Dilon Navigator 2.0 Troubleshooting guide

User/Service Manual

Manufactured by: Authorized 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/

N2-5000-07-001 Rev 7 -2- Revised 10/16/2018

www.Dilon.com

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 manual applies to white and purple colored Navigator 2.0 systems. The images of both systems

are used interchangeably.

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 improve reliability, function, or design. Dilon

Technologies may make improvements or changes in the products or programs described in this

document at any time.

Navigator 2.0TM is a trademark of Dilon Technologies.

Other trademarks and trade names are those of their respective owners.

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 7 / October 2018

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

Navigator 2.0 User Manual & Service Guide

N2-5000-07-001 Rev 7 -5- Revised 10/16/2018

www.Dilon.com

USER MANUAL

1. Introduction

Operating Principle

The Navigator 2.0 System detects presence of gamma rays, emitted from radioactive isotopes in

body organs or tissue. 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 system provides an increasing or decreasing sound and visual counts that vary as

level of gamma radiation increases or decreases.

The control unit works in conjunction with a hand-held probe that is connected to the control unit

either via a cable or wireless technology. Detecting gamma radiation with a hand-held probe is

based on nuclear physics laws which allow detection of radiation emitted from a small source.

Placing probe close to a radioactive site increases number of counts detection and localization

occurs. Excision of the region of interest is then performed using standard surgical technique. On

the other hand, as the distance between the probe and the radiation source is increased, the sound

signal and number of counts decrease.

The control unit is used with any of the following Navigator™hand-held probe 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 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 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.

The year of manufacture on the control unit are indicated in the first four numbers of the serial

number. The year of manufacture on the probe are indicated in the last two numbers of the serial

numbers.

Navigator 2.0 User Manual & Service Guide

N2-5000-07-001 Rev 7 -6- Revised 10/16/2018

www.Dilon.com

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.

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 l, Class B

EN 55011

EMC Directive 89/336/EEC

IEC 60601-1-2: 3rd 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:

•Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral

Standard: Safety Requirements For Medical Electrical Systems –IEC 60601-1-1: 3rd Ed.

•Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral

Standard: Electromagnetic Compatibility - Requirements and Tests –IEC 60601-1-2: 3rd Ed.

Safety

•Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral

Standard: Safety Requirements For Medical Electrical Systems –IEC 60601-1: 2nd & 3rd Ed.

•Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral

Standard: Electromagnetic Compatibility - Requirements and Tests –IEC 60601-1-2: 3rd Ed.

•Medical Electrical Equipment - Part 1-6: General Requirements For Safety - Collateral

Standard: Usability - IEC 60601-1-6: 3rd Ed.

•Information supplied by the manufacturer of medical devices- EN 1041:2008

•Symbols for use in the labeling of medical devices - EN 980 :2008

•CAN/CSA C22.2 No. 60601-1, "Medical Electrical Equipment, Part 1: General Requirements

for Safety & Essential Performance; issued 2008-02-01 Ed. 2

•AS/NZS 3200-1-0, Deviations to IEC 601-1 for Application in Australia and New Zealand

CAUTION: Federal (USA) law restricts this device to sale and use by, or on the

order of, a physician.

Navigator 2.0 User Manual & Service Guide

N2-5000-07-001 Rev 7 -7- Revised 10/16/2018

www.Dilon.com

Table 1A. Explanation of Symbols

Type-CF Equipment

RX only Caution: Federal

(USA) law restricts this device

to sale and use by, or on the

order of, a physician.

Probe Date of Manufacture

Data Port Manufactured by

Eject

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

Navigator 2.0 User Manual & Service Guide

N2-5000-07-001 Rev 7 -8- Revised 10/16/2018

www.Dilon.com

Table 1A. Explanation of Symbols (Continued)

Battery Power Level Caution: High Voltage

ON/OFF

Wireless Capability

Acceptable shipping conditions: -15° C to 40° C

WEEE Symbol (EU only)

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 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’interférences, et (2) cet appareil doit accepter toute interférence, y compris les

interferences qui peuvent causer un mauvais fonctionnement de l’appareil.

Navigator 2.0 User Manual & Service Guide

N2-5000-07-001 Rev 7 -9- Revised 10/16/2018

www.Dilon.com

2. System Overview and Components

Probes are Type CF Applied Parts. See Table 2A below for a list of Probes.

Table 2A. Type CF Applied Parts and Probe Dimensions.

Probe Tip

Diameter Tip Angle Length Weight

Wireless Pilot Probe 14mm 30 260mm 255g

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 mm Wireless Pilot Probe

14 mm Standard Sentinel Node Mapping

Probe

11 mm Superficial Head & Neck Probe

10 mm Laparoscopic Probe (310 mm long)

Navigator 2.0 User Manual & Service Guide

N2-5000-07-001 Rev 7 -10- Revised 10/16/2018

www.Dilon.com

3. Precautions

3A. General

·The output of this system is not to be considered a diagnostic measureof 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.

CAUTION: To avoid malfunction of the system, only the manufacturer’s approved

replacement parts shall be used. This includes the manufacture’s approved

replacement parts such as the fuse, control unit battery, 2-bay battery charger,

power supply l

ine

ord

, w

ireless

ilot

robe

attery

, and probe cable.

CAUTION: To avoid fire hazard, do not insert a fuse with higher rating than the

manufacturer’s specification (0.75A).

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.

·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

electricalisolation from earth ground. Theoptional 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 procedure.

·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.

CAUTION:

To avoid the risk of electric shock, the battery charger cord must only be

connected to a supply mains with protective earth

CAUTION: To avoid malfunction of the system, no components are to be serviced

while the system is in use with a patient. Service activity includes changing batteries,

changing fuse, inspecting the probe or cable, and cleaning the probe or cable.

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