Navigator GPS™ System
Contents
1. 33 SI IAIN diit 7 gt 33 6 mM Dame Sr oT 33 LEE 33 SA Clean Disinfect Immediately Before Use 34 5B For Dilon Navigator 12 mm Probe and Gamma PET Probe only 36 5C Place Probe and Probe Cable in a Sterile Drape mmnnnnennnnnnena nae 37 5D Clean Disinfect Store Probe and Probe Cable Immediately After Use 37 Radioactive Decontamination Procedure OPTIONAL eene nnn nnns nnn nna 41 5E Clean Store Control Unit Gain Module 41 6 Gain Module and Peak Procedure nnonnvnnnnnnnnnnnnnnnnnnnnannnannnnnnnnnnn nnn 43 GA Connecting the Gain Module to the Control Unit 43 Removing the Gain MOGUIB iieu ii rta een taion Fkn o ava Ea xus roa OE a kaltsiit tinati sama 44 6B Connecting the Probe to the Gain Module VU 45 Do R nnng a Pak ROCCO Cars seite start M m c EU 45 Dilon Navigator V 12mm Probe Technetium 99m isotope Peak Procedure 46 Gamma PET Probe 511KeV pharmaceutical Peak Procedure 0404 444044200 47 Example Peak Procedure Peak Setting for Probe A ss 48 Example Peak Procedure Peak Setting for Probe B eene 49 GP 9200 96 001 RO 3 Revised 7 22 2014 Navigator GPS System User Manual 2 7 Probe Assembly and Use 1 eeeeee Leser iee2. System User Manual Table 4 Controls and Displays on the Front of the Control Unit Control Display Description Power Turns on power Volume Increases decreases the volume of the audible signal Display The photon count second is normally shown At the end of a 10 second count the total photons detected is shown then the display returns to showing counts second Isotope Indicator Indicates the isotope selected 1125 51160 81131 In111 20 Control Unit GP 9200 96 001 RO Revised 7 22 2014 Control Unit PowerPak and Co Pilot Table 4 Controls and Displays on the Front of the Control Unit Continued Control Display Description Range Controls when the audible pitch is heard 1X low event rates 10X medium event rates 100X high event rates Pressing the Range button cycles through the ranges select the one most useful to the procedure being performed NOTE Range Selection only controls the pitch of the sound generated by the unit Range selection and the corresponding indicators have no effect on count rates or signal conditioning Range Selection has no impact on the performance or counts displayed by the unit Threshold Controls the range of the photon energy detected by the Probe When the Threshold is off all photon energy including scattered photons are detected The indicator is not illuminated When the Threshold is on the detection of the scattered photons is red
3. Navigator GPS System User and Service Manual LINE ILI I L M VIGATOI GPS Manufactured by Authorized European Representative Dilon Technologies Inc AG Medical DI on 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 mee 0459 GP 9200 96 001 RO Revised 7 22 2014 Navigator GPS System User Manual User Manual CC GUO EE cca vce ce eae se ace E E 7 E n 8 Iniceisqec u i cs S 8 c r ET 8 8 MNT eo de Re emits 8 2 System Overview and Components eeeeeeee esee eese nennen nnn 11 2A Navigator GPS M System Probe Modes naene annae 14 3 lo 5 4 Control Unit PowerPak and Co Pilot 19 AA je kina ane arr an va laka 19 SCAN Calibrate 0 25 BODE 67079114 einan r N 25 4B PowerPak iii 26 7 188 FOMEIF AK s als 26 Removing the TOW qur quc 27 Charging the TOW 541 DRE MAR 27 Remon TINS FOV OO de de da ie de m m ammu m 29 4C Optional Co Pilot Device 29 4D Useful Adjustments That Can be Made During Procedures 32 5 Cleaning Disinfection and Sterile Use of Probes and Probe Cables
4. Navigator GPS System User Manual 70 GP 9200 96 001 RO Revised 7 22 2014 8 Troubleshooting GP 9200 96 001 RO Revised 7 22 2014 71 Navigator GPS System User Manual Table 17 Problem 1 Display is dark No power to unit 2 Green Zero in Display No signal under presence of a radioactive source 3 Spurious high counts such as 80000 counts a second when Probe is held in air for example 4 Incomplete digits in display 72 Troubleshooting Problems Causes Remedies Turn power on Recharge battery Replace fuse Damaged printed circuit board Contact Dilon for assistance inside Control Unit No connection between Probe Check that connections are Cable Gain Module if present secure and Control Unit Isotope Control is incorrectly set Change Isotope Control on to isotope 1 131 back of Control Unit to TC 99 Gain Module if used is set to Run Peak Procedure page Zero 45 There is an open circuit in the Replace cable Probe Cable Circuit inside the Control Unit Try a different Control Unit has been damaged Contact Dilon for assistance Probe is damaged Try a different Dilon Navigator 12 mm Probe Contact Dilon for assistance Intermittent short in the cable Replace Cable Display or display driver is Contact Dilon for assistance damaged GP 9200 96 001 RO Revised 7 22 2014 9 Specifications The Navigator GPS system consists of the
5. Collateral Standard Usability IEC 60601 1 6 3 Ed e Information supplied by the manufacturer of medical devices EN 1041 2008 e Symbols for use in the labeling of medical devices EN 980 2008 e 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 e AS NZS 3200 1 0 Deviations to IEC 601 1 for Application in Australia and New Zealand Other C The following are trademarks of Dilon Technologies Inc Dilon Navigator Dilon Navigator GPS M Navigator GPS Dilon Navigator 12 mm Probe Gamma PET Probe Beta PET Probe Daniel Probe M and Navigator M when used in context with the above A CAUTION Federal USA law restricts this device to sale and use by or on the order of a physician 8 GP 9200 96 001 RO Revised 7 22 2014 Introduction Explanation of Symbols Table 1 Symbols RX only Caution Federal USA Type CF Equipment Rx only law restricts this device to sale and use by or on the order of a physician Data Port Attention consult accompanying documents Date of Manufacture Manufactured by Consult instructions for use Temperature limitation Remote Count Control JE do Humidity limitation In111 1131 Te99 p25 Isotope Control Serial number Calibra 1 0 4 DER Calibrate Control Catalogue number 39200 European Auth
6. Will change to a solid light before the useful charge is exhausted oee PowerPak on page 26 for more information Signal Input For the Dilon Navigator 12 mm Probe and the Gamma PET Probe connect the Gain Module here oee Connecting the Gain Module to the Control Unit on page 43 for more information For Standard Lymphatic Mapping probe and similar probes connects the Probe Cable here See 6 mm Diameter Cable on page 33 for more information Connection for the Co Pilot accessory oee Optional Co Pilot Device on page 29 for more information Control Unit GP 9200 96 001 RO Revised 7 22 2014 Control Unit PowerPak and Co Pilot Isotope Selector Data Scan Calibrate Control 16097 nas Manufacturer s Serial Fuse Number Label GP 9200 96 001 RO Control Unit 23 Revised 7 22 2014 Navigator GPS System User Manual Table 5 Controls and Displays on the Back of the Control Unit Control Display Description SCAN Calibrate set to SCAN Calibrate when using Probes The SCAN position is the only correct position when a Probe is being used When set to SCAN the CAL indicator on the front of the Control unit will not be illuminated nor will it flash See SCAN Calibrate Control on page 25 for more information See also Peak Procedure and Verification of Standard Gain on page 79 lsotope Selector selects the Isotope to be detected by the Control Unit am m oee Isoto
7. Control Unit one or more Probes and the system accessories 9A Navigator GPS Control Unit Specifications Table 18 Navigator GPSTM Control Unit Specifications Item Control Unit Power Source PowerPak New PowerPak Charge Life full charge PowerPak Recharge Cycle 10096 discharge Fuse Control Unit Sound Indicators Visual Indicators Energy Range Storage Conditions Maximum Count Rate Control Unit Dimensions GP 9200 96 001 RO Revised 7 22 2014 Description Replaceable internal PowerPak Sealed lead acid rechargeable 12V nominal voltage 2 0Ah nominal capacity Approximate weight 590 g 4 hours continuous nominal 150 200 cycles 80 of new PowerPak charge life UL CSA 198G standards 0 75 amp Slow blow Glass Housing 250 volt rating 5x20mm IEC 127 standards Type 7 0 63 amp 250 volts 5x20mm T0 63AL250V Pitch sound Frequency proportional to event rate Beep Indicates need to recharge PowerPak Occurs when Lower PowerPak indicators comes on Digital Count Vacuum Fluorescent Display oingle Count LED Sample Time Active LED PowerPak Low LED PowerPak Recharge Required LED Range 1X 10X 100X LED Isotope LED four Up to and including 511 keV 15 C to 40 C 5 F to 104 F 0 80 relative humidity 25 000 s 20cm W x 24cm H x 18cm D 73 Navigator GPS System User Manual Table 18 Navigator GPS Control Unit Specification
8. Table 6 PowerPak Charger Indicator Lights yellow OFF PowerPak absent fully charged Use only PowerPaks supplied by Dilon This PowerPak has the proper dimensions and a key feature that holds it securely in the Navigator GPS control unit The PowerPak supplied with the Navigator GPS System contains lead If the PowerPak requires disposal recycle the PowerPak locally in a manner appropriate for its lead content Consider using a second PowerPak A second PowerPak may be kept in the Charger while the first PowerPak is being used in the Control Unit PowerPak GP 9200 96 001 RO Revised 7 22 2014 Control Unit PowerPak and Co Pilot Removing the PowerPak Clip Push the PowerPak Clip off the PowerPak with your thumb 4C Optional Co Pilot Device The optional Co Pilot Device initiates counting periods and changes the audible range The Co Pilot includes two small buttons and a long small diameter cable The Co Pilot is clipped onto the end of a Probe and connected to the Control Unit at the Co Pilot receptacle GP 9200 96 001 RO Optional Co Pilot Device 29 Revised 7 22 2014 Navigator GPS System User Manual The Co Pilot is supplied sterile and may be used inside or outside the sterile drape Count The C button is the COUNT button A one second count is obtained by pushing and releasing this button once A ten second count is obtained by pushing this button twice in quick succession The total i
9. the remainder of the test maintain this exact position between the source and the probe tip 5 Place the system controls as indicated in Table 23 System Configuration Cobalt 57 Alignment on page 81 6 Place the SCAN Calibrate Control in the CENTERED position which is indicated by the following symbol on the SCAN Calibrate Control lt 0 gt Obtain a ten second count Record this total T Place the SCAN Calibrate Control in the BELOW position which is indicated by the 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 in the CENTERED lt 0 gt position The count in the ABOVE position and the count in the BELOW position should be less than the count in the CENTERED lt 0 gt 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 Endof 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 d
10. 6 e Connect the Probe Cable and Gain Module to Control Unit e Runa Peak Procedure page 45 You will see the system as shown above e Use Probe and Cable in a Sterile Drape page 37 During Surgery e See also Useful Adjustments That Can Be Made During Procedures page 32 e See also Optional Co Pilot Device page 29 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables page 33 52 GP 9200 96 001 RO Revised 7 22 2014 Probe Assembly and Use NOTE The time to charge a PowerPak by the Charger may take as long as two hours NOTE Keep Control Unit Power off until all components are connected This helps preserve component life NOTE A Peak Procedure must be performed before using the Probe in the first surgical procedure of the day See page 45 NOTE Although the Peak Procedure is typically performed with no sterile drape around the probe and cable the Peak Procedure may also be performed with the probe and cable inside a sterile drape NOTE After a peak procedure has been performed the control unit and Module settings are given in the table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe and Cable Table 9 Dilon Navigator 12 mm Probe Settings and Indicators Control Indicator Setting Controls in back Calibrate SCAN Isotope 9 Indicators in front Range 1X Threshold Illuminated Display 0 Isotope 9 Gain Modu
11. RT and the inside of the control unit The external DATA PORT can be connected to earth ground Electrical isolation between the DATA PORT and the internal circuit of the control unit maintains electrical isolation of the patient When optional system components are used with the system maintain Probe and patient electrical isolation from earth ground The optional components include the Co Pilot Device the Gamma Probe drape and a cart or stand In the operating room use the Charger at a distance of six feet or greater from the patient The charger has a rating in the United States of a patient proximity charger Fully charge the PowerPak before use in the system This system is not designed for use in an explosive atmosphere Keep the Control Unit off when changing the PowerPak and when changing connections between the Probe Cable Control Unit and Gain Module if used The Control Unit PowerPak and Charger are non sterile Do not sterilize these components GP 9200 96 001 RO 15 Revised 7 22 2014 Navigator GPS System User Manual Probes Table 3 Precautions DO NOT put the Probe or Probe Cable in an autoclave DO NOT open the Probe The Probe is tested and sealed at the factory Attempting to open or opening the Probe may damage the Probe and will void the warranty DO NOT drop the Probe DO NOT strike the Probe tip against a hard surface The detector element may become damaged The Probe may no longer be a
12. S M Control Unit The Control Unit allows the user to adjust the system s settings and produces a variety of signal outputs The Control Unit is powered by the PowerPak battery e Navigator GPS Control Unit Control Unit e PowerPak and Charger The Control Unit is used with any of eight Navigator M probe models The probes differ primarily in their shape which the user may prefer for a particular procedure e Dilon Navigator 12 mm Probe e Gamma PET Probe e Standard Lymphatic Mapping Probe angled tip e Straight Lymphatic Mapping Probe straight tip e Superficial Head and Neck Probe e Abdominal Probe e Thoracic Probe e Daniel Probe The system is supplied non sterile This manual includes guidelines for the use of the Probe and Probe Cable in 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 radionuclide 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 laparoscopic or thoracoscopic surgical procedures Manufacture and Distribution The system is manufactured and distributed by Dilon Technologies Please direct all inq
13. age is for illustrative purposes only 4B PowerPak Inserting the PowerPak PowerPak in place Right Side Direction of PowerPak Insert the PowerPak in the opening on the right side of the Control Unit The notched end of the PowerPak is inserted first notched corner on top The Control Unit will click when the PowerPak is positioned properly 26 PowerPak GP 9200 96 001 RO Revised 7 22 2014 Control Unit PowerPak and Co Pilot Removing the PowerPak Press the eject latch The PowerPak will be released and will protrude slightly from the Control Unit Charging the PowerPak di E o Charger PowerPak gt t PowerPak Clip 1 Snap the PowerPak Clip onto the PowerPak cord side up at the corner of the PowerPak that has the purple arrow pointing to it Ensure that the PowerPak Clip is connected to the Charger cable NOTE There is only one way to snap the PowerPak Clip to the PowerPak GP 9200 96 001 RO PowerPak 27 Revised 7 22 2014 Navigator GPS System User Manual 2 NOTE Indicator Power Power otatus Light otatus Light NOTE NOTE NOTE 28 Plug the Charger into a normal electrical outlet 110 240 VAC 50 60 Hz It takes approximately two hours to charge a completely drained PowerPak Having a fully charged spare PowerPak is recommended The Charger has two indicator lights Power and Status Power is green Status is yellow
14. ak Procedure was performed earlier in the day for the Probe ensure that the Gain Module dial is in the same Peak Setting 36 For Dilon Navigator 12 mm Probe and Gamma PET Probe only GP 9200 96 001 RO Revised 7 22 2014 Cleaning Disinfection and Sterile Use of Probes and Probe Cables 5C Place Probe and Probe Cable in a Sterile Drape 1 Wipe the Probe and Probe Cable with a soft cloth moistened with ethyl or isopropyl alcohol 7096 concentration 2 Place the Dilon Navigator M 12 mm Probe and Probe Cable into a suitable sterile drape Spectrum Laboratories Inc Part Number 719 03883 000 or equivalent WARNING Do not drop the Probe or strike the Probe tip against a hard surface Doing so may damage the detector element and the Probe may no longer be able to measure radiation 3 The Probe and Probe Cable are now ready for use Refer to other sections of this manual start with the section on the specific probe model 5D Clean Disinfect Store Probe and Probe Cable Immediately After Use 1 Disconnect Probe Cable from Control Unit or Gain Module if using Put Control Unit and Gain Module if using to one side GP 9200 96 001 RO Place Probe and Probe Cable in a Sterile Drape 37 Navigator GPS System User Manual 2 Disconnect the Cable from the Probe 38 Clean Disinfect Store Probe and Probe Cable Immediately After Use GP 9200 96 001 RO Revised 7 22 2014 Cleaning Disinfection and Sterile Use of Probes
15. alities be discovered by the user they should contact their sales representative or customer support person 3 To ensure proper functionality the user should follow each step as outlined in Chapter 4 Control Unit PowerPak and Co Pilot on page 19 and the section on the Probe that is used Should abnormalities be discovered by the user they should contact their sales representative or customer support person 4 In addition to the above preventive maintenance suggests that every two years a new Cable PowerPak and fuse might be considered 11A Peak Procedure and Verification of Standard Gain The Navigator GPS system is designed to minimize periodic maintenance such as might be performed by a clinical engineering department or the manufacturer Depending on the probe used one of two procedures can be performed by the user Peak Procedure Applies to the Dilon Navigator 12 mm Probe and Gamma PET Probe The Peak Procedure involves the Probe and Gain Module This procedure is performed each day one these Probes is used The procedure gives the Probe its maximum sensitivity for that day s use GP 9200 96 001 RO 19 Revised 7 22 2014 Navigator GPS System User Manual Verification of Standard Gain Applies to the Standard Lymphatic Mapping Probe Family These probes include the Standard Lymphatic Mapping Probe Straight Lymphatic Mapping Probe Superficial Head and Neck Probe Thoracic Probe Abdominal Probe and the Danie
16. and Probe Cables 3 Wipe all visible contaminants from the Probe and Probe Cable with a clean sponge moistened with distilled water Va 4 Wipe Probe and Probe Cable with a soft cloth soaked in an enzymatic detergent solution suitable for surgical instruments for approximately 30 seconds 4 30 seconds 4 A gt Repeat Step 4 until visual inspection shows no contaminated areas Clean Disinfect Store Probe and Probe Cable Immediately After Use GP 9200 96 001 RO Revised 7 22 2014 39 Navigator GPS System User Manual 5 If the probe tip and cable end show visual signs of contamination or may possibly be contaminated then proceed with this Step 5 Otherwise proceed with Step 6 owirl the covered plug ends of the Probe and Probe Cable in 100ml of enzymatic detergent solution for 90 seconds CAUTION Do not swirl the plug ends for more than two minutes 6 Ensure that the connector ends of the Probe and Probe Cable are dry CAUTION Do not contaminate other items by wiping them with used cleaning solution Dispose of used cleaning solution properly WARNING Do not scratch or abrade the Probe when decontaminating Scratching abrading the Probe will make future decontamination more difficult if not impossible 40 Clean Disinfect Store Probe and Probe Cable Immediately After Use GP 9200 96 001 RO Revised 7 22 2014 Cleaning Disinfection and Sterile Use of Probes and Probe Cables 7 When comple
17. aparoscopic techniques and familiarization with trocar placements under direct visualization through a laparoscope CAUTION A Endoscopic procedures should be performed only by Physicians having adequate training and familiarity with endoscopic techniques in addition medical literature should be consulted relative to techniques complications and hazards prior to the performance of endoscopic procedures GP 9200 96 001 RO 65 Revised 7 22 2014 Navigator GPS System User Manual 7TH Daniel Probe Navigator SCAN Calibrate Control SCAN Isotope Control Tc99 Probe Cable PowerPak Daniel Probe M am ns c icerum E The Daniel Probe is used in various procedures A typical sequence of setting up the Daniel Probe for a procedure with a 99mTechnetium isotope is as follows Before Surgery e Charge and insert the PowerPak into Control Unit page 26 e Connect the Probe Cable and Control Unit e Set Control Unit rear Panel SCAN Calibrate control to SCAN e Set Control Unit rear Panel Isotope control to Tc99 Use Probe and Cable in a Sterile Drape page 37 During Surgery e See also Useful Adjustments That Can Be Made During Procedures page 32 e See also Optional Co Pilot Device page 29 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables page 33 GP 9200 96 001 RO 66 Revised 7 22 2014 Probe Assembly and Use NOTE The time to char
18. around the probe and cable the Peak Procedure may also be performed with the probe and cable inside a sterile drape NOTE After a peak procedure has been performed the control unit and Module settings are given in the table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe and Cable Table 10 Gamma PET Probe Settings and Indicators Control Indicator Setting Controls in back Calibrate SCAN Isotope 1131 works for 511 Indicators in front Range 1X Threshold Illuminated Display 0 Isotope 511keV amp 1131 Gain Module Perform Peak Procedure on that Probe that Dial at Peak Setting day GP 9200 96 001 RO 55 Revised 7 22 2014 Navigator GPS System User Manual 7C Standard Lymphatic Mapping Probe Navigator a SCAN Calibrate Control SCAN Isotope Control Tc99 Probe Cable PowerPak Po L N SS Standard Lymphatic Mapping Probe L m T ET du Ran The Standard Lymphatic Mapping Probe is used in various procedures A typical sequence of setting up the Standard Lymphatic Mapping probe for a procedure with a 99mTechnetium isotope such as may be used in a lymphatic mapping procedure for a sentinel node is as follows Before Surgery e Charge and insert the PowerPak into Control Unit page 26 e Connect the Probe Cable and Control Unit e Set Control Unit rear Panel SCAN Calibrate cont
19. be use a cable that has two conductors and a cable outside diameter of approximately 3 mm The connector is a locking connector To disconnect the cable from the probe pull on the hood Do not pull on the jacket To disconnect the cable from the Navigator Gain Module pull on the connector s hood Do not pull on the connector jacket 6 mm Diameter Cable A different cable used for the Standard Lymphatic Mapping Probe the Straight Lymphatic Mapping Probe the Superficial Head and Neck Probe the Thoracic Probe the Abdominal Probe and the Daniel Probe This cable has five receptacles inside the probe end and seven pins inside the plug that connects to the Navigator GPS control unit The cable is approximately 6 mm in diameter The connector is a locking connector To disconnect the cable from the probe pull on the hood Do not pull on the jacket To disconnect the cable from the Navigator GPS control unit pull on the hood Do not pull on the jacket 6mm Cable 6mm Cable Navigator End 6mm Cable Probe End GP 9200 96 001 RO Clean Disinfect Imediately Before Use 33 Revised 7 22 2014 Navigator GPS System User Manual 5A Clean Disinfect Immediately Before Use 1 Remove Probe and Probe Cable from storage container Discard container 2 Visually inspect the Probe and Probe Cable for contamination If the probe or cable shows visual signs of contamination or may possibly be contaminated then proce
20. ble to measure radiation This may also void the warranty DO NOT place probe on or near a magnetic instrument pad 16 GP 9200 96 001 RO Revised 7 22 2014 Precautions Laparoscopic and Thoracoscopic Probe Use This user and service manual is designed to assist the use of the Navigator system This user service manual is not a reference to surgical techniques For information on endoscopic procedures techniques complications and hazards please see the books Surgical Laparoscopy Zuker KA ed St Louis MO 1991 and Endoscopic Surgery White RA Klein SR Mosby Year Book Inc St Louis MO 1991 CAUTION AN Endoscopic procedures should be performed only by Physicians having adequate training and familiarity with endoscopic techniques in addition medical literature should be consulted relative to techniques complications and hazards prior to the performance of endoscopic procedures Contraindications e This device is intended for use only as indicated It is not intended for use when endoscopic techniques are generally contraindicated Please see the book Textbook of Laparoscopy Hulka JF Grunda and Stratton inc Orlando FL 1985 op114 116 for information on Absolute Contraindications High Risk Patients and Low Risk Patients e The use of the Navigator GPS system with laparoscopy should only be attempted where there is adequate visualization of the target tissue e rocars should be placed in accordance with standard
21. e esee nennen nhanh nnn annt 51 ZA NON Navigator 12 miri a aa Each prn Ene aa 52 7B Ganmma PETMPIODE su cxecinvesfaxickP v ina k lakast nam dd Gasp S Road VE 54 7C Standard Lymphatic Mapping Probe 56 7D Straight Lymphatic Mapping Probe VV 58 7E Superficial Head and Neck Probe 60 77 Thoracic PR Te 62 70 118 md 9 87 MEER RTL 64 Aa D AMOR en ma en ee 66 B TTOUDIES OO ns see 20 582 ss 02 22053027 71 9 73 JA Navigator GPS M Control Unit Specifications 73 9B Product Cio PR et ee er eee RE 74 nn 74 10 75 10A Product Ordering Codes and Part Numbers 76 10B OS DO 77 0 79 11A Peak Procedure and Verification of Standard Gain 79 POS PROC D ee 79 Verification OF Standard GAIN 2122 422 2 ees siens coute canine disease oia ae oie sainte Cisco nel 80 Vernlication of 072111 0 ROI PEINT 80 ee 83 e 0 c 85 14 Limited VV AE isa aside as es isi 87 4 GP 9200 96 001 RO Revised 7 22 2014 User Manual GP 9200 96 001 RO Revised 7 22 2014 Navigator GPS System User Manual 6 GP 9200 96 001 RO Revised 7 22 2014 1 Introduction Description The Navigator GPS System detects gamma photons such as are produced by radioactive decay The Navigator GPS M System is a portable battery powered system oystem use requires the Navigator GP
22. e in the Navigator Display Starting with the dial in the full clockwise position the location on the Gain Module Dial where the count rate first reaches a maximum value is called the Peak Setting The Probe must be held in a fixed position with respect to an isotope source during a Peak Procedure This source can be either a Check Source or the injection site or some other region of high activity of the patient Only the Dilon Navigator 12 mm Probe and the Gamma PET Probe require a Peak Procedure because they are the only probes that use the Gain Module EACH Probe 1 Requires a Peak Procedure 2 Needs a Peak Procedure run on EACH day of use before the first surgical procedure 3 Has its own Peak Setting on the Gain Module which may have its Peak Setting change slightly day to day GP 9200 96 001 RO Connecting the Probe to the Gain Module 45 Navigator GPS System User Manual Dilon Navigator 12mm Probe Technetium 99m isotope Peak Procedure COUNTS Increase decrease When counts are greatest Peak Setting has been determined leave dial at that setting Start with a full counter clockwise setting then find the Peak Setting N ZU t a ADJUST SCAN Tc99 Controls on back Dial setting Keep position steady Dilon Naviaator 12 mm Probe The Peak Procedure finds Peak Setting for the module s Dial for that Probe for that day 1 99m techne
23. ed The Surgical Team chooses to use Probe B for the rest of the procedures A Peak Procedure is run on Probe B before the next surgical procedure or before continuing the current surgical procedure Probe B counts are highest when the dial on the Gain Module set to just above 6 The dial is left at that location Probe B is ready for the rest of the surgical procedures Description DO NOT USE Running a Peak Procedure GP 9200 96 001 RO Revised 7 22 2014 Probe Assembly and Use 7T Probe Assembly and Use All Probes should be cleaned and disinfected immediately before and immediately after use See Cleaning Disinfection and Sterile Use of Probes and Probe Cables on page 33 for more information Also the PowerPak should be charged prior to use oee PowerPak on page 26 for more information NOTE A full charge for a discharged PowerPak takes two hours GP 9200 96 001 RO 51 Revised 7 22 2014 Navigator GPS System User Manual 7A Dilon Navigator 12 mm Probe Navigator PowerPak Gain Module Gain Module Cable Navigator 12mm Probe The Dilon Navigator 12 mm Probe is used in various procedures A typical sequence of setting up the Dilon Navigator M 12 mm Probe for a procedure with a 99mTechnetium isotope such as may be used in a lymphatic mapping procedure for a sentinel node is as follows Before Surgery e Charge and insert the PowerPak into Control Unit page 2
24. ed with Step 3 and Step 4 otherwise go to Step 5 34 Clean Disinfect Immediately Before Use GP 9200 96 001 RO Revised 7 22 2014 Cleaning Disinfection and Sterile Use of Probes and Probe Cables 3 Wipe all visible contaminants from the Probe and Probe Cable with a clean sponge moistened with distilled water 4 Wipe Probe and Probe Cable with a soft cloth soaked in an enzymatic detergent solution suitable for surgical instruments for approximately 30 seconds 30 seconds 5 Wey Repeat Step 4 until visual inspection shows no contaminated areas GP 9200 96 001 RO Clean Disinfect Imediately Before Use 35 Revised 7 22 2014 Navigator GPS System User Manual 5 If the probe tip and cable end show visual signs of contamination or may possibly be contaminated then proceed with this Step 5 Otherwise proceed with Step 6 owirl the covered plug ends of the Probe and Probe Cable in 100ml of enzymatic detergent solution for 90 seconds 90 seconds 4 AN CAUTION Do not swirl the plug ends for more than two minutes 6 Ensure that the connector ends of the Probe and Probe Cable are dry 7 Connect the Probe to the Probe Cable WARNING Do not scratch or abrade the Probe when decontaminating Scratching abrading the Probe will make future decontamination more difficult if not impossible 5B For Dilon Navigator 12 mm Probe and Gamma PET Probe only 1 Run the Peak Procedure see page 45 If the Pe
25. edure finds Peak Setting for the module s Dial for that Probe for that day 511 keV pharmaceutical is in patient 2 On Control Unit Isotope control set to 1131 and Isotope indicator 511keV amp 1131 is illuminated On Control Unit SCAN Calibrate control is set to SCAN On Control Unit Threshold is ON and Threshold Indicator is illuminated On Module the Dial is at full counter clockwise position near zero On Module increase Dial to the first dial setting that maximizes the counts shown in the display This is the Peak Setting E E am NOTE On the module the Dial can be set very closely to the Peak Setting for that Probe for that day NOTE f uncertain about the Peak Setting achieve it again Remember the current dial setting as tentative Hemember the event rate shown in the display Turn the dial to maximum the event rate is typically lower than your tentative setting Turn the dial to minimum the event rate should be lower than your tentative setting Then perform Step 6 again and achieve the Peak Setting GP 9200 96 001 RO Running a Peak Procedure 47 Revised 7 22 2014 Navigator GPS System User Manual Example Peak Procedure Peak Setting for Probe A Turn dial until counts are highest Keep position IM Probe A is going to be used on Monday for surgical procedures Peak Procedure is run on Probe A before the first surgical procedure of the day Probe A counts are highest when the Gain Modu
26. ge a PowerPak by the Charger may take as long as two hours NOTE Keep Control Unit Power off until all components are connected This helps preserve component life NOTE For 99mTechnetium the Control Unit settings are also given in the attached table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe and Cable Table 16 Daniel Probe Settings and Indicators Control Indicator Setting Controls in back Calibrate SCAN Isotope 9 Indicators in front Hange 1X Threshold Illuminated Display 0 Isotope 9 CAUTION Trocars should be placed in accordance with standard laparoscopic and thoracoscopic techniques with specific regard to target organ geometry to assure probe access to the target organ Please reference current Trocar labeling suggesting working knowledge of laparoscopic techniques and familiarization with trocar placements under direct visualization through a laparoscope CAUTION A Endoscopic procedures should be performed only by Physicians having adequate training and familiarity with endoscopic techniques in addition medical literature should be consulted relative to techniques complications and hazards prior to the performance of endoscopic procedures GP 9200 96 001 RO 67 Revised 7 22 2014 Navigator GPS System User Manual GP 9200 96 001 RO Revised 7 22 2014 68 Probe Assembly and Use Service Manual BAVC ATO GPS GP 9200 96 001 RO 69 Revised 7 22 2014
27. irect alignment and distance from the probe tip throughout the calibration tests 80 GP 9200 96 001 RO Revised 7 22 2014 NOTE The front panel CALIBRATION INDICATOR blinks when the SCAN Calibrate Control is in either the BELOW CENTERED lt 0 gt or ABOVE test position The CALIBRATION INDICATOR is OFF when the CALIBRATION control is in the SCAN position NOTE When the SCAN Calibrate Control is in either the BELOW position the CENTERED position gt 0 lt or the ABOVE position the CONTROL UNIT automatically disables the ISOTOPE control and the THRESHOLD control These controls are enabled when the SCAN Calibrate Control is returned to the SCAN position NOTE Any probe in the Standard Lymphatic Mapping probe family can be used with any Navigator GPS Control Unit The Verification of Standard Gain is an optional procedure that demonstrates this fact Table 23 System Configuration Cobalt 57 Alignment Setting Item Navigator GPS M Probe connected to PROBE input gt 0 lt CALIBRATE control rear panel Technetium 99m ISOTOPE control rear panel OFF THRESHOLD control ON POWER switch as desired RANGE control as desired VOLUME control Table 24 System Configuration Verification of Standard Gain Setting Item Navigator GPS M Probe connected to PROBE input ON POWER switch Varies CALIBRATE control rear panel as desired VOLUME control as desired RANGE control no effect ISOTOPE control rear panel no effec
28. it both straight and flexible probes e Low density soft polyethylene e elescopically folded w rubber bands and medical grade tape strips e Drape features o 100 latex Free all components including rubber bands guaranteed Latex free o All available ETO Sterile o Strong and durable Anti Static material GP 9200 96 001 RO Peak Procedure and Verificaton of Standard Gain 77 Revised 7 22 2014 Navigator GPS System User Manual 78 Peak Procedure and Verificaton of Standard Gain GP 9200 96 001 RO Revised 7 22 2014 11 Maintenance While the Navigator GPS System is virtually maintenance free there are a number of steps the use should follow to ensure proper performance prior to each use 1 Check each system component for any visible signs of abuse neglect or wear before each use and storage This includes checking the following components and these features Table 22 Component Check Component Feature Probe Overall Also tip and connector Cable Each connector the connector pins and integrity of cable Module If present dial cable and connector Control Unit Overall housing integrity of switches PowerPak Charger Battery clips Should abnormalities be discovered by the user the user should contact their sales representative or customer support person Do not use a damaged Probe Cable Gain Module Control Unit PowerPak or Charger 2 The user should check each battery for function and charge before use Should abnorm
29. l Probe Some institutions perform this Verification of Standard Gain every six months or every year The procedure does not change the system The procedure reveals whether or not the Probe and Control unit are set to a common gain standard 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 5 7 Cobalt 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 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 Verification of Calibration Quick Test 1 Clean the PROBE and CABLE page 34 2 Charge the POWERPAK and install it into the CONTROL UNIT page 26 3 Place the system controls as indicated in Table 23 System Configuration Cobalt 57 Alignment on page 81 4 Align a 57 Cobalt source directly with the probe tip at a distance such that the total shown in the system display when the ENERGY THRESHOLD Control is off is in the range of 2 000 to 10 000 counts per second For
30. laparoscopic and thoracoscopic techniques with specific regard to target organ geometry to assure probe access to the target organ Please reference current Trocar labeling suggesting working knowledge of laparoscopic techniques and familiarization with trocar placements under direct visualization through a laparoscope GP 9200 96 001 RO 17 Revised 7 22 2014 Navigator GPS System User Manual 18 GP 9200 96 001 RO Revised 7 22 2014 4 Control Unit PowerPak and Co Pilot 4A Control Unit Count Display Isotope Indicator Threshold 10 second Button and Count Button Indicators and Indicator 25 BiikeV amp l31 miti Calibrate Indicator Low Battery Range Indicator Button and Indicators Volume Power Button Co Pilot Signal Input Receptacle The Control Unit contains the display the PowerPak and most of the controls The controls are located on the front and back of the Control Unit The Control Unit allows the user to adjust the system s settings and produces signal outputs in the form of a count rate shown in the display and an audible pitch that represents the intensity of a Probe s signal The number of gamma photons called events shown in the Control Unit display is determined primarily by a Probe and the Probe s position with respect to the radioactively tagged tissue and secondarily by the position of the controls on the Control Unit GP 9200 96 001 RO Control Unit 19 Revised 7 22 2014 Navigator GPS
31. le Dial at Peak Setting Perform Peak Procedure on that Probe that day GP 9200 96 001 R0 B8 Revised 7 22 2014 Navigator GPS System User Manual 7B Gamma PET Probe Navigator Gain Module PET Probe The Gamma PET M Probe is used in various procedures A typical sequence of setting up the Gamma PET M Probe for a procedure with pharmaceutical that emits 511 keV Photons such as those that proceed from PET pharmaceuticals such as F FDG is as follows Before Surgery e Charge and insert the PowerPak into Control Unit page 26 e Connect the Probe Cable and Gain Module to Control Unit e Runa Peak Procedure page 45 You will see the system as shown above Use Probe and Cable in a Sterile Drape page 37 During Surgery e See also Useful Adjustments That Can be Made During Procedures page 32 e See also Optional Co Pilot Device page 29 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables page 33 54 GP 9200 96 001 RO Revised 7 22 2014 Probe Assembly and Use NOTE The time to charge a PowerPak by the Charger may take as long as two hours NOTE Keep Control Unit Power off until all components are connected This helps preserve component life NOTE A Peak Procedure must be performed before using the Gamma PET Probe in the first surgical procedure of the day See page 45 NOTE Although the Peak Procedure is typically performed with no sterile drape
32. le dial is set to just above 4 The dial is kept at that location This is the Peak Setting for that probe Probe A is now ready for surgical procedures The dial on the Gain Module is not adjusted for the rest of the day A pd 9 I9 x 48 Running a Peak Procedure GP 9200 96 001 RO Revised 7 22 2014 Gain Module and Peak Procedure Example Peak Procedure Peak Setting for Probe B Turn dial until counts are highest Keep position Probe B is going to be used on Tuesday for surgical procedures Peak Procedure is run on Probe B before the first surgical procedure of the day Probe B counts are highest when the Gain Module dial is set to just above 6 The dial is left at that location That is the Peak Setting for that probe Probe B is now ready for surgical procedures The dial on the Gain Module is not adjusted for the rest of the day RUE a tS s GP 9200 96 001 RO Running a Peak Procedure 49 Revised 7 22 2014 Navigator GPS System User Manual Table 8 Using Multiple Probes During One Surgical Day Control Display 50 Probe A is going to be used on Wednesday for all surgical procedures A Peak Procedure is run on Probe A before the first surgical procedure of the day Probe A counts are highest when the Gain Module dial is set to about 4 1 2 The dial is left at that location Probe A is ready for all surgical procedures Probe A is dropped It cannot be used again until tested and disinfect
33. m Overview and Components 2A Navigator GPS System Probe Modes um Dilon Navigator 12 mm Probe page 52 N cd Cable Gain Module Gamma PET Probe page 54 p Standard Lymphatic Mapping Probe page 56 N mudi i Straight Lymphatic Mapping Probe page 58 m DataPak Abdominal Probe page 64 Thoracic Probe page 62 Charger Daniel Probe page 66 GP 9200 96 001 RO Navigator GPS System Probe Modes 14 3 Precautions 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 Failure to thoroughly review and adhere to the information contained in this User and Service Manual may pose a potential hazard to the patient and or user and may void the warranty Control Unit PowerPak and Charger During system use maintain electrical isolation of the patient Do not connect either the probe the cable or the internal circuit of the control unit to earth ground or to other voltage potentials Maintain patient electrical isolation Do not defeat the electrical isolation of the probe cable surface and the control unit housing These isolate the battery power circuit inside the control unit the conductors inside the probe cable the probe surface and the patient Do not defeat the electrical isolation between the control unit s external DATA PO
34. orized mes GP 9200 96 001 R0 9 Revised 7 22 2014 Navigator GPS System User Manual Table 1 Symbols Continued PowerPak Low A Caution High Voltage Acceptable shipping storage conditions 15 C to 40 C X WEEE Symbol EU only 10 GP 9200 96 001 RO Revised 7 22 2014 2 System Overview and Components Navigator GPS TM Control Unit PowerPak Charger Gain Module Probe DILON Navigator 12mm Probe Navigator GPS Control Unit with Dilon Navigator 12 mm Probe The Navigator GPS Control Unit supports several Dilon Probe Models The illustration shows each probe model available for use with the system The Table gives probe model dimensions Subsequent sections of this manual describe in detail probe and system use GP 9200 96 001 RO 11 Revised 7 22 2014 Navigator GPS System User Manual PowerPak Charger Navigator GPS Control Unit Standard Lymphatic Mapping Probe Navigator GPS Control Unit with Dilon Standard Lymphatic Mapping Probe 12 GP 9200 96 001 RO Revised 7 22 2014 System Overview and Components Table 2 Probe Dimensions Probe Tip Tip Shaft Shaft Probe Diameter Angle Diameter Length Length Dilon Navigator 12 12mm 35 12mm 242mm mm Probe Standard Lymphatic 14mm 35 6mm 67mm Mapping Probe Straight Lymphatic 14mm 6mm 67mm Mapping Probe Superficial Head and 11mm 6mm 53mm Neck Probe GP 9200 96 001 RO 13 Revised 7 22 2014 Syste
35. ows Before Surgery e Charge and insert the PowerPak into Control Unit page 26 e Connect the Probe Cable and Control Unit e Set Control Unit rear Panel SCAN Calibrate control to SCAN e Set Control Unit rear Panel Isotope control to Tc99 e Use Probe and Cable in a Sterile Drape page 37 During Surgery e See also Useful Adjustments That Can be Made During Procedures page 32 e See also Optional Co Pilot Device page 29 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables page 33 64 GP 9200 96 001 RO Revised 7 22 2014 Probe Assembly and Use NOTE The time to charge a PowerPak by the Charger may take as long as two hours NOTE Keep Control Unit Power off until all components are connected This helps preserve component life NOTE For 99mTechnetium the Control Unit settings are also given in the attached table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe and Cable Table 15 Abdominal Probe Settings and Indicators Control Indicator Setting Controls in back Calibrate SCAN Isotope 9 Indicators in front Range 1X Threshold Illuminated Display 0 Isotope Tc99 CAUTION Trocars should be placed in accordance with standard laparoscopic and thoracoscopic techniques with specific regard to target organ geometry to assure probe access to the target organ Please reference current Trocar labeling suggesting working knowledge of l
36. pe Control on page 25 for more information Data Port Unused 24 Control Unit GP 9200 96 001 RO Revised 7 22 2014 Control Unit PowerPak and Co Pilot SCAN Calibrate Control This control should be in the SCAN Position On some probe models such as the Standard Lymphatic Mapping Probe this control is temporarily placed in other positions during an optional VERIFICATION procedure NOTE The SCAN Calibrate Control has four positions Make sure it is set to SCAN prior to a procedure See Verification of Standard Gain on page 80 for information on Verification NOTE f the front panel CAL indicator is flashing move the control to the SCAN position 1699 1125 SCAN low center high Isotope Control The Isotope Control sets the Navigator M to detect specific isotopes when in use CAUTION A It is important that the Isotope Control is set to the isotope that is going to be used in the procedure Setting the Isotope Control incorrectly will result in incorrect detection uH OM 5 3 Eun x Tc99 In111 511keV amp 1131 1125 GP 9200 96 001 RO Control Unit 25 Revised 7 22 2014 Navigator GPS System User Manual The Isotope Control setting on the back of the Control Unit illuminates the corresponding light on the Isotope Indicator on the front of the Control Unit SE E E E rr Bdu n25 SiikeV 81131 In111 5 we Only one Isotope Indicator will light up at a time the above im
37. phatic Mapping probe for a procedure with a 99mTechnetium isotope such as may be used in a lymphatic mapping procedure for a sentinel node is as follows Before Surgery e Charge and insert the PowerPak into Control Unit page 26 e Connect the Probe Cable and Control Unit e Set Control Unit rear Panel SCAN Calibrate control to SCAN e Set Control Unit rear Panel Isotope control to Tc99 Use Probe and Cable in a Sterile Drape page 37 During Surgery e See also Useful Adjustments That Can Be Made During Procedures page 32 e See also Optional Co Pilot Device page 29 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables page 33 58 GP 9200 96 001 RO Revised 7 22 2014 Probe Assembly and Use NOTE The time to charge a PowerPak by the Charger may take as long as two hours NOTE Keep Control Unit Power off until all components are connected This helps preserve component life NOTE For 99mTechnetium the Control Unit settings are also given in the attached table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe and Cable Table 12 Straight Lymphatic Mapping Probe Settings and Indicators Control Indicator Setting Controls in back Calibrate SCAN Isotope 9 Indicators in front Range 1X Threshold Illuminated Display 0 Isotope 9 GP 9200 96 001 RO 59 Revised 7 22 2014 Navigator GPS System User Manual 7E Supe
38. pport Items Continued ltem Description Marketing Order Code Co Pilot See Optional Co Pilot Device on page 29 2 for more information 10A Product Ordering Codes and Part Numbers Items are typically ordered by the Marketing Order Code The corresponding Dilon Engineering part number appears on some items Table 21 Marketing Order Codes Dilon Part Nos Marketing Order Code Description Dilon Part No E097113 DILON NVG GPS BATTERY ASSY GP 5500 00 E297000 DILON NVG GPS SYS GP 8500 00 E297400 NAV GPS SYS LEDS GP 9000 00 E397400 NAV GPS SYS LEDS GP 9100 00 E297500 12MM SYSTEM US GP 9200 00 E397500 12MM SYSTEM EU GP 9210 00 E097500 12MM PROBE UPGRADE GP 9220 00 E097300 PET PROBE UPGRADE GP 9320 00 E 198003 TOP GUN COLLIMATOR 2 SP 1800 00 E097CBL CABLE 12mm PET PROBES PM 4000 20 E097002 PRB 14MM ANGLE 67MM SHAFT SP 2A14 67 E097012 PRB 14MM STRHT 67MM SHAFT SP 2514 67 E097016 PRB 11MM STRHT 53MM SHAFT SP 2511 53 E097202 PRB 10MM STRT 310MM SHAFT SP 2510 31 E097102 PRB 10MM STRT 190MM SHAFT SP 2510 19 E097620 DANIEL PROBE SP 2510 31D E097015 CABLE 10mm 11mm 14mm PROBES 0 16 Peak Procedure and Verificaton of Standard Gain GP 9200 96 001 RO Revised 7 22 2014 10B Sterile Drape A sterile drape is an accessory A sterile drape is not sold or supported by Dilon Technologies Typical characteristics of a suitable intra operative prove drape are as follows e Universal Gamma Probe Cover 5 x 24 e Sized with tapered tip to f
39. rficial Head and Neck Probe Navigator SCAN Calibrate Control M ae SCAN 4 Isotope Control Tc99 Probe Cable PowerPak The Superficial Head and Neck Probe is used in various procedures A typical sequence of setting up the Superficial Head and Neck Probe for a procedure with a 99mTechnetium isotope such as may be used in a procedure locating a hyperactive parathyroid gland is as follows Before Surgery e Charge and insert the PowerPak into Control Unit page 26 e Connect the Probe Cable and Control Unit e Set Control Unit rear Panel SCAN Calibrate control to SCAN e Set Control Unit rear Panel Isotope control to Tc99 e Use Probe and Cable in a Sterile Drape page 37 During Surgery e See also Useful Adjustments That Can Be Made During Procedures page 32 e See also Optional Co Pilot Device page 29 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables page 33 60 GP 9200 96 001 RO Revised 7 22 2014 Probe Assembly and Use NOTE The time to charge a PowerPak by the Charger may take as long as two hours NOTE Keep Control Unit Power off until all components are connected This helps preserve component life NOTE For 99mTechnetium the Control Unit settings are also given in the attached table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe and Cable Table 13 Superficial Head and Neck Probe Settings and Indica
40. robe Cable of the Dilon Navigator M 12 mm Probe or the Gamma PET Probe 6A Connecting the Gain Module to the Control Unit Line up the key on the Gain Module plug with the key on the Control Unit Probe receptacle and insert the Gain Module plug into the Probe receptacle on the front of the Control Unit Key Key WARNING The key on the plug MUST line up with the key on the receptacle Do not try to jam the plug into the receptacle this may damage the cable GP 9200 96 001 RO 43 Revised 7 22 2014 Navigator GPS System User Manual The plug will click when it is seated properly Removing the Gain Module There is a hood at the end of the plug Grasp the hood and pull straight out until the plug detaches from the Control Unit WARNING Do not pull on the jacket of the Cable You must pull on the hood at the very end of the Cable Pulling on the jacket may damage the Cable Pull Here DON T Pull Here kaid 44 Connecting the Gain Module tothe Control Unit GP 9200 96 001 RO Revised 7 22 2014 Gain Module and Peak Procedure 6B Connecting the Probe to the Gain Module Connect the Probe end of the Cable to the Probe Connect the Gain Module End of the Cable to the Gain Module ec Running a Peak Procedure A Peak Procedure finds the best sensitivity of a probe the setting on the Gain Module at which the Probe counts the most events Adjusting the Gain Module Dial increases decreases the count rat
41. rol to SCAN e Set Control Unit rear Panel Isotope control to Tc99 Use Probe and Cable in a Sterile Drape page 37 During Surgery e See also Useful Adjustments That Can be Made During Procedures page 32 e See also Optional Co Pilot Device page 29 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables page 33 56 GP 9200 96 001 RO Revised 7 22 2014 Probe Assembly and Use NOTE The time to charge a PowerPak by the Charger may take as long as two hours NOTE Keep Control Unit Power off until all components are connected This helps preserve component life NOTE For 99mTechnetium the Control Unit settings are also given in the attached table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe and Cable Table 11 Standard Lymphatic Mapping Probe Settings and Indicators Control Indicator Setting Controls in back Calibrate SCAN Isotope 9 Indicators in front Range 1X Threshold Illuminated Display 0 Isotope 9 GP 9200 96 001 RO 57 Revised 7 22 2014 Navigator GPS System User Manual 7D Straight Lymphatic Mapping Probe TM Navigator SCAN Calibrate Control SCAN Isotope Control Tc99 Probe Cable A Se HAVIGATOR TES GPS MMil PowerPak m Straight Lymphatic Mapping Probe The Straight Lymphatic Mapping Probe is used in various procedures A typical sequence of setting up the Straight Lym
42. rrence of a second gamma photon during the short time period a few microseconds it takes the system to count a detected gamma photon The Navigator GPS Device exhibits at least 95 accuracy across its dynamic range 74 Product Life GP 9200 96 001 RO Revised 7 22 2014 10 Support Items The Navigator GPS7M System is typically supplied as a complete system Support items may be purchased from the local Dilon Navigator representative At time of publication of this manual some support items have the following order codes Feel free to contact your local representative for additional information Table 20 Navigator GPS System Support Items Item Description Marketing Order Code Cable for 12mm Probe Connects Dilon Navigator 12 mm Probe E097CBL and Gamma PET Probe to Gain Module Cable has two conductors one central and one circular Connects 14mm Probes to Control Unit E097015 Cable has six conductors See PowerPak on page 26 for more E097113 information Black color body Rectangular shape E097013 Includes cable that terminates in a circular receptacle Supplied with two replaceable PowerPak clips See Charging the PowerPak on page 27 for more information Spare PowerPak Clips Re Usable Set of Two E297413 See Charging the PowerPak on page 27 for CIIM more information GP 9200 96 001 RO 5 Revised 7 22 2014 Navigator GPS System User Manual Table 21 Navigator GPS System Su
43. s Continued Item Description Control Unit Weight w PowerPak 2 0kg Accuracy 9596 9996 across the dynamic range of the instrument with probes 9B Product Life The products supplied by Dilon are non sterile durable goods The product warranty is for a one year time period consistent with use described in this user service manual Dilon defines the end of life of the product by the accumulation of wear abrasion and damage encountered during use The rate of wear abrasion and damage varies among users For practical purposes of record keeping Dilon further defines the life time of the product components to these time periods given below Table 19 Product Life Control Unit 3 years PowerPak 2 years Charger 2 years Probe 2 years Cable 2 years Gain Module 2 years The control unit contains a fuse The life time of the fuse is two years for normal use The fuse is meant to be replaced when necessary when the fuse is blown by the user Instructions for replacing a fuse are given in the operating manual Consistent with Dilon s understanding of the current MDD record retention is 5 years following the last production of the instrument 9C System Accuracy The Navigator GPS System with Probe counts gamma photons that proceed from radioisotopes At event rates around 20 000 counts per second the event rate shown in the display may be slightly less than the event rate seen by the probe This is due to the possible occu
44. s shown in the DISPLAY on the Control Unit The R button is the RANGE button This button operates the Range control on the Control Unit Push and release the RANGE button to select an audible range appropriate to the signal detected by the system 30 Optional Co Pilot Device GP 9200 96 001 RO Revised 7 22 2014 Control Unit PowerPak and Co Pilot M25 511keV amp 131 In111 Match the spacing of the prongs with the spacing of the receptacles The Co Pilot is attached to the Control Unit at the Co Pilot receptacle CAUTION The Co Pilot can only be attached one way the prongs are not evenly spaced GP 9200 96 001 RO Optional Co Pilot Device 31 Revised 7 22 2014 Navigator GPS System User Manual 4D Useful Adjustments That Can be Made During Procedures Threshold Button 10 second Indicator Button Indicator 1125 6 511 8 31 1 Range Button NAVIGATOR Indicator Volume Adjustment Threshold Range 10 Second Count Volume 32 Table 7 Useful Adjustments Benefit Increases signal when only a low number of events are observed Threshold control is normally ON When On the system counts only the events in a narrow energy range around the signal Change Threshold to OFF to allow the system to count all signals it detects You will be able to hear changes in high event rates The Range is normally 1X In the X10 position every tenth signal produces an audible outpu
45. ser Manual 84 GP 9200 96 001 RO 13 Recycling At the end of the device life and or accessories please send the device and or its accessories back to Dilon Technologies Authorize Representative in Europe Ensure the cleaning of the device and or it accessories before shipment The disposables of the product are made out of plastic and cannot be reused and must be disposed as standard disposables GP 9200 96 001 RO 85 Navigator GPS System User Manual 86 GP 9200 96 001 RO 14 Limited Warranty Dilon Technologies Inc Dilon warrants to its customers that subject to the below provisions the Navigator GPS system and Probes 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 equal 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 tha
46. t In X100 only every one hundredth produces an audible output The Range control only affects the sound The count shown in the display is independent of the range setting Press to obtain a 10 Second count The total is displayed for at least four seconds so one may if desired record the total Adjust to desired loudness Useful Adjustments That Can be Made During Procedures GP 9200 96 001 RO Cleaning Disinfection and Sterile Use of Probes and Probe Cables 5 Cleaning Disinfection and Sterile Use of Probes and Probe Cables All Probes and Probe Cables require cleaning and disinfection immediately after and immediately before use Follow these steps to ensure that cleaning and disinfection is done correctly e Clean Disinfect Immediately Before Use on page 34 e Place Probe and Probe Cable in a Sterile Drape on page 37 e Clean Disinfect Store Probe and Probe Cable Immediately After Use on page 37 e Radioactive Decontamination Procedure OPTIONAL on page 41 e Clean Store Control Unit Gain Module on page 41 CAUTION All Probes and Probe Cables are used inside a sterile drape The Control Unit Gain Module if used and PowerPak Charger are used outside the sterile field Probes and Probe Cables should be cleaned and disinfected separately from the other components Cables One of two cables is used depending on the Probe 3 mm Diameter Cable The Dilon Navigator 12 mm Probe and the Gamma PET M Pro
47. t THRESHOLD control GP 9200 96 001 RO 81 Revised 7 22 2014 Navigator GPS System User Manual 82 GP 9200 96 001 RO Revised 7 22 2014 12 Repair The Probes are sealed at the factory No user serviceable parts are inside the Probes Damage to a Probe will result if a Probe is opened by the user The Navigator GPSTM control unit includes a Fuse which may be inspected and replaced by the user The Control Unit may include a bracket by which the user affixes the Gain Module to the control unit The Control unit includes a PowerPak which the user may remove and replace into the control unit Beyond these three items the control unit contains no user serviceable parts and should not be opened by the user Please contact Dilon for additional service Dilon Technologies Inc 12050 Jefferson Avenue Suite 340 Newport News VA 23606 USA Phone 1 844 DILONNAV Fax 757 269 4912 www dilon com CAUTION 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 If a system or system components are to be shipped from your institution for repair then please clean and disinfect the components as described in this manual before packing for shipment Indicate on the outside of the shipping carton that the items have been cleaned and disinfected GP 9200 96 001 RO 83 Navigator GPS System U
48. t 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 repair or replacement 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 SIATED ABOVE DILON EXPRESSLY DISCLAIMS ALL WARRANTIES e Manufactured by Authorized European Representative Dilon Technologies Inc AG Medical on 12050 Jefferson Avenue Route de l Orme Technologies Suite 340 Parc des Algorithmes Imm Hom re Newport News VA 23606 91190 Saint Aubin USA France Phone 757 269 4910 http ag medical com C us 2014 Dilon Technologies Inc All Rights Reserved May 2014 Made in USA GP 9200 96 001 RO 87 Navigator GPS System User Manual 88 GP 9200 96 001 RO
49. tely dry loosely coil the Probe Cable about six coils and place the Probe and Probe Cable into a clean plastic bag container or other suitable storage container 8 Store the container in a clean safe environment Hadioactive 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 5E Clean Store Control Unit Gain Module 1 If unclean wipe Control Unit and Gain Module if present with a soft cloth moistened with mild soap and water Dry with a soft cloth 2 Store the Control Unit and Gain Module in a clean safe environment CAUTION A Follow universal generally accepted practices when handling components that have come in contact with blood or tissue GP 9200 96 001 RO Clean Store Control Unit Gain Module 41 Revised 7 22 2014 Navigator GPS System User Manual 42 Clean Store Control Unit Gain Module GP 9200 96 001 RO Revised 7 22 2014 6 Gain Module and Peak Procedure The Gain Module sits between the Control Unit and the P
50. the Control Unit settings are also given in the attached table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe and Cable Table 14 Thoracic Probe Settings and Indicators Control Indicator Setting Controls in back Calibrate SCAN Isotope 9 Indicators in front Hange 1X Threshold Illuminated Display 0 Isotope 9 AN CAUTION Trocars should be placed in accordance with standard laparoscopic and thoracoscopic techniques with specific regard to target organ geometry to assure probe access to the target organ Please reference current Trocar labeling suggesting working knowledge of laparoscopic technigues and familiarization with trocar placements under direct visualization through a laparoscope CAUTION A Endoscopic procedures should be performed only by Physicians having adequate training and familiarity with endoscopic techniques in addition medical literature should be consulted relative to techniques complications and hazards prior to the performance of endoscopic procedures GP 9200 96 001 RO 63 Revised 7 22 2014 Navigator GPS System User Manual 7G Abdominal Probe Navigator SCAN Calibrate Control M SCAN 4 Isotope Control Tc99 Probe Cable s PowerPak Abdominal Probe Pon oc T The Abdominal Probe is used in various procedures A typical sequence of setting up the Abdominal Probe for a procedure with a 99mTechnetium isotope is as foll
51. tium pharmaceutical is in patient 2 On Control Unit Isotope control set to Tc99 and Isotope indicator Tc99 is illuminated 3 On Control Unit SCAN Calibrate control is set to SCAN 4 On Control Unit Threshold is ON and Threshold Indicator is illuminated D On Module the Dial is at full counter clockwise position near zero 6 On Module increase Dial to the first dial setting that maximizes the counts shown in the display This is the Peak Setting NOTE On the module the Dial can be set very closely to the Peak Setting for that Probe for that day NOTE f uncertain about the Peak Setting achieve it again Remember the current dial setting as tentative Hemember the event rate shown in the display Turn the dial to maximum the event rate is typically lower than your tentative setting Turn the dial to minimum the event rate should be lower than your tentative setting Then perform Step 6 again and achieve the Peak Setting 46 Running a Peak Procedure GP 9200 96 001 RO Revised 7 22 2014 Gain Module and Peak Procedure Gamma PET Probe 511KeV pharmaceutical Peak Procedure COUNTS Increase decrease When counts are greatest Peak Setting has been determined leave dial at that setting Start with a full counter clockwise setting then find the Peak Setting Controls on back ES EU ob m ADJUST Dial Setting oa position steady The Peak Proc
52. tors Control Indicator Setting Controls in back Calibrate SCAN Isotope 9 Indicators in front Range 1X Threshold Illuminated Display 0 Isotope Tc99 GP 9200 96 001 RO 61 Revised 7 22 2014 Navigator GPS System User Manual 7F Thoracic Probe Navigator n SCAN Calibrate Control SCAN Isotope Control Probe Cable Tc99 22 PowerPak Thoracic Probe P t P m Oo 7 dd ax P z sbim E E PE i The Thoracic Probe is used in various procedures A typical seguence of setting up the Superficial Head and Neck Probe for a procedure with a 99mTechnetium isotope is as follows Before Surgery e Charge and insert the PowerPak into Control Unit page 26 e Connect the Probe Cable and Control Unit e Set Control Unit rear Panel SCAN Calibrate control to SCAN e Set Control Unit rear Panel Isotope control to Tc99 Use Probe and Cable in a Sterile Drape page 37 During Surgery e See also Useful Adjustments That Can Be Made During Procedures page 32 e See also Optional Co Pilot Device page 29 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables page 33 62 GP 9200 96 001 RO Revised 7 22 2014 Probe Assembly and Use NOTE The time to charge a PowerPak by the Charger may take as long as two hours NOTE Keep Control Unit Power off until all components are connected This helps preserve component life NOTE For 99mTechnetium
53. uced or eliminated Signals of amplitude outside the pre configured energy range are discarded Only those events within the particular energy range are counted and displayed The indicator is illuminated NOTE The Threshold is normally on when using Probes The Threshold may be set to off to count all events seen by a Probe otarts a 10 second photon count When Count has been pressed the Count indicator is illuminated When the 10 seconds is complete the Control Unit beeps and the total count is shown in the display for four seconds After giving the total count the Display goes back to showing counts per second GP 9200 96 001 RO Control Unit 21 Revised 7 22 2014 Navigator GPS System User Manual Table 4 Controls and Displays on the Front of the Control Unit Continued Control Display Cal Low PowerPak Signal Input Co Pilot 22 Description Probes are used with the SCAN Calibrate Control in the SCAN position only The Calibrate Indicator blinks when the SCAN Calibrate Control is in any position other than SCAN NOTE The SCAN Calibrate Control should be to SCAN for all uses of all Probes The SCAN position is the only correct setting and when the SCAN Calibrate Control is set to SCAN indicator is not illuminated See Peak Procedure and Verification of Standard Gain on page 79 for more information Blinks when the PowerPak charge has only 30 minutes of useful charge remaining
54. uiries about the Navigator GPSTM System to Dilon Technologies Standards The Dilon Navigator GPS M System including Probes and accessories complies with the following standards GP 9200 96 001 RO 1 Revised 7 22 2014 Navigator GPS System User Manual EC Directives EMC Directive 89 336 EEC Group Class B EN 5501 1 EMC Directive 89 336 EEC IEC 60601 1 2 3 Edition Reciprocal Interference This product has been tested and verified to ensure that there are no issues or concerns regarding reciprocal interference This includes EMI EMC and RF This product has been certified and tested by 3rd party testing facilities List of standards is as follows e Medical Electrical Equipment Part 1 General requirements For Safety 1 Collateral Standard Safety Requirements For Medical Electrical Systems IEC 60601 1 1 3 Ed e Medical Electrical Equipment Part 1 General Requirements For Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 3 Ed Safety e Medical Electrical Equipment Part 1 General requirements For Safety 1 Collateral Standard Safety Requirements For Medical Electrical Systems IEC 60601 1 1 3 Ed e Medical Electrical Equipment Part 1 General Requirements For Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 3 Ed e Medical Electrical Equipment Part 1 6 General Requirements For Safety
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