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Dilon Navigator 2.0 Manual

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Manufactured by:
Dilon Technologies, Inc.
701 Mariners Row
Suite 200
Newport News, VA 23606
USA
Phone: 1-844-DILONNAV

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Summary of Contents for Dilon Navigator 2.0

  • Page 1 Manufactured by: Dilon Technologies, Inc. 701 Mariners Row Suite 200 Newport News, VA 23606 Phone: 1-844-DILONNAV...
  • Page 2 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.
  • Page 3 Navigator 2.0 User Manual and Service Guide TABLE OF CONTENTS Introduction ........................... 5 1.1 Purpose............................5 1.2 Intended Audience ........................5 1.3 Safety Information ........................5 1.4 Product Lifetime ......................... 5 Device Description ........................5 Product Name and Model Number ..................5 General Description and Components ..................
  • Page 4 Navigator 2.0 User Manual and Service Guide 7.6 Prior to Surgery- Surgical Set Up Sequence Example .............. 27 8.0 Post-Use Handling And Data Management.................. 29 8.1 Recording and Storing Measurement Data ................29 8.2 Device Cleaning and Decontamination ..................29 8.3 Control Unit Cleaning .......................
  • Page 5 This document is intended for healthcare professionals, including surgeons, physicians, nurses, and medical technicians, who are trained in the use of the Dilon Navigator 2.0 system. It provides essential guidance on proper setup, operation, maintenance, and troubleshooting to ensure safe and effective use.
  • Page 6 The Navigator 2.0 System detects the 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 7 Navigator 2.0 User Manual and Service Guide 2.4 Device Specifications Figure 1 – System Overview and Components Table 3 – Navigator 2.0 System Specifications Item Description Control Unit Power Source Replaceable, internal battery Rechargeable Smart Lithium-Ion Battery; 10.8V (nominal) Battery voltage, 8.7Ah (nominal) capacity, 99.6Wh SOC (state-of-...
  • Page 8 Navigator 2.0 User Manual and Service Guide Table 3 – Navigator 2.0 System Specifications Item Description UL/CSA (198G) standards; 0.80 amp. Glass housing. 250- volt rating. 5x20m. (REF: SC-0099-00) Fuse – Control Unit IEC 127 standard : Type 7. 0.80 amp, 250 volts. 5x20m T0.63AL250V.
  • Page 9 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 10 If too hot, remove the battery and allow it to cool before • charging. The battery is either damaged or a non-rechargeable conventional Red light battery. NOTE: Use only batteries supplied by Dilon Technologies. No unauthorized accessories should be used. www.Dilon.com N2-5000-07-001 Rev 20...
  • Page 11 3.2 Functional Overview The Navigator 2.0™ Control Unit with Wireless Probe detects gamma photons during surgery. Before the procedure, a radiopharmaceutical is injected into the patient, concentrating at specific sites that emit gamma photons. During surgery, the handheld probe is used to scan areas both in and outside of the patient.
  • Page 12 Navigator 2.0 User Manual and Service Guide The Navigator 2.0 ™ Control Unit: • Provides electrical power for the cabled probes. • Receives wireless transmissions from the wireless probe • Accepts a signal from the probe. • Performs energy analysis of the probe signal.
  • Page 13 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 Button and Indicator Settings: Adjusts the audible signal based on the density of detected events.
  • Page 14 Navigator 2.0 User Manual and Service Guide Control Display Description scattered photons, is counted, expanding the value range. The indicator is not illuminated in this setting. For Wireless Probes only, the Threshold functionality is integrated into the probe, and the Control Unit setting does not affect its operation.
  • Page 15 Navigator 2.0 User Manual and Service Guide Control Display Description Co-Pilot Receptacle: Connection port for the optional Co-Pilot accessory. Integrated Handle Fuse Holder Pole Mount Connection Battery Compartment Door Scan/Cal-check Isotope Control Control Figure 4– Control Unit (Back) www.Dilon.com N2-5000-07-001 Rev 20...
  • Page 16 Set the control unit switch to SCAN for normal use. In SCAN mode, the CAL indicator will remain off. For details on the ‘+,’ ‘0,’ and ‘-’ positions, contact Dilon Customer Service or your local distributor. Isotope Control Setting: Allows the user to designate the specific isotope in use.
  • Page 17 3.5 Cabled Probes 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 18 • The Navigator 2.0 system is not intended for use in the central nervous system. • This User/Service manual is designed to assist the use of the Navigator 2.0 system and is not a reference to surgical techniques. • Do not use products near sources of extreme magnetism, such as MRI equipment.
  • Page 19 Navigator 2.0 User Manual and Service Guide communicating on (e.g. 11). • Contact your Dilon Technologies representative to report any incidents or injuries that occur during use of the Navigator 2.0 System and its accessories. • Operation near X-ray equipment may cause incorrect counts.
  • Page 20 Navigator 2.0 User Manual and Service Guide 6.6 Electromagnetic Compatibility This equipment has been certified to be protected to emissions and immunity according to EN/IEC-60601-1-2:2015. 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.
  • Page 21 Navigator 2.0 User Manual and Service Guide Electromagnetic Environment Immunity Test IEC 60601 Test Level Compliance Level Guidance Electrical fast Mains power quality should be ±2 kV for power ±2 kV for power Transient/burst that of a typical commercial or...
  • Page 22 Navigator 2.0 User Manual and Service Guide Electromagnetic Environment Immunity Test IEC 60601 Test Level Compliance Level Guidance 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.
  • Page 23 Navigator 2.0 User Manual and Service Guide 7.4 Installation and Removal of Control Unit and Probe Batteries To install battery: 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 24 Figure 10 – Inserting Battery Holder 3. Inspect the rubber 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. Figure 11 – Rubber O-ring www.Dilon.com...
  • Page 25 Navigator 2.0 User Manual and Service Guide 4. Install battery cap onto probe and turn clockwise until O-ring is no longer visible. Figure 12 – Installing Battery Cap To remove the Wireless Pilot Probe Battery: Figure 13 – Removing Battery Cap 1.
  • Page 26 Navigator 2.0 User Manual and Service Guide 7.5 Cabled Probe Flexible Cable Assembly Connection Instructions Connecting and disconnecting the flexible cable assembly to the control unit: To Connect: Match the arrows on the plastic cable connector to the arrow above the signal input port on the control unit, then gently push the connector in until it clicks into place.
  • Page 27 • After Surgery o Refer to Section 8 for Probe and Cable Cleaning Table 12 – Navigator 2.0 with Standard Lymphatic Mapping Probes, Superficial Head & Neck Probe, Daniel Lung Probe, and Laparoscopic Probes - Settings and Indicators Control / Indicator...
  • Page 28 Navigator 2.0 User Manual and Service Guide Display: Isotope: Tc99 Illuminated Indicator (On the Wireless Pilot Probe handle) Probe LED: Illuminated Table 14 – Useful adjustments Adjustment Benefit For Cabled Probes only, this feature increases specificity when only a low number of events are observed.
  • Page 29 8. POST-USE HANDLING AND DATA MANAGEMENT 8.1 Recording and Storing Measurement Data The Navigator 2.0 System does not store, record, or have the capability to retain any form of data. The system operates in real-time without saving user inputs, patient information, or device settings.
  • Page 30 Air-dry or dry with clean towel. 8.5 Sterilization of Navigator Probes and Cables Dilon has identified that Navigator Gamma Probes that enter sterile tissue are to be considered critical devices and treated according to guidelines for this category as established by:...
  • Page 31 Tray may only contain one probe. Cabled Probe Tray: 2. Place the cleaned cabled probe in the Dilon Navigator tray using the customized rubber inserts. Lightly coil the cleaned cable and position it alongside the probe. Secure the tray cover and wrap according to hospital and manufacturer sterilization system guidelines. Only one cleaned probe and one cleaned cable may be placed in each tray.
  • Page 32 Navigator Gamma Probes Used in Non-Critical Environments, such as to perform pre-operative scans, should first be processed using the cleaning and preparation instructions identified in Section Sterile Dilon Probe Covers, part number WP-9003-DRT and SP-9004-DRC can also be used after cleaning, disinfection, and/or sterilization of probes. 9. MAINTENANCE AND CALIBRATION 9.1 Routine Maintenance Schedule...
  • Page 33 WARNING: Modifications will void the warranty. 9.2 Performance and Calibration Procedures 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, the user can perform one of two procedures.
  • Page 34 Navigator 2.0 User Manual and Service Guide 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.
  • Page 35 CALIBRATION-CHECK MODE INDICATOR is OFF when the CALIBRATION control is in the SCAN position. NOTE: All cabled Navigator 2.0 probes are compatible with any Navigator 2.0 control unit. Wireless probes require software that matches the console software version 9.5 Navigator Control Unit Fuse Replacement The Navigator 2.0 fuse may be replaced, when necessary, by the user.
  • Page 36 10. TROUBLESHOOTING AND ERROR HANDLING 10.1 Common Errors and Resolutions 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 37 Navigator 2.0 User Manual and Service Guide - Display, or display driver, is 2. Incomplete digits damaged. Contact Dilon Technologies for assistance. in display. - Unit may be damaged. Table 23 – Navigator Control Unit with Wireless Pilot Probe – Settings and Indicators...
  • Page 38 In an error condition, the system will require a reboot or user intervention as described in table 20. The Navigator 2.0 system enters the warning or error mode and displays a specific value on the display that is outside the range of normal operations of the gamma probe count value.
  • Page 39 Navigator 2.0 User Manual and Service Guide Warning Mode ID Alarm State (Counts) ERROR Mode ID Error State (Counts) System Software version mismatch – the controller and wireless probe software 7777 versions are incompatible. The EEPROM (memory) in the control unit has been damaged. If this error...
  • Page 40 Navigator 2.0 User Manual and Service Guide 11. SYMBOLS, GLOSSAY, AND ABBREVIATIONS 11.1 Explanation of Symbols Used RX only Caution: Federal (USA) law Type-CF Applied Part restricts this device to sale and use by, or on the order of, a physician.
  • Page 41 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 42 Navigator 2.0 User Manual and Service Guide 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: •...
  • Page 43 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 manual is also suitable for:

N2-9800-00