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1 2 3 | ID Label/Location Info | November 03 2014 | ||||||
1 2 3 | ID Label/Location Info | November 03 2014 | ||||||
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1 2 3 | User Manual orlite | Users Manual | 3.62 MiB | November 03 2014 |
OR Lite RFID-BASED SYSTEM TO HELP ASSEMBLE SURGICAL SETS ACCURATELY AND EASILY USER MANUAL REVISION 0 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 1 out of 48 User Manual ORLocateR ORLite Copyright 2014 Haldor Advanced Technologies Ltd. All rights reserved. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photo reproductive, recording or otherwise without the express prior written permission of Haldor Advanced Technologies Ltd. Haldor Advanced Technologies Ltd. reserves the right to change or improve its products and accompanying technical literature without specific notice to changes or improvements. Text revised August 2014. 2 Habanai Street, Hod Hasharon 45319, Israel Tel: +972 9 7885858 , Fax: +972 9 7885861, Email: support@haldor-tech.com European Authorized Representative:
Obelis s.a Boulevard Gnral Wahis 53 1030 Brussels, BELGIUM Tel: +(32) 2. 732.59.54 Fax: +(32) 2.732.60.03 E-Mail : mail@obelis.net 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 2 out of 48 User Manual ORLocateR ORLite Table of Contents 4. 3. 2. 1. INTRODUCTION ............................................................................................................................................. 4 R 1.1 THE HALDOR ORLOCATE ORLITE SYSTEM ....................................................................................................... 4 1.2 ABOUT THIS MANUAL .................................................................................................................................... 4 1.3 GLOSSARY ...................................................................................................................................................... 4 SAFETY .......................................................................................................................................................... 6 2.1 GENERAL SAFETY INSTRUCTIONS................................................................................................................... 6 2.2 WARNINGS .................................................................................................................................................... 6 2.3 INDICATIONS ................................................................................................................................................. 8 2.4 CONTRAINDICATIONS .................................................................................................................................... 8 2.5 SYSTEM LABELS .............................................................................................................................................. 9 INTRODUCTION TO THE HALDOR ORLOCATER ORLITE SYSTEM .................................................................... 13 R 3.1 SYSTEM ORLOCATE CONSOLE ....................................................................................................................... 13 3.2 SPONGE ADD ............................................................................................................................................... 13 3.3 FLAT ANTENNA ............................................................................................................................................ 13 3.4 LOCATOR ANTENNA ..................................................................................................................................... 14 3.5 HANDHELD RFID & BARCODE READER ......................................................................................................... 15 3.6 TOOL ADD ANTENNA ................................................................................................................................... 15 3.7 SPONGE BUCKET .......................................................................................................................................... 16 3.8 TAGGED AND UNTAGGED ITEMS ................................................................................................................. 17 STERILE CONSIDERATIONS .......................................................................................................................... 17 4.1 TOOL ADD AND LOCATOR ............................................................................................................................ 17 4.2 LOCATOR ..................................................................................................................................................... 17 4.3 SPONGE BUCKET .......................................................................................................................................... 17 4.4 FLAT ANTENNA ............................................................................................................................................ 17 R 4.5 SYSTEM ORLOCATE CONSOLE ....................................................................................................................... 18 4.6 CLEANING SURGICAL INSTRUMENTS THAT HAVE RFID TAGS ....................................................................... 18 4.7 RECOMMENDED DIMENSIONS FOR STERILE COVERS .................................................................................. 18 INSTALLATION OF ORLOCATER ORLITE SYSTEM ........................................................................................... 18 5.1 FIRST TIME INSTALLATION ........................................................................................................................... 19 5.2 POWER AND GND INSTALLATION ................................................................................................................ 20 R 5.3 CONECTING THE ANTENNAS TO THE ORLOCATE CONSOLE .......................................................................... 20 5.4 LOCATION OF THE SPONGE BUCKET, TOOL ADD AND LOCATOR ANTENNAS ............................................... 21 5.5 SYSTEM CONFIGURATION............................................................................................................................ 21 6. USING THE SYSTEM ..................................................................................................................................... 21 R 6.1 GENERAL PRINCIPLES HOW THE ORLOCATE COUNTS ................................................................................ 21 6.2 SYSTEM WORKFLOW USER INTERFACE ..................................................................................................... 22 THE ORLOCATER ORLITE FUNCTIONALITY .................................................................................................... 37 7.1 INFORMATION THAT IS AVAILABLE IN THE SYSTEM ..................................................................................... 37 7.2 PRODUCT FUNCTIONS ................................................................................................................................. 37 8. SHUTTING DOWN THE SYSTEM ................................................................................................................... 38 9. MAINTENANCE AND SERVICE ...................................................................................................................... 38 9.1 PERIODIC MAINTENANCE SCHEDULE ........................................................................................................... 38 9.2 MAINTENANCE PROCEDURE ........................................................................................................................ 38 9.3 OBTAINING SERVICE: ................................................................................................................................... 39 9.4 STORAGE ...................................................................................................................................................... 40 9.5 SYSTEM OR COMPONENTS END-OF-LIFE: .................................................................................................... 40 TROUBLE SHOOTING ................................................................................................................................ 40 OPERATING SPECIFICATIONS .................................................................................................................... 44 11.1 OPERATING, STORAGE AND TRANSPORTATION ENVIRONMENT ................................................................ 44 11.2 ELECTRICAL POWER ..................................................................................................................................... 44 SYSTEM SPECIFICATIONS .......................................................................................................................... 45 FCC ID CROSS REFERENCE TABLE .............................................................................................................. 45 EMC CONSIDERATIONS ............................................................................................................................. 46 12. 13. 14. 10. 11. 5. 7. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 3 out of 48 User Manual ORLocateR ORLite INTRODUCTION 1. 1.1 THE HALDOR ORLOCATE R ORLITE SYSTEM Haldor ORLocateR ORLite system is an RFID system that provide a solution enabling the enumeration of RFID tagged sponges and surgical instruments in order to keep track of the items during surgery, by utilizing passive RFID tags (battery-less transponder that not radiate any electromagnetic field when not activated). In addition, the system provides a non-invasive means of locating retained RFID-tagged surgical items within a surgical site. The system also supplies a semi-automatic application to help counting untagged items: the count information is first entered manually and the calculations are done automatically. 1.2 ABOUT THIS MANUAL This manual provides the necessary information to operate the Haldor ORLocateR ORLite system in a safe and efficient manner. Please read this manual before operating the system. If any part of this manual is not clear, contact Haldor Customer Support for clarification. 1.2.1 WARNINGS, CAUTIONS AND NOTES Three types of special messages appear in this User Guide:
- A warning indicates the possibility of injury to the patient or operator.
- A caution indicates a condition that may lead to equipment malfunction.
- A note provides additional important information. 1.3 GLOSSARY ADDITIONS:
Items that are not part of the inventory before the start of surgery and that are added during surgery. ANTENNA:
A powered device that is capable of sending and receiving signals from the RFID tags. There are 5 antennas in the ORLocateR ORLite system. AUTOMATIC COUNT:
Count performed automatically by the system every 5 minutes (can be configured to any other counting interval depending on the O.R users needs). 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 4 out of 48 User Manual ORLocateR ORLite CIRCULATING NURSE:
The nurse who works in the non-sterile areas. The Circulating Nurse is responsible for the counts, and for the addition of new items to the sterile field. CLEAN SPONGES:
Sterile and ready for use Sponges, gauzes or pads. ADD SPONGES:
Functionality to add sponges at the beginning or during surgery. IN OR:
The difference between the numbers of items that were registered initially plus number of items added and the number of items that were removed. For example, if ten items are registered, and only seven items were removed, then In OR is equal to three. INITIAL COUNT:
The number of items that were registered in the preparation stage. This count is confirmed by the user. INSTRUMENT SET/ TRAY:
A box that contains a pre-packaged set of sterile surgical instruments. The Instrument Set includes a non-sterile external container, and a sterile inner net that contains the instruments. FLAT ANTENNA:
Antenna installed on the OR console to allow user to add tagged sponges and remove tagged instruments. RFID:
Radio Frequency Identification a technology that enables communication with items that have RFID-tags attached to them. An RFID system includes a small radio transmitter that is activated by an antenna and in response sends its ID back to the antenna. Passive RFID tags, like those used in ORLocateR, do not contain a battery. RFID TAG:
A small, self-powered, self-enclosed device that contains an RFID and is placed inside a surgical sponge or is attached to a surgical instrument. SCRUB NURSE:
The nurse who works in the sterile area assisting the surgeon. SOILED SPONGES:
Sponges, gauzes or pads that are contaminated and cannot be further used. UNTAGGED ITEMS:
Instruments or sponges that do not have an RFID tag attached, for example due to the small size of the instrument. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 5 out of 48 User Manual ORLocateR ORLite 2. SAFETY 2.1 GENERAL SAFETY INSTRUCTIONS. Do not use before reading this manual. Plug the System ORLocateR Console into a properly installed power outlet of the appropriate voltage. Caution: Do not use the system if the power supply is faulty or unreliable. Changes or modifications not expressly approved by Haldor Advanced Technologies Ltd. can affect the safety and effectiveness of the system and will void the system's warranty. Do not operate with damaged cords or plugs. If damaged, have the cord or plug replaced immediately by a qualified service technician. The system contains no user-serviceable components. Do not open the system covers. 2.2 WARNINGS FCC Warning: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. For the ORLocateR system to operate use only Haldor's RFID tagged instruments and RFID tagged sponges obtained from Haldor or any sponge supplier as long as they conforming Haldor standards. Do not use the system in the presence of flammable anesthetic mixture with air, or with oxygen or nitrous oxide. Keep the ORLocateR Console out of the sterile field. Sponges are for single-use only. Do not reuse sponges. If the RFID tag is disconnected from a sponge or instrument, do not use the item. The ORLocateR system is not indicated for use in emergency surgeries, in surgeries which involve the use of an MRI machine, with patients who have a pacemaker, cardioverter defibrillators and implantable neurostimulators and with patients who have an implanted metal plate in the area of the operation. The Sponge Bucket should be used only for the disposal of sponges from the current surgery. The Locator must not be used near metal objects. 1 2 3 4 5 6 7 8 9 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 6 out of 48 User Manual ORLocateR ORLite To avoid contaminating the sterile field, always use a sterile cover with the Locator, the Tool Add, and the Sponge Bucket. Do not remove sterile covers from the antennas during the procedure. Clean all instruments according to their standard protocol before use. Clean all antennas and the System ORLocateR Console, before the procedure. Do not use sponges if the sponge package is open or otherwise compromise. Dispose RFID tags according to standard environmental regulations. Do not cut or tear RFID tagged sponges. Do not retain RFID tagged items inside the patient for more than 24 hours. While using the Locator interference may appear on the Ultrasound image. Do not use Locator while using this device. An MRI scan must not be performed on a patient who has a retained RFID-tagged item. When using a surgical laser, ensure that the laser is not used while an RFID tagged item is inside patient. Do not use the system in the presence of a flammable gas. While using Diathermia or Argon Diathermia do not use the Locator due to possible interference with antenna detection. Locator will shut down after 72 Seconds of continuous operation. Locator search will be available for use after 5 minutes timeout. Continuous stay next to the Tool Add Antenna once it is activated should be limited for up to 3 minutes within a distance of 10 cm (4") or less. While using Diathermia or Argon diathermia, cables of diathermia device should not cross less than 20 cm (8) from the top of the Sponge Add and Flat antenna surface due to possible interference with proper antenna function. If the RFID tag separates from an instrument or sponge during use, the item will not be detected by the ORLocateR system. Search for the item according to standard search protocols. If the patient has metallic implants or other objects in his body, the system may not correctly detect RFID-tagged instruments or sponges. Search for the items according to standard search protocols. 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 7 out of 48 User Manual ORLocateR ORLite If items are not detected with the Locator, search for the items according to standard search protocols. It is possible that two RFID-tagged items may be placed proximately in the patient in such a way that one of the instruments is not detected by the system. Search for the item according to standard search protocols. If one of the antennas appears to be not functioning, do not use the system. Lock the wheels on the System ORLocateR Console before setting up the system. The FCC Wants You to Know This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at his own expense. 28 29 30 31 32 2.3 INDICATIONS The ORLocateR system is indicated for use in recording, tracking and counting the number of RFID-
tagged surgical sponges, laparotomy sponges, towels, surgical instruments and other tagged items used during surgical procedures in which counting is required. In addition, the product is indicated for providing a non-invasive means of detecting retained RFID-
tagged surgical sponges, towels, surgical instruments and other tagged items within a surgical site 2.4 CONTRAINDICATIONS The ORLocateR system is not indicated for use in emergency surgeries, in surgeries which involve the use of an MRI machine, with patients who have a pacemaker, cardiac defibrillators, or neurostimulators and with patients who have an implanted metal plate in the area of the operation. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 8 out of 48 User Manual ORLocateR ORLite 2.5 SYSTEM LABELS 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 9 out of 48 User Manual ORLocateR ORLite 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 10 out of 48 User Manual ORLocateR ORLite Package Label In addition, specific Warning Labels are attached to the system components, as shown for each component below. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 11 out of 48 User Manual ORLocateR ORLite 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 12 out of 48 User Manual ORLocateR ORLite INTRODUCTION TO THE HALDOR ORLOCATE R ORLITE SYSTEM 3. 3.1 SYSTEM ORLOCATE R CONSOLE The System ORLocateR Console contains the computer and touch screen monitor that the circulating nurse uses to control the system. It also houses the Sponge Add. The System ORLocateR Console is placed outside of the sterile field. 3.2 SPONGE ADD If operated as part of the ORLite suite, the Sponge Add is located in the upper panel of the System ORLocateR Console, unless the Flat antenna (3.3) is located there instead of it. It is used to scan sponges added during surgery. The sponges are scanned while still in their packaging. After they are scanned, the sponges can be used or be placed into the Sponge Tray. Warning: Do not place any object on top of the Sponge Add (except for sponge packages). Note: sponges should be placed on top of the Sponge Add in the marked area, as shown in the in the figure on the right:
Warning Label on System ORLocateR Console:
The ORLocate system is not indicated for use in emergency surgeries, in surgeries which involve the use of an MRI machine, with patients who have a pacemaker, cardiac defibrillators, or neurostimulators and with patients who have an implanted metal plate in the area of the operation. 3.3 FLAT ANTENNA The Flat Antenna is located on the OR console. It is used for counting instruments and sponges. Note: Maximum 60 instruments should be scanned at one time, according to the detailed instructions and obligations that shall be trained with the user. Warning Labels on Flat Antenna:
While using Diathermia or Argon diathermia, cables of diathermia device should not cross less than 20 cm (8) from the top of the ORLocate antenna surface due to possible interference with proper antenna function. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 13 out of 48 User Manual ORLocateR ORLite 3.4 LOCATOR ANTENNA The Locator is used to search for sponges or surgical instruments that may be in the Operating Room or in the surgical cavity. To use the Locator, first remove it from the ORLocateR Console hook. Holding the Locator by its handle, pass it over the patient. Scan the surgical cavity and its surrounding area in all directions. Move the Locator at a maximum rate of 20 centimeters a second (7 inches/sec), maintaining a distance of 2.5 to 7.5 centimeters (1 to 3 inches) above the body, as illustrated in the figures below:
If the Locator detects an item, the screen will identify the instrument or sponge and a beep will be heard. After the item was located it must be placed on the appropriate Antenna, i.e.: Instrument on flat antenna, sponge in the Sponge Bucket, in order to be included in next count. Note: The detection of a tag by the Locator is affected by tag angle compared to antenna. Therefore, when used to scan the patient for retained items, the Locator should be held close to the operating site and be moved slowly in different angles. Note: When not in use, the Locator is placed on a hook on the System ORLocateR Console, as shown:
Warning: The Locator and the portion of its cable must be covered with a fresh sterile cover before starting a search. Warning: The Locator must not be used near metal objects. Warning Labels on Locator:
While using the Locator, interference may appear on ECG Graph Monitor display. User must be aware of this momentary influence on the graph. While using the Locator interference may appear on the Ultrasound image. Do not use Locator while using this device. While using Diathermia or Argon Diathermia do not use the Locator due to possible interference with antenna detection. Locator will shut down after 72 Seconds of continuous operation. Locator search will be available for use after 5 minutes timeout. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 14 out of 48 User Manual ORLocateR ORLite 3.5 HANDHELD RFID & BARCODE READER Surgical set RFID tag or barcode can be scanned by the user utilizing a handheld reader during the surgery preparation stage. This device is also used to scan the user cards which are RFID as well. The handheld device supported is PANMOBIL SmartScandy II. 3.6 TOOL ADD ANTENNA The Tool Add is used to detect surgical instruments that are added or removed during surgery. The nurse holds the instrument near the Tool Add, close to the side where the LED is located (see figure). There are two types of feedback:
(1) Beep, indicating that the instrument is detected by the Tool Add.
(2) A pop up message on the touch screen, specifying which instrument was detected. Note: The Scrub nurse should move the instrument close to the Tool Add and hold it steady /
rotate it for two seconds in front of the Tool Add. Note: Maximum 5 instruments should be scanned at one time. Note: Instrument tag should be located near the marked area as shown:
Warning: The Tool Add and the portion of its cable that on the sterile surface must be covered with a fresh sterile cover before each procedure. Warning Label on Tool Add:
Continuous stay next to the Tool Add should be limited for up to 3 minutes within a distance of 10 cm (4") or less. While using Diathermia or Argon diathermia, cables of diathermia device should not cross less than 20 cm
(8) from the top of the ORLocate antenna surface due to possible interference with proper antenna function. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 15 out of 48 User Manual ORLocateR ORLite 3.7 SPONGE BUCKET The Sponge Bucket is located near the surgical team, and is used for soiled sponges. The Sponge Bucket replaces the standard sponge bowl used for the disposal of used surgical sponges. Warning: The Sponge Bucket must be covered with a fresh sterile cover before each procedure. Note: When a sponge is deposited into the Sponge Bucket, and once a count is performed, the updated quantity will be presented. Later, when the sponge is physically removed from the Sponge Bucket, for the purpose of replacing the bucket liner, the sponge is still considered to be in the Sponge Bucket and is not included in the count for the maximum number of sponges that can be in the Sponge Bucket (see next Note). Note: The Sponge Bucket can hold a maximum of 70 sponges. When the number of sponges in the Sponge Bucket is more than 30, the system will display a reminder message to empty the Sponge Bucket. If the number of sponges in the Sponge Bucket is more than 50, a second message will be displayed. Note: The Sponge Bucket cable should be secured using T raps or strips as shown in the following figure, to prevent tiring-off of the cable from its connector. When the user empties the Sponge Bucket, the total number of sponges in the Sponge Bucket is resets. Warning Labels on Sponge Bucket:
While using Diathermia or Argon diathermia, cables of diathermia device should not cross less than 20 cm (8) from the top of the ORLocate antenna surface due to possible interference with proper antenna function. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 16 out of 48 User Manual ORLocateR ORLite 3.8 TAGGED AND UNTAGGED ITEMS Tagged items are RFID-tagged surgical instruments and sponges. The system is designed to track tagged items. Untagged items do not have RFID tags. Examples of untagged items are blades and needles. The system allows for the optional manual recording of untagged items. 4. STERILE CONSIDERATIONS The following sterile procedures are required in order to use ORLocateR in a safe manner. Warning: In order to avoid contamination, all sterile procedures described in this section must be followed. 4.1 TOOL ADD AND LOCATOR These components must be covered with a sterile cover including the portion of the cable in the sterile zone (table surface) before each procedure. 4.2 LOCATOR The Locator must be covered with a sterile cover before each use, including an appropriate portion of the cable that might have contact with the patient. Warning: If the Locator is dropped on the floor with the sterile cover intact, or when placing back on the ORLocateR Console (in the non-sterile zone) - a new sterile cover must be placed on the Locator. Warning: If the Locator is dropped to the floor without the sterile cover, it must be cleaned with alcohol, as in the standard procedure before placing a new sterile cover on it. 4.3 SPONGE BUCKET The Sponge Bucket must be covered with a sterile cover or a suitable liner. The cover must extend down the sides of the Sponge Bucket. 4.4 FLAT ANTENNA The flat antenna is cleaned with alcohol, as in the standard procedure. The flat antenna is also cleaned with alcohol and placed on top of the system console. Both components are then covered with a single sterile hospital sheet. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 17 out of 48 User Manual ORLocateR ORLite 4.5 SYSTEM ORLOCATE R CONSOLE The system ORLocateR Console is not sterile. It should be maintained in a clean condition. Place sponges on the Sponge Add while in their original package. Warning: If the touch screen display is blank, or if the screen is not responsive to touch commands, do not use the system until the problem is solved. Warning: If the touch screen is cracked, do not use the system until the problem is solved. Warning: If you experience problems calibrating the touch screen, do not use the system until the problem is solved. 4.6 CLEANING SURGICAL INSTRUMENTS THAT HAVE RFID TAGS Surgical instruments and tools with RFID tags shall be sterilized only using Steam Sterilization, according to the standard protocol. 4.7 RECOMMENDED DIMENSIONS FOR STERILE COVERS 5. Image Element Approximate Size Recommended Sponge Bucket Tool Add Locator and Cable 100 X 150 cm
(40" x 60") 50 X 100 cm
(20" X 40") 90 X 160 cm
(36" X 64") INSTALLATION OF ORLOCATE R ORLITE SYSTEM This section describes the installation procedures required, prior to using the ORLocateR ORLite System. Warning: The ORLocateR system must be connected to the main power supply and assembled by a technician authorized by Haldor, and not by the user. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 18 out of 48 User Manual ORLocateR ORLite General cautions and instruction for Installation:
Install the system in a dry and clean environment. Handle the LCD screen with care. The system contains no user-serviceable components. Do not open the system covers. If any component of the ORLocateR system is cracked or damaged, do not use the system until the problem is corrected. If the touch screen display is blank, the screen is not responsive to touch commands, or you experience problems calibrating the touch screen - do not use the system until the problem is corrected. See the Troubleshooting section of this document. 5.1 FIRST TIME INSTALLATION Follow these steps only for first time installation.
(1) Unpack all system components at or near the designated working area, handle the LCD Screen with care.
(2) Ensure that all system components are present according to the following list (as relevant according Locator to user requirements):
Main ORLocateR Console Unit Tool Add Flat Antenna Sponge Bucket Power and GND Cables 2 Antenna Cables Locator Cable
(3) Lift the LCD Screen and mount it to its designated place with 4 screws supplied with the system.
(4) Connect the keyboard and the mouse to the dedicated USB port.
(5) Perform System power-up:
Switch main power switch to l:
Press top tray pushbutton:
(6) First run set-up:
Update Time. Update the ORLocateR System Database to comply with the Hospital Database. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 19 out of 48 User Manual ORLocateR ORLite 5.2 POWER AND GND INSTALLATION Power connection:
Power line Protective GND 5.3 CONECTING THE ANTENNAS TO THE ORLOCATE R CONSOLE The System ORLocateR Console is the central connection point for the system. Connect all antennas to the ORLocateR Console according to the following diagram:
ORLocate Console Flat Antenna Installed on the system Console Locator Tool Add Sponge Bucket 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 20 out of 48 User Manual ORLocateR ORLite 5.4 LOCATION OF THE SPONGE BUCKET, TOOL ADD AND LOCATOR ANTENNAS The Sponge Bucket should be located close to the surgeons and scrub nurse and should be covered with a sterile cover. The Tool Add is located on top of system consol attached on the arm. The Locator should be located during surgery in the designated location on the System ORLocateR Console. 5.5 SYSTEM CONFIGURATION Perform System power-up:
Switch main power switch to l:
Press top tray pushbutton:
6. USING THE SYSTEM After the Operating Room has been configured for the ORLocateR ORLite System, as detailed in the previous section, use of ORLocateR ORLite can begin. System is turned on by pressing the black push button on the right panel of the system ORLocateR Console, as shown in the following figure:
6.1 GENERAL PRINCIPLES HOW THE ORLOCATE R COUNTS
(1) The initial count in surgery preparation includes all items that contained in the scanned surgical sets and sponges located on the flat antenna.
(2) Any new sponge that is added during surgery, after the initial count, must be scanned before use. Surgical instruments set tags must be scanned by the handheld or Tool Add and sponges must be scanned on the Sponge add or flat antenna. If the system detects items that were not registered in either of these two antennas, it alerts the user that items were improperly added to the inventory. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 21 out of 48 User Manual ORLocateR ORLite
(3) The system displays the number of Items "In OR" = {Items that were registered in the system} minus
{Items that were removed}.
(4) If an instrument falls on the floor or is otherwise contaminated, the instrument must be placed outside the sterile field, according to standard hospital procedure.
(5) If in the final count the Circulating Nurse sees that there are items missing ("In OR"), he / she can scan the contaminated items using the Tool Add or handheld antenna to reconcile the count.
(6) Use the Locator to search the surgical cavity for retained RFID tagged items before ending the surgery.
(7) Nurses may End Surgery with missing items and write down the reason why these items are missing.
(8) Do not place instruments into the Sponge Bucket.
(9) Do not place instruments on the Sponge Add.
(10) Untagged items are registered manually using the touch screen. Warning: Do not place metal devices on the flat antenna or sponge add. If a metal basket is used, place it on a separate trolley. Warning: During the initial registration, the system counts the number of sponges on the Flat Antenna. If the system count does not match your manual count, discard all sponges from the Flat Antenna. Warning: During surgery, the user enters additional packages of sponges into the system via the Sponge Add. If the sponges fail to register, or if the system registers the sponges with an incorrect count, discard the sponge package. Warning: If a package of sponges is opened before registration, this will compromise the sterility of the sponges. The package of sponges must be discarded, but NOT into the Sponge Bucket. Warning: The system checks for available system resources (hard disk space and computer memory) during system initialization. If a message is displayed indicating insufficient resources, stop using the system until the problem is solved. Warning: The system beeper should be operated during system initialization. If no beep is heard stop using the system until the problem is solved. Note: Before each surgery, clean the system and visual inspect the cables according to paragraphs 9.2.1 and 9.2.2. 6.2 SYSTEM WORKFLOW USER INTERFACE 6.2.1 PREPARATION MODE During the organization of the operating room, the required antennas are located in the room in the desired locations. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 22 out of 48 User Manual ORLocateR ORLite The circulating nurse touches the "Start" on the welcome view, as shown in the following figureError!
Reference source not found.:
(1) Step 1 Nurse Login:
To start the preparation mode it is required to enter the names and password of the authorized nurses, this can be done either manually by typing the nurse's details / name and password or by scanning the nurse's swipe card over using the handheld reader. The circulating nurse will also type the case #
number, as shown in the following figure:
Step 2 Antennas:
At this point the nurse is asked to make sure all the antennas are connected properly and system sound works as well. As shown in the following figure:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 23 out of 48 User Manual ORLocateR ORLite
(2) Step 3 Equipment Preparation:
Adding untagged items The nurse may add items that are not tagged with RFID tags, by pressing the "Select New untagged Item" as shown in the following figure:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 24 out of 48 User Manual ORLocateR ORLite Then the nurse selects a group (needles, blades, etc.) and type (if applicable), and inserts the quantity by clicking the "#" button or using the arrows, as shown in the following figureError! Reference source not found.:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 25 out of 48 User Manual ORLocateR ORLite Adding Sponges For adding sponges the circulating nurse places the required clean sponges on the Flat Antenna and presses the "Add Sponge" button, as shown in the following figures:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 26 out of 48 User Manual ORLocateR ORLite Sponges Mismatch:
If the system detects a quantity of sponges that cannot be divided by five or ten (depending on the type of sponge), the number of sponges is displayed in red. This indicates to the user that one or more sponges were not detected. In this case the user must discard the sponge packages that are on the Flat Antenna or Sponge Add, place new ones, and count again.
(3) Step 4 Confirm Count Results:
Adding instruments Scan the set RFID tag using the handheld reader in order to add all the instruments packed in the set, as shown in the following figure:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 27 out of 48 User Manual ORLocateR ORLite The nurse can see a detailed view of all added items the type and quantity of each item is specified, pressing on an item will display an image of the item. The nurse must then confirm these details, as shown in the following figure:Error! Reference source not found. The nurse can now press the Finish button and the system will enter the Surgery in Process phase. 6.2.2 SURGERY PHASE During the surgery, the nurse may view the count in several ways, as shown in the following figures below (pressing on an item will display an image of the item):
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 28 out of 48 User Manual ORLocateR ORLite
(4) Sponges view:
In this view the system displays information regarding the sponges count - Initial Count, Recent Additions, Total Opened sponge, and sponges that are currently still and the OR an were not removed yet (marked in red color), as shown in the following figureError! Reference source not found.:
(5) Instruments view:
In this view the system displays information regarding the instruments count - initial count, additions and removals, and instruments that are currently still and the OR an were not removed yet
(marked in red color). At the top of the screen the system displays the total number of instruments that are still in OR, As shown in the following figure:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 29 out of 48 User Manual ORLocateR ORLite
(6) Untagged Items view:
In this view the system displays information regarding the untagged items count - initial count, additions, and items that are currently still and the OR. The nurse can also register new untagged items by clicking the Select new untagged item button ,or add more unites to the untagged items types that are already registered by clicking the + button. The system also allows the nurse to register his / her count and get information on the items not located, as shown in the following figureError! Reference source not found.:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 30 out of 48 User Manual ORLocateR ORLite In all views the nurse can perform the following functions using the buttons on the screens:
.
(7) Add sponges When the nurse wishes to add new sponges to the inventory, the nurse should place a sponge package (closed package) on the Flat Antenna and click the "Add Sponges" button. The system will display the number of sponges that are detected in the package for user confirmation. If the system detects a number that cannot be divided by five or ten, it will notify the user and the user should discard the whole package. Only sponge packages that are confirmed are registered in the system, as shown in the following figure:
See also figure (11) - Display sponges' inventory.
(8) Remove sponges When the "Remove sponges" button is clicked, the system generates a count of the Sponges in the Bucket and display the quantity of the soiled sponges. After counting, the nurse should replace the bucket liner, as shown in the following figure:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 31 out of 48 User Manual ORLocateR ORLite The user must not remove or add sponges to the Sponge Bucket while a count is being performed for the Empty bucket operation, as noted in the pop up during the count. Unintended placement of instrument in Sponge Bucket In case that instrument is identified by the system in the Sponge Bucket, the following message will appear, as shown in the following figure:
(9) Remove tools - The circulating nurse may scan instrument back into set, removing it from the inventory, by placing the instruments on the Flat Antenna and clicking on the "Remove Tool" button. A Back to set pop up will open displaying the quantity of instruments removed, as shown in the following figures:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 32 out of 48 User Manual ORLocateR ORLite Note: The user must not add, remove or move instruments while the Count is being performed. If one of the instruments removed was not previously added to the system. The instrument will now be removed; all the instruments packed in the same set will now be added to the inventory, a pop up will be displayed. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 33 out of 48 User Manual ORLocateR ORLite
(10) Locator search During surgery the nurse can activate the Locator in order to locate an item in the surgical site, as shown in the following figure:
Use the Locator as specified in paragraph 3.4 Locator Antenna. When the Locator detects an item, it will be displayed on the screen, as shown in the following figure:
To end the Locator search the nurse should press the OK button and the Locator will be deactivated. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 34 out of 48 User Manual ORLocateR ORLite
(11) Add Instrument using the handheld reader:
The circulating nurse may add a new set to the inventory by scanning the set/instrument (packed in the set) using the handheld reader. The system will display the all the instruments packed in the set
(tagged and untagged) for user confirmation. Display of added and removed items:
When nurse adds new items, these additional items will be displayed as Items In OR. Each addition or removal of item will be recorded and displayed with the time it was added or removed (with - mark) and name of the nurse who was logged-in at that time, as shown in the following figure:
If more than 3 additions occur, this button appears. Upon clicking this button the nurse will get a full list of additions during surgery.
(12) Change user if a nurse is being replaced (due to shift change or breaks) the circulating nurse should clicking the "Change user" button (top of main view) and enter his/her name and password in the open pop up as shown in the following figure, either manually or by scanning the user card with the handheld device or with Tool Add antenna.
(13) End Surgery When this button is clicked, the system will display a pop up as shown in the following figure, indicating whether there are still item in OR and ask for confirmation to finish surgery. After 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 35 out of 48 User Manual ORLocateR ORLite confirmation the system will enter the "End Surgery" phase - as specified in paragraph 6.2.3 - End Surgery phase. If the count is not balanced the team must find the items, first visually and if not found, by using the Locator to search the surgical cavity for retained RFID tagged items, as specified in paragraph 3.4 -
Locator Antenna, before ending the surgery. 6.2.3 END SURGERY PHASE At the end of surgery the Circulating Nurse clicks on the End Surgery button the system enters the End Surgery phase. If the count of all the tagged items (Instruments and Sponges) is balanced the system will inform that the count is balanced, as shown in the following figure:
If the count in not balanced the system will ask the nurse to go back to the Surgery in Process module or to approve the unbalanced count. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 36 out of 48 User Manual ORLocateR ORLite After clicking the Next button, the system will request the nurses to count all untagged items, as shown in the following figure:
The system will indicate whether the count entered matches the registered untagged item count by displaying any mismatch in red color. The system will require a confirmation by an authorized user to end the surgery without balanced count, as shown in the following figure:
The system displays a full count report, as shown in the following figure, and the surgery may be closed by pressing the "Next" button:
2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 37 out of 48 User Manual ORLocateR ORLite 7. THE ORLOCATE R ORLITE FUNCTIONALITY 7.1 INFORMATION THAT IS AVAILABLE IN THE SYSTEM The user interface displays the following information:
Items In OR - Number and type of items that were registered but were not removed. Initial count numbers of items opened/placed on tables before start of surgery (by item type). Additions number and type of items added to sterile field during surgery, and the team member responsible for the addition. Expected total total number of items and type that were included in the inventory. Number of sponges (Initial Count and Total Opened). Last time the count was performed (either automatically or upon nurse request). 7.2 PRODUCT FUNCTIONS Antenna set-up check Add sponges during surgery Add untagged items during surgery Add instruments during surgery Status report Detection warnings End Surgery Locator search Change user Remove instruments 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 38 out of 48 User Manual ORLocateR ORLite Remove Untagged items Remove sponges 8. SHUTTING DOWN THE SYSTEM In order to shut down the system user should press the black push-button on the right panel of the system console top panel, as shown in the following figure:
9. MAINTENANCE AND SERVICE 9.1 PERIODIC MAINTENANCE SCHEDULE Routine maintenance should be performed on the system as follows:
Action Clean System (see below) Visual Inspection - Check cords and cables for signs of wear (see below) Visual Inspection - Check components for signs of damage (see below) Yearly system check When is Action Performed Action is Performed by Before and after each surgery Operating Room personnel Before each surgery Operating Room or Maintenance personnel Maintenance personnel. Monthly Once each year Haldor authorized Technician In case of damage, wear or any other problem, contact service. 9.2 MAINTENANCE PROCEDURE 9.2.1 CLEANING BEFORE EACH SURGERY Caution: Power Off and Unplug the AC power cord before cleaning the system. In order to maintain the system in optimum condition, clean the system before each surgery:
(1) Wipe down all system components with a damp cloth and then dry thoroughly.
(2) Wipe the entire length of all cables and power cords with a cloth soaked with 70% alcohol. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 39 out of 48 User Manual ORLocateR ORLite
(3) Wipe down the entire system with a cloth soaked with 70% alcohol. This includes all Antennas, and the inside and outside of the Sponge Bucket.
(4) Wipe the Touch Screen panel with a damp cloth.
(5) In case of dirt that is not removed using a damp cloth, such as blood stains, use a spray cleaner for LCD panels or a cloth soaked with 70% alcohol. 9.2.2 VISUAL INSPECTION BEFORE EACH SURGERY Check the following cables and cords for signs of wear:
(1) Antenna cables:
Sponge Bucket Tool Add Locator
(2) Power Cables:
Power Line cable Protective GND cable 9.2.3 VISUAL INSPECTION MONTHLY CHECK Check the following system components for signs of damage:
(1) System ORLocateR Console:
LCD Touchscreen Top Tray Plastics. Wheels are not jammed.
(2) Antennas:
Verify that antennas are not damaged, cracks. 9.3 OBTAINING SERVICE:
Contact the Haldor ORLocateR representative:
USA Support Haldor USA Inc. E-mail: support@haldor-tech.com ROW (Rest Of the World) Support Advanced Technologies Ltd. Tel: +972 9 7885858 Fax: +972 9 7885861 Address: 2 Habanai Street Hod Hasharon 45319, Israel E-mail: support@haldor-tech.com 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 40 out of 48 User Manual ORLocateR ORLite 9.4 STORAGE Between operations the system may be stored in the OR room, or, if needed by the user, in a dedicated dry and reasonably clean storage area, as specified below. The system should be cleaned as described in paragraph 9.2.1 Cleaning, prior to storing in storage area. While system is stored, it should be plugged to the AC power and LAN, and its components shall be placed on appropriate surfaces in such a manner that prevents mechanical or other damages to its components, including cables and screen. 9.5 SYSTEM OR COMPONENTS END-OF-LIFE:
Note: Do not discard. At end of life or end of use of the system or one of its components, please inform your Haldor representative, for disposal arrangement. 10. TROUBLE SHOOTING The following chart lists some typical conditions or problems that may occur with the Haldor ORLocateR ORLite System. Condition System Will Not Turn On Sponge or Instrument registered into System, but Subsequent Counts No Longer Indicate Item as Present Possible Cause Power cord is not plugged into the System or wall outlet. Power cord is damaged. Power is not available at power outlet. Main Power Switch is at On position and Top Tray LED is lit. ORLocateR System failure. Antennas have been affected by surrounding electro-surgical equipment. Item's tag is not located properly on top of the antenna. RFID tag is faulty. Antenna Housing is Cracked or Broken System does not update any data received, leading to wrong instrument and sponge counts Antenna has been dropped or misused. Hard disk is full. RAM memory is full. Recommended Action Ensure that both ends of the power cord are plugged in. Contact service for replacement cord. Check that the power source is working properly. Press 10 Sec at On/Off Push button wait 2 Sec and press again shortly at the On/Off push button. Contact service. Remove electro-surgical equipment from the vicinity of the system, or wait until ES equipment is no longer in use. Locate item close to its designated antenna. Remove the item that is faulty and contact Haldor Advanced Technologies Ltd. for a replacement. Contact service for an antenna replacement. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 41 out of 48 User Manual ORLocateR ORLite Condition Screen freezes system crash loses all data Possible Cause Faulty computer CPU. Faulty power supply. No indication if Tag is read and is correct, leading to Instrument not monitored and a wrong instrument count Antenna is not functional System not functional --
counting is discontinued, and current count is lost Display on screen is faulty or incorrect position, causing errors in Touchscreen use Touchscreen detects touch in wrong position Instrument not detected, leading to a wrong instrument count Faulty/crashed Windows operating system. Faulty beeper mechanism on Tool Add or Locator. Faulty LEDs on Tool Add or Locator. Faulty digital input/output mechanism Module (internal component of System ORLocateR Console). Faulty RF Multiplexor unit Module (internal component of System ORLocateR Console). Faulty RF Module (internal component of System ORLocateR Console). Faulty RF Multiplexor Module
(internal component of System ORLocateR Console). Power supply failure. DC Converter is not working properly. Touchscreen is cracked. Touchscreen is not calibrated. Touchscreen is dirty. Touchscreen is not calibrated. Not receiving any electrical signals because connector to Flat Antenna or Tool Add or Locator is faulty. Not receiving any electrical signals because cable to Flat Antenna or Tool Add or Locator is damaged. Not receiving any electrical signals because antenna of Flat Antenna or Tool Add or Locator is not tuned. Recommended Action Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Clean the screen. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 42 out of 48 User Manual ORLocateR ORLite Condition Possible Cause RFID tag is disconnected from the instrument. Recommended Action Stop using the instrument if the RFID tag is disconnected. RFID tag damaged during production, transportation or storage. Sterilization process damaged the RFID tag and it is not functional. Temperature or humidity in the operating room is too high or low, causing the RFID tag to not function. Instrument placed in Sponge Bucket and discarded in external bio-hazardous bags. Instrument is added without prior registration. Sponge not monitored, leading to a wrong sponge count Not receiving any electrical signals because connector to Sponge Bucket or Sponge Add is disconnected or faulty. Not receiving any electrical signals because cable of Sponge Bucket or Sponge Add is damaged. Not receiving any electrical signals because antenna of Sponge Bucket or Sponge Add is damaged. Not receiving any electrical signals because antenna of Sponge Bucket or Sponge Add is not tuned. The RFID tag damaged during production, transportation or storage. The RFID tag is disconnected from the sponge when the sponge is first opened. Sterilization process damaged the RFID tag and it is not functional. Temperature or humidity in the operating room is too high or low, interfere the RFID function. Stop using the item and contact Haldor Advanced Technologies Ltd. for a replacement. Register all instruments prior to use, and take appropriate action for a bad instrument. Observe the temperature and humidity ranges for operating the system. Extract the instrument and set it aside until the final count. Each instrument must be scanned under the Tool Add before being placed into the sterile field. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Stop using the system until the problem is corrected. Register sponges prior to use, and take appropriate action for a bad sponge. Do not use the sponge. Register all sponges prior to use, and take appropriate action for a bad sponge. Observe the temperature and humidity ranges for operating the system. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 43 out of 48 User Manual ORLocateR ORLite Condition Sponge becomes non-
sterile, leading to patient contamination Locator is not sterile Locator is not sterile and may be contaminated with blood Misuse of instrument causes patient injury Misuse of sponge causes patient injury RFID tag is in the operational site Instrument or sponge is in the operational site and cannot be located or cannot be removed Instrument becomes non-
sterile, leading to patient contamination Instrument or sponge not found and may lead to incorrect count Sponge package fails to register Sponges not registered and therefore are not monitored, leading to a wrong sponge count Wrong sponge registration, leading to an incorrect sponge count Possible Cause Sponge discarded straight into external bio-hazardous bags, bypassing the Sponge Bucket Sponge is added without prior registration. Recommended Action Discard used sponges into Sponge Bucket, and from the Sponge Bucket to the external bio-hazardous bags. Scan each sponge package under the Sponge Add Sterile sponge placed on Sponge Add. Place sponges on the Sponge Add only while in original package. Locator was dropped to the floor while enclosed in sterile cover. Locator was dropped to the floor while not enclosed in sterile cover. Instrument tag location interferes with the intended use of the instrument. Instrument tag location changes instrument balance, causing incorrect use of the instrument. Sponge tag location changes sponge balance causing incorrect use of the instrument. RFID tag disconnects from the instrument or sponge during use. RFID tag disconnects from the item during use. Replace sterile cover Clean the Locator. Discard the instrument until the final count. Discard the instrument until the final count. Discard the sponge. Item will be missing in final count. Refer to paragraph 3.4 for instructions on how to perform a Locator Search to locate the missing RFID tag. Find the item according to existing protocols. Instrument is placed on Sponge Add antenna Set aside the instrument until the final count. RFID tag inside patient is blocked by metallic objects in the patient, is out of range, or is interfered with by another tag, and is not detected Defective RFID tag Change the position and angle of the Locator, in order to get more complete coverage. If item remains missing, search for item according to hospital procedures. Discard the package of sponges Sponges are still in their non-
sterile packaging and their tags interfere with each other Sponge package not full Discard the package of sponges Discard the package of sponges when the number of sponges is less than a full package 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 44 out of 48 User Manual ORLocateR ORLite Condition Bio-contamination leading to patient infection Possible Cause Sponge package opened before registration Sterile covering is removed from Flat Antenna during procedure Sterile covering is removed from Locator during procedure ORLocateR Console/Sponge Add biocontaminated Tools not cleaned and sterilized well enough Sponges not sterile due to compromised packaging Recommended Action Discard the package of sponges Do not remove the sterile covering on the antenna during the procedure. Do not remove the sterile covering on the antenna during the procedure. Clean the ORLocateR Console after every use. Clean the tools after every use. Do not use products with open or damaged packaging. 11. OPERATING SPECIFICATIONS Note: Unless otherwise indicated, all specifications are subject to change without notice. Specifications and test methods will be made available upon request. 11.1 OPERATING, STORAGE AND TRANSPORTATION ENVIRONMENT Operating Environment Storage and Transportation Environment Temperature:
10C to 40C (50 F to 104 F)
-40C to 70C (-40F to 158F) Relative Humidity:
30% to 75%
10% to 100%
Pressure:
700 hPa to 1060 hPa 500 hPa to 1060 hPa 11.2 ELECTRICAL POWER Consumption (max): Up to 120 Watt Input Voltage Range: 100 to 240 VAC at 50 to 60 Hz 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 45 out of 48 User Manual ORLocateR ORLite 12. SYSTEM SPECIFICATIONS In addition to the specified in paragraph 3 - Introduction to the Haldor ORLocateR ORLite System -
Description of System Components, for each Component, the following specification shall be applied:
Note: The System and its components can hold a maximum quantity of RFID- tagged items
(instruments and sponges). Do not exceed the quantities detailed in the table below:
Max. items Max detection distance /
limitation Weight
(Kg) Flat Antenna Sponge Bucket Tool Add Sponge Add Locator quantity of 70 instruments 70 7 sponges instrument Up to 5 cm (2). Items No stacked items on should be Up to 5 cm
(2.5). top of the other. Tags horizontal inside bucket
(2) Inside the 10 36 5 (2 w/o the base) Dimensions
(cm /
inches) 60.5x47x6.5 55x55x88 22x13x33 cm 24x18.5x2.5 inches cm 22x22x35 inches cm 9x5x13 inches 10 Sponges (1 package) Up to 6 cm lines NA NA NA 4 items (instruments and sponges) up to 38 cm (15) for tagged sponges and up to 28 cm (11) for tagged instrument 2.3 57x51x9.5 cm 22.5x20x4 inches System ORLocateR Console dimensions: 50x58x130cm (20x23x51), weight: 63 Kg. Maximum quantity of sponges that can be detected in one cycle of count: 120 sponges. Maximum quantity of instruments that can be detected in one cycle of count: 75. 13. FCC ID CROSS REFERENCE TABLE ORLocateR OR-
Lite System Flat Antenna Sponge Bucket Tool Add Locator Channel Setting Single Channel Single Channel Single Channel Single Channel Max. Output Power Power Supply FCC ID 4W 4W 2W 4W RPS-60-24
(Meanwell) X4V-ORL-L40 RPS-60-24
(Meanwell) X4V-ORL-L40 RPS-60-24
(Meanwell) X4V-ORL-L40 RPS-60-24
(Meanwell) X4V-ORL-L40 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 46 out of 48 User Manual ORLocateR ORLite 14. EMC CONSIDERATIONS The ORLocateR System needs special precautions regarding Electromagnetic Compatibility (EMC), and must be installed and put into service according to the EMC information provided in this manual. Portable and Locator RF equipment can affect the ORLocateR System. Compatibility of cables, transducers, and other accessories: Not applicable Table 1 - According to Table 204 from IEC 60601-1-2 Guidance and Manufacturers Declaration Emissions Equipment and Systems that is NOT Life-supporting The ORLocateR System is intended for use in the electromagnetic environment specified below. The customer or user of the ORLocateR System should ensure that it is used in such an environment. Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 Test Compliance Level 3 Vrms Level 150 kHz to 80 3Vrms MHz 3 V/m 80 MHz to 2.5 3V/m GHz Electromagnetic Environment - Guidance Portable and Locator communications equipment should be separated from the ORLocateR System by no less than the distances calculated/listed below:
D = (3.5/3)(P) D = (3.5/3)(P) - 80 to 800 MHz D = (7/3)(P) - 800 MHz to 2.5 GHz Where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
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. 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 ORLocateR System is used exceeds the applicable RF compliance level above, the ORLocateR System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ORLocateR System. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 47 out of 48 User Manual ORLocateR ORLite Table 2 - According to Table 206 from IEC 60601-1-2 Recommended Separation Distances between portable and Mobile RF Communications equipment and the ORLocateR System Equipment and Systems that is NOT Life-supporting The ORLocateR system is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ORLocateR System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications Equipment and the ORLocateR System as recommended below, according to the maximum output power of the communications equipment. Max Output Power
(Watts) Separation (m) 150 kHz to 80MHz D = (3.5/3)(P) Separation (m) 80 to 800MHz D = (3.5/3)(P) Separation (m) 800MHz to 2.5GHz D = (7/3)(P) 0.01 0.1 1 10 100 0.1166 0.3689 1.1666 3.6893 11.6666 0.1166 0.3689 1.1666 3.6893 11.6666 0.2333 0.7378 2.3333 7.3786 23.3333 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: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The ORLocateR System contains a receiver operating at a frequency of 13.56 MHz +/- 7 kHz. The ORLocateR System may be affected by other equipment, even if that other equipment complies with CISPR EMISSION requirements. If abnormal behavior is observed, please refer to the separation distance chart provided in this appendix. The ORLocateR system contains a transmitter operating at a frequency of 13.56 MHz, using 10%
amplitude shift keying at a modulation frequency of 423.75 kHz, and maximum Effective Radiated Power of 130.7 mW. 2014 Haldor Advanced Technologies Ltd. P0051 Rev.0 Page 48 out of 48
1 2 3 | User Manual reception | Users Manual | 3.44 MiB | November 03 2014 |
SPD
(Sterile Processing Department) Work Stations RFID-BASED SYSTEM TO HELP ASSEMBLE SURGICAL SETS ACCURATELY AND EASILY USER MANUAL REVISION 3.0 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 1 out of 43 User Manual ORLocateR Packing System Copyright 2014 Haldor Advanced Technologies Ltd. All rights reserved. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photo reproductive, recording or otherwise without the express prior written permission of Haldor Advanced Technologies Ltd. Haldor Advanced Technologies Ltd. reserves the right to change or improve its products and accompanying technical literature without specific notice to changes or improvements. Text revised January 2014. 2 Habanai Street, Hod Hasharon 45319, Israel Tel: +972 9 7885858 , Fax: +972 9 7885861, Email: support@haldor-tech.com TABLE OF CONTENTS Introduction Safety Introduction to the Haldor ORLocateR SPD Work Stations System Sterile and Cleaning Considerations Setting ORLocateR Packing system Components Using the System The ORLocateR functionality Shutting down the system 1. 2. 3. 4. 5. 6. 7. 8. 9. Maintenance and Service 10. Trouble Shooting 11. Operating Specifications 12. 13. 14. System Specification FCC ID Cross Reference Table EMC Considerations 1. INTRODUCTION 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 2 out of 43 2 5 8 10 10 11 36 37 37 38 40 40 41 42 User Manual ORLocateR Packing System 1.1 THE HALDOR ORLOCATE R SPD WORK STATIONS Haldor ORLocateR SPD Work Stations system is a supplementary system for the Operating Room ORLocateR system and to the ORLocateR Management system, which is described in a different User Manuals. Generally, Haldor ORLocateR system is an RFID system that provides a solution enabling the enumeration of RFID tagged sponges and surgical instruments to keep track of the items during surgery, by utilizing passive RFID tags (battery-less transponder that does not radiate any electromagnetic field when not activated). Haldor ORLocateR SPD Work Stations system is an RFID system that provides a solution enabling the enumeration of RFID tagged surgical instruments to keep track of the items during their usage (OR-SPD cycle), by utilizing passive RFID tags (battery-less transponder that do not radiate any electromagnetic field when not activated). The ORLocateR SPD Work Stations provides a method for packing RFID-tagged surgical items within a surgical set, and is to be used during washing, sterilization and while packing units in hospitals. 1.2 ABOUT THIS MANUAL This manual provides the information necessary to operate the Haldor ORLocateR SPD Work Stations in a safe and efficient manner. Please read this manual before operating the system. If any part of this manual is not clear, contact Haldor Customer Support for clarification. 1.2.1 WARNINGS, CAUTIONS AND NOTES Three types of special messages appear in this User Guide:
- A warning indicates the possibility of injury to the patient or operator.
- A caution indicates a condition that may lead to an equipment malfunction.
- A note provides other important information. 1.3 GLOSSARY ANTENNA:
A powered device that is capable of sending and receiving signals from the RFID tags. There is one antenna in the ORLocateR SPD Work Stations called Tool Pack. ITEMS MISSING:
Items that are listed in the inventory list but were not scanned in the Tool Pack antenna during assembly. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 3 out of 43 User Manual ORLocateR Packing System INVENTORY LIST:
The list of items that create a surgical set. This list is uploaded to the system by a system administrator at the ORLocateR management system. INSTRUMENT:
A specific tool that can be used on surgeries performed at a hospital. An instrument in the system will usually be part of a set and will be tracked and managed by ORLocateR Management system. INSTRUMENT TYPE:
a template of instrument that defines its expected use, the set in which it may belong to and its exact shape. Each instrument in the system is characterized by a single instrument type. INSTRUMENT SET/ TRAY:
A box that contains a set of sterile surgical instruments. The Set includes a non-sterile external container, and a sterile inner net that contains the instruments. The instruments are arranged in a predefined layout within the set (in a Tray). A set in the system will be tracked and managed by ORLocateR Management system. SET TYPE:
A template of a set that defines its expected use, the procedures it might be used in, its specific packaging instructions, the type and quantity of required instruments and the layout of instruments in it. RFID:
Radio Frequency Identification a technology that enables communication with items that have RFID-tags attached to them. An RFID system includes a small radio transmitter that is activated by an antenna and in response sends its ID back to the antenna. Passive RFID tags, like those used in ORLocateR, do not contain a battery. RFID TAG:
A small, self-enclosed device that contains an RFID and is attached to a surgical instrument or is attached to an instrument set/tray. PACKING PERSONNEL/TECHNICIAN:
A trained team member whose job is to assemble surgical sets at the packing unit. PACKING INSTRUCTIONS:
Instructions written by a system administrator that guides how to pack or place a certain item. SET TAG An RFID tag that is attached to a specific instrument set/tray. The tag is attached with a metal ring and is removable. UNTAGGED ITEMS:
Instruments that do not have an RFID tag attached, for example due to the small size of the instrument. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 4 out of 43 User Manual ORLocateR Packing System 2. SAFETY 2.1 GENERAL SAFETY INSTRUCTIONS Do not use before reading this manual. Plug the Tool Pack Antenna into a properly installed power outlet of the appropriate voltage. Caution: Do not use the system if the power supply is faulty or unreliable. Changes or modifications not expressly approved by Haldor Advanced Technologies Ltd. can affect the safety and effectiveness of the system and will void the system's warranty. Do not operate with damaged cords or plugs. If damaged, have the cord or plug replaced immediately by a qualified service technician. The system contains no user-serviceable components. Do not open the system covers. 2.2 WARNINGS FCC Warning: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. For the ORLocate Packing system to operate use only Haldor's RFID tags. Dispose RFID tags according to standard environmental regulations. Do not use the system in the presence of a flammable gas. Continuous stay next to the Tool Pack Antenna should be limited for up to 3 minutes within a distance of 10 cm (4") or less. The FCC Wants You to Know This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at his own expense. 1 2 3 4 5 6 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 5 out of 43 User Manual ORLocateR Packing System 2.3 INDICATIONS The ORLocateR Packing system is indicated for use in detecting RFID-tagged surgical instruments and set tags. The product is indicated for providing a method of packing surgical items to create surgical sets. 2.4 SYSTEM LABELS Flat Antenna (new revision name of the Mayo Antenna):
Discard properly 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 6 out of 43 User Manual ORLocateR Packing System Package Labeling for the ORLocateR Packing System:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 7 out of 43 User Manual ORLocateR Packing System 3. INTRODUCTION TO THE HALDOR ORLOCATE R SPD WORK STATIONS SYSTEM For general introduction - see chapter 1.1. The Haldor ORLocateR SPD Work Stations System. The functionality of the SPD System and its stations in the complete solution workflow is presented in the following diagram:
3.1 DESCRIPTION OF SYSTEM COMPONENTS The system includes the following main components:
3.1.1 USER INTERFACE COMPONENTS The interface hardware consists of two modules:
1. PC Intel Core 2 Duo, 1.8MHz, 2G memory, 160G disk, Serial, USB and LAN ports. 2. Touch screen 15 or 17 touch screen The modules can be provided as one component combining both
(Panel PC) or two separate components. Figure 1 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 8 out of 43 User Manual ORLocateR Packing System 3.1.2 FLAT ANTENNA The Flat Antenna is used for counting RFID tagged surgical instruments, in the SPD Reception station. Note: Maximum 60 instruments should be scanned at one time, according to the detailed instructions and obligations that shall be trained with the user. 3.1.3 TOOL-PACK ANTENNA The Tool Pack Antenna is used to scan RFID tagged surgical instruments before placing them inside the set. RFID tagged instruments should be held near the antenna as shown in the figure on the right. The feedback for reading the instrument is an indication on the currently opened screen, specifying which instrument was detected. Note: Move the RFID tagged item close to the Tool Pack Antenna and hold it steady / rotate it for two seconds in front of the antenna until all RFID tagged items are registered in the system
(i.e. information appears on screen). Note: Maximum 5 instruments should be scanned at one time. Warning Label on Tool Pack:
Continuous stay next to the Tool Pack should be limited for up to 3 minutes within a distance of 10 cm
(4") or less. 3.1.4 TOOL-ADD ANTENNA The Tool Add Antenna is used to scan RFID tagged surgical instruments before placing them inside the set. RFID tagged instruments should be held near the antenna as shown in the figure on the right. The feedback for reading the instrument is an indication on the currently opened screen, specifying which instrument was detected. Note: Move the RFID tagged item close to the Tool Add Antenna and hold it steady / rotate it for two seconds in front of the antenna until all RFID tagged items are registered in the system
(i.e. information appears on screen). Note: Maximum 5 instruments should be scanned at one time. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 9 out of 43 User Manual ORLocateR Packing System Warning Label on Tool Add:
Continuous stay next to the Tool Add should be limited for up to 3 minutes within a distance of 10 cm (4") or less. While using Diathermia or Argon diathermia, cables of diathermia device should not cross less than 20 cm
(8) from the top of the ORLocate antenna surface due to possible interference with proper antenna function. 3.1.5 HAND HELD READER (SCANNER) The Hand-Held Reader is used to scan ID card, set, net, rack or trolley ID, in the Packing stations. Note: Only Single tag\barcode should be scanned at one time. 3.1.6 TAGGED AND UNTAGGED ITEMS Tagged items are RFID-tagged surgical instruments and trays. The system is designed to detect tagged items. Untagged items do not have RFID tags. Examples of untagged items are screws, blades and needles. The system allows for manual recording of untagged items. 4. STERILE AND CLEANING CONSIDERATIONS 4.1 SURGICAL INSTRUMENTS THAT HAVE RFID TAGS Unless specifically noted, surgical instruments with RFID tags shall be sterilized according to the standard protocol. 4.2 CLEANING ANTENNAS The Flat Antenna and Tool Pack Antenna can be cleaned with any conventional material that is used to clean the packing station (see section 9.2 for detailed cleaning instructions). 5. SETTING ORLOCATE R PACKING SYSTEM COMPONENTS This section describes the setup procedures required, prior to using the ORLocateR Packing System. 5.1 SETTING THE PANEL PC (TOUCH SCREEN) 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 10 out of 43 User Manual ORLocateR Packing System The Panel PC should be located close to where the processing personnel/technician is located during assembly to enable easy viewing of the screen, and close enough to the Hand Held reader or the Flat or Tool Pack/Add Antenna to enable an ergonomic operation, as shown in the following picture of each SPD station. The components (Panel PC, Hand Held Reader and/or antenna) shall be connected to AC power and to the network as detailed in the specific following table in each SPD station. 5.2 SETTING THE TOOL PACK ANTENNA The Tool Pack Antenna should be located on top of a table where the instrument sets/trays are located, and close to where the packing personnel/technician is located during assembly. The Tool Pack Antenna should be connected to an AC power supply and to the panel PC/ touch screen, as shown in the following figure:
Network Tool Pack AC power Panel PC AC power supplier Tool Pack Com. to Panel PC 6. USING THE SYSTEM 6.1 GENERAL PRINCIPLES OF USE
(1) Each set tray has a unique barcode label and/or an RFID tag that indicates which type of set it is
(e.g., "General Basic").
(2) Before the packing personnel/technician starts packing, the set barcode or tag should be scanned via the Hand held reader (Scandy), to specify to the system which type of set is going to be assembled. Set inventory list will appear on the screen with two values for each item 1) the quantity that is defined for that item (required quantity), and 2) the actual number that was inserted into the set.
(3) Any RFID tagged instrument that is added to the set tray during packing must be scanned via "tool pack" antenna before inserting it into the set. The system will display the details of the scanned items on the screen. The inventory list will be updated automatically according to the progress of packing. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 11 out of 43 User Manual ORLocateR Packing System
(4) Items that were already scanned (i.e., registered as part of the set) will not be displayed again on the screen when scanned again. The system ignores re-scanning.
(5) Untagged items should be registered manually.
(6) The system has two main views: the full inventory list or a list of only the missing items (items needed minus items scanned).
(7) Set may be sealed with missing items. 6.2 SYSTEM WORKFLOW USER INTERFACE 6.2.1 SPD RECEPTION Reception Station Picture:
Station to be located on a table as shown:
Reception Station Components:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 12 out of 43 User Manual ORLocateR Packing System Required Infrastructure:
5 x power sockets. 1 x network socket. Reception Station User Interface:
To login scan ID card of authorized technician using the handheld reader or manually enter ID # of the authorized technician by pressing on the Keyboard icon and then typing the name and password and touching the "Login" button as shown in the following figure. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 13 out of 43 User Manual ORLocateR Packing System Scan Trolley ID by the handheld reader:
Scan Wash Net, Plastic Bin or Peel-Pack by the handheld reader:
The system will automatically move to the next screen, reception main screen as shown in the following figure. The main screen includes 5 areas:
1. On the top of the screen is the main title displaying the set details: ID, Name, customer, priority. 2. Beneath this area is the secondary title displaying related Wash nets. 3. The table displaying the inventory list in the center of the screen. The inventory list includes all items that comprise the set divided to different areas or levels of packing. In the forth area of the screen (bottom left and center) the function buttons are located. In the fifth area (bottom right) the navigation button is located. 4. 5. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 14 out of 43 User Manual ORLocateR Packing System Activate Flat Antenna to count by clicking on the "Scan All" button. 6.2.2 SPD PRE-W ASH Pre-Wash Station Picture:
Station to be located on a table or mount on the wall with arm as shown. Pre-Wash Station Components:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 15 out of 43 User Manual ORLocateR Packing System Required Infrastructure:
2 x power sockets. 1 x network socket. Pre-Wash Station User Interface:
Scan ID card or enter ID # :
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 16 out of 43 User Manual ORLocateR Packing System Review & Execute washing instructions per item:
Separate to sub-net per instructions. 6.2.3 SPD W ASH Wash Station Picture:
Station to be located on a table or mount on the wall with arm as shown:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 17 out of 43 User Manual ORLocateR Packing System Pre-Wash Station Components:
Required Infrastructure:
2 x power sockets. 1 x network socket. Wash Station User Interface:
Scan ID card or enter ID # :
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 18 out of 43 User Manual ORLocateR Packing System Select Washer:
Load Wash Rack with items, and scan Wash Rack & items (create batch):
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 19 out of 43 User Manual ORLocateR Packing System 6.2.4 SPD W ASH RELEASE Wash Release Station Picture:
Station to be located on a table or mount on the wall with arm as shown. Wash Release Station Components:
Required Infrastructure:
2 x power sockets. 1 x network socket. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 20 out of 43 User Manual ORLocateR Packing System Wash Release Station User Interface:
Select Washer and Manage Dryer Cycles:
Release from Dryer:
6.2.5 SPD PACKING 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 21 out of 43 User Manual ORLocateR Packing System Packing Station Picture:
Station to be located on a table as shown. Packing Station Components:
Laser Printer Required Infrastructure:
4 x power sockets. 2 x network sockets. A4 laser printer. Packing Station User Interface:
Scan Set/Net ID:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 22 out of 43 User Manual ORLocateR Packing System The next screen is the packing main screen shown in the following figure. Once the main screen appears, start packing by scanning items according to the inventory list or enter manually if the instrument is not tagged. In this screen you can also view the list of sets with high priority that are pending for packing and sets that are in delay by touching the relevant icon. The areas of the main screen will now be described in detail. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 23 out of 43 User Manual ORLocateR Packing System
(1) The top part of the screen displays:
The packaging type required for the set. Show all / Show mismatches - Toggle buttons that displaying two different views of the table:
a. Show all - for a view in which all items are listed. b. Show mismatches - the default view that filter the list so that only types of items that are still not packed (either not packed at all or have not been fully packed) or packed with more than required will appear on the list. Progress bar that represents graphically the progress of the assembly. Scanned box- displaying the number of instruments that are now being scanned.
(2) The table:
Each row displays the item details:
a. Item name b. Article # (if there are several article numbers the system will display the first) c. Inventory required of the item d. Number of packed (scanned or manually registered). e. If a test is required for this item it will an icon will be displayed on the row . f. Once all items of a certain type are packed the row changes the color to green in the Show all view. In the Show mismatches view the row disappears. g. Options for registering manually into the system the quantity of untagged items:
- Pressing on the "+" or "-" icons.
- Pressing on the number field will open a pop up for entering the number of items, as shown
-
in the following figure. If the item was taken from the storage also press on the number field for opening the pop up and then press on the plus button next to the storage icon, as shown in the following figure:
Touching any row of the list will display details of the item on the right side: a photo of the set and of the item and its packing instructions, if specified. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 24 out of 43 User Manual ORLocateR Packing System a. Pressing on a photo will display the image enlarged. Pressing on the arrows next to the photo will move between the different images of the item, as shown in the following figure:
b. If a test is required for this item on the right side user will be required to mark that test was completed . c. If in the last time the set was packed it was without the required inventory of the item, an icon of the approval will be displayed and the quantity that was missing . d. Touching the info button will display general information about the item, as shown in the following figure:
Three function buttons exist on the bottom part of the main screen, as shown in following figure:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 25 out of 43 User Manual ORLocateR Packing System
(3) Remove button:
If items were scanned by mistake or for any other reason, they can be removed from the set inventory by touching the Remove button. The Remove Item pop will be opened, as shown in following figure:
(4) Delay button If for any reason you wish to stop packing the packing process, at any time you can press the delay button and later start the packing process from begging. After delaying the set the number of sets in delay status will increase by one and you can view the list in the Scan set screen. For delaying the set touch the delay button and a pop up will open for selecting the delay reason, as shown in following figure:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 26 out of 43 User Manual ORLocateR Packing System
(5) Finish packing + print Count Sheet. After completing the packing process touch the "Next" button. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 27 out of 43 User Manual ORLocateR Packing System If all the items were indeed packed the system will automatically open the Packing completed pop up and the content report will be printed, as shown in following figure:
If not all the items were packed a pop will open indicating that not all the items were packed and ask you to confirm that you wish to continue to the next screen. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 28 out of 43 User Manual ORLocateR Packing System Since not all the items were packed the next screen will be Instrument Count Mismatches screen, supervisor approval will be required for completing the packing process with missing items (two types of approvals can be given regular approval and approval for critical items), as shown in following figure:
(6) System alert - Flow process - Cannot treat the scanned item:
If according to the flow process as defined by your organization the set cannot be proceed in the current station an alert will be displayed, as shown in following figure:
(7) System alert - Related Wash Nets*:
System requires the set and all the related Wash nets arrived to the Packing station before starting the packing process, as shown in following figure:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 29 out of 43 User Manual ORLocateR Packing System System requires the user to scan all related Wash nets for starting the packing process, as shown in following figure:
* Related wash nets- if the instruments of a set were distributed to different Wash nets (either because the set is big or some of the instruments requires different cleaning procedure such as hand washing). The set and wash nets are called Related.
(8) System alert - Set was delayed/ exception attached:
If the set was delayed or an exception was assigned to it or to one of the instruments in the set, in the first screen in the Packing station the user will be required to treat the delay/exception reasons, as shown in following figure:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 30 out of 43 User Manual ORLocateR Packing System
(9) System alert as defined in Management at the set type or in the set instance level. The system will alert the users in of different alerts: Sterilization cycles until maintenances, Sterilization cycles until discard, set has a hold request. 6.2.6 SPD STERILIZATION Sterilization Station Picture:
Station to be located on a table or mount on the wall with arm as shown. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 31 out of 43 User Manual ORLocateR Packing System Sterilization Station Components:
Required Infrastructure:
4 x power sockets. 2 x network sockets. Sterilization Station User Interface:
Select Machine:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 32 out of 43 User Manual ORLocateR Packing System Define Machine status (Malfunction):
Machine status Malfunction:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 33 out of 43 User Manual ORLocateR Packing System Create Batch:
Select Machine:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 34 out of 43 User Manual ORLocateR Packing System 6.2.7 SPD STERILIZATION RELEASE Sterilization Release Station Picture:
Station to be located on a table or mount on the wall with arm as shown. Sterilization Release Station Components:
Required Infrastructure:
2 x power sockets. 1 x network sockets. Sterilization Release Station User Interface:
Select Machine:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 35 out of 43 User Manual ORLocateR Packing System Release Batch:
7. THE ORLOCATE R FUNCTIONALITY 7.1 INFORMATION THAT IS ALWAYS AVAILABLE IN THE SYSTEM The user interface continuously displays the following information (main screen):
Number and type of items that need to be in the set. Number and type of items that were already scanned for this set. Set name and ID number. Assembly progress status (% of set already packed). 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 36 out of 43 User Manual ORLocateR Packing System Number and type of items recently scanned. Upon user request the system will show a photo of the item chosen along with packing instructions, if they exist for that item. System shows an indication for an untagged item. 7.2 PRODUCT FUNCTIONS Scan RFID tagged items. Update inventory according to scan. View only missing items (items not yet packed). Untagged items registration. Warnings - item that was registered as defected at a different station cannot be packed. Registering items as defected (during the quality check of an item, before scanning into Item information photo and packing instructions for items. the set). Change user in the middle of packing. 8. SHUTTING DOWN THE SYSTEM In order to shut down the system the user should turn off the on/off switch on the back of the Panel PC as shown in the following figure:
9. MAINTENANCE AND SERVICE 9.1 PERIODIC MAINTENANCE SCHEDULE Routine maintenance should be performed on the system as follows:
Action Clean the System (see below) Check components and cables for signs of damage or wear. When is Action Performed From time to time, as needed Monthly Action is Performed by User / cleaning personnel Maintenance personnel. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 37 out of 43 User Manual ORLocateR Packing System In case of damage, wear or any other problem, contact service. 9.2 CLEANING PROCEDURE In order to maintain the system in optimum condition, clean the system periodically. Caution: Unplug the AC power cord before cleaning the system. To clean the system:
(1) Wipe down the Antennas with a damp cloth and then dry thoroughly.
(2) Wipe the entire length of all cables and power cords with a cloth soaked with 70% alcohol.
(3) Wipe the Touch Screen panel with a damp cloth.
(4) In case of dirt that is not removed using a damp cloth, use a spray cleaner for LCD panels or a cloth soaked with 70% alcohol. 9.3 OBTAINING SERVICE:
Contact the Haldor ORLocateR representative:
USA Support Haldor USA Inc. E-mail: support@haldor-tech.com 9.4 SYSTEM COMPONENTS END-OF-LIFE:
Outside of USA Support Haldor Advanced Technologies Ltd. Tel: +972 9 7885858 Fax: +972 9 7885861 Address: 2 Habanai Street Hod Hasharon 45319, Israel E-mail: support@haldor-tech.com Note: Do not discard. At end of life or end of use of the system or one of its components, please inform your Haldor representative, for disposal arrangement. 10. TROUBLE SHOOTING The following chart lists some problems that may occur with the Haldor ORLocateR System. Condition Possible Cause Recommended Action System Will Not Turn On Power cord is not plugged into the System or wall outlet. Ensure that both ends of the power cord are plugged in. Power cord is damaged. Contact service for replacement cord. Power is not available at power outlet. Check that the power source is working properly. ORLocateR Packing System failure. Contact service. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 38 out of 43 User Manual ORLocateR Packing System Condition Possible Cause Recommended Action Item scanned but does not appear on screen Antennas have been affected by surrounding electro-surgical equipment. Remove electro-surgical equipment from the vicinity of the system, or wait until ES equipment is no longer in use. Item's tag is not located properly on top of the antenna. Locate item closer to the antenna RFID tag is faulty. Remove the item that is faulty and contact Haldor Advanced Technologies Ltd. for a replacement. System Indicates Antenna Failure An Antenna has been placed on or near a metal surface. Move Antenna away from metal. System Indicates Antenna Failure Antenna Housing is Cracked or Broken Screen freezes system crash loses all data An Antenna cable has become detached. Connect cable. An Antenna cable is damaged Contact service for a replacement. An Antenna is disconnected from the Panel PC Connect cable An Antenna is disconnected from power supply Connect cable to power supply Antenna electronics have failed. Antenna has been dropped or misused. Faulty computer CPU. Contact service for an antenna replacement. Contact service for an antenna replacement. Stop using the system and contact service for support. Faulty power supply. Stop using the system and contact service for support. Faulty/crashed Windows operating system. Stop using the system and contact service for support. Antenna is not functional Faulty digital input/output mechanism Module (internal component of Tool Pack). Stop using the system and contact service for support. System not functional Power supply failure. Stop using the system and contact service for support. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 39 out of 43 User Manual ORLocateR Packing System Condition Possible Cause Recommended Action Display on screen is faulty or incorrect position, causing errors in touch screen use Touch screen is cracked. Stop using the system and contact service for support. Touch screen is not calibrated. Stop using the system and contact service for support. Touch screen is dirty. Clean the screen. Touch screen detects touch in wrong position Touch screen is not calibrated. Stop using the system and contact service for support. 11. OPERATING SPECIFICATIONS Note: Unless otherwise indicated, all specifications are subject to change without notice. Specifications and test methods will be made available upon request. 11.1 OPERATING, STORAGE AND TRANSPORTATION ENVIRONMENT Operating Environment Storage and Transportation Environment Temperature:
10C to 40C (50 F to 104 F)
-20C to 60C (-4F to 140F) Relative Humidity:
30% to 75%
10% to 100%
Pressure:
700 hPa to 1060 hPa 500 hPa to 1060 hPa 11.2 ELECTRICAL POWER Consumption (max):
Tool Pack - Up to 12 Watt Reader Controller, Tool Add, Flat Antenna, Locator - Up to 60 Watt Input Voltage Range:
100 to 240 VAC at 50 to 60 Hz 12. SYSTEM SPECIFICATION In addition to the specified in paragraph 3.1 - Description of System Components, the following specifications shall apply to each component:
Note: The Tool Add antenna can hold a maximum amount of RFID- tagged items (instruments). Do not exceed the quantities detailed in the table below:
2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 40 out of 43 User Manual ORLocateR Packing System Flat Antenna Tool Add/Pack Antenna Handheld Scanner Reader Controller Panel PC Max. quantity of items 60 instrument Max detection Up to 5 cm distance Weight (Kg)
(2) 10 5 1 instrument Up to 5 cm instrument Up to 5 cm
(2) 5
(2) 0.1 NA NA 3 Dimensions
(cm / inches) 60.5x47x6.5 22x33x13 11.5x5x3 50x30x5 cm 24x18.5x2.5 inches cm 9x13x5 inches cm 4.5x2x1.2 inches cm 20x12x2 Inches NA NA According to the PC model According to the PC model 13. FCC ID CROSS REFERENCE TABLE ORLocate SPD Reception ORLocate SPD Packing Flat Antenna Tool Add Antenna Tool Pack Antenna Channel Setting Max. Output RF Power Single Channel Single Channel Single Channel 4W 2W 1W Power Supply RPS-60-24 (Meanwell) RPS-60-24 (Meanwell) 1829584 (Friwo) FCC ID X4V-ORL-L40 X4V-ORL-L40 X4V-SPD 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 41 out of 43 User Manual ORLocateR Packing System 14. EMC CONSIDERATIONS The ORLocate System needs special precautions regarding Electromagnetic Compatibility (EMC), and must be installed and put into service according to the EMC information provided in this manual. Portable and Locator RF equipment can affect the ORLocate System. Compatibility of cables, transducers, and other accessories: Not applicable Table 1 - According to Table 204 from IEC 60601-1-2 Guidance and Manufacturers Declaration Emissions Equipment and Systems that is NOT Life-supporting The ORLocate System is intended for use in the electromagnetic environment specified below. The customer or user of the ORLocate System should ensure that it is used in such an environment. Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 Test Compliance Level 3 Vrms Level 150 kHz to 80 3Vrms MHz 3 V/m 80 MHz to 2.5 3V/m GHz Electromagnetic Environment - Guidance Portable and mobile communications equipment should be separated from the ORLocate System by no less than the distances calculated/listed below:
D = (3.5/3)(P) D = (3.5/3)(P) - 80 to 800 MHz D = (7/3)(P) - 800 MHz to 2.5 GHz Where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
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. 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 ORLocate System is used exceeds the applicable RF compliance level above, the ORLocate System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ORLocate System. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 42 out of 43 User Manual ORLocateR Packing System Table 2 - According to Table 206 from IEC 60601-1-2 Recommended Separation Distances between portable and Mobile RF Communications equipment and the ORLocate System Equipment and Systems that is NOT Life-supporting The ORLocate system is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ORLocate System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications Equipment and the ORLocate System as recommended below, according to the maximum output power of the communications equipment. Max Output Power
(Watts) Separation (m) 150 kHz to 80MHz D = (3.5/3)(P) Separation (m) 80 to 800MHz D = (3.5/3)(P) Separation (m) 800MHz to 2.5GHz D = (7/3)(P) 0.01 0.1 1 10 100 0.1166 0.3689 1.1666 3.6893 11.6666 0.1166 0.3689 1.1666 3.6893 11.6666 0.2333 0.7378 2.3333 7.3786 23.3333 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: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The ORLocate Packing System contains a receiver operating at a frequency of 13.56 MHz +/- 7 kHz. The ORLocate Packing System may be affected by other equipment, even if that other equipment complies with CISPR EMISSION requirements. If abnormal behavior is observed, please refer to the separation distance chart provided in this appendix. The ORLocate Packing system contains a transmitter operating at a frequency of 13.56 MHz, using 10%
amplitude shift keying at a modulation frequency of 423.75 kHz, and maximum Effective Radiated Power of 130.7 mW. 2014 Haldor Advanced Technologies Ltd. P0037 Rev.3.0 Page 43 out of 43
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2014-03-11 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Class II permissive change or modification of presently authorized equipment |
2 | 2013-12-26 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Change in identification of presently authorized equipment. Original FCC ID: QHKMEDIOL40 Grant Date: 05/09/2011 |
3 | JBP - Part 15 Class B Computing Device Peripheral |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 3 | Effective |
2014-03-11
|
||||
1 2 3 |
2013-12-26
|
|||||
1 2 3 | Applicant's complete, legal business name |
Haldor Advanced Technologies
|
||||
1 2 3 | FCC Registration Number (FRN) |
0019429836
|
||||
1 2 3 | Physical Address |
Habanay 2 street
|
||||
1 2 3 |
Hod Hasharon, 45106
|
|||||
1 2 3 |
Israel
|
|||||
app s | TCB Information | |||||
1 2 3 | TCB Application Email Address |
T******@TIMCOENGR.COM
|
||||
1 2 3 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 2 3 | Grantee Code |
X4V
|
||||
1 2 3 | Equipment Product Code |
ORL-L40
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 3 | Name |
M**** A********
|
||||
1 2 3 | Title |
Product Manager
|
||||
1 2 3 | Telephone Number |
97252********
|
||||
1 2 3 | Fax Number |
97297********
|
||||
1 2 3 |
m******@haldor-tech.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 3 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
1 2 3 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 3 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 3 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 2 3 | JBP - Part 15 Class B Computing Device Peripheral | |||||
1 2 3 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | RFID TAG READER | ||||
1 2 3 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 3 | Modular Equipment Type | Limited Single Modular Approval | ||||
1 2 3 | Does not apply | |||||
1 2 3 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 3 | Change in identification of presently authorized equipment. Original FCC ID: QHKMEDIOL40 Grant Date: 05/09/2011 | |||||
1 2 3 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 3 | Yes | |||||
1 2 3 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
1 2 3 | No | |||||
1 2 3 | Grant Comments | This device must be professionally installed. (Date of Grant: 12/26/2013) Class II Permissive Change: This Class II Permissive Change is to use antennas manufactured by Haldor Advanced Technologies Ltd.; and for Limited Modular Approval in hosts manufactured by Haldor Advanced Technologies Ltd. Limited Single Modular Approval. This module is approved for use when installed in hosts manufactured by Haldor Advanced Technologies Ltd. Separate approval is required for all other operating configurations, including portable configurations with respect to 2.1093 and different antenna configurations. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. | ||||
1 2 3 | This device must be professionally installed. | |||||
1 2 3 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 3 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 3 | Firm Name |
ITL Product Testing LTD
|
||||
1 2 3 |
Israel Testing Laboratories
|
|||||
1 2 3 | Name |
S**** L******
|
||||
1 2 3 |
I**** C********
|
|||||
1 2 3 | Telephone Number |
972-8******** Extension:
|
||||
1 2 3 |
972-3********
|
|||||
1 2 3 | Fax Number |
972 8********
|
||||
1 2 3 |
972-3********
|
|||||
1 2 3 |
i******@itl.co.il
|
|||||
1 2 3 |
s******@itl.co.il
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 19 28 | 13.56000000 | 13.56000000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | 19 28 CC | 13.56000000 | 13.56000000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
3 | 1 | 15B | 19 28 CC |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC