Navigator GPS System User and Service Manual Feb 2010

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 Navigator GPS™ System - Probe Modes ... 14

3. Precautions ... 15 4. Control Unit, PowerPak, and Co-Pilot... 19 Control Unit ... 19 SCAN/Calibrate Control ... 25 Isotope Control ... 25

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

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

5. Cleaning, Disinfection, and Sterile Use of Probes and Probe Cables ... 33 3 mm Diameter Cable ... 33 6 mm Diameter Cable ... 33

Clean/Disinfect Immediately Before Use ... 34 For RMD Navigator™ 12 mm Probe and Gamma-PET™ Probe only 36 Place Probe and Probe Cable in a Sterile Drape ... 37 Clean/Disinfect/Store Probe and Probe Cable Immediately After Use 37 Radioactive Decontamination Procedure – OPTIONAL ... 41

Clean/Store Control Unit/Gain Module ... 41

6. Gain Module and Peak Procedure... 43 Connecting the Gain Module to the Control Unit ... 43 Removing the Gain Module ... 44

Connecting the Probe to the Gain Module ... 45 Running a Peak Procedure ... 45 RMD Navigator™ 12 mm Probe - Technetium-99m isotope - Peak Procedure 46 Gamma-PET™ Probe - 511KeV pharmaceutical - Peak Procedure ... 47 Example - Peak Procedure/Peak Setting for Probe A ... 48 Example - Peak Procedure/Peak Setting for Probe B ... 49

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Navigator GPS™ System User Manual

7. Probe Assembly and Use... 51 RMD Navigator™ 12 mm Probe ... 52 Gamma-PET™ Probe ... 54 Standard Lymphatic Mapping Probe ... 56 Straight Lymphatic Mapping Probe ... 58 Superficial Head and Neck Probe ... 60 Thoracic Probe... 62 Abdominal Probe... 64 Daniel-Probe™... 66

Service Manual 8. Troubleshooting... 71 9. Specifications... 73 Navigator GPS™ Control Unit Specifications ... 73 Product Life ... 74 System Accuracy ... 74

10. Support Items... 75 Product Ordering Codes and Part Numbers ... 76 Sterile Drape ... 77

11. Maintenance ... 79 Peak Procedure and Verification of Standard Gain ... 79 Peak Procedure ... 79 Verification of Standard Gain ... 80 Verification of Calibration Quick Test ... 80

12. Repair... 83 13. Limited Warranty... 85

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GP-9200-96EN

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. • • • • • • • •

RMD 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 RMD Instruments Corp. Please direct all inquiries about the Navigator GPS™ System to RMD Instruments Corp. Standards The RMD 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 EN 60601-1-2: 1993 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 – EN 60601-1-1:2004 Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests – EN 60601-1-2:2004 Safety

Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: Safety Requirements For Medical Electrical Systems – EN 60601-1-1:2004 Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests – EN 60601-1-2:2004 Medical Electrical Equipment - Part 1-6: General Requirements For Safety - Collateral Standard: Usability - EN 60601-1-6:2009 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. 601.1 -M90, "Medical Electrical Equipment, Part 1: General Requirements for Safety, including C22.2 NO. 601.IS1-94 (IEC601-1, Amendment 1:1991) Supplement No. 194 to CAN/CSA 22.2 No. 601-1-M90" AS/NZS 3200-1-0, Deviations to IEC 601-1 for Application in Australia and New Zealand Other

The following are trademarks of RMD Instruments Corp.: RMD Navigator™, RMD Navigator GPS™, Navigator GPS™, RMD 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

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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

Power Pak

Batch code

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Navigator GPS™ System User Manual Table 1. Symbols (Continued)

Power Pak Low

Caution: High Voltage

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

System conforms with CE standards. The manufacturer's registration number is located on the control unit.

Document: GP-9200-96EN

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GP-9200-96EN

2. System Overview and Components

PowerPak Charger

Navigator GPS™ Control Unit

PowerPak

Gain Module Probe Cable

RMD Navigator™ 12 mm Probe

Navigator GPS™ Control Unit with RMD Navigator™ 12 mm Probe The Navigator GPS™ Control Unit supports several RMD 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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Navigator GPS™ System User Manual

PowerPak Charger Navigator GPS™ Control Unit

PowerPak

Probe Cable

Standard Lymphatic Mapping Probe

Navigator GPS™ Control Unit with 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

RMD 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

10mm

30

6mm

190mm

-

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System Overview and Components

2A.

Navigator GPS™ System - Probe Modes

12mm

Gamma-PET

Cable

Gain Module

Standard Lymphatic Mapping

Straight Lymphatic Mapping PowerPak Superficial Head and Neck

Abdominal Cable Thoracic Charger Daniel

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Navigator GPS™ 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 CoPilot 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 GPS™ 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. Control Unit, PowerPak, and Co-Pilot 4A.

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.

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Navigator GPS™ System User Manual

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

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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.

Control Unit

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Control Unit, PowerPak, and Co-Pilot Table 4. Controls and Displays on the Front of the Control Unit (Continued) Control Display

Description

Range

Controls when the audible pitch is heard: 1X – low event rates 10X – medium event rates 100X – high event rates Pressing the Range button cycles through the ranges; select the one most useful to the procedure being performed.

NOTE:Range Selection only controls the pitch of the sound generated by the unit. Range selection and the corresponding indicators have no effect on count rates or signal conditioning. Range Selection has no impact on the performance or counts displayed by the unit. Threshold

Controls the range of the photon energy detected by the Probe. When the Threshold is off, all photon energy, including scattered photons, are detected. The indicator is not illuminated. When the Threshold is on the detection of the 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. The indicator is illuminated.

NOTE:The Threshold is normally on when using Probes. The Threshold may be set to off to count all events seen by a Probe. Count

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Starts a 10-second photon count. When Count has been pressed, the Count indicator is illuminated. When the 10 seconds is complete the Control Unit beeps and the total count is shown in the display for four seconds. After giving the total count, the Display goes back to showing counts per second.

Control Unit

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Navigator GPS™ System User Manual Table 4. Controls and Displays on the Front of the Control Unit (Continued) Control Display

Description

Cal

Probes are used with the SCAN/Calibrate Control in the SCAN position only. The Calibrate Indicator blinks when the SCAN/Calibrate Control is in any position other than SCAN.

NOTE:The SCAN/Calibrate Control should be to SCAN for all uses of all Probes. The SCAN position is the only correct setting, and when the SCAN/ Calibrate Control is set to SCAN indicator is not illuminated. See “Peak Procedure and Verification of Standard Gain” on page 79 for more information.

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Low PowerPak

Blinks when the PowerPak charge has only 30 minutes of useful charge remaining. Will change to a solid light before the useful charge is exhausted. See “PowerPak” on page 26 for more information.

Signal Input

Signal Input For the RMD Navigator™ 12 mm Probe and the Gamma-PET™ Probe, connect the Gain Module here. See “Connecting the Gain Module to the Control Unit” on page 43 for more information. For Standard Lymphatic Mapping probe, and similar probes, connect the Probe Cable here. See See “6 mm Diameter Cable” on page 33 for more information.

Co-Pilot

Connection for the Co-Pilot accessory. See “Optional Co-Pilot Device” on page 29 for more information.

Control Unit

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Control Unit, PowerPak, and Co-Pilot

Isotope Selector Data Port

Scan/Calibrate Control

Fuse

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Control Unit

Manufacturer’s Serial Number Label

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