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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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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Signal input port

Control Display Description

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 goes back to showing counts per second.

Cal-check: This light indicates when the system is in ‘Calibration-Check’ mode on the back 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 “Verification of Standard Gain (Calibration Quick Test)” for more information on Calibration.

The Battery indicator 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 immediately with a fully-charged battery.

Please note that the charge status on the control unit may differ from charge status reflected on the battery, due to a higher power requirement on the control unit. Refer to charge status on control unit rather than the battery itself.

, for cable connection. The signal input port is not applicable when using the Wireless Pilot Probe with the Navigator 2.0.

For the 12mm Lymphatic Mapping Probe, connect the cable attached to the Gain Module here, matching the arrows on the cable connector to the arrow above the signal input port. See “3mm Diameter Cable” for more information.

For all other cabled probes, connect the probe cable here, matching the arrow on the cable connector to the arrow above the signal input port. See “6mm Diameter Cable” for more information.

Connection port for the optional Co-Pilot accessory. See “Optional Co-Pilot Device” for more information.

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4A-2. Control Unit Features: Back

Fuse Holder

Scan/Cal-check

Control

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Integrated Handle

Isotope Control

Battery Compartment Door

Pole Mount Connection

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the procedure. Setting the isotope control incorrectly will

result in incorrect detection.

Table 4A-2. Controls and Displays on the Back of the Control Unit

Control Display Description

For CABLED PROBES only. The SCAN position is the only correct position when a probe is being used during a procedure. 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, see “Verification of Standard Gain (Calibration Quick Test)”.

Selects the isotope to be detected by the control unit.

SCAN/Calibrate Control

For CABLED PROBES only. The SCAN/Calibrate Control has FOUR POSITIONS. During all surgical procedures, this control should be in the SCAN Position. During the calibration verification procedure, this control uses the remaining three settings, “+”, “0”, and “-”.

NOTE: See “Verification of Standard Gain (Calibration Quick Test)” for information on calibration

verification.

NOTE: If the front panel CAL indicator is flashing before a procedure, move the control to the SCAN

position.

Isotope Control

The Isotope Controls allow the user to designate the specific isotope in use.

Switch set on: I125

Switch set on:

Switch set on: In111 Switch set on: Tc99

511keV

Iodine-125

The Isotope Control setting on the back of the control unit illuminates the corresponding light on the Isotope Indicator on the front of the control unit.

F-FDG (and I131) Indium111 Technetium-99m

CAUTION:

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It is important that the isotope control is set to the isotope that is going to be used in

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

Navigator 2.0 User Manual & Service Guide

4B-1. Inserting the Battery

Open the door to the battery port, located on the right side of the control unit. Insert a fully charged battery with the battery label facing toward the rear of the unit, with battery contacts inward and tab on side of battery positioned outward. Use direction indicator arrow on battery label for guidance.

Shut the door of the battery port. The door will “click” when closed properly.

4B-2. Removing the Battery

Open the door to the battery port, located on the right side of the control unit. To remove the battery, pull the tab attached to the end of the battery.

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4B-3. Charging the Battery (Battery Charger Part # N2-8000-02)

Place the charger on a flat, level surface, away from sources of heat and moisture. Plug the DC connector from the power supply into the back of the charger, and connect the power supply to the mains AC, using the cable supplied. All of the LEDs will flash momentarily to indicate that power is present.

DC Connector

Calibration buttons

Battery Bays

Status window

Recharge Time: Approximately 3.5 hours

Place the battery into either battery bay, ensuring that the 5-way connector is fully seated. The battery should feel secure once inserted correctly. The LEDs in the battery status window will provide charge status, and the charger will automatically begin charging. Each charge bay operates independently, providing simultaneous charge of each battery inserted.

While there is a calibration button for each bay, calibration is not necessary for use with the Navigator 2.0. If calibration button is inadvertently pressed, either a flashing blue or solid blue light will illuminate. Simply remove battery and reinsert in order to resume charge. A green light will indicate that it is in charge mode.

If charger has flashing red light, the battery fuel gauge requires calibration. Only in this case, should the calibration button be pressed. Recalibration can take 10-13 hours.

If charger lights solid red, please refer to troubleshooting guide.

Table 4B-4. Charge Bay LED Indications

Indication Battery Charge Status

Green Flashing Battery Charging

Green Solid Battery Fully Charged

Blue Flashing or Solid Calibration mode: UNNECESSARY. Do not use.

Red Flashing Battery fuel gauge in need of calibration

Red Solid Error

NOTE:

Use only batteries supplied by Dilon Technologies. The Dilon Technologies control unit battery has the proper dimensions and a key feature that holds it securely in the Navigator

2.0 control unit.

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CAUTION:

Place the charger in a cool spot, away from external heat sources.

NOTE: Approximately 3.5 hours are required to charge a completely drained battery. Having a

second, fully charged battery available while the first battery is in use, is recommended.

Do not expose the charger or power supply to water or liquids; the case is not sealed. Do not open the charger or power supply case; no user-serviceable parts are inside. Do not cover the fan exhaust or obstruct the airflow; this will cause overheating.

4C. Cables

In addition to the Wireless Pilot Probe, the Navigator 2.0 may also be used with cabled probes. One of the following two cables is used, depending on the wired probe selected.

4C-1. 3mm Diameter Cable (Part # PM-4000-20) and Gain Module (Part # PM-0400-40)

The 12mm Lymphatic Mapping Probe uses a cable that has two conductors and an outside diameter of approximately 3mm. It also uses a Gain Module (pictured below), which connects the control unit to the probe cable.

1. Connect the 3mm Diameter Cable to the probe, matching the red indicator dot on the probe to the red indicator dot on the cable.

2. Connect the other end of the 3mm Diameter Cable to the gain module, matching the red

indicator dot on the cable to the gain module’s cable input port.

3. Connect the gain module to the control unit, matching the arrows on the gain module cable connector to the arrow above the signal input port. The gain module connector will “click” when it is seated properly.

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The connector has a locking mechanism. To disconnect the cable from the probe and from the gain module, pull directly back on the hood; DO NOT pull or twist the connector jacket.

4C-2. 6mm Diameter Cable (Part # GP-4001-00)

A different cable is used for the standard lymphatic mapping probes (straight or angled), Superficial Head & Neck Probe, laparoscopic probes, and the Daniel™ Lung Probe. This cable has five receptacles inside the probe end, and seven pins inside the plug, that connect to the control unit. The cable is approximately 6mm in diameter.

Connect the cable to the control unit, matching the arrows on the cable connector to the arrow above the signal input port.

The connector is a locking connector. To disconnect the cable from the probe and from the control unit, pull directly back on the hood; DO NOT pull or twist on the jacket.

WARNING! Do not pull or twist the jacket of the cable, to remove from control unit. You must

pull on the hood at the end of the cable.

damage the cable and render it unusable.

Pulling or twisting the jacket may

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evenly spaced (see image below).

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

The optional Co-Pilot is a single-use device used for initiating counting periods and adjusting the audible range from the probe, inside the sterile field. It includes two small buttons, and a long, smalldiameter cable.

To plug in the Co-Pilot, match the spacing of the prongs with the spacing of the receptacles on the control unit. It should then be clipped onto the base of the probe.

The Co-Pilot is supplied sterile and may be used inside or outside of the sterile drape.

R Button (Range)

C Button (Count)

The “C” button is the COUNT Button. Obtain a one-second count by pushing and releasing this button once. Obtain a ten-second count by pushing this button twice, in quick succession. Each time, total counts are shown in the display screen on the control unit.

The “R” button is the RANGE Button. This button operates the Range control mentioned above on the control unit. Push and release the RANGE Button to select an audible range, appropriate to the signal detected by the system.

CAUTION:

The Co-Pilot can only be attached to the control unit one way – the prongs are not

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Range Button and

4E. Useful Adjustments That Can Be Made During Procedures

Threshold Control

Indicators

Volume Knob

10-second Count Button and

Indicator

Power Button

Table 4D-1. Useful Adjustments

Adjustment Benefit

Threshold For Cabled Probes only, this feature increases specificity when only a low

number of events are observed. Threshold control defaults to ON. When ON, the system counts only the events in a narrow energy range around the signal. Change Threshold to OFF to allow the system to count all signals it detects, opening the value range to scatter. (NOTE: The Wireless Pilot Probe features integrated threshold.)

Range

The Range function defaults to 1X, meaning that the audible signal fluctuates according to every single count it detects. In the 10X position, every 10th event produces an audible output. In 100X, only every 100th event produces an audible output.

The Range control only affects the sound. The count shown in the display is independent of the range setting.

10-Second Count

Press to obtain a 10-second count, keeping probe in fixed position each time.

The total is displayed for at least four seconds, allowing time to record the total. Volume Adjust to desired volume. Power Press to turn on the control unit or to safely turn off the device.

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5. Probe Connectivity and Use

6A. Navigator 2.0 with Wireless Pilot Probe

Navigator 2.0 User Manual & Service Guide

The Wireless Pilot Probe is used in various procedures. A typical sequence of setting up the Wireless Pilot Probe for a procedure with a Technetium-99m isotope (such that may be used in a lymphatic mapping procedure for a sentinel node biopsy) is as follows:

6A-1. Before Surgery

Insert a charged battery into control unit.

· Upon initial insertion of new Wireless Pilot Probe battery, probe may need to be lightly shaken to activate LED in probe base.

· LED on the Pilot Probe indicates that it is linked with control unit and ready for use. When the Control Unit is turned off, the Probe’s LED will turn off within seconds of being placed in a resting position. When the Control Unit is turned on, the Pilot Probe will instantly power up when moved. It is now ready for use.

· For intraoperative use, insert the Wireless Pilot Probe into a sterile drape.

· Insert a probe battery into the Pilot Probe as follows:

1. Hold probe firm; turn battery cap counterclockwise and remove from probe. Inspect Oring integrity. If O-ring is missing or damaged, use new battery cap. Contact Dilon Technologies or your distributor for battery cap reorder information.

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2. Install 3V CR 2 lithium battery in Pilot Probe battery holder with positive (+) end facing toward the base of the probe and negative (-) end toward the middle of the probe.

Incorrect placement of battery into battery holder for extended periods of time will cause battery to drain quickly.

3. Insert battery holder into probe negative (-) end in. Lightly turn until holder lowers into place.

4. Hold probe firm; push battery cap into probe and turn clockwise until O-ring is no longer visible.

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Table 6A-1. Pilot Probe LED Indicator

Indication Status

On/Flashing Probe is linked and ready for use.

Navigator 2.0 User Manual & Service Guide

Probe is in a resting position to conserve power when the Control Unit is off; to reactivate LED indicator, turn on the Control Unit and simply pick up probe, or if

needed, lightly shake probe If no power upon ready to use, the battery needs

Off

to be installed or replaced. If battery has been replaced and LED light is still off, contact your

distributor or Dilon Technologies directly.

6A-2. During Surgery

· See ‘Useful Adjustments that can be made During Procedures’.

NOTE: For Technetium-99m (Tc99), the control unit settings are given in the following table. NOTE: Follow the instructions on ‘Cleaning, Disinfection, and Sterile Use of Probe’ (Dilon doc. # 141-

00005).

Table 6A-2. Navigator 2.0 with Wireless Pilot Probe – Settings & Indicators (just prior to surgery)

Control / Indicator Setting

Controls (back of Control Unit)

SCAN/Calibrate: SCAN Isotope: Tc99 Indicators (front of the Control Unit) Range: 1x Threshold: Illuminated Display: 0 Isotope: Tc99

Indicator (top of the Pilot Probe handle)

Probe LED: Illuminated; flashing.

6A-3. After Surgery

· See: ‘Cleaning, Disinfection, and Sterile Use of Navigator Probes & Cables’ (Dilon doc. # 141-00005).

6B. Navigator 2.0 with Standard Lymphatic Mapping Probes, Superficial Head & Neck

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Probe, Daniel Lung Probe, and Laparoscopic Probes

Standard Lymphatic Mapping Probe: SP-2A14-67 (Angled) SP-2S14-67 (Straight) Superficial Head & Neck Probe: SP-2S11-53 Daniel Lung Probe: SP-2S10-31D Laparoscopic Probe: SP-2S10-31 (310 mm shaft) SP-1S10-19 (190 mm shaft)

These Navigator probes are used in various procedures. A typical sequence of setting up these probes for procedures with a Technetium-99m isotope (such as may be used in a lymphatic mapping procedure for a sentinel node biopsy, localization of a parathyroid adenoma, or localization of a subcentimeter lung nodule) is as follows:

6B-1. Before Surgery

· See: ‘Cleaning, Disinfection, and Sterile Use of Probes and Cables’ (Dilon doc. # 141-00005).

· Insert a fully charged battery into control unit.

· Connect the probe and cable to control unit.

· For intraoperative use, insert probe and cable in a sterile drape.

Table 6B-1. Navigator 2.0 with Standard Lymphatic Mapping Probes, Superficial Head & Neck

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under direct visualization through a laparoscope.

CAUTION:

performance of endoscopic procedures.

Probe, Daniel Lung Probe, and Laparoscopic Probes - Settings and Indicators (just prior to surgery)

Control/Indicator Setting (with Tc99 example)

Controls (back of Control Unit)

SCAN/Calibrate: SCAN Isotope: Tc99

Indicators (front of the Control Unit) Range: 1x Threshold: Illuminated Display: 0 Isotope: Tc99

6B-2. During Surgery

· See ‘Useful Adjustments that can be made During Procedures’.

· See ‘Optional Co-Pilot Device’.

6B-3. After Surgery

· See: ‘Cleaning, Disinfection, and Sterile Use of Probes and Cables’ (Dilon doc. # 141-00005).

NOTE: The time to charge a battery by the charger may take as long as 3.5 hours. NOTE: Keep control unit powered off until all components are connected. This helps preserve

component life.

Cautions for Thoracoscopic, Laparoscopic, and Endoscopic Procedures:

CAUTION:

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

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

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6C. Navigator 2.0 with 12mm Lymphatic Mapping Probe (Part # N2-9001-12)

Navigator 2.0 Control Unit

Cable for 12 mm

Gain Module

Lymphatic Mapping

Probe

The Navigator 12mm lymphatic mapping probe is used in various lymphatic mapping procedures. Please note that the system pictured above also includes battery and charger.

6C-1. Before Surgery

· Charge and insert the battery into control unit.

· Connect the probe, cable, and gain module to control unit.

· Run a Peak Procedure.

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Table 6C-1. Navigator 12 mm Probe - Settings and Indicators for use with Tc99 (just prior to surgery)

Control/Indicator Setting

Controls (back of Control Unit)

SCAN/Calibrate: SCAN Isotope: Tc99

Indicators (front of the Control Unit)

Range: 1x Threshold: Illuminated Display: 0 Isotope: Tc99

Gain Module

Dial at Peak Setting: Perform peak procedure

NOTE: Keep control unit power off, until all components are connected. NOTE: A ‘peak procedure’ must be performed before using the probe in the first surgical procedure

of the day.

NOTE: Although the ‘peak procedure’ is typically performed with no sterile drape around the probe

and cable, it may also be performed with the probe and cable inside a sterile drape.

NOTE: After a ‘peak procedure’ has been performed, the control unit and gain module settings are

given in the table above.

NOTE: Follow the instructions on ‘Cleaning, Disinfection, and Sterile Use of Probe and Cable’ (Dilon

doc. # 141-00005).

CAUTION:

For intraoperative use, insert probe and cable in a sterile drape.

6C-2. During Surgery

· See ‘Useful Adjustments that can be made During Procedures’.

6C-3. After Surgery

· See: ‘Cleaning, Disinfection, and Sterile Use of Probes and Probe Cables’ (Dilon doc. # 141-

00005).

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6. Running the Peak Procedure: 12mm Lymphatic Mapping Probe Only

It is important to note that the 12mm Lymphatic Mapping Probe DOES NOT use the ‘Calibration Verification Quick Test’, instead, the probe-control unit configuration is brought to its highest sensitivity point via the ‘Peak Procedure,’ described below.

7A. Running a Peak Procedure

A Peak Procedure finds the best “sensitivity” of a probe when “paired” with a control unit. The setting on the gain module at which the probe counts the most events.

Adjusting the gain module dial increases/decreases the count rate in the Navigator 2.0 Display. Starting with the control unit turned on and the dial in the full counter-clockwise position (0), the location on the gain module dial where the count rate reaches its maximum value is called the Peak Setting. The system should then be left in this setting for any subsequent procedures that day.

The probe must be held in a fixed position with respect to an isotope source during a Peak Procedure. This source can be either a check source or the injection site (or some other region of high activity) of the patient.

Only the Navigator 12mm Lymphatic Mapping Probe requires a Peak Procedure, because it is the only probe that uses the gain module. The Peak Procedure should be performed on EACH day of use, before the first surgical procedure.

Above: Example of a Peak Procedure using a Cobalt-57 check source

Table 7A-1. Example: Using and “pairing” multiple 12mm Sentinel Node Mapping Probes

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during one surgical day with the same control unit

1. Probe A is going to be used on Monday for all surgical procedures scheduled on that day.

2. Peak Procedure is run on Probe A before the first surgical procedure of that day.

3. Probe A counts are highest when the Gain Module dial is set to about 4.5. The dial is left at that location.

4. Probe A is ready for all surgical cases for the day.

5. Probe A is dropped and damaged. It cannot be used again until tested and/or repaired.

6. The Surgical Team chooses to use Probe B for the rest of the case and for all others scheduled on that day.

7. A Peak Procedure is run on Probe B before the next case or before continuing the current surgical procedure to “pair” it with the control unit.

8. Probe B counts are highest when the Gain Module dial is set just above 6. The dial is left at that location.

9. Probe B is ready for all surgical cases for the day.

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SERVICE MANUAL

7. Troubleshooting

With the exception of the Wireless Pilot Probe’s battery holder, no serviceable components are located inside the control unit or probes. Contact your representative or Dilon Technologies for additional assistance if more detail is required.

Table 8A-1. Control Unit Only - Settings and Indicators

Problem Possible Causes Remedies

1. Display is dark; No power to unit.

2. Incomplete digits in display.

Power switch is off; Switch is broken. Unit may have been

dropped. Battery is dead. Recharge battery, or replace with new

Fuse is blown or missing. Replace fuse. Damaged PCB (board) in

control unit Display, or display driver, is

damaged.

Turn power on; Contact Dilon Technologies for

assistance.

battery.

Contact Dilon Technologies for assistance.

Unit may have been dropped.

Table 8A-2. Navigator 2.0 Control Unit with WIRELESS PILOT PROBE- Settings and Indicators

Problem Possible Causes Remedies

1. Zero in display. No signal under presence of a radioactive source.

No wireless connection between probe and control unit.

Isotope control is set to incorrect isotope.

Circuit inside the control unit has been damaged.

Probe LED is illuminated but not transmitting signal to unit (LED flashes when transmitting).

Probe is damaged / probe cap not secure.

Replace the probe battery. Verify that battery was inserted

correctly into probe (‘+’ should face toward base of probe).

Change isotope control (on back of control unit) to Tc-99.

Try a different control unit. Contact Dilon Technologies for assistance.

Gently shake probe to activate connectivity.

Try a different probe, or contact Dilon Technologies for assistance.

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Problem Possible Causes Remedies

2. LED on Pilot Probe does not illuminate.

Probe battery is dead or installed incorrectly.

Replace with new battery. Verify that battery was inserted

correctly into probe (‘+’ should face

toward base of probe). Battery was not installed. Install new battery. LED on probe is damaged. Contact Dilon Technologies for

assistance.

Table 8A-3. Control Unit with CABLED PROBE- Settings and Indicators

Problem Possible Causes Remedies

1. Zero in display. No signal under presence of a radioactive source.

No connection between probe, cable, gain module (if present), and control unit.

Isotope control is set to incorrect isotope.

Gain module, if used, is set to zero.

There is an open circuit in the probe cable.

Check that all connections are secure.

Change Isotope Control (on back of

control unit) to Tc-99.

Run Peak Procedure (Sec. 7A).

Replace cable.

2. Spurious high counts, such as 80,000 counts a second (when probe is held in air, for example).

Circuit inside the control unit has been damaged.

Probe is damaged / probe cap not secure / detector damaged.

Intermittent short in the cable.

Try a different control unit. Contact

Dilon Technologies for assistance.

Try a different probe or contact Dilon

Technologies for assistance.

Replace cable.

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8. Specifications

9A. Navigator 2.0 System Specifications

The Navigator 2.0 system consists of the control unit, one or more probes, and the system accessories.

Table 9A-1. Navigator 2.0 System Specifications

Item Description

Control Unit Power Source Replaceable, internal battery Battery

New Battery Charge Life – full

charge

Battery Recharge Cycle -100%

discharge

Wireless Pilot Probe Power

Source

Wireless Pilot Probe

Transmission Distance

Industry Standard Wireless

Operating Frequency

Fuse – Control Unit UL/CSA (198G) standards; 0.75 amp. Glass housing. 250

Sound Indicators Pitch variations - Frequency proportional to event rate.

Rechargeable Smart Lithium Ion Battery; 10.8V (nominal) voltage, 8.7Ah (nominal) capacity, 94Wh SOC (state-ofcharge) indicator. Approximate weight: 470g

Approximately 10-12 hours continuous use (nominal)

300 full charge/discharge cycles at room temperature and under normal discharge rates.

Battery. Single use CR2, 3 V Lithium; capacity 750-850 mAh

Up to 9 meters

2.4 GHz.

volt rating. 5x20m. IEC 127 standards: Type 7. 0.75 amp,

250 volts. 5x20m T0.63AL250V.

Upon completion of 10-second count, device emits doublebeep sound.

Visual Indicators Control Unit:

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· Digital count – Vacuum fluorescent display

· Single count – LED

· Calibration-check - LED

· 10-second count – LED

· Battery energy level – LED

· Range 1X/10X/100X – LED

· Isotope – LED (four)

Battery:

· Battery state-of-charge – 4 LED’s

Wireless Pilot Probe:

· Probe connection – LED

· Isotope Indicator – LED

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Item Description

Energy Range 0 - 650 keV

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Operating Conditions

Temperature: 15°C to 40°C (5°F to 104°F) Humidity: 0%-80% relative humidity Atmospheric Pressure: 80 kPa to 106 kPa

Storage

Temperature: -15°C to 40°C (5°F to 104°F) Humidity: 0%-80% relative humidity

Atmospheric Pressure: 50 kPa to 106 kPa Maximum Count Rate 90,000/s Color of Housing Light gray and dark gray Control Unit Dimensions 20cm W x 24cm H x 12cm D Control Unit Weight w/Battery 2.0kg Accuracy 95%-99% across the dynamic range of the instrument with

probes

9B. System Accuracy

The Navigator 2.0 System with Probe counts gamma photons that proceed from radioisotopes. At event rates around 20,000 counts per second, the event rate shown in the display may be slightly less than the event rate seen by the probe. This is due to the possible occurrence of a second gamma photon during the short time period (a few microseconds) it takes the system to count a detected gamma photon.

The Navigator 2.0 Device exhibits at least 95% accuracy across its dynamic range.

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Navigator 2.0 Battery

N2-8500

Battery Charger Power Cord

SC-

2000

-00

Navigator 2.0 Stand with

Pole Clamps

N2-

8800

-00

6mm Diameter Cable

(for CdTe

Probes)

GP-

4001

-00

Probe)

PM-

4000

-20

Gain Module for 12mm Probe

PM-

4000

-40

End Cap for Wireless Pilot Probe

(pack of 10)

WP-

2000

-10

Battery Holder for Wireless Pilot Probe

(pack of 5)

WP-

9050

-00

9. Support Items

The Navigator 2.0 control unit is typically supplied with a complete system. Support items may be purchased from the local Dilon Technologies Navigator representative. At time of publication of this manual, the primary support items have the following part numbers. Feel free to contact your local representative for additional information.

10A. Product Part Numbers

Table 10A-1. Navigator 2.0 System Support Items with Part Numbers

Item Dilon Part Number

2-Bay Battery Charger N2-8000-02 Batteries for Wireless Pilot Probe (pack of 10) WP-8500-01

3mm Diameter Cable (for 12mm Lymphatic Mapping Optional Storm Case (for travel and storage) N2-8000-07 Optional Top Gun Collimator SP-1800-00

Optional Co-Pilot Devices GP-6801-00

10B. Sterile Drape

A sterile drape is an additional accessory, but it is not sold or supported by Dilon Technologies. Typical characteristics of a suitable intra-operative probe drape are as follows:

· Universal gamma probe cover, 5 x 24

· Sized with tapered tip to fit both straight and flexible probes

· Low density, soft polyethylene

· Telescopically folded w/rubber bands and medical grade tape strips

· Drape features:

o 100% guaranteed latex-free - All components, including rubber bands o All available EtO Sterile o Strong and durable Anti-Static material

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10. Maintenance

11A. Overview

While the Navigator 2.0 System is virtually maintenance-free, the user should follow a number of steps to ensure proper performance prior to each use.

Check each system component for any visible signs of abuse, neglect, or wear, before each use and storage. This includes checking the following components and these features:

Table 11A-1. Component Check

Component Check Feature Check

Control Unit

Battery Charger Overall check - Housing and integrity of connections. Probe (Wireless or cabled) Overall check. Also tip and connector. Cable (if used) Each connector, the connector pins, and integrity of cable. Gain Module (if used) Dial, cable and connector.

· Should abnormalities be discovered, contact your sales representative or Dilon

Technologies directly.

· Do not use a damaged control unit, battery, battery charger, probe, cable, or gain module.

2. Check each battery for function and charge before use. Should abnormalities be discovered, contact your sales representative or customer support person.

3. To ensure proper functionality, follow each step as outlined in: “Control unit, Battery, and CoPilot,” and the section in the manual pertaining to the relevant probe.

4. In addition to the above, preventive maintenance suggests that every two years a new battery, fuse and cable (if used) might be considered.

5. User maintenance for the Wireless Pilot Probe is restricted to battery and battery cap replacement. There are no user serviceable components or items on the Pilot Probe. Do not attempt to repair damaged battery contacts, or any other damage to the probe.

Overall check - Housing, integrity of switches and integrity of connections.

WARNING! No modification of this equipment is allowed. Any modification to this will void any

remaining warranty, if attempted.

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

The Navigator 2.0 system is designed to minimize periodic maintenance, such that would be performed by a clinical engineering department or the manufacturer. Depending on the probe used, one of two procedures can be performed by the user.

11B-1. Verification of Standard Gain (Calibration Quick Test) - Background

For CABLED PROBES only. Applies to the Standard Lymphatic Mapping Probes (SP-2A14-67 & SP- 2S14-67), Superficial Head & Neck Probe (SP-2S11-53), Laparoscopic Probes (SP-2S10-19 and SP2S10-31), and the Daniel™ Lung Probe of Standard Gain every six months or every year. The procedure does not calibrate the system; it simply reveals whether or not the probe and control unit are set to a common gain standard (calibration). That common standard relates the gamma photon energy detected by the probe to an

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energy window inside the control unit. The Verification of Standard Gain uses 122 keV energy photons produced by the Isotope of Cobalt-

57, to create a known signal in the probe. The control unit expects these detected photons to be in an energy window corresponding to the CENTERED (>0<) position of the test. The control unit also has a test setting for an energy window BELOW (-) the expected signal, and an energy window for a signal ABOVE (+) the expected signal. The desired outcome of the test is that the signal is greatest in the CENTERED (>0<) position, as revealed by the highest count rate seen in the control unit’s display. The details of the test are given below.

11B-2. Verification of Standard Gain (Calibration Quick Test) – Procedure. For CABLED PROBES only.

1. Clean the PROBE and, if used, the CABLE.

2. Charge the BATTERY, and install it into the CONTROL UNIT.

3. Place the system controls as indicated in Table 11B-2, “System Configuration - Cobalt-57 Alignment”.

4. Align a 57 Cobalt source directly with the probe tip. Maintain this exact position between the source and the probe tip for the duration of the test.

5. Place the system controls as indicated in Table 11B-2 “System Configuration - Cobalt-57 Alignment.”

6. Place the SCAN/Calibrate Control in the CENTERED position, which is indicated by the following symbol on the SCAN/Calibrate Control (>0<). Obtain a ten-second count. Record this total.

7. Place the SCAN/Calibrate Control in the BELOW position which is indicated by the following symbol on the SCAN/Calibrate Control ( - ). Press the COUNT control to obtain a ten-second count. Record this total.

8. Place the SCAN/Calibrate Control in the ABOVE position which is indicated by the following symbol on the SCAN/Calibrate Control ( + ). Obtain a ten-second count. Record this total.

9. The highest count should be when the SCAN/Calibrate Control is in the CENTERED (>0<) position. The count in the ABOVE position ( + ) and the count in the BELOW position ( - ) should be less than the count in the CENTERED ( >0< ) position. The observance of these relationships verifies that the probe and control unit have the same standard gain.

10. Return the SCAN/Calibrate Control to the SCAN position.

11. Return the other system controls to the settings for normal use.

12. End of Test.

Table 11B-2. System Configuration – Cobalt-57 Alignment during Calibration Quick Test

Component/Feature Setting

Cabled Probe Cable connected to probe input CALIBRATE control (rear panel) (>0<), ( - ), ( + )

ISOTOPE control (rear panel) Technetium-99m THRESHOLD control As desired (no effect) POWER switch ON RANGE control As desired VOLUME control As desired

NOTE: Because the system is designed to detect slight changes in the location and intensity of

radioisotopes, the test source must be maintained in the same direct alignment and distance

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from the probe tip throughout the three calibration tests.

NOTE: The front panel CALIBRATION INDICATOR blinks when the SCAN/Calibrate Control

is in either the BELOW ( - ), CENTERED (>0<), or ABOVE ( + ) test position. The

CALIBRATION INDICATOR is OFF when the CALIBRATION control is in the SCAN position.

NOTE: All Dilon Technologies probes can be used with any Navigator 2.0 control unit.

The 12mm Lymphatic Mapping Probe, used with a Gain Module, requires a different method of peak calibration assurance, entitled “Running a Peak Procedure".”

11C. Fuse Replacement Procedure

The fuse is to be replaced when necessary by the user (when the fuse is "blown"). The Navigator 2.0 fuse is to be replaced as follows:

1. Push-in and twist the fuse holder cap counter-clockwise.

2. Remove the fuse from the fuse holder.

3. Insert a new fuse into the holder.

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4. Press-in and twist the fuse holder cap clockwise to lock it in place

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CAUTION:

protective wrapping upon return for repair.

11. Repair

Probes are sealed at the factory. No user serviceable parts are inside the probes. Damage to a probe may result if a probe is opened by the user and will void any remaining warranty, if attempted.

Serviceable parts on the Navigator 2.0 control unit include a fuse, which may be inspected and replaced by the user, and a replaceable battery. Beyond these two items, the control unit contains no user serviceable parts and should not be opened by the user.

Please contact Dilon Technologies for additional service. An RMA number is required upon return for service.

If the device cannot be repaired and or it is determined that its useful life is at an end, contact Dilon Technologies for proper disposal of the unit.

12050 Jefferson Avenue Suite 340 Newport News, VA 23606 USA Phone: +1-844-DILONNAV www.Dilon.com

Before using loose packing materials, such as foam pellets, shredded paper, or excelsior, be sure to wrap the component(s) separately in protective bags or other

CAUTION:

If a system, or system components, are to be shipped from your institution for repair, then please clean and disinfect the components as described in this manual before packing for shipment. Dilon Technologies require that the Navigator Service Sheet

be attached to the outside of the shipping box, certifying that the items have been cleaned and disinfected to manufacturer’s specifications. This form can be found on the Dilon Technologies website (www.DilonProducts.com) or by

contacting your distributor or Dilon Technologies directly.

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12. Recycling

At the end of the device life and/or accessories, please send the device and/or its accessories back to Dilon Technologies Authorize Representative in Europe.

Ensure the cleaning of the device and/or it accessories before shipment. The disposables of the product are made out of plastic and cannot be reused and must be

disposed as standard disposables.

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13. Limited Warranty

Dilon Technologies (Dilon), warrants to its customers that, subject to the below provisions, the Navigator 2.0 system and probes will be free from defects in materials and workmanship for twelve (12) months, commencing upon the date of shipment from Dilon.

Replacement parts and products are warranted to be free from defects in material and workmanship for a period equal to the balance of the warranty period remaining on the original part or product.

Dilon will repair or replace, at its option and without charge, any of the above products which are returned to Dilon or its designated repair site, within the applicable warranty period, with prepayment of shipping costs, and which are determined by Dilon to be defective in materials or workmanship.

This Limited Warranty does not apply to any product or replacement part or replacement product which has been subjected to any damage as a result of an accident or abuse, or that has not been used and maintained in accordance with the information contained in the literature accompanying the product, or that has been modified, repaired or serviced by any person or company other than Dilon or its authorized representative.

Dilon’s sole liability for any defective product shall be repaired or replaced as set forth above. Dilon shall not be liable to anyone, under any circumstances, for any special, punitive, incidental or consequential damages whatsoever, including without limitation any costs, expenses, lost profits or other losses however designated. EXCEPT AS STATED ABOVE, NO WARRANTIES ARE EXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND, EXCEPT AS STATED ABOVE, DILON EXPRESSLY DISCLAIMS ALL WARRANTIES.

Manufactured by: Authorized European Representative:

Dilon Technologies, Inc. 12050 Jefferson Avenue Suite 340 Newport News, VA 23606 USA Phone: +1-844-DILONNAV www.Dilon.com

AG Medical Route de l'Orme, Parc des Algorithmes - Imm. "Homère" 91190 Saint-Aubin , France http://ag-medical.com/

N2-5000-07-001 Rev 7 -

www.Dilon.com

43-

Revised 10/16/2018

Dilon Navigator 2.0 User & Service Manual

Specifications and Main Features

Frequently Asked Questions

User Manual