Wireless Upgrade - Dilon Diagnostics
Contents
1. The wireless receiver allows the user to adjust the system s isotope setting specific to the isotope in use When the wireless receiver is connected to the control unit and the control unit is turned on the isotope control will automatically default to the Tc99 setting CAUTION It is important that the isotope control is set to the isotope to be used in the procedure Setting the isotope control incorrectly will result in incorrect detection WP 5220 00 001 Rev O 9 Revised 7 22 2014 Addendum GPS User Manual Table 4A 1 Isotopes Switch set on 1125 Switch set on 511keV Switch set on In1 lodine 125 8 F FDG and 1131 Indium111 Technetium 99m The Wireless Receiver and Navigator GPS Control Unit must both be set to the same isotope setting For Navigator GPS units built after 2006 the isotope control setting on the back of the device will illuminate the corresponding light on the control unit s isotope indicator 1125 511keV8 1131 In111 For earlier Navigator GPS systems that lack the isotope indicator built between 1999 and 2006 check the back of the control unit to ensure that the isotope setting switch matches the isotope specified on the receiver Table 4A 2 Controls and Displays on the Front of the Wireless Receiver Control Display Description Power LED Indicates that the signal between receiver and Pilot Probe is connected It will flash during receiving transmission from the probe Is2. Addendum to Navigator GPS System User and Service Manual Wireless Upgrade Manufactured by Authorized European Representative Dilon Technologies Inc AG Medical 12050 Jefferson Avenue Route de l Orme Suite 340 Parc des Algorithmes Imm Hom re Technologies Newport News VA 23606 91190 Saint Aubin USA France Phone 757 269 4910 http ag medical com EE CE 0459 Addendum GPS User Manual Important Note This document and the information contained therein is proprietary information of Dilon Technologies and may not be reproduced copied in whole or in part adapted modified disclosed to others or disseminated without prior written consent of the Dilon Technologies This document is intended to be used by customers as part of their Dilon Technologies eguipment purchase Dilon Technologies provides this document without warranty of any kind implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose Dilon Technologies has taken care to ensure the accuracy of this document However Dilon Technologies assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability function or design Dilon Technologies may make improvements or changes in the products or programs described in this document at any time Navigator GPS is a trademark of Dilon Techn
3. 6 1 Wireless Receiver LED Power Indicator On Flashing Wireless receiver and Wireless Pilot Probe are linked and ready for use Off The GPS system is off or there may be a connection error between the receiver and the control unit Table 6 2 Wireless Pilot Probe LED Indicator On Flashing Probe is linked and ready for use Probe is in a resting position to conserve power to reactivate LED indicator simply pick up probe or if needed lightly shake probe Off If no power upon ready to use the battery needs to be installed or replaced If battery has been replaced and LED lightis still off contact your distributor or Dilon Technologies directly 6 2 During Surgery NOTE For Technetium 99m Tc 99 the control unit settings are given in the following table Table 6 3 Navigator GPS with Wireless Pilot Probe Settings and Indicators w Tc 99 Example ic ES Controls back of Control Unit SCAN Calibrate SCAN Isotope Tc 99 Indicators front of the Control Unit Threshold Illuminated this control is for CABLED PROBES only The Wireless Pilot Probe features integrated threshold which controls the count range of photon energy detected by the probe 6 3 After Surgery WP 5220 00 001 Rev 0 17 Revised 7 22 2014 Addendum GPS User Manual e See Cleaning Disinfection and Sterile Use of Probe Section 5 WP 5220 00 001 Rev 0 18 Revised 7 22 2014 Addendum GPS User Manual SERVIGE MANUAL 7 T
4. insert the Wireless Pilot Probe into a sterile drape Insert a probe battery into the Pilot Probe as follows 1 Hold probe firm turn battery cap counterclockwise and remove from probe Inspect O ring integrity If O ring is missing or damaged use new battery cap Contact Dilon Technologies or your distributor for battery cap reorder information WP 5220 00 001 Rev 0 15 Revised 7 22 2014 Addendum GPS User Manual 2 Install one 3V CR 2 lithium battery in Pilot Probe battery holder with positive end facing toward the base of the probe and negative end toward the middle of the probe Incorrect placement of battery into battery holder for extended periods of time will cause battery to drain guickly 3 Insert battery holder into probe negative end in Lightly turn until holder lowers into place 4 Hold probe firm push battery cap into probe and turn clockwise until O ring is no longer visible e Upon initial insertion of new Wireless Pilot Probe battery probe may need to be lightly shaken to activate LED in probe base e LED on the Pilot Probe indicates that it is linked with control unit and ready for use When placed in a resting position the LED turns off within seconds to save energy When the Pilot Probe is moved it instantly powers up for immediate use e For intraoperative use insert the Pilot Probe into a sterile drape WP 5220 00 001 Rev 0 16 Revised 7 22 2014 Addendum GPS User Manual Table
5. probe with a brisk stream of lukewarm tap Method water 98 F to 105 F 36 5 C to 40 5 C Prepare enzymatic cleaner Suitable for surgical instruments according to the manufacturer s recommendation Swirl the proximal end of the probe in enzymatic cleaner for a minimum of 10 seconds Thoroughly scrub the plastic end cap with a toothbrush style latex free nylon bristle cleaning brush i e Key Surgical N 3000 or a similar brush Lightly scrub the probe and lens with a latex free nylon bristle cleaning brush Repeat separately for collimator cleaning if used Wipe the entire probe with soft cloth or sponge soaked in enzymatic cleaner Visually inspect device s for contaminated areas Repeat steps 2 through 5 until visual inspection reveals instrument s is clean Rinse equipment with a brisk stream of lukewarm tap water 98 F to 105 F 36 5 C to 40 5 C for 30 seconds Prepare OPA high level disinfectant solution according to manufacturer s instructions Immerse probe completely for a minimum of 12 minutes at 68 F 20 C or higher to destroy all pathogenic microorganisms Note that probes that are compromised can be damaged if detergent seeps into them Rinse with a brisk stream of tap water 98 F to 105 F 36 5 C to 40 5 C for approximately 1 minute Repeat rinse two additional times Air dry or dry with clean towel WP 5220 00 001 Rev O 11 Revised 7 22 2014 Addendum GPS User Manual CAUTION A Do not contami
6. signal The desired outcome of the test is that the signal is greatest in the CENTERED position as revealed by the highest count rate seen in the control units display The details of the test are given below 10B 1 Verification of Standard Gain Calibration Quick Test Procedure 1 Clean the PROBE 2 Charge the POWERPAK and install it into the CONTROL UNIT 3 Place the system controls as indicated in Table 10B 1 System Configuration Cobalt 57 Alignment 4 Align a Cobalt 57 source directly with the probe tip Maintain this exact position between the source and the probe tip for the duration of the test 5 Place the system controls as indicated in Table 10B 1 System Configuration Cobalt 57 Alignment 6 Place the SCAN Calibrate Control in the CENTERED position which is indicated by the following symbol on the SCAN Calibrate Control gt 0 lt Obtain a ten second count Record this total 7 Place the SCAN Calibrate Control in the BELOW position which is indicated by the WP 5220 00 001 Rev O 22 Revised 7 22 2014 Addendum GPS User Manual following symbol on the SCAN Calibrate Control Press the COUNT control to obtain a ten second count Record this total 8 Place the SCAN Calibrate Control in the ABOVE position which is indicated by the following symbol on the SCAN Calibrate Control Obtain a ten second count Record this total 9 The highest count should be when the SCAN Calibrate Control is i
7. adionuclide absorbed by a particular organ or body region Indications for Use For the detection and quantification of gamma radiation from gamma emitting isotopes in the body or tissues Use for non imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open surgical procedures Manufacture and Distribution The system is manufactured and distributed by Dilon Technologies of Newport News VA Please direct all inquiries to Dilon Technologies Trademarks The following are trademarks of Dilon Technologies Navigator 2 0 Wireless Pilot Probe Dilon Navigator GPS Dilon Navigator Dilon Technologies Navigator GPS Dilon Technologies Navigator Dilon Technologies Navigator 2 0 Daniel Lung Probe and Navigator when used in context with the above Navigator GPS is a registered trademark of Dilon Technologies WP 5220 00 001 Rev 0 4 Revised 7 22 2014 Addendum GPS User Manual Regulatory and Safety Reguirements The Dilon Navigator GPSTM System including Probes and accessories complies with the following standards EC Directives EMC Directive 89 336 EEC Group Class B EN 55011 EMC Directive 89 336 EEC IEC 60601 1 2 3 Edition Reciprocal Interference The Wireless Upgrade components were designed manufactured and tested in accordance to the following standards recognized for Medical Devices under Directive 93 42 EEC 1993 This product has been cer
8. al to the balance of the warranty period remaining on the original part or product Dilon will repair or replace at its option and without charge any of the above products which are returned to Dilon or its designated repair site within the applicable warranty period with prepayment of shipping costs and which are determined by Dilon to be defective in materials or workmanship This Limited Warranty does not apply to any product or replacement part or replacement product which has been subjected to any damage as a result of an accident or abuse or that has not been used and maintained in accordance with the information contained in the literature accompanying the product or that has been modified repaired or serviced by any person or company other than Dilon or its authorized representative Dilon s sole liability for any defective product shall be repaired or replaced as set forth above Dilon shall not be liable to anyone under any circumstances for any special punitive incidental or consequential damages whatsoever including without limitation any costs expenses lost profits or other losses however designated EXCEPT AS STATED ABOVE NO WARRANTIES ARE EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND EXCEPT AS STATED ABOVE DILON EXPRESSLY DISCLAIMS ALL WARRANTIES Dilon Technologies Manufactured by Authorized European Representative Dilon Tech
9. ceiver in a clean safe environment CAUTION A Follow universal generally accepted practices when handling components that have come in contact with blood or tissue WP 5220 00 001 Rev 0 13 Revised 7 22 2014 Addendum GPS User Manual 6 Probe Connectivity and Use Navigator GPS System with Wireless Upgrade The Navigator GPS is compatible with the wireless Pilot Probe A typical seguence of setting up the Wireless Pilot Probe for a procedure with Technetium 99m isotope such that would be used in a lymphatic mapping procedure for a sentinel node biopsy is as follows WP 5220 00 001 Rev 0 14 Revised 7 22 2014 Addendum GPS User Manual 6 1 Before Surgery Insert a fully charged PowerPak battery into the Navigator GPS control unit see Navigator GPS System User Service Manual for insertion instructions Attach the wireless receiver to the cable port on the front of the control unit Note that the isotope indicator will default to Tc 99 when turned on An LED will illuminate on the receiver once the control unit is on Upon initial insertion of new Wireless Pilot Probe battery probe may need to be lightly shaken to activate LED in probe base A flashing LED on the Pilot Probe indicates that it is linked with control unit and ready for use When placed in a resting position the LED turns off within seconds to save energy When the Pilot Probe is moved it instantly powers up for immediate use For intraoperative use
10. e 1 Explanation of Symbols A A Attention consult accompanying documents RX only Caution Federal USA law restricts this device to sale and use Rx only by or on the order of a physician ee UP E ee FCC statements This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interterence received including interference that may cause undesired operation IC statements This device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 This device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Cet appareil est conforme avec Industrie Canada RSS exemptes de licence standard s Son fonctionnement est soumis aux deux conditions suivantes 1 Ce dispositif ne doit pas causer d interf rences et 2 cet appareil doit accepter toute interference y compris les interferences qui peuvent causer un mauvais fonctionnement de l appareil WP 5220 00 001 Rev 0 6 Revised 7 22 2014 Addendum GPS User Manual 2 Product Overview and Components Table 2A 1 Probe Dimensions Wireless Pilot Probe 35 2559 Table 2A 2 Receiver Dimensions Wireless Pilot 25mm 68 mm 159 Probe Receiver WP 5220 00 001 Rev 0 7 R
11. evised 7 22 2014 Addendum GPS User Manual 3 Precautions 3A General The output of this system is not to be considered a diagnostic measure of the extent of disease in the patient nor the recommended source of therapy e Failure to thoroughly review and adhere to the information contained in this addendum and the Navigator GPS System User Service Manual may pose a potential hazard to the patient and or user and may void the warranty 3B Wireless Pilot Probe Wireless Receiver and Navigator GPS Control Unit e Replace the wireless probe battery with a new battery on EACH day of use before the first Surgical procedure e This system is not designed for use in an explosive atmosphere e Keep the control unit off while connecting the wireless receiver e The probes probe batteries receiver and control unit are sold non sterile e No components should be sterilized e DO NOT put any probe in an autoclave e With the exception of the Wireless Pilot Probe s battery bay DO NOT attempt to open probes o All probes are tested and sealed at the factory Attempting to open the probe may cause damage and will void the warranty e DO NOT drop the probe e DO NOT strike the probe tip against a hard surface the detector element may become damaged and no longer be able to measure radiation o This will also void the warranty WP 5220 00 001 Rev 0 8 Revised 7 22 2014 Addendum GPS User Manual 4 Wireless Receiver 4A Isotope Control
12. fore each use and storage This includes checking the following Table 10A 1 Component Check Component Wireless Pilot Probe Overall check Also probe bay battery cap and O ring Wireless Receiver Overall check Housing integrity of its electrical connector and the connector pins Do not use a damaged probe wireless receiver or probe batteries Should abnormalities be discovered contact Dilon Technologies directly 10B Verification of Standard Gain Calibration Quick Test All Dilon Technologies Navigator systems are designed to minimize periodic maintenance such that may be performed by a clinical engineering department or the manufacturer Some institutions however do choose to perform Verification of Standard Gain tests every six months or every year The procedure does not calibrate the system it simply reveals whether or not the probe and control unit are set to a common gain standard calibration That common standard relates the gamma photon energy detected by the probe to an energy window inside the control unit The Verification of Standard Gain uses 122 keV energy photons produced by the Isotope of Cobalt 57 to create a known signal in the probe The control unit expects these detected photons to be in an energy window corresponding to the CENTERED position of the test The control unit also has a test setting for an energy window BELOW the expected signal and an energy window for a signal ABOVE the expected
13. ining warranty if attempted Please contact Dilon Technologies for additional service An RMA number is reguired upon return for service Dilon Technologies 12050 Jefferson Avenue Suite 340 Newport News VA 23606 USA Phone 1 844 DILONNAV www Dilon com CAUTION A Before using loose packing materials such as foam pellets shredded paper or excelsior be sure to wrap the component s separately in plastic bags or film or other protective wrapping CAUTION A If a system or system components are to be shipped from your institution for repair then please clean and disintect the components as described in this manual before packing for shipment Dilon Technologies reguires that a Navigator Service Sheet be attached to the outside of the shipping box certifying that the items have been cleaned and disinfected to manufacturer s specifications This form can be found on the Dilon Technologies website www Dilon com or by contacting your distributor or Dilon Technologies directly WP 5220 00 001 Rev O 24 Revised 7 22 2014 Addendum GPS User Manual 12 Limited Warranty Dilon Technologies Dilon warrants to its customers that subject to the below provisions the Wireless Upgrade will be free from defects in materials and workmanship for twelve 12 months commencing upon the date of shipment from Dilon Replacement parts and products are warranted to be free from defects in material and workmanship for a period equ
14. n the CENTERED gt 0 lt position The count in the ABOVE position and the count in the BELOW position should be less than the count in the CENTERED gt 0 lt position The observance of these relationships verifies that the probe and control unit have the same standard gain 10 Return the SCAN Calibrate Control to the SCAN position 11 Return the other system controls to the settings for normal use 12 End of Test NOTE Because the system is designed to detect slight changes in the location and intensity of radioisotopes the test source must be maintained in the same direct alignment and distance from the probe tip throughout the calibration tests NOTE The front panel CALIBRATION INDICATOR blinks when the SCAN Calibrate Control is in either the BELOW CENTERED gt 0 lt or ABOVE test position The CALIBRATION INDICATOR is OFF when the CALIBRATION control is in the SCAN position Table 10B 1 System Configuration Cobalt 57 Alignment Calibration Quick Test ComponentFeature tem Comrie o ISOTOPE control rear panel Tc 99 THRESHOLD control As desired no effect VOLUME control CALIBRATE control rear panel gt 0 lt WP 5220 00 001 Rev 0 23 Revised 7 22 2014 Addendum GPS User Manual 11 Repair The Wireless Pilot Probe is sealed at the factory No user serviceable parts are inside the probes Damage to a probe may result if a probe is opened by the user and will void any rema
15. nate other items by wiping them with used cleaning solution CAUTION The cleaning instructions provided above have been validated by the medical device manufacturer for preparing this device for re use It remains the responsibility of the re processor to ensure that the reprocessing is actually performed using qualified equipment materials and personnel in the processing facility to achieve the desired result This requires validation and routine monitoring of the process Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences 5B Radioactive Decontamination Procedure OPTIONAL An increase in background counts may signal radioactive contamination of the probe or the environment If a process of elimination shows the probe to be contaminated with radioactive material the probe must be decontaminated 1 Decontaminate the probe using standard Nuclear Medicine Department techniques which may involve washing the probe with a solution such as Radiacwash M 2 Ensure that all recesses crevices and mating surfaces are clean 3 Dispose of pads and cleaning solution in approved containers WP 5220 00 001 Rev O 12 Revised 7 22 2014 Addendum GPS User Manual 5C Cleaning Storing Wireless Receiver 1 If unclean wipe wireless receiver with a soft cloth moistened with mild soap and water Dry with a soft cloth 2 Store the re
16. nologies AG Medical 12050 Jefferson Avenue Route de l Orme Suite 340 Parc des Algorithmes Imm Hom re Newport News VA 23606 91190 Saint Aubin France USA http ag medical com Phone 1 844 DILONNAV www Dilon com ee REP 2014 Dilon All Rights Reserved May 2014 Made in USA WP 5220 00 001 Rev O 25 Revised 7 22 2014 Addendum GPS User Manual WP 5220 00 001 Rev 0 26 Revised 7 22 2014
17. ns sese ses sese sise sene sen esene aaa aoa aonana 19 SS CTU MUI ON gcse asec cs eens a to do oo do oo 20 DEOUDDO OME NEMS Seesama TT 21 JA Product Pat NUMDO S Lia kaka St Sterne een Rte 21 S peg 5141 20 Drap 2 Umer eee nee ee rena eRe dd 21 DO Maitena C Css ss ss se A 22 TOA COMPONENT GACCK RS ala Katalaani a 22 10B Verification of Standard Gain Calibration QUICK Test 22 Tie ES C2 025 L Aaa 24 12 AASA Waray inaa 25 WP 5220 00 001 Rev O 3 Revised 7 22 2014 Addendum GPS User Manual USER MANUAL 1 Introduction Description This addendum to the Navigator GPS System User Service Manual PN GP 9200 96EN details how to use the Wireless Upgrade option for existing Navigator Gamma Positioning systems This optional feature adds wireless gamma probe capability to Navigator GPS Control Units PN GP 2800 00 Use this addendum as a supplement to the Navigator GPS System User Service Manual If this manual is not readily available download the electronic version from www Dilon com The wireless receiver when paired with the control unit can only be used with the Wireless Pilot Probe M The system is supplied non sterile This addendum includes guidelines for the use of the Wireless Pilot Probe and accessories within the sterile field Intended Use For the detection and quantification of gamma radiation from gamma emitting isotopes in the body or tissues Use for non imaging procedures to measure the amount of r
18. ologies Other trademarks and trade names are those of their respective owners Copyright Notice Copyright 2014 Dilon Technologies Newport News VA 23606 United States of America Trademarks Dilon Technologies is a registered trademark of Dilon Technologies All other company and product names are trademarks or registered trademarks of their respective owners Part Number WP 5220 00 001 Rev 0 July 2014 WP 5220 00 001 Rev 0 2 Revised 7 22 2014 Addendum GPS User Manual User Manual Mla gore 8703 4707 9 EEE mmm dm 4 DCS CHOON se de D eee 4 Tg fel gle e USE seman esters RAA Mure Mere mtn nn t a 4 MACON ORU E e ue 4 Manutacture and DISMIDUHOM aiinsir a S 4 Mad EMAK aaa a E A E A O 4 Regulatory and Satety Requirements 2 28 nn E 5 2 Product Overview and Components ss 7 SE LSGAUHONS Se 907 aal 8 ACER dd oT eee oon RC ne ee OE 8 3B Wireless Pilot Probe Wireless Receiver and Navigator GPS Control Unit 8 A NVINCICSS RECEIVER ASTMA NEE EEE cet e sata cata 9 APA ISOTOPE CONTO irere rre E aE rt taat 9 5 Cleaning Disinfection and Sterile Use of the wireless Pilot Probe 11 SA Wireless Pilot Probe ONY visas aaa aa mamma ahmi AD de ok nn nr 11 5B Radioactive Decontamination Procedure OPTIONALJ 12 5C Gleaning Storing Wireless Receiver sise 13 6 Pr0D6 Connectivity and USe s mean 14 Navigator GPS System with Wireless Upgrade 14 LF TROUDIESNOOUNG EP se
19. ontrol unit LED on wireless receiver is Contact Dilon Technologies for damaged assistance No connection between Check that the connection wireless receiver and control between the wireless receiver unit and control unit is secure LED on wireless receiver is Contact Dilon Technologies for damaged assistance LED on probe is damaged Contact Dilon Technologies for assistance Probe LED is illuminated but Gently shake probe to activate not transmitting signal to unit connectivity LED flashes when transmitting Probe battery is dead Replace with new battery Battery was not installed Install new battery 19 Revised 7 22 2014 Addendum GPS User Manual 8 Specifications The Wireless Upgrade consists of the wireless receiver Wireless Pilot Probe and probe batteries Table 8A 1 Wireless Upgrade Specifications Wireless Pilot Probe Power Source Pilot Probe Power Source Replaceable Internal battery 0 Internal battery Battery Single use CR2 3 V Lithium capacity 1550 mAh Wireless Pilot Probe Transmission Up to 9 meters Distance Industry Standard Wireless Operating 2 4 GHz Frequency Visual Indicators Wireless Receiver e Power On LED e Isotope LED four Wireless Pilot Probe e Probe Connection LED e Isotope LED four storage Conditions Operating Temperature Range 15 C to 40 C 5 F to 104 F Humidity 0 80 relative humidity Atmospheric Pressure 50 kPa
20. otope Indicators Select the isotope to be detected by the control unit Be sure to select the same isotope on the back of the Control Unit as well Tc99 In111 511keV See Isotope Control section of Navigator GPS System User Service Manual for more leo information WP 5220 00 001 Rev 0 10 Revised 7 22 2014 Addendum GPS User Manual 9 Cleaning Disinfection and Sterile Use of the wireless Pilot Probe All probes reguire cleaning and disinfecting immediately after use Follow these steps to ensure that cleaning and disinfection are done correctly Before Use visually inspect probe to ensure that itis free of contamination During Use place probe in a sterile drape After Use Clean Disinfect Store Probe OPTIONAL Radioactive Decontamination Procedure see section 5B 5A Wireless Pilot Probe only The Wireless Pilot Probe and all other Dilon probes and accessories are sold non sterile WARNING Before cleaning inspect probe to ensure its integrity Compromised probes can be further damaged as a result of the cleaning process Probes in poor condition due to wear and fatigue should be returned to Dilon Technologies for repair Table 5A 1 Cleaning Preparation for Remove battery from Wireless Pilot Probe and secure battery cap to the bottom cleaning of probe before cleaning Cleaning Enzymatic detergent OPA high level disinfectant running water Equipment Cleaning Rinse the outside surfaces of the
21. roubleshooting With the exception of the Wireless Pilot Probe s battery holder there are no serviceable components within the Wireless Pilot Probe body or wireless receiver Contact your representative or Dilon Technologies for additional assistance if more detail is required Table 7 1 Navigator GPS Control Unit with WIRELESS PILOT PROBE Settings and Indicators No connection between probe Check that the connection 1 Zero in display No signal under presence of a radioactive source 2 LED on wireless receiver does not illuminate when power is on 3 Isotope control on wireless receiver does not illuminate when power is on 4 LED on Pilot Probe does not light as indicated WP 5220 00 001 Rev O receiver and control unit between the receiver and control unit Is secure No connection between probe Replace the probe battery receiver and control unit Isotope control indicates Change isotope control on front incorrect isotope of wireless receiver to desired isotope Circuit inside the control unit Try a different control unit has been damaged Contact Dilon Technologies for assistance Probe is damaged Try a different probe or contact Dilon Technologies for assistance Wireless receiver is damaged Try a different receiver or contact Dilon Technologies for assistance No connection between Check that the wireless receiver wireless receiver and control is securely connected to the unit c
22. tified and tested by 3rd party testing facilities 0459 Medical Electrical Equipment Part 1 General requirements For Safety 1 Collateral Standard Safety Requirements For Medical Electrical Systems IEC 60601 1 1 3rd Ed Medical Electrical Equipment Part 1 General Requirements For Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 3rd Ed Medical Electrical Equipment Part 1 General requirements For Safety 1 Collateral Standard Safety Requirements For Medical Electrical Systems IEC 60601 1 2nd amp 3rd Ed Medical Electrical Equipment Part 1 General Requirements For Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 3rd Ed Medical Electrical Equipment Part 1 6 General Requirements For Safety Collateral Standard Usability IEC 60601 1 6 3rd Ed Information supplied by the manufacturer of medical devices EN 1041 2008 symbols for use in the labeling of medical devices EN 980 2008 CAN CSA C22 2 No 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety amp Essential Performance issued 2008 02 01 Ed 2 AS NZS 3200 1 0 Deviations to IEC 601 1 for Application in Australia and New Zealand CAUTION Federal USA law restricts this device to sale and use by or on the order of a physician WP 5220 00 001 Rev O 5 Revised 7 22 2014 Addendum GPS User Manual Tabl
23. to 106 kPa WP 5220 00 001 Rev 0 20 Revised 7 22 2014 Addendum GPS User Manual 9 Support Items The Wireless Upgrade is typically supplied as a complete system Part WP 9220 00 Support items may be purchased from the local Dilon Technologies Navigator representative At time of publication of this addendum the primary support items have the following part numbers Feel free to contact your local representative for additional information 9A Product Part Numbers Table 9A 1 Product Part Numbers Wireless Receiver for Navigator GPS WP 8000 01 Wireless Pilot Probe WP 9000 14 Wireless Pilot Probe Batteries Pack of 10 9B Sterile Drape A sterile drape is an accessory that is not sold or supported by Dilon Technologies Typical characteristics of a suitable intra operative probe drape are as follows Universal Gamma Probe Cover 5 x 24 Sized with tapered tip to fit both straight and flexible probes Low density soft polyethylene Telescopically folded w rubber bands and medical grade tape strips Drape features o All components including rubber bands guaranteed 100 Latex free o All available EtO Sterile o Strong and durable Anti Static material WP 5220 00 001 Rev O 21 Revised 7 22 2014 Addendum GPS User Manual 10 Maintenance 10A Component Check While Wireless Upgrade is virtually maintenance free a check of each system component for any visible signs of abuse neglect or wear should be conducted be
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