2 L (67 ounces) or more in front of the equipment. 8 Put the tube-side ends of the two filter tubes in the container placed and insert the connector ends of the two filter tubes into the connector above the water filter housing and the connector below the water filter housing until they click. Water will start to flow from the tube connected to the connector below the water filter housing. Connector above water filter housing Connector below water filter housing Figure 4.208 9 Press the Continue button. Ch.4 Figure 4.209 OER-Elite INSTALLATION MANUAL 173 4.22 Water line disinfection 10 When water flow stops, disconnect the two filter tubes by pushing the lock levers on their connectors. Lock lever Figure 4.210 11 Press the Continue button. Ch.4 12 Step on the foot pedal to open the lid. 13 Connect the water supply piping disinfection hose between the connector C1 in the reprocessing basin and the water supply piping disinfection connector. Figure 4.211 Connector C1 Water supply piping disinfection connector Temperature sensor Washing case mount Figure 4.212 14 Close the lid. 174 OER-Elite INSTALLATION MANUAL 4.22 Water line disinfection 15 Press the Continue button to supply the disinfectant solution in the reprocessing basin. Figure 4.213 16 When the reprocessing basin is filled with disinfectant solution, a buzzer sounds three times and the touch screen displays the following screen. Ch.4 Figure 4.214 17 Put the tube-side end of the filter tube and put it in the container. 18 Insert the connector end of the filter tube into the connector above the water filter housing until it clicks. Do not connect anything to the connector below the water filter housing. Figure 4.215 OER-Elite INSTALLATION MANUAL 175 4.22 Water line disinfection 19 Press the Continue button twice. Figure 4.216 20 When the disinfection process starts, the touch screen displays the remaining time and the progress bar. Ch.4 21 When water starts to flow continuously from the filter tube, disconnect the tube by pushing its lock lever. Water flow should stop when the filter tube is disconnected. Figure 4.217 Figure 4.218 176 OER-Elite INSTALLATION MANUAL 4.22 Water line disinfection NOTE If the temperature of the disinfectant solution is less than 20qC (68qF), it will be heated to 20qC (68qF). During heating, the remaining time countdown and the progress bar display stop and turn gray. After the completion of heating, the remaining time countdown and progress bar display resume. Progress stops and turn gray Figure 4.219 22 Make sure that a jet of fluid is output from the water supply/circulation nozzle to the dome of lid during the process. It blinks Current and target temperature of the disinfectant solution Ch.4 23 When the remaining time displayed on the touch screen reaches 0 minutes, the buzzer sounds and the touch screen displays the following screen. Figure 4.220 Figure 4.221 24 Put the tube-side end of the filter tube back in the container. OER-Elite INSTALLATION MANUAL 177 4.22 Water line disinfection 25 Insert the connector end of the filter tube into the connector above the water filter housing. Do not connect a filter tube to the connector below the water filter housing. 26 Press the Continue button. The touch screen displays a screen as shown in the following figure and water will flow from the filter tube. Figure 4.222 Ch.4 Figure 4.223 27 After several seconds, the buzzer sounds indicating the end of the process and the touch screen displays the following screen. 28 Disconnect the filter tube by pushing its lock lever. 29 Close the front door. 30 Step on the foot pedal to open the lid. Figure 4.224 178 OER-Elite INSTALLATION MANUAL 4.22 Water line disinfection WARNING Disconnect the water supply piping disinfection hose from the connector, covering the connector of the hose with hands in waterproof gloves. Otherwise, water pooled inside of the hose may spill out. 31 Disconnect the water supply piping disinfection hose and close the lid. Water supply piping disinfection hose connector Washing case mount Ch.4 Connector C1 Temperature sensor Figure 4.225 32 Rinse the filter tube and water supply piping disinfection hose thoroughly in running water, dry them thoroughly, and store in a clean place. 33 Press the OK button to complete the water filter replacement process. Figure 4.226 OER-Elite INSTALLATION MANUAL 179 4.23 Checking the operation of optional accessories 4.23 Checking the operation of optional accessories Checking the operation of the bar code reader (MAJ-2130) To input the patient ID from a bar code, it is required to connect the optional MAJ-2130 bar code reader. For the installation of the bar code reader, refer to the Instructions - Installation Manual for this equipment and the Instructions for the MAJ-2130 bar code reader. CAUTION Do not connect anything other than the designated bar code reader to the bar code reader port. Otherwise, the IDs may not be read out correctly or the instrument may malfunction. NOTE
A patient ID can be input by either bar code reader or software keyboard
(on-screen), but a patient name can be input by only software keyboard. It is possible to input the patient name by software keyboard (on-screen) after entering the patient ID by the bar code reader.
The OER-Elite can read the top 23 characters of each bar code. When the bar code contains data other than patient data, the equipment reads all of 23 characters including data other than the patient data that a bar code has.
Do not alter the settings of the bar code reader. It has been set to the optimum settings for combined use with this equipment. If the Settings are altered, it may be impossible to read the bar codes, contact Olympus. Ch.4 180 OER-Elite INSTALLATION MANUAL 4.23 Checking the operation of optional accessories Required items Check Bar code Table 4.12 NOTE Required items The bar code that equipment can read is a bar code of the following standards.
UPC/EAN
Code 128
GS1-128
Code 39
Trioptic Code 39
Code 93
Code 11
Interleaved 2 of 5
Discrete 2 of 5
Codabar
MSI
Chinese 2 of 5
Matrix 2 of 5
Korean 3 of 5
Inverse 1D
GS1 DataBar
Composite Codes Ch.4 OER-Elite INSTALLATION MANUAL 181 4.23 Checking the operation of optional accessories Checking the operation of the bar code reader 1 Press the Reprocessing button to display the reprocessing standby screen. Ch.4 Figure 4.227 2 Place the bar code under the bar code reader to read the bar code and adjust the distance between them so that the entire bar code is within the scanning area of the bar code reader. When the bar code reader succeeds in scanning of the bar code, the bar code reader sounds a short beep. If the bar code reader dose not sound a short beep, correct problems in reference to the instruction manual for the bar code reader MAJ-2130 or Section 13.2, Troubleshooting guide in Instructions-Operation Manual. Bar code reader Bar code Figure 4.228 182 OER-Elite INSTALLATION MANUAL 4.23 Checking the operation of optional accessories NOTE When the bar code reader scans bar code, the bar code reader projects a green aiming pattern. The scanning pattern of the bar code reader is formed by the aiming pattern. When the entire bar code does not cross the scanning pattern, the bar code reader cannot scan the entire bar code. Bar code Aiming pattern Suitable examples Ch.4 Unsuitable examples Figure 4.229 3 Then the touch screen displays data scanning form bar code as shown in the following figure. Check the data of bar code on the touch screen. If the touch screen does not display a screen as shown in the following figure, or if the displayed data has errors, correct problems in reference to the instruction manual for the bar code reader MAJ-2130 or Section 13.2, Troubleshooting guide in Instructions-Operation Manual. Figure 4.230 OER-Elite INSTALLATION MANUAL 183 4.23 Checking the operation of optional accessories NOTE
A patient ID can be input by either bar code reader or software keyboard
(on-screen), but a patient name can be input by only software keyboard. It is possible to input the patient name by software keyboard (on-screen) after entering the patient ID by the bar code reader.
When the patient ID setting is inactivated, the touch screen does not display information on bar code. For changing the patient ID setting, refer to Section 4.7, Patient ID setting in Instructions-Operation Manual.
The entered patient ID can be checked on the scope1 associated ID information screen. Press the Scope 1 button to display the scope1 associated ID information screen. Ch.4 Displays Name of the patient ID Displays ID of the patient ID Press to delete the patient ID Reprocessing standby screen Scope1 associated ID information Figure 4.231 4 Press the Scope 1 button on the reprocessing standby screen to display the Scope1 associated ID information screen. Figure 4.232 184 OER-Elite INSTALLATION MANUAL 4.23 Checking the operation of optional accessories 5 Press the Delete button of the patient ID to delete the patient ID. 6 Press the OK button to return to the reprocessing standby screen. Figure 4.233 Ch.4 Figure 4.234 OER-Elite INSTALLATION MANUAL 185 4.23 Checking the operation of optional accessories Checking the operation of the printer (MAJ-1937) When the optional printer set MAJ-2144 is installed in the equipment, check the operation of the printer MAJ-1937 by following procedure. For the operation of the printer and the set of roll paper, refer to the instruction manual for the printer set. Make sure that this checking exist record data of reprocessing record, leak test records, or leaking scope decontamination records. CAUTION
Do not connect any other power cord to the printer (MAJ-1937) other than the power cord which provided with the printer. Connecting any power cord except the one specified may result in failure or burnout of the equipment.
Do not connect any cables other than the interface cable of the printer MAJ-1937 to the printer communication port. Connecting except the specified cable may result in failure or burnout of the equipment. NOTE Make sure that this checking exist record data of reprocessing record, leak test records, or leaking scope decontamination records. Otherwise, checking cannot executed. Be sure to execute the reprocessing, leak test, or leaking scope decontamination. Ch.4 1 Turn on the equipment and the printer MAJ-1937. 2 Press the Log button on the Menu screen. Figure 4.235 186 OER-Elite INSTALLATION MANUAL 4.23 Checking the operation of optional accessories 3 Press the Printout button. 4 Press the Reprocessing Record button. Figure 4.236 Ch.4 5 Press the Include Error Result button. Figure 4.237 Figure 4.238 OER-Elite INSTALLATION MANUAL 187 4.23 Checking the operation of optional accessories 6 Enter the date of select to be displayed. Press the + button to increase or the button to decrease. 7 Press the Start button to start printing the reprocessing records. During printing, the touch screen displays a progress status of printing. Figure 4.239 Ch.4 Figure 4.240 8 When the screen as shown in Figure 4.241 appears, the printing process is complete. Press the OK button. Figure 4.241 188 OER-Elite INSTALLATION MANUAL 4.23 Checking the operation of optional accessories 9 Check that the printed information is correct. If no information is printed, or if the printed information has errors, reference the instruction manual for the printer set. Error code Serial number of this equipment Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of first endoscope Ch.4 Information of second endoscope Figure 4.242 OER-Elite INSTALLATION MANUAL 189 4.23 Checking the operation of optional accessories Ch.4 190 OER-Elite INSTALLATION MANUAL Installation work check points Installation Work Check Points Installation work check points To prevent problems due to improper installation, check the following during installation of the equipment. Installation of buckling guard The provided buckling guard should be attached to the rear of the equipment. Installation of retaining rack, washing case and drain/circulation port mesh filters The drain port mesh filter should be installed properly. The retaining rack should be installed properly. The washing case should be installed properly. The two circulation port mesh filters should be installed properly. Installation of water tray The water tray should be installed properly. Installation of stylus pen The stylus pen holder should be attached to the right side of the equipment. Connection of water supply hose Packing should be present inside the water supply plug and the connection ring. Pull the water supply hose lightly to ensure that there is no loose connection or buckle of the hose. Tighten the water supply plug and the connection rings on the equipment end of the water supply hose. To secure the water supply plug, use the provided wrench. Pull the water faucet end of the water supply hose to ensure that it is not disconnected. When the water faucet is open, no water should leak from the water supply hose connection area. Connection of drain hose The drain hose should not be buckled. The drain height should be appropriate. The hose should be cut to an appropriate length. Connection of power supply The hospital-grade wall mains mains power outlet should meet the rating (120 V AC/5.5 A) used for the equipment. The power cord should be plugged firmly into the equipment and the power outlet. The power switch should be able to be set to ON. Installation of equipment The equipment should be fixed in place by locking the two front casters. Check for RFID function The scope IDs should be recognized properly. OER-Elite INSTALLATION MANUAL 191 App. Installation work check points The user IDs should be recognized properly. The physician IDs should be recognized properly. Setting of date and time The built-in clock should be set to the present date and the time. Installation of gas filters The gas filters should be installed in the gas filter cases. The gas filter cases should be present in the two specified positions. Installation of air filter The filter should be installed properly. Installation of water filter The water filter should be installed with correct (up/down) orientation. The water filter should be installed properly. The water filter housing is secured without loosening by the water filter wrench. No water should leak from the water filter housing. Air should be drained properly from the water filter housing. Correction of equipment tilt The equipment should be level. App. Addition of alcohol 70% ethyl alcohol or 70% isopropyl alcohol should be present in the alcohol tank. Installation of the detergent tank The detergent tank should be installed on the detergent/alcohol drawer. The detergent/alcohol inner tray should be installed in position. Setup of disinfectant solution Confirm that a buzzer beeps at the end of the supplying process to indicate optimum supplying of disinfectant solution. The amount of disinfectant solution should be within the specified range. Setting of self-disinfection and water sampling Set the date and time of completion of Self disinfection and water sampling. Checking Functions No error code should be displayed. A jet of fluid should be squirted from the water supply/circulation nozzle to the dome of lid. Water should not leak from the following positions.
Water supply hose connector
Drain hose connector
Water filter housing and surrounding area
Lid and surrounding area
Lower part of the equipment Disinfection of the water supply piping No error code should be displayed. 192 OER-Elite INSTALLATION MANUAL 2017 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved. No part of this publication may be reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS is a registered trademark of OLYMPUS CORPORATION. Trademarks, product names, logos, or trade names used in this document are generally registered trademarks or trademarks of each company. Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (042)646-2429 Telephone: (042)642-2111 Distributed by 3500 Corporate Parkway, P.O. Box 610, Center Valley, PA 18034-0610, U.S.A. Fax: (484)896-7128 Telephone: (484)896-5000 5301 Blue Lagoon Drive, Suite 290 Miami, FL 33126-2097, U.S.A. Fax: (305)261-4421 Telephone: (305)266-2332
(Premises/Goods delivery) Wendenstrasse 14-18, 20097 Hamburg, Germany
(Letters) Postfach 10 49 08, 20034 Hamburg, Germany Fax: (040)23773-4656 Telephone: (040)23773-0 KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom Fax: (01702)465677 Telephone: (01702)616333 Elektrozavodskaya str. 27 bld.8, 107023 Moscow, Russia Fax: (7)495-663-8486 Telephone: (7)495-926-7077 A8F, Ping An International Financial Center, No. 1-3, Xinyuan South Road, Chaoyang District, Beijing, 100027 P.R.C. Fax: (86)10-5976-1299 Telephone: (86)10-5819-9000 Olympus Tower 9F, 446, Bongeunsa-ro, Gangnam-gu, Seoul, Korea 135-509 Fax: (02)6255-3494 Telephone: (02)6255-3210 491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: 6834-2438 Telephone: 6834-0010 3 Acacia Place, Notting Hill, VIC 3168, Australia Fax: (03)9543-1350 Telephone: (03)9265-5400 GT9883 01 Printed in Japan 20170303 *0000
1 | Operation Manual 1 | Users Manual | 2.70 MiB |
INSTRUCTIONS ENDOSCOPE REPROCESSOR OER-Elite OPERATION MANUAL Labels and Symbols Important Information Please Read Before Use 1 7 Chapter 1 Checking the Package Contents 19 Chapter 2 Nomenclature and Functions Chapter 3 Basic Operation Chapter 4 Settings Chapter 5 Inspection and Preparation Before Use Chapter 6 Reprocessing Operations Chapter 7 Functions Chapter 8 Replacement of Consumable Items Chapter 9 Routine Maintenance Chapter 10 End-of-Day Checks Chapter 11 Log Management Chapter 12 Information Menu Screen 23 35 75 127 147 239 339 423 451 463 589 Chapter 13 Troubleshooting and Repair 599 Appendix 647 For details on installation and setup, refer to Instructions - Installation Manual. Contents Contents Labels and Symbols .......................................................................................................... 1 Important Information Please Read Before Use ......................................................... 7 Intended use .......................................................................................................................... 7 Instruction manuals ............................................................................................................... 7 Terms used in these manuals ................................................................................................ 8 User qualifications ................................................................................................................ 11 Ensuring the safety of reprocessing personnel ................................................................... 12 Equipment compatibility ....................................................................................................... 13 Care and storage ................................................................................................................. 13 Maintenance and Inspection ................................................................................................ 13 Repair and modification ....................................................................................................... 13 Disposal of disinfectant solution .......................................................................................... 14 Disposal of this reprocessor ................................................................................................ 14 Signal words ........................................................................................................................ 14 Warnings and cautions ........................................................................................................ 14 Outline of Functions ........................................................................................................ 16 Chapter 1 Checking the Package Contents ....................................... 19 1.1 Checking the package contents ............................................................................ 19 Chapter 2 Nomenclature and Functions ............................................ 23 2.1 Front panel .............................................................................................................. 23 2.2 Top panel ................................................................................................................. 24 2.3 Inside ....................................................................................................................... 25 2.4 Rear panel ............................................................................................................... 26 2.5 Side panel ................................................................................................................ 27 2.6 Reprocessing basin ............................................................................................... 28 2.7 Control panels ........................................................................................................ 30 2.8 Consumable accessories (Optional) .................................................................... 31 Chapter 3 Basic Operation .................................................................. 35 3.1 Turning power ON .................................................................................................. 35 3.2 Alarm indicator ....................................................................................................... 37 3.3 Control panel operation ......................................................................................... 40 3.4 Menu screen ........................................................................................................... 41 3.5 LCG Info. screen ..................................................................................................... 42 OER-Elite OPERATION MANUAL i Contents 3.6 Entering ID .............................................................................................................. 44 Entering through the RFID reader ....................................................................................... 45 Entering by the software keyboard ...................................................................................... 48 Entering the patient ID by the optional bar code ................................................................. 65 3.7 Checking the MRC level and entering the check result ...................................... 69 Required items .................................................................................................................... 70 Checking the MRC level ...................................................................................................... 70 Chapter 4 Settings ................................................................................ 75 4.1 Setting menu ........................................................................................................... 75 4.2 Auto leak test setting ............................................................................................. 79 4.3 MRC check setting ................................................................................................. 81 4.4 Manual cleaning and leak test setting .................................................................. 82 4.5 User ID Setting ........................................................................................................ 83 User ID setting (reprocessing) ............................................................................................. 84 User ID setting (functions and replacement) ....................................................................... 86 User ID setting (Heat LCG Timer) ....................................................................................... 87 4.6 Physician ID setting ............................................................................................... 88 4.7 Patient ID setting .................................................................................................... 89 4.8 Patient ID security setting ..................................................................................... 90 4.9 Procedure ID setting .............................................................................................. 91 4.10 Detergent replacement indicator .......................................................................... 92 4.11 Detergent lot number and shelf-life management ............................................... 94 4.12 LCG replacement indicator .................................................................................... 95 4.13 LCG lot number and shelf-life management ........................................................ 98 4.14 Filter replacement indicator .................................................................................. 99 4.15 Filter lot number management ............................................................................ 103 4.16 Auxiliary water tube cleaning setting ................................................................. 104 4.17 Print option ........................................................................................................... 106 Print format setting ............................................................................................................ 107 Auto Print Setting ............................................................................................................... 108 4.18 Start screen ........................................................................................................... 109 4.19 Connection guide ................................................................................................. 110 4.20 Volume and brightness ........................................................................................ 111 4.21 Date and time ........................................................................................................ 112 4.22 Temperature scale ................................................................................................ 115 4.23 Network setting ..................................................................................................... 116 4.24 Network security ................................................................................................... 121 ii OER-Elite OPERATION MANUAL Contents Chapter 5 Inspection and Preparation Before Use .......................... 127 5.1 Inspection before use .......................................................................................... 127 5.2 Flow of inspection ................................................................................................ 128 5.3 Inspecting the power activation .......................................................................... 129 Inspecting for fluid leaks ..................................................................................... 132 5.4 Inspecting the lid and lid packing ....................................................................... 133 5.5 5.6 Inspecting the connectors ................................................................................... 134 Inspecting the connecting tubes and leak test air tube ................................... 137 5.7 Inspecting the remaining detergent ................................................................... 138 5.8 5.9 Inspecting and replenishing alcohol .................................................................. 139 Inspection of the amount of alcohol ................................................................................... 140 Replenishing of alcohol ..................................................................................................... 140 5.10 Inspecting the mesh filters .................................................................................. 143 5.11 Inspecting the washing case (MAJ-2121) .......................................................... 144 5.12 Inspecting the labels on the reprocessing basin .............................................. 145 5.13 Inspecting for disinfectant solution odor ........................................................... 145 Chapter 6 Reprocessing Operations ................................................ 147 6.1 General flow of endoscope reprocessing using OER-Elite .............................. 147 6.2 Precleaning, leak testing, and manual cleaning ................................................ 148 Modified manual cleaning process for preparing endoscopes for processing in the OER-Elite ........................................................................................................................... 149 Endoscope precleaning
(Procedure performed at bedside immediately after patient examination) ........................ 149 Endoscope precleaning continued
(Procedure performed at bedside immediately after patient examination) ........................ 150 Leakage testing ................................................................................................................. 152 Manual cleaning (procedure performed in reprocessing area) .......................................... 152 Loading the endoscope and their accessories into the OER-Elite .................................... 154 6.3 Reprocessing operation in the OER-Elite .......................................................... 155 Warnings ............................................................................................................................ 155 Outline of reprocessing operation in the OER-Elite ........................................................... 157 6.4 Worst case load condition of endoscopes and accessories ........................... 158 6.5 Basic operation for reprocessing ....................................................................... 160 Reprocessing standby screen ........................................................................................... 160 Reprocessing program ...................................................................................................... 162 OER-Elite OPERATION MANUAL iii Contents 6.6 Loading of endoscopes and accessories .......................................................... 163 Outline of loading operation of endoscopes and accessories ........................................... 163 Input scope ID of first endoscope ...................................................................................... 165 Loading of first endoscopes in the reprocessing basin ...................................................... 166 Loading of the accessories of first endoscope (valves, etc.) ............................................. 173 Attaching the connecting tubes loading to first endoscope ............................................... 177 Loading of auxiliary water tube of first endoscope ............................................................ 186 Attaching the Leak test air tube loading to first endoscope ............................................... 189 Input connection information of first endoscope ................................................................ 194 Input results of manual cleaning and leak test of first endoscope ..................................... 195 Inputs user ID, physician ID, patient ID, and procedure ID of first endoscope .................. 196 Input scope ID of second endoscope ................................................................................ 197 Loading of second endoscopes in the reprocessing basin ................................................ 197 Loading of the accessories of second endoscope (valves, etc.) ....................................... 202 Attaching the connecting tubes loading to second endoscope .......................................... 205 Loading of auxiliary water tube of second endoscope ........................................................ 211 Attaching the Leak test air tube loading to second endoscope ......................................... 213 Input connection information of second endoscope .......................................................... 214 Input results of manual cleaning and leak test of second endoscope ............................... 214 Inputs user ID, physician ID, patient ID, and procedure ID of second endoscope ............ 214 Loading the stylus pen ....................................................................................................... 215 6.7 Inspection before starting reprocessing process ............................................. 216 6.8 Reprocessing ........................................................................................................ 220 Auto leak test ..................................................................................................................... 221 Channel monitoring ........................................................................................................... 223 Reprocessing operation ..................................................................................................... 225 6.9 Removing the endoscopes and accessories ..................................................... 228 6.10 Printing of the reprocessing records ................................................................. 232 Printing reprocessing results after completion of reprocessing ......................................... 234 Printing error code details in case of error ......................................................................... 237 Chapter 7 Functions ........................................................................... 239 7.1 Function menu ...................................................................................................... 239 Function menu ................................................................................................................... 239 7.2 Heat LCG ............................................................................................................... 242 7.3 Heat LCG Timer ..................................................................................................... 244 Flow of Heat LCG Timer .................................................................................................... 245 Starting the Heat LCG Timer ............................................................................................. 245 Standing by and starting the Heat LCG Timer ................................................................... 253 Finishing the Heat LCG Timer ........................................................................................... 254 7.4 Mix LCG ................................................................................................................. 255 7.5 Rinse ...................................................................................................................... 258 7.6 Air purge ................................................................................................................ 260 iv OER-Elite OPERATION MANUAL Contents 7.7 Water line disinfection ......................................................................................... 262 Workflow of water line disinfection ..................................................................................... 263 Required items .................................................................................................................. 264 Checking the MRC level and entering the check result ..................................................... 264 Water line disinfection ........................................................................................................ 266 7.8 Self-disinfection and water sampling ................................................................. 274 Workflow of self-disinfection .............................................................................................. 274 Required items .................................................................................................................. 275 Checking the MRC level and entering the check result ..................................................... 275 Performing the self-disinfection ......................................................................................... 277 Microbiological Surveillance .............................................................................................. 281 7.9 Detergent line disinfection .................................................................................. 282 Required items .................................................................................................................. 283 Detergent line disinfection ................................................................................................. 283 7.10 Alcohol line disinfection ...................................................................................... 293 Required items .................................................................................................................. 294 Alcohol line disinfection ..................................................................................................... 294 7.11 Manual leak test .................................................................................................... 303 Workflow of manual leak test ............................................................................................. 304 Performing manual leak test .............................................................................................. 305 7.12 Auto leak test ........................................................................................................ 310 Workflow of auto leak test .................................................................................................. 312 Performing auto leak test ................................................................................................... 313 7.13 Self-check of auto leak test ................................................................................. 321 7.14 Alcohol flush ......................................................................................................... 323 7.15 Leaking scope decontamination ......................................................................... 326 Workflow of leaking scope decontamination ...................................................................... 328 Required items .................................................................................................................. 328 Performing leaking scope decontamination ....................................................................... 329 Chapter 8 Replacement of Consumable Items ................................ 339 8.1 Replacement of consumable items menu .......................................................... 339 8.2 Replacing the disinfectant solution .................................................................... 340 Workflow of replacement the disinfectant solution ............................................................. 341 Draining the disinfectant solution ....................................................................................... 342 Load the disinfectant solution ............................................................................................ 354 Required items .................................................................................................................. 355 Setting the disinfectant solution ......................................................................................... 356 8.3 Replacing the detergent tank .............................................................................. 364 Required item .................................................................................................................... 365 Replacing the detergent tank ............................................................................................. 366 OER-Elite OPERATION MANUAL v Contents 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) ............................................ 375 Replacing the water filter workflow (when performing the water line disinfection followed by the replacement of the water filter) .......................................................................................... 377 Required items .................................................................................................................. 377 MRC check, check result input .......................................................................................... 378 Replacing the water filter ................................................................................................... 380 Draining air in the water filter housing ............................................................................... 389 Disinfecting the water line .................................................................................................. 392 8.5 Replacing the air filter (MAJ-823) ........................................................................ 402 Workflow of replacement of the air filter ............................................................................ 402 Required items .................................................................................................................. 402 Replacing the air filter ........................................................................................................ 403 Inspecting air leakage from the air filter connectors .......................................................... 408 8.6 Replacing the gas filter (MAJ-822) ...................................................................... 411 Required items .................................................................................................................. 412 Replacing the gas filter on the lid ...................................................................................... 412 Replacing the gas filter on the disinfectant solution tank ................................................... 416 Chapter 9 Routine Maintenance ........................................................ 423 9.1 Periodic inspection .............................................................................................. 423 9.2 Cleaning the detergent/alcohol drawer .............................................................. 425 9.3 Cleaning the accessories and accessory holder .............................................. 426 Required items .................................................................................................................. 426 Cleaning the accessories and accessory holder ............................................................... 426 9.4 Cleaning the alcohol tank .................................................................................... 428 9.5 Checking cassette cutters ................................................................................... 429 9.6 Cleaning the disinfectant bottle drawer ............................................................. 429 9.7 Cleaning the mesh filter in the water supply hose connector .......................... 430 Required items .................................................................................................................. 430 Cleaning the mesh filter in the water supply hose connector ............................................ 430 9.8 Replacing the fuse ................................................................................................ 434 9.9 Preparing the reprocessor for long-term storage ............................................. 436 Workflow of Preparing the reprocessor for long-term storage ........................................... 437 Required items .................................................................................................................. 437 Preparing the reprocessor for long-term storage ............................................................... 438 9.10 Care and maintenance after long-term storage ................................................. 448 Chapter 10 End-of-Day Checks ........................................................... 451 10.1 Inspection at the end of every working day ....................................................... 451 10.2 Turning the power OFF and closing the water faucet ....................................... 452 10.3 Cleaning the mesh filters ..................................................................................... 453 10.4 Cleaning the float switches ................................................................................. 454 10.5 Cleaning the fluid level sensor ............................................................................ 458 vi OER-Elite OPERATION MANUAL Contents 10.6 Cleaning the stylus pen ....................................................................................... 460 Wiping the stylus pen with alcohol ..................................................................................... 460 Reprocessing together with endoscopes ........................................................................... 460 10.7 Cleaning the outer surface .................................................................................. 461 Chapter 11 Log Management .............................................................. 463 11.1 Log menu .............................................................................................................. 463 11.2 Log display and output ........................................................................................ 464 Information recorded in each record .................................................................................. 470 11.3 Log management with PC ................................................................................... 533 Flow of electronic log management ................................................................................... 534 Required item .................................................................................................................... 534 Output of recorded data to the portable memory ............................................................... 535 Log management on PC .................................................................................................... 541 11.4 Printing records .................................................................................................... 575 Printing .............................................................................................................................. 575 Print format ........................................................................................................................ 579 Chapter 12 Information Menu Screen ................................................. 589 12.1 RFID data check .................................................................................................... 589 12.2 Reprocessor information check ......................................................................... 592 12.3 List management .................................................................................................. 595 Chapter 13 Troubleshooting and Repair ............................................ 599 13.1 Emergency stop and automatic processing after stopping ............................. 599 13.2 Troubleshooting guide ......................................................................................... 600 When the error code [E024] is displayed during the reprocessing process ...................... 614 When any leaks are detected ............................................................................................ 617 When the message screen Message 087 is displayed ................................................... 627 When the Message 093 is displayed .............................................................................. 635 Other problems and remedial actions ................................................................................ 642 13.3 OER-Elite return ................................................................................................... 645 Appendix ............................................................................................... 647 System chart .................................................................................................................. 647 Specifications ................................................................................................................ 649 Shipping environment ........................................................................................................ 649 Operating environment ...................................................................................................... 649 Specifications ..................................................................................................................... 650 EMC information ............................................................................................................ 653 License information of Open Source Software ........................................................... 658 License information of Open Source Software ........................................................... 670 OER-Elite OPERATION MANUAL vii Contents viii OER-Elite OPERATION MANUAL Labels and Symbols Labels and Symbols The meaning(s) of the symbol(s) shown on the component packaging, the back cover of this instruction manual and/or this reprocessor are as follows:
Symbol Description Refer to instructions. Endoscope reprocessor Manufacturer Authorized representative in the European Community Lot number Serial number Non-ionizing electromagnetic radiation Date of manufacture Fuse General prohibition sign For US Customers only For a Symbols Glossary, visit us:
http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf Safety-related labels and symbols are attached to the reprocessor at the locations shown next page. If labels or symbols are missing or illegible, contact Olympus. OER-Elite OPERATION MANUAL 1 Labels and Symbols Front panel UDI label A label required by some countries regulations regarding identification of medical device also known as Unique Device Identification (UDI). RFID marking 2 OER-Elite OPERATION MANUAL Labels and Symbols Inner side FRA Rotation direction indicator label Indicates the rotation direction for locking and releasing gas filter case (tank). Rating plate Shows the product model, power rating, and serial number. FRA Date of manufacture OER-Elite OPERATION MANUAL 3 Labels and Symbols Rear panel CSA/UL MARKING 4 OER-Elite OPERATION MANUAL Top panel FRA Rotation direction indicator label Indicates the rotation directions for locking and releasing gas filter case (lid). Labels and Symbols FRA FRA OER-Elite OPERATION MANUAL 5 Labels and Symbols Reprocessing basin Fonts displayed on the touch screen Ricoh bitmap fonts designed by RICOH Company, Ltd. are used. 6 OER-Elite OPERATION MANUAL Important Information Please Read Before Use Important Information Please Read Before Use Intended use The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite. Instruction manuals The instructions for this reprocessor are divided into two volumes: Instructions-Installation Manual, and Instructions-Operation Manual. Instructions regarding the preparation of endoscopes prior to placing them in the OER-Elite are found in Instructions-Operation Manual. Each of these manuals contains essential information for using this reprocessor safely and effectively. The Instructions-Installation Manual describes how to install the reprocessor. The Instructions-Operation Manual describes how to operate and maintain the reprocessor and describes modifications to the manual endoscope cleaning process that can save the user time and inconvenience, if the endoscope is going to be subsequently reprocessed using the OER-Elite. The List of Compatible Endoscopes/Connecting Tubes <OER-Elite> identifies all Olympus model endoscopes that are compatible with the OER-Elite, plus the specific connecting tube(s) required for each of these endoscope models. The descriptions in these manuals assume that all endoscopes are reprocessed in the OER-Elite using both an Olympus-validated detergent and disinfectant. Contact Olympus to obtain the list of both Olympus-validated disinfectant solutions and detergents. Before using this reprocessor, be sure to review all of the above-mentioned manuals, the safety information provided with Olympus-validated detergents and disinfectants, and the manuals for all other equipment used in the process. Always use this reprocessor as instructed. It might cause unexpected danger if you do not follow the installation and operation manual. Keep these and all related instruction manuals and documents in a safe and accessible location. If you have any questions or comments about any information in these manuals, contact Olympus. OER-Elite OPERATION MANUAL 7 Important Information Please Read Before Use Terms used in these manuals ALT Stands for Auto Leak Test. Air purge In this operation, air is fed into an endoscope channel to blow out residual fluid. This operation is usually performed automatically during a process, but it can also be activated independently. Air purge is also used to drain cleaning fluid or disinfectant solution from inside the reprocessor when the operation has stopped due to an error code, etc. Alcohol 70% ethyl alcohol or 70% isopropyl alcohol. Alcohol flush To assist in drying the channels after reprocessing, alcohol is flushed through the endoscope channels followed by air. This operation can be performed as the last step of the reprocessing program or as an independent operation. Automatic processing When the reprocessor is stopped by the operator or due to an error, it identifies its status and executes the optimum operation automatically. For example, if the reprocessor stops in the middle of the disinfection process, it terminates the disinfection process and removes the disinfectant solution. Channel blockage monitoring This function monitors the channel blockage of endoscopes suction channel due to a foreign object, etc., during a reprocessing program. Channel connectivity monitoring This function monitors the connection status of the connecting tubes during a reprocessing program. Channel monitoring Channel monitoring will be used as a generic term meaning Channel connectivity monitoring and Channel blockage monitoring. Cleaning fluid Refers to filtered water with detergent that is used during the cleaning process. Cleaning process A series of operations programmed into the reprocessor that enable it to perform ultrasonic cleaning and detergent cleaning of endoscopes. 8 OER-Elite OPERATION MANUAL Important Information Please Read Before Use Detergent Olympus-validated detergent. Refer to Section 2.8, Consumable accessories (Optional) for details. Disinfectant solution Olympus-validated disinfectant solution. Refer to Section 2.8, Consumable accessories
(Optional) for details. Disinfection process A series of operations programmed into the reprocessor that enable it to perform disinfection of endoscopes. Error code A code consisting of [E] and a three-digit number. This code is displayed on the touch screen if there is a problem with the reprocessor. When an error code is displayed, check the troubleshooting guide. LCG Liquid Chemical Germicide. It refers to disinfectant solution displayed on GUI. Leak test A test to confirm that an endoscope is free of leaks. This reprocessor is capable of both the auto leak test and the manual leak test. Manual cleaning Cleaning of an endoscope by hand. Modified precleaning and manual cleaning A precleaning and manual cleaning method that is simplified due to subsequent use of the OER-Elite which automates cleaning steps in the process. MRC Minimum Recommended Concentration. Patient ID Identity information specific to each patient. It can be recorded in the histories of reprocessing, etc. For the patient ID input method, refer to Section 3.6, Entering ID. Physician ID Identity information specific to each endoscopist. It can be recorded in the histories of reprocessing, etc. For the physician ID input method, refer to Section 3.6, Entering ID. Portable memory A digital medium for storage. OER-Elite OPERATION MANUAL 9 Important Information Please Read Before Use Precleaning Cleaning of an endoscope performed after each procedure at the bedside in the endoscopy room. Procedure ID Identity information specific to each procedure of the patient. It can be recorded in the histories of reprocessing, etc. For the procedure ID input method, refer to Section 3.6, Entering ID. Process Generic term for any operation, including cleaning and disinfection that is performed automatically by this reprocessor. Reprocessing process A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush of the outer surface or channels of endoscopes that run in a specified sequence and for a specified time. Reprocessing programs [1] to [4] can be selected by the user. Programs [1] to [4] have a fixed cleaning process time and disinfection process time. They also have different patterns of auto leak test and channel monitoring respectively. Scope ID Identity information specific to each endoscope. It can be recorded in the historical data of reprocessing, etc. For the scope ID input method, refer to Section 3.6, Entering ID. Shelf life The date of expiration of the effectiveness of a detergent or disinfectant before it is opened. Test strip Device used to test if the concentration of disinfectant solution is effective for disinfection. Refer to Section 2.8, Consumable accessories (Optional) for details. (i.e., the minimum recommended concentration (MRC) specified by the disinfectant manufacturer) User ID Identity information specific to each reprocessing operator. It can be recorded in the histories of reprocessing, etc. For the user ID input method, refer to Section 3.6, Entering ID. 10 OER-Elite OPERATION MANUAL Important Information Please Read Before Use User qualifications The operator of this reprocessor must be sufficiently trained in reprocessing of endoscopes. The medical literature reports cases of infections due to inappropriate cleaning, disinfection, and /or sterilization. Thoroughly review and understand the following items before use:
Cleaning, disinfection, and sterilization procedures described in the instruction manuals for the endoscope and ancillary equipment.
Professional health and safety standards.
Applicable guidelines on cleaning, disinfection, and sterilization of endoscopy equipment.
Structure and handling of endoscopic equipment.
Personal protective equipment requirements to minimize exposure to chemicals and infectious materials. These manuals do not explain or discuss detailed cleaning, disinfection, and sterilization procedures. For more details, consult your facilitys procedures, professional guidelines, and regulatory requirements for reprocessing endoscopes. OER-Elite OPERATION MANUAL 11 Important Information Please Read Before Use Ensuring the safety of reprocessing personnel Disinfectant solution and detergent may irritate the mucous membranes in the eyes and respiratory organs. If disinfectant solution contacts the skin directly and eyes, it may cause irritation or damage. Therefore, before handling high-level disinfectant solution and detergent, carefully read the instructions for use and the safety data sheet. For further details, contact Olympus. While using chemicals, wear appropriate personal protective gear to prevent contact with or inhalation of chemicals or infectious substances. Personal protective gear includes eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective gear should be inspected before use and replaced periodically before it is damaged. When using disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task they are performing and vacate the room. Before handling the detergent or disinfectant, read the SDS (material safety data sheets) and learn what measures to take in the event of exposure. Operators who exhibit symptoms of an allergic reaction or sensitivity to the reprocessing chemicals should not operate this reprocessor. This reprocessor can be set up to use the RFID (Radio Frequency Identification) function. Be aware that the radio waves emitted from the RFID reader of the reprocessor may cause medical devices such as pacemakers to malfunction. If any interference with the equipment is found, immediately move away from the RFID reader or set the power switch to OFF. Contact a medical professional immediately if symptoms persist. 12 OER-Elite OPERATION MANUAL Important Information Please Read Before Use Equipment compatibility Use the OER-Elite in combination with ancillary equipment listed in System chart on page 647. Using incompatible equipment may result in patient or operator injury and equipment damage and/or malfunction. Olympus has not tested the efficacy of reprocessing on the OER-Elite in combination with endoscopes that are not listed on the List of compatible Endoscopes/Connecting Tubes <OER-Elite>. If using endoscopes that are not listed on the List of compatible Endoscopes/Connecting Tubes
<OER-Elite>, reprocessing of endoscopes may be insufficient. Care and storage After use, reprocess and store this reprocessor referring to the instructions in Chapter 10, End-of-Day Checks in this manual. Inappropriate care and storage could present an infection control risk and/or cause reprocessor damage or malfunction. Maintenance and Inspection The OER-Elite requires routine maintenance and inspection. In addition to checks before use, the person in charge of maintenance and administration of the medical equipment at the facility should periodically check all of the items described in this manual. If any irregularity is found, do not use the reprocessor and inspect it as described in Section 13.2, Troubleshooting guide. If the irregularity is still present, the reprocessor must be repaired prior to next use. If the PERIODIC MAINTENANCE indicator starts to indicate on the touch screen, described in Section 2.7, Control panels, the time for regularly scheduled maintenance is near. Contact Olympus to perform the maintenance. Repair and modification Do not disassemble, modify, or attempt to repair this reprocessor and its accessories. Doing so could result in operator or patient injury and/or equipment damage or malfunction. Some problems that appear to be malfunctions may be corrected by referring to Chapter 13, Troubleshooting and Repair. If the problem cannot be resolved using the information in Chapter 13, Troubleshooting and Repair, contact Olympus. OER-Elite OPERATION MANUAL 13 Important Information Please Read Before Use Disposal of disinfectant solution Expired disinfectant solution for this reprocessor should be handled as directed in the Olympus-validated disinfectant product label and instructions. Follow all applicable national, state, and local guidelines. Disposal of this reprocessor When disposing of this reprocessor and accessories, follow all applicable national, state, and local regulations and guidelines. Signal words The following signal words are used throughout these manuals:
WARNING CAUTION Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. NOTE Indicates additional helpful information. Warnings and cautions Follow the warnings and cautions given below when handling this reprocessor. This information is supplemented by warnings given in each chapter. WARNING Do not insert an EndoTherapy accessory or other object through an opening including the air vent of the reprocessor. Do not allow any liquid (including water or disinfectant solution) to flow into an opening. Contact with an electrical part inside the reprocessor could cause an electric shock or reprocessor failure. Always remove the tank from the detergent/alcohol drawer before putting detergent or alcohol in the tank. If detergent or alcohol is spilled on the detergent/alcohol drawer, it could get inside the reprocessor and contact an electrical part inside, causing an electric shock or fire hazard. 14 OER-Elite OPERATION MANUAL Important Information Please Read Before Use WARNING Do not install this reprocessor in any place where any of the following are present.
High oxygen concentration
Oxidizing substance such as Nitrous Oxide (N2O)
Flammable anesthetic gas This reprocessor is not explosion-proof and may explode or cause a fire under these conditions. Always use the power cord provided with this reprocessor. Otherwise, reprocessor failure or power cord burnout may result. Also, remember that the provided power cord is for use only with this reprocessor and should not be used with any other equipment. CAUTION Do not press any of the switches on the control panel of this reprocessor with a pointed or hard object. Otherwise, the switch may be damaged. Be sure to turn off the water faucet and the power switch of the reprocessor at the end of the day to avoid potential water leaks. To avoid malfunctions, do not use this reprocessor in a dusty environment. To avoid electromagnetic interference from other equipment, do not install any other electrical devices in close proximity to this reprocessor (aside from ancillary devices used with this reprocessor). This equipment enables radio communication by RFID and emits RF (radio frequency: 13.56 MHz) energy to perform the said intended functions. It may cause electromagnetic interference in nearby electronic equipment, and is labeled with the symbol below. If electromagnetic interference occurs, mitigation measures may be necessary, such as moving the electronic equipment away, reorienting or relocating this instrument, or shielding the location. An electromagnetic interference with other devices may shorten the communications distance of the designated ID tag and cause signals to become unreadable. Try to take mitigation measures such as keeping the affecting device away from this equipment. OER-Elite OPERATION MANUAL 15 Outline of Functions Outline of Functions Following functions are available in this reprocessor. Reprocessing A series of operations that enable the reprocessor to perform ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush. A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush of the outer surface and channels of endoscopes in a specified sequence and for a specified time. Reprocessing programs [1] to [4] can be selected by the user. Programs [1] to [4] have a fixed cleaning process time and disinfection process time. They also have different patterns of auto leak test and channel monitoring respectively. For details, refer to Chapter 6, Reprocessing Operations. Heat LCG A process for heating disinfectant solution until it reaches the specified temperature (22q, 72qF). This process is performed automatically during the reprocessing program. It can also be performed as an independent operation. For details, refer to Section 7.2, Heat LCG. Heat LCG Timer The function for heating the disinfectant solution until the specified temperature (22q, 72qF) by the specified time. For details, refer to Section 7.3, Heat LCG Timer. Drain LCG This function drains the disinfectant solution from the disinfectant tank. For details, refer to Section 8.2, Replacing the disinfectant solution. Load LCG This function loads the disinfectant solution after inserting a new disinfectant bottle. For details, refer to Section 8.2, Replacing the disinfectant solution. Mix LCG This function mixs the disinfectant solution to the appropriate concentration and enables accurate concentration check. 16 OER-Elite OPERATION MANUAL Outline of Functions Water line disinfection This function disinfects the water supply line and other lines inside the reprocessor. For details, refer to Section 7.7, Water line disinfection. Self disinfection and water sampling This function disinfects the basin and internal piping of the reprocessor. End of the process, sampling of rinse water can be performed for microbiological surveillance. For details, refer to Section 7.8, Self-disinfection and water sampling. Detergent/Alcohol line disinfection This function disinfects the detergent line and alcohol line of the reprocessor. For details, refer to Section 7.9, Detergent line disinfection and Section 7.10, Alcohol line disinfection. Auto leak test The endoscope leak test can be executed automatically by programming it in a user-configured reprocessing process. It can also be performed as an independent operation. For details, refer to Section 7.12, Auto leak test. Manual leak test Manual inspection for endoscope leakage during immersion of water can be performed as an independent operation. For details, refer to Section 7.11, Manual leak test. Alcohol flush To assist in drying the channel after reprocessing, alcohol is flushed through the endoscope channels followed by air. This function performs alcohol flush into the endoscope channels. The alcohol flush can be executed automatically in a reprocessing process. It can also be performed as an independent operation. For details, refer to Section 7.14, Alcohol flush. Air purge This function drains the remaining fluid from the basin after an irregularity occurs, or if the process is stopped before it completes. Air purge also eliminates residual fluid from the endoscope channels. For details, refer to Section 7.6, Air purge. OER-Elite OPERATION MANUAL 17 Outline of Functions Rinse This function performs the rinsing process if the fluid remains in the basin or in the endoscopes after an irregularity occurs or the process is stopped midway. For details, refer to Section 7.5, Rinse. Leaking scope decontamination This function decontaminates a leaking endoscope prior to repair. During the decontamination, positive pressure is applied to the leaking endoscope to avoid fluid invasion and damage to the endoscope. For details, refer to Section 7.15, Leaking scope decontamination. ALT self-check This function checks the auto leak test function of the reprocessor. It is performed automatically at the end of Load LCG function or as an independent operation. For details, refer to Section 7.13, Self-check of auto leak test. 18 OER-Elite OPERATION MANUAL 1.1 Checking the package contents Chapter 1 Checking the Package Contents 1.1 Checking the package contents Ch.1 Check that the package contains all the items listed below. Inspect each item for damage. If the device is damaged, a component is missing, or there is any question regarding items, do not use the device and contact Olympus immediately. Endoscope reprocessor Accessories for use in installation Endoscope reprocessor OER-Elite Buckling guard (GT970400) Buckling guard retaining screw
(GC783700, 2 pcs) Grommet (GC784100, 4 pcs) Wrench (GC748400) Drain hose (GJ853400) Water supply hose (GC416500) Power cord (RL545000) Water supply plug (GN573800) OER-Elite OPERATION MANUAL 19 1.1 Checking the package contents Accessories for use in reprocessing Ch.1 Connecting tube (MAJ-2110, 2 pcs) Connecting tube (MAJ-2111, 2 pcs) Connecting tube (MAJ-2112, 2 pcs) Connecting tube (MAJ-2113, 2 pcs) Leak test air tube
(MAJ-2127, 2 pcs) Accessories to be attached to the reprocessor Gas filter case (GJ460700) Gas filter (2 pcs) (MAJ-822) Gas filter adapter (splash guard)
(GC949900) Washing case (MAJ-2121) Air filter (MAJ-823) Water filter (MAJ-824 or MAJ-2318) Stylus pen holder (RA016500) Hex wrench (GT804300) M4 10 mm cap bolt (2 pcs) Stylus pen (GT944200) 20 OER-Elite OPERATION MANUAL 1.1 Checking the package contents Accessories preattached to the reprocessor Alcohol tank (RU715000) Circulation port mesh filter
(GC574000 and GC693900) Ch.1 Retaining rack (GT943000) Detergent/alcohol inner tray
(GT647800) Drain port mesh filter
(GC220100) Gas filter case (GJ460700) Water tray (GT949200) Accessories for use in maintenance Syringe (GT173600) Tube (GC651300) Disinfectant collection hose
(GJ668000) Disinfectant removal tube
(GJ460200) Filter tube (GJ460500, 2 pcs) Water filter wrench (GC601300) Drain connector (GL366300) Connector jig (RU726500) Spare fuse (DB181500, 2 pcs) Water supply piping disinfection hose (RU205800) Card holder (GT271000, 2 pcs) OER-Elite OPERATION MANUAL 21 1.1 Checking the package contents Ch.1 Scope ID master card (GT970700) User ID master card (GT970600) Accessory for use in record management Portable memory (MAJ-1925) Manuals Instructions-Installation Manual Instructions-Operation Manual
(this manual) OER-Elite Quick Reference Guide OER-Elite Operation Guide 22 OER-Elite OPERATION MANUAL List of Compatible Endoscopes/Connecting Tubes
<OER-Elite>
Chapter 2 Nomenclature and Functions 2.1 Front panel 2.1 Front panel Ch.2 11 10 9 8 7 6 No. 1 2 3 Nomenclature Power switch Power indicator Disinfectant bottle drawer 4 5 Disinfectant bottle drawer check windows Casters 1 2 3 4 5 Description Press to turn the reprocessor ON or OFF. Lights up when the reprocessor is ON. Accommodates disinfectant cassette bottles. This door can be opened when the load LCG function is started. Check an inside of bottles in the disinfectant bottle drawer. The two front casters have lock mechanisms. The caster heights can be adjusted to level the reprocessor. Step to open the lid. It is locked during the reprocessing process. Push the area marked PUSH to open. Checks the amount of alcohol remaining. Foot pedal Front door Alcohol tank check window Detergent tank check window Checks the amount of detergent remaining. 6 7 8 9 10 Detergent/alcohol drawer Accommodates the specially designed tanks of detergent for cleaning and alcohol for alcohol flush. Insert the portable memory into this port. 11 Portable memory port OER-Elite OPERATION MANUAL 23 2.2 Top panel 2.2 Top panel Ch.2 7 6 5 1 2 3 4 Nomenclature No. 1 Water supply hose 2 Water supply hose Description Supplies water for use in cleaning. Connect the water supply hose. A mesh filter is built in this connector. 3 4 5 6 7 connector Lid Control panel RFID reader Gas filter case (lid) Ventilation openings on the gas filter case Step on the foot pedal to open the lid. Used for various setup and operation. Refer to Section 2.7, Control panel. Reads RFID tag for user ID, scope ID, and physician ID. Accommodates the gas filter which removes the odor and vapor of the disinfectant solution. These are the slots for intake and exhaust of air into/from the reprocessing basin. Do not block the ventilation openings on the gas filter case. 24 OER-Elite OPERATION MANUAL 2.3 Inside Ch.2 2.3 Inside 11 10 9 8 7 1 2 3 4 6 5 No. 1 Nomenclature Gas filter case (tank) 2 3 4 5 Ventilation opening on the gas filter case Disinfectant solution tank window Accessory holder Disinfectant removal port 6 Maintenance terminal 7 Water tray 8 9 Air filter Connector below water filter housing Description Accommodates the gas filter which removes the odor and vapor of the disinfectant solution. These are the slots for intake and exhaust of air into/from the disinfectant solution tank. Do not block the ventilation openings on the gas filter cases. Used to check the amount of remaining disinfectant solution. Used to store the connecting tubes, etc. Used to remove the residual disinfectant solution in the tank by using the disinfectant removal tube. It is also used to withdraw the amount of disinfectant solution by using the drain connector for detergent/alcohol piping disinfection.
(Remove the rubber cap and attach the drain connector or the disinfectant removal tube.) Used for connecting ancillary equipment (for trained service personnel only). Collects water during maintenance such as the water filter replacement. Accommodates the 0.2-micron air filter. For use in draining water from the water filter housing. 10 Water filter (housing) 11 Connector above water Accommodates the 0.2-micron internal water filter. For use in draining water and air from the water filter housing. filter housing OER-Elite OPERATION MANUAL 25 2.4 Rear panel 2.4 Rear panel 1 2 3 4 Ch.2 7 8 Description Connect the power cord of the printer (MAJ-1937) provided with the optional printer set (MAJ-2144) to feed power to it. Do not connect any devices other than the specified printer. Connect the optional bar code reader (MAJ-2130). Do not connect any devices other than the specified bar code reader. Protects the reprocessor from an over-current. Connect the power cord. Used to access the Olympus-designated external devices (for trained service personnel only). 6 5 No. 1 Nomenclature Printer outlet Bar code reader port Fuse (BOX) Power cord receptacle 100BASE-TX terminal 2 3 4 5 6 7 8 Printer communication port Connects the printer (MAJ-1937) provided with the optional printer set Buckling guard attaching holes Drain hose connector
(MAJ-2144). Do not connect any devices other than the specified printer. Screw holes used to attach the buckling guard. Connect the drain hose. 26 OER-Elite OPERATION MANUAL 2.5 Side panel Ch.2 2.5 Side panel 1 2 3 4 5 Left Right No. 1 2 3 4 5 Nomenclature Description Bar code reader attaching holes Printer set attaching holes Used to attach the optional printer set (MAJ-2144). The connector hanger cannot Used to attach the optional bar code reader (MAJ-2130). Stylus pen holder attaching holes Connector hanger attaching holes Grommet attaching holes
(4) be attached if the printer set is already attached. Used to attach the provided stylus pen holder. Used to attach the optional connector hanger (MAJ-865). The printer set cannot be attached if the connector hanger is already attached. Used to attach the grommets. OER-Elite OPERATION MANUAL 27 2.6 Reprocessing basin 2.6 Reprocessing basin 1 2 3 4 Ch.2 22 19 21 20 18 17 16 15 14 13 5 6 7 8 9 10 11 12 23 28 OER-Elite OPERATION MANUAL 2.6 Reprocessing basin No. 1 Nomenclature Description Connector A2 (Light blue) Connect a connecting tube colored light blue. Connector B2 (Blue) Connector B1 (Blue) This connector is mainly used for second endoscope. Connect a connecting tube colored blue. This connector is mainly used for second endoscope. Connect a connecting tube colored blue. This connector is mainly used for first endoscope. Connector A1 (Light blue) Connect a connecting tube colored light blue. Ch.2 2 3 4 5 6 7 8 9 Connector D2 (Orange) Connector C2 (Green) Connector C1 (Green) Connector D1 (Orange) Circulation port 10 Drain port 11 Leak test connector E2
(Purple) Leak test connector E1
(Purple) 12 13 Washing case mount 14 Temperature sensor 15 Water supply piping disinfection connector Fluid level sensor 16 17 Disinfectant solution nozzle 18 Float switch (long) 19 Detergent nozzle 20 Float switch (short) 21 Circulation nozzle 22 Water supply/circulation nozzle 23 Water level scale ( 3) This connector is mainly used for first endoscope. Connect a connecting tube colored orange. This connector is mainly used for second endoscope. Connect a connecting tube colored green. This connector is mainly used for second endoscope. Connect a connecting tube colored green. This connector is mainly used for first endoscope. Connect a connecting tube colored orange. This connector is mainly used for first endoscope. Aspirates the cleaning fluid or disinfectant solution for circulation during cleaning or disinfection. Drains liquid from the reprocessing basin. Connect the leak test air tube that is connected to the second endoscope here. Connect the leak test air tube that is connected to the first endoscope here. Mount for the Washing case that is used to hold the endoscope accessories including valves for reprocessing. Monitor the temperature of the fluid in the reprocessing basin. Connect the water supply piping disinfection hose here. Detects abnormal fluid level in the reprocessing basin. Supplies disinfectant solution to the reprocessing basin. Also, used to check if the disinfectant concentration meets the recommended level by the disinfectant manufacturer. (Open the cap and insert the chemical indicator (test strip).) Detects the fluid level in the reprocessing basin to control it. Supplies detergent to the reprocessing basin. Detects the fluid level in the reprocessing basin to control it. Supplies the cleaning fluid or disinfectant solution aspirated through the circulation port for circulation. Supplies water for cleaning. Also, supplies the cleaning fluid or disinfectant solution aspirated through the circulation port for circulation. Marks for confirming that the reprocessor is level. OER-Elite OPERATION MANUAL 29 2.7 Control panels 2.7 Control panels Ch.2 1 2 No. 1 Nomenclature Touch screen 2 3 4 5 Heat LCG Timer indicator Heat LCG Timer button Stop button Start button 3 4 5 Description Used to control and set the reprocessor. Also, the information and state of the reprocessor can be displayed. The indicator lights when the Heat LCG Timer is in progress. Press this button to active the Heat LCG Timer. Press this button to stop process. Press this button to start process. 30 OER-Elite OPERATION MANUAL 2.8 Consumable accessories (Optional) 2.8 Consumable accessories (Optional) WARNING Before using consumable items, be sure to check its shelf-life and expiration date items. If these items are expired, effectiveness of items may be compromised. Ch.2 Water filter (MAJ-824 or MAJ-2318) Internal 0.2 micron water filter. Internal 0.2 micron water filter. Figure 2.1 Gas filters (MAJ-822) Figure 2.2 Inserted in the gas filter cases to absorb disinfectant odors and vapors. OER-Elite OPERATION MANUAL 31 2.8 Consumable accessories (Optional) Air filter (MAJ-823) Ch.2 Filters microorganisms and fine particles in the air fed into the reprocessor. Figure 2.3 Olympus-validated detergent Figure 2.4 Name Type EndoQuick Alkaline detergent Manufacturer Best Sanitizers, Inc.
(154 Mullen Drive, Walton, KY) Remarks 2.8 L disposable tank Table 2.1 NOTE EndoQuick is distributed by Olympus America, Inc. To obtain EndoQuick listed above, contact Olympus. 32 OER-Elite OPERATION MANUAL 2.8 Consumable accessories (Optional) Olympus-validated concentrated disinfectant solution
(1,065 ml cassette bottles) Ch.2 Figure 2.5 Name Type Acecide-C Peracetic Acid
(PAA) Manufacturer Best Sanitizers, Inc. (154 Mullen Drive, Walton, KY) Remarks 1,065 ml cassette bottles For use in OER-Elite 510(k) number K091210 Table 2.2 NOTE Acecide-C is distributed by Olympus America, Inc. To obtain Acecide-C listed above, contact Olympus. OER-Elite OPERATION MANUAL 33 2.8 Consumable accessories (Optional) Chemical indicator (test strip) Ch.2 Figure 2.6 FDA-cleared Chemical indicator (test strip) used to determine if Olympus-validated disinfectant meets the minimum recommended concentration. Name Manufacturer 510(k) number ACECIDE test strips Best Sanitizers, Inc. (154 Mullen Drive, Walton, KY) K091210 Table 2.3 NOTE ACECIDE test strips is distributed by Olympus America, Inc. To obtain ACECIDE test strips listed above, contact Olympus. 34 OER-Elite OPERATION MANUAL Chapter 3 Basic Operation 3.1 Turning power ON 1 Press the power switch of the reprocessor. 3.1 Turning power ON Ch.3 CAUTION Figure 3.1 Connect the connection ring on the reprocessor end of the water supply hose to the water supply hose connection port by tightening securely. An insecure connection may lead to a risk of a water leak. For detail, refer to Section 4.4 Connection of the water supply hose in Instructions-Installation Manual. NOTE Lighting of Heat LCG Timer indicator means that Heat LCG Timer is being activated. For the operation during running of the Heat LCG Timer, refer to Section 7.3, Heat LCG Timer. Heat LCG Timer indicator Figure 3.2 OER-Elite OPERATION MANUAL 35 3.1 Turning power ON 2 The power indicator lights up and the touch screen displays the initial screen for few seconds. Ch.3 3 The Start screen appears. Start screen will display the Menu screen or Reprocess standby screen. Initial screen Figure 3.3 Menu screen Reprocessing Standby screen Figure 3.4 NOTE The Start Screen is set to Menu screen at the factory. For how to set the Reprocessing Standby screen, refer to Section 4.18, Start screen. Before using the reprocessor, always show the confirmation information. Refer to Figure 3.5. 36 OER-Elite OPERATION MANUAL Figure 3.5 3.2 Alarm indicator 3.2 Alarm indicator When the timing of periodical maintenance comes, the number of usage days or cycles of a consumable item reaches the set value, shelf-life of the item expires or the network setting is activated, the alarm indicator displays on the top right of the touch screen. Alarm indicator information button Communication status indicator Filter replacement indicator Detergent replacement indicator Disinfectant solution replacement indicator Periodic maintenance indicator Ch.3 Figure 3.6 Periodic maintenance indicator If the PERIODIC MAINTENANCE indicator starts to indicate on the touch screen, Control panels, the time for regularly scheduled maintenance is near. Contact Olympus to perform the maintenance. If you do not know when the indicator started to light, do not use the reprocessor and contact Olympus. Otherwise, the reprocessing may be insufficient. OER-Elite OPERATION MANUAL 37 3.2 Alarm indicator Disinfectant replacement indicator The indicator lights when the following reaches set value. The number of days of disinfectant usage The number of cycle count of disinfectant usage The number of day of shelf-life reaches Ch.3 For how to set the disinfectant solution counter, refer to Section 4.12, LCG replacement indicator. For how to set the shelf-life, refer to Section 4.13, LCG lot number and shelf-life management. WARNING Be sure to check the concentration of the disinfectant solution by using the separately available test strips. The disinfectant replacement indicator does not determine the effectiveness of the disinfectant solution. The expiration of the disinfectant solution varies depending on many factors including the time since activation, the temperature of the environment where the reprocessor is installed, and the number and types of endoscopes that have been reprocessed. The disinfectant replacement indicator does not take these and other factors into consideration. Detergent replacement indicator The indicator lights when the following reaches set value. The number of days of detergent usage The number of day of shelf-life reaches For details on the setting change, refer to Section 4.10, Detergent replacement indicator. For how to set the shelf-life, refer to Section 4.11, Detergent lot number and shelf-life management. Filter replacement indicator The lamp light when the number of days of filter usage reaches set value.
The number of days of water filter usage.
The number of days of air filter usage.
The number of days of gas filter (lid) usage.
The number of days of gas filter (tank) usage. For details on the setting change, refer to Section 4.14, Filter replacement indicator. 38 OER-Elite OPERATION MANUAL 3.2 Alarm indicator Communication status indicator This indicator shows the network status of the reprocessor. The network function setting and connection status can be confirmed depending on the type of indicator. When the non-connected status is displayed (yellow indicator), the reprocessor is not connected to a network. Check the power supply to the external devices and the connection between the external devices and the OER-Elite. If the problem cannot be resolved, contact Olympus. Indicator green yellow Not displayed Table 3.1 Description Communication is established. Communication is interrupted. Communication setting is OFF. Ch.3 Alarm indicator information button Press the button to view the information about the displayed alarm indicator. When no alarm indicator is displayed When alarm indicators are displayed Figure 3.7 NOTE If the network function is disabled, the information screen does not show information on the network. The information screen shows only the explanations of the warnings indicated by the displayed alarm indicator. OER-Elite OPERATION MANUAL 39 3.3 Control panel operation 3.3 Control panel operation This reprocessor employs a touch screen control panel. The touch screen should be manipulated by pressing with a finger of the operator or touching with the provided stylus pen. Ch.3 Pressing with a finger of the operator. Touching with the provided stylus pen. Figure 3.8 40 OER-Elite OPERATION MANUAL 3.4 Menu screen 3.4 Menu screen In the menu screen, there are six buttons. Select the desired category here. 1 2 3 4 5 6 Ch.3 No. 1 Button Reprocessing 2 3 4 5 6 Functions Replacement of Consumable Items Log Settings Information NOTE Description Press this button to display the Reprocessing Standby screen. oRefer to Section 6.5, Basic operation for reprocessing. Press this button to go to Functions menu. oRefer to Section 7.1, Function menu. Press this button to go to Replacement of Consumable Items menu. oRefer to Section 8.1, Replacement of consumable items menu. Press this button to go to Log menu. oRefer to Section 11.1, Log menu. Press this button to go to Setting menu. oRefer to Section 4.1, Setting menu. Press this button to go to Information menu. oRefer to Chapter 12, Information Menu Screen. The operational buttons are expressed by a box with gradation. Figure 3.9 OER-Elite OPERATION MANUAL 41 3.5 LCG Info. screen 3.5 LCG Info. screen This reprocessor can display the information on the disinfectant solution including the temperature and usage count. 1 Press the Reprocessing button on the touch screen. Ch.3 2 Press the LCG Info. button on the touch screen. Figure 3.10 3 The LCG Info. screen pops up. Figure 3.11 42 OER-Elite OPERATION MANUAL 3.5 LCG Info. screen 5 6 Ch.3 Description Information on the latest MRC check result. Usage count of the current disinfectant solution. When this setting is activated, the reprocessor counts the number after each process that uses the disinfectant solution (e.g. reprocessing, water line disinfection or leaking scope decontamination) is performed. Number of days the current disinfectant solution has been used. Current temperature of the disinfectant solution. Opens the MRC check result input screen. Closes the LCG Info. screen. 1 2 3 4 No. 1 2 Item/Button Latest MRC Check Result LCG Cycle Count LCG Usage LCG Temp. 3 4 5 MRC Check Result 6 OK OER-Elite OPERATION MANUAL 43 3.6 Entering ID 3.6 Entering ID Five kinds of IDs can be input, including the scope ID, user ID, physician ID, patient ID and procedure ID. The IDs can be input with one of the following four methods. The input methods are variable depending on the types of IDs. Ch.3
Input through the RFID reader built into the reprocessor.
Input from the software keyboard displayed on the touch screen.
Recalling ID information registered in advance (Recalling the pre-registered ID).
Input using the optional MAJ-2130 bar code reader. RFID reader Software keyboard Recalling the pre-registered ID Optional bar code reader Scope ID User ID Physician ID Patient ID Procedure ID Possible Impossible NOTE If the scope ID is input by using the scope ID master card, input by the software keyboard or input by recalling the pre-registered ID, the Auto leak test and Channel Monitoring are disabled. When reprocessing endoscope and accessories with no ID tag such as ultrasonic probes, enter the master ID as the scope ID. If the master ID is entered as the scope ID, N/A is entered as physician, patient and procedure IDs. Do not use anything other than the designated ID tag/chip. Otherwise correct data will not be inputted. 44 OER-Elite OPERATION MANUAL 3.6 Entering ID Entering through the RFID reader WARNING Be aware that the radio waves emitted from the RFID reader of the reprocessor may cause medical devices such as pacemakers to malfunction. If any interference with the equipment is observed, immediately move away from the RFID reader or set the power switch to OFF. Call your doctor if you do not begin to feel better. CAUTION Ch.3 Electromagnetic interference with other devices may reduce the communication distance of the designated ID tag and cause signals to become unreadable. Try to take mitigation measures such as keeping other radio frequency emitting or other energy emitting devices, such as electrosurgical units, away from this reprocessor. Perform the following operations on a screen that requests an ID input such as the Reprocessing Standby screen. OER-Elite OPERATION MANUAL 45 3.6 Entering ID Scope ID entry 1 Press the Reprocessing button on the Menu Screen. 2 Hold the internal ID endoscope connector or the external ID tag near the RFID reader on the OER-Elite. A short beep will indicate the tag was read successfully. Ch.3 For internal ID endoscope
(For example 180 series endoscope) For external ID tag Scope ID mark For internal ID endoscope (190 series endoscope 1) 1 190 series endoscopes may not be available in some areas. Figure 3.12 3 If the connection guide display setting is activated, when the ID has been read, the following screen appears. Figure 3.13 46 OER-Elite OPERATION MANUAL User or physician ID entry 1 Press the Reprocessing button on the Menu screen. 2 Hold the user or physician ID card parallel with the ID reader section and approach it until a short beep is generated. Figure 3.14 3 When the ID has been read, the following screen appears. 3.6 Entering ID Ch.3 The information on the input ID is displayed. Figure 3.15 NOTE The user ID (load) and physician ID of second endoscope can be read after reading the ID of second endoscope. OER-Elite OPERATION MANUAL 47 3.6 Entering ID Entering by the software keyboard An ID can be entered by the software keyboard (on-screen) on the touch screen as described below. 1 If it is during the reprocessing process, press or Standby screen. If it is during the leaking scope decontamination, press the ID input screen. button on the Reprocessing button on Ch.3 Reprocessing Leaking scope decontamination Figure 3.16 2 Then, the ID select screen is displayed. 1 2 3 4 5 Note Button Edit button of scope ID Edit button of patient ID Edit button of physician ID Edit button of user ID (load) Edit button of procedure ID No. 1 2 3 4 5 48 Opens the scope ID list. Opens the patient ID list. Opens the physician ID list. Opens the user ID (load) list. Opens the procedure ID list. OER-Elite OPERATION MANUAL 3.6 Entering ID NOTE When scope ID is entered using the software keyboard, the auto leak test and channel blockage monitoring functions will not be available. In the manual leak test function, the scope ID can be entered by the software keyboard. To enter the scope ID, Press the Edit button during the manual leak test. Then, refer to step 2 in Scope ID entry on page 49. In the auto leak test function, the scope ID cannot be entered by the software keyboard (on-screen). RFID of the endoscope is necessary to perform the auto leak test. When User ID setting of Reprocessing (end of reprocessing) is activated, the user ID can be entered by the software keyboard (on-screen) at the end of reprocessing. To enter the user ID, press the Edit button at the end of reprocessing. Then, refer to Step 2 in Physician ID, user ID, or procedure ID entry on page 59. For details of User ID setting, refer to Section 4.5, User ID Setting. When user ID setting of Functions & Replacement of Consumable Items is activated, the user ID can be entered by the software keyboard (on-screen) before starting each function or replacement. To enter the user ID, Press the Edit button during each function or replacement. Then, refer to Step 2 in Physician ID, user ID, or procedure ID entry on page 59. For details of User ID setting, refer to Section 4.5, User ID Setting. Ch.3 Scope ID entry 1 Press the Edit button of scope ID on the ID select screen. Figure 3.17 OER-Elite OPERATION MANUAL 49 3.6 Entering ID 2 Then the scope ID list is displayed. When the Scope ID is not listed on the ID list, go to (a) Select a Scope ID that is not listed on page 51. When the Scope ID is listed on the ID list, go to (b) Recalling the pre-registered ID on page 54. 1 2 3 4 5 Ch.3 Item/Button No. 1 ID type 2 Model #
3 4 5 6 7 8 Serial #
Edit Set Previous page button Next page button Back 6 7 8 Note Type of the currently edited ID. Registered model number of the endoscope. These areas are blank if no ID has been registered. Registered serial number of the endoscope. These areas are blank if no ID has been registered. Press one of the buttons to open the ID information edit screen. Press one of the buttons to set a registered ID. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to close the ID select screen. 50 OER-Elite OPERATION MANUAL 3.6 Entering ID
(a) Select a Scope ID that is not listed 1 To set a new scope ID, press the Edit button that no ID has been registered. To change the registered Scope ID, press the Edit button of the Scope ID. 2 The software keyboard (on-screen) is opened. Enter the model number of the endoscope on the software keyboard. Figure 3.18 Alphabet input Numeral input 4 5 6 1 2 3 Ch.3 4 5 6 7 8 9 7 8 9 Button Alphabet/
Numeral key Uppercase/
Lowercase Numeric/
Alphabetic Backspace Space Cursor move Delete Cancel Save Enter an alphabet or a numeral. Note Press Uppercase/lowercase button to switch alphabet character on the software keyboard (on-screen) between uppercase characters and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. Press the Backspace button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Press the Space button to insert a space character. Press the Cursor move button to move the cursor left or right. Press the Delete button to delete about all information. Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. OER-Elite OPERATION MANUAL 51 1 2 3 No. 1 2 3 4 5 6 7 8 9 3.6 Entering ID 3 Press the Serial # button on the software keyboard. Ch.3 4 Enter the serial number of the endoscope. Press the Save button, then the scope ID was set to the reprocessing process. Figure 3.19 Figure 3.20 5 The connection information screen is displayed on the touch screen. Connect the suitable connecting tubes according to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>, then press the No Connection buttons corresponding to the reprocessing basin connectors to which the connecting tubes are connected. The No Connection indicator will now change to Connection. Figure 3.21 52 OER-Elite OPERATION MANUAL 6 Press the OK button. 3.6 Entering ID 7 The following message is displayed. After reading the message, Press the OK button again. Figure 3.22 Ch.3 NOTE Figure 3.23 When the Manual Cleaning and Leak Test Setting is activated, select the manual cleaning and leak testing results after Step 7. For detail, refer to Input results of manual cleaning and leak test of second endoscope on page 214. 8 Once the scope ID is entered, the ID select screen appears. To go back to the reprocessing standby screen, press OK button. Figure 3.24 OER-Elite OPERATION MANUAL 53 3.6 Entering ID
(b) Recalling the pre-registered ID NOTE The ID edited on (a) Select a Scope ID that is not listed on page 51 is registered to the ID list. The ID list can be edited on the list management function. For detail, refer to Section 12.3, List management. Ch.3 1 Press the Set button for the ID to be recalled. 2 On the Connection information screen, Press the No Connection buttons corresponding to the reprocessing basin connectors to which the connecting tubes are connected. The No Connection indicator will now change to Connection. Figure 3.25 Figure 3.26 54 OER-Elite OPERATION MANUAL 3 Press the OK button. 3.6 Entering ID 4 The following message is displayed. After reading the message, Press the OK button again. Figure 3.27 Ch.3 NOTE Figure 3.28 When the Manual Cleaning and Leak Test Setting is activated, select the manual cleaning and leak testing results after Step 4. For detail, refer to Input results of manual cleaning and leak test of second endoscope on page 214. 5 When the scope ID is completed to enter, the ID select screen appears. Figure 3.29 OER-Elite OPERATION MANUAL 55 3.6 Entering ID Patient ID entry NOTE When the patient ID setting is not activated, patient ID cannot be entered. 1 Press the Edit button of the patient ID on the ID select screen. Ch.3 Figure 3.30 56 OER-Elite OPERATION MANUAL 3.6 Entering ID 2 The software keyboard (on-screen) is opened. Enter the ID number of the patient on the software keyboard (on-screen). Alphabet input Numeral input 1 2 3 4 5 6 1 2 3 4 5 6 Ch.3 7 8 9 8 9 No. 1 2 3 4 5 6 7 8 9 Button Alphabet/
Numeral key Uppercase/
Lowercase Numeric/
Alphabetic Backspace Space button Cursor move Name Cancel Save Enter an alphabet or a numeral. Note Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. Press the Backspace button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Press the Space button to insert a space character. Press the cursor move button to move the cursor left or right. Press Name or ID button to switch the input mode between a Name and an ID. Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 3 Press the Name button. OER-Elite OPERATION MANUAL 57 Figure 3.31 3.6 Entering ID 4 Enter the patient name. Ch.3 5 Press the Save button. Figure 3.32 6 When the patient ID is completed to enter, the following screen appears. Figure 3.33 Figure 3.34 58 OER-Elite OPERATION MANUAL 3.6 Entering ID Physician ID, user ID, or procedure ID entry 1 Press the Edit button to enter each ID on the ID select screen. 1 2 3 Ch.3 No. 1 Button Edit physician ID button Note Opens the physician ID list. When the physician ID setting is not activated, item of the physician ID is not displayed. For physician ID setting, refer to Section 4.6, Physician ID setting. 2 3 Edit user ID button Opens the user ID list. When the user ID setting is not activated, item of the user ID is Edit procedure ID button not displayed. For user ID setting, refer to Section 4.5, User ID Setting. Opens the procedure ID list. When the procedure ID setting is not activated, item of the procedure ID is not displayed. For procedure ID setting, refer to Section 4.9, Procedure ID setting. OER-Elite OPERATION MANUAL 59 3.6 Entering ID 2 Then the ID list is displayed. When the ID is not listed on the ID list, go to (a) Select each ID that is not listed on page 61. When the Scope ID is listed on the ID list, go to
(b) Recalling the pre-registered ID on page 63. 1 2 3 4 5 Ch.3 No. 1 2 3 4 5 6 7 8 Item/Button ID type Name ID Edit buttons Set buttons Previous page button Next page button Back 6 7 8 Note Type of the currently edited ID. Name of the registered IDs. These areas are blank if no ID has been registered. ID number of registered IDs. These areas are blank if no ID has been registered. Press one of the buttons to open the ID information edit screen. Press one of the buttons to set a registered ID. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to close the ID select screen. 60 OER-Elite OPERATION MANUAL 3.6 Entering ID
(a) Select each ID that is not listed 1 Press the Edit button that no ID has been registered. 2 The software keyboard (on-screen) is opened. Enter the ID number of the physician, user, or procedure on the software keyboard (on-screen). Figure 3.35 Alphabet input Numeral input Ch.3 1 2 3 No. 1 2 3 4 5 6 7 8 9 4 5 6 1 2 3 4 5 6 7 8 9 7 8 9 Button Alphabet/
Numeral key Uppercase/
Lowercase Numeric/
Alphabetic Backspace Space Cursor move Delete Cancel Save Enter an alphabet or a numeral. Note Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. Press the Backspace button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Press the Space button to insert a space character. Press the Cursor move button to move the cursor left or right. Press the Delete button to delete about all information. Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. OER-Elite OPERATION MANUAL 61 3.6 Entering ID 3 Press the Name button. Ch.3 4 Enter the physician, user, or procedure name. Figure 3.36 5 Press the Save button. Figure 3.37 Figure 3.38 62 OER-Elite OPERATION MANUAL 6 When the ID is completed to enter, the following screen appears. 3.6 Entering ID Figure 3.39 Ch.3
(b) Recalling the pre-registered ID NOTE The ID edited on (a) Select each ID that is not listed is registered to the ID list. The ID list can be edited on the list management function. For detail, refer to Section 12.3 List management. 1 Press the Set button for the ID to be recalled. 2 When the ID is completed to enter, the following screen appears. Figure 3.40 Figure 3.41 OER-Elite OPERATION MANUAL 63 3.6 Entering ID Confirmation of the input ID 1 Open the ID select screen. 2 Confirm each ID information. Ch.3 1 4 7 10 13 3 6 9 12 15 2 5 8 11 14 16 No. 1 2 3 4 5 6 7 8 9 10 Item/Button Note View Scope ID information Displays the scope ID information (endoscope type and serial number). This area is blank when no scope ID has been input. Opens the scope ID list to modify. Deletes the input scope ID information. Displays the patient ID information (patient name and ID number). This area is blank when no patient ID has been input. Opens the patient ID list to modify. Deletes the input patient ID information. Displays the physician ID information (physician name and ID number). This area is blank when no physician ID has been input. Opens the physician ID list to modify. Edit Scope ID button Delete Scope ID button View Patient ID information Edit Patient ID button Delete Patient ID button View Physician ID information Edit Physician ID button Delete Physician ID button Deletes the input physician ID information. View user ID information Edit user ID button 11 12 Delete user ID button 13 View procedure ID information Edit procedure ID button Displays the user ID (load) information (user name and ID number). This area is blank when no user ID has been input. Opens the user ID list to modify. Deletes the input user ID information. Displays the procedure ID information (procedure name and ID number). This area is blank when no procedure ID has been input. Opens the procedure ID list to modify. 14 15 Delete procedure ID button Deletes the input procedure ID information. 16 OK button Returns to the Reprocessing standby screen. 64 OER-Elite OPERATION MANUAL 3.6 Entering ID Entering the patient ID by the optional bar code To input the patient ID from a bar code, it is required to connect the optional MAJ-2130 bar code reader. For the installation of the bar code reader, refer to the Instructions - Installation Manual for this reprocessor and the Instructions for the MAJ-2130 bar code reader. CAUTION Do not connect anything other than the designated bar code reader to the bar code port. Otherwise, the IDs may not be read out correctly or the instrument may malfunction. Ch.3 NOTE A patient ID can be input by either bar cord reader or software keyboard
(on-screen), but a patient name can be input only by the software keyboard. It is possible to input the patient name by software keyboard (on-screen) after entering the patient ID by the bar code reader. The OER-Elite can read the top 23 characters of each bar code. When the bar code contains data other than patient data, the reprocessor reads all of 23 characters including data other than the patient data that a bar code has. Do not alter the settings of the bar code reader. It has been set to the optimum settings for combined use with this reprocessor. If the Settings are altered, it may be impossible to read the bar code, contact Olympus. OER-Elite OPERATION MANUAL 65 3.6 Entering ID Readable bar code standards The optional MAJ-2130 bar code reader can read below as a bar cord standards. Ch.3 UPC/EAN Code 128 GS1-128 Code 39 Trioptic Code 39 Code 93 Code 11 Interleaved 2 of 5 Discrete 2 of 5 Codabar MSI Chinese 2 of 5 Matrix 2 of 5 Korean 3 of 5 Inverse 1D GS1 DataBar Composite Codes 66 OER-Elite OPERATION MANUAL 3.6 Entering ID Scanning area of the bar code reader When the bar code reader scans a bar code, the bar code reader projects a green aiming pattern. The scanning pattern of the bar code reader is formed by the aiming pattern. When the entire bar code does not cross the scanning pattern, the bar code reader cannot scan the entire bar code. For how to install the bar code reader (for example setting), refer to Figure 3.43. Bar code Aiming pattern Ch.3 Suitable examples Unsuitable examples Figure 3.42 Figure 3.43 OER-Elite OPERATION MANUAL 67 3.6 Entering ID Reading a bar code Ch.3 1 Press the Reprocessing button on the touch screen. 2 Place the bar code under the bar code reader to read the bar code and adjust the distance between them so that the entire bar code is within the scanning area of the bar code reader. When the bar code reader succeeds in scanning of the bar code, the bar code reader sounds a short beep. If the bar code reader does not sound a short beep, correct problems in reference to the instruction manual for the bar code reader MAJ-2130 or Section 13.2, Troubleshooting guide. NOTE If the bar code reader does not sound a short beep, correct problems in reference to the instruction manual for the bar code reader MAJ-2130 and Section 13.2, Troubleshooting guide. 3 The touch screen displays data scanning form bar code as shown in the following figure. Check if the patient ID matches the actual patient information. Screen of information on the input ID Figure 3.44 68 OER-Elite OPERATION MANUAL 3.7 Checking the MRC level and entering the check result 3.7 Checking the MRC level and entering the check result Before starting any of the following processes, be sure to check that the concentration of the disinfectant solution is no less than the Minimum Recommended Concentration (MRC). If the concentration is below the recommended minimum concentration or the shelf life of the disinfectant solution has expired, replace the disinfectant solution. The result of MRC can be recorded with the reprocessor.
Reprocessing
Leaking scope decontamination
Water line disinfection
Self-disinfection & Water sampling
Detergent line disinfection
Alcohol line disinfection WARNING Ch.3 The use life of the disinfectant solution may vary depending on many factors, including storage conditions, and the temperature of the environment where the reprocessor is installed. Routinely check the concentration of the disinfectant solution with the test strip before performing endoscope disinfection. If this check is not performed, the disinfection process may be ineffective. Replace the disinfectant solution when it fails to meet the minimum recommended concentration or beyond the specified use life. Before handling the disinfectant solution, read the SDS and instructions for use of the disinfectant solution carefully, get fully accustomed to the contents, and use the disinfectant solution as instructed. Be sure to fully understand what to do if the disinfectant solution comes in contact with your skin and eyes. When handling the disinfectant solution, wear appropriate personal protective equipment. Avoid direct physical contact and inhalation of vapors. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Personal protective equipment includes eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically. If personal protective gear is damaged or defective in anyway, do not handle hazardous chemicals and refer to the facility policies. OER-Elite OPERATION MANUAL 69 3.7 Checking the MRC level and entering the check result Required items Check Required Items Chemical indicator (Test strip) Clean cloth Table 3.2 NOTE Ch.3 For the usable test strips, refer to Section 2.8, Consumable accessories
(Optional). Checking the MRC level WARNING Since the period of validity of the disinfectant solution varies depending on multiple factors including the storage condition and the environmental temperature of the reprocessors installation location, be sure to check the concentration of the disinfectant solution before reprocessing endoscopes. If the concentration is below the recommended minimum concentration or the validity date specified for the disinfectant solution has expired, replace the disinfectant solution. Otherwise, the endoscope reprocessing would become insufficient. NOTE If you collect the disinfectant solution from the drain port, the reduction of the solution inside the disinfectant solution tank may make it impossible to start reprocessing. 70 OER-Elite OPERATION MANUAL 3.7 Checking the MRC level and entering the check result Checking the MRC level 1 Press the foot pedal to open the lid. 2 Uncap the disinfectant solution nozzle of the reprocessing basin by turning the disinfectant solution nozzle cap in the direction shown right. Disinfectant solution nozzle cap Ch.3 3 Insert the test strip all the way into the disinfectant solution nozzle and check the MRC as described in the test strip instruction manual. If the concentration is lower than the effective level, replace the disinfectant solution by following the instructions in Section 8.2, Replacing the disinfectant solution. Figure 3.45 Figure 3.46 NOTE Under high temperature and extreme temperature fluctuations, test strip may result in fail. In such cases, Olympus recommends performing mix LCG and check the MRC level again. Depending on conditions of internal valve, there is a possibility that no disinfectant solution exist in the disinfectant solution nozzle. In the following cases, perform the mix LCG, then check the MRC level again.
No reaction is observed on the chemical indicator after checking the MRC level.
Reaction is observed only from the edge parts of the chemical indicator after checking the MRC level. If the disinfectant solution in the disinfectant solution nozzle is found insufficient for checking the MRC level on a regular basis, contact Olympus. OER-Elite OPERATION MANUAL 71 3.7 Checking the MRC level and entering the check result 4 Attach the disinfectant solution nozzle cap to the original position on the disinfectant solution nozzle. Make sure that the pin returns to the original position, and the projection of the disinfectant solution nozzle cap is aligned to the projection of the disinfectant solution nozzle. Pin projection Ch.3 Figure 3.47 NOTE Be sure to return the disinfectant solution nozzle cap to the original position. Otherwise, the disinfectant solution inside the nozzle may be diluted in the next process and next MRC check will be failed even if the concentration of LCG in the tank is above its MRC. In this case, perform mix LCG, then check MRC again. Entering the check result 1 Display the Reprocessing Standby screen and Press the MRC Check button. Figure 3.48 72 OER-Elite OPERATION MANUAL 3.7 Checking the MRC level and entering the check result NOTE If the touch screen displays a screen as shown in following figure, perform the LCG Mixing. If not completed Mix LCG, cannot see the MRC check result. For detailed on Mix LCG, refer to Section 7.4, Mix LCG. Ch.3 Figure 3.49 2 Select the button that corresponds with the result of the MRC check. The button turns white. Select the result of the MRC check using the test strip. Figure 3.50 OER-Elite OPERATION MANUAL 73 3.7 Checking the MRC level and entering the check result NOTE Input the user ID by following the instructions in Section 3.6, Entering ID (If applicable). Hold the user ID card in parallel with the ID reader section of the reprocessor or press the Edit button for software keyboard input. Ch.3 Figure 3.51 The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. 3 Press the Save button. Figure 3.52 NOTE If the Save button is pressed after Fail has been selected, the processes that use the disinfectant solution cannot be started. 74 OER-Elite OPERATION MANUAL 4.1 Setting menu Chapter 4 Settings 4.1 Setting menu To change the settings of the reprocessor, press Settings on the Menu Screen. This menu is composed of three pages. To go between the pages, press the next page button or the previous page button. Ch.4 OER-Elite OPERATION MANUAL 75 4.1 Setting menu 1 2 3 Ch.4 No. 1 Button Setting item button Page 1 Auto Leak Test Setting Description Press to display the buttons for starting various Functions. Press the button for the desired function. This setting sets the timing of auto leak test when it is included in the reprocessing process. oRefer to Section 4.2, Auto leak test setting. MRC Check Setting When this setting is activated and the MRC check result is not input before Manual Cleaning and Leak Test Setting Patient ID Security Setting User ID Setting Physician ID Setting start of the following process, the reprocessor inhibits the start of the following process and message screen is displayed. oRefer to Section 4.3, MRC check setting. When this setting is activated, the confirmation results of a manual cleaning and the leak test before manual cleaning can be selected after the scope ID input. oRefer to Section 4.4, Manual cleaning and leak test setting. When the setting is activated, patient data will not be exported or printed from the OER-Elite. Even this setting is activated, data except the patient data can be exported to the portable memory or printed. oRefer to Section 4.8, Patient ID security setting. When this setting is activated, the user ID can be input in each process. oRefer to Section 4.5, User ID Setting. When this setting is activated, the physician ID of the endoscope performing the examination can be input before starting reprocessing process and leaking scope decontamination and recorded in the reprocessing record. oRefer to Section 4.6, Physician ID setting. Patient ID Setting When this setting is activated, the ID of the patient receiving the endoscopic Procedure ID Setting 2 Menu button 3 Next page button examination can be input and recorded in the reprocessing records. oRefer to Section 4.7, Patient ID setting. When this setting is activated, the procedure ID can be entered before starting Reprocessing. oRefer to Section 4.9, Procedure ID setting. Press to go to the Menu. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. 76 OER-Elite OPERATION MANUAL 4.1 Setting menu 1 No. 1 Page 2 Button Detergent Replacement Indicator Detergent Lot # &
Shelf-Life Management LCG Replacement Indicator LCG Lot # &
Shelf-Life Management Filter Replacement Indicator Filter Lot #
Management Auxiliary Water Tube Cleaning Setting Print Option 2 Menu button 3 LCG Info. button 4 5 Previous page button Next page button 2 3 4 5 Description Ch.4 When this setting is activated, the reprocessor counts the day count (number of days the detergent is effective after replacement) after each replacement of detergent and displays the detergent replacement indicator when the day counts reach to the set value. After reaching to the set value, a pop-up message screen opens prior to the start of reprocessing and inhibit starting the process. oRefer to Section 4.10, Detergent replacement indicator. This setting sets the shelf life and lot number that are input when replacing the detergent. oRefer to Section 4.11, Detergent lot number and shelf-life management. This setting sets the display of the disinfectant solution replacement indicator. oRefer to Section 4.12, LCG replacement indicator. This setting sets the shelf life and lot number that are input when replacing the disinfectant solution. oRefer to Section 4.13, LCG lot number and shelf-life management. This setting sets the display of the Filter Replacement Indicator. oRefer to Section 4.14, Filter replacement indicator. This setting sets the lot number that is input when replacing the filters. oRefer to Section 4.15, Filter lot number management. This setting sets the reprocessing of the auxiliary water tube together with endoscopes. oRefer to Section 4.16, Auxiliary water tube cleaning setting. This setting sets the auto printing of the result of reprocessing, auto leak test, manual leak test or leaking scope decontamination. To activate this setting, an optional MAJ-2144 printer set is necessary. oRefer to Section 4.17, Print option. Press to go to the Menu. Press to open the LCG Info. display. oRefer to Section 3.5, LCG Info. screen. Press to return to the previous. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. OER-Elite OPERATION MANUAL 77 4.1 Setting menu 1 Ch.4 No. 1 Page 3 Button Start Screen Connection Guide Volume and Brightness Date and Time 2 3 4 Description This setting sets the display that appears after the startup display at power ON. oRefer to Section 4.18, Start screen. This setting sets the automatic display of the Connection Guide screen after the Scope ID reading in the reprocessing program. oRefer to Section 4.19, Connection guide. This setting sets the volume of buzzer sound, etc., the brightness of the touch screen and the panel press tone. oRefer to Section 4.20, Volume and brightness. This setting sets the date display format and the clock of the reprocessor. oRefer to Section 4.21, Date and time. Temperature Scale This setting sets the scale used in the disinfectant solution temperature Network Network Security 2 Menu button 3 LCG Info. button 4 Previous page button display. oRefer to Section 4.22, Temperature scale. This setting sets the information required for connecting the reprocessor to a Network. oRefer to Section 4.23, Network setting. This setting sets the security of the Network-related Settings. oRefer to Section 4.24, Network security. Press to go to the Menu. Press to open the LCG Info. display. oRefer to Section 3.5, LCG Info. screen. Press to return to the previous. When there is no further page to turn back to, the button turns gray and becomes unavailable. 78 OER-Elite OPERATION MANUAL 4.2 Auto leak test setting 4.2 Auto leak test setting This setting is to set the timing of the auto leak test when this function is included in the reprocessing process. For the auto leak test in the reprocessing process, refer to Auto leak test on page 221. CAUTION Always perform leak test in a sink before manual cleaning. If the endoscope has a water leaking point, water may penetrate the scope during manual cleaning, in which case the scope may break down. Ch.4 1 Select the Auto Leak Test Setting on the settings menu. OER-Elite OPERATION MANUAL 79 4.2 Auto leak test setting 2 Select setting from options. 1 Ch.4 2 3 No. 1 Item/Button ALT setting Setting options Beginning of the process End of the process
(default) 2 3 Cancel Save NOTE Description Auto leak test is performed at the starting of Reprocessing. The reprocessing process time is extended by about 2 minutes. If Beginning of the process is selected and hot water is used for manual cleaning, the ALT result may be Leaked even though the endoscope has no leakage. The leak test result may become Leaked depending on the temperature of the endoscope. To perform auto leak test with the ultrasonic endoscope, wait for more than 30 minutes. To perform it with the other type of endoscope, wait for more than 15 minutes. Auto leak test is performed at the end of Reprocessing. The reprocessing process time is extended by about 2 7 minutes. When End of the process was chosen and there is a leak with an endoscope, water may enter the endoscope from the leakage point. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. 80 OER-Elite OPERATION MANUAL 4.3 MRC check setting 4.3 MRC check setting When this setting is activated and the MRC check result is not input before start of the following process, the reprocessor inhibits the start of the following process and message screen is displayed.
Reprocessing
Leaking Scope Decontamination
Water Line Disinfection
Self-disinfection & Water sampling
Detergent Line Disinfection
Alcohol Line Disinfection NOTE Ch.4 This setting is provided to prevent forgetting of the input of the MRC check result. The MRC check result can be input even when this setting is disabled. 1 Select MRC Check Setting on the settings menu. 2 Select setting from options. 1 2 3 Item/Button No. 1 MRC Check Setting OFF Setting options ON (default) 2 3 Cancel Save Description The reprocessing process starts even if the disinfectant solution concentration check result is not input. If the disinfectant solution concentration check result is not input before start of the process, the reprocessor inhibits start of the process and notifies that the check result is not input. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. OER-Elite OPERATION MANUAL 81 4.4 Manual cleaning and leak test setting NOTE The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. 4.4 Manual cleaning and leak test setting Ch.4 When this setting is activated, users can confirm if a manual cleaning and leak test have been performed based on the scope ID. When the setting is On, those inputs are necessary. The manual cleaning and leak test confirmations are linked to the scope ID's reprocessing records or leaking scope decontamination records. 1 Select Manual Cleaning and leak test Setting on the settings menu. 2 Select setting from options. 1 2 3 Item/Button No. 1 Manual Cleaning and leak test Setting Setting options OFF ON (default) 2 3 Cancel Save NOTE Description Disables the data entry for result of manual cleaning and leak test. Before starting Reprocessing and Leaking Scope Decontamination are entered for each endoscope's result about manual cleaning and leak test. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. The selected settings are displayed with white buttons. 82 OER-Elite OPERATION MANUAL 4.5 User ID Setting 3 Press the Save button to save the selected setting. 4.5 User ID Setting When this setting is activated, the user ID can be inputted in each process and the process cannot be started without inputting User ID. 1 Select User ID setting on the Settings menu. 2 Select the function to change the user ID setting. Ch.4 1 2 3 4 5 6 No. 1 2 3 Button Reprocessing Functions & Replacement of Consumable Items Heat LCG Timer 4 Menu 5 6 LCG Info. Cancel Description Goes to the user ID Setting for Reprocessing. oRefer to User ID setting (reprocessing) on page 84. Goes to the user ID Setting for Functions and Replacement of Consumable Items. oRefer to User ID setting (functions and replacement) on page 86. Goes to the user ID Setting for Heat LCG Timer. oRefer to User ID setting (Heat LCG Timer) on page 87. Returns to the Menu screen. Open the disinfectant information screen. Returns to the Setting menu. OER-Elite OPERATION MANUAL 83 4.5 User ID Setting User ID setting (reprocessing) When this setting is activated, User ID can be entered before and/or after starting reprocessing process and recorded in the reprocessing record. 1 Select the setting for user ID entry before beginning of reprocessing process. 1 2 3 Ch.4 No. 1 2 4 5 Setting Options Description Disables the user ID entry before starting reprocessing process. One User ID can be input for two endoscopes before starting reprocessing process. User ID can be input for each endoscope before starting reprocessing process. Returns to the previous screen. Goes to the next setting. OFF
(A) ON 3 4 5
(B) ON (default) Cancel Next NOTE The selected settings are displayed with white buttons. Only one User ID can be input at the end of reprocessing process. If the setting is activated, User ID input before beginning reprocessing process cannot be skipped. 2 Press the Next button. 84 OER-Elite OPERATION MANUAL 3 Select the setting for User ID entry at the end of reprocessing process. 4.5 User ID Setting 1 2 No. 1 2 Setting Options OFF ON (default) 3 4 Back Save NOTE 3 4 Ch.4 Description Disable the user ID entry at the end of reprocessing process. User ID can be input at the end of reprocessing process. The lid is locked until user ID entry is completed. Returns to the previous screen. Returns to two previous menu after saving the selected setting. The selected settings are displayed with white buttons. If the setting is activated, user ID input at the end of reprocessing process cannot be skipped. 4 Press the Save button to save the selected settings. OER-Elite OPERATION MANUAL 85 4.5 User ID Setting User ID setting (functions and replacement) When this setting is activated, user ID can be entered before starting each process of Functions and Replacement of Consumable Items and recorded in the reprocessing record. 1 Select setting from options. Ch.4 1 2 3 No. 1 Item/Button User ID Setting
(Functions &
Replacement of Consumable Items) Setting options OFF ON (default) 2 3 Cancel Save Description Disable the user ID entry for Functions and Replacement of Consumable Items. User ID can be input before starting each process of Functions and Replacement of Consumable Items. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. 2 Press the Save button to save the selected setting. 86 OER-Elite OPERATION MANUAL 4.5 User ID Setting User ID setting (Heat LCG Timer) When this setting is activated, user ID can be entered before starting Heat LCG Timer and recorded in the reprocessing record. 1 Select setting from options. 1 Ch.4 2 3 No. 1 Item/Button User ID Setting
(Heat LCG Timer) 2 3 Cancel Save Setting options OFF ON (default) Description Disable the user ID entry for Heat LCG Timer. Before starting Heat LCG Timer are entered the user ID. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. 2 Press the Save button to save the selected setting. OER-Elite OPERATION MANUAL 87 4.6 Physician ID setting 4.6 Physician ID setting When this setting is activated, the physician ID of the endoscopist can be input before starting reprocessing process and leaking scope decontamination and recorded in the reprocessing record. 1 Select Physician ID Setting on the settings menu. 2 Select setting from options. Ch.4 1 2 3 No. 1 Item/Button Physician ID Setting Setting options OFF ON (default) 2 3 Cancel Save NOTE Description Disable the physician ID entry for Reprocessing and Leaking Scope Decontamination. User can enter the physician ID before starting Reprocessing and Leaking Scope Decontamination. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. 88 OER-Elite OPERATION MANUAL 4.7 Patient ID setting 4.7 Patient ID setting When this setting is activated, the ID of the patient receiving the endoscopic examination can be input and recorded in the reprocessing records and recorded in the reprocessing record. 1 Select Patient ID Setting on the settings menu. 2 Select setting from options. 1 Ch.4 2 3 No. 1 Item/Button Patient ID Setting Setting options OFF ON (default) 2 3 Cancel Save NOTE Description Disable the patient ID entry for Reprocessing and Leaking Scope Decontamination. User can enter the patient ID before starting Reprocessing and Leaking Scope Decontamination. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. OER-Elite OPERATION MANUAL 89 4.8 Patient ID security setting 4.8 Patient ID security setting When the setting is activated, patient data will not be exported or printed from the OER-Elite. Even this setting is activated, all data, with exception of patient data can be exported to the portable memory or printed and recorded in the reprocessing record. 1 Select Patient ID Security Setting on the settings menu. 2 Select setting from options. Ch.4 1 2 3 No. 1 Item/Button Patient ID Security Setting Setting options OFF (default) 2 3 Cancel Save ON NOTE Description The patient ID is printed on the printer and output to a portable memory. The printout of the patient ID and its output to a portable memory are inhibited. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. 90 OER-Elite OPERATION MANUAL 4.9 Procedure ID setting 4.9 Procedure ID setting When this setting is activated, the procedure ID can be entered before starting reprocessing process and recorded in the reprocessing record. 1 Select Procedure ID on the Settings menu. 2 Select setting from options. 1 Ch.4 2 3 No. 1 Item/Button Procedure ID Settings Setting options OFF ON (default) 2 3 Cancel Save NOTE Description Disable the procedure ID entry for Reprocessing and Leaking scope decontamination. User can enter the procedure ID before starting Reprocessing and Leaking scope decontamination. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. The selected settings are displayed with white buttons. 3 Press the Save button to save the selected settings. OER-Elite OPERATION MANUAL 91 4.10 Detergent replacement indicator 4.10 Detergent replacement indicator When this setting is activated, the reprocessor counts the day count (number of days the detergent is effective after replacement) after each replacement of detergent and displays the detergent replacement indicator when the day counts reach to the set value. After reaching to the set value, a pop-up message screen opens prior to the start of reprocessing. NOTE Ch.4 For details of the indicator, refer to Section 3.2, Alarm indicator. When replace the consumable item after changing date and time, the Detergent replacement indicator might not be displayed incorrectly. 1 Select Detergent Replacement Indicator on the settings menu. 2 Select setting from options of the Detergent replacement indicator. To change the setting value, press Edit button. 1 2 3 4 No. 1 Item/Button Detergent replacement indicator Setting options OFF ON (default) 2 3 4 Edit Cancel Save NOTE Description Disables the detergent replacement indicator. The reprocessor counts the day count (number of days the detergent is effective after replacement) after each replacement of detergent. And the detergent replacement indicator is displayed when the day count is reached to the set value. Goes to the screen for editing set value of day count. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. The selected settings are displayed with white buttons. 92 OER-Elite OPERATION MANUAL 4.10 Detergent replacement indicator 3 If Edit button is pressed in the previous screen, following screen is displayed. Edit the number of days, and press OK button. 1 2 3 Ch.4 No. 1 Item/Button Days Setting options 1 30 [days]
(default: 30) 2 3 Cancel OK Description Sets the set value of days for the detergent replacement indicator. Pressing the + button increments the setting and pressing the button decrements it. Returns to the previous screen without saving the edited information. Returns to the previous menu after saving the edited information. 4 Press the Save button to return to the Setting menu after saving the edited information. Figure 4.1 NOTE For details of the indicator, refer to Section 3.2, Alarm indicator. OER-Elite OPERATION MANUAL 93 4.11 Detergent lot number and shelf-life management 4.11 Detergent lot number and shelf-life management When this setting is activated, the detergent lot number and shelf life can be input during a detergent replacement. For details on replacement of each information, both information is referred to Section 8.2, Replacing the disinfectant solution and Section 8.3, Replacing the detergent tank. The reprocessor displays the detergent replacement indicator when the shelf life is reached. After reaching the shelf life, a pop-up message screen opens prior to the start of reprocessing and inhibits starting the process. The lot number and shelf life are linked with the detergent replacement record. Ch.4 1 Select Detergent Lot #& shelf life management on the Setting menu. 2 Select each setting from options. 1 2 3 4 Setting options OFF (default) ON OFF (default) ON Description Disables the lot number entry for detergent. User can enter lot number of detergent. Disables the shelf-life entry for detergent. User can enter shelf-life of detergent. Returns to the Setting menu without saving the selected settings. Returns to the Setting menu after saving the selected settings. No. 1 Item/Button Lot # Management
(Detergent) 2 3 4 Shelf-life Management
(Detergent) Cancel Save NOTE The selected settings are displayed with white buttons. 3 Press the Save button to return to the Setting menu after saving the selected settings. 94 OER-Elite OPERATION MANUAL 4.12 LCG replacement indicator 4.12 LCG replacement indicator When this setting is activated, the reprocessor counts a LCG day count (number of days the disinfectant solution is effective after replacement) and a LCG usage count (number of cycles the disinfectant solution is effective after replacement) after Loading LCG process. In addition, the reprocessor displays the disinfectant replacement indicator when the day counts or the usage counts reach each set value. You can set the number of days and the maximum number of disinfection cycles prior to replacement of the disinfectant solution. The reprocessor indicates the replacement timing when the set value for the elapsed days or operations is reached as a reference or reminder for disinfectant solution replacement. Note that this reprocessor does not determine the degradation of the disinfectant concentration. It is recommended to update the set value according to changes in the operating environment, etc. Ch.4 WARNING Be sure to check a concentration of the disinfectant solution by using a separately available test strips. The LCG replacement indicator does not determine the effectiveness of the disinfectant solution. The expiration of the disinfectant solution varies depending on many factors including the time after activation, the temperature of the environment where the reprocessor is installed, and the number and types of endoscopes that have been reprocessed. The LCG replacement indicator does not take these and other factors into consideration. NOTE For details of indicator, refer to Section 3.2, Alarm indicator. When replace the consumable item after changing date and time, the disinfectant solution replacement indicator might not be displayed incorrectly. OER-Elite OPERATION MANUAL 95 4.12 LCG replacement indicator 1 Select LCG Replacement Indicator on the Setting menu. 2 Select setting from options. To change the setting value, press Edit button. 1 2 Ch.4 3 4 No. 1 Item/Button LCG Replacement Indicator Setting options OFF ON (default) 2 3 4 Edit Cancel Save NOTE Description Disables the LCG replacement indicator. The LCG replacement indicator is displayed when a day count or usage count is reached to the set value. Edit the setting value. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. The selected settings are displayed with white buttons. 96 OER-Elite OPERATION MANUAL 4.12 LCG replacement indicator 3 If Edit button is pressed in the previous screen, following screen is displayed. Edit the number of days and cycles, and press OK button. 1 2 3 4 Ch.4 No. 1 2 3 4 Item/Button Days Cycles Cancel OK Setting options 1 5 [days]
(default: 3) 1 35 [usages]
(default: 15) Description Sets the set value of days for the LCG replacement indicator. Pressing the + button increments the setting and pressing the button decrements it. Sets the set value of cycles for the LCG replacement indicator. Pressing the + button increments the setting and pressing the button decrements it. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. 4 Press the Save button to return to the Setting menu after saving the edited information. Figure 4.2 NOTE For details of the indicator, refer to Section 3.2, Alarm indicator. OER-Elite OPERATION MANUAL 97 4.13 LCG lot number and shelf-life management 4.13 LCG lot number and shelf-life management When this setting is activated, the disinfectant solution lot number and shelf life can be input during Loading LCG process. If the shelf life is reached, both the message and disinfectant replacement indicator are displayed on the screen and the reprocessor inhibits starting the process automatically. For details how to do setting the Lot number and shelf-life, refer to Section 8.2, Replacing the disinfectant solution. 1 Select LCG Lot # & Shelf-Life Management on the Setting menu. 2 Select each setting from options. Ch.4 1 2 3 4 Setting options OFF (default) ON OFF (default) ON Description Disables the lot number entry for disinfectant solution. Enables the lot number is entered for disinfectant solution. Disables the shelf-life entry for disinfectant solution. User can enter shelf-life of disinfectant solution. Returns to the Setting menu without saving the selected settings. Returns to the Setting menu after saving the selected settings. No. 1 Item/Button Lot # Management
(Disinfectant) 2 3 4 Shelf-life Management
(Disinfectant) Cancel Save NOTE The selected settings are displayed with white buttons. 3 Press the Save button to return to the Setting menu after saving the selected settings. 98 OER-Elite OPERATION MANUAL 4.14 Filter replacement indicator 4.14 Filter replacement indicator When this setting is activated, the reprocessor displays the filter replacement indicator when day counts of each filter reach the set value. After reaching the set value, a pop-up message screen opens soon after powering ON the reprocessor. When this setting is activated, the reprocessor counts the day count (number of days of the each filter is effective after replacement) after each replacement of filters. If the day counts reach the set value, both the message and the filter replacement indicator are displayed on the touch screen. NOTE For details of indicator, refer to Section 3.2, Alarm indicator. When replace the consumable item after changing date and time, the filter replacement indicator might not be displayed incorrectly. Ch.4 1 Select Filter Replacement Indicator on the Setting menu. 2 Select each setting from options. To change the setting value, press Edit button. OER-Elite OPERATION MANUAL 99 4.14 Filter replacement indicator 1 3 5 2 4 6 Ch.4 Item/Button No. 1 Water filter replacement indicator Edit Air filter replacement indicator Edit Gas filter replacement indicator Edit Cancel Save 2 3 4 5 6 7 8 7 8 Setting options OFF ON (default) OFF ON (default) OFF ON (default) Description Disables the filter replacement indicator of water filter. The water filter replacement indicator is displayed when the day count is reached the set value. To change the day count of water filter, press the Edit button to open the Water Filter Indicator screen. oRefer to Editing the set value for water filter on page 101. Disables the filter replacement indicator of air filter. The air filter replacement indicator is displayed when the set day count is reached. To change the day count of the air filter, press the Edit button to open the Air Filter Indicator screen. oRefer to Editing the setting value for air filter on page 102. Disables the filter replacement indicator of gas filter. The gas filter replacement indicator is displayed when the set day count is reached. To change the day count of the gas filters on lid and tank, press the Edit button to open the Gas Filter Indicator screen. oRefer to Editing the set value for gas filter on page 102. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. NOTE The selected settings are displayed with white buttons. 3 Press the Save button to save the edited information. 100 OER-Elite OPERATION MANUAL 4.14 Filter replacement indicator Editing the set value for water filter 1 2 3 4 Ch.4 No. 1 Item/Button Pre-filtering Setting options With the pre-filter When the pre-filter is used, select this option to expand the setting Description 2 Days Without the pre-filter (default) 1 180 [days]
or 1 30 [days]
(default: 30) 3 4 Cancel OK NOTE range of day count up 180 days. When the pre-filter is not used, select this option to restrict the setting range of day count 30 days. Sets the set value of days for the filter replacement indicator of water filter. Pressing the + button increments the setting and pressing the button decrements it. The setting range varies depending on the usage of pre-filter. Returns to the previous screen without saving the edited information. Returns to the previous screen after saving the edited information. The selected settings are displayed with white buttons. OER-Elite OPERATION MANUAL 101 4.14 Filter replacement indicator Editing the setting value for air filter 1 Ch.4 2 3 No. 1 Item/Button Days Setting options 1 30 [days]
(default: 30) 2 3 Cancel Save Description Sets the set value of days for the filter replacement indicator of air filter. Pressing the + button increments the setting and pressing the button decrements it. Returns to the previous screen without saving the edited information. Returns to the previous screen after saving the edited information. Editing the set value for gas filter 1 2 3 No. 1 Item/Button Days Setting options 1 30 [days]
(default: 30) 2 3 Cancel Save Description Sets the set value of days for the filter replacement indicator of gas filter. Pressing the + button increments the setting and pressing the button decrements it. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. 102 OER-Elite OPERATION MANUAL 4.15 Filter lot number management 4.15 Filter lot number management When this setting is activated, filter lot number can be input during replacement of a water, air, or gas filter. For details on replacement of each filters, water filter is referred to Section 8.4, Replacing the water filter (MAJ-824 or MAJ-2318), air filter is referred to Section 8.5, Replacing the air filter
(MAJ-823), and gas filter is referred to Section 8.6, Replacing the gas filter (MAJ-822). 1 Select Filter Lot # Management on the Setting menu. 2 Press ON or OFF button for each setting. Ch.4 1 3 2 4 5 6 Item/Button No. 1 Water Filter 2 3 4 5 6 Air Filter Gas Filter (Lid) Gas Filter (Tank) Cancel Save Setting options OFF (default) ON OFF (default) ON OFF (default) ON OFF (default) ON Description Disables the lot number entry for water filter. Enables the lot number is entered for water filter. Disables the lot number entry for air filter. User can enter the lot number of air filter. Disables the lot number entry for gas filter on the lid. User can enter the lot number of gas filter on the lid. Disables the lot number entry for gas filter on the tank. User can enter the lot number of gas filter on the tank. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. NOTE The selected settings are displayed with white buttons. 3 Press the Save button to save the selected settings. OER-Elite OPERATION MANUAL 103 4.16 Auxiliary water tube cleaning setting 4.16 Auxiliary water tube cleaning setting When this setting is activated, an auxiliary water tube (MAJ-855) can be reprocessed simultaneously with an endoscope with water jet function by using dedicated connecting tube MAJ-2138. In this case, two endoscopes with two auxiliary water tubes can be reprocessed in one reprocessing process. To obtain optional connecting tube MAJ-2138, contact Olympus. WARNING Ch.4 If the setting is activated, always use connecting tube MAJ-2138 for an endoscope with water jet function. Otherwise, channel connectivity monitoring may not be able to detect improper connection of the connecting tubes. NOTE If the setting is activated, the Connection guide screen which appears after reading the scope ID displays MAJ-2138 as the connecting tube to be connected to the water jet function. If the setting is activated, an endoscope with water jet function cannot be reprocessed without an auxiliary water tube (MAJ-855). If this setting is disabled, either 2 endoscopes or 1 endoscope and 1 auxiliary water tube (MAJ-855) can be simultaneously reprocessed. For details how to install endoscopes and auxiliary water tubes simultaneously, refer to Section 6.6, Loading of endoscopes and accessories. 1 Select Auxiliary Water Tube Cleaning Setting on the Setting menu. 2 Select setting from options. Then press OK or Save button. 104 OER-Elite OPERATION MANUAL 4.16 Auxiliary water tube cleaning setting 1 2 3 Ch.4 No. 1 Item/Button Auxiliary Water Tube Cleaning Setting Setting options OFF (default) ON 2 3 Cancel Save/OK Description Disables the auxiliary water tube cleaning setting. Auxiliary water tubes (MAJ-855 or MAJ-2021) can be reprocessed simultaneously with endoscopes with water jet function by using dedicated connecting tube MAJ-2138. Returns to the Setting menu without saving the selected setting. When the OFF is selected, Save button is displayed here. Press this button to return to the setting menu after saving the selected setting. When the ON is selected, OK button is displayed here. Press this button to go to the confirmation screen about activating this setting. NOTE The selected settings are displayed with white buttons. 3 When ON was selected in the setting, this confirmation screen is displayed. Read the description and press the Save button to save the setting. Figure 4.3 OER-Elite OPERATION MANUAL 105 4.17 Print option 4.17 Print option This step is to make the settings for the auto printing function and the print format for auto printing function. NOTE To print a record, an optional MAJ-2144 printer set is necessary. 1 Select Print Option on the Setting menu. 2 Select the item that you want to change the print option settings. Ch.4 1 2 3 4 5 No. 1 Item/Button Print Format 2 Auto Print 3 Menu 4 LCG Info 5 Cancel Description Goes to the Print Format Setting. oRefer to Print format setting on page 107. Goes to the Auto Print. oRefer to Auto Print Setting on page 108. Returns to the Menu. Press to open the LCG Info display. oRefer to Section 3.5. LCG Info. Screen Returns to the Setting menu. 106 OER-Elite OPERATION MANUAL 4.17 Print option Print format setting 1 Select Print Format on the Print option menu. 2 Select setting from options. 1 2 3 Ch.4 No. 1 Item/Button Print Format Setting Setting options
(A) Separate
(default)
(B) Combine 2 3 Cancel Save NOTE Description The results of two endoscopes in a process are printed out one after the other. The results of two endoscopes in a process are combined in one result and printed out. Returns to the previous screen without saving the selected setting. Returns to the previous screen after saving the selected setting. For details of the print format, refer to Section 6.10, Printing of the reprocessing records. The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. OER-Elite OPERATION MANUAL 107 4.17 Print option Auto Print Setting If this setting is activated, Reprocessing result and Leak Testing result will print automatically after the process is complete. NOTE To print a record, an optional MAJ-2144 printer set is necessary. If the printer is not connected to the reprocessor although Auto Print is selected,
[E094] error occurs at the completion of reprocessing process, leak test, and leaking scope decontamination. Ch.4 1 Select Auto Print on the Print option menu. 2 Select setting from options. 1 2 3 No. 1 Item/Button Auto Print Setting 2 3 Cancel Save Setting options OFF (default) ON Description Disable the auto printing for Reprocessing. Enable the auto printing for Reprocessing. Returns to the previous screen without saving the selected setting. Returns to the previous screen after saving the selected setting. NOTE The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. 108 OER-Elite OPERATION MANUAL 4.18 Start screen 4.18 Start screen The start screen, which is displayed after turning on the reprocessor, can be chosen from Reprocess standby screen or Menu screen. 1 Select Start Screen on the Setting menu. 2 Select setting from options. 1 Ch.4 2 3 No. 1 Item/Button Setting options Start Screen setting Reprocessing standby Menu (default) 2 3 Cancel Save NOTE Description The menu screen does not appear automatically the reprocessing standby screen. The menu screen appears as the start screen. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. OER-Elite OPERATION MANUAL 109 4.19 Connection guide 4.19 Connection guide When this setting is activated, the connection guide screen is displayed after inputting scope ID with RFID. For details, refer to Connection guide of first endoscope on page 179, or Connection guide of second endoscope on page 206. 1 Select Connection Guide on the Setting menu. 2 Select setting from options. Ch.4 1 2 3 No. 1 Item/Button Setting options Connection Guide OFF ON (default) 2 3 Cancel Save NOTE Description Disable the Connection Guide screen. The Connection Guide screen appears automatically when scope ID is entered. Returns to the Setting menu without saving the selected setting. Returns to the Setting menu after saving the selected setting. The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. 110 OER-Elite OPERATION MANUAL 4.20 Volume and brightness 4.20 Volume and brightness The buzzer volumes and touch screen brightness can be adjusted. Also, when the panel click sound setting is activated, a click sound can be generated when a button on the touch screen is pressed. 1 Select Volume and Brightness on the Setting menu. 2 Edit the settings. 1 2 3 Ch.4 4 5 No. 1 Item/Button Volume Setting options 5 steps
(default: 3) 2 3 4 5 Brightness 5 steps
(default: 3) Click Sound ON (default) OFF Cancel Save Description Sets the volume of the buzzer in 5 steps. Pressing the + button increments the setting and pressing the button decrements it. Sets the brightness of the touch screen in 5 steps. Pressing the + button increases the brightness and pressing the button decreases it. The click sound is generated when a button on the touch screen is pressed. The click sound is not generated even when a button on the touch screen is pressed. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. 3 Press the Save button to save the edited information. OER-Elite OPERATION MANUAL 111 4.21 Date and time 4.21 Date and time This setting can not only select date format and time format (either 12 or 24 hour clock), but also adjust date and time. NOTE When replace the consumable item after changing date and time, the alarm indicator might not be displayed incorrectly. Ch.4 1 Select Date and Time on the Setting menu. 2 Select date format and time format. 1 2 3 4 No. 1 Item/Button Date Format 2 3 4 Time Format Cancel Next Setting options Year/Month/Day Month/Day/Year
(default) Day/Month/Year 12-hour clock
(default) 24-hour clock Sets the format of the date display on the touch screen. Description The hour is displayed in the 12-hour system, with AM for before noon or PM for the afternoon. The hour is displayed in the 24-hour system. Returns to the Setting menu without saving the edited information. Goes to the next setting. NOTE The selected settings are displayed with white buttons. 112 OER-Elite OPERATION MANUAL 4.21 Date and time 3 Press the Next button. 4 Check and correct the date, and then press the Next button. 1 2 3 Ch.4 4 5 6 Item/Button No. 1 Month Setting options 1 12 2 3 4 5 6 Day Year Cancel Back Next 1 31 2012 2087 NOTE Description Edit the figure of the current month. Pressing the + button increments the setting and pressing the button decrements it. Edit the figure of the current day. Pressing the + button increments the setting and pressing the button decrements it. Edit the figure of the current year. Pressing the + button increments the setting and pressing the button decrements it. Returns to the Setting menu without saving the edited information. Returns to the previous screen. Goes to the next setting. The order of year, month, and day displayed on the screen depends on the date format setting. OER-Elite OPERATION MANUAL 113 4.21 Date and time 5 Check and correct the time, and then press the Next button. 1 2 Ch.4 3 4 5 No. 1 Item/Button Hour 2 Minute 3 4 5 Cancel Back Next Setting options 0 11
(12-hour clock) 0 23
(24-hour clock) 0 59 Description Edit the figure of the current hour. Pressing the + button increments the setting and pressing the button decrements it. Edit the figure of the current minute. Pressing the + button increments the setting and pressing the button decrements it. Returns to the Setting menu without saving the edited information. Returns to the previous screen. Goes to the confirmation screen. 6 Confirm the edited information and press the Save button. 1 2 3 No. 1 2 3 114 Item/Button Cancel Back Save Setting options Description Returns to the Setting menu without saving the edited information. Returns to the previous screen. Returns to the Setting menu after saving the edited information. OER-Elite OPERATION MANUAL 4.22 Temperature scale 4.22 Temperature scale The temperature scale displayed on the touch screen can be selected in this setting. 1 Select Temperature Scale from the Settings menu. 2 Select setting from options. 1 Ch.4 2 3 Description Setting options Fahrenheit (default) The temperature is displayed in the Fahrenheit scale (unit: qF). Celsius The temperature is displayed in the Celsius scale (unit: qC). Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. No. 1 Item/Button Setting 2 3 Cancel Save NOTE The selected settings are displayed with white buttons. 3 Press the Save button to save the selected setting. OER-Elite OPERATION MANUAL 115 4.23 Network setting 4.23 Network setting The communication parameters with external equipment can be set. 1 On the Setting menu, select Network. If the Network Security setting is not activated, go to Step 3 below. For details of Network Security, refer to Section 4.24, Network security. 2 If the Network Security setting is activated, the password authentication screen appears. Enter the password and press the OK button. If a wrong password is entered, the entire password is cleared. In this case, re-enter the correct password. Ch.4 1 2 3 4 No. 1 2 3 4 Button Numeric buttons Delete Cancel OK Description Press to enter the value. Deletes one character. Returns to the Setting menu without saving the edited information. The input password will be checked. When the password is correct, the network setting screen appears. If the password is erroneous, the entire input password is cleared. NOTE If you forget the password, contact Olympus. 3 This setting consists of three pages. Switch the page using the next page button or the previous page button, and edit the settings in each page. 116 OER-Elite OPERATION MANUAL 4.23 Network setting Page 1 1 2 3 4 5 Ch.4 No. 1 Item/Button Communication 2 3 4 5 Previous page button Next page button Cancel Save NOTE Setting options OFF (default) ON Description The network communication function is disabled. The network communication function is enabled. This button is unavailable on this page. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. Turning ON the Communication setting without connecting the OLYMPUS KE to the OER-Elite may lead to slower communications when connecting the OLYMPUS KE afterward. OER-Elite OPERATION MANUAL 117 4.23 Network setting Page 2 1 2 3 4 5 Ch.4 5 6 7 8 No. 1 Item/Button IP address >
OER-Elite Setting options Conforming to the IPV4 address setting.
(default: 127.000.000.001) 2 3 4 Net mask >
OER-Elite Gateway >
OER-Elite Port No. >
OER-Elite 5 Mac address >
OER-Elite Previous page button Next page button Cancel Save 6 7 8 9 Conforming to the IPV4 address setting.
(default: 255.255.255.0) Conforming to the IPV4 address setting.
(default: 127.000.000.001) 0 65535
(default: 51900) Description The IP address of the OER-Elite is displayed. Press the Edit button to open the screen for use in input. The following addresses are invalid:
x.x.x.0 x.x.x.255 The subnet address of the OER-Elite is displayed. Press the Edit button to open the screen for use in input. The gateway of the OER-Elite is displayed. Press the Edit button to open the screen for use in input. The port No. of the OER-Elite is displayed. Press the Edit button to open the screen for use in input. The MAC address of the OER-Elite is displayed. The MAC address cannot be modified. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. 118 OER-Elite OPERATION MANUAL 4.23 Network setting Page 3 1 2 3 4 5 6 7 Ch.4 Setting options Description ON (default), OFF 100 Mbps full duplex (default), 100 Mbps half duplex, 10 Mbps full duplex, 10 Mbps half duplex 1 255 seconds
(default: 120 seconds) No. 1 Item/Button Auto negotiation 2 COMM Settings 3 4 5 6 7 Timeout Previous page button Next page button Cancel Save The status of auto negotiation is displayed. Each press of the Edit button switches the setting values alternately. OFF: The auto negotiation is disabled. ON: The auto negotiation is enabled. The communication method is displayed. Each press of the Edit button switches the communication method. The time-out time is displayed. Press the Edit button to open the screen for use in input. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. This button is unavailable on this page Returns to the Setting menu without saving the edited information. Returns to the Setting menu after saving the edited information. 4 Press the Save button to save the edited information. OER-Elite OPERATION MANUAL 119 4.23 Network setting Editing the setting of each item The settings of the following items can be edited:
Reprocessor IP address Reprocessor net mask Reprocessor gateway Reprocessor port number Auto negotiation COMM Settings Timeout Ch.4 1 Press the Edit button for the IP address, etc. to open the screen for use in input. 2 Enter the figures using the numeric buttons. 1 2 3 4 5 Button Description Numeric buttons No. 1 2 m 3 o 4 5 Cancel OK Press to enter the value. Moves the cursor to the right. Moves the cursor to the left. Returns to the previous screen by disabling the edited settings. Returns to the previous screen by enabling the edited settings. While the settings are not changed, the OK button turns gray. 3 Confirm the edited information and press the OK button to return to the previous screen. 120 OER-Elite OPERATION MANUAL 4.24 Network security 4.24 Network security When this setting is activated, the network setting is protected with a password lock. The password can be changed by editing the network security password in this setting. When this setting is performed, the Network Settings are password-protected, and the screen of password authentication is displayed as Section 4.23, Network setting. 1 Select Network Security on the Setting menu. 2 Edit the settings. Ch.4 1 2 3 4 5 No. 1 Item/Button Network Security Lock Setting options OFF (default) ON 2 3 4 5 Edit button
(Network Security Lock) Edit button
(Network Security Password) Cancel Save Description Password is unnecessary to open the network setting. Password is necessary to open the network setting. oRefer to Section 4.23, Network setting. If the network security lock is OFF, press to activate it and edit the new network security password. If the network security lock is ON, press to inactivate it. In this case, to input the network security password is necessary. Press to change the password. If the network security lock is OFF, the button turns gray and becomes unavailable. Returns to the Setting menu without saving the edited information Returns to the Setting menu after saving the edited information. 3 To change the Network Security Lock, refer to the following sections:
Enabling the Network Security Lock on page 122. Disabling the Network Security Lock on page 123. To set a password, refer to Changing the password on page 124. 4 After completing the editing, press the Save button to save the edited information. OER-Elite OPERATION MANUAL 121 4.24 Network security Enabling the Network Security Lock 1 Press the Edit button for the network security lock on the Network Security setting screen. Ch.4 2 Enter the new password up to 10 numbers and press the OK button. The password re-input screen appears. Figure 4.4 1 2 3 4 No. 1 2 3 4 Button Numeric buttons Delete Cancel OK Description Press to enter the value. Deletes one character entered immediately before. Returns to the Setting menu without saving the edited information. Returns to the previous screen if the entered password is correct. All of the entered characters are cleared if the entered password is erroneous. 3 Enter the new password again and press the OK button. When the input password is correct, the password is changed and the screen returns to the Network Security setting screen. 122 OER-Elite OPERATION MANUAL 4.24 Network security Disabling the Network Security Lock 1 Press the Edit button for the network security lock on the Network Security setting screen. 2 Enter the current password. When the entered password is correct, the password input screen closes and the security setting is disabled. Figure 4.5 Ch.4 1 2 3 4 No. 1 2 3 4 Button Numeric buttons Delete Cancel OK Description Press to enter the value. Deletes one character entered immediately before. Returns to the previous screen by disabling the edited settings. Returns to the previous screen if the entered password is correct. All of the entered characters are cleared if the entered password is erroneous. OER-Elite OPERATION MANUAL 123 4.24 Network security Changing the password 1 Press the Edit button for the network security password on the Network Security setting screen. 2 Enter the current password. The password input screen appears when the entered password is correct. Ch.4 1 2 3 4 No. 1 2 3 4 Button Numeric buttons Delete Cancel OK Description Press to enter the value. Deletes one character entered immediately before. Returns to the previous screen by disabling the edited settings. Returns to the previous screen if the entered password is correct. All of the entered characters are cleared if the entered password is erroneous. 124 OER-Elite OPERATION MANUAL 4.24 Network security 3 On the password input screen, enter the new password and press the OK button. When the entered password is correct, the password re-input screen appears. 1 2 3 4 Ch.4 No. 1 2 3 4 Button Numeric buttons Delete Cancel OK Description Press to enter the value. Deletes one character entered immediately before. Returns to the previous screen by disabling the edited settings. Returns to the previous screen if the entered password is correct. All of the entered characters are cleared if the entered password is erroneous. 4 On the password re-input screen, enter the new password again and press the OK button. When the input password is correct, the password is changed and the screen returns to the Network Security setting screen. OER-Elite OPERATION MANUAL 125 4.24 Network security Ch.4 126 OER-Elite OPERATION MANUAL 5.1 Inspection before use Chapter 5 Inspection and Preparation Before Use 5.1 Inspection before use To ensure that this reprocessor operates safely and reliably, inspect and clean all parts before first use of the day. Also, check all consumables and replace or replenish as necessary. WARNING When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and Ch.5 skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task they are performing and vacate the room. Be sure to perform all inspections and replenish consumables as described in this chapter. Otherwise, the reprocessor may not work properly. If any irregularity is found during the inspections, do not use the reprocessor and contact Olympus. Using the reprocessor when an irregularity has been detected may impair operation of the reprocessor and could cause leakage, an electric shock, burns, and/or a fire and create an infection control risk. OER-Elite OPERATION MANUAL 127 5.2 Flow of inspection WARNING During inspection, always wear appropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. 5.2 Flow of inspection On the first day you use the reprocessor, inspect it by following the procedure below. Ch.5 1 Check that the reprocessor can be turned ON.
Section 5.3 on page 129 2 Check that no fluid leaks from the water supply line and inside the reprocessor.
Section 5.4 on page 132 3 Check that the lid and its packing are free of irregularity.
Section 5.5 on page 133 4 Check that the connectors of reprocessor are free of irregularity.
Section 5.6 on page 134 5 Check that the connecting tubes and leak test air tube are free of irregularity.
Section 5.7 on page 137 6 Check the remaining amount of detergent.
Section 5.8 on page 138 7 Check the remaining amount of alcohol.
Section 5.9 on page 139 128 OER-Elite OPERATION MANUAL
1 | Operation Manual 2 | Users Manual | 2.47 MiB |
5.3 Inspecting the power activation 8 Check that the mesh filters are not clogged.
Section 5.10 on page 143 9 Check that the cleaning case is free of abnormality.
Section 5.11 on page 144 10 Check that the labels on the reprocessing basin are not peeled.
Section 5.12 on page 145 11 Check that the disinfectant vapor is not abnormal.
Section 5.13 on page 145 5.3 Inspecting the power activation Check that the reprocessor can be turned ON. 1 Make sure that the disinfectant solution Heat LCG Timer indicator is not illuminated. If it is lighting up, it is not necessary to inspect the reprocessor power switch again. Ch.5 Disinfectant solution Heat LCG Timer indicator Figure 5.1 NOTE The lighting of the disinfectant solution Heat LCG Timer indicator indicates that the disinfectant solution Heat LCG Timer is running. For operation of the disinfectant solution Heat LCG Timer process, refer to Section 7.3, Heat LCG Timer. OER-Elite OPERATION MANUAL 129 5.3 Inspecting the power activation 2 When the disinfectant solution Heat LCG Timer indicator does not light up, press the power switch of the reprocessor. 3 Make sure that the power indicator lights up and the touch screen displays the following initial screen. Figure 5.2 Ch.5 Initial screen Figure 5.3 NOTE When the optional bar code reader MAJ-2130 is connected to the reprocessor and the MAJ-2130 is turned ON, the indicator of the bar code reader will light up alternating red and blue. If the indicator of the bar code reader is not lit, refer to the instruction manual for bar code reader MAJ-2130 and Section 13.2, Troubleshooting guide. Indicator lights up alternately red and blue. Figure 5.4 130 OER-Elite OPERATION MANUAL 5.3 Inspecting the power activation 4 When the optional printer MAJ-1937 is connected to the reprocessor, press the power button of the printer until the power LED turns ON (about 1 second). Power LED Power button Ch.5 Figure 5.5 If either the touch screen is blanking or the power indicator does not light up If the initial screen does not appear on the touch screen or the power indicator does not light up, turn the printer OFF by pressing the power switch, wait for a few seconds and press the power switch to ON again. If the problem is not corrected, press the power switch to OFF again, unplug the power cord from the power outlet and contact Olympus. If the touch screen is blank and the power indicator does not light up If the initial screen does not appear on the touch screen and the power indicator does not light up, inspect the reprocessor in the procedure described in Section 9.8, Replacing the fuse. If the problem is not corrected, press the power switch to OFF again, unplug the power cord from the power outlet and contact Olympus. OER-Elite OPERATION MANUAL 131 5.4 Inspecting for fluid leaks 5.4 Inspecting for fluid leaks Confirm that water or fluid does not leak from the water supply piping, inside the reprocessor, drain hose connector, etc. WARNING Do not continue using the reprocessor if it is leaking water. Doing so may result in an electric shock or malfunction. If water or fluid leaks from inside the reprocessor, close the water faucet, set the power switch to OFF, unplug the power cord, and contact Olympus. Ch.5 1 Slowly open the water faucet. 2 Confirm that water is not leaking from where the water supply hose is connected to the water faucet or reprocessor. 3 Confirm there is no water or fluid on the floor underneath the reprocessor. If water leaks from the water supply hose connector 1 Close the water faucet. 2 Check the loading of the water supply devices by referring to Section 4.4, Connection of the water supply hose in Instructions-Installation Manual. If water leaks from the water filter housing 1 Close the water faucet. 2 Check the loading of the water filter housing by referring to Section 4.14, Installation of the water filter (MAJ-824 or MAJ-2318) in Instructions-Installation Manual. If water or fluid leaks from inside the reprocessor 1 Close the water faucet. 2 Set the power switch of the reprocessor to OFF. 3 Unplug the power cord from the power outlet. 4 Contact Olympus. 132 OER-Elite OPERATION MANUAL 5.5 Inspecting the lid and lid packing If water leaks from the drain hose connector 1 Close the water faucet. 2 Check the drain hose loading by referring to Section 4.5, Connection of the drain hose in Instructions-Installation Manual. 5.5 Inspecting the lid and lid packing Before using the reprocessor, always check that there is no irregularity regarding the following points on the lid and the lid packing. If there is any irregularity, cleaning fluid or disinfectant solution may leak out. The lid is not cracked, broken, or otherwise damaged. The packing is not cracked, torn, or otherwise damaged. The packing is not separated or detached from the lid. The lid can be properly opened and closed without restriction or abnormal noise. Ch.5 Packing If any irregularity is found, do not use the reprocessor and contact Olympus. Figure 5.6 WARNING Do not use the reprocessor if the lid or the lid packing seems to be damaged or defective. Using the reprocessor when an irregularity has been detected may interfere with reprocessing. Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment. If any irregularity is found with the lid or the lid packing, contact Olympus. Do not remove the lid packing. Otherwise, disinfectant solution may leak and damage for the reprocessor and areas near the equipment by reprocessing or opening the lid. OER-Elite OPERATION MANUAL 133 5.6 Inspecting the connectors WARNING If replacement or adjustment of the lid packing is required, please contact Olympus. Only Olympus-trained personnel are permitted to replace the lid packing or adjust its position. Improper installation or positioning of the lid packing may result in leakage of water, detergent solution, or disinfectant solution. This may result in injury to personnel and/or damage to the equipment. 5.6 Inspecting the connectors Check the following for each connector. Ch.5
The connector should be fixed firmly.
The O-rings should be free of irregularities such as cracks, tears, or dents. If any irregularity is found, do not use the reprocessor and contact Olympus. WARNING Do not use the reprocessor if any connector seems to be damaged or defective. Using the reprocessor when an irregularity has been detected may interfere with reprocessing. Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment. CAUTION Connect each connector firmly by pushing until the connector clicks into place. After connection, pull the connector gently to confirm that it cannot be disconnected easily. NOTE After long-term using the OER-Elite, the color of O-rings on each connector may be changed into whitish color. This case is not irregularity. 134 OER-Elite OPERATION MANUAL Connectors inside the reprocessing basin:
Check Connectors inside the reprocessing basin:
Connector A1 Connector A2 Connector B1 Connector B2 Connector C1 Connector C2 Connector D1 Connector D2 Connector E1 Connector E2 Water supply piping disinfection connector Table 5.1 5.6 Inspecting the connectors Ch.5 O-ring O-ring Figure 5.7 OER-Elite OPERATION MANUAL 135 5.6 Inspecting the connectors Other connectors Check Other connectors Connector above water filter housing Connector below water filter housing Disinfectant removal port Tube connector on detergent tank Tube connector on alcohol tank Table 5.2 Ch.5 O-ring O-ring Figure 5.8 O-ring Figure 5.9 136 OER-Elite OPERATION MANUAL O-ring O-ring 5.7 Inspecting the connecting tubes and leak test air tube 5.7 Inspecting the connecting tubes and leak test air tube Before using the reprocessor, always check that there is no irregularity regarding the following points on the connecting tubes and leak test air tube.
All tubes should be free of cracks, breaks, fissures, scratches, or stains.
There should be no cracks in the lock levers of connecting tube connectors and leak test air tube connectors.
There should be no bends or breaks in the pin of connecting tubes connector and leak test air tube connector.
The tube should not be easy to disconnect once connected. Ch.5 Pin Lock lever Figure 5.10 If a tube has any irregularity, do not use it and replace with a new one. WARNING Do not use the connecting tubes or leak test air tubes if they have any irregularity. Doing so could prevent effective reprocessing or damage the endoscope. OER-Elite OPERATION MANUAL 137 5.8 Inspecting the remaining detergent 5.8 Inspecting the remaining detergent Check Required items Olympus-validated detergent Table 5.3 Check the amount of detergent remaining in the detergent tank through the detergent tank check window on the detergent/alcohol drawer of the reprocessor. If the detergent level cannot be viewed from the window, the detergent in the detergent tank should be replaced after executing the reprocessing process for a few times. When the detergent level is not visible through the window or the touch screen shows the detergent supply insufficiency message (together with the detergent replacement indicator) after the start of a process, replace the detergent tank as described in Section 8.3, Replacing the detergent tank. Ch.5 Figure 5.11 138 OER-Elite OPERATION MANUAL 5.9 Inspecting and replenishing alcohol 5.9 Inspecting and replenishing alcohol Check how much alcohol is in the alcohol tank and add more as required. Check Required items 70% ethyl alcohol or 70% isopropyl alcohol Table 5.4 WARNING The alcohol used with the reprocessor must be 70% ethyl alcohol or 70% isopropyl alcohol. Using any other kind of alcohol may result in malfunction of the reprocessor or the endoscope, difficulty drying the endoscope, fire hazard, or a hazard due to toxic vapor emitted from the alcohol. Alcohol is flammable and should be handled with extra care. Remove the alcohol in the alcohol tank and replace it with new alcohol at least once a week. Otherwise, the alcohol in the alcohol tank may degrade. Before handling the alcohol, carefully read the cautions for use carefully, and use the alcohol as instructed. Ch.5 NOTE If alcohol flush is initiated without alcohol in the tank, the message screen Alcohol cannot be supplied will be displayed and the process will be stopped temporality. When reprocessing is performed with newly-installed equipment or with reprocessor after Section 9.9, Preparing the reprocessor for long-term storage is performed, reprocessing may stop with the message screen Alcohol cannot be supplied during the process displayed even though there is enough alcohol in the tank. Refer to When the message screen Message 087 is displayed on page 627 to solve this problem. OER-Elite OPERATION MANUAL 139 5.9 Inspecting and replenishing alcohol Inspection of the amount of alcohol Ensure that the alcohol is present through the alcohol tank check window on the detergent/alcohol drawer of the reprocessor. If the alcohol level cannot be viewed from the window, the alcohol in the alcohol tank should be replaced after executing the reprocessing process for a few times. When the alcohol level becomes invisible through the window, replenish the alcohol as described in Replenishing of alcohol below. NOTE If alcohol flush is performed without alcohol, the touch screen shows the Alcohol supply insufficiency message and the flushing pauses. Replenishing of alcohol Ch.5 1 Hold the section on the detergent/alcohol drawer marked PULL and pull it out. 2 Push the lock lever on the connector of the tube connected to the cap on the alcohol tank to detach the tube. Figure 5.12 Lock lever Cap Alcohol tank 3 Remove the alcohol tank and put it in a sink or other tub. Figure 5.13 140 OER-Elite OPERATION MANUAL 5.9 Inspecting and replenishing alcohol 4 Turn the cap on the alcohol inlet in the direction shown to remove the cap. Cap Alcohol inlet Figure 5.14 CAUTION Do not add alcohol while the tank is in the detergent/alcohol drawer. If alcohol is spilled on the tray, it could damage the reprocessor. Do not tilt the alcohol tank while there is still alcohol inside. Otherwise, the alcohol may spill. Ch.5 5 Pour alcohol until it is level with the line inside the alcohol tank. Do not to spill any. If any alcohol spills from the tank, wipe it off with a clean cloth. After adding the alcohol, replace the cap on the alcohol tank. Line Figure 5.15 NOTE The amount of alcohol required to fill the tank up to the level line is about 1 L
(enough for about 20 alcohol flushes). 6 Place the alcohol tank in the detergent/alcohol drawer so that the ventilation tube of the alcohol tank sits on the front of the tray. CAUTION Placing the alcohol tank so that the ventilation tube sits on the deeper side of the tray could damage the alcohol tank. OER-Elite OPERATION MANUAL 141 5.9 Inspecting and replenishing alcohol 7 Connect the tube that was originally connected to the cap. Alcohol tank Ventilation tube Figure 5.16 8 Turn the connector to correct the tube orientation as shown below. Confirm that the tube is not bent. Ch.5 Connector 9 Close the detergent/alcohol drawer. Figure 5.17 142 OER-Elite OPERATION MANUAL 5.10 Inspecting the mesh filters 5.10 Inspecting the mesh filters Make sure that the circulation port mesh filters (two types) and the drain port mesh filter are not clogged. WARNING A clogged mesh filter not only prevents the reprocessor from functioning properly, but may also result in ineffective reprocessing. CAUTION If the mesh filters have been removed, be sure to put them back in their original positions before using the reprocessor. If you forget to attach the mesh filters, the pump may malfunction and/or foreign objects may clog the endoscope channels including the nozzle. Ch.5 When cleaning the mesh filters, take care not to leave brush hair or cotton swab fiber in the meshes. Otherwise, their filtering effectiveness may be reduced. If a mesh filter is dropped or subjected to an impact, make sure that the mesh shape is not deformed. Otherwise, the filtering effect may degrade. Two-type mesh filters are installed on the outer and inner sides of the circulation port. Be sure to remove, inspect, and clean both of them. 1 Step on the foot pedal to open the lid. 2 Remove the mesh filters from the reprocessing basin. Circulation port mesh filters Drain port mesh filter Figure 5.18 3 Check that the mesh filters are not clogged by a foreign object. OER-Elite OPERATION MANUAL 143 5.11 Inspecting the washing case (MAJ-2121) 4 If any foreign object is found to be clogging the filter, clean the mesh filter in running water using a brush. 5 Attach the mesh filters in their original positions. Figure 5.19 Ch.5 5.11 Inspecting the washing case (MAJ-2121) Make sure that the washing case (with a gray cover) for exclusive use with this reprocessor is attached. Also, check that the washing case is free of irregularity such as a crack or fissure. If any irregularity is found, do not use the washing case and contact Olympus. WARNING Do not use the washing case if any irregularity is found with it. If an abnormal washing case is used, the reprocessing may be insufficient. Make sure that the washing case is located in correct position. Otherwise, the reprocessing may be insufficient. 144 OER-Elite OPERATION MANUAL 5.12 Inspecting the labels on the reprocessing basin 5.12 Inspecting the labels on the reprocessing basin Check that the labels on the reprocessing basin are not peeled off. If a label is peeled off, contact Olympus. Ch.5 Figure 5.20 5.13 Inspecting for disinfectant solution odor Check that the disinfectant solution is not producing an abnormal odor. CAUTION If the odor increases after replacement of the gas filters, contact Olympus. 1 Check that the gas filter is placed properly in the gas filter case (tank). 2 Check that the gas filter case (tank) is attached properly to the disinfectant solution tank. 3 Activate the rooms ventilation system. 4 Check that there is no abnormal disinfectant solution odor coming from the reprocessor or its surroundings. OER-Elite OPERATION MANUAL 145 5.13 Inspecting for disinfectant solution odor Ch.5 146 OER-Elite OPERATION MANUAL 6.1 General flow of endoscope reprocessing using OER-Elite Chapter 6 Reprocessing Operations 6.1 General flow of endoscope reprocessing using OER-Elite The endoscope reprocessing using OER-Elite is performed in the following flow. Patient procedure. 1 2 Precleaning. 3 Leak testing. 4 Manual cleaning.
Refer to reprocessing instructions provided in the endoscope manual
Section 6.2 on page 148 Ch.6
Section 6.2 on page 148
Section 6.2 on page 148 5 Reprocessing operation in the OER-Elite.
Section 6.3 on page 155 6 Storing the reprocessed endoscope and accessories.
Refer to reprocessing instructions provided in the endoscope manual OER-Elite OPERATION MANUAL 147 6.2 Precleaning, leak testing, and manual cleaning Ch.6 6.2 Precleaning, leak testing, and manual cleaning Endoscopes must be first cleaned according to one of two ways, prior to reprocessing in the OER-Elite:
Precleaning and manual cleaning Immediately after each patient examination, perform bedside precleaning, clean the outer surfaces of the endoscope, brush the suction channel, flush and rinse all channels according to the step-by-step cleaning procedure described in the endoscopes reprocessing manual. Complete both the prescribed bedside and manual cleaning procedures. After the endoscope undergoes full manual cleaning, it can be reprocessed in the OER-Elite. The OER-Elite then provides supplemental cleaning and high-level disinfection. Modified precleaning and manual cleaning Immediately after each patient examination, perform the bedside-precleaning and manual-cleaning procedures for the endoscope as described in the endoscopes instruction manual, but with the modifications described in this section. This section describes: 1) how certain steps performed at the bedside can be performed using less fluid volume, and using water in place of detergent, 2) how the manual steps for brushing the channels and the elevator
(if applicable), and for cleaning the outside surfaces of the endoscope are unchanged, and 3) how the requirement to connect certain flushing tubes, and the need to manually flush detergent and rinse water through the channels can be omitted. The functions of the modified/omitted steps are covered by the cleaning process of the OER-Elite. After cleaning the endoscope following this modified procedure, the endoscope can be placed in the OER-Elite. The OER-Elite completes the cleaning process and follows this with high-level disinfection. WARNING Always preclean each endoscope immediately after the examination. If precleaning is not executed promptly, debris will solidify and may prevent effective reprocessing. Failure to preclean will leave excessive amounts of debris adhering to the endoscope and may compromise the effectiveness of the reprocessing. It may also result in debris accumulating in the endoscope, preventing the endoscope from working correctly. 148 OER-Elite OPERATION MANUAL 6.2 Precleaning, leak testing, and manual cleaning Modified manual cleaning process for preparing endoscopes for processing in the OER-Elite Endoscopes must be subject to cleaning by the user prior to reprocessing in the OER-Elite. However, when using the OER-Elite, the endoscope can be reprocessed according to the modified procedure described below. WARNING The cleaning steps for external surfaces and reusable parts must be performed according to the reprocessing instructions provided in the endoscope manual. Failure to preclean may compromise the effectiveness of the reprocessing. Valves and accessories must be manually cleaned as per the endoscope manual prior to placement in the OER-Elite. Otherwise, effectiveness of the reprocessing may be compromised. Ultrasonic probes must be manually cleaned as per the ultrasonic probe manual prior to placement in the OER-Elite. Otherwise, effectiveness of the reprocessing may be compromised. Ch.6 Even when modified precleaning is applied, need to perform the works according to Endoscope precleaning continued (Procedure performed at bedside immediately after patient examination) on page 150. Omitting the works according to the Endoscope precleaning continued (Procedure performed at bedside immediately after patient examination) may lead to insufficient reprocessing. Follow the modified manual cleaning procedure exactly as described in the Manual cleaning (procedure performed in reprocessing area) on page 152. Omitting any steps according to the Manual cleaning (procedure performed in reprocessing area) may lead to insufficient reprocessing. Endoscope precleaning
(Procedure performed at bedside immediately after patient examination) Perform the following precleaning procedure when reprocessing Olympus flexible endoscopes with the OER-Elite. Wipe down the insertion section Wipe the entire insertion section with a clean, lint-free cloth soaked in clean water. Wipe from the boot of the control section toward the distal end. OER-Elite OPERATION MANUAL 149 6.2 Precleaning, leak testing, and manual cleaning Endoscope precleaning continued
(Procedure performed at bedside immediately after patient examination) Based upon the Olympus endoscope model described below, suction and/or flush endoscope channels as specified to confirm channels are not obstructed. For endoscopes with an instrument and suction channel, confirm that the instrument and suction channel is not obstructed Ch.6 1 Aspirate or flush clean water into the instrument and suction channel to confirm that the channel is not obstructed and to remove gross debris. If aspirating, confirm that a continuous water flow to the suction container is observed. If flushing, confirm that water is emitted from that channel at the distal end. Perform this procedure in accordance with the reprocessing instructions provided in the endoscope manual. 2 Aspirate or flush air into the instrument and suction channel in accordance with the reprocessing instructions provided in the endoscope manual. For endoscopes with an air/water channel, confirm that the air/water channel is not obstructed 1 Feed clean water through the air/water channels in accordance with the reprocessing instructions provided in the endoscope manual. Remove the distal tip from the water. Check for continuous water flow from the air/water nozzle to confirm that the channel is not obstructed. 2 Feed air through the air/water channels in accordance with the reprocessing instructions provided in the endoscope manual. For endoscopes with an auxiliary water channel, confirm that the auxiliary water channel is not obstructed 1 Slowly flush clean water through the auxiliary water channel in accordance with the reprocessing instructions provided in the endoscope manual. In order to confirm that the auxiliary water channel is not obstructed, check for a continuous flow of water exiting from the channel. 150 OER-Elite OPERATION MANUAL 6.2 Precleaning, leak testing, and manual cleaning 2 Slowly flush air through the auxiliary water channel several times in accordance with the reprocessing instructions provided in the endoscope manual. Perform this operation until a steady stream of air bubbles exits from the distal end. For ultrasonic endoscopes with balloon channels, confirm that the balloon channel is not obstructed 1 Aspirate or flush clean water through the balloon channel in accordance with the reprocessing instructions provided in the endoscope manual. In order to confirm that the balloon channel is not obstructed, check for a continuous flow of water exiting from the channel. 2 Aspirate or flush air through the balloon channel in accordance with the reprocessing instructions provided in the endoscope manual. For ultrasonic endoscopes with de-aerated water supply channel, confirm that the de-aerated water supply channel is not obstructed Ch.6 1 Aspirate clean water through the de-aerated water supply channel in accordance with the reprocessing instructions provided in the endoscope manual. In order to confirm that the de-aerated water supply channel is not obstructed, check for a continuous flow of water exiting from the channel. 2 Aspirate air through the de-aerated water supply channel in accordance with the reprocessing instructions provided in the endoscope manual. For endoscopes with an elevator wire In accordance with the reprocessing instructions provided in the endoscope manual. WARNING When reprocessing the endoscope that has a forceps elevator using OER-Elite, conduct precleaning and manual cleaning as detailed in each endoscope's reprocessing manual. Otherwise, the effectiveness of the reprocessing may be compromised. OER-Elite OPERATION MANUAL 151 6.2 Precleaning, leak testing, and manual cleaning For all endoscopes Disconnect the endoscope, reusable parts and reprocessing equipment Disconnect the endoscope, reusable parts and reprocessing equipment according to the reprocessing instruction provided in the endoscopes manual. Place the reusable parts such as air/water valve, suction valve and biopsy valve in a container of clean water. WARNING Even when modified precleaning is applied, need to perform the works according to Endoscope precleaning continued (Procedure performed at bedside immediately after patient examination) on page 150. Omitting any steps according to the Endoscope precleaning continued (Procedure performed at bedside immediately after patient examination) may lead to insufficient reprocessing. Leakage testing Ch.6 Perform leakage testing on the endoscope according to the reprocessing instruction provided in the endoscopes manual. NOTE The OER-Elite can automatically detect whether or not the endoscopes leak in the reprocessing process. The auto leak test supports the user by reducing mistakes that may happen in the visual endoscope leak test leads to the improvement of safety. In addition to this function, also be sure to perform a leak test when performing manual cleaning. Manual cleaning (procedure performed in reprocessing area) After completing the leakage test, perform manual cleaning according to the procedures described below. If manual cleaning was not performed within 1 hour after removing the endoscope from the patient or if you are not sure whether manual cleaning could be performed within 1 hour, perform Presoak for excessive bleeding and/or delayed reprocessing after each procedure or Presoaking the endoscope according to the reprocessing instructions provided in the endoscopes manual. Refer each endoscope's instruction manual for the procedure of presoaking. 152 OER-Elite OPERATION MANUAL 6.2 Precleaning, leak testing, and manual cleaning Preparation Fill a basin with detergent solution at the temperature and concentration recommended by the detergent manufacturer. Use a basin that is at least 40 cm by 40 cm (16 by 16) in size and deep enough to completely immerse the endoscope. Manual cleaning of the external surfaces Perform manual cleaning of the external surfaces in accordance with the reprocessing instructions provided in the endoscope manual. Brushing the endoscope (i.e., channels, valve cylinders, and other ports if present) Brush the endoscope in accordance with the reprocessing instructions provided in the endoscope manual, including the instrument and suction channels, balloon channels, de-aerated water supply channel, suction cylinders, instrument channel ports, and distal end as applicable. Ch.6 Cleaning the endoscopes accessories Manually clean the reusable parts such as the air/water valve, suction valve and biopsy valve, according to the instructions provided in the endoscope manual. Inspection of no residual debris on the external surface of the endoscope Inspect the external surface of the endoscope for the residual debris. Should any debris remain, repeat the manual cleaning procedure until all debris is removed. WARNING Follow the modified manual cleaning procedure exactly as described in the Manual cleaning (procedure performed in reprocessing area) on page 152. Omitting any steps according to the Manual cleaning (procedure performed in reprocessing area) may lead to insufficient reprocessing. OER-Elite OPERATION MANUAL 153 6.2 Precleaning, leak testing, and manual cleaning Loading the endoscope and their accessories into the OER-Elite Carefully lift the endoscope out of the detergent solution, allowing excess fluid to drain into the basin. Carry the endoscope to the reprocessing basin of the OER-Elite. Place the endoscope in the reprocessing basin and connect the required connecting tube(s) to the endoscope. Place the valves in the washing case in the center of the retaining rack according to the instruction manual for the OER-Elite. Continue reprocessing, according to the instruction manual for the OER-Elite. CAUTION Make sure that the detergent solution or water is not dripping from the endoscope after pulling the endoscope out of the detergent solution or water. Otherwise, unexpected interruption of reprocessing process by the OER-Elite may occur error code [E005], etc. If detergent is used in the manual cleaning, rinse the endoscope thoroughly. Otherwise, detergent used in manual cleaning remains in the endoscopes and unexpected interruption of reprocessing process in the OER-Elite may occur. Ch.6 154 OER-Elite OPERATION MANUAL 6.3 Reprocessing operation in the OER-Elite 6.3 Reprocessing operation in the OER-Elite Before using this reprocessor for the first time, full setup is required including installing accessories, connecting power and water supplies, and disinfecting the reprocessors internal piping. Refer to OER-Elite Instructions-Installation Manual for details. When it has not been used for more than 14 days, refer to Section 9.10, Care and maintenance after long-term storage. Be sure to perform the preliminary checks before reprocessing endoscopes with this reprocessor. Otherwise, the reprocessor may not function at optimal levels. Refer to Chapter 5, Inspection and Preparation before use for details on the preliminary checks and Chapter 9, End-of-Day Checks for details on the final checks at the end of the day. Warnings WARNING Ch.6 When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task they are performing and vacate the room. OER-Elite OPERATION MANUAL 155 6.3 Reprocessing operation in the OER-Elite WARNING All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Before using this reprocessor for the first time, after storage for 14 days or after the integrity of the water system is compromised, such as water filter replacement, disinfection of the reprocessors internal piping is required. If the reprocessors internal piping is not properly disinfected, the endoscope will not be properly reprocessed. For any endoscope that requires sterilization, always be sure to sterilize the endoscope as instructed in its instruction manual after cleaning/disinfection in the OER-Elite. Certain endoscopes cannot be reprocessed with this reprocessor. Refer to the provided List of compatible Endoscopes/Connecting Tubes <OER-Elite> to see which endoscopes are compatible. Accessories (e.g., valves) that can be reprocessed with this reprocessor are accessories of endoscopes compatible with this reprocessor. To reprocess accessories, be sure to put them in the washing case. Do not attempt to reprocess an endoscope and its accessories that are not designated as compatible with the OER-Elite or that are modified by a third party repair company; not only will the reprocessor be unable to function at optimal levels, the safety of the patient and operator may be endangered and this reprocessor and/or the endoscope may be damaged. Without knowledge of the materials used or the final quality of repair being provided by third party repair companies, Olympus is unable to validate the compatibility or reprocessing efficacy of the OER-Elite instructions manual. Ch.6 156 OER-Elite OPERATION MANUAL 6.3 Reprocessing operation in the OER-Elite Outline of reprocessing operation in the OER-Elite Inspection before reprocessing 1 Checking the disinfectant solution concentration level and entering the check result.
Section 3.7 on page 69 Reprocessing operation in the OER-Elite 1 Select the Reprocessing program.
Section 6.5 on page 160 Ch.6 Loading of endoscopes and accessories. Scope ID entry Loading endoscopes and accessories Attaching the connecting tubes Leak test air tube loading Other data entry 2
Section 6.6 on page 163 3 Inspection before starting reprocessing process.
Section 6.7 on page 216 4 Reprocessing.
Section 6.8 on page 220 5 Removing the endoscopes and accessories.
Section 6.9 on page 228 OER-Elite OPERATION MANUAL 157 6.4 Worst case load condition of endoscopes and accessories 6.4 Worst case load condition of endoscopes and accessories Before placing endoscopes and accessories, confirm that your endoscopes and accessories do not exceed the worst case load condition.
For worst case load condition of endoscopes, see Table 6.1.
For worst case load condition of accessories, see Table 6.2. CAUTION Endoscopes that exceed the listed specification or present new features that may create additional disinfection challenges should not be reprocessed in the OER-Elite. Ch.6 Worst case load condition of endoscopes Item Condition Remarks column Number of endoscopes Max 2 endoscopes Channel length Max 1,680 mm
(Working length) Channel inner diameter Min 1.2 mm Max 6.0 mm Number of channel (lumen) External shape/dimension Max 2 instrument/suction channel Endoscope that is fully submerged is acceptable. Table 6.1 158 OER-Elite OPERATION MANUAL Some endoscope can be reprocessed simultaneously. For details on combination of endoscope, refer to the provided List of compatible Endoscopes/Connecting Tubes <OER-Elite>. Working length of endoscope is specified in the endoscopes instruction manual. This condition is applied only when two endoscopes are reprocessed at one time. For details on combination of endoscope, refer to the provided List of compatible Endoscopes/Connecting Tubes <OER-Elite>. Channel inner diameter of the endoscope is specified in the endoscopes instruction manual. For check point of fully submerged, refer to Section 6.7, Inspection before starting reprocessing process. 6.4 Worst case load condition of endoscopes and accessories Worst case load condition of endoscope accessories Compatible accessories Item Endoscope accessories reprocessed in the washing case Endoscope accessories reprocessed in the reprocessing basin. Condition Remarks column All reusable endoscope accessories
(e.g., valves, plugs) except for accessories written in remarks column are compatible. Following accessories can be reprocessed in the reprocessing basin. Ultrasonic probe UPD probe Auxiliary water tube Following accessories cannot be reprocessed in the OER-Elite. Cleaning brush, mouth piece and other cleaning accessories except for AW channel cleaning adapter and auxiliary water tube. For details on combination of endoscope, refer to the provided List of compatible Endoscopes/Connecting Tubes
<OER-Elite>. Ch.6 All single-use accessories Injection adapter (MAJ-1235) Probe/Irrigation plug (MD-807) Balloon sheath connector
(MAJ-667) Connector section of MH-246
(Balloon sheath) Balloon applicator (MAJ-564, MAJ-864) Light guide cable/adapter Camera head Endotherapy accessories except for Distal hood and Distal attachment Forceps Suction Plug (MH-405) Video converter For details on combination of endoscope, refer to the provided List of compatible Endoscopes/Connecting Tubes
<OER-Elite>. For details on combination of endoscope, and/or endoscope accessory refer to the provided List of compatible Endoscopes/Connecting Tubes
<OER-Elite>. Number and combination of accessories Endoscope accessories reprocessed in the washing case All set of compatible accessories per endoscopes installed in the reprocessing basin can be reprocessed at one time. Endoscope accessories reprocessed in the outside of washing case Endoscope accessories reprocessed in the outside of washing case should be treated the same as endoscopes reprocessed in the basin. Table 6.2 NOTE Stylus pen can be reprocessed under any condition. OER-Elite OPERATION MANUAL 159 6.5 Basic operation for reprocessing 6.5 Basic operation for reprocessing Reprocessing standby screen Select the program by pressing the program selection buttons. 1 2 3 4 5 6 1 2 3 4 5 6 7 8 Ch.6 7 8 9 10 11 9 10 11 12 13 14 12 13 14 Description Nomenclature Scope 1 button No. 1 2 Model number of 3 6 7 8 9 Goes to the ID information screen associated with the first endoscope. Displays the model number of the first endoscope. It is blank when the Scope ID is not entered. scope 1 ID status of scope 1 Displays the input status of patient ID, physician ID, user ID (load), and procedure ID Scope 2 button 4 5 Model number of associated with the first scope. Goes to the ID information screen associated with the second endoscope. Displays the model number of the second endoscope. It is blank when the Scope ID is not entered. scope 2 ID status of scope 2 Displays the input status of patient ID, physician ID, user ID (load), and procedure ID Program selection button Program number display Process time associated with the second scope. Press these buttons to select the reprocessing program. Displays the selected reprocessing program number. For details of the reprocessing program number, refer to Reprocessing Program on the next page. Displays the process time of the selected reprocessing program. If any of the following methods are used to input the scope ID, the reprocessing time will be extended by 3 minutes.
The scope ID master card is used
The scope ID is entered using the software keyboard
The pre-registered scope ID is recalled 10 Alcohol flush indicator Any endoscope with a forceps elevator will take an additional 3 minutes to reprocess. Indicate that the Alcohol Flush is incorporated in the reprocessing program. Alcohol flush cannot be eliminated from the reprocessing program. 160 OER-Elite OPERATION MANUAL 6.5 Basic operation for reprocessing No. Nomenclature 11 Heat LCG indicator 12 Menu button 13 14 MRC Check Result LCG Info. button button Description Indicate that the Heat LCG is incorporated in the reprocessing program. Heat LCG cannot be eliminated from the reprocessing program. Returns to the Menu screen, Goes to the LCG info. screen. Goes to the MRC Check Result entry screen. 1 3 2 Ch.6 4 No. 1 Nomenclature Program information Cln. Dis. Channel Monitor indicator Auto Leak Test indicator 2 3 4 Display LCG Info. Button LCG information LCG Cycle Count LCG Usage LCG Temp. MRC Check Result Display Program Info. button Description Displays information about the selected reprocessing program. Displays the cleaning time Displays the disinfecting time. If PCM is displayed, channel monitor is executed in the cleaning and disinfection process. If FCM is displayed, channel monitor is executed in the cleaning, disinfection and rinsing process. If ALT ON is displayed, auto leak test is incorporated in the reprocessing process. If ALT OFF is displayed, auto leak test is not incorporated in the reprocessing process. Press to display the disinfectant solution information on the area of No.1. Refer to No.3. Displays information about the current disinfectant solution. Usage count of the disinfectant solution. Number of days that have elapsed since preparation of the disinfectant solution. Temperature of disinfectant solution during reprocessing process. Input result of MRC check. Press to display the information of the selected reprocessing program on the area of No.3. Refer to No.1. OER-Elite OPERATION MANUAL 161 6.5 Basic operation for reprocessing Reprocessing program OER-Elite has four reprocessing programs. Selection of the reprocessing programs depends on the settings of ALT and Channel monitoring. See the table below for the details of the programs. If any of the following methods are used to input the scope ID, the reprocessing time will be extended by 3 minutes.
The scope ID master card is used
The scope ID is entered using the software keyboard
The pre-registered scope ID is recalled Any endoscope with a forceps elevator will take an additional 3 minutes to reprocess. No. Auto Leak Test Channel Monitoring
(Process that the channel monitoring executes.) Cleaning Disinfection Rinse Ch.6 1 2 3 4 OFF OFF ON ON Partial (PCM) Full (FCM) Partial (PCM) Full (FCM) NOTE The program number to be displayed after turning the power ON the reprocessor is the one which was executed just before turning the power OFF the reprocessor. The reprocessing time of the programs in which auto leak test is ON is 2 7 minutes longer than that of the programs in which Auto leak test is OFF. The reprocessing time of the programs in which Channel monitoring is Full is approximately 8 minutes longer than that of the programs in which Channel monitoring is Partial. 162 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 6.6 Loading of endoscopes and accessories Outline of loading operation of endoscopes and accessories 1 Input scope ID of first endoscope.
on page 165 2 Loading of first endoscope in the reprocessing basin
on page 166 3 Loading of the accessories of first endoscope (valves, etc.).
on page 173 Ch.6 4 Attaching the connecting tubes loading to first endoscope.
on page 177 5 Attaching the Leak test air tube loading to first endoscope. (*)
on page 189 6 Loading of auxiliary water tube of first endoscope. (*)
on page 186 7 Input connection port of first endoscope. (*)
on page 194 8 Input results of manual cleaning and leak test on page of first endoscope. (*)
on page 195 9 Input user ID, physician ID, and patient ID of first endoscope. (*)
on page 196 OER-Elite OPERATION MANUAL 163 6.6 Loading of endoscopes and accessories 10 Input scope ID of second endoscope.
on page 197 11 Loading of second endoscope in the reprocessing basin.
on page 197 12 Loading of the accessories of second endoscope (valves, etc.).
on page 202 13 Attaching the connecting tubes loading to second endoscope.
on page 205 Ch.6 14 Attaching the Leak test air tube loading to second endoscope. (*)
on page 213 15 Loading of auxiliary water tube of second endoscope. (*)
on page 211 16 Input connection port of second endoscope. (*)
on page 214 Input results of manual cleaning and leak test on page of second endoscope. (*)
on page 214 Input user ID, physician ID, and patient ID of second endoscope.
(*) 17 18
on page 214
on page 215 19 Loading stylus pen. 164 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories NOTE Operations marked with (*) may be skipped depending on the endoscope to be reprocessed or the setting of the reprocessor. Input scope ID of first endoscope To maintain an endoscope reprocessing record, this reprocessor is capable of recognizing the individual scope ID that identifies the endoscope being reprocessed. The scope ID can be input with the following methods. Input from RFID Software keyboard input Input from pre-registered information For details on the input methods, refer to Section 3.6, Entering ID (If applicable). When the scope ID is input, the touch screen displays the model number of the first endoscope. Ch.6 Displays the model number of the first endoscope Figure 6.1 NOTE Before entering scope ID of second endoscope, complete IDs entry associated with first endoscope. If scope ID of second endoscope is entered without completing IDs entry associated with first endoscope, the message is displayed on the touch screen. OER-Elite OPERATION MANUAL 165 Ch.6 6.6 Loading of endoscopes and accessories Loading of first endoscopes in the reprocessing basin OER-Elite can reprocess up to two endoscopes at one time. For details on combination of endoscope that can be reprocessed simultaneously, refer to List of Compatible Endoscopes/Connecting Tubes
<OER-Elite>. Before placing endoscopes and accessories, thoroughly review the worst case load condition of endoscopes and accessories instructed in Section 6.4, Worst case load condition of endoscopes and accessories, and confirm that your endoscopes and accessories do not exceed the worst case load condition. The instruction below is compiled assuming the loading of standard-type gastroenterological endoscopes. If a different type of endoscope(s) is to be reprocessed, refer to the provided OER-Elite Quick Reference Guide. WARNING The injection adapter (MAJ-1235) cannot be reprocessed with the reprocessor. If it is placed in the washing case, reprocessing of this adapter will not be effective. When placing the endoscopes in the basin, make sure that the major parts such as the insertion tube and universal cord are loaded correctly. If the endoscopes are placed carelessly with many parts overlapping incorrectly reprocessing may be ineffective. Do not attempt to reprocess an endoscope that is not designated for use with the reprocessor. Do not reprocess two endoscopes that should not be reprocessed simultaneously with each other. Doing so will prevent the reprocessor from functioning properly and may endanger the safety of the patient and operator. In this case, the durability of the reprocessor and its ancillary equipment cannot be guaranteed. Place only the valves and other specified endoscope components in the washing case in the reprocessing basin. If any object other than those specified is placed in the washing case, reprocessing of the endoscope valves will not be effective. When reprocessing an endoscope with a forceps elevator, the connecting tube must be connected to the distal end of the insertion tube. Otherwise, the reprocessing may be insufficient. For the appropriate connecting tube, refer to the List of Compatible Endoscope/Connecting Tubes <OER-Elite>. For the connection method of the connecting tube, refer to the instruction manual for the connecting tube. If the distal end cap of an endoscope is removable, remove the distal end cap before putting the endoscope in the reprocessing basin. Otherwise, reprocessing may be insufficient. Do not obstruct the circulation port inside the reprocessing basin. Otherwise, the liquid feed pressure on the endoscopes will be decreased and reprocessing will be insufficient. 166 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories WARNING Before starting the reprocessing cycle, be sure to confirm that the endoscopes are installed below the disinfectant solution level index line on the cover of float switch
(long) and the cover of float switch (long) is attached firmly. If the endoscope is not fully submerged in the disinfectant solution, reprocessing may be insufficient. When loading endoscopes, always be sure to disconnect cleaning accessories used for manual process from the endoscope. Otherwise, reprocessing may be insufficient. Be sure to check that the whole of endoscope and accessories is installed below the disinfectant solution level index line on the cover of float switch (long). If the endoscope and accessories is installed above the disinfectant solution level index line, the reprocessing may be insufficient. Refer to Figure 6.37. CAUTION When installing an endoscope that requires water-resistant cap, attach water-resistant cap by following the instructions for the endoscope. If a cap is not attached or a cap with moisture inside is attached, the endoscope will fail or malfunction. Ch.6 Ensure that each endoscope is free of noticeable damage before placing it in this reprocessor. Otherwise, fluid leak may occur during the reprocessing. If damage is noticed, perform the leaking scope decontamination and contact Olympus for servicing. For details on the leaking scope decontamination, refer to Section 7.15, Leaking scope decontamination. Do not let the distal end of an endoscope drop from the retaining rack or contact the reprocessing basin directly. Otherwise, the endoscope may be damaged. When the leak test air tube is not used, disconnect it from the connector and be sure to remove it from the reprocessing basin. If reprocessing is performed without removing it, water or disinfectant solution may enter inside the tube and may cause a failure of the tube. Also, if the water or disinfectant solution entering the leak test air tube during the scope leak test enters inside the endoscope, endoscope failure may result. When reprocessing is started without disconnecting the unused leak test air tube(s), error code [E024] is generated and the process stops. For detail on this error code, refer to When the error code [E024] is displayed during the reprocessing process on page 614. When reprocessing endoscopes, always be sure to attach the retaining rack in the reprocessing basin. Otherwise, external surface of endoscopes may contact the heating portion of the reprocessing basin, resulting in possible damage to endoscopes. OER-Elite OPERATION MANUAL 167 6.6 Loading of endoscopes and accessories NOTE In the ID inputs for each endoscope, there is no determined order for the inputs of the scope ID, user ID (load), physician ID, patient ID, and procedure ID. To input the patient ID from a bar code, it is required to connect the optional MAJ-2130 bar code reader. Be sure to place the endoscopes into the reprocessing basin in the correct orientation. Otherwise, the water or the detergent solution feed from the endoscope may enter the inside of the nozzle and dilutes disinfectant solution inside of the nozzle. In this case, the next MRC check will be failed even if the concentration of LCG in the tank is above its MRC. Loading of first endoscope in the reprocessing basin 1 Ch.6 1 Step on the foot pedal to open the lid. 2 Gently place the control section of the first endoscope on the depressed part of the reprocessing basin located on the left of the index pin 1, refer to Figure 6.2 image. Depressed part Index pin 2 Index pin 1 Index pin 2 Index pin 1 Figure 6.2 168 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 3 Wrap the insertion tube clockwise around the retaining rack from the perimeter in. Wrap the first turn of the insertion tube outside the black markings from M1 to M5 and inside the index pin 2 and 3 (shown in light gray). Wrap the second turn inside the black markings from M1 to M5 and outside the hooks (shown in dark gray). Refer to Figure 6.3. Index pin 2 Black Marking M5 Index pin 3 Black Marking M4 Hooks Black Marking M3 Figure 6.3 Black Marking M1 Ch.6 Black Marking M2 OER-Elite OPERATION MANUAL 169 6.6 Loading of endoscopes and accessories 4 Wrap the universal cord (light and dark gray) in a counterclockwise direction on the right of index pin 3 in the inside section (for detail, refer to the Figure 6.4) on the retaining rack by placing it under the hooks so that it will not move upward. If the scope ID tag is attached to the endoscope, move the scope ID tag toward the endoscope connector. Straighten the ID tags band if it is twisted. Ch.6 Index pin 3 Figure 6.4 Hooks 170 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 5 Gently place the first endoscope connector on the specified position on the right side of the reprocessing basin (above the drain port, and inside the Black Marking: M2). Do not put the endoscope connector in the step area. Step area
(Do not put the endoscope on the step area.) Ch.6 Drain port Black Marking: M2 Figure 6.5 OER-Elite OPERATION MANUAL 171 6.6 Loading of endoscopes and accessories 6 Adjust the positions of the insertion tube and universal cord to minimize overlapping. Also, adjust the positioning of the insertion tubes distal end by turning the angulation control knobs (lever) on the control section. Again, make sure that the universal cord is placed on the inside of the hooks. Ch.6 Figure 6.6 172 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Loading of the accessories of first endoscope (valves, etc.) The valves and specified parts of the endoscopes installed in the reprocessing basin can be reprocessed in the washing case together with forceps plugs and AW channel cleaning adapters. Before placing endoscopes and accessories, thoroughly review the worst case load condition of endoscopes and accessories instructed in Section 6.4, Worst case load condition of endoscopes and accessories, and confirm that your endoscopes and accessories do not exceed the worst case load condition. WARNING Place only the valves and AW channel cleaning adapters of the endoscopes installed in the reprocessing basin and the specified scope parts in the washing case. If an item other than the valves of the installed endoscopes and specified scope parts are installed, the valves and specified scope parts cannot be reprocessed sufficiently. Be sure to clean the accessories manually before placing in the washing case. Otherwise, the reprocessing may be ineffective. The biopsy valve should be opened before being placed in the reprocessing basin. Also, other accessories that can be disassembled should be disassembled before being placed in the washing case. Otherwise, they may not be sufficiently reprocessed. Do not put endoscope accessories such as valves and plugs on outside of the washing case. Otherwise, reprocessing of endoscope accessories may be insufficient. Always be sure to close the lid of washing case before starting reprocessing. Otherwise, reprocessing of endoscope accessories may be insufficient. Ch.6 OER-Elite OPERATION MANUAL 173 6.6 Loading of endoscopes and accessories 1 Check if the accessories that can be disassembled are disassembled completely. Example Forceps/Irrigation plug (MAJ-891) Suction valve (MAJ-207) Biopsy valve (MAJ-419) Ch.6 Figure 6.7 2 Open the washing case cover and put the accessories (e.g., biopsy valve, air/water valve, suction valve, auxiliary water inlet cap) into the washing case. Figure 6.8 174 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 3 Put the AW channel cleaning adapter in the washing case and place the indicator plate outside the washing case. Ensure the indicator plate is placed between both hooks. Place the chain of the AW channel cleaning adapter in the designated grooves on the rim of the washing case. Groove on the rim of the washing case. Chains of the adapter placed in the groove on the rim. Figure 6.9 WARNING Hooks Ch.6 Do not pile up the chain of AW channel cleaning adapter. Otherwise, effectiveness of the reprocessing of AW channel cleaning adapter may be compromised. Do not place more than two AW channel cleaning adapters in the case. Otherwise, the reprocessing may be insufficient. When the chains of AW channel cleaning adapter are set on the rim, make sure that the indicator plates of AW channel cleaning adapters are set between the hooks by referring the Figure 6.43 and 6.53. Otherwise, the reprocessing of AW channel cleaning adapter may be insufficient. OER-Elite OPERATION MANUAL 175 6.6 Loading of endoscopes and accessories 4 Close the washing case cover so that the chains of AW channel cleaning adapter are not caught between the case and the cover. Place the indicator plate of AW channel cleaning adapter on the endoscopes as shown in the Figure 6.10. Ch.6 Figure 6.10 WARNING Do not place endoscope on the indicator plate of AW channel cleaning adapter. Otherwise, reprocessing of AW channel cleaning adapter may be insufficient. The indicator plates of the AW channel cleaning adapters should not be placed in an area other than specified. Otherwise, the adapters may encounter strong force when the lid is closed which may cause damage to the endoscopes, AW channel cleaning adapters, retaining rack and/or lid. CAUTION Place the AW channel cleaning adapters in the reprocessing basin without twisting of the chains of the adapters. If a chain is twisted excessively, the chain may be caught by the washing case and the adapter, washing case and/or lid may be damaged. 176 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Attaching the connecting tubes loading to first endoscope The OER-Elite is shipped with two sets of four connecting tubes: MAJ-2110, MAJ-2111, MAJ-2112, and MAJ-2113. Check the List of Compatible Endoscopes/Connecting Tubes <OER-Elite> to confirm whether these connecting tubes are the correct connecting tubes for the particular model endoscope that you are reprocessing. If the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>
indicates that a different connecting tube is required, contact Olympus to obtain the necessary connecting tube. Each Olympus endoscope requires a specific connecting tube (or tubes). Do not attempt to reprocess any endoscope without the correct connecting tube. Before using connecting tubes, be sure to inspect the connecting tubes as instructed in Section 5.7, Inspecting the connecting tubes and leak test air tube. WARNING Ch.6 Each connecting tube is supplied with an instruction manual that describes its method of attachment. Follow these instructions to attach the connecting tube to the OER-Elite and the endoscope. Incorrect attachment will result in insufficient reprocessing. After attaching each connecting tube, visually confirm that there are no irregularities such as kinking, accidental detachment or use of wrong connecting tube and confirm that each connecting tube is firmly attached. If any irregularity is observed, it must be corrected. Otherwise, the reprocessing may be insufficient. If you are reprocessing two endoscopes in the OER-Elite, and a problem is observed with the connecting tubes on one of the endoscopes, correct the problem and then reprocess both endoscopes again, starting from the beginning. Disconnect the connecting tubes from the connectors on the reprocessor whenever the tubes are not used for reprocessing. If reprocessing is performed while the unnecessary tubes are connected, the effectiveness of reprocessing may be reduced. When closing the lid, do not get the connecting tube caught between the reprocessing basin and lid and make sure the endoscopes and the washing case are not touching the lid. Otherwise, the endoscopes, the connecting tubes, the washing case and the reprocessor may be reprocessed insufficiently or get damaged or water leakage from the reprocessing basin may occur. To confirm the correct connecting tubes are attached to the endoscope, always refer to the instruction manuals for endoscope or the latest List of Compatible Endoscopes/Connecting Tubes <OER-Elite>. Using incorrect connecting tubes may result in ineffective reprocessing of endoscopes. If you do not have the latest List of Compatible Endoscopes/Connecting Tubes <OER-Elite>, contact Olympus. OER-Elite OPERATION MANUAL 177 6.6 Loading of endoscopes and accessories WARNING If two endoscopes are reprocessed simultaneously, connect the connecting tube to the connector in the basin in order of number of the connector (e.g., connector A1 should be connected to the 1st endoscope, connector A2 should be connected to the 2nd endoscope). If connecting tube is connected to the wrong connector, channel blockage monitoring and channel connectivity monitoring cannot work properly (e.g., connecting tube for 1st endoscope is connected to the connector of 2nd endoscope). Labels and color of connector used for the first endoscope Labels are provided in the reprocessing basin to distinguish each connector. It also provides information about which connectors are used for the first endoscope and which are used for the second endoscope. Each connector has a specified color identical to the color of connecting tubes and leak test air tubes that can connect to the connector. Ch.6 Labels Color of connector is identical to the color of connecting tubes that can connect to the connector. Black colored label mean this connector is used in most cases for second endoscope. Figure 6.11 White colored label means this connector is used in most cases for first endoscope. 178 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Connection guide of first endoscope When connection guide setting is activated, connection guide screen is displayed after inputting scope ID with RFID. Connection Guide screen provides the information about the type of connecting tubes required for the endoscope and the location of connectors that these connecting tubes are connected. The below figure is example case. If endoscope with two instrument channel ports is set, it is required to connect B2. Refer to the connection guide information and List of Compatible Endoscopes/Connecting Tubes <OER-Elite>. Ch.6 Identical colors to the colors of labels attached on the reprocessing basin. Figure 6.12 NOTE Background colors identical to the connector colors. When the scope ID is input using the master scope ID card or with the manual input, the Connection Guide screen is not displayed. In this case, connect the designated connecting tubes by referring to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>. OER-Elite OPERATION MANUAL 179 6.6 Loading of endoscopes and accessories Connection of the connecting tubes of first endoscope The instruction below is compiled assuming the loading of standard-type gastroenterological endoscopes using standard-set of connecting tubes MAJ-2110, MAJ-2111, MAJ-2112, and MAJ-2113. WARNING If two endoscopes are reprocessed simultaneously, connect the connecting tube to the connector in the basin in order of number of the connector (e.g., connector A1 should be connected to the 1st endoscope, connector A2 should be connected to the 2nd endoscope). If connecting tube is connected to the wrong connector, channel blockage monitoring and channel connectivity monitoring cannot work properly (e.g., connecting tube for 1st endoscope is connected to the connector of 2nd endoscope). Ch.6 NOTE If reprocessing a different type of endoscope(s) requires different types of connecting tubes, refer to the instruction manual for the connecting tube. 1 Insert the endoscope side connector of the MAJ-2110 connecting tube all the way into the suction cylinder and air/water supply cylinder of the endoscope. After the endoscope side connector is inserted until it is stopped at the bottom, keep pushing the connector and slide it toward the eyepiece/remote switch side to secure the connection. To the light blue connectors. Connecting tube (MAJ-2110) Eyepiece/remote switch side Air/water and suction cylinders Figure 6.13 180 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 2 Insert the reprocessor-side connector of the MAJ-2110 connecting tube into the connector with the same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. In this case, connect to the connector A1 for the first endoscope. For first endoscope A1 Figure 6.14 3 Insert the MAJ-2111 connecting tube into the instrument channel port of the endoscope until it clicks. Light blue connectors Ch.6 To the blue connectors. Connecting tube
(MAJ-2111) Instrument channel port NOTE Figure 6.15 Conform the control section of the first endoscope on the depressed part of the reprocessing basin located on the left of the index pin. For detail of image, refer to Figure 6.15 and Figure 6.2. OER-Elite OPERATION MANUAL 181 6.6 Loading of endoscopes and accessories 4 Insert the reprocessor-side connector of the MAJ-2111 connecting tube into the connector with the same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. In this case, connect to the connector B1 for the first endoscope. For first endoscope B1 Ch.6 Figure 6.16 5 Insert the MAJ-2112 connecting tube into the suction connector of the endoscope until it clicks. For details, refer to Figure 6.17. Blue connectors To the green connectors. To the green connectors. Connecting tube
(MAJ-2112) Connecting tube
(MAJ-2112) Suction connector Suction connector Figure 6.17 182 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 6 Insert the reprocessor-side connector of the MAJ-2112 connecting tube into connector with the same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. In this case, connect to the connector C1 for the first endoscope. For first endoscope C1 Figure 6.18 Green connectors Ch.6 OER-Elite OPERATION MANUAL 183 6.6 Loading of endoscopes and accessories 7 Insert the MAJ-2113 connecting tube into the endoscope side connector straight into the endoscopes auxiliary water inlet/elevator channel plug, and turn the outer ring clockwise to connect firmly. Refer to Figure 6.19 for the three options for mounting the MAJ-2113. When using the MAJ-2138 refer to Loading of auxiliary water tube of first endoscope on page 186 and Figure 6.21 on page 186. For scope with inlet/plug on the control panel For scope with inlet on the 180 series or older scope connector For scope with inlet on the 190 series scope connector To the orange connectors. To the orange connectors. Connecting tube
(MAJ-2113) Ch.6 Auxiliary water inlet/
Elevator channel plug Auxiliary water inlet To the orange connectors. Connecting tube
(MAJ-2113) Auxiliary water inlet Figure 6.19 NOTE If reprocessing the auxiliary water tube together with the endoscope, optional MAJ-2138 connecting tube is used instead of MAJ-2113. Also, the auxiliary water tube cleaning setting should be activated when using optional MAJ-2138 connecting tube. For details on setting, refer to Section 4.16, Auxiliary water tube cleaning setting. 184 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 8 Insert the reprocessor-side connector of the MAJ-2113 connecting tube into connector with the same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. In this case, connect to the connector D1 for the first endoscope. For first endoscope D1 Figure 6.20 NOTE Orange connectors Ch.6 When reprocessing an endoscope with a forceps elevator, the connecting tube must be connected to the distal end of the insertion tube. For the appropriate connecting tube, refer to the List of Compatible Endoscope/Connecting Tubes <OER-Elite>. For the connection method of the connecting tube, refer to the instruction manual for the connecting tube. 9 If the auto leak test is not included in the reprocessing program, press the OK button on the touch screen. If the auto leak test is programmed, perform the operation in Connection of the leak test air tubes of first endoscope on page 192. OER-Elite OPERATION MANUAL 185 6.6 Loading of endoscopes and accessories Loading of auxiliary water tube of first endoscope When the auxiliary water tube cleaning setting is activated, an endoscope with the auxiliary water supply function can be reprocessed together with the auxiliary water tube. To reprocess the auxiliary water tube together with the endoscope, the optional MAJ-2138 connecting tube is required. For the setting change method, refer to Section 4.16, Auxiliary water tube cleaning setting. WARNING If an endoscope incorporating the auxiliary water supply function is not reprocessed together with the auxiliary water tube, do not use the MAJ-2138 connecting tube. Otherwise, the auxiliary water tube connection port is left open and the fluid may not be supplied to the endoscope channels. When reprocessing an endoscope incorporating the auxiliary water supply function alone without the auxiliary water tube, be sure to use only the provided MAJ-2113 connecting tubes. Ch.6 1 Insert the endoscope side connector of the MAJ-2138 connecting tube into the auxiliary water inlet of first endoscope. Turn the outer ring clockwise to connect firmly. Refer to right of the Figure 6.21. 2 Insert the auxiliary water tube side connector of the MAJ-2138 connecting tube into the Luer port of the auxiliary water tube. Turn the outer ring clockwise to connect firmly. Refer to left of the Figure 6.21. MAJ-2138 connecting tube MAJ-2138 connecting tube To the orange connectors. Figure 6.21 To the orange connectors. Auxiliary water tube
(MAJ-855/MAJ-2021) 186 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 3 Insert the reprocessor-side connector of the MAJ-2138 connecting tube into the connector of the same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. For detail, refer to Figure 6.22. For first endoscope D1 Orange connectors Figure 6.22 4 Temporarily place the indicator plate of the AW channel cleaning adapter on the washing case. Wrap the auxiliary water tube clockwise around on the inner section of the retaining rack. Do not to place the first endoscope and auxiliary water tube on the indicator plate of the AW channel cleaning adapter. Ch.6 Figure 6.23 OER-Elite OPERATION MANUAL 187 6.6 Loading of endoscopes and accessories 5 After loading the first endoscope and auxiliary water tube, place the indicator plate of the AW channel cleaning adapter on the first endoscope and auxiliary water tube. Make sure that the indicator plates of AW channel cleaning adapters are set between hooks. Ch.6 Hooks Figure 6.24 WARNING Do not wrap the auxiliary water tube on the AW channel cleaning adapters. If the auxiliary water tubes are on the plate or the chain of the AW channel cleaning adapters, the reprocessing of AW channel cleaning adapter may be insufficient. 188 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Attaching the Leak test air tube loading to first endoscope When the auto leak test is included in the reprocessing program, connect the leak test air tube. CAUTION Disconnect the leak test air tube from the connectors on the reprocessor whenever the tubes are not used for leak test. If reprocessing is performed while the unnecessary tubes are connected, fluid may get inside the leak test air tube and could cause it to malfunction. The fluid inside the tube may also damage the endoscope when the leak test is performed next time. The leak test air tube will disconnect easily if it is not attached properly or if the lock lever is degraded. Air cannot be fed properly if the leak test air tube is bent. In these cases, an accurate leak test is not possible. Make sure that there are no cracks, breaks, fissures, scratches, or stains on the leak test air tube according to Section 5.7, Inspecting the connecting tubes and leak test air tube. Using an abnormal or damaged leak test air tube may result in an inaccurate leak test or cause the endoscope to malfunction. If an irregularity is found with the leak test air tube, replace it with a new one and retry the leak test. Do not connect the leak test air tube if the inside of the tube, the endoscopes venting connector, or the reprocessors leak test connector is wet. Doing so could allow water to get inside the endoscope and cause the endoscope to malfunction. When connecting the leak test air tube, ensure that the tube connector is fully and properly attached. Improper connection will prevent the endoscope from being pressurized, preventing an accurate leak test. This could also allow water to get inside the endoscope and cause the endoscope to malfunction. Ch.6 OER-Elite OPERATION MANUAL 189 6.6 Loading of endoscopes and accessories Labels and color of connector used for the first endoscope Labels are provided in the reprocessing basin to distinguish each connector. It also provides information about which connector is used for the first endoscope or the second endoscope. Each connector has a specified color identical to the color of the connecting tubes and leak test air tubes that can connect to the connector. E2 Purple connectors E1 Ch.6 Figure 6.25 190 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Connection guide of first endoscope When the scope ID was input by reading the ID tag with the RFID reader of the reprocessor, connect the specified connecting tubes to the connectors on the endoscope and reprocessing basin by following the instructions given by the Connection Guide screen displayed on the touch screen. The position relationship between the connectors shown on the Connection Guide screen and those in the reprocessing basin is shown below. Background colors identical to the connector colors. Identical colors to the colors of labels attached on the reprocessing basin. Ch.6 Figure 6.26 NOTE When the scope ID is input using the master scope ID card or with the manual input, the Connection Guide screen is not displayed. OER-Elite OPERATION MANUAL 191 6.6 Loading of endoscopes and accessories Connection of the leak test air tubes of first endoscope Connect the leak test air tube to connectors on the endoscope and reprocessing basin by following the instructions. NOTE Certain endoscopes are incapable of auto leak test. For the endoscopes which are compatible with the auto leak test, refer to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>. Do not connect the leak test air tube to the wrong connector (e.g., leak test air tube for 1st endoscope is connected to the connector for 2nd endoscope). Otherwise, auto leak testing cannot work properly since the error occurs. Ch.6 1 Wipe the venting connector of the first endoscope or that of the waterproof cap with a clean cloth immersed in 70% ethyl alcohol or 70% isopropyl alcohol. 2 If the leak test connector E1 in the reprocessing basin is wet, remove moisture by wiping the whole connector with a clean cloth. 3 Aligning the groove on the metal connector of the MAJ-2127 leak test air tube with the pin on the venting connector of the first endoscope or that of the waterproof cap, insert the connector into the port by turning the connector by 90 in the clockwise direction while pushing it. Figure 6.27 NOTE Conform the first endoscope connector on the specified position on the right side of the reprocessing basin (above the drain port). For detail of image, refer to Figure 6.5 on page 171. 192 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories CAUTION Be sure to connect the leak test air tube to the specified leak test connector in the reprocessing basin. If auto leak test is performed while the leak test air tube is connected to a wrong connector, the auto leak test may become incapable of correct leak detection. 4 Insert the reprocessor-side connector of MAJ-2127 leak test air tube into the connector E1 until its lock lever is securely engaged with a snap. First endoscope Figure 6.28 5 Press the OK button on the touch screen to close the Connection Guide screen. Ch.6 OER-Elite OPERATION MANUAL 193 6.6 Loading of endoscopes and accessories Input connection information of first endoscope When the scope ID is entered by method other than RFID, connection information screen described below is displayed on the touch screen. In this case, input of connection information is required. NOTE According to the input of connection information, the OER-Elite monitors the channel flow to check the internal valves are properly operated. This function does not support the detection of channel blockage and disconnection of connecting tube of endoscope side. 1 On the Connection information screen, press the No Connection buttons corresponding to the reprocessing basin connectors to which the connecting tubes are connected. The No Connection indicator will now change to Connection. Ch.6 Each press of either button alternates the displayed button name between Connection and No Connection. Figure 6.29 NOTE If status other than the actual connecting tube connection status is selected, error code [E024] is generated during reprocessing and the reprocessing process stops. 2 Press the OK button. 194 OER-Elite OPERATION MANUAL Figure 6.30 6.6 Loading of endoscopes and accessories 3 When the OK button is pressed, the following warning message is displayed. After reading the message, press the OK button again. Figure 6.31 Input results of manual cleaning and leak test of first endoscope When the manual cleaning and leak test setting is activated, result of manual cleaning and leak test can be entered and associated with the endoscope. Ch.6 NOTE The input of the result of manual cleaning and leak test can be disabled by changing a setting. For details, refer to Section 4.4, Manual cleaning and leak test setting. When No is selected either of them, reprocessing process cannot be started. Select whether or not the endoscope has been cleaned manually and whether or not leak was found during the leak testing, and press the OK button. Figure 6.32 OER-Elite OPERATION MANUAL 195 6.6 Loading of endoscopes and accessories Inputs user ID, physician ID, patient ID, and procedure ID of first endoscope User ID (load), physician ID, patient ID, and procedure ID can be entered and associated with the endoscope. Each ID entry can be changed by settings, refer to Section 4.5 4.9. For details on the input methods, refer to Section 3.6, Entering ID (If applicable). When ID is input, the icon of input ID is displayed with a white icon. Patient ID Physician ID User ID (load) Procedure ID Ch.6 Figure 6.33 NOTE Before entering user ID (load), physician ID, patient ID, or procedure ID of second endoscope, complete IDs entry associated with first endoscope. If user ID (load), physician ID, patient ID or procedure ID of second endoscope is entered without completing IDs entry associated with first endoscope, message is displayed on the touch screen. The user ID setting provides options of 2 users, 1 user and OFF as the number of user IDs to be set. For the method of changing the use ID setting, refer to Section 4.5, User ID Setting. The physician ID input can be omitted by changing the physician ID setting. For the physician ID setting, refer to Section 4.6, Physician ID setting. The patient ID input can be omitted by changing the patient ID setting. For the patient ID setting, refer to Section 4.7, Patient ID setting. The procedure ID input can be omitted by changing the procedure ID setting. For the procedure ID setting, refer to Section 4.9, Procedure ID setting. 196 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Input scope ID of second endoscope To maintain an endoscope reprocessing record, this reprocessor is capable of recognizing the individual scope ID that identifies the endoscope being reprocessed. The scope ID can be input with the following methods. Input from RFID Software keyboard input Input from pre-registered information For details on the input methods, refer to Section 3.6, Entering ID (If applicable). When the scope ID is input, the touch screen displays the model number of the second endoscope. Displays the model number of the second endoscope Ch.6 Figure 6.34 Loading of second endoscopes in the reprocessing basin For detail of warning and caution, refer to Loading of first endoscopes in the reprocessing basin on page 166. Loading of second endoscope in the reprocessing basin 1 Confirm the lid is opened. If the lid is closed, step on the foot pedal to open the lid. 2 Place the indicator plate of the first AW channel cleaning adapter on the washing case
(if applicable). OER-Elite OPERATION MANUAL 197 6.6 Loading of endoscopes and accessories 3 Place the control section of the second endoscope on the left of the control section of the first endoscope between index pin1 and index pin 2. Adjust it to be below the disinfectant solution level index line indicated in the float sensor protection cover. Index pin 2 Index pin 1 The disinfectant solution level index line Ch.6 Control section of the second endoscope Figure 6.35 198 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 4 Wrap the insertion tube clockwise around the retaining rack from the perimeter in. Wrap the first turn of the insertion tube outside the black markings from M1 to M5 and inside the index pin 2 and 3 (shown in light gray). Wrap the second turn inside the black markings from M1 to M5 and outside the hooks
(shown in dark gray). Refer to Figure 6.36. Do not wrap the insertion tube of second endoscope on the AW channel cleaning adapters. Black Marking M4 Black Marking M5 Index pin 3 Index pin 2 Ch.6 Black Marking M3 Black Marking M2 Black Marking M1 Hooks Figure 6.36 OER-Elite OPERATION MANUAL 199 6.6 Loading of endoscopes and accessories 5 Wrap the universal cord (light and deep gray) in a counterclockwise direction on the left of index pin 3 in the inside section (for detail, refer to the Figure 6.37) on the retaining rack by placing it under the hooks so that it will not move upward. If the scope ID tag is attached to the endoscope, move the scope ID tag toward the endoscope connector. Straighten the ID tags band if it is twisted. Do not wrap the universal cord of second endoscope on the AW channel cleaning adapters. Index pin 3 Ch.6 Hooks Figure 6.37 200 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 6 Gently place the second endoscope connector on the first endoscope connector as shown in Figure 6.38. The second endoscope connector on the first endoscope connector. Figure 6.38 7 Adjust the positions of the insertion tube and universal cord to minimize overlapping. Also, adjust the positioning of the insertion tubes distal end by turning the angulation control knobs (lever) on the control section. Again, make sure that the universal cord is placed on the inside of the hooks. Ch.6 Figure 6.39 OER-Elite OPERATION MANUAL 201 6.6 Loading of endoscopes and accessories Loading of the accessories of second endoscope (valves, etc.) The valves and specified parts of the endoscopes installed in the reprocessing basin can be reprocessed in the washing case together with forceps plugs and AW channel cleaning adapters. For detail of warning and caution, refer to Loading of the accessories of first endoscope (valves, etc.) on page 173. 1 Check if the accessories that can be disassembled are disassembled completely. Example Forceps/Irrigation plug (MAJ-891) Suction valve (MAJ-207) Ch.6 Biopsy valve (MAJ-419) Figure 6.40 2 Open the washing case cover and put the accessories (e.g., biopsy valve, air/water valve, suction valve, auxiliary water inlet cap) into the washing case. Make sure that the auxiliary inlet cap is removed from endoscope. Figure 6.41 202 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 3 Put the AW channel cleaning adapters in the washing case and place the indicator plates outside the washing case. Ensure the indicator plates is placed between both hooks. Place the chain of the AW channel cleaning adapter in the designated grooves on the rim of the washing case. Deep part of the rim of the washing case. Chains of the adapter place on the deep part of the rim. Figure 6.42 WARNING Hooks Ch.6 Do not pile up the chain of AW channel cleaning adapter. Otherwise, effectiveness of the reprocessing of AW channel cleaning adapter may be compromised. Do not place three or more AW channel cleaning adapters in the case. Otherwise, the reprocessing may be insufficient. When the chain of AW channel cleaning is set on the rim, make sure that the indicator plates of AW channel cleaning adapters are set between the hooks by referring the Figure 6.43 and 6.53. Otherwise, the reprocessing may be insufficient. OER-Elite OPERATION MANUAL 203 6.6 Loading of endoscopes and accessories 4 Close the washing case cover so that the chains of AW channel cleaning adapter are not caught between the case and the cover. Ensure the indicator plates of AW channel cleaning adapter between the hooks. Figure 6.43 Ch.6 WARNING Hooks Do not place endoscope on the indicator plate of AW channel cleaning adapter. Otherwise, reprocessing of AW channel cleaning adapter may be insufficient. The indicator plates of the AW channel cleaning adapters should not be placed in an area other than specified. Otherwise, the adapters may encounter strong force when the cover is closed which may cause damage to the endoscopes, AW channel cleaning adapters, retaining rack and/or lid. CAUTION Place the AW channel cleaning adapters in the reprocessing basin so that twisting or overlapping of the chains of the adapters is minimized. If a chain is twisted or overlapped excessively, the chain may be caught by the washing case and the adapter, washing case and/or lid may be damaged. 204 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Attaching the connecting tubes loading to second endoscope The OER-Elite is shipped with two sets of four connecting tubes: MAJ-2110, MAJ-2111, MAJ-2112, and MAJ-2113. Check the List of Compatible Endoscopes/Connecting Tubes <OER-Elite> to confirm whether these connecting tubes are the correct connecting tubes for the particular model endoscope that you are reprocessing. If the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>
indicates that a different connecting tube is required, contact Olympus to obtain the necessary connecting tube. Each model Olympus endoscope requires a specific connecting tube (or tubes). Do not attempt to reprocess any endoscope without the correct connecting tube. For detail of warning and caution, refer to Attaching the connecting tubes loading to first endoscope on page 177. Labels and color of connector used for the second endoscope Labels are provided in the reprocessing basin to distinguish each connector. It also provides information about which connectors are used for the first endoscope and which are used for the second endoscope. Each connector has a specified color identical to the color of connecting tubes and leak test air tubes that can connect to the connector. Ch.6 Labels Color of connector is identical to the color of connecting tubes that can connect to the connector. Black colored label mean this connector is used in most cases for second endoscope. Figure 6.44 White colored label means this connector is used in most cases for first endoscope. OER-Elite OPERATION MANUAL 205 6.6 Loading of endoscopes and accessories Connection guide of second endoscope When connection guide setting is activated, connection guide screen is displayed after inputting scope ID with RFID. Connection Guide screen provides the information about the type of connecting tubes required for the endoscope and the location of connectors that these connecting tubes are connected. Identical colors to the colors of labels attached on the reprocessing basin. Background colors identical to the connector colors. Ch.6 Figure 6.45 NOTE When the scope ID is input using the master scope ID card or with the manual input, the Connection Guide screen is not displayed. In this case, connect the designated connecting tubes by referring to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>. 206 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Connection of the connecting tubes of second endoscope The instruction below is compiled assuming the loading of standard-type gastroenterological endoscopes using standard-set of connecting tubes MAJ-2110, MAJ-2111, MAJ-2112, and MAJ-2113. WARNING If two endoscopes are reprocessed simultaneously, connect the connecting tube to the connector in the basin in order of number of the connector (e.g., connector A1 should be connected to the 1st endoscope, connector A2 should be connected to the 2nd endoscope). If connecting tube is connected to the wrong connector, channel blockage monitoring and channel connectivity monitoring cannot work properly (e.g., connecting tube for 1st endoscope is connected to the connector of 2nd endoscope). NOTE If reprocessing a different type of endoscope(s) requires different types of connecting tubes, refer to the instruction manual for the connecting tube. Ch.6 1 Insert the endoscope side connector of the MAJ-2110 connecting tube all the way into the suction cylinder and air/water supply cylinder of the endoscope. After each connector is inserted until it is stopped at the bottom, keep pushing the connector and slide it toward the eyepiece/remote switch side to secure the connection. For detail of MAJ-2110, refer to Attaching the connecting tubes loading to first endoscope on Figure 6.13 on page 180. OER-Elite OPERATION MANUAL 207 6.6 Loading of endoscopes and accessories 2 Insert the reprocessor-side connector of the MAJ-2110 connecting tube into the connector with same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. In this case, connect to the connector A2 for the second endoscope. For second endoscope A2 Light blue connectors Ch.6 Figure 6.46 3 Insert the MAJ-2111 connecting tube into instrument channel port of the endoscope until it clicks. For detail of MAJ-2111, refer to Attaching the connecting tubes loading to first endoscope on Figure 6.15 on page 181. 4 Insert the reprocessor-side connector of the MAJ-2111 connecting tube into the connector with the same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. In this case, connect to the connector B2 for the second endoscope. For second endoscope B2 Figure 6.47 Blue connectors 208 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories 5 Insert the MAJ-2112 connecting tube into the suction connector of the endoscope until it clicks. For details, refer the Figure 6.45 of Connection guide of second endoscope on page 206. For detail of MAJ-2112, refer to Attaching the connecting tubes loading to first endoscope on Figure 6.17 on page 182. 6 Insert the reprocessor-side connector of the MAJ-2112 connecting tube into connector with the same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. In this case, connect to the connector C2 for the second endoscope. For second endoscope C2 Ch.6 Green connectors Figure 6.48 7 Insert the MAJ-2113 connecting tube into the auxiliary water port of the endoscope until it clicks. For detail of MAJ-2113, refer to Attaching the connecting tubes loading to first endoscope on Figure 6.19. When using the MAJ-2138 refer to Loading of auxiliary water tube of first endoscope on page 186 and Figure 6.21 on page 186. NOTE If reprocessing the auxiliary water tube together with the endoscope, optional MAJ-2138 connecting tube is used instead of MAJ-2113. Also, the auxiliary water tube cleaning setting should be activated when using optional MAJ-2138 connecting tube. For details on setting, refer to Section 4.16, Auxiliary water tube cleaning setting. OER-Elite OPERATION MANUAL 209 6.6 Loading of endoscopes and accessories 8 Insert the reprocessor-side connector of the MAJ-2113 connecting tube into connector with the same color (refer to the Connection Guide screen) on the deeper side of the reprocessing basin by pushing in until it clicks. In this case, connect to the connector D2 for the second endoscope. For second endoscope D2 Ch.6 Figure 6.49 NOTE Orange connectors When reprocessing an endoscope with a forceps elevator, the connecting tube must be connected to the distal end of the insertion tube. For the appropriate connecting tube, refer to the List of Compatible Endoscope/Connecting Tubes <OER-Elite>. For the connection method of the connecting tube, refer to the instruction manual for the connecting tube. 9 If the auto leak test is not included in the reprocessing program, press the OK button on the touch screen. If the auto leak test is programmed, perform the operation in Connection of the leak test air tubes of second endoscope on page 213. 210 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Loading of auxiliary water tube of second endoscope When the auxiliary water tube cleaning setting is activated, an endoscope with the auxiliary water supply function can be reprocessed together with the auxiliary water tube. For detail of warning and caution, refer to Loading of auxiliary water tube of first endoscope on page 186. 1 Insert the endoscope side connector of the MAJ-2138 connecting tube into the auxiliary water inlet of second endoscope. Turn the outer ring clockwise to connect firmly. Refer to Figure 6.21 on page 186. 2 Insert the auxiliary water tube (MAJ-855) side connector of the MAJ-2138 connecting tube into the Luer port of the auxiliary water tube. Turn the outer ring clockwise to connect firmly. Refer to Figure 6.21 on page 186. 3 Insert the reprocessor-side connector of the MAJ-2138 connecting tube into the connector of the same color (refer to the Connection Guide screen) of the reprocessing basin by pushing in until it clicks. 4 Temporarily place the indicator plate of both AW channel cleaning adapters on the washing case. Wrap the auxiliary water tube clockwise around on the inner section of the retaining rack. Do not to place the second endoscope and auxiliary water tube on the indicator plate of the AW channel cleaning adapter. Ch.6 Figure 6.50 OER-Elite OPERATION MANUAL 211 6.6 Loading of endoscopes and accessories 5 After loading the second endoscope and auxiliary water tube, place the indicator plates of the AW channel cleaning adapter on the second endoscope and auxiliary water tube. Make sure that the indicator plates of AW channel cleaning adapters are set between the hooks. Ch.6 Figure 6.51 WARNING Hooks Do not wrap the auxiliary water tube on the AW channel cleaning adapters. If the auxiliary water tubes are on the plate or the chain of the AW channel cleaning adapters, the reprocessing of AW channel cleaning adapters may be insufficient. 212 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Attaching the Leak test air tube loading to second endoscope When the auto leak test is included in the reprocessing program, connect the leak test air tube. For detail of warning and caution, refer to Attaching the Leak test air tube loading to first endoscope on page 189. Connection of the leak test air tubes of second endoscope NOTE Certain endoscopes are incapable of auto leak test. For the endoscopes which are compatible with the auto leak test, refer to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>. Do not connect the leak test air tube to the wrong connector (e.g., leak test air tube for 1st endoscope is connected to the connector for 2nd endoscope). Otherwise, auto leak testing cannot work properly. Ch.6 1 Wipe the venting connector of the second endoscope or that of the waterproof cap with a clean cloth immersed in 70% ethyl alcohol or 70% isopropyl alcohol. 2 If the leak test connector E2 in the reprocessing basin is wet, remove moisture by wiping the whole connector with a clean cloth. 3 Aligning the groove on the metal connector of the MAJ-2127 leak test air tube with the pin on the venting connector of the second endoscope or that of the waterproof cap, insert the connector into the port by turning the connector by 90 in the clockwise direction while pushing it. For detail of MAJ-2127, refer to Connection of the leak test air tubes of first endoscope on Figure 6.28 on page 193. CAUTION Be sure to connect the leak test air tube to the specified leak test connector in the reprocessing basin. If auto leak test is performed while the leak test air tube is connected to a wrong connector, the auto leak test may become incapable of correct leak detection. OER-Elite OPERATION MANUAL 213 6.6 Loading of endoscopes and accessories 4 Insert the reprocessor-side connector of MAJ-2127 leak test air tube into the connector E2 until its lock lever is securely engaged with a snap. Second endoscope Figure 6.52 5 Press the OK button on the touch screen to close the Connection Guide screen. Ch.6 Input connection information of second endoscope When the scope ID is entered by method other than RFID, connection information screen described below is displayed on the touch screen. In this case, input of connection information is required. For detail, refer to Input connection information of first endoscope on page 194. Input results of manual cleaning and leak test of second endoscope When the manual cleaning and leak test setting is activated, result of manual cleaning and leak test can be entered and associated with the endoscope. For detail of warning and caution, refer to Input results of manual cleaning and leak test of first endoscope on page 195. Inputs user ID, physician ID, patient ID, and procedure ID of second endoscope User ID (load), physician ID, patient ID, and procedure ID can be entered and associated with the endoscope. Each ID entry can be changed by settings, refer to Section 4.5 4.9. For details on the input methods, refer to Section 3.6, Entering ID (If applicable). When ID is input, the icon of input ID is displayed with a white icon. For detail of warning and caution, refer to Inputs user ID, physician ID, patient ID, and procedure ID of first endoscope on page 196. 214 OER-Elite OPERATION MANUAL 6.6 Loading of endoscopes and accessories Loading the stylus pen The stylus pen can be reprocessed together with the endoscope. When reprocessing the stylus pen, set the stylus pen by fitting the hole of the stylus pen around the Pin (Black marking M4) of the retaining rack in the reprocessing basin. Make sure that the indicator plates of AW channel cleaning adapters are set between the hooks by referring the Figure 6.53. Pin (Black Marking M4) Ch.6 First endoscope Second endoscope Washing case Hole of the stylus pen Stylus pen AW channel cleaning adapter Figure 6.53 OER-Elite OPERATION MANUAL 215 6.7 Inspection before starting reprocessing process 6.7 Inspection before starting reprocessing process Before starting the reprocessing program, be sure to check all descriptions on page149 to page208 to avoid process interruption and compromise of reprocessing efficacy. 1 Check the connections between endoscope and the OER-Elite.
The connecting tubes and leak test air tube are not kinked and bent.
The unnecessary connecting tubes and leak test air tube are not connected to the OER-Elite.
The wrong connecting tube is not used.
The connecting tube is not connected to the wrong connector in the basin (e.g., connector B1 should be connected to the 1st endoscope, connector B2 should be connected to the 2nd endoscope).
The connecting tubes should be connected firmly to the connectors. 2 Check the washing case.
The cover of the washing case should be closed.
The washing case should be located on the washing case mount.
Any accessories are placed only in the washing case.
The chains of AW channel cleaning adapter are not piled up.
The indicator plate of AW channel cleaning adapter should be located between the hooks. Ch.6 216 OER-Elite OPERATION MANUAL 6.7 Inspection before starting reprocessing process 3 Check the endoscopes placed in the reprocessing basin.
The whole of endoscope is installed below the disinfectant solution level index line on the cover of float switch (long). The cover of float switch (long) should be attached firmly. Disinfectant solution level index line Ch.6 Figure 6.54 WARNING Be sure to check that the entire endoscope and all accessories are installed below the disinfectant solution level index line on the cover of float switch (long). If the endoscope and all accessories are installed above the disinfectant solution level index line, the reprocessing may be insufficient. When reprocessing an endoscope with a forceps elevator, the connecting tube must be connected to the distal end of the insertion tube. Otherwise, the reprocessing may be insufficient. For the appropriate connecting tube, refer to the List of Compatible Endoscope/Connecting Tubes <OER-Elite>. For the connection method of the connecting tube, refer to the instruction manual for the connecting tube. 4 Close the lid by pushing until it clicks and check that any parts of endoscopes do not touch the lid. Figure 6.55 shows the case of the reprocessing one endoscope. Figure 6.58 shows the case of reprocessing two endoscopes. OER-Elite OPERATION MANUAL 217 6.7 Inspection before starting reprocessing process WARNING When closing the lid, do not get the connecting tube caught between the reprocessing basin and lid and make sure the endoscopes and the washing case are not touching the lid. Otherwise, the endoscopes, the connecting tubes, the washing case and the reprocessor may be reprocessed insufficiently or get damaged or water leakage from the reprocessing basin may occur. When reprocessing one endoscope Ch.6 Figure 6.55 218 OER-Elite OPERATION MANUAL 6.7 Inspection before starting reprocessing process When reprocessing two endoscopes Ch.6 Figure 6.56 OER-Elite OPERATION MANUAL 219 6.8 Reprocessing 5 Check the contents of the selected reprocessing program and status of IDs entry. Confirm that the checking of concentration of disinfectant solution and MRC check result entry is completed. Contents of the selected reprocessing program Process time of selected reprocessing program Figure 6.57 Ch.6 6.8 Reprocessing The reprocessing time can be selected from four reprocessing programs [1] to [4]. The auto leak test and channel monitoring will be performed following the selected reprocessing program. If any of the following methods are used to input the scope ID, the reprocessing time will be extended by 3 minutes.
The scope ID master card is used
The scope ID is entered using the software keyboard
The pre-registered scope ID is recalled Any endoscope with a forceps elevator will take an additional 3 minutes to reprocess. No. Auto leak Test Channel Monitoring
(Process that the channel monitoring executes.) Cleaning Disinfection Rinse 1 2 3 4 OFF OFF ON ON Table 6.3 Partial (PCM) Full (FCM) Partial (PCM) Full (FCM) 220 OER-Elite OPERATION MANUAL Auto leak test 6.8 Reprocessing This reprocessor can automatically detect a leak in the endoscope during the reprocessing cycle. The results can be recorded in the reprocessing record. The auto leak test can reduce the mistakes of manual leak test. In addition to this function, also be sure to perform a leak test before performing manual cleaning. Not all endoscopes are capable of auto leak test. For the endoscopes with the auto leak test capability, refer to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>. If the scope ID is input by using the scope ID master card, input by the software keyboard or input by recalling the pre-registered ID, the auto leak test is not available. The timing of the auto leak test can be selected at the start of reprocessing or at the end of reprocessing by ALT setting. Refer to Section 6.8, Reprocessing. At the start of reprocessing When warm water is used in manual cleaning, the result of the auto leak test may be erroneous because the internal pressure of endoscope(s) is unstable due to temperature change. If the auto leak test is to be performed at the start of reprocessing, begin the reprocessing process after the endoscope temperature has returned to the room temperature. To return the room temperature, it takes 15 minutes for endoscopes other than ultrasonic endoscopes and 30 minutes for ultrasonic endoscopes. When the auto leak test is performed at the start of reprocessing, the reprocessing time is extended for about 2 minutes. If leak is detected with an endoscope, follow the procedure for leaking scope decontamination on it and contact Olympus for servicing. For details on the leaking scope decontamination, refer to Section 7.15, Leaking scope decontamination. Ch.6 At the end of reprocessing When the auto leak test is performed at the end of reprocessing, the reprocessing time is extended for about 2 7 minutes depending on the type of endoscopes and the atmospheric temperature surrounding the reprocessor. If there is a leak with an endoscope, water may enter the endoscope from the leakage point. When the reprocessor detects disconnection of the leak test air tube during the reprocessing process, it generates error code [E024] and stops the process. For the related setting changes, refer to Section 4.2, Auto leak test setting. OER-Elite OPERATION MANUAL 221 6.8 Reprocessing WARNING Ch.6 When water leak is detected with one endoscope, the other endoscope without water leak might be reprocessed insufficiently. In this case, perform the reprocessing process again. Avoid exposure to direct sunlight or air conditioning vents. If there is drastic temperature change due to the exposure to direct sunlight or air conditioning, the leak test result may be erroneous. If the leak test result is Fail, do not execute reprocessing process. In this case, perform the leaking scope decontamination process with the leaking endoscope and contact Olympus for servicing. For details on the leaking scope decontamination process, refer to Section 7.15, Leaking scope decontamination. CAUTION Even if the auto leak test is incorporated in the reprocessing program, be sure to perform manual leak test before manual cleaning. If water leaks occur with an endoscope, fluid invasion and damage to the endoscope may occur during manual cleaning. The touch screen may display error code [E114] (Leaked) due to the effect of the temperature of the endoscope(s). If this happens, execute the auto leak detection again after the endoscope temperature has returned to the room temperature. If error code [E114] is displayed again, perform the leaking scope decontamination process with the leaking endoscope and contact Olympus for servicing. For details on the leaking scope decontamination, refer to Section 7.15, Leaking scope decontamination. NOTE The covering of the bending section of the endoscope may dilate slightly during the leak test. This is not malfunction. The auto leak test may sometimes be incapable of detecting a very small hole. 222 OER-Elite OPERATION MANUAL 6.8 Reprocessing Channel monitoring This reprocessor has the channel monitoring function, which monitors the fluid flow of each endoscope channel during the reprocessing process and checks clogging of the endoscopes suction channel
(channel blockage monitoring) and the connection status of the connecting tubes (channel connectivity monitoring). The channel monitoring function can detect the following status during the reprocessing process. Channel blockage monitoring Complete blocking of the endoscopes suction channel (stoppage by foreign object or buckling of suction channel). NOTE Channel blockage monitoring cannot detect a partial blockage of the endoscope's suction channel. The Channel Blockage Monitoring is not available for some endoscopes. See List of Compatible Endoscopes/Connecting Tubes <OER-Elite> for the compatible endoscopes. If the scope ID is input by any of the following methods, the Channel blockage monitoring is not available.
Using the scope ID master card,
Software keyboard.
Recalling the pre-registered ID. Ch.6 Channel connectivity monitoring
(A) Disconnection of the necessary connecting tube from the connector on the endoscope.
(B) Disconnection of the necessary connecting tube from the connector on the reprocessing basin.
(C) Connection of the unnecessary connecting tube to the connector on the reprocessing basin. OER-Elite OPERATION MANUAL 223 6.8 Reprocessing NOTE Disconnection of the necessary connecting tube from the connector on the endoscope cannot be detected for some endoscopes. See List of Compatible Endoscopes/Connecting Tubes <OER-Elite> for the compatible endoscopes. If the scope ID is input in any of the following methods, the function (A) would not work.
The scope ID master card is used
The scope ID is entered using the software keyboard
The pre-registered scope ID is recalled If a connecting tube is disconnected, the channel blockage monitoring may not work properly and this reprocessor may detect disconnection of the other connecting tubes from the connector on the endoscope despite the fact that they are connected properly. Ch.6 When the channel monitoring is detected during the reprocessing process, the reprocessor displays error code [E024] on the touch screen and stops the process. The detection timings can be selected from PCM (partial channel monitoring) for detection in the cleaning and disinfection processes and FCM (full channel monitoring) for detection in the cleaning, disinfection and rinsing processes. The selected detection timings are recorded in the reprocessing process record. When FCM (full channel monitoring) is selected, the process time extends by about 8 minutes. For the setting change, refer to Section 6.5, Basic operation for reprocessing. CAUTION The following procedures must be performed. Otherwise, the channel monitoring may not be able to detect clogged suction channel of the endoscope or improper connection of the connecting tubes.
Clean the Circulation port mesh filters at the end of every working day.
Check that the connectors on the reprocessing basin are not damaged prior to every use.
Check that the connecting tubes are not damaged prior to every use.
The endoscope(s) must be placed in the reprocessing basin in accordance with the instructions in Chapter 6. 224 OER-Elite OPERATION MANUAL 6.8 Reprocessing Reprocessing operation 1 Press the START button. The reprocessing process starts. 2 When the reprocessing process starts, the touch screen displays the following. Figure 6.58 Ch.6 Remaining time Process progress bar Figure 6.59 Current process name Temperature of disinfectant solution in reprocessing basin during disinfection process and water supply temperature Show the detail for each LCG information Show the detail for each program information OER-Elite OPERATION MANUAL 225 6.8 Reprocessing NOTE When the disinfectant solution temperature is below 20qC (68qF), it is heated to 20qC (68qF). During heating the disinfectant solution, the remaining time countdown and progress bar on the touch screen stops and turns gray. The remaining time countdown restarts after completion of heating the disinfectant solution. Flashes during heating Temperature of disinfectant solution in reprocessing basin The countdown stops and turns gray Ch.6 Figure 6.60 It takes about 6 minutes to raise the temperature of the disinfectant solution by 1qC. To display the remaining time, the reprocessor measures the water supply time at the first time the reprocessing process. During each reprocessing process, the reprocessor measures the water flow and correct the remaining time. 226 OER-Elite OPERATION MANUAL 3 When reprocessing process is complete, the buzzer beeps and the touch screen shows the following. 6.8 Reprocessing When the user ID (remove) setting for end of reprocessing is activated Model number of reprocessed first endoscope Number given to each record in the order of reprocessing Date and time of completion of reprocessing Press to check the ID information related to the second endoscope Displays the input status of patient ID, physician ID, user ID (remove), and procedure ID associated with the first scope Press to check the ID information related to the first endoscope Cleaning time/
disinfection time
(minutes) Setting of reprocessing program Input results of manual cleaning and leak test Figure 6.61 Ch.6 Model number of reprocessed second endoscope Displays the input status of patient ID, physician ID, user ID (remove), and procedure ID associated with the second scope Usage count of the disinfectant solution Number of days that have elapsed since preparation of the disinfectant solution Temperature of disinfectant solution during water line disinfection Input result of MRC check When the user ID (remove) setting for end of reprocessing is disabled Total count of the reprocessor OER-Elite OPERATION MANUAL 227 Ch.6 6.9 Removing the endoscopes and accessories 6.9 Removing the endoscopes and accessories This section describes how to take the endoscopes out of the reprocessing basin after disconnecting the connecting tubes. Also, be sure to remove the valves and other items from the washing case. WARNING If there is an irregularity of the connecting tube on either endoscope, it must be corrected and both endoscopes must be reprocessed again. Otherwise, the reprocessing of endoscopes may be insufficient. After reprocessing, maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscope or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/or operators who touch them. Wear sterilized gloves when taking reprocessed endoscopes out of the reprocessor. Otherwise, the endoscopes may be contaminated and cause infections. If this happens, you must reprocess the endoscopes again. After reprocessing, always confirm that no liquid has leaked from the outside surface of lid and lid packing. Dry the external surface and all channels before storing the endoscope. Otherwise, miscellaneous bacteria and other sources of contamination may contaminate the endoscope. When taking the endoscopes out of the reprocessor, make sure the endoscopes do not touch any parts of the reprocessor that has not been disinfected. This may contaminate the endoscopes. If this happens, you must reprocess the endoscope again. CAUTION Prevent water from getting into the leak test air tube. Otherwise, the endoscope may be damaged the next time it is used. NOTE Disinfectant vapor may still be in the reprocessing basin immediately after the lid is opened. 228 OER-Elite OPERATION MANUAL 6.9 Removing the endoscopes and accessories 1 When the user ID (remove) setting for end of reprocessing is activated, enter the operators user ID as instructed in Section 3.6, Entering ID (If applicable). When the user ID (remove) is input from the RFID, the touch screen switches to the Reprocessing Compete screen. When the input is performed manually or from the previous registration, press the OK button to switch the screen. Ch.6 Figure 6.62 OER-Elite OPERATION MANUAL 229 6.9 Removing the endoscopes and accessories NOTE When the MAJ-1937 printer included in the optional MAJ-2144 printer set is connected and the auto print setting is activated, the result of reprocessing is printed automatically. To set the auto print setting, refer to Section 4.17, Print option. To print the result of reprocessing, press the Print button. The lid is locked until user ID (remove) entry is completed. When the user ID (remove) setting for end of reprocessing is disabled, completion screen is displayed after the reprocessing is complete. Ch.6 Figure 6.63 2 Wear a face mask, gloves, and protective clothes. Step on the foot pedal to open the lid. 3 Check the condition of the connecting tubes.
The connecting tubes should not be bent.
The connecting tubes should be connected firmly to the connectors.
The connecting tubes should be free of irregularities including cracks, scratches, etc. WARNING Before disconnecting a connecting tube, visually confirm that there are no irregularities such as kinking, accidental detachment or use of wrong connecting tube and confirm that each connecting tube is firmly attached. If any irregularity is observed, it must be corrected and the endoscope must be reprocessed again. Otherwise, the reprocessing may be insufficient. 230 OER-Elite OPERATION MANUAL 6.9 Removing the endoscopes and accessories NOTE If the connecting tube is connected to the wrong connector in the reprocessing basin (e.g. a connecting tube for the 1st endoscope is connected to the connector for the 2nd endoscope), the endoscope does not have to be reprocessed again. 4 Take out the stylus pen from the reprocessing basin. 5 Take out the accessories from the washing case. 6 If using the auxiliary water tube (MAJ-855/MAJ-2021), disconnect and take out the auxiliary water tubes (MAJ-855/MAJ-2021) from connecting tube MAJ-2138. 7 Disconnect and take out all connecting tubes and leak test air tubes from each endoscope and reprocessor. 8 Take out the endoscope(s) from the reprocessing basin. When taking out the endoscope(s), make sure the endoscopes do not touch any parts of the reprocessor that have not been disinfected. 9 Wipe off any water on the endoscopes using a piece of sterile gauze. 10 If the endoscopes have the auxiliary water inlet, attach the auxiliary water inlet cap to the auxiliary water inlet. Ch.6 WARNING After reprocessing, maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscope or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/or operators who touch them. 11 According to the endoscopes instruction manual, store the endoscopes and valves in a clean place. 12 Take the connecting tubes and leak test air tubes out of the reprocessing basin, wipe off any water on the tubes using a piece of sterile gauze, and store them in a clean place. OER-Elite OPERATION MANUAL 231 6.10 Printing of the reprocessing records 13 Press the OK button. 14 Reprocessed endoscopes are now ready for use. Figure 6.64 6.10 Printing of the reprocessing records Ch.6 When the MAJ-1937 printer included in the optional MAJ-2144 printer set is connected to this reprocessor, the results of reprocessing and the information on the error code, if generated, after the completion of reprocessing. For how to install the printer set, refer to Section 3.11, Loading of the optional accessories in Instructions-Installation Manual and to the instruction manual for the printer set. Auto printing after the end of reprocessing or in the case of error generation is possible by a setting change. For the setting change method, refer to Section 4.17, Print option. WARNING Do not touch the thermal head or its surroundings immediately after printing. They will be very hot and cause burns. CAUTION The printed information does not guarantee the reprocessing of endoscopes. Use the printed sheets as a record of the reprocessors operations. Printed data may be lost as the paper ages and deteriorates. If you want to store this information for a month or more, transfer it to a medium with long-term storage capability. To prevent printer failure or printer paper roll discoloration, do not touch the printer or printer paper roll with wet hands. To prevent the printer from malfunctioning, do not moisten it or printer paper roll. Be sure to attach the printer hood. Otherwise, the printer and/or printer paper roll may get wet and cause a malfunction. 232 OER-Elite OPERATION MANUAL 6.10 Printing of the reprocessing records CAUTION To avoid damage to or deterioration of the printout, do not allow the paper to make contact with the following:
Alcohol or detergent
Oil, fat, organic solvents, or chemicals (medical, industrial or cosmetic)
Stamp ink
Water
Materials containing plasticizer (PVC film, desk mat, leather products, journal cover, etc.)
Certain stationery (plastic tape, mending tape, fluorescent-ink pen, oil-ink pen, adhesives other than starchy paste) To prevent discoloration of unused paper, store unused printer paper rolls according to the following conditions.
Dark, cool place
Not to exceed 25qC (77qF)
Not to exceed 65%RH
Not exposed to NOx (nitrogen oxide(s)), SOx (sulfur oxide(s)), or O3 (ozone) To prevent discoloration of paper after printing, store it in a place of the following conditions. If it is required to store the printed results for a month or more, it is recommended to copy the information printed on the paper to durable sheets and store the copies.
Dark, cool place
Not exceed 25qC (77qF)
Not exceed 65%RH
Not exposed to NOx (nitrogen oxide(s)), SOx (sulfur oxide(s)), or O3 (ozone) When red lines appear on both sides of the printer paper roll during printing, replace the printer paper roll. Do not touch the paper cutter of the printer when cutting the printed paper. Otherwise, it may injure your hand. Cut the printed paper after every printing. Otherwise, the printer paper roll may jam and/or be damaged. Pay attention to handle the portable memory and printed paper that include patient information exported from the OER-Elite. Ch.6 OER-Elite OPERATION MANUAL 233 6.10 Printing of the reprocessing records Printing reprocessing results after completion of reprocessing 1 After completion of the reprocessing process, ensure that the following screen is shown on the touch screen. Ch.6 NOTE Figure 6.65 If the OK button is pressed here, the touch screen switches to the Reprocessing Standby screen. If the Reprocessing Standby screen appears, select Log, Info from the menu to open the screen of each record and press the Print button to start printing. For how to view a record, refer to Section 11.2, Log display and output. 2 Press the Print button. 3 A buzzer beep and stopping of paper feed mean that the printing is complete. Cut the printed paper and ensure that the required information is printed correctly. Figure 6.66 Print format (reprocessing result) The reprocessing result is printed in the following 2 options. To change the option, refer to Section 4.17, Print option. 234 OER-Elite OPERATION MANUAL
(a) Separate 6.10 Printing of the reprocessing records Serial number of this reprocessor Total accumulated of reprocessing process count Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Setting details LCG Info. Detergent Info. Information of first endoscope User ID (remove) of the end of process of first endoscope Ch.6 Serial number of this reprocessor Total accumulated of reprocessing process count Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Setting details LCG Info. Detergent Info. Information of second endoscope User ID (remove) of the end of process Figure 6.67 OER-Elite OPERATION MANUAL 235 Serial number of this reprocessor Total accumulated of reprocessing process count Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Setting details LCG Info. Detergent Info. Information of first endoscope Information of second endoscope User ID (remove) of the end of process 6.10 Printing of the reprocessing records
(b) Combine Ch.6 Figure 6.68 236 OER-Elite OPERATION MANUAL 6.10 Printing of the reprocessing records Printing error code details in case of error 1 The following screen appears after auto processing of a generated error. On this screen, press the Error Info. button. NOTE Figure 6.69 The displayed information varies depending on the generated error. Ch.6 2 Press the Print button. 3 A buzzer beep and stopping of paper feed mean that the printing is complete. Cut the printed paper and ensure that the required information is printed correctly. Figure 6.70 OER-Elite OPERATION MANUAL 237 6.10 Printing of the reprocessing records Print format (error result) Ch.6 Figure 6.71 Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of first endoscope Information of second endoscope 238 OER-Elite OPERATION MANUAL 7.1 Function menu Chapter 7 Functions 7.1 Function menu Function menu This menu is composed of two pages. To go between the pages, press the next page button or previous page button. NOTE To set the Heat LCG Timer, press the HEAT LCG TIMER button on the control panel. For details, refer to Section 7.3, Heat LCG Timer. Ch.7 OER-Elite OPERATION MANUAL 239 7.1 Function menu 1 Ch.7 No. 1 Button Function item button Page 1 Heat LCG Mix LCG Rinse Air Purge Water Line Disinfection Self-Disinfection &
Water Sampling Detergent Line Disinfection Alcohol Line Disinfection Description Press to display the buttons for starting various functions. Press to heat the disinfectant solution. oRefer to Section 7.2, Heat LCG. Press to mix the disinfectant solution. oRefer to Section 7.4, Mix LCG. Press to rinse the disinfected articles. oRefer to Section 7.5, Rinse. Press to perform air purge. oRefer to Section 7.6, Air purge. Press to disinfect the water supply line. oRefer to Section 7.7, Water line disinfection. Press to perform self-disinfection. oRefer to Section 7.8, Self-disinfection and water sampling. Press to disinfect the detergent line. oRefer to Section 7.9, Detergent line disinfection. Press to disinfect the alcohol line. oRefer to Section 7.10, Alcohol line disinfection. 240 OER-Elite OPERATION MANUAL 7.1 Function menu 1 No. 1 Button Page 2 Manual Leak Test Auto Leak Test ALT Self-Check Alcohol Flush Leaking Scope Decontamination 2 Menu button 3 LCG Info. button 4 5 Previous page button Next page button 2 3 4 5 Description Press to perform manual leak test. oRefer to Section 7.11, Manual leak test. Press to perform the auto leak test. oRefer to Section 7.12, Auto leak test. Press to perform the self-check of the auto leak test function. oRefer to Section 7.13, Self-check of auto leak test. Press to perform alcohol flush. oRefer to Section 7.14, Alcohol flush. Press to perform the leaking scope decontamination. oRefer to Section 7.15, Leaking scope decontamination. Press to open the Menu screen. Press to open the LCG Info. screen. oRefer to Section 3.5, LCG Info. screen. Press to return to the previous page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Ch.7 OER-Elite OPERATION MANUAL 241 7.2 Heat LCG 7.2 Heat LCG This section explains how to heat the disinfectant solution independently of the reprocessing programs. The operation consists of heating disinfectant solution to 22qC (72qF) when the disinfectant solution temperature is below 20qC (68qF). CAUTION Before starting heating the disinfectant solution, always confirm that there is no foreign material on the ventilation openings on the gas filter cases. Blocking the ventilation not only hinders deodorization but may also cause the reprocessor to malfunction. NOTE Before performing the Heat LCG, disconnect the leak test air tube from the connector on the reprocessor and take the tube out of the reprocessing basin. If leak test air tubes are left in the basin, it becomes wet through the Heat LCG process. For how to check the disinfectant solution temperature, refer to Section 3.5, LCG Info. screen. Ch.7 1 Press the Functions button on the Menu screen. Figure 7.1 242 OER-Elite OPERATION MANUAL 2 Press the Heat LCG button on the 1st page of the Function menu. 7.2 Heat LCG 3 Close the lid by pushing until it clicks and make sure water faucet is open. 4 Enter the user ID. (If applicable) Figure 7.2 NOTE For the detailed procedure of ID entry, refer to Section 3.6, Entering ID (If applicable). 5 Press the Start button. The Heat LCG process will begin. Put the duration time on the same page as this step. Ch.7 Figure 7.3 NOTE Heating normally takes approximately 5 minutes for every 1qC temperature rise. 6 When the disinfectant solution is heated to the specified temperature, the disinfectant solution is collected automatically and the reprocessing basin is rinsed. OER-Elite OPERATION MANUAL 243 7.3 Heat LCG Timer 7 When the Heat LCG process completes, the reprocessor generates a buzzer beep and will display the following screen on the touch screen. Press the OK button to finish. Figure 7.4 7.3 Heat LCG Timer Ch.7 This function heats the disinfectant solution to the appropriate temperature by a specified time. When the temperature of the disinfectant solution is below 20C (68F), the OER-Elite will heat the disinfectant solution to 22C (72F). WARNING Before performing the Heat LCG Timer, clean and inspect the reprocessor by following the instructions in Chapter 10, End-Of-Day Checks. Otherwise, the functions and performance of the reprocessor would be unable to be maintained. CAUTION Before performing to Heat LCG Timer function, disconnect the leak test air tube from the connector on the reprocessor and be sure to take the tube out of the reprocessing basin. Otherwise, penetration of water or disinfectant solution inside the leak test air tube may cause its failure. Also, the endoscope may also fail if the water or disinfectant solution penetrating in the leak test air tube enters the endoscope during the leak test. Keep the water faucet closed during standby of the Heat LCG Timer. Otherwise, the change in the water pressure could disconnect the water supply hose and cause water leak. NOTE The user ID can be recorded in the Heat LCG record. For setting change of the user ID input function, refer to Section 4.5, User ID Setting. Heating normally takes approximately 5 minutes for every 1qC temperature rise. 244 OER-Elite OPERATION MANUAL Flow of Heat LCG Timer 1 Starting the Heat LCG Timer. 2 Standing by and starting the Heat LCG Timer. 3 Finishing of the Heat LCG Timer. Starting the Heat LCG Timer 1 Close the water faucet. 2 Ensure that the reprocessor is ON. 3 Close the lid by pushing until it clicks. 4 Press the HEAT LCG TIMER button on the control panel. 7.3 Heat LCG Timer
on page 245
on page 253
on page 254 Ch.7 Figure 7.5 OER-Elite OPERATION MANUAL 245 7.3 Heat LCG Timer 5 Input the user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 7.6 NOTE The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. When the user ID setting (Heat LCG Timer) is not activated, this screen is not displayed. Skip this step. Ch.7 6 When set Heat LCG Timer just for one time, press the OFF button in the repeat setting. Then Press OK button. Refer to (a) When repeat setting is selected OFF on page 248. When you want to set Heat LCG Timer repeatedly, press the ON button in the repeat setting. Refer to (b) When repeat setting is selected ON on page 250. Figure 7.7 246 OER-Elite OPERATION MANUAL 7.3 Heat LCG Timer NOTE Do not turn the main power off. Doing so disables the Heat LCG. To display the touch screen again, press the touch screen or any button on the control panel. To stop the Heat LCG Timer setting, press STOP button on the reprocessor. The Heat LCG Timer Indicator light even when the touch screen displays nothing. Heat LCG timer indicator Figure 7.8 Ch.7 OER-Elite OPERATION MANUAL 247 7.3 Heat LCG Timer
(a) When repeat setting is selected OFF 1 Change the completion date/time and press the OK button. 1 2 3 4 5 Ch.7 No. 1 2 3 4 5 Item/Button Description Change completion date Change completion time (Hour) Change completion time (Min.) Cancel OK Sets the date of Heat LCG Timer completion. Pressing the + button increments the setting and pressing the button decrements it. Sets hour of Heat LCG Timer completion. Pressing the + button increments the setting and pressing the button decrements it. Sets minute of Heat LCG Timer completion. Pressing the + button increments the setting and pressing the button decrements it. Cancels the setting change. Goes to the next screen page after saving the edited information. 2 The touch screen display changes as shown Figure 7.9 and appear to turn off after 5 minutes of inactivity, the touch screen appears to turn off and the Heat LCG Timer enters the standby mode. Heat LCG Timer completion date/time setting Figure 7.9 248 OER-Elite OPERATION MANUAL 7.3 Heat LCG Timer NOTE If no operation is made more than 5 minutes, the touch screen appears to turn off. To display the touch screen again, press the touch screen or the button on the control panel. For detail of executing, the touch screen displays a screen as shown Figure 7.10. Figure 7.10 The Heat LCG Timer Indicator light even when the touch screen displays nothing. Ch.7 Heat LCG timer indicator Figure 7.11 OER-Elite OPERATION MANUAL 249 7.3 Heat LCG Timer
(b) When repeat setting is selected ON Under the repeat setting, the Heat LCG Timer is repeated weekly based on the specified day(s). 1 Press the Edit button in the repeat setting. 2 Select the day(s) of you want to run the Heat is LCG Timer and press the OK button. marked on the selected day(s). Figure 7.12 Ch.7 Figure 7.13 250 OER-Elite OPERATION MANUAL 3 Set the Heat LCG Timer completion time and press the OK button. 7.3 Heat LCG Timer 1 2 3 4 5 No. 1 2 3 4 5 Item/Button Description Change completion time (Hour) Change completion time (Min.) Cancel Back OK Sets hour of Heat LCG Timer completion. Pressing the + button increments the setting and pressing the button decrements it. Sets minute of Heat LCG Timer completion. Pressing the + button increments the setting and pressing the button decrements it. Cancels the setting change. Returns to the days of the week selection menu. Returns to the setting menu of Heat LCG Timer after saving the edited information. Ch.7 1 2 No. 1 2 Item Completion Time Completion day of week Description Sets the time of Heat LCG Timer completion. Sets the day of week of Heat LCG Timer completion. Su: Sunday, Mo: Monday, Tu: Tuesday, We: Wednesday, Th: Thursday, Fr: Friday, Sa: Saturday OER-Elite OPERATION MANUAL 251 7.3 Heat LCG Timer 4 Press the Start button on the touch screen. Then, the Heat LCG Timer is started. The touch screen display changes as shown Figure 7.14 and appear to turn off after 5 minutes of inactivity, the touch screen appears to turn off and the Heat LCG Timer enters the standby mode. Figure 7.14 NOTE If no operation is made more than 5 minutes, the touch screen appears to turn off. To display the touch screen again, press the touch screen or the button on the control panel. For detail of executing, the touch screen displays a screen as shown Figure 7.15. Ch.7 Figure 7.15 The Heat LCG Timer Indicator light even when the touch screen displays nothing. Heat LCG timer indicator Figure 7.16 252 OER-Elite OPERATION MANUAL 7.3 Heat LCG Timer Standing by and starting the Heat LCG Timer During standby and the heating process, the Heat LCG indicator lights and the touch screen appears to turn off. If the touch screen or any button on the control panel is pressed during heating process, the touch screen displays the following screen. Figure 7.17 Heat LCG timer indicator Ch.7 Figure 7.18 NOTE Heating normally takes approximately 5 minutes for every 1qC temperature rise. OER-Elite OPERATION MANUAL 253 7.3 Heat LCG Timer Finishing the Heat LCG Timer 1 When heating process completes, the touch screen display changes as shown on the Figure 7.19. Figure 7.19 NOTE When heating process completes, the reprocessor starts the mixing LCG process. Because the MRC check result may become erroneous. Ch.7 2 Open the water faucet. 3 Press the Continue button to start mixing the disinfectant solution. Figure 7.20 254 OER-Elite OPERATION MANUAL 7.4 Mix LCG 4 When the mixing the disinfectant solution completes, the touch screen displays the following screen. Press the OK button. Then, the OER-Elite will reboot automatically. Figure 7.21 7.4 Mix LCG This function mixes the disinfectant solution to enable an accurate concentration check. WARNING If Mix LCG is performed while the endoscopes are placed in the reprocessing basin, the endoscopes must be reprocessed after the Mix LCG. Otherwise, the endoscopes cannot be reprocessed sufficiently. Ch.7 NOTE To ensure accurate MRC check, mix LCG is generally required at the first use of the day. Also, mix LCG is required when the interval of reprocessing operation is beyond 4 hours. If the mix LCG is required, the message is automatically displayed on the touch screen. If the MRC check is entered a long time (maximum 5 days) after the previous use of the disinfectant, the touch screen may display the guidance for the request of the Mix LCG. OER-Elite OPERATION MANUAL 255 7.4 Mix LCG 1 Press Functions on the Menu screen. 2 Press the Mix LCG button on the Function menu. Figure 7.22 Ch.7 3 Follow the guide displayed on the touch screen. Close the lid by pushing until it clicks and make sure the water faucet is open. Figure 7.23 4 Enter the user ID. (If applicable) NOTE The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. 256 OER-Elite OPERATION MANUAL 5 Press the Start button. Mix LCG process starts. 7.4 Mix LCG Figure 7.24 6 When the Mix LCG process completes, the reprocessor generates a buzzer beep and displays the following screen on the touch screen. Press the OK button to finish. Ch.7 Figure 7.25 OER-Elite OPERATION MANUAL 257 7.5 Rinse 7.5 Rinse If cleaning fluid or disinfectant solution remains in the reprocessing basin or inside the lumens of the endoscope after an irregularity occurs or if the process is stopped before it completes, please the rinse process after the completion of the air purge process. After disinfection, a water rinse is performed three times. Rinse conditions such as number of rinses performed and rinse time cannot be changed. Worst case time and water volume of each rinse cycle are shown below. Time and water volume can vary depending on endoscope models, number of endoscopes loaded and water supply conditions. Rinse cycle Time Rinse water volume 1st cycle 100 s 14.7 L 3.9 gallons 2nd cycle 110 s 17.9 L 4.7 gallons 3rd cycle 130 s 17.9 L 4.7 gallons Table 7.1 CAUTION Ch.7 Be sure to perform the air purge first if cleaning fluid or disinfectant solution is still in the reprocessing basin or endoscopes. Otherwise, rinse may be insufficient. Before starting the rinse, always confirm that there is no foreign material on the ventilation openings on the gas filter cases. Blocking the ventilation not only hinders deodorization but may also cause the reprocessor to malfunction. 1 Press the Functions button on the Menu screen. Figure 7.26 258 OER-Elite OPERATION MANUAL 2 Press the Rinse button on the Function menu. 7.5 Rinse 3 Follow the guide displayed on the touch screen. Close the lid by pushing until it clicks and make sure water faucet is open. Figure 7.27 4 Enter the user ID. (If applicable) NOTE The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. 5 Press the Start button. Rinse starts and the touch screen displays the remaining time, which will count down every minute. Ch.7 Figure 7.28 OER-Elite OPERATION MANUAL 259 7.6 Air purge 6 When the rinse process completes, the reprocessor generates a buzzer beep and displays the following screen on the touch screen. Press the OK button to finish. Figure 7.29 7.6 Air purge Ch.7 Air purge is performed to drain the remaining cleaning fluid and disinfectant solution from the basin after an irregularity occurs, or if the process is stopped before it completes. Air purge also eliminates residual fluid from the endoscope channels. 1 Press the Functions button on the Menu screen. 2 Press the Air Purge button on the Function menu. Figure 7.30 260 OER-Elite OPERATION MANUAL Figure 7.31 7.6 Air purge 3 Follow the guide displayed on the touch screen. Close the lid by pushing until it clicks. 4 Enter the User ID (If applicable). NOTE The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. 5 Press the Start button. Air purge starts and the touch screen displays the remaining time, which will count down every minute. Figure 7.32 NOTE To finish the process in the middle, press the Stop button on the touch screen. Ch.7 6 When the air purge process completes, the reprocessor generates a buzzer beep and displays the following screen on the touch screen. Press the OK button to finish. Figure 7.33 OER-Elite OPERATION MANUAL 261 7.7 Water line disinfection 7.7 Water line disinfection Ch.7 Disinfection of water supply piping is required in the following cases. Immediately after replacement of water filter. Before using this reprocessor for the first time (after loading of the water filter). Whenever bacteria in the water supply piping is identified.
&RQGXFW the water line disinfection at least every month. Before using the reprocessor if it has not been used for more than 14 days. The disinfectant solution stored in the reprocessor is used for disinfection of the water supply piping. WARNING Before disinfecting the water supply piping, check the concentration of the disinfectant solution with the test strip, and replace the disinfectant solution if the disinfectant concentration is below the required level. If this check is not performed, disinfection may be insufficient. Disinfection of the water supply piping is required each time the water filter is replaced (i.e., at least once a month). There may be other circumstances where this is required, for example a flood or hurricane. Microbiological sampling of the OER-Elite rinse water may indicate disinfection is required. Disconnect the connecting tubes from the connectors on the reprocessor before disinfecting the water supply piping. Otherwise, a jet of disinfectant solution may be output from the connecting tubes and leak from a connector such as the gas filter case connector. Before handling the disinfectant solution, read the cautions carefully and use it as instructed. It is especially important to know what to do if the disinfectant solution comes in contact with your skin and eyes. When handling the disinfectant solution, wear personal protective equipment to prevent any disinfectant from getting on your skin and eyes or being inhaled. Avoid direct physical contact and inhalation of vapors. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. 262 OER-Elite OPERATION MANUAL 7.7 Water line disinfection NOTE Olympus recommends performing microbiological sampling of the OER-Elite rinse water quality right after performing the water supply piping disinfection if the reprocessor has not been used for more than 14 days. For details on sampling rinse water, refer to Section 7.8, Self-disinfection and water sampling. When disinfection of water supply piping is required, Olympus recommends performing it prior to replacement of the disinfectant solution. The disinfectant solution must still meet the MRC using the test strip. After disinfection of water supply piping, drain the disinfectant solution according to the instructions in the instruction manual and the facility policy. Fill the OER-Elite with fresh disinfectant solution prior to proceeding with endoscope reprocessing. After disinfection of the water supply piping, the quantity and/or concentration of the disinfectant solution might be reduced, which prevents additional reprocessing cycles from being performed. Do not add fresh disinfectant solution to the used disinfectant solution. Drain the disinfectant solution completely and replace with fresh disinfectant solution after disinfection of the water supply piping. It is recommended to perform disinfection of the water supply piping immediately before routine replacement of the disinfectant solution. Disinfecting the water supply piping also disinfects the water filter and other components in the piping. Ch.7 Workflow of water line disinfection 1 Checking the MRC level and entering the check result.
on page 264 2 Water line disinfection.
on page 266 OER-Elite OPERATION MANUAL 263 7.7 Water line disinfection Required items Check Required items Chemical indicator (test strip) Container with 2 L (67 ounces) or larger capacity (wide-mouthed container such as a vat) Filter tube ( 2) Water supply piping disinfecting hose Table 7.2 NOTE For the test strip, refer to Section 2.8, Consumable accessories (Optional). Checking the MRC level and entering the check result Ch.7 1 Press the Functions button on the Menu screen. 2 Press the Water Line Disinfection. Figure 7.34 Figure 7.35 264 OER-Elite OPERATION MANUAL 3 Press the LCG Info. button. 7.7 Water line disinfection Figure 7.36 4 Check the concentration of the disinfectant solution with a test strip, and enter the result of the concentration of the disinfectant solution as described in Section 3.7, Checking the MRC level and entering the check result. If the disinfectant concentration is below required level and the disinfectant solution is beyond shelf-life of disinfectant solution, replace the disinfectant solution. 5 Press the OK button to close the LCG Info screen and press the Next button. Ch.7 Figure 7.37 OER-Elite OPERATION MANUAL 265 7.7 Water line disinfection Water line disinfection 1 Make sure that the water faucet is open. 2 Follow the guide displayed on the touch screen. Press the Next button. 3 Input the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID
(If applicable). Figure 7.38 Ch.7 Figure 7.39 NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 4 Press the Start button. 5 Push the area marked PUSH on the front door to open it. 6 Prepare a container with a capacity of 2 L (67 ounces) or more in front of the reprocessor. 266 OER-Elite OPERATION MANUAL
1 | Operation Manual 3 | Users Manual | 2.37 MiB |
7.7 Water line disinfection 7 Put the tube-side ends of the two filter tubes in the container placed and insert the connector ends of the two filter tubes into the connector above the water filter housing and the connector below the water filter housing until they click. Water will start to flow from the tube connected to the connector below the water filter housing. Connector above water filter housing Connector below water filter housing Figure 7.40 8 Press the Continue button. If need more information, press the Detail button. Ch.7 9 When water flow stops, disconnect the two filter tubes by pushing the lock levers on their connectors. Figure 7.41 Lock lever Figure 7.42 OER-Elite OPERATION MANUAL 267 7.7 Water line disinfection 10 Press the Continue button. 11 Step on the foot pedal to open the lid. 12 Connect the water supply piping disinfection hose between the connector C1 in the reprocessing basin and the water supply piping disinfection connector. Figure 7.43 Connector C1 Ch.7 Water supply piping disinfection connector Temperature sensor Washing case mount Figure 7.44 13 Close the lid by pushing until it clicks. 14 Press the Continue button to supply the disinfectant solution in the reprocessing basin. Figure 7.45 268 OER-Elite OPERATION MANUAL 7.7 Water line disinfection 15 When the reprocessing basin is filled with disinfectant solution, a buzzer sounds three times and the touch screen displays the following screen. Figure 7.46 16 Put the tube-side end of the filter tube and put it in the container. 17 Insert the connector end of the filter tube into the connector above the water filter housing until it clicks. Do not connect anything to the connector below the water filter housing. 18 Press the Continue button. Please do not walk away from the reprocessor. Figure 7.47 Ch.7 Figure 7.48 OER-Elite OPERATION MANUAL 269 7.7 Water line disinfection 19 Disconnect the filter tube as soon as disinfectant solution starts to flow from it continuously. Figure 7.49 20 Press the Continue button. Ch.7 21 When the disinfection process starts, the touch screen displays the remaining time and the progress bar. Figure 7.50 Figure 7.51 270 OER-Elite OPERATION MANUAL 7.7 Water line disinfection NOTE If the temperature of the disinfectant solution is less than 20qC (68qF), it will be heated to 20qC (68qF). During heating, the remaining time countdown and the progress bar display stop and turn gray. After the completion of heating, the remaining time countdown and progress bar display resume. Progress stops and turns gray. Figure 7.52 It blinks Current temperature of the disinfectant solution Target temperature of the disinfectant solution 22 Make sure that a jet of fluid is output from the water supply/circulation nozzle to the dome of lid during the process. Ch.7 NOTE Figure 7.53 Fluid jet from the water supply/circulation nozzle of this process is gentler than other processes such as the endoscope reprocessing process. As a result, fluid spreads on less than half of dome part of the lid whereas the fluid jet of other process spreads on entire dome part of the lid. This difference is due to use of a different pump and therefore the gentle fluid flow of this process is adequate. OER-Elite OPERATION MANUAL 271 7.7 Water line disinfection 23 When the remaining time displayed on the touch screen reaches 0 minutes, the buzzer sounds and the touch screen displays the following screen. Figure 7.54 24 Put the tube-side end of the filter tube back in the container. 25 Connect the connector end of the filter tube into the connector above the water filter housing. Do not connect a filter tube to the connector below the water filter housing. Ch.7 26 Press the Continue button. The touch screen displays a screen as shown in the following figure and water will flow from the filter tube. Figure 7.55 Figure 7.56 272 OER-Elite OPERATION MANUAL 7.7 Water line disinfection 27 After several seconds, the buzzer sounds indicating the end of the process and the touch screen displays the following screen. Figure 7.57 28 Disconnect the filter tube by pushing its lock lever. 29 Close the front door. 30 Step on the foot pedal to open the lid. 31 Disconnect the water supply piping disinfection hose and close the lid by pushing until it clicks. Ch.7 Water supply piping disinfection hose connector Washing case mount Connector C1 Temperature sensor Figure 7.58 32 Rinse the filter tube and water supply piping disinfection hose thoroughly in running water, dry them thoroughly, and store in a clean place. OER-Elite OPERATION MANUAL 273 7.8 Self-disinfection and water sampling 33 Press the OK button to complete the water filter replacement process. Figure 7.59 7.8 Self-disinfection and water sampling Self-Disinfection is required in the following cases. Ch.7
Before using this reprocessor for the first time.
Before using this reprocessor when it has not been used for more than 14 days. In addition, it is recommended that sampling for microbiological surveillance is performed at the end of self-disinfection process. Workflow of self-disinfection See the self-disinfection workflow below. 1 Checking the MRC level and entering the check result.
on page 275 2 Performing the Self-disinfection and water sampling.
on page 277 3 Performing the water sampling and microbiological surveillance.
on page 281 274 OER-Elite OPERATION MANUAL 7.8 Self-disinfection and water sampling Required items Check Required items Sterilized syringe Sterilized bottle Connector jig Table 7.3 NOTE Sterilized syringe and Sterilized bottle are needed to perform a microbiological surveillance. Perform microbiological sampling of the OER-Elite rinse water quality as required by your hospitals policy. Also, Olympus recommends to perform microbiological sampling of the rinse water right after performing the water supply piping disinfection if the reprocessor has not been used for more than 14 days. Checking the MRC level and entering the check result Ch.7 Before performing the self-disinfection, check the concentration of the disinfectant solution with the test strip, and replace the disinfectant solution if the disinfectant concentration is below the required level. 1 Press the Functions button on the Menu screen. Figure 7.60 OER-Elite OPERATION MANUAL 275 7.8 Self-disinfection and water sampling 2 Press the Self-Disinfection & Water Sampling button on the Function menu. 3 Press the LCG Info. button to display the LCG Info. screen. Figure 7.61 Ch.7 Figure 7.62 4 Check the concentration of the disinfectant solution with the test strip, and enter the check result as described in Section 3.7, Checking the MRC level and entering the check result. 5 Press the OK button to close the LCG Info screen. Figure 7.63 276 OER-Elite OPERATION MANUAL 7.8 Self-disinfection and water sampling Performing the self-disinfection 1 If you want to perform sampling for microbiological surveillance followed by the self-disinfection process, press the Yes button. Otherwise, press the No button. Figure 7.64 2 Step on the foot pedal to open the lid. 3 Connect the connector jig to the same-colored connector at the reprocessing basin by pushing down on the connector jig until it clicks. Ch.7 4 Press the Next button repeatedly until the touch screen display changes as shown Figure 7.66. Figure 7.65 Figure 7.66 5 Close the lid by pushing until it clicks. 6 Make sure that the water faucet is open. 7 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). OER-Elite OPERATION MANUAL 277 7.8 Self-disinfection and water sampling NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 8 Press the Start button. Ch.7 9 The touch screen displays the remaining time. If sampling water was selected in the Step 1, go to the Step 10. Otherwise, go to the step 17. Figure 7.67 Figure 7.68 NOTE The cleaning, disinfection and rinse are executed in the process. If the temperature of the disinfectant solution is less than 20qC (68qF), it will be heated to 20qC (68qF). During heating, the remaining time countdown and the progress bar display stop and turn gray. After the completion of heating, the remaining time countdown and progress bar display resume. 278 OER-Elite OPERATION MANUAL 7.8 Self-disinfection and water sampling 10 When the reprocessing basin is filled with water, the buzzer beeps and the touch screen displays the following screen. 11 Step on the foot pedal to open the lid. 12 Using a sterilized syringe, collect an amount of water for the microbiological examination from the reprocessing basin. Figure 7.69 CAUTION Be sure to wear sterile gloves when collecting the water in the reprocessing basin to prevent contamination. Do not touch the lid, the reprocessing basin, the bottle or any area while wearing the sterile gloves. Otherwise, the collected water may become contaminated. Ch.7 13 Put the collected water in the sterile bottle. 14 Close the lid by pushing until it clicks to drain the water in the reprocessing basin. During draining the water, the touch screen displays the following screen. Figure 7.70 OER-Elite OPERATION MANUAL 279 7.8 Self-disinfection and water sampling 15 When discharge is completed, the buzzer beeps and the touch screen displays the following screen. 16 Step on the foot pedal to open the lid. 17 Disconnect the connector jig from the reprocessing basin, wipe off any water using a piece of sterile gauze, and store them in a clean place. Figure 7.71 18 Press the OK button. Ch.7 Figure 7.72 280 OER-Elite OPERATION MANUAL 7.8 Self-disinfection and water sampling Microbiological Surveillance Methods for how to determine microbial level of rinse water There are several methods for determining the microbial level. For further information on determining the microbial level, consult other relevant guidelines or standards. AAMI TIR34: 2014 is the latest edition of this TIR 34, one of the relevant guideline, includes the information about available methods for how to determine microbial level of rinse water. Acceptable microbial levels of rinse water The acceptable microbial levels of rinse water are bacteria-free. Action to be taken if microbial levels exceed acceptable level If unacceptable bacterial levels are detected, the site should be sampled again to confirm that unacceptable levels are a consistent finding. If repeat testing confirms unacceptable levels, then perform decontamination process described below to reduce the microbial level contamination. Ch.7
(a) Decontamination process 1 Perform Self-Disinfection again. For detailed instruction, refer to Section 7.8, Self-disinfection and water sampling. 2 Perform Disinfection of the water supply piping. For detailed instruction, refer to Section 4.20, Disinfection of the water supply piping in Instructions-Installation Manual. If the microbial levels continue to exceed acceptable level despite the decontamination process, an internal problem with the reprocessor or degradation of main water is suspected. In this case, it is recommended to contact Olympus. OER-Elite OPERATION MANUAL 281 7.9 Detergent line disinfection 7.9 Detergent line disinfection WARNING Ch.7 When handling the disinfectant solution and detergent, carefully read the cautions for its use to fully understand the given information and use as instructed. Particular understanding is required for measures to be taken in case the disinfectant solution comes into contact with your skin and eyes. When handling the disinfectant solution and detergent, wear appropriate personal protective equipment to avoid direct contact with your skin and eyes or excessive inhalation of its vapor. The disinfectant solution and its vapor may affect the human body. Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Do not block the disinfectant removal port with a finger or other objects when the rubber cap is not attached. Otherwise, the disinfectant solution may flow out. To prevent peripheral devices and areas near the reprocessor from being damaged by leaked disinfectant solution, do not leave the rubber cap off from the disinfectant removal port. If disinfectant solution leaks out of the disinfectant removal port when the rubber cap has been removed, immediately reattach the rubber cap and follow the procedure in Section 13.2, Troubleshooting guide. For details, refer to Fluid leak the disinfectant removal port of Other problems and remedial actions on page 642. If leaking does not stop, contact Olympus. CAUTION To prevent spills, keep the detergent tanks upright. 282 OER-Elite OPERATION MANUAL Required items 7.9 Detergent line disinfection Check Required items FDA-cleared chemical indicator (test strip) Drain connector (should be dry) Clean cloth Two beakers with 300 ml or larger capacity (e.g. beaker) Disinfectant solution: approximately 120 ml Sterile water: more than 300 ml Table 7.4 NOTE For the test strip, refer to Section 2.8, Consumable accessories (Optional). Detergent line disinfection Before disinfecting, disinfectant solution temperature is confirmed. When disinfectant solution temperature is below 20qC (68qF), execute the Heat LCG. For detail of Heat LCG, refer to Section 7.2, Heat LCG. Ch.7 1 Close the lid by pushing until it clicks. 2 Make sure that the water faucet is open. 3 Press the Functions button on the Menu screen. Figure 7.73 OER-Elite OPERATION MANUAL 283 7.9 Detergent line disinfection 4 Press the Detergent Line Disinfection button. 5 Press the Next button. Figure 7.74 Ch.7 Figure 7.75 6 Push [PUSH] on the front door to open the front door. Remove the rubber cap from the disinfectant removal port. Disinfectant removal port Rubber cap 7 Push the drain connector into the disinfectant removal port until it clicks. Figure 7.76 WARNING When connecting the drain connector to the disinfectant removal port, do not push on the connectors valve. Otherwise, disinfectant solution will leak out of it. 284 OER-Elite OPERATION MANUAL 7.9 Detergent line disinfection 8 Place a beaker below the drain connector, push the connectors valve, and collect approximately 120 ml of disinfectant solution. Figure 7.77 9 Place the prepared cloth under the drain connector, hold the lock lever, and slowly disconnect the connector. Wipe off any disinfectant solution if it leaks. 10 Wipe the disinfectant removal port with a clean cloth and put the rubber cap back on. Rinse the drain LCG connector thoroughly in running water, dry it thoroughly and store in a clean place. 11 Close the front door. NOTE The front door cannot be closed unless the rubber cap is attached. Ch.7 12 Check the disinfectant solution concentration level in the beaker by using the test strip while taking care not to inhale the disinfectant solution vapor. If the concentration is below its MRC, replace the disinfectant solution as described in Section 8.2, Replacing the disinfectant solution. NOTE In the detergent line disinfection, always check the disinfectant concentration level in the beaker. OER-Elite OPERATION MANUAL 285 7.9 Detergent line disinfection 13 Press the LCG Info button. 14 Press the MRC Check button. Figure 7.78 Ch.7 15 Input the MRC Check Result. Figure 7.79 Select the result of check using the test strip. Figure 7.80 16 Input the operators user ID. For the detailed procedure, refer to Section 3.6, Entering ID (If applicable). 286 OER-Elite OPERATION MANUAL 7.9 Detergent line disinfection NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 17 Press the Save button. 18 Press the OK button and the Next button repeatedly until the touch screen display changes as shown Figure 7.82. Figure 7.81 Ch.7 19 Pull out the detergent/alcohol drawer. Detach the detergent tank cap to which the tube is connected. (Do not disconnect the connector.) Figure 7.82 20 Press the Next button. Input the operators user ID. For the detailed procedure, refer to Section 3.6, Entering ID (If applicable). Figure 7.83 OER-Elite OPERATION MANUAL 287 7.9 Detergent line disinfection NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 21 Press the Start button. The drain of detergent solution from the detergent line starts. Figure 7.84 Ch.7 22 Pour approximately 150 ml of sterile water into another beaker. 23 When the touch screen display changes as shown Figure 7.85, put the nozzle of detergent cap in the beaker filled with the sterile water. 24 Press the Continue button. The rinse of the detergent lines starts. Wait for a few seconds. Figure 7.85 288 OER-Elite OPERATION MANUAL Figure 7.86 7.9 Detergent line disinfection 25 When the touch screen display changes as shown Figure 7.87, take the nozzle of detergent cap out of the beaker. 26 Press the Continue button and wait for a few seconds. Figure 7.87 Figure 7.88 Ch.7 CAUTION Do not block the tube-shaped tip of the detergent tank cap. Otherwise, the fluid inside the detergent line may not be able to be drained. 27 When the touch screen display changes as shown Figure 7.89, put the nozzle of the detergent cap in the beaker filled with the disinfectant solution. Figure 7.89 OER-Elite OPERATION MANUAL 289 7.9 Detergent line disinfection 28 Press the Continue button. The disinfection of the detergent lines starts and the touch screen displays the remaining disinfectant time. Wait a few minutes. Figure 7.90 29 When the touch screen display changes as shown Figure 7.91, take the nozzle of detergent cap out of the beaker. Ch.7 30 Press the Continue button and wait for a few seconds. Figure 7.91 Figure 7.92 290 OER-Elite OPERATION MANUAL 7.9 Detergent line disinfection 31 When the touch screen display changes as shown Figure 7.93. Put the nozzle of detergent cap in the beaker filled with more than 150 ml of sterile water. 32 Press the Continue button. Rinse of the detergent lines starts. Figure 7.93 33 When the touch screen display changes as shown Figure 7.95, take the nozzle of detergent cap out of the beaker. Figure 7.94 Ch.7 34 Press the Continue button. Draining of the detergent lines starts. Figure 7.95 OER-Elite OPERATION MANUAL 291 Figure 7.96 7.9 Detergent line disinfection 35 When the touch screen display changes as shown below, attach the detergent cap to the detergent tank. Figure 7.97 36 Press the Continue button. Injection of detergent in the detergent lines starts and the water in the reprocessing basin is drained. Ch.7 37 Press the OK button to finish disinfection of the detergent lines. Figure 7.98 Figure 7.99 292 OER-Elite OPERATION MANUAL 7.10 Alcohol line disinfection 7.10 Alcohol line disinfection WARNING When handling the disinfectant solution and alcohol, carefully read the cautions for its use to fully understand the given information and use as instructed. Particular understanding is required for measures to be taken in case the disinfectant solution comes into contact with your skin and eyes. When handling the disinfectant solution and alcohol, wear appropriate personal protective equipment to avoid direct contact with your skin and eyes or excessive inhalation of its vapor. The disinfectant solution and its vapor may affect the human body. Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Do not block the disinfectant removal port with a finger or other objects when the rubber cap is not attached. Otherwise, the disinfectant solution may flow out. Ch.7 To prevent peripheral devices and areas near the reprocessor from being damaged by leaked disinfectant solution, do not leave the rubber cap off from the disinfectant removal port except when connecting the drain connector to the disinfectant removal port. If disinfectant solution leaks out of the disinfectant removal port when the rubber cap has been removed, immediately reattach the rubber cap and follow the procedure in Section 13.2, Troubleshooting guide. For details, refer to Fluid leak the disinfectant removal port of Other problems and remedial actions on page 642. If leaking does not stop, contact Olympus. Make sure to attach the connector jigs. Otherwise, the disinfection of the alcohol supply line may not be effective. After disinfecting the alcohol supply line, always rinse it thoroughly. Otherwise, disinfectant solution may remain on the endoscope following reprocessing and pose a patient safety risk. CAUTION To prevent spills, keep the alcohol tanks upright. OER-Elite OPERATION MANUAL 293 7.10 Alcohol line disinfection Required items Check Required items FDA-cleared chemical indicator (test strip) Drain connector (should be dry) Clean cloth Two beakers with 200 ml or larger capacity (e.g. beaker) Disinfectant solution: approximately 120 ml Sterile water: more than 150 ml Table 7.5 NOTE For the test strip, refer to Section 2.8, Consumable accessories (Optional). Alcohol line disinfection Ch.7 Before disinfecting, disinfectant solution temperature is confirmed. When disinfectant solution temperature is below 20qC (68qF), execute the Heat LCG. For detail of Heat LCG, refer to Section 7.2, Heat LCG. 1 Close the lid by pushing until it clicks. 2 Make sure that the water faucet is open. 3 Press the Functions button on the Menu screen. Figure 7.100 294 OER-Elite OPERATION MANUAL 4 Press the Alcohol Line Disinfection button. 7.10 Alcohol line disinfection 5 Press the Next button. Figure 7.101 Figure 7.102 6 Push [PUSH] on the front door to open the front door. Remove the rubber cap from the disinfectant removal port. Ch.7 Disinfectant removal port Rubber cap 7 Push the drain connector into the disinfectant removal port until it clicks. Figure 7.103 WARNING When connecting the drain connector to the disinfectant removal port, do not push on the connectors valve. Otherwise, disinfectant solution will leak out of it. OER-Elite OPERATION MANUAL 295 7.10 Alcohol line disinfection 8 Place a beaker below the drain connector, push the connectors valve, and collect approximately 120 ml of disinfectant solution. Figure 7.104 9 Place the prepared cloth under the drain connector, hold the lock lever, and slowly disconnect the connector. Wipe off any disinfectant solution if it leaks. 10 Wipe the disinfectant removal port with a clean cloth and put the rubber cap back on. Rinse the drain LCG connector thoroughly in running water, dry it thoroughly and store in a clean place. 11 Close the front door. Ch.7 NOTE The front door cannot be closed unless the rubber cap is attached. 12 Check the disinfectant solution concentration level in the beaker by using the test strip while taking care not to inhale the disinfectant solution vapor. If the concentration is below its MRC, replace the disinfectant solution as described in Section 8.2, Replacing the disinfectant solution. NOTE In the alcohol line disinfection, always check the disinfectant concentration level in the beaker. 296 OER-Elite OPERATION MANUAL 13 Press the LCG Info button. 7.10 Alcohol line disinfection 14 Press the MRC Check button. Figure 7.105 15 Input the MRC Check Result. Figure 7.106 Ch.7 Select the result of check using the test strip. Figure 7.107 16 Input the operators user ID. For the detailed procedure, refer to Section 3.6, Entering ID (If applicable). OER-Elite OPERATION MANUAL 297 7.10 Alcohol line disinfection NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 17 Press the Save button. 18 Press the OK button and the Next button repeatedly until the touch screen display changes as shown Figure 7.109. Ch.7 Figure 7.108 19 Pull out the detergent/alcohol drawer. Detach the alcohol tank cap to which the tube is connected. (Do not disconnect the connector.) Figure 7.109 20 Press the Next button. Input the operators user ID. For the detailed procedure, refer to Section 3.6, Entering ID (If applicable). 298 OER-Elite OPERATION MANUAL Figure 7.110 7.10 Alcohol line disinfection NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 21 Press the Start button. The drain of alcohol from the alcohol line starts. 22 Pour approximately 120 ml of disinfectant solution into another beaker. 23 When the touch screen display changes as shown Figure 7.112, put the nozzle of alcohol cap in the beaker filled the disinfectant solution. Figure 7.111 Ch.7 24 Press the Continue button. The disinfection of the alcohol lines starts and the touch screen displays the remaining disinfectant time. Wait a few minutes. Figure 7.112 Figure 7.113 OER-Elite OPERATION MANUAL 299 7.10 Alcohol line disinfection 25 When the touch screen display changes as shown Figure 7.114, take the nozzle of the alcohol cap out of the beaker. 26 Press the Continue button and wait for a few seconds. Figure 7.114 Ch.7 27 When the touch screen display changes as shown Figure 7.116, Put the nozzle of alcohol cap in the beaker filled with more than 150ml of sterile water. Figure 7.115 Figure 7.116 300 OER-Elite OPERATION MANUAL 7.10 Alcohol line disinfection 28 Press the Continue button. Rinse of the alcohol lines starts. 29 When the touch screen display changes as shown Figure 7.118, take the nozzle of alcohol cap out of the beaker. Figure 7.117 30 Press the Continue button. Draining of the alcohol lines starts. Figure 7.118 Ch.7 Figure 7.119 OER-Elite OPERATION MANUAL 301 7.10 Alcohol line disinfection 31 When the touch screen display changes as shown Figure 7.120, attach the nozzle of alcohol cap to the alcohol tank. Figure 7.120 32 Press the Continue button. Injection of alcohol in the alcohol lines starts and the water in the reprocessing basin is drained. Ch.7 33 Press the OK button to finish disinfection of the alcohol lines. Figure 7.121 Figure 7.122 302 OER-Elite OPERATION MANUAL 7.11 Manual leak test 7.11 Manual leak test The manual leak test confirmations are linked to the scope ID's reprocessing records or leaking scope decontamination records. To prevent endoscope damage due to water invasion, always check for leaks before reprocessing the endoscope to ensure that you discover any irregularity, such as small holes, at an early stage. The leak test consists of filling the reprocessing basin with water and observing the endoscopes outer surfaces and the leak test air tube to ensure that air bubbles are not produced continuously from any point and that there is no sound of air leakage. Refer to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite> for the necessary tubing required for proper leakage testing. WARNING When reprocessing the endoscopes after the manual leak test, be sure to straighten their bending sections. Otherwise, the reprocessing may become insufficient. Ch.7 CAUTION The leak test air tube will disconnect easily if it is not attached properly or if the lock lever is degraded. Air cannot be fed properly if the leak test air tube is bent. In these cases, an accurate leak test is not possible. Ensure that each leak test air tube is free of irregularity such as a crack, fissure, scratch, or contamination. If an abnormal leak test air tube is used, the endoscope may fail or the leak test will be erroneous. Replace it with a new tube and retry the Manual Leak test. Do not connect the leak test air tube if the inside of the tube, the endoscopes venting connector, or the reprocessors leak test connector is wet. Doing so could allow water to get inside the endoscope and cause the endoscope to malfunction. Do not perform the manual leak test while connecting tubes are connected. Otherwise, irregularity in the endoscope may not be detected. Do not disconnect the leak test air tubes in the middle of the process or while the water is remaining in the reprocessing basin. Otherwise, the endoscopes may fail due to the fluid entering inside them or the retention of the pressurized status inside them. Do not leave an unused leak test air tube in the basin. Otherwise, water penetrating inside the leak test air tube may cause malfunctions of the reprocessor. OER-Elite OPERATION MANUAL 303 7.11 Manual leak test CAUTION If air bubbles are produced continuously from an endoscope or leak test air tube during a leak test, press the Stop button on the touch screen to discontinue the leak test process, remove the scope or tube from the reprocessing basin and contact Olympus. Otherwise, water may penetrate the scope via the area around where the bubbles are exiting. NOTE During leak test, the angulating sections covering may expand. This is not a malfunction. Workflow of manual leak test 1 Input scope ID of first endoscope.
on page 305 Ch.7 Loading of first endoscope in reprocessing basin and attaching the connecting tubes. 2 4 3 Input scope ID of second endoscope. Loading of second endoscope in reprocessing basin and attaching the connecting tubes.
on page 306
on page 307
on page 307
on page 307
on page 309 5 Performing manual leak test. 6 Print format. 304 OER-Elite OPERATION MANUAL 7.11 Manual leak test Performing manual leak test 1 Make sure that the water faucet is open. 2 Press the Functions on the Menu screen. 3 Press the Manual Leak Test button on the 2nd page of the Functions menu. Figure 7.123 Ch.7 4 Step on the foot pedal to open the lid. 5 Input the Scope IDs. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 7.124 OER-Elite OPERATION MANUAL 305 7.11 Manual leak test 6 Place the endoscope carefully, checking the following:
The distal end of the insertion tube is straight.
The distal end of the insertion tube is not on or beneath another object.
The leak test air tube is not twisted.
The endoscope is not contacting the lid.
The connecting tube is not connected. When reprocessing one endoscope When reprocessing two endoscope Ch.7 Figure 7.125 7 Wipe the venting connector of the endoscope or that of the waterproof cap with a clean cloth immersed in 70% ethyl alcohol or 70% isopropyl alcohol. 8 If the leak test connector E1/E2 in the reprocessing basin is wet, wipe the entire connector with a clean cloth. First endoscope 9 Connect the MAJ-2127 leak test air tubes to the venting connector or the water resistant cap of the first endoscope and leak test connector E1 in the reprocessing basin. When placing the second endoscope, connect the MAJ-2127 leak test air tubes to the second endoscope and leak test connector E2 in the reprocessing basin. 306 OER-Elite OPERATION MANUAL Figure 7.126 7.11 Manual leak test 10 Place the second endoscope, same as from Step 1 through 9 of the first endoscope. 11 Close the lid by pushing until it clicks. 12 Press the Next button. 13 Input the operators user ID. For the detailed procedures, refer to Section 3.6, Entering ID. (If applicable) Figure 7.127 NOTE The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. Ch.7 14 Press the Start button. Water supply starts and the touch screen changes as shown below. Figure 7.128 OER-Elite OPERATION MANUAL 307 7.11 Manual leak test 15 When the water supply completes, the reprocessor generates three buzzer beeps and unlock the lid. 16 Ensure that the water supply is stopped and then step on the foot pedal to open the lid. When the lid is opened, the touch screen displays the following screen. Perform from Step 16 to Step 19 within 10 minutes after opening the lid. Ch.7 Figure 7.129 Figure 7.130 NOTE If the lid is not opened within 10 minutes, the fluid in the reprocessing basin is drained automatically and the manual leak test stops. The touch screen will then display the error code [E092]. 17 Check that there are not any bubbles produced continuously from the outer surface of the endoscope and/or leak test air tube while angulating the bending section of the endoscope. Check for leaks at least for 30 seconds. CAUTION When angulating the endoscopes bending section, do not to let the bending section touch the reprocessing basin or retaining rack as this could damage the endoscope. After bending, straighten the bending section and place it properly on the retaining rack. During the manual leak test, be sure to angulate the bending section. Otherwise, it would be impossible to find abnormalities in the endoscopes. 308 OER-Elite OPERATION MANUAL 7.11 Manual leak test NOTE Adjust the position of endoscope to immerse all outer surface of endoscope in the water as needed. If you set two endoscopes in the basin, it may be difficult to sufficiently immerse endoscopes to inspect bubbles. In this case, perform the leakage test for each endoscope separately. 18 Press the Continue button, and then input each manual leak test result on the touch screen. Selection of leak test Result for each endoscope Ch.7 Figure 7.131 19 Close the lid by pushing until it clicks. The water starts to be drained. NOTE Even if the process is not completed by closing the lid, the water is drained automatically 10 minutes after the water supply stopped. The touch screen will then display error code [E092]. 20 When draining has completed, the reprocessor generates three buzzer beeps and the touch screen shows the following screen. Press the OK button to finish. Figure 7.132 OER-Elite OPERATION MANUAL 309 7.12 Auto leak test WARNING When reprocessing the endoscopes after the manual leak test, be sure to straighten their bending sections. Otherwise, the reprocessing may become insufficient. NOTE When the MAJ-1937 printer included in the optional MAJ-2144 printer set is connected and the auto print setting is activated, the result of manual leak test is printed automatically. For the setting changes of the auto print setting, refer to Section 4.17, Print option. To print the manual leak test result without using the auto print setting, press the Print button. 7.12 Auto leak test Ch.7 This function is used to perform auto leak test independently. Auto leak test is not available with certain endoscopes. For detail unavailable of Auto leak test, refer to Unavailable endoscope with the functions of the OER-Elite in List of compatible Endoscopes/Connecting Tubes <OER-Elite>. A scope ID has to be input by an RFID. If a scope ID is input by using the scope ID master card, input by the software keyboard or input by recalling the pre-registered ID, the auto leak test is not available. CAUTION The leak test air tube may easily disconnect spontaneously if it is connected insufficiently or, particularly if the lock lever is degraded. If the leak test air tube is bent, sufficient air supply will not be possible. In both cases, the leak test of endoscopes will be erroneous. Ensure that each leak test air tube is free of irregularity such as a crack, fissure, scratch, or contamination. If an abnormal leak test air tube is used, the endoscope may fail or the leak test will be erroneous. Before connecting a leak test air tube, ensure that the inner side of the tube, the venting connector of the endoscope and the leak test connector of the reprocessor are not wet. Otherwise, water penetrating inside the endoscope may cause a failure of the endoscope. Be sure to connect the leak test air tubes securely. If the connection is insufficient, the leak test may be abnormal because the inside of the endoscope cannot be pressurized. 310 OER-Elite OPERATION MANUAL 7.12 Auto leak test CAUTION If an irregularity is found with a leak test air tube, replace it with a new tube and retry the leak test. When a leak test air tube is not to be used, disconnect it from the connector and be sure to remove it from the reprocessing basin. If reprocessing is performed without removing it, the leak test may be erroneous. When the auto leak test gives a Leaked judgment to an endoscope do not execute reprocessing program [1] to [4] on the endoscope. Otherwise, water may penetrate inside the endoscope. The endoscope should be subjected to the leaking scope decontamination and then serviced. For details on the leaking scope decontamination, refer to Section 7.15, Leaking scope decontamination. The leak test result may become Leaked depending on the temperature of the endoscope. To perform auto leak test with the ultrasonic endoscope, wait for more than 30 minutes. To perform it with the other type of endoscope, wait for more than 15 minutes. Then, re-execute the auto leak test. If the result is Leaked again, the scope should be subjected to the leaking scope decontamination and then serviced. For details on the leaking scope decontamination, refer to Section 7.15, Leaking scope decontamination. NOTE The covering of the bending section of the endoscope may dilate slightly during the leak test. This is not malfunction. The auto leak test may sometimes be incapable of detecting a very small hole. Ch.7 OER-Elite OPERATION MANUAL 311 7.12 Auto leak test Workflow of auto leak test 1 Input scope ID of first endoscope.
on page 313 Loading of first endoscope in reprocessing basin and attaching the leak test air tube. 2 3 Input scope ID of second endoscope. Loading of second endoscope in reprocessing basin and attaching the leak test air tube. 4 Ch.7
on page 314
on page 315
on page 315
on page 316
on page 316 5 Performing auto leak test. 6 Print format. 312 OER-Elite OPERATION MANUAL 7.12 Auto leak test Performing auto leak test 1 Step on the foot pedal to open the lid. 2 Press the Functions button on the Menu Screen. 3 Press the Auto Leak Test button on the 2nd page of the Functions menu. Figure 7.133 Ch.7 4 Enter scope ID by RFID. Figure 7.134 Figure 7.135 NOTE To perform auto leak test, scope ID entry is allowed only by RFID. Other ID entry method cannot be performed. OER-Elite OPERATION MANUAL 313 7.12 Auto leak test 5 Place the endoscope carefully, checking the following:
The distal end of the insertion tube is straight.
The distal end of the insertion tube is not on or beneath another object.
The leak test air tube is not twisted.
The leak test air tube is not contacting the lid. 6 Wipe the venting connector of the endoscope or that of the waterproof cap with a clean cloth immersed in 70% ethyl alcohol or 70% isopropyl alcohol. When reprocessing one endoscope When reprocessing two endoscope Ch.7 Figure 7.136 7 If the leak test connector E1/E2 in the reprocessing basin is wet, wipe the entire connector with a clean cloth. 8 Entry the scope ID of the first endoscope, then the message is displayed. Figure 7.137 314 OER-Elite OPERATION MANUAL 7.12 Auto leak test First endoscope 9 Connect the MAJ-2127 leak test air tubes to the venting connector or the water resistant cap of the first endoscope and leak test connector E1 in the reprocessing basin. When placing the second endoscope, entry the scope ID of the second endoscope, then connect the MAJ-2127 leak test air tubes to the second endoscope and leak test connector E2 in the reprocessing basin. CAUTION Figure 7.138 Connect the first endoscope to the leak test connector E1 in the reprocessing basin and the second endoscope to the leak test connector E2. If the endoscopes are connected improperly, reconnect them by following the instructions displayed on the touch screen. If the Auto leak Test is performed with wrong connections, the leak test may be incorrect. 10 Place the second endoscope, same as from Step 2 through 9 of the first endoscope. Ch.7 NOTE If the first endoscope is connected to connector E2 by mistake, the notification of erroneous connection of the leak test air tube is displayed. Correct this by following the instructions displayed on the touch screen. If the message is still displayed after connecting the MAJ-2127 leak test air tubes, check the connector pin of leak test air tube connect and the connectivity between the E1 connector and the first endoscope. If any irregularity is not found, contact OLYMPUS. 11 Press the Next button. Figure 7.139 OER-Elite OPERATION MANUAL 315 7.12 Auto leak test 12 Follow the guide displayed on the screen until process starts. Enter user ID. For detailed procedure, refer to Section 3.6, Entering ID (If applicable). Figure 7.140 NOTE The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. 13 When the auto leak test process completes, the reprocessor generates a buzzer beep and shows the following screen on the touch screen. Ch.7 Results of auto leak test of each endoscope Figure 7.141 NOTE When the MAJ-1937 printer included in the optional MAJ-2144 printer set is connected and the auto print setting is activated, the results of auto leak test are printed automatically. For the setting changes of the auto print setting, refer to Section 4.17, Print option. To print the auto leak test results without using the auto print setting, press the Print button. If any leak were detected, refer to When any leaks are detected on page 617. 316 OER-Elite OPERATION MANUAL 14 Press the OK button to finish. 7.12 Auto leak test Figure 7.142 Ch.7 OER-Elite OPERATION MANUAL 317 7.12 Auto leak test Print format
(a) When the print format setting is Separated:
Serial number of this reprocessor Number given to each record in the order of occurrence Type of the leak test Date and time of start of process Date and time of end of process Information of first endoscope Serial number of this reprocessor Number given to each record in the order of occurrence Type of the leak test Date and time of start of process Date and time of end of process Information of second endoscope Ch.7 Figure 7.143 318 OER-Elite OPERATION MANUAL
(b) When the print format setting is Combine:
7.12 Auto leak test Serial number of this reprocessor Number given to each record in the order of occurrence Type of the leak test Date and time of start of process Date and time of end of process Information of first endoscope Information of second endoscope Figure 7.144 Ch.7 OER-Elite OPERATION MANUAL 319 7.12 Auto leak test
(c) When error occurs during auto leak test:
Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of first endoscope Information of second endoscope Ch.7 Figure 7.145 320 OER-Elite OPERATION MANUAL 7.13 Self-check of auto leak test 7.13 Self-check of auto leak test This function is checked the operation of the auto leak test function. The self-check of auto leak function is performed automatically during the load LCG process. However, if the load LCG process stops and an error code ([E112], etc.) is generated, execute the Self-check of auto leak test. CAUTION Do not connect any leak test air tubes to leak test connectors E1 or E2 on the reprocessing basin. Otherwise, the self-check will not run properly and Auto Leak Test function will not work properly. 1 Press the Functions button on the Menu screen. Ch.7 2 Press the ALT Self-Check button on the 2nd page of the Function menu. Figure 7.146 3 Input the operators user ID. For the detailed procedure, refer to Section 3.6, Entering ID (If applicable). Figure 7.147 OER-Elite OPERATION MANUAL 321 7.13 Self-check of auto leak test NOTE The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. 4 Press the Start button. The process starts. Figure 7.148 Ch.7 5 When the process completes, the reprocessor generates a buzzer beep and displays the result. 6 Press the OK button to finish. Figure 7.149 Figure 7.150 322 OER-Elite OPERATION MANUAL 7.14 Alcohol flush 7.14 Alcohol flush This process automates the flushing of the endoscope channels with alcohol followed by air to help dry the channels. WARNING When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) Ch.7 If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task they are performing and vacate the room. When the alcohol flush process is stopped due to an reprocessor error, do not use the endoscope and restart the alcohol flush process from the beginning. Otherwise, alcohol may remain in the endoscope channel and pose a risk to patient safety. CAUTION Do not perform alcohol flush without connecting the connecting tubes. Otherwise, excessive pressure on the pipes in the reprocessor may damage it. OER-Elite OPERATION MANUAL 323 7.14 Alcohol flush 1 Check the alcohol tank check window on the reprocessors detergent/alcohol drawer to confirm that the surface of alcohol is visible. If the alcohol has reduced, add more alcohol as described in Section 5.9, Inspecting and replenishing alcohol. NOTE Alcohol flush includes the water feed and drain operations. These operations are intended to drain alcohol while diluting it. 2 Press the Functions button on the Menu screen. Ch.7 3 Press the Alcohol Flush button on the 2nd page of the Function menu. Figure 7.151 Figure 7.152 4 Follow the guide displayed on the touch screen. Firstly, step on the foot pedal to open the lid. 5 Place the endoscope(s) in the reprocessing basin. 6 Connect connecting tubes to the endoscope(s) and the connectors on the reprocessing basin according to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>. 7 Enter the user ID. (If applicable) 324 OER-Elite OPERATION MANUAL 7.14 Alcohol flush NOTE The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, User ID Setting. 8 Press the Start button. Alcohol flush starts and the touch screen displays the remaining time, which will count down every minute. Figure 7.153 NOTE Ch.7 Water supply and draining are performed in this process. These operations are intended to dilute the alcohol and drain the dilution. 9 When the alcohol flush process completes, the reprocessor generates a buzzer beep and shows the following screen on the touch screen. Press the OK button to finish. Figure 7.154 OER-Elite OPERATION MANUAL 325 7.15 Leaking scope decontamination 7.15 Leaking scope decontamination Ch.7 If water leak of endoscope is detected in a leak test before manual cleaning or an auto leak test before reprocessing, apply leaking scope decontamination for the endoscope before sending it for servicing center. By using this function the endoscope can be immersed in the disinfectant solution while preventing from influx of disinfectant solution into the internal of the endoscope. In case error code [E115] is displayed during the auto leak test process, perform the manual leak test and confirm area(s) of the leaking point(s). If a leaking point is found, thoroughly dry the identified location of the leak on the outer area of the endoscope using alcohol and a clean lint-free cloth. Carefully apply a piece of electrical tape or other waterproof tape over the location of the leak prior to immersing the endoscope in detergent solution. Wrapping the tape too tightly may result in damage to the endoscope. Then perform the Leaking scope decontamination with the endoscope. If error code
[E115] is generated again in Leaking scope decontamination, the leaking point cannot be stopped by taping, or a leaking point is not found, do not perform this process but contact Olympus. For details, refer to Manual decontamination for leaking endoscope on page 619. WARNING The leaking scope decontamination process is intended to decontaminate a leaking endoscope before sending it to a servicing center. It does not guarantee the reprocessing of the endoscope and its accessories after this process. After completing this process, do not use the endoscope and its accessories in examination but send it to a servicing center. Do not subject an endoscope without leak (correctly functioning endoscope) in this process. Do not perform the Leaking scope decontamination process with auxiliary water tubes. This process is not capable of high-level disinfection of the auxiliary water tubes. Even when the auxiliary water tube cleaning setting is activated, do not use the MAJ-2138. Instead, be sure to use the provided MAJ-2113. Otherwise, the reprocessing of the auxiliary water tubes may be insufficient. When handling the disinfectant solution, wear personal protective equipment to prevent any disinfectant solution from getting on your skin and eyes or being inhaled. Avoid direct physical contact and inhalation of vapors. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically. 326 OER-Elite OPERATION MANUAL 7.15 Leaking scope decontamination WARNING Before proceeding to the leaking scope decontamination, always be sure to check using a test strip that the concentration of the disinfectant solution is no less than the minimum recommended concentration. If this check is not performed, decontamination may be insufficient. The disinfectant solution should be replaced when the concentration falls below the minimum recommended concentration or the shelf life of the disinfectant solution has expired. Disinfectant vapor may still be in the reprocessing basin immediately after the lid is opened. Wear appropriate personal protective gear to prevent excessive inhalation of the vapor. Before disconnecting a connecting tube, visually confirm that there are no irregularities such as kinking, accidental detachment or use of wrong connecting tube and confirm that each connecting tube is firmly attached. If any irregularity is observed, it must be corrected and the endoscope must be reprocessed again. Otherwise, the reprocessing may insufficient. If any irregularity is found with the connection of the connecting tubes, connect them correctly and retry leaking scope decontamination. Otherwise, decontamination may be insufficient. Be sure to wear sterilized gloves when taking out the decontaminated endoscope. Otherwise, attaching of dirt on the hand on the endoscope may cause infection. Ch.7 This process does not guarantee reprocessing of the endoscope. Pay attention to in handling the endoscope by wearing protective gear, etc. CAUTION Only one endoscope can be installed in the leaking scope decontamination. Otherwise, more water may leak into the endoscope during leaking scope decontamination. Always install only one endoscope. If two scopes are installed, water may penetrate inside them. NOTE If water leak is detected in the auto leak test performed according to the setting for the operation after reprocessing, send the endoscope to repair without performing this process. OER-Elite OPERATION MANUAL 327 7.15 Leaking scope decontamination Workflow of leaking scope decontamination 1 Performing leaking scope decontamination 2 Print format Required items
on page 329
on page 337 Check Required Item FDA-cleared chemical indicator (test strip) Connector jig Connecting tubes Leak test air tube Ch.7 Table 7.6 NOTE For the usable test strips, refer to Section 2.8, Consumable accessories
(Optional). For connecting tubes required for leaking scope decontamintation, refer to the Connection Guide screen or List of Compatible Endoscopes/Connecting Tubes
<OER-Elite>. 328 OER-Elite OPERATION MANUAL Performing leaking scope decontamination 7.15 Leaking scope decontamination WARNING Always use the connecting tube MAJ-2113 for endoscope with the auxiliary water channel and do not use connecting tube MAJ-2138 in this process. Otherwise, insufficient fluid supply to them may make their decontamination insufficient. CAUTION Before performing the leak scope decontamination, make sure that the leak test air tubes and the connectors of reprocessing basin are free of irregularities such as cracks, breaks, and so on. Otherwise, the endoscopes may malfunction. 1 Press the Functions button on the Menu screen. Ch.7 2 Press the Leaking Scope Decontamination button on the 2nd page of the functions menu screen. Figure 7.155 Figure 7.156 OER-Elite OPERATION MANUAL 329 7.15 Leaking scope decontamination 3 Press the LCG Info. button to display the LCG Info screen. 4 Check the MRC and input the result by following the instructions given in Section 3.7, Checking the MRC level and entering the check result. Figure 7.157 5 Press the Next button repeatedly until the touch screen display changes as shown below. Ch.7 6 Input the scope ID of the leaking endoscope. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 7.158 Figure 7.159 7 Place the leaking endoscope in the reprocessing basin. For the detailed procedures, refer to Loading of second endoscopes in the reprocessing basin on page 197. 8 Connect the connecting tubes by following the instructions given on the connection guide screen. For the connecting tube connection method, refer to Loading of second endoscopes in the reprocessing basin on page 197. 330 OER-Elite OPERATION MANUAL 7.15 Leaking scope decontamination CAUTION If the scope ID is input by the software keyboard or input by recalling the pre-registered ID, confirm the connecting tubes to be used in List of Compatible Endoscopes/Connecting Tubes <OER-Elite> and connect all of them. Otherwise, disinfectant solution cannot be fed into the scope channels. 9 Wipe the venting connector of the endoscope or that of the waterproof cap with a clean moistened with 70% ethyl alcohol or 70% isoproply alcohol. 10 If the leak test connector E1 in the reprocessing basin is wet, wipe the entire connector with a clean cloth. 11 Connect the MAJ-2127 leak test air tubes to the venting connector or the water resistant cap of the first endoscope and leak test connector E1 in the reprocessing basin. 12 Connect the connector jig to remaining connectors in the reprocessing basin. 13 Place unused connectors of connector jig as shown in the figure. Ch.7 14 Press the OK button on the Connection Guide screen. Figure 7.160 Figure 7.161 OER-Elite OPERATION MANUAL 331 7.15 Leaking scope decontamination 15 Check that connector jig is connected to remaining connectors in the reprocessing basin and then press the Yes button. 16 Select whether or not the endoscope has been cleaned manually and whether or not leak was found, and press the OK button. Figure 7.162 Ch.7 Figure 7.163 CAUTION Connect the connector jig to all of the reprocessing basins connectors to which the connecting tubes are not connected except for connector E2. If the connector jig are not connected or connected improperly, water may leak into the endoscope. NOTE The input of the result of manual cleaning and leak test can be disabled by changing a setting. For details, refer to Section 4.4, Manual cleaning and leak test setting. 17 Check the connection between endoscope and the OER-Elite.
The connecting tubes and leak test air tube are not kinked and bent.
The unnecessary connecting tubes are not connected to the OER-Elite except for the connector jig. 332 OER-Elite OPERATION MANUAL 7.15 Leaking scope decontamination 18 When the touch screen display changes as shown below, input the user ID (load), physician ID and patient ID and procedure ID. For the ID input procedure, refer to Section 3.6, Entering ID (If applicable). NOTE Figure 7.164 The user ID (load) input can be omitted by changing the user ID setting. For the user ID setting, refer to Section 4.5, User ID Setting. The physician ID input can be omitted by changing the physician ID setting. For the physician ID setting, refer to Section 4.6, Physician ID setting. The patient ID input can be omitted by changing the patient ID setting. For the patient ID setting, refer to Section 4.7, Patient ID setting. The procedure ID input can be omitted by changing the procedure ID setting. For the procedure ID setting, refer to Section 4.9, Procedure ID setting. Ch.7 19 Close the lid by pushing until it clicks. 20 Press the Start button. The process starts and the touch screen displays the remaining time, which will count down every minute. Figure 7.165 OER-Elite OPERATION MANUAL 333 7.15 Leaking scope decontamination NOTE When the disinfectant solution temperature is below 20C (68F), it is heated to 20C (68F). During heating, the remaining time countdown and progress bar on the touch screen stops and turns gray. The remaining time countdown restarts after completion of heating. Flashes during heating Current temperature of disinfectant solution Target temperature of disinfectant solution Remaining time Process progress bar Figure 7.166 Ch.7 21 When the user ID (remove) setting for end of reprocessing is activated, enter the operators user ID as instructed in Section 3.6, Entering ID (If applicable). When the user ID (remove) is input from the RFID, the touch screen switches to the next screen. When the input is performed manually or from the previous registration, press the OK button to switch the screen. Figure 7.167 334 OER-Elite OPERATION MANUAL 7.15 Leaking scope decontamination 22 When this process completes, the reprocessor generates three buzzer beeps and the touch screen shows the following screen. Figure 7.168 NOTE When the MAJ-1937 printer included in the optional MAJ-2144 printer set is connected and the auto print setting is activated, the result of leaking scope decontamination is printed automatically. For the setting changes of the auto print setting, refer to Section 4.17, Print option. To print the leaking scope decontamination result without using the auto print setting, press the Print button. Ch.7 23 Press the foot switch to open the lid. 24 Check the connecting tubes and Leak test air tube status.
if the tubes are bent,
if they are connected securely to the connectors,
if they are free of abnormality such as a crack. CAUTION The endoscope may fail when the tube is used the next time. 25 Disconnect the connecting tubes and leak test air tube from the endoscope. 26 Take the endoscope out of the reprocessing basin. Wipe off any water using a piece of clean gauze. 27 Take the connecting tubes, leak test air tube and connector jig out of the reprocessing basin, wipe off any water using a piece of clean gauze, and store them in a clean place. OER-Elite OPERATION MANUAL 335 7.15 Leaking scope decontamination 28 Press the OK button twice to finish. Figure 7.169 NOTE Be sure to have the decontaminated endoscope serviced. Ch.7 336 OER-Elite OPERATION MANUAL 7.15 Leaking scope decontamination Serial number of this reprocessor Total accumulated of reprocessing process count Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Setting details LCG Info. Information of endoscope Ch.7 User ID (remove) of the end of process Print format
(a) Normal Figure 7.170 OER-Elite OPERATION MANUAL 337 7.15 Leaking scope decontamination
(b) Error Ch.7 Figure 7.171 Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of endoscope 338 OER-Elite OPERATION MANUAL 8.1 Replacement of consumable items menu Chapter 8 Replacement of Consumable Items 8.1 Replacement of consumable items menu 5 6 7 8 9 Description 1 2 3 4 No. 1 Button Drain LCG button 2 3 4 5 6 7 Replace Water Filter button Replace Air Filter button Replace Gas Filter on the Lid button Replace the Gas Filter on the Tank button 8 Menu button 9 LCG Info. button NOTE Press to drain the disinfectant solution in the disinfectant solution tank. When the usage count setting of the disinfectant solution counter or the shelf life of the disinfectant solution is reached, the disinfectant solution replacement indicator appears in the button. Press to prepare a new disinfectant solution. Ch.8 Load LCG button Replace Detergent button Press to load the detergent tank. When the usage count setting of the detergent counter or the shelf life of the detergent is reached, the detergent replacement indicator appears in the button. Press to replace the water filter. When the usage count setting of the water filter counter, the water filter replacement indicator appears in the button. Press to replace the air filter. When the usage count setting of the air filter counter, the air filter replacement indicator appears in the button. Press to replace the gas filter on the lid. When the usage count setting of the lids gas filter counter, the filter replacement indicator appears in the button. Press to replace the gas filter on the disinfectant solution tank. When the usage count setting of the disinfectant solution tanks gas filter counter, the filter replacement indicator appears in the button. Press to display the Menu screen. Press to display the LCG Info. screen. There is no button for replenishing alcohol. For replenishing alcohol, refer to Section 5.9, Inspecting and replenishing alcohol. OER-Elite OPERATION MANUAL 339 8.2 Replacing the disinfectant solution 8.2 Replacing the disinfectant solution When the disinfectant solution in the reprocessor is no longer effective, or beyond the specified use life, drain the disinfectant solution completely and replace with fresh disinfectant solution. Expired disinfectant solution should be treated as directed in the documents supplied with the disinfectant solution. WARNING Remove all endoscopes, valves, and connecting tubes from the reprocessing basin before draining the disinfectant solution. Otherwise, the disinfectant solution cannot be drained properly, it cannot be mixed sufficiently, and the endoscopes and valves may be unable to be rinsed sufficiently. Before handling the disinfectant solution, read the cautions carefully and use it as instructed. Be sure that you fully understand what measures need to be taken if you get any disinfectant solution on your skin and eyes. Always use a disinfectant that has been validated by Olympus. High-level disinfectants that are not validated by Olympus for use in the OER-Elite may be unsafe and ineffective due to improper dilution, incorrect contact time and temperature, excessive foaming, inadequate rinse, and therefore may compromise patient safety. Use of a high-level disinfectant that has not been validated by Olympus may also damage internal OER-Elite components (e.g., seals, valves, etc.) and the endoscopes being reprocessed. When handling the disinfectant solution, wear appropriate personal protective equipment to prevent direct contact with your skin and eyes or excessive inhalation of the vapor. The disinfectant solution and its vapor may adversely affect the human body. If you get disinfectant solution in your eyes, immediately rinse with a large quantity of water and then call the doctor. Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. CAUTION Expired disinfectant solution should be treated in accordance with the instructions supplied with the disinfectant solution. It is recommended to treat the waste fluid properly and to dispose of it according to local wastewater standards defined by law, or temporarily collect and store the waste fluid and have it treated by a waste disposal firm. Ch.8 340 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution NOTE When the disinfectant solution counter setting and/or shelf life setting is activated, the disinfectant solution replacement indicator can be displayed on the top right of the touch screen and on the Drain LCG button on the Replacement of Consumable Items menu when the counter setting value or shelf life setting value is reached. For the disinfectant solution counter setting, refer to Section 4.12, LCG replacement indicator. For the shelf life setting, refer to Section 4.13, LCG lot number and shelf-life management. Workflow of replacement the disinfectant solution See the replacement of the disinfectant solution workflow below. 1 Drain the disinfectant solution. Draining through the disinfectant collection hoseon page 342 Draining through the drain hoseon page 350 2 Load the disinfectant solution.
on page 354 Ch.8 OER-Elite OPERATION MANUAL 341 8.2 Replacing the disinfectant solution Draining the disinfectant solution Drainage disinfectant solution Approximately 24 L (6.4 gallons) Drainage volume Table 8.1 Draining through the disinfectant collection hose WARNING Ch.8 Do not push the disinfectant removal port when the rubber cap is not attached. To do so may cause the disinfectant solution to flow out. To prevent peripheral device and areas near the reprocessor from being damaged by leaking disinfectant solution, do not remove the rubber cap from the disinfectant removal port except when the disinfectant removal tube is connected. When handling the disinfectant solution, wear appropriate personal protective equipment to prevent it from making direct contact with your skin and eyes and to prevent excessive inhalation of the vapor. The disinfectant solution and its vapor may adversely affect the human body. If you get disinfectant solution in your eyes, immediately rinse with a large quantity of water and then call the doctor. Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Be sure to disconnect the drain connector except when collecting the disinfectant solution or checking its strength. Otherwise, disinfectant solution may leak and damage the reprocessor and areas near the equipment. Be sure to attach the disinfectant solution nozzle cap on the disinfectant solution nozzle. Otherwise, the disinfectant solution may spill out. 342 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution
(a) Required item Check Required items Disinfectant collection hose Disinfectant removal tube Containers (large) with 24 L (6.4 gallons) or larger capacity such as PVC tanks
(u2) Beaker (small) with 200 ml or larger capacity (wide-mouthed beaker such as a beaker) Clean cloth Table 8.2 NOTE Prepare more than one tank when using a tank of smaller capacity than that of the containers (large) listed in Table 8.2 or a tank with some liquid inside. Pressing the Pause button on the touch screen while draining LCG interrupts the process of draining LCG. Then you can exchange the tanks. For details, refer to Step 11 of
(b) Draining through the disinfectant collection hose on page 344. Ch.8 OER-Elite OPERATION MANUAL 343 8.2 Replacing the disinfectant solution
(b) Draining through the disinfectant collection hose 1 Press the Replacement of Consumable items button on the Menu screen. 2 Press the Drain LCG button. Figure 8.1 Ch.8 3 Press the Through the Disinfectant Collection Hose button. Figure 8.2 4 Step on the foot pedal to open the lid. Figure 8.3 344 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution 5 While pulling the sleeve on the connector of the disinfectant collection hose, connect the connector into the disinfectant solution nozzle inside the reprocessing basin. After connection, pull the hose gently to make sure it is properly attached. Figure 8.4 WARNING Be sure to attach the disinfectant solution nozzle cap to the original position. Otherwise, the disinfectant solution will spatter. NOTE If DRAIN LCG is selected and the FUNC START button is pressed without connecting the disinfectant collection hose, the buzzer repeats short beeps, disinfectant solution will fill the reprocessing basin and error code [E72] is displayed. In this case, treat it by following the procedure in Section 13.2, Troubleshooting guide. Ch.8 Make sure that the disinfectant collection hose is not kinked and the end of hose in container is not clogged. Otherwise, the disinfectant solution will be spattered. 6 Put the other end of the disinfectant collection hose (the end without a connector) in a large container that can hold up to 24 liters. OER-Elite OPERATION MANUAL 345 Figure 8.5 8.2 Replacing the disinfectant solution 7 Press the Next button repeatedly until the touch screen display changes as shown below. 8 Input the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 8.6 NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. Ch.8 9 Press the Start button. The buzzer repeats short beeps to indicate that the disinfectant solution drain process is underway, the touch screen changes the following screen, and the disinfectant solution begins draining. Figure 8.7 346 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution 10 When the container (large) becomes nearly full, press the Pause button on the touch screen to interrupt the disinfectant solution collection. Figure 8.8 11 Prepare a new container (large) and put the other end of the disinfectant collection hose in it. 12 Hold the disinfectant collection hose so that it does not move, then press the Continue button on the touch screen, and then press the OK button to restart draining of the disinfectant solution. Ch.8 Figure 8.9 13 When draining is stopped, the long buzzer beeps, and the touch screen displays the following screen. Figure 8.10 OER-Elite OPERATION MANUAL 347 8.2 Replacing the disinfectant solution 14 Pull the sleeve on the connector of the disinfectant collection hose to disconnect it from the disinfectant solution nozzle. Be sure to drain the disinfectant solution that remains in the disinfectant collection hose into the container (large). 15 Rinse both the outside and inside of the disinfectant collection hose thoroughly in running water, dry it thoroughly, and store it in a clean place. Figure 8.11 16 Open the front door and remove the rubber cap from the disinfectant removal port. Ch.8 Disinfectant removal port Rubber cap 17 Put the tube-side end of the disinfectant removal tube in the beaker (small), and connect the disinfectant removal tube to the disinfectant removal port to drain the small amount of residual disinfectant solution from the disinfectant solution tank. Figure 8.12 Figure 8.13 348 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution 18 Hold the lock levers and slowly disconnect the tube. Lock levers Figure 8.14 19 Rinse the disinfectant removal tube thoroughly under running water, dry it completely, and store it in a clean place. 20 Wipe the disinfectant removal port with the clean cloth and attach the rubber cap to it. 21 Close the front door. NOTE The front door cannot be closed unless the rubber cap is attached. 22 Press the Continue button. Then, press the OK button. Ch.8 Figure 8.15 OER-Elite OPERATION MANUAL 349 8.2 Replacing the disinfectant solution Draining through the drain hose WARNING Do not push the disinfectant removal port with a finger while the rubber cap is not attached. Otherwise, the disinfectant solution may flow out. To prevent peripheral device and facilities near the reprocessor from being damaged by leaked disinfectant solution, do not remove the rubber cap from the disinfectant removal port except when the disinfectant removal tube is connected.
(a) Required items Check Required items Disinfectant removal tube Beaker (small) with a capacity of about 200 ml, such as a beaker Clean cloth Table 8.3
(b) Draining through the disinfectant collection hose Ch.8 1 Press the Replacement of Consumable items button on the Menu screen. 2 Press the Drain LCG button. Figure 8.16 350 OER-Elite OPERATION MANUAL Figure 8.17 8.2 Replacing the disinfectant solution 3 Press the Through the Drain Hose button. Figure 8.18 4 Close the lid by pushing it until it clicks. 5 Slowly open the water faucet. 6 Input the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 7 Press the Start button. The buzzer beeps, the disinfectant solution begins draining, and the reprocessing basin is rinsed. The touch screen displays the following screen to indicate that the process is underway. Ch.8 Figure 8.19 OER-Elite OPERATION MANUAL 351 8.2 Replacing the disinfectant solution 8 When draining is stopped, the long buzzer beeps, and the touch screen displays the following screen. 9 Open the front door and remove the rubber cap from the disinfectant removal port. Figure 8.20 Disinfectant removal port Rubber cap Ch.8 10 Put the tube-side end of the disinfectant removal tube in the beaker (small), and connect the disinfectant removal tube to the disinfectant removal port to drain the small amount of residual disinfectant solution from the disinfectant solution tank. Figure 8.21 Figure 8.22 352 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution 11 Hold the lock levers and slowly disconnect the tube. Lock levers Figure 8.23 12 Rinse the disinfectant removal tube thoroughly under running water, dry it completely, and store it in a clean place. 13 Wipe the disinfectant removal port with the clean cloth and attach the rubber cap to it. 14 Close the front door. NOTE The front door cannot be closed unless the rubber cap is attached. 15 Press the Continue button, and then press the OK button. Ch.8 Figure 8.24 OER-Elite OPERATION MANUAL 353 8.2 Replacing the disinfectant solution Load the disinfectant solution WARNING Before handling the disinfectant solution, read the cautions carefully and use as instructed. It is especially important to know what to do if the disinfectant solution comes in contact with your skin and eyes. Always use disinfectant that has been validated by Olympus. High-level disinfectants that are not validated by Olympus for use in the OER-Elite may be unsafe and ineffective due to improper dilution, incorrect contact time and temperature, excessive foaming, inadequate rinse, and therefore may compromise patient safety. Use of a high-level disinfectant that has not been validated by Olympus may also damage internal OER-Elite components (e.g., seals, valves, etc.) and the endoscopes being reprocessed. When handling the disinfectant solution, wear personal protective equipment to prevent any disinfectant from getting on your skin and eyes or being inhaled. Avoid direct physical contact and inhalation of vapors. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact. Ch.8
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task they are performing and vacate the room. 354 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution WARNING Effective reprocessing cannot be guaranteed when a nonvalidated disinfectant solution is used. Reprocessor malfunction may also result. Follow the disinfectant manufacturers instructions for any preparation or activation required prior to loading into the OER-Elite. If the disinfectant solution in the cassette bottles has not completely drained after preparation of disinfectant solution, do not use the reprocessor and contact Olympus. Inappropriate preparation of disinfectant solution will prevent proper endoscope reprocessing. Do not touch inside the caps of cassette bottles. Do not push or apply strong pressure to the bottle. Otherwise, disinfectant solution may leak from the bottle. CAUTION To avoid malfunction, do not attempt to pull out the disinfectant bottle drawer while it is locked. Do not put your hand into the disinfectant bottle drawer or near the cassette bottle cutters. Irritation of skin due to contact with concentrated disinfectant solution, injury by touching a projection, or malfunction of this reprocessor may result. Required items Ch.8 Check Required items Acecide-C high level disinfectant solution Table 8.4 NOTE For Acecide-C high level disinfectant solution, refer to Section 2.8, Consumable accessories (Optional). OER-Elite OPERATION MANUAL 355 8.2 Replacing the disinfectant solution Setting the disinfectant solution 1 Press the Replacement of Consumable Items button on the Menu screen. 2 Press the Load LCG button. Figure 8.25 Ch.8 Figure 8.26 3 Close the lid by pushing until it clicks. 4 Make sure that the water faucet is open. 5 Input the operators user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 356 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution 6 Press the Start button to unlock the disinfectant bottle drawer. NOTE Figure 8.27 The Load LCG cannot be started unless the disinfectant solution tank is empty. If the shelf-life and/or lot number management of the disinfectant solution are activated, the shelf-life and/or lot number of the disinfectant solution can be entered after pressing the Next button. For entering the shelf-life and/or lot number of the disinfectant solution, refer to When entering the shelf-life and/or lot number of the disinfectant solution: on page 361. 7 Pull out the disinfectant bottle drawer. Cassette bottles Ch.8 8 To remove the empty cassette bottles from the disinfectant bottle drawer, position the bottle mouths upward so that the disinfectant solution does not come out. Figure 8.28 Purple cap OER-Elite OPERATION MANUAL 357 Figure 8.29 8.2 Replacing the disinfectant solution 9 If any disinfectant solution spills, wipe it away with a clean cloth. If the disinfectant bottle drawer is dirty, clean using a clean cloth moistened with neutral detergent solution and then wipe with a clean cloth. WARNING Do not put your hand behind the disinfectant bottle drawer. Irritation of skin due to contact with concentrated disinfectant solution, injury by touching a projection, or malfunction of this reprocessor may result. If the cassette cutters are abnormal, do not use the reprocessor and contact Olympus. If the cassette cutters are abnormal, the disinfectant solution cannot be properly prepared. This will prevent effective endoscope reprocessing and may cause the reprocessor to malfunction. 10 Check the two cassette cutters (blades for ripping caps on disinfectant cassette bottles) placed at the back of the disinfectant bottle drawer. Compare the two blades and make sure that neither cutter is bent, cracked, or deformed. Changes in color are not a malfunction. Ch.8 Figure 8.30 11 Hold the new disinfectant cassette bottles together and place them on the disinfectant bottle drawer so that the bottle with the purple cap is on the right. Cassette cutters Purple cap Figure 8.31 358 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution CAUTION When pushing in the disinfectant bottle tray, hold the disinfectant drawer horizontally and push it all the way in. Otherwise, the disinfectant cassette bottle would be unable to be opened and the disinfectant solution would be unable to be prepared normally. 12 Lift the disinfectant bottle drawer so that it is level, and insert it all the way. The buzzer should beep, the drawer should lock, and the disinfectant cassette bottles should open automatically. Figure 8.32 13 Look at the disinfectant bottle drawer and check the windows to verify that the disinfectant solution in both bottles has decreased. Ch.8 Disinfectant bottle drawer check windows Figure 8.33 OER-Elite OPERATION MANUAL 359 8.2 Replacing the disinfectant solution 14 The buzzer generates short beeps and the touch screen displays a screen indicating that the disinfectant solution is being prepared. Figure 8.34 NOTE Preparation of disinfectant solution includes single rinse process to rinse the reprocessing basin. While executing the preparation of disinfectant solution, buzzer beeps intermittently and the main control panel displays as shown in Figure 8.34. STOP button is deactivated during the process. The required time for preparation of disinfectant solution may vary depending on the water supply condition. Ch.8 15 The touch screen displays the following screen. This screen indicates the process is completed. Press the OK button. Figure 8.35 360 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution When entering the shelf-life and/or lot number of the disinfectant solution:
If the shelf-life and lot number management is activated, enter the shelf-life and/or lot number according to the following procedure. NOTE The lot number and shelf-life are printed on the bottle. The shelf life and lot number of the disinfectant solution can be recorded. For the setting change method, refer to Section 4.13, LCG lot number and shelf-life management. 1 If the shelf-life and/or lot number management of the disinfectant solution are activated, the touch screen displays a screen as shown in following figure at Step 6 in Setting the disinfectant solution on page 357. Press the Next button. When the lot number management of the disinfectant solution is activated, go to Step 2. When the lot number management of the disinfectant solution is inactivated, go to Step 5. 2 Press the Edit button to display the Lot No. Entry screen. Figure 8.36 Ch.8 3 Enter the lot number of the disinfectant solution by operating the software keyboard on the touch screen and press the Save button. Figure 8.37 OER-Elite OPERATION MANUAL 361 8.2 Replacing the disinfectant solution Alphabet input Numeral input 4 5 6 1 2 3 4 5 6 7 8 7 8 Enter an alphabet or a numeral. Note Button Alphabet/
Numeral key Uppercase/
Lowercase button Numeric/
Alphabetic button Backspace button Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercase and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between numeric and alphabetic. Press the Backspace button to delete the character to the left of the cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Press the Space button to insert a space character. Space button Cursor move button Press the cursor move button to move the cursor the left or right. Cancel button Save button Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 1 2 3 No. 1 2 3 4 5 6 7 8 Ch.8 4 Press the Next button. If the Expiration Date management of the disinfectant solution is activated, go to Step 5. If the Expiration Date management of the disinfectant solution is inactivated, go to Step 6. Figure 8.38 362 OER-Elite OPERATION MANUAL 8.2 Replacing the disinfectant solution 5 Enter the Expiration Date of the disinfectant solution. Press the + button to increase or the button to decrease. And then press the Next button. 6 Check the displayed lot number and the expiration date, and press the Start button. Go to Step 7 in Setting the disinfectant solution on page 357. Figure 8.39 Figure 8.40 Ch.8 OER-Elite OPERATION MANUAL 363 8.3 Replacing the detergent tank 8.3 Replacing the detergent tank When the detergent level can no longer be visualized through the detergent tank check window or the touch screen displays the message screen Detergent cannot be supplied after the start of a process, replace the detergent tank. To create the record of the replacement of the detergent tank, select Replace Detergent in the Replacement of Consumable Items menu. WARNING Before handling the detergent, read the cautions carefully and use it as instructed. It is especially important to know what to do if the detergent solution comes in contact with your skin and eyes. Always use an Olympus-validated detergent. Otherwise, the endoscope may not be properly cleaned and as a result, the endoscope may not achieve reprocessing. When handling the detergent, always wear appropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. To prevent the detergent from leaking, do not tilt the detergent tank when there is detergent inside. CAUTION Do not attempt to detergent into the detergent tank. The detergent tank is disposable and it is not intended to be reused. NOTE When the detergent counter setting and/or detergent shelf life setting is activated, the detergent replacement indicator can be displayed on the top right of the touch screen and on the Replace Detergent button on the Replacement of Consumable Items menu when the counter setting value or shelf life setting value is reached. For the detergent counter setting, refer to Section 4.10, Detergent replacement indicator. For the shelf life setting, refer to Section 4.11, Detergent lot number and shelf-life management. If reprocessing is initiated without detergent, the reprocessing is stopped with displaying the message and the detergent replacement indicator. Ch.8 364 OER-Elite OPERATION MANUAL 8.3 Replacing the detergent tank NOTE The detergent tank can hold about 2.8 L (95 ounces) of detergent (which can be used for approximately 30 reprocessing operations). When reprocessing is performed with newly-installed reprocessor or with reprocessor after Section 9.9, Preparing the reprocessor for long-term storage is performed, reprocessing may stop with the message screen Detergent cannot be supplied even though there is enough detergent in the tank. To solve this problem, refer to Section 13.2, Troubleshooting guide, Message, caution, and warning screens on page 621. The shelf life and lot number of the detergent tank can be recorded. For the setting change method, refer to Section 4.11, Detergent lot number and shelf-life management. If reprocessing is initiated without detergent, error code [E095] is displayed and the reprocessing is stopped. The detergent replacement indicator on the main panel blinks. When reprocessing is performed with newly-installed reprocessor or with reprocessor after Section 9.9, Preparing the reprocessor for long-term storage is performed, reprocessing may stop with error code [E095] displayed even though there is enough detergent in the tank. Refer to When the Message 093 is displayed on page 635 to solve this problem. Ch.8 Required item Check Required items Olympus-validated detergent Clean gauze or similar cloth. Table 8.5 NOTE For Olympus-validated detergent, refer to Section 2.8, Consumable accessories
(Optional). OER-Elite OPERATION MANUAL 365 8.3 Replacing the detergent tank Replacing the detergent tank NOTE If you do not need to create the record of the replacement of the detergent tank, the following operations of GUI can be skipped. 1 Press the Replacement of Consumable Items button on the Menu screen. 2 Press the Replace Detergent button. Figure 8.41 Ch.8 3 Input the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID
(If applicable). Figure 8.42 Figure 8.43 366 OER-Elite OPERATION MANUAL 8.3 Replacing the detergent tank NOTE The shelf life and lot number of the detergent tank can be recorded. For the setting change method, refer to Section 4.11, Detergent lot number and shelf-life management. The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. NOTE When the detergent shelf life and lot number management is activated, the shelf and lot number of detergent tank are entered after Step 14. For details, refer to When entering the lot number of detergent and shelf life: on page 372. 4 Hold the section marked PULL of the detergent/alcohol drawer and pull it out. 5 Push the lock lever on the connector of the tube connected to the detergent tank to detach the tube. Figure 8.44 Ch.8 Figure 8.45 OER-Elite OPERATION MANUAL 367 8.3 Replacing the detergent tank NOTE If a few drops of detergent drip from the connector, wipe it with a piece of clean gauze or similar cloth. 6 Remove the detergent tank. 7 Place a new detergent tank on the left side of the detergent/alcohol drawer. Figure 8.46 NOTE Refer the lot number of new detergent tank. Press Edit and enter the lot number and expiration date. Ch.8 Figure 8.47 368 OER-Elite OPERATION MANUAL 8.3 Replacing the detergent tank 8 Detach the cap of the new detergent tank. 9 Remove the seal on the new detergent tank. Figure 8.48 10 Attach the cap with connector to the new detergent tank. Figure 8.49 Ch.8 Figure 8.50 OER-Elite OPERATION MANUAL 369 8.3 Replacing the detergent tank 11 Insert the white connector into the connector on the detergent tank until it clicks. 12 Turn the connector to correct tube orientation as shown below. Confirm that the tube is not bent. Figure 8.51 Ch.8 13 Close the detergent/alcohol drawer. 14 Press the Next button on the touch screen. Figure 8.52 Figure 8.53 370 OER-Elite OPERATION MANUAL 8.3 Replacing the detergent tank 15 Press the OK button. Figure 8.54 Ch.8 OER-Elite OPERATION MANUAL 371 8.3 Replacing the detergent tank When entering the lot number of detergent and shelf life:
If the lot number of detergent and Shelf life management is activated, enter the lot number and/or shelf life according to the following procedure. NOTE The shelf life and lot number of the detergent tank can be recorded. For the setting change method, refer to Section 4.11, Detergent lot number and shelf-life management. The lot number and shelf life are printed on the detergent tank. 1 If the lot number management of detergent is activated, the touch screen displays the screen as shown in following figure after Step 14 in Replacing the detergent tank on page 370. If the lot number management of the detergent is inactivated, go to Step 5. Ch.8 2 Press the Edit button to display the lot number entry screen. Figure 8.55 3 Enter the lot number of the new detergent by operating the software keyboard on the touch screen and press the Save button. Figure 8.56 372 OER-Elite OPERATION MANUAL 1 2 3 No. 1 2 3 4 5 6 7 8 8.3 Replacing the detergent tank Alphabet input Numeral input 4 5 6 1 2 3 4 5 6 7 8 7 8 Enter the alphabet or a numeral. Note Button Alphabet/
Numeral key Uppercase/
Lowercase button Numeric/
Alphabetic button Backspace button Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. Press the Backspace button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Press the Space button to insert a space character. Ch.8 Space button Cursor move button Press the cursor move button to move the cursor left or right. Cancel button Save button Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 4 Press the Next button. If the Expiration Date management of the detergent is activated, go to Step 5. If the Expiration Date management of the detergent is inactivated, go to Step 6. Figure 8.57 OER-Elite OPERATION MANUAL 373 8.3 Replacing the detergent tank 5 Enter the Expiration Date of the detergent. Press the Plus button to increase or the Minus button to decrease. Then press the Next button. 6 Check the displayed lot number and the expiration date, and press the Next button. Then, press the OK button. For detail of GUI, refer to Figure 8.54. Figure 8.58 Ch.8 Figure 8.59 374 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) To prevent contamination of the rinse water, the water filter should be replaced every month when the prefilter is not used or every six months when the prefilter is used. The water filter should also be replaced whenever an error code indicating water supply insufficiency [E001] is displayed. To create the record of the replacement of the water filter, select Replace Water Filter in the Replacement of Consumable Items menu. WARNING Replace the water filter in a clean environment. Do not touch the inner side of the water filter or allow dust to get in it. Replace the water filter at least every month and pre-water filter at least every six month. If the performance of the water filter drops, insufficient elimination of miscellaneous bacteria in the tap water may cause contamination of the instrument and scopes and make the reprocessing insufficient. After replacing the water filter, be sure to perform the water line disinfection to prevent the growth of water-borne microorganisms. Failure to perform this operation could result in contamination of the reprocessor piping and ineffective reprocessing of the endoscope. Always be sure to attach the specified water filter. Otherwise, water-borne microorganisms and particulates in the water may contaminate the reprocessor piping and prevent effective reprocessing of the endoscope. Before handling the disinfectant solution, read the SDS and instructions for use of the disinfectant solution carefully, get fully accustomed to the contents, and use the disinfectant solution as instructed. Be sure to fully understand what to do if the disinfectant solution comes in contact with your skin and eyes. When handling the disinfectant solution, wear personal protective equipment to prevent any disinfectant from getting on your skin and eyes or being inhaled. Avoid direct physical contact and inhalation of vapors. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Ch.8 OER-Elite OPERATION MANUAL 375 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) CAUTION Hold the water filter wrench at a point below the projection on the grip. If you hold it at a point closer to the water filter housing connector than the projection, you might catch your finger in the reprocessor. If air gets in the water filter housing, it may extend the process time. In case of an irregularity such as extension of the process time or lack of water supply, drain the air as described in Draining air in the water filter housing on page 389. Do not to drop the removed water filter housing to avoid damaging the connector below the water filter housing. Make sure that the O-ring at the head of the water filter housing is free of irregularities such as cracks, breaks, rips, scratches, or stains. Water leakage may result if the O-ring is not attached or is abnormal. NOTE When replacing water filter, select the Replace water filter in the Replacement of Consumable Items screen. Otherwise, the record of the replacement of the water filter will not be created. Filter life varies depending on a number of factors including incoming water quality and use volume. Using at least a prefilter (0.45 micron or less) can extend the life of the water filter. If the prefilter is properly installed, the water filter and the prefilter should be replaced at least once every 6 months. For information on the water pre-filtration system, contact Olympus. After disinfection of the water supply piping, the quantity and/or concentration of the disinfectant solution might be reduced, which prevents additional reprocessing cycles from being performed. Do not add fresh disinfectant solution to the used disinfectant solution. Except for the case of performing water line disinfection with fresh new disinfectant solution, do not add fresh disinfectant solution to increase the volume of the disinfectant solution in the OER-Elite. Drain the disinfectant solution completely and replace with fresh disinfectant solution after disinfection of the water supply piping. It is recommended to perform disinfection of the water supply piping immediately before routine replacement of the disinfectant solution. Disinfecting the water supply piping also disinfects the water filter and other components in the piping. Ch.8 376 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) Replacing the water filter workflow (when performing the water line disinfection followed by the replacement of the water filter) See the replacement of the water filter workflow below. 1 MRC check, check result input. 2 Replacing the water filter. 3 Disinfecting the water line. Required items
on page 378
on page 380
on page 392 Check Required items FDA-cleared chemical indicator (test strip) Water filter (MAJ-824 or MAJ-2318) Water filter wrench Water filter tubes (u 2) Container with 2 L or larger capacity (wide-mouthed container such as a vat) Water supply piping disinfection hose Ch.8 Table 8.6 NOTE The test strip and water supply piping disinfection hose are required only when the water line disinfection is performed after the water filter replacement. For the test strip, refer to Section 2.8, Consumable accessories (Optional). OER-Elite OPERATION MANUAL 377 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) MRC check, check result input Before proceeding to the water line disinfection, always be sure to check using a test strip that the concentration of the disinfectant solution is no less than the minimum recommended concentration. For the MRC check, refer to Section 3.7, Checking the MRC level and entering the check result. The disinfectant should be replaced when the concentration falls below the minimum recommended concentration or the shelf life of the disinfectant has expired. 1 Press the Replacement of Consumable Items button on the Menu screen. 2 Press the Replace Water Filter button on the Replacement of Consumable Items menu. Figure 8.60 Ch.8 3 Press the YES button. Figure 8.61 Figure 8.62 378 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) NOTE If water lines are not to be disinfected immediately after the water filter replacement, press No and go to Replacing the water filter on page 380. However, the water line disinfection must be executed even if it is not immediately after the water filter replacement. Refer to Section 7.7, Water line disinfection. 4 Press the Next button repeatedly until the touch screen display changes as shown below. 5 Press the LCG Info. button to display the LCG Info screen. Figure 8.63 6 Check the concentration of the disinfectant solution with the test strip, and entering the result of the concentration of the disinfectant solution as described in Section 3.7, Checking the MRC level and entering the check result. 7 Press the OK button to close the LCG Info screen. Ch.8 Figure 8.64 OER-Elite OPERATION MANUAL 379 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) Replacing the water filter 1 Close the lid by pushing it until it clicks. 2 Input the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID
(If applicable). Figure 8.65 NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. Ch.8 3 Press the Next or Start button. NOTE Figure 8.66 When the lot number management of the water filter is activated, the lot number of the water filter is entered after Step 3. For details, refer to When entering the lot number of the water filter on page 400. 4 Open the Front door. Place a container with a capacity of 2 L or more in front of the reprocessor. 5 Put the tube-side ends of the two filter tubes in the container placed above. 380 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 6 Insert the connector ends of the two filter tubes into the connector above the water filter housing and the connector below the water filter housing until they click. Water will start to flow from the tube connected to the connector below the water filter housing. Connector above water filter housing Connector below water filter housing Figure 8.67 7 Press the Next button. Ch.8 8 When the water flow stops, disconnect the two filter tubes by pushing the lock levers on their connectors. Figure 8.68 Lock lever Figure 8.69 OER-Elite OPERATION MANUAL 381 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 9 Press the Next button. 10 Insert the water filter wrench from below the water case and rotate the tool as shown below to loosen the water filter housing. Figure 8.70 Ch.8 Projection Figure 8.71 CAUTION Hold the water filter wrench at a point closer to you than to the projection on the grip. If you hold it at a point closer to the water filter housing connector than the projection, you might catch your finger in the mechanism. 382 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 11 Hold the water filter housing with both hands and rotate it in the direction shown to remove it. CAUTION Figure 8.72 Once the water filter housing has been fully loosened, hold it with both hands and remove it. If the case is not fully loosened, your hands may slip and you could be injured. When the water filter is removed, residual water flows from the connectors. Therefore, you should cover the water filter with the water filter housing when removing so that the residual water is caught in the case. If the water tray fills with residual water, remove the water tray and drain it. Do not to drop the removed water filter housing to avoid damaging the water housing. Water leakage may result if the water filter housing is cracked, broken, or otherwise damaged. Ch.8 12 Pull both the water filter housing and the old water filter downward to remove. Figure 8.73 NOTE When the reprocessor is shipped from the factory, the water filter is not mounted in the water filter housing. OER-Elite OPERATION MANUAL 383 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 13 Open the bottom (the side without the O-ring) of the package containing the new water filter. 14 Place the new water filter directly from the bag into the water filter housing so that O-ring will be positioned upward. NOTE Do not touch the inner side of the water filter or allow dust to get in it. O-ring Figure 8.74 Ch.8 15 Rotate the water filter housing in the direction shown. Figure 8.75 NOTE To ensure smooth loading, it is recommended to moisten the O-ring at the head of the water filter with clean water or 70% ethyl alcohol or 70% isopropyl alcohol before securing it temporarily. The rotation drag increases during temporary securing, but rotate the case all the way until it is stopped. 384 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 16 Attach the water filter wrench and rotate it slowly in the direction shown to tighten. Figure 8.76 CAUTION Tighten the water filter case securely. Insecure tightening may lead to a risk of water leak. 17 Remove the water filter wrench and place it in the space on the left of the water filter housing. Ch.8 18 Press the Continue button. Figure 8.77 Figure 8.78 OER-Elite OPERATION MANUAL 385 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 19 Put the tube-side end of the filter tube in the container, and insert the connector end of the filter tube into the connector above the water filter housing until it clicks. Do not connect anything to the connector bottom of the water filter housing. CAUTION Figure 8.79 Be sure to drain air from the newly attached water filter. If air gets in the water filter housing, the process time may be extended. Air should also be drained from the water filter housing whenever there is an irregularity such as extension of the process time. 20 Make sure that the water faucet is open. 21 Press the Continue button. Ch.8 Figure 8.80 386 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 22 When water starts to flow continuously from the filter tube, disconnect the tube by pushing its lock lever. Water flow should stop when the filter tube is disconnected. Figure 8.81 23 Make sure that no water leaks from the water filter housing. If no water leaks, press the Continue button. If a water leak is observed, immediately press the STOP button to stop water supply and reinstall the water filter. 24 Press the Continue button. Ch.8 Figure 8.82 OER-Elite OPERATION MANUAL 387 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) NOTE When disinfecting the water line later is not selected, the following screen is displayed. Close the front door, Rinse the filter tubes with running water, dry it completely and store in a clean place to complete the water filter replacement procedure. In this case, the water lines should be disinfected later. Figure 8.83 25 Press OK button to finish. Ch.8 388 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) Draining air in the water filter housing CAUTION Be sure to drain air from the newly attached water filter. If air gets in the water filter housing, the process time may be extended. Air should also be drained from the water filter housing whenever there is an irregularity such as extension of the process time. 1 Close the lid by pushing it until it clicks. 2 Open the Front door. Place a container with a capacity of 2 L or more in front of the reprocessor. 3 Put the tube-side ends of the two filter tubes in the container placed above. 4 Insert the connector ends of the two filter tubes into the connector above the water filter housing and the connector below the water filter housing until they click. Water will start to flow from the tube connected to the connector below the water filter housing. Connector above water filter housing Connector below water filter housing Ch.8 Figure 8.84 5 Press the Functions button on the Menu screen. Figure 8.85 OER-Elite OPERATION MANUAL 389 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 6 Press the Rinse button on the Function menu. 7 Input the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID
(If applicable). Figure 8.86 Ch.8 8 Press the Start button. Rinse starts and the touch screen displays the remaining time, which will count down every minute. Figure 8.87 Figure 8.88 390 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 9 When water starts to flow continuously from the filter tube, disconnect the tube by pushing its lock lever. Water flow should stop when the filter tube is disconnected. Lock lever Figure 8.89 10 Press the STOP button to drain water from the reprocessing basin. 11 Close the front door. 12 Rinse the filter tube with running water, dry it completely and store in a clean place. Ch.8 OER-Elite OPERATION MANUAL 391 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) Disinfecting the water line WARNING Before disinfecting the water supply piping, check the concentration of the disinfectant solution with the test strip, and replace the disinfectant solution if the disinfectant concentration is below the required level. If this check is not performed, disinfection may be insufficient. Disinfection of the water supply piping is required each time the water filter is replaced (i.e., at least once a month). There may be other circumstances where this is required, for example a flood or hurricane. Microbiological sampling of the OER-Elite rinse water may indicate disinfection is required. Disconnect the connecting tubes from the connectors on the reprocessor before disinfecting the water supply piping. Otherwise, a jet of disinfectant solution may be output from the connecting tubes and leak from a connector such as the gas filter case connector. 1 Place as container with a capacity of 2 L or more in front of the reprocessor. 2 Put the tube-side ends of the two filter tubes in the container placed and insert the connector ends of the two filter tubes into the connector above the water filter housing and the connector below the water filter housing until they click. Water will start to flow from the tube connected to the connector below the water filter housing. Ch.8 Connector above water filter housing Connector below water filter housing Figure 8.90 392 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 3 Press the Continue button. 4 When water flow stops, disconnect the two filter tubes by pushing the lock levers on their connectors. Figure 8.91 Lock lever Figure 8.92 5 Press the Continue button. Ch.8 6 Step on the foot pedal to open the lid. Figure 8.93 OER-Elite OPERATION MANUAL 393 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 7 Connect the water supply piping disinfection hose between the connector C1 in the reprocessing basin and the water supply piping disinfection connector. Connector C1 Water supply piping disinfection connector Temperature sensor Washing case mount Figure 8.94 8 Close the lid by pushing until it clicks. 9 Press the Continue button to supply the disinfectant solution in the reprocessing basin. Ch.8 Figure 8.95 10 When the reprocessing basin is filled with disinfectant solution, a buzzer sounds three times and the touch screen displays the follow screen. 11 Put the tube-side end of the filter tube and put it in the container. Figure 8.96 394 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 12 Insert the connector end of the filter tube into the connector above the water filter housing until it clicks. Do not connect anything to the connector below the water filter housing. 13 Press the Continue button twice. Figure 8.97 Figure 8.98 14 When the disinfection process starts, the touch screen displays the remaining time and the progress bar. Ch.8 Figure 8.99 OER-Elite OPERATION MANUAL 395 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 15 When water starts to flow continuously from the filter tube, disconnect the tube by pushing its lock lever. Water flow should stop when the filter tube is disconnected. Figure 8.100 NOTE If the temperature of the disinfectant solution is less than 20qC (68qF), it will be heated to 20qC (68qF). During heating, the remaining time countdown and the progress bar display stop and turn gray. After the completion of heating, the remaining time countdown and progress bar display resume. Ch.8 Progress stops and turns gray. Figure 8.101 It blinks Current temperature of the disinfectant solution Target temperature of the disinfectant solution 396 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 16 Make sure that a jet of fluid is output from the water supply/circulation nozzle to the dome of lid during the process. 17 When the remaining time displayed on the touch screen reaches 0 minute, the buzzer sounds and the touch screen displays the following screen. Figure 8.102 Figure 8.103 18 Put the tube-side end of the filter tube back in the container. 19 Insert the connector end of the filter tube into the connector above the water filter housing. Do not connect a filter tube to the connector below the water filter housing. Ch.8 Figure 8.104 OER-Elite OPERATION MANUAL 397 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 20 Press the Continue button. The touch screen displays a screen as shown in the following figure and water will flow from the filter tube. Figure 8.105 21 After several seconds, the buzzer sounds indicating the end of the process and the touch screen displays the following screen. Ch.8 22 Disconnect the filter tube by pushing its lock lever. 23 Close the front door. 24 Step on the foot pedal to open the lid. Figure 8.106 398 OER-Elite OPERATION MANUAL 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 25 Disconnect the water supply piping disinfection hose and close the by pushing until it clicks. Water supply piping disinfection hose connector Washing case mount Connector C1 Temperature sensor Figure 8.107 26 Rinse the filter tube and water supply piping disinfection hose thoroughly in running water, dry them thoroughly, and store in a clean place. 27 Press the OK button to complete the water filter replacement process. Ch.8 Figure 8.108 OER-Elite OPERATION MANUAL 399 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) When entering the lot number of the water filter If the lot number management is activated, enter the lot number according to the following procedure. NOTE The lot number is printed on a label affixed to the box containing the water filter. The lot number of water filter can be recorded. For the setting change method, refer to Section 4.15, Filter lot number management. 1 If the filter lot number management of the water filter is active, the touch screen displays a screen as shown in following figure at Step 3 in Replacing the water filter on page 380. Press the Next button. Ch.8 2 Press the Edit button to display the lot entry screen. Figure 8.109 Figure 8.110 NOTE If the Delete button is pressed, the entered lot number can be deleted. 400 OER-Elite OPERATION MANUAL 1 2 3 No. 1 2 3 4 5 6 7 8 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) 3 Enter the lot number of the new water filter by the software keyboard on the touch screen and press the Save button. Alphabet input Numeral input 4 5 6 1 2 3 4 5 6 7 8 7 8 Enter the alphabet or a numeral. Note Button Alphabet/
Numeral key Uppercase/
Lowercase button Numeric/
Alphabetic button Backspace button Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. Press the Backspace button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Press the Space button to insert a space character. Ch.8 Space button Cursor move button Press the cursor move button to move the cursor left or right. Cancel button Save button Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 4 Press the Start button. Go to Step 4 in Replacing the water filter on page 380. Figure 8.111 OER-Elite OPERATION MANUAL 401 8.5 Replacing the air filter (MAJ-823) 8.5 Replacing the air filter (MAJ-823) Replace the air filter every month. To create the record of the replacement of the air filter, select Replace Air Filter in the Replacement of Consumable Items menu. WARNING Always be sure to attach the specified air filter. Otherwise, the air may contaminate the reprocessor piping and/or the scope and prevent effective reprocessing. Replace the air filter at least every month. If the performance of the air filter drops, insufficient elimination of miscellaneous bacteria in air may cause contamination of the instrument and scopes and make the reprocessing insufficient. NOTE When the air filter counter setting is activated, the filter replacement indicator can be displayed on the top right of the touch screen and on the Replace Air Filter button on the Replacement of Consumable Items menu when the counter setting value is reached. Ch.8 Workflow of replacement of the air filter See the replacement of air filter workflow below. 1 Replacing the air filter.
on page 403 2 Inspecting air leakage from the air filter connectors.
on page 408 Required items Check Required items Air filter (MAJ-823) Table 8.7 402 OER-Elite OPERATION MANUAL 8.5 Replacing the air filter (MAJ-823) Replacing the air filter NOTE If you do not need to create the record of the replacement of the air filter, the following operations of GUI can be skipped. 1 Press the Replacement of Consumable items button on the Menu screen. 2 Press the Replace Air Filter button. Figure 8.112 Ch.8 Figure 8.113 OER-Elite OPERATION MANUAL 403 8.5 Replacing the air filter (MAJ-823) 3 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID
(If applicable). Then, press the Edit button to display the lot entry screen. Figure 8.114 Ch.8 NOTE Figure 8.115 The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. If the Delete button is pressed, the entered lot number can be deleted. 4 Open the front door of the reprocessor. 5 Remove the old air filter by pushing the sleeves on the two connectors toward the device. Sleeves Figure 8.116 404 OER-Elite OPERATION MANUAL
1 | Operation Manual 4 | Users Manual | 2.17 MiB |
8.5 Replacing the air filter (MAJ-823) NOTE
The air filter is not installed on the reprocessor when it is shipped from the factory.
When the lot number management of the air filter is activated, the lot number of the air filter is entered after Step 7. For details, refer to When entering the Lot number of air filter on page 406. 6 With the FLOW indicator pointing upwards, attach a new air filter by fitting into the two connectors until they click. Then lightly pull the air filter to confirm that the sleeves fit on the connectors. 7 Press the Next button. Figure 8.117 Ch.8 8 Press the OK button. Figure 8.118 Figure 8.119 OER-Elite OPERATION MANUAL 405 8.5 Replacing the air filter (MAJ-823) When entering the Lot number of air filter If the lot number management is activated, enter the Lot number according to the following procedure. NOTE The Lot number is printed on a label affixed to the package containing the air filter. The lot number of the air filter can be recorded. For the setting change method, refer to Section 4.15, Filter lot number management. 1 If the filter lot number management of the air filter is active, the touch screen displays a screen as shown in following figure after Step 7 in Replacing the air filter on page 403. Ch.8 2 Press the Edit button to display the lot entry screen. Figure 8.120 Figure 8.121 NOTE If the Delete button is pressed, the entered Lot No can be deleted. 3 Enter the Lot No of the new air filter by the software keyboard on the touch screen and press the Save button. 406 OER-Elite OPERATION MANUAL 1 2 3 No.
2 3 4 5 6 7 8 8.5 Replacing the air filter (MAJ-823) Alphabet input Numeral input 4 5 6 1 2 3 4 5 6 7 8 7 8 Enter the alphabet or a numeral. Note Button Alphabet/
Numeral key Uppercase/
Lowercase button Numeric/
Alphabetic button Backspace button Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. Press the Backspace button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Press the Space button to insert a space character. Ch.8 Space button Cursor move button Press the cursor move button to move the cursor left or right. Cancel button Save button Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 4 Press the Next button. Figure 8.122 OER-Elite OPERATION MANUAL 407 8.5 Replacing the air filter (MAJ-823) 5 Check the displayed lot number and press the Next button. 6 Press the OK button. Figure 8.123 Ch.8 Figure 8.124 Inspecting air leakage from the air filter connectors 1 Close the lid by pushing it until it clicks. 2 Press the Function button on the Menu screen. Figure 8.125 408 OER-Elite OPERATION MANUAL 8.5 Replacing the air filter (MAJ-823) 3 Press the Air Purge button. 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 8.126 NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 5 Press the Start button. Ch.8 6 When for about 40 seconds after air purge started. Then, touch the air filter connectors to ensure that air is not leaking out. Also, ensure that the connectors do not produce a whistling sound, which would mean there is an air leak. Figure 8.127 Connector Connector Figure 8.128 OER-Elite OPERATION MANUAL 409 8.5 Replacing the air filter (MAJ-823) NOTE It takes about 40 seconds to feed air into the air filter. 7 Press the Stop button on the touch screen to end Air Purge. If an air leak is detected or the error code [E021] is displayed, reinstall the air filter as described in Replacing the air filter on page 403
8 The touch screen displays the error code [E000]. Press the OK button repeatedly until the error screen is closed. Figure 8.129 Ch.8 410 OER-Elite OPERATION MANUAL 8.6 Replacing the gas filter (MAJ-822) 8.6 Replacing the gas filter (MAJ-822) Replace two gas filters every month or whenever the odor of the disinfectant solution seems to have increased, whichever comes first. To create the record of the replacement of the gas filter, select Replace Gas Filter on the Lid or Replace Gas Filter on the Tank in the Replacement of Consumable Items menu. WARNING The disinfectant vapor generated by the reprocessor has been proven safe in in-house testing. Nevertheless, as individual reactions to the disinfectant may vary, Olympus recommends the use of gas filters and enhanced protection by observing the ventilation conditions given in Ensuring the safety of reprocessing personnel on page 12. The use of the gas filter does not replace the need for proper room ventilation. CAUTION Always be sure to attach the specified gas filter. Otherwise, the vapor of the disinfectant may not be eliminated sufficiently. Do not block the ventilation openings on the gas filter cases with the replacement date indication sticker or any other foreign material. Blocking the ventilation not only hinders deodorization but may also cause the reprocessor to malfunction. If the odor of the disinfectant solution seems to have increased after replacement of gas filters, contact Olympus. If the gas filter is expired, the performance of gas filter may decrease and cannot remove the odor of disinfectant solution sufficiently. Ch.8 NOTE When the gas filter counter setting is activated, the filter replacement indicator can be displayed on the top right of the touch screen and on the Replace Gas Filter on the lid and/or Replace Gas Filter on the Tank button on the Replacement of Consumable Items menu when the counter setting value is reached. For the gas filter counter setting, refer to Section 4.14, Filter replacement indicator. OER-Elite OPERATION MANUAL 411 8.6 Replacing the gas filter (MAJ-822) Required items Check Required items Gas filter (MAJ-822) (u 2 pieces) Table 8.8 Replacing the gas filter on the lid NOTE If you do not need to create the record of the replacement of the gas filter, the following operations of GUI can be skipped. 1 Press the Replacement of Consumable items button on the Menu screen. Ch.8 2 Press the Replace Gas Filter on the Lid button. Figure 8.130 3 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 8.131 412 OER-Elite OPERATION MANUAL 8.6 Replacing the gas filter (MAJ-822) NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 4 Remove the gas filter case from the deep part of the lid. Figure 8.132 NOTE When the reprocessor is shipped from the factory, the gas filters are not installed in the reprocessor. 5 Unlock each gas filter case cover and open it. Ch.8 Ventilation opening Lock Figure 8.133 OER-Elite OPERATION MANUAL 413 8.6 Replacing the gas filter (MAJ-822) 6 Remove the old gas filter. The gas filter case designed for the lid has a gas filter adapter
(splash guard) inside of it to prevent water droplet penetration. Gas filter adapter
(splash guard) Figure 8.134 CAUTION Do not discard the gas filter adapter (splash guard). If the adapter is not installed to the gas filter case, disinfectant solution may adhere to the gas filter during processes such as reprocessing process. 7 Place a new gas filter in the gas filter case. Ventilation opening Ch.8 Figure 8.135 8 Close and lock the cover. Do not to catch the gas filter when closing the cover. 9 Insert the gas filter case designed for the reprocessing basin (the one with gas filter adapter (splash guard) attached to it) into the mount on the deep part of the lid, and then turn it all the way in the direction shown below until it is stopped. Gas filter case mount Figure 8.136 414 OER-Elite OPERATION MANUAL 8.6 Replacing the gas filter (MAJ-822) 10 Press the Next button. Figure 8.137 NOTE When the lot number management of the gas filter is activated, the lot number of the gas filter is entered after Step 10. For details, refer to When entering the lot number of the gas filter on the lid and tank on page 419. 11 Press the OK button. Ch.8 Figure 8.138 OER-Elite OPERATION MANUAL 415 8.6 Replacing the gas filter (MAJ-822) Replacing the gas filter on the disinfectant solution tank 1 Press the Replacement of Consumable items button on the Menu Screen. 2 Press the Replace Gas Filter on the Tank button. Figure 8.139 Ch.8 3 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 8.140 NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 416 OER-Elite OPERATION MANUAL 8.6 Replacing the gas filter (MAJ-822) 4 Open the front door and remove the gas filter case from the top right position. Gas filter case Gas filter case mount Figure 8.141 5 Unlock each gas filter case cover and open it. Ventilation opening 6 Remove the old gas filter. 7 Place the new gas filter in the gas filter case. Lock Figure 8.142 Ch.8 Ventilation opening Figure 8.143 8 Close and lock the cover. Do not catch the gas filter when closing the cover. OER-Elite OPERATION MANUAL 417 8.6 Replacing the gas filter (MAJ-822) 9 Insert the gas filter case designed for the disinfectant solution tank into the gas filter case mount at the top right of the inside of the front door, and then turn it all the way in the direction shown below until it is stopped. Gas filter case mount Figure 8.144 10 Close the front door. 11 Press the Next button. Ch.8 Figure 8.145 NOTE When the lot number management of the water filter is activated, the lot number of the water filter is entered after Step 11. For details, refer to When entering the lot number of the gas filter on the lid and tank on page 419. 418 OER-Elite OPERATION MANUAL 8.6 Replacing the gas filter (MAJ-822) 12 Press the OK button. Figure 8.146 When entering the lot number of the gas filter on the lid and tank If the lot number management is activated, enter the Lot number according to the following procedure. NOTE The Lot number is printed on a label affixed to the package containing the gas filter. The lot number of the gas filter can be recorded. For the setting change method, refer to Section 4.15, Filter lot number management. 1 If the filter lot number management of the gas filter (Lid and/or Tank) is active, the touch screen displays a screen as shown in following figure after Step 10 in Replacing the gas filter on the lid on page 415 or Step 11 in Replacing the gas filter on the disinfectant solution tank on page 418. Press the Next button. Figure 8.147 Ch.8 OER-Elite OPERATION MANUAL 419 8.6 Replacing the gas filter (MAJ-822) 2 Press the Edit button to display the lot entry screen. Figure 8.148 NOTE If the Delete button is pressed, the entered Lot No can be deleted. 3 Enter the lot number of the new gas filter by the software keyboard on the touch screen and press the Save button. Ch.8 420 OER-Elite OPERATION MANUAL 8.6 Replacing the gas filter (MAJ-822) Alphabet input Numeral input 4 5 6 1 2 3 4 5 6 7 8 7 8 Button Note Enter the alphabet or a numeral. Alphabet/Numeral key Uppercase/
Lowercase button Numeric/Alphabetic button Back space button Press the Backspace button to delete the left character of a cursor. Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. Ch.8 When a cursor is on the leftmost, this button becomes gray and cannot be pressed. Press the Space button to insert a space character. Space button Cursor move button Press the cursor move button to move the cursor left or right. Cancel button Save button Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 1 2 3 No. 1 2 3 4 5 6 7 8 4 Press the Next button. Figure 8.149 OER-Elite OPERATION MANUAL 421 8.6 Replacing the gas filter (MAJ-822) 5 Check the displayed lot number and press the Next button. 6 Press the OK button. Figure 8.150 Ch.8 Figure 8.151 422 OER-Elite OPERATION MANUAL 9.1 Periodic inspection Chapter 9 Routine Maintenance 9.1 Periodic inspection To ensure safe operation of the reprocessor, it should be cleaned and inspected regularly. Parts and consumables should be added or replaced as required. WARNING When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) Ch.9 If the person performing the inspection or maintenance exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task and vacate the room. Be sure to perform all the inspections, cleaning, replacement of consumables and other tasks described in this chapter. Otherwise, this reprocessor may cease to operate and perform as expected. When inspecting or cleaning this reprocessor, always wear appropriate personal protective equipment, such as goggles, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. If you find any problems or observe an irregularity, do not use the reprocessor and contact Olympus. If the reprocessor is used when an irregularity is found, the reprocessor may malfunction. Water leakage, electric shock, burns, and/or fire may also result. OER-Elite OPERATION MANUAL 423 9.1 Periodic inspection WARNING Alcohol is flammable. Before handling the alcohol, carefully read the cautions for use, become fully acquainted with all safety materials, and use the alcohol as instructed. Check Monthly maintenance Section 8.6, Replacing the gas filter (MAJ-822) Section 8.4, Replacing the water filter (MAJ-824 or MAJ-2318)*1 Section 7.7, Water line disinfection Section 8.5, Replacing the air filter (MAJ-823) Section 9.2, Cleaning the detergent/alcohol drawer Section 9.3, Cleaning the accessories and accessory holder Table 9.1
*1 Using a prefilter of 0.45 micron or less can extend the life of the water filter
(MAJ-824 or MAJ-2318). If the prefilter is properly installed, and one of the prefilters is 0.45 microns or less, it is recommended that the water filter (MAJ-824 or MAJ-2318) be replaced at least once every 6 months. If there is no prefilter installed then it is recommended that the water filter (MAJ-824 or MAJ-2318) be replaced at least every 30 days. For information on the Water Pre-filtration system, contact Olympus. Check Weekly maintenance Section 9.4, Cleaning the alcohol tank Ch.9 Table 9.2 Check Work to be performed as required Section 8.3, Replacing the detergent tank Section 9.5, Checking cassette cutters Section 9.6, Cleaning the disinfectant bottle drawer Section 8.2, Replacing the disinfectant solution Section 9.7, Cleaning the mesh filter in the water supply hose connector Section 9.8, Replacing the fuse Section 7.9, Detergent line disinfection Section 7.10, Alcohol line disinfection Section 9.9, Preparing the reprocessor for long-term storage Section 9.10, Care and maintenance after long-term storage Table 9.3 424 OER-Elite OPERATION MANUAL 9.2 Cleaning the detergent/alcohol drawer 9.2 Cleaning the detergent/alcohol drawer Clean the detergent/alcohol drawer every month. CAUTION Pay attention to not to injure your hand by hitting the detergent/alcohol drawer. 1 Pull out the detergent/alcohol drawer. 2 Disconnect the tubes from the detergent tank and alcohol tank, and take both tanks out of the drawer. 3 Take the detergent/alcohol inner tray out of the detergent/alcohol drawer. 4 Clean the detergent/alcohol inner tray in fresh running water. 5 After cleaning, dry it thoroughly with a clean cloth. 6 Place the detergent/alcohol inner tray back on the detergent/alcohol drawer. 7 Place the detergent tank and alcohol tank on the detergent/alcohol drawer and connect the tubes to the original positions on the tanks. 8 Turn the connectors to correct the orientations of the tubes as shown Figure 9.1. Connectors Ch.9 9 Close the detergent/alcohol drawer. Figure 9.1 OER-Elite OPERATION MANUAL 425 9.3 Cleaning the accessories and accessory holder 9.3 Cleaning the accessories and accessory holder As the accessories listed below tend to attract dirt and dust, they should be cleaned at least every month and stored in a clean environment. The accessory holder used for storage should also be kept clean in the same way. Connecting tubes Filter tubes Hoses Gas filter case excluding the gas filter Gas filter adapter (splash guard), etc. Accessory holder Card holders Required items Ch.9 Check Required items 70% ethyl alcohol or 70% isopropyl alcohol Clean cloth Neutral detergent Table 9.4 Cleaning the accessories and accessory holder 1 Remove the accessory holder from the back side of the front door by loosening the two retaining screws. Accessory holder 426 OER-Elite OPERATION MANUAL Figure 9.2 9.3 Cleaning the accessories and accessory holder 2 Using a cloth moistened with neutral detergent, clean the external surfaces of the accessory holder and the accessories listed above, rinse them in running water, and wipe them with a clean cloth. To prevent the growth of microorganisms, it is also recommended to wipe the accessories and accessory holder with a cloth moistened with 70% ethyl alcohol or 70% isopropyl alcohol. 3 Dry the accessories and accessory holder thoroughly and store them in a clean place near the device. 4 Attach the accessory holder to the back side of the front door using the two retaining screws. 5 Store the frequently used connector tubes in the accessory holder. Note that the accessory holder cannot accommodate all of the connector tubes. Figure 9.3 CAUTION Do not hook connector tubes on the accessory holder in a disorderly fashion as this could make it difficult or impossible to open and close the front door and may also damage the accessories. Ch.9 OER-Elite OPERATION MANUAL 427 9.4 Cleaning the alcohol tank 9.4 Cleaning the alcohol tank Clean the alcohol tank every week. CAUTION Do not tilt the alcohol or detergent tank while fluid is still inside. Otherwise, the fluid may spill. 1 Pull out the detergent/alcohol drawer. 2 Disconnect the tube from the alcohol tank and take the tank out of the detergent/alcohol drawer. 3 Empty the tank. 4 Rinse inside of the tank with running water. Repeat this rinse process several times with fresh water to rinse it thoroughly. 5 Using a cloth moistened with neutral detergent, clean the external surface, rinse the external surface of the tank in running water, and wipe it with a clean cloth. To prevent growth of microorganisms, it is also recommended to wipe the outside of the tank with a cloth moistened with 70% ethyl alcohol or 70% isopropyl alcohol. 6 Drain out the water inside the tank, dry it thoroughly, put it back on the detergent/alcohol drawer and attach the cap and tube to it. 7 Turn the connectors to correct the orientations of the tubes as shown below. Connectors Ch.9 8 Close the detergent/alcohol drawer. Figure 9.4 428 OER-Elite OPERATION MANUAL 9.5 Checking cassette cutters 9.5 Checking cassette cutters Inspect the cassette cutters when replacing the disinfectant solution. For details, refer to Section 8.2, Replacing the disinfectant solution. 9.6 Cleaning the disinfectant bottle drawer It is necessary to clean the disinfectant bottle drawer if it is dirty or if any disinfectant solution spills into the drawer. The disinfectant solution bottle drawer can be opened only when replacing the concentrated disinfectant solution. For details, refer to Section 8.2, Replacing the disinfectant solution. CAUTION Pay attention to not to injure your hand by hitting the disinfectant bottle drawer. Ch.9 OER-Elite OPERATION MANUAL 429 9.7 Cleaning the mesh filter in the water supply hose connector 9.7 Cleaning the mesh filter in the water supply hose connector When the reprocessor stops with error code [E001], the water filter should be replaced first. However, if the reprocessor stops again with error code [E001], clean the mesh filter as described below. Required items Check Required items User ID card Clean tweezers Brush Table 9.5 Cleaning the mesh filter in the water supply hose connector Ch.9 To relieve the incoming water, perform Rinse process and stop that. NOTE 1 Close the water faucet. 2 Press the Functions button on the Menu screen. Figure 9.5 430 OER-Elite OPERATION MANUAL 9.7 Cleaning the mesh filter in the water supply hose connector 3 Press the Rinse button. 4 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 9.6 NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 5 Press the Start button to relieve the incoming water pressure. Ch.9 Figure 9.7 6 After the pressure has been relieved (approximately 10 seconds), press the STOP button on the control panel to stop the rinse. The touch screen displays the error code
[E000]. Figure 9.8 OER-Elite OPERATION MANUAL 431 9.7 Cleaning the mesh filter in the water supply hose connector 7 Press the OK button repeatedly until the error screen is closed. Figure 9.9 8 Turn the connection ring on the reprocessor side of the water supply hose in the direction shown to disconnect the hose from the reprocessor. If residual water is spilled from the water supply hose, wipe it up with a clean cloth. Ch.9 9 Using clean tweezers, remove the mesh filter from the water supply hose connector. Figure 9.10 Water supply hose connector Figure 9.11 CAUTION Do not pinch the mesh filter in the water supply hose connector too hard. This could deform the mesh filter or injure your fingers. 432 OER-Elite OPERATION MANUAL 9.7 Cleaning the mesh filter in the water supply hose connector 10 Clean the mesh filter in running water using a brush. 11 Place the mesh filter in the original position in the water supply connector. Pay attention to the up-down orientation. Figure 9.12 CAUTION Be sure to install the mesh filter in the water supply hose connector. Otherwise, dirt and foreign matter in the water could enter the reprocessor and cause it to malfunction. 12 Attach the connection ring of the water supply hose in the original position on the reprocessor. Ch.9 OER-Elite OPERATION MANUAL 433 9.8 Replacing the fuse 9.8 Replacing the fuse If the power switch does not turn on, replace the fuse with the following procedure. WARNING Before removing the fuse box, be sure to set the power switch to OFF and unplug the power cord from the connector on the reprocessor and the hospital-grade power outlet. Otherwise, a fire or an electric shock may result. To prevent an electric shock, do not check or inspect the reprocessor with wet hands. 1 Ensure that the power cord is connected securely to the connector on the reprocessor and to the hospital-grade power outlet. 2 Set the power switch to OFF and unplug the power cord from the hospital-grade power outlet. 3 Unplug the power cord from the power cord receptacle on the reprocessor. 4 Push the tabs on the fuse box in the directions shown and take out the fuse holder
(1) Ch.9 5 Visually confirm that neither fuse is blown.
(2)
(1) The numbers in the figure indicate the fuse box removal sequence. Figure 9.13 Figure 9.14 434 OER-Elite OPERATION MANUAL 9.8 Replacing the fuse WARNING Always use the fuses specified below. Otherwise, malfunction or failure of the reprocessor may cause a fire or an electric shock. Spare fuses: DB181500 CAUTION If the power indicator does not light even when neither fuse is blown or after the fuses are replaced, contact Olympus. 6 Push the fuse holder into the reprocessor until it clicks. Confirm that the fuse holder is fitted firmly into the reprocessor body. The fuse holder is properly installed
(Both the top and bottom projections touch the surface of the fuse holder cavity) The fuse holder is not properly installed
(Both the top and bottom projections do not touch the surface of the fuse holder cavity) Ch.9 Figure 9.15 7 Connect the power cord, set the power switch to ON and confirm that the power indicator lights up. WARNING If the power indicator does not light even after the fuses are replaced, be sure to unplug the power cord from the power outlet. Otherwise, an electric shock may result. OER-Elite OPERATION MANUAL 435 9.9 Preparing the reprocessor for long-term storage 9.9 Preparing the reprocessor for long-term storage When the reprocessor will be stored for more than 14 days, follow the procedure described in this section. WARNING When handling the disinfectant solution and detergent and alcohol, carefully read the cautions for its use to fully understand the given information and use as instructed. Understanding the measures to be taken if the disinfectant solution comes into contact with your skin and eyes is of paramount importance. When handling the disinfectant solution and detergent/alcohol, wear appropriate personal protective equipment to avoid direct contact with your skin and eyes or excessive inhalation of its vapor. The disinfectant solution and its vapor may have effects on the human body. Personal protective equipment, such as goggles, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. CAUTION Ch.9 Do not tilt the detergent tank while there is still detergent inside. If detergent is spilled on the tray, it could damage the reprocessor. Do not tilt the alcohol tank while there is still alcohol inside. If alcohol is spilled on the tray, it could damage the reprocessor. 436 OER-Elite OPERATION MANUAL 9.9 Preparing the reprocessor for long-term storage Workflow of Preparing the reprocessor for long-term storage 1 Suction the disinfectant solution from disinfectant solution nozzle.
on page 438 2 Suction the detergent solution from detergent nozzle inside.
on page 440 3 Empty the detergent/alcohol tank. 4 Empty the water filter. 5 Remove the water supply hose.
on page 443
on page 445
on page 447 Required items Ch.9 Check Required items Syringe and tube Connector jigs 70% ethyl alcohol or 70% isopropyl alcohol Beaker (small) with a capacity of about 200 ml, such as a beaker Provided wrench Clean cloth Sterile water: more than 50 ml Filter tube ( 2) Container with 2 L or larger capacity (wide-mouthed container such as a vat) Table 9.6 OER-Elite OPERATION MANUAL 437 9.9 Preparing the reprocessor for long-term storage Preparing the reprocessor for long-term storage 1 Discharge disinfectant solution from the reprocessor as described in Draining the disinfectant solution on page 342. 2 Step on the foot pedal to open the lid. 3 Uncap the disinfectant solution nozzle of the reprocessing basin by turning the disinfectant solution nozzle cap. Refer to the Figure 9.16. Disinfectant solution nozzle cap 4 Connect the provided syringe and tube. Figure 9.16 Ch.9 5 Remove the disinfectant solution nozzle filter from the disinfectant solution nozzle. Figure 9.17 438 OER-Elite OPERATION MANUAL Figure 9.18 9.9 Preparing the reprocessor for long-term storage 6 Insert the tube attached to the syringe deeply enough into the disinfectant solution nozzle. Figure 9.19 7 Suction the disinfectant solution with the syringe until no more disinfectant solution comes out of the disinfectant solution nozzle. 8 Remove the tube from the disinfectant solution nozzle. 9 Dip alcohol to the O-ring of disinfectant solution nozzle filter, be sure to attach into the disinfectant solution nozzle. 10 Attach the disinfectant solution nozzle cap to the original position above the disinfectant solution nozzle. Make sure that the pin returns to the original position, and the projection of the disinfectant solution nozzle cap is aligned to the projection of the disinfectant solution nozzle. Pin projection Ch.9 11 Drain the disinfectant solution from syringe. 12 Pull out the detergent/alcohol drawer. Figure 9.20 OER-Elite OPERATION MANUAL 439 9.9 Preparing the reprocessor for long-term storage 13 Turn the detergent tank cap to remove it. (Do not disconnect the connector.) 14 Connect the provided syringe and tube. Figure 9.21 Ch.9 15 Connect the tube attached to the syringe to the detergent nozzle inside the reprocessing basin. Figure 9.22 440 OER-Elite OPERATION MANUAL 9.9 Preparing the reprocessor for long-term storage 16 To remove detergent from inside the detergent line, connect the tube attached to the syringe to the detergent nozzle inside the reprocessing basin. Suction the detergent with the syringe until no more detergent comes out of the line. Figure 9.23 17 Prepare a container or similar beaker and pour more than 50 ml of the sterile water into it. 18 Put the cap and uptake tube in the beaker filled with the sterile water. Ch.9 Figure 9.24 19 To rinse the line with water, connect the tube attached to the syringe to the detergent nozzle and suction more than 50 ml of sterile water with the syringe. (See Figure 9.23) 20 To remove rinse water from inside the line, connect the tube attached to the syringe to the detergent nozzle inside the reprocessing basin. Suction the water with the syringe until no more water comes out of the line. (See Figure 9.23) 21 Prepare a container or similar beaker and pour about 50 ml of the 70% ethyl alcohol or 70% isopropyl alcohol into it. 22 Put the detached cap and the uptake tube in the beaker of the 70% ethyl alcohol or 70% isopropyl alcohol. (See Figure 9.24) OER-Elite OPERATION MANUAL 441 9.9 Preparing the reprocessor for long-term storage 23 To rinse the line with alcohol, connect the tube attached to the syringe to the detergent nozzle and suction more than 50 ml of 70% ethyl alcohol or 70% isopropyl alcohol with the syringe. (See Figure 9.23) 24 To remove 70% ethyl alcohol or 70% isopropyl alcohol from inside the line, connect the tube attached to the syringe to the detergent nozzle inside the reprocessing basin. Suction the alcohol with the syringe until no more alcohol comes out of the line. (See Figure 9.23) 25 Remove the tube from the detergent nozzle. 26 Remove the detergent tank. 27 To disconnect the tube connected to the alcohol tank cap, push and hold the lock lever on the connector and pull the tube. Ch.9 Figure 9.25 Cap 28 Take the alcohol tank out of the reprocessor. Alcohol tank Figure 9.26 442 OER-Elite OPERATION MANUAL 9.9 Preparing the reprocessor for long-term storage 29 Turn the alcohol tank cap to remove it, empty the alcohol from the tank and dry the inside. Cap Figure 9.27 30 Put the cap back on the tank, place the tank on the detergent/alcohol drawer, and connect the tube to the cap again. Alcohol tank Ventilation tube Figure 9.28 31 Close the detergent/alcohol drawer. 32 Attach the connector jigs to the connectors on the reprocessing basin. Ch.9 33 Close the lid by pushing until it clicks. 34 Perform the operation described in Section 7.6, Air purge. 35 Close the water faucet. Figure 9.29 OER-Elite OPERATION MANUAL 443 9.9 Preparing the reprocessor for long-term storage 36 Press the Function button on the Menu Screen. 37 Press the Rinse button. Figure 9.30 Ch.9 38 Enter the operator's user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). Figure 9.31 NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. If the Delete button is pressed, the entered ID can be deleted. 39 Press the Start button to relieve the incoming water pressure. Figure 9.32 444 OER-Elite OPERATION MANUAL 9.9 Preparing the reprocessor for long-term storage 40 Press the STOP button on the control panel to stop the rinse. The touch screen displays the error code [E000]. 41 Press the OK button repeatedly until the error screen is closed. Figure 9.33 Figure 9.34 42 Open the front door of the reprocessor. 43 Place a container with a capacity of 2 L or more in front of the reprocessor. 44 Put the tube-side ends of the two filter tubes in the container placed above. 45 Insert the connector ends of the two filter tubes into the connector below the water filter housing and the connector above the water filter housing until they click. Water will start to flow from the tube connected to the connector below the water filter housing. Ch.9 Connector below water filter housing Connector above water filter housing Figure 9.35 OER-Elite OPERATION MANUAL 445 9.9 Preparing the reprocessor for long-term storage 46 Press the Air Purge button on the first page of the Function menu. 47 Hold the scope ID master card to the RFID reader of the reprocessor, and scan the tag with the reader until a short beep (If applicable). 48 Press the Start button to start the air purge. Figure 9.36 Ch.9 49 When the water flow stops, press the Stop button on the touch screen to end the air purge process, and disconnect the two filter tubes by pushing the lock levers on their connectors. Figure 9.37 Figure 9.38 50 Step on the foot pedal to open the lid, disconnect the connector jigs, dry them thoroughly, and store them in a clean place. 446 OER-Elite OPERATION MANUAL 9.9 Preparing the reprocessor for long-term storage 51 Press the power switch to set it to OFF. 52 Turn the connection ring on the reprocessor side of the water supply hose in the direction shown to disconnect the hose from the reprocessor. If residual water spills from the water supply hose, wipe it up with a clean cloth. Figure 9.39 53 Put the reprocessor-side end of the hose in the wide-mouthed container to collect any residual water that may flow from the water supply hose. 54 While holding the lock lever of the water supply socket of the water supply hose, pull the sleeve toward the hose to disconnect the water supply socket from the water faucet.
(3) The numbers in the figure indicate the sequence for disconnecting the water supply socket.
(2)
(1) Ch.9 Figure 9.40 55 Step on the foot pedal to open the lid, dry the reprocessing basin thoroughly so that no bacterial growth will occur inside it, and then close the lid by pushing until it clicks. 56 Disconnect the power cord plug from the hospital-grade power outlet. OER-Elite OPERATION MANUAL 447 9.10 Care and maintenance after long-term storage 9.10 Care and maintenance after long-term storage When using the reprocessor after it has been stored for more than 14 days without being used, setting up the reprocessor, performing the reprocessing program, and performing the water supply piping disinfection are required. Perform the following procedure. Setting up the reprocessor 1 Connect the water supply hose. For detailed instruction, refer to Section 4.4, Connection of the water supply hose in Instructions-Installation Manual. 2 Connect the power cord. For detailed instruction, refer to Section 4.6, Connection of the power supply in Instructions-Installation Manual. 3 Confirm the power supply. For detailed instruction, refer to Section 4.7, Confirmation of power to unit in Instructions-Installation Manual. 4 Install the detergent tank. For detailed instruction, refer to Section 4.18, Installation of the detergent tank in Instructions-Installation Manual. 5 Add alcohol into the alcohol tank. For detailed instruction, refer to Section 4.17, Addition of alcohol in Instructions-Installation Manual. 6 Replace the water filter (MAJ-824 or MAJ-2318). For detailed instruction, refer to Replacing the water filter on page 380. 7 Set up the disinfectant solution. For detailed instruction, refer to Load the disinfectant solution on page 354 in this manual. 8 Inspect and clean all parts before use. For detailed instruction, refer to Chapter 5, Inspection and Preparation Before Use in this manual. Performing the reprocess program 9 Perform Self-Disinfection. For detailed instruction, refer to Section 4.20, Checking the functions in Instructions-Installation Manual. Ch.9 448 OER-Elite OPERATION MANUAL 9.10 Care and maintenance after long-term storage Performing the water supply piping disinfection 10 Olympus recommends performing microbiological sampling of the OER-Elite rinse water quality right after performing the water supply piping disinfection. For details on sampling rinse water, refer to Section 7.8, Self-disinfection and water sampling. NOTE Be sure to perform routine maintenance as required depending on the length of unused time. Otherwise, this reprocessor may cease to operate and/or perform as expected. For details on routine maintenance, refer to Chapter 9, Routine Maintenance. Ch.9 OER-Elite OPERATION MANUAL 449 9.10 Care and maintenance after long-term storage Ch.9 450 OER-Elite OPERATION MANUAL 10.1 Inspection at the end of every working day Chapter 10 End-of-Day Checks 10.1 Inspection at the end of every working day Inspect and clean all parts of the reprocessor regularly to ensure safe and reliable operation. The Heat LCG Timer should be activated after completing the inspections and cleaning described in this section. Check Checks at the end of every working day Section 10.2, Turning the power OFF and closing the water faucet Section 10.3, Cleaning the mesh filters Section 10.4, Cleaning the float switches Section 10.5, Cleaning the fluid level sensor Section 10.6, Cleaning the stylus pen If the stylus pen is reprocessed in every reprocessing cycle, it has not to be cleaned at the end of every work day. Section 10.7, Cleaning the outer surface Table 10.1 Check Required items 70% ethyl alcohol or 70% isopropyl alcohol Clean cloth (Should clean up the Touch screen or any panel by using the lint-free clean cloth.) Filter cleaning brush Neutral detergent Sterile gauze Ch.10 Table 10.2 WARNING Be sure to inspect and clean the reprocessor as described in this chapter. Otherwise, the functions and performance of the reprocessor may not operate properly. If any irregularity is found, do not use the reprocessor and contact Olympus. If the reprocessor is used when an irregularity is found, the reprocessor may malfunction. Water leakage, electric shock, burns, and/or fire may also result. When inspecting the reprocessor, always wear appropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. OER-Elite OPERATION MANUAL 451 10.2 Turning the power OFF and closing the water faucet 10.2 Turning the power OFF and closing the water faucet WARNING To prevent water leakage, be sure to close the water faucet at the end of the working day. After using the reprocessor, dry it thoroughly (so that no water remains in the reprocessing basin) and close the lid before storage. Otherwise, microorganisms may proliferate in the reprocessor. If the reprocessor has been stored after closing the lid without drying the reprocessing basin completely, thoroughly wipe the inside of the reprocessing basin with a cloth moistened with 70% ethyl alcohol or 70% isopropyl alcohol before the next use. 1 Close the water faucet. 2 Make sure that the Heat LCG indicator is not lit. NOTE When the Heat LCG Timer indicator lights up, the Heat LCG Timer is set. Ch.10 3 Press the power switch to OFF. If the Heat LCG Timer indicator is lit, stop the Heat LCG Timer and turn the reprocessor OFF. 4 Step on the foot pedal to open the lid, let the inside of the reprocessing basin dry completely (so that no water remains in the basin), and close the lid by pushing until it clicks. If the lid is open, the Heat LCG Timer cannot perform. 452 OER-Elite OPERATION MANUAL 10.3 Cleaning the mesh filters 10.3 Cleaning the mesh filters Clean the two circulation port mesh filters and the drain port mesh filter. WARNING A clogged mesh filter not only prevents the reprocessor from functioning properly, but may also result in ineffective reprocessing. CAUTION If the mesh filters have been removed, be sure to put them back in their original positions before using the reprocessor. If you forget to attach the mesh filters, the pump may malfunction and/or foreign matter might get into the OER-Elite piping or endoscope nozzles and channels clog them. When cleaning the mesh filters, take care not to leave brush hair or cotton swab fiber in the mesh. Otherwise, their filtering effectiveness may be reduced. If a mesh filter is dropped or subjected to an impact, make sure that the mesh shape is not deformed. Otherwise, the filtering effect may degrade. Two mesh filters are installed on the outer and inner sides of the circulation port. Be sure to remove, inspect, and clean both of them. 1 Step on the foot pedal to open the lid. 2 Remove the mesh filters from the reprocessing basin. Ch.10 Circulation port mesh filters Drain port mesh filter Figure 10.1 OER-Elite OPERATION MANUAL 453 10.4 Cleaning the float switches 3 Clean each mesh filter in running water using a brush. 4 Attach the mesh filters in their original positions. Figure 10.2 10.4 Cleaning the float switches Ch.10 WARNING Take care not to damage the float switches when cleaning it. If the float switch is damaged, it may not be able to correctly detect the fluid level and the endoscope reprocessing may be insufficient. CAUTION Always press the power switch OFF before cleaning the float switch. Moving the float switch while the power switch is ON will be detected as an error by the reprocessor and result in error processing. Do not disassemble components of float switch (e.g., stopper). Otherwise it may not be able to detect the fluid correctly and the process may stop due to erroneous error detection. 1 Make sure that the power switch is OFF. 454 OER-Elite OPERATION MANUAL 10.4 Cleaning the float switches 2 Lift two float switch cover up to remove. Float switch (short) cover Float switch (long) cover Stopper Figure 10.3 Ch.10 OER-Elite OPERATION MANUAL 455 10.4 Cleaning the float switches 3 While applying clean water to the float switches, clean the stem using brush. Move the float up and down manually and thoroughly clean around the stem. Rinse the float switches by pouring clean water over it. Ch.10 Figure 10.4 4 Dry around the float switches using a lint-free clean cloth. 5 Clean two float switch covers in running water and dry. 456 OER-Elite OPERATION MANUAL 10.4 Cleaning the float switches 6 Reinstall the float switch covers. Float switch (short) cover Float switch (long) cover Figure 10.5 Ch.10 OER-Elite OPERATION MANUAL 457 10.5 Cleaning the fluid level sensor 10.5 Cleaning the fluid level sensor After using the reprocessor, clean the fluid level sensor to ensure correct detection of the fluid level in the reprocessing basin. WARNING Take care not to damage the fluid level sensor when cleaning it. If the sensor is damaged, it may not be able to correctly detect the fluid level and the endoscope reprocessing may be insufficient. CAUTION Do not use detergent to clean the fluid level sensor. If any detergent is left on the sensor, it may not be able to correctly detect the fluid level and the cycle may stop due to erroneous error detection. Be sure to completely dry the fluid level sensor. Otherwise, the sensor may not be able to correctly detect the fluid level. Be sure to turn the reprocessor OFF before cleaning the fluid level sensor. Otherwise, the reprocessor may malfunction. Be sure to reinstall the fluid level sensor covers to the fluid level sensor after cleaning. Otherwise, the sensor may not be able to correctly detect the fluid level and the reprocessor may malfunction. Ch.10 1 Press the power switch to OFF. 2 Lift the fluid level sensor cover up to remove as shown with the arrow in Figure 10.6. Fluid level sensor cover Figure 10.6 458 OER-Elite OPERATION MANUAL 10.5 Cleaning the fluid level sensor 3 Clean the fluid level sensor using a lint-free clean cloth moistened with 70% ethyl alcohol or 70% isopropyl alcohol. Figure 10.7 4 Dry around the fluid level sensor using a lint-free clean cloth. 5 Clean the fluid level sensor cover in running water and then completely dry the cover using a lint-free cloth. 6 Reinstall the fluid level sensor cover. Fluid level sensor cover Ch.10 Figure 10.8 OER-Elite OPERATION MANUAL 459 10.6 Cleaning the stylus pen 10.6 Cleaning the stylus pen Clean the stylus pen. There are two methods to clean the stylus pen:
Wipe the stylus pen with a cloth moistened with 70% ethyl alcohol or 70% isopropyl alcohol. Reprocess the stylus pen together with endoscopes with the reprocessor. Wiping the stylus pen with alcohol Wipe the stylus pen with a cloth moistened with 70% ethyl alcohol or 70% isopropyl alcohol. Reprocessing together with endoscopes Setting the stylus pen 1 Set endoscopes and accessories in the reprocessing basin. For the detailed procedures, refer to Section 6.6, Loading of endoscopes and accessories. 2 Set the stylus pen by fitting the hole of the stylus pen around the Pin (Black marking M4) of the retaining rack in the reprocessing basin. Ch.10 Stylus pen Figure 10.9 460 OER-Elite OPERATION MANUAL 10.7 Cleaning the outer surface Reprocessing Start the reprocessing process. For details, refer to Section 6.8, Reprocessing. Removing the stylus pen 1 Take the stylus pen out of the reprocessing basin. Dry using a piece of sterile gauze. 2 Place the stylus pen in the stylus pen holder. 10.7 Cleaning the outer surface 1 Using a clean cloth moistened with neutral detergent, clean the following parts of the reprocessor the front and back of the lid, the lid packing, the edge and inside of the reprocessing basin, the RFID reader, and the control panel. After using the neutral detergent, rinse them with clean cloth moistened with clean water. Figure 10.10 2 Then wipe them with a dry clean cloth. To prevent growth of microorganisms, it is also recommended to wipe those areas with a cloth moistened with 70% ethyl alcohol or 70% isopropyl alcohol and then air-dry the alcohol. 3 After completing the alcohol wipe down close the lid by pushing until it clicks. If the reprocessor has been stored with the lid closed without drying the reprocessing basin completely, wipe the inside of the reprocessing basin with a cloth moistened with 70%
ethyl alcohol or 70% isopropyl alcohol completely before the next use. 4 Step on the foot pedal to open the lid, let the inside of the reprocessing basin dry completely (so that no water remains in the basin), and close the lid by pushing until it clicks. If the lid is open, the Heat LCG Timer cannot perform. Ch.10 OER-Elite OPERATION MANUAL 461 10.7 Cleaning the outer surface WARNING Do not use the reprocessor if the lid or the lid packing seems to be damaged or defective. Using the reprocessor when an irregularity has been detected may interfere with reprocessing. Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment. If any irregularity is found with the lid or the lid packing, contact Olympus. Do not remove the lid packing. Otherwise, disinfectant solution may leak and damage for the reprocessor and areas near the equipment by reprocessing or opening the lid. If replacement or adjustment of the lid packing is required, please contact Olympus. Only Olympus-trained personnel are permitted to replace the lid packing or adjust its position. Improper installation or positioning of the lid packing may result in leakage of water, detergent solution, or disinfectant solution. This may result in injury to personnel and/or damage to the reprocessor. Ch.10 462 OER-Elite OPERATION MANUAL 11.1 Log menu Chapter 11 Log Management Records of reprocessing, functions, and replacement of consumable items can be displayed on the touch screen, output to a portable memory, or printed out. 11.1 Log menu 1 2 3 4 Description Button No. 1 2 3 Menu button 4 LCG Info. button Display and Output button Press to perform log display and output. For details, refer to page 464. Printout button Press to perform log printout. For details, refer to page 575. Press to display the Menu screen. Press to display the LCG Info. screen. Ch.11 OER-Elite OPERATION MANUAL 463 11.2 Log display and output 11.2 Log display and output The records below can be displayed on the touch screen. Reprocessing records and Logs can be also outputted to a portable memory. Record type Description The record of replacements of the gas filter on the disinfectant solution tank. The record of reprocessing process, including errors. The record of errors occurred in the reprocessor. The record of auto and manual leak tests performed on the reprocessor. The record of MRC check result. The record of replacements of the disinfectant solution. The record of replacements of the detergent. The record of replacements of the water filter. The record of replacements of air filter. The record of water supply line disinfections. The record of rinse water collections. Reprocessing Records Error Records Leak Test Records MRC Check Records LCG Replacement Records Detergent Replacement Records Water Filter Replacement Records Air Filter Replacement Records Gas Filter (Lid) Replacement Records The record of replacements of the gas filter on the lid. Gas Filter (Tank) Replacement Records Water Line Disinfection Records Self Disinfection & Water Sampling Records Detergent Line Disinfection Records Alcohol Line Disinfection Records Heat LCG Records Mix LCG Records Rinse Records Air Purge Records Alcohol Flush Records Leaking Scope Decontamination Records ALT Self-Check Records Periodic Maintenance and Repair Records Portable Memory Records Table 11.1 The record of detergent line disinfections. The record of alcohol line disinfections. The record of Heat LCG operations. The record of disinfectant solution mixing process. The record of rinse process. The record of air purge process. The record of alcohol flush process. The record of leaking scope decontamination process. The record of self-check of the auto leak test function. The record of periodic maintenance and servicing operations. The record of portable memory outputs. Ch.11 464 OER-Elite OPERATION MANUAL 11.2 Log display and output 1 Press the Log button on the Menu Screen. 2 Press the Display and Output button. Figure 11.1 3 Select the type of the record to be displayed or output to the portable memory by feeding pages as required. Figure 11.2 Ch.11 Figure 11.3 OER-Elite OPERATION MANUAL 465 11.2 Log display and output 4 Press the Reprocessing Records button. 1 2 3 4 5 6 Description Press to specify the period that displays the records. Press to specify the month that displays the records. Press to display the records that have not been output to a portable memory. Press to display all records. Press to go to the Menu screen. Press to returns to the previous screen. No. 1 2 3 Button Select Dates Select Month Data Since Last Export All Records 4 5 Menu Cancel 6 Ch.11 466 OER-Elite OPERATION MANUAL 11.2 Log display and output To display the records of Select dates:
1 Press the Select Dates button. 2 Enter the date of start of the period to be displayed. Press the OK button. 1 2 3 Item/Button No. 1 Month 2 3 4 5 Day Year Cancel OK 4 5 Description Set the month of the start date of the period to be viewed. Pressing the + button increments the setting and pressing the button decrements it. Set the day of the start date of the period to be viewed. Pressing the + button increments the setting and pressing the button decrements it. Set the year of the start date of the period to be viewed. Pressing the + button increments the setting and pressing the button decrements it. Returns to the previous screen page. Advances to the end date setting. Ch.11 OER-Elite OPERATION MANUAL 467 11.2 Log display and output 3 Enter the end date of the desired period. Press the OK button. 1 2 3 4 5 Description Set the month of the start date of the period to be viewed. Pressing the + button increments the setting and pressing the button decrements it. Set the day of the start date of the period to be viewed. Pressing the + button increments the setting and pressing the button decrements it. Set the year of the start date of the period to be viewed. Pressing the + button increments the setting and pressing the button decrements it. Returns to the previous screen page. Advances to the end date setting. Item/Button No. 1 Month 2 3 4 5 Day Year Cancel OK 4 The list of the records in the selected period appears. Ch.11 Figure 11.4 468 OER-Elite OPERATION MANUAL 11.2 Log display and output To display the records of Select months 1 Press the Select Month button. 2 Enter the year and month. 1 2 Item/Button No. 1 Month 2 3 4 Year Cancel OK 3 4 Description Set the month of the start date of the period to be viewed. Pressing the + button increments the setting and pressing the button decrements it. Set the day of the start date of the period to be viewed. Pressing the + button increments the setting and pressing the button decrements it. Returns to the previous screen page. Advances to the end date setting. 3 Press the OK button. The list of the records in the selected month appears. When checking the records that have not been output to the portable memory:
Press the Data Since Last Export button. The record list appears. Ch.11 When checking all records:
Press the All Records button. The record list appears. OER-Elite OPERATION MANUAL 469 11.2 Log display and output Information recorded in each record Reprocessing Records
(a) Records list The list of entire data records of the selected range will be displayed. Five items of data items in the records are displayed per a page. Press the Record number button to check more information. 1 2 3 4 5 6 7 8 9 10 Ch.11 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & time Scope S.N. Result Record # button Previous page button Next page button Export button 9 10 Cancel button Description Number given to each record in the order of reprocessing process. Date and time of completion of reprocessing process. Model number of reprocessed endoscope(s). Serial number(s) of reprocessed endoscope(s). Result of reprocessing process. Press to check the details of each record. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data records of the selected range to a portable memory. Returns to the viewing range selection screen. 470 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details Normal (When reprocessing completed successfully) 1 2 3 4 5 6 7 8 9 Description 4 5 6 7 8 9 No. 1 2 3 Item/Button Record #
Date & time Scope 1 button Number given to each record in the order of occurrence. Date and time of completion of reprocessing. Press to check the ID information related to the first endoscope. For detail, refer to Confirmation of the input ID on page 64. Model number of reprocessed first endoscope. Scope 1 model number ID status of scope 1 Displays the input status of patient ID, physician ID, user ID (load), and procedure ID Scope 2 button associated with the first scope. Press to check the ID information related to the second endoscope. For detail, refer to Confirmation of the input ID on page 64. Model number of reprocessed second endoscope. Scope 2 model number ID status of scope 2 Displays the input status of patient ID, physician ID, user ID (load), and procedure ID associated with the second scope. Name of user who removed the endoscope(s) and the accessories. Ch.11 User name (End of reprocessing) OER-Elite OPERATION MANUAL 471 11.2 Log display and output 10 11 12 13 14 15 16 17 18 19 20 21 Item/Button No. 10 Cleaning/
Cleaning time/disinfection time (minutes). Description disinfection time Program Info. Input result LCG Cycle Count LCG Usage LCG Temp. 11 12 13 14 15 16 MRC Check Result 17 18 Total Count Previous page button 19 Next page button Ch.11 Print button 20 21 Cancel button Setting of reprocessing program. Input results of manual cleaning and leak test. Usage count of the disinfectant solution. Elapsed days since loading of the disinfectant solution. Temperature of disinfectant solution at the end of heating. Input result of MRC check. Total count of the reprocessor. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to print the record by using an optional printer. Returns to record list. 472 OER-Elite OPERATION MANUAL 11.2 Log display and output
(c) Record details Error (Except for E114) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Description No. 1 2 3 Item/Button Record #
Date & time Scope 1 button Number given to each record in the order of occurrence. Date and time of occurrence of error. Press to check the ID information related to the first endoscope. For detail, refer to Confirmation of the input ID on page 64. Model number of reprocessed first endoscope. Scope 1 model number ID status of scope 1 Displays the input status of patient ID, physician ID, user ID (load), and procedure ID Scope 2 button associated with the first scope. Press to check the ID information related to the second endoscope. For detail, refer to Confirmation of the input ID on page 64. Model number of reprocessed second endoscope. Scope 2 model number ID status of scope 2 Displays the input status of patient ID, physician ID, user ID (load), and procedure ID Error code Error Info. Previous page button 12 Next page button Print button 13 14 Cancel button associated with the second scope. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to print the record on the optional printer. Returns to record list. Ch.11 4 5 6 7 8 9 10 11 OER-Elite OPERATION MANUAL 473 11.2 Log display and output
(d) Record details Error (When leak was detected, E114) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Description No. 1 2 3 Item/Button Record #
Date & time Scope 1 button Number given to each record in the order of occurrence. Date and time of occurrence of error. Press to check the ID information related to the first endoscope. For detail, refer to Confirmation of the input ID on page 64. Model number of reprocessed first endoscope. 4 5 6 7 8 Scope 1 model number ID status of scope 1 Displays the input status of patient ID, physician ID, user ID (load), and procedure ID Scope 2 button associated with the first scope. Press to check the ID information related to the second endoscope. For detail, refer to Confirmation of the input ID on page 64. Model number of reprocessed second endoscope. Scope 2 model number ID status of scope 2 Displays the input status of patient ID, physician ID, user ID (load), and procedure ID Ch.11 Error code 9 10 Result 11 12 Error Info. Previous page button 13 Next page button Print button 14 15 Cancel button associated with the second scope. Error code, error details. Results of auto leak test. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to print the record on the optional printer. Returns to record list. 474 OER-Elite OPERATION MANUAL 11.2 Log display and output Error Records
(a) Record list 1 2 3 4 5 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & Time Error Code Process Record # button Previous page button Next page button Export button Cancel button 6 7 8 9 Description Number given to each record in the order of occurrence of error. Date and time of occurrence of error. Error code. Process in which error was generated. Press to check the details of each record. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to a portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 475 11.2 Log display and output
(b) Record details 1 2 3 4 5 6 7 8 9 10 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & time Error Code OER-Elite S.N. Software Ver. Process Error Info. Previous page button Next page button 10 Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Error code. Reprocessor serial No. Reprocessor software version. Process in which error was generated. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 476 OER-Elite OPERATION MANUAL 11.2 Log display and output Leak Test Records This section is defined the Auto Leak test records and Manual Leak test records.
(a) Record list 1 2 3 4 5 6 7 8 9 10 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & Time Scope S.N. Result Record # button Previous page button Next page button Export button 10 Cancel button Description Number given to each record in order of leak test. Date and time of completion of leak test. Model number of endoscope(s). Serial number of endoscopes. Result of each record. Press to check the details of each record. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 477 11.2 Log display and output
(b) Record details Normal 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & time Scope 1 Info. Scope 2 Info. User name Test type Result Total Leak Test Previous page button 10 Next page button Ch.11 Print button 11 12 Cancel button 9 10 11 12 Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Model number and serial number of first endoscope. Model number and serial number of second endoscope. Name of user who performed leak test. Type of leak test. Results of leak test. Total counts of leak test of the reprocessor. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to print the record on the optional printer. Returns to record list. 478 OER-Elite OPERATION MANUAL 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 9 10 11 12 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & time Scope 1 Info. Scope 2 Info. User name Test type Error code Error Info. Previous page button 10 Next page button Print button 11 12 Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Model number and serial number of the first endoscope. Model number and serial number of the second endoscope. Name of user who performed leak test. Type of leak test. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to print the record on the optional printer. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 479 11.2 Log display and output MRC Check Records
(a) Record list 1 2 3 4 5 6 7 8 9 10 No. 1 2 3 Item/Button Record #
Date & Time Cycles Description Number given to each record in order of MRC Check. Date and time of completion of MRC check. Usage count of the disinfectant solution. Disinfectant solution is used at following functions:
Reprocessing process
Water line disinfection
Self-disinfection & water sampling
Detergent line disinfection
Alcohol line disinfection
Leaking scope decontamination. Ch.11 4 5 6 7 8 9 Days Result Record # button Previous page button Next page button Export button 10 Cancel button Elapsed days since loading of the disinfectant solution. Result of MRC check. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. 480 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details 1 2 3 4 5 6 7 8 9 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & time User name LCG Cycle Count LCG Usage Result Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of MRC Check. Name of user who performed MRC check. Usage count of the disinfectant solution. Elapsed days since loading of the disinfectant solution. Input result of MRC check. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 481 11.2 Log display and output LCG Replacement Records
(a) Record list 1 2 3 4 5 6 7 8 9 10 11 No. 1 2 3 4 5 Item/Button Description Record #
Loaded Drained Option Cycles Number given to each record in the order of replacing LCG. Date and time of completion of draining disinfectant solution. Date and time of completion of draining disinfectant solution. Method of draining of disinfectant solution. Usage count of the disinfectant solution. Disinfectant solution is used at following functions:
Reprocessing process
Water line disinfection
Self-disinfection & water sampling
Detergent line disinfection
Alcohol line disinfection
Leaking scope decontamination. Ch.11 6 7 8 9 Days Record # button Previous page button Next page button 10 Export button 11 Cancel button Elapsed days since loading of the disinfectant solution. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. 482 OER-Elite OPERATION MANUAL
(b) Record details 1 2 3 4 5 6 7 11.2 Log display and output 8 9 10 11 12 13 Item/Button Description No. 1 2 3 4 5 6 7 8 9 10 11 Number given to each record in the order of occurrence. Record #
Loaded date & time Date and time of completion of loading of disinfectant solution Loaded user name Name of user who loaded disinfectant solution. Drained date & time Date and time of completion of draining disinfectant solution Drained user name Name of user who drained disinfectant solution. Option LCG Cycle Count LCG Usage Lot #
Expiration Date Previous page button Method of drain disinfectant solution. Usage count of the disinfectant solution. Elapsed days from loaded date to drained date. Lot number of the disinfectant solution. Expiration date of the disinfectant solution. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. 12 Next page button 13 Cancel button Ch.11 OER-Elite OPERATION MANUAL 483 11.2 Log display and output Detergent Replacement Records
(a) Record list 1 2 3 4 5 6 7 8 9 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & Time Lot #
Expiration Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of replacing detergent. Date and time of completion of replacement of detergent. Lot number of detergent. Expiration date of detergent. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 484 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Lot Expiration date Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of replacement of detergent. Name of user who replaced detergent. Lot number of detergent. Expiration date of detergent. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 485 11.2 Log display and output Water Filter Replacement Records
(a) Record list 1 2 3 4 5 6 7 8 9 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & Time Lot #
Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of replacing water filter. Date and time of completion of replacement of water filter. Lot number of water filter. Result of replacement of water filter. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 486 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details Normal 1 2 3 4 5 6 7 No. 1 2 3 4 5 6 7 Item/Button Record#
Date & Time User name Lot #
Previous page button Next page button Cancel button Description Number given to each record in order of occurrence. Date and time of completion of replacement of water filter. Name of user who replaced water filter. Lot number of water filter. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 487 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & time User name Error code Error Info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who replaced the water filter. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 488 OER-Elite OPERATION MANUAL 11.2 Log display and output Air Filter Replacement Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Lot #
Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of replacing air filter. Date and time of completion of replacement of air filter. Lot number of air filter. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 489 11.2 Log display and output
(b) Record details 1 2 3 4 5 6 7 No. 1 2 3 4 5 6 7 Item/Button Record #
Date & Time User name Lot #
Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of replacement of air filter. Name of user who replaced air filter. Lot number of air filter. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 490 OER-Elite OPERATION MANUAL 11.2 Log display and output Gas Filter (Lid) Replacement Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Lot #
Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of replacing gas filter on the lid. Date and time of completion of replacement of gas filter on the lid. Lot number of gas filter on the lid. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 491 11.2 Log display and output
(b) Record details 1 2 3 4 5 6 7 No. 1 2 3 4 5 6 7 Item/Button Record #
Date & Time User name Lot #
Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of replacement of gas filter on the lid. Name of user who replaced gas filter on the lid. Lot number of gas filter on the lid. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 492 OER-Elite OPERATION MANUAL 11.2 Log display and output Gas Filter (Tank) Replacement Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Lot #
Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of replacing gas filter on the tank. Date and time of completion of replacement of gas filter on the tank. Lot number of gas filter on the tank. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 493 11.2 Log display and output
(b) Record details 1 2 3 4 5 6 7 No. 1 2 3 4 5 6 7 Item/Button Record #
Date & Time User name Lot #
Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of replacement of gas filter on the tank. Name of user who replaced gas filter on the tank. Lot number of gas filter on the tank. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 494 OER-Elite OPERATION MANUAL 11.2 Log display and output Water Line Disinfection Records
(a) Record list 1 2 3 4 5 6 7 8 9 10 No. 1 2 3 Item/Button Record #
Date & Time Cycles Description Number given to each record in order of water line disinfection. Date and time of completion of water line disinfection. Number of times the disinfectant solution has been used. Disinfectant solution is used at following functions:
Reprocessing process
Water line disinfection
Self-disinfection & water sampling
Detergent line disinfection
Alcohol line disinfection
Leaking scope decontamination. 4 5 6 7 8 9 Days Result Record # button Previous page button Next page button Export button 10 Cancel button Number of days that have elapsed since preparation of the disinfectant solution. Result of water line disinfection. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 495 11.2 Log display and output
(b) Record details Normal 1 2 3 4 5 6 7 8 9 10 Description Number given to each record in the order of occurrence. Date and time of completion of water line disinfection. Name of user who performed water line disinfection. Usage count of the disinfectant solution. Number of days that have elapsed since preparation of the disinfectant solution. Temperature of disinfectant solution at the end of heating. Input result of MRC check. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Item/Button Record #
Date & time User name LCG Cycle Count LCG Usage LCG Temp. No. 1 2 3 4 5 6 7 MRC Check Result 8 Previous page button Next page button 9 10 Cancel button Ch.11 496 OER-Elite OPERATION MANUAL 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed water line disinfection. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 497 11.2 Log display and output Self-Disinfection & Water Sampling Records
(a) Record list 1 2 3 4 5 6 7 8 9 10 No. 1 2 3 Item/Button Record #
Date & Time Cycles Description Number given to each record in order of self disinfection and water sampling. Date and time of completion of self disinfection and water sampling. Number of times the disinfectant solution has been used. Disinfectant solution is used at following functions:
Reprocessing process
Water line disinfection
Self-disinfection & water sampling
Detergent line disinfection
Alcohol line disinfection
Leaking scope decontamination. Ch.11 4 5 6 7 8 9 Days Result Record # button Previous page button Next page button Export button 10 Cancel button Number of days that have elapsed since preparation of the disinfectant solution. Result of self disinfection and water sampling. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. 498 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details Normal 1 2 3 4 5 6 7 Item/Button Record #
Date & time User name LCG Cycle Count LCG Usage LCG Temp. No. 1 2 3 4 5 6 7 MRC Check Result 8 Previous page button Next page button 9 10 Cancel button 8 9 10 Description Number given to each record in the order of occurrence. Date and time of completion of self-disinfection and water sampling. Name of user who performed self-disinfection and water sampling. Usage count of the disinfectant solution. Number of days that have elapsed since preparation of the disinfectant solution. Temperature of disinfectant solution at the end of heating. Input result of MRC check. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 499 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed self-disinfection & water sampling. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 500 OER-Elite OPERATION MANUAL 11.2 Log display and output Detergent Line Disinfection Records
(a) Record list 1 2 3 4 5 6 7 8 9 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & Time Dis.Time Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in order of detergent line disinfection. Date and time of completion of detergent line disinfection. Disinfection time. Result of detergent line disinfection. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 501 11.2 Log display and output
(b) Record details Normal 1 2 3 4 5 6 7 8 Description Number given to each record in the order of occurrence. Date and time of completion of detergent line disinfection. Name of user who performed detergent line disinfection. Item/Button Record #
Date & Time User name No. 1 2 3 4 MRC Check Result Result of MRC check. 5 6 Disinfection Time Previous page button Next page button Cancel button Disinfection time. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. 7 8 Ch.11 502 OER-Elite OPERATION MANUAL 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed detergent line disinfection. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 503 11.2 Log display and output Alcohol Line Disinfection Records
(a) Record list 1 2 3 4 5 6 7 8 9 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & Time Dis. Time Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in order of alcohol line disinfection. Date and time of completion of alcohol line disinfection. Disinfection time. Result of alcohol line disinfection. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 504 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details Normal 1 2 3 4 5 6 7 8 Description Number given to each record in the order of occurrence. Date and time of completion of alcohol line disinfection. Name of user who performed alcohol line disinfection. Item/Button Record #
Date & Time User name No. 1 2 3 4 MRC Check Result Result of MRC check. 5 6 Disinfection Time Previous page button Next page button Cancel button Disinfection time. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. 7 8 Ch.11 OER-Elite OPERATION MANUAL 505 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed alcohol line disinfection. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 506 OER-Elite OPERATION MANUAL 11.2 Log display and output Heat LCG Records
(a) Record list 1 2 3 4 5 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & time Option Result Record # button Previous page button Next page button Export button Cancel button 6 7 8 9 Description Number given to each record in the order of Heat LCG Date and time of completion of Heat LCG. Method of Heat LCG. Timer or Manual is represented. Result of Heat LCG Press to check the details of each record. Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 507 11.2 Log display and output
(b) Record details Normal 1 2 3 4 5 6 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
User name Date & time LCG Temp. Setting Date &
Time Option Previous page button Next page button Cancel button 7 8 9 Description Number given to each record in the order of occurrence. Name of user who performed Heat LCG. Date and time of completion of Heat LCG. Temperature of disinfectant solution at the end of heating. Date and time that was set on Heat LCG Timer Setting. ( is represented if the option is Manual). Method of Heat LCG. Timer or Manual is represented. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 508 OER-Elite OPERATION MANUAL 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed Heat LCG. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 509 11.2 Log display and output Mix LCG Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of Mix LCG. Date and time of completion of Mix LCG. Result of Mix LCG. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 510 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details Normal 1 3 2 4 5 6 No. 1 2 3 4 5 6 Item/Button Record #
Date & Time User name Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of Mix LCG. Name of user who performed Mix LCG. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 511 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed Mix LCG. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 512 OER-Elite OPERATION MANUAL 11.2 Log display and output Rinse Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of performing rinse. Date and time of completion of rinse. Result of rinse. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 513 11.2 Log display and output
(b) Record details Normal 1 3 2 4 5 6 No. 1 2 3 4 5 6 Item/Button Record #
Date & Time User name Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of rinse. Name of user who performed rinse. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 514 OER-Elite OPERATION MANUAL 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed rinse. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 515 11.2 Log display and output Air Purge Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of performing air purge. Date and time of completion of air purge. Result of air purge. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 516 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details Normal 1 3 2 4 5 6 No. 1 2 3 4 5 6 Item/Button Record #
Date & Time User name Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of air purge. Name of user who performed air purge. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 517 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed air purge. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 518 OER-Elite OPERATION MANUAL 11.2 Log display and output Alcohol Flush Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of performing alcohol flush. Date and time of completion of alcohol flush. Result of alcohol flush. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 519 11.2 Log display and output
(b) Record details Normal 1 3 2 4 5 6 No. 1 2 3 4 5 6 Item/Button Record #
Date & Time User name Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of alcohol flush. Name of user who performed alcohol flush. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 520 OER-Elite OPERATION MANUAL 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed alcohol flush. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 521 11.2 Log display and output Leaking Scope Decontamination Records
(a) Record list 1 2 3 4 5 6 7 8 9 10 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & Time Scope S.N. Result Record # button Previous page button Next page button Export button 10 Cancel button Description Number given to each record in the order of performed leaking scope decontamination. Date and time of completion of leaking scope decontamination. Model number of endoscopes. Serial number of endoscopes. Result of leaking scope decontamination. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 522 OER-Elite OPERATION MANUAL
(b) Record details Normal 1 2 3 7 8 9 10 11.2 Log display and output 4 5 6 Item/Button Record #
Date & time Scope button Scope model number ID status of scope No. 1 2 3 4 5 6 User name (End of leaking scope decontamination) LCG Cycle Count LCG Usage LCG Temp. 7 8 9 10 MRC Check Result 11 Previous page button 12 Next page button Print button 13 14 Cancel button 11 12 13 14 Description Number given to each record in the order of occurrence. Date and time of completion of leaking scope decontamination. Press to check the ID information related to the endoscope. For detail, refer to Confirmation of the input ID on page 64. Model number of endoscope. Displays the input status of patient ID, physician ID, user ID (load), and procedure ID associated with the scope. Name of user who removed the endoscope. Usage count of the disinfectant solution. Number of days that have elapsed since preparation of the disinfectant solution. Temperature of disinfectant solution at the end of heating. Input result of MRC check. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to print the record on the optional printer. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 523 11.2 Log display and output
(c) Record details Error 1 2 3 6 7 4 5 8 9 10 11 Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Press to check the ID information related to the endoscope. Model number of endoscope. Displays the input status of patient ID, physician ID, user ID (load), and procedure ID associated with the scope. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to print the record on the optional printer. Returns to record list. No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & time Scope button Scope model number ID status of scope Error code Error Info. Previous page button Next page button Ch.11 Print button 10 11 Cancel button 524 OER-Elite OPERATION MANUAL 11.2 Log display and output ALT Self-Check Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of performing ALT self check. Date and time of completion of ALT self check. Result of ALT self check. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 OER-Elite OPERATION MANUAL 525 11.2 Log display and output
(b) Record details Normal 1 2 3 4 5 6 7 8 Description Number given to each record in the order of occurrence. Date and time of completion of ALT self check. Name of user who performed ALT self check. Result of ALT self check. Atmospheric pressure during ALT self check. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Result Atmospheric pressure Previous page button Next page button Cancel button Ch.11 526 OER-Elite OPERATION MANUAL 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who performed ALT self check. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 527 11.2 Log display and output Periodic Maintenance and Repair Records NOTE These records are created when maintenance and repair is performed by OLYMPUS service. There records are not matched the actual records in some cases.
(a) Record list 1 2 3 4 5 6 7 8 9 Ch.11 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & Time Total Count Type Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of periodic maintenance and repair. Date and time of completion of periodic maintenance and repair. Total count of reprocessing process the reprocessor has performed. Type (Periodic Maintenance or Repair). Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. 528 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details 1 2 3 4 5 6 7 8 9 No. 1 2 3 4 5 6 7 8 9 Item/Button Record #
Date & time Name Type Total Cycle Count Scheduled Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of periodic maintenance and repair. Name who performed periodic maintenance and repair. Type (Periodic Maintenance or Repair). Total count of reprocessing process the reprocessor has performed. Schedule of next periodic maintenance (PM). Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 529 11.2 Log display and output Portable Memory Records
(a) Record list 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time Result Record # button Previous page button Next page button Export button Cancel button Description Number given to each record in the order of exporting to portable memory. Date and time of completion of exporting to portable memory. Result of exporting to a portable memory. Press to check the details of each record. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to send the entire data items in the record of the selected range to the portable memory. Returns to the viewing range selection screen. Ch.11 530 OER-Elite OPERATION MANUAL 11.2 Log display and output
(b) Record details Normal 1 3 2 4 5 6 No. 1 2 3 4 5 6 Item/Button Record #
Date & Time User name Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of completion of exporting to a portable memory. Name of user who exported to a portable memory. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to record list. Ch.11 OER-Elite OPERATION MANUAL 531 11.2 Log display and output
(c) Record details Error 1 2 3 4 5 6 7 8 No. 1 2 3 4 5 6 7 8 Item/Button Record #
Date & Time User name Error code Error info. Previous page button Next page button Cancel button Description Number given to each record in the order of occurrence. Date and time of occurrence of error. Name of user who exporting to a portable memory. Error code, error details. Information required for contacting Olympus. Press to show the former record. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to show the later record. When there is no further page to go forward to, the button turns gray and becomes unavailable. Returns to the viewing range selection screen. Ch.11 532 OER-Elite OPERATION MANUAL 11.3 Log management with PC 11.3 Log management with PC The record data can be saved in a MAJ-1925 portable memory. The output data be opened with a PC spreadsheet program supporting. CSV file formats. CAUTION The portable memory must be formatted on this reprocessor. If it is formatted on a PC, etc., recording and playback may be impossible. Handle the portable memory. Otherwise, the portable memory and/or the internal data may be destroyed. Do not place the portable memory in a place subjected to strong static electricity, electromagnetic wave, magnetism, high temperature, high humidity, or corrosive atmosphere. Otherwise, the portable memory and/or the internal data may be damaged. Do not touch the portable memory with a wet hand. Otherwise, the portable memory may fail. Do not allow the portable memory to come in contact with water. Otherwise, the portable memory may be damaged. Attention should be paid to handling of containing data of patient information. Otherwise, data leak may result. Do not use a portable memory other than one validated by Olympus. Otherwise, malfunction may result. The portable memory is projected slightly from this reprocessor when it is attached. Do not to apply impact to it. Otherwise, the portable memory and/or data may be destroyed. Also, remove the portable memory when it is not to be used. When malfunction of the internal memory of the reprocessor occurs, the reliability and validity of the data cannot be guaranteed. It is recommended to export to the portable memory on a daily basis. Ch.11 Pay attention to handle the portable memory and printed paper that include patient information exported from the OER-Elite. It may take additional time to export (e.g.: several months). Also when malfunction of the internal memory occurs, the reliability and validity of the data cannot be guaranteed. It is recommended to perform the export to the PORTABLE MEMORY on a daily basis. OER-Elite OPERATION MANUAL 533 11.3 Log management with PC NOTE The portable memory is intended for temporary saving of records. If they are to be stored for a long period, store the data in a PC (long term storage media). If there is a large quantity of data, it may take long time to export. If the patient ID security setting is activated, the patient data will not be exported to the portable memory. Refer to Section 4.8, Patient ID security setting. Flow of electronic log management The electronic management of record data is performed in the flow shown below. 1 Output of record data to the portable memory. 2 Record management on PC. Required item
on page 535
on page 541 Check Required item Portable memory (MAJ-1925) PC Table 11.2 Ch.11 534 OER-Elite OPERATION MANUAL 11.3 Log management with PC Output of recorded data to the portable memory NOTE At least 100 MB capacity is necessary for data export to the portable memory. The required capacity depends on the data size to be exported. 1 Select the record type and viewing range by referring to Section 11.2, Log display and output and display the record list. 2 Press the Export button on the each record list screen. 3 Remove the cover of the portable memory port on the front of the reprocessor and insert the portable memory all the way into the portable memory port. Figure 11.5 CAUTION Do not remove the cover of the portable memory port on the front of the reprocessor. Otherwise, water and foreign objects may penetrate the inside of the portable memory port and cause malfunction of the reprocessor. Ch.11 Figure 11.6 OER-Elite OPERATION MANUAL 535 11.3 Log management with PC 4 Confirm that the portable memory connection status screen on the touch screen changes from Not Connected to Connected. Portable memory connection status Range of data selected Figure 11.7 5 Input the user ID. For the detailed procedures, refer to Section 3.6, Entering ID (If applicable). 6 Press the Start button. The record save operation starts. Do not disconnect the portable memory during export. Figure 11.8 Ch.11 536 OER-Elite OPERATION MANUAL 11.3 Log management with PC NOTE If the portable memory has not been formatted, the portable memory formatting confirmation screen displays a screen as shown in the following figure. To format the portable memory, refer to If portable memory has not been formatted on page 539. Figure 11.9 7 When the save operation completes, the following screen appears. 8 Remove the portable memory by pulling it straight and replace the cover. Figure 11.10 Ch.11 Figure 11.11 OER-Elite OPERATION MANUAL 537 11.3 Log management with PC CAUTION Do not leave the potable port cover open after the potable memory is removed from the reprocessor. Otherwise, water and foreign objects may penetrate the inside of the portable memory port and cause malfunction of the reprocessor. Do not allow a foreign object to penetrate the inside of the portable memory port. The reprocessor may be damaged. Do not drop or give any impact to the portable memory. The memory or data may be damaged. Also, remove the portable memory when it is not used. 9 Press the OK button to finish. Figure 11.12 Ch.11 538 OER-Elite OPERATION MANUAL 11.3 Log management with PC If portable memory has not been formatted If a portable memory is not supported by OER-Elite, the following screen is displayed at the moment the Start button is pressed to enable data saving in the portable memory. Figure 11.13 CAUTION Confirm that important data is not contained before performing the process. Initializing portable memory delete all data in the portable memory. 1 Press the Start button on the portable memory formatting confirmation screen. The formatting starts. Figure 11.14 Ch.11 OER-Elite OPERATION MANUAL 539 11.3 Log management with PC 2 When the formatting completes, the following screen appears. 3 Press the OK button to close the portable memory formatting confirmation screen. Figure 11.15 4 Go back to Step 6 in Output of recorded data to the portable memory on page 535. Figure 11.16 Ch.11 540 OER-Elite OPERATION MANUAL 11.3 Log management with PC Log management on PC Configuration of saved record data The record data is saved in the portable memory in the hierarchical structure shown below. This record data is sample information. 1st Level 2nd Level 3rd Level 4th Level 5th Level Reprocessing Room OER-Elite Work Reprocessing All CSV Files All Data 7/4/2013 All Data 7/5/2013 Set Period From 7/4/2013 to 7/5/2013 SetPeriod Set Period From 7/5/2013 to 7/6/2013 Set Month From June, 2013. SetMonth Set Month From July, 2013. USB memory unoutput 7/4/2013 Differential USB memory unoutput 7/5/2013 Function
(process name) Same as Reprocessing folder Same as Reprocessing folder
(process name) Same as Reprocessing folder Error Same as Reprocessing folder Ch.11 Replacement of Consumable Items
(Consumable Item)
(Consumable Item) Same as Reprocessing folder Same as Work folder BackUp Figure 11.17 OER-Elite OPERATION MANUAL 541 11.3 Log management with PC CAUTION Do not modify any data inside BackUp folder. It is defined as master data after it transferred to PC. The master data inside BackUp folder is recommended in order to maintain the reliability and validity of any data. To properly manage master data inside BackUp folder so that the master data is not edited on PC. NOTE Two same files are recorded in Back Up folder and Work folder. The data inside Work folder can be edited.
(a) Folder hierarchy 1st level: Reprocessing Room The Reprocessing Room folder is created. 2nd level: OER-Elite The folder for this reprocessor (OER-Elite) is created. 3rd level: BackUp, Work The BackUp and Work folders are created. The files in the BackUp and Work folders consist of identical downloaded data. The files in the Work folders are used for the editing. The files in the BackUp folders are master files that should not be altered. 4th level, 5th level: Process category Ch.11 A folder is created for each process category. For detail of name of each folder, refer to the following table. 542 OER-Elite OPERATION MANUAL
1 | Operation Manual 5 | Users Manual | 1.53 MiB |
11.3 Log management with PC 4th Level Reprocessing Function Error ReplacementOf ConsumableItems Table 11.3 5th Level Description The folder for Reprocessing record. The folder for air purge record. The folder for alcohol flush record. The folder for alcohol line disinfection record. The folder for ALT self-check record. The folder for detergent line disinfection record. The folder for heat LCG record. Air Purge Alcohol Flush Alcohol Line Disinfection ALT Self-Check Detergent Line Disinfection Heat LCG Leaking Scope Decontamination The folder for leaking scope decontamination record. Leak Test Maintenance Mix LCG MRC Check Result Portable Memory Rinse Self Disinfection WaterLine Disinfection Replace Air Filter Replace Detergent Replace Gas Filter (lid) Replace Gas Filter (tank) Replace LCG Replace Water Filter The folder for auto and manual leak test record. The folder for periodic maintenance and repair record. The folder for Mix LCG record. The folder for MRC check result record. The folder for portable memory record. The folder for rinse record. The folder for self disinfection record. The folder for water line disinfection record. The folder for error record. The folder for replace air filter record. The folder for replace detergent record. The folder for replace gas filter (lid) record. The folder for replace gas filter (tank) record. The folder for replace LCG record. The folder for replace water filter record. 5th level (Reprocessing) & 6th level (the others): Output range The ALL folder is created when the data of all records are saved. The SetMonth folder is created when the record data is saved by selecting a month. The SetPeriod folder is created when the record data is saved by selecting a period. The Differential folder is created when the record data that has not been output to the portable memory is saved. Ch.11 OER-Elite OPERATION MANUAL 543 11.3 Log management with PC
(b) File type The record data in the CSV (Comma-Separated Values) format is saved.
(c) File names The files are named based on the range selected when data is saved in the portable memory, the type of record, etc. Selected period Reprocessor name Reprocessor serial number Process name Portable memory save count Figure 11.18 Example Ch.11 544 OER-Elite OPERATION MANUAL Items constituting the file names This item indicates the output mode selected when downloading the records. ALL (20170601) 11.3 Log management with PC Description ALL data output setting. The figures inside the parentheses indicate the date of downloading. Selected period (when more than one day is specified) Selected period (when one day is specified) Selected month (displayed according to the date display format setting) Data not output to portable memory 20170501 20170615 20170501 201706 Diff (20170601) OER-Elite 1234567 Type of the saved records. Displayed record names Reprocessing LeakTest ReplaceLCG MRCCheckResult HeatLCG MixLCG ReplaceWaterFilter ReplaceAirFilter ReplaceGasFilter(lid) ReplaceGasFilter(tank) ReplaceDetergent WaterLineDisinfection AlcoholLineDisinfection DetergentLineDisinfection Rinse AirPurge AlcoholFlush SelfDisinfection PortableMemory Error ALTSelf-Check LeakingScopeDecontamination Maintenance Total number of portable memory saving operations in 5 digits. Range: 00001 to 65535. The count after 65535 becomes 00001. Reprocessing record Leak test record Disinfectant replacement record MRC check result record Heat LCG record Mix LCG record Water filter replacement record Air filter replacement record Gas filter (lid) replacement record Gas filter (tank) replacement record Detergent replacement record Water line disinfection record Alcohol line disinfection record Detergent line disinfection record Rinse record Air purge record Alcohol flush record Self disinfection record USB memory output record Error record Auto Leak Test Self-check record Leaking scope decontamination record Periodic Maintenance and repair records Ch.11 OER-Elite OPERATION MANUAL 545 Item Selected period Reprocessor name Reprocessor serial number Data type Portable memory save count Table 11.4 11.3 Log management with PC NOTE If the same filename is already there in the folder, a number is appended to the end of the filename of the new file (Example:
2120_02-01_1700_OER-Elite_2700000_Reprocessing_00010(2).csv). This number is appended to prevent the edited file in the PC from being overwritten.
(d) Information in each file Each file is saved in a portable memory in the CSV format. Every file is composed of the header, data and footer sections. The header and footer sections are common to all record data. The data section varies depending on the data type. For detail of record data, refer to Figure 11.19. There is no color in each column of record data. Header section Data section Memo section Major item Minor item Description Figure 11.19 Ch.11 Footer section 546 OER-Elite OPERATION MANUAL Header section Line No. 1 2 3 Information Reprocessor name Reprocessor serial number File output date File output time Output mode 4 Output range 5 7 Blanks 8 Process name 11.3 Log management with PC Example OER-Elite 1234567 06/01/2017 9:00:30 PM All Set period Set month Differential: Blank. Blank
(When output mode is All) 2017/05/01 2017/05/31
(When output mode is Set period and more than one day is specified) 2017/05/01
(When output mode is Set period and one day is specified) 2017/05
(When output mode is Set month) Reprocessing Leak Test Replace LCG MRC Check Result Heat LCG Mix LCG Replace Water Filter Replace Air Filter Replace Gas Filter (lid) Replace Gas Filter (tank) Replace Detergent Water Line Disinfection Alcohol Line Disinfection Detergent Line Disinfection Rinse Air Purge Alcohol Flush Self Disinfection & Water Sampling Portable Memory Error ALT Self-Check Leaking Scope Decontamination Maintenance Ch.11 Table 11.5 OER-Elite OPERATION MANUAL 547 11.3 Log management with PC Data section Reprocessing records Major item Minor item Description Reprocessing Record #
Reprocess Result Record number Results of reprocessing Date/Time ID/Name Started (Day) Started (Time) Completed (Day) Completed (Time) Scope No Reprocessing start date Reprocessing start time Reprocessing completion date Reprocessing completion time Endoscope number Scope Model Model number of endoscope Scope ID Endoscope serial number User ID User Name ID number of user installing the endoscope(s) Name of user installing the endoscope(s) Physician ID ID number of physician Physician Name Name of physician Patient ID ID number of patient Ch.11 Patient Name Name of patient Procedure ID ID number of procedure Procedure Name Name of procedure User3 ID User3 Name ID number of user removing the endoscope(s) Name of user removing the endoscope(s) 548 OER-Elite OPERATION MANUAL Examples 5000, 4999, 4998, Completed E XXX (in case of error) 06/01/2017 15:30:30 06/01/2017 16:00:30 1 (First endoscope) 2 (Second endoscope) GIF-H190 Master (Master card input)
(Not input) 12800542
(Not input) 12345678
(Not input) User Master (Master card input)
(Not input)
(Not input) 12345678
(Not input) Physician
(Not input) 12345678
*****
(Not input) Patient
(Not input) 0123456
(Not input) ERCP
(Not input) 1
(Not input) User 11.3 Log management with PC Major item Minor item Description Examples Program Info. Cln time Dis Time ALT Cleaning time (minutes) Disinfection time (minutes) Auto leak test setting Heat LCG Alcohol Flush Channel Monitor Heat LCG setting Alcohol flush setting Channel Monitoring setting Check Program No. Leak Test (Sink) Program number Input result of leak test before manual cleaning Manual Cleaning Input result of manual cleaning Function Result Leak Test Result Result of leak test during the reprocessing LCG Info. Expiry Lot #
MRC Check Result Result of MRC check Expiry of disinfectant solution Lot number of the disinfectant solution Temp Cycle #
Days Detergent Info. Expiry Disinfectant solution temperature Usage count of the disinfectant solution Number of days that have elapsed since preparation of the disinfectant solution Expiry of the detergent solution Lot #
Lot number of the detergent solution Model Name Serial No. Total Count Reprocessor name Reprocessor serial number Total number of reprocessing processes performed Memorandum (Free input by user) AER Info. Memo Table 11.6 3 7 ON OFF ON ON Full Partial 1, 2, 3, 4
(Not input) Pass Fail
(Not input) Done Pass Fail 08/30 AA123
(Not input) Fail Pass 20
(Not input) 1
(Not input) 1
(Not input) 09/15
(Not input) DD1234 OER-Elite 1234567 1
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 549 11.3 Log management with PC Leak test records Major item Minor item Description Leak Test Record #
Process Result Record number Result of leak test Option Method of leak test Date/Time ID/Name Started (Day) Started (Time) Completed (Day) Completed (Time) Scope No Start date of leak test Start time of leak test Completion date of leak test Completion time of leak test Endoscope number Scope Model Model number of endoscope Scope ID Endoscope serial number User ID User Name ID number of user installing the endoscope(s) Name of user installing the endoscope(s) Function Result Leak Test Result Result of leak test AER Info. Ch.11 Memo Model Name Serial No. Total Leak Test #
Reprocessor name Reprocessor serial number Total number of performing leak test Memorandum (Free input by user) Table 11.7 Examples 5000, 4999, 4998, Complete E XXX (in case of error) Auto (Auto leak test) Manual (Manual leak test) 2017/06/01 15:30:30 2017/06/01 15:45:10 1 (First endoscope) 2 (Second endoscope) GIF-H190 Master (Master card input)
(Not input) 12800542
(Not input) 1
(Not input) 1 Master (Master card input)
(Not input) Pass Fail
(in case of error) OER-Elite 1234567 10
(Not input) Free input by user 550 OER-Elite OPERATION MANUAL 11.3 Log management with PC LCG replacement records Major item Minor item Replace LCG Date/Time Record #
Loaded (Day) Loaded (Time) Drained (Day) Drained (Time) User ID User Name User ID User Name ID/Name
(Load LCG) ID/Name
(Drain LCG) Option LCG Info. Cycle #
Days Lot #
Expiry Description Record number Completion date of preparation of disinfectant solution Completion time of preparation of disinfectant solution Completion date of discharge of disinfectant solution Completion time of draining disinfectant solution ID number of user who prepared disinfectant solution Name of user who prepared disinfectant solution ID of user who drained disinfectant solution Name of user who drained disinfectant solution Method that discharged the disinfectant solution Usage count of the disinfectant solution Number of days that have elapsed since preparation of the disinfectant solution Lot number of disinfectant solution Expiration date of disinfectant solution Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.8 Examples 5000, 4999, 4998, 06/01/2017 08:45:30 06/05/2017 17:30:30
(Not input) 1
(Not input) User
(Not input) 1
(Not input) User Drain Collect
(Not input) 20
(Not input) 5
(Not input) 123456789
(Not input) 2013/09 OER-Elite 1234567
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 551 11.3 Log management with PC MRC Check records Major item Minor item Description MRC Check Result Record #
Date/Time Completed (Day) Completed (Time) User ID Record number Completion date of MRC check Completion time of MRC check ID number of user who performed MRC check Name of user who performed MRC check Expiration date of disinfectant solution Lot number of disinfectant solution User Name Expiry Lot #
MRC Check Result Result of MRC check Temp Cycle #
Days Disinfectant solution temperature Disinfectant cycle count Disinfectant day count Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) ID/Name LCG Info. AER Info. Memo Table 11.9 Ch.11 Examples 5000, 4999, 4998, 06/01/2017 14:00:30
(Not input) 1
(Not input) User
(Not input) 09/2013
(Not input) 123456789 Fail Pass
(Not input) 20
(Not input) 1
(Not input) 5 OER-Elite 1234567
(Not input) Free input by user 552 OER-Elite OPERATION MANUAL 11.3 Log management with PC Heat LCG records Major item Minor item Description Heat LCG Record #
Process Result Record number Result of Heat LCG Option Method of Heat LCG Date/Time ID/Name Started (Day) Started (Time) Completed (Day) Completed (Time) User ID Start date of Heat LCG Start time of Heat LCG Completion date of Heat LCG Completion time of Heat LCG ID number of user performed Heat LCG User Name Name of user performed Heat LCG Timer Info. Setting Date Setting date of Heat LCG Setting Time Setting time of Heat LCG Temp Model Name Serial No. Disinfectant solution temperature Reprocessor name Reprocessor serial number Memorandum (Free input by user) LCG Info. AER Info. Memo Table 11.10 Examples 5000, 4999, 4998, Complete E XXX (in case of error) Manual Timer 06/01/2017 08:30:30 06/01/2017 10:00:30
(Not input) 1
(Not input) User 06/01/2017 (In case Heat LCG Timer) 10:00 (In case Heat LCG Timer) 20 OER-Elite 1234567
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 553 11.3 Log management with PC Mix LCG records Major item Minor item Description Record #
Process Result Record number Result of mix LCG Started (Day) Started (Time) Completed (Day) Completed (Time) User ID Start date of mix LCG Start time of mix LCG Completion date of mix LCG Completion time of mix LCG ID number of user performed mix LCG User Name ID number of user performed mix LCG Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) Mix LCG Date/Time ID/Name AER Info. Memo Table 11.11 Water filter replacement records Major item Replace Water Filter Minor item Record #
Process Result Description Record number Result of Water filter replacement Ch.11 Date/Time ID/Name Started (Day) Started (Time) Replaced (Day) Replaced (Time) User ID Start date of Water filter replacement Start time of Water filter replacement Completion date of Water filter replacement Completion time of Water filter replacement ID number of user who replaced water filter User Name Name of user who replaced water filter Filter Info. Lot #
Lot number of water filter Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.12 554 OER-Elite OPERATION MANUAL Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 15:30:30 06/01/2017 15:45:10
(Not input) 1
(Not input) User OER-Elite 1234567
(Not input) Free input by user Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:00 06/01/2017 09:15:30
(Not input) 1
(Not input) User
(Not input) 2017/05 OER-Elite 1234567
(Not input) Free input by user 11.3 Log management with PC Air filter replacement records Major item Replace Air Filter Date/Time ID/Name Minor item Record #
Replaced (Day) Replaced (Time) User ID Description Record number Completion date of air filter replacement Completion time of air filter replacement ID number of user who replaced air filter User Name Name of user who replaced air filter Filter Info. Lot #
Lot number of air filter Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.13 Gas filter (lid) replacement records Major item Minor item Description Replace Gas Filter
(lid) Date/Time ID/Name Record #
Record number Replaced (Day) Replaced (Time) User ID Completion date of gas filter replacement Completion time of gas filter replacement ID number of user who replaced gas filter User Name Name of user who replaced gas filter Filter Info. Lot #
Lot number of gas filter Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.14 Examples 5000, 4999, 4998, 06/01/2017 11:30:45
(Not input) 1
(Not input) User
(Not input) 987654321 OER-Elite 1234567
(Not input) Free input by user Examples 5000, 4999, 4998, 06/01/2017 12:15:30
(Not input) 1
(Not input) User
(Not input) 2017/05 OER-Elite 1234567
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 555 11.3 Log management with PC Gas filter (tank) replacement records Major item Minor item Description Replace Gas Filter
(tank) Date/Time ID/Name Record #
Record number Replaced (Day) Replaced (Time) User ID Completion date of gas filter replacement Completion time of gas filter replacement ID number of user who replaced gas filter User Name Name of user who replaced gas filter Filter Info. Lot #
Lot number of gas filter Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.15 Detergent replacement records Major item Minor item Description Replace Detergent Record #
Date/Time Replaced (Day) Replaced (Time) User ID Record number Completion date of detergent replacement Completion time of detergent replacement ID number of user who replaced detergent ID/Name User Name Name of user who replaced detergent Ch.11 Detergent info. Expiry Expiration date of detergent Lot #
Lot number of detergent Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.16 556 OER-Elite OPERATION MANUAL Examples 5000, 4999, 4998, 06/01/2017 15:30:30
(Not input) 1
(Not input) User
(Not input) 2017/05 OER-Elite 1234567
(Not input) Free input by user Examples 5000, 4999, 4998, 06/01/2017 09:15:30
(Not input) 1
(Not input) User
(Not input) 09/2017
(Not input) 0987654321 OER-Elite 1234567
(Not input) Free input by user 11.3 Log management with PC Water line disinfection records Major item Minor item Description Record #
Process Result Record number Result of water line disinfection Started (Day) Started (Time) Completed (Day) Completed (Time) User ID User Name Expiry Lot #
Start date of water line disinfection Start time of water line disinfection Completion date of water line disinfection Completion time of water line disinfection ID number of user performed water line disinfection Name of user performed water line disinfection Expiration date of disinfectant solution Lot number of disinfectant solution MRC Check Result Result of MRC check Temp Cycle #
Days Disinfectant solution temperature Disinfectant cycle count Disinfectant day count Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) Water Line Disinfection Date/Time ID/Name LCG Info. AER Info. Memo Table 11.17 Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:30 06/01/2017 10:00:30
(Not input) 1
(Not input) User
(Not input) 09/2013
(Not input) 123456789
(Not input) Fail Pass
(Not input) 20
(Not input) 1
(Not input) 5 OER-Elite 1234567
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 557 11.3 Log management with PC Alcohol line disinfection records Major item Minor item Description Alcohol Line Disinfection Record #
Process Result Record number Result of alcohol line disinfection Date/Time ID/Name Started (Day) Started (Time) Completed (Day) Completed (Time) User ID User Name Program Dis Time Start date of alcohol line disinfection Start time of alcohol line disinfection Completion date of alcohol line disinfection Completion time of alcohol line disinfection ID number of user performed alcohol line disinfection Name of user performed alcohol line disinfection Disinfection time LCG Info. MRC Check Result Result of MRC check Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.18 Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:30 06/01/2017 10:00:30
(Not input) 1
(Not input) User
(Not input) 10
(Not input) Fail Pass OER-Elite 1234567
(Not input) Free input by user Ch.11 558 OER-Elite OPERATION MANUAL 11.3 Log management with PC Detergent line disinfection records Major item Detergent Line Disinfection Minor item Record #
Process Result Description Record number Result of detergent line disinfection Date/Time ID/Name Started (Day) Started (Time) Completed (Day) Completed (Time) User ID User Name Program Dis Time Start date of detergent line disinfection Start time of detergent line disinfection Completion date of detergent line disinfection Completion time of detergent line disinfection 10:00:30 ID number of user performed detergent line disinfection Name of user performed detergent line disinfection Disinfection time LCG Info. MRC Check Result Result of MRC check Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.19 Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:30 06/01/2017
(Not input) 1
(Not input) User
(Not input) 10
(Not input) Fail Pass OER-Elite 1234567
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 559 11.3 Log management with PC Rinse records Major item Minor item Description Record #
Process Result Record number Result of rinse Started (Day) Started (Time) Completed (Day) Completed (Time) User ID Start date of rinse Start time of rinse Completion date of rinse Completion time of rinse ID number of user performed rinse User Name Name of user performed rinse Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) Rinse Date/Time ID/Name AER Info. Memo Table 11.20 Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:30 06/01/2017 10:00:30
(Not input) 1
(Not input) User OER-Elite 1234567
(Not input) Free input by user Ch.11 560 OER-Elite OPERATION MANUAL 11.3 Log management with PC Air purge records Major item Minor item Description Record #
Process Result Record number Result of air purge Started (Day) Started (Time) Completed (Day) Completed (Time) User ID Start date of air purge Start time of air purge Completion date of air purge Completion time of air purge ID number of user performed air purge User Name Name of user performed air purge Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) Air Purge Date/Time ID/Name AER Info. Memo Table 11.21 Alcohol flush records Major item Minor item Description Alcohol flush Record #
Process Result Record number Result of alcohol flush Date/Time ID/Name Started (Day) Started (Time) Completed (Day) Completed (Time) User ID Start date of alcohol flush Start time of alcohol flush Completion date of alcohol flush Completion time of alcohol flush ID number of user performed alcohol flush User Name Name of user performed alcohol flush Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.22 Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:30 06/01/2017 10:00:30
(Not input) 1
(Not input) User OER-Elite 1234567
(Not input) Free input by user Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:30 06/01/2017 10:00:30
(Not input) 1
(Not input) User OER-Elite 1234567
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 561 11.3 Log management with PC Self disinfection and water sampling records Major item Minor item Self Disinfection &
Water Sampling Record #
Process Result Description Record number Result of self-disinfection and water sampling Whether water sampling was performed or not. Start date of self-disinfection Start time of self-disinfection Completion date of self-disinfection Completion time of self-disinfection ID number of user performed self-disinfection Name of user performed self-disinfection Water Sampling Started (Day) Started (Time) Completed (Day) Completed (Time) User ID User Name Expiry Lot #
Expiration date of disinfectant solution Lot number of disinfectant solution MRC Check Result Result of MRC check Temp Cycle #
Days Disinfectant solution temperature Disinfectant cycle count Disinfectant day count Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) Examples 5000, 4999, 4998, Complete E XXX (in case of error)
(Not input) Done 06/01/2017 08:30:30 06/01/2017 10:00:30
(Not input) 1
(Not input) User
(Not input) 09/2013
(Not input) 123456789
(Not input) Fail Pass
(Not input) 20
(Not input) 1
(Not input) 5 OER-Elite 1234567
(Not input) Free input by user Date/Time ID/Name LCG Info. Ch.11 AER Info. Memo Table 11.23 562 OER-Elite OPERATION MANUAL 11.3 Log management with PC Portable memory records Major item Portable Memory Date/Time ID/Name AER Info. Memo Table 11.24 Minor item Record #
Process Result Started (Day) Started (Time) Completed (Day) Completed (Time) User ID User Name Model Name Serial No. Description Record number Result of portable memory output Start date of portable memory output Start time of portable memory output Completion date of portable memory output Completion time of portable memory output ID number of user performed portable memory output Name of user performed portable memory output Reprocessor name Reprocessor serial number Memorandum (Free input by user) Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:30 06/01/2017 10:00:30
(Not input) 1
(Not input) User OER-Elite 1234567
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 563 11.3 Log management with PC Error records Major item Minor item Description Error Date/Time ID/Name Record #
Error code Record number Error code of error Started (Day) Started (Time) Canceled (Day) Canceled (Time) Scope No Start date of rinse Start time of rinse Date of occurrence of error Time of occurrence of error Endoscope number Scope Model Model number of endoscope Scope ID Endoscope serial number User ID User Name ID number of user installing the endoscope(s) Name of user installing the endoscope(s) Physician ID ID number of physician Physician Name Name of physician Patient ID ID number of patient Patient Name Name of patient Procedure ID ID number of procedure Procedure Name Name of procedure User3 Name Name of user removing the endoscope(s) User3 ID ID number of user removing the endoscope(s) Ch.11 Examples 5000, 4999, 4998,
(Not input) EXXX (in case of error) 06/01/2017 08:30:30 06/01/2017 10:00:30 1 (First endoscope) 2 (Second endoscope) GIF-H190
(Not input) 12800542
(Not input)
(Not input) 1
(Not input) User
(Not input) 1
(Not input) Doctor
(Not input) 1
(Not input) Patient
(Not input) 0123456
(Not input) ERCP
(Not input) User
(Not input) 1 564 OER-Elite OPERATION MANUAL 11.3 Log management with PC Major item Minor item Description Examples Program Info. Cln time Dis Time ALT Cleaning time (min.) Disinfection time (min.) Auto leak test setting Heat LCG Heat LCG setting Alcohol Flush Alcohol flush setting Channel Monitor Channel Monitoring setting Program No. Program number Check Leak Test (Sink) Input result of leak test before manual cleaning Manual Cleaning Input result of manual cleaning Function Result Leak Test Result Result of leak test during the reprocessing LCG Info. Expiry Lot #
Expiration date of disinfectant solution Lot number of disinfectant solution MRC Check Result Result of MRC check Temp Cycle #
Days Disinfectant solution temperature Disinfectant cycle count Disinfectant day count Detergent Info. Expiry Expiry of the detergent solution Lot #
Lot number of the detergent solution 3 7
(Not input) ON OFF
(Not input) ON OFF
(Not input) ON OFF
(Not input) Full, Partial
(Not input) 1, 2, 3, 4
(Not input) Pass Fail Done
(Not input) Fail Pass
(Not input) 2017/05
(Not input) 123456789
(Not input) Fail Pass
(Not input) 20
(Not input) 1
(Not input) 1
(Not input) 09/15
(Not input) DD1234 Ch.11 OER-Elite OPERATION MANUAL 565 11.3 Log management with PC Major item ErrorDetails Minor item Process Name Process No. Process Time Description Process in which error is generated Number associated with the process
(number is hexadecimal) Elapsed time of the process Error Information 1 38 Error value 1 38 Model Name Serial No. Total Count Reprocessor name Reprocessor serial number Total accumulated of reprocessing process count Memorandum (Free input by user) AER Info. Memo Table 11.25 Ch.11 Examples Cleaning, Heat LCG, etc.
(Not input) 0001, 0002
(Not input) 00:03:00
(Not input) Pass Fail On Off No Connect Connect Unknown Flow Side Water Side Moving Actual measurement value of each error(e.g., decimal place from first to third) OER-Elite 1234567 4000
(Not input) Free input by user 566 OER-Elite OPERATION MANUAL 11.3 Log management with PC Examples 5000, 4999, 4998, 06/01/2017 8:30:30 Periodic Maintenance Repair
(Not input), Person name 25000 Periodic Maintenance and Repair Major item Minor item Description Maintenance Date/Time Service Program Record #
Working (Day) Working (Time) Type Record number Working date of Maintenance Working start time of Maintenance Detail for working Person Scheduled PM Cycle Scheduled PM Date Maintenance Total Count Model Name Serial No. Total Count Working person name Next Periodic Maintenance date Number of Periodic Maintenance 06/01/2018 Number of Periodic Maintenance 0 Reprocessor name Reprocessor serial number Total number of reprocessing processes performed OER-Elite 1234567 1 AER Info. Parts Operation Count/Time Channel Valve A1 count Channel Valve B1 count Channel Valve C1 count Channel Valve D1 count Channel Valve A2 count Channel Valve B2 count Channel Valve C2 count Channel Valve D2 count Bypass Valve count Adjust Valve count Water Supply Valve Water Supply Valve count Channel Valve A1 Channel Valve B1 Channel Valve C1 Channel Valve D1 Channel Valve A2 Channel Valve B2 Channel Valve C2 Channel Valve D2 Bypass Valve Adjust Valve Relief Shutoff Valve Relief Shutoff Valve count Pump Valve ALT Valve (Front) ALT Valve (Back) Drain Valve Collection Valve Three Port Valve Alcohol Valve Channel Pump Channel Pump Pump Valve count ALT Valve (Front) count ALT Valve (Back) count Drain Valve count Collection Valve count Three Port Valve count Alcohol Valve count Channel Pump count Channel Pump time (min) 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Ch.11 OER-Elite OPERATION MANUAL 567 11.3 Log management with PC Major item Parts Operation Count/Time Ch.11 Minor item Disinfectant Solution Pump Disinfectant Solution Pump Drain Pump Drain Pump Circulation Pump Circulation Pump Alcohol Pump Alcohol Pump Alkali Detergent Pump Alkali Detergent Pump Compressor Compressor Ultrasonic Transducer Ultrasonic Transducer Basin Heater Basin Heater Tank Heater Tank Heater Solenoid Lock for Lid Solenoid Lock for Cassette Print Start Button Stop Button Heat LCG Timer Button Touch Screen Operation ALT Function MLT Function MLT Function ALT Self-Check LCD Backlight Battery Working Barcode Scan Description Examples Disinfectant Solution Pump count Disinfectant Solution Pump time (min) Drain Pump count Drain Pump time (min) Circulation Pump count Circulation Pump time (min) Alcohol Pump count Alcohol Pump time (min) Alkali Detergent Pump count Alkali Detergent Pump time (min) Compressor count Compressor time (min) Ultrasonic Transducer count Ultrasonic Transducer time (min) Basin Heater count Basin Heater time (min) Tank Heater count Tank Heater time (min) Solenoid Lock for Lid count Solenoid Lock for Cassette count Print count Start Button count Stop Button count Heat LCG Timer Button count Touch Screen Operation count ALT Function count MLT Function count MLT Function time (min) ALT Self-Check count LCD Backlight time (min) Battery Working Days Barcode Scan count 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 568 OER-Elite OPERATION MANUAL 11.3 Log management with PC Major item Minor item Description Examples Parts Replacement Water Supply Valve With or without replacement for water supply 0, 1 Channel Valve 1 Channel Valve 2 Bypass Valve 0, 1 valve With or without replacement for Channel Valve 1 With or without replacement for Channel Valve 2 With or without replacement for Bypass Valve With or without replacement for Adjust Valve 0, 1 0, 1 0, 1 0, 1 Adjust Valve Relief Shutoff Valve With or without replacement for Relief Pump Valve ALT Valve (Front) With or without replacement for ALT Valve Shutoff Valve With or without replacement for Pump Valve 0, 1 0, 1
(Front) ALT Valve (Back) With or without replacement for ALT Valve 0, 1 Switching Valve Three Port Valve Alcohol Valve Channel Pump 0, 1 0, 1
(Back) With or without replacement for Switching Valve With or without replacement for Three Port Valve With or without replacement for Alcohol Valve With or without replacement for Channel Pump With or without replacement for Disinfectant Solution Pump With or without replacement for Drain Pump 0, 1 0, 1 0, 1 0, 1 0, 1 Disinfectant Solution Pump Drain Pump Circulation Pump With or without replacement for Circulation Ch.11 Alcohol Pump Alkali Detergent Pump Compressor Ultrasonic Transducer Basin Heater Tank Heater Solenoid Lock for Lid Solenoid Lock for Cassette Printer 0, 1 0, 1 Pump With or without replacement for Alcohol Pump With or without replacement for Alkali Detergent Pump With or without replacement for Compressor 0, 1 With or without replacement for Ultrasonic 0, 1 Transducer With or without replacement for Basin Heater 0, 1 With or without replacement for Tank Heater 0, 1 0, 1 With or without replacement for Solenoid Lock for Lid With or without replacement for Solenoid Lock for Cassette With or without replacement for Printer 0, 1 0, 1 OER-Elite OPERATION MANUAL 569 11.3 Log management with PC Major item Minor item Parts Replacement Panel Switch Touch Screen Description Examples With or without replacement for Panel Switch 0, 1 0, 1 With or without replacement for Touch Screen With or without replacement for ALT With or without replacement for LCD With or without replacement for Battery ALT LCD Battery Barcode Scanner With or without replacement for Barcode 0, 1 0, 1 0, 1 0, 1 Table 11.26 Scanner Ch.11 570 OER-Elite OPERATION MANUAL 11.3 Log management with PC ALT self check records Major item ALT Self-Check Date/Time ID/Name Minor item Record #
Process Result Option Atmospheric Pressure Started (Day) Started (Time) Completed (Day) Completed (Time) User ID Description Record number Result of ALT self check Examples 5000, 4999, 4998, Complete E XXX (in case of error) Periodic (Auto) or Manual is represented Periodic (Auto), Manual Atmospheric pressure during ALT self check (Not input) Start date of ALT self check Start time of ALT self check Completion date of ALT self check Completion time of ALT self check ID number of user performed ALT self check (Not input) 101.3 kPa 06/01/2017 08:30:30 06/01/2017 10:00:30 User Name Name of user performed ALT self check Function Result Self-Check Result Result of ALT self check Model Name Serial No. Reprocessor name Reprocessor serial number Memorandum (Free input by user) AER Info. Memo Table 11.27 1
(Not input) User
(Not input) Pass Fail OER-Elite 1234567
(Not input) Free input by user Ch.11 OER-Elite OPERATION MANUAL 571 11.3 Log management with PC Leaking scope decontamination records Major item Leaking Scope Decontamination Minor item Record #
Process Result Description Record number Result of leaking scope decontamination Date/Time Started (Day) Started (Time) Completed (Day) Completed (Time) ID/Name Scope Model Start date of leaking scope decontamination Start time of leaking scope decontamination Completion date of leaking scope decontamination Completion time of leaking scope decontamination Model number of endoscope. Scope ID Endoscope serial number User ID User Name Physician ID ID number of user performed portable memory output Name of user performed portable memory output ID number of physician Physician Name Name of physician Patient ID ID number of patient Patient Name Name of patient Procedure ID ID number of procedure Ch.11 Procedure Name Name of procedure User 2 Name Name of user removing the endoscope User 2 ID ID number of user removing the endoscope Check Leak Test (Sink) Input result of leak test before manual cleaning Manual Cleaning Input result of manual cleaning Examples 5000, 4999, 4998, Complete E XXX (in case of error) 06/01/2017 08:30:30 06/01/2017 10:00:30 GIF-H190 Master (Master card input)
(Not input) 12800542
(Not input)
(Not input) 1
(Not input) User
(Not input) 1
(Not input) Physician
(Not input) 1
(Not input) Patient
(Not input) 0123456
(Not input) ERCP
(Not input) User
(Not input) 1
(Not input) Pass Fail
(Not input) Done 572 OER-Elite OPERATION MANUAL 11.3 Log management with PC Major item Minor item Description Examples LCG Info. Expiry Lot #
Expiration date of disinfectant solution Lot number of disinfectant solution MRC Check Result Result of MRC check Temp Cycle #
Days Model Name Serial No. Total Count Disinfectant solution temperature Disinfectant cycle count Disinfectant day count Reprocessor name Reprocessor serial number Total accumulated of reprocessing process count Memorandum (Free input by user) AER Info. Memo Table 11.28
(Not input) 07/01/2017
(Not input) 123456789
(Not input) Fail Pass
(Not input) 20
(Not input) 1
(Not input) 1 OER-Elite 1234567 4000
(Not input) Free input by user Managing records on PC CAUTION The reprocessing data copied and saved in the BackUp folder in the PC becomes the master data. Do not alter the master data. Ch.11 NOTE For the operating environment of the portable memory, see the instructions provided with it. To manage the record at the facility the use of a PC installed with application software such as spreadsheet software that enables editing of a CSV file is recommended. If a file exists in the Work folder in the portable memory from which data is downloaded, a number is appended to the end of the filename
(Example: 2120_02-01_1700_OER-Elite_2700000_Reprocessing_00010(2).csv). This number is appended to prevent the edited file in the PC from being overwritten. After transferring data in the PC, delete the OER-Elite folder in the portable memory. Otherwise, there would be a possibility that a file having a name identical to a file already existing in the Work folder in the PC is saved with the same name except for the number appended to the end of the filename. OER-Elite OPERATION MANUAL 573 11.3 Log management with PC
(a) Copying data in PC When saving data in a PC for the backup purpose 1 Attach the portable memory containing record data to the PC. 2 Copy the OER-Elite folder in the portable memory to the PC. NOTE If a message confirming overwriting of a folder or file is displayed when you attempt to copy data in the PC, select Overwrite in any case. 3 After completion of the copying, remove the portable memory from the PC. NOTE Also, refer to the instruction manual for the PC.
(b) Managing the record data To manage the record data, use the record data in the Work folder copied to the PC. The record data should be managed according to the purpose of application of data. Example of record management (Reference) The records can be managed as shown in the following example. NOTE Ch.11 The following example uses Microsoft Excel for managing the CSV files. The management tool can be selected from the desired application software including statistical software according to the purpose and application of data. 1 Open the Work folder copied to the PC. 2 Open the file to be edited, check the header and data sections, and enter desired information in the edit section. 3 When the entry completes, save the edited file. Do not need rename file name. NOTE When editing a CSV file using application software such as statistical software, there is a risk that the operation above cannot save the edited data. It is therefore recommended to save the edited data in the dedicated file format of the software in use. 574 OER-Elite OPERATION MANUAL 11.4 Printing records 11.4 Printing records The records of the following processes can be printed with the MAJ-1937 printer included in the optional MAJ-2144 printer set. Reprocessing process: The record of reprocessing process, including errors. Leak test processes (auto, manual): The record of auto and manual leak tests performed on the reprocessor. Leaking scope decontamination process: The record of leaking scope decontamination process. CAUTION Pay attention to handle the portable memory and printed paper that include patient information exported from the OER-Elite. NOTE Printing records is also possible on the record details screens. Refer to the record details in 11.2 Log display for the details. Printing This section is defined method for printing of daily basis. For other printing method, refer to page 232. 1 Turn this reprocessor and the printer ON. 2 Press the Log button on the Menu screen. Ch.11 Figure 11.20 OER-Elite OPERATION MANUAL 575 11.4 Printing records 3 Press the Printout button. 4 Select the record to be printed. Figure 11.21 1 2 3 4 5 6 No. 1 2 3 Ch.11 Description Prints the records of the reprocessing processes. Button Reprocessing Records Leak Test Records Prints the records of the leak tests. Leaking Scope Decontamination Records Prints the records of the leaking scope decontamination. 4 Menu 5 6 LCG info. Cancel Returns to the Menu screen. Opens the disinfectant information screen. Returns to the previous screen. 576 OER-Elite OPERATION MANUAL 11.4 Printing records 5 Select whether or not the error records are to be printed. 1 2 3 4 Button Description Include error results Records are printed including error records. Excludes error results 3 Menu 4 Return Records are printed without error records. (Only the records of successfully completed operations are printed.) Returns to the menu. Returns to the previous screen. No. 1 2 6 Set the date of the records to be printed by pressing the + or button. Ch.11 Figure 11.22 OER-Elite OPERATION MANUAL 577 11.4 Printing records 7 Press the Start button. Printing starts and the touch screen displays the progress. Figure 11.23 8 When the printing completes, the following screen appears. Press the OK button. Progress bar Figure 11.24 NOTE Ch.11 Characters PRINT END are printed at the end of each print session. If they are not printed, not all the records of the selected period are printed out. Restart printing from the beginning. Records are printed according to the time. Figure 11.25 578 OER-Elite OPERATION MANUAL 11.4 Printing records Print format Reprocessing Normal (Separate) Serial number of this reprocessor Total accumulated of reprocessing process count Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Setting details LCG Info. Detergent Info. Information of first endoscope User ID (remove) of the end of process of first endoscope Serial number of this reprocessor Total accumulated of reprocessing process count Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Setting details LCG Info. Detergent Info. Information of second endoscope User ID (remove) of the end of process Ch.11 Figure 11.26 OER-Elite OPERATION MANUAL 579 11.4 Printing records Reprocessing Normal (Combine) Serial number of this reprocessor Total accumulated of reprocessing process count Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Setting details LCG Info. Detergent Info. Information of first endoscope Information of second endoscope Ch.11 User ID (remove) of the end of process Figure 11.27 580 OER-Elite OPERATION MANUAL Reprocessing Error (Separate) 11.4 Printing records Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of first endoscope Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of second endoscope Ch.11 Figure 11.28 OER-Elite OPERATION MANUAL 581 11.4 Printing records Reprocessing Error (Combine) Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of first endoscope Information of second endoscope Ch.11 Figure 11.29 582 OER-Elite OPERATION MANUAL Leak test Normal (Separate) 11.4 Printing records Serial number of this reprocessor Number given to each record in the order of occurrence Type of the leak test Date and time of start of process Date and time of end of process Information of first endoscope Serial number of this reprocessor Number given to each record in the order of occurrence Type of the leak test Date and time of start of process Date and time of end of process Information of second endoscope Figure 11.30 Ch.11 OER-Elite OPERATION MANUAL 583 11.4 Printing records Leak test Normal (Combine) Serial number of this reprocessor Number given to each record in the order of occurrence Type of the leak test Date and time of start of process Date and time of end of process Information of first endoscope Information of second endoscope Figure 11.31 Ch.11 584 OER-Elite OPERATION MANUAL Leak test Error (Separate) 11.4 Printing records Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of first endoscope Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of second endoscope Ch.11 Figure 11.32 OER-Elite OPERATION MANUAL 585 11.4 Printing records Leak test Error (Combine) Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of first endoscope Information of second endoscope Figure 11.33 Ch.11 586 OER-Elite OPERATION MANUAL Leaking scope decontamination Normal 11.4 Printing records Serial number of this reprocessor Total accumulated of reprocessing process count Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Setting details LCG Info. Information of endoscope User ID (remove) of the end of process Figure 11.34 Ch.11 OER-Elite OPERATION MANUAL 587 11.4 Printing records Leaking scope decontamination Error Error code Serial number of this reprocessor Number given to each record in the order of occurrence Date and time of start of process Date and time of end of process Process number of occurrence of error Information of endoscope Figure 11.35 Ch.11 588 OER-Elite OPERATION MANUAL Chapter 12 Information Menu Screen 12.1 RFID data check 12.1 RFID data check This function is to check the RFID data of Scope, User, and Physician. WARNING If electromagnetic interference is caused by the radio wave radiated from the RFID reader of this reprocessor, immediately move the interfered device apart from the RFID reader or turn the reprocessor OFF. If you still do not feel well, consult a physician. The radio wave radiated from the RFID reader of this reprocessor may cause malfunction of medical devices such as a pacemaker or other electronic equipment. CAUTION An electromagnetic interference with other devices may shorten the communications distance of the designated ID tag and cause signals to become unreadable. Try to take mitigation measures such as keeping the affecting device away from this reprocessor. 1 Press the Information button on the Menu screen. Ch.12 Figure 12.1 OER-Elite OPERATION MANUAL 589 12.1 RFID data check 2 Press the RFID Information button on the Information menu. 3 Hold the internal ID endoscope connector, the external ID tag of endoscope, the user ID card, or the physician ID card to the RFID reader of the reprocessor, and scan the tag with the reader until a short beep sounds. Figure 12.2 For internal ID endoscope
(For example 180 series endoscope) For external ID tag For user ID card or physician ID card Ch.12 Scope ID mark For internal ID endoscope
(190 series endoscope) Figure 12.3 590 OER-Elite OPERATION MANUAL 4 The touch screen displays the RFID data. 12.1 RFID data check Scope ID data User ID data Physician ID data ID type Scope model number Scope serial number ID type User name User ID ID type Physician name Physician ID Figure 12.4 5 Repeat Step 4 to remove current display information if check another RFID data. Ch.12 OER-Elite OPERATION MANUAL 591 12.2 Reprocessor information check 6 Press the End button to go back to the Information menu. Figure 12.5 12.2 Reprocessor information check This function is used to check the information on the reprocessor. 1 Press the Information button on the Menu screen. Ch.12 2 Press the OER-Elite Information button on the Information menu. Figure 12.6 Figure 12.7 592 OER-Elite OPERATION MANUAL 12.2 Reprocessor information check 3 The touch screen displays the OER-Elite Information. 12 13 14 15 16 17 10 11 18 19 Item/Button Description Body number of the reprocessor. Date of installation of the reprocessor. Total count of reprocessing cycles performed on the reprocessor. Total count of loading disinfectant solution on the reprocessor. Total count of loading detergent solution on the reprocessor. Total count of loading water filter on the reprocessor. Total count of loading air filter on the reprocessor. Body number Installation Date Total Cycle Counts Total LCG Loads Total Detergent Loads Total Water Filter Loads Total Air Filter Loads Total Gas Filter (Lid) Loads Total count of loading gas filter on the lid on the reprocessor. Total Gas Filter (Tank) Loads Total count of loading gas filter on the tank on the reprocessor. 1 2 3 4 5 6 7 8 9 No. 1 2 3 4 5 6 7 8 9 10 Cancel button 11 Next button 12 Software version 13 Hardware version 14 MAC address 15 Scheduled PM Cycles/Date Last PM Date Last Repair Date Back button 16 17 18 19 OK button Returns to information menu screen. Goes to the next information screen. Version number of the software used in the reprocessor. Version number of the hardware used with the reprocessor. MAC address of the reprocessor. Information of the next periodic maintenance. Date of the last periodic maintenance. Date of the last repair. Goes to the previous information screen. Returns to information menu screen. Ch.12 OER-Elite OPERATION MANUAL 593 12.2 Reprocessor information check 4 Press the Cancel button or OK button to go back to the information menu screen. Figure 12.8 Ch.12 594 OER-Elite OPERATION MANUAL 12.3 List management 12.3 List management This section is to edit the ID list. The IDs edited here can be used in the step (b) Recalling the pre-registered ID on page 54. NOTE The ID list contains the following IDs
Scope ID
User ID
Physician ID
Procedure ID 1 Press the Information button on the Menu screen. 2 Press the List Management button. 3 After selecting the ID list to edit, the ID list appears. Figure 12.9 Ch.12 4 On the ID select screen, press the Edit button to be input. The ID input screen
(software keyboard) will appear. Figure 12.10 OER-Elite OPERATION MANUAL 595 12.3 List management NOTE Fifty IDs can be registered for each ID type. 1 2 3 4 Item/Button No. 1 2 Model # or Name ID type 3 Serial # or ID Ch.12 4 5 6 7 Edit buttons Previous page button Next page button Back 5 6 7 Description Type of the currently edited ID. Scope ID list: Displays the model numbers of the endoscopes. User ID list: Displays the user names. Physician ID list: Displays the physician names. Procedure ID list: Displays the procedure names. Scope ID list: Displays the serial numbers of the endoscopes. User ID list: Displays the ID number of users. Physician ID list: Displays the ID number of physicians. Procedure ID list: Displays the ID number of procedures. Press one of the buttons to open the ID information edit screen. Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Press to return to the next page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Press to close the ID select screen. 5 Enter the name on the software keyboard displayed on the touch screen. 596 OER-Elite OPERATION MANUAL 12.3 List management 1 2 3 No. 1 2 3 4 5 6 7 8 9 Alphabet input Numeral input 4 5 6 1 2 3 4 5 6 7 8 9 7 8 9 Button Alphabet/
Numeral key Uppercase/
Lowercase Numeric/
Alphabetic Backspace Space Cursor move Delete Cancel Save Enter an alphabet or a numeral. Note Press Uppercase/lowercase button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Press Numeric or Alphabetic button to switch the input mode between a numeral and the alphabet. Press the Backspace button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Press the Space button to insert a space character. Press the Cursor move button to move the cursor left or right. Press the Delete button to delete about all information. Return to the previous screen without saving the setting value. Return to the previous screen and save the entered value. 6 Press the Save button to save the selected setting. 7 Press the Back button. Ch.12 OER-Elite OPERATION MANUAL 597 12.3 List management Ch.12 598 OER-Elite OPERATION MANUAL 13.1 Emergency stop and automatic processing after stopping Chapter 13 Troubleshooting and Repair WARNING If the reprocessing process is interrupted, the endoscopes will not be properly reprocessed. In this case, reprocessing in the OER-Elite should be started again from the beginning. If any irregularity is detected during an inspection or if the reprocessor is clearly malfunctioning, do not use it. Contact Olympus for repair. Some malfunctions may be corrected by referring to the Section 13.2, Troubleshooting guide. If the problem cannot be resolved by the described remedial action, do not use the reprocessor and contact Olympus. 13.1 Emergency stop and automatic processing after stopping The OER-Elite can be stopped at any time during operation by pressing the STOP button on the main control panel. The touch screen will display error code [E000] at this time. When the reprocessor is stopped, it identifies the situation in which it was stopped and automatically performs the required operations (including draining of the reprocessing basin), to return the unit to an idle state. WARNING When a process is interrupted, be sure to execute it again from the beginning. An endoscope that has not been subjected to a complete, error-free process is not safe for patient use. Otherwise, the endoscope reprocessing may be insufficient. If the process is stopped because of a problem with the reprocessor, contact Olympus. CAUTION Ch.13 Do not press the power switch OFF during operation. Otherwise, fluid will remain in the reprocessing basin without automatic draining and Air Purge, and the reprocessor may malfunction. Treatment after automatic processing has completed Remove the cause of the reprocessor stoppage, and start the process again from the beginning. OER-Elite OPERATION MANUAL 599 13.2 Troubleshooting guide 13.2 Troubleshooting guide WARNING Before handling the disinfectant solution, read the cautions carefully and use it as instructed. It is especially important to know what to do if the disinfectant solution comes in contact with your skin and eyes. When handling the disinfectant solution, wear personal protective equipment to prevent any disinfectant from getting on your skin and eyes or being inhaled. Avoid direct physical contact and inhalation of vapors. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. Do not put your hand behind the disinfectant solution bottle drawer. Irritation of skin due to contact with concentrated disinfectant solution, injury by touching a projection, or malfunction of this reprocessor may result. In the event, in case the process stops and fluid remains in the reprocessing basin due to a power failure or malfunction, keep the lid closed and do not contact with fluid in the basin. Also, do not put the fluid close to fire. Otherwise, adverse physical effects caused by inhalation of disinfectant vapor or physical contact with chemicals, or fire hazard from the residual alcohol may occur. Ch.13 600 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide WARNING When using disinfectant solution and alcohol, Olympus recommends the use of gas filters and operating this reprocessor in a well-ventilated area.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection. Refer to the following associations guidelines related to ventilation:
(Society of Gastroenterology Nurses and Associates)
(American Society of Gastroenterological Endoscopy)
(Association for Professionals of Infection Control and Epidemiology) SGNA ASGE APIC AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA
(Occupational Safety and Health Administration)
(American Institute of Architects) If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task they are performing and vacate the room. In the event, in case the process stops and fluid remains in the reprocessing basin due to a power failure or malfunction, keep the lid closed and do not contact with fluid in the basin. Also, do not put the fluid close to fire. Otherwise, adverse physical effects caused by inhalation of disinfectant vapor or physical contact with chemicals, or fire hazard from the residual alcohol may occur. CAUTION If a rinse is performed while an error is actively being displayed and disinfectant solution is still in the reprocessing basin, the rinse process will drain the disinfectant out of the reprocessor. To prevent this, refer to Error codes and remedial actions on page 602 for instructions for collecting the disinfectant. Do not press the power switch OFF when an error code is displayed. Doing so may result in malfunction. The reprocessor will automatically start a process to address the error code. (The error code will blink during automatic processing.) After the error code starts blinking, follow the instructions in Error codes and remedial actions below. Ch.13 OER-Elite OPERATION MANUAL 601 13.2 Troubleshooting guide NOTE To complete the process properly, some process cannot be stopped with STOP button. Error codes and remedial actions 1 If the reprocessor detects irregularity, buzzer beeps for three seconds and the error code will be displayed on the touch screen. While the touch screen displays the following screen, the reprocessor executes the automatic processing. Figure 13.1 2 When the automatic processing is completed, the buzzer beeps for three second and the touch screen displays the possible cause or the remedial action. The error code remains on the touch screen and the buzzer beeps intermittently until the error code is cleared. If the touch screen displays possible causes, press the OK button to display the remedial actions. Ch.13 602 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide Possible causes screen Remedial action screen 1 2 1 2 3 No. 1 2 3 Button Error Info. OK Detail Description Press to display the error info screen. Press to go to the next screen. Press to display the details of remedial actions. 3 Perform remedial actions according to the instruction described in the table on page 605 through 613 or the instructions displayed on the touch screen. 4 Press the OK button. 5 Read the instructions displayed on the touch screen and conduct the processes. Then Press the OK button to clear the error code. Ch.13 Figure 13.2 OER-Elite OPERATION MANUAL 603 13.2 Troubleshooting guide 1 2 3 4 Description Press to display the error info screen. Press to display the remedial actions. Press to display the possible causes. Press to clear the error. No. 1 2 3 4 Button Error Info. Remedial Actions Possible Causes OK NOTE For the error info screen, see the following figure. 1 2 3 4 5 6 7 8 Item/Button Serial number Software Ver. Process Error Code Date & Time Error Info. Print button OK button Description Serial number of the reprocessor. Version number of the software used in the reprocessor. Process in which error is generated. Error code of error. Date and time of occurrence of error. Information required for contacting Olympus. Press to print information of the error. Press to close the error info screen. OER-Elite OPERATION MANUAL Ch.13 No. 1 2 3 4 5 6 7 8 604 13.2 Troubleshooting guide Error code E000 E001 Problem Possible causes Remedial actions Process was interrupted. Filling the basin with water took too long
(water supply time is beyond maximum setting). Stop button was pressed during the process. The water faucet is not open enough. Water flow rate is too low. Water is leaking from the water supply hose. Float switch (long) is stuck. The water filter is clogged. The mesh filter in the water supply hose connector is clogged. Perform the process again. 1 Perform the following.
Open the water faucet all the way.
Check if water is leaking from the water supply hose.
Power off the OER-Elite and check the float switch (long) for a proper movement. If not, clean that. 2 Perform the process again. If the error repeats, perform the following.
Replace the water filter. oRefer to Section 8.4, Replacing the water filter (MAJ-824 or MAJ-2318).
Clean the mesh filter in the water supply hose connection port. oRefer to Section 9.7, Cleaning the mesh filter in the water supply hose connector. E002 Cleaning fluid is not discharged. Drain hose is improperly installed. Drain port mesh filter in basin is clogged. 1 Check the drain hose for proper installation.
(Height of the drain hose should be less than 60 cm.) 2 Wait until the fluid in the basin drained completely. 3 Wear appropriate protective gear and clean the drain port mesh filter basin. oRefer to Section 10.3, Cleaning the mesh filters. 4 Close the lid by pushing until it clicks and perform the air purge to remove water. oRefer to Section 7.6, Air purge. 5 Perform Rinse. oRefer to Section 7.5, Rinse. 6 Perform the process again. Contact Olympus. 1 Close the water faucet. 2 Contact Olympus. 1 Clean the float switches. oRefer to Section 10.4, Cleaning the float switches. 2 Perform Rinse.oRefer to Section 7.5, Rinse. 3 Perform the process again. Ch.13 E004 E005 E006 Cleaning fluid decreases during the cleaning process. Basin fluid level is too high. Fluid level sensor malfunctions. Internal problem with the reprocessor. Irregularity in the fluid level sensor. Float switch (short) or float switch (long) is stuck. OER-Elite OPERATION MANUAL 605 13.2 Troubleshooting guide Problem Possible causes Remedial actions Error code E007 Fluid level sensor malfunctions. Float switch (short) is stuck. 1 Clean the float switches. oRefer to Section 10.4, Cleaning the float switches. 2 Perform Rinse. oRefer to Section 7.5, Rinse. 3 Perform the process again. Check the water temperature is in the range of 5 28 qC (41 82 qF.) Close the lid if it is open. Automatic Processing will start after the lid is closed. Perform the following. 1 Check the drain hose for proper installation
(height of the drain hose should be less than 60 cm.) 2 Wear appropriate protective gear and clean the mesh filter in the drain port of the basin. oRefer to Section 10.3, Cleaning the mesh filters. 3 Perform Rinse. oRefer to Section 7.5, Rinse. 4 Perform MRC check. oRefer to Section 4.3, MRC check setting. 5 Perform the process again. 1 Check that the ventilation openings on the gas filter case (lid) are not blocked. 2 Perform Drain LCG. oRefer to Section 8.2, Replacing the disinfectant solution. 3 Perform Load LCG. oRefer to Section 8.2, Replacing the disinfectant solution. 4 Perform the process again. 1 Check the drain hose for proper installation.
(Height of the drain hose should be less than 60 cm.) 2 Wait until the fluid is drained completely. 3 Wear appropriate protective gear and clean the drain port mesh filter in basin. 4 Perform Rinse. oRefer to Section 7.5, Rinse. 5 If the quantity of LCG in the disinfectant solution tank is not sufficient, perform Drain LCG, then Load LCG. oRefer to Section 8.2, Replacing the disinfectant solution. 6 Perform the process again. E008 E011 Inappropriate water temperature. There is too much LCG in the disinfectant solution tank. Water temperature is too high. Irregularity in the drain hose. Clogging of the drain port of the reprocessing basin. E012 There is insufficient amount of LCG in the disinfectant solution tank. Blockage of the ventilation openings on the gas filter case (lid). E013 Basin exists a rinse water. Drain hose is improperly installed. Drain port mesh filter in basin is clogged. Ch.13 606 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide Problem Possible causes Remedial actions Error code E014 LCG cannot be returned to the tank. Blockage of the ventilation openings on the gas filter case (lid). Drain port mesh filter in basin is clogged. 1 Check that the ventilation openings on the gas filter case (lid) are not blocked. 2 Wait until the fluid in the basin collected completely. 3 Wear appropriate protective gear and clean the drain port mesh filter in basin. 4 Perform Rinse. oRefer to Section 7.5, Rinse. 5 If the quantity of LCG in the disinfectant solution tank is not sufficient, perform Drain LCG, then Load LCG. oRefer to Section 8.2, Replacing the disinfectant solution. 6 Perform the process again. 1 Power off the OER-Elite. Wear appropriate protective gear and check the float switch
(short) for proper function. If not clean, clean the fluid level sensor. 2 Perform Rinse. oRefer to Section 7.5, Rinse. 3 Perform the process again. Contact Olympus. Contact Olympus. Contact Olympus. 1 Power off the OER-Elite. 2 Contact Olympus. Perform Heat LCG. oRefer to Section 7.2, Heat LCG. 1 Check if the air filter is firmly attached. 2 If the air filter is firmly attached, the air filter may be clogged. Perform Replacing the air filter. oRefer to Section 8.5, Replacing the air filter (MAJ-823). 3 Perform the air purge. oRefer to Section 7.6, Air purge. 4 Perform the process again. 1 Wear appropriate protective gear and clean the circulation port mesh filter in basin. oRefer to Section 10.3, Cleaning the mesh filters. 2 Perform the process again. Ch.13 E015 Fluid level sensor malfunctions. Float switch (short) is stuck. E016 E017 E018 E019 E020 E021 It takes too long to fill the basin with LCG. LCG cannot be heated. Temperature sensor malfunctions. LCG temperature out of range. Heat LCG Timer could not be executed. Insufficient air purge pressure. Internal problem with the reprocessor. Internal problem with the reprocessor. Internal problem with the reprocessor. Internal problem with the reprocessor. OER-Elite was powered off. Power loss. Air filter is not installed properly. Air filter is clogged. E022 Insufficient fluid pressure. The circulation port mesh filter in basin is clogged. OER-Elite OPERATION MANUAL 607 Problem Possible causes Remedial actions 13.2 Troubleshooting guide Error code E023 Excessive fluid pressure. E024 Channel Monitor Error E026 Insufficient fluid flow rate. E027 E031 E041 Internal valves malfunction. The lid is open. The power was lost during the process. Internal problem with the reprocessor. Connecting tubes are not connected. Leak test air tube is not connected. Endoscopes suction channel is clogged. Unnecessary connecting tubes are connected to connectors in the reprocessing basin. The circulation port mesh filter in basin is clogged. Internal problem with the reprocessor. Internal problem with the reprocessor. Power loss. OER-Elite was powered off. E051 Fluid leakage inside the OER-Elite. Internal problem with the reprocessor. E052 Fluid leakage inside the OER-Elite. Internal problem with the reprocessor. Ch.13 E061 E071 Ultrasonic cleaning is not functioning. Abnormalities with the disinfectant bottle drawer sensor. Irregularity in the ultrasonic oscillator. Internal problem with the reprocessor. 608 OER-Elite OPERATION MANUAL Contact Olympus. Take optimum remedial actions as described in When the error code [E024] is displayed during the reprocessing process on page 614. 1 Wear appropriate protective gear and clean the circulation port mesh filter in basin. oRefer to Section 10.3, Cleaning the mesh filters. 2 Perform the process again. Contact Olympus. Contact Olympus. 1 Check that the power cord is connected firmly. 2 Perform the process again. Note:
Do not power off the OER-Elite during the process. 1 Close the water faucet. 2 Turn the power off. 3 Disconnect the power cord from the outlet. 4 Contact Olympus. 1 Close the water faucet. 2 Turn the power off. 3 Disconnect the power cord from the outlet. 4 Check the O-ring of leak test connector is firmly attached. 5 Contact Olympus. Contact Olympus. Contact Olympus. If the odor of disinfectant solution increases, wear appropriate personal protective reprocessor. 13.2 Troubleshooting guide Error code E072 Problem Possible causes Remedial actions LCG in the tank cannot be discharged. Disinfectant collection When draining through the disinfectant hose is improperly connected. collection hose is selected 1 Check the disinfectant collection hose for Drain port mesh filter in proper connection. basin is clogged. Drain hose is improperly installed. The water faucet is not open enough. Drain port mesh filter in basin is clogged. Water flow rate is too low. Water is leaking from the water supply hose. The water filter is clogged. The mesh filter in the water supply hose connector is clogged. Internal problem with the reprocessor. 2 Perform Drain LCG again. oRefer to Section 8.2, Replacing the disinfectant solution. When draining through the drain hose is selected. 1 Check the drain hose for proper installation.
(Height of the drain hose should be less than 60 cm.) 2 Wait until the fluid in the basin drained completely. 3 Wear appropriate protective gear and clean the drain port mesh filter in basin. oRefer to Section 10.3, Cleaning the mesh filters. 4 Perform Drain LCG again. oRefer to Section 8.2, Replacing the disinfectant solution. 1 Open the water faucet all the way. 2 Wear appropriate protective gear and clean the drain port mesh filter in basin. 3 Check if water is leaking from the water supply hose. 4 Close the lid by pushing until it clicks and restart Load LCG according to the guide on the touch screen. Contact Olympus. Ch.13 E073 Water supply irregularity during the Load LCG process. E074 LCG in the cassette bottles is not supplied to the disinfectant solution tank. OER-Elite OPERATION MANUAL 609 13.2 Troubleshooting guide Error code E075 Problem Possible causes Remedial actions Water supply irregularity during the Load LCG process. The water faucet is not open enough. 1 Open the water faucet all the way. 2 Wear appropriate protective gear and clean Drain port mesh filter in the drain port mesh filter in basin. basin is clogged. Water flow rate is too low. Water is leaking from the water supply hose. The water filter is clogged. The mesh filter in the water supply hose connector is clogged. Internal problem with the reprocessor. 3 Check if water is leaking from the water supply hose. 4 Close the lid by pushing until it clicks and restart Load LCG according to the guide on the touch screen. Contact Olympus. Disinfectant bottle drawer is not completely closed. Ensure that the disinfectant bottle drawer is completely closed. Empty cassette bottles were installed. Irregularity in the valve inside the reprocessor. Irregularity in the electrical circuitry inside the reprocessor. Irregularity in the electrical circuitry inside the reprocessor. Irregularity in the electrical circuitry inside reprocessor. Irregularity in the pump inside the reprocessor. Irregularity in the flow sensor inside the reprocessor. The circulation port mesh filter in the basin is clogged. Perform the Load LCG with new cassette bottles. Contact Olympus. Contact Olympus. Contact Olympus. Contact Olympus. To continue using the OER-Elite, and manually input the ID information via the touch screen. RFID will be disabled. Contact Olympus. Contact Olympus. 1 Wear appropriate protective gear and clean the circulation port mesh filter in basin. oRefer to Section 10.3, Cleaning the mesh filters. 2 Perform the process again. E076 E077 E078 E081 E082 E083 E084 E086 E087 Irregularity of the fluid level sensor in the disinfectant solution tank. Incomplete positioning of the disinfectant bottle drawer. Cassette bottles are empty. The process cannot be properly controlled. Internal irregularity in the OER-Elite. The process cannot be properly controlled. Malfunction of the RFID reader. Internal irregularity in the OER-Elite. Internal irregularity in the OER-Elite. E088 Insufficient fluid flow. Ch.13 610 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide Error code E089 E092 E093 E094 Problem Possible causes Remedial actions Internal irregularity in the OER-Elite. Manual leak test time has been exceeded. Alcohol cannot be supplied during the process. Date cannot be printed. Irregularity in the electrical circuitry inside the reprocessor. Manual leak test time of 10 minutes has been exceeded. Clogging of the alcohol piping. Contact Olympus. Perform manual leak test again. Refer to Section 7.14, Alcohol flush. Printer is not properly 1 If the printer paper runs out, replace the connected to the OER-Elite. Printer paper roll has run out. Malfunction of printer. E095 Detergent cannot be supplied during the process. Clogging of the detergent piping. E111 E112 Internal irregularity in the OER-Elite. ALT Self-Check Error Internal problem with the reprocessor. Leak test air tube was connected during the ALT Self-Check. printer paper roll. 2 If the paper cover is open, close the cover. 3 Check the power LED of the printer lights up. If not, press power button on the operational panel of the printer to ON. 4 Check the interface cable is connected properly. 5 Print the data again. Refer to If the message screen Message 093 is displayed again after replacing the detergent tank and restarting the reprocessing process: on page 638. Contact Olympus. 1 Confirm the leak test air tube is not connected. 2 Perform ALT Self-Check again. oRefer to Section 7.13, Self-check of auto leak test. Ch.13 OER-Elite OPERATION MANUAL 611 13.2 Troubleshooting guide Problem Possible causes Remedial actions Leak detected during ALT process. There is a leak within the endoscope. Leak test air tube is broken. When the ALT is incorporated in the beginning of the reprocessing process:
1 If warm water was used in manual cleaning, the auto leak test may be erroneous because the temperature of endoscope(s) may change drastically after the manual cleaning. If the auto leak test is to be performed at the start of reprocessing, begin the reprocessing after the endoscope temperature has returned to the room temperature. Wait more than 15 minutes after manual cleaning for the endoscope temperature to return to room temperature. 2 If warm water was not used in manual cleaning, perform the following.
Identify the endoscope with leak from the scope IDs displayed on the touch screen.
Start the process again for the non-leaking endoscope.
Be sure to perform Leaking Scope Decontamination with the leaking endoscope before returning for repair. When the ALT is incorporated in the end of the reprocessing process:
1 Identify the endoscope with leak from the scope IDs displayed on the touch screen. 2 Remove the leaking endoscope from the OER-Elite, then start the process again for the non-leaking endoscope. 3 Return the leaking endoscope for repair. Error code E114 Ch.13 612 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide Error code E115 Problem Possible causes Remedial actions Leak test air pressure is low. Irregularities of leak test air tube. Perform the manual leak test to check if the endoscope or the leak test air tube leaks. Irregularities of the O-ring of the leak test connector. Excessive leak exists within the endoscope.
If a leak point exists on the leak test air tube, replace it with new one and retry the process.
If a leak point exists between the connector of the leak test air tube and the leak test connector (E1 or E2), or between the metallic connector and the venting connector of the endoscope, contact Olympus.
If a leak point exists on the outer surface, stop it with a piece of tape and perform the leaking scope decontamination. After it, send the scope for servicing. If a leak cannot be reduced by taping and this error occurs, contact Olympus.
If the leak point exists in a position where taping is impossible, do not execute this process but contact Olympus. Excessive leak test air pressure. Internal problem with the reprocessor. 1 Contact Olympus. 2 If you wish to continue reprocessing, disable E117 E118 E119 E124 E131 E132 Cannot release the pressure of endoscope. Auto leak test system malfunction. Auto leak test system malfunction. Portable memory was disconnected. Cannot write to portable memory. E134 Portable memory port malfunction. the ALT function. Contact Olympus. 1 Contact Olympus. 2 If you wish to continue reprocessing, disable the ALT function. 1 Contact Olympus. 2 If you wish to continue reprocessing, disable the ALT function. Re-insert the portable memory and export data again. Use another portable memory and export data again. Ch.13 Contact Olympus. Internal problem with the reprocessor. Irregularity in the electrical circuitry inside the reprocessor. Irregularity in the electrical circuitry inside the reprocessor. Portable memory was disconnected while the data was exported. Improper connection of the portable memory. Abnormalities of the portable memory. Irregularity in the electrical circuitry inside the reprocessor. OER-Elite OPERATION MANUAL 613 13.2 Troubleshooting guide When the error code [E024] is displayed during the reprocessing process If an error such as clogging of an endoscope channel or connection irregularity of the connecting tube or leak test air tubes occurs during the process, the error code [E024] is displayed on the touch screen and the reprocessor will stop the process. After the auto processing, the touch screen displays the following screen. 1st page 2nd page 1 2 3 4 5 6 4 5 7 8 No. 1 2 Item/Button Connector Detection result 3 4 5 6 7 8 Detail button Error Info. button Connection Guide button Next button Back button OK button Description Show Connector in the reprocessing basin. Displays a detection result if any irregularity is detected to a connector. Blank cell means that there are not any irregularities with the connector. Press to display the remedial actions of a connector that detected an irregularity. The button is unavailable if there are not any irregularities with the connector. Press to display the error information. Press to display the connection guide screen. For detail, refer to Connection guide of first endoscope on page 179, Connection guide of second endoscope on page 206. Press to display the next screen. Press to return to the first page. Press to go to the next page. Ch.13 614 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide 1 Step on the foot pedal to open the lid. 2 According to the detection result displayed on the touch screen, corrects as follows. Remedial actions 1 Check the connecting tube is not kinked. 2 Check the connectivity between the connecting tube and OER-Elite. 3 Remove the endoscope and perform manual cleaning. Refer to Reprocessing manual of the endoscope for details. 1 Check the correct connecting tube is used. 2 Check the connecting tube is connected to the correct connector in the basin. 3 Check the connecting tube is not kinked. 4 Remove the endoscope and perform manual cleaning. Refer to Reprocessing manual of the endoscope for details. 1 Disconnect the connecting tube and confirm the correct connecting tube is used. 1 Check the correct connecting tube is used. 2 Check the connecting tube is connected to the correct connector in the basin. 3 Check the connectivity between the connecting tube and the endoscope. 4 Check the connectivity between the leak test air tube and the OER-Elite. Detection Result Disconnection
(OER-Elite side) Blocked Channel Wrong connection Disconnection (Scope side) Table 13.1 NOTE If the Detail button is pressed, the remedial actions can be displayed on the touch screen. 3 Press the Next button on the first page to display the second page. 4 According to the detection result displayed on the touch screen, corrects as Step 2. Figure 13.3 Ch.13 OER-Elite OPERATION MANUAL 615 13.2 Troubleshooting guide 5 Press the OK button on the second page. 6 Press the OK button to finish remedial actions. If the endoscope will be removed from the reprocessing basin, select Yes button and press OK. Then, the IDs for this scope will be deleted. Figure 13.4 Figure 13.5 Ch.13 Figure 13.6 7 Start the reprocessing process and rinse from the beginning. 616 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide When any leaks are detected When the error code [E114] or [E115] is displayed on the touch screen, the result of auto leak test is Leaked, or any leaks are detected during manual leak test, perform following. NOTE When the error code [E114] is displayed, leak detected during ALT process at the reprocessing process. When the error code [E115] is displayed, leak test air pressure is low. When these errors frequently occur, perform self-check of auto leak test. For detail, refer to Section 7.13, Self-check of auto leak test. Workflow when the error code [E114] is displayed, or the result of auto leak test is Leaked The result of auto leak test is Leaked. The error code [E114]
is displayed during reprocessing process.
(The auto leak setting is Beginning of the process). Did each process perform immediately after completing manual cleaning using warm water?
Yes Wait for more than 15 minutes (In the case of the ultrasonic endoscope, wait for more than 30 minutes) after completing manual cleaning. Retry reprocessing process or auto leak test. Is the following occurred again?
The error code [E114] is displayed during reprocessing process. The result of auto leak test is Leaked. No No Yes The error code [E114]
is displayed during reprocessing process.
(The auto leak setting is End of the process). Perform the leaking scope decontamination. Refer to Section 7.15, Leaking scope decontamination. Ch.13 The endoscope has no leaks. Contact Olympus to repair the endoscope. Figure 13.7 OER-Elite OPERATION MANUAL 617 13.2 Troubleshooting guide Workflow when the error code [E115] is displayed The error code [E115] is displayed during reprocessing process. The error code [E115] is displayed during auto leak test function. The error code [E115] is displayed during manual leak test function. Perform the manual leak test. Is the error code [E115]
displayed again?
NO Is there leak on the tube section of the leak test air tube?
NO Is there leak between the connector of the leak test air tube and the leak test connector
(E1 or E2), or between the metallic connector and the venting connector of the endoscope?
NO Is there leak from the endoscope?
NO YES YES YES YES Contact Olympus to repair the reprocessor. Replace the leak test air tube with a new one. If there are no more leak test tube, contact Olympus. Contact Olympus to replace a new O-ring. Refer to Workflow when any leaks are detected during manual leak test on page 619. Then contact Olympus to repair the endoscope. Contact Olympus to repair the reprocessor. Ch.13 Figure 13.8 618 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide Workflow when any leaks are detected during manual leak test 1 Perform the leaking scope decontamination. For the detail, refer to Section 7.15, Leaking scope decontamination. 2 If the leaking scope decontamination is completed without errors, contact Olympus to repair the endoscope. If any errors occur, perform manual decontamination for leaking endoscope below. Then, contact Olympus to repair the endoscope. Manual decontamination for leaking endoscope
(a) Manual cleaning for leaking endoscope 1 For a leak detected in the covering of the insertion tube, bending section, or universal cord, dry the leaking area thoroughly and wipe with alcohol. Tape over the location of the leak with a piece of electrical tape or other waterproof tape prior to immersing in detergent solution. Wrap the tape tightly. For leaks detected in other locations (e.g., internal channel), proceed with the instructions provided below. 2 Fill a basin with detergent solution at the temperature and concentration recommended by the detergent manufacturer. Use a basin that is at least 40 cm by 40 cm (16 by 16) in size and deep enough to allow the endoscope to be completely immersed. 3 Insert the leakage tester connector into the output socket of the maintenance unit such as MU-1 or the light source and turn the maintenance unit or the light source ON. Set the light sources airflow regulator switch to HIGH or 3. 4 Connect the leakage testers connector cap to the venting connector of the water-resistant cap. 5 Immerse the endoscope in the detergent solution. 6 Perform manual cleaning according to the instructions provided in the reprocessing manual. Minimize unnecessary flexion of the insertion tube and universal cord during cleaning. Ch.13 OER-Elite OPERATION MANUAL 619 13.2 Troubleshooting guide
(b) Sterilization for leaking endoscope Following manual cleaning, the preferred method of rendering a leaking endoscope safe to handle is ethylene oxide sterilization. Ethylene oxide sterilization should be performed according to the instruction provided in the reprocessing manual. If electrical tape was applied to a leak detected in the endoscopes external surface, remove the tape and wipe with 70% ethyl or isopropyl alcohol prior to ethylene oxide sterilization. If ethylene oxide sterilization is not possible, perform high-level disinfection according to the instructions provided below.
(c) High-level disinfection for leaking endoscope 1 Fill a basin with disinfectant solution at the temperature and concentration recommended by the disinfectant manufacturer. Use a basin that is at least 40 cm by 40 cm (16 by 16) in size and deep enough to allow the endoscope to be completely immersed. 2 Insert the leakage tester connector into the output socket of the maintenance unit or the light source and turn the maintenance unit or the light source ON. Set the light sources airflow regulator switch to HIGH or 3. 3 Connect the leakage testers connector cap to the venting connector of the water-resistant cap. 4 Immerse the endoscope in the disinfectant solution. 5 Perform high-level disinfection according to the instructions provided in the reprocessing manual. Minimize unnecessary flexion of the insertion tube and universal cord during reprocessing. WARNING This process is intended to treat the endoscope with water leak before sending it for servicing. It does not guarantee the reprocessing of the endoscope and its accessories after this process. After completing this process, do not use the endoscope and its accessories in examination but send it for servicing. Ch.13 620 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide Message, caution, and warning screens 1 If the reprocessor requires operator action, the buzzer beeps and the message screen will be displayed on the touch screen. 2 Perform remedial actions according to the instruction described in the table below or the instructions displayed on the touch screen. 3 Press the OK button to resume a process. Figure 13.9 Figure 13.10 NOTE The button for resuming a process varies based on message screens displayed on the touch screen. The message cannot record to logs. Ch.13 OER-Elite OPERATION MANUAL 621 13.2 Troubleshooting guide No. Message 001 Message 002 Message 003 Message Remedial actions Scope ID has not been entered. User ID has been entered. OER-Elite cannot accept more than two user IDs per reprocessing cycle. Enter scope ID before starting the process. Enter user ID before starting the process. 1 Verify the entered user ID information is correct. 2 Delete the incorrect user information. Re-enter user Message 004 Message 005 ID entry for 1st endoscope has not been completed. User ID Setting has not been activated. Message 005 Message 005 Message 006 Message 008 Message 009 Message 010, 011 Message 014 Message 015 Message 016 Patient ID Setting has not been activated. Physician ID Setting has not been activated. OER-Elite cannot accept more than two Scope IDs per reprocessing cycle. Scope ID master has been entered. Channel Monitoring, auto leak testing and Connection Guide will be disabled. Scope ID has been entered from the touch screen. Channel monitoring, auto leak testing and connection guide will be disabled. This endoscope is incompatible for auto leak testing. Auto leak testing will be disabled. Patient ID has not been entered. Physician ID has not been entered. OER-Elite cannot accept more than two patient IDs per reprocessing cycle. ID. Before entering the 2nd endoscope ID, enter the remaining IDs for the 1st endoscope. To enter user ID, go to Menu screen, then change the User ID Setting. To enter patient ID, go to Menu screen, then change the Patient ID Setting. To enter physician ID, go to Menu screen, then change the Physician ID Setting. 1 Verify the entered scope ID information is correct. 2 Delete the incorrect scope information. Re-enter scope ID. Refer to the List of compatible Endoscopes/Connecting Tubes <OER-Elite> to confirm the correct connecting tubes for this endoscope. Refer to the List of compatible Endoscopes/Connecting Tubes <OER-Elite> to confirm the correct connecting tubes for this endoscope. No additional action is required. Enter patient ID before starting the process. Enter physician ID before starting the process. 1 Verify the entered patient ID information is correct. 2 Delete the incorrect patient information. Re-enter patient ID. Message 017 OER-Elite cannot accept more than two physician IDs per reprocessing cycle. 1 Verify the entered physician ID information is correct. 2 Delete the incorrect physician information. Re-enter physician ID. Message 018 Malfunction of the RFID reader. 1 Manually input the ID information via the touch Ch.13 Message 019 Message 020 Procedure ID has not been entered. This endoscope is incompatible for channel connectivity monitoring.Channel connectivity monitoring will be disabled. screen. 2 Contact Olympus. Enter procedure ID before starting the process. No additional action is required. 622 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide No. Message 021 Message 022 Message 023 Message 024 Message 025 Message 031 Message 032 Message 034 Message 035 Message 036 Message 037 Message 038 Message This endoscope is incompatible for channel blockage monitoring.Channel blockage monitoring will be disabled. This endoscope is incompatible for channel monitoring. Channel monitoring will be disabled. Refer to the Message 008 Scope ID of endoscope that cannot be reprocessed simultaneously has been entered. OER-Elite cannot accept more than one User ID per reprocessing cycle. This endoscope combination is incompatible for auto leak testing. LCG cycle count/usage exceeds the set value. There is no LCG in the disinfectant solution tank. Load LCG cannot be performed with LCG in the disinfectant solution tank. Drain LCG cannot be performed with no LCG in the disinfectant solution tank. An invalid set time for Heat LCG Timer has been entered. The LCG temperature is already above the specified temperature. Cannot activate the Heat LCG Timer. System clock battery low. Remedial actions No additional action is required. No additional action is required. Refer to the Message 008. 1 Verify the entered user ID information is correct. 2 Delete the incorrect user information. Re-enter user ID. Perform Auto Leak Test separately for second scope. Perform MRC check before performing the process. Perform Load LCG. Perform Drain LCG, then Load LCG. No additional action is required. 1 Enter a minimum time of at least 2.5 hours. 2 Enter a date of less than 5 days. No additional action is required. Contact Olympus. Message 047 More than 1 hour has passed since the Perform MRC check again and enter the result. MRC check result has been entered. Message 048 MRC check result has not been Perform MRC check again and enter the result. Message 050 Message 061 Message 062 Message 070 Message 071 Message 080 Perform Load LCG before MRC check. entered. There is no LCG in the disinfectant solution tank. Portable memory is full, cannot Export data. No record exists for the selected period. Confirm the dates for the period selected. The lid is open. Cannot drain LCG through the disinfectant collection hose with the lid closed. Time for periodic maintenance. Close the lid to perform the process. 1 Verify the collection method selected is correct. 2 Follow the prompts on the OER-Elite. Insert portable memory that has sufficient capacity. At least 100MB capacity is necessary. The time for regularly scheduled maintenance is near. Contact Olympus to perform the maintenance. Perform Replace Water Filter. Message 081 Water filter usage exceeds the set Message 081 value. Air filter usage exceeds the set value. OER-Elite OPERATION MANUAL Perform Replace Air Filter. 623 Ch.13 13.2 Troubleshooting guide No. Message Message 081 Gas filter usage exceeds the set value. Message 082 Message 083 The OER-Elite has not been used for more than 14 days. ALT Self-check failed. Message 086 Leak has been selected as a manual leak test result. Message 087 Alcohol cannot be supplied. Message 088 Fluid cannot be drained from the alcohol line. Message 088 Fluid cannot be drained from the detergent line. Message 089 Fluid cannot be supplied from the alcohol line. Message 089 Fluid cannot be supplied from the detergent line. Message 091 Message 093 To enable the mode setting, turn the power off and boot with service mode. Detergent cannot be supplied. Ch.13 Message 095 An invalid time has been entered. Remedial actions Perform Replace Gas Filter on the Lid or perform Replace Gas Filter on the Tank. Perform Self-Disinfection and Water Line Disinfection. Contact Olympus. To continue reprocessing, choose a program with the ALT Setting disabled. (Program 3 or 4) 1 Close the lid by pushing until it clicks. The water will automatically be discharged from the basin. 2 Perform Leaking Scope Decontamination. 1 Confirm the amount of alcohol in the alcohol tank. If no alcohol is remaining, replenish the alcohol. 2 Confirm the alcohol tubing is not bent and press Restart. 3 To cancel the process, press Stop. Refer to Section 5.9, Inspecting and replenishing alcohol. 1 Confirm the nozzle of the cap is out of the beaker. 2 Confirm the alcohol tubing is not bent and press Restart. 3 To cancel the process, press Stop. 1 Confirm the nozzle of the cap is out of the beaker. 2 Confirm the detergent tubing is not bent and press Restart. 3 To cancel the process, press Stop. 1 Confirm the nozzle of the cap is in the beaker. 2 Confirm the alcohol tubing is not bent and press Restart. 3 To cancel the process, press Stop. 1 Confirm the nozzle of the cap is in the beaker. 2 Confirm the detergent tubing is not bent and press Restart. 3 To cancel the process, press Stop. No additional action is required. 1 Confirm the amount of detergent in the detergent tank. If no detergent is remaining, replace a new detergent tank. 2 Confirm the detergent tube is not bent and press Restart. 3 To cancel the process, press Stop. Refer to Section 8.3, Replacing the detergent tank. Set the time within following range. Range: 1/1/2012 00:00 12/31/2087 23:59 624 OER-Elite OPERATION MANUAL No. Message 100 Message 101 Message 102 Message 110 Message 120 Message 132 Warning 026 13.2 Troubleshooting guide Message Leak test air tube for scope 1 has not been connected within 5 minutes. Remedial actions 1 Enter scope ID for scope 1 again. 2 Within 5 minutes, connect the leak test air tube for scope 1 to the E1 connector. Leak test air tube has been connected to the endoscope before entering scope ID. 1 Disconnect the leak test air tube from the connector. 2 Enter scope ID for scope 1 again. 3 Connect the leak test air tube for scope 1 to the E1 Program has been changed and OER-Elite cannot detect the proper connection of leak test air tube. Process interrupted before rinse. Chemical may remain in the basin. Detergent cycle count/usage exceeds the set value. An invalid date has been entered. This endoscope requires special procedures for reprocessing in the OER-Elite. Warning 096 Warning 121 Caution 007 ALT Self-Check has not been performed. Detergent has expired based on its shelf life expiration date. Incompatible combination of endoscope. Caution 013 This endoscope is incompatible with OER-Elite. Caution 033 Caution 039 Caution 040 Caution 041 Caution 046 Caution 084 LCG has expired based on its shelf life expiration date. Load LCG has not been completed properly. Fail has been entered as an MRC check result, cannot perform the process. Mix LCG has not been performed. More than 4 hours has passed since the last cycle. To ensure accurate MRC testing, perform Mix LCG. System clock battery has run out. connector. 1 Disconnect the leak test air tube from the connector. 2 Press OK. 1 Press Rinse to continue now. 2 Press OK to perform Rinse later. Perform Replace Detergent. Set the expiration date properly. Before reprocessing the endoscope in the OER-Elite, thoroughly review and follow the procedures described in the respective endoscope reprocessing manual or the OER-Elite Instructions Operation Manual. Otherwise, reprocessing may be insufficient. 1 Press ALT Self-Check to continue now. 2 Press OK to perform ALT Self-Check later. Perform Replace Detergent. Refer to the List of compatible Endoscopes/Connecting Tubes <OER-Elite> to confirm the applicable combination of endoscopes. 1 Reprocess this endoscope using another method. 2 For a list of compatible endoscopes, refer to the List of compatible Endoscopes/Connecting Tubes
<OER-Elite>. Perform Drain LCG, then Load LCG. Perform Drain LCG, then Load LCG. Perform Drain LCG, then Load LCG. 1 Press Mix LCG to continue now. 2 Press OK to perform Mix LCG later. 1 Press Mix LCG to continue now. 2 Press OK to perform Mix LCG later. Contact Olympus. Ch.13 OER-Elite OPERATION MANUAL 625 13.2 Troubleshooting guide No. Caution 085 Message System clock battery low. Caution 092 No has been selected as the result of manual cleaning and leak test for scope 1. Caution 092 Caution 092 Caution 092 Caution 092 Caution 094 No has been selected as the result of manual cleaning for scope 1. No has been selected as the result of leak test for scope 1. Pass has been selected as the result of leak test. No has been selected as the result of manual cleaning. Pass has been selected as the result of leak test. Water Line Disinfection has not been completed after replacing the water filter. Remedial actions 1 Contact Olympus. 2 To continue using the OER-Elite, make sure the system clock indicates the actual current date and time. If not, perform Date and Time setting and set the current date and time. The system clock will function until OER-Elite is powered off. 1 Perform leak test and manual cleaning before starting reprocessing. 2 If a leak has been detected, perform Leaking Scope Decontamination. Perform manual cleaning before starting reprocessing. 1 Perform leak test before starting reprocessing. 2 If a leak has been detected, perform Leaking Scope Decontamination. Perform manual cleaning before starting reprocessing.
(Do not use leaking scope decontamination for this endoscope) Perform reprocessing. (Do not use leaking scope decontamination for this endoscope.) Perform Water Line Disinfection. Ch.13 626 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide When the message screen Message 087 is displayed If alcohol has run out and the message screen Message 087 is displayed, the reprocessor will stop the process. In this case, you can restart the process from the alcohol flush by implementing the following procedure. Figure 13.11 NOTE The reprocessing process can be restarted from the alcohol flush if the Restart button is pressed in Message 087. In that case, the reprocessing record is recorded as normal. The lid will remain locked until the message screen is cleared, and you cannot access the reprocessing basin even after pressing the foot pedal. If you want to interrupt the reprocessing process, press STOP button and follow the procedure described in Section 13.1, Emergency stop and automatic processing after stopping. Ch.13 OER-Elite OPERATION MANUAL 627 13.2 Troubleshooting guide When the Message 087 is displayed during the alcohol flush process Message 087 Alcohol cannot be supplied is displayed. 1. Confirm whether alcohol still present in the alcohol tank. If alcohol still present in the tank. Refer to If the Message 087 is displayed again after replenishing alcohol and restarting the alcohol flush process: on page 629. Inspect the tube and connector connected to the alcohol tank. If any irregularity is found. If no irregularity is found. Correct irregularities. Press the Stop button to cancel the reprocessing process and perform remedial actions of E093 to resolve the problem. If the message screen is displayed again. If no alcohol remain in the tank. 2. Replenish alcohol.
(Refer to Section 5.9, Inspecting and replenishing alcohol.) 3. Press the Restart button to restart the reprocessing cycle. 4. Reprocessing process restarts from alcohol flush process. Figure 13.12 Ch.13 WARNING The alcohol used with the reprocessor must be 70% ethyl alcohol or 70% isopropyl alcohol. Using any other kind of alcohol may result in malfunction of the reprocessor or the endoscope, difficulty drying the endoscope, fire hazard, or a hazard due to toxic vapor emitted from the alcohol. Alcohol is flammable and should be handled with extra care. Remove the alcohol in the alcohol tank and replace it with new alcohol at least once a week. Otherwise, the alcohol in the alcohol tank may degrade. Before handling the alcohol, read the cautions carefully and use it as instructed. 628 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide 1 Inspect the alcohol tank. If alcohol is still present in the alcohol tank, go to the procedure of If the Message 087 is displayed again after replenishing alcohol and restarting the alcohol flush process: on page 629 described in this section. 2 Replenish alcohol into the alcohol tank as described in Section 5.9, Inspecting and replenishing alcohol. 3 Press Restart button on the touch screen to restart the reprocessing process. 4 Reprocessing process restarts from alcohol flush process. Figure 13.13 If the Message 087 is displayed again after replenishing alcohol and restarting the alcohol flush process:
When message screen Alcohol cannot be supplied is displayed again after restarting the reprocessing process, check that there is no irregularity regarding the following points. The tube connected to the alcohol tank is not kinked. The connector of alcohol tank is attached firmly. If any irregularity is found by inspection, correct these points and press the Restart button on the touch screen to restart the alcohol flush process. If no irregularity is found during an inspection or the message screen is displayed again, internal problem with the reprocessor may be suspected. In this case, follow the procedure below. WARNING The alcohol used with the reprocessor must be 70% ethyl alcohol or 70% isopropyl alcohol. Using any other kind of alcohol may result in malfunction of the reprocessor or the endoscope, difficulty drying the endoscope, fire hazard, or a hazard due to toxic vapor emitted from the alcohol. Ch.13 Alcohol is flammable and should be handled with extra care. Remove the alcohol in the alcohol tank and replace it with new alcohol at least once a week. Otherwise, the alcohol in the alcohol tank may degrade. Before handling the alcohol, read the cautions carefully and use it as instructed. OER-Elite OPERATION MANUAL 629 13.2 Troubleshooting guide
(a) Required items Check Required items Syringe Tube Table 13.2
(b) Remedial actions 1 Press the Stop button on the touch screen to cancel the reprocessing process. 2 The touch screen displays the error code
[E093]. Press the OK button. Then, troubleshooting guide is displayed on the touch screen. Figure 13.14 Ch.13 Figure 13.15 630 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide 3 Connect the provided syringe and tube. For detail, refer the detail button on E093 on the touch screen. 4 Disconnect the ventilation tube from the guide of the alcohol tank. 5 Fill the syringe with air and insert the tube connected to the syringe all the way into the far end of the alcohol tank ventilation tube. Figure 13.16 Figure 13.17 Ventilation tube Guide Figure 13.18 Figure 13.19 OER-Elite OPERATION MANUAL 631 Ch.13 13.2 Troubleshooting guide 6 Press the OK button repeatedly until error screen is closed. 7 Go to the Function menu. Press the Alcohol Flush button on the second page. Figure 13.20 8 Enter the operator's user ID. For entering ID, refer to Section 3.6, Entering ID (If applicable). Figure 13.21 NOTE The input of the user ID can be omitted by modifying the User ID Setting. For details, refer to Section 4.5, User ID Setting. Ch.13 632 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide 9 Press the Start button on the touch screen. Flush air in the syringe within 30 seconds. Figure 13.22 10 Press the Stop button to stop the alcohol flush. Then, error code E000 is displayed on the touch screen. After confirming that, disconnect the syringe's tube from the ventilation tube. Figure 13.23 Figure 13.24 Ch.13 OER-Elite OPERATION MANUAL 633 13.2 Troubleshooting guide 11 Disconnect the tube from the cap on the alcohol tank, remove the tank from the detergent/alcohol drawer and insert the ventilation tube into the guide. Figure 13.25 12 Carefully pour the 70% ethyl alcohol or 70% isopropyl alcohol into the alcohol tank until it is level with the line inside the tank. If any alcohol is spilled from the tank, wipe it with a clean cloth. Replace the cap on the alcohol tank, making sure that it is tight. NOTE When the alcohol tank is filled to the line, it will hold about 1 L (33 ounces) of alcohol (enough for about 20 alcohol flushes). 13 After confirming that alcohol has not spilled from the alcohol tank and there is enough alcohol remaining in the alcohol tank, place the alcohol tank in the detergent/alcohol drawer and connect the tube that is designed to be connected to the cap of the alcohol tank. Alcohol tank Ventilation tube Ch.13 Figure 13.26 14 Close the detergent/alcohol drawer. Rinse the syringe and tube with running water, dry them completely, and store in a clean place. 15 Perform the alcohol flush again from the beginning. 634 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide 16 If alcohol flush is successfully completed, the problem is resolved and alcohol flush was performed with the endoscopes. If the Message 087 is displayed again, the reprocessor component malfunction is suspected. In this case, do not use the reprocessor and contact Olympus. Remove endoscope(s) from the basin and perform alcohol flush again by another method. When the Message 093 is displayed If detergent has run out and the message screen Detergent cannot be supplied is displayed, the reprocessor will stop the process. In this case, reprocessing can be restarted by implementing the following procedure. Figure 13.27 Ch.13 OER-Elite OPERATION MANUAL 635 13.2 Troubleshooting guide NOTE The reprocessing process can be restarted only when the message screen Detergent cannot be supplied during the process is displayed. The lid will remain locked until the error is cleared, and you cannot access the reprocessing basin even after pressing the foot pedal. If you want to interrupt the reprocessing process, press the Stop button and follow the procedure described in Section 13.1, Emergency stop and automatic processing after stopping. When the message 093 is displayed during the reprocessing process Message screen is displayed. 1. Confirm whether the detergent still present in the detergent tank. If detergent still present in the tank. Refer to If the message screen Message 093 is displayed again after replacing the detergent tank and restarting the reprocessing process: on page 638. Inspect the tube and connector connected to the detergent tank. If any irregularity is found. If no irregularity is found. Correct irregularities. Perform remedial action to resolve the problem. If the same message screen is displayed again. If no detergent remain in the tank. 2. Replace the detergent tank. 3. Press the Restart button to restart the reprocessing process. Ch.13 4. Restarted process is completed. Figure 13.28 636 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide WARNING Before handling the detergent, read the cautions carefully and use it as instructed. It is especially important to know what to do if the detergent solution comes in contact with your skin and eyes. When handling the detergent, always wear appropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. 1 Inspect the detergent tank. If detergent is still present in the detergent tank, go to the procedure of If the message screen Message 093 is displayed again after replacing the detergent tank and restarting the reprocessing process: on page 638 described in this section. 2 Replace the detergent tank as described in Section 5.8, Inspecting the remaining detergent. 3 Enter the operators user ID. For the detailed procedure, refer Section 3.6, Entering ID (If applicable). Then, press the Restart button to restart the process. Figure 13.29 NOTE The input of the user ID can be omitted by modifying the user ID input setting. For details, refer to Section 4.5, User ID Setting. When the Delete button is pressed, the entered ID is deleted. When the detergent lot and shelf-life management setting are activated, the touch screen displays the lot entry screen or shelf-life entry screen. For details, refer to When entering the lot number of detergent and shelf life: on page 372. Ch.13 OER-Elite OPERATION MANUAL 637 13.2 Troubleshooting guide If the message screen Message 093 is displayed again after replacing the detergent tank and restarting the reprocessing process:
When the message screen Detergent cannot be supplied is displayed again after restarting the process, check that there is no irregularity regarding the following points. The tube connected to the detergent tank is not kinked. The connector of detergent tank is attached firmly. If any irregularity is found by inspection, correct these points and press start button to restart the process. If no irregularity is found during an inspection or the Detergent cannot be supplied is displayed again, internal problem with the reprocessor may be suspected. In this case, follow the procedure below. WARNING Before handling the detergent, read the cautions carefully and use it as instructed. It is especially important to know what to do if the detergent solution comes in contact with your skin and eyes. When handling the detergent, always wear appropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. NOTE Detergent replacement indicator is turned off when running a reprocessing program after performing 1 to 11 below to fill detergent in the detergent supply piping. Ch.13 638 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide
(a) Required items Check Required items Syringe Tube Table 13.3
(b) Remedial actions 1 Press the Stop button. 2 The touch screen displays the error code
[E095]. Press the OK button. Then, troubleshooting guide is displayed on the touch screen. Figure 13.30 3 Step on the foot pedal to open the lid. 4 Prepare the provided syringe and the provided tube. Figure 13.31 Ch.13 OER-Elite OPERATION MANUAL 639 13.2 Troubleshooting guide 5 Press the Next button. 6 Connect the provided syringe and tube. Figure 13.32 7 Connect the tube to the detergent nozzle inside the reprocessing basin and suction it with the syringe until detergent comes out. Figure 13.33 Ch.13 Figure 13.34 640 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide 8 Pinch the tube at the closest point to the detergent nozzle with your fingers and disconnect the tube from the detergent nozzle. 9 Rinse the syringe and tube thoroughly in running water, dry them well, and store in a clean place. 10 Press the OK button repeatedly until the error screen is closed. Figure 13.35 Figure 13.36 11 Start the reprocessing process from the beginning. 12 If the reprocessing process is successfully completed, the problem is resolved and reprocessing process was performed with the endoscopes. If the Message 093 is displayed again, the reprocessor component malfunction is suspected. In this case, do not use the reprocessor and contact Olympus. Remove endoscope(s) from the basin and perform reprocessing process again by another method. Ch.13 OER-Elite OPERATION MANUAL 641 13.2 Troubleshooting guide Other problems and remedial actions Remedial actions Replace the gas filter as described in Section 8.6, Replacing the gas filter
(MAJ-822). If the problem persists after replacement, contact Olympus. Check if disinfectant solution is leaking. If it is, do not use the reprocessor and contact Olympus. Stop the current process and reattach the water filter housing as described in Section 8.4, Replacing the water filter
(MAJ-824 or MAJ-2318). However, the STOP button may not work if stopping the water might cause a hazardous situation, for example during disinfectant solution replacement. In this case, close the water faucet, tighten the water filter housing, then open the water faucet again and continue the process. If an error code is displayed, take the appropriate remedial action for that error. Inspect the lid packing. oRefer to Section 5.5, Inspecting the lid and lid packing. If the lid packing is abnormal, contact Olympus. Close the water faucet, set the power switch to OFF, disconnect the power cord plug from the wall mains outlet and contact Olympus. Connect the drain connector as described in to Section 3.7, Checking the MRC level and entering the check result, push the valve on the connector several times so that the material stuck in the port is removed. If leakage is still detected, attach the rubber cap to the disinfectant solution drain port and contact Olympus. Problem The odor of the disinfectant solution is stronger than expected. Possible causes The gas filter has expired. Disinfectant solution is leaking. Water leak from the reprocessor. Improper installation of water filter housing. Irregularity in the lid packing Internal problem with the reprocessor. Fluid leak from the disinfectant removal port. Something is clogging the disinfectant removal port. Ch.13 642 OER-Elite OPERATION MANUAL 13.2 Troubleshooting guide Problem Possible causes Remedial actions Flow of the water in the reprocessing basin is weaker than before. Incomplete opening of the water faucet. Improper installation of water filter. Clogging of water filter. Clogging of the mesh filter in the water supply hose connector. The disinfectant bottle drawer cannot be pulled out. The disinfectant bottle drawer is locked. Connecting tube cannot be connected. The lid cannot be closed. Not using the appropriate connecting tube. The lid is locked. Internal components are pressing against the lid. Disinfectant solution remains in the reprocessing basin. STOP button was pressed during disinfection process to force it to stop. Cleaning fluid remains in the reprocessing basin. STOP button was pressed during cleaning process to force it to stop. Open the water faucet fully. Reattach the water filter as described in Section 8.4, Replacing the water filter
(MAJ-824 or MAJ-2318). Replace the water filter as described in Section 8.4, Replacing the water filter
(MAJ-824 or MAJ-2318). Clean the mesh filter as described in Section 9.7, Cleaning the mesh filter in the water supply hose connector. After draining the disinfectant solution from the reprocessor as described in Section 8.2, Replacing the disinfectant solution, perform Load LCG and unlock the disinfectant bottle drawer. Consult the List Of Compatible Endoscopes/Connecting Tubes <OER-Elite>. Step on the foot pedal to unlock the lid. Check that the lid is not pushed by the fluid level sensor, washing case or endoscope inside the basin. If it is pushed out of position, correct its positioning. If an error code is displayed, take the corresponding remedial action. Collect or drain the disinfectant solution and then rinse the basin as described in Section 7.5, Rinse. Since the endoscopes may not be properly disinfected, they should be put through the reprocessing process again from the beginning. Rinse the basin as described in Section 7.5, Rinse. Since the endoscopes may not be properly disinfected, they should be put through the reprocessing process again from the beginning. Ch.13 OER-Elite OPERATION MANUAL 643 13.2 Troubleshooting guide Problem Possible causes Remedial actions The touch screen appears to turn off completely during an operation. The Heat LCG Timer process started. Power cord is disconnected from the power outlet. Circuit breaker is activated. A power failure has occurred. Power indicator does not light when the reprocessor is turned on. Reprocessing operator feels sick during work. Disinfectant solution is judged to be ineffective with the test strip. Bacteria were detected as a result of culture test of a reprocessed endoscope. Power switch is set to ON immediately after it was set to OFF. The operator may be allergic to the disinfectant, detergent or alcohol. Expiration of the service life of the disinfectant solution. Expiration of service life of filters, degradation of disinfectant solution, etc. Water supply piping is not disinfected. Bacteria were detected as a result of culture test of rinse water collected from the reprocessor. Expiration of service life of filters, degradation of disinfectant solution, etc. Water supply piping is not Endoscopes were not precleaned before being reprocessed. Printed paper is not output from the printer. Abnormal noise from the reprocessor. Non-connected status is displayed (yellow indicator) on the touch screen. disinfected. Printer paper roll has run out. Paper jam. Internal problem with the reprocessor. The connection with a network is not established. Check that the Heat LCG Timer indicator on the control panel is lit. If it is lit, pressing the touch screen or a button will cause the touch screen to display a screen. Perform the checks described in Section 5.3, Inspecting the power activation. Error code
[E041] will be displayed when the reprocessor is turned ON. After checking, release the error code. Note that, however, any button is disabled during collection of the disinfectant solution from the reprocessing basin to the tank. Set the power switch to OFF, wait for a few seconds or more and set the power switch to ON again. Stop doing any reprocessing, move away from the reprocessor and consult a medical specialist. Replace the solution as described in Section 8.2, Replacing the disinfectant solution. Inspect the reprocessor as described in Chapter 5, Inspection and Preparation Before Use, preclean the endoscope and put it through the reprocessing process again from the beginning. If bacteria are detected again in the next culture test, contact Olympus. Inspect the reprocessor as described in Chapter 5, Inspection and Preparation Before Use. If bacteria are detected again in the next culture test, contact Olympus. Inspect the reprocessor as described in Chapter 5, Inspection and Preparation Before Use. Then, preclean the endoscopes and reprocess them again from the beginning. Take the remedial action by referring to the MAJ-2144 instruction manual for printer. Contact Olympus. Check the connection of the network cable and the network setting of the reprocessor. Ch.13 644 OER-Elite OPERATION MANUAL 13.3 OER-Elite return Remedial actions Check if the endoscope has a water leaking point with manual leak test. If a leak point exists on the outer surface, stop it with a piece of tape and perform the leaking scope decontamination as described in Section 7.15, Leaking scope decontamination. After it, return the endoscope to Olympus for servicing. If the leak point exists in a position where taping is impossible, do not execute this process but contact Olympus. Perform the ALT self-check. If an error is detected, contact Olympus. Check the leaking point of the endoscope with manual leak test. If the leak point exists on the outer surface, stop it with a piece of tape and perform the leaking scope decontamination as described in Section 7.15, Leaking scope decontamination. After it, return the endoscope to Olympus for servicing. If the leak point exists in a position where taping is impossible, do not execute this process but contact Olympus. If the leaking scope decontamination is already completed, return the endoscope to Olympus for servicing. Do not retry leaking scope decontamination, as this may cause excessive water leak inside the endoscope. Contact Olympus. Problem Auto leak test conducted independently gave the Leaked judgment result. Possible causes Water leak of an endoscope. Irregularity with the leak test air tube. Endoscope is warm because it was cleaned manually with warm water. Do not know how to return the leaking endoscope to Olympus for servicing. Leaking scope decontamination is performed without attaching connector jigs. Error code [E115] is generated several times during leaking scope decontamination. Connection of connector jigs was forgotten. Water leak from the endoscope is serious (the leaking hole is big). 13.3 OER-Elite return Contact Olympus for information about packing and shipping the reprocessor for return. When you return the reprocessor, include a description of the malfunction or damage and how it occurred. Ch.13 OER-Elite OPERATION MANUAL 645 13.3 OER-Elite return Ch.13 646 OER-Elite OPERATION MANUAL System chart Appendix System chart The recommended combinations of equipment and accessories that can be used with this reprocessor are listed below. Some items may not be available in some areas. New products released after the introduction of this reprocessor may also be compatible with this equipment. For further details, contact Olympus. WARNING If combinations of equipment other than those shown below are used, Olympus cannot guarantee that the device will perform as expected. Nor can Olympus guarantee the safety of patients and operators. Nor can the durability of the device be guaranteed when nondesignated equipment is used. Any damage resulting from improper combinations will not be serviced or repaired free of charge. App. OER-Elite OPERATION MANUAL 647 System chart Reprocessing basin Olympus endoscopes (for compatible models, refer to the separately provided List of Compatible Endoscopes/Connecting Tubes
<OER-Elite>). Connecting tubes (for the connecting tubes compatible to each endoscope model, also refer to the List of Compatible Endoscopes/Connecting Tubes <OER-Elite>). Connector hanger
(MAJ-865) Gas filter (MAJ-822) Olympus-validated concentrated disinfectant solution Portable memory
(MAJ-1925) Olympus-validated detergent Alcohol Printer set
(MAJ-2144) Bar code reader
(MAJ-2130) Endoscope reprocessor
(OER-Elite) Water filter
(MAJ-824 or MAJ-2318) Air filter (MAJ-823) This device is connected to back side. App. Olympus-designated external devices
(for communication with OER-Elite)*1 Water pre-filtration system Using a prefilter can extend the life of the water filter. 1 Always use Olympus designated external devices for communication with OER-Elite. If not, Olympus cannot guarantee that the device will perform as expected. For more details on external devices available in your area, contact Olympus. 648 OER-Elite OPERATION MANUAL Specifications Specifications Shipping environment Shipping environment Ambient temperatures Relative humidity Atmospheric pressure 47 to +60qC (52 to +140qF) 10 95
700 1060 hPa Operating environment Operating environment Ambient temperatures Relative humidity Elevation Designed for use Water supply flow 10 40qC (50 104qF) 30 85
3000 meters Indoors Minimum quantity of water supply (from the water supply/circulation nozzle) to complete a reprocessing process:
6 L/min or more Recommended quantity of water supply (from the water supply/circulation nozzle) to achieve the minimum reprocessing time: 18 L/min Water supply pressure Water supply temperature Water type Water hardness 0.1 0.5 MPa (include water hammer) 5 28qC (41 82qF) Potable water, softened water or purified water 0 400 ppm 0 150 ppm (Recommended value) *1
*1 The recommended value is in reference to AAMI TIR34: 2014 Water for the reprocessing of medical devices. App. NOTE Purified water is water that has been produced through the methods of either reverse osmosis (RO), deionization (DI), distillation or other methods that meet USP standards to remove impurities. When the water supply flow is less than 18 l/min, the reprocessing process time is extended. OER-Elite OPERATION MANUAL 649 Specifications Specifications Compatible endoscopes Number of reprocessed endoscopes Cleaning method Disinfection method Exterior surfaces Channel interiors Valves Exterior surfaces Channel interiors Valves Cleaning time setting Disinfection time setting Heat LCG setting Heat LCG method App. Olympus flexible endoscopes
(Refer to the List of Compatible Endoscopes/Connecting Tubes
<OER-Elite> for details) Note:
The OER-Elite does not sterilize endoscopes. Therefore, after cleaning/disinfecting an endoscope that requires sterilization, always sterilize the endoscope as instructed in its instruction manual. Max. 2 (1 with certain models)
(Refer to the List of Compatible Endoscopes/Connecting Tubes
<OER-Elite> for combinations) Ultrasonic cleaning, turbulent bath Fluid flushing Ultrasonic cleaning, fluid flushing Disinfectant solution immersion Disinfectant solution flushing and filling Disinfectant solution immersion 3 minutes 7 minutes Heating immediately before disinfection process in a reprocessing program. 20qC (68qF)
(If the temperature of disinfectant solution is below 20qC, it is heated to 20qC (68qF).) Heating before the start of a reprocessing program. 22qC (72qF)
(If the temperature of disinfectant solution is below 20qC, it is heated to 22qC (72qF).) Heating by the timer. 22qC (72qF)
(If the temperature of disinfectant solution is below 20qC, it is heated to 22qC (72qF).) Built-in heater in the disinfectant solution tank. 1 Heating before the start of a reprocessing program. 2 Heating by the timer. Built-in heater in the reprocessing basin. 1 Heating immediately before disinfection process in a reprocessing program. Water discharge method Forced draining using a pump (The top of the drain hose should be 60 cm or less. A floor drain is recommended.) 650 OER-Elite OPERATION MANUAL Disinfectant solution discharge method Reprocessing basin capacity Disinfectant solution tank capacity Disinfectant solution Detergent Manual leak test Auto leak test Alcohol flush Dimensions Weight Power supply Ultrasonic wave EMC Voltage Frequency Rated input Voltage fluctuation Frequency fluctuation Fuse rating Fuse size Frequency Power Applied standard Electrical safety Applied standard Radio transmitter Compliance Center frequency Modulation Effective radiated power Specifications 1 Draining through disinfectant collection hose 2 Draining through drain hose Approximately 17.9 L Approximately 21.1 L Olympus-validated disinfectant solution
(Refer to Section 2.8, Consumable accessories (Optional) for Olympus-validated disinfectant solution.) Olympus-validated detergent
(Refer to Section 2.8, Consumable accessories (Optional) for Olympus-validated disinfectant solution.) Visual inspection of bubble during immersion. Detects automatically for a pin hole by feeding air into the endoscope and computing a changed air pressure. Automatic flushing/draining using a pump and compressor 500 (W) u 945 (H) u 774 (D) mm 133 kg (dry condition) 120 V AC 60 Hz 660 VA Within r10
Within r1 Hz 10 A, 250 V 5 20 mm 36 r2 kHz 100 W IEC 61326-1: 2012 CISPR 11 of emission:
Group 1, Class B UL 61010-1: 2012 CSA C22.2 No. 61010-1: 2012 CSA C22.2 No. 61010-2-040: 2016 IEC 61010-1: 2010 IEC 61010-2-040: 2015 Installation category: II Pollution degree: 2 ISO/IEC 18000-3 (Mode1) 13.56 MHz ASK 200 mWr20
OER-Elite OPERATION MANUAL 651 App. Specifications UDI label Indication A label required by some countries regulations regarding identification of medical device also known as Unique Device Identification (UDI). The following information is being coded in the 2-dimensional barcode (GS1 Date Matrix):
(01) 14-digit GS1 Global Trade Item Number;
(11) 6-digit date of manufacture;
(21) 7-digit serial number. FCC and IC information This equipment complies with part15 of the FCC rules and the IC RSS210. FCC ID: S8Q-RU2020 IC: 4763B-RU2020 FCC WARNING Change or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. NOTE This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help. App. 652 OER-Elite OPERATION MANUAL EMC information EMC information Guidance and manufacturers declaration Electromagnetic emissions This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment Guidance RF emissions CISPR 11 Radiated emissions CISPR 11 Main terminal conducted emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 Group 1 Class B This instrument uses RF (Radio Frequency) energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. This instruments RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Not applicable Not applicable Power supply specification of this instrument is less than 220 VAC, and this instrument is exempt from requirements of IEC 61000-3-2. Power supply specification of this instrument is less than 220 VAC, and this instrument is exempt from requirements of IEC 61000-3-3. App. OER-Elite OPERATION MANUAL 653 EMC information Guidance and manufacturers declaration Electromagnetic immunity This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 Definition App. IEC 61326-1 test level Contact:
r2, r4 kV Air:
r2, r4, r8 kV r2 kV for power supply lines r1 kV for input/output lines Differential mode:
r1 kV Common mode:
r1, r2 kV 0% UT
(100% dip in UT) for 1 cycle 40% UT
(60% dip in UT) for 200 ms 70% UT
(30% dip in UT) for 500 ms 0% UT
(100% dip in UT) for 5 seconds 30 A/m Compliance level Same as left Same as left Electromagnetic environment Guidance Floors should be made of wood, concrete, or ceramic tile that hardly produces static. If floors are covered with synthetic material that tends to produce static, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial (original condition feeding the facilities) or hospital environment. Same as left Mains power quality should be that of a typical commercial or hospital environment. Same as left Mains power quality should be that of a typical commercial or hospital environment. If the user of this instrument requires continued operation during power mains interruptions, it is recommended that this instrument be powered from an uninterruptible power supply or a battery. Same as left It is recommended to use this instrument by maintaining enough distance from any equipment that operates with high current. UT is the a.c. mains voltage prior to application of the test level. 654 OER-Elite OPERATION MANUAL EMC information Guidance and manufacturers declaration Electromagnetic immunity This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of this model, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Immunity test IEC 61326-1 test level Compliance level Electromagnetic environment Guidance Conducted RF IEC 61000-4-6 3 Vrms
(150 kHz 80 MHz) 3 V (V1) Radiated RF IEC 61000-4-3 10 V/m (E1) 3 V/m (E2) 1 V/m (E3) 10V/m
(80 MHz 1 GHz) 3V/m
(1.4 GHz 2 GHz) 1V/m
(2 GHz 2.7 GHz) Recommended separation distance
(V1=3 according to the compliance level) d
=
3.5
-------
V1 P Recommended separation distance
(E1=10, E2=3, E3=1 according to the compliance level) d
=
d
=
d
=
d
=
3.5
-------
E1 7
------
E1 7
------
E2 7
------
E3 P P P P 80 MHz 800 MHz 800 MHz 1 GHz 1.4 GHz 2 GHz 2 GHz 2.7 GHz Definition Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). NOTE At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Electromagnetic interference may occur in the vicinity of high-frequency electrosurgical equipment and/or other equipment marked with the following symbol:
App. OER-Elite OPERATION MANUAL 655 EMC information NOTE Field strength from fixed RF transmitters as determined by an electromagnetic site surveya) should be less than the compliance level in each frequency rangeb). a) Field strength from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this model is used exceeds the applicable RF compliance level above, this model should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating this model. b) Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m. App. 656 OER-Elite OPERATION MANUAL EMC information Recommended separation distances between portable and mobile RF communications equipment and this model This model is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this model can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this model as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter (m)
(calculated as V1=3, E1=10, E2=3 and E3=1) 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 1 GHz P (W) 0.01 0.1 1 10 100 d
=
1.2 P d
=
0.35 P d
=
0.7 P 0.12 0.38 1.2 3.8 12 0.04 0.12 0.35 1.2 3.5 0.07 0.23 0.70 2.3 7 Rated maximum output power of transmitter Separation distance according to frequency of transmitter (m)
(calculated as V1=3, E1=10, E2=3 and E3=1) 1.4 GHz 2 GHz 2 GHz 2.7 GHz P (W) 0.01 0.1 1 10 100 d
=
2.4 P d
=
7 P 0.24 0.76 2.4 7.6 24 0.7 2.3 7 23 70 Others For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. App. OER-Elite OPERATION MANUAL 657 License information of Open Source Software License information of Open Source Software GNU GPL This product uses software modules licensed under the terms of the GNU GENERAL PUBLIC LICENSE(GPL). Please see the following table for the software module made the target. Software modules concerned libgcc libstdc++
End User License Agreement of software modules GNU GENERAL PUBLIC LICENSE Version 2 with Exception z End User License Agreement of Open Source Software modules This section must not be translated by any language and must not be changed from original text. Because these license description must be described original description in English according to these license. GNU GENERAL PUBLIC LICENSE Version 2 with Exception About libgcc and libstdc++, those are licensed under the terms of the GNU GENERAL PUBLIC LICENSE Version 2 with special exception or additional permission to show in the following. a) libstdc++
The libstdc++ source code is distributed under the GNU General Public License version 2, with the so-called Runtime Exception as follows (or see any header or implementation file). As a special exception, you may use this file as part of a free software library without restriction. Specifically, if other files instantiate templates or use macros or inline functions from this file, or you compile this file and link it with other files to produce an executable, this file does not by itself cause the resulting executable to be covered by the GNU General Public License. This exception does not however invalidate any other reasons why the executable file might be covered by the GNU General Public License. App. b) libgcc GCC is free software; you can redistribute it and/or modify it under the terms of the GNU General Public License as published by the Free Software Foundation; either version 2, or (at your option) any later version. 658 OER-Elite OPERATION MANUAL License information of Open Source Software In addition to the permissions in the GNU General Public License, the Free Software Foundation gives you unlimited permission to link the compiled version of this file into combinations with other programs, and to distribute those combinations without any restriction coming from the use of this file. (The General Public License restrictions do apply in other respects; for example, they cover modification of the file, and distribution when not linked into a combined executable.) GCC is distributed in the hope that it will be useful, but WITHOUT ANY WARRANTY; without even the implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE. See the GNU General Public License for more details. Others This instrument contains software modules which are not licensed under the terms of GPL. This section must not be translated by any language and must not be changed from original text. Because these license description must be described original description in English according to these license. The Licensed Software may include (i) some open source software and (ii) other third party software
(collectively, Third Party Software). Regarding the use of the Third Party Software, you shall follow the license terms and conditions applied to such Third Party Software. Any part of this License Agreement does not restrict, change or alter any of your rights and obligations imposed by the license terms and conditions of the Third Party Software. newlib This product uses the open source software program newlib which applies the terms and conditions provided by owner of the copyright to the newlib. The newlib subdirectory is a collection of software from several sources. Each file may have its own copyright/license that is embedded in the source file.
(1) Red Hat Incorporated Copyright (c) 1994-2007 Red Hat, Inc. All rights reserved. This copyrighted material is made available to anyone wishing to use, modify, copy, or redistribute it subject to the terms and conditions of the BSD License. This program is distributed in the hope that it will be useful, but WITHOUT ANY WARRANTY expressed or implied, including the implied warranties of MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE. A copy of this license is available at http://www.opensource.org/licenses. Any Red Hat trademarks that are incorporated in the source code or documentation are not subject to the BSD License and may only be used or replicated with the express permission of Red Hat, Inc. App.
(2) University of California, Berkeley Copyright (c) 1981-2000 The Regents of the University of California. All rights reserved. OER-Elite OPERATION MANUAL 659 License information of Open Source Software Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
* Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.
* Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.
* Neither the name of the University nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT OWNER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITYOF SUCH DAMAGE.
(3) David M. Gay at AT&T The author of this software is David M. Gay. Copyright (c) 1991 by AT&T. Permission to use, copy, modify, and distribute this software for any purpose without fee is hereby granted, provided that this entire notice is included in all copies of any software which is or includes a copy or modification of this software and in all copies of the supporting documentation for such software. THIS SOFTWARE IS BEING PROVIDED AS IS, WITHOUT ANY EXPRESS OR IMPLIED WARRANTY. IN PARTICULAR, NEITHER THE AUTHOR NOR AT&T MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND CONCERNING THE MERCHANTABILITY OF THIS SOFTWARE OR ITS FITNESS FOR ANY PARTICULAR PURPOSE.
-------------------------------------------------------------------
The author of this software is David M. Gay. App. Copyright (C) 1998-2001 by Lucent Technologies All Rights Reserved 660 OER-Elite OPERATION MANUAL License information of Open Source Software Permission to use, copy, modify, and distribute this software and its documentation for any purpose and without fee is hereby granted, provided that the above copyright notice appear in all copies and that both that the copyright notice and this permission notice and warranty disclaimer appear in supporting documentation, and that the name of Lucent or any of its entities not be used in advertising or publicity pertaining to distribution of the software without specific, written prior permission. LUCENT DISCLAIMS ALL WARRANTIES WITH REGARD TO THIS SOFTWARE, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS. IN NO EVENT SHALL LUCENT OR ANY OF ITS ENTITIES BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER IN AN ACTION OF CONTRACT, NEGLIGENCE OR OTHER TORTIOUS ACTION, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS SOFTWARE.
(4) Advanced Micro Devices Copyright 1989, 1990 Advanced Micro Devices, Inc. This software is the property of Advanced Micro Devices, Inc (AMD) which specifically grants the user the right to modify, use and distribute this software provided this notice is not removed or altered. All other rights are reserved by AMD. AMD MAKES NO WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH REGARD TO THIS SOFTWARE. IN NO EVENT SHALL AMD BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS SOFTWARE. So that all may benefit from your experience, please report any problems or suggestions about this software to the 29K Technical Support Center at 800-29-29-AMD (800-292-9263) in the USA, or 0800-89-1131 in the UK, or 0031-11-1129 in Japan, toll free. The direct dial number is 512-462-4118. Advanced Micro Devices, Inc. 29K Support Products Mail Stop 573 5900 E. Ben White Blvd. Austin, TX 78741 800-292-9263
(5) C.W. Sandmann Copyright (C) 1993 C.W. Sandmann This file may be freely distributed as long as the author's name remains. App. OER-Elite OPERATION MANUAL 661 License information of Open Source Software
(6) Eric Backus
(C) Copyright 1992 Eric Backus This software may be used freely so long as this copyright notice is left intact. There is no warrantee on this software.
(7) Sun Microsystems Copyright (C) 1993 by Sun Microsystems, Inc. All rights reserved. Developed at SunPro, a Sun Microsystems, Inc. business. Permission to use, copy, modify, and distribute this software is freely granted, provided that this notice is preserved.
(8) Hewlett Packard
(c) Copyright 1986 HEWLETT-PACKARD COMPANY To anyone who acknowledges that this file is provided AS IS without any express or implied warranty:
permission to use, copy, modify, and distribute this file for any purpose is hereby granted without fee, provided that the above copyright notice and this notice appears in all copies, and that the name of Hewlett-Packard Company not be used in advertising or publicity pertaining to distribution of the software without specific, written prior permission. Hewlett-Packard Company makes no representations about the suitability of this software for any purpose.
(9) Hans-Peter Nilsson Copyright (C) 2001 Hans-Peter Nilsson Permission to use, copy, modify, and distribute this software is freely granted, provided that the above copyright notice, this notice and the following disclaimer are preserved with no changes. THIS SOFTWARE IS PROVIDED AS IS AND WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
(11) Christopher G. Demetriou Copyright (c) 2001 Christopher G. Demetriou All rights reserved. App. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
662 OER-Elite OPERATION MANUAL License information of Open Source Software 1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. 3. The name of the author may not be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(12) SuperH, Inc. Copyright 2002 SuperH, Inc. All rights reserved This software is the property of SuperH, Inc (SuperH) which specifically grants the user the right to modify, use and distribute this software provided this notice is not removed or altered. All other rights are reserved by SuperH. SUPERH MAKES NO WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH REGARD TO THIS SOFTWARE. IN NO EVENT SHALL SUPERH BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS SOFTWARE. So that all may benefit from your experience, please report any problems or suggestions about this software to the SuperH Support Center via e-mail at softwaresupport@superh.com . SuperH, Inc. 405 River Oaks Parkway San Jose CA 95134 USA App.
(13) Royal Institute of Technology Copyright (c) 1999 Kungliga Tekniska H skolan (Royal Institute of Technology, Stockholm, Sweden). All rights reserved. OER-Elite OPERATION MANUAL 663 License information of Open Source Software Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. 3. Neither the name of KTH nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED BY KTH AND ITS CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL KTH OR ITS CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(14) Alexey Zelkin Copyright (c) 2000, 2001 Alexey Zelkin <phantom@FreeBSD.org>
All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. App. 664 OER-Elite OPERATION MANUAL License information of Open Source Software
(15) Andrey A. Chernov Copyright (C) 1997 by Andrey A. Chernov, Moscow, Russia. All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE REGENTS OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(16) FreeBSD Copyright (c) 1997-2002 FreeBSD Project. All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. App. OER-Elite OPERATION MANUAL 665 License information of Open Source Software
(17) S. L. Moshier Author: S. L. Moshier. Copyright (c) 1984,2000 S.L. Moshier Permission to use, copy, modify, and distribute this software for any purpose without fee is hereby granted, provided that this entire notice is included in all copies of any software which is or includes a copy or modification of this software and in all copies of the supporting documentation for such software. THIS SOFTWARE IS BEING PROVIDED AS IS, WITHOUT ANY EXPRESS OR IMPLIED WARRANTY. IN PARTICULAR, THE AUTHOR MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND CONCERNING THE MERCHANTABILITY OF THIS SOFTWARE OR ITS FITNESS FOR ANY PARTICULAR PURPOSE.
(18) Citrus Project Copyright (c)1999 Citrus Project, All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(19) Todd C. Miller Copyright (c) 1998 Todd C. Miller <Todd.Miller@courtesan.com>
All rights reserved. App. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
666 OER-Elite OPERATION MANUAL License information of Open Source Software 1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. 3. The name of the author may not be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(26) Mike Barcroft Copyright (c) 2001 Mike Barcroft <mike@FreeBSD.org>
All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. App. OER-Elite OPERATION MANUAL 667 License information of Open Source Software
(27) Konstantin Chuguev (--enable-newlib-iconv) Copyright (c) 1999, 2000 Konstantin Chuguev. All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. iconv (Charset Conversion Library) v2.0
(28) Artem Bityuckiy (--enable-newlib-iconv) Copyright (c) 2003, Artem B. Bityuckiy, SoftMine Corporation. Rights transferred to Franklin Electronic Publishers. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. App. 668 OER-Elite OPERATION MANUAL License information of Open Source Software THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. libhal_bsp This product uses the open source software program libhal_bsp which applies the terms and conditions provided by owner of the copyright to the libhal_bsp. Copyright (c) 2003 Altera Corporation, San Jose, California, USA. All rights reserved. Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the Software), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:
The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. App. OER-Elite OPERATION MANUAL 669 License information of Open Source Software License information of Open Source Software z End User License Agreement of Open Source Software modules This instrument contains software modules which are not licensed under the terms of GPL. This section must not be translated by any language and must not be changed from original text. Because these license description must be described original description in English according to these license. The Licensed Software may include (i) some open source software and (ii) other third party software
(collectively, Third Party Software). Regarding the use of the Third Party Software, you shall follow the license terms and conditions applied to such Third Party Software. Any part of this License Agreement does not restrict, change or alter any of your rights and obligations imposed by the license terms and conditions of the Third Party Software. newlib MAJ-2130, which is NLV-3101 manufactured by OPTO ELECTORONICS CO.,LTD, uses the open source software program newlib which applies the terms and conditions provided by owner of the copyright to the newlib. The newlib subdirectory is a collection of software from several sources. Each file may have its own copyright/license that is embedded in the source file(s), the following copyright notices will apply to the contents of the newlib subdirectory:
(1) Red Hat Incorporated Copyright (c) 1994-2009 Red Hat, Inc. All rights reserved. This copyrighted material is made available to anyone wishing to use, modify, copy, or redistribute it subject to the terms and conditions of the BSD License. This program is distributed in the hope that it will be useful, but WITHOUT ANY WARRANTY expressed or implied, including the implied warranties of MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE. A copy of this license is available at http://www.opensource.org/licenses. Any Red Hat trademarks that are incorporated in the source code or documentation are not subject to the BSD License and may only be used or replicated with the express permission of Red Hat, Inc. App.
(2) University of California, Berkeley Copyright (c) 1981-2000 The Regents of the University of California. All rights reserved. 670 OER-Elite OPERATION MANUAL License information of Open Source Software Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
* Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.
* Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.
* Neither the name of the University nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT OWNER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITYOF SUCH DAMAGE.
(3) David M. Gay at AT&T The author of this software is David M. Gay. Copyright (c) 1991 by AT&T. Permission to use, copy, modify, and distribute this software for any purpose without fee is hereby granted, provided that this entire notice is included in all copies of any software which is or includes a copy or modification of this software and in all copies of the supporting documentation for such software. THIS SOFTWARE IS BEING PROVIDED AS IS, WITHOUT ANY EXPRESS OR IMPLIED WARRANTY. IN PARTICULAR, NEITHER THE AUTHOR NOR AT&T MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND CONCERNING THE MERCHANTABILITY OF THIS SOFTWARE OR ITS FITNESS FOR ANY PARTICULAR PURPOSE.
-------------------------------------------------------------------
The author of this software is David M. Gay. Copyright (C) 1998-2001 by Lucent Technologies All Rights Reserved App. OER-Elite OPERATION MANUAL 671 License information of Open Source Software Permission to use, copy, modify, and distribute this software and its documentation for any purpose and without fee is hereby granted, provided that the above copyright notice appear in all copies and that both that the copyright notice and this permission notice and warranty disclaimer appear in supporting documentation, and that the name of Lucent or any of its entities not be used in advertising or publicity pertaining to distribution of the software without specific, written prior permission. LUCENT DISCLAIMS ALL WARRANTIES WITH REGARD TO THIS SOFTWARE, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS. IN NO EVENT SHALL LUCENT OR ANY OF ITS ENTITIES BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER IN AN ACTION OF CONTRACT, NEGLIGENCE OR OTHER TORTIOUS ACTION, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS SOFTWARE.
(4) Advanced Micro Devices Copyright 1989, 1990 Advanced Micro Devices, Inc. This software is the property of Advanced Micro Devices, Inc (AMD) which specifically grants the user the right to modify, use and distribute this software provided this notice is not removed or altered. All other rights are reserved by AMD. AMD MAKES NO WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH REGARD TO THIS SOFTWARE. IN NO EVENT SHALL AMD BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS SOFTWARE. So that all may benefit from your experience, please report any problems or suggestions about this software to the 29K Technical Support Center at 800-29-29-AMD (800-292-9263) in the USA, or 0800-89-1131 in the UK, or 0031-11-1129 in Japan, toll free. The direct dial number is 512-462-4118. Advanced Micro Devices, Inc. 29K Support Products Mail Stop 573 5900 E. Ben White Blvd. Austin, TX 78741 800-292-9263 App. 672 OER-Elite OPERATION MANUAL License information of Open Source Software
(7) Sun Microsystems Copyright (C) 1993 by Sun Microsystems, Inc. All rights reserved. Developed at SunPro, a Sun Microsystems, Inc. business. Permission to use, copy, modify, and distribute this software is freely granted, provided that this notice is preserved.
(8) Hewlett Packard
(c) Copyright 1986 HEWLETT-PACKARD COMPANY To anyone who acknowledges that this file is provided AS IS without any express or implied warranty:
permission to use, copy, modify, and distribute this file for any purpose is hereby granted without fee, provided that the above copyright notice and this notice appears in all copies, and that the name of Hewlett-Packard Company not be used in advertising or publicity pertaining to distribution of the software without specific, written prior permission. Hewlett-Packard Company makes no representations about the suitability of this software for any purpose.
(9) Hans-Peter Nilsson Copyright (C) 2001 Hans-Peter Nilsson Permission to use, copy, modify, and distribute this software is freely granted, provided that the above copyright notice, this notice and the following disclaimer are preserved with no changes. THIS SOFTWARE IS PROVIDED AS IS AND WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
(10) Stephane Carrez (m68hc11-elf/m68hc12-elf targets only) Copyright (C) 1999, 2000, 2001, 2002 Stephane Carrez (stcarrez@nerim.fr) The authors hereby grant permission to use, copy, modify, distribute, and license this software and its documentation for any purpose, provided that existing copyright notices are retained in all copies and that this notice is included verbatim in any distributions. No written agreement, license, or royalty fee is required for any of the authorized uses. Modifications to this software may be copyrighted by their authors and need not follow the licensing terms described here, provided that the new terms are clearly indicated on the first page of each file where they apply. App. OER-Elite OPERATION MANUAL 673 2017 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved. No part of this publication may be reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS is a registered trademark of OLYMPUS CORPORATION. Trademarks, product names, logos, or trade names used in this document are generally registered trademarks or trademarks of each company. Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (042)646-2429 Telephone: (042)642-2111 Distributed by 3500 Corporate Parkway, P.O. Box 610, Center Valley, PA 18034-0610, U.S.A. Fax: (484)896-7128 Telephone: (484)896-5000 5301 Blue Lagoon Drive, Suite 290 Miami, FL 33126-2097, U.S.A. Fax: (305)261-4421 Telephone: (305)266-2332
(Premises/Goods delivery) Wendenstrasse 14-18, 20097 Hamburg, Germany
(Letters) Postfach 10 49 08, 20034 Hamburg, Germany Fax: (040)23773-4656 Telephone: (040)23773-0 KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom Fax: (01702)465677 Telephone: (01702)616333 Elektrozavodskaya str. 27 bld.8, 107023 Moscow, Russia Fax: (7)495-663-8486 Telephone: (7)495-926-7077 A8F, Ping An International Financial Center, No. 1-3, Xinyuan South Road, Chaoyang District, Beijing, 100027 P.R.C. Fax: (86)10-5976-1299 Telephone: (86)10-5819-9000 Olympus Tower 9F, 446, Bongeunsa-ro, Gangnam-gu, Seoul, Korea 135-509 Fax: (02)6255-3494 Telephone: (02)6255-3210 491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: 6834-2438 Telephone: 6834-0010 3 Acacia Place, Notting Hill, VIC 3168, Australia Fax: (03)9543-1350 Telephone: (03)9265-5400 GT9882 01 Printed in Japan 20170706 *0000 License information of Open Source Software
(11) Christopher G. Demetriou Copyright (c) 2001 Christopher G. Demetriou All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. 3. The name of the author may not be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(12) SuperH, Inc. Copyright 2002 SuperH, Inc. All rights reserved This software is the property of SuperH, Inc (SuperH) which specifically grants the user the right to modify, use and distribute this software provided this notice is not removed or altered. All other rights are reserved by SuperH. SUPERH MAKES NO WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH REGARD TO THIS SOFTWARE. IN NO EVENT SHALL SUPERH BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS SOFTWARE. App. So that all may benefit from your experience, please report any problems or suggestions about this software to the SuperH Support Center via e-mail at softwaresupport@superh.com . 674 OER-Elite OPERATION MANUAL License information of Open Source Software SuperH, Inc. 405 River Oaks Parkway San Jose CA 95134 USA
(13) Royal Institute of Technology Copyright (c) 1999 Kungliga Tekniska H skolan (Royal Institute of Technology, Stockholm, Sweden). All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. 3. Neither the name of KTH nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED BY KTH AND ITS CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL KTH OR ITS CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(14) Alexey Zelkin Copyright (c) 2000, 2001 Alexey Zelkin <phantom@FreeBSD.org>
All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. App. OER-Elite OPERATION MANUAL 675 License information of Open Source Software THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(15) Andrey A. Chernov Copyright (C) 1997 by Andrey A. Chernov, Moscow, Russia. All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE REGENTS OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(16) FreeBSD Copyright (c) 1997-2002 FreeBSD Project. All rights reserved. App. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
676 OER-Elite OPERATION MANUAL License information of Open Source Software 1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(17) S. L. Moshier Author: S. L. Moshier. Copyright (c) 1984,2000 S.L. Moshier Permission to use, copy, modify, and distribute this software for any purpose without fee is hereby granted, provided that this entire notice is included in all copies of any software which is or includes a copy or modification of this software and in all copies of the supporting documentation for such software. THIS SOFTWARE IS BEING PROVIDED AS IS, WITHOUT ANY EXPRESS OR IMPLIED WARRANTY. IN PARTICULAR, THE AUTHOR MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND CONCERNING THE MERCHANTABILITY OF THIS SOFTWARE OR ITS FITNESS FOR ANY PARTICULAR PURPOSE.
(18) Citrus Project Copyright (c)1999 Citrus Project, All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. App. OER-Elite OPERATION MANUAL 677 License information of Open Source Software THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(19) Todd C. Miller Copyright (c) 1998 Todd C. Miller <Todd.Miller@courtesan.com>
All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. 3. The name of the author may not be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(26) Mike Barcroft Copyright (c) 2001 Mike Barcroft <mike@FreeBSD.org>
All rights reserved. App. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
678 OER-Elite OPERATION MANUAL License information of Open Source Software 1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
(35) - ARM Ltd (arm and thumb variant targets only) Copyright (c) 2009 ARM Ltd All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. 3. The name of the company may not be used to endorse or promote products derived from this software without specific prior written permission. THIS SOFTWARE IS PROVIDED BY ARM LTD AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL ARM LTD BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. App. OER-Elite OPERATION MANUAL 679 License information of Open Source Software
(41) Ed Schouten - Free BSD Copyright (c) 2008 Ed Schouten <ed@FreeBSD.org>
All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. THIS SOFTWARE IS PROVIDED BY THE AUTHOR AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES
(INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;
LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. App. 680 OER-Elite OPERATION MANUAL
1 | Authorization Letter | Attestation Statements | 340.38 KiB |
OLYMPUS Your Vision, Our Future June 16, 2017 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Attn: Reviewing Engineer RE: LETTER OF AGENT AUTHORIZATION To Whom It May Concern:
We, the undersigned, hereby authorize any individual within Intertek Japan K.K. to act on our behalf in all matters relating to application for equipment authorization, including the signing of all documents relating to these matters. We also hereby certify that no party to the application authorized hereunder is subject to the denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988,21 US.C.862. This agreement expires one year from the current date. Sincerely, EL2LCL Shigeki Okuno Manager Regulatory Compliance Quality & Regulatory Management Department Medical Quality & Regulatory Division OLYMPUS MEDICAL SYSTEMS CORP.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2017-09-22 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2017-09-22
|
||||
1 | Applicant's complete, legal business name |
Olympus Medical Systems Corp.
|
||||
1 | FCC Registration Number (FRN) |
0013084561
|
||||
1 | Physical Address |
2951 Ishikawa-machi
|
||||
1 |
hachioji-shi, N/A
|
|||||
1 |
Japan
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@pctest.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
S8Q
|
||||
1 | Equipment Product Code |
RU2020
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
T**** N********
|
||||
1 | Title |
Chief Manager
|
||||
1 | Telephone Number |
81426********
|
||||
1 | Fax Number |
81426********
|
||||
1 |
t******@ot.olympus.co.jp
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
PCTEST Engineering Laboratory, Inc.
|
||||
1 | Name |
R****** O******
|
||||
1 | Physical Address |
6660-B Dobbin Road
|
||||
1 |
Columbia, Maryland 21045
|
|||||
1 |
United States
|
|||||
1 | Telephone Number |
410-2********
|
||||
1 | Fax Number |
410-2********
|
||||
1 |
t******@pctest.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 03/21/2018 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Endoscope Reprocessor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Intertek Japan K.K.(Kashima Laboratory)
|
||||
1 | Name |
J******** O********
|
||||
1 | Telephone Number |
81-29********
|
||||
1 | Fax Number |
81-29********
|
||||
1 |
j******@intertek.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC