Navigator GPS System User and Service Manual April 2016

Navigator GPS™ System User Manual

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Navigator GPS™ System User Manual

User Manual 1.

Introduction ... 7 EC Directives ... 8 Reciprocal Interference... 8 Safety ... 8 Other ... 8

2.

System Overview and Components ... 11 2A. Navigator GPS™ System - Probe Modes ... 14

3.

Precautions ... 15

4.

Control Unit, PowerPak, and Co-Pilot ... 19 4A. Control Unit... 19 SCAN/Calibrate Control ... 25 Isotope Control ... 25

4B. PowerPak ... 26 Inserting the PowerPak... 26 Removing the PowerPak ... 27 Charging the PowerPak ... 27 Removing the PowerPak Clip ... 29

4C. Optional Co-Pilot Device ... 29 4D. Useful Adjustments That Can be Made During Procedures ... 32

5.

Gain Module and Peak Procedure ... 33 5A. Connecting the Gain Module to the Control Unit ... 33 Removing the Gain Module ... 34

5B. Connecting the Probe to the Gain Module ... 35 5C. Running a Peak Procedure ... 35 Dilon Navigator™ 12mm Probe - Technetium-99m isotope - Peak Procedure ... 36 Gamma-PET™ Probe - 511KeV pharmaceutical - Peak Procedure ... 37 Example - Peak Procedure/Peak Setting for Probe A ... 38 Example - Peak Procedure/Peak Setting for Probe B ... 39

6.

Probe Assembly and Use ... 41 6A. Dilon Navigator™ 12 mm Probe ... 42 6B. Gamma-PET™ Probe ... 44 6C. Standard Lymphatic Mapping Probe ... 46 6D. Straight Lymphatic Mapping Probe ... 48 6E. Superficial Head and Neck Probe ... 50 6F. Thoracic Probe ... 52 6G. Abdominal Probe ... 54 6H. Daniel-Probe™ ... 56

7.

Troubleshooting ... 61

8.

Specifications ... 63 8A. Navigator GPS™ Control Unit Specifications ... 63 8B. Product Life ... 64 8C. System Accuracy ... 64

9.

Support Items ... 65

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9A. Product Ordering Codes and Part Numbers... 66 9B. Sterile Drape... 67

10. Maintenance ... 69 10A. Peak Procedure and Verification of Standard Gain ... 69 Peak Procedure... 69 Verification of Standard Gain ... 70 Verification of Calibration Quick Test ... 70

11. Repair ... 73 12. Recycling ... 75 13. Limited Warranty ... 77

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User Manual

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Navigator GPS™ System User Manual

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1.

Introduction

Description The Navigator GPS™ System detects gamma photons, such as are produced by radioactive decay. The Navigator GPS™ System is a portable, battery powered system. System use requires the Navigator GPS™ Control Unit: The Control Unit allows the user to adjust the system's settings and produces a variety of signal outputs. The Control Unit is powered by the PowerPak (battery). •

Navigator GPS ™ Control Unit (“Control Unit”)

•

PowerPak and Charger

The Control Unit is used with any of eight Navigator™ probe models. The probes differ primarily in their shape, which the user may prefer for a particular procedure. •

Dilon Navigator™ 12 mm Probe

•

Gamma-PET™ Probe

•

Standard Lymphatic Mapping Probe (angled tip)

•

Straight Lymphatic Mapping Probe (straight tip)

•

Superficial Head and Neck Probe

•

Abdominal Probe

•

Thoracic Probe

•

Daniel-Probe™

The system is supplied non-sterile. This manual includes guidelines for the use of the Probe and Probe Cable in 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. Please direct all inquiries about the Navigator GPS™ System to Dilon Technologies.

Standards The Dilon Navigator GPS™ System including Probes and accessories complies with the following standards:

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Navigator GPS™ System User Manual

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 60601-1-1: 3rd Ed.

•

Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests – IEC 60601-1-2: 3rd Ed.

•

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

Other

The following are trademarks of Dilon Technologies, Inc.: Dilon Navigator™, Dilon Navigator GPS™, Navigator GPS™, Dilon Navigator™ 12 mm Probe, Gamma-PET™ Probe, Beta-PET™ Probe, Daniel-Probe™, and Navigator™ when used in context with the above. CAUTION Federal (USA) law restricts this device to sale and use by, or on the order of, a physician.

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Introduction

Explanation of Symbols

Table 1.

Symbols RX only

Type-CF Equipment

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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

PowerPak

Batch code

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Navigator GPS™ System User Manual

Table 1.

Symbols (Continued)

PowerPak Low

Caution: High Voltage

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

WEEE Symbol (EU only)

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2.

System Overview and Components Navigator GPS™ Control Unit PowerPak Charger

PowerPak

Gain Module

Probe Cable

DILON Navigator™ 12mm Probe

Navigator GPS™ Control Unit with Dilon Navigator™ 12 mm Probe The Navigator GPS™ Control Unit supports several Dilon Probe Models. The illustration shows each probe model available for use with the system. The Table gives probe model dimensions. Subsequent sections of this manual describe in detail probe and system use.

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PowerPak Charger Navigator GPS™ Control Unit

PowerPak

Probe Cable

Standard Lymphatic Mapping Probe

Navigator GPS™ Control Unit with Dilon Standard Lymphatic Mapping Probe

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System Overview and Components

Table 2.

Probe Dimensions

Probe

Tip Diameter

Tip Angle

Shaft Diameter

Shaft Length

Probe Length

Dilon Navigator™ 12 mm Probe

12mm

35

12mm

-

242mm

Gamma-PET™ Probe

22mm

0

14mm

-

157mm

Standard Lymphatic Mapping Probe

14mm

35

6mm

67mm

-

Straight Lymphatic Mapping Probe

14mm

0

6mm

67mm

-

Superficial Head and Neck Probe

11mm

0

6mm

53mm

-

Abdominal Probe

10mm

0

6mm

190mm

-

Thorascopic Probe

10mm

0

6mm

130mm

-

Daniel-Probe TM

10mm

30

6mm

190mm

-

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System Overview and Components

2A.

Navigator GPS™ System - Probe Modes

Dilon Navigator™ 12 mm Probe

Cable

Gain Module

Gamma-PET™ Probe

Standard Lymphatic Mapping Probe

Straight Lymphatic Mapping Probe

Superficial Head and Neck Probe DataPak

Abdominal Probe Cable

Thoracic Probe

Charger

Daniel-Probe™

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Navigator GPSTM System – Probe Modes

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3.

Precautions

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

Control Unit, PowerPak, and Charger •

During system use, maintain electrical isolation of the patient. Do not connect either the probe, the cable, 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 probe cable surface 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.

•

Do not defeat the electrical isolation between the control unit's external DATA PORT and the inside of the control unit. The external DATA PORT can be connected to earth ground. Electrical isolation between the DATA PORT and the internal circuit of the control unit maintains electrical isolation of 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 Gamma Probe drape, and a cart or stand.

•

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 PowerPak before use in the system.

•

This system is not designed for use in an explosive atmosphere.

•

Keep the Control Unit off when changing the PowerPak, and when changing connections between the Probe, Cable, Control Unit and Gain Module, if used.

•

The Control Unit, PowerPak, and Charger are non-sterile. Do not sterilize these components.

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Navigator GPSTM System User Manual

Probes Table 3.

Precautions DO NOT put the Probe or Probe Cable in an autoclave

DO NOT open the Probe. The Probe is tested and sealed at the factory. Attempting to open or opening the Probe may damage the Probe and will void the warranty.

DO NOT drop the Probe. DO NOT strike the Probe tip against a hard surface. The detector element may become damaged. The Probe may no longer be able to measure radiation. This may also void the warranty. DO NOT place probe on or near a magnetic instrument pad.

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Precautions

Laparoscopic and Thoracoscopic Probe Use •

This user and service manual is designed to assist the use of the Navigator™ system. This user/service manual is not a reference to surgical techniques. For information on endoscopic procedures, techniques, complications and hazards please see the books: Surgical Laparoscopy (Zuker KA ed. St. Louis MO 1991) and Endoscopic Surgery (White RA Klein SR, Mosby Year Book Inc. St Louis MO 1991). CAUTION Endoscopic procedures should be performed only by Physicians having adequate training and familiarity with endoscopic techniques in addition medical literature should be consulted relative to techniques, complications and hazards prior to the performance of endoscopic procedures.

Contraindications •

This device is intended for use only as indicated. It is not intended for use when endoscopic techniques are generally contraindicated. Please see the book: 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 GPS™ 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.

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4. 4A.

Control Unit, PowerPak, and Co-Pilot Control Unit Count Display

Isotope Indicator

10-second Count Button and Indicator

Threshold Button and Indicators

Calibrate Indicator

Low Battery Indicator

Range Button and Indicators

Volume Co-Pilot Receptacle

Signal Input

Power Button

The Control Unit contains the display, the PowerPak, and most of the controls. The 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 shown in the display and 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. GP-9200-96-001 R2 Revised 3/4/2016

Control Unit

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Navigator GPSTM System User Manual

Table 4.

Controls and Displays on the Front of the Control Unit

Control Display

Description

Power

Turns on power

Volume

Increases/decreases the volume of the audible signal

Display

The photon count/second is normally shown. At the end of a 10-second count, the total photons detected is shown, then the display returns to showing counts/second.

Isotope Indicator

Indicates the isotope selected.

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Control Unit

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