Dilon Navigator 2.0 User and Service Manual Rev 12 May 2022

Navigator 2.0 User Manual and Service Guide Important Notes 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. Copyright Notice Copyright 2022 Dilon Technologies, Newport News, VA 23606 United States of America. 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 12 / 12May2022

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User Manual: Table of Contents 1

2 3

4

5 6 7

8 9 10 11 12

13 14 15

Introduction ...3 1.1 Operating Principle ... 3 1.2 Intended Use ... 3 1.3 Indications for Use ... 3 1.4 Manufacture and Distribution ... 3 1.5 Trademarks ... 4 1.6 Regulatory and Safety Requirements ... 4 System Overview and Components ...6 Precautions ...7 3.1 General ... 7 3.2 Control Unit, Battery, and Charger ... 7 3.3 Probe ... 8 3.4 Electromagnetic Compatibility IEC 60601-1-2:2014 ... 8 3.5 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ... 9 3.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ... 9 Control Unit, Battery, and Cable ...13 4.1 Control Unit Features: Front ... 13 4.2 Control Unit Features: Rear ... 16 4.3 Battery (Part # N2-8500-02) ... 18 4.4 Installing the Wireless Pilot Probe Battery ... 19 4.5 Charging the Battery (Battery Charger Part # N2-8000-02) ... 20 4.6 Table 4B-4. Charge Bay LED Indications ... 20 4.7 Flexible Probe Cable (Part # GP-4001-00) ... 21 4.8 Useful Adjustments That Can Be Made During Procedures ... 22 4.9 Alarm Mode Indications ... 23 Probe Connectivity and Use ...24 5.1 Navigator 2.0 with Wireless Pilot Probe ... 24 5.2 Navigator 2.0 with Cabled Probes... 25 Control Unit Cleaning ...28 Probe and Cable Cleaning ...28 7.1 PREPARATION STEPS: ... 29 7.2 Sterilization of Navigator Gamma Probes ... 30 7.3 Navigator Gamma Probes Used in Non-Critical Environments:... 32 Specifications...33 8.1 Navigator 2.0 System Specifications ... 33 Accessories ...34 Navigator 2.0 to 2.0 System Upgrade ...35 Troubleshooting ...35 Maintenance ...38 12.1 Overview ... 38 12.2 Verification of Standard Gain (Calibration Quick Test) ... 39 12.3 Navigator Control Unit Fuse Replacement ... 41 Repair...43 Disposal ...44 Limited Warranty ...44

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USER MANUAL 1

1.1

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 a rechargeable battery. The system provides an increasing or decreasing sound and visual counts that vary as the 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. Placing the probe close to a radiation source increases the number of counts detected and localization occurs. As the distance between the probe and the radiation source increases, the number of gamma rays detected decreases. The Navigator 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 & straight tip)

•

14mm Standard Lymphatic Mapping Probes (angled tip & straight tip)

•

11mm Superficial Head & Neck Probe (straight tip)

•

10mm Daniel Lung Probe™ (angled 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. 1.2

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.

1.3

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.

1.4

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.

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Trademarks The following are trademarks of Dilon Technologies: Navigator 2.0™, Wireless Pilot Probe™, Dilon Navigator™, , Dilon Technologies Navigator™, Dilon Technologies Navigator 2.0™, Daniel Lung Probe™, and Navigator™ when used in context with the above.

1.6

Regulatory and Safety Requirements The Dilon Navigator 2.0™ System including Probes 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: 3Ed: Amendment 1. Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility – IEC 60601-1-2: 4th Ed.

Safety •

Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: Safety Requirements For Medical Electrical Systems – IEC 60601-1: 3rd and 4th Ed.

•

Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests – IEC 60601-1-2: 3rd and 4th edition.

•

Medical Electrical Equipment - Part 1-6: General Requirements For Safety - Collateral Standard: Usability - IEC 60601-1-6: 2010 + Am. 1: 2013.

•

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.

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Navigator 2.0 User Manual and Service Guide Table 1A. Explanation of Symbols

Type-CF Applied Part

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

Date of Manufacture

Follow Instructions for Use

Manufactured by

Consult the Instructions for Use

ON/OFF

Attention, consult accompanying documents

Temperature limit

Serial number

Humidity limitation

Catalogue number

Wireless Capability

European Community Representative

Fuse

WEEE

Battery

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.”

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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.

Wireless Pilot Probes

Tip Diameter 14mm

Standard Lymphatic Mapping Probes Superficial Head & Neck Probe Daniel Lung Probe™ Laparoscopic Probe

14mm 11mm 10mm 10mm

Probe

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Tip Angle (degrees) 0/30 0/30 0 30 0

Length (mm) 257/260 224/220 207 465 467

Weight (grams) 255g 185g 161g 195g 195g

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3.1

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.

•

This User/Service manual is designed to assist the use of the Navigator 2.0 system and is not a reference to surgical techniques. 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 line cord, wireless pilot probe battery, and probe cable. CAUTION: To avoid fire hazard, do not insert a fuse with higher rating than the manufacturer’s specification (0.8A). .

3.2

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 probe drape, the Top Gun™ Collimator, Sterilization trays, and Navigator 2.0 roll stand.

•

In the operating room, use the charger at a distance of six feet or greater from the patient.

•

Fully charge the Control Unit battery before each use.

•

Replace the wireless probe battery before each surgical procedure or prior to sterilization.

•

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

•

Keep the control unit off when changing connections between the probe, cable, and control unit. The control unit should also be off when inserting a battery into the Wireless Pilot Probe.

•

The control unit, cables, batteries, charger, and probes are sold non-sterile. CAUTION: Service activities should not be performed when the Navigator System is in use.

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Navigator 2.0 User Manual and Service Guide 3.3

Probe •

DO NOT put any probe or probe cable in an autoclave.

•

With the exception of the Wireless Pilot Probe’s battery holder, DO NOT attempt to open probes. o

• 3.4

All probes are tested and sealed at the factory. Attempting to open the probe may cause damage and will void the warranty.

DO NOT drop or strike the probe tip against a hard surface; this may result in damage to the probe.

Electromagnetic Compatibility IEC 60601-1-2:2014 This equipment has been certified to be protected to emissions and immunity according to IEC-60601-1-2:2014. CAUTION: Medical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Operation Manual. CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. The Navigator Control Unit and Probes are ME EQUIPMENT (Medical Electrical Equipment) that is intended to be used for patients under medical supervision. The Navigator Control Unit and Probes must be operated by trained and qualified medical personnel only. WARNING: The use of accessories other than those specified may result in increased emissions or decreased immunity of the equipment. WARNING: The Navigator Control Unit and Probes should not be used adjacent to or stacked with other equipment. However, if adjacent or stacked use is necessary, the Navigator Control Unit and Probes should be observed to verify normal operation in the configuration in which it will be used.

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3.5

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Navigator Control Unit and Probes are intended for use in the electromagnetic environment specified below. The customer or the user of the Navigator Control Unit and Probes should ensure that it is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF emissions

Group 1

CISPR 11 Radiated

Class A

The Navigator Control Unit and Probes uses RF energy only for its internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

Class A

CISPR 11 Conducted

3.6

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Class A

The Navigator Control Unit and Probes are suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Navigator Control Unit and Probes are intended for use in the electromagnetic environment specified below. The customer or the user of the Navigator Control Unit and Probes should ensure that it is used in such environment. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test Electrostatic discharge (ESD) IEC 61000-4-2

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IEC 60601 Test Level

Compliance Level

±8 kV contact

±8 kV contact

±15 kV air

±15 kV air

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Electromagnetic Environment Guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. N2-5000-07-001 Rev 12

Navigator 2.0 User Manual and Service Guide Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test

Electromagnetic Environment Guidance

IEC 60601 Test Level

Compliance Level

Electrical fast Transient/burst IEC 61000-4-4

±2 kV for power supply lines

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC61000-4-11

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec cycle

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec cycle

Mains power quality for the Battery Charger should be that of a typical commercial or hospital environment.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m

30 A/m

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The Navigator Control Unit is powered from the internal battery. The Navigator 2.0 met criteria C.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial, hospital environment.

N2-5000-07-001 Rev 12

Navigator 2.0 User Manual and Service Guide Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test Radiated RF IEC 61000-4-3

Electromagnetic Environment Guidance

IEC 60601 Test Level

Compliance Level

3 V/m

3 V/m

Recommended separation distance

80 MHz to 2.7 GHz

80 MHz to 2.7 GHz

3 V/m

3 V/m

d = 1.2 �𝑝𝑝

80 MHz to 2.7 GHz

80 MHz to 2.7 GHz

d = 2.3 �𝑝𝑝 800 MHz to 2.7 GHz

80% AM @ 2 Hz

80% AM @ 2 Hz

Including Clause 8.10, Table 9, for proximity to wireless devices

Including Clause 8.10, Table 9, for proximity to wireless devices

Where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

d = 1.2 �𝑝𝑝 80 MHz to 800 MHz

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of the equipment marked with the following symbol:

Guideline Notes Note 1 - At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

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IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Assessment of the Electromagnetic Environment Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Navigator Control Unit and Probes are used exceeds the applicable RF compliance level above, the Navigator Control Unit and Probes should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Navigator Control Unit and Probes. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

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4.1

Control Unit, Battery, and Cable Control Unit Features: Front

The control unit contains the display, the battery, and most of the system controls. These system controls are located on the front and rear 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 on the display, as well as an audible pitch that correlates to the intensity of the measured gamma photons. 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 radioactive site), and secondarily by the setting of the controls on the control unit. Count Display

Threshold Control 10-second Count Button and Indicator Isotope Indicators

Calibration –Check Mode Indicator Battery Charge Status

Range Button and Indicators Volume Knob

Power Button

Co-Pilot Receptacle

Signal Input (Cable Port)

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Navigator 2.0 User Manual and Service Guide ` 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 on, the indicator is illuminated. In this setting, the detection of scattered photons is reduced or eliminated. Signals of amplitude outside the preconfigured energy range are discarded. Only those events within the particular energy range are counted and displayed. When the Threshold is off, the indicator is not illuminated, and all photon energy, including scattered photons, is detected. For Wireless Probes only: The Threshold functionality is not www.Dilon.com

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Description applicable for the Wireless Probes. Count: Initiates a 10-second photon count. When Count has been pressed, the count indicator on the display screen is illuminated and the display screen will show increasing counts. Probe must be held in a fixed position for entire duration of 10-second count. When the 10 seconds are complete, the control unit beeps, and the total count is shown in the display. After displaying the total count for four seconds, the display shows the counts per second. Cal-check: This light indicates when the system is in ‘Calibration-Check’ mode on the rear of the unit. The light will be illuminated when in any of the 3 calibration-check settings and will not be illuminated when the system is set to the ‘Scan’ mode. The SCAN / Calibrate Control must be set to the SCAN position only, for all probes for all procedures. In this mode, the ‘Cal’ light will be turned off. See Section 12.2. Verification of Standard Gain (Calibration Quick Test) for more information on Calibration. The Battery indicator on the Control Unit shows the charge status of the battery in use. When the indicator level on the Control Unit is at 25%, the battery should be replaced with a fully charged battery. Please note that the charge status on the control unit may differ from charge status reflected on the battery. Signal input port, for cable connection. For all cabled probes, connect the probe cable matching the arrow on the cable connector to the arrow above the signal input port. See “6mm Diameter Cable” for more information . The signal input port is not applicable when using the Wireless Pilot Probe with the Navigator 2.0. Connection port for the optional Co-Pilot accessory.

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Navigator 2.0 User Manual and Service Guide 4.2

Control Unit Features: Rear

Integrated Handle Scan/Cal-check Control

Fuse Holder

Isotope Control

Pole Mount Connection

Battery Compartment Door

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Navigator 2.0 User Manual and Service Guide Table 4A-2. Controls and Displays on the Rear of the Control Unit Control Display

Description The SCAN/Calibrate Control has four positions. The control unit should be set to SCAN when is normal use. When set to SCAN, the CAL indicator on the front of the control unit will not illuminate. For instructions on use of the ‘+’, ‘0’, and ‘-‘positions, contact Dilon Customer Service or the local distributor for additional information. Allows the user to designate the specific isotope in use • • • •

I125 – Iodine-125 511keV – 18F-FDG (and I131) In111 – Indium 111 Tc99 - Technetium-99m

The Isotope Control setting on the rear of the control unit illuminates the corresponding light on the Isotope Indicator on the front of the control unit Note: If the front panel CAL indicator is flashing before a procedure, move the control to the SCAN position.

CAUTION: The isotope control must be set to the isotope in use. Setting the isotope control incorrectly will result in incorrect counts displayed.

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Navigator 2.0 User Manual and Service Guide 4.3 Battery (Part # N2-8500-02) 4.3.1 Inserting the Battery into the Control Unit 1. Open the door to the battery port, located on the side of the control unit. 2. Insert a charged battery (Part #: N2-8500-02) into the battery port. The battery label should be facing toward the rear of the unit. The battery contacts will be inserted first. The tab on the side of the battery is positioned outward. Use the direction indicator arrow on the battery label for guidance.

3. Close the battery door. The door will “click” when closed properly. CAUTION: The battery must be removed prior to installing the Pole Mount. 4.3.2

Removing the Battery from the Control Unit

1. Turn off the Navigator Control Unit. 2. Open the door to the battery port, located on the side of the control unit. 3. The battery should partially eject when the door is opened. Use the tab attached to the end of the battery to slide the battery out of the Control Unit.

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Navigator 2.0 User Manual and Service Guide 4.4 Installing the Wireless Pilot Probe Battery 1. Hold the Wireless Pilot Probe firmly while turning the battery cap counterclockwise until the cap is removed.

2. Inspect O- ring on the cap. If O-ring is missing or damaged, do not use the Battery Cap. Contact Dilon Technologies or your distributor for a new cap, if required. 3. Remove the Wireless Battery Holder (Part # WP-9050-00) from the probe.

4. Install 3V CR 2 battery (Part # WP-8500-01) into the Wireless Battery Holder with positive (+) end of the battery aligned with the (+) as shown on the label. 5. Insert Wireless Battery Holder into probe with battery aligned with the serial number of the probe. Lightly turn until battery holder lowers into place. Note: The wireless antenna is located on the battery holder. Do not insert the antenna end of the battery holder into the probe. This will damage the antenna and may lead to wireless communication failures.

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