Dilon 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/

User/Service Manual

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

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

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Navigator 2.0 User Manual & Service Guide

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

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Navigator 2.0 User Manual & Service Guide

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

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.

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

order of, a physician.

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

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Table 1A. Explanation of Symbols

Type-CF Equipment

Navigator 2.0 User Manual & Service Guide

RX only Caution: Federal (USA) law restricts this device to sale and use by, or on the order of, a physician.

Probe

Data Port

Eject

Attention, consult accompanying documents

Remote Count Control

Isotope Control

Date of Manufacture

Manufactured by

Consult instructions for use

Temperature limitation

Humidity limitation

Serial number

Calibrate Control

Fuse

Battery

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Catalogue number

European Authorized Representative

Batch code

Table 1A. Explanation of Symbols (Continued)

Navigator 2.0 User Manual & Service Guide

Battery Power Level

ON/OFF

Wireless Capability

Caution: High Voltage

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.

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Navigator 2.0 User Manual & Service Guide

Charger and

2. System Overview and Components

Control Unit Battery

2-bay Battery

Line Cord

Navigator 2.0 Control Unit

Wireless Pilot Probe

10 mm Daniel Lung Probe

Battery

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)

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

Wireless Pilot Probe 14mm 30 260mm 255g

Standard Lymphatic Mapping Probes

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

14mm 14mm

10mm

Tip Angle Length Weight

0 0

224mm 220mm

467mm 347mm

185g 185g

195g 190g

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Navigator 2.0 User Manual & Service Guide

power supply l

ine cord

, w

ireless

ilot probe

attery

, and probe cable.

manufacturer’s specification (0.75A).

CAUTION:

connected to a supply mains with protective earth

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

3. 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.

CAUTION: To avoid malfunction of the system, only the manufacturer’s approved replacement parts shall be used. This includes the manufacture’s approved

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

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 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.

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

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

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

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,

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CAUTION

Failure to comply, may result in poor performance of the 12mm probe.

CAUTION:

performance of endoscopic procedures.

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

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. 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 absolute contraindications, high-risk patients and low-risk patients.

· The use of the Navigator 2.0 system with laparoscopy should only be attempted where there is adequate visualization of the target tissue.

· 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.

Endoscopic procedures should be performed only by physicians with adequate training and familiarity with endoscopic techniques. Medical literature should be consulted relative to techniques, complications, and hazards, prior to the

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Range Button and

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

4A-1. Control Unit Features: Front

Count Display

Threshold Control

Isotope Indicators

Indicators

Volume Knob

Co-Pilot Receptacle

Signal Input (Cable Port)

10-second Count Button and

Indicator

Calibration –Check

Mode Indicator

Battery Charge

Status

Power Button

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.

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Table 4A-1. Controls and Displays on the Front of the Control Unit

Control Display Description

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 display returns to showing counts per second.

Isotope Indicator: Indicates the isotope selected. Isotopes detected on the Navigator 2.0 are I125, 511keV (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.

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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)

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Dilon Navigator 2.0 User & Service Manual

Specifications and Main Features

Frequently Asked Questions

User Manual