User/Service Manual
Contents
1. A e Visually inspect the probe and cable for contamination before storing If the probe or cable show visual signs of contamination or may possibly be contaminated then proceed to Table 5A 1 Cleaning amp Disinfection WARNING Do not scratch or abrade the probe when decontaminating Scratching abrading the probe will make future decontamination difficult if not impossible Table 5A 1 Cleaning amp Disinfection Cleaning Enzymatic detergent OPA high level disinfectant running water Equipment Cleaning Rinse the outside surfaces of the probe with a brisk stream of lukewarm tap water Method 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 Wipe with soft cloth or sponge soaked in enzymatic cleaner Repeat separately for collimator cleaning if used Visually inspect device s for contaminated areas Repeat steps 1 amp 2 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 Disinfection Prepare Mixture according to manufacturer s instructions Immerse probe and cable completely for a minimum of 12 minutes at 68 F 20 C or higher to destroy all pathogenic microorganisms e Note that probes that are compromised can be damaged if detergent seeps into them 3 Rinse equipment with a brisk stream of lu2. kie Tieg User Service Manual Manufactured by Authorized European Representative Dilon Technologies Inc AG Medical 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 1 844 DILONNAV http ag medical com CIC 0459 N2 5000 07 001 Rev O 1 Revised 7 22 2014 www Dilon com Navigator 2 0 User Manual amp Service Guide Important Note All personnel that will interact with this Navigator 2 0 System and Probes should read this Manual and Service Guide to ensure proper use handling storage and maintenance This document and the information contained herein 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 Dilon Technologies This document is intended to be used by customers as part of their Dilon Technologies equipment 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 im
3. in Section 11B Selects the isotope to be detected by the control unit SCAN Calibrate Control The SCAN Calibrate Control has FOUR POSITIONS During all surgical procedures this control should be in the SCAN Position During the calibration verification procedure this control uses the remaining three settings AT 0 and a NOTE See Verification of Standard Gain Calibration Quick Test in Section 11B for information on calibration verification NOTE f the front panel CAL indicator is flashing before a procedure move the control to the SCAN position Isotope Control The Isotope Controls allow the user to designate the specific isotope in use lodine 125 8F FDG and 1131 Indium111 Technetium 99m 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 o11keV 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 N2 5000 07 001 Rev O 16 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 4B Battery Part N2 8500 00 4B 1 Inserting the Battery Open the door to the battery port located on the right side of the control unit Insert a fully charged battery with the battery label facing toward the rear of the unit with battery contacts inward and
4. Indicator top of the Pilot Probe handle Probe LED Illuminated flashing 6A 3 After Surgery e See Cleaning Disinfection and Sterile Use of Navigator Probes amp Cables Section 5 N2 5000 07 001 Rev 0 27 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 6B Navigator 2 0 with Standard Lymphatic Mapping Probes Superficial Head amp Neck Probe Daniel Lung Probe and Laparoscopic Probes Standard Lymphatic Mapping Probe SP 2A14 67 Angled SP 2S14 67 Straight Superficial Head amp Neck Probe SP 2S11 53 Daniel Lung Probe SP 2S10 31D Laparoscopic Probe SP 2S10 31 310 mm shaft SP 1S10 19 190 mm shaft A mmm E j f e e e a k These Navigator probes are used in various procedures A typical sequence of setting up these probes for procedures with a Technetium 99m isotope such as may be used in a lymphatic mapping procedure for a sentinel node biopsy localization of a parathyroid adenoma or localization of a sub centimeter lung nodule is as follows 6B 1 Before Surgery e See Cleaning Disinfection and Sterile Use of Probes and Cables Section 5 e Insert a fully charged battery into control unit Section 4B 3 e Connect the probe and cable to control unit Section 4C 2 e For intraoperative use insert probe and cable in a sterile drape N2 5000 07 001 Rev 0 28 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide Table 6B 1
5. Range X CButton Count The C button is the COUNT Button Obtain a one second count by pushing and releasing this button once Obtain a ten second count by pushing this button twice in quick succession Each time total counts are shown in the display screen on the control unit The R button is the RANGE Button This button operates the Range control mentioned above on the control unit Push and release the RANGE Button to select an audible range appropriate to the signal detected by the system CAUTION The Co Pilot can only be attached to the control unit one way the prongs are not evenly spaced see image below A N2 5000 07 001 Rev O 21 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 4E Useful Adjustments That Can Be Made During Procedures 10 second Count Button and Indicator Threshold Control Range Button and Range Indicators akuma d 4 ___ Power Button Volume Knob Table 4D 1 Useful Adjustments Threshold For Cabled Probes only this feature increases specificity when only a low number of events are observed Threshold control defaults to 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 opening the value range to scatter NOTE The Wireless Pilot Probe features integrated threshold independent of the range setting Press to obtai
6. the CALIBRATION control is in the SCAN position NOTE All Dilon Technologies probes can be used with any Navigator 2 0 control unit The 12mm Lymphatic Mapping Probe used with a Gain Module requires a different method of peak II A8 calibration assurance detailed in the section 7A entitled Running a Peak Procedure 11C Fuse Replacement Procedure The fuse is to be replaced when necessary by the user when the fuse is blown The Navigator 2 0 fuse is to be replaced as follows 1 Push in and twist the fuse holder cap counter clockwise mp 2 Remove the fuse from the fuse holder 3 Inserta new fuse into the holder N2 5000 07 001 Rev O 41 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 4 Press in and twist the fuse holder cap clockwise to lock it in place N2 5000 07 001 Rev 0 42 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 12 Repair Probes are 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 remaining warranty if attempted Serviceable parts on the Navigator 2 0 control unit include a fuse which may be inspected and replaced by the user and a replaceable battery Beyond these two items the control unit contains no user serviceable parts and should not be opened by the user Please contact Dilon Technologies for additional service An RMA number is requ
7. 2 0 User Manual amp Service Guide 10 Support Items The Navigator 2 0 control unit is typically supplied with a complete system Support items may be purchased from the local Dilon Technologies Navigator representative At time of publication of this manual the primary support items have the following part numbers Feel free to contact your local representative for additional information 10A Product Part Numbers Table 10A 1 Navigator 2 0 System Support Items with Part Numbers rem 10B Sterile Drape Optional Storm Case for travel and storage N2 8000 07 A sterile drape is an additional accessory but it is not sold or supported by Dilon Technologies Typical characteristics of a suitable intra operative probe drape are as follows e Universal gamma probe cover 5 x 24 e Sized with tapered tip to fit both straight and flexible probes e Low density soft polyethylene e Telescopically folded w rubber bands and medical grade tape strips e Drape features o 100 guaranteed latex free All components including rubber bands o All available EtO Sterile o Strong and durable Anti Static material N2 5000 07 001 Rev 0 38 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 11 Maintenance 11A Overview While the Navigator 2 0 System is virtually maintenance free the user should follow a number of steps to ensure proper performance prior to each use 1 Check each system component for any visible sign
8. Circuit inside the control unit Try a different control unit Contact Dilon has been damaged Technologies for assistance Probe LED is illuminated but Gently shake probe to activate not transmitting signal to unit connectivity LED flashes when transmitting Probe is damaged probe cap Try a different probe or contact Dilon not secure Technologies for assistance N2 5000 07 001 Rev 0 34 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 2 LED on Pilot Probe Probe battery is dead or Replace with new battery does not illuminate installed incorrectly Verify that battery was inserted correctly into probe should face toward base of probe Battery was not installed Install new battery LED on probe is damaged Contact Dilon Technologies for assistance Table 8A 3 Control Unit with CABLED PROBE Settings and Indicators 1 Zero in display No No connection between probe Check that all connections are secure signal under presence cable gain module if present of a radioactive and control unit source Isotope control is set to Change Isotope Control on back of incorrect isotope control unit to Tc 99 Gain module if used is set to Run Peak Procedure Sec 7A zero There is an open circuit in the Replace cable probe cable Circuit inside the control unit Try a different control unit Contact Dilon has been damaged Technologies for assistance Probe is damaged prob
9. Navigator 2 0 with Standard Lymphatic Mapping Probes Superficial Head amp Neck Probe Daniel Lung Probe and Laparoscopic Probes Settings and Indicators just prior to surgery Ce 6B 2 During Surgery e See Useful Adjustments that can be made During Procedures Section 4E e See Optional Co Pilot Device Section 4D 6B 3 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Cables Section 5 NOTE The time to charge a battery by the charger may take as long as 3 5 hours NOTE Keep control unit powered off until all components are connected This helps preserve component life Cautions for Thoracoscopic Laparoscopic and Endoscopic Procedures CAUTION Trocars should be placed in accordance with standard laparoscopic and thoracoscopic T 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 Endoscopic procedures should be performed only by physicians having adequate training and A familiarity with endoscopic techniques In addition medical literature should be consulted relative to techniques complications and hazards prior to the performance of endoscopic procedures N2 5000 07 001 Rev 0 29 Revised 7 22 2014 Navigator 2 0
10. User Manual amp Service Guide 6C Navigator 2 0 with 12mm Lymphatic Mapping Probe Part N2 9001 12 Navigator 2 0 Control Unit Cable for 12 mm Lymphatic Mapping Probe Gain Module 12 mm Lymphatic Mapping Probe The Navigator 12mm lymphatic mapping probe is used in various lymphatic mapping procedures Please note that the system pictured above also includes battery and charger 6C 1 Before Surgery e Charge and insert the battery into control unit Section 4B 3 e Connect the probe cable and gain module to control unit Section 4C 1 e Runa Peak Procedure Section 7A N2 5000 07 001 Rev O 30 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide Table 6C 1 Navigator 12 mm Probe Settings and Indicators for use with Tc99 just prior to surgery PN E X NOTE Keep control unit power off until all components are connected NOTE A peak procedure must be performed before using the probe in the first surgical procedure of the day see Section 7A NOTE Although the peak procedure is typically performed with no sterile drape around the probe and cable it 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 gain module settings are given in the table above NOTE Follow the instructions in Section 5 on Cleaning Disinfection and Sterile Use of Probe and Cable 6C 2 Dur
11. are made out of plastic and cannot be reused and must be disposed as standard disposables N2 5000 07 001 Rev 0 44 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 14 Limited Warranty Dilon Technologies Dilon warrants to its customers that subject to the below provisions the Navigator 2 0 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 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
12. by or on the order of a physician N2 5000 07 001 Rev 0 6 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide Table 1A Explanation of Symbols RX only Caution Federal USA law restricts this device Rx only to sale and use by or on the order of a physician Type CF Equipment Data Port 2 Cc 1 Attention consult Date of Manufacture Manufactured by ern O Consult instructions for use Temperature limitation accompanying documents Remote Count Control Humidity limitation In111 i r 511keV Serial numbe Isotope Control Calibrate Control RER Catalogue number HENe European Authorized Representative m H Batch code O N2 5000 07 001 Rev 0 7 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide Table 1A Explanation of Symbols Continued Battery Battery Power Level AN Caution High Voltage Acceptable shipping storage conditions 15 C to 40 C 40 C X WEEE Symbol EU only BS 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 interference 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
13. 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 N2 5000 07 001 Rev 0 8 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 2 System Overview and Components Control Unit Battery Navigator 2 0Control Unit den Navigator 2 bay Battery Charger and ED Zu BS Line Cord SC Ween Wireless Pilot Probe Battery T 14 mm Wireless Pilot Probe 14 mm Standard Sentinel Node Mapping rr Probe ege E 10 mm Daniel Lung Probe E eg 11 mm Superficial Head amp Neck Probe e Sen d em E m Sam en n Laparoscopic Probe 310 mmlong C O e Table 2A Probe Dimensions Wireless Pilot Probe 2558 14mm A 224mm 185g Standard Lymphatic Mapping Probes WAN 185 235 g 161g 195g 12mm Lymphatic Mapping Probe Superficial Head amp Neck Probe Daniel Lung Probe Laparoscopic Probes 10mm 467mm 195g 10mm 347mm 190g N2 5000 07 001 Rev 0 9 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 3
14. display returns to showing counts per second Isotope Indicator Indicates the isotope selected Isotopes detected on the Navigator 2 0 are 1125 511 keV for I 131 or FDG 18 In111 and Tc99 Range Settings Adjusts the audible pitch based on density of events detected 1x Low event rates all events are heard 10x Medium event rates 1 in 10 events are heard 100x High event rates 1 in 100 events are heard Pressing the Range button cycles through the ranges Select the one most useful to the procedure being performed NOTE Range selection only controls pitch of the sound generated by the unit it has no effect on count rates displayed or signal conditioning Threshold For CABLED PROBES only it controls the count range of photon energy detected by the probe When the Threshold is off the indicator is not illuminated and all photon energy including scattered photons is detected When the Threshold is on the indicator is illuminated In this setting the detection of scattered photons is reduced 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 NOTE The Threshold is normally on when using probes The Threshold may be set to off to count all events detected by a cabled probe The Wireless Pilot Probe features integrated threshold 13 Revised 7 22 2014 Navigator 2 0 User Manual a
15. 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 Technologies 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 N2 5000 07 001 Rev 0 45 Revised 7 22 2014
16. tab on side of battery positioned outward Use direction indicator arrow on battery label for guidance A N R gato Di S Shut the door of the battery port The door will click when closed properly 4B 2 Removing the Battery Open the door to the battery port located on the right side of the control unit To remove the battery pull the tab attached to the end of the battery w Navigator dr N2 5000 07 001 Rev O 17 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 4B 3 Charging the Battery Battery Charger Part N2 8000 02 Place the charger on a flat level surface away from sources of heat and moisture Plug the DC connector from the power supply into the back of the charger and connect the power supply to the mains AC using the cable supplied All of the LEDs will flash momentarily to indicate that power is present DC Connector g ez _ Calibration buttons Battery Bays gt LE TE 7 Status window Recharge Time Approximately 3 5 hours Place the battery into either battery bay ensuring that the 5 way connector is fully seated The battery should feel secure once inserted correctly The LEDs in the battery status window will provide charge status and the charger will automatically begin charging Each charge bay operates independently providing simultaneous charge of each battery inserted While there is a calibration button for each bay calibration
17. 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 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 3B Control Unit Battery and Charger During system use maintain electrical isolation of the patient Do not connect the probe cable if used 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 surface of a probe cable if used 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 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 probe drape the Top Gun Collimator and Navigator 2 0 cart 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 battery before use in the system Replace the wireless probe battery with a new battery on EACH day of use before the first surgical pro
18. al to event rate Upon completion of 10 second count device emits double beep sound Visual Indicators Control Unit Digital count Vacuum fluorescent display Single count LED Calibration check LED 10 second count LED Battery energy level LED Range 1X 10X 100X LED Isotope LED four Battery e Battery state of charge 4 LED s Wireless Pilot Probe e Probe connection LED e Isotope Indicator LED N2 5000 07 001 Rev 0 36 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide OE Energy Range 0 650 keV Operating Conditions Operating Temperature Range 15 C to 40 C 5 F to 104 F Storage Temperature 10 C to 85 C 15 F to 185 F Humidity 0 80 relative humidity Atmospheric Pressure 50 kPa to 106 kPa Control Unit Weight w Battery 95 99 across the dynamic range of the instrument with probes 9B System Accuracy The Navigator 2 0 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 occurrence 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 2 0 Device exhibits at least 95 accuracy across its dynamic range N2 5000 07 001 Rev 0 3 7 Revised 7 22 2014 Navigator
19. anual amp Service Guide 6 Probe Connectivity and Use 6A Navigator 2 0 with Wireless Pilot Probe The Wireless Pilot Probe is used in various procedures A typical sequence of setting up the Wireless Pilot Probe for a procedure with a Technetium 99m isotope such that may be used in a lymphatic mapping procedure for a sentinel node biopsy is as follows 6A 1 Before Surgery ge Insert a charged battery into control unit see Section 4B 1 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 Wireless Pilot Probe into a sterile drape e 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 N2 5000 07 001 Rev 0 25 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 2 Install 3V CR 2 lithium battery in Pilot Probe battery holder with positive end facing toward the base of the probe and negative end to
20. bration Check Mode rai ex Navigator Indicator ix ie ICE EC Range Button and Hke Indicators Si d Battery Charge k Status Yuma d Volume Knob Power Button Co Pilot Receptacle Signal Input Cable Port The control unit contains the display the battery and most of the system controls These system 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 viewable in the display as well as 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 N2 5000 07 001 Rev 0 12 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide Table 4A 1 Controls and Displays on the Front of the Control Unit 51ikeV In111 1X 10X 100X Range Threshold REA HS N2 5000 07 001 Rev 0 Power button Turns power on and off Volume knob Increases decreases the volume of the audible signal Display Screen When turned on displays the photon count per second Upon completion of a 10 second count the total number of photons detected will show on the display screen for 4 seconds and then the
21. cedure This system is not designed for use in an explosive atmosphere Keep the control unit off when changing connections between the probe cable control unit and gain module when used Control unit should also be off when inserting battery into Wireless Pilot Probe The control unit cables batteries charger and probes are sold non sterile 3C Probe DO NOT put any probe or probe cable in an autoclave 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 Remove probe battery before cleaning Wireless Pilot Probe DO NOT drop the probe 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 When using the 12mm probe DO NOT place it on or near a magnetic instrument pad 3C 1 Laparoscopic and Thoracoscopic Probe Use This User Service manual is designed to assist the use of the Navigator 2 0 system and is not a reference to surgical techniques For information on endoscopic procedures techniques complications and hazards please reference the following publications Surgical Laparoscopy Zuker KA ed St Louis MO 1991 and Endoscopic Surgery White RA Klein SR Mosby Year Book Inc St Louis MO 1991 This device is intended for use only as indicated I
22. ciprocal 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 24 amp 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 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 AS NZS 3200 1 0 Deviations to IEC 601 1 for Application in Australia and New Zealand CE CAUTION Federal USA law restricts this device to sale and use
23. e cap Try a different probe or contact Dilon not secure detector damaged Technologies for assistance 2 Spurious high Intermittent short in the cable Replace cable counts such as 80 000 counts a second when probe is held in air for example N2 5000 07 001 Rev 0 35 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 9 Specifications 9A Navigator 2 0 System Specifications The Navigator 2 0 system consists of the control unit one or more probes and the system accessories Table 9A 1 Navigator 2 0 System Specifications Description Control Unit Power Source Replaceable internal battery Battery Rechargeable Smart Lithium lon Battery 10 8V nominal voltage 8 7Ah nominal capacity 94Wh SOC state of charge indicator Approximate weight 470g New Battery Charge Life full Approximately 10 12 hours continuous use nominal charge Battery Recharge Cycle 100 300 full charge discharge cycles at room temperature and under discharge normal discharge rates Wireless Pilot Probe Power Source Battery Single use CR2 3 V Lithium capacity 1550 mAh Wireless Pilot Probe Transmission Up to 9 meters Distance Industry Standard Wireless 2 4 GHz Operating Frequency Fuse Control Unit UL CSA 198G standards 0 75 amp Glass housing 250 volt rating 5x20m IEC 127 standards Type 7 0 63 amp 250 volts 5x20m TO 63AL250V Sound Indicators Pitch variations Frequency proportion
24. eeeeeenteeeeeeteueteneeeeeeeeeeeeeeeeeees 17 ee 19 4D Optional Co Pilot Device Part GP 6801 00 cccescssscccescenscenscteestenseeuseeseseuseenseesceeesseusees 20 4E Useful Adjustments That Can Be Made During Procedures ssssssssssrrsessrrsrrrerrrsersersrreeserresersersee 22 5 Cleaning Disinfection and Sterile Use of Navigator Probes and Cables ss 23 SA Cleaning e 23 5B Radioactive Decontamination Procedure OPIIONAL sr 24 5C Cleaning Storing Control Unit amp Gain Module 24 6 Probe Connectivity and RH TE 25 DA Navigator 2 0 with Wireless Pilot Probe sise 25 6B Navigator 2 0 with Standard Lymphatic Mapping Probes Superficial Head amp Neck Probe Daniel Lung Probe and Laparoscopic Probes cccceeccseceseceecesecenccseceeuccseceneeuctseeeeeeenteucteeceseeeuetseceseeeeeeaaees 28 GC Navigator 2 0 with 12mm Lymphatic Mapping Probe Part N2 9001 12 30 7 Running the Peak Procedure 12mm Lymphatic Mapping Probe Only ccsscssssscceccescesccsscecceccess 32 ess lee ER AGB FO te EE ER N2 5000 07 001 Rev O 3 Revised 7 22 2014 www Dilon com Navigator 2 0 User Manual amp Service Guide Service Manual S MON e e CIN EE 34 d E eh dee Un CN 36 OA iNavigator 2 0 SVSteni SDeCINICATIONS EE 36 OB SYSTEM EEN 37 10 SUPPO ILCINS EE 38 10A Product Part INTO CS de nd R 38 OBS SCOTIA GR DSC A 38 11 Een Te 39 TIA EIERE dee Ee dee ee E ee dee 39 11B Verificati
25. ge to the probe WARNING No modification of this equipment is allowed Any modification to this will void any remaining warranty if attempted 11B Verification of Standard Gain Calibration Quick Test The Navigator 2 0 system is designed to minimize periodic maintenance such that would 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 11B 1 Verification of Standard Gain Calibration Quick Test Background Applies to the Wireless Pilot Probe WP 9000 14 Standard Lymphatic Mapping Probes SP 2A14 67 amp SP 2S14 67 Superficial Head amp Neck Probe SP 2S11 53 Laparoscopic Probes SP 2S10 19 and SP 2S10 31 and the Daniel Lung Probe SP 2S10 31D all Dilon Technologies CdTe probes Some institutions perform this Verification of Standard Gain 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 N2 5000 07 001 Rev O 39 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 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
26. hat location Probe B is ready for all surgical cases for the day N2 5000 07 001 Rev 0 33 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide SERVICE MANUAL 8 Troubleshooting With the exception of the Wireless Pilot Probe s battery holder no serviceable components are located inside the control unit or probes Contact your representative or Dilon Technologies for additional assistance if more detail is required Table 8A 1 Control Unit Only Settings and Indicators 1 Display is dark No Power switch is off Turn power on DOME ORNE Switch is broken Contact Dilon Technologies for assistance Unit may have been dropped Battery is dead Recharge battery or replace with new battery Fuse is blown or missing Replace fuse Damaged PCB board in Contact Dilon Technologies for assistance control unit 2 Incomplete digits in Display or display driver is Contact Dilon Technologies for assistance display damaged Unit may have been dropped Table 8A 2 Navigator 2 0 Control Unit with WIRELESS PILOT PROBE Settings and Indicators 1 Zero in display No No wireless connection Replace the probe battery signal under presence between probe and control of a radioactive unit source Verify that battery was inserted correctly into probe should face toward base of probe Isotope control is set to Change isotope control on back of incorrect isotope control unit to Tc 99
27. her than the battery itself Signal input port for cable connection The signal input port is not applicable when using the Wireless Pilot Probe with the Navigator 2 0 For the 12mm Lymphatic Mapping Probe connect the cable attached to the Gain Module here matching the arrows on the cable connector to the arrow above the signal input port See 3mm Diameter Cable in Section 4C for more information For all other cabled probes connect the probe cable here matching the arrow on the cable connector to the arrow above the signal input port See 6mm Diameter Cable in Section 4C for more information Connection port for the optional Co Pilot accessory See Optional Co Pilot Device in Section 4D for more information 14 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 4A 2 Control Unit Features Back Integrated Handle Scan Cal check Control Fuse Holder Isotope Control Pole Mount Connection Battery Compartment Door N2 5000 07 001 Rev O 15 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide Table 4A 2 Controls and Displays on the Back of the Control Unit The SCAN position is the only correct position when a probe is being used during a procedure When set to SCAN the CAL indicator on the front of the control unit will not illuminate For instructions on use of the 0 and positions see Verification of Standard Gain Calibration Quick Test
28. ich 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 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 Table 11B 2 System Configuration Cobalt 57 Alignment during Calibration Quick Test Probe Wireless Pilot Probe Probe LED ON Flashing Cabled Probe Cable connected to probe input CALIBRATE control rear panel gt 0 lt ISOTOPE control rear panel Technetium 99m owen 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 three calibration tests N2 5000 07 001 Rev O 40 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 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
29. in an energy window corresponding to the CENTERED gt 0 lt 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 gt 0 lt position as revealed by the highest count rate seen in the control unit s display The details of the test are given below 11B 2 Verification of Standard Gain Calibration Quick Test Procedure 1 Clean the PROBE and if used the CABLE 2 Charge the BATTERY and install it into the CONTROL UNIT 3 Place the system controls as indicated in Table 11B 2 System Configuration Cobalt 57 Alignment 4 Align a 57 Cobalt source directly with the probe tip Maintain this exact position between the source and the probe tip for the duration of the test Place the system controls as indicated in Table 11B 2 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 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 wh
30. ing Surgery CAUTION For intraoperative use insert probe and cable in a sterile drape e See Useful Adjustments that can be made During Procedures Section 4E 6C 3 After Surgery e See Cleaning Disinfection and Sterile Use of Probes and Probe Cables Section 5 N2 5000 07 001 Rev 0 31 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 7 Running the Peak Procedure 12mm Lymphatic Mapping Probe Only It is important to note that the 12mm Lymphatic Mapping Probe DOES NOT use the Calibration Verification Quick Test referenced later in section 11B instead the probe control unit configuration is brought to its highest sensitivity point via the Peak Procedure described below 7A Running a Peak Procedure A Peak Procedure finds the best sensitivity of a probe when paired with a control unit The setting on the gain module at which the probe counts the most events Adjusting the gain module dial increases decreases the count rate in the Navigator 2 0 Display Starting with the control unit turned on and the dial in the full counter clockwise position 0 the location on the gain module dial where the count rate reaches its maximum value is called the Peak Setting The system should then be left in this setting for any subsequent procedures that day The probe must be held in a fixed position with respect to an isotope source during a Peak Procedure This source can be eithe
31. ired upon return for service If the device cannot be repaired and or it is determined that its useful life is at an end contact Dilon Technologies for proper disposal of the unit Dilon Technologies 12050 Jefferson Avenue Suite 340 Newport News VA 23606 USA Phone 1 844 DILONNAV 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 protective bags or other protective wrapping upon return for repair 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 Dilon Technologies require that the 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 DilonProducts com or by contacting your distributor or Dilon Technologies directly N2 5000 07 001 Rev 0 43 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 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
32. is not necessary for use with the Navigator 2 0 If calibration button is inadvertently pressed either a flashing blue or solid blue light will illuminate Simply remove battery and reinsert in order to resume charge A green light will indicate that it is in charge mode If charger has flashing red light the battery fuel gauge requires calibration Only in this case should the calibration button be pressed Recalibration can take 10 13 hours If charger lights solid red please refer to troubleshooting guide Table 4B 4 Charge Bay LED Indications D r Lem Green Flashing Battery Charging Green Solid Battery Fully Charged Blue Flashing or Solid Calibration mode UNNECESSARY Do not use Red Flashing Battery fuel gauge in need of calibration NOTE Use only batteries supplied by Dilon Technologies The Dilon Technologies control unit battery has the proper dimensions and a key feature that holds it securely in the Navigator 2 0 control unit NOTE Approximately 3 5 hours are required to charge a completely drained battery Having a second fully charged battery available while the first battery is in use is recommended N2 5000 07 001 Rev 0 18 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide CAUTION Do not expose the charger or power supply to water or liquids the case is not sealed A Do not open the charger or power supply case no user serviceable parts are inside Do not cover the fan exhaust or obstruct
33. kewarm tap water 98 F to 105 F 36 5 C to 40 5 C for approximately1 minute Repeat rinse two additional times Air dry or dry with clean towel Flush the probe connector with 70 isopropyl or ethyl alcohol and then flush with air Ensure that the connector ends of the probe and cable are completely dry before storing N2 5000 07 001 Rev 0 23 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 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 2 Ensure that all recesses crevices and mating surfaces are clean 3 Dispose of pads and cleaning solution in approved containers 5C Cleaning Storing Control Unit amp 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 N2 5000 07 001 Rev 0 24 Revised 7 22 2014 Navigator 2 0 User M
34. lymphatic mapping probes straight or angled Superficial Head amp Neck Probe laparoscopic probes and the Daniel Lung Probe This cable has five receptacles inside the probe end and seven pins inside the plug that connect to the control unit The cable is approximately 6mm in diameter Connect the cable to the control unit matching the arrows on the cable connector to the arrow above the signal input port Volume The connector is a locking connector To disconnect the cable from the probe and from the control unit pull directly back on the hood DO NOT pull or twist on the jacket WARNING Do not pull or twist the jacket of the cable to remove from control unit You must pull on the hood at the end of the cable Pulling or twisting the jacket may damage the cable and render it unusable 4D Optional Co Pilot Device Part GP 6801 00 The optional Co Pilot is a single use device used for initiating counting periods and adjusting the audible range from the probe inside the sterile field It includes two small buttons and a long small diameter cable To plug in the Co Pilot match the spacing of the prongs with the spacing of the receptacles on the control unit It should then be clipped onto the base of the probe The Co Pilot is supplied sterile and may be used inside or outside of the sterile drape N2 5000 07 001 Rev O 20 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide R Button
35. mp Service Guide N2 5000 07 001 Rev 0 Count Initiates a 10 second photon count When Count has been pressed the count indicator on the display screen is illuminated and the display screen will show increasing counts Probe must be held in a fixed position for entire duration of 10 second count When the 10 seconds are complete the control unit beeps and the total count is shown in the display After displaying the total count for four seconds the display goes back to showing counts per second Cal check This light indicates when the system is in Calibration Check mode on the back of the unit The light will be illuminated when in any of the 3 calibration check settings and will not be illuminated when the system is set to the Scan mode The SCAN Calibrate Control must be set to the SCAN position only for all probes for all procedures In this mode the Cal light will be turned off See Verification of Standard Gain Calibration Quick Test in Section 11B for more information on Calibration The Battery indicator shows the charge status of the battery in use When the indicator level on the control unit is at 25 the battery should be replaced immediately with a fully charged battery Please note that the charge status on the control unit may differ from charge status reflected on the battery due to a higher power requirement on the control unit Refer to charge status on control unit rat
36. n a 10 second count keeping probe in fixed position each time The total Count is displayed for at least four seconds allowing time to record the total Press to turn on the control unit or to safely turn off the device Range The Range function defaults to 1X meaning that the audible signal fluctuates according to every single count it detects In the 10X position every 10 event produces an audible output In 100X only every 100 event produces an audible output The Range control only affects the sound The count shown in the display is N2 5000 07 001 Rev 0 22 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 5 Cleaning Disinfection and Sterile Use of Navigator Probes and Cables All probes and probe cables require cleaning and disinfecting immediately after use Follow these steps to ensure that cleaning and disinfection are done correctly e Before Use visually inspect probe and probe cable to ensure that it is free of contamination e Place probe and cable in a sterile drape while in use e After Use Clean Disinfect Store Probe and Probe Cable e Radioactive Decontamination Procedure OPTIONAL see section 50 CAUTION All Dilon probes and probe cables must be used inside a sterile drape The control unit gain module if used and battery charger are used outside of the sterile field Probes and probe cables should be cleaned and disinfected separately from the other components 5A Cleaning Probes
37. on of Standard Gain Calibration Quick Test 39 E FUSE Replacement Procedure EE 41 LR E A E A A A A A 43 De ag ln E 44 145 TALEO Mitel d EE 45 N2 5000 07 001 Rev 0 4 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide USER MANUAL 1 Introduction Description The Navigator 2 0 System detects gamma photons such as those produced by radioactive decay The Navigator 2 0 System is a portable battery powered system System use requires the Navigator 2 0 Control Unit which allows the user to adjust the system s settings and produces a variety of signal outputs The control unit is powered by battery The Control Unit is used with any of the following Navigator probe models The probes differ primarily in their size shape detector technology and connection to the control unit e 14mm Wireless Pilot Probe angled tip e 14mm Standard Lymphatic Mapping Probes angled tip amp straight tip e 12mm Lymphatic Mapping Probe angled tip e 11mm Superficial Head amp Neck Probe straight tip e 10mm Daniel Lung Probe straight tip e 10mm Laparoscopic Probes 310mm amp 190mm Lengths straight tips The system is supplied non sterile This manual includes guidelines for the use of the probes 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
38. prove reliability function or design Dilon Technologies may make improvements or changes in the products or programs described in this document at any time Navigator 2 0 is a trademark of Dilon Technologies 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 N2 5000 07 001 Rev 0 July 2014 N2 5000 07 001 Rev 0 2 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide User Manual Table of Contents L WINER O QU CHO EE 5 Bel eidel EE 5 PEN Eeer e 5 Jelli Ee e 5 Manufacture and DIS gl UT ON EE 5 EE EENEG 5 R p ulatorv and KEE ele He E EC 6 D A 6 Reciproc alim ee 6 Eege 6 2 System Overview and Components sccsccsccccccceccsccsccsccsccscecceccecceccscceccscescescecceccecceccecescesceccecceccecens 9 3 TU Tu CN 10 SEENEN 10 3B Control Unit Battery PETER ere 10 I ee 10 4 Control Unit Battery Cables and Co Pilot sccsccscceccesccsccscceccesccsccsccecceccescesccssceccescessessceccecceses 12 TE BE Control UNIT Features FO E 12 4A 2 Control Unit Features Back 15 AB Battery Part N2 8500 00 cccccecccseccseceeeceeneceeceecceeeceeecteneeenee
39. r a check source or the injection site or some other region of high activity of the patient Only the Navigator 12mm Lymphatic Mapping Probe requires a Peak Procedure because it is the only probe that uses the gain module The Peak Procedure should be performed on EACH day of use before the first surgical procedure Ec N gt e WY P y Fe 7 a i Above Example of a Peak Procedure using a Cobalt 57 check source N2 5000 07 001 Rev 0 32 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide Table 7A 1 Example Using and pairing multiple 12mm Sentinel Node Mapping Probes during one surgical day with the same control unit Probe A is going to be used on Monday for all surgical procedures scheduled on that day Peak Procedure is run on Probe A before the first surgical procedure of that day Probe A counts are highest when the Gain Module dial is set to about 4 5 The dial is left at that location Probe A is ready for all surgical cases for the day Probe A is dropped and damaged It cannot be used again until tested and or repaired The Surgical Team chooses to use Probe B for the rest of the case and for all others scheduled on that day A Peak Procedure is run on Probe B before the next case or before continuing the current surgical procedure to pair it with the control unit Probe B counts are highest when the Gain Module dial is set just above 6 The dial is left at t
40. 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 of Newport News VA Please direct all inquiries about the Navigator 2 0 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 N2 5000 07 001 Rev O 5 Revised 7 22 2014 www Dilon com Navigator 2 0 User Manual amp Service Guide Regulatory and Safety Requirements The Dilon Navigator GPS System including Probes and accessories complies with the following standards EC Directives EMC Directive 89 336 EEC Group Class B EN 55011 EMIC 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 re
41. s of abuse neglect or wear before each use and storage This includes checking the following components and these features Table 11A 1 Component Check Component Check Feature Check Control Unit Overall check Housing integrity of switches and integrity of connections Battery Charger Overall check Housing and integrity of connections Probe Wireless or cabled Overall check Also tip and connector Cable if used Each connector the connector pins and integrity of cable Gain Module if used Dial cable and connector e Should abnormalities be discovered contact your sales representative or Dilon Technologies directly e Do not use a damaged control unit battery battery charger probe cable or gain module 2 Check each battery for function and charge before use Should abnormalities be discovered contact your sales representative or customer support person 3 To ensure proper functionality follow each step as outlined in Section 4 Control unit Battery and Co Pilot and the section in the manual pertaining to the relevant probe 4 In addition to the above preventive maintenance suggests that every two years a new battery fuse and cable if used might be considered 5 User maintenance for the Wireless Pilot Probe is restricted to battery and battery cap replacement There are no user serviceable components or items on the Pilot Probe Do not attempt to repair damaged battery contacts or any other dama
42. t is not intended for use when endoscopic N2 5000 07 001 Rev 0 10 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide techniques are generally contraindicated Please reference Textbook of Laparoscopy Hulka JF Grunda and Stratton Inc Orlando FL 1985 o0p114 116 for information on absolute contraindications high risk patients and low risk patients e The use of the Navigator 2 0 system with laparoscopy should only be attempted where there is adequate visualization of the target tissue e 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 Endoscopic procedures should be performed only by physicians with adequate 1 training and familiarity with endoscopic techniques Medical literature should be consulted relative to techniques complications and hazards prior to the performance of endoscopic procedures N2 5000 07 001 Rev 0 11 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide 4 Control Unit Battery Cables and Co Pilot 4A 1 Control Unit Features Front Count Display 10 second Count Button and Indicator Threshold Control Isotope Indicators LS RL E Cali
43. the airflow this will cause overheating Place the charger in a cool spot away from external heat sources 4C Cables In addition to the Wireless Pilot Probe the Navigator 2 0 may also be used with cabled probes One of the following two cables is used depending on the wired probe selected 4C 1 3mm Diameter Cable Part PM 4000 20 and Gain Module Part PM 0400 40 The 12mm Lymphatic Mapping Probe uses a cable that has two conductors and an outside diameter of approximately 3mm It also uses a Gain Module pictured below which connects the control unit to the probe cable 1 Connect the 3mm Diameter Cable to the probe matching the red indicator dot on the probe to the red indicator dot on the cable 2 Connect the other end of the 3mm Diameter Cable to the gain module matching the red indicator dot on the cable to the gain module s cable input port 3 Connect the gain module to the control unit matching the arrows on the gain module cable connector to the arrow above the signal input port The gain module connector will click when it is seated properly N2 5000 07 001 Rev O 19 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide The connector has a locking mechanism To disconnect the cable from the probe and from the gain module pull directly back on the hood DO NOT pull or twist the connector jacket 4C 2 6mm Diameter Cable Part GP 4001 00 A different cable is used for the standard
44. ward the middle of the probe Incorrect placement of battery into battery holder for extended periods of time will cause battery to drain quickly 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 N2 5000 07 001 Rev O 26 Revised 7 22 2014 Navigator 2 0 User Manual amp Service Guide Table 6A 1 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 opt If no power upon ready to use the battery needs to be installed or replaced If battery has been replaced and LED light is still off contact your distributor or Dilon Technologies directly 6A 2 During Surgery e See Useful Adjustments that can be made During Procedures Section 4E NOTE For Technetium 99m Tc99 the control unit settings are given in the following table NOTE Follow the instructions in the section on Cleaning Disinfection and Sterile Use of Probe Section 5 Table 6A 2 Navigator 2 0 with Wireless Pilot Probe Settings amp Indicators just prior to surgery Control Indicator Controls back of Control Unit SCAN Calibrate Isotope Indicators front of the Control Unit Range Threshold Illuminated Display Isotope
Download Pdf Manuals
Related Search