Dilon Navigator 2.0 User And Service Manual
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User/Service Manual
Manufactured by:
Dilon Technologies, Inc.
12050 Jefferson Avenue
Suite 340
Newport News, VA 23606
USA
Phone: 1-844-DILONNAV

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Summary of Contents for Dilon Navigator 2.0

  • Page 1 User/Service Manual Manufactured by: Dilon Technologies, Inc. 12050 Jefferson Avenue Suite 340 Newport News, VA 23606 Phone: 1-844-DILONNAV...
  • Page 2 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.
  • Page 3: Table Of Contents

    Flexible Probe Cable (Part # GP-4001-00) ................20 Useful Adjustments That Can Be Made During Procedures ............. 21 Probe Connectivity and Use ......................22 Navigator 2.0 with Wireless Pilot Probe ..................22 Navigator 2.0 with Cabled Probes ..................... 24 Control Unit Cleaning ........................26 Probe and Cable Cleaning ........................
  • Page 4: Introduction

    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.
  • Page 5: Trademarks

    Navigator 2.0 User Manual & Service Guide 1.5 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.
  • Page 6 Navigator 2.0 User Manual & Service Guide Table 1A. Explanation of Symbols RX only Caution: Federal (USA) law restricts this device Type-CF Applied Part to sale and use by, or on the order of, a physician. Date of Manufacture Follow Instructions for Use...
  • Page 7: System Overview And Components

    Navigator 2.0 User Manual & Service Guide 2 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. Tip Angle Length Weight...
  • Page 8: Precautions

    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.
  • Page 9: Probe

    Navigator 2.0 User Manual & Service Guide CAUTION: Service activities should not be performed when the Navigator System is in use. 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.
  • Page 10: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Navigator 2.0 User Manual & Service Guide 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.
  • Page 11 Navigator 2.0 User Manual & Service Guide Guidance and Manufacturer’s Declaration – Electromagnetic Immunity IEC 60601 Test Electromagnetic Immunity Test Compliance Level Level Environment Guidance Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be...
  • Page 12 Navigator 2.0 User Manual & Service Guide Guidance and Manufacturer’s Declaration – Electromagnetic Immunity IEC 60601 Test Electromagnetic Immunity Test Compliance Level Level Environment Guidance Radiated RF IEC Recommended separation 3 V/m 3 V/m 61000-4-3 distance d = 1.2 % ��...
  • Page 13: Control Unit, Battery, And Cable

    Navigator 2.0 User Manual & Service Guide 4 Control Unit, Battery, and Cable 4.1 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.
  • Page 14 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 –...
  • Page 15 Navigator 2.0 User Manual & Service Guide 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.
  • Page 16: Control Unit Features: Rear

    Navigator 2.0 User Manual & Service Guide 4.2 Control Unit Features: Rear Integrated Handle Scan/Cal-check Control Fuse Holder Isotope Control Pole Mount Connection Battery Compartment Door N2-5000-07-001 Rev 11 www.Dilon.com - 15 -...
  • Page 17 Navigator 2.0 User Manual & 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.
  • Page 18: Battery (Part # N2-8500-02)

    Navigator 2.0 User Manual & 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.
  • Page 19: Installing The Wireless Pilot Probe Battery

    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.
  • Page 20: Charging The Battery (Battery Charger Part # N2-8000-02)

    Battery fuel gauge in need of calibration Red Solid Error. R efer to troubleshooting guide. NOTE: Use only batteries supplied by Dilon Technologies. No unauthorized accessories should be used. NOTE: Approximately 3.5 hours are required to charge a completely drained battery. www.Dilon.com...
  • Page 21: Flexible Probe Cable (Part # Gp-4001-00)

    Charger Operators Manual for further instruction on installation. 4.7 Flexible Probe Cable (Part # GP-4001-00) The Navigator 2.0 may be used with cabled Standard Lymphatic Mapping Probes (straight or angled), Superficial Head & Neck Probe, Laparoscopic Probes, or the Daniel™ Lung Probe. The Flexible Probe Cable (GP-4001-00) is required to connect the cabled probes to the Control Unit.
  • Page 22: Useful Adjustments That Can Be Made During Procedures

    Navigator 2.0 User Manual & Service Guide 4.8 Useful Adjustments That Can Be Made During Procedures Table 4D-1. Useful Adjustments Threshold Control 10-second Count Button and Indicator Range Button Indicators Volume Knob Power Button Adjustment Benefit Threshold For Cabled Probes only, this feature increases specificity when only a low number of events are observed.
  • Page 23: Probe Connectivity And Use

    5A-1. Before Surgery • Insert a charged battery into the Navigator Control Unit. • Insert a new battery (Dilon Part # WP-8500-01) into the Wireless Pilot Probe. Refer to Section 4.4- Installing the Wireless Pilot Probe Battery. Note: If Wireless Pilot Probe was sterilized, skip this step. Replacing the Wireless Pilot Probe battery may render the probe non- sterile.
  • Page 24 If no power upon ready to use, the battery needs to be installed or replaced. NOTE: If battery has been replaced and LED light is still off, contact your distributor or Dilon Technologies directly. 5A-2. During Surgery •...
  • Page 25: Navigator 2.0 With Cabled Probes

    Navigator 2.0 User Manual & Service Guide 5.2 Navigator 2.0 with Cabled Probes Standard Lymphatic Mapping Probe: SP-2A14-67 (Angled) SP-2S14-67 (Straight) Superficial Head & Neck Probe: SP-2S11-53 (Straight) Daniel Lung Probe: SP-2S10-31D Laparoscopic Probe: SP-2S10-31 (310 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 is as follows: 5B-1.
  • Page 26 Navigator 2.0 User Manual & Service Guide Table 5B-1. Navigator 2.0 with Standard Lymphatic Mapping Probes, Superficial Head & Neck Probe, Daniel Lung Probe, and Laparoscopic Probes - Settings and Indicators Control/Indicator Setting (with Tc99 example) Controls (Rear of Control Unit)
  • Page 27: Control Unit Cleaning

    The Navigator Control Unit may be cleaned prior and after use. Before cleaning, inspect the control unit for signs of visual damage. If a damage is noticed, discontinue use and contact Dilon Technologies for service. The following wipes may be used to clean the control unit. Follow the manufacturer’s Instructions for Use.
  • Page 28: Preparation Steps

    Navigator 2.0 User Manual & Service Guide 7.1 PREPARATION STEPS: WARNING: To avoid permanent damage of the Navigator Control Unit, do Preparation not sterilize the Navigator Control Unit or immerse it in fluids. of probes and cables WARNING: To avoid permanent damage of the probes and cables, prior to cleaning and sterilization, always inspect them for cracks, wear or other damages.
  • Page 29: Sterilization Of Navigator Gamma Probes

    Navigator 2.0 User Manual & Service Guide 7.2 Sterilization of Navigator Gamma Probes Dilon has identified that Navigator Gamma Probes that enter sterile tissue are to be considered critical items and treated according to guidelines for this category as established by:...
  • Page 30 Navigator 2.0 User Manual & Service Guide storing sterile products. 3. The wireless probe with battery inside has a two-week shelf life of storage and no use after sterilization WARNING: Do not exceed the two-week shelf life after sterilization for a wireless probe with battery inside.
  • Page 31: Navigator Gamma Probes Used In Non-Critical Environments

    Section 7 “Probe and Cable Cleaning” before and after each procedure. Sterile Dilon Probe Covers, part number WP-9003-DRT and SP-9004-DRT can also be used after cleaning, disinfection and or sterilization.
  • Page 32: Specifications

    Navigator 2.0 User Manual & Service Guide 8 Specifications 8.1 Navigator 2.0 System Specifications The Navigator 2.0 system consists of the control unit, one or more probes, and the system accessories. Table 8A-1. Navigator 2.0 System Specifications Item Description Control Unit Power Source Replaceable, internal battery Rechargeable Smart Lithium Ion Battery;...
  • Page 33: Accessories

    9 Accessories Accessories may be purchased from the local Dilon Technologies Navigator representative. CAUTION: Only approved Accessories listed above should be used with the Dilon Navigator and Probes. Use of unapproved accessories may result in damage to the Navigator Control Unit and Probes.
  • Page 34: Troubleshooting

    SP-9004-DRC 10 Troubleshooting The Navigator Control Unit, Probes, and Cables contain no user serviceable parts. Dilon offers Wireless Pilot Probe Battery Holders, Wireless Pilot Probe Batteries, and Navigator Control Unit Batteries and Fuses for sale for use with the Navigator System.
  • Page 35 Navigator 2.0 User Manual & Service Guide Problem Possible Causes Remedies Probe is damaged / Try a different probe or contact Dilon probe cap not secure. Technologies for assistance. 2. LED on Pilot Probe battery is dead Replace with new battery.
  • Page 36: Maintenance

    Navigator 2.0 User Manual & Service Guide 11 Maintenance 11.1 Overview While the Navigator 2.0 System is virtually maintenance-free, the user should routinely inspect their equipment to ensure proper performance. Prior to each use, check each system component for any visible signs of damage or wear.
  • Page 37: Navigator Control Unit Fuse Replacement

    CAUTION: Use of an unapproved replacement fuse may alter the performance of the Navigator Control Unit. The Navigator 2.0 fuse may be replaced when necessary by the user. 1. Locate the fuse holder on the rear of the Navigator Control Unit.
  • Page 38: Repair

    Serviceable parts on the Navigator 2.0 control unit include a fuse and a replaceable battery. The control unit contains no additional user serviceable parts and should not be opened by the user.
  • Page 39: Disposal

    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.

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