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Navigator 2.0 User Manual & Service Guide 

 

N2-5000-07-001 Rev 7 

-

3-

 

Revised 10/16/2018 

 

www.Dilon.com

 

User Manual: Table of Contents

 

1.

 

Introduction

 ........................................................................................................................................ 5 

Operating Principle

 ............................................................................................................................. 5 

Intended Use

 ....................................................................................................................................... 5 

Indications for Use

 .............................................................................................................................. 5 

Manufacture and Distribution

 ............................................................................................................. 5 

Trademarks

 .......................................................................................................................................... 6 

Regulatory and Safety Requirements

 ............................................................................................... 6 

2.

 

System Overview and Components

 .............................................................................................. 9 

3.

 

Precautions

 ...................................................................................................................................... 10 

3A. General

........................................................................................................................................ 10 

3B. Control Unit, Battery, and Charger

 ........................................................................................... 10 

3C. Probe

 ........................................................................................................................................... 11 

4.

 

Control Unit, Battery, Cables, and Co-Pilot

 ............................................................................... 12 

4A-1. Control Unit Features: Front

 .................................................................................................. 12 

4A-2. Control Unit Features: Back

 ................................................................................................... 15 

4B. Battery (Part # N2-8500-00)

 ...................................................................................................... 17 

4C. Cables

 ......................................................................................................................................... 19 

4D. Optional Co-Pilot

™ Device (Part # GP-6801-00)

 .................................................................... 21 

4E. Useful Adjustments That Can Be Made During Procedures

 .................................................. 22 

5.

 

Probe Connectivity and Use

 ......................................................................................................... 23 

6A. Navigator 2.0 with Wireless Pilot Probe

 ................................................................................... 23 

6B. Navigator 2.0 with Standard Lymphatic Mapping Probes, Superficial Head & Neck Probe, 
Daniel Lung Probe, and Laparoscopic Probes

 ............................................................................... 25 

6C. Navigator 2.0 with 12mm Lymphatic Mapping Probe (Part # N2-9001-12)

 .......................... 28 

6.

 

Running the Peak Procedure: 12mm Lymphatic Mapping Probe Only

 ................................ 30 

7A. Running a Peak Procedure

 ....................................................................................................... 30 

7.

 

Troubleshooting

 .............................................................................................................................. 32 

8.

 

Specifications

 .................................................................................................................................. 34 

9A. Navigator 2.0 System Specifications

 ........................................................................................ 34 

9B. System Accuracy

 ........................................................................................................................ 35 

9.

 

Support Items

 .................................................................................................................................. 36 

10A. Product Part Numbers

 ............................................................................................................. 36 

10B. Sterile Drape

 ............................................................................................................................. 36 

10.

 

Maintenance

 ..................................................................................................................................... 37 

11A. Overview

 ................................................................................................................................... 37 

11B. Verification of Standard Gain (Calibration Quick Test)

 ......................................................... 37 

11C. Fuse Replacement Procedure

 ................................................................................................ 39 

11.

 

Repair

 ................................................................................................................................................ 41 

12.

 

Recycling

 .......................................................................................................................................... 42 

13.

 

Limited Warranty

 ............................................................................................................................. 43 

 

 

Summary of Contents for Navigator 2.0

Page 1: ...thorized European Representative Dilon Technologies Inc AG Medical 12050 Jefferson Avenue Route de l Orme Suite 340 Parc des Algorithmes Imm Homère Newport News VA 23606 91190 Saint Aubin USA France Phone 1 844 DILONNAV http ag medical com ...

Page 2: ...nty of any kind implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose Dilon Technologies has taken care to ensure the accuracy of this document However Dilon Technologies assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability f...

Page 3: ...6801 00 21 4E Useful Adjustments That Can Be Made During Procedures 22 5 Probe Connectivity and Use 23 6A Navigator 2 0 with Wireless Pilot Probe 23 6B Navigator 2 0 with Standard Lymphatic Mapping Probes Superficial Head Neck Probe Daniel Lung Probe and Laparoscopic Probes 25 6C Navigator 2 0 with 12mm Lymphatic Mapping Probe Part N2 9001 12 28 6 Running the Peak Procedure 12mm Lymphatic Mapping ...

Page 4: ......

Page 5: ...obe models The probes differ primarily in their size shape detector technology and connection to the control unit 14mm Wireless Pilot Probe angled tip 14mm Standard Lymphatic Mapping Probes angled tip straight tip 12 mm Lymphatic Mapping Probe angled tip 11mm Superficial Head Neck Probe straight tip 10mm Daniel Lung Probe straight tip 10mm Laparoscopic Probes 310mm 190mm Lengths straight tips The ...

Page 6: ...uipment Part 1 General requirements For Safety 1 Collateral Standard Safety Requirements For Medical Electrical Systems IEC 60601 1 1 3rd Ed Medical Electrical Equipment Part 1 General Requirements For Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 3rd Ed Safety Medical Electrical Equipment Part 1 General requirements For Safety 1 Collateral Standard ...

Page 7: ...icts this device to sale and use by or on the order of a physician Probe Date of Manufacture Data Port Manufactured by Eject or Consult instructions for use Attention consult accompanying documents Temperature limitation Remote Count Control Humidity limitation Isotope Control Serial number Calibrate Control Catalogue number Fuse European Authorized Representative Battery Batch code ...

Page 8: ...ved including interference that may cause undesired operation IC statements This device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 This device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Cet appareil est conforme avec Industri...

Page 9: ... Standard Lymphatic Mapping Probes 14mm 14mm 0 35 224mm 220mm 185g 185g 12mm Lymphatic Mapping Probe 12mm 35 242mm 235 g Superficial Head Neck Probe 11mm 0 207mm 161g Daniel Lung Probe 10mm 30 465mm 195g Laparoscopic Probes 10mm 10mm 0 0 467mm 347mm 195g 190g Control Unit Battery 2 bay Battery Charger and Line Cord Wireless Pilot Probe Battery Navigator 2 0 Control Unit 10 mm Daniel Lung Probe 14 ...

Page 10: ...er circuit inside the control unit the conductors inside the probe cable the probe surface and the patient The Line Cord of the 2 bay battery charger is used as the disconnect device for the charger 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 Gu...

Page 11: ...owing 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 It is not intended for use when endoscopic techniques are generally contraindicated Please reference Textbook of Laparoscopy Hulka JF Grunda and Stratton Inc Orlando FL 1985 op114 116 for information on ...

Page 12: ...s 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 Count Display 10...

Page 13: ... 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 en...

Page 14: ...ed off See Verification of Standard Gain Calibration Quick Test 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 batt...

Page 15: ...nual Service Guide N2 5000 07 001 Rev 7 15 Revised 10 16 2018 www Dilon com 4A 2 Control Unit Features Back Integrated Handle Scan Cal check Control Isotope Control Battery Compartment Door Fuse Holder Pole Mount Connection ...

Page 16: ...in the SCAN Position During the calibration verification procedure this control uses the remaining three settings 0 and NOTE See Verification of Standard Gain Calibration Quick Test for information on calibration verification NOTE If 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 th...

Page 17: ...d battery with the battery label facing toward the rear of the unit with battery contacts inward and tab on side of battery positioned outward Use direction indicator arrow on battery label for guidance 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 ba...

Page 18: ...ion button for each bay calibration 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...

Page 19: ...so 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 th...

Page 20: ...ung 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 The connector is a locking connector To disconnect the cable from the probe and from the control unit pull d...

Page 21: ...he probe The Co Pilot is supplied sterile and may be used inside or outside of the sterile drape 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 operate...

Page 22: ...e features integrated threshold 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 10th event produces an audible output In 100X only every 100th event produces an audible output The Range control only affects the sound The count shown in the display is independent of the range setting 10 Second Co...

Page 23: ... probe may need to be lightly shaken to activate LED in probe base LED on the Pilot Probe indicates that it is linked with control unit and ready for use When the Control Unit is turned off the Probe s LED will turn off within seconds of being placed in a resting position When the Control Unit is turned on the Pilot Probe will instantly power up when moved It is now ready for use For intraoperativ...

Page 24: ... toward the base of the probe and negative end toward the middle of the probe Incorrect placement of battery into battery holder for extended periods of time will cause battery to drain 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 ...

Page 25: ...ring Surgery See Useful Adjustments that can be made During Procedures NOTE For Technetium 99m Tc99 the control unit settings are given in the following table NOTE Follow the instructions on Cleaning Disinfection and Sterile Use of Probe Dilon doc 141 00005 Table 6A 2 Navigator 2 0 with Wireless Pilot Probe Settings Indicators just prior to surgery Control Indicator Setting Controls back of Contro...

Page 26: ...ical 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 See Cleaning Disinfection and Sterile Use of Probes and Cables Dilon doc 141 00005 Insert a fully charged battery ...

Page 27: ...s 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 techniques with specific regard to target organ geometry to assure probe access to the target organ Please reference ...

Page 28: ... 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 Charge and insert the battery into control unit Connect the probe cable and gain module to control unit Run a Peak Procedure Navigator 2 0 Control Unit Gain Module Cable for 12 mm Lymphatic Mapping Probe 12 mm Lymphatic Mapping Probe ...

Page 29: ...rmed before using the probe in the first surgical procedure of the day 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 on C...

Page 30: ...splay 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 T...

Page 31: ... 4 5 The dial is left at that location 4 Probe A is ready for all surgical cases for the day 5 Probe A is dropped and damaged It cannot be used again until tested and or repaired 6 The Surgical Team chooses to use Probe B for the rest of the case and for all others scheduled on that day 7 A Peak Procedure is run on Probe B before the next case or before continuing the current surgical procedure to...

Page 32: ...es for assistance 2 Incomplete digits in display Display or display driver is damaged Unit may have been dropped Contact Dilon Technologies for assistance Table 8A 2 Navigator 2 0 Control Unit with WIRELESS PILOT PROBE Settings and Indicators Problem Possible Causes Remedies 1 Zero in display No signal under presence of a radioactive source No wireless connection between probe and control unit Rep...

Page 33: ... No signal under presence of a radioactive source No connection between probe cable gain module if present and control unit Check that all connections are secure Isotope control is set to incorrect isotope Change Isotope Control on back of control unit to Tc 99 Gain module if used is set to zero Run Peak Procedure Sec 7A There is an open circuit in the probe cable Replace cable Circuit inside the ...

Page 34: ...rge discharge cycles at room temperature and under normal discharge rates Wireless Pilot Probe Power Source Battery Single use CR2 3 V Lithium capacity 750 850 mAh Wireless Pilot Probe Transmission Distance Up to 9 meters Industry Standard Wireless Operating Frequency 2 4 GHz Fuse Control Unit UL CSA 198G standards 0 75 amp Glass housing 250 volt rating 5x20m IEC 127 standards Type 7 0 75 amp 250 ...

Page 35: ...ay Control Unit Dimensions 20cm W x 24cm H x 12cm D Control Unit Weight w Battery 2 0kg Accuracy 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 th...

Page 36: ... Clamps N2 8800 00 6mm Diameter Cable for CdTe Probes GP 4001 00 3mm Diameter Cable for 12mm Lymphatic Mapping Probe PM 4000 20 Optional Storm Case for travel and storage N2 8000 07 Gain Module for 12mm Probe PM 4000 40 Optional Top Gun Collimator SP 1800 00 End Cap for Wireless Pilot Probe pack of 10 WP 2000 10 Battery Holder for Wireless Pilot Probe pack of 5 WP 9050 00 Optional Co Pilot Devices...

Page 37: ... 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 ...

Page 38: ...te Control in the CENTERED position which is indicated by the following symbol on the SCAN Calibrate Control 0 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 AB...

Page 39: ...trol 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 calibration assurance 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...

Page 40: ...Navigator 2 0 User Manual Service Guide N2 5000 07 001 Rev 7 40 Revised 10 16 2018 www Dilon com 4 Press in and twist the fuse holder cap clockwise to lock it in place ...

Page 41: ...s useful life is at an end contact Dilon Technologies for proper disposal of the unit 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...

Page 42: ...evice 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 ...

Page 43: ...o any damage as a result of an accident or abuse or that has not been used and maintained in accordance with the information contained in the literature accompanying the product or that has been modified repaired or serviced by any person or company other than Dilon or its authorized representative Dilon s sole liability for any defective product shall be repaired or replaced as set forth above Di...

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