Dilon Navigator 2.0 Guide de dépannage

Gamma Detection system

Navigator 2.0

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/

Navigator 2.0 User Manual & Service Guide

141-00002-001 Rev 3 -2- Revised 10/16/2018

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 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

141-00002-001 Rev 3 / October, 2018

Navigator 2.0 User Manual & Service Guide

User Manual: Table of Contents

1. Introduction .......................................................................................................................................... 5

Description ............................................................................................................................................ 5

Intended Use ......................................................................................................................................... 5

Indications for Use................................................................................................................................. 5

Manufacture and Distribution................................................................................................................ 5

Trademarks............................................................................................................................................ 5

Regulatory and Safety Requirements ..................................................................................................... 6

2. System Overview and Components .................................................................................................... 13

3. Precautions ......................................................................................................................................... 14

3A. General.......................................................................................................................................... 14

3B. Control Unit, Battery, and Charger ................................................................................................. 14

3C. Probe............................................................................................................................................. 14

4. Control Unit, Battery, Cables, and Co-Pilot ......................................................................................... 15

4A-1. Control Unit Features: Front ....................................................................................................... 15

4A-2. Control Unit Features: Back ........................................................................................................ 18

4B. Battery (Part # N2-8500-00) ........................................................................................................... 19

4D. Optional Co-Pilot™Device (Part # GP-6801-00) .............................................................................. 21

4E. Useful Adjustments That Can Be Made During Procedures ............................................................. 23

5. Cleaning and Disinfection of Navigator Probes and Cables ................................................................. 24

5A. Cleaning Probes............................................................................................................................. 24

5B. Radioactive Decontamination Procedure –OPTIONAL.................................................................... 26

5C. Cleaning/Storing Control Unit & Gain Module ................................................................................ 26

6. Probe Connectivity and Use ................................................................................................................ 27

6A. Navigator 2.0 with Wireless Pilot Probe ......................................................................................... 27

7. Troubleshooting.................................................................................................................................. 30

8. Specifications ...................................................................................................................................... 32

8A. Navigator 2.0 System Specifications............................................................................................... 32

8B. Navigator 2.0 System Lifetime........................................................................................................ 33

Support Items ............................................................................................................................................. 34

10A. Product Part Numbers ................................................................................................................. 34

10B. Sterile Drape................................................................................................................................ 34

9. Maintenance....................................................................................................................................... 35

11A. Overview ..................................................................................................................................... 35

11B. Verification of Standard Gain (Calibration Quick Test) .................................................................. 35

11C. Fuse Replacement Procedure....................................................................................................... 37

Navigator 2.0 User Manual & Service Guide

Service Manual

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10. Repair.................................................................................................................................................. 38

11. Recycling ............................................................................................................................................. 39

12. Limited Warranty ................................................................................................................................ 40

Navigator 2.0 User Manual & Service Guide

Service Manual

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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 the following Navigator™probe models:

·14mm Wireless Pilot Probe™(angled tip)

·14mm Standard Lymphatic Mapping Probes (angled tip)

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 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™,

Dilon Technologies Navigator GPS™, Dilon Technologies Navigator™, Dilon Technologies Navigator 2.0™, and

Navigator™when used in context with the above.

Navigator 2.0 User Manual & Service Guide

Service Manual

141-00002-001 Rev 3 -6- Revised 10/16/2018

Regulatory and Safety Requirements

The Dilon Navigator 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

Service Manual

141-00002-001 Rev 3 -7- Revised 10/16/2018

CAUTION: Medical Electrical Equipment needs special precautions regarding EMC and

needs to be

installed and put into service according to the EMC information provided in

table 1, 2, 4 and 6.

CAUTION: Portable and Mobile RF Communications Equipment can affect Medical

Electrical

Equipment.

WARNING: The use of accessories, transducers and/or cables other than those specified,

with the

exception of those sold by the manufacturer as replacement parts for internal

components, may result

in increased emissions or decreased immunity of the equipment

or system

WARNING: The equipment or system should not be used adjacent to or stacked with

other equipment

and that if adjacent or stacked use is necessary, the equipment or

system should be observed to verify

normal operation in the configuration in which it will

be used

WARNING: The Control unit and Wireless probe may be interfered with by other equipment, even if

that other

equipment complies with CISPR Emissions requirements. See Specifications for frequency

range operation of the system.

Table 1 –Guidance and Manufacturer’s Declaration –Emissions

All ME

Equipment and ME Systems

EmissionsTest

Compliance

Electromagnetic Environment –Guidance

RF Emissions

CISPR 11 Group 1

The Navigator II uses RF energy only for its internal

function. Therefore, its RF emissions are very low and

are not likely to cause any interference in nearby

electronicequipment.

Guidance and Manufacturer’s Declaration - Emissions

The Navigator II is intended for use in the electromagnetic environment

specified below. The customer or user of the Navigator II should ensure that it is

used in such an environment.

Navigator 2.0 User Manual & Service Guide

Service Manual

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Table 2 –Guidance and Manufacturer’s Declaration –Immunity

All ME

Equipment and ME Systems

ImmunityTest

IEC 60601

Test Level

Compliance

Level Electromagnetic

Environment–

Guidance

ESD

IEC61000-4-2 ±6kV Contact

±8kV Air ±6kV Contact

±8kV Air Floors should be

wood, concrete or

ceramic tile. If floors

are synthetic, the r/h

should be at least

30%

PowerFrequency

50/60Hz

MagneticField

IEC61000-4-8

3A/m

Powerfrequency

magnetic fields should

be that of a typical

commercial or hospital

environment.

Guidance and Manufacturer’s Declaration –Immunity

The Navigator II is intended for use in the electromagnetic environment

specified below. The customer or user of the Navigator II should ensure that it is

used in such an environment.

Navigator 2.0 User Manual & Service Guide

Service Manual

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Table 4 –Guidance and Manufacturer’s Declaration –Immunity

Equipment and ME Systems that are NOT Life-supporting

ImmunityTest

IEC 60601Test Level

Compliance

Level Electromagnetic

Environment–

Guidance

RadiatedRF

IEC61000-4-3

3 V/m

80 MHz to 2.5 GHz

(E1)=3V/m

Portable andmobile

communications

equipment should be

separatedfrom the

Navigator II by no

less thanthe

distances

calculated/listed

below:

D=(3.5/V1)(SqrtP)

150kHzto 80MHz

D=(3.5/E1)(SqrtP)

80 to 800 MHz

D=(7/E1)(Sqrt P)

800 MHz to 2.5 GHz

where P is the max

power in watts and D

is the recommended

separation distance in

meters.

Field strengthsfrom

fixed transmitters, as

determined by an

electromagneticsite

survey, should beless

thanthe compliance

levels (V1 and E1).

Interferencemay

occur in the vicinity of

equipmentcontaining

atransmitter.

Guidance and Manufacturer’s Declaration –Immunity

The Navigator II is intended for use in the electromagnetic environment

specified below. The customer or user of the Navigator II should ensure that it is

used in such an environment.

Navigator 2.0 User Manual & Service Guide

Service Manual

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Table 6 –Recommended Separation Distances between portable and mobile RF

Communications

equipment and the Navigator II

ME Equipment and ME Systems that are NOT Life-supporting

Max Output Power

(Watts) Separation (m)

150kHzto 80MHz

D=(3.5/V1)(SqrtP)

Separation (m)

80 to 800MHz

D=(3.5/E1)(SqrtP)

Separation (m)

800MHzto 2.5GHz

D=(7/E1)(Sqrt P)

0.01

0.11667

0.23333

0.1

0.36894

0.73785

1.1667

2.3333

3.6894

7.3785

100

11.667

23.333

Recommended Separations Distances for the Navigator II

The Navigator II is intended for use in the electromagnetic environment in which

radiated disturbances are controlled. The customer or user of the Navigator II can

help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF Communications Equipment and the Navigator II

as recommended below, according to the maximum output power of the

communications equipment.

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