FCC ID: 2AR2I-CSCM6000 CADD Solis

2110 Software version 4.2 The CADD-Solis Ambulatory Infusion System is designed to promote patient care and safety for a variety of adult and pediatric patients and clinical care areas, including but not limited to post-operative, trauma, critical care, oncology, and labor and delivery. The pump can be programmed with a protocol configuration consisting of a therapy, qualifier, and drug. Medication is delivered at a constant rate, and/or with an intermittent bolus, and/or with a patient dose. This manual concerns CADD-Solis Ambulatory Infusion Pumps, model 2110, with software version 4.2

(Software package # 97-0582-0402XX-01). Smiths Medical recommends that you maintain the same software version across all CADD-Solis pump models in your facility. This operators manual, the pump, and its accessories are intended for trained clinician use only. Do not permit unauthorized clinicians or patients to have access to it. The pump has three security levels designed to limit overall patient access, and clinician access to certain pump features. Only disclose the pump security codes to those who are authorized. Access to the pump key should also be restricted. Contact Smiths Medical and/or your facilitys policies and procedures for additional training information and materials for the safe and effective use of the pump. The issue date of this operators manual is included on the back cover. In the event one year has elapsed between the issue date and product use, contact Smiths Medical to see if an updated version is available. Technical Assistance If you have comments or questions concerning the operation of the CADD-Solis Ambulatory Infusion Pump, call the number given below. When calling, specify the pump software version number. This information is located in the device information report (See Reports on page 39). Smiths Medical is available to help with the programming and operation of the CADD-Solis Ambulatory Infusion Pump. If this manual is being viewed electronically, a printed copy is available from Smiths Medical upon request. U.S. Distribution:

Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 USA Tel: 1 800 258 5361 (US/CA) Tel: +1 614 210 7300 European Representative:

Smiths Medical Czech Republic a.s. Olomouck 306, Hranice 1 - Msto, 753 01 Hranice, Czech Republic Tel: +44 (0) 1233 722100 www.smiths-medical.com 2 Read this entire Operators Manual before operating the CADD-Solis Ambulatory Infusion Pump. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. Contraindications The pump is not to be used for delivery of blood or cellular blood products, as blood and cellular blood products will be damaged by the pumping mechanism. This pump is not to be used in any intra-articular space infusion. Warnings This operators manual, the pump, and its accessories should be used only by clinicians that have been trained and authorized per your facilitys policies and procedures. To avoid explosion hazard, do not use the pump in the presence of flammable anesthetics or explosive gases. For patients likely to be adversely affected by unintended operations and failures, including interrupted medication or fluid delivery from the device, close supervision and provision for immediate corrective action should be provided in order to assure minimum medication delivery interruption. Pump failure suspends medication delivery, and unintended pump operations could lead to a variety of consequences for the patient. If the pump is used to deliver life-sustaining medication, an additional pump must be available, and close supervision and provision for immediate corrective action should be provided to assure minimum medication delivery interruption in the event of a pump failure. Pump failure suspends medication delivery. The user should ensure that the performance offered by the pump is fit for the intended use and that the pump is not used in any way or for any purpose other than its intended use. If the pump is dropped or hit, inspect it for damage. Do not use a pump that is damaged or not functioning properly. Contact Smiths Medical Customer Service to return a pump for service. To avoid patient injury and electric shock, remove the pump from patient use prior to any preventative maintenance and servicing of the pump. Do not use a syringe with the CADD-Solis pump. The use of a syringe could result in underdelivery of medication. The CADD-Solis pump and accessories include small component pieces that could pose a choking hazard to young children. Do not administer drugs to the epidural space or subarachnoid space unless the drug is indicated for administration to those spaces. To prevent the infusion of drugs that are not indicated for epidural space or subarachnoid space infusion, DO NOT use administration sets that incorporate injection sites. If a CADD medication cassette reservoir, CADD extension set, or CADD administration set is used for epidural space or subarachnoid space drug delivery, it is strongly recommended that it be clearly differentiated from those used for other routes of infusion (for example, by color coding or other means of identification). If the air detector is turned off, the pump does not detect air in the fluid path. It is recommended that you periodically inspect the fluid path and remove any air to prevent air embolism. The air detector, when turned on, may be set to detect and alarm for air bubbles as small as 150 uL. The High Sensitivity setting and/or filtered sets should be considered for patients and therapies with a risk of harm due to an air embolism. 3 When the upstream occlusion sensor is turned off, the pump does not detect occlusions upstream between the pump and the reservoir. Periodic inspection of the fluid path for kinks, a closed clamp, or other upstream obstructions is recommended. Upstream occlusions may result in underdelivery of medication. Do not use rechargeable NiCd or nickel metal hydride (NiMH) batteries. Do not use carbon zinc (heavy duty) batteries. They do not provide sufficient power for the pump to operate properly. Always have new batteries available for replacement. If power is lost, nondelivery of drug occurs. A rechargeable battery pack that has reached the end of it useful life must be replaced with either another CADD-Solis rechargeable battery pack or with 4 AA batteries. There is no pump alarm to alert users that a battery has not been properly installed. An improperly installed battery could result in loss of power and nondelivery of drug. A hazard can exist if different alarm styles are used on multiple pumps in the same single care area; for example, a critical care area or operating room. Auditory alarm signal sound levels that are less than ambient levels can hinder operator recognition of alarm conditions. A hazard can exist if a user depends on audible alarm indications without a corresponding visual indication. Use of low volume alarm settings or distance from the device can hinder operator recognition of alarm conditions when hearing impairment may be a concern, or when the clinician may be away from the device. Always check the battery compartment for fluid or debris before inserting the batteries and do not allow any fluid or debris to fall into the battery compartment. Fluid or debris in the battery compartment may damage the battery contacts and could result in loss of power and nondelivery of drug. If the pump is dropped or hit, the battery door may become broken or damaged. Do not use the pump if the battery door is damaged because the batteries will not be properly secured. This may result in loss of power and non-delivery of drug. Follow the instructions for use provided with the CADD medication cassette reservoir, CADD extension set, or CADD administration set, paying particular attention to all warnings and cautions associated with their use. Carefully route tubing, cords, and cables to reduce the possibility of patient entanglement or strangulation. Attach the cassette properly. A detached or improperly attached cassette could result in unregulated gravity infusion of medication from the reservoir or a reflux of blood. If you are using a CADD administration set or CADD medication cassette reservoir that does not have the Flow Stop feature, you must use a CADD extension set with anti-siphon valve or a CADD administration set with either an integral or add-on anti-siphon valve to protect against unregulated gravity infusion that can result from an improperly attached cassette. Per general rules of safe practice, always clamp the tubing before removing the cassette from the pump. Removing the cassette without closing the clamp could potentially cause unregulated gravity infusion. Do not disclose pump security codes or any other information that would allow the patient or unauthorized clinician complete access to programming and operating functions. Do not leave the pump unattended while unlocked. Many programming functions are accessible while the pump is unlocked. Exercise care when using the clinician bolus function. Because there are no limits to the frequency of delivering a bolus, and because the bolus amount may be set as high as 50 mL (or the mg or mcg equivalent), do not permit the patient or an unauthorized clinician to become familiar with the procedure for giving a clinician bolus. To prevent the patient from accessing the clinician bolus function, do not let the patient know the security codes. 4 Never leave the pump unattended while on the clinician bolus edit screen. You must deliver the programmed value, or cancel to leave the screen. Do not prime the fluid path with the tubing connected to a patient as this could result in overdelivery of medication or air embolism. To prevent air embolism, ensure that the entire fluid path is free of all air bubbles before connecting to the patient. The remote dose cord is for patient use only. Operation by anyone other than the patient may cause overdelivery of medication. The manual program mode does not contain programming limits. Carefully review each parameter to ensure it accurately matches the prescription. Always carefully review the program on the pump after it has been programmed to verify that the pump is programmed correctly. The pump and reusable accessories should be cleaned and disinfected after each patient use and in accordance with this manual and your organizations policies and procedures for reusable, solid surface, non-critical medical devices. Ensure that debris is not allowed to build up on the pressure plate surface of the pumping mechanism. Inspect the air detector sensor slot and remove any debris. A blocked air detector sensor may not detect air present in the fluid path. Ensure that the 6% system delivery accuracy specification is taken into account when programming the pump and/or filling the reservoir. Failure to do so may result in medication in the reservoir becoming depleted sooner than expected. System delivery inaccuracies beyond 6% may occur as a result of back pressure or fluid resistance, which depends upon temperature, drug viscosity, catheter size, extension set tubing (for example, microbore), in-line components (such as filters and needleless access connectors), and placing the infusion reservoir and/or pump above or below the level of the patient. System delivery inaccuracy may result in under or overdelivery of medication. (See System Delivery Accuracy on page 75 for more information.) The use of power supplies and a remote dose cord other than those listed in the electromagnetic emissions declaration may result in increased emissions or decreased immunity of the pump. Serious harm to the patient or operator may result from the use of modified parts or parts not authorized by Smiths Medical. Do not modify the system, parts, or accessories. The pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, you should verify normal operation of the pump in the configuration in which it is to be used. Common portable and mobile consumer electronic devices may cause interference with the pump. Observe the pump to verify normal operation. If abnormal performance is observed, it may be necessary to reorient or relocate the pump away from radio frequency transmitting devices. To avoid electric shock, do not touch the Power Jack, Remote Dose Cord Jack, USB Port, Battery Terminals, or any other connectors and the patient simultaneously. Residential/facility wiring must comply with all applicable electrical codes. Do not bypass power cord connections. Do not remove a prong from the power cord. There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) reservoirs and extension sets. Dispose of used batteries, reservoirs, extension sets, and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply. Always set the Delivery Limit amount alarm, Reservoir Volume Low alarm, and all other variable alarm settings to clinically appropriate settings. Setting alarm limits to values not clinically safe for the patient may cause patient harm due to a delay in therapy. To avoid any potential electrical interference or delivery inaccuracies, power off the pump when the pump is being transported in an aircraft. 5 Cautions Do not operate the pump at temperatures below 2C (36F) or above 40C (104F) to avoid damaging the electronic circuitry. Do not store the pump at temperatures below 20C (4F) or above 60C (140F) to avoid damaging the electronic circuitry. Do not store the pump with a CADD medication cassette reservoir or CADD administration set attached. If the pump is stored outside of the environmental operating conditions and within the specified environmental storage conditions, allow the pump to warm or cool to operating temperature for at least one hour prior to use to avoid damaging the electronic circuitry. Do not expose the pump to humidity levels below 20% or above 90% relative humidity to avoid damaging the electronic circuitry. CADD pumps are sealed units. A broken or damaged seal will therefore be considered conclusive evidence that the pump has been misused and/or altered, which voids any and all warranties. All service and repair of CADD pumps must be performed by Smiths Medical or its authorized agents. Inspect the AA batteries for damage or wear to the metal or plastic insulation prior to use, or after the pump has been dropped or hit. Replace the batteries if any damage is noted. Do not store the pump for prolonged periods with the batteries installed. Battery leakage could damage the pump. If the power up results in an error message indicating that the protocol library was lost, do not proceed with using the pump. Follow your facilitys procedures for downloading protocol libraries. Use only Smiths Medical accessories that are specified for use with the CADD-Solis Ambulatory Infusion Pump, as other brands may adversely affect pump operation. If you are using a CADD medication cassette reservoir in which the medication is frozen, thaw at room temperature only. Do not heat in a microwave oven as this may damage the product and cause leakage. Do not immerse the pump in cleaning fluid or water. Do not allow solution to soak in to the pump, accumulate on the keypad, or enter the battery compartment, USB port, remote dose cord jack, or power jack areas. Moisture buildup inside the pump may damage the pump. Do not oversaturate the chassis area on the bottom of the pump with cleaning or disinfecting solutions. Oversaturating this area can cause damage to the pump sensors over time. Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners, as damage to the pump may occur. Also refer to the instructions for use for each accessory before proceeding with cleaning and disinfecting. Some accessories may have their own list of acceptable cleaning and disinfecting solutions. The pump should not be directly irradiated by therapeutic levels of ionizing radiation due to the risk of permanent damage to the pumps electronic circuitry. The best procedure to follow is to remove the pump from the patient during therapeutic radiation sessions or diagnostic levels of radiographic and fluoroscopic radiation. If the pump must remain in the vicinity during a diagnostic or therapy session, it should be shielded, and its ability to function properly should be confirmed following treatment. Do not expose the pump directly to ultrasound, as permanent damage to the electronic circuitry may occur. The pump should not be exposed to MRI equipment because the pump is not intended or designed to be used in the MRI environment. Exposing the pump to magnetic fields that exceed the 600 gauss line may cause irreversible damage, rendering the pump inoperable. Use of this pump on patients monitored by electronic equipment may cause artifactual interference. As with all electronic equipment, electrical artifacts which affect the performance of other equipment, such as ECG monitors, can occur. The user should check the correct function of the equipment prior to use. Do not use the pump in hyperbaric chambers as they affect how the pump works and may also cause damage to the pump. 6 Table of Contents Technical Assistance . 2 Contraindications . 3 Warnings . 3 Cautions . 6 General Description Introduction . 9 Indications . 9 Contraindications . 9 Epidural/Subarachnoid Administration . 9 Analgesics . 9 Anesthetics . 9 Delivery Methods . 10 Symbols . 12 Pump Components, Ports, and Connectors . 15 Indicator Lights . 15 Display with Backlighting . 15 Keypad . 15 Power Switch . 16 Power Jack . 16 USB Port . 16 Remote Dose Cord Jack . 16 Battery Compartment . 16 Cassette Latch . 16 Cassette/Keypad Lock . 16 Air Detector . 16 Downstream Occlusion Sensor . 16 Upstream Occlusion Sensor . 17 Pump Accessories . 17 AC Adapter . 17 Rechargeable Battery Pack . 17 CADD-Solis Communication Module . 17 Pump Key . 18 Cassette, Extension Set, Administration Set 18 Remote Dose Cord . 18 Polemount Bracket . 18 Polemount Bracket Adapter . 18 Polemount Swivel . 19 Pouches and Backpacks . 19 LockBox . 19 PharmGuard Medication Safety Software . 19 PharmGuard Server Software . 19 SureLink Remote Support Software . 19 CADD-Solis Network Setup Utility Software . 19 Pump Setup Installing the Batteries . 20 Replacing the Battery Door . 21 Power Up . 22 Power Down . 22 Software Updates . 22 Programming the Pump: General Instructions . 23 The Pump Screen . 23 Color Display . 24 Before Programming . 24 Attaching a Cassette . 25 Removing a Cassette . 27 Starting the Pump . 27 Stopping the Pump . 27 Programming and Operation Security Settings . 28 Security Level Tables . 28 Autolock . 30 Entering Security Codes. 30 Tasks . 31 Give Clinician Bolus . 31 Start New Patient . 32 Start New Protocol, Same Patient . 33 Prime Tubing . 34 Set Time and Date . 34 Adjust Backlight Intensity . 36 Adjust Alarm Volume . 37 View Reports . 37 Turn Wireless On/Off . 38 Adjust Admin Settings . 38 Reports . 39 Intermittent Bolus Status . 39 Given and PCA Dose Counters (Given and PCEA Dose Counters) . 39 PCA Dose Graph (PCEA Dose Graph). 40 Intermittent Bolus Graph. 41 PCA and Intermittent Graph (PCEA and Intermittent Graph) . 41 Delivery History and Pie Chart . 41 Current Profile / Protocol (if configured) . 42 Delivery Log . 42 Event Log . 43 Daylight Saving Time . 43 Protocol Library Summary . 43 Wireless Status . 44 Wireless Settings . 44 Device Information . 44 Patient Specific Parameters

(Programming Screens) . 45 Intermittent Bolus . 46 Bolus Interval . 46 Next Bolus . 47 Continuous Rate . 48 PCA Dose (PCEA Dose) . 48 PCA Lockout (PCEA Lockout) . 49 Hourly Limit . 49 Max Doses/Hr . 49 Reservoir Volume . 50 Manual Mode Programming . 51 Wireless Function (Communication Module) . 54 7 General Descriptionpump setupproGramminG anD operationreferences anD troubleshootinGinDex References and Troubleshooting Alarms and Messages . 55 Types of Alarms . 55 System Fault Alarm . 55 High Priority Alarm . 55 Medium Priority Alarm . 55 Low Priority Alarm . 56 Alarm Help Screens . 56 User Position . 57 Alarms and Messages, Alphabetical List . 58 Exposure to Radiation or Magnetic Resonance Imaging (MRI) . 65 Cleaning and Disinfecting the Pump and Accessories . 65 Technical Description . 69 Standards used in development of the pump . 69 Essential Performance . 69 Specifications (Nominal) . 70 General Pump Specifications . 70 Delivery Specifications . 75 Collect Separately . 80 Programming Screens/Menus Maps . 81 Default Factory Settings . 82 Accuracy Test Results . 83 Index 8 IndexRefeRences and TRoubleshooTIngPRogRammIng and oPeRaTIonsPumP seTuPgeneRal descRIPTIon General Description Introduction The CADD-Solis Ambulatory Infusion System provides measured drug therapy to patients in hospital or outpatient settings. Therapy should always be overseen by a physician or a certified, licensed healthcare professional. As appropriate, the patient should be instructed in using the pump. Indications The CADD-Solis Ambulatory Infusion Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses. Contraindications The pump is not to be used for delivery of blood or cellular blood products, as blood and cellular blood products will be damaged by the pumping mechanism. This pump is not to be used in any intra-articular space infusion. Epidural/Subarachnoid Administration The selected drug must be used in accordance with the indications included in the package insert accompanying the drug. Administration of any drug by this pump is limited by any warnings, precautions, or contraindications in the drug labeling. Smiths Medical has performed neurotoxicological testing using 0.9% saline to represent aqueous drugs infused into epidural and subarachnoid spaces. WARNING:

Do not administer drugs to the epidural space or subarachnoid space unless the drug is indicated for administration to those spaces. Drugs not intended for epidural or subarachnoid space infusion could result in serious patient injury or death. To prevent the infusion of drugs that are not indicated for epidural space or subarachnoid space infusion, DO NOT use administration sets that incorporate injection sites. The inadvertent use of injection sites for infusion of such drugs may cause serious patient injury or death. If a CADD medication cassette reservoir, CADD extension set, or CADD administration set is used for epidural space or subarachnoid space drug delivery, it is strongly recommended that it be clearly differentiated from those used for other routes of infusion (for example, by color coding, or other means of identification). Drugs not intended for epidural or subarachnoid space infusion could result in serious patient injury or death. Analgesics Administration of analgesics to the epidural space is limited to use with indwelling catheters specifically indicated for either short or long-term drug delivery. Anesthetics Administration of anesthetics to the epidural space is limited to use with indwelling catheters specifically indicated for short-term drug delivery. Delivery Methods The pump provides the following methods of delivery:

Continuous rate: infusion of drug at a constant, programmed rate 9 General DescriptionGeneral Description Intermittent bolus (IB): a series of doses automatically delivered at regular, programmed intervals PCA (PCEA) dose: a demand dose activated by the patient Clinician bolus: a dose activated by the clinician Each of the methods may be programmed individually or in combination with each other. The figures below illustrate examples of combined delivery methods. Ranges, programming increments, rates, and volumes are listed in Specifications (Nominal) on page 10. Example 1: Continuous Rate, PCA Doses, and Clinician Bolus Clinician Bolus

(used here as a loading dose) PCA Lockout e g a s o D PCA dose PCA dose denied Continuous Rate PCA dose Time PCA dose Example 2: Intermittent Boluses (IB) and PCA Doses, with Bolus Interval Type set as PCA Lockout Delivery of PCA dose moves out the delivery of the next IB. IB IB IB IB PCA dose PCA dose denied Time Next Bolus delay Intermittent Bolus (IB) Interval Bolus Interval Type (set as PCA Lockout) PCA Lockout e g a s o D 10 General DescriptionGeneral Description Example 3: Intermittent Boluses (IB) and PCA doses, with Bolus Interval Type set as Bolus Interval Delivery of PCA dose moves out the delivery of the next IB. e g a s o D IB IB IB IB PCA dose PCA dose denied Time Next Bolus delay Intermittent Bolus (IB) Interval Bolus Interval Type

(set as Bolus Interval) Intermittent Bolus (IB) Interval Programming Flexibility With the CADD-Solis system, you have the flexibility to delay a PIB following a PCEA dose based on the PIB interval or PCEA dose lock out interval. Intermittent Bolus Examples

) L m

(

e s o D 10 5 0 Bolus Interval : 1 hour PCEA Dose Lockout : 15 min Bolus Interval : 1 hour PCEA Dose Lockout : 15 min

) L m

(

e s o D 10 5 0 Intermittent Intermittent Bolus 5:00 Bolus 6:00 PCEA Dose 6:50 Intermittent Bolus 7:05 7:00 Time Intermittent Intermittent Bolus 5:00 Bolus 6:00 PCEA Dose 6:50 Time 7:00 Intermittent Bolus 7:50 Bolus Interval Type Setting = PCEA Dose Lockout Intermittent boluses will deliver every hour unless the time between a delivered PCEA Dose and the next scheduled PIB is less than the PCEA Dose Lockout time Bolus Interval Type Setting = PIB Bolus Interval Intermittent boluses will deliver every hour unless a PCEA Dose is delivered 11 General DescriptionGeneral Description Symbols Symbol Definition Symbol Definition Symbols on the Pump and Labels Power on/off button Cassette unlock/lock B Soft key U Up button D Down button S Select button 9 Start/Stop button

@ PCA (PCEA) dose button AA battery location, positive terminal faces up AA battery location, negative terminal faces up AA battery location, positive terminal faces up AA battery location, negative terminal faces up USB port Direct current (power jack) Remote dose cord jack f Caution Follow Instructions for Use (The symbol appears on the device with a blue background.) European Community

< Catalog number

> Serial number J Date of manufacture H Manufacturer

@ Authorized representative in the P Temperature limitation _ Humidity limitation i Atmospheric pressure limitation J Type CF applied part K Class II equipment IP24 Solid Particulate Protection:

Protected from solid foreign objects greater than 12.5 millimeters in diameter. Liquid Ingress Protection:

Splashproof - water splashed against the pump housing will have no harmful effects. Z Collect separately 6 Caution: Federal (USA) law restricts MR Unsafe this device to sale by or on the order of a physician. 12 General DescriptionGeneral Description Symbol Definition Symbol Definition Symbols on the Pump Display Reservoir volume Charge level of rechargeable battery pack Item highlighted in the work area is at the top of the menu. Press D to scroll down. Item highlighted in the work area is at the bottom of the menu. Press U to scroll up. Charge level of rechargeable battery pack. AC adapter connected. Home screen Charge level of AA batteries Keypad is locked Charge level of AA batteries. AC adapter connected. No battery installed, AC power only Incompatible battery Incompatible battery. AC Adapter connected. Wireless Off*

Keypad is unlocked Appears next to a parameter that was reviewed and accepted. On edit screens. Indicates current parameter value. Press U or D to scroll up or down to edit the value. On edit screens with a menu of options. Indicates which setting is being selected. The requested action can not be performed. Wireless On*, not associated with wireless access point More data is available. On PCA dose report only. Wireless On*, associated with wireless access Point Wireless On*, associated with wireless access Point, and communicating with PharmGuard Server Pump status is Started or Running. Pump status is Paused or in KVO. Pump status is Stopped. Review screen Saving There are more items to see in the work area. Press U or D to scroll up or down.

* Visible only when a CADD-Solis Communication Module is installed. 13 General DescriptionGeneral Description Compartment for AA batteries, rechargeable battery, or CADD-Solis Communication Module (with integrated rechargeable battery) Display Pump Diagram Front View Indicator Lights Amber Green USB Port Blue AC Power Light AC Power Jack Remote Dose Cord Jack Keypad Rear View Power Switch Cassette/Keypad Lock

(Unlock/Lock) Cassette Latch Cassette

(The part of the CADD medication cassette reservoir or CADD administration set that attaches to the pump) 14 Serial number General DescriptionGeneral Description Pump Components, Ports, and Connectors Indicator Lights When the pump is powered, one or both of the indicator lights flash. Green: The green light flashes to indicate that the pump is running and delivering fluid as programmed. Amber: The amber light flashes when the pump is stopped, an alarm condition exists, or the battery or the reservoir volume is low. It stays on continuously when the pump is inoperable. The display briefly describes the alarm condition when the amber light is flashing. Note: At times both lights may flash. This indicates that the pump is running, but there is a condition the clinician should be aware of (for example, low battery or low reservoir volume). Display with Backlighting The liquid crystal display (LCD) shows programming information and messages. Backlighting helps keep the display visible in low light. In this manual, display is synonymous with display panel or LCD. After a period in which no keys are pressed, the backlighting turns off and the display goes blank to save battery power (except during an alarm or when an external power source is in use). To turn the display back on, press any key except the PCA (PCEA) dose key when the PCA (PCEA) dose option is available. Note:

When the display is blank, you can determine that the pump is powered by observing either the green or amber (or both) indicator lights periodically flashing. Therapies incorporating patient-controlled analgesia are configured with the PharmGuard Administrator software to display either PCA (patient-controlled analgesia) or PCEA (patient-controlled epidural analgesia). The examples shown in this manual display only PCA. However, menus, submenus, and screens on the pump will appear with PCEA if they are programmed to do so. If you press stop/start 9, the display reappears with a message asking if you wish to start or stop the pump. If you press PCA dose @ while the pump screen is blank, the pump delivers a PCA dose, if available. Keypad The pump has either a gray or yellow keypad. The keys on the keypad are described below. A key beeps when pressed if it is operable in the current state of the pump. However, the keys do not beep if the key beep function is turned off in the protocol or the PharmGuard system administrator settings. 5 1 stop/start select PCEA dose Starts and stops pump delivery. Referred to as soft keys. Allows you to answer a question on the pumps display. For example, the screen above this key may display Yes, in which case pressing this key would give the question displayed on the screen an answer of Yes. Also allows you to navigate through some of the pumps screens (for example, canceling an action, opening the reports/tasks menus, or backing out of an open screen). Allows you to navigate through the menus on the pump, scrolling down, or decreasing a value. Allows you to navigate through the menus on the pump, scrolling up, or increasing a value. Used to select a menu item. Allows the patient to request a PCA (PCEA) dose if the remote dose cord is not connected, and if the PCA

(PCEA) dose option is available. If the remote dose cord is connected, this key is inactive. 15 General DescriptionGeneral Description WARNING: To avoid electric shock, do not touch the Power Jack, Remote Dose Cord Jack, USB Port, Battery Terminals, or any other connectors and the patient simultaneously. Power Switch Turns the pump on or off. Press and hold the switch to turn the pump on. Press the switch to turn the pump off and confirm that you want to power down by selecting Yes. Power Jack You may plug the AC adapter into the power jack. When the AC adapter is plugged in, the blue power light turns on. This light is on regardless of the pumps on or off status. USB Port A mini-B USB cord can be attached to the USB port for communications with the PharmGuard Medication Safety Software. This jack is also used for communications with SureLink Remote Support Software and the CADD Solis Network Setup Utility software. For more information, see the documentation that accompanies these software products. CAUTION: The USB port is intended for communication to the PharmGuard Medication Safety Software, SureLink Remote Support Software, and the CADD Solis Network Setup Utility software only. Do not connect unsupported accessories to the USB port (e.g., charging other devices, attaching a wireless dongle) as this could damage the pump. Remote Dose Cord Jack The remote dose cord jack is used for attaching the remote dose cord. (See Remote Dose Cord on page 18 for more information.) Battery Compartment Four AA batteries, rechargeable battery pack, or the CADD Solis Communication Module (with integrated rechargeable battery) fit into this compartment. The batteries serve as the primary source of power, or as a backup when the AC adapter is in use. (See Installing the Batteries on page 20 for information on how to install the batteries.) Cassette Latch This is used to attach the cassette to the pump. When the pump is turned on, it detects whether the cassette is latched properly. Delivery stops and an alarm occurs if the cassette becomes unlatched. (See Attaching a Cassette on page 25 and Removing a Cassette on page 27.) Cassette/Keypad Lock Secures the cassette to the pump using the pump key provided. The cassette latch must be latched before it can be locked. The cassette/keypad lock can be configured to unlock only the cassette latch or to unlock the cassette latch as well as the keypad. This is configured by your PharmGuard system administrator. (See Security Settings on page 28.) Air Detector The air detector may be turned on or off, depending on facility or therapy requirements (for more information, see the Administrator Settings Guide). If enough air is detected in the part of the tubing that passes the air detector sensor, an alarm sounds and delivery stops. If an air detector is not required, it may be turned off. WARNING:

If the air detector is turned off, the pump does not detect air in the fluid path. It is recommended that you periodically inspect the fluid path and remove any air to prevent air embolism, which could result in serious patient injury or death. The air detector, when turned on, may be set to detect and alarm for air bubbles as small as 150 uL. The High Sensitivity setting and/or filtered sets should be considered for patients and therapies with a risk of harm due to an air embolism. Downstream Occlusion Sensor The pump contains a downstream occlusion sensor. When a downstream occlusion (between the pump and the patient) is detected, an alarm sounds, delivery stops, and the display shows Downstream occlusion. Clear occlusion between pump and patient. 16 General DescriptionGeneral Description Upstream Occlusion Sensor The pump contains an upstream occlusion sensor. This feature may be turned on or off (for more information, see the Administrator Settings Guide). When an upstream occlusion (between the pump and the reservoir) is detected, an alarm sounds, delivery stops, and the display shows Upstream occlusion. Clear occlusion between pump and reservoir. WARNING: When the upstream occlusion sensor is turned off, the pump does not detect occlusions upstream between the pump and the reservoir. Periodic inspection of the fluid path for kinks, a closed clamp, or other upstream obstructions is recommended. Upstream occlusions may result in underdelivery of medication. If undetected, these occlusions could lead to death or serious injury to the patient. Pump Accessories CAUTION: Use only Smiths Medical accessories that are specified for use with the CADD-Solis Ambulatory Infusion Pump, as other brands may adversely affect pump operation. CADD-Solis accessories may be obtained through the Customer Service department at Smiths Medical. For detailed instructions and warnings applicable to each accessory, refer to the instructions for use provided with the product. The Pump Diagram on page 14 illustrates the location of ports, jacks, latches, and compartments used with the accessories. AC Adapter The AC adapter can be used as an alternate source of power for the pump and/

or to recharge the rechargeable battery pack or CADD-Solis Communication Module with integrated rechargeable battery. The pump requires that 4 AA batteries, rechargeable battery pack, or CADD-Solis Communication Module with integrated rechargeable battery are installed as a backup while using the AC adapter. Access to the AC adapter power cords should not be blocked at the AC adapter and at the pump connector so they can be easily disconnected. Rechargeable Battery Pack The rechargeable battery pack is an alternative to using four AA batteries. The rechargeable battery pack can be recharged with the AC adapter, either inside or outside of the pump. CADD-Solis Communication Module with integrated rechargeable battery CADD-Solis Communication Module

(Models 2130 and 2131) The CADD-Solis Communication Module

(optional, contact Smiths Medical for availability) adds wireless features to the pump, allowing the pump to communicate with PharmGuard Server. With the communication module installed the pump can send event history and receive pump firmware and library updates from the server wirelessly. The communication module is securely installed in the battery compartment of the pump and includes an integrated rechargeable battery that powers the pump and module. The rechargeable battery is charged via the CADD-Solis AC Adapter connection to the pump. If necessary, the pump operator can turn off wireless capabilities of the communication module while still providing power to the pump and without affecting any of the pumps clinical operations. When installed, the wireless capabilities of the module may be turned on or off via the pump menus (see Turn Wireless On/Off on page 38). 17 General DescriptionGeneral Description For more information about installing the CADD-Solis Communication Module, see the documentation provided with the module. For configuration of the wireless network settings of the pump and communication module see operators manual for the Network Setup Utility software. Pump Key The pump key is used to securely lock a cassette or administration set to the pump. It can also be used to lock and unlock the keypad, if allowed by the protocol setting. Cassette, Extension Set, Administration Set The cassette is the part of the CADD medication cassette reservoir or CADD administration set that attaches to the bottom of the pump. The following single-use products are compatible with the pump:

CADD medication cassette reservoir with a CADD extension set CADD administration set CADD high volume administration set (with pump model 2110 only) WARNING:

Follow the instructions for use provided with the CADD medication cassette reservoir, CADD extension set, or CADD administration set, paying particular attention to all warnings and cautions associated with their use. Incorrect preparation and/or use of these products could result in serious patient injury or death. Carefully route tubing, cords, and cables to reduce the possibility of patient entanglement or strangulation. Failure to observe this warning could result in patient injury or death. Note:

A CADD set with free-flow protection must be used in order to prevent free-flow. The maximum delivery rate is 500 mL/hr, however, programmed delivery rates exceeding 250 mL/hr require the use of a high volume administration set. Do not manually adjust the delivery rate to override pump programming without written authorization from the prescribing physician. Smiths Medical recommends that the appropriate supplies needed to replace the cassettes are available in case of a damaged cassette. For detailed instructions and warnings pertaining to the CADD medication cassette reservoir or CADD administration set, refer to the instructions for use supplied with the product for preparing the product for use. Remote Dose Cord The remote dose cord can be attached to the pump and provided to the patient as an alternative to pushing the PCA (PCEA) dose @ key to request a PCA dose. The LED on the remote dose cord indicates PCA dose status:

Off: A PCA dose is not available. Flashing: A PCA dose is available. On: A PCA dose has been requested and delivery has started. Polemount Bracket The polemount bracket is used along with the polemount bracket adapter to attach the pump to an IV pole. Polemount Bracket Adapter The polemount bracket adapter attaches to the back of the pump so that it can be mounted on an IV pole or in a LockBox. (When a CADD Solis Communication Module is installed, a polemount adapter is integrated with the mounting bracket of the communication module.) 18 General DescriptionGeneral Description Polemount Swivel The polemount swivel allows the pump to rotate while it is attached to the CADD-Solis polemount bracket. With the swivel attached, the pump can be tilted or rotated 230 for easy viewing of the display. The swivel can not be used in a LockBox. Pouches and Backpacks Several styles of pump pouches and backpacks are available. They can carry a CADD-Solis ambulatory infusion pump with either a CADD medication cassette reservoir (50 mL to 250 mL) or a flexible, plastic IV bag up to 3 liters. LockBox Clear and yellow lockboxes are available to hold both the CADD-Solis ambulatory infusion pump and a CADD administration set or high flow administration set. The pump attaches to the lockbox with a polemount bracket adapter, and the lockbox can be attached to an IV pole. The lockbox allows for viewing of its contents and access to the keypad, remote dose cord jack, and AC power jack. PharmGuard Medication Safety Software PharmGuard Medication Safety Software is PC software that allows you to create and manage protocol libraries and then send them to the pump. For more information, see the installation guide and online help for PhamGuard Administrator software and PharmGuard Point of Care software. PharmGuard Server Software When a CADD-Solis pump has a CADD-Solis Communication Module installed (see page page 17), the pump can communicate with a wireless access point at your facilty and to a PharmGuard Server for reporting and administration purposes. When the CADD-Solis pump has wireless turned on and a wireless access point is in range, the pump sends history data to the server periodically, and can also receive authorized pump firmware and library updates from the server. For more information, contact your PharmGuard Server system administrator. SureLink Remote Support Software The CADD-Solis Ambulatory Infusion Pump is upgradeable (when updates are available from Smiths Medical) using SureLink Remote Support Software PC Direct Connect. This application, available separately, may be used to receive available pump software updates from Smiths Medical Customer Service via the Internet and install those updates onto eligible pumps via USB connection. For more information about using SureLink Remote Support Software, see the documentation provided with the software. CADD-Solis Network Setup Utility Software All wireless and network configuration for the CADD-Solis Communication Module is set using the CADD-Solis Network Setup Utility software. This software, available separately, programs the CADD-Solis Communication Module via USB connection to the CADD-Solis pump. For more information about using the CADD-Solis Network Setup Utility Software, see the documentation provided with the software. The configuration settings are stored by the pump and not the communication module. A pump may be configured for wireless without a communication module installed. The communication module will obtain configuration settings upon pump power up after the communication module is installed in an already configured pump. The communication module settings are not retained once it is removed from a pump. 19 General DescriptionGeneral Description Pump Setup Installing the Batteries Four AA, 1.5 volt primary (non-rechargeable) alkaline batteries (for example, Duracell PC1500 / MN1500, IEC LR6), the Smiths Medical rechargeable battery pack, or the CADD-Solis Communication Module (with integrated rechargeable battery) are required for use in the CADD-Solis pump. Note: Smiths Medical does not recommend mixing new and used AA batteries because it may affect low battery alarm times. Always use four new batteries when replacing depleted ones. CAUTION: Inspect the AA batteries for damage or wear to the metal or plastic insulation prior to use, or after the pump has been dropped or hit. Replace the batteries if any damage is noted. The pump retains all programmed values while the batteries (or the CADD-Solis Communication Module with integrated rechargeable battery) are removed, but the pumps batteries must be in place during delivery. If the batteries are removed while the pump is delivering, and an AC adapter is connected, delivery stops. If an AC adapter is not connected and the batteries are removed, delivery stops and the pump loses power. Delivery will not begin without proper batteries installed (with or without an AC adapter). CAUTION: Do not store the pump for prolonged periods with the batteries installed. Battery leakage could damage the pump. Note:

Battery life is dependent on the amount of medication delivered, delivery rate, battery age, temperature, active display time, and backlight intensity. The power of the battery is quickly depleted at temperatures below 10C (50F). Dispose of used batteries in an environmentally safe manner, and according to any regulations which may apply. WARNING:

Do not use rechargeable NiCd or nickel metal hydride (NiMH) batteries. Do not use carbon zinc (heavy duty) batteries. They do not provide sufficient power for the pump to operate properly, which could result in death or serious injury to the patient. Always have new batteries available for replacement. If power is lost, nondelivery of drug occurs and depending on the type of drug being administered, could result in death or serious injury to the patient. A rechargeable battery pack that has reached the end of it useful life must be replaced with either another CADD-Solis rechargeable battery pack, a replacement communication module rechargeable battery, or with 4 AA batteries. Using rechargeable battery packs from other manufacturers could result in fire or explosion. There is no pump alarm to alert users that a battery has not been properly installed. An improperly installed battery could result in loss of power and nondelivery of drug and, depending on the type of drug being administered, could result in death or serious injury to the patient. Always check the battery compartment for fluid or debris before inserting the batteries or communication module and do not allow any fluid or debris to fall into the battery compartment. Fluid or debris in the battery compartment may damage the battery contacts and could result in loss of power and nondelivery of drug and, depending on the type of drug being administered, could result in death or serious injury to the patient. If the pump is dropped or hit, the battery door may become broken or damaged. Do not use the pump if the battery door is damaged because the batteries will not be properly secured; this may result in loss of power, nondelivery of drug and, depending on the type of drug being administered, could result in death or serious injury to the patient. 20 PumP SetuPPumP SetuP To install the batteries or rechargeable battery pack:

1. Make sure the pump is stopped or powered off. Using your fingers, the pump key, or a coin, turn the knob on the battery door counter-

clockwise and open the battery door. 2. Hold the pump at an angle and place 4 AA batteries in the pump, from the bottom up (see picture). Match the + and - markings on the new batteries with the markings on the pump. OR If using a rechargeable battery pack, insert it into the pump as shown. OR 3. Close the battery door and using your fingers, the pump key, or a coin, turn the knob on the battery door clockwise to lock. Note: If you put the batteries in backwards, the pump will not power up. Check the batteries, making sure to match the + and - markings. To install a CADD-Solis Communication Module:

See the CADD Solis Communication Module Operators Manual to install the communication module into the pump. Replacing the Battery Door If the battery door is removed or needs replacing (e.g., after removing the CADD-Solis Communication Module to use AA batteries instead), simply snap the battery door onto the bar that is located on the pump (see picture). 21 PumP SetuPPumP SetuP Power Up Press and hold the power switch to turn the pump on. The pump starts the power up sequence during which it performs various self-tests and tests for alarm conditions. Watch for the following during power-up:

Both the green and amber indicator lights flash. The display quickly flashes gray, then blue. An amber swirl then fills the display, followed by a CADD-Solis Ambulatory Infusion System display. Look for any stripes or black or white pixels, which would indicate a faulty display. If you see any indication of a faulty display, remove the pump from service and contact Smiths Medical Customer Service. After the power up is completed, listen for the Morse Code OK sound (a series of six audible beeps). If you do not hear this sound, there may be a problem with the audible alarms. If you believe there is a problem, remove the pump from service and contact Smiths Medical Customer Service. If any issues are found while the pump is performing the self tests, alarms will sound (for example, if the battery is low or a key on the keypad is stuck in the pressed position). CAUTION: If the power up results in an error message indicating that the protocol library was lost, do not proceed with using the pump. Follow your facilitys procedures for downloading protocol libraries. Power Down Press the power switch to turn the pump off. You must acknowledge the Power down? prompt by selecting Yes. The pump then powers down. Be aware of the following conditions when the pump is powered down:

The display is blank. Keypad presses are not detected. The remote dose cord does not function. Medication is not infused. Alarm conditions are not sensed. Audio alarms do not sound. Visual alarms are not displayed. Communication with PharmGuard Medication Safety Software or PharmGuard Server is not possible. The internal battery used to retain time and date does not charge. If the pump is connected to AC power and a rechargeable battery pack or a CADD-Solis Communication module (with integrated battery pack) is installed, the battery continues to charge. If the AC adapter is plugged in, the blue AC power light is on. No other lights are lit. Software Updates If the pump is equipped with a CADD-Solis Communication Module and is in communication with PharmGuard Server, the following may occur before the pump powers down:

A screen appears briefly to advise you that pump data is being sent to PharmGuard Server. If a software update has been sent to the pump by the PharmGuard Server administrator, a screen notifies you and you are given the option to accept the update. Upon selecting Yes to accept the update, and confirming security measures (see Security Settings on page 28), it is installed and the pump powers down. If you select No, the update is not installed and the pump powers down (you will be given the option again to update the pump the next time it is powered down). For more information, contact your PharmGuard Server system administrator. 22 PumP SetuPPumP SetuP Programming the Pump: General Instructions The Pump Screen The sample screens in this manual are only examples of what might be displayed. The protocols, consisting of therapies, qualifiers, drugs and concentrations, and all associated pump settings in your pump library will be established by your facility. i g The therapy, qualifier, and drug from the current protocol. Where a long drug name is used, it will scroll from right to left on the pump screen to allow you to view the entire drug name. The status bar shows the status of the pump. It also displays messages and alerts. Current reservoir volume. The color of the screen is dependent on how the protocol is set up in the PharmGuard Medication Safety Software. If the screen color is black, the protocol has been modified in the PharmGuard system administrator settings (see the Administrator Settings Guide for more information) or the pump is in manual mode (see Manual Mode Programming on page 23). The delivery status of the pumpstopped or running. The type of battery being used and an estimation of the approximate amount of battery life remaining. Also indicates if an AC adapter is in use. AA batteries. Fully or near fully charged. AA batteries with AC adapter.

~50% charge. Rechargeable battery or Communication Module. Low battery,

<25% charge. Rechargeable battery or Communication Module with AC adapter. Depleted battery. Keypad lock statuslocked or unlocked. i Wireless status indicator (when a CADD-Solis Communication Module is installed) Off; On; On and associated with wireless access point; On and not associated with wireless access point; or, On and associated with wireless access point and communicating with PharmGuard Server. Units of measurement and concentration (if applicable) for the drug or solution in the current protocol. Screen name and help text, if there is any. TALL/short characters improve readability to avoid dosing errors. The work area/contents for the displayed screen Trailing zeros are eliminated to avoid dosing errors. g Options for navigating the pump. These options change depending on the screen you are on and what functions you are performing with the pump. 23 PumP SetuPPumP SetuP Color Display The CADD-Solis pump display uses color to help the clinician recognize critical information quickly and easily. Protocol Screen Colors Your facility may choose to relate a specific color to each protocol in its library. This is customizable by your PharmGuard Medication Safety Software system administrator. Protocols may be color coded in several different ways depending on the needs of your pain management program, including:

Route of administration (for example, all epidural protocols may be yellow, and used with a pump with a yellow keypad, yellow cassette reservoir or administration set, yellow extension set, and a yellow lockbox), Patient type (for example, all pediatric protocols may be blue), Or by any other hierarchy which fits the needs of your institution There are five protocol colors available: purple, yellow, gray, blue, and green. A protocol displayed in black signifies that the protocol being used is a non-standard protocol or that the pump is programmed using the manual mode (see Manual Mode Programming on page 51). Refer to your facilitys policies and procedures to understand how colors are used to identify your protocols. Pump Status Colors The pump colors green, amber, red, and blue are used to help the clinician recognize pump status. Similar to a traffic control light: green means go, amber indicates caution, and red means stop:

Green: Pump conditions are satisfactory. Green numbers in the work area indicate that a programmed value falls within the soft limit range for the parameter. Amber: There is a condition to watch, but the current pump conditions are satisfactory. Medium priority alarms and values outside soft limits display in amber. Red: There is a warning condition that requires immediate attention and infusion has stopped. All high priority and system fault alarms display in red Blue: Low priority alarms and informational messages display in blue. To understand how colors relate to alarm screens, refer to Types of Alarms on page 55. Before Programming Protocol libraries are created with the PharmGuard Medication Safety Software and can be imported into the pump by your PharmGuard system administrator. Before programming the pump for a patient, make sure the pump contains a protocol library. If you are not using the CADD-Solis pump with a protocol library, see Manual Mode Programming on page 51. A protocol from the library may be manually edited in the PharmGuard system administrator settings. If you are authorized, see the Administrator Settings Guide or contact your facilitys PharmGuard system administrator for further information. Making edits to the protocol changes the settings for the current protocol only. The edits do not change the settings for any future selections of the protocol from the library. 24 PumP SetuPPumP SetuP Attaching a Cassette WARNING:

Attach the cassette properly. A detached or improperly attached cassette could result in unregulated gravity infusion of medication from the reservoir or a reflux of blood, which could result in death or injury to the patient. If you are using a CADD administration set or CADD medication cassette reservoir that does not have the Flow Stop feature, you must use a CADD extension set with anti-siphon valve or a CADD administration set with either an integral or add-on anti-siphon valve to protect against unregulated gravity infusion that can result from an improperly attached cassette. Unregulated gravity infusion can result in death or serious injury. Carefully route tubing, cords, and cables to reduce the possibility of patient entanglement or strangulation. Failure to observe this warning could result in patient injury or death. CAUTION: If you are using a CADD medication cassette reservoir in which the medication is frozen, thaw at room temperature only. Do not heat in a microwave oven as this may damage the product and cause leakage. Before attaching a new cassette, make sure the pump is powered on. Once the cassette is attached, the pump automatically displays screens that allow you to verify the cassette type, prime the fluid path, reset the reservoir volume, review pump settings, and/or start the pump. To attach the cassette to the pump:

1. Obtain a new, filled CADD medication cassette reservoir, or CADD administration set attached to a flexible IV bag. Refer to the instructions for use supplied with the product for information on preparing the product for use. 2. Clamp the tubing. 3. Make sure the cassette latch is unlocked and open the cassette latch. 4. Insert the cassette hooks into the hinge pins on the bottom of the pump. 5. Without holding the cassette latch:

Push up on the cassette until it firmly clicks into place.

-OR-

Place the pump upright on a firm, flat surface, and then press down on the latch side of the pump until the cassette firmly clicks into place. 25 PumP SetuPPumP SetuP 6. Lift the cassette latch into the closed position. You should be able to move the latch into the closed position with minimal to no resistance. If you experience resistance when lifting the cassette latch, DO NOT FORCE the latch. If you are unable to attach the cassette to the pump with minimal to no resistance, the cassette is not in the proper latching position. If the pump does not latch easily, unlatch the cassette and repeat the process. If unsuccessful on the second attempt, do not use the pump. Contact Smiths Medical Customer Service for further assistance. 7. Verify the cassette is attached correctly. Looking from left to right, the top of the cassette should line up evenly with the bottom of the pump and be securely attached. If the cassette is attached incorrectly, there will be an uneven gap between the cassette and the pump, with the gap appearing on the latch side of the pump. If an uneven gap exists, unlatch the cassette and repeat the process. If the gap exists after the second latch-up attempt, do not use the pump. Contact Smiths Medical Customer Service for further assistance. An uneven gap indicates that the cassette is not properly latched. Correct Incorrect 8. A brief message appears on the pump screen so you can verify the type of cassette you have attached. 9. To lock the cassette, insert the pump key into the cassette/keypad lock and turn it clockwise into the locked position. Cassette Locked appears briefly in the status bar. 26 PumP SetuPPumP SetuP Removing a Cassette WARNING: Per general rules of safe practice, always clamp the tubing before removing the cassette from the pump. Removing the cassette without closing the clamp could potentially cause unregulated gravity infusion, which could result in patient injury or death. To remove the cassette:

1. Make sure the pump is stopped before removing the cassette. 2. Close the tubing clamp. 3. If locked, insert the pump key and turn the cassette/keypad lock counter-clockwise into the unlocked position. Cassette Unlocked briefly appears in the status bar. 4. Push down on the cassette latch until the cassette detaches. Starting the Pump Starting the pump starts delivery. When the pump is running, Running appears with green highlighting on the status bar and the green indicator light flashes. If the pump does not start, a message appears on the display. Refer to the Alarms and Messages on page 58. Note: Before starting the pump, ensure correct protocol and patient specific parameters are displayed (see Patient Specific Parameters page 45). Also be sure the tubing is primed and the pump is connected to the patient, according to your facilitys standards of practice. To start the pump:

1. Press stop/start 9. Note: If the patient specific parameters have not been reviewed and the values have not been accepted, the pump requires you to do so before the pump will run. If a clinical advisory note has been defined by your facility for the selected protocol, it will appear after accepting all values. To acknowledge the clinical advisory note, select OK. If you have a question about the note, contact your PharmGuard system administrator. 2. When Start Pump? appears, select Yes. Stopping the Pump Stopping the pump stops delivery. When the pump is stopped, Stopped appears with red highlighting on the status bar, the amber indicator light flashes, and the green indicator light is off. Note: Stopping the pump while an Intermittent Bolus is in progress will cancel the remainder of the Intermittent Bolus dose. To stop the pump:

1. Press stop/start 9. Note: If a PCA dose or clinician bolus is in progress, Stop PCA dose? or Stop clinician bolus? appears. Select Yes to stop the dose. 2. When Stop Pump? appears, select Yes. 27 PumP SetuPPumP SetuP Programming and Operation Security Settings Security settings are used to limit patient and unauthorized clinician access to certain programming and operating functions of the pump. Pump functions are protected by three different security codes, and may also be protected by the cassette/keypad lock. The security level table below lists the functions that are available under each security code. The factory default settings for the security codes are as follows:

Keypad Code: 201 Clinician Code: 997 Administrator (Admin) Code: See your PharmGuard system administrator. WARNING Do not disclose pump security codes or any other information that would allow the patient or unauthorized clinician complete access to programming and operating functions. Improper programming could result in serious patient injury or death. Do not leave the pump unattended while unlocked. Many programming functions are accessible while the pump is unlocked, and improper programming could result in serious patient injury or death. The keypad, clinician, and administrator codes can all be customized by the PharmGuard system administrator while setting up the protocol using the PharmGuard Medication Safety Software, or in the administrator settings. The PharmGuard system administrator also determines whether or not to allow use of the cassette/keypad lock to unlock the keypad. See your PharmGuard system administrator for more information or to learn the security code you should use if the codes have been customized. Security Level Tables The keypad code is for clinicians who need to set up and manage a protocol for a patient. The clinician code allows access to all the functions the keypad code allows, as well as the clinician bolus feature. The administrator code allows access to all functions of the pump and its use should be restricted to the PharmGuard system administrator and certain designees. The administrator code gives the user the ability to change protocol ranges and all settings in the pump. 28 Programming and oPerationProgramming and oPeration Pump Operations and Programming Stop/Start 9 Reset Reservoir Volume Start PCA Dose @

Change (Titrate) Continuous Rate Change (Titrate) Intermittent Bolus Change (Titrate) Bolus Interval Change Next Bolus Change (Titrate) PCA Dose Change (Titrate) PCA Lockout Change (Titrate) Delivery Limit Amount Change (Titrate) Max Doses/Hr Pump Tasks Give Clinician Bolus Start New Patient Start New Protocol/Same Patient Prime Tubing Set Time and Date Adjust Time and Date Format Adjust Backlight Intensity Adjust Alarm Volume View/Clear Reports Turn Wireless On/Off

(when a communication module is installed) Update Software Access Administrator Settings Keypad Security Locked Keypad Security Unlocked Clinician Security Unlocked Administrator Security Unlocked Running Stopped Running Stopped Running Stopped Running Stopped

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

Keypad Security Locked

*

*

Keypad Security Unlocked

*

*

Clinician Security Unlocked Administrator Security Unlocked Running Stopped Running Stopped Running Stopped Running Stopped

*

*

*

*

Table Key:

No Yes

*

Yes. If using a manual mode protocol, the setting depends on the Manual Programming Security parameter. 29 Programming and oPerationProgramming and oPeration Autolock The CADD-Solis ambulatory infusion pump is designed to meet both safety and usability needs. The autolock feature reduces the chance of unauthorized pump programming. When the keypad is unlocked with a security code and left unlocked, the software automatically locks the keypad. The autolock feature takes affect on the Home screen approximately 30 seconds after the last key press, or when reverting back to the Home screen from other screens. Autolock takes longer on programming or task screens when you typically need more time to perform an action. From some of these screens, it may take up to 4 minutes after the last key press to revert back to the Home screen. If the pump is alarming, autolock does not take affect. If using the key to unlock the keypad while the pump is running, you should relock the keypad using the key. Note: The keypad can be re-locked by pushing the right soft key twice from the Home screen or once from the tasks menu. As a recommended safety precaution, you should always manually lock the pump using this feature. Entering Security Codes To enter a security code when prompted:

1. Press U or D to scroll up or down to the correct digit. Press S or Accept Value to advance to the next digit. Once the complete code has been entered, press S or Accept Value. 2. If an incorrect code is entered, a wrong code error appears. It includes the security level required to access the function. Select Retry to enter the code again. Note: If you enter a code that you believe is correct and receive a wrong code message, check the screen to see if the code has been customized. If the code is not customized, it was entered incorrectly and you should retry. If the code is customized, enter the customized code. If you do not know the code, contact your PharmGuard system administrator. 3. Depending on the level of security required and how the PharmGuard system administrator has programmed the security settings, you may be able to use the pump key to unlock the keypad. When accessing a menu or function that requires a security code, 1 of 2 prompts appears, as shown in the sample screens to the right. To unlock the keypad with the pump key, turn the pump key counterclockwise. Note: It is possible for the keypad to be locked while the cassette/keypad lock is unlocked. To use the pump key to unlock the keypad, first lock the cassette/keypad lock, and then unlock it. 30 Programming and oPerationProgramming and oPeration Tasks The tasks menu leads you to most of the pumps operating functions. On this menu, you can perform a range of tasks from giving a clinician bolus, starting a new patient, to changing the date and time, turning wireless on/off, or adjusting the PharmGuard system administrator settings. Some of the items on the tasks menu are protected by the various security levels. To learn more about the security codes, see Security Settings on page 28. To access the tasks menu, select Tasks on the Home screen. The following functions can be found on the tasks menu:

Tasks Give Clinician Bolus Start New Patient Start New Protocol, Same Patient Prime Tubing Set Time and Date Adjust Backlight Intensity Adjust Alarm Volume View Reports Turn Wireless On/Off Adjust Admin Settings Give Clinician Bolus A clinician bolus may only be delivered while the pump is running. It allows you to deliver a specified amount of drug, for example, as a loading dose. A clinician bolus cannot be started while a PCA (PCEA) dose or intermittent dose is in progress. The amount delivered decreases the reservoir volume and increases the given amount, but does not add to the dose counters or to the delivery limit. A clinician bolus may be stopped in progress. Note: If a clinician bolus is manually stopped by a clinician or automatically stopped by an alarm, power failure, or other condition that stops delivery, the pump remembers what point the bolus was at when it stopped. The next time you choose to give a clinician bolus, it gives you the option to restart the clinician bolus where it left off or to start with a new clinician bolus. WARNING: Exercise care when using the clinician bolus function. Because there are no limits on the frequency of delivering a bolus, and because the bolus amount may be set as high as 50 mL (or the mg or mcg equivalent), do not permit the patient or an unauthorized clinician to become familiar with the procedure for giving a clinician bolus. Improper programming could result in serious patient injury or death. Note: The maximum clinician bolus may be limited by the settings in the protocol, which is determined by the PharmGuard system administrator. To give a clinician bolus:

1. Make sure the pump is running. Start the pump if necessary. 2. From the Home screen, select Tasks. 3. From the Tasks menu, press U or D until Give Clinician Bolus is highlighted, then press S. 31 Programming and oPerationProgramming and oPeration 4. Unlock the keypad using the pump key (if allowed) or press U or D to enter the clinician code (or a higher level code). Press S to advance to the next digit. Once the code is entered, select Accept Value. Note: If you enter a code that you believe is correct and receive a wrong code error, check the screen to see if the clinician code is customized. If the code was not customized, it was entered incorrectly. Retry. If the code is customized, use the custom clinician code. If you do not know this code, contact your PharmGuard system administrator. WARNING: To prevent the patient from accessing the clinician bolus function, do not let the patient know the security codes. Improper programming could result in serious patient injury or death. 5. Make sure the clinician bolus amount is at the desired value and select Deliver. Note: If you enter a value outside the soft limit, a screen appears asking you to confirm the soft limit override. 6. The screen shows the amount decreasing as the bolus is delivered. You may stop the bolus at any time by selecting Stop Bolus. WARNING: Never leave the pump unattended while on the clinician bolus edit screen. You must deliver the programmed value, or cancel to leave the screen. Failure to do so could result in serious patient injury or death. Start New Patient Each time a new patient is started, it is recorded in the event log. All other delivery related reports are cleared. To start a new patient:

1. Stop the pump if it is running. 2. From the Home screen, select Tasks. 3. From the Tasks menu, press U or D until Start New Patient is highlighted and press S. 4. If your library was setup to use profiles by the PharmGuard system administrator, the previously selected profile is shown. Profiles contain a grouping of protocols (e.g., profiles can be defined for specific care areas, etc.). If your desired therapy is contained within the profile shown, select Yes, otherwise select No. If No is selected, you may press U or D to highlight the desired profile and press S. 5. The therapies contained within your selected profile are shown. Press U or D to highlight the desired therapy and press S. 32 Programming and oPerationProgramming and oPeration 6. Press U or D to highlight the desired qualifier and press S. 7. Press U or D to highlight the desired drug(s) and concentration, and press S. 8. Unlock the keypad using the security code. 9. The new protocol is displayed on the screen and the pump asks if you have selected the correct therapy, qualifier, drug, and concentration. Confirm that you have selected the correct profile, therapy, qualifier, drug, and concentration or units. Note: If programming in mL, you are not asked to confirm the concentration. Select Yes to program the pump with the protocol you have chosen. Select No to go back to the Select Drug screen. If you want to change the drug, repeat the process for selecting a new drug. Otherwise, select Back until you reach the screen you want to change (profile, therapy or qualifier). You will be asked to enter a security code after selecting Back and reselecting any profile, therapy, qualifier, or drug. 10. You will be prompted to review the pump settings to accept each value before the pump can be started. During the review, the pump settings may be edited if necessary. Note: If a clinical advisory note has been defined by your facility for the selected protocol, it will appear after accepting all values. To acknowledge the clinical advisory note, select OK. If you have a question about the note, contact your PharmGuard system administrator. Start New Protocol, Same Patient The process for starting a new protocol for the same patient is much like starting a new patient; however, the event log does not insert a new patient marker (all other delivery related reports are cleared except the delivery log). See Start New Patient on page 32 for directions on selecting a profile, therapy, qualifier, and drug for the new protocol. Note: When starting a new protocol, be sure to attach a new reservoir with the proper drug and concentration. 33 Programming and oPerationProgramming and oPeration Prime Tubing Priming the tubing is done to fill the tubing downstream of the pump with fluid, removing any air bubbles. Prime the tubing before connecting it to the patients infusion set or indwelling catheter. The pump must be stopped and you must enter the security code or the cassette/keypad lock must be unlocked. Note: The air detector is disabled while the pump is priming. WARNING: Do not prime the fluid path with the tubing connected to a patient as this could result in overdelivery of medication or air embolism, which could result in serious patient injury or death. To prime the tubing:

1. From the Home screen, select Tasks. 2. From the Tasks menu, press U or D until Prime Tubing is highlighted and press S. 3. Unlock the keypad using the security code or the pump key. 4. If you have not already done so, disconnect the tubing from the patient, open clamps, and select Prime, and turn pump with latch facing down (as shown below). You may stop priming at any time by selecting Stop Priming. Otherwise priming automatically stops once it has primed 10 mL (or 20 mL if using a high volume administration set). Continue priming as needed. WARNING: To prevent air embolism, ensure that the entire fluid path is free of all air bubbles before connecting to the patient. Air embolism could result in serious patient injury or death. Note: If the fluid path contains an air eliminating filter, it is acceptable for air bubbles to be present on the vent side of the filter. For more information, see the administration set or extension set instructions for use. Set Time and Date The set time and date screen allows you to view daylight saving time settings and edit the current time and date. Additionally, you can choose a time and date format. The time and date options should reflect the current time and date, and follow the standard format used in your facility. The pump time and date do not automatically update for daylight saving time unless it has been configured to do so by your PharmGuard system administrator. If you live in a geographical area that follows daylight saving time, and the pump is not configured to automatically adjust for daylight saving time, you must manually update the time and date. You may choose to change the time while the pump is currently being used by a patient, or wait until the patient is finished with therapy. 34 Programming and oPerationProgramming and oPeration Note:

If you manually update the time while the pump is in use, the timestamps in the event and delivery logs are not updated to reflect daylight saving time prior to the change. All events record the reported pump time from when the event actually occurred. For your reference, the event log records the time when it was changed. If the pump is configured to adjust time automatically for daylight saving time, the time will update at the configured time if the pump is in stop mode, or the first time it enters stop mode after the configured time. When the pump clock is changed automatically due to daylight saving time, a message appears on the pump to notify you. The pump clock is powered by a separate, internal battery that retains the time and date even when the 4 AA batteries, the battery pack, or communication module is removed. The pump uses this feature to record the time and date of events in the delivery and event logs. In addition, the date is used to determine when preventive maintenance alarms occur. Note:

The internal battery is rechargeable and automatically recharges when the pump is powered on. If the pump is off for a long period of time, it may not show the correct time and date when it is powered on. Check the time and date, and edit these settings if necessary. Protocol information remains the same regardless of changing the time and/or date during a patients therapy. To access the set time and date feature:

1. From the Home screen, select Tasks. 2. Press U or D to choose Set Time and Date and press S. To view the daylight saving time setting:

Press U or D until Daylight Saving Time is highlighted and press S. Depending on how your pump is configured by your PharmGuard system administrator, the pump either displays when daylight saving time will change (if the pump is set to change for daylight saving time automatically), or that the daylight saving time feature is disabled. To set the current time:

1. Press U or D until Current Time is highlighted and press S. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D to scroll to the correct hour and press S to navigate to the minutes. 4. Press U or D to scroll to the correct minutes and select Save. To set the current date:

1. Press U or D until Current Date is highlighted and press S. 35 Programming and oPerationProgramming and oPeration 2. Unlock the keypad using the security code or the pump key. 3. Press U or D to scroll to the correct month and press S to navigate to the day. 4. Press U or D to scroll to the correct day and press S to navigate to the year. 5. Press U or D to scroll to the correct year and select Save. To set the time format:

1. Press U or D until Time Format is highlighted and press S. 2. Unlock the keypad using the administrator code. 3. Press U or D until the desired time format is highlighted and select Save. To set the date format:

1. Press U or D until Date Format is highlighted and press S. 2. Unlock the keypad using the administrator code. 3. Press U or D until the desired date format is highlighted and select Save. Adjust Backlight Intensity The backlight intensity feature allows you to adjust the brightness of the pump display within the range of 1 to 10. Note: Increasing the backlight intensity shortens the battery life. To adjust the backlight intensity:

1. From the Home screen, select Tasks. 2. Press U or D to choose Adjust Backlight Intensity and press S. 36 Programming and oPerationProgramming and oPeration 3. Unlock the keypad using the security code or the pump key. 4. Press U or D to scroll from 1 to 10. The pump displays the intensity of each number as it appears. Once you have found the desired backlight intensity, select Save. Adjust Alarm Volume The adjust alarm volume feature allows you to determine the volume of the alarms in the protocol. You may choose between 3 volumes: low, medium, and high. Note:

Use of a pouch, lockbox, or backpack may muffle audible alarms. If a high or medium priority alarm exists for 2 or more minutes without being acknowledged, the alarm volume automatically adjusts to High. To adjust the alarm volume:

1. From the Home screen, select Tasks. 2. Press U or D to choose Adjust Alarm Volume and press S. 3. Unlock the keypad using the security code or the pump key. 4. Press U or D to choose Low, Medium, or High and select Save. View Reports The reports screen is used to access a variety of reporting and record-keeping functions. To access reports from the tasks menu:

Press U or D to choose View Reports and press S. Note: Reports may also be accessed from the Home screen. See Reports on page 39 for more information. 37 Programming and oPerationProgramming and oPeration CADD-Solis Communication Module (Model 2130 or 2131) Turn Wireless On/Off When the pump has a CADD-Solis Communication Module installed, its wireless radio can be turned off (and on) as necessary. The wireless capabilities are used to allow the pump to communicate to a PharmGuard Server system (i.e., sending pump data to the server, and receiving pump library and software updates from the server). Note: The clinical functions of the pump are not affected by the pumps wireless on/off status. Wireless can be turned off or on without affecting pump delivery. When wireless is turned off, the pump retains delivery history data within the pump which will be communicated to the PharmGuard Server system automatically later when wireless is turned on and connectivity to the server is established. To turn wireless capabilities on or off:

1. From the Home screen, select Tasks. 2. Press U or D until Turn Wireless On/Off is highlighted and press S. 3. Press U or D until the desired setting is highlighted and select Save. The wireless indicator in the pump display (below the keypad lock status) shows wireless and connectivity status:

Wireless Off Wireless Off

(white indicator) Wireless On Wireless On, not associated with wireless access point

(orange indicator) Wireless On, associated with wireless access point

(orange indicator with green center) Wireless On, associated with wireless access point, and communicating with PharmGuard Server

(green indicator with green center) Adjust Admin Settings The administrator settings contain pump configurations that are set up by the PharmGuard system administrator. Protocol libraries are created using the PharmGuard Medication Safety Software. The administrator settings only allow you to make changes to the protocol currently displayed. To access the administrator settings:

1. From the Home screen, select Tasks. 2. From the Tasks menu, press U or D to choose Adjust Admin Settings and press S. Note: You cannot access the administrator settings without the administrator code. See the Administrator Settings Guide for more information. 38 Programming and oPerationProgramming and oPeration Reports The reports screen is used to access a variety of reporting and record-keeping functions. Note: Therapies incorporating patient-controlled analgesia are configured with the PharmGuard Medication Safety Software to display either PCA or PCEA. Most examples shown in this manual display PCA. However, menus, submenus, and screens on the pump will appear with PCEA if they are programmed to do so. You may access the reports from the Home screen or the Tasks menu. To access the reports from the Home screen, select Reports. (To access the reports from the Tasks menu, see View Reports in the previous section.) Intermittent Bolus Status This screen shows the amount of time that has elapsed since the last intermittent bolus, and the amount of time until the next intermittent bolus is due to be delivered. To view the intermittent bolus status:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Intermittent Bolus Status and press S. Given and PCA Dose Counters (Given and PCEA Dose Counters) This screen shows the number of PCA doses given and attempted since the date and time indicated, which is the last time they were cleared manually, or when a new protocol or new patient was started. Total Given shows the amount of drug given (in programming units) in continuous rate, clinician boluses, intermittent boluses, and PCA doses. If the programming units are mg or mcg, the total volume of fluid

(mL) and amount of drug (mg or mcg) are shown. PCA Doses Given shows the number of PCA doses actually delivered to the patient, including any doses stopped in progress. PCA Doses Attempted shows the total number of PCA doses attempted by the patient while the pump was running, including those that were delivered, locked out, and stopped in progress. The dose counters can be viewed or cleared while the pump is running or stopped. Note: If the PCA dose is not available in the current protocol, you see only the Total Given when viewing this report. 39 Programming and oPerationProgramming and oPeration To view the Given and PCA dose counters:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Given and PCA Dose Counters and press S. To clear the total given counters:

1. Press U or D until the Given Amount and Given Volume section is highlighted. 2. Select Clear Given. To clear the PCA doses given and attempted counters:

1. Press U or D until the PCA Doses Given and PCA Doses Attempted section is highlighted. 2. Select Clear Doses. PCA Dose Graph (PCEA Dose Graph) This screen displays the number of doses attempted and given in 30 minute increments starting from the current time to 8 hours in the past or to the start of a new protocol or patient. The PCA dose graph can be viewed at any time, with the pump running or stopped. In this example, the patient has attempted 7 doses and 3 of those doses were given. This is a good place to review the number of attempted doses for a particular time frame. To view the PCA dose graph:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose PCA Dose Graph and press S. 40 Programming and oPerationProgramming and oPeration Intermittent Bolus Graph This screen displays the number of intermittent boluses given in 30 minute increments starting from the current time to 8 hours in the past or to the start of a new protocol or patient. The intermittent bolus graph can be viewed at any time, with the pump running or stopped. To view the intermittent bolus graph:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Intermittent Bolus Graph and press S. PCA and Intermittent Graph (PCEA and Intermittent Graph) This screen displays the number of intermittent boluses, and the number of PCA doses attempted and given in 30 minute increments starting from the current time to 8 hours in the past or to the start of a new protocol or patient. The PCA and intermittent graph can be viewed at any time, with the pump running or stopped. In this example, the patient attempted 6 doses and 3 of those doses were given. To view the PCA and intermittent graph:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose PCA and Intermittent Graph and press S. Delivery History and Pie Chart The delivery history and pie chart is a pie chart view of the total given over a specified time frame or to the start of a new patient or protocol. The time frame can be adjusted in various intervals from 30 minutes to 7 days. Press U or D to view the time chart in the various time frames. This provides a quick review of the methods of delivery over the interval selected. The delivery history is displayed in the units for the current protocol. The delivery history and pie chart can be viewed at any time, with the pump running or stopped. To view the delivery history and pie chart:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Delivery History and Pie Chart and press S. 41 Programming and oPerationProgramming and oPeration Current Profile / Protocol (if configured) The Current Profile / Protocol screen shows the profile, therapy, qualifier, drug and units in use based on your selected protocol or manually programmed protocol. To view the current profile / protocol:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Current Profile /

Protocol and press S. Delivery Log The delivery log is a subset of the event log and contains information having to do specifically with delivery events. Delivery log information includes:

PCA dose deliveries. Clinician boluses. Changes to the patient specific parameters (including continuous rate, intermittent boluses, PCA Intermittent boluses. dose, PCA dose lockout, delivery limit). Manually stopping a PCA dose and/or a clinician bolus. Starting a new protocol. Pump started, stopped, powered up, and powered down. The delivery log is maintained by the pump, and displays all entries since the last time a new patient was started. The delivery log can be viewed at any time, with the pump running or stopped. To view the delivery log:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Delivery Log and press S. While viewing the delivery log, you may quickly scroll from the oldest to newest by selecting Show Oldest or Show Newest. 42 Programming and oPerationProgramming and oPeration Event Log The event log records the following types of events: hourly given totals, dose delivery, alarms, error codes, power source changes (including power losses), cassette changes, protocol library changes, and changes to pump programming or settings. The pump records the time and date of each event, and lists events in order, with the most recent at the bottom of the screen through the last 5000 events. When the event log reaches 5000 events, and a new event occurs, the oldest event is replaced with the next oldest event in order of occurrence. The event log can be viewed at any time, with the pump running or stopped. The event log is maintained by an internal back up battery during and after the pump is powered off or when the pump loses power unexpectedly due to removal or depletion of power source (AC adapter, AA alkaline batteries, rechargeable battery pack, or communication module). To view the event log:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Event Log and press S. While viewing the event log, you may quickly scroll from the oldest to newest by selecting Show Oldest or Show Newest. Daylight Saving Time When the pump is configured by your PharmGuard system administrator to automatically change time due to daylight saving time, this screen displays time change information. If this screen states that the feature is disabled, time can be updated manually on the pump. For more information about time changes and when automatic time changes will occur on the pump, see page 34. To view the daylight saving time information:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Daylight Saving Time and press S. This option is also available from the Set Time and Date screen. Protocol Library Summary The protocol library summary allows you to view the protocol library currently installed in the pump. This screen tells you the name of the protocol library, the revision, and the number of protocols in the library. To view the protocol library summary:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Protocol Library Summary and press S. 43 Programming and oPerationProgramming and oPeration Wireless Status This screen is available only when a CADD-Solis Communication Module is installed. This report is used by network or systems adminstrators to view the current status of the pump wireless module and its connectivity to the wireless network If the Communication Module is incompatible with the wireless network configuration programmed in the pump, the status reported on the screen will be Incompatible Configuration. Note: For information about how to turn wireless on/off and viewing basic wireless status, see page 38. To view wireless status:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Wireless Status and press S. Wireless Settings This screen is available only when a CADD-Solis Communication Module is installed. This report is used by network or systems adminstrators to view the configuration settings for the communication module. Notes:

For information about how to turn wireless on/off and viewing basic wireless status, see page 38. Wireless settings can be modified only by network administrators using the CADD-Solis Network Setup Utility software. For more information, administrators should consult the documentation included with this software. To view wireless settings:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Wireless Settings and press S. Device Information The device information screen allows you to view the pump serial number, asset ID, software (package number) and hardware version numbers, and the last error code (if one exists). If a CADD-Solis Communication Module is installed, the communication module (CM) revision and MAC address is also shown. Note: Review your facilitys procedure for handling error codes (see Alarms and Messages, Alphabetical List on page 58 for more information). To view device information:

1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Device Information and press S. 44 Programming and oPerationProgramming and oPeration Max. hard limit range

(amber) Soft limit range

(green) Min. hard limit range

(amber) Patient Specific Parameters

(Programming Screens) The patient specific parameters are found on the Home screen and can be edited within limits that are set up by the PharmGuard system administrator in the protocol. The PharmGuard system administrator determines which parameters can be viewed and/or edited on the Home screen, as well as the initial values of the parameters. While determining the initial values, the PharmGuard system administrator also sets up hard and soft limits which may allow you to modify the parameters as necessary. The soft limits (displayed in green) are the range most commonly used for the protocol, and the hard limits (displayed in amber) extend to the highest and lowest amount that the PharmGuard system administrator chooses to allow for the protocol. If the doctors orders do not match the initial values, they should be edited to match. Editing the parameters above or below the soft limits results in a screen that requires you to confirm the soft limit override. You need the security code or the pump key to edit the patient specific parameters. The PharmGuard system administrator determines if the pump key can be used to unlock the keypad when setting up the protocol. If the option is available, use the pump key to place the pump in the unlocked position (see picture) or, enter the security code (see Security Settings on page 28). Outside soft limit range

(amber) Note:

Using the pump key to unlock the keypad also unlocks the cassette latch

(see Attaching a Cassette on page 25 for more information). When using the pump key to unlock the keypad, be sure to keep the cassette latch in the latched position. The pump provides the following methods of delivery:

Continuous rate: infusion of drug at a constant, programmed rate PCA dose: a demand dose activated by the patient Clinician bolus: a dose activated by the clinician Intermittent bolus: a series of doses activated at regular, programmed intervals Each of the methods may be programmed individually or in combination with each other. Ranges, programming increments, rates, and volumes are listed in the specifications section (see Specifications

(Nominal) on page 71). Note: Therapies incorporating patient-controlled analgesia are configured with the PharmGuard Medication Safety Software to display either PCA or PCEA. Most examples in this manual display PCA. However, menus, submenus, and screens on your pump will appear with PCEA if they are programmed to do so. 45 Programming and oPerationProgramming and oPeration Intermittent Bolus Each intermittent bolus is the infusion of a specific volume of drug at the programmed max delivery rate value. Programming the intermittent bolus is limited by the values of the max delivery rate, bolus interval, and continuous rate. Intermittent boluses are delivered at regular time intervals based on the programmed Bolus Interval, and as allowed by intermittent bolus limits, bolus interval limits, and bolus type. For more information, contact your PharmGuard system administrator. This value can be edited while the pump is running or stopped (if the keypad is unlocked). Note: Stopping the pump while an Intermittent Bolus is in progress will cancel the remainder of the Intermittent Bolus dose. To edit the intermittent bolus:

1. From the Home screen, press U or D to choose Intermittent Bolus and press S. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired intermittent bolus quantity and select Save. Bolus Interval The bolus interval is the amount of time that elapses from the beginning of one intermittent bolus to the beginning of the next one. The bolus interval cannot be programmed to a value that would prevent an intermittent bolus from being fully delivered within the bolus interval time period. Programming the bolus interval is limited by values of the max delivery rate, continuous rate, and intermittent bolus. For more information, contact your PharmGuard system administrator. This value can be edited while the pump is running or stopped (if the keypad is unlocked). To edit the bolus interval:

1. From the Home screen, press U or D to choose Bolus Interval and press S. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired bolus interval and select Save. 46 Programming and oPerationProgramming and oPeration Next Bolus The Next Bolus setting is the length of time between when the pump starts Running until when the first intermittent bolus will be delivered. After the initial intermittent bolus is delivered, Next Bolus functions as a timer to count down the time remaining until the next intermittent bolus is programmed to deliver. Note: The Next Bolus countdown does not begin until you start the pump by pressing the stop/start 9 button. Once the pump has been started, the countdown continues even if the pump is subsequently stopped. The Next Bolus setting may be edited to adjust the timing of the next Intermittent Bolus as defined by the bolus interval. This can be done prior to beginning an infusion or during an infusion. For example, a clinician can edit the next bolus setting to 0 minutes to immediately deliver an intermittent bolus. All subsequent intermittent bolus delivery times will be determined by the bolus interval. Note: When the Next Bolus is programmed to 0 Min and the pump is started, or when the pump is running and the Next Bolus has counted down and reaches 0 Min, the Intermittent Bolus delivery starts, PIB bolus is displayed in the status bar, and the Next Bolus time immediately resets to match the programmed Bolus Interval. Because the reset of the Next Bolus time occurs immediately, the value of 0 Min will only be seen if the pump is in stop mode. The following are examples of when the pump will deliver the intermittent bolus dose and what the pump will display based on how the bolus interval and the next bolus are programmed. When the pump is started:

If Bolus Interval is programmed to 1 Hrs and Next Bolus is programmed to 1 Hrs:

The Intermittent Bolus will occur in 1 hour. The status bar will display Running. Next Bolus will display 1 Hrs and will count down as time passes. If Bolus Interval is programmed to 1 Hrs and Next Bolus is programmed to 0 Min:

The Intermittent Bolus will occur immediately after starting the pump. The status bar will display PIB Bolus. Next Bolus will display 1 Hrs and will count down as time passes. The next bolus option can be edited only when the pump is stopped. The pump must be running at the selected time in order for delivery to begin. To edit the next bolus:

1. From the Home screen, press U or D to choose Next Bolus and press S. Note: If a protocol was running and medication was delivered, a confirmation screen appears showing the current, programmed setting. Select Yes to change the setting. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired next bolus time and select Save. 47 Programming and oPerationProgramming and oPeration Continuous Rate The continuous rate is the constant, hourly rate the drug is delivered at while the pump is running. Programming the continuous rate is limited by values of the max delivery rate, bolus interval, and intermittent bolus. For more information, contact your PharmGuard system administrator. The continuous rate value can be edited while the pump is running or stopped (if the keypad is unlocked). To edit the continuous rate:

1. From the Home screen, press U or D to choose Continuous Rate and press S. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired rate and select Save. PCA Dose (PCEA Dose) A PCA dose is a bolus of drug delivered by the pump in response to a request from the patient. The patient either presses the PCA dose @ key on the keypad or presses the remote dose cord button (if attached) to request a PCA dose. WARNING: The remote dose cord is for patient use only. Operation by anyone other than the patient may cause overdelivery of medication that could result in serious injury or death of the patient. Note: If a remote dose cord is attached to the pump, the PCA dose @ key on the keypad is inactive. If the PharmGuard system administrator has programmed a PCA dose into the protocol, the patient may start a PCA dose while the pump is running. The amount delivered is added to the amount provided by either the continuous rate and/or intermittent bolus. A PCA dose can be delivered during the next bolus countdown. Note:

A PCA dose cannot be started while another PCA dose or a clinician bolus is in progress. Pressing the remote dose cord button turns the display back on and delivers a PCA dose (if available). A If the delivery limit is reached while a PCA dose is in progress, the PCA dose will not be completed. blank display does not require two key presses to start a PCA dose. Each time the patient requests a PCA dose, the pump automatically adds it to the dose counters screen. If a PCA dose has not been programmed by the PharmGuard system administrator, the pump displays the message, PCA dose not available because no dose programmed. The PCA dose amount can be edited while the pump is running or stopped (if the keypad is unlocked). To edit the PCA dose:

1. From the Home screen, press U or D to choose PCA Dose and press S. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired PCA dose and select Save. 48 Programming and oPerationProgramming and oPeration PCA Lockout (PCEA Lockout) The PCA lockout is the minimum amount of time that must pass after a PCA dose and before the patient can successfully request another PCA dose. It is also the minimum time that must elapse between the time an intermittent bolus starts and the time that the next PCA dose is available. The PCA lockout can be edited while the pump is running or stopped (if the keypad is unlocked). To edit the PCA lockout:

1. From the Home screen, press U or D to choose PCA Lockout and press S. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired PCA lockout time and select Save. Hourly Limit The hourly limit is the amount of drug which can be delivered in a specified time frame (1-12 hours). The time frame is determined by your facilitys PharmGuard system administrator. This limit includes the continuous rate and PCA doses, but does not include clinician boluses. If the delivery limit is reached and a continuous rate is programmed (value other than zero), the status bar displays Delivery Limit and the pump delivers a KVO rate of 0.1 mL/hr. If the delivery limit is reached and no continuous rate is programmed (value = zero), the status bar displays KVO = 0 and the KVO rate is zero. Note: If the delivery limit is reached while a PCA dose is in progress, the dose will not be completed. The hourly limit can be edited while the pump is running or stopped (if the keypad is unlocked). To edit the hourly limit:

1. From the Home screen, press U or D to choose X* Hour Limit and press S.

*X is the number of hours set up by the PharmGuard system administrator. In the example shown, a 4 hour limit is being used. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired hourly limit amount and select Save. If the hourly limit is not visible on the Home screen, your PharmGuard system administrator has chosen not to require it. Instead you may be required to program the Max Doses/Hr. Max Doses/Hr The max doses/hr setting is used to further restrict the number of PCA doses available to the patient in 1 hour. The max doses/hr feature allows you to restrict the PCA doses beyond the PCA lockout time. The max doses/hr time can be edited while the pump is running or stopped (if the keypad is unlocked). 49 Programming and oPerationProgramming and oPeration Note: If the hourly limit or the max doses/hr settings are not visible on the Home screen, your facilitys PharmGuard system administrator has chosen not to require a delivery limit beyond the PCA lockout. To edit the max doses/hr:

1. From the Home screen, press U or D to choose Max Doses/Hr and press S. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired max doses/hr value and select Save. Reservoir Volume The reservoir volume is a program setting that allows you to set the amount of fluid that is contained in the reservoir. Once you set this number, the software keeps track of how much fluid is delivered and adjusts the reservoir volume accordingly. The pump must be stopped to adjust the reservoir volume amount. To edit the reservoir volume:

1. From the Home screen, press U or D to choose Reservoir Vol, and press S. Note: If a protocol was running and medication was delivered, a confirmation screen appears showing the amount remaining in the reservoir volume. Select Yes to adjust the reservoir volume. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired reservoir volume and select Save. You may press S to reset the pump to a default amount which appears on the screen in blue text, under the current value. In this example, pressing S resets the reservoir volume to 100 mL. 50 Programming and oPerationProgramming and oPeration Manual Mode Programming The manual mode is for situations when the doctors orders may not match any of the protocols in the library, or when a protocol library is not available. The screen for the manual mode is always black in color and the therapy, qualifier, and drug and concentration listing will look like this (see page 23 for a diagram of the pump screen):

Units and concentration chosen after the manual mode is selected. Note: The protocol title bar may be black even when the pump is not in manual mode if the protocol was modified in the administrator settings (see the Administrator Settings Guide for more information). Be sure to check the therapy, qualifier, drug, and concentration or units displayed to ensure you are in manual mode. Unlike protocols that are created and downloaded into the pump by the PharmGuard Medication Safety Software System, the manual mode allows you to choose the units (mL, mg, mcg) and concentration, and does not contain any programming limits. Many of the parameters in the manual mode remain the same as the parameters from the previously used protocol. For example, if the previous protocol had delivery limit set as its delivery limit method, the manual mode will also have delivery limit as its delivery limit method. However, the actual programming limits of the previous protocol are erased. The hard and soft limits are all set to the factory default, which means the delivery ranges are not limited. See the following chart for details. Note: If the pump was set to the factory default, or if you are using the pump for the first time, the previously selected protocol is the factory default settings. Refer to the table on page 82 to see what the factory default settings are. If you desire to set programming limits after choosing the manual mode, you may do so. See the Administrator Settings Guide for more information. Note: The manual mode is designed to be used in unusual circumstances when an order is received which is different than any of your standard protocols. Use of the manual mode does not allow you to use all of the medication safety features built into the CADD-Solis pump. If you find the manual mode is being used frequently, consider contacting your PharmGuard system administrator to discuss if additional protocols should be created. 51 Programming and oPerationProgramming and oPeration Manual Mode Initial Settings Pump Function Protocol Setting User selects mL, mg, or mcg User selects if the programming units are mg or mcg. Range is 0.1100 mg/mL or 1500 mcg/mL On Range is 0100 mL/hour (or mg or mcg equivalent). Value is 0 On Range is 050 mL (or mg or mcg equivalent). Value is 0 Range is 1 min24 hours. Value is 1 hour (when PCA dose is programmed) Off Range is 050 mL. Value is 0 mL Range is 1 minute4 hours. Value is 1 hour Bolus Interval or PCA Lockout. Value is Bolus Interval Range is 0 minutes4 hours. Value is 0 hr Range is 0.11000 mL (or mg or mcg equivalent) Range is 160. Value is 1 1 mL 100 mL Remains the same as the previously used protocol 5.0 mL Remains the same as the previously used protocol Range is 050 mL (or mg or mcg equivalent) Remains the same as the previously used protocol Remains the same as the previously used protocol Remains the same as the previously used protocol Remains the same as the previously used protocol Remains the same as the previously used protocol On Remains the same as the previously used protocol Remains the same as the previously used protocol Remains the same as the previously used protocol Remains the same as the previously used protocol Remains the same as the previously used protocol Remains the same as the previously used protocol Programming Units Concentration Continuous Rate On/Off Continuous Rate Limits PCA Dose On/Off PCA Dose Limits PCA Lockout Limits Intermittent Bolus On/Off Intermittent Bolus Limits Bolus Interval Limits Intermittent Bolus Type Next Bolus Delivery limit amount*

Max doses/hour*

Reservoir volume Reservoir volume reset value Delivery limit method Reservoir volume low trip point Reservoir low alarm type Clinician bolus amount Delivery limit period Maximum Delivery Rate Pump stopped alarm type Upstream sensor on/off Downstream sensor sensitivity Air detector on/off Air detector sensitivity Time and date settings PM reminder on/off PM reminder interval Display and sound settings Security settings

*Only if feature was used in the previous protocol. 52 Programming and oPerationProgramming and oPeration To use the manual mode:

1. Determine whether you are starting a new patient, or starting a new protocol with the same patient. Select the appropriate task from the tasks menu. 2. On the Select Therapy screen, scroll to the bottom of the therapies until

[Program Manually] is highlighted and press S. The protocol title bar is displayed in the color black. Instead of a therapy and qualifier, you see the Manual Program screen (see page 51). 3. Unlock the keypad using the security code. 4. Press U or D to select the desired units (mL, mg, mcg), and then press S. If you selected mg or mcg, press U or D to scroll to the desired concentration and select Confirm. If you selected mL, proceed to the next step. 5. The therapy, qualifier, units and concentration, if applicable, that you have selected now appear. Confirm that you have selected the correct units and concentration and select Yes. Note: If the information displayed is incorrect, selecting the left soft key backs you out of each screen, allowing you to start over. 6. The pump takes a moment to set the program before it asks you to review the pump settings. Select Review. 7. Carefully review each patient specific parameter. If the parameters are not at the desired values, press S to edit. (See Patient Specific Parameters on page 45 for more information.) If the parameters are correct, select Accept Value. Note: When the pump is in the manual mode, only the factory default settings are considered to be within the soft limits. If you edit any of the parameters outside of the factory default, you will exceed the soft limit range and will be asked to confirm the soft limit override on each screen (see page 82 for the factory default settings). The parameter and value are displayed in amber. WARNING: The manual mode does not contain programming limits. Carefully review each parameter to ensure it accurately matches the prescription. Failure to set the manual mode to the correct values could result in serious patient injury or death. 8. Once you have accepted each of the values, follow the instructions on the pump to attach the cassette, prime the set, and start the pump. 53 Programming and oPerationProgramming and oPeration Wireless Function (Communication Module) When the pump has the optional CADD-Solis Communication Module installed, its wireless capabilities allow the pump to communicate to a PharmGuard Server system (i.e., sending pump data to the server, receiving pump library updates, and software updates (pump and communication module) from the server). The communication module also features a built in rechargeable battery to power the pump. The communication module is recharged while installed in the pump using the pump AC adapter connected to the pump AC power jack. For installation and additional information, see the CADD-Solis Communication Module Operators Manual. Note: The wireless feature can be turned off or on without affecting pump delivery. The communication module is an added feature and not required for normal pump operation. Lack of wireless connection to an access point does not impact delivery accuracy. Functionality of the CADD-Solis Communication Module:

PharmGuard library updates occur without impact to current delivery. The new libraries are effective upon the next start new patient setup. PharmGuard software downloads occur without impact to current delivery and only take effect upon the acceptance of the new software. The communication module allows the pump to send event history and status to the PharmGuard Server. The events match those from the pump event log. Rechargeable battery built into the communication module powers wireless function and pump delivery (four hours run time) when the AC adapter is not used. Built in Pole Mount adapter. The mounting bracket of the communication module also provides a built in pole mount bracket. Heat Reduction Mode:

When the communication module is sending and/or receiving large amounts of data in an operating environment that is near the higher end of the specified operating environment temperature range, wireless functionality may be temporarily limited as a safeguard to prevent overheating. If heat reduction mode occurs, pump function and delivery accuracy are not impacted, only the wireless functionality. If heat reduction mode is active, the pump Wireless Status Indicator will show, associated with wireless access point. Move the pump and communication module into a cooler area to expedite cooling and resume wireless functionality.

- Wireless On, not 54 Programming and oPerationProgramming and oPeration References and Troubleshooting Alarms and Messages The pump can produce multiple alarms. For many of the alarms, you have one or more options available:

Acknowledgethe alarm clears from the screen. Silencethe alarm stays on the screen, but is silenced for 2 minutes before it sounds again. The alarm continues until it is acknowledged or resolved. Power Downavailable from some select alarms, this option powers the pump down. Stop Pump available from some select alarms, this option stops pump delivery. The alarms may have different sounds depending on the sound theme selected in the PharmGuard administrator settings. There are 3 different sound themes for the alarms that the pump makes: standard, intense, and distinctive. See the Administrator Settings Guide for more information on previewing and selecting the sound themes. Types of Alarms System Fault Alarm If this screen appears, an unrecoverable error may have occurred, such as a hardware or software fault. The amber indicator light is continuously illuminated during these conditions and is accompanied by an audible two-tone alarm. If a system fault occurs, the fault should be reported to Customer Service at Smiths Medical or Smiths Medical International Ltd. There are two ways to clear this alarm (pump will power down):

Two key press; separately press the left and right soft keys on the keypad, or press either the left or right soft key and then press the power switch. Or Remove power from the pump by opening the battery door and, if necessary, removing the AC power. Close the battery door and turn the pump back on. If the error code does not repeat, Customer Service may suggest continued use of the pump. However, if the error is persistent, the pump must be returned for service. Note: Document the error numbers displayed on the system fault screen to System fault alarm (red). The numbers relate to the error that caused the system fault. help Customer Service identify the problem. CAUTION: If the power up results in an error message indicating that the protocol library was lost, do not proceed with using the pump. Follow your facilitys procedures for downloading protocol libraries. High Priority Alarm A high priority alarm always pauses or stops the pump if it is running. The alarm is accompanied by a red screen, and it persists until acknowledged by the press of a key on the pump or until the condition that triggered the alarm goes away (for example, high pressure). The alarm can be silenced with a key press and will sound again after 2 minutes if the alarm condition still exists. Medium Priority Alarm A medium priority alarm does not stop the pump if it is running. The alarm is accompanied by an amber screen, and it persists until acknowledged by the press of a key on the pump or until the condition that triggered the alarm goes away. The alarm can be silenced with a key press and will sound again after 2 minutes if the alarm condition still exists. High priority alarm (red) Medium priority alarm

(amber) 55 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Low Priority Alarm A low priority alarm does not stop the pump if it is running. The alarm is accompanied by a blue screen, and it persists for 5 seconds unless it is acknowledged by the press of a key or the condition that triggered the alarm goes away before the 5 seconds have passed. (Some low priority alarms persist for longer than 5 seconds.) Low priority alarm (blue) Multiple Alarms The alarm system will maintain and manage multiple alarm conditions at the same time, but will only generate alarm signals from a single alarm at any time. When an alarm of higher priority is activated, its alarm signals will supersede those of any currently active lower priority alarm. When an alarm of equal or lower priority is activated, its alarm signals will follow at the removal of any currently active higher or of equal priority alarm. In this way, the operator awareness of lower or of equal priority alarms may be delayed until existing higher priority alarms are addressed by the operator. Informational Messages and Signals An informational priority message does not stop the pump if it is running. This message appears in the status bar, and does not display over any existing screen. It persists for 5 seconds and may be silent, requiring no acknowledgement. Some informational examples are Cassette Locked and Cassette Unlocked. When an alarm condition is active, in addition to the visual indication, the pump will sound an audible alarm that is distinguishable from other pump sounds. All audible alarms, no matter the sound theme used, will be distinguishable from other information signals that the device may sound. The audible informational signals are not impacted by the sound theme settings. Audible informational signals include: key beeps, PCA dose granted beeps, stop mode beeps, informational message beeps, low battery beeps, and power on beeps. The audible characteristics of these informational signals may also be previewed along with the sound themes (see Administrator Settings Guide). Alarm Algorithms Most alarm algorithms are based on simple, singular, and unchangeable alarm limits; for example, Reservoir Volume Empty, Remote Dose Cord Disconnected, Delivery Cannot Be Started, Battery Removed, and Disposable Detached. Alarm algorithms based on user configurable alarm limits are: High/Standard Flow Disposable Not Allowed, Delivery Limit, Reservoir Volume Low, Downstream Occlusion, Upstream Occlusion, Air In-Line, and Stop Mode Reminder. Other alarm algorithm details included in the table of alarm messages. Alarm Help Screens Additional information may be displayed when certain alarms occur. The help screens describe what you can do to try to solve the current problem that is causing the alarm. 1. When an alarm occurs, select Silence to quiet the alarm. 2. If help screens are available for the alarm, Help appears above the right soft key. To view the help screens, select Help. 56 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing 3. Follow the applicable instructions provided on the help screen. To page through all available help screens, press Next repeatedly. Press Acknowledge at any time to exit Help. 4. Retry Help appears when no additional help steps are available. To page through the help screens again, press Retry Help. The Alarm screen reappears as in Step 2 above. Repeat Steps 2 and 3. When the alarm clears, the help screens will no longer be displayed. User Position The user must position themself to ensure alarm visibility and audibility with respect to distance from the device in the expected ambient light and noise conditions. Note: Perform an alarm risk assessment to determine compatibility with facility alarm policies and care area requirements. If choosing an alternative alarm style, perform a risk assessment to ensure the operators recognition of the audible alarm. Note: There is no power interruption limit to the devices ability to restore alarm settings and behavior. The pump will retain alarm state upon power interruption if the alarm condition persists through the power interruption, and alarm algorithms are unaffected by power interruption. Troubleshooting Issue A continuous two-tone alarm is sounding, and the amber light is lit or flashing. The pump is sounding persistent audible beeps, and the amber light is flashing. Three beeps sound every 5 minutes. After installing 4 new AA batteries and powering up the pump, no screen appears and no beep sounds. Possible Solution Delivery has stopped. Read the message on the display and refer to the list of messages in the table below. If the display is blank or contains random characters, the 4 AA batteries , the rechargeable battery pack, or the CADD-Solis Communication Module with integrated rechargeable battery may be depleted. Install 4 new AA batteries, a fully charged rechargeable battery pack, or attach an AC adapter to charge a rechargeable battery pack or communication module battery. Look at the message on the display and refer to the list of messages in the table below. This may be a reminder that the pump is stopped. The batteries may be installed incorrectly. Review the procedure for installing batteries. Be sure to match the polarity (+ and ) markings inside the battery door with the markings on the batteries. If there is still no power, the batteries may be completely depleted. Install 4 new AA batteries. 57 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Alarms and Messages, Alphabetical List Alarms and Messages

(Screen is blank and alarm is sounding) Alarm Priority High Description / Corrective Action The pump was delivering and the batteries or the CADD-Solis Communication Module with integrated rechargeable battery was removed, the battery door was opened, or the batteries are too depleated to power the pump. The pump lost power and is no longer delivering. Clear this alarm by turning the pump back on, or the alarm stops after the power is off for a minimum of 2 minutes. Medium A parameter was being manually edited, but it wasnt saved and the pump reverted to the Home screen. Select Acknowledge to clear the alarm, and if appropriate, edit the parameter and save. A setting was edited, but not saved, and the edit was lost. AC Adapter disconnected. Air in-line detected. Press Acknowledge then prime tubing. Low High Battery depleted. Pump stopped. High The AC adapter was disconnected and the pump is being powered by the 4 AA batteries , rechargeable battery pack or the CADD-Solis Communication Module with integrated rechargeable battery. Select Acknowledge to clear the alarm or the alarm will automatically clear after 5 seconds. If desired, reconnect the AC adapter. The air detector has detected accumulated air in the fluid path; the fluid path may contain air bubbles. The pump was delivering and is now stopped and will not run. Select Acknowledge to clear the alarm. If the fluid path contains air bubbles, close the clamps and disconnect the fluid path from the patient. Follow the instructions for removing air by priming (see Prime Tubing on page 34 for more information on priming). Restart the pump. The pump was delivering and is now stopped and the battery power is too low to operate the pump. If the AC adapter is attached, select Acknowledge to clear the alarm. If the AC adapter is not attached, select Power Down to power down the pump. Charge the rechargeable battery pack or the CADD-Solis Communication Module with integrated rechargeable battery. Install 4 new AA batteries or a fully charged rechargeable battery pack. To start delivery, good batteries must always be installed, even when an external source of power is connected. If appropriate, restart the pump. Battery depleted. Pump will not run. Medium The battery power is too low to operate the pump. If the AC adapter is attached, select Acknowledge to clear the alarm. If the AC adapter is not attached, select Power Down to power down the pump. Charge the rechargeable battery pack or the CADD-Solis Communication Module with integrated rechargeable battery. Install 4 new AA batteries or a fully charged rechargeable battery pack. To start delivery, good batteries must always be installed, even when an external source of power is connected. Battery low. Replace battery. Low The rechargeable battery pack, CADD-Solis Communication Module with integrated rechargeable battery, or 4 AA batteries are low but the pump is still operable. Select Acknowledge to clear the alarm or the alarm automatically clears after 5 seconds. Recharge or change the rechargeable battery pack or CADD-Solis communication module, or replace the 4 AA batteries soon. 58 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Alarms and Messages Battery removed. Pump stopped. Alarm Priority High Description / Corrective Action The rechargeable battery pack, CADD-Solis Communication Module with integrated rechargeable battery, or the 4 AA batteries were removed. The pump was delivering and is now stopped. Select Acknowledge to clear the alarm. Install 4 new AA batteries, a fully charged rechargeable battery pack, or CADD-Solis communication module. To start delivery, good batteries must always be installed, even when an external source of power is connected. If appropriate, restart the pump. Battery removed. Pump will not run. Cannot start pump. Rechargeable battery has reached end of use. Cannot start pump with a depleted battery. Cannot start pump with a reservoir volume of zero. Cannot start the pump with air in-line. Prime tubing. Cannot start pump with an unusable battery Medium The pump is stopped and the rechargeable battery pack, CADD-Solis Communication Module with integrated rechargeable battery, or the 4 AA batteries were removed, but the pump is still powered by the AC adapter. Select Acknowledge to clear the alarm. Install a fully charged rechargeable battery pack, CADD-Solis communication module, or 4 new AA batteries. To start delivery, good batteries must always be installed, even when an external source of power is connected. Medium The rechargeable battery pack or the rechargable battery integrated with the CADD-Solis Network Comunication Module is at the end of its life. It has been discharged and recharged so many times that it is no longer able to hold a good charge. Remove the battery from service. To start delivery, good batteries must always be installed even when an external source of power is connected. Select Acknowledge to clear the alarm. Install 4 new AA batteries, a new rechargeable battery pack, or the CADD-Solis Communication Module with a its rechargeable battery replaced. If appropriate, start the pump. Medium The battery power is too low to operate the pump. To start delivery, good batteries must always be installed even when an external source of power is connected. Select Acknowledge to clear the alarm. Install 4 new AA batteries, a fully charged rechargeable battery pack, or attach an AC adapter to charge a rechargeable battery pack or communication module battery. If appropriate, start the pump. Medium The reservoir volume in the pump is set to zero. Select acknowledge to clear the alarm. Edit the reservoir volume to the correct value. If appropriate, start the pump. See Reservoir Volume on page 50 for more information about the reservoir volume. Medium The air detector has detected air in the fluid path directly under the air detector; the fluid path may contain air bubbles. Select Acknowledge to clear the alarm, then:

If the fluid path contains air bubbles, close the clamps and disconnect the fluid path from the patient. Follow the instructions for removing air by priming (see page 34 ). If appropriate, start the pump. Medium The batteries installed are either the wrong kind of AA batteries, or you are using a rechargeable battery pack that is not compatible with the pump. To start delivery, good batteries must always be installed even when an external source of power is connected. Select Acknowledge to clear the alarm. Remove the batteries and install the 4 new AA batteries, or fully-charged rechargeable battery pack. If appropriate, start the pump. For more information on what type of batteries to use, see Installing the Batteries on page 20 59 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Alarm Priority Medium The pump does not have any batteries installed. To start delivery, Description / Corrective Action good batteries must always be installed even when an external source of power is connected. Select Acknowledge to clear the alarm. Install 4 new AA batteries, rechargeable battery pack, or the CADD-Solis Communication Module with integrated rechargeable battery. If appropriate, start the pump. Medium The pump will not start without a cassette attached. Select High High High Acknowledge to clear the alarm. Make sure a cassette is properly attached, then start the pump. Note: This alarm has associated help screens. The cassette was detached while the pump was delivering and the pump is now stopped. Select Acknowledge to clear the alarm. Reattach the cassette and, if appropriate, restart the pump. The cassette/keypad lock is locked, but there is no cassette attached. The pump is stopped and will not run. Select Acknowledge to clear the alarm. Unlock the cassette/keypad lock and reattach the cassette. The pump detects the cassette is not properly attached. Close the tubing and remove the cassette, then reattach. If the alarm persists, replace the cassette. Note: You must remove the cassette to continue. Medium This is a reminder that the cassette is not locked while the pump is delivering. If this alarm is sounding, lock the cassette to clear it. Medium The cassette was not completely removed from the pump before it was reattached and the pumps sensors are not able to detect the cassette type. Remove the cassette and reattach it, then verify the cassette type in the pump display. If this alarm persists, replace the cassette. Note: You must remove the cassette to continue. The tubing beneath the pump may not contain fluid, or the fluid container may be empty. The pump is stopped and will not run. Select Acknowledge to clear the alarm. Check whether the fluid container is empty; or clamp the tubing, remove the cassette, and check for air in the tubing. If the alarm persists after trying the above, the pumps pressure sensor is faulty. Remove the pump from service and contact Smiths Medical Customer Service. The delivery-specific parameters are programmed to values that cause the maximum delivery rate to exceed 250 mL/hr, which requires a high volume administration set. The pump is stopped and will not run. Replace the standard volume cassette with a high volume administration set to continue. Note: Do not manually adjust the delivery rate to override pump programming without written authorization from the prescribing physician. Alarms and Messages Cannot start pump without a battery. Cannot start pump without a latched and locked cassette. Cassette detached. Pump stopped. Cassette locked, but not latched. Unlock and reattach the cassette. Cassette not attached properly. Reattach cassette. Cassette unlocked. Lock cassette. Cassette was partially unlatched. Fully remove and reattach the cassette. Check for empty tubing or reservoir. Pump stopped. High High Current settings require high volume set. Change cassette. 60 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Alarm Priority High Alarms and Messages Current settings require standard volume set. Change cassette. Delivery limit reached. Partial PCA (PCEA) dose delivered. Running at KVO rate. Delivery limit reached. Running at KVO rate. Low Low Description / Corrective Action The CADD high volume administration set cannot be used with the selected protocol. The pump is stopped and will not run. Replace the high volume administration set with a standard volume cassette to continue. Note: Do not manually adjust the delivery rate to override pump programming without written authorization from the prescribing physician. The programmed delivery limit has been reached, and the pump is delivering fluid at the KVO rate. This alarm occurs when PCA (PCEA) dose caused the delivery limit to be exceeded. Select Acknowledge to clear the alarm or the alarm automatically clears after 5 seconds. Note: The status bar display remains after the alarm has cleared. The programmed delivery limit has been reached, and the pump is delivering fluid at the KVO rate. This alarm occurs when continuous rate with PCA, or intermittent bolus, caused the delivery limit to be exceeded. Select Acknowledge to clear the alarm or the alarm automatically clears after 5 seconds. Note: The status bar display remains after the alarm has cleared. Delivery too slow. Medium The pump is busy with too many activities and does not have Depleted battery is charging. Low High Downstream occlusion. Clear occlusion between pump and patient. sufficient resources to support the programmed delivery rate. The delivery has fallen behind by 2 mL. Select Acknowledge to clear the alarm. If this alarm occurs regularly, the pump may be faulty. Remove the pump from use and contact Smiths Medical Customer Service. The rechargeable battery pack or the CADD-Solis Communication Module is depleted and is being recharged with the AC adapter. Select Acknowledge to clear the alarm or the alarm automatically clears after 5 seconds. The pump detects high pressure, which may be resulting from a downstream blockage, a kink in the fluid path, or a closed tubing clamp. Delivery is paused and will resume if the occlusion is removed. Remove the obstruction to resume operation. Or select Stop Pump to stop the pump and silence the alarm for 2 minutes, then remove the obstruction and restart the pump. Note: To reduce the potential bolus delivery after an occlusion, perform the following:

1. Press stop/start 9 to stop the pump. 2. Close the distal clamp. If the distal clamp is the cause of the obstruction, keep it closed and continue with step 4. 3. Remove the obstruction. 4. Detach the CADD medication cassette reservoir or CADD administration set from the pump. 5. Open the Flow Stop feature, if present. 6. Wait 10 seconds. 7. Close the Flow Stop feature, if present. 8. Reattach the CADD medication cassette reservoir or CADD administration set to the pump. 9. Open the distal clamp. 10. Review the pumps program. 11. Restart the pump. Note: This alarm has associated help screens. 61 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Alarms and Messages External power source faulty. Change power source. Key stuck. Release key or remove power. Pump stopped. Lock cassette to start pump. Loss of power occurred while running. Replace AA batteries. Alarm Priority Medium The AC adapters output voltage is too high. Select Acknowledge to Description / Corrective Action clear the alarm. The AC adapter is faulty, remove from service. High A key may be pressed down. The pump is stopped and will not run. Make sure there is nothing pressing on any of the keys. If the alarm persists, close the tubing clamp, remove the batteries to turn off the pump, and remove the pump from use, and contact Smiths Medical Customer Service to return the pump for service. Medium The cassette must be locked onto the pump before beginning delivery. If this alarm is sounding, lock the cassette to clear the alarm and the pump will automatically start. Note: This alarm has associated help screens. Medium The pump lost power while it was running. This alarm occurs when the pump restarts. The battery power is too low to operate the pump. If the AC adapter is attached, select Acknowledge to clear the alarm. Remove the batteries. Install 4 new AA batteries, rechargeable battery pack, or the CADD-Solis Communication Module with integrated rechargeable battery. To start delivery, good batteries must always be installed, even when an external source of power is connected. If appropriate, restart the pump. Motor service due. Medium The pumps motor requires service. Select Acknowledge to clear the alarm. Remove the pump from use at the next cassette change and contact Smiths Medical Customer Service to return the pump for service. A new protocol was just sent to the pump from the PharmGuard Point of Care Medication Safety Software. Select Acknowledge to clear the alarm. Review the protocol to ensure that it is correct. Low New pump settings downloaded. Press Acknowledge then review. PCA (PCEA) dose cord button stuck. Release or remove cord. High PCA (PCEA) dose cord disconnected. Medium /

Low The PCA remote dose cord button may be pressed down. The pump is stopped and will not run. Make sure there is nothing pressing on the PCA remote dose cord button. If the alarm persists, remove the PCA remote dose cord to clear the alarm and contact Smiths Medical Customer Service. You may continue using the pump with another PCA remote dose cord, or using the PCA (PCEA) dose @ button on the pump. Medium: The PCA remote dose cord was disconnected from the pump while the pump is delivering. Select Acknowledge to clear the alarm or reattach the PCA remote dose cord. Low: The PCA remote dose cord was disconnected from the pump while the pump is stopped. Select Acknowledge to clear the alarm or the alarm automatically clears after 5 seconds. Preventive maintenance due. Medium Your facility may have established a maintenance program for the pump, and the pump is due for preventive maintenance. Select Acknowledge to clear the alarm and refer to your facilitys policy for preventive maintenance. 62 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Alarms and Messages Protocol library updating. Reselect protocol when update is complete. Pump does not have a protocol library. Pump settings and patient data lost. Pump stopped by an alarm that has since cleared. Pump stopped reminder. When ready, press stop/start key. Rechargeable battery near end of use. Replace battery. Rechargeable battery reached end of use. Pump will not run. Alarm Priority Medium A new or updated library is currently being downloaded into the Description / Corrective Action pump. You cannot select any new protocols while this update is in process. Select Acknowledge to clear the alarm or it will automatically clear when the update is complete. Medium The pump had a protocol library the last time it was powered on, but now it does not. This could happen if the pump was manually reverted to the factory default, recently had a software update, or if an attempt to install a protocol library failed. Select Acknowledge to clear the alarm and refer to your facilitys PharmGuard system administrator to download a new protocol library. High Medium The pump reverted to the factory default. The pump was manually reverted to this default, has recently had a software update, or has not been in use for some time. Select Acknowledge to clear the alarm and refer to your facilitys PharmGuard system administrator to reprogram the pump. The pump was stopped by another high priority alarm. That alarm was not acknowledged, but the problem has since cleared. Select Acknowledge to clear the alarm and restart the pump, if appropriate. The event log has recorded the alarm that stopped the pump. For information on accessing the event log, see page 43. This is a reminder that the pump is stopped and not delivering. Select Acknowledge to clear the alarm. Start the pump, if appropriate. The alarm will repeat in 5 minutes if the pump is not restarted or powered down. High Medium The rechargeable battery pack or the CADD-Solis Communication High Module is near the end of its life. It has been discharged and recharged so many times that it will soon be at the end of its use. You may continue to use it in this state. The rechargeable battery pack or the CADD-Solis Communication Module is at the end of its life. It has been discharged and recharged so many times that it is no longer able to hold a good charge. Remove the battery from service. Install 4 new AA batteries or a fully charged rechargeable battery pack. To start delivery, good batteries must always be installed even when an external source of power is connected. The pump detects a damaged cassette. Close the tubing clamp and inspect the cassette for damage. The pump is stopped and will not run. Replace the cassette if necessary. Note: You must remove the cassette to continue. Note: This alarm also occurs if a cassette is attached during one of the following situations:

The pump is set to the factory default, powered off, and then The pump was loaded with new software, powered off, and then powered on. powered on. Remove and reattach cassette. High Reservoir volume is zero. Pump stopped. High The reservoir volume has reached 0.0 mL. The pump was delivering, is now stopped, and will not run. Select Acknowledge to clear the alarm. Install a new fluid container and edit the value of the reservoir volume, if appropriate. 63 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Alarms and Messages Reservoir volume low. Alarm Priority Medium /

Low*

Unknown cassette type. Remove cassette. High Unusable battery. Pump stopped High Description / Corrective Action Medium: The programmed reservoir volume trip point has been reached, indicating the level of fluid in the reservoir is low. Select Acknowledge to clear the alarm. Low: The reservoir volume value is low, indicating that the level of fluid in the fluid container is low. Select Acknowledge to clear the alarm or the alarm automatically clears after 5 seconds. Prepare to install a new fluid container and edit the value of the reservoir volume, if appropriate.

* The low reservoir alarm can be set to one of two alarm types:

Insistent and One Time Only (Medium) or Non-Insistent and Repeating (Low). The Insistent and One Time Only alarm does not reoccur once it is acknowledged. The Non-Insistent and Repeating alarm repeats at the 75%, 50%, and 25% marks of the Reservoir Low Trip Point. The pump detects a cassette incompatible with the pump. The pump is stopped and will not run. Close the tubing clamp, remove and then reattach the cassette. If the alarm persists, replace the cassette. Note: You must remove the cassette to continue. The batteries installed are either the wrong kind of AA batteries, or you are using a rechargeable battery pack that is not compatible with the pump. The pump was delivering and is now stopped and will not run. Select Acknowledge to clear the alarm. Remove the batteries and install a fully charged rechargeable battery pack or 4 new AA batteries. For more information on what type of batteries to use, see Installing the Batteries on page 20. Medium The batteries installed are either the wrong kind of AA batteries, or Unusable battery. Pump will not run. you are using a rechargeable battery pack that is not compatible with the pump. Select Acknowledge to clear the alarm. Remove the batteries and install a fully charged rechargeable battery pack or 4 new AA batteries. For more information on what type of batteries to use, see Installing the Batteries on page 20. Fluid is not flowing from the fluid container to the pump, which may be resulting from a kink, a closed clamp, or an air bubble in the tubing between the fluid container and pump. Delivery is paused and will resume if the occlusion is removed. Remove the obstruction to resume operation. The alarm clears when the occlusion is removed. After it clears, you must acknowledge this alarm if it has occurred and cleared more than 3 times within 15 minutes. Note: This alarm has associated help screens. The internal hardware connection between the CADD-Solis Communication Module and the pump is intermittent. Select Power Down to power down the pump. Service personnel shall attempt to re-install the CADD-Solis Communication Module and power the pump back up. If the alarm persists, install another communication module or contact Smiths Medical Customer Service to return the pump for service. High High Upstream occlusion. Clear occlusion between pump and reservoir. Wireless Module intermittent connection with pump. 64 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing WARNING:

A hazard can exist if different alarm styles are used on multiple pumps in the same single care area, for example, a critical care area or operating room. Auditory alarm signal sound levels that are less than ambient levels can hinder operator recognition of alarm conditions. Always set the Delivery Limit amount alarm, Reservoir Volume Low alarm, and all other variable alarm settings to clinically appropriate settings. Setting alarm limits to values not clinically safe for the patient may cause patient harm due to a delay in therapy. Note: The measured audible alarm sound pressure level range, as tested in accordance with IEC 60601-1-8, is 53 (4) dBA for high priority alarms and 50 (4) dBA for medium priority alarms. Exposure to Radiation or Magnetic Resonance Imaging (MRI) CAUTION:

The pump should not be directly irradiated by therapeutic levels of ionizing radiation due to of the risk of permanent damage to the pumps electronic circuitry. The best procedure to follow is to remove the pump from the patient during therapeutic radiation sessions or diagnostic levels of radiographic and fluoroscopic radiation. If the pump must remain in the vicinity during a diagnostic or therapy session, it should be shielded, and its ability to function properly should be confirmed following treatment. Do not expose the pump directly to ultrasound, as permanent damage to the electronic circuitry may occur. The pump is considered MR Unsafe and should not be exposed to or used in the MRI environment because the pump is not intended or designed to be used in the MRI environment. Exposing the pump to strong magnetic fields can damage the pump. Use of this pump on patients monitored by electronic equipment may cause artifactual interference. As with all electronic equipment, electrical artifacts which affect the performance of other equipment, such as ECG monitors, can occur. The user should check the correct function of the equipment prior to use. Do not use the pump in hyperbaric chambers as they affect how the pump works and may also cause damage to the pump. Cleaning and Disinfecting the Pump and Accessories WARNING:

The pump and reusable accessories should be cleaned and disinfected after each patient use and in accordance with this manual and your organizations policies and procedures for reusable, solid surface, non-critical medical devices. Failure to do so could result in serious patient injury or death. Ensure that debris is not allowed to build up on the pressure plate surface of the pumping mechanism. Inspect the air detector sensor slot and remove any debris. A blocked air detector sensor may not detect air present in the fluid path, which could result in serious patient injury or death. CAUTION:

Do not immerse the pump in cleaning fluid or water. Do not allow solution to soak into the pump, accumulate on the keypad, or enter the battery compartment, USB port, remote dose cord jack, or power jack areas. Moisture buildup inside the pump may damage the pump. Do not oversaturate the chassis area on the bottom of the pump with cleaning or disinfecting solutions. Oversaturating this area can cause damage to the pump sensors over time. Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners, as damage to the pump may occur. Also refer to the instructions for use for each accessory before proceeding with cleaning and disinfecting. Some accessories may have their own list of acceptable cleaning and disinfecting solutions. 65 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Note: Refer to the instructions for use for each accessory before proceeding with cleaning. For optimal efficiency, it is recommended best practice to clean first and then disinfect. All disinfectants require pre-cleaning, except for disinfectant cleaners that are tested to disinfect in the presence of 5% of organic matter. 1. Inspect the Downstream Occlusion (DSO) seal for damage or wear to the rubber material during cleaning and at each preventative maintenance service. DSO seals that show signs of cracking or abrasion(s) should be returned to a Smiths Medical Service Center for replacement of the DSO seal, sensor, and bezel. If the DSO seal does not have cracking and/or abrasion(s), continue with the following steps to clean and disinfect the pump and accessories, unless otherwise specified in the instructions for use for an accessory:

2. Clean the pump and its accessories using a mild detergent soap solution to remove residuals or contaminated material. Apply solution to a soft, lint-free cloth and then wipe the pump or accessory. Do not allow the solution to soak into the pump or accessory. 3. Disinfect the pump and its accessories by applying a disinfecting solution (listed below) according to the disinfecting product label instructions. If using a liquid or spray, apply solution to a soft, lint-

free cloth and then wipe the pump or accessory. Follow the disinfectant manufacturers recommendations for disinfectant contact times. Do not allow the solution to soak into the pump or accessory. Acceptable disinfecting solutions for the CADD-Solis pump and its accessories are listed below. Note: For the CADD-Solis LockBox, use only the Sani-Cloth Bleach product listed below as other products may affect the transparency of the lockbox. Product Manufacturer Registration Active Ingredient(s) Number EPA Contact/

Kill Time CaviWipes

(Do not use with CADD-Solis LockBox) Sani-Cloth Super

(Do not use with CADD-Solis LockbBox) Metrex 46781-8 17.2% Isopropanol 3 minutes PDI 9480-4 Dimethyl Benzyl Ammonium Chloride, Dimethyl Ethyl Benzyl Ammonium Chloride 2 minutes Sani-Cloth Bleach PDI 9480-8 0.60% Sodium Hypochlorite 4 minutes 4. Allow the pump and accessories to dry completely before use. Scroll Ranges Continuous Rate Scroll Ranges Units Milliliters Milligrams only Micrograms only Milligrams and Micrograms Starting Value 0 10% of concentration 10% of concentration 10% of concentration Increment Maximum Values between 0.01 and 0.5:

100 0.1 0.01 Concentration x 100 Values between 0.1 and 0.5:

0.1 Concentration x 100 Values between 0.5 and 100:

Values between 100 and 1000:

Values greater than 1000:

0.1 1.0 10.0 Concentration x 100 66 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges Units Starting Value Increment Milliliters 0 0.05 Max. 50 Concentration

(mg/mL)

(mg/mL) Increment Increment Concentration PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges: Milligrams Max.

(mg) 1000 1250 1500 1750 2000 2250 2500 2750 3000 3250 3500 3750 4000 4250 4500 4750 5000

(mg) 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50 3.75 4.00 4.25 4.50 4.75 5.00 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 Max.

(mg) 5 10 15 20 25 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750

(mg) 0.01 0.02 0.03 0.04 0.05 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.1 0.2 0.3 0.4 0.5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 67 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Concentration

(mcg/mL)

(mcg/mL) Increment Increment Concentration PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges: Micrograms Max.

(mcg) 1750 2000 2250 2500 2750 3000 3250 3500 3750 4000 4250 4500 4750 5000 10,000 15,000 20,000 25,000 Max.

(mcg) 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 1000 1250 1500

(mcg) 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 1.00 1.25 1.50

(mcg) 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50 3.75 4.00 4.25 4.50 4.75 5.00 10.00 15.00 20.00 25.00 35 40 45 50 55 60 65 70 75 80 85 90 95 100 200 300 400 500 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 20 25 30 68 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Technical Description Standards used in development of the pump The following standards were used in whole or part in the development of the pump. Medical Electrical Equipment:

EN 60601-1 (2006 + A1:2013 + A11:2011 + A12:2014) Ed3.1, Medical Electrical Equipment, Part I: General Requirements for Safety. Amendment A1 (1993) Amendment A13 (1996) Amendment A2 (1995). EN 60601-2-24 (2015), Medical Electrical Equipment, Part 2-24: particular Requirements for Safety of Infusion Pumps and Controllers. IEC 60601-1 (2005 + A1:2012) Ed3.1, Medical Electrical Equipment, Part 1: General Requirements for Safety. Amendment 1 (1991) Amendment 2 (1995). IEC 60601-2-24 (2012), Medical Electrical Equipment, Part 2-24: Particular Requirements for Safety of Infusion Pumps and Controllers. CAN/CSA-C22.2 601.1-M90, Medical Electrical Equipment, Part 1: General Requirements for Safety - November 1990

(Canadian Deviations to IEC 60601-1) Update No. 2 (November 2003). ANSI/AAMI ES60601-1 (2005/(R2012) + A1:2012) Ed 3.1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-8 (2012), Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 (2007 + AC:2010), Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 62304 (2015), Medical device software - Software life-cycle processes EN 62304 (2006 + AC:2008), Medical device software - Software life-cycle processes Electromagnetic Compatibility:

RTCA/DO -160G (2010), Radiated Emissions Only, Category M Limit. EN 60601-1-2 (2015), Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:

Electromagnetic Compatibility - Requirements and Tests. IEC 60601-1-2 (2014), Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:

Electromagnetic Compatibility - Requirements and Tests. CISPR11 (2016), Limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment. Amendment 1 (1999) Amendment 2 (2002). Miscellaneous Standards IEC 60529 (2001), Degrees of protection provided by enclosures (IP Code). EU RoHS Directive 2011/65/EU, Restriction of Hazardous Substances in Electrical and Electronic Equipment REACH Regulation (EC) No.1907/2006, Registration, Evaluation, and Authorization of Chemicals (REACH) 2012/19/EU, Waste Electrical and Electronic Equipment (WEEE) Essential Performance The CADD-Solis pump has the following essential performance characteristics:

The pump delivery will be at the set rate within the declared limits of accuracy under nominal conditions or will provide an alarm. The pump high priority alarms will remain operable. The following pump protective systems will be operable or alarm:

Pump Clock Self-Test Motor Safety Circuit Test Disposable Detection Air Detection Occlusion Detection Latch/Lock Sensors 69 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Specifications (Nominal) General Pump Specifications CADD-Solis pump with 1 of the following attached:

Medication cassette reservoir and CADD extension set Medication cassette reservoir with Flow Stop feature and CADD extension set CADD administration set CADD administration set with Flow Stop feature CF J Class II K CADD medication cassette reservoirs, < 21-7002 and < 21-7309 CADD extension sets, < 21-7047 and < 21-7046 CADD administration sets, < 21-7091 and < 21-7321 CADD high volume administration sets, < 21-7355 and < 21-7357 CADD medication cassette reservoir: 0.05 mL per pump stroke nominal CADD administration set: 0.05 mL per pump stroke nominal CADD high volume administration set: 0.1 mL per pump stroke nominal Excluding cassette and accessories:

4.1 cm 10.2 cm 12.7 cm 1.6 in 4 in 5 in Including 4 AA alkaline batteries, excluding other accessories:

595 g 21 oz 2C to 40C 36F to 104F 20C to 60C 4F to 140F 48C (118F) Maximum Splashproof (E ) per IEC 60529 20% to 90% relative humidity, non-condensing 70 kPa to 106 kPa 10.2 psi to 15.4 psi 5 years AC adapter CADD-Solis rechargeable battery pack CADD-Solis Communication Module with integrated rechargeable battery Four AA alkaline batteries (for example, Duracell PC1500 / MN1500, IEC LR6) The internal memory backup battery uses lithium manganese dioxide technology. It charges whenever the pump is powered on and has a 10-month memory capacity once it has been charged for 250 hours at 20C (68F). Alarm sounds for at least 2 minutes if the pump has been powered up for a minimum of 4 minutes. Note: Alarm enabled while pump is in run mode only. System definition Classification Used to test the pump Resolution Size Weight System operating temperature System storage and transportation temperature Maximum surface Temperature

(pump, while operating) Moisture protection Relative humidity Atmospheric pressure Expected Service Life Power sources Charging system for internal memory backup battery Battery fallout alarm 70 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Battery status Alkaline battery life with screen backlight intensity set to 3 Depleted battery Battery State 25% to 100% No alarm Low battery CADD-Solis Pump Status Transition to low battery condition Battery low message appears Pump emits 3 beeps every 5 min Low battery warning message appears on pump display Pump is operable LCD backlight flashes for 12 ms during each motor operation Transition to depleted battery condition Battery depleted message appears Pump emits a continuous, variable-tone alarm Depleted battery warning message appears on pump display Battery power is too low to operate pump Pump delivery operation stops Pump shuts off due to low operating voltage Shut down These estimates are based on laboratory tests conducted at room temperature using new batteries (Duracell PC1500 / MN1500, IEC LR6). Actual battery life varies depending on the battery brand, shelf life, temperature conditions, delivery rate, and frequency of screen display and backlighting. It is recommended that new batteries be kept available for replacement. Delivery Rate

(mL/hr) 0.4 1. 5.0 10.0 30.0 Continuous Delivery Operating Time

(hr) 142 139 124 113 69 Intermittent Bolus Delivery Volume Delivered

(mL) 56 139 620 1130 2070 IB Volume

(mL) IB Interval

(min) Maximum Delivery Rate

(mL/hr) 5 10 10 30 30 30 40 250 500 Operating Time

(hrs) 90 104 88 Volume Delivered

(mL) 900 2080 1760 71 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Rechargeable battery pack life with screen backlight intensity set to 3 These estimates are based on laboratory tests conducted at room temperature using a new CADD-Solis rechargeable battery pack. Actual battery life varies depending on the temperature conditions, delivery rate, and frequency of screen display and backlighting. It is recommended that new batteries be kept available for replacement. Delivery Rate

(mL/hr) 0.4 1. 5.0 10.0 30.0 Continuous Delivery Operating Time

(hr) 74 67 60 50 40 Volume Delivered

(mL) 29 67 300 500 1200 Intermittent Bolus Delivery IB Volume

(mL) IB Interval

(min) Maximum Delivery Rate

(mL/hr) 5 10 10 30 30 30 40 250 500 Operating Time

(hrs) 71 60 58 Volume Delivered (mL) 710 1200 1160 High priority alarms: Air in line detected, Battery depleted while delivering, Battery removed while delivering, Battery unusable while delivering, Disposable attached improperly, Disposable damaged, Disposable detached while delivering, Disposable locked but not latched, Disposable type high flow administration set not allowed, Disposable type high flow administration set required, Disposable type invalid, Downstream occlusion, Key stuck, Pressure sensor faulty, Pump automatically stopped, Rechargeable battery end of life, Remote dose cord key stuck, Reservoir volume empty, Stop mode reminder, Upstream occlusion, wireless communication module intermittent connection Medium priority alarms: 19 Low priority alarms: 8 Informational messages/alerts 23 Standard volume cassette tubing: approx. 250 mL/hr High flow volume cassette tubing: approx 500 mL/hr Air-In Line 1.86 bar 27.0 psi 1.24 bar 0.62 bar 18 9 psi High Sensitivity: Single bubble > 150 L Accumulated air > 2mL over 15 minutes Low Sensitivity: Single bubble > 2mL (2000 L) Accumulated air > 4mL over 15 minutes Note: Bubbles smaller than 50 L are not included in the accumulated air measurement. Statistical tolerance limits calculated at 95/99 level. CADD administration set: 0.15 mL CADD high volume administration set: 0.30 mL Pump alarms Delivery rate during priming Alarm disabled during priming Maximum infusion pressure High pressure alarm threshold Air detector alarm Maximum volume infused under single-

fault conditions 72 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Maximum time to occlusion alarm and Maximum Bolus volume at occlusion alarm The pressure build-up that occurs after an occlusion may cause fluid to accumulate or be stored in the line. This extra fluid may be delivered as a bolus when the occlusion is released. For corrective action, see the steps listed under Downstream occlusion in the Alarms and Messages, Alphabetical List on page 58. Flow Rate

(mL/hr) 0.1 Flow Rate

(mL/hr) 10 Tubing Set Max. Time to Max. Bolus at Occlusion Occlusion CADD medication cassette reservoir < 21-7002 with CADD extension set < 21-7047 CADD administration set

< 21-7091 CADD high volume administration set < 21-7055 Tubing Set Spec.

(min) Spec.

(mL) 160 0.25 190 1200 0.30 1.40 Max. Time to Max. Bolus at Occlusion Occlusion Spec.

(sec) Spec.

(mL) CADD medication cassette reservoir < 21-7002 with CADD extension set < 21-7047 CADD administration set

< 21-7091 CADD high volume administration set < 21-7055 60 0.25 150 580 0.30 1.40 73 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing 6% at nominal (at 90/90 tolerance level). At low infusion rates, stated accuracy may not be achieved for short periods. During the total infusion time, the accuracy averages out. System delivery accuracy is determined under the following nominal conditions:

Infusion rate of 10mL/hr Ambient temperature of 22 degree C Fluid viscosity of 0.89 cP (i.e., water) 0.2 mmHg (0.004 PSI) back pressure (i.e., 2 inch 18Ga needle) Pump and Reservoir both placed at the same height as the infusion site CADD Administration Set with Flow Stop Free Flow Protection (i.e., 21-7322-24) Accuracy testing was performed using 22 CADD-Solis Ambulatory Infusion Pumps and 22 CADD Administration Sets with Flow Stop Free Flow Protection. All accuracy is stated for a 90/90 tolerance level. Intermediate Rate Accuracy testing methods defined in industry standard IEC 60601-2-24 is performed using an `intermediate rate representative of typical rates for various therapies. The intermediate rate of 10 mL/hr is representative for use with standard volume administration sets. WARNING:

Ensure that the 6% system delivery accuracy specification is taken into account when programming the pump and/or filling the reservoir. Failure to do so may result in medication in the reservoir becoming depleted sooner than expected. If the pump is being used to deliver critical or life sustaining medication, the interruption in the delivery of medication could result in patient injury or death. System delivery inaccuracies beyond 6% may occur as a result of back pressure or fluid resistance, which depends upon temperature, drug viscosity, catheter size, extension set tubing (for example, microbore), in-line components (such as filters and needleless access connectors), and placing the infusion reservoir and/or pump above or below the level of the patient. System delivery inaccuracy may result in under or over delivery of medication, which could result in patient injury or death. Alternate System Configurations at Nominal Conditions Flow Stop administration set with air eliminating filter

(0.2 m and 1.2 m) Non-Flow Stop administration set All 50/100 mL medication cassette reservoirs with 21-7046-24 extension set All 250 ml medication cassette reservoirs with 21-7046-24 extension set System Delivery Accuracy

-8% to 8%

-9% to 2%

-9% to 11%

-13% to 8%

System Delivery Accuracy 74 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Patient Selection It is important to consider patient selection with regard to clinical factors and environmental factors. These factors can include the route of administration, the prescribed medication, and the system configuration chosen to ensure acceptable delivery accuracy is appropriate for your patient. Consideration of Continuous Flow at Low Rates Delivery accuracy is not tested below 10 mL/hr. When intending to deliver therapies that require a low continuous flow rate, consider using another type of infusion pump, such as a syringe pump. Challenge Conditions The adjusted flow rate accuracy for non-nominal environmental conditions when using a CADD Administration Set with Flow Stop Free Flow Protection is summarized below as determined per testing methods defined in industry standard IEC 60601-2-24. Challenge Conditions Pump & reservoir height approximately four feet below the infusion site (backpressure increase of 100mmHg) Backpressure increase of 300mmHg Pump & reservoir height approximately four feet above the infusion site (backpressure decrease of 100mmHg) Reservoir height 0.3 m below pump & infusion site Temperature at 2C, 20% RH Temperature at 40C, 90% RH 21 Gauge Epidural Catheter System Delivery Accuracy

-10% to 5%

-17% to -7%

-6% to 11%

-12% to 7%

-12% to -1%

-10% to 10%

-20% to -1%

Bolus accuracy specification: 6%

Tested with CADD administration set with Flow Stop free flow protection Actual test data for bolus accuracy at 0.05 mL:

Average

% Error Minimum Error %

Maximum Error %

0.0508 mL 1.6%

3.0%

4.2%

Actual test data for bolus accuracy at 50 mL:

Average

% Error Minimum Error %

Maximum Error %

50.77 mL 1.55%

0.07%

2.35%

Challenge test conditions (min and max % error from set value):

0.05 mL at 2C, 20% RH 0.05 mL at 40C, 90% RH 50 mL at 2C, 20% RH 50 mL at 40C, 90% RH

-14% to -1%

-1% to 12%

-16% to -7%

-8% to 2%

75 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Delivery Specifications Programming units Concentration Reservoir volume Given Delivery limit amount Continuous rate Clinician bolus PCA dose PCA dose lockout Intermittent bolus Intermittent bolus interval Next bolus Maximum doses per hour Milliliters (mL) Milligrams (mg) Micrograms (mcg) mg/mL:

0.1 to 0.5 mg/mL in increments of 0.1 mg/mL 0.5 to 1 mg/mL in increments of 0.5 mg/mL 1 to 15 mg/mL in increments of 1 mg/mL 15 to 100 mg/mL in increments of 5 mg/mL mcg/mL:

1 to 15 mcg/mL in increments of 1 mcg/mL 15 to 100 mcg/mL in increments of 5 mcg/mL 100 to 500 mcg/mL in increments of 100 mcg/mL 0 to 9999 Programmable in 1 mL increments. Displayed in 0.1 mL increments. 0 to 99,999.99 in 0.01 unit increments 0.1 to 1,900 mL (or the mg or mcg equivalent) in increments of:

0.01 mL from 0.1 to 0.5 mL 0.1 mL from 0.5 to 100 mL 1 mL from 100 to 1,000 mL 10 mL from 1,000 to 1,900 mL 0 to 100 mL/hr (or the mg or mcg equivalent) 0 mL to 50 mL (or mg or mcg equivalent) Delivery rate: 40 mL/hr to the maximum delivery rate in 1 mL increments. 0 mL to 50 mL (or the mg or mcg equivalent) Delivery rate: 40 mL/hr to the maximum delivery rate in 1 mL increments. 1 minute to 24 hours in the following increments:

1 minute for values between 1 and 20 minutes 5 minutes between 20 minutes and 24 hours 0 mL to 50 mL (or the mg or mcg equivalent) Delivery rate: 40 mL/hr to the maximum delivery rate in 1 mL increments. 0 to 4 hours 0 to 4 hours 1 to 60 CADD Ambulatory Tubing Set Testing One representative medication for each of the following routes of delivery was tested for drug interaction with pump disposables. Use any selected drug in accordance with the indications included in the drug package insert. Administration of any drug by the CADD-Solis ambulatory infusion pump is limited by any warnings, precautions, or contraindications in the drug labeling. Route of Delivery Intravenous, subarachnoid space (intrathecal) Intra-arterial Intraperitoneal Epidural space, local infiltration(subcutaneous, perineural, surgical site) Ropivacaine HCl Injection Morphine Sulfate Injection Floxuridine for Injection, USP Dianeal with dextrose Drug Tested 76 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Administrator Settings Specifications KVO rate Bolus interval type Maximum delivery rate (PCA dose, clinician bolus, intermittent bolus) 0 mL/hr if continuous rate is 0 mL/hr 0.1 mL/hr if continuous rate > 0 mL/hr, with standard administration set 0.2 mL/hr if continuous rate > 0 mL/hr, with high volume administration set Bolus interval PCA lockout With standard administration set: 250 mL/hr With high volume administration set: 500 mL/hr Max. delivery rate = continuous rate + bolus rate (PCA dose or clinician bolus or intermittent bolus) Boluses may not be delivered simultaneously Delivery limit method Delivery limit Max doses per hour Not in use 1 to 12 hours in increments of 1 hour Informational High priority 1 to 999 mL in increments of 1 mL Delivery limit period Pump stopped alarm Res vol low trip point Res vol empty alarm Insistent and one time only Non-insistent and repeating On Off High Low On Off Note: The upstream occlusion sensor is automatically disabled during use with medication cassette reservoirs. High Sensitivity: When the high pressure alarm threshold is reached, the Air detector sensitivity Upstream occlusion sensor Air detector Downstream occlusion sensitivity downstream occlusion alarm is triggered immediately. Low Sensitivity: When the high pressure alarm threshold is reached, the downstream occlusion alarm is delayed for 2 seconds. This allows for the pressure to stabilize before a possible alarm. If the pressure stabilizes below the high pressure alarm threshold before the 2 second delay is complete, the alarm will not occur. PM reminder Interval: 1 to 24 months in 1 month increments Enable: On or Off Custom keypad code 001 to 899 in increments of 1 Custom clinician 001 to 899 in increments of 1 code Custom admin. code 001 to 899 in increments of 1 Time format Date format Alarm volume Key beep 00:00 to 23:59 military 12-hour am/pm US standard (month/day/year) European standard (day/month/year) International standard ISO 8601:2004 (year/month/day) High Medium Low On Off 77 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Electromagnetic Emissions and Immunity Declarations Guidance and Manufacturers DeclarationElectromagnetic Emissions The CADD-Solis pump is intended for use in the electromagnetic environment specified below. The customer or the user of the CADD-Solis pump should assure that it is used in such an environment. Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Compliance Group 1 Electromagnetic EnvironmentGuidance The Pump uses RF 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. Class B Not applicable The Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Not applicable Voltage fluctuations/ flicker emissions IEC 61000-3-3 Compliance using: 100240 VAC 50/60 Hz to 7 VDC switching AC adapter, with an AC power cord length of 1.8 m (6 ft); rechargeable battery pack; remote dose cord with a length of 152 cm 5 cm (60 in 2 in); and a USB cable length of less than 2 m (6.5 ft). WARNING:

The use of power supplies and a remote dose cord other than those listed in the electromagnetic emissions declaration may result in increased emissions or decreased immunity of the pump. The pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, you should verify normal operation of the pump in the configuration in which it is to be used. Common portable and mobile consumer electronic devices may cause interference with the pump. Observe the pump to verify normal operation. Facility wiring must comply with all applicable electrical codes. Do not bypass power cord connections. Do not remove a prong from the power cord. Failure to comply may result in fire or electrical shock. Guidance and Manufacturers Declaration Electromagnetic Immunity The CADD-Solis pump is intended for use in the electromagnetic environment specified below. The customer or user of the CADD-Solis pump should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Electrostatic discharge

(ESD) 6 kV contact 8 kV air Compliance Level Electromagnetic Environment Guidance 8 kV contact 15 kV air

(IEC 60601-2-24) Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. 1 kV for input/output lines Not applicable Surge 1 kV line(s) to line(s) 1 kV line(s) to line(s) IEC 61000-4-5 2 kV line(s) to earth 2 kV line(s) to earth Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

< 5% Ut (> 95% dip in Ut) for 0.5 cycle

< 5% Ut (> 95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles 70% Ut (30% dip in Ut) for 25 cycles

< 5% Ut (> 95% dip in Ut) for 5 sec

< 5% Ut (> 95 % dip in Ut) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the Pump requires continued operation during power mains interruptions, it is recommended that the Pump be powered from an uninterruptible power supply or a battery. Power frequency 50/60 Hz magnetic field 3 A/m IEC 61000-4-8 400 A/m

(IEC 60601-2-24) Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: Ut is the a.c. mains voltage prior to application of the test level. 78 IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Guidance and Manufacturers DeclarationElectromagnetic Immunity The CADD-Solis pump is intended for use in the electromagnetic environment specified below. The customer or user of the CADD-Solis pump should assure that it is used in such an environment. Immunity Test Electromagnetic EnvironmentGuidance Compliance IEC 60601 Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC 3 Vrms 3 Vrms Recommended separation distance 61000-4-6 150 kHz to 80 MHz outside ISM bandsa d = 1.2 Conducted RF IEC 10 Vrms 10 Vrms Recommended separation distance 61000-4-6 150 kHz to 80 MHz in ISM bandsb Radiated RF IEC 10 V/m 10 V/m 61000-4-3 80 MHz to 2.5 GHz d = 1.2 d = 1.2 80 MHz to 800 MHz d = 2.3 800 MHz to 2.5 GHz 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).c Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,c should be less than the compliance level in each frequency range.d Interference may occur in the vicinity of equipment marked with the following symbol: R Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. c Field strengths 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 the CADD-Solis pump is used exceeds the applicable RF compliance level above, the CADD-Solis pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CADD-Solis pump. d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 79 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Recommended separation distances between portable and mobile RF communications equipment and the CADD-Solis pump The CADD-Solis pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CADD-Solis pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CADD-Solis pump as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power or transmitter W 0.01 0.1 1 10 100 150 kHz to 80 MHz outside ISM bands d = 1.2 0.12 0.38 1.2 3.8 12 80 MHz to 800 MHz in ISM bands d = 1.2 0.12 0.38 1.2 3.8 12 m 80 MHz to 800 MHz d = 1.2 800 MHz to 2.5 GHz d = 2.3 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Collect Separately This product contains electrical and electronic components (including batteries) that may contain materials, which if disposed of with general waste, could be damaging to the environment. In accordance with Directive 2002/96/EC Waste Electrical and Electronic Equipment, residents of the European Union must follow specific disposal or recycling instructions for this product. Contact your local distributor, or visit the following web site for specific instructions:

http://www.smiths-medical.com/recycle/index.html Non-European Union residents must dispose of or recycle this product (including batteries) in accordance with the local laws or regulations that apply. WARNING: There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) reservoirs and extension sets. Dispose of used batteries, reservoirs, extension sets, and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply. 80 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Programming Screens/Menus Maps Patient Specific Parameters and/or Home Screen Continuous Rate*

Intermittent Bolus*

Bolus Interval*

Next Bolus*

PCA Dose*

PCA Lockout*

Hourly Limit*

Max Doses / Hour*

Reservoir Vol. Tasks Give Clinician Bolus Start New Patient Start New Protocol, Same Patient Prime Tubing Set Time and Date Adjust Background Intensity Adjust Alarm Volume View Reports Turn Wireless On/Off Adjust Admin Settings Reports Intermittent Bolus Status Given and PCA Dose Counters PCA Dose Graph Intermittent Bolus Graph PCEA and Intermittent Graph Delivery History and Pie Chart Current Profile / Protocol Delivery Log Event Log Daylight Saving Time Protocol Library Summary Wireless Status**

Wireless Settings**

Device Information Administrator Settings Delivery Alarms Security Set Time and Date Display and Sound Default to Factory Settings

* If configured in the PharmGuard system administrator settings to appear.

** Available when a CADD-Solis Communication Module is installed. The PharmGuard Medication Safety Software administrator may configure a therapy to display either PCA or PCEA. See the Administrator Settings Guide for detailed information on navigating the administrator settings menu. 81 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Default Factory Settings The first time you use the pump, the protocol is set to the factory default. You may reset the pump to the factory default at any time. Refer to the Administrator Settings Guide for more information on how to reset the pump to the factory default. The factory default is a manual mode programming, see page 51. The following chart details the factory default parameters:

Parameter Default Factory Setting Programming Units Continuous Rate On/Off Continuous Rate PCA Dose On/Off PCA Dose PCA Lockout Intermittent Bolus On/Off Max Delivery Rate Delivery Limit Method Reservoir Volume Reservoir Reset Volume Clinician Bolus Pump Stopped Alarm Type Reservoir Low Trip Point Reservoir Low Alarm Type Air Detector On/Off Air Detector Sensitivity Upstream Sensor On/Off Downsteam Sensor Sensitivity PM Reminder Reservoir Empty Alarm Type Keypad Code Clinician Code Admin Code Manual Programming Security Keypad Security Time Format Date Format Backlight Intensity Alarm Volume Sound Theme Key Beep On/Off Numeric Format Color Theme mL Off 0 mL/hr Off 0 mL 1 hour Off 175 mL/hr (combined bolus + continuous) Not in Use 1 mL 100 mL 0 mL Informational 5.0 mL Insistent and One Time Only On Low On Low Off One Time Only 201 997 See your PharmGuard system administrator Admin Code Code only 24:00:00 Month/Day/Year 3 High Standard On 1,234.56 Black (manual mode programming) 82 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Accuracy Test Results In this device, as with all infusion pumps, the motion of the pumping mechanism and variations in individual disposables cause short-term fluctuations in rate accuracy. The following curves show typical performance of the pump system in two ways:

1. A flow versus time graph during the stabilization period (start-up curves). 2. The accuracy of fluid delivery of particular time periods or observation windows is measured (trumpet curves). The start-up curve displays flow rate continuously from the start of the infusion. The curve visually represents flow rate uniformity. The trumpet curve is derived from the last hour of this data. Tests performed per IEC 60601-2-24 standard. Over long observation windows, short term fluctuations have minimal effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short term fluctuations have an increasing effect as represented by the mouth of the trumpet. Being aware of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short term fluctuations in rate accuracy may have clinical impact depending on the half-life of the drug being infused, both the trumpet curve and drug half-life should be taken into consideration. Start-up curves over the stabilization period T(1) Flow rate (10 mL/hr) CADD administration set with Flow Stop Start-Up Graph

) r h

/

L m

(

w o F l 12 10 8 6 4 2 0 0 200 400 600 800 1000 1200 1400 1600 Time (Mins) Flow Qi Set Rate Trumpet curves over the analysis period T(2) Flow rate (10 mL/hr) CADD administration set with Flow Stop Trumpet Curve Over T2 (Analysis Period of 50 min)

)

%

(

r o r r E e g a t n e c r e P 60 40 20 0

-20

-40

-60 0 2 4 6 10 Observation Window (Mins) 8 12 14 Ep(Min) Ep(Max) Zero Error (%) Mean Flow Error (%) 83 RefeRences and TRoubleshooTingRefeRences and TRoubleshooTing Page Intentionally Blank 84 Warranty Index A C AC adapter 17 Alarms and messages 58, 61, 62 Battery backup 16, 20 CADD-Solis Communication Module 17 Power jack 16 Rechargeable battery pack 17 Symbols 13, 23 Accessories 17 Accuracy Bolus accuracy specification 75 System delivery 74 Test results 83 Adjust admin settings 38 Adjust alarm volume 37 Adjust backlight intensity 36 Administrator (admin) code 28 Admin settings 38 See also Administrator Settings Guide Air detector 34, 65 Alarms and messages 55, 72 Alphabetical list 58 Amber indicator light 15 Help screens 56 High priority alarms 55, 72 Informational messages 56 Low priority alarms 56 Medium priority alarms 55 System fault alarm 55 Troubleshooting 57 Volume 37, 77 Alphabetical list of alarms and messages 58 Analgesics 9 Anesthetics 9 Autolock 30 B Backlight 15, 36 Backpack 19 Batteries Alarms and messages 58, 59, 60, 61, 63, 64 Alkaline battery life 72 Battery compartment 16 Battery fallout alarm 71 Battery status 13, 23, 72 CADD-Solis Communication Module 20, 21 High priority alarms 73 Installing 20, 21 Internal backup battery 35 Rechargeable battery pack 17, 21, 59, 63, 73 Replacing the battery door 21 Symbols 12, 13, 23 Bolus interval 10, 11, 46, 77 CADD-Solis Communication Module 17, 20, 21, 44 CADD-Solis Network Setup Utility 19 Cassettes 14, 18 Alarms and messages 60, 61, 62, 63, 64 Attaching a cassette 25 Cassette/Keypad lock 14, 16, 28, 30 Delivery rate 18 Latch 14, 16 Removing a cassette 27 Cautions 6 Cleaning the pump and accessories 65 Clinician bolus 10, 31, 76, 77 Clinician code 28 Continuous rate 10, 48, 76 Contraindications 3, 9 Current Profile / Protocol 42 D Date settings Current date 35 Date format 36 Set time and date task 34 Daylight saving time 34, 35, 43 Default factory settings 82 Delivery history and pie chart 41 Delivery limit Alarms and messages 61 Clinician bolus 31 Hourly limit 49 Max doses/hr 50 Specifications 76, 77 Delivery log 33, 34, 35 Delivery methods 10, 45 Delivery rate 18 Device information 44 Diagram of pump 14 Disinfecting the pump and accessories 65 Display 14, 15, 24 Appearance on power up 22 Blank 58 Colors 24 Home screen 23 Symbols 13, 23 Dose counters 31, 39, 40 Downstream occlusion sensor 16 E Electromagnetic emissions and immunity 78 Epidural administration 9 Event log 32, 33, 34, 35 85 IndexIndex Factory settings 82 F G Give clinician bolus 31 Given and PCA dose counters 39 H Hard limits 45, 51 Hardware version 44 Help Screens 56 High priority alarms 55, 73 Home screen Symbols 13 Hourly limit 49 I Indications 9 Indicator lights See Lights Informational messages 56, 58 Intermittent bolus 10, 46, 77 Bolus interval 46, 77 Intermittent bolus graph 41 Intermittent bolus status 39 Next bolus 77 PCA and intermittent graph 41 PCA dose 48 PCA lockout 49 Key 18 Keypad 14, 15 Keypad code 28 K L Latch, cassette 14, 16 Lights Amber indicator light 14, 15, 27, 55 Blue power light 14 Green indicator light 14, 15, 27 Lock Autolock feature 30 Cassette/Keypad 14, 16 LockBox 19 Low priority alarms 56 M Manual mode programming 51, 54 Max doses/hr 49 Maximum delivery rate 77 86 Medium priority alarms 55 Menu maps 81 Messages See Informational messages Help screens 56 MRI exposure 65 N New patient 32 New protocol, same patient 33 Next bolus 10, 11, 47, 76 Occlusion sensor Downstream 16 Upstream 17 O P Patient specific parameters (programming screens) 27, 45, 81 Bolus interval 46 Continuous rate 48 Hourly limit 49 Intermittent bolus 46 Max doses/hr 49 PCA dose 48 PCA lockout 49 Reservoir volume 50 PCA and intermittent graph 41 PCA dose 10, 48 Button symbol 12 Delivery specifications 76 Max doses/hr 49 PCA dose graph 40 Stopping delivering 27 PCA lockout 49, 77 PCEA See PCA PharmGuard Medication Safety Software 19 PharmGuard Server 17, 19, 22, 38, 54 Pie chart 41 Polemount bracket 18 Polemount bracket adapter 18 Polemount swivel 19 Pouch 19 Power Blue power light 14, 16 Power down/Turning the pump off 16 Power jack 12, 14, 16 Power switch 14 Power up/Turning the pump on 22 Prime tubing 34 Programming screens See Patient specific parameters (programming screens) Protocol libraries 24 Protocol library summary 43 IndexIndex R Radiation exposure 65 Rechargeable battery pack 17 AC adapter 17 Alarms and messages 59, 61, 63 Battery life 73 Installing 21 Symbols 13, 23 Recycling the pump 80 Remote dose cord 18 Alarms and messages 62 PCA dose delivery 48 Remote dose cord jack 12, 14, 16 Reports 37, 39 Current profile / protocol 42 Daylight saving time 43 Delivery history and pie chart 41 Delivery log 42 Device information 44 Event log 43 Given and PCA dose counters 39 Intermittent bolus graph 41 Intermittent bolus status 39 PCA and intermittent graph 41 PCA dose graph 40 Protocol library summary 43 Wireless settings 44 Wireless status 44 Reservoir volume 50, 76 Alarms and messages 59, 63, 64 Symbols 13, 23 S Same patient, new protocol 33 Screen See Display Security 28 Entering codes 30 Serial number 14, 44 Set time and date 34 Setup 20 Soft limits 45, 51, 53 Software Updating 22 Version 44 Specifications Administrator settings specifications 77 Delivery specifications 76 General pump specifications 71 Start new patient 32 Start the pump 27 Stop the pump 27 Subarachnoid administration 9 SureLink Remote Support Software 19 Symbols 12, 13 System fault alarm 55 T Tasks 31 Adjust admin settings 38 Adjust alarm volume 37 Adjust backlight intensity 36 Give clinician bolus 31 Prime tubing 34 Set time and date 34 Start new patient 32 Start new protocol, same patient 33 Turn Wireless On/Off 38 View reports 37 Time settings Current time 35 Set time and date task 34 Time format 36 Turn Wireless On/Off 38 U Unlock cassette and/or keypad 14, 16, 18, 25, 27, 30 Update software 22 Upstream occlusion sensor 17 USB port 14, 16 V View reports 37 Volume Administration sets 60, 61 Alarms 37, 78 Reservoir volume See Reservoir volume W Warnings 3 WEEE 80 Wireless Communications 17, 21, 38, 44 Function 54 Settings 44 Status 23, 38, 44 Turn On/Off 38 87 IndexIndex Manufacturer:

Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 USA Tel: 1 800 258 5361 (USA/CA) Tel: +1 614 210 7300 European Representative:

Smiths Medical Czech Republic a.s. Olomouck 306, Hranice 1 - Msto, 753 01 Hranice, Czech Republic Tel: +44 (0) 1233 722100 www.smiths-medical.com CADD-Solis, CADD, the CADD design mark, and the Smiths Medical design mark are trademarks of Smiths Medical. The symbol indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are trade names, trademarks, or service marks of their respective owners. 2016, 2017, 2018, 2019 Smiths Medical. All rights reserved. 2019-07 10013037-006

-

CADD-Solis Communication Module Model 2131 Operator's Manual For use only with the CADD Solis infusion pump model 2110 x

. Manuel de loprateur -

/ Bedienungshandbuch -

0 Manuale delloperatore -

1 Manual del operador -

2 Manual do operador -

3 Gebruikershandleiding -

4 Bruksanvisning -

5 Brugervejledning -

9 -

Utilisation uniquement avec la pompe perfusion CADDSolis, modle2110 Nur zur Verwendung mit der CADD Solis

-Infusionspumpe, Modell 2110 Per luso solo con la pompa per infusioneCADD Solis modello 2110 Para uso exclusivo con la bomba de infusin CADD Solis, modelo 2110 Para utilizao apenas com a bomba de infuso ambulatria CADD Solis modelo 2110 Uitsluitend voor gebruik met de CADD Solis-

infuuspomp model 2110 Endast fr anvndning med CADD Solis-

infusionspumpen av modell 2110 Kun til brug med CADD Solis infusionspumpe model2110 CADD -Solis 2110 Symbols

-

f Caution

< Catalog Number

= Batch Code J Date of Manufacture H Manufacturer

@ Authorized Representative in the European Community Temperature Limitation P _ Humidity Limitiation i Atmospheric pressure limitation

: Do not use if package is L Keep dry Z Collect separately 6 Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician damaged

. Attention

/

Vorsicht 0 Attenzione 1 Precaucin Numro de catalogue Bestellnummer Numero di catalogo Nmero de catlogo Numro de lot Chargenbezeichnung Codice del lotto Cdigo de lote Date de fabrication Herstellungsdatum Data di fabbricazione Fecha de fabricacin Fabricant Hersteller Fabbricante Fabricante Mandataire dans la Communaut europenne Autorisierter Vertreter in der Europischen Gemeinschaft Mandatario per la Comunit Europea Representante autorizado en la Comunidad Europea Limite de temprature Temperaturbereich Limiti di temperatura Lmite de temperatura Limites dhumidit Feuchtigkeitsbeschrnkung Limiti di umidit Lmite de humedad Limites de pression atmosphrique Ne pas utiliser si lemballage est endommag Conserver au sec Luftdruckbeschrnkung Limiti di pressione atmosferica Lmite de presin atmosfrica Inhalt bei beschdigter Verpackung nicht verwenden Trocken aufbewahren Non utilizzare se la confezione danneggiata Tenere allasciutto No utilizar si el envase est daado Mantngase en un lugar seco Recueillir sparment Getrennt sammeln Smaltire separatamente Recoger por separado Attention : La lgislation fdrale amricaine nautorise la vente de ce produit que sur prescription mdicale Non-ionizing radiation Rayonnement non ionisant UL Registered Component mark. This is an electrostatic-sensitive device. Handle only at a static safe workstation. Transport only in approved containers. Australian Communications and Media Authority (ACMA) Regulatory Compliance Mark (RCM) Federal Communications Commission (FCC) Marque de composant enregistre UL. Ceci est un dispositif sensible aux dcharges lectrostatiques. Manipuler uniquement sur un poste de travail statique. Transporter uniquement dans des contenants approuvs. Australian Communications and Media Authority (ACMA, autorit australienne des communications et des mdias) Marque de conformit rglementaire (RCM) Commission fdrale des communications (FCC) 2 Vorsicht: Gem US-amerikanischem Bundesgesetz ist der Verkauf dieses Gerts nur durch oder im Auftrag eines Arztes gestattet. Nichtionisierende Strahlung Kennzeichnung fr eine UL-zugelassene Komponente. Dies ist ein elektrostatisch empfindliches Gert. Nur an einer statisch sicheren Arbeitsstation handhaben. Nur in zugelassenen Behltern transportieren. Kennzeichnung der behrdlichen Konformitt

(Regulatory Compliance Mark, RCM) von der australischen Communications and Media Authority (ACMA) Federal Communications Commission (FCC) Attenzione - La legge federale

(U.S.A.) limita la vendita di questo dispositivo ai medici o su prescrizione medica. Precaucin: Las leyes federales de EE. UU. restringen la venta de este dispositivo a un mdico o por prescripcin facultativa Radiazioni non ionizzanti Radiacin no ionizante Marchio componente registrato UL. Questo un dispositivo sensibile alle scariche elettrostatiche. Maneggiare solo in una stazione di lavoro antistatica. Trasportare solo in contenitori approvati. Marchio di conformit regolatoria (RCM) dellAustralian Communications and Media Authority (ACMA) Marca UL de componente reconocido Dispositivo sensible a las cargas electrostticas. Manejar solamente en una estacin de trabajo con proteccin antiesttica. Transportarnicamente en contenedores autorizados. Marca de cumplimiento normativo (RCM) de la Autoridad Australiana de Comunicaciones y Medios (ACMA) Commissione federale per le comunicazioni (FCC) Comisin Federal de Comunicaciones (FCC) 2 f Precauo

< Nmero de catlogo

= Cdigo de Lote J Data de fabrico H Fabricante

@ Representante Autorizado na Comunidade Europeia Limites de temperatura P _ Limites de humidade i Limites de presso atmosfrica

: No utilizar se a embalagem L Manter seco Z Eliminar em separado 6 Precauo: A lei federal dos estiver danificada E.U.A. restringe a venda deste dispositivo a mdicos ou mediante receita mdica 3 Let op 4 Frsiktighet 5 Forsigtig Catalogusnummer Katalognummer Katalognummer Batchcode Batchkod Batchkode Fabricagedatum Tillverkningsdatum Fremstillingsdato Fabrikant Tillverkare Fabrikant 9 Gemachtigde in de Europese Gemeenschap Auktoriserad representant i Europeiska unionen Reprsentant i det Europiske Fllesskab Temperatuurlimiet Temperaturbegrnsning Temperaturbegrnsning Vochtigheidslimieten Luftfuktighetsgrns Fugtighedsbegrnsning Luchtdruklimitent Atmosfrtrycksgrns Atmosfrisk trykbegrnsning Niet gebruiken indien de verpakking beschadigd is Droog bewaren Fr inte anvndas om frpackningen r skadad Frvaras torrt M ikke anvendes, hvis emballagen er beskadiget Opbevares trt Apart inzamelen Insamlas separat Indsamles separat Let op: Krachtens de nationale wetgeving (van de VS) mag dit product uitsluitend door of op voorschrift van een arts worden verkocht Frsiktighet: Enligt amerikansk federal lagstiftning fr denna produkt endast sljas av eller p ordination av lkare Forsigtig: Iflge amerikansk lov m dette produkt kun slges af eller p ordination af en lge Radiao no ionizante Niet-ioniserende straling Icke-joniserande strlning Ikke-ioniserende strling Marca de componente registado UL. um dispositivo sensvel a eletricidade esttica. Manusear apenas numa estao de trabalho segura anti-esttica. Transportar apenas em recipientes aprovados. Marca de conformidade regulamentar (RCM) da Australian Communications and Media Authority (ACMA) Comisso Federal de Comunicaes (FCC) Registered Component-

keurmerk, uitgegeven door UL. Dit apparaat is gevoelig voor elektrostatische ontlading. Uitsluitend hanteren op een antistatische werkplek. Uitsluitend vervoeren in goedgekeurde containers. RCM-markering voor regelnaleving (Regulatory Compliance Mark) van het Australische toezichthoudende orgaan van de media (ACMA) Federal Communications Commission (FCC) UL-registrerad komponentmrkning. Denna enhet r knslig fr elektrostatisk urladdning. Hantera den endast p en statiskt sker arbetsstation. Transportera endast igodkndabehllare. Mrke for UL-registreret komponent Dette produkt er flsomt over for elektrostatiske udladninger. Det m kun hndteres p en statisk sikker arbejdsstation. Det m kun transporteres i godkendte beholdere. Australiska kommunikations-

och mediamyndighetens (ACMA) regelefterlevnadsmrkning

(RCM) USA:s federala kommunikations-

kommission (FCC) Mrke for regulatorisk overensstemmelse (RCM) fra ACMA (Australian Communications and Media Authority) Federal Communications Commission (FCC)

(U.S.A.) UL

(ACMA)

(RCM)

(FCC) 3

-

English Table of Contents Warnings . 5 Cautions

. 6 About The CADD-Solis Communication Module, Model 2131 . 6 Installing the CADD-Solis Communication Module . 7 Charging the Rechargeable Battery . 11 Configuring Wireless Settings Using the CADD-Solis Network Setup Utility Software . 12 Turning Wireless Radio On/Off . 13 Viewing Wireless Status and Settings . 13 Troubleshooting . 14 Transportation . 15 Disposal / Collect Separately . 15 REACH Information . 15 Part 15 Certification . 15 Cleaning and Disinfecting the Communication Module . 15 Specifications . 17 Limited Warranty. 19 French / Franais . 20 German / Deutsch . 36 Italian / Italiano . 52 Spanish / Espaol . 68 Portuguese / Portugus . 84 Dutch / Nederlands . 100 Swedish / Svenska . 116 Danish / Dansk . 132 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 4 IMPORTANT: The rechargeable battery, in the CADD-Solis Communication Module, must be internally connected and fully charged within the pump before placing the system into service. Review and follow the instructions in this Operator's Manual to install and charge the battery prior to use. Read the instructions completely before installing the CADD-Solis Communication Module to the CADD-Solis Ambulatory Infusion Pump, Model 2110. Retain these instructions for future reference. For detailed instructions, warnings, specifications, and additional information for operating the CADD-

Solis Ambulatory Infusion Pump, refer to the pump Operators Manual. For detailed instructions, warnings, specifications, and additional information for using the CADD-Solis AC Adapter, refer to the Instructions for Use supplied with that product. WARNINGS To avoid serious personal injury, it is essential to observe the following warnings:

Do not expose the communication module to rain, water, or moisture. Shock or other hazard may result. Do not immerse the CADD-Solis Communication Module rechargeable battery in liquid. Shock or other hazard may result. Do not use the CADD-Solis Communication Module rechargeable battery with any device except the CADD-Solis Communication Module. Do not connect any AC adapters directly to the CADD-Solis Communication Module rechargeable battery. Directly connecting any AC adapter could be hazardous and can damage the rechargeable battery, communication module, and the pump. A CADD-Solis Communication Module rechargeable battery that has reached the end of its useful life must be replaced with another CADD-Solis Communication Module rechargeable battery. Using rechargeable batteries from other manufacturers could result in fire or explosion. Do not allow the electronic contacts of the communication module to simultaneously touch a piece of metal (a coin or paper clip, for instance). Do not use the CADD-Solis Communication Module if it has been damaged, if internal electronics become exposed due to wear, or if the electronic contacts are damaged in any way. Fire, shock, or other hazard may result. Do not attempt to crush the CADD-Solis Communication Module or the rechargeable battery. Fire, shock, or other hazard may result. Do not destroy the CADD-Solis Communication Module rechargeable battery by incineration. It may explode. Do not use the communication module in the CADD-Solis Infusion Pump pouch or any other pouch or bag. The communication module could overheat and power off utilizing the thermal protection circuit. There are potential health hazards associated with improper disposal of batteries and other electronics. Dispose of used batteries and other used accessories in an environmentally safe manner, and according to any regulations that may apply. 5 CAUTIONS Do not use excessive force when separating the CADD-Solis Communication Module cap from the base. The antenna cable must remain attached to both the cap and base. Disconnecting the antenna cable may result in damage to the antenna and/or communication module electronics. Failure to fully charge the CADD-Solis Communication Module rechargeable battery prior to initial use and during prolonged storage may cause deep battery discharge, leading to premature battery replacement. The USB port on the CADD-Solis Infusion Pump is intended for communication to the PharmGuard Medication Safety Software, SureLink Remote Support Software, and the CADD Solis Network Setup Utility software only. Do not connect unsupported accessories to the USB port (e.g., charging other devices, attaching a wireless dongle) as this could damage the pump. If the CADD-Solis Communication Module is stored outside of the environmental operating conditions and within the specified environmental storage conditions, allow the communication module to warm or cool to operating temperature for at least one hour prior to use to avoid damaging the electronic circuitry. 6 About The CADD-Solis Communication Module, Model 2131 The CADD-Solis Network Communication System

(NCS) consists of a CADD-Solis Ambulatory Infusion Pump, Model 2110 (software version 4.2 or greater), with a CADD-Solis Communication Module installed and configured for your wireless network and PharmGuard Server. When installed and appropriately configured, the communication module lets the pump wirelessly send pump history to a PharmGuard Server, and to receive pump firmware and library updates. The model 2131 is an upgraded communication module from the 2130. The radio is more robust, including better security and encryption and incorporating 20 MHz channel n band support. The CADD-Solis Communication Module includes the wireless radio and a rechargeable battery inside the module. The battery powers the communication module, and provides power for the CADD-Solis pump when AC power is not readily available. The rechargeable battery is charged whenever the pump is plugged into AC power via the CADD-Solis AC Adaptereven if the pump is turned off. The CADD-Solis AC adapter and power cord (available separately) is used to connect to the pump to recharge the battery when the communication module is installed in the CADD-

Solis pump. The CADD-Solis Network Setup Utility software

(available separately) is used to configure the wireless network settings for the specific pump when a CADD-Solis Communication Module is installed. For information about using this software, refer to the installation instructions provided with the software. NOTE: Version 1.1 of the Network Setup utility must be used. WARNING: A CADD-Solis Communication Module rechargeable battery that has reached the end of its useful life must be replaced with another CADD-

Solis rechargeable battery. Do not use replacement batteries from other manufacturers as that could result in fire or explosion. For more information, see the pump Operator's Manual, Rechargeable battery reached end of use alarm. WARNING: Do not connect any AC adapters directly to the CADD-Solis Communication Module rechargeable battery. Directly connecting any AC adapter could be hazardous and can damage the rechargeable battery, communication module, and the pump. Installing the CADD-Solis Communication Module CAUTION: The installation and configuration of the CADD-Solis Communication Module in a pump should only be performed by service personnel. CAUTION: To avoid damage to the communication module, power off the pump and disconnect all cables connected to the pump prior to installing the communication module to the pump. CAUTION: Because the initial installation of the communication module requires opening the module housing, this installation should only be performed at a workstation with electrostatic discharge (ESD) controls, including a grounded mat and wrist strap. 1. Make sure the CADD-Solis pump is powered off and there are no cables attached to the pump. 2. Using your fingers, the pump key, or a coin, turn the knob on the battery door counter-clockwise and open the battery door. 3. Remove any batteries that may be in the pump. Also, ensure that there is no debris in the battery compartment. 4. Pull the battery door rearward, as shown, to remove it from the pump. The battery door is not used with the CADD-Solis Communication Module. Keep the battery door in an accessible location to allow the pump to be used later with AA batteries or the CADD-

Solis Rechargeable Battery Pack. 7 5. The three pogo pin insulators located on the three pogo pins in the pump battery compartment must be replaced with the insulators supplied with the communications module assembly. Three insulators are required and a fourth insulator is supplied as an extra. Discard the original insulators. Using a tweezers, carefully remove and discard the three original pogo pin insulators as shown. Pogo Pin Insulator 6. Install three new pogo pin insulators supplied with the communication module assembly. 8 7. Verify the three new pogo pin insulators are fully seated around the pins. NOTE: The three new pogo pin insulators are also compatible with AA batteries and the CADD-Solis Rechargeable Battery Pack. Discard the original pogo pin insulators as they are no longer needed. 8. The rechargeable battery inside the communication module is not connected and must be internally connected. To access the battery to connect it, use a 10 IP star-shaped drive bit to remove the two screws under the cap of the communication module. WARNING: To avoid potential injury and damage, do not remove the cap of the communication module while it is installed and connected to the pump or allow the electronic contacts of a Communication Module to simultaneously touch a piece of metal (a coin or paper clip, for in stance). 9. Gently remove the cap from the base of the communication module, taking care to keep the antenna cable from pulling loose from either the cap or the base, and then attach the battery plug to the battery receptacle on the communication module printed circuit board. 9 CAUTION: Do not use excessive force when separating the communication module cap from the base. The antenna cable must remain attached to both the cap and base. Disconnecting the antenna cable may result in damage to the antenna and/or communication module electronics. 10. Place the cap of the communication module onto the base, taking care to tuck the antenna cable completely inside the communication module. 11. Insert and tighten the two star screws under the communication module cap using the 10 IP star-

shaped drive bit until they are fully seated then another 1/8 turn (45 degrees) approximately. Do not over tighten. WARNING: Ensure that the seals around the module cap perimeter and screw holes are not lost or damaged as the module is opened or closed. These O-ring seals are necessary for water ingress and ESD protection. 10 CommunicationModuleCapCommunication Module BaseAntenna CableBattery PlugBattery Receptacle 12. Insert the communication module into the pump battery compartment. Hook the bottom of the polemount adapter to the bottom of the pump, and then snap the top of the polemount adapter onto the base of the module. NOTE: Align the teeth of the polemount adapter to the recessed opening in the pump housing. Polemount Adapter Alignment Teeth Pump Recessed Opening 13. Use a CADD-Solis Pump Key, standard screwdriver, or a coin to tighten the screw to attach the polemount adapter and secure the communication module to the pump. Tighten the screw until it is fully seated then another 1/8 turn

(45 degrees) approximately. Do not over tighten. 14. Before configuring the pump and first use, the communication module will need to be fully charged. See the next section for more information about charging the rechargeable battery in the CADD-Solis Communication Module. 15. If the CADD-Solis Communication Module is being installed into a specific pump for the first time, the wireless settings for the pump will need to be configured using the CADD-Solis Network Setup Utility software (available separately). For more information, see the documentation provided with the network setup utility software. Charging the Rechargeable Battery The communication module rechargeable battery is charged whenever the CADD-Solis pump is plugged into AC power via the CADD-Solis AC Adaptereven when the pump is turned off. Within the operating temperature range of 2C to 40C

(35Fto 104F), the rechargeable battery will become fully charged in 10 hours or less. Fully charge the rechargeable battery:

Before the first use At least every 30 days while in regular use At least once every 6 months while in storage When the pump indicates the battery is low or depleted CAUTION: Failure to charge the rechargeable battery during prolonged storage may cause deep battery discharge, leading to premature battery replacement. CAUTION: To avoid damaging the AC adapter connector or the pump, do not use excessive force or instruments such as pliers to attach or detach the AC adapter connector. 11 To charge the rechargeable battery:

1. Plug the power cord for the CADD-Solis AC adapter into an AC outlet and the other end into the AC adapter. 2. Plug the AC adapter connector into the AC power jack (labeled 7V) on the CADD-Solis pump. When properly connected, the blue light next to the connector on the pump lights up. WARNING: Do not connect any AC adapters directly to the CADD-Solis Communication Module rechargeable battery. Directly connecting any AC adapter could be hazardous and can damage the battery, communication module, and the pump. CAUTION: Failure to push the AC adapter output connector all the way inward to the pump may result in an intermittent connection and the connector may dislodge, causing a loss of power and will no longer charge the rechargeable battery. 3. When the pump is powered on, the pump status bar briefly shows AC Adapter Connected. 4. When the pump is powered on, the pump 12 status bar shows that the pump is connected to AC power. A small plug indicator is shown to the right of the battery icon. 5. When the pump is powered on, you can assess the estimated battery power level from the status bar on the pump display. For more information, refer to the pump Operator's Manual. When the battery is fully charged, you may choose to disconnect the AC adapter plug. The AC adapter disconnected message is briefly displayed after disconnecting the plug. Configuring Wireless Settings Using the CADD-Solis Network Setup Utility Software All wireless settings for the pump and CADD-Solis Communication Module are configured using the CADD-Solis Network Setup Utility software

(available separately) via a USB connection from a PC to the CADD-Solis pump. The CADD-Solis Network Setup Utility software lets you select and enter all wireless settings for configuration to your wireless network access points, and your PharmGuard Server. Those settings can be saved to the CADD-Solis pump. Therefore, if a CADD-Solis Communication Module is replaced for the pump, the new communication module will automatically use the pump's pre-configured wireless settings. Additionally, you can view detailed wireless status and wireless settings. From the pump Reports menu, select Wireless Status or Wireless Settings. To view communication module (CM) version and MAC address, select Device Information from the Reports menu. For more information, see the pump Operator's Manual For more information, see the documentation provided with the CADD-Solis Network Setup Utility software. Turning Wireless Radio On/Off When the CADD-

Solis Communication Module is installed, its wireless radio can be turned on or off as necessary (e.g., turn off to conserve battery, etc.). This can be done at any time from the Tasks menu on the pump screen without interrupting clinical functions of the pump such as a running infusion. For more information, see the pump Operator's Manual. Viewing Wireless Status and Settings While the CADD-Solis Network Setup Utility software lets you view and change wireless settings, you can also view wireless status and settings on the CADD-Solis pump screen. Wireless status is indicated on the pump main screen:

Wireless Off

(white indicator) Wireless On, not associated with wireless access point

(orange indicator) Wireless On, associated with wireless access point

(orange indicator with green center) Wireless On, associated with wireless access point, andcommunicating with PharmGuard Server

(green indicator with green center) 13 Troubleshooting Problem The rechargeable battery wont charge. The rechargeable battery is fully charged but wont work in the pump. Wireless radio is turned on and the pump wireless status icon is displaying

"Wireless On, not associated with wireless access point"

(orange indicator). Probable Cause / Solution The AC adapter connector may not be completely inserted into the connection port on the pump. Fully insert the AC adapter connector into the pump. The battery may be too hot or too cold. Make sure the environmental conditions meet those specified for operation. The three replacement pogo pin insulators are not installed or are improperly installed. There may be a problem with contact between the pump and communication module. Make sure the contact pads on the communication module are clean. Make sure the battery compartment and the contacts on the pump are clean. Try the communication module in another pump. If it works in the second pump then there is likely a problem with the first pump. If the communication module still doesnt work in the second pump, there is likely a problem with the communication module and/or the rechargeable battery. Contact Smiths Medical Customer Service. The Communication Module may be in heat reduction mode, see the pump Operator's Manual. Wireless settings are improperly configured. Check and/or configure settings. Communication module is too far from a wireless access point. Move closer to an access point. Pump is automatically turning off the radio due to a depleted battery. Connect pump to AC Communication module in vicinity of an operating microwave oven. Move away from Adapter. microwave oven. Pump Alarms Associated with the Communication Module Rechargeable battery near end of use. Replace battery. Rechargeable battery reached end of use. Pump will not run. Battery Unusable. Pump will not run. Communication module intermittent connection to pump 14 The rechargeable battery pack is near the end of its life. It has been discharged and recharged so many times that it will soon be at the end of its use. You may continue to use it in this state. The CADD-Solis Communication Module rechargeable battery pack is at the end of its life. It has been discharged and recharged so many times that it is no longer able to hold a good charge. Replace with a new CADD-Solis Communication Module rechargeable battery. The battery is not compatible with the pump or a communication error occurred. For more information, see the pump Operator's Manual. The connection between the communication module and the pump is intermittent. For more information, see the pump Operator's Manual. Transportation The communication module has been tested to and complies with the United Nations transportation regulations of UN/DOT ST/SG/AC.10/11 (Rev. 5) Section 38.3 testing requirements T1-T5, T7. Disposal / Collect Separately The communication module rechargeable battery should be completely discharged prior to disposal and/or the terminals should be taped or capped to prevent short circuit. Non-European Union residents must dispose of or recycle this product in accordance with the local laws or regulations that apply. Collect Separately This product contains electrical and electronic components that may contain materials, which if disposed of with general waste, could be damaging to the environment. In accordance with Directive 2002/96/EC Waste Electrical and Electronic Equipment, residents of the European Union must follow specific disposal or recycling instructions for this product. Contact your local distributor, or visit the following web site for specific instructions:

http://www.smiths-medical.com/recycle/index.html WARNING: There are potential health hazards associated with improper disposal of batteries and other electronics. Dispose of used batteries and other used accessories in an environmentally safe manner, and according to any regulations that may apply. REACH Information Under the European Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH Regulation EC No. 1907/2006) companies are required to disclose to customers if a product contains any of the substances identified on the Candidate List of Substances for Authorization

(also known as the Substances of Very High Concern

(SVHC)) at a concentration above 0.10% by weight. Smiths Medicals declarations regarding SVHCs in products can be found at: www.smiths-medical.com/

environment Part 15 Certification and RSS standard(s) This device complies with part 15 of the FCC Rules and Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:

(1) this device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. Cleaning and Disinfecting the Communication Module For optimal efficiency, it is recommended best practice to clean first and then disinfect. All disinfectants require pre-cleaning, except for disinfectant cleaners that are tested to disinfect in the presence of 5% of organic matter. CAUTION: Do not immerse the communication module in cleaning fluid or water. Do not allow solution to soak into the communication module. Moisture buildup inside the communication module may damage the device. Clean and disinfect the exposed surfaces of the communication module when installed in the pump. 15 Acceptable disinfecting solutions for the CADD-Solis Communication Module are listed below. Product Manufacurer

(EPA Registration Number) CaviWipes Metrex

(46781-8) Sani-Cloth Super PDI

(9480-4) Sani-Cloth Bleach PDI

(9480-8) Active Ingredient(s) Contact/

Kill Time 17.2%

Isopropanol Dimethyl Benzyl Ammonium Chloride, Dimethyl Ethyl Benzyl Ammonium Chloride 0.60%

Sodium Hypochlorite 3 minutes 2 minutes 4 minutes 3. Allow the communication module to dry completely before use. CAUTION: To avoid damage to the communication module internal electronics, do not allow solution to soak into the electronic contacts area or in any openings and seams. Use only a dry lint-free cloth to clean the electronic contacts and the area surrounding normally enclosed when installed in the pump. The following steps may be used to clean and disinfect the communication module:

1. Clean the communication module using a mild detergent soap solution to remove residuals or contaminated material. Apply solution to a soft, lint-

free cloth and then wipe the exposed surfaces of the communication module when installed in the pump. Do not allow the solution to soak into the pump or the communication module. 2. Disinfect the communication module by applying a disinfecting solution (listed below) according to the disinfecting product label instructions. If using a liquid or spray, apply solution to a soft, lint-free cloth and then wipe the exposed surfaces of the communication module when installed in the pump. Follow the disinfectant manufacturers recommendations for disinfectant contact times. Do not allow the solution to soak into the pump or the communication module. 16 Specifications Battery type Rechargeable Lithium-ion battery (2 cells) Equivalent Lithium content < 1.6 g Battery capacity 18.7 Wh (when fully charged) Battery output 3.6V (nominal) Rechargeable battery weight

< 100 g Operating environmental requirements Temperature . 2C to 40C

(35F to 104F) Humidity . 20% to 90% relative humidity, non-condensing Atmospheric pressure . 70 kPa to 106 kPa

(10.2 psia to 15.4 psia) Storage and transportation environmental requirements Temperature . 20C to 60C

(4F to 140F) Humidity . 20% to 90% relative humidity, non-condensing Atmospheric pressure . 70 kPa to 106 kPa

(10.2 psia to 15.4 psia) Product battery life 400 full cycles (charge / discharge) at room temperature, 23C (73F) Pump and communication module run time (new battery) 4 hours at pump nominal settings (see the pump Operator's Manual for nominal settings information) Safety The communication module complies with Underwriters Laboratories UL 2054, IEC 60601-1(2005 + A1:2012) Ed 3.1 [when installed in the CADD-Solis Model 2110 infusion pump], IEC 60601-1-2 (2014), and IEC 62133 (2002). The lithium-ion cells comply with Underwriters Laboratories UL 1642. IEEE 802.11 a,b,g,n Radio for Network Communication The CADD-Solis Communication Module intentionally receives and transmits Radio Frequency (RF) electromagnetic energy for non-

critical communication. RF transmit / receive, "a" band . 5180 MHz to 5320 MHz &

5500 MHz to 5825 MHz RF transmit / receive, "b", "g" and "n" bands ... 2412 MHz to 2472 MHz Bandwidth of "a", "b", "g" and "n" signals .........20 MHz Maximum RF transmit power of band "a" .......10mW Maximum RF transmit power of bands "b", "g" and

"n" ..................................................................................100mW Maximum charge time (fully depleted battery to fully charged) 10 hours when plugged into AC Adapter 17 Note: The communication module may be interfered with by other equipment, even if that other equipment complies with CISPR 11 requirements. Communication Module Wireless Range:

36.58 meters (120 feet) (line-of-sight operation with access point) Network Modes and Encryption Network Modes:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Encryption Modes:

None TKIP CCMP TKIP/CCMP Authentication Modes:

EAP Modes:

None EAP-TLS (v1.0 and v1.2) EAP-TTLS EAP-PEAPV0 (PEAP with MS-CHAPv2) EAP-PEAPV1 (PEAP with GTC) EAP-LEAP EAP-FAST OPEN WPA-ENT WPA2-ENT WPA-PSK WPA2-PSK Certificates:

SSL SHA-1 SSL SHA-2 For additional CADD-Solis Communication Module network specifications and setup information, see the Network Setup Utility Installation and User Guide (Version 1.1). Interference / Separation Distances Other electronic communication devices used in the vicinity of the communication module may cause interrupted transmission of data. Interrupted transmission of data does not impact pump delivery. The table below specifies what effect each type of device causes and describes the minimum separation distance that should be observed. Interferer (type of electronic device) 2.4GHz/5GHz Wireless Transmitter Base Stations (e.g. Wi-Fi Access Points, Wireless Telephone Base Stations) 2.4GHz/5GHz Wireless Medical Devices and other Peripherals (e.g., Wi-Fi enabled patient monitors, infusion pumps, computers/smart-

phones/tablets; Bluetooth-enabled devices; Zigbee-enabled devices;

Wireless telephone handsets) Other Smiths Medical CADD-Solis pumps with Wireless Connectivity 433MHz/2.4GHz/5GHz RFID Asset Location Tags Min. Separation Distance 3 meters

(9.84 feet) 1 meter

(3.28 feet) 0.3 meters

(1 foot) Direct contact 18 Limited Warranty Warranty: Smiths Medical ASD, Inc. (Manufacturer) warrants to the Original Purchaser that all parts and components of the CADD-Solis Communication Module(the Communication Module) that are manufactured by or for the Manufacturer, excepting those items indicated below, shall be free from defects in materials and workmanship under normal use, if used in accordance with the Instructions for Use, for a period of one (1) year from the actual date of sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES. Exceptions: This warranty does not cover normal wear and tear and maintenance items, and specifically excludes any other accessory items or equipment used with the Communication Module. Warranty Procedures: Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or replace at its option without charge (except for a minimal charge for postage and handling) any Communication Module (not including accessories) that is defective if a claim is made during such one-year period. DO NOT send any Communication Module or component in to the Manufacturer for warranty repair without specific forwarding information from the Customer Service Department. Conditions: The following conditions, limitations and exclusions apply to the Manufacturers obligations under this warranty:

A. Voiding of Warranty: This warranty is null and void if the Communication Module, or any part or component thereof, has been (1) repaired by someone other than the Manufacturer or its authorized agent; (2) altered so that its stability or reliability is affected; (3) misused; or, (4) damaged by negligence or accident. Misuse includes, but is not limited to, use not in compliance with the Instructions for Use of the Communication Module or use with non-approved accessories. B. Limitations and Exclusions: Replacement of the Communication Module or any component part is the EXCLUSIVE remedy offered by the Manufacturer. All recommendations, information and descriptive literature supplied by the Manufacturer with respect to the Communication Module are believed to be accurate and reliable, but do not constitute warranties. No agent, representative, or employee of the Manufacturer has authority to bind the Manufacturer to any representation or warranty, expressed or implied. THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OF THE COMMUNICATION MODULE FOR ANY PARTICULAR PURPOSE. THE MANUFACTURER DISCLAIMS RESPONSIBILITY FOR THE SUITABILITY OF THE COMMUNICATION MODULE FOR A PARTICULAR MEDICAL TREATMENT OR FOR ANY MEDICAL COMPLICATIONS RESULTING FROM THE USE OF THE COMMUNICATION MODULE. THE MANUFACTURER SHALL NOT BE RESPONSIBLE FOR ANY INCIDENTAL DAMAGES OR CONSEQUENTIAL DAMAGES TO PROPERTY, LOSS OF PROFITS, OR LOSS OF USE CAUSED BY ANY DEFECT OR MALFUNCTION OF THE COMMUNICATION MODULE. This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may have other legal rights that may vary from state to state. 19

. French / Franais Table des matires English . 4 Avertissements . 21 Mises en garde . 22 propos du module de communication CADD-Solis, modle 2131 . 22 Installation du module de communication CADD-Solis . 23 Charge de la batterie rechargeable . 27 Configuration des paramtres sans fil laide du logiciel Network Setup Utility de CADD-Solis . 28 Activation et dsactivation de la radio sans fil . 29 Affichage de ltat et des paramtres sans fil . 29 Dpannage . 30 Transport . 31 limination/Collecte spare . 31 Informations REACH . 31 Chapitre 15 : Certification . 31 Nettoyage et dsinfection du module de communication . 31 Caractristiques techniques . 33 Garantie limite . 35 German / Deutsch . 36 Italian / Italiano . 52 Spanish / Espaol . 68 Portuguese / Portugus . 84 Dutch / Nederlands . 100 Swedish / Svenska . 116 Danish / Dansk . 132 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 20 IMPORTANT : La batterie rechargeable du module de communication CADD-Solis doit tre branche en interne et entirement charge dans la pompe avant la mise en service du systme. Lisez et suivez les instructions figurant dans le prsent manuel de loprateur pour installer et charger la batterie avant utilisation. Lisez attentivement les instructions avant dinstaller le module de communication CADD-Solis sur la pompe perfusion ambulatoire CADD-Solis, modle 2110. Conservez les prsentes instructions pour pouvoir les consulter ultrieurement. Pour obtenir des instructions dtailles, des avertissements, des spcifications et des informations supplmentaires sur le fonctionnement de la pompe perfusion ambulatoire CADD-Solis, consultez le manuel de loprateur de la pompe. Pour obtenir des instructions dtailles, des avertissements, des spcifications et des informations supplmentaires sur lutilisation de ladaptateur secteur CADD-Solis, consultez le mode demploi fourni avec ce produit. AVERTISSEMENTS En vue dviter des blessures corporelles graves, il est primordial de respecter les avertissements suivants :

Nexposez pas le module de communication la pluie, leau ou lhumidit. Un choc ou dautres dangers peuvent sensuivre. Nimmergez pas la batterie rechargeable du module de communication CADD-Solis dans du liquide. Un choc ou dautres dangers peuvent sensuivre. Nutilisez pas la batterie rechargeable du module de communication CADD-Solis avec un dispositif autre que le module de communication CADD-Solis. Ne connectez aucun adaptateur secteur directement la batterie rechargeable du module de communication CADD-Solis. Le branchement direct de tout adaptateur secteur peut tre dangereux et risque dendommager la batterie rechargeable, le module de communication et la pompe. Une batterie rechargeable du module de communication CADD-Solis qui a atteint la fin de sa dure de vie doit tre remplace par une autre batterie rechargeable du module de communication CADD-Solis. Lutilisation de batteries rechargeables dautres fabricants pourrait entraner un incendie ou une explosion. vitez tout contact lectronique simultan du module de communication avec un lment en mtal (par exemple, une pice de monnaie ou un trombone). Nutilisez pas le module de communication CADD-Solis sil a t endommag, si des composants lectroniques internes sont exposs en raison de lusure, ou si des contacts lectroniques sont endommags dune manire quelconque. Un incendie, un choc ou dautres dangers peuvent sensuivre. Nessayez pas dcraser le module de communication CADD-Solis ou la batterie rechargeable. Un incendie, un choc ou dautres dangers peuvent sensuivre. Ne dtruisez pas la batterie rechargeable du module de communication CADD-Solis par incinration. Elle peut exploser. Nutilisez pas le module de communication dans ltui de la pompe perfusion CADD-Solis ou dans tout autre tui ou poche. Le module de communication peut surchauffer et steindre par lintermdiaire du circuit de protection thermique. 21 Il existe des risques potentiels pour la sant associs llimination inapproprie des batteries et des autres composants lectroniques. Mettez au rebut les batteries usages et tout autre accessoire usag de faon cologique et en respectant toutes les rglementations en vigueur. MISES EN GARDE :

Ne forcez pas lorsque vous retirez le couvercle du module de communication CADD-Solis de lembase. Le cble de lantenne doit rester branch au couvercle et lembase. Le dbranchement du cble de lantenne peut endommager lantenne et/ou llectronique du module de communication. Le fait de ne pas charger la batterie du module de communication CADD-Solis avant son utilisation initiale et pendant une dure de stockage prolonge peut la dcharger compltement, et entraner ainsi son remplacement prmatur. Le port USB de la pompe infusion CADD-Solis est destin la communication uniquement avec le Medication Safety Software (logiciel de scurit des mdicaments) de PharmGuard, le Remote Support Software (logiciel dassistance distance) de SureLink et le logiciel Network Setup Utility (logiciel utilitaire de configuration rseau) de CADD Solis. Ne connectez aucun accessoire non pris en charge au port USB (par exemple, le chargement dautres dispositifs ou la connexion dune cl de scurit sans fil), car la pompe peut tre endommage. Si le module de communication CADD-Solis est stock dans des conditions autres que les conditions environnementales de fonctionnement qui ne respectent pas les conditions environnementales de stockage spcifies, laissez le module de communication chauffer ou refroidir la temprature de fonctionnement au 22 moins une heure avant son utilisation pour viter dendommager le circuit lectronique. propos du module de communication CADD-Solis, modle 2131 Le systme de communication rseau (NCS) CADD-Solis est compos dune pompe perfusion ambulatoire CADD-Solis, modle 2110 (version logicielle 4.2 ou ultrieure), avec un module de communication CADD-Solis install et configur pour votre rseau sans fil et le logiciel PharmGuard Server. Une fois le module de communication install et configur correctement, il permet la pompe denvoyer sans fil lhistorique de la pompe au logiciel PharmGuard Server et de recevoir les mises jour du logiciel et de la bibliothque de la pompe. Le modle 2131 est une version plus rcente du module de communication 2130. La radio est plus solide ;

la scurit et le cryptage sont notamment amliors et elle prend en charge le canal 20 MHz dans la bande n . Le module de communication CADD-Solis comprend une radio sans fil et une batterie rechargeable lintrieur du module. La batterie alimente le module de communication et la pompe CADD-Solis lorsque lalimentation secteur nest pas facilement accessible. La batterie rechargeable est charge lorsque la pompe est branche lalimentation secteur par le biais de ladaptateur secteur CADD-Solis, et ce, mme lorsque la pompe est teinte. Ladaptateur secteur CADD-

Solis et le cordon secteur

(disponibles sparment) sont utiliss pour connecter la pompe afin de recharger la batterie lorsque le module de communication est install dans la pompe CADD-Solis. Le logiciel Network Setup Utility de CADD-Solis est utilis pour configurer les paramtres du rseau sans fil dune pompe spcifique lorsquun module de communication CADD-Solis est install. Pour obtenir plus dinformations concernant lutilisation dudit logiciel, consultez les instructions dinstallation fournies avec le logiciel. REMARQUE : La version 1.1 du logiciel Network Setup Utility doit tre utilise. AVERTISSEMENT : Une batterie rechargeable du module de communication CADD-Solis qui a atteint la fin de sa dure de vie doit tre remplace par une autre batterie rechargeable CADD-Solis. Nutilisez pas de batteries de remplacement provenant dautres fabricants, au risque dentraner un incendie ou une explosion. Pour obtenir plus dinformations, consultez le manuel de loprateur de la pompe, et plus prcisment la section concernant lalarme de batterie rechargeable en fin de vie. AVERTISSEMENT : Ne connectez aucun adaptateur secteur directement la batterie rechargeable du module de communication CADD-Solis. Le branchement direct de tout adaptateur secteur peut tre dangereux et risque dendommager la batterie rechargeable, le module de communication et la pompe. Installation du module de communication CADD-Solis MISE EN GARDE : Linstallation et la configuration du module de communication CADD-Solis dans une pompe doivent tre effectues uniquement par un membre du personnel technique. MISE EN GARDE : Pour viter dendommager le module de communication, teignez la pompe et dbranchez tous les cbles connects la pompe avant dinstaller le module de communication sur la pompe. MISE EN GARDE : Puisque linstallation initiale du module de communication ncessite louverture du botier du module, cette installation doit uniquement tre effectue un poste de travail quip de commandes de dcharge lectrostatique (DES), y compris un tapis reli la terre et une dragonne. 1. Vrifiez que la pompe CADD-Solis est teinte et quaucun cble nest branch la pompe. 2. laide de vos doigts, de la cl de la pompe ou dune pice de monnaie, tournez le bouton situ sur la porte du compartiment des piles dans le sens inverse des aiguilles dune montre et ouvrez la porte du compartiment des piles. 3. Retirez toute pile qui pourrait se trouver dans la pompe. Veillez galement ce quaucun dbris ne se trouve dans le compartiment des piles. 4. Tirez la porte du compartiment des piles vers larrire, comme illustr, pour la retirer de la pompe. La porte du compartiment des piles nest pas utilise avec le module de communication CADD-Solis. Gardez la 23 porte du compartiment des piles un endroit accessible pour pouvoir utiliser la pompe ultrieurement avec des piles AA ou une batterie rechargeable CADD-Solis. 5. Les trois isolateurs broches pogo situs sur les trois broches pogo dans le compartiment des piles de la pompe doivent tre remplacs par des isolateurs fournis avec lensemble du module de communication. Trois isolateurs sont ncessaires et un quatrime isolateur est fourni en plus. Jetez les isolateurs dorigine. laide dune pince piler, retirez soigneusement les trois isolateurs broches pogo dorigine et jetez-les, comme illustr. Isolateur broches pogo 6. Installez trois nouveaux isolateurs broches pogo fournis avec lensemble du module de communication. 24 7. Vrifiez que les trois nouveaux isolateurs broches pogo sont correctement fixs autour des broches. REMARQUE : Les trois nouveaux isolateurs broches pogo sont galement compatibles avec des piles AA et la batterie rechargeable CADD-Solis. Jetez les isolateurs broches pogo dorigine ; vous nen aurez plus besoin. 8. La batterie rechargeable lintrieur du module de communication nest pas connecte et doit tre branche en interne. Pour accder la batterie et la brancher, utilisez un embout dentranement en forme dtoile 10 IP pour retirer les deux vis situes sous le couvercle du module de communication. AVERTISSEMENT : Afin dviter tout risque de blessure ou dommage, ne retirez pas le couvercle du module de communication lorsquil est install et branch la pompe ; vitez galement tout contact lectronique simultan du module de communication avec un lment en mtal (par exemple, une pice de monnaie ou un trombone). 9. Retirez dlicatement le couvercle de lembase du module de communication, en prenant soin de ne pas dbrancher le cble de lantenne du couvercle ou de lembase, puis branchez la fiche de la batterie au rceptacle de la batterie sur la carte circuits imprims du module de communication. 25 MISE EN GARDE : Ne forcez pas lorsque vous retirez le couvercle du module de communication de lembase. Le cble de lantenne doit rester branch au couvercle et lembase. Le dbranchement du cble de lantenne peut endommager lantenne et/ou llectronique du module de communication. 10. Placez le couvercle du module de communication sur lembase, en prenant soin de rentrer entirement le cble de lantenne lintrieur du module de communication. 11. Insrez et serrez les deux vis toile sous le couvercle du module de communication, en utilisant un embout dentranement en forme dtoile 10 IP, jusqu ce quelles soient correctement mises en place, puis faites un autre tour denviron 1/8

(45 degrs). Ne serrez pas trop. AVERTISSEMENT : Veillez ne pas perdre ou endommager les joints dtanchit autour du couvercle du module et les trous de vis lors de louverture et de la fermeture du module. Ces joints toriques sont ncessaires pour la protection contre linfiltration deau et les DES. 26 Couvercle du module de communicationEmbase du module de communicationCble de lantenneFiche de la batterieRceptacle de la batterie 12. Insrez le module de communication dans le compartiment des piles de la pompe. Accrochez le bas de ladaptateur de montage au bas de la pompe, puis insrez le haut de ladaptateur de montage sur lembase du module. REMARQUE : Alignez les dents de ladaptateur de montage louverture encastre dans le botier de la pompe. Adaptateur de montage Alignement des dents Ouverture encastre de la pompe 13. Utilisez une cl de la pompe CADD-Solis, un tournevis standard ou une pice de monnaie pour serrer la vis permettant de fixer ladaptateur de montage et de fixer correctement le module de communication la pompe. Serrez la vis jusqu ce quelle soit correctement fixe, puis faites un autre tour denviron 1/8 (45 degrs). Ne serrez pas trop. 14. Avant de configurer la pompe et de lutiliser pour la premire fois, le module de communication doit tre entirement charg. Lisez la section suivante pour obtenir plus dinformations concernant la charge de la batterie rechargeable dans le module de communication CADD-Solis. 15. Si le module de communication CADD-Solis est install dans une pompe spcifique pour la premire fois, les paramtres sans fil de la pompe doivent tre configurs via le logiciel Network Setup Utility de CADD-Solis (disponible sparment). Pour obtenir plus dinformations, consultez la documentation fournie avec le logiciel Network Setup Utility. Charge de la batterie rechargeable La batterie rechargeable du module de communication est charge lorsque la pompe CADD-Solis est branche lalimentation secteur par le biais de ladaptateur secteur CADD-Solis, et ce, mme lorsque la pompe est teinte. Dans la plage de temprature de fonctionnement comprise entre 2 C et 40 C (35 F 104 F), la batterie rechargeable sera pleinement charge au bout de 10 heures ou moins. Chargez compltement la batterie rechargeable :

avant la premire utilisation, au moins tous les 30 jours lorsque le dispositif est utilis rgulirement, au moins une fois tous les 6 mois lorsque le dispositif est stock et lorsque la pompe indique que la batterie est faible ou dcharge. MISE EN GARDE : Le fait de ne pas charger la batterie rechargeable pendant une dure de stockage prolonge peut la dcharger compltement, et entraner ainsi son remplacement prmatur. 27 MISE EN GARDE : Afin dviter dendommager le connecteur de ladaptateur secteur ou la pompe, ne forcez pas ou nutilisez pas dinstruments comme une pince pour fixer ou dtacher le connecteur de ladaptateur secteur. Pour charger la batterie rechargeable :

1. Branchez le cordon secteur de ladapteur secteur CADD-Solis dans une prise secteur et lautre extrmit dans ladaptateur secteur. 2. Branchez le connecteur de ladaptateur secteur dans la prise jack dalimentation secteur (tiquete 7V ) sur la pompe perfusion CADD-Solis. Si le branchement est correct, le voyant bleu ct du connecteur de la pompe sallume. AVERTISSEMENT : Ne connectez aucun adaptateur secteur directement la batterie rechargeable du module de communication CADD-Solis. Le branchement direct de tout adaptateur secteur peut tre dangereux et risque dendommager la batterie, le module de communication et la pompe. MISE EN GARDE : Le fait de ne pas enfoncer compltement le connecteur de sortie de ladaptateur secteur dans la pompe peut se traduire par une connexion intermittente et le connecteur risque de bouger, entranant ainsi une perte dalimentation et larrt de la charge de la batterie rechargeable. 28 3. Lorsque la pompe est sous tension, la barre dtat de la pompe affiche brivement Adaptateur secteur connect . 4. Lorsque la pompe est sous tension, la barre dtat de la pompe indique que la pompe est connecte lalimentation secteur. Un petit indicateur de fiche est affich droite de licne de la batterie. 5. Lorsque la pompe est sous tension, vous pouvez valuer le niveau de batterie estim partir de la barre dtat de lcran de la pompe. Pour obtenir plus dinformations, consultez le manuel de loprateur de la pompe. Lorsque la batterie est compltement charge, vous pouvez choisir de dbrancher la fiche de ladaptateur secteur. Le message Adaptateur secteur dconnect saffiche brivement une fois la fiche dbranche. Configuration des paramtres sans fil laide du logiciel Network Setup Utility de CADD-Solis Tous les paramtres sans fil de la pompe et du module de communication CADD-Solis sont configurs laide du logiciel Network Setup Utility de CADD-Solis

(disponible sparment) via une connexion USB dun ordinateur la pompe CADD-Solis. Le logiciel Network Setup Utility de CADD-Solis vous permet de slectionner et de saisir tous les paramtres sans fil pour la configuration de vos points daccs rseau et de votre logiciel PharmGuard Server. Ces paramtres peuvent tre sauvegards dans la pompe CADD-Solis. Par consquent, si un module de communication CADD-Solis dune pompe est remplac, le nouveau module de communication utilisera automatiquement les paramtres sans fil prconfigurs de la pompe. Pour obtenir plus dinformations, consultez la documentation fournie avec le logiciel Network Setup Utility de CADD-Solis. Activation et dsactivation de la radio sans fil Lorsque le module de communication CADD-Solis est install, sa radio sans fil peut tre allume ou teinte au besoin (par exemple, elle peut tre teinte pour conomiser la batterie). Lactivation et la dsactivation de la radio sont possibles tout moment partir du menu Tches sur lcran de la pompe sans interrompre les fonctions cliniques de la pompe, comme une perfusion en cours. Pour obtenir plus dinformations, consultez le manuel de loprateur de la pompe. Affichage de ltat et des paramtres sans fil Le logiciel Network Setup Utility de CADD-Solis vous permet dafficher et de modifier les paramtres sans fil ;

vous pouvez galement afficher ltat et les paramtres sans fil sur lcran de la pompe CADD-Solis. Ltat sans fil est affich sur lcran principal de la pompe :

Connexion sans fil dsactive (voyant blanc) Connexion sans fil active, non associe un point daccs sans fil (voyant orange) Connexion sans fil active, associe un point daccs sans fil (voyant orange avec centre vert) Connexion sans fil active, associe un point daccs sans fil et connecte au logiciel PharmGuard Server (voyant vert avec centre vert) De plus, vous pouvez afficher en dtail ltat et les paramtres sans fil. partir du menu Rapports de la pompe, slectionnez tat connexion WIFI ou Paramtres WIFI. Pour afficher la version du module de communication (CM) et ladresse MAC, slectionnez Infos sur le dispositif dans le menu Rapports. Pour obtenir plus dinformations, consultez le manuel de loprateur de la pompe. 29 Dpannage Problme La batterie rechargeable ne charge pas. La batterie rechargeable est compltement charge, mais ne fonctionne pas dans lapompe. La radio sans fil est allume et licne de ltat sans fil de la pompe affiche Connexion sans fil active, non associe un point daccs sans fil

(voyant orange). Cause/Solution probable Le connecteur de ladaptateur secteur nest peut-tre pas compltement insr dans le port deconnexion de la pompe. Insrez compltement le connecteur de ladaptateur secteur dans lapompe. La batterie est peut-tre trop chaude ou trop froide. Vrifiez que les conditions environnementales respectent celles spcifies pour le fonctionnement du dispositif. Les trois isolateurs broches pogo de remplacement ne sont pas installs ou sont installs de manire incorrecte. Il peut y avoir un problme de contact entre la pompe et le module de communication. Veillez ce que les plages de contact du module de communication soient propres. Veillez ce que le compartiment des piles et les contacts de la pompe soient propres. Essayez le module de communication dans une autre pompe. Sil fonctionne dans la deuxime pompe, la premire pompe a alors probablement un problme. Si le module de communication ne fonctionne toujours pas dans la deuxime pompe, ce dernier et/ou la batterie rechargeable aalors probablement un problme. Contactez le Service clientle de SmithsMedical. Le module de communication est peut-tre en mode rduction de chaleur; consultez le manuel Les paramtres sans fil ne sont pas configurs correctement. Vrifiez et/ou configurez les paramtres. Le module de communication est trop loin dun point daccs sans fil. Rapprochez-vous dun La pompe teint automatiquement la radio, car la batterie est dcharge. Branchez la pompe de loprateur de la pompe. point daccs. surladaptateur secteur. Le module de communication se trouve proximit dun four micro-ondes en fonctionnement. loignez-vous du four micro-ondes. Alarmes de la pompe associes au module de communication Batterie rechargeable presque en fin de vie. Remplacer la batterie. La batterie rechargeable est proche de la fin de sa dure de vie. Elle a t dcharge et recharge tellement de fois quelle atteindra bientt la fin de sa dure dutilisation. Vous pouvez continuer lutiliser dans cet tat. Batterie rechargeable enfinde vie. La pompe est larrt. La batterie rechargeable du module de communication CADD-Solis a atteint la fin de sa dure de vie. Elle a t dcharge et recharge tellement de fois quelle nest plus capable de maintenir une charge suffisante. Remplacez-la par une nouvelle batterie rechargeable du module de communication CADD-Solis. Batterie inutilisable. Lapompe est larrt. La batterie nest pas compatible avec la pompe ou une erreur de communication sest produite. Pour obtenir plus dinformations, consultez le manuel de loprateur de la pompe. Connexion intermittente du module de communication la pompe. 30 La connexion entre le module de communication et la pompe est intermittente. Pour obtenir plus dinformations, consultez le manuel de loprateur de la pompe. Transport Le module de communication a t test et est conforme aux rglementations en matire de transport des Nations Unies UN /DOT ST/SG/AC.10/11

(Rev. 5), Section 38.3, exigences dessais T1-T5, T7. limination/Collecte spare La batterie rechargeable du module de communication doit tre compltement dcharge avant dtre limine et/ou les bornes doivent tre colmates ou bouches pour viter tout court-circuit. Les rsidents des pays nappartenant pas lUnion europenne doivent liminer ou recycler ce produit conformment aux lois ou rglementations locales applicables. Collecter sparment Ce produit contient des composants lectriques et lectroniques qui peuvent contenir des matriaux qui, sils taient limins avec les dchets ordinaires, pourraient tre nocifs pour lenvironnement. Conformment la Directive 2002/96/CE relative aux dchets dquipements lectriques et lectroniques, les rsidents de lUnion europenne doivent suivre des instructions spcifiques de mise au rebut ou de recyclage pour ce produit. Contactez votre distributeur local ou consultez le site Web suivant pour obtenir des instructions spcifiques :

http://www.smiths-medical.com/recycle/index.html AVERTISSEMENT : Il existe des risques potentiels pour la sant associs llimination inapproprie des batteries et des autres composants lectroniques. Mettez au rebut les batteries usages et tout autre accessoire usag de faon cologique et en respectant toutes les rglementations en vigueur. Informations REACH Aux termes du rglement europen concernant lenregistrement, lvaluation et lautorisation des substances chimiques, ainsi que les restrictions applicables ces substances (Rglement REACH, CE n 1907/2006), les entreprises sont tenues dindiquer leurs clients si un produit contient lune des substances figurant sur la liste des substances candidates en vue dune autorisation (galement dnommes substances extrmement proccupantes (SVHC)) ds lors que la concentration excde 0,10 % du poids. Les dclarations de Smiths Medical concernant les SVHC prsentes dans les produits sont consultables sur le site :

www.smiths-medical.com/environment Chapitre 15 : Certification et normes RSS Le prsent dispositif est conforme au chapitre 15 des rgles FCC et aux normes RSS exemptes de licence d'Industrie Canada. Lutilisation est soumise aux deux conditions suivantes : (1) le prsent dispositif ne doit pas causer dinterfrences nuisibles, et (2) le prsent dispositif doit accepter toute interfrence reue, y compris les interfrences susceptibles dentraner un fonctionnement non souhait. Nettoyage et dsinfection du module de communication Pour une efficacit optimale, les meilleures pratiques recommandent de nettoyer dabord, puis de dsinfecter. Avant de dsinfecter, veuillez effectuer un nettoyage pralable, sauf dans les cas o vous utilisez des agents dsinfectants qui sont tests pour dsinfecter en prsence de 5 % de matire organique. MISE EN GARDE : Nimmergez pas le module de communication dans du liquide de nettoyage ou de leau. Ne laissez pas la solution sinfiltrer lintrieur du module de communication. Laccumulation dhumidit lintrieur du module de communication risque dendommager le dispositif. Nettoyez et dsinfectez les surfaces exposes du module de communication lorsquil est install dans la pompe. 31 Les solutions de dsinfection pouvant tre utilises pour le module de communication CADD-Solis figurent dans la liste ci-dessous. Produit Fabricant

(Numro denregistre-

ment EPA) CaviWipes Metrex

(46781-8) Sani-Cloth Super PDI (9480-4) Sani-Cloth Bleach PDI (9480-8) Ingrdient(s) actif(s) Temps de pose 3minutes 2minutes 4minutes Isopropanol 17,2%

Chlorure de benzyldi-

mthylam-

monium, chlorure dthylbenzyl-

dimthylam-

monium Hypochlorite de sodium 0,60%

3. Laissez le module de communication scher compltement avant de lutiliser. MISE EN GARDE : Afin dviter dendommager llectronique interne du module de communication, ne laissez pas la solution sinfiltrer lintrieur de la zone de contacts lectroniques ou dans les ouvertures ou les joints. Utilisez uniquement un chiffon sec et non pelucheux pour nettoyer les contacts lectroniques et la zone close qui se trouve autour, une fois le module install dans la pompe. Vous pouvez suivre les tapes suivantes pour nettoyer et dsinfecter le module de communication :

1. Nettoyez le module de communication laide dune solution savonneuse lgrement dtergente afin dliminer tout rsidu ou matriau contamin. Appliquez la solution sur un chiffon doux et non pelucheux, puis essuyez les surfaces exposes du module de communication, une fois ce dernier install dans la pompe. Ne laissez pas la solution sinfiltrer lintrieur de la pompe ou du module de communication. 2. Dsinfectez le module de communication en appliquant une solution de dsinfection (figurant dans la liste ci-dessous) conformment aux instructions de ltiquette du produit dsinfectant. Si vous utilisez un liquide ou un spray, appliquez la solution sur un chiffon doux et non pelucheux, puis essuyez les surfaces exposes du module de communication, une fois de dernier install dans la pompe. Reportez-vous aux recommandations du fabricant du dsinfectant pour connatre les temps de pose respecter. Ne laissez pas la solution sinfiltrer lintrieur de la pompe ou du module de communication. 32 Caractristiques techniques Type de batterie Batterie rechargeable ion-lithium (2 cellules) Teneur quivalente en lithium < 1,6 g Capacit de la batterie 18,7 Wh (lorsquelle est compltement charge) Puissance de sortie de la batterie 3,6 V (nominale) Poids de la batterie rechargeable

< 100 g Exigences environnementales de fonctionnement Temprature . 2 C 40 C Humidit . 20 % 90 %

(35 F 104 F) dhumidit relative, sans condensation

(10,2 psi 15,4 psi) Pression atmosphrique . 70 kPa 106 kPa Exigences environnementales de transport et de stockage Temprature . 20 C 60 C

(4 F 140 F) Humidit . 20 % 90 %

Pression atmosphrique . 70 kPa 106 kPa dhumidit relative, sans condensation

(10,2 psi 15,4 psi) Dure de vie de la batterie du produit 400 cycles complets (charge/dcharge) temprature ambiante, 23 C (73 F) Temps de charge maximal (dune batterie compltement dcharge une batterie compltement charge) 10 heures lorsquelle est branche ladaptateur secteur Dure de fonctionnement de la pompe et du module de communication (batterie neuve) 4 heures aux paramtres nominaux de la pompe

(consultez le manuel de loprateur de la pompe pour obtenir des informations concernant les paramtres nominaux). Scurit Le module de communication est conforme aux normes Underwriters Laboratories UL 2054, CEI 60601-1(2005 + A1:2012) d. 3.1 [lorsquil est install dans la pompe perfusion CADD-

Solis, modle 2110], CEI 60601-1-2 (2014) et CEI 62133 (2002). Les cellules ion-lithium sont conformes la norme Underwriters Laboratories UL 1642. IEEE 802.11 (a,b,g,n) Radio pour la communication rseau Le module de communication CADD-Solis reoit et transmet intentionnellement une nergie lectromagntique de radiofrquence (RF) pour une communication non critique. Transmission/Rception RF, bande a . 5 180 MHz 5 320 MHz et 5 500 MHz 5 825 MHz Transmission/Rception RF, bandes b , g et n ........................... 2 412 MHz 2 472 MHz Bande passante des signaux a , b , g et n ................20 MHz Puissance de transmission RF maximale de la bande a ..................10 mW Puissance de transmission RF maximale des bandes a , b , g et n .................100 mW 33 Porte du module de communication sans fil :

36,58 mtres (120 pieds) (fonctionnement en visibilit directe avec point daccs) Modes rseau et cryptage Modes rseau:

Modes de cryptage:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Aucun TKIP CCMP TKIP/CCMP Modes dauthentification: Modes EAP:

OUVERT WPA-ENT WPA2-ENT WPA-PSK Aucun EAP-TLS (v1.0 et v1.2) EAP-TTLS WPA2-PSK EAP-PEAPV0 (PEAP avec MS-CHAPv2) EAP-PEAPV1 (PEAP avec GTC) EAP-LEAP EAP-FAST Certificats:

SSL SHA-1 SSL SHA-2 Remarque : Le module de communication peut tre perturb par dautres quipements, mme si ces derniers sont conformes aux exigences de la norme CISPR 11. Pour obtenir plus dinformations concernant les caractristiques techniques et linstallation du rseau du module de communication CADD-Solis, consultez le guide dinstallation et dutilisation du logiciel Network Setup Utility (version 1.1). Interfrence/Distances de sparation Lutilisation dautres dispositifs de communication lectroniques proximit du module de communication peut interrompre la transmission des donnes. Linterruption de la transmission des donnes na aucune incidence sur la perfusion de la pompe. Le tableau ci-dessous spcifie lincidence de chaque type de dispositif et dcrit la distance de sparation minimale respecter. Brouilleur (type de dispositif lectronique) Stations de base pour metteurs sans fil de 2,4GHz/5GHz (par exemple, points daccs Wi-Fi, stations de base pour tlphones sans fil) Dispositifs mdicaux sans fil et autres priphriques de 2,4GHz/5GHz (par exemple, moniteurs de surveillance des patients, pompes perfusion et ordinateurs/smartphones/tablettes compatibles Wi-Fi; dispositifs compatibles Bluetooth; dispositifs compatibles Zigbee; ou systmes tlphoniques sans fil) Autres pompes CADD-Solis de SmithsMedical avec une connexionsans fil tiquettes de localisation des produits RFDI de 433MHz/2,4GHz/5GHz 34 Distance de sparation minimale 3mtres

(9,84pieds) 1mtre

(3,28pieds) 0,3mtre

(1pied) Contact direct Garantie limite Garantie : Smiths Medical ASD, Inc. (ci-aprs dsign le Fabricant ) garantit lAcheteur dorigine que toutes les pices et tous les composants du module de communication CADD-Solis (ci-aprs dsign le Module de communication ) fabriqus par ou pour le Fabricant, lexception des lments indiqus ci-dessous, sont exempts de dfauts de matriaux et de fabrication dans des conditions normales dutilisation, si utiliss conformment au Mode demploi, et ce, durant une priode dun (1) an partir de la date relle de vente lAcheteur dorigine. IL NEXISTE AUCUNE AUTRE GARANTIE. Exceptions : La prsente garantie ne couvre pas lusure normale et les pices de maintenance, et elle exclut spcifiquement tout autre accessoire ou appareil utilis avec le Module de communication. Procdures de garantie : Sous rserve des conditions et en conformit avec la prsente Garantie limite, le Fabricant sengage rparer ou remplacer son gr et sans frais ( lexception de frais minimes denvoi et de traitement) tout Module de communication ( lexception des accessoires) dfectueux si une requte est introduite au cours de cette priode dun an. NE RENVOYEZ aucun Module de communication ou composant au Fabricant pour une rparation couverte par la garantie sans avoir reu des informations spcifiques du Service clientle. Conditions : Les conditions, limites et exclusions suivantes sappliquent aux obligations du Fabricant dans le cadre de la prsente garantie :

A. Nullit de la garantie : La prsente garantie est nulle et non avenue si le Module de communication, ou toute partie ou tout autre composant de ce dernier, a t 1) rpar par une personne autre que le Fabricant ou son agent agr ; 2) modifi de telle sorte que sa stabilit ou sa fiabilit en est affecte ; 3) utilis de manire inapproprie ; ou 4) endommag par ngligence ou accident. Lutilisation inapproprie inclut, mais pas uniquement, une utilisation non conforme au Mode demploi ou une utilisation du Module de communication avec des accessoires non agrs. B. Limites et exclusions : Le remplacement du Module de communication ou de tout composant constitue le recours EXCLUSIF offert par le Fabricant. Toutes les recommandations, toutes les informations et toute la documentation descriptive fournies par le Fabricant relatives au Module de communication sont supposes tre exactes et fiables, mais ne constituent pas des garanties. Aucun agent, reprsentant ou employ du Fabricant na autorit lier le Fabricant une quelconque dclaration ou garantie, expresse ou implicite. IL NEXISTE AUCUNE GARANTIE DE VALEUR MARCHANDE OU DADQUATION DU MODULE DE COMMUNICATION UN BUT PARTICULIER. LE FABRICANT DCLINE TOUTE RESPONSABILIT CONCERNANT LADQUATION DU MODULE DE COMMUNICATION UN TRAITEMENT MDICAL PARTICULIER OU TOUTE COMPLICATION MDICALE RSULTANT DE LUTILISATION DU MODULE DE COMMUNICATION. LE FABRICANT NE SERA PAS TENU RESPONSABLE DE DOMMAGES MATRIELS ACCIDENTELS OU CONSCUTIFS, NI DE PERTES DE PROFIT OU DUTILISATION RSULTANT DUN DFAUT OU DUN DYSFONCTIONNEMENT DU MODULE DE COMMUNICATION. La prsente garantie accorde lAcheteur dorigine des droits lgaux spcifiques et lAcheteur dorigine peut bnficier dautres droits lgaux qui peuvent varier dun tat lautre. 35

/

German / Deutsch Inhalt English . 4 French / Franais . 20 Warnhinweise. 37 Vorsichtshinweise . 38 ber das CADD-Solis-Kommunikationsmodul, Modell 2131 . 38 Installation des CADD-Solis-Kommunikationsmoduls . 39 Laden des wiederaufladbaren Akkus . 43 Konfigurieren der Drahtlos-Einstellungenmit der CADD-Solis Network Setup Utility-Software . 44 Ein- und Ausschalten des WLAN . 45 Anzeigen des WLAN-Status und der Einstellungen . 45 Fehlerbehebung . 46 Transport . 47 Entsorgung/Getrennte Sammlung . 47 REACH-Informationen . 47 Zertifizierung gem Teil 15 . 47 Reinigung und Desinfektion des Kommunikationsmoduls . 47 Technische Angaben . 49 Eingeschrnkte Gewhrleistung . 51 Italian / Italiano . 52 Spanish / Espaol . 68 Portuguese / Portugus . 84 Dutch / Nederlands . 100 Swedish / Svenska . 116 Danish / Dansk . 132 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 36 WICHTIG: Der wiederaufladbare Akku im CADD-Solis-

Kommunikationsmodul muss intern angeschlossen und in der Pumpe vollstndig geladen werden, bevor das System in Betrieb genommen werden kann. Lesen und befolgen Sie die in diesem Bedienungs-

handbuch aufgefhrten Anweisungen zur Installation und zum Laden des Akkus vor derVerwendung. Lesen Sie die Anweisungen vollstndig, bevor Siedas CADD-Solis-Kommunikationsmodul an derambulanten CADD-Solis-Infusionspumpe, Modell 2110, installieren. Bewahren Sie die Anweisungen zum spteren Nachschlagen auf. Detaillierte Anweisungen, Warnhinweise, Spezifikationen und zustzliche Informationen zum Betrieb der ambulanten CADD-Solis-Infusionspumpe finden Sie im Bedienungshandbuch der Pumpe. Detaillierte Anweisungen, Warnhinweise, Spezifikationen und zustzliche Informationen zur Verwendung des CADD-Solis-Netzteils finden Sie in der Gebrauchsanleitung, die im Lieferumfang dieses Produkts enthalten ist. WARNHINWEISE Um schwere Verletzungen an Personen zu vermeiden, sind unbedingt folgende Warnhinweise zu beachten:

Das Kommunikationsmodul nicht Regen, Wasser oder Feuchtigkeit aussetzen. Es besteht die Gefahr eines elektrischen Schlags und andere Gefahren. Den Akku des CADD-Solis-Kommunikations-

moduls nicht in Flssigkeit eintauchen. Esbesteht die Gefahr eines elektrischen Schlags und andere Gefahren. Den Akku des CADD-Solis-Kommunikations-

moduls mit keinem anderen Gert zusammen auer dem CADD-Solis-

Kommunikationsmodul verwenden. Kein Netzteil direkt an den Akku des CADD-Solis-Kommunikationsmoduls anschlieen. Der direkte Anschluss eines Netzteils knnte gefhrlich sein und den Akku, dasKommunikationsmodul und die Pumpebeschdigen. Ein Akku des CADD-Solis-Kommunikations-

moduls, dessen Lebensdauer abgelaufen ist, muss durch einen anderen wieder-

aufladbaren Akku des CADD-Solis-

Kommunikationsmoduls ersetzt werden. Beider Verwendung wiederaufladbarer Akkusvon anderen Herstellern besteht Brand-oder Explosionsgefahr. Die elektronischen Kontakte des Kommunikationsmoduls drfen nicht gleichzeitig ein Objekt aus Metall berhren

(z.B. eine Mnze, eine Broklammer usw.). Das CADD-Solis-Kommunikationsmodul nicht verwenden, wenn es beschdigt wurde, wenn die innere Elektronik aufgrund von Abnutzung freiliegt oder wenn die elektronischen Kontakte auf irgendeine Art beschdigt sind. Es bestehen Brandgefahr, Gefahr eines elektrischen Schlags und andere Gefahren. Nicht versuchen, das CADD-Solis-

Kommunikations modul oder den Akku zu zerdrcken. Es bestehen Brandgefahr, Gefahr eines elektrischen Schlags und andere Gefahren. Den Akku des CADD-Solis-

Kommunikationsmoduls nicht durch Verbrennung zerstren. Er kann explodieren. Das Kommunikationsmodul nicht im Beutel der CADD-Solis-Infusionspumpe oder in einem anderen Beutel oder einer Tasche verwenden. Das Kommunikationsmodul knnte sich berhitzen und sich mithilfe des thermischen berlastungsschutzes ausschalten. Mit der nicht ordnungsgemen Entsorgung von Akkus und sonstigen Elektronikteilen sind mgliche Gesundheitsrisiken verbunden. Entsorgen Sie die gebrauchten Akkus und anderes gebrauchtes Zubehr auf umweltvertrgliche, sichere Weise und entsprechend den gltigen Vorschriften. 37 VORSICHTSHINWEISE Keine bermige Kraft aufwenden, um die Kappe des CADD-Solis-Kommunikationsmoduls von der Basis zu trennen. Das Antennenkabel muss sowohl an die Kappe als auch an die Basis angeschlossen bleiben. Das Abtrennen des Antennenkabels kann zu Schden an der Antenne und/oder an der Elektronik des Kommunikationsmoduls fhren. Wird der Akku des CADD-Solis-

Kommunikationsmoduls vor der ersten Verwendung oder aufgrund lngerer Lagerung nicht vollstndig geladen, kann dies zur Tiefenentladung fhren, wodurch ein frhzeitiger Austausch des Akkus notwendig wird. Der USB-Anschluss an der CADD-Solis-

Infusionspumpe dient ausschlielich zur Kommunikation mit der PharmGuard Medication Safety-Software, SureLink Remote Support-

Software und der CADD Solis Network Setup Utility-Software. Es darf ausschlielich untersttztes Zubehr an den USB-Anschluss angeschlossen werden (d. h. es drfen z. B. keine anderen Gerte geladen oder ein drahtloses Dongle angeschlossen werden), da dies die Pumpe beschdigen knnte. Wenn das CADD-Solis-Kommunikationsmodul auerhalb der Umgebungsbedingungen fr den Betrieb und innerhalb der fr die Lagerung angegebenen Umgebungsbedingungen gelagert wird, so muss man das Kommunikationsmodul mindestens eine Stunde vor seiner Verwendung auf Betriebstemperatur aufwrmen bzw. abkhlen lassen, um Schden an den elektronischen Schaltkreisen zu verhindern. 38 ber das CADD-Solis-

Kommunikationsmodul, Modell 2131 Das CADD-Solis-Netzwerkkommunikationssystem

(NCS) besteht aus einer ambulanten CADD-Solis-

Infusionspumpe, Modell 2110 (Softwareversion 4.2 oder hher), mit einem CADD-Solis-Kommunikationsmodul, das fr Ihr Drahtlosnetzwerk und den PharmGuard Server installiert und konfiguriert ist. Nach Installation und ordnungsgemer Konfiguration ermglicht das Kommunikationsmodul, dass die Pumpe drahtlos den Pumpenverlauf an einen PharmGuard Server senden und Pumpen-Firmware und Bibliothek-Updates empfangen kann. Beim Modell 2131 handelt es sich um ein von Modell 2130 aktualisiertes Kommunikationsmodul. Das Funkgert ist robuster, besser gesichert und verschlsselt und es umfasst 20-MHz-Kanal- und Band-Untersttzung. Das CADD-Solis-

Kommunikations modul umfasst das drahtlose Funkgert und einen wiederaufladbaren Akku im Inneren des Moduls. Der Akku versorgt das Kommunikationsmodul mit Strom und bernimmt die Stromversorgung der CADD-Solis-

Pumpe, wenn kein Netzstrom zur Verfgung steht. Der Akku wird immer dann aufgeladen, wenn die Pumpe an den Netzstrom ber das CADD-Solis-Netzteil angeschlossen ist, auch wenn diePumpe ausgeschaltet ist. Das CADD-Solis-Netzteil und das Netzkabel (separat erhltlich) werden verwendet, umdie Pumpe anzuschlieen und den Akku aufzuladen, wenn das Kommunikationsmodul in der CADD-Solis-Pumpe installiert ist. Die CADD-Solis Network Setup Utility-Software

(separat erhltlich) wird verwendet, um die drahtlosen Netzwerkeinstellungen fr eine spezifische Pumpe zu konfigurieren, wenn ein CADD-Solis-

Kommunikationsmodul installiert ist. Informationen zur Nutzung dieser Software finden Sie in den Installationsanweisungen, die zusammen mit der Software zur Verfgung gestellt werden. HINWEIS: Es muss Version 1.1 des Network Setup Utility verwendet werden. WARNUNG: Ein Akku des CADD-Solis-

Kommunikations moduls, dessen Lebensdauer abgelaufen ist, muss durch einen anderen wiederaufladbaren CADD-Solis-Akku ersetzt werden. Verwenden Sie keine Ersatzakkus von anderen Herstellern, da dies zu Explosion oder Feuer fhren knnte. Weitere Informationen finden Sie im Bedienungshandbuch der Pumpe, Alarm Lebensdauer des wiederaufladbaren Akkus ist abgelaufen. WARNUNG: Kein Netzteil direkt an den Akku des CADD-Solis-Kommunikationsmoduls anschlieen. Der direkte Anschluss eines Netzteils knnte gefhrlich sein und den Akku, das Kommunikationsmodul und die Pumpe beschdigen. Installation des CADD-Solis-

Kommunikationsmoduls VORSICHT: Die Installation und Konfiguration des CADD-Solis-Kommunikationsmoduls in einer Pumpe darf nur von Mitarbeitern des technischen Kundendienstes vorgenommen werden. VORSICHT: Vor der Installation des Kommunikationsmoduls an der Pumpe die Pumpe ausschalten und alle Kabel abziehen, die mit der Pumpe verbunden sind, um Schden am Kommunikationsmodul zu vermeiden. VORSICHT: Da bei der Erstinstallation des Kommunikationsmoduls das Modulgehuse geffnet werden muss, darf diese Installation nur an einer Arbeitsstation mit Kontrollen gegen elektrostatische Entladung (ESD), darunter geerdete Matte und Handgelenkband, durchgefhrt werden. 1. Sicherstellen, dass die CADD-Solis-Pumpe ausgeschaltet ist und keine Kabel mehr an die Pumpe angeschlossen sind. 2. Den Knopf an der Batteriefachabdeckung mit den Fingern, dem Pumpenschlssel oder einer Mnze entgegen dem Uhrzeigersinn drehen und den Batteriefachdeckel ffnen. 3. Alle Batterien entfernen, die sich eventuell in der Pumpe befinden. Auerdem sicherstellen, dass sich kein Schmutz im Batteriefach befindet. 4. Die Batterie-

fachabdeckung wie abgebildet zurck ziehen, um sie von der Pumpe zu entfernen. Die Batteriefachabdeckung wird nicht zusammen mit dem CADD-Solis-

Kommunikationsmodul verwendet. Die Batterie-

fachabdeckung an einem zugnglichen Ort aufbewahren, damit die Pumpe spter mitAA-Batterien oder dem wiederaufladbaren Akku fr CADD-Solis verwendet werden kann. 39 5. Die drei Federkontaktstiftisolatoren auf den drei Federkontaktstiften im Batteriefach der Pumpe mssen durch die Isolatoren ersetzt werden, die mit dem Bausatz fr das Kommunikationsmodul zusammen geliefert wurden. Es sind drei Isolatoren notwendig und im Lieferumfang ist noch ein vierter als Ersatz enthalten. Die Originalisolatoren entsorgen. Mit einer Pinzette vorsichtig die drei originalen Federkontaktstiftisolatoren entfernen, siehe Abbildung. Federkontakt-

stiftisolator 6. Die drei neuen Federkontaktstiftisolatoren installieren, die im Lieferumfang des Kommunikationsmoduls enthalten sind. 40 7. Sicherstellen, dass die drei neuen Federkontaktstiftisolatoren vollstndig um die Kontaktstifte herum sitzen. HINWEIS: Die drei neuen Federkontaktstiftisolatoren sind auch mit AA-Batterien und dem wiederaufladbaren Akku von CADD-Solis kompatibel. Die originalen Federkontaktstiftisolatoren entsorgen, da sie nicht mehr gebraucht werden. 8. Der wiederaufladbare Akku innerhalb des Kommunikationsmoduls ist nicht angeschlossen und muss im Inneren angeschlossen werden. Um auf die Batterie zuzugreifen und sie anzuschlieen, die beiden Schrauben unter der Kappe des Kommunikationsmoduls mit einem sternfrmigen 10-IP-

Schraubenzieheraufsatz herausdrehen. WARNUNG: Um mgliche Verletzungen und Schden zu verhindern, die Kappe des Kommunikationsmoduls nicht entfernen, whrend sie noch an der Pumpe installiert und damit verbunden ist; auerdem drfen die elektronischen Kontakte des Kommunikationsmoduls nicht gleichzeitig ein Stck Metall (z. B. eine Mnze oder eine Broklammer) berhren. 9. Die Kappe sanft von der Basis des Kommunikationsmoduls abheben und dabei darauf achten, dass sich das Antennenkabel nicht von der Kappe oder der Basis lst; dann den Akkustecker in die Akkubuchse auf der Leiterplatine des Kommunikationsmoduls stecken. 41 VORSICHT: Keine bermige Kraft aufwenden, um die Kappe des Kommunikationsmoduls von der Basis zu trennen. Das Antennenkabel muss sowohl an die Kappe als auch an die Basis angeschlossen bleiben. Das Abtrennen des Antennenkabels kann zu Schden an der Antenne und/oder an der Elektronik des Kommunikationsmoduls fhren. 10. Die Kappe des Kommunikationsmoduls auf die Basis setzen und dabei sicherstellen, dass das Antennenkabel vollstndig im Kommunikationsmodul verstaut ist. 11. Die beiden sternfrmigen Schrauben unter der Kappe des Kommunikationsmoduls anbringen und mit dem sternfrmigen 10-IP-

Schraubenzieheraufsatz anziehen, bis sie fest sitzen, und dann nochmal etwa 1/8 Drehung

(45Grad) weiter anziehen. Nicht zu fest anziehen. WARNUNG: Sicherstellen, dass die Dichtungen um den Umfang der Modulkappe herum und die Schraubenlcher nicht verloren gehen oder beschdigt werden, wenn das Modul geffnet oder geschlossen wird. Diese O-Ring-Dichtungen sind notwendig gegen Eindringen von Wasser und fr den Schutz vor ESD. 42 Kappe des Kommunikations-modulsBasis des KommunikationsmodulsAntennenkabelAkkusteckerAkkubuchse 12. Das Kommunikationsmodul ins Pumpen batteriefach einsetzen. Die Unterseite des Halterungsadapters an die Unterseite der Pumpe hngen und dann die Oberseite des Halterungsadapters auf der Basis des Moduls einrasten lassen. HINWEIS: Die Zhne am Halterungsadapter an der Aussparung am Pumpengehuse ausrichten. Halterungsadapter Ausrichtungs-

zhne Aussparungen an der Pumpe 13. Die Schraube mit einem CADD-Solis-

Pumpenschlssel, einem normalen Schraubenzieher oder einer Mnze anziehen, um den Halterungsadapter anzubringen und das Kommunikationsmodul an der Pumpe zu befestigen. Die Schraube anziehen, bis sie vollstndig sitzt, unddann noch einmal um etwa 1/8 Drehung

(45 Grad) anziehen. Nicht zu fest anziehen. 14. Vor dem Konfigurieren der Pumpe und ihrer ersten Verwendung muss das Kommunikationsmodul vollstndig aufgeladen werden. Weitere Informationen zum Laden des wiederaufladbaren Akkus im CADD-Solis-Kommunikationsmodul finden sich im nchsten Abschnitt. 15. Wenn das CADD-Solis-Kommunikationsmodul zum ersten Mal in einer spezifischen Pumpe installiert wird, mssen die Drahtlos-Einstellungen fr die Pumpe mithilfe der CADD-Solis Network Setup Utility-Software konfiguriert werden

(separat erhltlich). Weitere Informationen siehe Dokumentation im Lieferumfang der Network Setup Utility-Software. Laden des wiederaufladbaren Akkus Der Akku des Kommunikationsmoduls wird immer dann aufgeladen, wenn die CADD-Solis-Pumpe ber das CADD-Solis-Netzteil an den Netzstrom angeschlossen ist, auch wenn die Pumpe ausgeschaltet ist. Innerhalb des Temperaturbereichs von 2C bis40C

(35F bis 104F) ist der Akku nach sptestens 10Stunden voll aufgeladen. Der Akku ist vollstndig aufzuladen:

vor der ersten Verwendung mindestens alle 30 Tage bei regelmiger Verwendung mindestens einmal alle 6 Monate whrend der Lagerung wenn die Pumpe anzeigt, dass der Akkustand niedrig oder leer ist VORSICHT: Wird der Akku aufgrund lngerer Lagerung nicht geladen, kann dies zur Tiefenentladung fhren, wodurch ein frhzeitiger Austausch des Akkus notwendig wird. 43 VORSICHT: Um Schden am Netzteilstecker oder an der Pumpe zu vermeiden, keine bermige Kraft oder Instrumente wie Zangen verwenden, um den Netzteilstecker anzubringen bzw. abzuziehen. Aufladen des Akkus:

1. Das Netzkabel des CADD-Solis Netzteils in eineSteckdose stecken und das andere Ende indas Netzteil. 2. Den Netzteilstecker in die Netzstrombuchse

(mitder Aufschrift 7V) an der CADD-Solis-Pumpe stecken. Bei korrektem Anschluss leuchtet das blaue Licht neben dem Stecker an der Pumpe auf. WARNUNG: Kein Netzteil direkt an den Akku des CADD-Solis-Kommunikationsmoduls anschlieen. Der direkte Anschluss eines Netzteils knnte gefhrlich sein und den Akku, das Kommunikationsmodul und die Pumpe beschdigen. VORSICHT: Wenn der Ausgangsstecker des Netzteils nicht vollstndig in die Pumpe eingefhrt wird, kann dies zu einer intermittierenden Verbindung fhren und der Stecker kann sich lsen, wodurch die Stromversorgung unterbrochen und der Akku nicht weiter geladen wird. 44 3. Wenn die Pumpe eingeschaltet wird, zeigt die Pumpenstatusleiste kurz Netzteil angeschlossen an. 4. Wenn die Pumpe eingeschaltet wird, zeigt die Pumpenstatusleiste an, dass die Pumpe mit Netzstrom versorgt wird. Eine kleine Steckeranzeige wird rechts neben dem Batteriesymbol angezeigt. 5. Wenn die Pumpe eingeschaltet wird, kann der geschtzte Akkustand aus der Statusleiste der Pumpenanzeige abgelesen werden. Weitere Informationen sind dem Bedienungshandbuch derPumpe zu entnehmen. Wenn der Akku vollstndig geladen ist, kann der Netzteilstecker abgezogen werden. Die Meldung Netzteilentfernt wird kurz nach dem Abziehen des Steckers angezeigt. Konfigurieren der Drahtlos-Einstellungen mit der CADD-Solis Network Setup Utility-Software Alle Drahtlos-Einstellungen fr die Pumpe und das CADD-Solis Kommunikationsmodul werden mit der CADD-Solis Network Setup Utility-Software

(separat erhltlich) konfiguriert, und zwar ber eineUSB-Verbindung zwischen einem PC und derCADD-Solis-Pumpe. Mit der CADD-Solis Network Setup Utility-

Software knnen alle Drahtlos-Einstellungen zur Konfiguration an Ihren Drahtlos-Zugriffspunkten und Ihrem PharmGuard Server ausgewhlt und eingegeben werden. Diese Einstellungen knnen auf der CADD-Solis-Pumpe gespeichert werden. Wenn ein CADD-Solis-Kommunikationsmodul an der Pumpe ausgetauscht wird, nutzt das neue Kommunikationsmodul darum automatisch die vorkonfigurierten Drahtlos-Einstellungen der Pumpe. Weitere Informationen siehe Dokumentation im Lieferumfang der CADD-Solis Network Setup Utility-Software. Ein- und Ausschalten desWLAN Wenn das CADD-Solis-

Kommunikations-

modul installiert ist, kann sein WLAN nach Bedarf ein- und ausgeschaltet werden (z. B. Ausschalten, um Akkulaufzeit zu verlngern usw.). Dies kann jederzeit ber das Men Optionen auf dem Pumpenbildschirm ohne Unterbrechen der klinischen Funktionen der Pumpe, wie z. B. eine laufende Infusion, erfolgen. Weitere Informationen siehe Bedienungshandbuch derPumpe. Anzeigen des WLAN-Status und der Einstellungen Whrend mit der CADD-Solis Network Setup Utility-

Software die Drahtlos-Einstellungen angezeigt und gendert werden knnen, sind der WLAN-Status und die Einstellungen ebenfalls auf dem Bildschirm der CADD-Solis-Pumpe sichtbar. Der WLAN-Status wird auf dem Hauptbildschirm der Pumpe angezeigt:

WLAN aus (weie Anzeige) WLAN ein, mit keinem WLAN-Zugangspunkt verbunden (orangefarbene Anzeige) WLAN ein, mit einem WLAN-Zugangspunkt verbunden (orangefarbene Anzeige mit grnem Mittelpunkt) WLAN ein, mit einem WLAN-Zugangspunkt verbunden und Kommunikation mit PharmGuard Server hergestellt (grne Anzeige mit grnem Mittelpunkt) Auerdem knnen der WLAN-Status und die Drahtlos-Einstellungen im Detail angezeigt werden. Im Pumpenmen Reporte Status drahtlose Verbindung oder Einstellungen drahtlose Verbindung auswhlen. Zum Anzeigen der Version und der MAC-Adresse des Kommunikationsmoduls Gerteinformationen aus dem Men Reporte auswhlen. Weitere Informationen siehe Bedienungshandbuch der Pumpe. 45 Fehlerbehebung Problem Der wiederaufladbare Akku ldt sich nichtauf. Der wiederaufladbare Akku ist voll geladen, aber funktioniert nicht in der Pumpe. WLAN ist eingeschaltet und das Symbol fr den WLAN-Status der Pumpe zeigt an WLAN ein, mit keinem WLAN-Zugangspunkt verbunden

(orangefarbene Anzeige). Wahrscheinliche Ursache/Lsung Eventuell ist der Netzteilstecker nicht vollstndig in den Anschluss an der Pumpe gesteckt. DenNetzteilstecker vollstndig in die Pumpe stecken. Der Akku ist eventuell zu hei oder zu kalt. Sicherstellen, dass die Umgebungsbedingungen denfr den Betrieb angegebenen Spezifikationen entsprechen. Die drei Federkontaktstiftisolatoren zum Ersatz sind nicht oder falsch installiert. Eventuell besteht ein Problem mit dem Kontakt zwischen der Pumpe und dem Kommunikationsmodul. Sicherstellen, dass die Kontaktstellen am Kommunikationsmodul sauber sind. Sicherstellen, dass das Batteriefach und die Kontakte an der Pumpe sauber sind. Das Kommunikationsmodul in einer anderen Pumpe ausprobieren. Wenn es in einer zweiten Pumpe funktioniert, besteht wahrscheinlich ein Problem mit der ersten Pumpe. Wenn das Kommunikationsmodul auch in einer zweiten Pumpe nicht funktioniert, besteht wahrscheinlich ein Problem mit dem Kommunikationsmodul und/oder dem Akku. Setzen Sie sich mit dem Kundendienst von Smiths Medical in Verbindung. Das Kommunikationsmodul befindet sich eventuell im Wrmereduktions-Modus, siehe Bedienungshandbuch der Pumpe. Die Drahtlos-Einstellungen sind falsch konfiguriert. Einstellungen prfen und/oder konfigurieren. Das Kommunikationsmodul befindet sich zu weit weg von einem WLAN-Zugangspunkt. Nher an Die Pumpe schaltet die WLAN-Funktion automatisch wegen eines niedrigen Akkustandes aus. Die Das Kommunikationsmodul befindet sich in der Nhe einer laufenden Mikrowelle. Von der einen Zugangspunkt bewegen. Pumpe an ein Netzteil anschlieen. Mikrowelle entfernen. Pumpenalarme in Verbindung mit dem Kommunikationsmodul Akku fast leer. Akku ersetzen. Der wiederaufladbare Akku nhert sich dem Ende seiner Lebensdauer. Er wurde so oft entladen undwieder aufgeladen, dass er bald keine volle Aufladung mehr erreicht. In diesem Zustand knnen Sie ihn evtl. weiter benutzen. Die Lebensdauer des wiederaufladbaren Akkus ist abgelaufen. Pumpe startet nicht. Der wiederaufladbare Akku der CADD-Solis-Kommunikationsmoduls befindet sich am Ende seiner Lebensdauer. Er wurde so oft entladen und wieder aufgeladen, dass er keine volle Aufladung mehr erreicht. Durch einen neuen wiederaufladbaren Akku fr das CADD-Solis-Kommunikationsmodul ersetzen. Der Akku ist nicht mit der Pumpe kompatibel oder es ist ein Kommunikationsfehler aufgetreten. Weitere Informationen siehe Bedienungshandbuch der Pumpe. Die Verbindung zwischen dem Kommunikationsmodul und der Pumpe wird unterbrochen. Weitere Informationen siehe Bedienungshandbuch der Pumpe. Akku nicht brauchbar. Pumpe startet nicht. Unterbrochene Verbindung zwischen Kommunikationsmodul und Pumpe 46 Transport Das Kommunikationsmodul wurde entsprechend den Transportvorschriften der Vereinten Nationen, UN/DOT ST/SG/AC.10/11 (Rev. 5) Abschnitt 38.3 Prfanforderungen T1-T5, T7, geprft und erfllt diese. Entsorgung/Getrennte Sammlung Der wiederaufladbare Akku des Kommunikationsmoduls sollte vor der Entsorgung vollstndig entladen und/oder seine Anschlsse mit Klebeband abgeklebt oder abgedeckt sein, um einen Kurzschluss zu verhindern. Auerhalb der EU muss dieses Produkt entsprechend den lokal geltenden Richtlinien und Verordnungen entsorgt oder recycelt werden. Getrennt sammeln Dieses Produkt enthlt elektrische und elektronische Komponenten, die Materialien enthalten, welche bei der Entsorgung mit allgemeinen Abfllen schdlich fr die Umwelt sein knnten. Gem Richtlinie 2002/96/EG ber Elektro- und Elektronik-Altgerte mssen Einwohner der Europischen Union spezifische Entsorgungs- und Recyclinganweisungen fr dieses Produkt befolgen. Detaillierte Informationen knnen Sie bei Ihrer lokalen Vertretung oder auf der folgenden Internetseite erhalten:

http://www.smiths-medical.com/recycle/index.html WARNUNG: Mit der nicht ordnungsgemen Entsorgung von Akkus und sonstigen Elektronikteilen sind mgliche Gesundheitsrisiken verbunden. Entsorgen Sie die gebrauchten Akkus und anderes gebrauchtes Zubehr auf umweltvertrgliche, sichere Weise und entsprechend den gltigen Vorschriften. REACH-Informationen Im Rahmen der EU-Verordnung zur Registrierung, Bewertung, Zulassung und Beschrnkung chemischer Stoffe (REACH-Verordnung EG Nr. 1907/2006) mssen Unternehmen ihren Kunden offenlegen, ob ein Produkt einen Stoff enthlt, der im Verzeichnis der fr eine Einbeziehung in das Zulassungsverfahren in Frage kommenden Stoffe aufgefhrt ist (auch bekannt als besonders besorgniserregende Stoffe, SVHC), in einer Konzentration ber 0,10% Anteil am Gewicht. Die Erklrungen von Smiths Medical zu diesen SVHVs in Produkten finden sich unter: www.smiths-medical.com/

environment Zertifizierung gem Teil 15 Dieses Gert erfllt Teil 15 der Regeln der US-amerikanischen Bundesbehrde Federal Communications Commission (FCC Rules). Der Betrieb unterliegt den folgenden beiden Bedingungen: (1) Dieses Gert darf keine schdlichen Strungen verursachen, und (2) dieses Gert muss alle empfangenen Strungen akzeptieren, einschlielich Strungen, die einen unerwnschten Betrieb verursachen knnen. Reinigung und Desinfektion des Kommunikationsmoduls Fr eine optimale Wirksamkeit wird empfohlen, die Reinigung vor der Desinfektion durchzufhren. Bei Verwendung von Desinfektionsmitteln ist stets eine Vorreinigung erforderlich. Davon ausgenommen sind Desinfektionsreiniger, die bei 5 % organischer Substanz wirksam sind. VORSICHT: Das Kommunikationsmodul nicht in Reinigungsflssigkeit oder Wasser tauchen. Verhindern, dass die Lsung in das Kommunikationsmodul eindringt. Wenn sich innerhalb des Kommunikationsmoduls Feuchtigkeit ansammelt, kann das Gert beschdigt werden. Die freiliegenden Oberflchen des Kommunikationsmoduls abwischen, whrend es in der Pumpe installiert ist. 47 Zulssige Desinfektionslsungen fr das CADD-Solis-

Kommunikationsmodul sind nachfolgend aufgelistet. Produkt Hersteller

(EPA-

Registrie-

rungsnummer) CaviWipes Sani-Cloth Super Metrex

(46781-8) PDI (9480-4) Einwirk-/

Abt-

tungszeit 3 Minuten 2 Minuten Wirk-

substanz(en) 17,2 % Isopro-

panol Dimethylben-

zylammoni-

umchlorid, Dimethylethyl-

benzylammoni-

umchlorid Sani-Cloth Bleach PDI (9480-8) 0,60 % Natrium-

hypochlorit 4 Minuten 3. Vor dem Gebrauch das Kommunikationsmodul vollstndig trocknen lassen. VORSICHT: Um Schden an der internen Elektronik des Kommunikationsmoduls zu verhindern, die Lsung nicht in den elektronischen Kontaktbereich oder in ffnungen und Fugen eindringen lassen. Die elektronischen Kontakte und den umliegenden Bereich, der normalerweise bei Installation in der Pumpe verschlossen ist, nur mit einem trockenen, fusselfreien Tuch reinigen. Die folgenden Schritte knnen zum Reinigen und Desinfizieren des Kommunikationsmoduls verwendetwerden:

1. Das Kommunikationsmodul mit einer milden Seifenlsung reinigen, um Rckstnde oder kontaminiertes Material zu entfernen. Die Lsung auf ein weiches, fusselfreies Tuch auftragen und die freiliegenden Oberflchen des Kommunikationsmoduls abwischen, whrend es an der Pumpe installiert ist. Verhindern, dass die Lsung in die Pumpe oder das Kommunikationsmodul eindringt. 2. Das Kommunikationsmodul desinfizieren, indem eine Desinfektionslsung (unten aufgefhrt) entsprechend der auf dem Produktetikett befindlichen Desinfektionsanleitung aufgetragen wird. Bei Verwendung einer Flssigkeit oder eines Sprays die Lsung auf ein weiches, fusselfreies Tuch auftragen und damit das Kommunikationsmodul abwischen. Die Empfehlungen des Desinfektionsmittelherstellers zu den Einwirkzeiten des Desinfektionsmittels beachten. Verhindern, dass die Lsung in die Pumpe oder das Kommunikationsmodul eindringt. 48 Technische Angaben Akkutyp Wiederaufladbarer Lithium-Ionen-Akku (2 Zellen) quivalenter Lithiumgehalt <1,6g Laufzeit von Pumpe und Kommunikationsmodul

(neuer Akku) 4 Stunden bei Nenneinstellung der Pumpe

(siehe Bedienungshandbuch der Pumpe fr Informationen zu den Nenneinstellungen) Akkukapazitt Sicherheit 18,7Wh (in vollstndig geladenem Zustand) Akkuausgang 3,6V (Nennwert) Akkugewicht

<100g Anforderungen an die Betriebsumgebung Temperatur . 2C bis 40C

(35F bis 104F) Feuchtigkeit . 20% bis90% relative Luftfeuchtigkeit, nicht kondensierend Luftdruck . 70kPa bis 106kPa

(10,2psia bis 15,4psia) Anforderungen an Lager- und Transportumgebung Temperatur . 20C bis 60C

(4F bis 140F) Feuchtigkeit . 20% bis 90% relative Luftfeuchtigkeit, nicht kondensierend Luftdruck . 70kPa bis 106kPa

(10,2psia bis 15,4psia) Lebensdauer des Produktakkus 400 volle Zyklen (Laden/Entladen) bei Raumtemperatur, 23C (73F) Maximale Ladezeit (vollstndig entladener Akku bis vollstndig geladen) 10 Stunden bei Anschluss an das Netzteil Das Kommunikationsmodul erfllt die Normen Underwriters Laboratories UL 2054, IEC 60601-1

(2005 + A1:2012) Ed 3.1 [bei Installation in der CADD-Solis Infusionspumpe, Modell 2110], IEC60601-1-2 (2014) und IEC 62133 (2002). Die Lithium-Ionen Zellen erfllen die Norm Underwriters Laboratories UL 1642. IEEE 802.11 a,b,g,n Funk fr Netzwerkkommunikation Das CADD-Solis-Kommunikationsmodul empfngt und sendet absichtlich hochfrequente (HF) elektromagnetische Energie fr nicht kritische Kommunikation. HF-Senden/Empfangen, Band a . 5180MHz bis 5320MHz und 5500MHz bis 5825MHz HF-Senden/Empfangen, Bnder b, g und n ................................... 2412MHz bis 2472MHz Bandbreite der Signale a, b, g und n ..........................................20MHz Maximale HF-Sendeleistung von Band a ....................................................10mW Maximale HF-Sendeleistung von Bndern b, g und n ......................100mW 49 Drahtlose Reichweite des Kommunikationsmoduls:

36,58Meter (120Fu) (Betrieb durch Sichtverbindung mit Zugangspunkt) Netzwerkmodi und Verschlsselung Netzwerkmodi:

Verschlsselungsmodi:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Keine TKIP CCMP TKIP/CCMP Authentifizierungsmodi: EAP-Modi:

OPEN WPA-ENT WPA2-ENT WPA-PSK Keine EAP-TLS (v1.0 und v1.2) EAP-TTLS WPA2-PSK EAP-PEAPV0 (PEAP mit MS-CHAPv2) EAP-PEAPV1 (PEAP mit GTC) EAP-LEAP EAP-FAST Zertifikate:

SSL SHA-1 SSL SHA-2 Hinweis: Das Kommunikationsmodul kann durch andere Gerte gestrt werden, selbst wenn dieses andere Gert die Anforderungen von CISPR 11 erfllt. Weitere Netzwerkspezifikationen und Einrichtungsinformationen fr das CADD-Solis-

Kommunikationsmodul sind der Installations- und Bedienungsanleitung des Network Setup Utility

(Version 1.1) zu entnehmen. Strungen/Schutzabstand Andere elektronische Kommunikationsgerte, die sich in der Nhe des Kommunikationsmoduls befinden, knnen zu einer unterbrochenen Datenbertragung fhren. Eine unterbrochene Datenbertragung beeintrchtigt nicht die Pumpenzufuhr. In der Tabelle unten ist angegeben, welche Auswirkungen welche Art von Gert verursacht und welcher Mindestabstand eingehalten werden sollte. Strer (Art des elektronischen Gerts) Drahtlose Sendestationen von 2,4GHz/5GHz (z.B. Wi-Fi-

Zugangspunkte, drahtlose Telefonbasisstationen) Drahtlose Medizinprodukte und andere Peripheriegerte von 2,4GHz/5GHz (z. B. Patienten monitore mit aktiviertem Wi-Fi, Infusionspumpen, Computer/Smartphones/Tablets, Gerte mit aktiviertem Bluetooth, Gerte mit aktiviertem Zigbee, drahtlose Telefonhrer) Andere CADD-Solis-Pumpen von Smiths Medical mit Drahtlosverbindung RFID-Tags zur Standortbestimmung 433MHz/2,4GHz/5GHz 50 Empfohlener Mindestab-

stand 3 Meter

(9,84Fu) 1 Meter

(3,28Fu) 0,3 Meter

(1Fu) Direkter Kontakt Eingeschrnkte Gewhrleistung Gewhrleistung: Smiths Medical ASD, Inc. (Hersteller) gewhrleistet gegenber dem ursprnglichen Kufer fr die Dauer von einem (1) Jahr ab dem effektiven Datum des Verkaufs an diesen, dass alle Teile und Komponenten des CADD-Solis-Kommunikationsmoduls

(Kommunikationsmodul), die vom oder fr den Hersteller hergestellt werden, mit Ausnahme der unten aufgefhrten Artikel, bei normaler Verwendung keine Mngel hinsichtlich Material oder Verarbeitung aufweisen, wenn sie gem dieser Gebrauchsanweisung eingesetzt werden. ESWERDEN KEINE ANDEREN GEWHRLEISTUNGEN GEGEBEN. Ausnahmen: Diese Gewhrleistung bezieht sich nicht auf den blichen Verschlei und auf Wartungs- bzw. Ersatzteile und schliet ausdrcklich alle anderen Zubehrteile und Gerte, die zusammen mit dem Kommunikationsmodul verwendet werden, aus. Verfahren der Gewhrleistung: Gem den Bedingungen dieser eingeschrnkten Gewhrleistung und bei Einhaltung ihrer Bedingungen repariert oder ersetzt der Hersteller nach seinem Ermessen kostenlos (mit Ausnahme einer geringen Porto- und Bearbeitungsgebhr) jedes Kommunikationsmodul

(ausgenommen Zubehr), das defekt ist, sofern ein Anspruch in der genannten Frist von einem Jahr erhoben wird. Senden Sie KEIN Kommunikationsmodul oder eine seiner Komponenten beim Hersteller zur Reparatur im Rahmen der Gewhrleistung ein, ohne vorher die spezifischen Informationen zur Weiterleitung vom Kundendienst erhalten zu haben. B e d i n g u n g e n : F o l g e n d e B e d i n g u n g e n , Einschrnkungen und Ausnahmen gelten fr die Gewhrleistungsverpflichtung des Herstellers:

A. Erlschen der Gewhrleistung: Die Gewhrleistung ist null und nichtig, wenn das Kommunikationsmodul bzw. eines seiner Teile oder Komponenten (1) von einer anderen Stelle als dem Hersteller oder seinem bevollmchtigten Vertreter repariert wurde,

(2) so verndert wurde, dass seine Stabilitt oder Zuverlssigkeit beeintrchtigt ist, (3) unsachgem verwendet wurde oder (4) durch Fahrlssigkeit oder ein Missgeschick beschdigt wurde. Unsachgemer Gebrauch bedeutet u. a. einen Gebrauch abweichend von der Gebrauchsanweisung des Kommunikationsmoduls oder in Verbindung mit unzulssigen Zubehrteilen. B. Einschrnkungen und Ausschlsse: Ersatz des Kommunikationsmoduls oder eines seiner Bestandteile ist die EINZIGE vom Hersteller angebotene Abhilfe. Alle durch den Hersteller bereitgestellten Empfehlungen, Informationen sowie beschreibende Literatur zum Kommunikationsmodul gelten als genau und zuverlssig, stellen aber keine Gewhrleistung dar. Kein Vertreter, Auendienstmitarbeiter oder Angestellter des Herstellers ist bevollmchtigt, den Hersteller an eine Zusicherung oder Gewhrleistung, ausdrcklich oder stillschweigend, zu binden. DIE MARKTGNGIGKEIT ODER TAUGLICHKEIT DES KOMMUNIKATIONSMODULS FR EINEN BESTIMMTEN ZWECK IST NICHT TEIL DIESER GEWHRLEISTUNG. DER HERSTELLER SCHLIESST DIE VERANTWORTUNG FR DIE EIGNUNG DES KOMMUNIKATIONSMODULS FR EINE BESTIMMTE RZTLICHE THERAPIE BZW. FR EINE MEDIZINISCHE KOMPLIKATION AUS, DIE SICH AUS DEM EINSATZ DES KOMMUNIKATIONSMODULS ERGEBEN KANN. DER HERSTELLER BERNIMMT K E I N E V E R A N T W O R T U N G F R J E G L I C H E FOLGESCHDEN ODER NEBENSCHDEN AN EIGENTUM, GEWINNVERLUSTE ODER ENTGANGENEN NUTZEN AUFGRUND JEGLICHEN DEFEKTS ODER JEGLICHER FUNKTIONSSTRUNG DES KOMMUNIKATIONSMODULS. Diese Gewhrleistung gibt dem ursprnglichen Kufer besondere gesetzliche Rechte, wobei der ursprngliche Kufer sonstige gesetzliche Rechte haben kann, die von Staat zu Staat variieren knnen. 51 0 Italian / Italiano Sommario English . 4 French / Franais . 20 German / Deutsch . 36 Avvertenze . 53 Precauzioni . 54 Informazioni sul modulo di comunicazione CADD-Solis, modello 2131 . 54 Installazione del modulo di comunicazione CADD-Solis . 55 Caricamento della batteria ricaricabile . 59 Configurazione delle impostazioni wireless tramite il software Network Setup Utility CADD-Solis . 60 Accensione/Spegnimento della radio wireless . 61 Visualizzazione dello stato e delle impostazioni wireless . 61 Risoluzione dei problemi . 62 Trasporto . 63 Smaltimento / Raccolta differenziata . 63 Informazioni REACH . 63 Certificazione Parte 15 . 63 Pulizia e disinfezione del modulo di comunicazione . 63 Specifiche . 65 Garanzia limitata . 67 Spanish / Espaol . 68 Portuguese / Portugus . 84 Dutch / Nederlands . 100 Swedish / Svenska . 116 Danish / Dansk . 132 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 52 IMPORTANTE: la batteria ricaricabile, nel modulo di comunicazione CADD-Solis, deve essere collegata internamente e caricata completamente allinterno della pompa prima di mettere in funzione il sistema. Rivedere e seguire le istruzioni incluse in questo Manuale delloperatore per installare e caricare la batteria prima delluso. Leggere tutte le istruzioni prima di installare il modulo di comunicazione CADD-Solis nella pompa per infusione ambulatoriale CADD-Solis, modello 2110. Conservare queste istruzioni per riferimenti futuri. Per istruzioni dettagliate, avvertenze, specifiche e ulteriori informazioni per il funzionamento della pompa per infusione ambulatoriale CADD-Solis, fare riferimento al Manuale delloperatore della pompa. Per istruzioni dettagliate, avvertenze, specifiche e ulteriori informazioni per lutilizzo delladattatore CA CADD-Solis, fare riferimento alle Istruzioni per luso fornite con il prodotto. AVVERTENZE Per evitare gravi lesioni personali, fondamentale osservare le seguenti avvertenze:

Non esporre il modulo di comunicazione a pioggia, acqua o umidit. Esiste il rischio di scossa elettrica o di altro tipo. Non immergere la batteria ricaricabile del modulo di comunicazione CADD-Solis nel liquido. Esiste il rischio di scossa elettrica o dialtro tipo. Non usare la batteria ricaricabile del modulo di comunicazione CADD-Solis con alcun dispositivo, ma solo con il modulo di comunicazione CADD-Solis. Non collegare alcun adattatore CA direttamente alla batteria ricaricabile del modulo di comunicazione CADD-Solis. Collegare direttamente gli adattatori CA potrebbe essere pericoloso e danneggiare la batteria ricaricabile, il modulo di comunicazione e la pompa. Una batteria ricaricabile del modulo di comunicazione CADD-Solis che ha raggiunto il termine della sua vita utile deve essere sostituita con unaltra batteria ricaricabile per modulo di comunicazione CADD-Solis. Se si utilizzano batterie ricaricabili di altri produttori si corre il rischio di incendio o di esplosione. Non lasciare che i contatti elettronici del modulo di comunicazione tocchino contemporaneamente un componente di metallo (ad esempio una moneta o una graffetta). Non utilizzare il modulo di comunicazione CADD-Solis se stato danneggiato, se i componenti elettronici interni sono esposti a causa dellusura o se i contatti elettronici sono in qualche modo danneggiati. Esiste il rischio di incendio, scossa elettrica o di altro tipo. Non tentare di schiacciare il modulo di comunicazione CADD-Solis o la batteria ricaricabile. Esiste il rischio di incendio, scossa elettrica o di altro tipo. Non distruggere la batteria ricaricabile del modulo di comunicazione CADD-Solis tramite incinerazione. Potrebbe esplodere. Non usare il modulo di comunicazione nella custodia della pompa per infusione CADD-

Solis o in altre custodie o sacche. Il modulo di comunicazione potrebbe surriscaldarsi espegnersi utilizzando il circuito di protezione termica. Esistono rischi potenziali per la salute associati a uno smaltimento non corretto delle batterie e di altri componenti elettronici. Smaltire le batterie usate e gli altri accessori usati in conformit alle normative vigenti in materia ambientale. 53 PRECAUZIONI Non esercitare una forza eccessiva quando si separa il tappo del modulo di comunicazione CADD-Solis dalla base. Il cavo dellantenna deve rimanere attaccato sia al tappo che alla base. Lo scollegamento del cavo dellantenna potrebbe danneggiare lantenna e/o le componenti elettroniche del modulo di comunicazione. Il mancato caricamento completo della batteria ricaricabile del modulo di comunicazione CADD-

Solis prima delluso iniziale e durante lunghi periodi di inattivit pu causarne il completo esaurimento e rendere necessaria la sostituzione prima del dovuto. La porta USB sulla pompa per infusione CADD-

Solis prevista per la comunicazione solo con il PharmGuard Medication Safety Software, ilSureLink Remote Support Software e il software CADD Solis Network Setup Utility. Non collegare accessori non supportati alla porta USB (ad es. caricamento di altri dispositivi, collegamento di un dongle wireless) poich tale operazione potrebbe danneggiare la pompa. Se il modulo di comunicazione CADD-Solis viene conservato fuori dalle condizioni operative ambientali e allinterno delle condizioni ambientali di conservazione specificate, lasciare che il modulo di comunicazione si riscaldi o si raffreddi alla temperatura operativa per almeno unora prima delluso per evitare di danneggiare il circuito elettronico. 54 Informazioni sul modulo di comunicazione CADD-Solis, modello 2131 Il CADD-Solis Network Communication System (NCS) formato da una pompa per infusione ambulatoriale CADD-Solis, modello 2110 (software versione 4.2 o successiva), con un modulo di comunicazione CADD-Solis installato e configurato per la rete wireless e il PharmGuard Server. Se installato e configurato correttamente, il modulo di comunicazione consente alla pompa di inviare via wireless lo storico pompa ad un PharmGuard Server e di ricevere gli aggiornamenti firmware e della libreria per la pompa. Il modello 2131 un modulo di comunicazione aggiornato dal modello 2130. La radio pi resistente, con una maggiore sicurezza e una migliore crittografia, e incorpora un supporto di banda n per canale da 20MHz. Il modulo di comunicazione CADD-Solis include al suo interno la radio wireless e una batteria ricaricabile. La batteria alimenta il modulo di comunicazione e fornisce alimentazione alla pompa CADD-

Solis quando lalimentazione CA non subito disponibile. La batteria ricaricabile si carica ogni qualvolta la pompa viene collegata ad unalimentazione CA tramite ladattatore CA CADD-Solis, anche se la pompa spenta. Ladattatore CA CADD-Solis e il cavo di alimentazione

(disponibile separatamente) vengono usati per il collegamento alla pompa per ricaricare la batteria quando il modulo di comunicazione installato nella pompa CADD-Solis. Il software CADD-Solis Network Setup Utility

(disponibile separatamente) viene usato per configurare le impostazioni di rete wireless per la pompa specifica quando si installa un modulo di comunicazione CADD-Solis. Per informazioni sullutilizzo di questo software, fare riferimento alle istruzioni di installazione fornite con il software. NOTA: utilizzare la versione 1.1 del software Network Setup Utility. AVVERTENZA: una batteria ricaricabile del modulo di comunicazione CADD-Solis che ha raggiunto il termine della sua vita utile deve essere sostituita con unaltra batteria ricaricabile CADD-Solis. Nonusare batterie di ricambio di altri produttori poich si corre il rischio di incendio o di esplosione. Per ulteriori informazioni, fare riferimento al Manuale delloperatore della pompa, allarme Batteria ricaricabile definitivamente esaurita. AVVERTENZA: non collegare alcun adattatore CA direttamente alla batteria ricaricabile del modulo di comunicazione CADD-Solis. Collegare direttamente gli adattatori CA potrebbe essere pericoloso e danneggiare la batteria ricaricabile, ilmodulo di comunicazione e la pompa. Installazione del modulo di comunicazione CADD-Solis ATTENZIONE: linstallazione e la configurazione del modulo di comunicazione CADD-Solis in una pompa devono essere eseguite esclusivamente dal personale di assistenza. ATTENZIONE: per evitare danni al modulo di comunicazione, spegnere la pompa e scollegare tutti i cavi collegati alla pompa prima di installare il modulo di comunicazione nella pompa. ATTENZIONE: poich linstallazione iniziale del modulo di comunicazione richiede lapertura dellalloggiamento del modulo, questa installazione deve essere eseguita esclusivamente in una workstation dotata di controlli per scariche elettrostatiche (ESD), compresi un tappeto e un braccialetto antistatici. 1. Accertarsi che la pompa CADD-Solis sia spenta e che non vi siano cavi collegati alla pompa. 2. Aprire lo sportello del vano batterie ruotando in senso antiorario il pomello sullo sportello utilizzando le dita, la chiave della pompa o unamoneta. 3. Rimuovere le batterie che possono essere nella pompa. Inoltre, verificare che non vi siano residui nel vano batteria. 4. Tirare indietro lo sportello batteria, come mostrato, per rimuoverlo dalla pompa. Lo sportello batteria non viene usato con il modulo di comunicazione CADD-Solis. Tenere lo sportello batteria in una posizione accessibile per consentire di usare la pompa in un secondo tempo con batterie AA o con le batterie ricaricabili CADD-Solis. 55 5. I tre isolanti pogo pin ubicati sui tre pogo pin nel vano batteria della pompa devono essere sostituiti con gliisolanti forniti con il gruppo del modulo di comunicazione. Tre isolanti sono necessari, mentre un quarto fornito in pi. Eliminare gli isolanti originali. Usando delle pinzette, rimuovere con attenzione ed eliminare i tre isolanti pogo pin originali come mostrato. Isolante pogo pin 6. Installare i tre nuovi isolanti pogo pin forniti nel gruppo del modulo di comunicazione. 56 7. Verificare che i tre isolanti pogo pin nuovi siano completamente alloggiati attorno ai pin. NOTA: i tre isolanti pogo pin nuovi sono compatibili anche con le batterie AA e le batterie ricaricabili CADD-

Solis. Eliminare gli isolanti pogo pin originali quando non servono pi. 8. La batteria ricaricabile allinterno del modulo di comunicazione non collegata e deve essere collegata internamente. Per accedere alla batteria per collegarla, usare un cacciavite torx a stella 10 IP per rimuovere le due viti sotto il tappo del modulo di comunicazione. AVVERTENZA: per evitare potenziali lesioni o danni, non rimuovere il tappo del modulo di comunicazione quando installato e collegato alla pompa, n consentire ai contatti elettronici di un modulo di comunicazione di toccare contemporaneamente un componente di metallo (ad esempio una moneta o una graffetta). 9. Rimuovere delicatamente il tappo dalla base del modulo di comunicazione, prestando attenzione per evitare che il cavo dellantenna venga tirato e si allenti dal tappo o dalla base, quindi attaccare la spina della batteria alla presa della batteria sulla scheda di circuito stampato del modulo di comunicazione. 57 ATTENZIONE: non esercitare una forza eccessiva quando si separa il tappo del modulo di comunicazione dalla base. Il cavo dellantenna deve rimanere attaccato sia al tappo che alla base. Lo scollegamento del cavo dellantenna potrebbe danneggiare lantenna e/o le componenti elettroniche del modulo di comunicazione. 10. Posizionare il tappo del modulo di comunicazione sulla base, prestando attenzione a inserire completamente il cavo dellantenna allinterno del modulo di comunicazione. 11. Inserire e serrare le due viti a stella sotto il tappo del modulo di comunicazione usando il cacciavite torx a stella 10 IP finch non sono completamente inserite, poi ruotare di un altro 1/8 di giro

(45gradi) circa. Non serrare eccessivamente. AVVERTENZA: verificare che le guarnizioni attorno al perimetro del tappo del modulo e i fori per le viti non siano danneggiati o andati persi quando il modulo viene aperto o chiuso. Queste guarnizioni O-ring sono necessarie per la protezione da ESD o dallingresso di acqua. 58 Tappo del modulo di comunicazioneBase del modulo di comunicazioneCavo dellantennaSpina della batteriaPresa della batteria 12. Inserire il modulo di comunicazione nel vano della batteria della pompa. Agganciare il fondo delladattatore per montaggio su asta al fondo della pompa, quindi assemblare a scatto la parte superiore delladattatore per montaggio su asta sulla base del modulo. 14. Prima di configurare la pompa e prima del primo utilizzo, il modulo di comunicazione deve essere caricato completamente. Vedere la sezione successiva per ulteriori informazioni sul caricamento della batteria ricaricabile nel modulo di comunicazione CADD-Solis. NOTA: allineare i denti delladattatore per montaggio su asta allapertura incassata nellalloggiamento pompa. Adattatore per montaggio su asta Denti di allineamento Apertura incassata della pompa 13. Usare una chiave per pompa CADD-Solis, un cacciavite standard o una moneta per serrare la vite per attaccare ladattatore per montaggio su asta e fissare il modulo di comunicazione alla pompa. Serrare la vite finch non viene inserita completamente, poi ruotare di un altro 1/8 di giro

(45 gradi) circa. Non serrare eccessivamente. 15. Se il modulo di comunicazione CADD-Solis viene installato in una pompa specifica per la prima volta, sar necessario configurare le impostazioni wireless per la pompa usando il software CADD-Solis Network Setup Utility (disponibile separatamente). Per ulteriori informazioni, fare riferimento alla documentazione fornita con il software Network Setup Utility. Caricamento della batteria ricaricabile La batteria ricaricabile del modulo di comunicazione si carica ogni qualvolta la pompa CADD-Solis viene collegata ad unalimentazione CA tramite ladattatore CA CADD-Solis, anche se la pompa spenta. All'interno dell'intervallo di temperatura operativa compreso tra 2C e 40C (35Fe 104F), la batteria si carica completamente in 10ore o meno. Caricare completamente la batteria ricaricabile:

Prima del primo utilizzo Almeno ogni 30 giorni in condizioni di normale utilizzo Almeno una volta ogni 6 mesi in fase di inattivit Quando la pompa indica che la batteria sta per esaurirsi o esaurita ATTENZIONE: il mancato caricamento della batteria ricaricabile durante lunghi periodi di inattivit pu causarne il completo esaurimento e rendere necessaria la sostituzione prima del dovuto. ATTENZIONE: per evitare di danneggiare il connettore delladattatore CA o la pompa, non esercitare una forza eccessiva n utilizzare strumenti come pinze per attaccare o staccare il connettore delladattatore CA. 59 Per caricare la batteria ricaricabile:

1. Collegare il cavo di alimentazione per ladattatore CA CADD-Solis nella presa CA e laltra estremit nelladattatore CA. 2. Collegare il connettore delladattatore CA alla presa di alimentazione CA (con etichetta 7V) sulla pompa CADD-Solis. Quando collegato correttamente, si accende la spia blu accanto al connettore sulla pompa. AVVERTENZA: non collegare alcun adattatore CA direttamente alla batteria ricaricabile del modulo di comunicazione CADD-Solis. Collegare direttamente gli adattatori CA potrebbe essere pericoloso e danneggiare la batteria, il modulo di comunicazione e la pompa. ATTENZIONE: se il connettore di uscita delladattatore CA non inserito fino in fondo nella pompa, possono derivarne connessioni intermittenti e lo spostamento del connettore, con conseguenti perdite di alimentazione e incapacit di caricare la batteria ricaricabile. 3. Quando la pompa accesa, la barra di stato della pompa mostra brevemente Adattatore CA collegato. 60 4. Quando la pompa accesa, la barra di stato della pompa mostra che la pompa collegata allalimentazione CA. A destra dellicona della batteria viene visualizzato un piccolo indicatore aforma di spina. 5. Quando la pompa accesa, possibile valutare il livello di alimentazione stimato della batteria dalla barra di stato visualizzata sul display della pompa. Per ulteriori informazioni, fare riferimento al Manuale dell'operatore della pompa. Quando la batteria del tutto carica, possibile scegliere di scollegare la spina delladattatore CA. Il messaggio Adattatore CA scollegato viene brevemente visualizzato dopo aver scollegato la spina. Configurazione delle impostazioni wireless tramite il software Network Setup Utility CADD-Solis Tutte le impostazioni wireless per la pompa e il modulo di comunicazione CADD-Solis sono configurate con il software Network Setup Utility CADD-Solis (disponibile separatamente) tramite una connessione USB da un PC alla pompa CADD-Solis. Il software Network Setup Utility CADD-Solis consente di selezionare e inserire tutte le impostazioni wireless per la configurazione nei punti di accesso della rete wireless e nel PharmGuard Server. Tali impostazioni possono essere salvate nella pompa CADD-Solis. Pertanto, se un modulo di comunicazione CADD-

Solis viene sostituito per la pompa, il nuovo modulo di comunicazione utilizzer automaticamente le impostazioni wireless preconfigurate della pompa. Per ulteriori informazioni, fare riferimento alla documentazione fornita con il software Network Setup Utility CADD-Solis. Accensione/

Spegnimento della radio wireless Quando il modulo di comunicazione CADD-Solis installato, la sua radio wireless pu essere accesa o spenta come opportuno (ad es. spegnerla per risparmiare batteria, ecc.). Tale operazione pu essere eseguita in qualsiasi momento dal menu Attivit sullo schermo della pompa senza interrompere le funzioni cliniche della pompa, come uninfusione in esecuzione. Per ulteriori informazioni, fare riferimento al Manuale delloperatore della pompa. Visualizzazione dello stato e delle impostazioni wireless Il software Network Setup Utility CADD-Solis consente di visualizzare e cambiare le impostazioni wireless, ma possibile visualizzare lo stato e le impostazioni wireless anche sullo schermo della pompa CADD-Solis. Lo stato wireless indicato sulla schermata principale della pompa:

Wireless spento (indicatore bianco) Wireless acceso, non associato al punto di accesso wireless (indicatore arancione) Wireless acceso, associato al punto di accesso wireless (indicatore arancione con centro verde) Wireless acceso, associato al punto di accesso wireless e comunicazione con PharmGuard Server (indicatore verde concentro verde) Inoltre, possibile visualizzare le informazioni dettagliate sullo stato e le impostazioni wireless. Dal menu Rapporti della pompa, selezionare Stato wireless o Impostaz. wireless. Per visualizzare la versione del modulo di comunicazione (CM) e lindirizzo MAC, selezionare Informazioni sul dispositivo dal menu Rapporti. Per ulteriori informazioni, fare riferimento al Manuale delloperatore della pompa. 61 Risoluzione dei problemi Problema La batteria ricaricabile non si carica. Causa probabile / Soluzione Il connettore delladattatore CA potrebbe non essere completamente inserito nella porta di connessione sulla pompa. Inserire completamente il connettore delladattatore CA nella pompa. La batteria potrebbe essere troppo calda o troppo fredda. Verificare che le condizioni ambientali soddisfino quelle specificate per il funzionamento. I tre isolanti pogo pin di ricambio non sono installati o sono installati in modo errato. La batteria ricaricabile completamente carica ma non funziona nella pompa. Ci potrebbe essere un problema di contatto tra la pompa e il modulo di comunicazione. Verificare che i contatti sul modulo di comunicazione siano puliti. Verificare che il vano batteria e i contatti sulla pompa siano puliti. Provare il modulo di comunicazione in unaltra pompa. Se funziona nella seconda pompa, probabilmente c un problema con la prima pompa. Se il modulo di comunicazione non funziona nemmeno nella seconda pompa, probabilmente c un problema con il modulo di comunicazione e/o la batteria ricaricabile. Contattare il servizio di assistenza clienti Smiths Medical. La radio wireless accesa e licona di stato wireless della pompa indica che il wireless acceso, ma non associato al punto di accesso wireless

(indicatore arancione). Il modulo di comunicazione potrebbe essere in modalit di riduzione calore, vedere il Manuale delloperatore della pompa. Le impostazioni wireless sono configurate in modo errato. Controllare e/o configurare le impostazioni. Il modulo di comunicazione troppo lontano da un punto di accesso wireless. Spostarlo pi vicino ad un punto daccesso. La pompa disattiva automaticamente la radio a causa della batteria esaurita. Collegare la pompa alladattatore CA. Il modulo di comunicazione si trova vicino ad un forno a microonde in funzione. Allontanarsi dal forno a microonde. Allarmi pompa associati al modulo di comunicazione La batteria ricaricabile quasi a fine vita. Sostituire la batteria. La batteria ricaricabile quasi esaurita. Il numero di caricamenti e scaricamenti a cui stata sottoposta talmente alto che presto sar completamente esaurita. Pu essere ancora utilizzata in questo stato. La batteria ricaricabile a fine vita. La pompa non funziona. La batteria ricaricabile del modulo di comunicazione CADD-Solis definitivamente esaurita. Ilnumero di caricamenti e scaricamenti a cui stata sottoposta talmente alto per cui non pi ingrado di conservare una carica ottimale. Sostituire con una nuova batteria ricaricabile per modulodi comunicazione CADD-Solis. Batteria inutilizzabile. Lapompa non funziona. La batteria non compatibile con la pompa oppure si verificato un errore di comunicazione. Perulteriori informazioni, fare riferimento al Manuale delloperatore della pompa. La connessione tra il modulo di comunicazione e la pompa intermittente. Per ulteriori informazioni, fare riferimento al Manuale delloperatore della pompa. Connessione intermittente del modulo di comunicazione con lapompa 62 Trasporto Il modulo di comunicazione stato testato ed conforme con le norme sul trasporto delle Nazioni Unite indicate in UN/DOT ST/SG/AC.10/11 (Rev. 5) Sezione 38.3 requisiti di test T1-T5, T7. Smaltimento / Raccolta differenziata La batteria ricaricabile del modulo di comunicazione deve essere completamente scaricata prima dello smaltimento e/o i morsetti devono essere nastrati o incappucciati per evitare cortocircuiti. I cittadini residenti in Stati non membri dell'Unione Europea devono smaltire o riciclare questo prodotto conformemente alle norme e ai regolamenti locali vigenti in materia. Raccolta differenziata Questo prodotto contiene componenti elettrici ed elettronici che possono contenere materiali che, se smaltiti nei rifiuti generici, potrebbero essere dannosi per lambiente. Nel rispetto della Direttiva 2002/96/CE Smaltimento delle apparecchiature elettriche ed elettroniche, i residenti nellUnione Europea devono attenersi alle specifiche istruzioni di smaltimento o riciclaggio di questo prodotto. Per istruzioni specifiche, rivolgersi al distributore locale o visitare il sito web:

http://www.smiths-medical.com/recycle/index.html AVVERTENZA: esistono rischi potenziali per la salute associati a uno smaltimento non corretto delle batterie e di altri componenti elettronici. Smaltire le batterie usate e gli altri accessori usati in conformit alle normative vigenti in materia ambientale. Informazioni REACH Ai sensi della normativa europea per la registrazione, valutazione, autorizzazione e restrizione delle sostanze chimiche (Regolamento REACH CE N. 1907/2006), le aziende sono tenute a informare i clienti qualora un prodotto contenga una delle sostanze indicate nella Candidate List delle sostanze soggette ad autorizzazione

(dette anche sostanze estremamente preoccupanti

(SVHC)) ad una concentrazione superiore allo 0,10%

in base al peso. Le dichiarazioni di Smiths Medical relativamente alle sostanze SVHC contenute nei prodotti sono disponibili sul sito www.smiths-medical.com/

environment. Certificazione Parte 15 Questo dispositivo conforme alla Parte 15 delle norme FCC. Il funzionamento soggetto alle seguenti due condizioni: (1) questo dispositivo non deve causare interferenze nocive e (2) questo dispositivo deve accettare qualsiasi interferenza ricevuta, comprese le interferenze che possono causare un funzionamento indesiderato. Pulizia e disinfezione del modulo di comunicazione Per un'efficienza ottimale, si consiglia di adottare la buona prassi di eseguire prima la pulizia e successivamente la disinfezione. Tutti i disinfettanti necessitano di una pre-pulizia, ad eccezione dei detergenti disinfettanti testati per la disinfezione in presenza del 5% di materia organica. ATTENZIONE: non immergere il modulo di comunicazione in un liquido detergente n in acqua. Non consentire alla soluzione di impregnare il modulo di comunicazione. Laumento di umidit allinterno del modulo di comunicazione potrebbe danneggiare il dispositivo. Pulire e disinfettare le superfici esposte del modulo di comunicazione quando installato nella pompa. 63 Le soluzioni disinfettanti accettabili per il modulo di comunicazione CADD-Solis sono elencate di seguito. Prodotto Produttore

(numero di serie EPA) Principio(i) attivo(i) CaviWipes Metrex

(46781-8) 17,2%

isopropanolo Sani-Cloth Super PDI (9480-4) Sani-Cloth Bleach PDI (9480-8) Cloruro di ammonio benzilico dimetilico, Cloruro di ammonio etilico benzilico dimetilico 0,60%

ipoclorito disodio Contatto/

Tempo di azione 3 minuti 2 minuti 4 minuti 3. Consentire al modulo di comunicazione di asciugarsi completamente prima delluso. ATTENZIONE: per evitare danni alle componenti elettroniche interne del modulo di comunicazione, non lasciare che la soluzione impregni la zona dei contatti elettronici o entri in qualsiasi apertura e giunzione. Usare solamente un panno asciutto privodi filacce per pulire i contatti elettronici e lazona circostante racchiusa, quando installato nella pompa. possibile utilizzare la seguente procedura per pulire e disinfettare il modulo di comunicazione:

1. Pulire il modulo di comunicazione con una soluzione detergente delicata per rimuovere residui o materiale contaminato. Applicare la soluzione su un panno soffice e privo di filacce, quindi pulire le superfici esposte del modulo di comunicazione quando installato nella pompa. Non consentire alla soluzione di impregnare la pompa o il modulo di comunicazione. 2. Disinfettare il modulo di comunicazione applicando una soluzione disinfettante (elencata di seguito) secondo le istruzioni di disinfezione riportate sull'etichetta del prodotto. Se si utilizza una soluzione liquida o spray, applicare la soluzione su un panno soffice e privo di filacce, quindi pulire le superfici esposte del modulo di comunicazione quando installato nella pompa. Seguire le raccomandazioni del produttore del disinfettante per i relativi tempi di contatto. Non consentire alla soluzione di impregnare lapompa o il modulo di comunicazione. 64 Specifiche Tipo di batteria Batteria ricaricabile agli ioni di litio (2 celle) Contenuto di litio equivalente <1,6g Capacit batteria 18,7Wh (quando completamente carica) Uscita batteria 3,6V (nominale) Peso della batteria ricaricabile

<100g Requisiti ambientali operativi Temperatura . 2C - 40C

(35F - 104F) Umidit . Umidit relativa 20% - 90%, senza condensa Pressione atmosferica . 70 kPa - 106 kPa

(10,2 psia - 15,4 psia) Requisiti ambientali per il trasporto e la conservazione Temperatura . 20C - 60C

(4F - 140F) Umidit . Umidit relativa 20% - 90%, senza condensa Pressione atmosferica . 70 kPa - 106 kPa

(10,2 psia - 15,4 psia) Durata della batteria del prodotto 400 cicli completi (carica/ricarica) a temperatura ambiente, 23C (73F) Tempo di carica massimo (da batteria esaurita a batteria completamente carica) 10 ore quando collegata ad un adattatore CA Tempo di funzionamento della pompa e del modulo di comunicazione (batteria nuova) 4 ore alle impostazioni nominali della pompa

(vedere il Manuale delloperatore della pompa per le informazioni sulle impostazioni nominali) Sicurezza Il modulo di comunicazione conforme alle norme Underwriters Laboratories UL 2054, IEC 60601-1(2005 + A1:2012) Ed 3.1 [quando installato nella pompa per infusione CADD-

Solis modello 2110], IEC 60601-1-2 (2014) e IEC 62133 (2002). Le celle agli ioni di litio sono conformi alle norme Underwriters Laboratories UL 1642. Norma IEEE 802.11 a,b,g,n Radio per comunicazioni di rete Il modulo di comunicazione CADD-Solis riceve e trasmette intenzionalmente lenergia elettromagnetica in radiofrequenza (RF) per lecomunicazioni non critiche. Trasmissione/ricezione RF, banda a . da 5.180 MHz a 5.320 MHz e da 5.500 MHz a 5.825 MHz Trasmissione/ricezione RF, bande b, g e n .......................................... da 2.412 MHz a 2.472 MHz Larghezza di banda dei segnali a, b, g e n ..................................20 MHz Potenza di trasmissione RF massima della banda a ................................................10mW Potenza di trasmissione RF massima delle bande b, g e n ...............................100mW 65 Intervallo wireless del modulo di comunicazione:

36,58 metri (120 piedi) (funzionamento visibile con punto di accesso) Modalit di rete e crittografia Modalit rete:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Modalit crittografia:

Nessuna TKIP CCMP TKIP/CCMP Modalit di autenticazione:

APERTA WPA-ENT WPA2-ENT WPA-PSK WPA2-PSK Modalit EAP:

Nessuna EAP-TLS (v1.0 e v1.2) EAP-TTLS EAP-PEAPV0 (PEAP con MS-CHAPv2) EAP-PEAPV1 (PEAP con GTC) EAP-LEAP EAP-FAST Certificati:

SSL SHA-1 SSL SHA-2 Nota: il modulo di comunicazione pu subire interferenze da altre apparecchiature, anche setalialtre apparecchiature sono conformi airequisiti CISPR 11. Per altre specifiche di rete del modulo di comunicazione CADD-Solis e ulteriori informazioni di configurazione, vedere la Guida di installazione e per lutente della Network Setup Utility

(Versione1.1). Interferenze/Distanze di separazione Altri dispositivi elettronici di comunicazione usati vicino al modulo di comunicazione possono causare linterruzione della trasmissione dei dati. Linterruzione della trasmissione dei dati non influisce sullerogazione della pompa. La tabella riportata di seguito specifica quale effetto causa ciascun tipo di dispositivo e descrive la distanza di separazione minima che necessario osservare. Origine dellinterferenza (tipo di dispositivo elettronico) Stazioni base del trasmettitore wireless da 2,4GHz/5GHz (ad es. punti di accesso Wi-Fi, stazioni base di telefoni wireless) Dispositivi medici wireless da 2,4GHz/5GHz e altre periferiche

(ad es. monitor paziente, pompe per infusione, computer/smartphone/

tablet abilitati Wi-Fi; dispositivi abilitati Bluetooth; dispositivi abilitati Zigbee;

telefoni wireless) Altre pompe CADD-Solis Smiths Medical con connettivit wireless Etichette di posizione asset RFID da 433MHz/2,4GHz/5GHz Distanza di separazione min. 3 metri

(9,84 piedi) 1 metro

(3,28 piedi) 0,3 metri

(1 piede) Contatto diretto 66 Garanzia limitata Garanzia: Smiths Medical ASD, Inc. (Produttore) garantisce allAcquirente originale che tutte le parti e i componenti del modulo di comunicazione CADD-

Solis (Modulo di comunicazione) prodotti da e per il Produttore, esclusi gli elementi indicati di seguito, sono privi di difetti di materiale e di fabbricazione, in condizioni duso normali, se utilizzati conformemente alle Istruzioni per luso, per un periodo di un (1) anno dalleffettiva data di acquisto da parte dellAcquirente originale. SI ESCLUDONO ALTRE GARANZIE. Eccezioni: la presente garanzia non copre la normale usura e azioni di manutenzione, ed esclude qualunque altro accessorio o apparecchiatura utilizzati con il Modulo di comunicazione. Procedure per lutilizzo della garanzia: secondo le condizioni e in conformit alla presente garanzia limitata, il Produttore riparer o sostituir a sua discrezione senza spese (tranne le spese di spedizione e trasporto) eventuali Moduli di comunicazione (esclusi gli accessori) che risultino difettosi, a condizione che la richiesta venga presentata durante il periodo di garanzia di un anno. NON inviare alcun Modulo di comunicazione o componente al Produttore per le riparazioni in garanzia senza informazioni specifiche di inoltro del servizio assistenza clienti. Condizioni: gli obblighi del Produttore, nellambito della presente garanzia, sono soggetti alle seguenti condizioni, limitazioni ed esclusioni:

A. Annullamento della garanzia: la presente garanzia viene annullata nel caso in cui il Modulo di comunicazione, o qualsiasi sua parte o componente,

(1) non sia stato riparato dal Produttore o da personale autorizzato; (2) sia stato modificato in modo da alterarne la stabilit o laffidabilit; (3) sia stato utilizzato impropriamente; oppure (4) sia stato danneggiato a causa di negligenza o incidente. Lutilizzo improprio comprende, senza esserne limitato, luso non conforme alle Istruzioni per luso del Modulo di comunicazione o luso con accessori non approvati. B. Limitazioni ed esclusioni: la sostituzione del Modulo di comunicazione o di qualsiasi componente costituisce lESCLUSIVO rimedio offerto dal Produttore. Tutte le raccomandazioni, le informazioni e la documentazione descrittiva fornite dal Produttore in merito al Modulo di comunicazione devono essere ritenute precise e affidabili, tuttavia non costituiscono garanzie. Nessun agente, rappresentante o dipendente del Produttore detiene lautorit per obbligare il Produttore a dichiarazioni o garanzie esplicite o implicite. NON ESISTE GARANZIA DI COMMERCIABILIT O IDONEIT DEL MODULO DI COMUNICAZIONE PER DETERMINATI SCOPI. IL PRODUTTORE DECLINA OGNI RESPONSABILIT PER LIDONEIT DEL MODULO DI COMUNICAZIONE AD UN DETERMINATO TRATTAMENTO MEDICO O PER COMPLICAZIONI MEDICHE DERIVANTI DALLUTILIZZO DEL MODULO DI COMUNICAZIONE. IL PRODUTTORE NON RESPONSABILE PER EVENTUALI DANNI INCIDENTALI O CONSEQUENZIALI A PROPRIET, PERDITA DI GUADAGNO O MANCATO UTILIZZO A CAUSA DI GUASTI O MALFUNZIONAMENTI DEL MODULO DI COMUNICAZIONE. La presente garanzia fornisce allAcquirente originario diritti legali specifici, che si uniranno eventualmente ad altri diritti legali che possono variare da uno Stato allaltro. 67 1 Spanish / Espaol ndice English . 4 French / Franais . 20 German / Deutsch . 36 Italian / Italiano . 52 Advertencias . 69 Precauciones . 70 Acerca del mdulo de comunicacin CADD-Solis, modelo 2131 . 70 Instalacin del mdulo de comunicacin CADD-Solis . 71 Carga de la batera recargable . 75 Realizacin de la configuracin inalmbrica con el software CADD-Solis Network Setup Utility . 76 Encendido/apagado de la radio inalmbrica . 77 Vista del estado y la configuracin inalmbricos . 77 Averas . 78 Transporte . 79 Eliminacin/recogida por separado . 79 Informacin sobre REACH . 79 Seccin 15 de la certificacin . 79 Limpieza y desinfeccin del mdulo de comunicacin . 79 Especificaciones . 81 Garanta limitada . 83 Portuguese / Portugus . 84 Dutch / Nederlands . 100 Swedish / Svenska . 116 Danish / Dansk . 132 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 68 IMPORTANTE: La batera recargable del mdulo de comunicacin CADD-Solis deber estar conectada internamente y completamente cargada dentro de la bomba antes de poner el sistema en funcionamiento. Lea y siga las instrucciones de este manual del operador para instalar y cargar la batera antes de usarla. Lea las instrucciones en su totalidad antes de instalar el mdulo de comunicacin CADD-Solis en la bomba de infusin ambulatoria CADD-Solis, modelo 2110. Guarde estas instrucciones para poder consultarlas en un futuro. Para obtener instrucciones detalladas, advertencias, especificaciones e informacin adicional sobre el funcionamiento de la bomba de infusin ambulatoria CADD-Solis, consulte el Manual del operador de labomba. Para obtener instrucciones detalladas, advertencias, especificaciones e informacin adicional sobre el uso del adaptador de CA CADD-Solis, consulte las Instrucciones de uso proporcionadas con el producto. ADVERTENCIAS Para evitar lesiones personales graves, es esencial tener en cuenta las siguientes advertencias:

No exponga el mdulo de comunicacin a la lluvia, el agua o la humedad; podra producirse una descarga elctrica u otro peligro. No sumerja la batera recargable del mdulo de comunicacin CADD-Solis en lquido; podra producirse una descarga elctrica u otro peligro. No utilice la batera recargable del mdulo de comunicacin CADD-Solis con ningn dispositivo que no sea el mdulo de comunicacin CADD-Solis. No conecte ningn adaptador de CA directamente a la batera recargable del mdulo de comunicacin CADD-Solis. Conectar de forma directa cualquier adaptador de CA podra resultar peligroso y daar la batera recargable, el mdulo de comunicacin y la bomba. Toda batera recargable del mdulo de comunicacin CADD-Solis que haya alcanzado el final de su vida til deber sustituirse por otra batera recargable del mdulo de comunicacin CADD-Solis. Si utiliza bateras recargables de otros fabricantes, podran producirse incendios o explosiones. No permita que los contactos electrnicos del mdulo de comunicacin entren en contacto de forma simultnea con una pieza de metal

(una moneda o un clip, por ejemplo). No utilice el mdulo de comunicacin CADD-Solis si est daado, si la electrnica interna queda expuesta debido al desgaste o si los contactos electrnicos estn daados de algn modo. Podra producirse un incendio, una descarga elctrica u otro peligro. No intente aplastar el mdulo de comunicacin CADD-Solis ni la batera recargable. Podra producirse un incendio, una descarga elctrica u otro peligro. No destruya la batera recargable del mdulo de comunicacin CADD-Solis mediante incineracin, pues podra explotar. No utilice el mdulo de comunicacin en la bolsa de la bomba de infusin CADD-Solis ni en ninguna otra bolsa o funda. El mdulo de comunicacin podra sobrecalentarse y apagarse mediante el circuito de proteccin trmica. Existen posibles riesgos sanitarios relacionados con la eliminacin inadecuada de las bateras y otros componentes electrnicos. Elimine las bateras y otros accesorios usados de forma medioambientalmente segura y segn las normativas vigentes. 69 PRECAUCIONES Evite aplicar demasiada fuerza al separar la tapa del mdulo de comunicacin CADD-Solis de la base. El cable de la antena deber permanecer conectado tanto a la tapa como a la base. Desconectar el cable de la antena puede daar esta o los componentes electrnicos del mdulo de comunicacin. Si no carga la batera recargable del mdulo de comunicacin CADD-Solis por completo antes de usarla por primera vez ni durante un almacenamiento prolongado, esta podra descargase completamente, teniendo que sustituirla antes de tiempo. El puerto USB de la bomba de infusin CADD-Solis est diseado para comunicarse nicamente con PharmGuard Medication Safety Software, SureLink Remote Support Software y el software CADD Solis Network Setup Utility. No conecte accesorios no compatibles al puerto USB (por ejemplo, para cargar otros dispositivos o conectar un adaptador inalmbrico), ya que esto podra daar la bomba. Si el mdulo de comunicacin CADD-Solis se almacena fuera de las condiciones ambientales de funcionamiento y cumpliendo las condiciones ambientales de almacenamiento especificadas, deje que el mdulo de comunicacin se caliente o se enfre hasta alcanzar la temperatura de funcionamiento durante al menos una hora antes de utilizarlo para evitar daos en los circuitos electrnicos. 70 Acerca del mdulo de comunicacin CADD-Solis, modelo 2131 El sistema de comunicacin de red (NCS) CADD-Solis consta de una bomba de infusin ambulatoria CADD-Solis, modelo 2110 (versin de software 4.2 o superior), con un mdulo de comunicacin CADD-Solis instalado y configurado para su red inalmbrica y PharmGuard Server. Cuando se instala y configura adecuadamente, el mdulo de comunicacin permite a la bomba enviar de forma inalmbrica el historial de la bomba a un PharmGuard Server y recibir actualizaciones de la biblioteca y el firmware de la bomba. El modelo 2131 es una versin actualizada del mdulo de comunicacin 2130. La radio es ms robusta, incluida una mejor seguridad y cifrado, e incorpora un soporte de banda n con canal de 20MHz. El mdulo de comunicacin CADD-Solis incluye la radio inalmbrica y una batera recargable dentro del mdulo. La batera alimenta el mdulo de comunicacin y proporciona energa a la bomba CADD-Solis cuando no se dispone de alimentacin CA. La batera recargable se carga cuando la bomba se conecta a la alimentacin CA a travs del adaptador de CA CADD-Solis, incluso si la bomba est apagada. El adaptador de CA y el cable de la red elctrica (disponible por separado) CADD-Solis se utilizan para conectar la bomba y recargar la batera cuando elmdulo de comunicacin estinstalado en la bomba CADD-Solis. El software CADD-Solis Network Setup Utility

(disponible por separado) se utiliza para realizar la configuracin de red inalmbrica de la bomba en concreto cuando se instala un mdulo de comunicacin CADD-Solis. Para obtener informacin sobre el uso de este software, consulte las instrucciones de instalacin que se suministran con l. NOTA: Deber utilizarse la versin 1.1 del software Network Setup Utility. ADVERTENCIA: Cualquier batera recargable del mdulo de comunicacin CADD-Solis que haya alcanzado el final de su vida til deber sustituirse por otra batera recargable CADD-Solis. No utilice bateras recargables de otros fabricantes, pues podran producirse incendios o explosiones. Para obtener ms informacin, consulte el Manual del operador de la bomba, alarma Batera recargable alcanz el final de su vida til. ADVERTENCIA: No conecte ningn adaptador de CA directamente a la batera recargable del mdulo de comunicacin CADD-Solis. Conectar de forma directa cualquier adaptador de CA podra resultar peligroso y daar la batera recargable, el mdulo de comunicacin y la bomba. Instalacin del mdulo de comunicacin CADD-Solis PRECAUCIN: Solo el personal de mantenimiento deber llevar a cabo la instalacin y configuracin del mdulo de comunicacin CADD-Solis en una bomba. PRECAUCIN: Para evitar daos en el mdulo de comunicacin, apague la bomba y desconecte todos los cables de esta antes de instalar el mdulo de comunicacin en la bomba. PRECAUCIN: Puesto que la instalacin inicial del mdulo de comunicacin requiere la apertura de la carcasa del mdulo, la instalacin solo deber llevarse a cabo en un puesto de trabajo con controles de descarga electrosttica (ESD), lo que incluye una alfombrilla y una correa de mueca conectadas a tierra. 1. Asegrese de que la bomba CADD-Solis est apagada y que no haya cables conectados a labomba. 2. Con la ayuda de los dedos, la llave de la bomba o una moneda, gire la palanca de la tapa de las bateras en sentido contrario a las agujas del reloj y brala. 3. Quite las bateras que haya en la bomba. Asegrese tambin de que no haya residuos en el compartimento de las bateras. 4. Tire de la tapa de las bateras hacia atrs, tal y como se muestra, para retirarla de la bomba. Latapa de las bateras no se utiliza con el mdulo de comunicacin CADD-

Solis. Mantenga la tapa de las bateras en un lugar accesible para que la bomba pueda utilizarse posteriormente con las bateras AA o el pack de bateras recargables CADD-Solis. 71 5. Los tres aisladores de pines pogo ubicados en los tres pines del compartimento de las bateras de la bomba debern reemplazarse por los aisladores suministrados con el conjunto del mdulo de comunicacin. Serequieren tres aisladores y se suministra un cuarto aislador adicional. Elimine los aisladores originales. Con unas pinzas, retire y elimine con cuidado los tres aisladores de los pines pogo originales tal y como semuestra. Aislador de pin pogo 6. Instale los tres nuevos aisladores de pines pogo suministrados con el conjunto del mdulo de comunicacin. 72 7. Compruebe que los tres aisladores de pines pogo estn bien fijados alrededor de los pines. NOTA: Los tres nuevos aisladores de pines pogo tambin son compatibles con las bateras AA y el pack de bateras recargables CADD-Solis. Elimine los aisladores de pines pogo originales puesto que ya no son necesarios. 8. La batera recargable interna que se encuentra dentro del mdulo de comunicacin no est conectada y debe conectarse internamente. Para acceder a la batera y conectarla, use una broca con punta en forma de estrella e IP 10 para quitar los dos tornillos situados bajo la tapa del mdulo de comunicacin. ADVERTENCIA: Para evitar posibles lesiones y daos, no retire la tapa del mdulo de comunicacin mientras este est instalado y conectado a la bomba, ni permita que los contactos electrnicos de un mdulo de comunicacin entren en contacto de forma simultnea con una pieza de metal (una moneda o un clip, por ejemplo). 9. Retire con suavidad la tapa de la base del mdulo de comunicacin, procurando que el cable de la antena no se suelte de la tapa ni de la base, y conecte el enchufe de la batera a su receptculo en la placa de circuito impreso del mdulo de comunicacin. 73 PRECAUCIN: Evite aplicar demasiada fuerza al separar la tapa del mdulo de comunicacin de la base. Elcable de la antena deber permanecer conectado tanto a la tapa como a la base. Desconectar el cable de la antena puede daar esta o los componentes electrnicos del mdulo de comunicacin. 10. Coloque la tapa del mdulo de comunicacin en la base, procurando introducir todo el cable de la antena dentro del mdulo de comunicacin. 11. Introduzca y apriete los dos tornillos de estrella situados bajo la tapa del mdulo de comunicacin usando una broca con punta en forma de estrella e IP 10 hasta que queden fijados por completo y luego aplique otro 1/8 de vuelta (45 grados) aproximadamente. No apriete demasiado. ADVERTENCIA: Asegrese de que las juntas que rodean el permetro de la tapa del mdulo y los orificios de los tornillos no se pierdan ni sufran daos al abrir o cerrar el mdulo. Estas juntas tricas son necesarias para la entrada de agua y la proteccin contra descargas electrostticas (ESD). 74 Tapa del mdulo de comunicacinBase del mdulo de comunicacinCable de la antenaEnchufe de la bateraReceptculo de la batera 12. Inserte el mdulo de comunicacin en el compartimento de las bateras de la bomba. Enganche la parte inferior del adaptador de palo de gotero a la parte inferior de la bomba, y despus encaje la parte superior del adaptador de palo de gotero en la base del mdulo. NOTA: Alinee los dientes del adaptador de palo de gotero con la abertura encastrada en la carcasa de la bomba. Adaptador de palo de gotero Dientes de alineacin Abertura encastrada de la bomba 13. Utilice una llave de bomba CADD-Solis, un destornillador estndar o una moneda para apretar el tornillo y colocar el adaptador de palo de gotero, fijando as el mdulo de comunicacin a la bomba. Apriete el tornillo hasta que est completamente fijado y aplique luego otro 1/8 de vuelta (45 grados) aproximadamente. No apriete demasiado. 14. Antes de configurar la bomba y al usarla por primera vez, el mdulo de comunicacin deber estar completamente cargado. Consulte la siguiente seccin para obtener ms informacin sobre cmo cargar la batera recargable en el mdulo de comunicacin CADD-Solis. 15. Si el mdulo de comunicacin CADD-Solis se instala en una bomba concreta por primera vez, la configuracin inalmbrica de la bomba deber realizarse con el software CADD-Solis Network Setup Utility (disponible por separado). Para obtener ms informacin, consulte la documentacin suministrada con el software Network Setup Utility. Carga de la batera recargable La batera recargable del mdulo de comunicacin se carga cuando la bomba CADD-Solis se conecta a la alimentacin CA a travs del adaptador de CA CADD-Solis, incluso si la bomba est apagada. Si est dentro del intervalo de temperatura de funcio-

namiento entre 2C y 40C (entre 35F y 104F), la batera recargable se cargar completamente en10horas o menos. Cargue la batera recargable por completo:

Antes de usarla por primera vez Al menos cada 30 das siempre que se utilice de forma regular Al menos cada 6 meses si est guardada Cuando la bomba indique que la batera est baja o se ha agotado PRECAUCIN: Si no carga la batera recargable durante un almacenamiento prolongado, esta podra descargase completamente, teniendo que sustituirla antes de tiempo. PRECAUCIN: Para evitar daos en el conector del adaptador de CA o la bomba, evite aplicar demasiada fuerza o utilizar instrumentos como pinzas paraconectar o desconectar el conector deladaptador de CA. 75 Para cargar la batera recargable:

1. Enchufe el cable de la red elctrica del adaptador de CA CADD-Solis a una toma de CA y el otro extremo al adaptador de CA. 2. Enchufe el conector del adaptador de CA al enchufe de alimentacin CA (etiquetado como 7V) en la bomba CADD-Solis. Cuando est adecuadamente conectado, se encender la luz azul situada junto al conector de la bomba. ADVERTENCIA: No conecte ningn adaptador de CA directamente a la batera recargable del mdulo de comunicacin CADD-Solis. Conectar de forma directa cualquier adaptador de CA podra resultar peligroso y daar la batera, el mdulo de comunicacin y la bomba. PRECAUCIN: Si no introduce el conector de salida del adaptador de CA por completo dentro de la bomba, pueden producirse conexiones intermitentes y el conector puede desplazarse, provocando una prdida de corriente y evitando que la batera recargable se cargue. 3. Cuando la bomba est encendida, la barra de estado de la bomba mostrar brevemente Adaptador de AC conectado. 76 4. Cuando la bomba est encendida, la barra de estado de la bomba mostrar que la bomba est conectada a la alimentacin CA. Se mostrar un pequeo indicador de enchufe a la derecha del icono de la batera. 5. Cuando la bomba est encendida, podr evaluar el nivel estimado de energa de la batera en la barra de estado de la pantalla de la bomba. Para obtener ms informacin, consulte el Manual del operador de la bomba. Cuando la batera est completamente cargada, podr optar por desconectar el enchufe del adaptador de CA. El mensaje Adaptador de AC desconectado se mostrar brevemente tras desconectar el enchufe. Realizacin de la configuracin inalmbricacon el software CADD-Solis Network Setup Utility Toda la configuracin inalmbrica de la bomba y el mdulo de comunicacin CADD-Solis se realizan mediante el software CADD-Solis Network Setup Utility (disponible por separado) a travs de una conexin USB desde un PC conectado a la bomba CADD-Solis. Con el software CADD-Solis Network Setup Utility podr seleccionar e introducir todos los ajustes de la configuracin inalmbrica para sus puntos de acceso ala red inalmbrica y su PharmGuardServer. Esos ajustes se pueden guardar en la bombaCADD-Solis. Por lo tanto, si se reemplaza un mdulo de comunicacin CADD-Solis de la bomba, el nuevo mdulo aplicar automticamente la configuracin inalmbrica preconfigurada de esa bomba. Para obtener ms informacin, consulte la documentacin suministrada con el software CADD-Solis Network Setup Utility. Vista del estado y la configuracin inalmbricos Si bien el software CADD-Solis Network Setup Utility le permite ver y cambiar la configuracin inalmbrica, tambin puede comprobar el estado y la configuracin inalmbricos en la pantalla de la bomba CADD-Solis. El estado inalmbrico se indica en la pantalla principal de la bomba:

Encendido/

apagado de la radio inalmbrica Cuando se instala el mdulo de comunicacin CADD-Solis, la radio inalmbrica se puede activar o desactivar segn sea necesario (por ejemplo, apagarla para conservar la batera, etc.). Esto se puede hacer en cualquier momento en el men Tareas en la pantalla de la bomba sin interrumpir las funciones clnicas de la bomba, como una infusin que se est ejecutando. Para obtener ms informacin, consulte el Manual del operador de la bomba. Conexin inalmbrica apagada (indicador blanco) Conexin inalmbrica encendida, no asociada al punto de acceso inalmbrico

(indicador naranja) Conexin inalmbrica encendida, asociada al punto de acceso inalmbrico (indicador naranja con centro verde) Conexin inalmbrica encendida, asociada al punto de acceso inalmbrico y en comunicacin con PharmGuard Server

(indicador verde con centro verde) Adems, puede ver el estado inalmbrico y la configuracin inalmbrica en detalle. En el men de la bomba Informes, seleccione Estado inalmbrico o Config. inalmbrica. Para ver la versin del mdulo de comunicacin (CM) y la direccin MAC, seleccione Informacin del dispositivo en el men Informes. Para obtener ms informacin, consulte el Manual del operador de la bomba. 77 Averas Problema La batera recargable no se carga. Posible causa/solucin Es posible que el conector del adaptador de CA no se haya introducido por completo en el puerto de conexin de la bomba. Introduzca por completo el conector del adaptador de CA en la bomba. La batera podra estar demasiado caliente o fra. Asegrese de que las condiciones ambientales cumplen las condiciones de funcionamiento especificadas. Los tres aisladores de pines pogo de repuesto no estn instalados o bien no se han instalado incorrectamente. La batera recargable est completamente cargada pero no funciona en la bomba. Puede que haya un problema de contacto entre la bomba y el mdulo de comunicacin. Asegrese de que las almohadillas de contacto del mdulo de comunicacin estn limpias. Asegrese de que el compartimento de las bateras y los contactos de la bomba estn limpios. Pruebe el mdulo de comunicacin en otra bomba. Si funciona en la segunda bomba, es probable que haya un problema con la primera. Si el mdulo de comunicacin tampoco funciona en la segunda bomba, es probable que haya un problema con el mdulo o la batera recargable. Pngase en contacto con el servicio de atencin al cliente de Smiths Medical. El mdulo de comunicacin podra estar en modo de reduccin de calor, consulte el Manual del La configuracin inalmbrica no se ha realizado correctamente. Compruebe o realice la configuracin. El mdulo de comunicacin est demasiado lejos de un punto de acceso inalmbrico. Aproxmelo La bomba apaga automticamente la radio porque la batera est agotada. Conecte la bomba al Mdulo de comunicacin prximo a un horno microondas en funcionamiento. Aljelo del horno operador de la bomba. a un punto de acceso. adaptador de CA. microondas. Alarmas de la bomba asociadas al mdulo de comunicacin El pack de bateras recargables se acerca al final de su vida til. Se ha cargado y descargado tantas veces que pronto llegar al final de su vida til. Puede seguir usndose en este estado. El pack de bateras recargables del mdulo de comunicacin CADD-Solis ha llegado al final de su vida til. Se ha cargado y descargado tantas veces que ya no es capaz de conservar una carga adecuada. Reemplcelo con una nueva batera recargable para el mdulo de comunicacin CADD-Solis. La radio inalmbrica est encendida y el icono de estado inalmbrico de la bomba muestra el mensaje Conexin inalmbrica encendida, no asociada al punto de acceso inalmbrico

(indicador naranja). Batera recargable cerca del final de vida til. Cambiar batera. Batera recargable alcanz el final de su vida til. La bomba no funcionar. Batera inutilizable. Labomba no funcionar. La batera no es compatible con la bomba o bien se ha producido un error de comunicacin. Paraobtener ms informacin, consulte el Manual del operador de la bomba. La conexin entre el mdulo de comunicacin y la bomba es intermitente. Para obtener ms informacin, consulte el Manual del operador de la bomba. Conexin intermitente del mdulo de comunicacin con labomba. 78 Transporte El mdulo de comunicacin se ha sometido a pruebas y cumple con la normativa de transporte de las Naciones Unidas UN/DOT ST/SG/AC.10/11 (Rev. 5) seccin 38.3 requisitos de prueba T1-T5, T7. Eliminacin/recogida por separado La batera recargable del mdulo de comunicacin deber descargarse por completo antes de su eliminacin o bien los terminales debern estar tapados o cubiertos para evitar cortocircuitos. Los residentes en pases no pertenecientes a la UninEuropea debern eliminar o reciclar este producto de acuerdo con la legislacin o lasnormativas locales vigentes. Recogida por separado Este producto contiene componentes elctricos y electrnicos que pueden contener materiales que, si se desechan con los residuos normales, pueden ser perjudiciales para el medio ambiente. De acuerdo con la directiva 2002/96/CE sobre residuos de aparatos elctricos y electrnicos, los residentes de la Unin Europea debern seguir las instrucciones especficas de eliminacin o reciclaje de este producto. Pngase en contacto con su distribuidor local o visitela siguiente pgina web para obtener instrucciones especficas:

http://www.smiths-medical.com/recycle/index.html ADVERTENCIA: Existen posibles riesgos sanitarios relacionados con la eliminacin inadecuada de las bateras y otros componentes electrnicos. Elimine las bateras y otros accesorios usados de forma medioambientalmente segura y segn las normativas vigentes. Informacin sobre REACH En virtud del Reglamento europeo de registro, evaluacin, autorizacin y restriccin de sustancias qumicas (Reglamento REACH CE n. 1907/2006) las empresas estn obligadas a revelar a los clientes si un producto contiene alguna de las sustancias identificadas en la lista de posibles sustancias para autorizacin, tambin conocidas como sustancias altamente preocupantes (SVHC, por sus siglas en ingls) en concentraciones superiores a 0,10% en peso. Las declaraciones de Smiths Medical sobre la presencia de SVHC en productos se pueden encontrar en www.smiths-medical.com/environment. Seccin 15 de la certificacin Este dispositivo cumple con la seccin 15 de la normativa de la FCC estadounidense. El funcionamiento est sujeto a las siguientes dos condiciones: (1) este dispositivo no puede causar interferencias perjudiciales, y (2) este dispositivo debe aceptar cualquier interferencia recibida, incluida la interferencia que pueda causar un funcionamiento no deseado. Limpieza y desinfeccin del mdulo de comunicacin Para que la eficacia sea ptima, se recomienda primero limpiar y luego desinfectar. Todos los desinfectantes requieren una limpieza previa, con la excepcin de los limpiadores desinfectantes que han demostrado desinfectar en presencia de un 5 % de materia orgnica. PRECAUCIN: No sumerja el mdulo de comunicacin en ninguna solucin limpiadora ni en agua. No permita que la solucin penetre en el mdulo de comunicacin. La acumulacin de humedad dentro del mdulo de comunicacin puede daar el dispositivo. Limpie y desinfecte las superficies expuestas del mdulo de comunicacin cuando est instalado en la bomba. 79 Los desinfectantes adecuados para el mdulo de comunicacin CADD-Solis se especifican a continuacin. Producto Fabricante

(nmero de registro de laEPA) Principio(s) activo(s) CaviWipes Sani-Cloth Super Metrex

(46781-8) PDI (9480-4) Isopropanol al 17,2%

Cloruro de dimetil bencil amonio, cloruro de dimetil etil bencil amonio Tiempo de contacto/

extermi-

nacin 3 minutos 2 minutos Leja Sani-Cloth PDI (9480-8) Hipoclorito de sodio al 0,60 %

4 minutos 3. Deje que el mdulo de comunicacin se seque completamente antes de usarlo. PRECAUCIN: Para evitar daos en los componentes electrnicos internos del mdulo de comunicacin, no permita que la solucin penetre en el rea de los contactos electrnicos o en las aberturas y juntas. Utilice nicamente un pao seco que no suelte pelusa para limpiar los contactos electrnicos y el rea circundante, que normalmente estn protegidos cuando se instalan en la bomba. Se pueden realizar los siguientes pasos para limpiar y desinfectar el mdulo de comunicacin:

1. Limpie el mdulo de comunicacin con una solucin jabonosa de detergente suave para eliminar los residuos o el material contaminado. Aplique la solucin a un pao suave y sin pelusas, y limpie las superficies expuestas del mdulo de comunicacin cuando est instalado en la bomba. No permita que la solucin penetre en la bomba o en el mdulo de comunicacin. 2. Desinfecte el mdulo de comunicacin con un desinfectante (consulte la lista a continuacin) de acuerdo con las instrucciones de la etiqueta del producto. Si utiliza un lquido o un pulverizador, aplique la solucin a un pao suave y sin pelusas, y limpie las superficies expuestas del mdulo de comunicacin cuando est instalado en la bomba. Siga las recomendaciones de los tiempos de contacto del desinfectante que seala el fabricante. No permita que la solucin penetre en la bomba o en el mdulo de comunicacin. 80

Especificaciones Tipo de batera Batera recargable de iones de litio (2 celdas) Contenido equivalente de litio <1,6g Capacidad de la batera 18,7Wh (cuando est cargada por completo) Salida de la batera 3,6V (nominal) Peso de la batera recargable

<100g Requisitos ambientales de funcionamiento Temperatura . Entre 2C y 40C

(entre 35F y 104F) Humedad . Entre el 20% y el 90% de humedad relativa, sin condensacin Presin atmosfrica . Entre 70kPa y 106kPa (entre 10,2psia y 15,4psia) Requisitos ambientales de almacenamiento y transporte Temperatura . Entre 20C y 60C

(entre 4F y 140F) Humedad . Entre el 20% y el 90% de humedad relativa, sin condensacin Presin atmosfrica . Entre 70kPa y 106kPa (entre 10,2psia y 15,4psia) Vida til de la batera 400 ciclos completos (carga/descarga) a temperatura ambiente, 23 C (73 F) 10 horas cuando se conecta al adaptador de CA Tiempo mximo de carga (batera completamente agotada a totalmente cargada) Tiempo de funcionamiento de la bomba y del mdulo de comunicacin (batera nueva) 4 horas con la configuracin nominal de la bomba (consulte el Manual del operador de la bomba para obtener informacin sobre dicha configuracin nominal) Seguridad El mdulo de comunicacin cumple con la certificacin UL 2054 de Underwriters Laboratories, las normas IEC 60601-1 (2005+

A1: 2012) Ed. 3.1 [si se instala en la bomba deinfusin CADD-Solis, modelo 2110], IEC 60601-1-2 (2014) e IEC 62133 (2002). Las celdas de iones de litio cumplen con la certificacin UL 1642 de Underwriters Laboratories. Protocolo IEEE 802.11 a,b,g,n - Radio para la comunicacin de red El mdulo de comunicacin CADD-Solis recibe y transmite intencionadamente energa electromagntica de radiofrecuencia (RF) para comunicaciones no crticas. Transmisin/recepcin de RF en la banda a . De 5180MHz a 5320MHz y de 5500MHz a 5825MHz Transmisin/recepcin de RF en las bandas b, g y n .......... De 2412MHz a 2472MHz Ancho de banda de las seales a, b, g y n ....................20MHz Potencia de transmisin de RF mxima de la banda a .............................10mW Potencia de transmisin de RF mxima de las bandas b, g y n .....100mW 81 Rango inalmbrico del mdulo de comunicacin:

36,58 metros (120 pies) (operacin con lnea visual con punto de acceso) Modos de red y cifrado Modos de red:

Modos de cifrado:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Ninguno TKIP CCMP TKIP/CCMP Modos de autenticacin: Modos EAP:

Ninguno ABIERTO EAP-TLS (v. 1.0 y 1.2) WPA-ENT WPA2-ENT EAP-TTLS WPA-PSK WPA2-PSK EAP-PEAPV0 (PEAP con MS-CHAPv2) EAP-PEAPV1 (PEAP con GTC) EAP-LEAP EAP-FAST Certificados:

SHA-1 para SSL SHA-2 para SSL Nota: El mdulo de comunicacin puede recibir interferencias de otros equipos, incluso si esos otros equipos cumplen con los requisitos de CISPR 11. Para ms informacin sobre las especificaciones de red y la configuracin del mdulo de comunicacin CADD-Solis, consulte la Gua de instalacin y del usuario de Network Setup Utility (versin 1.1). Interferencia/distancias de separacin Otros dispositivos de comunicacin electrnica utilizados cerca del mdulo de comunicacin pueden causar interrupciones en la transmisin de datos. Las interrupciones en la transmisin de datos no afectan al sistema de administracin de la bomba. La siguiente tabla describe el efecto que puede causar cada tipo de dispositivo y especifica la distancia mnima de separacin necesaria. Fuente de interferencia (tipo de dispositivo electrnico) Estaciones base de transmisores inalmbricos de 2,4GHz/5GHz (por ejemplo, puntos de acceso Wi-Fi, estaciones base de telfonos inalmbricos) Dispositivos mdicos inalmbricos de 2,4GHz/5GHz y otros dispositivos perifricos (por ejemplo, monitores de paciente habilitados para Wi-Fi, bombas de infusin, ordenadores/

smartphones/tabletas; dispositivos habilitados para Bluetooth; dispositivos habilitados para Zigbee; auriculares telefnicos inalmbricos) Otras bombas CADD-Solis de Smiths Medical con conectividad inalmbrica Etiquetas de ubicacin de activos por radiofrecuencia (RFID) 433MHz/2,4GHz/5GHz Distancia mn. de separacin 3 metros

(9,84 pies) 1 metro

(3,28 pies) 0,3 metros

(1 pie) Contacto directo 82 Garanta limitada Garanta: Smiths Medical ASD, Inc. (el fabricante) garantiza al comprador original que todas las piezas y componentes del mdulo de comunicacin CADD-Solis

(el mdulo de comunicacin) fabricados por o para el fabricante, a excepcin de los elementos indicados a continuacin, no presentarn defectos en los materiales ni en la mano de obra con un uso normal y de acuerdo con lo descrito en las instrucciones de uso durante un periodo de un (1) ao a partir de la fecha de la venta al comprador original. NO HAY NINGUNA OTRA GARANTA. Excepciones: Esta garanta no cubre el desgaste normal ni el mantenimiento, y excluye especficamente cualquier otro accesorio o equipo utilizados con el mdulo de comunicacin. Procedimientos de aplicacin de la garanta:

Elfabricante, sujeto a las condiciones y en cumplimiento de esta garanta limitada, reparar o sustituir a su discrecin y sin cargo alguno (salvo el cargo mnimo de franqueo y manipulacin) cualquier mdulo de comunicacin (sin incluir los accesorios) que est defectuoso si se realiza una reclamacin durante este periodo de un ao. NO enve ningn mdulo de comunicacin ni ningn componente al fabricante para su reparacin en garanta sin reenviar la informacin especfica proporcionada por el departamento del servicio de atencin al cliente. Condiciones: Las siguientes condiciones, limitaciones y exclusiones se aplican a las obligaciones del fabricante en virtud de esta garanta:

A. Anulacin de la garanta: Esta garanta se considerar nula y sin efecto si el mdulo de comunicacin, o cualquier parte o componente de este, ha sido (1) reparado por alguien que no sea el fabricante o personal autorizado; (2) se ha alterado de modo que se vean afectadas su estabilidad o fiabilidad; (3) se ha utilizado indebidamente o (4) se ha daado por negligencia o accidente. Seconsideran usos indebidos, entre otros, aquellos que no cumplan con las instrucciones de uso del mdulo de comunicacin o cualquier uso con accesorios no autorizados. B. Limitaciones y exclusiones: La sustitucin del mdulo de comunicacin o de cualquiera de sus componentes es la solucin EXCLUSIVA que ofrece el fabricante. Todas las recomendaciones, informacin y bibliografa descriptiva relacionadas con el mdulo de comunicacin suministradas por el fabricante se consideran exactas y fiables, pero no constituyen ninguna garanta. Ningn agente, representante o empleado del fabricante tienen autoridad para vincular al fabricante a cualquier representacin o garanta, expresa o implcita. NO EXISTE UNA GARANTA DE COMERCIABILIDAD O IDONEIDAD DEL MDULO DE COMUNICACIN PARA NINGN FIN PARTICULAR. EL FABRICANTE RECHAZA TODA RESPONSABILIDAD DE IDONEIDAD DEL MDULO DE COMUNICACIN PARA UN TRATAMIENTO MDICO CONCRETO O EN EL CASO DE COMPLICACIONES MDICAS COMO RESULTADO DEL USO DE DICHO MDULO. EL FABRICANTE NO SER RESPONSABLE DE LOS DAOS ACCIDENTALES O CONSECUENTES A LA PROPIEDAD, PRDIDA DE BENEFICIOS O PRDIDA DE USO POR CUALQUIER DEFECTO O UN MAL FUNCIONAMIENTO DEL MDULO DE COMUNICACIN. La garanta otorga al comprador original derechos legales especficos y el comprador original puede tener otros derechos legales que pueden cambiar en funcin de su ubicacin. 83 2 Portuguese / Portugus ndice English . 4 French / Franais . 20 German / Deutsch . 36 Italian / Italiano . 52 Spanish / Espaol . 68 Advertncias . 85 Precaues . 86 Acerca do mdulo de comunicao CADD-Solis, modelo 2131 . 86 Instalao do mdulo de comunicao CADD-Solis. 87 Carregamento da bateria recarregvel . 91 Configurao das definies sem fios utilizando o software CADD-Solis Network Setup Utility . 92 Ligar/Desligar o rdio sem fios . 93 Ver o estado e as definies sem fios . 93 Resoluo de problemas . 94 Transporte . 95 Eliminao/Recolha em separado . 95 Informaes referentes regulamentao REACH . 95 Certificao da Parte 15 . 95 Limpeza e desinfeo do mdulo de comunicao . 95 Especificaes . 97 Garantia limitada . 99 Dutch / Nederlands . 100 Swedish / Svenska . 116 Danish / Dansk . 132 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 84 IMPORTANTE: A bateria recarregvel no mdulo de comunicao CADD-Solis deve ser internamente ligada e totalmente carregada na bomba antes da colocao do sistema em servio. Reveja e siga as instrues neste Manual do operador para instalar e carregar a bateria antes da utilizao. Leia as instrues na ntegra antes de instalar o mdulo de comunicao CADD-Solis na bomba de infuso ambulatria CADD-Solis, Modelo 2110. Guarde estas instrues para consulta futura. Para obter instrues, advertncias, especificaes e informaes adicionais sobre o funcionamento da bomba de infuso ambulatria CADD-Solis, consulte o Manual do operador da bomba. Para instrues, advertncias, especificaes e informaes adicionais detalhadas sobre como utilizar o adaptador de CA CADD-Solis, consulte as Instrues de utilizao fornecidas com o produto. ADVERTNCIAS Para evitar ferimentos pessoais graves, essencial ter em ateno as seguintes advertncias:

No exponha o mdulo de comunicao a chuva, gua ou humidade. Da pode resultar choque ou qualquer outro perigo. No mergulhe a bateria recarregvel do mdulo de comunicao CADD-Solis em lquido. Da pode resultar choque ou qualquer outro perigo. No utilize a bateria recarregvel do mdulo de comunicao CADD-Solis com outro dispositivo que no o mdulo de comunicao CADD-Solis. No ligue quaisquer adaptadores de CA diretamente bateria recarregvel do mdulo de comunicao CADD-Solis. A ligao direta de um adaptador de CA pode ser perigosa e pode provocar danos na bateria recarregvel, no mdulo de comunicao e na bomba. Uma bateria recarregvel do mdulo de comunicao CADD-Solis cuja vida til terminou deve ser substituda por outra bateria recarregvel do mdulo de comunicao CADD-Solis. A utilizao de baterias recarregveis de outros fabricantes poder resultar em incndio ou exploso. No permita que os contactos eletrnicos do mdulo de comunicao toquem em simultneo num pedao de metal (uma moeda ou um clip para papel, por exemplo). No utilize o mdulo de comunicao CADD-Solis se este estiver danificado, se os componentes eletrnicos internos ficarem expostos devido a desgaste ou se os contactos eletrnicos estiverem danificados de alguma forma. Da pode resultar incndio, choque ou qualquer outro perigo. No tente destruir o mdulo de comunicao CADD-Solis ou a bateria recarregvel. Da pode resultar incndio, choque ou qualquer outro perigo. No destrua a bateria recarregvel do mdulo de comunicao CADD-Solis por incinerao. Pode explodir. No utilize o mdulo de comunicao na bolsa da bomba de infuso CADD-Solis ou em qualquer outra bolsa ou saco. O mdulo de comunicao pode sobreaquecer e desligar-se utilizando o circuito de proteo trmica. Existem potenciais perigos para a sade associados eliminao incorreta de pilhas e de outros componentes eletrnicos. Elimine as baterias e outros acessrios usados, de forma ecologicamente segura e em conformidade com quaisquer regulamentaes aplicveis. 85 PRECAUES No use fora excessiva ao separar a tampa do mdulo de comunicao CADD-Solis da respetiva base. O cabo da antena deve permanecer encaixado na tampa e na base. Desligar o cabo da antena pode resultar em danos na antena e/ou nos componentes eletrnicos do mdulo de comunicao. O no carregamento integral da bateria recarregvel do mdulo de comunicao CADD-

Solis antes da utilizao inicial e durante um perodo de armazenamento prolongado pode causar um descarregamento total da bateria, o que levar necessidade de substituio prematura da bateria. A porta USB na bomba de infuso CADD-

Solis destina-se a comunicao apenas com o PharmGuard Medication Safety Software, SureLink Remote Support Software e o software CADD Solis Network Setup Utility. No ligue acessrios no suportados porta USB (por ex., carregamento de outros dispositivos, ligao de um dongle sem fios), uma vez que tal pode danificar a bomba. Se o mdulo de comunicao CADD-Solis for armazenado fora das condies de ambiente operacional e nas condies de armazenamento ambientais especificadas, deixe o mdulo de comunicao aquecer ou arrefecer at atingir a temperatura ambiente durante pelo menos uma hora antes de utilizar, para evitar danos no circuito eletrnico. 86 Acerca do mdulo de comunicao CADD-Solis, modelo 2131 O sistema de comunicao de rede CADD-Solis(NCS) consiste numa bomba de infuso ambulatria CADD-

Solis, Modelo 2110 (verso de software 4.2 ou superior), com um mdulo de comunicao CADD-Solis instalado e configurado para a sua rede sem fios e para o servidor PharmGuard. Quando instalado e corretamente configurado, o mdulo de comunicao permite que a bomba envie, sem fios, o histrico da bomba para um servidor PharmGuard e permite receber atualizaes do firmware e da biblioteca da bomba. O modelo 2131 um mdulo de comunicao atualizado a partir do 2130. O rdio mais robusto, incluindo uma melhor segurana e encriptao e incorporando um suporte de banda n do canal de 20 MHz. O mdulo de comunicao CADD-Solis inclui um rdio sem fios e uma bateria recarregvel no interior do mdulo. A bateria alimenta o mdulo de comunicao e fornece alimentao bomba CADD-Solis quando a alimentao de CA no est prontamente disponvel. Abateria recarregvel carregada sempre que a bomba ligada fonte de alimentao deCA atravs do adaptador de CA CADD-Solis, mesmo seabomba estiver desligada. O adaptador de CA CADD-

Solis e o cabo de alimentao

(disponveis em separado) so utilizados para ligar bomba para carregar a bateria quando o mdulo de comunicao est instalado na bomba CADD-Solis. O software CADD-Solis Network Setup Utility

(disponvel em separado) utilizado para configurar as definies da rede sem fios para a bomba especfica quando um mdulo de comunicao CADD-Solis instalado. Para obter informaes sobre a utilizao deste software, consulte as instrues de instalao fornecidas com o software. NOTA: Deve ser utilizada a verso 1.1 do software Network Setup Utility. ADVERTNCIA: Uma bateria recarregvel do mdulo de comunicao CADD-Solis cuja vida til terminou deve ser substituda por outra bateria recarregvel CADD-Solis. No utilize baterias de substituio de outros fabricantes, uma vez que tal poder resultar em incndio ou exploso. Para obter mais informaes, consulte o alarme Bateria recarregvel em fim de validade no manual do operador da bomba. ADVERTNCIA: No ligue quaisquer adaptadores de CA diretamente bateria recarregvel do mdulo de comunicao CADD-Solis. A ligao direta de um adaptador de CA pode ser perigosa e pode provocar danos na bateria recarregvel, no mdulo de comunicao e na bomba. Instalao do mdulo de comunicao CADD-Solis PRECAUO: A instalao e configurao do mdulo de comunicao CADD-Solis numa bomba s devem ser efetuadas por pessoal da assistncia tcnica. PRECAUO: Para evitar danos no mdulo de comunicao, desligue a bomba e desligue todos os cabos conectados bomba antes de instalar o mdulo de comunicao na bomba. PRECAUO: Como a instalao inicial do mdulo de comunicao requer a abertura do alojamento do mdulo, esta instalao s deve ser efetuada numa estao de trabalho com controlos de descarga eletrosttica (DES), incluindo um tapete e uma pulseira antiesttica com ligao terra. 1. Certifique-se de que a bomba CADD-Solis est desligada e que no existem cabos ligados bomba. 2. Utilizando os dedos, a chave da bomba ou uma moeda, rode o boto que se encontra na porta do compartimento das pilhas no sentido oposto ao dos ponteiros do relgio e abra a porta do compartimento das pilhas. 3. Remova quaisquer pilhas que possam estar na bomba. Certifique-se tambm de que no existem detritos no compartimento das pilhas. 4. Puxe a porta do compartimento das pilhas para trs, conforme apresentado, para a retirar da bomba. A porta do compartimento das pilhas no utilizada com o mdulo de comunicao CADD-

Solis. Mantenha a porta do compartimento das pilhas num local acessvel para poder utilizar a bomba posteriormente com pilhas AA ou com a bateria recarregvel CADD-Solis. 87 5. Os trs isoladores com pinos pogo localizados nos trs pinos pogo no compartimento das pilhas da bomba devem ser substitudos pelos isoladores fornecidos com o conjunto do mdulo de comunicao. So necessrios trs isoladores, sendo que um quarto isolador fornecido como extra. Elimine os isoladores originais. Com uma pina, remova cuidadosamente e elimine os trs isoladores de pinos pogo originais conformeapresentado. Isolador de pinos pogo 6. Instale os trs novos isoladores com pinos pogo fornecidos com o conjunto do mdulo de comunicao. 88 7. Certifique-se de que os trs novos isoladores com pinos pogo esto devidamente encaixados em redor dospinos. NOTA: Os trs novos isoladores com pinos pogo so tambm compatveis com pilhas AA e com a bateria recarregvel CADD-Solis. Elimine os isoladores de pinos pogo originais, uma vez que estes j no so necessrios. 8. A bateria recarregvel no interior do mdulo de comunicao no est ligada e deve ser ligada internamente. Para aceder bateria para a ligar, use uma chave de estrela de 10 IP para retirar os dois parafusos por baixo da tampa do mdulo de comunicao. ADVERTNCIA: Para evitar potenciais leses e danos, no retire a tampa do mdulo de comunicao enquanto este estiver instalado e ligado bomba nem permita que os contactos eletrnicos de um mdulo de comunicao toquem em simultneo num pedao de metal (uma moeda ou um clip para papel, por exemplo). 9. Retire cuidadosamente a tampa da base do mdulo de comunicao, tendo cuidado para que o cabo da antena no seja retirado nem da tampa nem da base e, em seguida, ligue a ficha da bateria ao recetculo da bateria na placa de circuito impresso do mdulo de comunicao. 89 PRECAUO: No use fora excessiva ao separar a tampa do mdulo de comunicao da respetiva base. O cabo da antena deve permanecer encaixado na tampa e na base. Desligar o cabo da antena pode resultar em danos na antena e/ou nos componentes eletrnicos do mdulo de comunicao. 10. Coloque a tampa do mdulo de comunicao na base, tendo cuidado para colocar o cabo da antena completamente dentro do mdulo de comunicao. 11. Insira e aperte os dois parafusos de estrela na tampa do mdulo de comunicao utilizando a chave de estrela de 10 IP at estarem completamente assentes e, em seguida, rode mais 1/8 de volta (45 graus) aproximadamente. No aperte demasiado. ADVERTNCIA: Certifique-se de que os vedantes volta do permetro da tampa do mdulo e dos orifcios dos parafusos no se perdem nem so danificados quando abre ou fecha o mdulo. Estes vedantes O-ring so necessrios para proteger contra a entrada de gua e DES. 90 Tampa do mdulo de comunicaoBase do mdulo de comunicaoCabo da antenaFicha da bateriaRecetculo da bateria 12. Insira o mdulo de comunicao no compartimento das pilhas da bomba. Fixe a parte inferior do adaptador de braadeira na parte inferior da bomba e, em seguida, encaixe a parte superior do adaptador de braadeira na base do mdulo. NOTA: Alinhe os dentes do adaptador de braadeira com a abertura com reentrncia no alojamento da bomba. Adaptador de braadeira Dentes de alinhamento Abertura com reentrncia da bomba 13. Utilize uma chave da bomba CADD-Solis, uma chave de fendas padro ou uma moeda para apertar o parafuso para fixar o adaptador de braadeira e o mdulo de comunicao na bomba. Aperte o parafuso at estar completamente assente e, em seguida, rode mais 1/8 de volta (45 graus) aproximadamente. No aperte demasiado. 14. Antes de configurar a bomba para a primeira utilizao, necessrio carregar totalmente o mdulo de comunicao. Consulte a seco seguinte para obter mais informaes sobre o carregamento da bateria recarregvel no mdulo de comunicao CADD-Solis. 15. Se o mdulo de comunicao CADD-Solis estiver a ser instalado numa bomba especfica pela primeira vez, necessrio configurar as definies sem fios da bomba utilizando o software CADD-Solis Network Setup Utility (disponvel em separado). Para obter mais informaes, consulte a documentao fornecida com o software Network Setup Utility. Carregamento da bateria recarregvel A bateria recarregvel do mdulo de comunicao carregada sempre que a bomba CADD-Solis ligada fonte de alimentao de CA atravs do adaptador de CA CADD-Solis, mesmo se a bomba estiver desligada. Dentro do intervalo de temperatura de funcionamento de 2 C a 40 C (35 F a 104 F), a bateria recarregvel fica totalmente carregada em 10 horas ou menos. Carregue completamente a bateria recarregvel:

Antes da primeira utilizao Pelo menos a cada 30 dias em caso de utilizao regular Pelo menos uma vez a cada 6 meses se estiver armazenada Quando a bomba indicar que a bateria est fraca ou descarregada PRECAUO: No recarregar a bateria recarregvel durante armazenamento prolongado pode causar o descarregamento total da bateria, o que levar necessidade de substituio prematura da bateria. PRECAUO: Para evitar danificar o conector do adaptador de CA ou a bomba, no exera fora excessiva ou utilize instrumentos, como alicates, para ligar ou desligar o conector do adaptador de CA. 91 Para carregar a bateria recarregvel:

1. Ligue o cabo de alimentao para o adaptador de CA CADD-Solis a uma tomada de CA e a outra extremidade ao adaptador de CA. 2. Ligue o conector do adaptador de CA ficha de alimentao de CA (com etiqueta 7V) na bomba CADD-Solis. Se estiver devidamente ligada, a luz azul na bomba, ao lado do conector, acende. ADVERTNCIA: No ligue quaisquer adaptadores de CA diretamente bateria recarregvel do mdulo de comunicao CADD-Solis. A ligao direta de um adaptador de CA pode ser perigosa e pode provocar danos na bateria, no mdulo de comunicao e na bomba. PRECAUO: No empurrar o conector de sada do adaptador de CA para dentro at ao limite na ligao bomba pode dar origem a uma ligao intermitente e o conector pode desligar-se, provocando uma falha de alimentao e no carregando a bateria recarregvel. 3. Quando a bomba ligada, a barra de estado da bomba indica por breves instantes Adaptador de CA ligado. 92 4. Quando a bomba est ligada, a barra de estado da bomba mostra que a bomba est ligadaaumafonte de alimentao de CA. Aparece um pequeno indicador de ficha direita do cone da bateria. 5. Quando a bomba est ligada, possvel aceder ao nvel de bateria estimado a partir da barra de estado no ecr da bomba. Para obter mais informaes, consulte o Manual do operador dabomba. Quando a bateria estiver completamente carregada, pode optar por desligar a ficha do adaptador de CA. Depois de desligar a ficha, aparece por breves instantes a mensagem Adaptador de CA desligado. Configurao das definies sem fios utilizando o software CADD-Solis Network Setup Utility Todas as definies sem fios da bomba e do mdulo de comunicao CADD-Solis so configuradas utilizando o software CADD-Solis Network Setup Utility (vendido em separado) atravs de uma ligao USB entre um PC e a bomba CADD-Solis. O software CADD-Solis Network Setup Utility permite-lhe selecionar e introduzir todas as definies sem fios para configurao dos pontos de acesso da rede sem fios e do seu servidor PharmGuard. Estas definies podem ser guardadas na bomba CADD-Solis. Por conseguinte, se um mdulo de comunicao CADD-

Solis for substitudo para a bomba, o novo mdulo de comunicao utilizar automaticamente as definies sem fios pr-configuradas da bomba. Para obter mais informaes, consulte a documentao fornecida com o software CADD-Solis Network Setup Utility. Ligar/Desligar o rdio sem fios Quando o mdulo de comunicao CADD-

Solis est instalado, o respetivo rdio sem fios pode ser ligado ou desligado conforme necessrio (por ex., desligar para poupar bateria, etc.). Isto pode ser feito a qualquer altura a partir do menu Tarefas no ecr da bomba sem interromper funes clnicas da bomba, como uma infuso em curso. Para obter mais informaes, consulte o Manual do operador da bomba. Ver o estado e as definies sem fios Embora o software CADD-Solis Network Setup Utility lhe permita ver e alterar as definies sem fios, pode tambm consultar o estado e as definies sem fios no ecr da bomba CADD-Solis. O estado sem fios indicado no ecr principal da bomba:

Sem fios desligado (indicador branco) Sem fios ligado, no associado ao ponto de acesso sem fios (indicador laranja) Sem fios ligado, associado ao ponto de acesso sem fios (indicador laranja com centro verde) Sem fios ligado, associado ao ponto de acesso sem fios e a comunicar com o servidor PharmGuard (indicador verde comcentro verde) Adicionalmente, pode ver o estado sem fios e as definies sem fios detalhadas. A partir do menu Relatrios da bomba, selecione Estado s/ fios ou Definies s/ fios. Para ver a verso do mdulo de comunicao (CM) e o endereo MAC, selecione Informaes sobre o dispositivo a partir do menu Relatrios. Para obter mais informaes, consulte o Manual do operador da bomba. 93 Resoluo de problemas Problema A bateria recarregvel no carrega. A bateria est totalmente carregada mas no funciona nabomba. O rdio sem fios est ligado e o cone de estado sem fios da bomba apresenta Sem fios ligado, no associado ao ponto de acesso sem fios

(indicador laranja). Causa provvel/Soluo O conector do adaptador de CA pode no estar completamente inserido na porta de ligao na bomba. Insira completamente o conector do adaptador de CA na bomba. A bateria pode estar demasiado quente ou demasiado fria. Certifique-se de que as condies ambientes esto em conformidade com as especificaes para funcionamento. Os trs isoladores de pinos pogo de substituio no esto instalados ou esto incorretamente instalados. Pode haver um problema de contacto entre a bomba e o mdulo de comunicao. Certifique-se de que os contactos no mdulo de comunicao esto limpos. Certifique-se de que o compartimento das pilhas e os contactos na bomba esto limpos. Experimente o mdulo de comunicao noutra bomba. Se funcionar na segunda bomba, porque provavelmente existe algum problema na primeira bomba. Se o mdulo de comunicao no funcionar na segunda bomba, existe provavelmente um problema com o mdulo de comunicao e/ou com a bateria recarregvel. Contacte o Servio de Atendimento a Clientes da Smiths Medical. O mdulo de comunicao pode estar no modo de reduo de calor, consulte o Manual do operador da bomba. As definies sem fios esto incorretamente configuradas. Verifique e/ou configure as definies. O mdulo de comunicao est demasiado afastado de um ponto de acesso sem fios. Mova-o para um local mais prximo de um ponto de acesso. A bomba desliga automaticamente o rdio devido a bateria descarregada. Ligue a bomba ao Mdulo de comunicao nas imediaes de um forno microondas em funcionamento. Afaste o adaptador de CA. mdulo do forno microondas. Bateria recarregvel prxima do prazo de validade. Substituir bateria. Alarmes da bomba associados ao mdulo de comunicao A bateria recarregvel est prxima do respetivo prazo de validade. Foi descarregada e recarregada tantas vezes que brevemente atingir o respetivo prazo de validade. Pode continuar a utiliz-la neste estado. Bateria recarregvel em fim de validade. A bomba no funciona. A bateria recarregvel do mdulo de comunicao CADD-Solis est no fim da validade. Foi descarregada e carregada tantas vezes que j no se encontra capaz de manter uma boa carga. Substituir por uma nova bateria recarregvel do mdulo de comunicao CADD-Solis. Bateria inutilizvel. Abomba no funciona. A bateria no compatvel com a bomba ou ocorreu um erro de comunicao. Para obter mais informaes, consulte o Manual do operador da bomba. Ligao do mdulo de comunicao intermitente com a bomba. A ligao entre o mdulo de comunicao e a bomba intermitente. Para obter mais informaes, consulte o Manual do operador da bomba. 94 Transporte O mdulo de comunicao foi testado e est em conformidade com os regulamentos de transporte nas Naes Unidas UN/DOT ST/SG/AC.10/11 (Rev. 5) Seco 38.3 Requisitos de teste T1-T5, T7. Eliminao/Recolha em separado A bateria recarregvel do mdulo de comunicao deve ser completamente descarregada antes da eliminao e/ou os terminais devem ser tapados com fita adesiva ou tampas para evitar curto-circuito. Os residentes fora da Unio Europeia devem eliminar ou reciclar este produto em conformidade com as leis ou regulamentos locais aplicveis. Recolher em separado Este produto contm componentes eltricos e eletrnicos que podem conter materiais que, se eliminados com os resduos urbanos, podero ser prejudiciais para o ambiente. Em conformidade com a Diretiva 2002/96/CE relativa aos Resduos de equipamentos eltricos e eletrnicos, os residentes na Unio Europeia devem seguir as instrues de reciclagem ou eliminao especficas para este produto. Contacte o seu distribuidor local ou visite o website seguinte para obter instrues especficas:

http://www.smiths-medical.com/recycle/index.html ADVERTNCIA: Existem potenciais perigos para a sade associados eliminao incorreta de pilhas e de outros componentes eletrnicos. Elimine as baterias e outros acessrios usados, de forma ecologicamente segura e em conformidade com quaisquer regulamentaes aplicveis. Informaes referentes regulamentao REACH Ao abrigo da Regulamentao Europeia para registo, avaliao, autorizao e restrio de produtos qumicos

(Regulamentao REACH CE No. 1907/2006) as empresas so obrigadas a divulgar aos clientes se um produto contm alguma das substncias identificadas na Lista de candidatos de substncias para autorizao (Candidate List of Substances for Authorization) (tambm conhecida como Substncias de preocupao muito elevada [Substances of Very High Concern, SVHC]) numa concentrao superior a0,10% por peso. Poder encontrar as declaraes daSmithsMedical relativas a SVHC em produtos em www.smiths-medical.com/environment. Certificao da Parte 15 Este dispositivo est em conformidade com a parte 15 das Regras da FCC. O funcionamento est sujeito s duas condies que se seguem: (1) este dispositivo no pode causar interferncias nocivas e (2) este dispositivo deve aceitar qualquer interferncia recebida, incluindo interferncia que possa causar um funcionamento indesejado. Limpeza e desinfeo do mdulo de comunicao Como boa prtica e para melhor eficcia, recomendamos que limpe primeiro e desinfete em seguida o mdulo. Todos os desinfetantes exigem uma pr-limpeza, exceto os produtos de limpeza desinfetantes que so testados para desinfetar na presena de 5% de matria orgnica. PRECAUO: No mergulhe o mdulo de comunicao em lquido de limpeza ou gua. No deixe que a soluo seja absorvida pelo mdulo de comunicao. A humidade acumulada no interior do mdulo de comunicao poder danificar o dispositivo. Limpe e desinfete as superfcies expostas do mdulo de comunicao quando este estiver instalado na bomba. 95 PRECAUO: Para evitar danos nos componentes eletrnicos internos do mdulo de comunicao, no deixe que a soluo seja absorvida pela rea dos contactos eletrnicos ou em aberturas e costuras. Utilize um pano seco sem pelos para limpar os contactos eletrnicos e a rea circundante normalmente fechada quando instalado na bomba. Para limpar e desinfetar o mdulo de comunicao, siga estes passos:

1. Limpe o mdulo de comunicao com uma soluo de detergente neutro para remover resduos ou material contaminado. Aplique a soluo num pano macio e sem pelos e, em seguida, limpe as superfcies expostas do mdulo de comunicao, quando instalado na bomba. No deixe que a soluo seja absorvida pela bomba ou pelo mdulo de comunicao. 2. Desinfete o mdulo de comunicao aplicando uma soluo desinfetante (listada abaixo) de acordo com as instrues do rtulo do produto desinfetante. Se utilizar um lquido ou spray, aplique a soluo num pano macio e sem pelos e, em seguida, limpe as superfcies expostas do mdulo de comunicao, quando instalado na bomba. Siga as recomendaes do fabricante do desinfetante relativamente aos tempos de contacto do mesmo. No deixe que a soluo seja absorvida pela bomba ou pelo mdulo de comunicao. As solues desinfetantes aceitveis para o mdulo de comunicao CADD-Solis encontram-se listadas abaixo. Produto Fabricante

(Nmero de registo EPA) Ingrediente(s) ativo(s) CaviWipes Metrex

(46781-8) 17,2% de isopropanol Sani-Cloth Super PDI (9480-4) Cloreto de dimetil benzil amnio, Cloreto de dimetil etil benzil amnio Tempo de contacto/

ao 3 minutos 2 minutos Lixvia Sani-

Cloth PDI (9480-8) 0,60% de hipoclorito desdio 4 minutos 3. Deixe o mdulo de comunicao secar completamente antes de utilizar. 96 Especificaes Tipo de bateria Bateria recarregvel de ies de ltio (2 clulas) Teor de ltio equivalente <1,6 g Capacidade da bateria 18,7 Wh (quando totalmente carregada) Sada da bateria 3,6 V (nominal) Peso da bateria recarregvel

<100 g Requisitos do ambiente operativo Temperatura . 2 C a 40 C

(35 F a 104 F) Humidade . 20% a 90% de humidade relativa, sem condensao Presso atmosfrica . 70 kPa a 106 kPa

(10,2 psia a 15,4 psia) Requisitos ambientais para armazenamento e transporte Temperatura . 20 C a 60 C

(4 F a 140 F) Humidade . 20% a 90% de humidade relativa, sem condensao Presso atmosfrica . 70 kPa a 106 kPa

(10,2 psia a 15,4 psia) Vida til da bateria 400 ciclos completos (carga/descarga) temperatura ambiente, 23 C (73 F) Tempo mximo de carga (bateria completamente descarregada a carga total) 10 horas quando ligada ao Adaptador de CA Tempo de execuo da bomba e do mdulo de comunicao (nova bateria) 4 horas com as definies nominais da bomba

(consulte o Manual do operador da bomba para informaes sobre as definies nominais) Segurana O mdulo de comunicao cumpre as normas do Underwriters Laboratories UL 2054, IEC60601-1(2005 + A1:2012) Ed 3.1 [quando instalado na bomba de infuso CADD-Solis Modelo 2110], IEC 60601-1-2 (2014) e IEC 62133

(2002). As clulas de ies de ltio cumprem a norma UL1642 do Underwriters Laboratories. IEEE 802.11 a,b,g,n Rdio para comunicao de rede O mdulo de comunicao CADD-Solis recebe e transmite intencionalmente energia eletromagntica de radiofrequncia (RF) para comunicao no crtica. Transmisso/receo RF, banda a . 5180 MHz a 5320 MHz e 5500 MHz a 5825 MHz Transmisso/receo RF, bandas b, g e n ............................................... 2412 MHz a 2472 MHz Largura de banda de sinais a, b, g e n .............................................20 MHz Potncia mxima de transmisso RF da banda a ............................10 mW Potncia mxima de transmisso RF das bandas b, g e n .......100 mW 97 Alcance sem fios do mdulo de comunicao:

36,58 metros (120 ps) (funcionamento na linha de viso com ponto de acesso) Modos de rede e encriptao Modos de rede:

Modos de encriptao:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Nenhum TKIP CCMP TKIP/CCMP Modos de autenticao: Modos EAP:

Nenhum ABERTO EAP-TLS (v1.0 e v1.2) WPA-ENT WPA2-ENT EAP-TTLS WPA-PSK WPA2-PSK EAP-PEAPV0 (PEAP com MS-CHAPv2) EAP-PEAPV1 (PEAP com GTC) EAP-LEAP EAP-FAST Certificados:

SSL SHA-1 SSL SHA-2 Nota: O mdulo de comunicao pode ser alvo de interferncia de outros equipamentos, mesmo queesses equipamentos cumpram os requisitos CISPR 11. Para especificaes e informaes de configurao adicionais da rede do mdulo de comunicao CADD-Solis, consulte o Guia de instalao e do utilizador do Network Setup Utility (Verso 1.1). Interferncia/Distncias de separao Outros dispositivos de comunicao eletrnicos utilizados nas proximidades do mdulo de comunicao podem gerar uma transmisso de dados com interrupes. Atransmisso de dados com interrupes no afeta a administrao da bomba. Atabela abaixo especifica que efeito causado por cada tipo de dispositivo e descreve adistncia de separao mnima a cumprir. Interferente (tipo de dispositivo eletrnico) Estaes-base para transmissores sem fios de 2,4 GHz/5 GHz (por ex., pontos de acesso Wi-Fi, estaes-

base para telefones sem fios) Dispositivos mdicos sem fios de 2,4 GHz/5 GHz e outros perifricos (por ex., monitores do paciente ativados por Wi-Fi, bombas de infuso, computadores/

smartphones/tablets; dispositivos ativados por Bluetooth; dispositivos ativados por Zigbee; aparelhos de telefone sem fios) Outras bombas CADD-Solis da Smiths Medical com conectividade sem fios Etiquetas de localizao de ativos RFID de 433 MHz/2,4 GHz/5 GHz 98 Distncia de separao mn. 3 metros

(9,84 ps) 1 metro

(3,28 ps) 0,3 metros

(1 p) Contacto direto Garantia limitada Garantia: A Smiths Medical ASD, Inc. (o Fabricante) garante ao Comprador Original que todas as peas e componentes do mdulo de comunicao CADD-Solis

(o Mdulo de comunicao), que so fabricados por ou para o Fabricante, excetuando os itens indicados abaixo, esto isentos de defeitos de material e fabrico em utilizao normal, se utilizado de acordo com as Instrues de Utilizao, pelo perodo de um ano (1) a contar da data de venda ao Comprador Original. NOEXISTEM QUAISQUER OUTRAS GARANTIAS. Excees: Esta garantia no cobre o normal uso e desgaste nem artigos de manuteno e exclui especificamente quaisquer outros artigos ou equipamento acessrio utilizado com o Mdulo de comunicao. Procedimentos de garantia: Sujeito s condies e em conformidade com a presente Garantia Limitada, o Fabricante ir reparar ou substituir, a seu prprio critrio e custo ( exceo de uma cobrana mnima relativa ao transporte e processamento) qualquer Mdulo de comunicao (no incluindo os acessrios) defeituoso caso seja efetuada uma reclamao durante o referido perodo de um ano. NO envie qualquer Mdulo de comunicao ou componente ao Fabricante para reparao ao abrigo da Garantia, sem informaes especficas de envio do Departamento de Assistncia ao Cliente. Condies: As condies, limitaes e excluses seguintes aplicam-se obrigao do Fabricante ao abrigo da presente garantia:

A. Anulao da Garantia: Esta garantia ser nula caso o Mdulo de comunicao ou qualquer pea ou componente do mesmo tenha sido 1) reparado por qualquer outro indivduo que no o Fabricante ou agente autorizado; 2) modificado de modo a afetar a estabilidade ou fiabilidade do mesmo; 3) utilizado indevidamente; ou, 4) danificado por negligncia ou acidente. Utilizao indevida inclui, sem se limitar a, utilizao de forma no conforme s Instrues de Utilizao do Mdulo de comunicao ou com acessrios no aprovados. B. Limitaes e excluses: A substituio do Mdulo de comunicao ou de qualquer componente do mesmo constitui uma soluo EXCLUSIVA oferecida pelo Fabricante. Todas as recomendaes, informaes e literatura descritiva fornecidas pelo Fabricante relativamente ao Mdulo de comunicao so consideradas como sendo exatas e fiveis mas no constituem quaisquer garantias. Nenhum agente, representante ou funcionrio do Fabricante tem autoridade para comprometer o Fabricante a qualquer compromisso ou garantia, expressos ou implcitos. NO EXISTE QUALQUER GARANTIA DE COMERCIABILIDADE OU ADEQUABILIDADE OU UTILIZAO DO MDULO DE COMUNICAO PARA QUALQUER FIM ESPECFICO. O FA B R I C A N T E D E C L I N A Q U A L Q U E R RESPONSABILIDADE PELA ADEQUABILIDADE DO MDULO DE COMUNICAO PARA UM TRATAMENTO MDICO ESPECFICO OU POR QUAISQUER COMPLICAES RESULTANTES DA UTILIZAO DO MDULO DE COMUNICAO. O FABRICANTE NO SER RESPONSABILIZADO POR QUAISQUER DANOS MATERIAS OCASIONAIS OU CONSEQUENCIAIS, PERDA DE LUCROS OU PERDA DE UTILIZAO CAUSADOS POR QUALQUER DEFEITO OU AVARIA DO MDULO DE COMUNICAO. Esta garantia confere ao Comprador Original direitos legais especficos e o Comprador Original poder teroutros direitos legais que podem variar de estado para estado. 99 3 Dutch / Nederlands Inhoud English . 4 French / Franais . 20 German / Deutsch . 36 Italian / Italiano . 52 Spanish / Espaol . 68 Portuguese / Portugus . 84 Waarschuwingen . 101 Aandachtspunten . 102 De CADD-Solis-communicatiemodule, model 2131 . 102 De CADD-Solis-communicatiemodule installeren . 103 De oplaadbare batterij opladen . 107 Instellingen voor draadloze verbinding met de CADD-Solis Network Setup Utility-software configureren . 108 Draadloze radio in-/uitschakelen . 109 Status en instellingen voor draadloze verbinding weergeven . 109 Problemen oplossen . 110 Transport . 111 Afvoer/gescheiden inzameling . 111 Informatie over REACH . 111 Certificatie conform Part 15 . 111 De communicatiemodule reinigen en desinfecteren . 111 Specificaties . 113 Beperkte garantie . 115 Swedish / Svenska . 116 Danish / Dansk . 132 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 100 BELANGRIJK: De oplaadbare batterij in de CADD-Solis-

communicatiemodule moet intern worden aangesloten en geheel opgeladen in de pomp geplaatst zijn voordat het systeem in gebruik wordt genomen. Lees en volg vr gebruik de instructies in deze gebruikershandleiding voor het installeren en opladen van de batterij. Lees de instructies volledig door voordat u de CADD-Solis-communicatiemodule aansluit op de CADD-Solis ambulante infuuspomp, model2110. Bewaar deze instructies voor toekomstige raadpleging. Raadpleeg de Gebruikershandleiding van de pomp voor uitgebreide instructies, waarschuwingen, specificaties en aanvullende informatie over de bediening van de CADD-Solis ambulante infuuspomp. Raadpleeg de gebruiksaanwijzing bij de CADD-

Solis AC-adapter voor uitgebreide instructies, waarschuwingen, specificaties en aanvullende informatie over het gebruik van deze adapter. WAARSCHUWINGEN Ter voorkoming van ernstig lichamelijk letsel dienen de volgende waarschuwingen in acht te worden genomen:

Stel de communicatiemodule tijdens gebruik niet bloot aan regen, water of vocht. Als u dit niet in acht neemt, kan dit leiden tot shock of ander gevaar. Dompel de oplaadbare batterij van de CADD-Solis-communicatiemodule niet onderin vloeistof. Als u dit niet in acht neemt, kan dit leiden tot shock of ander gevaar. Gebruik de oplaadbare batterij van de CADD-Solis-communicatiemodule met geen enkel ander apparaat dan de CADD-Solis-

communicatiemodule. Sluit geen AC-adapters rechtstreeks aan op de oplaadbare batterij van de CADD-Solis-

communicatiemodule. Een rechtstreekse aansluiting van een AC-adapter kan gevaarlijk zijn en kan de oplaadbare batterij, de communicatiemodule en de pomp beschadigen. Een oplaadbare batterij voor de CADD-Solis-

communicatiemodule waarvan de levensduur is verstreken, moet worden vervangen door een andere oplaadbare batterij voor de CADD-Solis-communicatiemodule. Gebruik van oplaadbare batterijen van een ander merk kan resulteren in brand of ontploffing. Zorg dat de elektronische contacten van de communicatiemodule niet tegelijkertijd in contact komen met metaal (bijv. een munt ofpaperclip). Gebruik de CADD-Solis-communicatiemodule niet als deze beschadigd is, als de interne elektronica blootliggen vanwege slijtage of als de elektronische contacten beschadigd zijn. Als u dit niet in acht neemt, kan dit leiden tot brand, shock of ander gevaar. Probeer niet de CADD-Solis-communicatie-

module of de oplaadbare batterij te pletten. Als u dit niet in acht neemt, kan dit leiden tot brand, shock of ander gevaar. Vernietig de oplaadbare batterij van de CADD-Solis-communicatiemodule niet door middel van verbranding. De batterij zou anders kunnen exploderen. Gebruik de communicatiemodule niet terwijl deze zich in de zak van de CADD-Solis-

infuuspomp of in een andere zak bevindt. Decommunicatiemodule kan oververhit raken en via de thermische beveiligingsschakeling worden uitgeschakeld. Aan het verkeerd afvoeren van batterijen of andere elektronica zijn gezondheidsrisicos verbonden. Voer gebruikte batterijen en andere accessoires af volgens de milieurichtlijnen en in overeenstemming met alle andere regelgeving die van toepassing kan zijn. 101 AANDACHTSPUNTEN Gebruik geen overmatige kracht om de kap van de CADD-Solis-communicatiemodule los te halen van de basis. De antennekabel moet zowel aan de kap als aan de basis bevestigd blijven. Als de antennekabel loskomt, kunnen de antenne en/of elektronica van de communicatiemodule beschadigd raken. Als u de oplaadbare batterij van de CADD-Solis-

communicatiemodule vr het eerste gebruik en tijdens langdurige opslag niet volledig oplaadt, kan dit volledige ontlading van de batterij veroorzaken. Hierdoor moet de batterij voortijdig worden vervangen. De USB-poort op de CADD-Solis infuuspomp is uitsluitend bestemd voor communicatie met de PharmGuard Medication Safety Software, SureLink Remote Support Software en CADD Solis Network Setup Utility-software. Sluit geen niet-ondersteunde accessoires aan op de USB-poort (bijv. opladen van andere apparaten, aansluiten van een draadloze dongle), omdat dit de pomp kan beschadigen. Als de CADD-Solis-communicatiemodule wordt bewaard buiten de grenzen van de omgevingsomstandigheden voor gebruik maar binnen de grenzen van de omgevingsomstandigheden voor opslag, moet minimaal een uur vr gebruik worden gewacht om de communicatiemodule te laten opwarmen of afkoelen ter voorkoming van beschadiging vande elektronische schakelingen. 102 De CADD-Solis-communicatiemodule, model 2131 Het CADD-Solis Network Communication System

(NCS) bestaat uit een CADD-Solis ambulante infuuspomp, model 2110 (softwareversie 4.2 of hoger), met een CADD-Solis-communicatiemodule genstalleerd en geconfigureerd voor gebruik met uw draadloze netwerk en PharmGuard Server. Nainstallatie en de juiste configuratie kan de pomp met behulp van de communicatiemodule de pompgeschiedenis draadloos versturen naar een PharmGuard Server, en tevens updates van depompfirmware en bibliotheken ontvangen. Model 2131 is een upgrade van communicatiemodule model 2130. De radio is krachtiger, omvat betere beveiliging en versleuteling en biedt ondersteuning voor gebruik van een 'n'-band voor het 20MHz-kanaal. De CADD-Solis-communicatie-

module is uitgerust met de draadloze radio en een oplaadbare batterij in de module. De batterij voedt de communicatiemodule en levert stroom aan de CADD-

Solis-pomp als er geen netvoeding beschikbaar is. De oplaadbare batterij wordt opgeladen wanneer de pomp is aangesloten op netvoeding via de CADD-Solis AC-

adapter, zelfs als de pomp uit staat. De CADD-Solis AC-adapter en het netsnoer (afzonderlijk verkrijgbaar) worden gebruikt om op de pomp aan te sluiten voor het opladen van de batterij wanneer de communicatiemodule in de CADD-Solis-pomp is genstalleerd. De CADD-Solis Network Setup Utility-software

(afzonderlijk verkrijgbaar) wordt gebruikt om de instellingen van het draadloze netwerk voor de pomp in kwestie te configureren als er een CADD-Solis-communicatiemodule is genstalleerd. Meer informatie over het gebruik van deze software vindtuin de installatie-instructies die met de software zijn meegeleverd. OPMERKING: Versie 1.1 van de Network Setup Utility moet worden gebruikt. WAARSCHUWING: Een oplaadbare batterij voor de CADD-Solis-communicatiemodule waarvan de levensduur is verstreken, moet worden vervangen door een andere oplaadbare batterij voor de CADD-Solis-communicatiemodule. Gebruik geen vervangende batterijen van een ander merk, aangezien dit kan resulteren in brand of ontploffing. Zie voor meer informatie het alarm Einde gebruiksduur oplaadbare batterij bereikt in de Gebruikershandleiding van de pomp. WAARSCHUWING: Sluit geen AC-adapters rechtstreeks aan op de oplaadbare batterij van de CADD-Solis-communicatiemodule. Een rechtstreekse aansluiting van een AC-adapter kan gevaarlijk zijn en kan de oplaadbare batterij, de communicatiemodule en de pomp beschadigen. De CADD-Solis-communicatiemodule installeren LET OP: Alleen onderhoudspersoneel mag de CADD-Solis-communicatiemodule op een pomp installeren en configureren. LET OP: Ter voorkoming van beschadiging van de communicatiemodule moet de pomp worden uitgeschakeld en moeten alle op de pomp aangesloten kabels worden losgekoppeld voordat de communicatiemodule op de pomp wordt genstalleerd. LET OP: Omdat bij de eerste keer installeren van de communicatiemodule de modulebehuizing moet worden geopend, mag deze installatie alleen worden verricht op een werkstation met voorzieningen voor elektrostatische ontlading(ESD), inclusief een geaarde mat en polsband. 1. Zorg dat de CADD-Solis-pomp is uitgeschakeld en dat er geen kabels op de pomp zijn aangesloten. 2. Draai de knop op het batterijklepje met uw vingers, de pompsleutel of een munt linksom enopen het batterijklepje. 3. Haal de batterijen (indien aanwezig) uit de pomp. Controleer meteen of het batterijvakje geen vuil of stof bevat. 4. Trek het batterijklepje naar achteren, zoals afgebeeld, om het van de pomp te verwijderen. Het batterijklepje wordt niet met de CADD-Solis-

communicatiemodule gebruikt. Bewaar het batterijklepje op een goed toegankelijke plaats zodat de pomp later met AA-batterijen of met de CADD-Solis oplaadbare batterij kan worden gebruikt. 103 5. De drie pogo-pen-isolators op de drie pogo-pennen in het batterijvakje op de pomp moeten worden vervangen door de isolators die met de communicatiemodule zijn meegeleverd. Er zijn drie isolators vereist; een vierde isolator wordt als reserve meegeleverd. Gooi de oorspronkelijke isolators weg. Verwijder de drie oorspronkelijke pogo-pen-isolators voorzichtig met een pincet zoals afgebeeld en gooize weg. Pogo-pen-isolator 6. Installeer de drie nieuwe pogo-pen-isolators die met de communicatiemodule zijn meegeleverd. 104 7. Controleer of de drie nieuwe pogo-pen-isolators helemaal over de pennen zijn geschoven. OPMERKING: De drie nieuwe pogo-pen-isolators kunnen ook worden gebruikt met AA-batterijen en de CADD-Solis oplaadbare batterij. Gooi de oorspronkelijke pogo-pen-isolators weg; deze zijn niet meer nodig. 8. De oplaadbare batterij in de communicatiemodule is niet aangesloten en moet intern worden aangesloten. U komt als volgt bij de batterij om deze aan te sluiten: gebruik een 10 IP torxschroefbit omdetwee schroeven onder de kap van de communicatiemodule te verwijderen. WAARSCHUWING: Om letsel en schade te voorkomen mag de kap van de communicatiemodule niet worden verwijderd terwijl deze is genstalleerd en is aangesloten op de pomp. Ook moet worden voorkomen dat de elektronische contacten van de communicatiemodule tegelijkertijd in contact komen met metaal (bijv. een munt of paperclip). 9. Verwijder de kap voorzichtig van de basis van de communicatiemodule zonder dat de antennekabel loskomt van de kap of de basis, en steek de batterijstekker in het batterijcontact op de printplaat vande communicatiemodule. 105 LET OP: Gebruik geen overmatige kracht om de kap van de communicatiemodule los te halen van de basis. De antennekabel moet zowel aan de kap als aan de basis bevestigd blijven. Als de antennekabel loskomt, kunnen de antenne en/of elektronica op de communicatiemodule beschadigd raken. 10. Plaats de kap van de communicatiemodule op de basis en stop de antennekabel hierbij helemaal weg in de communicatiemodule. 11. Plaats de twee torxschroeven onder de kap van de communicatiemodule, schroef ze helemaal in met de 10 IP torxschroefbit en draai ze tenslotte nog ongeveer 1/8 slag (45 graden) aan. Niet te strak aandraaien. WAARSCHUWING: Zorg dat de afdichtingsringen rondom de modulekap en de schroefgaten niet verloren gaan of beschadigd raken wanneer de module wordt geopend of gesloten. Deze O-ringen zijn nodig om de module tegen het binnendringen van water en tegen elektrostatische ontlading tebeschermen. 106 Kap communicatie-moduleBasis communicatiemoduleAntennekabelBatterijstekkerBatterijcontact 12. Steek de communicatiemodule in het batterijvakje van de pomp. Haak de onderkant van de infuusstandaardadapter vast aan de onderkant van de pomp en druk de bovenkant van de infuusstandaardadapter vervolgens vast op debasis van de module. OPMERKING: Zorg dat de tanden van de infuusstandaardadapter op n lijn liggen met de uitsparing in de pompbehuizing. Infuusstandaardadapter Uitlijntanden Uitsparing pomp 13. Gebruik de sleutel van de CADD-Solis-pomp, een gewone schroevendraaier of een munt om de schroef voor bevestiging van de infuusstandaard-

adapter aan te draaien en de communicatiemodule op de pomp vast te zetten. Schroef de schroef helemaal in en draai hem vervolgens nog ongeveer 1/8 slag (45 graden) aan. Niet te strak aandraaien. 14. Voordat de pomp wordt geconfigureerd en vr het eerste gebruik moet de communicatiemodule eerst volledig worden opgeladen. Zie de volgende paragraaf voor meer informatie over het opladen van de oplaadbare batterij in de CADD-Solis-communicatiemodule. 15. Als de CADD-Solis-communicatiemodule voor de eerste keer in een bepaalde pomp wordt genstalleerd, moeten de instellingen voor draadloze verbinding van de pomp worden geconfigureerd met de CADD-Solis Network Setup Utility-software (afzonderlijk verkrijgbaar). Meer informatie vindt u in de documentatie die met de Network Setup Utility-software is meegeleverd. De oplaadbare batterij opladen De oplaadbare batterij van de communicatiemodule wordt geladen wanneer de CADD-Solis-pomp is aangesloten op netvoeding via de CADD-Solis AC-adapter, zelfs als de pomp uit staat. Binnen het bedrijfstemperatuurbereik van 2C tot 40C (35Ftot 104F) wordt de oplaadbare batterij binnen 10uur helemaal opgeladen. Laad de oplaadbare batterij helemaal op:

vr het eerste gebruik;

ten minste om de 30 dagen bij regelmatig gebruik;

ten minste om de 6 maanden wanneer in opslag;

als de pomp aangeeft dat de batterij bijna of helemaal leeg is. LET OP: Als u de oplaadbare batterij tijdens langdurige opslag niet oplaadt, kan dit volledige ontlading van de batterij veroorzaken. Hierdoor moet de batterij voortijdig worden vervangen. LET OP: Gebruik geen overmatige kracht of gereedschap zoals een tang om de connector van de AC-adapter te bevestigen of te verwijderen. De pomp of de connector van de AC-adapter zou anders beschadigd kunnen raken. 107 Laad de oplaadbare batterij als volgt op:

1. Steek de stekker van het netsnoer voor de CADD-Solis AC-adapter in een stopcontact;

steekhet andere uiteinde van het netsnoer in deAC-adapter. 2. Steek de connector van de AC-adapter in de netvoedingsaansluiting (aangeduid met 7V) op de CADD-Solis-pomp. Bij een goede verbinding gaat het blauwe lampje naast de connector op de pomp branden. WAARSCHUWING: Sluit geen AC-adapters rechtstreeks aan op de oplaadbare batterij van de CADD-Solis-

communicatiemodule. Een rechtstreekse aansluiting van een AC-adapter kan gevaarlijk zijn en kan de batterij, de communicatiemodule en de pomp beschadigen. LET OP: Als de uitgangsconnector van de AC-adapter niet volledig in de pomp is geduwd, kan dit leiden tot een onderbroken verbinding en kan de connector loskomen, waardoor de stroom uitvalt en de oplaadbare batterij niet meer wordt opgeladen. 3. Wanneer de pomp is ingeschakeld, wordt op de statusbalk van de pomp kort het bericht

'AC-adapter aangesloten' weergegeven. 108 4. Als de pomp is ingeschakeld, wordt op de statusbalk van de pomp aangegeven dat de pomp op netvoeding is aangesloten. Rechts van het batterijpictogram ziet u een kleine indicator in de vorm van een stekker. 5. Wanneer de pomp is ingeschakeld, kunt u op de statusbalk op het pompscherm zien hoeveel batterijspanning er resteert. Zie voor meer informatie de Gebruikershandleiding van de pomp. Als de batterij helemaal is opgeladen, kunt u de stekker van de AC-adapter desgewenst loskoppelen. Nahet loskoppelen van de stekker wordt kort het bericht 'AC-adapter losgekoppeld'

weergegeven. Instellingen voor draadloze verbinding met de CADD-Solis Network Setup Utility-

software configureren Alle instellingen voor draadloze verbinding van de pomp en de CADD-Solis-communicatiemodule worden geconfigureerd met de CADD-Solis Network Setup Utility-software (afzonderlijk verkrijgbaar) via een USB-aansluiting van een pc op de CADD-Solis-pomp. Met de CADD-Solis Network Setup Utility-software kunt u alle instellingen voor draadloze verbinding selecteren en invoeren voor configuratie met de toegangspunten van uw draadloze netwerk en uw PharmGuard Server. Deze instellingen kunnen worden opgeslagen op de CADD-Solis-pomp. Als de CADD-

Solis-communicatiemodule op de pomp is vervangen, gebruikt de nieuwe communicatiemodule automatisch de reeds geconfigureerde instellingen voor draadloze verbinding van de pomp. Meer informatie vindt u in de documentatie die met de CADD-Solis Network Setup Utility-software is meegeleverd. Draadloze radio in-/uitschakelen Nadat de CADD-Solis-

communicatiemodule is genstalleerd, kunt u de draadloze radio naar wens in- of uitschakelen

(bijv. uitschakelen om batterij te sparen enz.). U kunt dit op elk gewenst moment doen via het menu Taken op het pompscherm zonder klinische functies van de pomp zoals een lopend infuus te onderbreken. Zievoor meer informatie de Gebruikershandleiding van depomp. Status en instellingen voor draadloze verbinding weergeven U kunt de instellingen voor draadloze verbinding weergeven en wijzigen in de CADD-Solis Network Setup Utility-software. Daarnaast kunt u de status en instellingen voor draadloze verbinding bekijken op het scherm van de CADD-Solis-pomp. De status van de draadloze verbinding wordt op het hoofdscherm van de pomp weergegeven:

Draadloos uitgeschakeld (witte indicator) Draadloos ingeschakeld, niet gekoppeld met draadloos toegangspunt (oranje indicator) Draadloos ingeschakeld, gekoppeld met draadloos toegangspunt (oranje indicator met groen middelpunt) Draadloos ingeschakeld, gekoppeld met draadloos toegangspunt en communicerend met PharmGuard Server (groene indicator met groen middelpunt) U kunt ook gedetailleerde informatie over de status en instellingen voor de draadloze verbinding weergeven. Selecteer in het menu Rapporten op de pomp de optie Status draadloos of Draadloos-instellingen. Als u de versie van de communicatiemodule (CM) en het MAC-adres wilt zien, selecteert u Toestel info in het menu Rapporten. Zie voor meer informatie de Gebruikershandleiding van de pomp. 109 Problemen oplossen Probleem De oplaadbare batterij wordt niet opgeladen. De oplaadbare batterij is volledig opgeladen maar werkt niet op de pomp. De draadloze radio is ingeschakeld en het statuspictogram van de draadloze verbinding van de pomp geeft 'Draadloos ingeschakeld, niet gekoppeld met draadloos toegangspunt' (oranje indicator) weer. Vermoedelijke oorzaak/oplossing De connector van de AC-adapter is mogelijk niet helemaal in de aansluitpoort op de pomp gestoken. Steek de connector van de AC-adapter helemaal in de pomp. De batterij is misschien te heet of te koud. Controleer of de omgevingsomstandigheden overeenstemmen met de gebruiksspecificaties. De drie vervangende pogo-pen-isolators zijn niet of verkeerd genstalleerd. Er kan een probleem zijn met het contact tussen de pomp en de communicatiemodule. Controleer of de contactoppervlakken op de communicatiemodule schoon zijn. Controleer of het batterijvakje en de contacten op de pomp schoon zijn. Probeer de communicatiemodule op een andere pomp uit. Als de module op de tweede pomp werkt, is er waarschijnlijk een probleem met de eerste pomp. Als de communicatiemodule ook op de tweede pomp niet werkt, is er waarschijnlijk een probleem met de communicatiemodule en/of de oplaadbare batterij. Neem contact op met de klantenservice van Smiths Medical. Misschien staat de communicatiemodule in de modus hittereductie; zie hiervoor de De instellingen voor draadloze verbinding zijn verkeerd geconfigureerd. Controleer en/of Gebruikershandleiding van de pomp. configureer de instellingen. De communicatiemodule is te ver van een draadloos toegangspunt verwijderd. Verplaats de module dichter naar een toegangspunt toe. De pomp schakelt de radio automatisch uit omdat de batterij leeg is. Sluit de pomp aan op de AC-adapter. De communicatiemodule bevindt zich in de nabijheid van een werkende magnetron. Verplaats de module verder van de magnetron vandaan. Pompalarmen die betrekking hebben op de communicatiemodule Einde gebruiksduur herlaadbare batt. bijna bereikt. Vervang batterij. De oplaadbare batterij heeft bijna het einde van de gebruiksduur bereikt. Door de vele keren opladen en gebruiken is de batterij bijna aan het einde van de gebruiksduur. U kunt de batterij in deze toestand nog blijven gebruiken. Einde gebruiksduur herlaadbare batterij bereikt. Pomp loopt niet. De oplaadbare batterij van de CADD-Solis-communicatiemodule heeft het einde van de gebruiksduur bereikt. Door de vele keren opladen en gebruiken kan de batterij geen energie meer vasthouden. Vervang de batterij door een nieuwe oplaadbare batterij voor de CADD-Solis-communicatiemodule. Onbruikbare batterij. Pomp loopt niet. De batterij is niet geschikt voor de pomp of er is een communicatiefout opgetreden. Zie voor meer informatie de Gebruikershandleiding van de pomp. De verbinding tussen de communicatiemodule en de pomp wordt telkens onderbroken. Zie voor meer informatie de Gebruikershandleiding van de pomp. Communicatie module intermitterende verbinding met pomp 110 Transport De communicatiemodule is getest en conform bevonden met de transportvoorschriften van de Verenigde Naties UN/DOT ST/SG/AC.10/11 (Rev. 5), Sectie 38.3 Beproevingseisen T1-T5, T7. Afvoer/gescheiden inzameling De oplaadbare batterij van de communicatiemodule moet helemaal ontladen zijn voordat deze wordt afgevoerd en/of de polen moeten met tape of doppen worden afgedekt om kortsluiting te voorkomen. Inwoners van landen buiten de Europese Unie dienen dit product af te voeren of te recyclen volgens de ter plaatse geldende wet- en regelgeving. Gescheiden inzamelen Dit product bevat elektrische en elektronische componenten die materialen kunnen bevatten die, wanneer ze bij het normale huishoudelijke afval worden weggegooid, milieuverontreiniging kunnen veroorzaken. Conform Richtlijn 2002/96/EG betreffende afgedankte elektrische en elektronische apparatuur moeten inwoners van de Europese Unie specifieke richtlijnen volgen voor afvalverwerking of recycling voor dit product. Neem contact op met uw plaatselijke distributeur of ga naar de volgende website voor specifieke instructies:

http://www.smiths-medical.com/recycle/index.html WAARSCHUWING: Aan het verkeerd afvoeren van batterijen of andere elektronica zijn gezondheidsrisicos verbonden. Voer gebruikte batterijen en andere accessoires af volgens de milieurichtlijnen en in overeenstemming met alle andere regelgeving die van toepassing kan zijn. Informatie over REACH Op grond van de Europese verordening inzake de registratie en beoordeling van en de autorisatie en beperkingen ten aanzien van chemische stoffen

('REACH-verordening EG nr. 1907/2006') zijn bedrijven verplicht afnemers ervan in kennis te stellen als een product een of meer van de stoffen bevat die worden vermeld in de lijst van stoffen die in aanmerking komen voor autorisatie (ook bekend als Zeer Zorgwekkende Stoffen (ZZS)), in een concentratie hoger dan 0,10%

(gewichtsprocent). Informatie over ZZS in producten van Smiths Medical vindt u op www.smiths-medical.com/

environment Certificatie conform Part 15 Dit apparaat voldoet aan de eisen van Part 15 van de FCC-regels. Op het gebruik van dit apparaat zijn de volgende twee voorwaarden van toepassing:

(1) dit apparaat mag geen schadelijke interferentie veroorzaken en (2) dit apparaat moet alle ontvangen interferentie aanvaarden, inclusief interferentie die een ongewenste werking kan veroorzaken. De communicatiemodule reinigen en desinfecteren Voor een optimale efficintie wordt aanbevolen omeerst te reinigen en vervolgens te desinfecteren. Bijgebruik van alle desinfectiemiddelen is voorafgaande reiniging vereist, behalve bij desinfecterende reinigingsmiddelen waarvan de desinfecterende werking in aanwezigheid van 5%

organisch materiaal via tests is aangetoond. LET OP: Dompel de communicatiemodule niet onder in een reinigingsvloeistof of in water. Laat de oplossing niet in de communicatiemodule intrekken. Vochtophoping in de communicatiemodule kan leiden tot beschadiging van het apparaat. Reinig en desinfecteer de blootliggende oppervlakken van de communicatiemodule als deze in de pomp is genstalleerd. 111 Acceptabele desinfectieoplossingen voor de CADD-

Solis-communicatiemodule staan hieronder vermeld. Product Fabrikant

(EPA-

registratie-

nummer) Werkzame bestand-

delen Inwerk-

tijd/afdo-

dingstijd CaviWipes Metrex

(46781-8) 17,2%

isopropanol Sani-Cloth Super PDI (9480-4) Sani-Cloth Bleach PDI (9480-8) Dimethylben-

zylammoni-

umchloride, dimethyl-

ethylben-

zylammoni-

umchloride 0,60%

natriumhypo-

chloriet 3 minuten 2 minuten 4 minuten 3. Laat de communicatiemodule vr gebruik eerst goed drogen. LET OP: Laat de oplossing niet in het gebied met de elektronische contacten of in openingen en naden intrekken ter voorkoming van schade aan de interne elektronica van de communicatiemodule. Gebruik uitsluitend een droge pluisvrije doek voor reiniging van de elektronische contacten en de omgeving van de onderdelen die bij installatie op de pomp normaliter omsloten worden. De communicatiemodule kan via de volgende stappen worden gereinigd en gedesinfecteerd:

1. Reinig de communicatiemodule met een milde zeepoplossing om resten of besmet materiaal te verwijderen. Breng de oplossing aan op een zachte, pluisvrije doek en neem de blootliggende oppervlakken van de communicatiemodule af wanneer deze in de pomp is genstalleerd. Laat de oplossing niet in de pomp of communicatiemodule intrekken. 2. Desinfecteer de communicatiemodule door een desinfectieoplossing (hieronder vermeld) aan te brengen volgens de instructies voor desinfectie op het productetiket. Bij gebruik van een vloeistof of spray: breng de oplossing aan op een zachte, pluisvrije doek en neem de blootliggende oppervlakken van de communicatiemodule af wanneer deze in de pomp is genstalleerd. Volg de aanbevelingen van de fabrikant van het desinfectiemiddel voor de inwerktijd van het desinfectiemiddel. Laat de oplossing niet in de pomp of communicatiemodule intrekken. 112 Specificaties Type batterij Oplaadbare lithium-ionbatterij (2 cellen) Equivalent lithiumgehalte <1,6 g Batterijvermogen 18,7 Wh (geheel opgeladen) Uitgangsspanning batterij 3,6V (nominaal) Gewicht oplaadbare batterij

<100 g Omgevingsvereisten voor gebruik Temperatuur . 2C tot 40C Vochtigheid . 20% tot 90%

(35F tot 104F) relatieve vochtigheid, niet-

condenserend Atmosferische druk . 70 kPa tot 106 kPa

(10,2 psia tot 15,4psia) Omgevingsvereisten voor opslag en transport Temperatuur . 20C tot 60C

(4F tot 140F) Vochtigheid . 20% tot 90%

relatieve vochtigheid, niet-

condenserend

(10,2 psia tot 15,4 psia) Atmosferische druk . 70 kPa tot 106 kPa Levensduur batterij 400 volledige cycli (laden/ontladen) op kamertemperatuur, 23C (73F) 10 uur bij aansluiting op AC-adapter Maximale oplaadduur (van volledig lege tot volledig opgeladen batterij) Gebruiksduur pomp en communicatiemodule

(nieuwe batterij) 4 uur bij nominale instellingen pomp (ziede Gebruikershandleiding van de pomp voor informatie over de nominale instellingen) Veiligheid De communicatiemodule voldoet aan de eisen van Underwriters Laboratories UL 2054, IEC60601-1(2005 + A1:2012) Ed 3.1 [bij installatie op de CADD-Solis Model 2110 infuuspomp], IEC60601-1-2 (2014) en IEC 62133 (2002). De lithium-ioncellen voldoen aan de eisen van Underwriters Laboratories UL 1642. IEEE 802.11 a,b,g,n Radio for Network Communication De CADD-Solis-communicatiemodule ontvangt en zendt opzettelijk radiofrequente (RF) elektromagnetische energie uit voor niet-kritieke communicatie. RF-uitzending/ontvangst, 'a'-band . 5180 MHz tot 5320 MHz en 5500 MHz tot 5825 MHz RF-uitzending/ontvangst,

'b'-, 'g'- en 'n'-banden ................................... 2412 MHz tot 2472 MHz Bandbreedte van 'a'-, 'b'-,

'g'- en 'n'-signalen .........................................20 MHz Maximaal RF-zendvermogen van band 'a' .....................................................10mW Maximaal RF-zendvermogen van banden 'b', 'g' en 'n' ..............................100mW 113 Opmerking: De communicatiemodule kan storing ondervinden van andere apparatuur, zelfs als dieandere apparatuur voldoet aan de eisen vanCISPR 11. Zie voor meer informatie over de netwerk-

specificaties en configuratie van de CADD-

Solis-communicatiemodule de installatie- en gebruikersgids voor de Network Setup Utility-

software (versie 1.1). Interferentie/scheidingsafstanden Andere elektronische communicatieapparaten die in de nabijheid van de communicatiemodule worden gebruikt, kunnen de verzending van gegevens onderbreken. Onderbreking van gegevensverzending heeft geen gevolgen voor de toediening van de pomp. In onderstaande tabel wordt uiteengezet wat voor effect de verschillende soorten apparaten hebben, en welke minimale scheidingsafstand moet worden aangehouden. Interferentiebron (soort elektronisch apparaat) Min. scheidings-

afstand Draadloos bereik communicatiemodule:

36,58 meter (120 ft) (werking met direct zicht op toegangspunt) Netwerkmodi en versleuteling Netwerkmodi:

Versleutelingsmodi:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Verificatiemodi:

OPEN WPA-ENT WPA2-ENT WPA-PSK WPA2-PSK Geen TKIP CCMP TKIP/CCMP EAP-modi:

Geen EAP-TLS (v1.0 en v1.2) EAP-TTLS EAP-PEAPV0 (PEAP met MS-CHAPv2) EAP-PEAPV1 (PEAP met GTC) EAP-LEAP EAP-FAST 2,4GHz/5GHz draadloze zendbasisstations (bijv. Wi-Fi toegangspunten, draadloze telefonische basisstations) 2,4GHz/5GHz draadloze medische hulpmiddelen en andere randapparatuur (bijv. patintmonitors, infuuspompen, computers/

smart phones/tablets met Wi-Fi ingeschakeld; Bluetooth-apparaten;

Zigbee-apparaten; handsets van draadloze telefoons) Andere CADD-Solis-pompen van Smiths Medical met draadloze connectiviteit 433MHz/2,4GHz/5GHz RFID Asset Location Tags 114 3 meter (9,84 ft) Certificaten:

SSL SHA-1 SSL SHA-2 1 meter (3,28 ft) 0,3 meter (1 ft) Direct contact Beperkte garantie Garantie: Smiths Medical ASD, Inc. (de 'fabrikant') garandeert aan de oorspronkelijke koper dat alle onderdelen en componenten van de CADD-Solis-

communicatiemodule (de 'communicatiemodule') die zijn vervaardigd door of voor de fabrikant, met uitzondering van hieronder vermelde artikelen, bij normaal gebruik gedurende een (1) jaar vanaf de feitelijke verkoopdatum aan de oorspronkelijke koper vrij zijn van materiaal- en fabricagegebreken, mits gebruikt overeenkomstig de gebruiksaanwijzing. ER WORDEN GEEN ANDERE GARANTIES GEBODEN. Uitzonderingen: Deze garantie geldt niet voor normale slijtage en onderhoudsartikelen; met name andere bij de communicatiemodule gebruikte accessoires of apparatuur zijn uitgesloten. Garantieprocedures: Met inachtneming van deze voorwaarden en mits voldaan is aan deze beperkte garantie zal de fabrikant een communicatiemodule

(met uitzondering van accessoires) die defect is, naar eigen goeddunken kosteloos (uitgezonderd minimale verzendkosten) repareren of vervangen indien er tijdens deze periode van n jaar beroep op de garantie wordt gedaan. Stuur communicatiemodules of componenten NIET naar de fabrikant voor reparatie volgens de garantie zonder specifieke adresinformatie van de afdeling Klantenservice. Voorwaarden: De volgende voorwaarden, beperkingen en uitsluitingen zijn van toepassing met betrekking tot de garantieverplichtingen van de fabrikant:

A. Vervallen van de garantie: Deze garantie is nietig en vervalt indien de communicatiemodule of een onderdeel of component hiervan (1) gerepareerd is door een ander dan de fabrikant of zijn officile vertegenwoordiger; (2) zodanig gewijzigd is dat dit afbreuk doet aan de stabiliteit of betrouwbaarheid;

(3) onjuist gebruikt is; of (4) door nalatigheid of een ongeluk beschadigd is. Onjuist gebruik omvat, maar is niet beperkt tot, gebruik dat niet overeenstemt met de gebruiksaanwijzing van de communicatiemodule of gebruik met niet-goedgekeurde accessoires. B. Beperkingen en uitsluitingen: Vervanging van de communicatiemodule of een onderdeel ervan is het ENIGE verhaal dat door de fabrikant wordt geboden. Alle door de fabrikant of diens vertegenwoordigers verstrekte aanbevelingen, informatie en beschrijvende documentatie in verband met de communicatiemodule worden geacht nauwkeurig en betrouwbaar te zijn, maar vormen geen garanties. Geen enkele tussenpersoon, vertegenwoordiger of werknemer van de fabrikant is gemachtigd om de fabrikant te verplichten tot ongeacht welke uitdrukkelijke of stilzwijgende verklaring of garantie. ER IS GEEN GARANTIE VAN VERKOOPBAARHEID OF GESCHIKTHEID VAN DE COMMUNICATIEMODULE VOOR ENIG BEPAALD DOEL. D E F A B R I K A N T A A N V A A R D T G E E N VERANTWOORDELIJKHEID VOOR GESCHIKTHEID VAN DE COMMUNICATIEMODULE VOOR BEPAALDE MEDISCHE BEHANDELINGEN OF VOOR MEDISCHE COMPLICATIES DIE VOORTVLOEIEN UIT HET GEBRUIK VAN DE COMMUNICATIEMODULE. DE FABRIKANT IS NIET VERANTWOORDELIJK VOOR INCIDENTELE SCHADE OF GEVOLGSCHADE AAN EIGENDOMMEN, W I N S T D E R V I N G O F G E B R U I K S D E R V I N G VEROORZAAKT DOOR EEN DEFECT OF EEN STORING VAN DE COMMUNICATIEMODULE. Deze garantie geeft de oorspronkelijke koper bepaalde wettelijke rechten, en de oorspronkelijke koper kan andere wettelijke rechten hebben die van land tot land verschillen. 115 4 Swedish / Svenska Innehllsfrteckning English . 4 French / Franais . 20 German / Deutsch . 36 Italian / Italiano . 52 Spanish / Espaol . 68 Portuguese / Portugus . 84 Dutch / Nederlands . 100 Varningar . 117 Frsiktighetstgrder . 118 Om CADD-Solis-kommunikationsmodulen, modell 2131 . 118 Installera CADD-Soliskommunikationsmodulen . 119 Ladda det uppladdningsbara batteriet . 123 ndra trdlsa instllningar med hjlp av programmet CADD-Solis Network Setup Utility . 124 Sl p/stnga av trdls radio . 125 Visa status och instllningar fr trdls anslutning . 125 Felskning . 126 Transport . 127 Kassering/insamlas separat . 127 REACH Information . 127 Certifiering enligt del 15. 127 Rengring och desinficering av kommunikationsmodulen . 127 Specifikationer . 129 Begrnsad garanti . 131 Danish / Dansk . 132 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 116 VIKTIGT: Det uppladdningsbara batteriet i CADD-Solis-

kommunikationsmodulen mste vara internt anslutet och fulladdat i pumpen innan systemet stts i drift. Ls och flj instruktionerna i denna bruksanvisning gllande installation och laddning av batteriet fre anvndning. Ls instruktionerna till fullo innan du installerar CADD-Solis-kommunikationsmodulen p CADD-

Solis ambulatorisk infusionspump, modell 2110. Spara dessa instruktioner fr framtida bruk. Se pumpens bruksanvisning fr detaljerade anvisningar, varningar, specifikationer och vrig information om anvndningen av CADD-Solis ambulatorisk infusionspump. Se anvndarinstruktionerna som medfljer produkten fr detaljerade anvisningar, varningar, specifikationer och vrig information om anvndningen av CADD-

Solis-ntadaptern. VARNINGAR Fr att undvika personskador r det viktigt att man fljer dessa varningar:

Utstt inte kommunikationsmodulen fr regn, vatten eller fukt. Det kan leda till elsttar eller andra faror. Snk inte ned CADD-Solis-kommunikations-

modulens uppladdningsbara batteri i vtska. Det kan leda till elsttar eller andra faror. Anvnd inte CADD-Solis-

kommunikationsmodulens uppladdningsbara batteri med ngon annan enhet n CADD-

Solis-kommunikationsmodulen. Anslut inte ngra ntadaptrar direkt till CADD-Solis-kommunikationsmodulens uppladdningsbara batteri. Det kan vara farligt att direktansluta en ntadapter och kan skada det uppladdningsbara batteriet, kommunikationsmodulen och pumpen. En CADD-Solis-kommunikationsmoduls uppladdningsbara batteri som har blivit fr gammalt mste ersttas med ett annat uppladdningsbart batteri fr CADD-Solis-

kommunikationsmodulen. Anvndning av uppladdningsbara batterier frn andra tillverkare kan leda till brand eller explosion. Lt inte ngra av de elektroniska kontakterna p kommunikationsmodulen samtidigt vidrra ett freml av metall (till exempel ett mynt eller ett gem). Anvnd inte CADD-Solis-kommunikations-

modulen om den har skadats, om den invndiga elektroniken exponeras p grund av slitage eller om de elektroniska kontakterna skadats p ngot stt. Det kan leda till brand, sttar eller andra faror. Frsk inte krossa CADD-Solis-

kommunikationsmodulen eller det uppladdningsbara batteriet. Det kan leda tillbrand, sttar eller andra faror. Frstr inte CADD-Solis-kommunikations-

modulens uppladdningsbara batteri genom frbrnning. Det kan explodera. Anvnd inte kommunikationsmodulen i CADD-Solis-infusionspumpens pse eller ngon annan pse eller vska. Kommunikationsmodulen kan d verhettas och stngas av med hjlp av termobrytaren. Det finns potentiella hlsorisker som frknippas med felaktig kassering av batterier och annan elektronik. Kassera anvnda batterier och andra anvnda tillbehr p ett miljvnligt stt och i enlighet med gllande lagstiftning. 117 FRSIKTIGHETSTGRDER Ta inte i fr mycket nr du avlgsnar CADD-

Solis-kommunikationsmodulens lock frn basen. Antennkabeln mste frbli ansluten till bde locket och basen. Om antennkabeln kopplas bort kan det medfra skada p antennen och/eller kommunikationsmodulens elektronik. Om CADD-Solis-kommunikationsmodulens uppladdningsbara batteri inte laddas fullt fre frsta anvndningstillfllet och under lngre frvaring kan det orsaka djup batteriurladdning som leder till att batteriet mste bytas ut i frtid. USB-porten p CADD-Solis-infusionspumpen r endast avsedd fr kommunikation med PharmGuard Medication Safety Software, SureLink Remote Support Software och CADD Solis Network Setup Utility. Du fr inte ansluta ngra tillbehr som inte stds till USB-porten

(t.ex. ladda andra enheter eller ansluta en dongel) eftersom det kan skada pumpen. Om CADD-Solis-kommunikationsmodulen frvaras utom miljfrhllanden fr drift men inom angivna miljfrhllande fr frvaring ska du lta kommunikationsmodulen vrmas upp eller svalna till drifttemperatur i minst en timme fre anvndning fr att undvika skada p den elektroniska kretsen. 118 Om CADD-Solis-kommunikationsmodulen, modell 2131 CADD-Solis-ntverkskommunikationssystemet (NCS) bestr av en CADD-Solis ambulatorisk infusionspump, modell 2110 (programvaruversion 4.2 eller senare), med en CADD-Solis-kommunikationsmodul installerad och konfigurerad fr ditt trdlsa ntverk och din PharmGuard-server. Nr kommunikationsmodulen r installerad och korrekt konfigurerad lter den pumpen trdlst skicka pumphistorik till en PharmGuard-server och ta emot uppdateringar av pumpens fasta program och bibliotek. Modellen 2131 r en uppgraderad version av kommunikationsmodul 2130. Radion r mer slittlig, inklusive bttre skerhet och kryptering med std fr n-bandet p 20MHz. CADD-Solis-

kommunikationsmodulen innefattar den trdlsa radion och ett uppladdningsbart batteri inuti modulen. Batteriet driver kommunikationsmodulen och frser CADD-Solis-pumpen med strm nr vxelstrm inte r tillgnglig. Det uppladdningsbara batteriet laddas nr pumpen r ansluten till vxelstrm via CADD-Solis-

ntadaptern ven om pumpen r avstngd. CADD-Solis-ntadaptern och ntsladden (tillhandahlls separat) anvnds fr att ansluta pumpen till det uppladdningsbara batteriet nr kommunikationsmodulen r installerad i CADD-Solis-

pumpen. Programmet CADD-Solis Network Setup Utility

(tillhandahlls separat) anvnds fr att konfigurera det trdlsa ntverket fr den specifika pumpen nr en CADD-Solis-kommunikationsmodul r installerad. Information om anvndning av programmet finns iinstruktionerna som medfljer programmet. OBS! Version 1.1 av Network Setup Utility mste anvndas. VARNING! En CADD-Solis-kommunikationsmoduls uppladdningsbara batteri som har blivit fr gammalt mste ersttas med ett uppladdningsbart CADD-Solis-batteri. Anvnd inte uppladdningsbara batterier frn andra tillverkare, d det kan leda till brand eller explosion. Fr mer information, se larmet Uppladdningsbart batteri har ntt slutet av sin livslngd i pumpens bruksanvisning. VARNING! Anslut inte ngra ntadaptrar direkt till CADD-Solis-kommunikationsmodulens uppladdningsbara batteri. Det kan vara farligt att direktansluta en ntadapter och kan skada det uppladdningsbara batteriet, kommunikationsmodulen och pumpen. Installera CADD-Solis-

kommunikationsmodulen FRSIKTIGHET! Installation och konfiguration av CADD-Solis-kommunikationsmodulen i en pump ska endast utfras av servicepersonal. FRSIKTIGHET! Fr att undvika skada p kommunikationsmodulen ska du stnga av pumpen och koppla ur alla kablar som r anslutna till pumpen innan du installerar kommunikationsmodulen p pumpen. FRSIKTIGHET! Eftersom den initiala installationen av kommunikationsmodulen krver att modulens hlje ppnas mste installationen utfras p en arbetsstation med kontroller fr elektrostatisk urladdning (ESD), inklusive en antistatisk matta och jordningsarmband. 1. Se till att CADD-Solis-pumpen stngs av och att inga kablar r anslutna till pumpen. 2. Med fingrarna, pumpnyckeln eller ett mynt ska du vrida vredet p batteriluckan moturs och ppna den. 3. Plocka ut eventuella batterier ur pumpen. Seven till att det inte frkommer ngot skrp ibatterifacket. 4. Dra batteriluckan bakt enligt bilden fr att avlgsna den frn pumpen. Batteriluckan anvnds inte tillsammans med CADD-Solis-

kommunikations-

modulen. Frvara batteriluckan p en tillgnglig plats fr att kunna anvnda pumpen senare med AA-batteri eller CADD-Solis uppladdningsbart batteripack. 119 5. De tre isolatorerna som sitter p fjderkontakterna i pumpens batterifack mste ersttas med isolatorerna som medfljer kommunikationsmodulen. Tre isolatorer krvs och en fjrde isolator medfljer som reserv. Kassera originalisolatorerna. Anvnd en pincett och avlgsna frsiktigt de tre originalisolatorerna frn fjderkontakterna enligt bilden och kassera dem. Isolator till

derkontakt 6. Montera de tre nya isolatorerna som medfljer kommunikationsmodulen p fjderkontakterna. 120 7. Bekrfta att de tre nya isolatorerna r korrekt monterade runt fjderkontakterna. OBS! De tre nya fjderkontaktsisolatorerna r ocks kompatibla med AA-batterier och CADD-Solis uppladdningsbart batteripack. Originalisolatorerna behvs inte lngre och kan kasseras. 8. Det uppladdningsbara batteriet inuti kommunikationsmodulen r inte anslutet och mste anslutas internt. Fr att komma t och ansluta batteriet anvnder du en 10 IP-stjrnmejsel fr att avlgsna de tv skruvarna under kommunikationsmodulens lock. VARNING! Fr att undvika potentiella skador ska du inte ta bort kommunikationsmodulens lock nr den r installerad och ansluten till pumpen eller lta kommunikationsmodulens elektroniska kontakter samtidigt vidrra ett freml av metall (till exempel ett mynt eller ett gem). 9. Avlgsna frsiktigt locket frn kommunikationsmodulens bas samtidigt som du ser till att antennkabeln inte lossnar frn varken locket eller basen, och anslut sedan batterikontakten till batteriuttaget p kommunikationsmodulens kretskort. 121 FRSIKTIGHET! Ta inte i fr mycket nr du avlgsnar kommunikationsmodulens lock frn basen. Antennkabeln mste frbli ansluten till bde locket och basen. Om antennkabeln kopplas bort kan det medfra skada p antennen och/eller kommunikationsmodulens elektronik. 10. Placera kommunikationsmodulens lock p basen och se till att antennkabeln r helt instoppad ikommunikationsmodulen. 11. Stt i och dra t de tv stjrnskruvarna under kommunikationsmodulens lock med hjlp av 10IP-stjrnmejseln tills de sitter ordentligt och vrid sedan ytterligare ca 1/8 varv (45 grader). Drainte t fr hrt. VARNING! Se till att ttningarna runt modullockets utkant och skruvhlen inte frsvinner eller skadas nr modulen ppnas eller stngs. Dessa O-ringsttningar behvs fr skydd mot intrngande vatten och statisk urladdning. 122 Kommunikations-modulens lockKommunikationsmodulens basAntennkabelBatterikontaktBatteriuttag 12. Stt in kommunikationsmodulen i pumpens batterifack. Haka fast den nedre delen av droppstllningsadaptern p den nedre delen avpumpen och snpp sedan fast den vre delen av droppstllningadaptern i modulens bas. OBS! Rikta in tnderna p droppstllningsadaptern efter ppningen p pumphuset. Droppstllningsadapter Inriktnings-

tnder ppning p pump 13. Anvnd en CADD-Solis-pumpnyckel, en sprskruvmejsel eller ett mynt fr att dra t skruven fr att fsta droppstllningsadaptern och stta fast kommunikationsmodulen p pumpen. Dra t skruven tills den sitter ordentligt och vrid sedan ytterligare ca 1/8 varv (45 grader). Dra inte t fr hrt. 14. Innan du konfigurerar pumpen och anvnder den fr frsta gngen mste kommunikationsmodulen vara fulladdad. Sensta avsnitt fr mer information hur du laddar det uppladdningsbara batteriet i CADD-Solis-

kommunikationsmodulen. 15. Om CADD-Solis-kommunikationsmodulen installeras i en specifik pump fr frsta gngen mste pumpens trdls instllningar konfigureras med hjlp av programmet CADD-Solis Network Setup Utility (tillhandahlls separat). Mer information finns i dokumentationen som medfljer Network Setup Utility. Ladda det uppladdningsbara batteriet Kommunikationsmodulens uppladdningsbara batteri laddar nr CADD-Solis-pumpen r ansluten till vxelstrm via CADD-Solis-ntadaptern ven nr pumpen r avstngd. Inom driftstemperaturintervallet p 2 till 40 C laddas det uppladdningsbara batteriet helt inom 10timmar eller mindre. Ladda det uppladdningsbara batteriet helt:

Fre frsta anvndningstillfllet Minst var 30:e dag under regelbunden anvndning Minst en gng var 6:e mnad under frvaring Nr pumpen indikerar att batteriet har lg laddningsniv eller r urladdat FRSIKTIGHET! Underltenhet att ladda det uppladdningsbara batteriet under lngvarig frvaring kan orsaka djup batteriurladdning som leder till att batteriet mste bytas ut i frtid. FRSIKTIGHET! Fr att undvika att skada ntadapter-

kontakten eller pumpen ska du inte anvnda fr hg kraft eller instrument ssom tnger fr att ansluta eller koppla bort ntadapterkontakten. 123 Ladda det uppladdningsbara batteriet:

1. Anslut CADD-Solis-ntadapterns ntsladd till ett eluttag och den andra nden till ntadaptern. 2. Anslut ntadapterkontakten till vxelstrmsuttaget

(mrkt 7V) p CADD-Solis-pumpen. Nr den r korrekt ansluten tnds den bl lampan bredvid kontakten p pumpen. 4. Nr pumpen r pslagen visar pumpens statusflt att pumpen r ansluten till vxelstrm. En liten stickkontaktsindikator visas till hger ombatteriikonen. 5. Nr pumpen r pslagen kan du se uppskattad batteriladdningsniv genom statusfltet p pumpens display. Mer information finns i pumpens bruksanvisning. Nr batteriet r fulladdat kan du vlja att koppla bort ntadapter-

kontakten. Meddelandet Ntadapter urkopplad visas kort efter att du kopplat bort kontakten. ndra trdlsa instllningar med hjlp avprogrammet CADD-Solis Network SetupUtility Alla trdlsa instllningar fr pumpen och CADD-

Solis-kommunikationsmodulen konfigureras med hjlp av programmet CADD-Solis Network Setup Utility (tillhandahlls separat) via en USB-anslutning frn en dator till CADD-Solis-pumpen. Med CADD-Solis Network Setup Utility kan du vlja och ange alla trdlsa instllningar fr dina trdlsa tkomstpunkter och din PharmGuard-server. Dessa instllningar kan sparas p CADD-Solis-pumpen. Om pumpens CADD-Solis-kommunikationsmodul byts ut kommer drfr den nya kommunikationsmodulen automatiskt att anvnda pumpens frvalda trdlsa instllningar. VARNING! Anslut inte ngra ntadaptrar direkt till CADD-Solis-kommunikationsmodulens uppladdningsbara batteri. Att direktansluta en ntadapter kan vara farligt och kan skada batteriet, kommunikationsmodulen och pumpen. FRSIKTIGHET! Underltenhet att trycka in ntadapterkontakten helt i pumpen kan leda till en intermittent anslutning och kontakten kan lossna, vilket orsakar strmfrlust och att det uppladdningsbara batteriet inte lngre laddas. 3. Nr pumpen r pslagen visar pumpens statusflt Ntadapter ansluten under enkort stund. 124 Mer information finns i dokumentationen som medfljer CADD-Solis Network Setup Utility. Sl p/stnga av trdls radio Nr CADD-Solis-

kommunikations-

modulen r installerad kan dess trdlsa radio sls p eller stngas av efter behov

(t.ex. stngas av fr att spara batteriet etc.). Detta kan gras nr som helst med hjlp av menyn Uppgifter p pumpskrmen utan att det avbryter pumpens kliniska funktioner, till exempel krning av en infusion. Mer information finns i pumpens bruksanvisning. Visa status och instllningar fr trdls anslutning Med programmet CADD-Solis Network Setup Utility kan du visa och ndra trdlsa instllningar och du kan ven visa status och instllningar fr trdls anslutning p CADD-Solis-pumpens skrm. Status fr trdls anslutning indikeras p pumpens huvudskrm:

Trdls anslutning av (vit indikator) Trdls anslutning p, inte frknippad med trdls tkomstpunkt (orange indikator) Trdls anslutning p, frknippad med trdls tkomstpunkt (orange indikator medgrn mittpunkt) Trdls anslutning p, frknippad med trdls tkomstpunkt och kommunicerar med PharmGuard-servern (grn indikator med grn mittpunkt) Du kan ven visa detaljerad status och detaljerade instllningar fr trdls anslutning. Frn pumpmenyn Rapporter vljer du Trdls status eller Trdlsa inst. Fr att visa kommunikationsmodulens

(CM) version och MAC-adress vljer du Enhetsinformation i menyn Rapporter. Mer information finns i pumpens bruksanvisning 125 Felskning Problem Det uppladdningsbara batteriet laddar inte. Det uppladdningsbara batteriet r fulladdat men fungerar inte i pumpen. Den trdlsa radion r pslagen och pumpens ikon fr trdls anslutning visar Trdls anslutning p, inte frknippad med trdls tkomstpunkt

(orange indikator). Orsak/lsning till problem Ntadapterkontakten kanske inte r korrekt ansluten till anslutningsporten p pumpen. Anslut Batteriet kanske r fr varmt eller fr kallt. Se till att miljfrhllanden stmmer verens med ntadapterkontakten helt p pumpen. angivna driftfrhllanden. De tre ersttningsfjderkontakternas isolatorer r inte monterade eller r felaktigt monterade. Det kan freligga ett problem med kontakten mellan pumpen och kommunikationsmodulen. Se till att kontaktdynorna p kommunikationsmodulen r rena. Se till att batterifacket och kontakterna p pumpen r rena. Testa kommunikationsmodulen i en annan pump. Om den fungerar i den andra pumpen r det troligtvis fel p den frsta pumpen. Om kommunikationsmodulen inte fungerar i den andra pumpen heller r det troligtvis fel p kommunikationsmodulen och/eller det uppladdningsbara batteriet. Kontakta Smiths Medicals kundtjnst. Kommunikationsmodulen kan vara frsatt i vrmereduktionslge, se pumpens bruksanvisning. Kommunikationsmodulen befinner sig fr lngt borta frn en trdls tkomstpunkt. Flytta den Instllningarna fr trdls anslutning r felaktiga. Kontrollera och/eller ndra instllningarna. Pumpen slr automatiskt av radion p grund av att batteriet r urladdat. Anslut pumpen till ntadaptern. Kommunikationsmodulen befinner sig i nrheten av en mikrovgsugn som anvnds. Flytta bort nrmare en tkomstpunkt. den frn mikrovgsugnen. Pumplarm som frknippas med kommunikationsmodulen Det uppladdningsbara batteripacket har nstan ntt slutet av sin livslngd. Det har laddats ur och laddats s mnga gnger att det snart r oanvndbart. Du kan fortstta att anvnda det i detta skick. CADD-Solis-kommunikationsmodulens uppladdningsbara batteripack har ntt slutet av sin livslngd. Det har laddats ur och laddats s mnga gnger att det inte lngre gr att ladda ordentligt. Erstt med ett nytt uppladdningsbart batteri fr CADD-Solis-

kommunikationsmodulen. Batteriet r inte kompatibelt med pumpen eller s har ett kommunikationsfel intrffat. Merinformation finns i pumpens bruksanvisning. Anslutningen mellan kommunikationsmodulen och pumpen r intermittent. Mer information finns i pumpens bruksanvisning. Rechargeable battery near end of use. Replace battery.

(Uppladdningsbart batteri nstan slut. Byt ut batteriet.) Rechargeable battery reached end of use. Pump will not run.

(Uppladdningsbart batteri slut. Pumpen grinte.) Battery Unusable. Pump will not run. (Uppladdningsbart batteri slut. Pumpen grinte.) Communication module intermittent connection to pump (Intermittent anslutning mellan kommunikations-

modul och pump) 126 Transport Kommunikationsmodulen har testats enligt och uppfyller FN:s transportfrordningar UN/DOT ST/SG/

AC.10/11 (rev. 5) avsnitt 38.3 testkrav T1-T5, T7. Kassering/insamlas separat Kommunikationsmodulens uppladdningsbara batteri ska laddas ur helt fre kassering och/eller kontakterna ska tejpas eller tckas ver fr att frhindra kortslutning. Personer utanfr EU mste kassera eller tervinna denna produkt i enlighet med gllande lokala lagar eller frordningar. Insamlas separat Denna produkt innehller elektriska och elektroniska komponenter som kan innehlla material som, om den kasseras bland vanligt hushllsavfall, kan skada miljn. I enlighet med direktiv 2002/96/EG WEEE om avfall som utgrs av eller innehller elektriska eller elektroniska produkter mste personer med hemvist inom EU flja specifika instruktioner betrffande avfallshantering eller tervinning nr det gller denna produkt. Kontakta din lokala distributr eller besk fljande webbsida fr specifika instruktioner:

http://www.smiths-medical.com/recycle/index.html VARNING! Det finns potentiella hlsorisker frknippade med felaktig kassering av batterier ochannan elektronik. Kassera anvnda batterier och andra anvnda tillbehr p ett miljvnligt stt och i enlighet med gllande lagstiftning. REACH Information Enligt den europeiska frordningen om registrering, utvrdering, godknnande och begrnsning av kemikalier (REACH-frordningen EG nr 1907/2006) r fretag skyldiga att meddela kunderna om en produkt innehller ngot av de mnen som har identifierats i Kandidatfrteckningen ver mnen fr auktorisering

(ven knda som SVHC-mnen, mnen som inger mycket allvarliga betnkligheter) vid en koncentration ver 0,10 viktprocent. Smiths Medicals uppgifter avseende SVHC-mnen i produkter finns p: www. smiths-medical.com/environment Certifiering enligt del 15 Den hr enheten uppfyller del 15 i FCC-reglerna. Driften omfattas av fljande tv villkor: (1) den hr enheten fr inte orsaka skadliga strningar och (2) den hr enheten mste acceptera alla strningar som tas emot, inklusive strningar som kan orsaka onskad drift. Rengring och desinficering av kommunikationsmodulen Fr optimal effektivitet rekommenderas frst rengring och drefter desinfektion som bsta praxis. Alla desinfektionsmedel krver frrengring utom desinficerande rengringsmedel som har testats fr desinfektion i nrvaro av 5 % organiska mnen. FRSIKTIGHET! Snk inte ned kommunikationsmodulen i rengringsvtska eller vatten. Lt ingen lsning genomdrnka kommunikationsmodulen. Fuktansamling inuti kommunikationsmodulen kan skada enheten. Rengr och desinficera kommunikationsmodulens exponerade ytor nr den r installerad i pumpen. 127 Godknda desinfektionsmedel fr CADD-Solis-

kommunikationsmodulen anges nedan. Produkt Tillverkare

(EPA-

registrerings-

nummer) CaviWipes Metrex

(46781-8) Sani-Cloth Super PDI (9480-4) Kontakt-/

avdd-

ningstid 3 minuter 2 minuter Aktivt/

aktiva inne-

hllsmne/

innehlls-

mnen 17,2 %

isopropanol Dimetylben-

sylammo-

niumklorid, Dimetyletyl-

bensylammo-

niumklorid Sani-Cloth blekmedel PDI (9480-8) 0,60 %

natrium-

hypoklorit 4 minuter 3. Lt kommunikationsmodulen torka fullstndigt fre anvndning. FRSIKTIGHET! Fr att undvika skador p kommunikationsmodulens inbyggda elektronik ska du inte lta lsning genomdrnka de elektroniska kontakternas ytor eller trnga in i ngra ppningar eller smmar. Anvnd endast en torr, luddfri trasa fr att rengra de elektroniska kontakterna och den omgivande ytan som vanligtvis r innesluten nr den r installerad i pumpen. Fljande procedur kan fljas fr att rengra och desinficera kommunikationsmodulen:

1. Rengr kommunikationsmodulen med ett milt tvlbaserat rengringsmedel fr att avlgsna rester och kontaminerat material. Applicera lsningen p en mjuk, luddfri trasa och torka sedan av kommunikationsmodulens exponerade ytor nr den r installerad i pumpen. Lt inte lsningen genomdrnka pumpen eller kommunikationsmodulen. 2. Desinficera kommunikationsmodulen genom att applicera en desinfektionslsning (se nedanstende lista) i enlighet med instruktionerna p desinfektionsmedlets etikett. Om du anvnder en lsning eller sprej ska du applicera lsningen p en mjuk, luddfri trasa och sedan torka av kommunikationsmodulens exponerade ytor nr den r installerad i pumpen. Flj desinfektionsmedelstillverkarens anvisningar fr desinfektionsmedlets kontakttider. Lt inte lsningen genomdrnka pumpen eller kommunikationsmodulen. 128 Specifikationer Batterityp Uppladdningsbart litiumjonbatteri (2 celler) Motsvarande litiuminnehll < 1,6 g Batterikapacitet 18,7 Wh (fulladdat) Batteriuteffekt 3,6V (nominellt) Det uppladdningsbara batteriets vikt

< 100 g Krav fr driftmilj Temperatur . 2 till 40 C Luftfuktighet . 20 till 90% relativ luftfuktighet, icke kondenserande Atmosfrtryck . 70 till 106 kPa Miljkrav fr frvaring och transport Temperatur . -20 till 60 C Luftfuktighet . 20 till 90% relativ luftfuktighet, icke kondenserande Atmosfrtryck . 70 till 106 kPa Livslngd fr produktbatteri 400 hela cykler (laddning/ urladdning) i rumstemperatur, 23 C Maximal laddningstid (frn helt urladdat batteri tillfulladdat) 10 timmar nr det r anslutet till ntadapter Anvndningstid fr pump och kommunikationsmodul (nytt batteri) 4 timmar p pumpens nominella instllningar

(se pumpens bruksanvisning fr information om nominella instllningar) Skerhet Kommunikationsmodulen uppfyller Underwriters Laboratories UL 2054, IEC 60601-1(2005

+ A1:2012) Ed 3.1 [nr den r installerad i CADD-Solis-infusionspumpen av modell 2110], IEC60601-1-2 (2014) och IEC 62133 (2002). Litiumjonceller uppfyller Underwriters Laboratories UL 1642. IEEE 802.11 a,b,g,n radio fr ntverkskommunikation CADD-Solis-kommunikationsmodulen tar emot och snder ut elektromagnetisk radiofrekvensenergi (RF) fr icke-kritisk kommunikation. Sndning/mottagning av RF, a-bandet . 5 180 till 5320MHz och5 500 till 5825 MHz Sndning/mottagning av RF, banden b, g och n .................................... 2412 till 2472 MHz Bandbredd fr signaler p banden a, b, g och n ....................... 20 MHz Maximal RF-sndningseffekt fr band a ......................................................... 10mW Maximal RF-sndningseffekt fr banden b, g och n .............................. 100mW 129 Kommunikationsmodulens trdlsa rckvidd Ntverkslgen och kryptering 36,58 meter (med klar sikt till tkomstpunkten) Ntverkslgen:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Krypteringslgen:

Inget TKIP CCMP TKIP/CCMP Autentiseringslgen:

EAP-lgen:

Inget EAP-TLS (v.1.0 och v.1.2) EAP-TTLS EAP-PEAPV0 (PEAP med MS-CHAPv2) EAP-PEAPV1 (PEAP med GTC) EAP-LEAP EAP-FAST PPEN WPA-ENT WPA2-ENT WPA-PSK WPA2-PSK Certifikat:

SSL SHA-1 SSL SHA-2 Obs! Kommunikationsmodulen kan stras av annan utrustning, ven om sdan annan utrustning uppfyller CISPR 11-kraven. Mer information om ntverksspecifikation och konfiguration av CADD-Solis-kommunikations-

modulen finns i installations- och bruksanvisningen fr Network Setup Utility (version 1.1). Strningar/separationsavstnd Andra elektroniska kommunikationsenheter som anvnds i nrheten av kommunikationsmodulen kan orsaka strningar i datasndningar. Strningar i datasndningar pverkar inte pumpens funktion. I tabellen nedan anges vilken effekt varje typ av enhet orsakar och en beskrivning av det minsta separationsavstnd som ska fljas. Strande enhet (typ av elektronisk enhet) Min. separation-

avstnd Trdlsa sndarbasstationer p 2,4/5GHz (t.ex. Wi-Fi-

tkomstpunkter, trdlsa telefonbasstationer) Trdlsa medicintekniska produkter och annan kringutrust-

ning p 2,4/5GHz (t.ex. patient-

monitorer, infusionspumpar, datorer/smarttelefoner/surfplattor med Wi-Fi; Bluetooth-enheter;

Zigbee-enheter; trdlsa telefoner) Andra Smiths Medical CADD-Solis-

pumpar med trdls anslutning RFID-tillgngsplatstaggar p 433MHz/2,4GHz/5GHz 3 meter 1 meter 0,3 meter Direktkontakt 130 Begrnsad garanti Garanti: Smiths Medical ASD, Inc. (tillverkaren) garanterar den ursprungliga kparen att alla delar och komponenter i CADD-Solis-kommunikationsmodulen

(kommunikationsmodulen) som r tillverkade av eller fr tillverkaren, frutom sdana freml som anges nedan, ska vara fria frn fel avseende material och konstruktion under normal anvndning, men de anvnds i enlighet med bruksanvisningen, under en period p ett (1) r frn det faktiska datumet fr frsljning till den ursprungliga kparen. DET FINNS INGA ANDRA GARANTIER. Undantag: Denna garanti omfattar inte normalt slitage och underhll, och exkluderar specifikt andra tillbehr eller annan utrustning som anvnds med kommunikationsmodulen. Garantiprocedurer: Med frbehll fr villkoren i och efterfljandet av denna begrnsade garanti kommer tillverkaren att kostnadsfritt reparera eller byta ut

(frutom en minimiavgift fr porto och hantering) alla felaktiga kommunikationsmoduler (ej inkluderat tillbehren) om ansprk grs inom en sdan ettrsperiod. Du ska INTE skicka ngon kommunikationsmodul eller komponent till tillverkaren fr garantireparation utan specifik information frn kundtjnst. Villkor: Fljande villkor, begrnsningar och undantag gller fr tillverkarens skyldigheter i enlighet med denna garanti:

A. Ogiltigfrklarande av garantin: Denna garanti gller inte om kommunikationsmodulen, eller ngon av dess delar eller komponenter, har (1) reparerats av ngon annan n tillverkaren eller dess godknda representanter, (2) har ndrats s att stabiliteten eller plitligheten har pverkats, (3) har anvnts felaktigt eller (4) skadats av ofrsiktighet eller olyckshndelse. Felaktig anvndning inkluderar, men r inte begrnsad till, anvndning som inte r enligt kommunikationsmodulens bruksanvisningen eller anvndning med icke-godknda tillbehr. B. Begrnsningar och undantag: Byte av kommunikationsmodulen eller ngon av dess komponenter r den ENDA kompensation som erbjuds av tillverkaren. Alla rekommendationer, information och beskrivande litteratur som tillhandahlls av tillverkaren med avseende p kommunikationsmodulen anses vara korrekta och tillfrlitliga, men utgr inga garantier. Inget ombud eller ingen representant fr eller anstlld hos tillverkaren r auktoriserad att binda tillverkaren till ngon uttalad eller underfrstdd representation eller garanti. DET FINNS INGEN GARANTI GLLANDE KOMMUNIKATIONSMODULENS ALLMNNA LMPLIGHET ELLER LMPLIGHET FR ETT VISST NDAML. TILLVERKAREN AVSGER SIG ANSVAR FR KOMMUNIKATIONSMODULENS LMPLIGHET FR EN VISS MEDICINSK BEHANDLING ELLER FR EVENTUELLA MEDICINSKA KOMPLIKATIONER S O M U P P S T R F R N A N V N D N I N G AV KOMMUNIKATIONSMODULEN. TILLVERKAREN SKA INTE HLLAS ANSVARIG FR NGRA OFRUTSEDDA SKADOR ELLER FLJDSKADOR P EGENDOM, FRLORAD VINST ELLER FRLORAD ANVNDNING SOM BEROR P NGON DEFEKT ELLER FEL P KOMMUNIKATIONSMODULEN. Denna garanti ger den ursprungliga kparen specifika juridiska rttigheter och den ursprungliga kparen kan ha andra juridiska rttigheter som kan variera mellan olika stater. 131 5 Danish / Dansk Indholdsfortegnelse English . 4 French / Franais . 20 German / Deutsch . 36 Italian / Italiano . 52 Spanish / Espaol . 68 Portuguese / Portugus . 84 Dutch / Nederlands . 100 Swedish / Svenska . 116 Advarsler . 133 Forsigtighedsregler . 134 Om CADD-Solis kommunikationsmodul, model 2131 . 134 Istning af CADD-Solis kommunikationsmodulet . 135 Opladning af det genopladelige batteri . 139 Konfiguration af trdlse indstillinger vha. CADD-Solis Network Setup Utility softwaren . 140 Sdan tndes og slukkes den trdlse radio . 141 Visning af status og indstillinger for trdls . 141 Fejlfinding . 142 Transport . 143 Bortskaffelse/separat indsamling . 143 REACH-oplysninger . 143 Certificering iht. afsnit 15 . 143 Rengring og desinfektion af kommunikationsmodulet . 143 Specifikationer . 145 Begrnset garanti . 147 Japanese / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 132 VIGTIGT: Det genopladelige batteri i CADD-Solis kommunikationsmodulet skal forbindes internt og vre fuldt opladet i selve pumpen, inden systemet idriftsttes. Gennemg og flg alle instruktionerne i denne brugervejledning for at istte og oplade batteriet inden ibrugtagning. Ls alle instruktioner fuldt ud inden istning af CADD-Solis kommunikationsmodulet i CADD-

Solis ambulatorisk infusionspumpe model2110. Gem disse instruktioner til senere brug. Der findes detaljerede instruktioner, advarsler, specifikationer og yderligere oplysninger om betjening af CADD-Solis ambulatorisk infusionspumpe i pumpens brugervejledning. Der findes detaljerede instruktioner, advarsler, specifikationer og yderligere oplysninger om brug af CADD-Solis vekselstrmsadapteren i brugsanvisningen, der fulgte med produktet. ADVARSLER Med henblik p at undg alvorlig personskade er det meget vigtigt at flgende advarsler overholdes:

Undlad at udstte kommunikationsmodulet for regn, vand eller fugt. Det kan medfre std eller anden fare. Undlad at nedsnke CADD-Solis kommunikations modulets genopladelige batteri i vske. Det kan medfre std eller anden fare. Undlad at bruge CADD-Solis kommunikationsmodulets genopladelige batteri sammen med andre enheder end CADD-Solis kommunikationsmodulet. Undlad at tilslutte en vekselstrmsadapter direkte til CADD-Solis kommunikations-

modulets genopladelige batteri. Direkte tilslutning af en vekselstrmsadapter kan vre farligt og kan beskadige det genopladelige batteri, kommunikationsmodulet og pumpen. Et genopladeligt batteri til CADD-Solis kommunikationsmodulet, som er udtjent, skal udskiftes med et andet genopladeligt batteri til CADD-Solis kommunikationsmodulet. Brug af genopladelige batterier fra andre producenter kan medfre brand eller eksplosion. Undlad at lade de elektroniske kontakter p kommunikationsmodulet berre en metalgenstand (f.eks. en mnt en papirklips) samtidigt. Undlad at bruge CADD-Solis kommunikations-

modulet, hvis det er beskadiget, hvis den interne elektronik eksponeres pga. slitage, eller hvis de elektroniske kontakter p nogen mde er beskadiget. Det kan medfre brand, std eller anden fare. Undlad at forsge at knuse CADD-

Solis kommunikationsmodulet eller det genopladelige batteri. Det kan medfre brand, std eller anden fare. Undlad at destruere CADD-Solis kommunikationsmodulets genopladelige batteri via forbrnding. Det kan eksplodere. Undlad at bruge kommunikationsmodulet i CADD-Solis infusionspumpens pose eller anden form for pose eller taske. Kommunikationsmodulet kan blive overophedet og slukke vha. varmebeskyttelseskredslbet. Der er potentielle sundhedsfarer forbundet med forkert bortskaffelse af batterier og anden elektronik. Brugte batterier og andet brugt tilbehr skal bortskaffes p en miljmssigt forsvarlig mde og i overensstemmelse med alle gldende bestemmelser. 133 FORSIGTIGHEDSREGLER Undlad at bruge overdreven kraft til at adskille CADD-Solis kommunikationsmodulets htte fra bunden. Antennekablet skal forblive fastgjort til bde htten og bunden. Frakobling af antennekablet kan medfre skade p antennen og/eller kommunikationsmodulets elektronik. Hvis CADD-Solis kommunikationsmodulets genopladelige batteri ikke lades helt op inden frste ibrugtagning og ved lngere opbevaring, kan det medfre kraftig afladning af batteriet, som kan fre til behov for at udskifte batteriet frtid. USB-porten p CADD-Solis infusionspumpen er kun beregnet til kommunikation til PharmGuard Medication Safety Software, SureLink Remote Support Software og CADD Solis Network Setup Utility. Undlad at tilslutte tilbehr, som ikke understttes, til USB-porten (f.eks. opladning af andre enheder, tilslutning af en trdls dongle), da det kan beskadige pumpen. Hvis CADD-Solis kommunikationsmodulet opbevares uden for dets miljmssige driftsforhold og inden for de angivne miljmssige opbevaringsforhold, skal kommunikationsmodulet have tid til at varme op eller kle ned til driftstemperaturen i mindst en time inden ibrugtagning, s elektronikkredslbene ikke beskadiges. 134 Om CADD-Solis kommunikationsmodul, model2131 CADD-Solis netvrkskommunikationssystemet (NCS) bestr af CADD-Solis ambulatorisk infusionspumpe model2110 (softwareversion 4.2 eller nyere) med et CADD-Solis kommunikationsmodul isat og konfigureret til dit trdlse netvrk og PharmGuard Server. Nr kommunikationsmodulet er isat og konfigureret korrekt, kan pumpen sende pumpehistorik trdlst til PharmGuard Server og modtage opdateringer af pumpefirmware og biblioteker. Model2131 er et opgraderet kommunikationsmodul i forhold til model2130. Radioen er mere robust med bedre sikkerhed og kryptering og understttelse af 20mHz kanal og bnd. CADD-Solis kommunikationsmodulet omfatter den trdlse radio og et genopladeligt batteri, som sidder inden i modulet. Batteriet driver kommunikationsmodulet og leverer strm til CADD-

Solis pumpen, nr der ikke er tilgngelig vekselstrm. Det genopladelige batteri oplades, nr pumpen er tilsluttet til vekselstrm via CADD-Solis vekselstrmsadapteren ogs selvom pumpen er slukket. CADD-Solis vekselstrmsadapteren og ledningen (fs separat) bruges til at tilslutte pumpen, s batteriet kan oplades, nr kommunikationsmodulet er isat i CADD-Solis pumpen. CADD-Solis Network Setup Utility softwaren

(fs separat) bruges til at konfigurere de trdlse netvrksindstillinger for den specifikke pumpe, nr CADD-Solis kommunikationsmodulet isttes. Der er oplysninger om brug af denne software i de installationsanvisninger, der flger med den. BEMRK: Version 1.1 af Network Setup Utility skal bruges. ADVARSEL: Et udtjent CADD-Solis kommunikations-

moduls genopladelige batteri skal udskiftes med et andet CADD-Solis genopladeligt batteri. Brug ikke batterier fra andre producenter, da det kan medfre brand eller eksplosion. Der er flere oplysninger ibrugervejledningen til pumpen under alarmen Genopladeligt batteri er ikke lngere anvendeligt. ADVARSEL: Undlad at tilslutte vekselstrms-

adaptere direkte til CADD-Solis kommunikations-

modulets genopladelige batteri. Direkte tilslutning af en vekselstrmsadapter kan vre farligt og kan beskadige det genopladelige batteri, kommunikationsmodulet og pumpen. Istning af CADD-Solis kommunikationsmodulet FORSIGTIG: Istning og konfigurationen af CADD-

Solis kommunikationsmodulet i en pumpe m kun udfres af servicepersonale. FORSIGTIG: For at undg skade p kommunikations-

modulet skal pumpen slukkes, og alle kabler, der er tilsluttet til pumpen, skal frakobles, inden kommunikationsmodulet isttes i pumpen. FORSIGTIG: Da den frste istning af kommunikations modulet krver bning af modulets kabinet, m denne istning kun udfres ved en arbejdsstation, hvor elektrostatisk udladning (ESD) er kontrolleret, herunder via en jordforbundet mtte og armbnd. 1. Srg for, at CADD-Solis pumpen er slukket, og at der ikke er tilsluttet kabler til pumpen. 2. Brug fingrene, pumpenglen eller en mnt til at dreje knappen p batteridkslet mod uret og bne batteridkslet. 3. Fjern eventuelle batterier i pumpen. Srg ogs for, at der ikke er snavs i batterirummet. 4. Trk batteridkslet tilbage som vist, og fjern det fra pumpen. Batteridkslet bruges ikke med CADD-Solis kommunikations-

modulet. Opbevar batteridkslet p et tilgngeligt sted, s pumpen kan anvendes med AA-

batterier eller CADD-

Solis genopladelig batteripakke senere. 135 5. De tre pogo-stiftisolatorer, der findes p de tre pogo-stifter i pumpens batterirum, skal udskiftes med de isolatorer, der leveres med kommunikationsmodulenheden. Der skal bruges tre isolatorer, og der medflger en fjerde som ekstra. Kasser de oprindelige isolatorer. Brug en pincet til forsigtig at fjerne og bortskaffe de tre oprindelige pogo-stiftisolatorer som vist. Pogo-stiftisolator 6. Monter de tre nye pogo-stiftisolatorer, der leveres med kommunikationsmodulenheden. 136 7. Kontroller, at de tre nye pogo-stiftisolatorer sidder helt fast omkring stifterne. BEMRK: De tre nye pogo-stiftisolatorer er ogs kompatible med AA-batterier og CADD-Solis genopladelig batteripakke. Kasser de oprindelige pogo-stiftisolatorer, da de ikke skal bruges lngere. 8. Det genopladelige batteri inden i kommunikationsmodulet er ikke tilsluttet og skal tilsluttes internt. For at f adgang til batteriet med henblik p tilslutning skal du bruge en 10 IP stjerneskruetrkker til at fjerne de to skruer under htten p kommunikationsmodulet. ADVARSEL: For at undg potentiel personskade og materiel skade m htten p kommunikationsmodulet ikke fjernes, mens modulet er isat og tilsluttet til pumpen, og de elektroniske kontakter p kommunikations-

modulet m ikke berre en metalgenstand (f.eks. en mnt eller en papirklips) samtidigt. 9. Fjern forsigtigt htten fra bunden af kommunikationsmodulet, og srg for, at antennekablet ikke trkkes af enten htten eller bunden, og st derefter batteristikket i modtagerstikket til batteriet pkommunikationsmodulets printkort. 137 FORSIGTIG: Undlad at bruge overdreven kraft til at adskille kommunikationsmodulets htte fra bunden. Antennekablet skal forblive fastgjort til bde htten og bunden. Frakobling af antennekablet kan medfre skade p antennen og/eller kommunikationsmodulets elektronik. 10. Monter kommunikationsmodulets htte p bunden, og srg for, antennekablet stoppes helt ind i kommunikationsmodulet. 11. Ist og spnd de to stjerneskruer under kommunikationsmodulets htte med en 10IP stjerneskruetrkker, til de er skruet helt i, og spnd derefter endnu ca. 1/8omgang

(45grader). Spnd ikke for hrdt. ADVARSEL: Srg for, at pakningerne langs httens kant og skruehuller ikke bliver vk eller beskadiges, nr modulet bnes og lukkes. Disse O-ringe er ndvendige for at forhindre indtrngen af vand samt beskyttelse mod ESD. 138 Htte til kommunikations-modulKommunikationsmodulbundAntennekabelBatteristikBatterimodtagerstik 12. Ist kommunikationsmodulet i pumpens batterirum. Hgt bunden af adapteren til montering p dropstativ til bunden af pumpen, og klik derefter toppen af adapteren til montering p dropstativ fast p bunden af modulet. 14. Inden pumpen konfigureres og anvendes frste gang, skal kommunikationsmodulet oplades fuldstndigt. Se nste afsnit for at f flere oplysninger om opladning af det genopladelige batteri i CADD-Solis kommunikationsmodulet. BEMRK: Juster tnderne p adapteren til montering p dropstativ, s de passer i de forsnkede bninger i pumpehuset. Adapter til montering p dropstativ Justerings-

tnder Forsnket bning p pumpe 13. Brug en CADD-Solis pumpengle, en almindelig skruetrkker eller en mnt til at spnde skruen for at fastgre adapteren til montering p dropstativ og fastgre kommunikationsmodulet til pumpen. Spnd skruen, til den er skruet helt i, og spnd derefter endnu ca. 1/8omgang (45grader). Spnd ikke for hrdt. 15. Hvis CADD-Solis kommunikationsmodulet isttes i en specifik pumpe frste gang, skal de trdlse indstillinger for pumpen konfigureres vha. CADD-Solis Network Setup Utility softwaren (fs separat). Der er flere oplysninger idokumentationen, der leveres med Network Setup Utility softwaren. Opladning af det genopladelige batteri Kommunikationsmodulets genopladelige batteri oplades, nr CADD-Solis pumpen er tilsluttet til vekselstrm via CADD-Solis vekselstrmsadapteren ogs selvom pumpen er slukket. Inden for driftstemperaturintervallet 2C til 40C

(35F til 104F) vil det tage maks. 10timer at oplade batteripakken fuldstndigt. Oplad den genopladelige batteripakke helt:

Inden frste ibrugtagning Mindst hver 30. dag ved regelmssig brug Mindst n gang hver 6. mned ved opbevaring Nr pumpen angiver, at batteriet er eller er ved at vre afladet. FORSIGTIG: Manglende opladning af det genopladelige batteri under lngere opbevaring kan forrsage kraftig afladning af batteriet, som kan fre til behov for at udskifte batteriet fr tid. FORSIGTIG: For at undg beskadigelse af vekselstrmsadapterens konnektor eller pumpen m der ikke anvendes overdreven kraft eller instrumenter, f.eks. en tang, til at tilslutte eller frakoble vekselstrmsadapterens konnektor. 139 Sdan oplades det genopladelige batteri:

1. St ledningen til CADD-Solis vekselstrms-

adapteren i en stikkontakt med vekselstrm og den anden ende i vekselstrmsadapteren. 2. St vekselstrmsadapterens konnektor i vekselstrmsstikket (mrket 7V) p CADD-Solis pumpen. Nr konnektoren er korrekt tilsluttet, lyser den bl lampe ved siden af konnektoren ppumpen. 4. Nr pumpen er tndt, viser pumpens statusbjlke, at pumpen er tilsluttet til vekselstrm. Der vises en lille stikindikator tilhjre for batteriikonet. 5. Nr pumpen er tndt, kan du vurdere det anslede batteriniveau ud fra statusbjlken p pumpens display. Se brugervejledningen til pumpen for at f flere oplysninger. Nr batteriet er fuldt opladet, kan du vlge at tage vekselstrms-

adapterens stik ud. Meddelelsen Vekselstrms-

adapter frakoblet vises kortvarigt, nr stikket tages ud. Konfiguration af trdlse indstillinger vha. CADD-Solis Network Setup Utility softwaren Alle trdlse indstillinger for pumpen og CADD-Solis konfigurationsmodulet konfigureres vha. CADD-Solis Network Setup Utility softwaren (fs separat) via en USB-forbindelse fra en PC til CADD-Solis pumpen. CADD-Solis Network Setup Utility softwaren lader dig vlge og angive alle trdlse indstillinger til konfiguration med dine trdlse netvrksadgangspunkter og din PharmGuard Server. Disse indstillinger kan gemmes p CADD-Solis pumpen. Det vil sige, at hvis du udskifter pumpens CADD-Solis kommunikationsmodul, kan det nye kommunikationsmodul automatisk bruge pumpens forudkonfigurerede trdlse indstillinger. ADVARSEL: Undlad at tilslutte vekselstrms-

adaptere direkte til CADD-Solis kommunikations-

modulets genopladelige batteri. Direkte tilslutning af en vekselstrmsadapter kan vre farligt og kanbeskadige batteriet, kommunikationsmodulet og pumpen. FORSIGTIG: Hvis vekselstrmsadapterens udgangskonnektor ikke skubbes helt ind i pumpen, kan forbindelsen vre ustabil, og konnektoren kan lsne sig, s pumpen mister strm, og det genopladelige batteri ikke lngere oplades. 3. Nr pumpen tndes, viser pumpens statusbjlke kortvarigt meddelelsen Vekselstrmsadapter tilsluttet. 140 Der findes flere oplysninger i dokumentationen, der leveres med CADD-Solis Network Setup Utility softwaren. Trdls slet fra (hvid indikator) Sdan tndes og slukkes den trdlse radio Nr CADD-Solis kommunikations-

modulet er installeret, kan den trdlse radio tndes og slukkes efter behov (du kan for eksempel slukke radioen for at spare p batteriet osv.). Dette kan gres nr som helst i menuen Opgaver p pumpens skrm, uden at det forstyrrer pumpens kliniske funktioner, f.eks. krsel af en infusion. Der findes flere oplysninger i pumpens brugervejledning. Visning af status og indstillinger for trdls CADD-Solis Network Setup Utility softwaren giver dig mulighed for at se og ndre de trdlse indstillinger, men du kan ogs f vist statussen og indstillingerne for trdls p CADD-Solis pumpens skrm. Status for trdls angives p pumpens hovedskrm:

Trdls slet til, ikke tilknyttet til et trdlst adgangspunkt (orange indikator) Trdls slet til, tilknyttet til et trdlst adgangspunkt (orange indikator, der er grn i midten) Trdls slet til, tilknyttet til et trdlst adgangspunkt og kommunikerer med PharmGuard Server (grn indikator, der er grn i midten) Du kan desuden fr vist detaljeret status for trdls og indstillinger for trdls. I menuen Rapporter p pumpen skal du vlge Trdls status eller Trdls - indstillinger. Vlg Information om enheden i menuen Rapporter for at f vist kommunikationsmodulets version og MAC-adresse. Der findes flere oplysninger i pumpens brugervejledning. 141 Fejlfinding Problem Det genopladelige batteri oplades ikke. Mulig rsag/lsning Vekselstrmsadapterens konnektor er muligvis ikke sat helt ind i tilslutningsporten p pumpen. St vekselstrmsadapterens konnektor helt ind i pumpen. Batteriet er muligvis for varmt eller for koldt. Srg for, at de miljmssige forhold er i overensstemmelse med dem, der er angivet for drift. De tre medflgende pogo-stiftisolatorer er ikke isat eller ikke isat korrekt. Det genopladelige batteri er fuldt opladet, men fungerer ikke i pumpen. Der kan vre et problem med kontakten mellem pumpen og kommunikationsmodulet. Srg for, at kontaktfladerne p kommunikationsmodulet er rene. Srg for, at batterirummet og kontakterne p pumpen er rene. Prv at bruge kommunikationsmodulet i en anden pumpe. Hvis det fungerer i den anden pumpe, er der sandsynligvis et problem med den frste pumpe. Hvis kommunikationsmodulet stadig ikke fungerer i den anden pumpe, er der sandsynligvis et problem med kommunikationsmodulet og/

eller det genopladelige batteri. Kontakt Smiths Medicals kundeservice. Den trdlse radio er tndt, og pumpens ikon for trdls status viser Trdls slet til, ikke tilknyttet til et trdlst adgangspunkt

(orange indikator). Genopladeligt batteriniveau lav. Udskiftbatteri. Kommunikationsmodulet kan vre i varmereduktionstilstand. Se pumpens brugervejledning. De trdlse indstillinger er forkert konfigureret. Kontroller og/eller konfigurer indstillingerne. Kommunikationsmodulet er for langt vk fra et trdlst adgangspunkt. Flyt det tttere p Pumpen slukker automatisk for radioen p grund af et afladet batteri. Tilslut pumpen til etadgangspunkt. vekselstrmsadapteren. Kommunikationsmodulet er i nrheden af en tndt mikroblgeovn. Flyt det vk fra mikroblgeovnen. Pumpealarmer relateret til kommunikationsmodulet Den genopladelige batteripakke er tt p afslutningen af sin levetid. Den er blevet afladet og opladet s mange gange, at den er nsten udtjent. Den kan fortsat anvendes idenne tilstand. Genopladeligt batteri er ikke lngere anvendeligt. Pumpen kan ikke kre. CADD-Solis kommunikationsmodulets genopladelige batteripakke har net afslutningen af sin levetid. Den er blevet afladet og opladet s mange gange, at den ikke lngere er i stand til at holde en god opladning. Udskift den med et nyt genopladeligt batteri til CADD-Solis kommunikationsmodulet. Ubrugeligt batteri. Pumpen kan ikke kre. Batteriet er ikke kompatibelt med pumpen, eller der opstod en kommunikationsfejl. Der findes flereoplysninger i pumpens brugervejledning. Kommunikationsmodul intermitterende forbindelse med pumpen Forbindelsen mellem kommunikationsmodulet og pumpen er ustabil. Der findes flere oplysninger ipumpens brugervejledning. 142 Transport Kommunikationsmodulet er blevet testet i henhold til og er i overensstemmelse med FN's transportbestemmelser UN/DOT ST/SG/AC.10/11

(Rev.5) Section 38.3 testing requirements T1-T5, T7. Bortskaffelse/separat indsamling Kommunikationsmodulets genopladelige batteri skal vre helt afladet inden bortskaffelse og/eller polerne skal vre tapet til eller monteret med htte for at forhindre kortslutning. Personer, der ikke er bosat i EU, skal bortskaffe eller genbruge dette produkt i henhold til gldende lokale love eller bestemmelser. Indsamles separat Dette produkt indeholder elektriske og elektroniske komponenter, der kan indeholde materialer, som kan vre skadelige for miljet, hvis de bortskaffes sammen med almindeligt affald. I henhold til Europa-Parlamentets og Rdets direktiv 2002/96/EF om affald af elektrisk og elektronisk udstyr (WEEE) skal personer bosat i EU flge srlige retningslinjer for bortskaffelse eller genbrug af dette produkt. Kontakt den lokale distributr, eller besg flgende websted for at f srlige instruktioner:

http://www.smiths-medical.com/recycle/index.html ADVARSEL: Der er potentielle sundhedsfarer forbundet med forkert bortskaffelse af batterier og anden elektronik. Brugte batterier og andet brugt tilbehr skal bortskaffes p en miljmssigt forsvarlig mde og i overensstemmelse med alle gldende bestemmelser. REACH-oplysninger I henhold til den europiske forordning om registrering, vurdering og godkendelse af samt begrnsninger for kemikalier (Forordning EF nr.1907/2006, REACH) er virksomhederne forpligtet til at informere kunderne, hvis et produkt indeholder et eller flere af de stoffer, der er opfrt som kandidatlistestoffer (ogs kaldet srligt farlige stoffer

(SVHC)), i en koncentration p over 0,10% af vgten. Smiths Medicals erklringer vedrrende SVHC i produkter kan findes p: www.smiths-medical.com/

environment. Certificering iht. afsnit15 Denne enhed er i overensstemmelse med afsnit15 i FCC-bestemmelserne. Drift er underlagt flgende to betingelser: (1) Denne enhed m ikke forrsage skadelig interferens, og (2) denne enhed skal kunne modst enhver type modtaget interferens, herunder interferens, som kan forrsage unsket drift. Rengring og desinfektion af kommunikationsmodulet For at f den optimale effektivitet er den anbefalede bedste praksis at rengre frst og derefter desinficere. Alle desinfektionsmidler krver forudgende rengring med undtagelser af desinficerende rengringsmidler, der er testet til at desinficere ved tilstedevrelsen af 5% organisk materiale. FORSIGTIG: Undlad at nedsnke kommunikationsmodulet i rengringsmiddel eller vand. Srg for, at der ikke trnger vske ind i kommunikationsmodulet. Fugtansamlinger inden i kommunikationsmodulet kan beskadige det. Rengr og desinficer de overflader p kommunikationsmodulet, der er eksponerede, nrmodulet er isat i pumpen. 143 De godkendte desinfektionsoplsninger til CADD-

Solis kommunikationsmodulet er angivet nedenfor. Produkt Producent

(EPA-

registrerings-

nummer) Aktiv(e) ingrediens(er) Kontakttid/

desinfek-

tionstid CaviWipes Metrex

(46781-8) 17,2%

isopropanol Sani-Cloth Super PDI (9480-4) Dimethyl-

benzylammo-

niumchlorid, dimethylethyl-

benzylammo-

niumchlorid 3minutter 2minutter Sani-Cloth Bleach PDI (9480-8) 0,60%

natrium-

hypochlorit 4minutter 3. Lad kommunikationsmodulet trre helt inden brug. FORSIGTIG: For at undg skader p kommunikationsmodulets interne elektronik m der ikke trnge nogen form for vske ind i omrderne med elektroniske kontakter eller andre bninger og sammenfjninger. Brug kun en tr, fnugfri klud til at rengre elektroniske kontakter og det omkringliggende omrde, der normalt er indkapslet, nr modulet er isat i pumpen. Flgende trin kan anvendes til at rengre og desinficere kommunikationsmodulet:

1. Rengr kommunikationsmodulet med et mildt rengringsmiddel for at fjerne rester eller kontamineret materiale. Pfr oplsningen p en bld, fnugfri klud, og aftr derefter de overflader p kommunikationsmodulet, der er eksponerede, nr modulet er isat i pumpen. Srg for, at der ikke trnger vske ind i pumpen eller kommunikationsmodulet. 2. Desinficer kommunikationsmodulet ved at pfre en desinficerende oplsning (angivet nedenfor) i henhold til instruktionerne p etiketten til desinfektionsproduktet. Hvis der anvendes vske eller en spray, skal oplsningen pfres p en bld, fnugfri klud, og derefter aftrres de overflader p kommunikationsmodulet, der er eksponerede, nr modulet er isat i pumpen. Flg anbefalingerne fra producenten af desinfektionsproduktet med hensyn til, hvor lnge desinfektionsproduktet skal have kontakt med udstyret. Srg for, at der ikke trnger vske ind i pumpen eller kommunikationsmodulet. 144 Specifikationer Batteritype Genopladeligt litiumionbatteri (2celler) Litiumindhold svarende til <1,6g Batterikapacitet 18,7Wh (ved fuld opladning) Batteri-output 3,6V (nominelt) Det genopladelige batteris vgt

<100g Krav til milj ved drift Temperatur . 2C til 40C

(35F til 104F) Luftfugtighed . 20% til 90% relativ luftfugtighed, ikke-

kondenserende Atmosfrisk tryk . 70kPa til 106kPa

(10,2psia til 15,4psia) Krav til milj ved opbevaring og transport Temperatur . -20C til 60C

(-4F til 140F) Luftfugtighed . 20% til 90% relativ luftfugtighed, ikke-

kondenserende Atmosfrisk tryk . 70kPa til 106kPa

(10,2psia til 15,4psia) Produktets batterilevetid 400 fulde cyklusser (opladning/afladning) ved stuetemperatur, 23C (73F) Maksimal opladningstid (fuldt afladet til fuldt opladet) 10timer ved tilslutning til vekselstrmsadapteren Brugstid for pumpe og kommunikationsmodul (nyt batteri) 4timer ved nominelle pumpeindstillinger (se pumpens brugervejledning for at f oplysninger om nominelle indstillinger) Sikkerhed Kommunikationsmodulet er i overensstemmelse med Underwriters Laboratories UL2054, IEC60601-1

(2005+A1:2012) Ed3.1 [nr det er isat i CADD-Solis infusionspumpe model2110], IEC60601-1-2 (2014) og IEC62133 (2002). Litiumioncellerne er i overensstemmelse med Underwriters Laboratories UL1642. IEEE802.11 a,b,g,n Radio til netvrkskommunikation CADD-Soliskommunikationsmodulet er beregnet til modtagelse og transmission af elektromagnetisk energi med radiofrekvens (RF) til ikke-kritisk kommunikation. RF-transmission/-modtagelse, a-bnd . 5180MHz til 5320MHz og 5500MHz til 5825MHz RF-transmission/-modtagelse, b-, g- og n-bnd .................................... 2412MHz til 2472MHz Bndbredde for a-, b-, g- og n-signaler ...................... 20MHz Maksimal RF-transmissionseffekt for bnd a ....................................................... 10mW Maksimal RF-transmissionseffekt for bnd b, g og n ................................... 100mW 145 Kommunikationsmodulets trdlse rkkevidde:

36,58meter (120fod) (drift med direkte udsyn til adgangspunktet) Netvrkstilstande og kryptering Netvrkstilstande:

Krypteringstilstande:

802.11 a/b/g/n 802.11 b/g/n 802.11 a/n Ingen TKIP CCMP TKIP/CCMP Godkendelsestilstande: EAP-tilstande:

BEN WPA-ENT WPA2-ENT WPA-PSK EAP-TLS (v1.0 og v1.2) EAP-TTLS Ingen WPA2-PSK EAP-PEAPV0 (PEAP med MS-CHAPv2) EAP-PEAPV1 (PEAP med GTC) EAP-LEAP EAP-FAST Certifikater SSL SHA-1 SSL SHA-2 Bemrk: Kommunikationsmodulet kan forstyrres af andet udstyr, selvom det andet udstyr er ioverensstemmelse med CISPR 11-kravene. Se installations- og brugervejledningen til Network Setup Utility (version 1.1) for at f yderligere oplysninger om specifikationer og opstning forCADD-Solis kommunikationsmodulet. Interferens/separationsafstande Andre elektroniske kommunikationsenheder, der bruges i nrheden af kommunikationsmodulet, kan forrsage forstyrrelser i transmission af data. Forstyrrelser i transmission af data pvirker ikke pumpens infusion. Tabellen nedenfor angiver, hvilken effekt hver enkelt type enhed forrsager, og angiver den mindste separationsafstand, der skal overholdes. Interferensgiver (type af elektroniskenhed) Min. separati-

onsafstand 2,4GHz/5GHz basestationer med trdls transmitter (f.eks. Wi-Fi adgangspunkter, basestationer til trdlse telefoner) 2,4GHz/5GHz trdlst medicinsk udstyr og andet perifert udstyr

(f.eks. Wi-Fi aktiverede patient-

monitorer, infusionspumper, computere/smartphones/tablets;

bluetooth-aktiverede enheder;

Zigbee-aktiverede enheder;

hndsttil trdlse telefoner) Andre Smiths Medical CADD-Solis pumper med trdls forbindelse 433MHz/2,4GHz/5GHz RFID-tags til registrering af placering af aktiver 3meter

(9,84fod) 1meter

(3,28fod) 0,3meter

(1fod) Direkte kontakt 146 Begrnset garanti Garanti: Smiths Medical ASD, Inc. (Producenten) garanterer over for den oprindelige kber, at alle dele og komponenter i CADD-Solis kommunikationsmodulet

(kommunikationsmodulet), som er fremstillet af eller for producenten, med undtagelse af de punkter, der er anfrt nedenfor, er fri for defekter i materialer og udfrelse ved normal brug, hvis det anvendes i overensstemmelse med brugsanvisningen, i en periode p t(1)r fra den faktiske dato for salg til den oprindelige kber. DER ER INGEN ANDRE GARANTIER. Undtagelser: Denne garanti dkker ikke almindeligt slid og udskiftningsdele og ekskluderer specifikt enhver anden tilbehrsdel eller udstyr, der anvendes med kommunikationsmodulet. Procedurer ved garanti: I henhold til betingelserne i og som opfyldelse af denne begrnsede garanti vil producenten efter eget skn og uden omkostninger

(bortset fra et minimalt belb til forsendelse og hndtering) reparere eller ombytte ethvert kommunikationsmodul

(ikke omfattende tilbehr), som er defekt, hvis et krav fremsttes i lbet af en sdan etrig periode. Send IKKE et kommunikationsmodul eller en komponent til producenten med henblik p reparation under garantien, uden at have modtaget specifikke forsendelsesoplysninger fra kundeserviceafdelingen. Betingelser: Flgende betingelser, begrnsninger og eksklusioner glder for producentens forpligtelse under denne garanti:

A. Ugyldiggrelse af garantien: Denne garanti er ugyldig, hvis kommunikationsmodulet eller nogen del eller komponent i det er blevet (1) repareret af en anden end producenten eller dennes autoriserede reprsentant, (2) ndret, s dens stabilitet eller plidelighed er pvirket, (3) brugt forkert, eller (4) beskadiget ved uagtsomhed eller uheld. Misbrug omfatter, men er ikke begrnset til, anvendelse, der ikke er i overensstemmelse med brugsanvisningen til kommunikationsmodulet, eller anvendelse sammen med ikke-godkendt tilbehr. B. Begrnsninger og eksklusioner: Ombytning af kommunikationsmodulet eller en komponent eller del deraf er den ENESTE afhjlpning, som producenten tilbyder. Alle anbefalinger, oplysninger samt beskrivende litteratur, der leveres af producenten eller dennes reprsentanter i forbindelse med kommunikationsmodulet, betragtes som njagtige og plidelige, men udgr ingen garanti. Ingen agent, reprsentant eller medarbejder hos producenten har autoritet til at binde producenten til nogen reprsentation eller garanti, uanset om det mtte vre udtrykkeligt eller underforstet. DER ER STILLES INGEN GARANTI FOR KOMMUNIKATIONSMODULETS SALGBARHED ELLER EGNETHED TIL NOGET SPECIFIKT FORML. PRODUCENTEN FRALGGER SIG ANSVARET FOR KOMMUNIKATIONSMODULETS EGNETHED TIL NOGEN BESTEMT MEDICINSK BEHANDLING OG FOR ENHVER MEDICINSK KOMPLIKATIONER, DER STAMMER FRA BRUGEN AF KOMMUNIKATIONSMODULET. PRODUCENTEN KAN IKKE HOLDES ANSVARLIG FOR NOGEN TILFLDIG SKADE ELLER FLGESKADE P EJENDOM, TAB AF INDTJENING ELLER TAB AF ANVENDELSE, FORRSAGET AF EN DEFEKT ELLER FUNKTIONSFEJL VED KOMMUNIKATIONSMODULET. Denne garanti giver den oprindelige kber specifikke juridiske rettigheder, og den oprindelige kber kan have andre juridiske rettigheder, som kan variere fra land til land. 147 9 Japanese /

English . 4 French / Franais . 20 German / Deutsch . 36 Italian / Italiano . 52 Spanish / Espaol . 68 Portuguese / Portugus . 84 Dutch / Nederlands . 100 Swedish / Svenska . 116 Danish / Dansk . 132

. 149

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150 CADD-Solis 2131 . 150 CADD-Solis . 151

. 155 CADD-Solis Network Setup Utility . 156

/. 157

. 157

. 158

. 159

/ . 159 REACH . 159 15 . 159

. 159

. 161

. 163 148 CADD-Solis CADD-Solis CADD-Solis 2110 CADD-Solis CADD-Solis AC CADD-Solis CADD-Solis CADD-Solis AC CADD-Solis AC CADD-Solis CADD-Solis CADD-Solis CADD-Solis CADD-Solis CADD-Solis 149 CADD-Solis

/

CADD-Solis CADD-Solis USB PharmGuard Medication Safety Software SureLink Remote Support Software CADD-Solis Network Setup Utility USB CADD-Solis 1 150 CADD-Solis 2131 CADD-Solis NCS CADD-Solis 2110 4.2 CADD-Solis PharmGuard PharmGuard 2131 2130 20 MHz n CADD-Solis AC CADD-

Solis CADD-Solis AC AC CADD-Solis AC CADD-Solis CADD-Solis Network Setup Utility CADD-Solis Network Setup Utility 1.1 CADD-Solis CADD-Solis AC CADD-Solis AC CADD-Solis CADD-Solis ESD 1. CADD-Solis 2. 3. 4. CADD-Solis 3 CADD-Solis 151 5. 3 3 31 3 6. 3 152 7. 3 3 3 CADD-Solis 8. 10 IP 2 9. 153

/

10. 11. 10 IP 2 1/8 45 O ESD 154 12. 14. CADD-Solis 13. CADD-Solis 1/8 45 15. CADD-Solis CADD-Solis CADD-Solis CADD-Solis AC AC 2C 40C 10 30 6 AC AC 155 1. CADD-Solis AC AC AC 2. AC CADD-Solis AC 7V 4. AC 5. AC AC CADD-Solis Network Setup Utility CADD-Solis PC USB CADD-Solis CADD-Solis Network Setup Utility CADD-Solis Network Setup Utility PharmGuard Server CADD-Solis CADD-Solis AC CADD-Solis AC AC 3. AC 156 Network Setup Utility

/

CADD-Solis

/

CADD-Solis Network Setup Utility CADD-Solis CADD-Solis CM MAC 157

/

AC AC AC 3

/

/

AC CADD-Solis /

CADD-Solis 158 UN/DOT ST/

SG/AC.10/11 (Rev. 5) 38.3 T1-T5T7

/

EU 2002/96/EC http://www.smiths-medical.com/recycle/index.html REACH REACH EC No. 1907/2006 0.10%

/

SVHC SVHC Smiths Medical www.smiths-medical.com/environment 15 FCC 15 2 (1)

(2) 5%

159 CADD-Solis

/

EPA CaviWipes Sani-Cloth Super 3 2 17.2%

46781-8 PDI (9480-4) Sani-Cloth Bleach PDI (9480-8) 4 0.60%

3. 1. 2. 160 2

< 1.6 g 18.7 Wh 3.6V

< 100 g

. 2C 40C

. 20% 90%

()

. 70 kPa 106 kPa

(10.2 psia 15.4 psia)

. 20C 60C

. 20% 90%

()

. 70 kPa 106 kPa 23 400 /

AC 10 4 Underwriters LaboratoriesUL 2054 IEC 60601-1(2005 +

A1:2012) Ed 3.1 [CADD-Solis 2110

]

IEC 60601-1-2 (2014) IEC 62133 (2002 Underwriters LaboratoriesUL 1642 IEEE 802.11 abgn CADD-Solis RF RF /a .................................. 5180 MHz 5320 MHz 5500MHz 5825 MHz RF /b gn ........................................ 2412 MHz 2472 MHz abgn

.......................................................... 20 MHz a RF .................................................... 10mW bgn RF ......................................... 100mW 161 36.58 TKIP CCMP TKIP/CCMP EAP EAP-TLS (v1.0 v1.2) EAP-TTLS EAP-PEAPV0 (PEAP MS-CHAPv2) EAP-PEAPV1 (PEAP GTC) EAP-LEAP EAP-FAST 802.11 a/b/g/n 802.11 b/g/n 802.11 a/n WPA-ENT WPA2-ENT WPA-PSK WPA2-PSK SSL SHA-1 SSL SHA-2 CISPR 11 CADD-Solis Network Setup Utility (

1.1

/

2.4 GHz/5 GHz Wi-Fi 2.4GHz/5GHz Wi-Fi

//

; Bluetooth

; Zigbee ;

SmithsMedical CADD-Solis 433MHz/2.4GHz/5GHz RFID 3 1 0.3 162 CADD-Solis 1

:

1

()(

) A.

(1)

(2) (3)

(4) B. 163 x

: CADD-Solis

: 22400BZX00216000 H Manufacturer:

Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 USA Tel: 1 800 258 5361 (US/CA) Tel: +1 614 210 7300

@ European Representative:

Smiths Medical Czech Republic a.s. Olomouck 306, Hranice 1 - Msto, 753 01 Hranice, Czech Republic Tel: +44 (0) 1233 722100 www.smiths-medical.com CADD-Solis, CADD, CADD design mark, and Smiths Medical design mark are trademarks of Smiths Medical. The symbol indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. Allother names and marks mentioned are the trade names, trademarks, or service marks of their respective owners. 2015, 2016, 2017, 2019 Smiths Medical. All rights reserved. 2019-04 10018347-001

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