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NAVIGATOR 2.0 STERILIZABLE SURGICAL GAMMA PROBE Ready When You Are No Calibration, No Probe Tethering Delay Certified sterilization options: Steris, STERRAD, TSO3 High sensitivity count detection Display High Visibility LED Screen with anti-glare display Control Unit Compact design Works with BOTH Weighs less Tc99 and I125 than 5 lbs May be attached to available cart or IV pole Battery Powered Full charge lasts 10-12 hours of continuous use Range Battery is replaceable Customize the sound Adjust dotted line to profile for the amount just meet the graphic of activity present on the device Power Button Instant Power On Button Probes Collimator Wireless Technology Probe Battery Specialized probes Built in collimator Duracell CR2 Batteries are readily remove the need for available, easy to replace and background filtering may be left in during sterilization Dilon Navigator 2.0 2 ALL Navigator 2.0 Gamma Probes may be Sterilized Gamma Probes pass through the mucus membranes so they are considered a critical device and should be sterilized according to IFU guidelines. Sterilization Tray – 2.5” 2.6”(6.6cm)x12”(30.5cm) Sterilization Tray – 6.5” (16.5 cm)x18”(45.7cm) (fits all probe sizes and cable) Reprocessing Standards for Surgical Gamma Probes Is your hospital meeting the Joint Commission standards for all critical devices? Contact your local Dilon Technologies rep to implement sterilization protocols today! 3 Advanced Surgical Probe Technology Precise localization in a broad range of anatomy. Certified sterilization procedures for superior infection control. Wireless and wired probes available. Advanced Lymphatic Mapping Head and Neck The internal collimator and detector design Designed for precise localization performs well in multiple applications. of parathyroid adenomas. 14mm Wireless Pilot Probe, Angled 11mm Superficial Head and Neck Probe 14mm Wireless Pilot Probe, Straight 14mm Standard Lymphatic Mapping Probe, Angled 14mm Standard Lymphatic Mapping Probe, Straight Laparoscopic Probe For use in radio-guided minimally Pulmonary Tumors invasive surgical procedures for thoracic and abdominal malignancy. Addresses the challenges of localizing small, difficult to visualize lesions in MIS pulmonary procedures. Potentially 10mm Laproscopic Probes eliminate guess work on tissue margins and target location. Robotic system compatible. Daniel Lung Probe™ Dilon Navigator 2.0 4 Navigator Accessories Superficial Head & Neck Probe (cabled, 11mm tip, straight) Standard Lymphatic Mapping Probe (cabled, 14mm tip, angled) Sterilization Tray – 6.5” (16.5 cm)x18”(45.7cm) (fits all probe sizes and cable) Standard Lymphatic Mapping Probe (cabled, 14mm tip, straight) Wireless Pilot Probe (14mm tip, angled) Sterilization Tray – 2.5” 2.6”(6.6cm)x12”(30.5cm) Wireless Pilot Probe (14mm, straight) Daniel Lung Probe™ (cabled, 10mm tip, angled, 310mm shaft length) Laparoscopic Probe Flexible Probe Cable (cabled, 10mm tip, straight, 310mm shaft length) Dilon Navigator 2.0 5 Navigator Accessories PRODUCT PART Navigator 2.0 Roll Stand 108-00001 Navigator 2.0 Storage & Carrying Case N2-8000-07 Pole Clamp N2-8800-00 Fuse SC-0099-00 Top Gun II Collimator SP-1800-00 (use with 14mm probes only) Wireless Probe End Cap WP-2000-10 Flexible Probe Cable GP-4001-00 Navigator Test Source N2-CO57-SC Wireless Pilot Probe Batteries (12/BX) WP-8500-12 Battery Pak N2-8500-02 2-Bay Battery Charger N2-8000-00 Battery Pak Line Cord SC-2000-00 Wireless Probe Battery Holder WP-9050-01 Sterilization Tray 2.6”(6.6cm) x 12”(30.5cm) WP-9000-TR Sterilization Tray 6.5” (16.5 cm) x 18” (45.7cm) SP-9000-TR (fits all probe sizes and cable) Wireless Pilot Probe (14mm, angled) WP-9000-14 Wireless Pilot Probe (14mm, straight) WP-9000-14S Standard Lymphatic Mapping Probe SP-2A14-67 (cabled, 14mm tip, angled) Standard Lymphatic Mapping Probe SP-2S14-67 (cabled, 14mm tip, straight) Superficial Head & Neck Probe SP-2S11-53 (cabled, 11mm tip, straight) Laparoscopic Probe SP-2S10-31 (cabled, 10mm tip, straight, 310mm shaft length) Navigator 2.0 Roll Stand Daniel Lung Probe™ SP-2S10-31D (cabled, 10mm tip, angled, 310mm shaft length) (Pole clamp sold separately) Dilon Navigator 2.0 6 Indications for Use SAFETY: The Navigator™ 2.0 System is indicated for the detection and quantification of gamma Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging Safety Requirements For Medical Electrical Systems – IEC 60601-1: 3rd and 4th Ed. procedures to measure the amount of radionuclide absorbed by a particular organ or Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral body region. Standard: Electromagnetic Compatibility - Requirements and Tests – IEC 60601-1-2: 3rd and 4th edition. Important Safety Information Medical Electrical Equipment - Part 1-6: General Requirements For Safety - Collateral The Dilon Navigator™ 2.0 System including Probes complies with the following standards: Standard: Usability - IEC 60601-1-6: 2010 + Am. 1: 2013. EC DIRECTIVES: CAN/CSA C22.2 No. 60601-1, “Medical Electrical Equipment, Part 1: General Requirements EMC Directive 89/336/EEC Group l, Class B for Safety & Essential Performance; issued 2008-02-01 Ed. 2 EN 55011 AS/NZS 3200-1-0, Deviations to IEC 601-1 for Application in Australia and New Zealand EMC Directive 89/336/EEC IEC 60601-1-2: 3rd Edition. Caution: Federal law restricts this device to sale by or on the order of a physician. RECIPROCAL INTERFERENCE: This product has been tested and verified to ensure that Navigator™ 2.0 System is a registered trademark of Dilon Technologies, Inc. All product there are no issues or concerns regarding reciprocal interference. This includes EMI, EMC names and any registered and unregistered trademarks mentioned in the Instructions for and RF. This product has been certified and tested by 3rd party testing facilities. List of Use that refer to goods or services offered by Dilon Technologies, Inc., its subsidiaries and standards is as follows: other affiliated companies are owned by Dilon Technologies, Inc. All third-party product Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral names and any registered or unregistered trademarks mentioned in the Instructions for Use Standard: Safety Requirements For Medical Electrical Systems – IEC 60601-1-1: 3 Ed: that refer to goods or services offered by parties other than Dilon Technologies, Inc. remain Amendment 1. the property of their respective owners. Medical Electrical Equipment - Part 1: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility – IEC 60601-1-2: 4th Ed. COPYRIGHT © 2022 Dilon Technologies, Inc. All rights reserved worldwide. MRK-00XXX Rev 1 dilon.com 4/16/2024 1 2 1 4/16/2024 3 4 2 4/16/2024 5 6 3 4/16/2024 7 8 4 4/16/2024 9 10 5 4/16/2024 11 12 6 4/16/2024 13 14 7 4/16/2024 15 16 8 4/16/2024 17 18 9 4/16/2024 19 20 10 4/16/2024 21 11 4/16/2024 1 2 1 4/16/2024 3 4 2 4/16/2024 5 6 3 4/16/2024 7 8 4 4/16/2024 9 10 5 4/16/2024 11 12 6 4/16/2024 13 14 7 4/16/2024 15 16 8 4/16/2024 17 18 9 4/16/2024 19 20 10 4/16/2024 21 22 11 4/16/2024 23 24 12 4/16/2024   25 26 13 4/16/2024 27   28 14 4/16/2024 29 30 15 4/16/2024 o o o o o o o 31 32 16 4/16/2024 1 1 2 2 1 4/16/2024 3 3 4 4 2 4/16/2024 5 5 6 6 3 4/16/2024 7 7 8 8 4 4/16/2024 9 9 10 10 5 4/16/2024 11 11 12 12 6 4/16/2024 13 13 14 14 7 4/16/2024 15 15 16 16 8 4/16/2024 17 17 18 18 9 4/16/2024 19 19 20 20 10 4/16/2024 21 21 22 22 11 4/16/2024 23 23 24 24 12 4/16/2024 25 25 26 26 13 4/16/2024 27 27 28 28 14 4/16/2024 29 29 30 30 15 4/16/2024 31 31 32 32 16 4/16/2024 33 33 34 34 17 4/16/2024 35 139-00016 Rev00 35 18 4/16/2024 1 2 1 4/16/2024 3 4 2 4/16/2024 5 6 3 4/16/2024 7 8 4 4/16/2024 9 10 5 4/16/2024 11 12 6 4/16/2024 13 14 7 4/16/2024 15 16 8 4/16/2024 536-00002 17 9 TrueView 100 Pro Specifications TrueView 100 Pro Specimen Radiography System Digital Image Receptor System Performance Active Imaging Area Size 4.49 x 5.75 in Time to Preview 10 lp/mm in 1.0x contact mode Indicators X-Ray On Output Image 14-bit image data Specimen tray positions at 1.0x, 1.5x, Magnification 2.0x, auto sensed Enhanced visualization adjustment Image Enhancement for image sharpness Multi-view Specimen Holder Yes X-ray Source Physical Energy Range 20-50 kV Construction Fully integrated system with movable base X-ray Tube Target Material Tungsten Dimensions (W x D x H in) 23.62 x 28.35 x 63.78 Tube Current up to 1 mA Exposure Continuous exposure Image Display Focal Spot Size 50 µm Filtration 127 µm beryllium Pan and zoom, magnifying glass, Magnification and Movement 900 rotate, etc. Preset/manual window/level, three Display Tools Acquisition Workstation sharpening levels Measure and Annotation Ruler, arrow, text, ellipse, comments Display Monitor 2.3 MP color diagnostic monitor Intelligent Contouring Intelligent calcification contouring Operating System Windows 10 DICOM Services Worklist, print, storage User Interface Touch screen, trackpad Wireless Connection Yes Electrical Requirements 23.62 inches Input Line Power 175-280 VAC 63.78 inches Peak Input Power 500 W Frequency 50/60 Hz 28.35 inches Manual User selects kV and mAs System determines optimum kV Auto and mAs Fast Precise Exclusive distributor in the United States of America www.comp-ai.com www.dilon.com 544-00001 Rev 01 Revision Date: 1/2/2023 Affordable Precise The Efficient Solution for Advanced and reliable detection technology provides high resolution images that can detect the smallest calcifications and features resulting in more accurate margins. The Specimen Radiography proprietary QuadraView specimen holder ensures a precise and multidimensional view of the specimen images without compromising resolution and increasing cost. 1. Scan Patient Information Fast Improved workflow with enhanced software provides 2. One Touch Auto Exposure automatic calcification recognition and image magnification. The user friendly interface has been upgraded with one-button X-ray exposure and intuitive software. 3. Review Images Affordable Latest X-ray technology and software enables a cost-effective and robust solution for any medical setting such as hospital, free standing clinic, or breast center for core biopsy imaging. QuadraView Specimen Holder A dedicated team provides quick delivery and installation. Multidimensional precision without compromising resolution The three-dimensional orthogonal and maximum slope images provide all-around information of the specimen and improve the complete tumor resection rate. In combination with the TrueView 100 Pro specimen radiography system, the distance from calcification to the resection edge can be calculated precisely. The specimen location assistance system allows the user to correlate the orientation of the specimen in the holder with its orientation in the breast to facilitate the comparison with preoperative imaging data. The elastic membrane can reduce the deformation of tissue samples, allowing for easy transportation to the pathology department for further examination. Clinical Cases User/Service Manual Manufactured by: Dilon Technologies, Inc. 701 Mariners Row Suite 200 Newport News, VA 23606 USA Phone: 1-844-DILONNAV Navigator 2.0 User Manual and Service Guide Important Notes All personnel that will interact with this Navigator 2.0 System and Probes should read this Manual and Service Guide to ensure proper use, handling, storage, and maintenance. This document and the information contained herein, is proprietary information of Dilon Technologies and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without prior written consent of Dilon Technologies. This document is intended to be used by customers as part of their Dilon Technologies equipment purchase. Dilon Technologies provides this document without warranty of any kind, implied, or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Dilon Technologies has taken care to ensure the accuracy of this document. However, Dilon Technologies assumes no liability for errors or omissions, and reserves the right to make changes without further notice to any products herein, to improve reliability, function, or design. Dilon Technologies may make improvements or changes in the products or programs described in this document at any time. Navigator 2.0™ is a trademark of Dilon Technologies. Other trademarks and trade names are those of their respective owners. Copyright Notice Copyright 2023 Dilon Technologies, Newport News, VA 23606 United States of America. Trademarks Dilon Technologies™ is a registered trademark of Dilon Technologies. All other company and product names are trademarks or registered trademarks of their respective owners. Part Number N2-5000-07-001 Rev 16 /09Nov2023 www.Dilon.com 1 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide User Manual: Table of Contents 1 Introduction..........................................................................................................................................3 1.1 Operating Principle......................................................................................................................3 1.2 Intended Use...............................................................................................................................3 1.3 Indications for Use.......................................................................................................................3 1.4 Product Lifetime...........................................................................................................................3 1.5 Manufacture and Distribution.......................................................................................................4 1.6 Trademarks.................................................................................................................................4 1.7 Regulatory and Safety Requirements..........................................................................................4 2 System Overview and Components...................................................................................................7 3 Precautions..........................................................................................................................................8 3.1 General........................................................................................................................................8 3.2 Control Unit, Battery, and Charger..............................................................................................8 3.3 Probe...........................................................................................................................................9 3.4 Electromagnetic Compatibility EN/IEC 60601-1-2:2015..............................................................9 3.5 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions.................................10 3.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity...................................10 4 Control Unit, Battery, and Cable.......................................................................................................14 4.1 Control Unit Features: Front......................................................................................................14 4.2 Control Unit Features: Rear.......................................................................................................17 4.3 Battery (Part # N2-8500-02)......................................................................................................19 4.4 Installing the Wireless Pilot Probe Battery.................................................................................20 4.5 Charging the Battery (Battery Charger Part # N2-8000-02)......................................................21 4.6 Table 4B-4. Charge Bay LED Indications..................................................................................21 4.7 Flexible Probe Cable (Part # GP-4001-00)................................................................................22 4.8 Useful Adjustments That Can Be Made During Procedures.....................................................23 4.9 Software Version Display..........................................................................................................24 4.10 Alarm Mode............................................................................................................................24 5 Probe Connectivity and Use..............................................................................................................26 5.1 Navigator 2.0 with Wireless Pilot Probe....................................................................................26 5.2 Navigator 2.0 with Cabled Probes.............................................................................................28 6 Control Unit Cleaning........................................................................................................................30 7 Probe and Cable Cleaning................................................................................................................30 7.1 Preparation Steps......................................................................................................................31 7.2 Sterilization of Navigator Gamma Probes.................................................................................32 7.3 Navigator Gamma Probes Used in Non-Critical Environments:................................................34 7.4 Radioactive Decontamination Procedure – OPTIONAL............................................................35 8 Specifications.....................................................................................................................................36 8.1 Navigator 2.0 System Specifications.........................................................................................36 9 Accessories........................................................................................................................................37 10 Troubleshooting.................................................................................................................................38 11 Maintenance.......................................................................................................................................41 11.1 Overview................................................................................................................................41 11.2 Verification of Standard Gain (Calibration Quick Test)..........................................................42 11.3 Navigator Control Unit Fuse Replacement............................................................................44 12 Repair..................................................................................................................................................46 13 Disposal..............................................................................................................................................47 14 Limited Warranty................................................................................................................................47 www.Dilon.com 2 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide USER MANUAL 1 Introduction 1.1 Operating Principle The Navigator 2.0 System detects presence of gamma rays, emitted from radioactive isotopes in body organs or tissue. System use requires the Navigator 2.0 Control Unit, which allows the user to adjust the system's settings and produces a variety of signal outputs. The control unit is powered by a rechargeable battery. The system provides an increasing or decreasing sound and visual counts that vary as the level of gamma radiation increases or decreases. The control unit works in conjunction with a hand-held probe that is connected to the control unit either via a cable or wireless technology. Placing the probe close to a radiation source increases the number of counts detected and localization occurs. As the distance between the probe and the radiation source increases, the number of gamma rays detected decreases. The Navigator Control Unit is used with any of the following Navigator™ hand-held probe models. The probes differ primarily in their size, shape, detector technology and connection to the control unit. x 14mm Wireless Pilot Probe™ (angled tip & straight tip) x 14mm Standard Lymphatic Mapping Probes (angled tip & straight tip) x 11mm Superficial Head & Neck Probe (straight tip) x 10mm Daniel Lung Probe™ (angled tip) x 10mm Laparoscopic Probes (310mm & 190mm Lengths, straight tips) The system is supplied non-sterile. This manual includes guidelines for the use of the probes and accessories within the sterile field. 1.2 Intended Use For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region. 1.3 Indications for Use For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region. 1.4 Product Lifetime This product has been manufactured for years. The rate of wear, abrasion and damage varies among users. For practical purposes of record keeping, Dilon Technologies further defines the “Product lifetime” of the product components to these time periods given below: x Navigator 2.0 Control Unit and Probes 7 Years x Rechargeable Battery Pak 3 Years x Cable 2 Years www.Dilon.com 3 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 1.5 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. 1.6 Trademarks The following are trademarks of Dilon Technologies: Navigator 2.0™, Wireless Pilot Probe™, Dilon Navigator™, , Dilon Technologies Navigator™, Dilon Technologies Navigator 2.0™, Daniel Lung Probe™, and Navigator™ when used in context with the above. 1.7 Regulatory and Safety Requirements The Dilon Navigator 2.0™ System including Probes complies with the following standards: EC Directives EMC Directive 89/336/EEC Group l, Class B EN 55011 EMC Directive 89/336/EEC IEC 60601-1-2 : 3rd Edition Reciprocal Interference This product has been tested and verified to ensure that there are no issues or concerns regarding reciprocal interference. This includes EMI, EMC, and RF. This product has been certified and tested by 3rd party testing facilities. List of standards is as follows: Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems – IEC 60601-1-1: 3Ed: Amendment 1. Medical Electrical Equipment - Part 1: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility – IEC 60601-1-2: 4th Ed. Safety Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems – IEC 60601-1: 3rd Ed. Medical Electrical Equipment - Part 1: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests – IEC 60601-1-2: 3rd edition. Medical Electrical Equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability - IEC 60601-1-6: 2010 + Am. 1: 2013. CAN/CSA C22.2 No. 60601-1, "Medical Electrical Equipment, Part 1: General Requirements for Safety & Essential Performance; issued 2008-02-01 Ed. 2 AS/NZS 3200-1-0, Deviations to IEC 601-1 for Application in Australia and New Zealand CAUTION: Federal (USA) law restricts this device to sale and use by, or on the order of, a physician. www.Dilon.com 4 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide Table 1A. Explanation of Symbols RX only Caution: Federal (USA) law restricts this device to sale Type-CF Applied Part and use by, or on the order of, a physician. Medical device Follow Instructions for Use Consult instructions for use or Manufactured consult electronic instructions for use ON/OFF Caution Temperature limit Serial number Humidity limitation Catalogue number Authorized representative Wireless Capability in the European Community/ European Union Fuse WEEE Battery Model number Keep dry Country of manufacture Japan Radio Law and Ordinance Concerning Technical Federal Communications Regulations Conformity Commission Certification of Specified Radio Equipment www.Dilon.com 5 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide Fragile, handle with care 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.” www.Dilon.com 6 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and 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 Tip Angle Length Weight Probe Diameter (degrees) (mm) (grams) Wireless Pilot Probes 14mm 0/30 257/260 255g Standard Lymphatic Mapping Probes 14mm 0/30 224/220 185g Superficial Head & Neck Probe 11mm 0 207 161g Daniel Lung Probe™ 10mm 30 465 195g Laparoscopic Probe 10mm 0 467 195g www.Dilon.com 7 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 3 Precautions 3.1 General x 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. x 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. x Keep the control unit within 15 feet (4.5m) of the patient within the line of sight of the surgeon and facing the surgeon. x Be sure the probe’s end cap is clear of obstructions, such as a misplaced hand. The probe should be held like a pencil. x The control unit will show the software version (like 270 for version 2.7.0) when first powered on. The second set of numbers is the channel it connects to-most likely 11. x The second set of numbers is the wireless channel the probe and the control unit are communicating on, most likely 11. x This User/Service manual is designed to assist the use of the Navigator 2.0 system and is not a reference to surgical techniques. CAUTION: To avoid malfunction of the system, only the manufacturer’s approved replacement parts shall be used. This includes the manufacture’s approved replacement parts such as the fuse, control unit battery, 2-bay battery charger, power supply line cord, wireless pilot probe battery, and probe cable. CAUTION: To avoid fire hazard, do not insert a fuse with higher rating than the manufacturer’s specification (0.8A). 3.2 Control Unit, Battery, and Charger x 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. x 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. x The Line Cord of the 2-bay battery charger is used as the disconnect device for the charger. x When optional system components are used with the system, maintain probe and patient electrical isolation from earth ground. The optional components include the probe drape, the Top Gun™ Collimator, Sterilization trays, and Navigator 2.0 roll stand. x In the operating room, use the charger at a distance of six feet or greater from the patient. x Fully charge the Control Unit battery before each use. x Replace the wireless probe battery before each surgical procedure or prior to sterilization. www.Dilon.com 8 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide x This system is not designed for use in an explosive atmosphere. x Keep the control unit off when changing connections between the probe, cable, and control unit. The control unit should also be off when inserting a battery into the Wireless Pilot Probe. x The control unit, cables, batteries, charger, and probes are sold non-sterile. CAUTION: Service activities should not be performed when the Navigator System is in use. 3.3 Probe x DO NOT put any probe or probe cable in an autoclave. x With the exception of the Wireless Pilot Probe’s battery holder, 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. x DO NOT drop or strike the probe tip against a hard surface; this may result in damage to the probe. 3.4 Electromagnetic Compatibility EN/IEC 60601-1-2:2015 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. CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. The Navigator Control Unit and Probes are ME EQUIPMENT (Medical Electrical Equipment) that is intended to be used for patients under medical supervision. Trained and qualified medical personnel must operate the Navigator Control Unit and Probes only. WARNING: The use of accessories other than those specified may result in increased emissions or decreased immunity of the equipment. WARNING: The Navigator Control Unit and Probes should not be used adjacent to or stacked with other equipment. However, if adjacent or stacked use is necessary, the Navigator Control Unit and Probes should be observed to verify normal operation in the configuration in which it will be used. WARNING: Electrosurgical equipment intentionally applies RF energy for diagnosis or treatment during activation. Observe the Navigator performance if it is in the vicinity of the electrosurgical equipment during activation for any possible adverse electromagnetic effects. Ensure adequate separation of the Navigator based on observed reactions. www.Dilon.com 9 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and 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. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment - Guidance RF emissions Group 1 The Navigator Control Unit and Probes uses RF energy only for its internal function. Therefore, CISPR 11 Radiated Class A their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class A CISPR 11 Conducted The Navigator Control Unit and Probes are suitable Harmonic emissions IEC for use in all establishments other than domestic Class A and those directly connected to the public low- 61000-3-2 voltage power supply network that supplies Voltage fluctuations/ buildings used for domestic purposes. flicker emissions IEC Class A 61000-3-3 3.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Navigator Control Unit and Probes are intended for use in the electromagnetic environment specified below. The customer or the user of the Navigator Control Unit and Probes should ensure that it is used in such environment. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Environment Immunity Test IEC 60601 Test Level Compliance Level Guidance Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, discharge (ESD) concrete, or ceramic tile. If IEC 61000-4-2 ±15 kV air floors are covered with ±15 kV air synthetic material, the relative humidity should be at least 30%. www.Dilon.com 10 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Environment Immunity Test IEC 60601 Test Level Compliance Level Guidance Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be Transient/burst supply lines supply lines that of a typical commercial or IEC 61000-4-4 hospital environment. Voltage dips, short 95 % dip in UT) Battery Charger should be that voltage variations for 0.5 cycle for 0.5 cycle of a typical commercial or on power supply 40 % UT 40 % UT hospital environment. input lines (60 % dip in UT) (60 % dip in UT) for The Navigator Control Unit is IEC61000-4-11 for 5 cycles 5 cycles powered from the internal 70 % UT 70 % UT battery. The Navigator 2.0 met (30 % dip in UT) (30 % dip in UT) for criteria C. for 25 cycles 25 cycles 95 % dip in UT) for 5 sec cycle for 5 sec cycle Power frequency 30 A/m 30 A/m Power frequency magnetic (50/60 Hz) fields should be at levels magnetic field IEC characteristic of a typical 61000-4-8 location in a typical commercial, hospital environment. www.Dilon.com 11 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Environment Immunity Test IEC 60601 Test Level Compliance Level Guidance Radiated RF IEC 3 V/m 3 V/m Recommended separation 61000-4-3 distance 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz d = 1.2 ඥ‫݌‬ 3 V/m 3 V/m d = 1.2 ඥ‫ ݌‬80 MHz to 800 MHz 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz d = 2.3 ඥ‫ ݌‬800 MHz to 2.7 GHz 80% AM @ 2 Hz 80% AM @ 2 Hz Where p is the maximum output power rating of the transmitter in watts (W) Including Clause Including Clause according to the transmitter 8.10, Table 9, for 8.10, Table 9, for manufacturer and d is the proximity to proximity to recommended separation wireless devices wireless devices distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of the equipment marked with the following symbol: Guideline Notes Note 1 - At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. www.Dilon.com 12 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Environment Immunity Test IEC 60601 Test Level Compliance Level Guidance Assessment of the Electromagnetic Environment Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Navigator Control Unit and Probes are used exceeds the applicable RF compliance level above, the Navigator Control Unit and Probes should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Navigator Control Unit and Probes. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m. www.Dilon.com 13 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and 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. The control unit allows the user to adjust the system’s settings and produces signal outputs in the form of a count rate, viewable on the display, as well as an audible pitch that correlates to the intensity of the measured gamma photons. The number of gamma photons (called “events”) shown in the control unit display is determined primarily by a probe and the probe’s position (with respect to the radioactive site), and secondarily by the setting of the controls on the control unit. Count Display Threshold Control 10-second Count Button and Indicator Isotope Indicators Calibration –Check Mode Indicator Range Button and Battery Charge Indicators Status Volume Knob Power Button Co-Pilot Receptacle Signal Input (Cable Port) www.Dilon.com 14 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide ` Table 4A-1. Controls and Displays on the Front of the Control Unit Control Display Description Power button: Turns power on and off. Volume knob: Increases/decreases the volume of the audible signal. Display Screen: When turned on, displays the photon count per second. Upon completion of a 10-second count, the total number of photons detected will show on the display screen for 4 seconds, and then the display returns to showing counts per second. Isotope Indicator: Indicates the isotope selected. Isotopes detected on the Navigator 2.0 are I125, 511keV (for I-131 or FDG-18), In111, and Tc99. Range Settings: Adjusts the audible pitch, based on density of events detected: 1x – Low event rates; all events are heard. 10x – Medium event rates; 1 in 10 events are heard. 100x – High event rates; 1 in 100 events are heard. Pressing the Range button cycles through the ranges; Select the one most useful to the procedure being performed. NOTE: Range selection only controls pitch of the sound generated by the unit; it has no effect on count rates displayed or signal conditioning. Threshold: For Cabled Probes only, it controls the count range of photon energy detected by the probe. When the Threshold is on, the indicator is illuminated. In this setting, the detection of scattered photons is reduced or eliminated. Signals of amplitude outside the pre- configured energy range are discarded. Only those events within the particular energy range are counted and displayed. When the Threshold is off, the indicator is not illuminated, and all photon energy, including scattered photons, is detected. For Wireless Probes only: The Threshold functionality is not applicable for the Wireless Probes. www.Dilon.com 15 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and 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. When the 10 seconds are complete, the control unit beeps, and the total count is shown in the display. After displaying the total count for four seconds, the display shows the counts per second. Cal-check: This light indicates when the system is in ‘Calibration-Check’ mode on the rear of the unit. The light will be illuminated when in any of the 3 calibration-check settings and will not be illuminated when the system is set to the ‘Scan’ mode. The SCAN / Calibrate Control must be set to the SCAN position only, for all probes for all procedures. In this mode, the ‘Cal’ light will be turned off. See Section 11.2 Verification of Standard Gain (Calibration Quick Test)for more information on Calibration. The Battery indicator on the Control Unit shows the charge status of the battery in use. When the indicator level on the Control Unit is at 50%, the battery should be replaced with a fully charged battery. Please note that the charge status on the control unit may differ from charge status reflected on the battery. Signal input port, for cable connection. For all cabled probes, connect the probe cable matching the arrow on the cable connector to the arrow above the signal input port. See Section 4.7 Flexible Probe Cable for more information. The signal input port is not applicable when using the Wireless Pilot Probe with the Navigator 2.0. Connection port for the optional Co-Pilot accessory. www.Dilon.com 16 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 4.2 Control Unit Features: Rear Integrated Handle Scan/Cal-check Control Fuse Holder Isotope Control Pole Mount Battery Connection Compartment Door www.Dilon.com 17 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide Table 4A-2. Controls and Displays on the Rear of the Control Unit Control Display Description The SCAN/Calibrate Control has four positions. The control unit should be set to SCAN when is normal use. When set to SCAN, the CAL indicator on the front of the control unit will not illuminate. For instructions on use of the ‘+,’ ‘0’, and ‘-‘positions, contact Dilon Customer Service or the local distributor for additional information. Allows the user to designate the specific isotope in use x I125 – Iodine-125 (Only for use with Wired Probes. Not Applicable for use with Wireless Probes x 511keV – 18F-FDG (and I131) (Only for use with Wired Probes. Not Applicable for use with Wireless Probes) x In111 – Indium 111 (Only for use with Wired Probes. Not Applicable for use with Wireless Probes) x Tc99 - Technetium-99m The Isotope Control setting on the rear of the control unit illuminates the corresponding light on the Isotope Indicator on the front of the control unit Note: If the front panel CAL indicator is flashing before a procedure, move the control to the SCAN position. CAUTION: The isotope control must be set to the isotope in use. Setting the isotope control incorrectly will result in incorrect counts displayed. www.Dilon.com 18 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 4.3 Battery (Part # N2-8500-02) 4.3.1 Inserting the Battery into the Control Unit 1. Open the door to the battery port, located on the side of the control unit. 2. Insert a charged battery (Part #: N2-8500-02) into the battery port. The battery label should be facing toward the rear of the unit. The battery contacts will be inserted first. The tab on the side of the battery is positioned outward. Use the direction indicator arrow on the battery label for guidance. 3. Close the battery door. The door will “click” when closed properly. CAUTION: The battery must be removed prior to installing the Pole Mount. 4.3.2 Removing the Battery from the Control Unit 1. Turn off the Navigator Control Unit. 2. Open the door to the battery port, located on the side of the control unit. 3. The battery should partially eject when the door is opened. Use the tab attached to the end of the battery to slide the battery out of the Control Unit. www.Dilon.com 19 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 4.4 Installing the Wireless Pilot Probe Battery 1. Hold the Wireless Pilot Probe firmly while turning the battery cap counterclockwise until the cap is removed. 2. Inspect O- ring on the cap. If O-ring is missing or damaged, do not use the Battery Cap. Contact Dilon Technologies or your distributor for a new cap, if required. 3. Remove the Wireless Battery Holder (Part # WP-9050-00) from the probe. 4. Install 3V CR2 Duracell battery (Part # WP-8500-01) into the Wireless Battery Holder with positive (+) end of the battery aligned with the (+) as shown on the label. 5. Insert Wireless Battery Holder into probe with battery aligned with the serial number of the probe. Lightly turn until battery holder lowers into place. Note: The wireless antenna is located on the battery holder. Do not insert the antenna end of the battery holder into the probe. This will damage the antenna and may lead to wireless communication failures. www.Dilon.com 20 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 6. Install battery cap onto probe and turn clockwise until O-ring is no longer visible. 4.5 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 only the cable provided. All of the LEDs will flash momentarily to indicate that power is present. DC Calibration Battery Status Place the battery into either battery bay, ensuring that the 5-way connector is fully seated. 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. CAUTION: To avoid the risk of electric shock, the battery charger cord must only be connected to a Supply Mains with protective earth. Mains power quality should be that of a typical commercial or hospital environment 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 the battery and reinsert in order to resume charge. A green light will indicate that it is in charge mode. If the charger has flashing red light, the battery fuel gauge requires calibration. Only in this case, should the calibration button be pressed. Once the calibration is complete, the blue light will be solid. 4.6 Table 4B-4. Charge Bay LED Indications Indication Battery Charge Status Green Flashing Battery Charging Green Solid Battery Fully Charged Blue Flashing Battery in calibration mode Blue Solid Battery fuel gauge calibrated Red Flashing Battery fuel gauge in need of calibration Red Solid Error. Contact your local representative or Dilon Technologies. 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 21 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide Note: Recalibration time is approximately 18-26 hours. CAUTION: Do not expose the charger or power supply to water or liquids. Do not open the charger or power supply case. No user-serviceable parts. Refer to 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. 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. CAUTION: 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. Pulling or twisting the jacket may damage the cable and render it unusable. www.Dilon.com 22 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide Threshold 10-second Count Button and Indicator Range Button and Volume Power Button 4.8 Useful Adjustments That Can Be Made During Procedures 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. For Wireless Pilot Probe only. The Threshold feature is integrated into the probe. The Control Unit setting will not affect the wireless probe functionality. Range The Range function defaults to 1X. When Range is set to 1X, the audible signal fluctuates according to every event detected. The 10X position will fluctuate the audible signal every 10th event. The 100X position will fluctuate the audible signal every 100th event. NOTE: The Range control only affects the sound. The count shown in the display is independent of the range setting. 10-Second Press to obtain a 10-second count, keeping probe in fixed position each time. The Count total is displayed for four seconds. Volume Adjust to desired volume. Power Press to turn on the control unit or to safely turn off the device. www.Dilon.com 23 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 4.9 Software Version Display To display the software version on systems with version 2.7.0 or later of the control unit, have the control unit in the Off state, and switch the Isotope Selection Switch to TC-99. Turn the control unit On, and three numbers will appear on the display. The three digits on the display will be the version of software. For example, if 270 is displayed, then 2.7.0 is the software version. See below for mismatched versions of probe and control unit software. 4.10 Error Message The Navigator 2.0 with software version 2.7.0 or later includes warning and error message features not available in previous versions of the Navigator 2.0 system. The warning and error message features are intended to notify users of conditions that may impact the operation of the device. In a warning condition, the controller will automatically attempt normal operation. In an error condition, the system will require a reboot or user intervention as described in table 4E-1 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. Table 4E-1. Alarm Mode Indications Warning Mode ID ALARM STATE (Counts) 8888 If the system disconnects, it will automatically attempt to reconnect. If it is unable to reconnect after 4 seconds, the display will show 8888 while continuing to reconnect. During this time, the display will show ‘0’ as it is not picking up additional data. 3333 While in normal operating mode, the system communicates with one probe. If this probe is inadvertently turned off and another unpaired probe is powered on in the vicinity, the controller will display 3333 to indicate a new probe is attempting to connect. When the original probe is powered back on and establishes a connection with the controller, normal operational mode will resume. If you want to use a different wireless probe the Control Unit must be turned off and restarted to pair to the different probe. ERROR Mode ID ERROR STATE (Counts) www.Dilon.com 24 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 7777 System Software version mismatch – the controller and wireless probe software versions are incompatible. 6666 The EEPROM (memory) in the control unit has been damaged. If this error occurs, please contact Dilon 5555 Wireless Probe Low Battery – Indicates a low battery condition on the wireless probe. 4444 The EEPROM (memory) in the wireless prove unit been damaged. If this error occurs, please contact Dilon Note: additional warning and error mode IDs may be added in future software versions. www.Dilon.com 25 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 5 Probe Connectivity and Use 5.1 Navigator 2.0 with Wireless Pilot Probe WP-9000-14 (Angled) 14 mm Wireless Pilot Probe: WP-9000-14S (Straight) 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: 5A-1. Before Surgery x Insert a charged battery into the Navigator Control Unit. x Insert a new battery (Dilon Part # WP-8500-01) into the Wireless Pilot Probe. Refer to Section 4.4- x x 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. Upon initial insertion of new Wireless Pilot Probe battery, lightly shake the Wireless Pilot Probe to activate. The www.Dilon.com 26 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide LED on the Wireless Pilot Probe will illuminate when the probe is on and connected to a Control Unit. Table 5A-1. Pilot Probe LED Indicator (Applies to software version 2.5.6 or later) Indication Status On/Slow Flash Probe is in paring mode, looking for a control unit to connect to. On Probe has paired with a control unit and is ready for use. On/Fast Flash Battery is low. Probe should not be used until the battery is replaced. 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 lightly Off shake probe. 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 x See ‘Useful Adjustments that can be made During Procedures.’ Note: If at any time the control unit displays all 8’s on the display that are flashing continuously, the probe has been disconnected from the control unit. Reset the probe and control unit by powering each off and trying again. If the problem persists, contact Dilon Support. Note: For Technetium-99m (Tc99), the control unit settings are given in the following table. Table 5A-2. Navigator 2.0 with Wireless Pilot Probe – Settings & Indicators Control / Indicator Setting Controls (Rear of Control Unit) SCAN/Calibrate: SCAN Isotope: Tc99 Indicators (Front of the Control Unit) Range: 1x Threshold: Illuminated Display: 0 Isotope: Tc99 Indicator (On the Wireless Pilot Probe handle) Probe LED: Illuminated www.Dilon.com 27 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and 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. Before Surgery x Refer to Section 7: “Probe and Cable Cleaning” x Insert a fully charged battery into control unit. x Connect the cabled probe and Flexible Probe Cable (Part # GP-4001-00) to Navigator Control Unit. For intraoperative use, insert probe and cable in a sterile drape. Note: Keep control unit powered off until all components are connected. www.Dilon.com 28 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and 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) SCAN/Calibrate: SCAN Isotope: Tc99 Indicators (Front of the Control Unit) Range: 1x Threshold: Illuminated Display: 0 Isotope: Tc99 5B-2. During Surgery x See ‘Useful Adjustments that can be made During Procedures.’ 5B-3. After Surgery x Refer to Section 7: “Probe and Cable Cleaning” www.Dilon.com 29 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 6 Control Unit Cleaning The Navigator Control Unit may be cleaned prior to 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. x Sani-Cloth ® Prime Germicidal Disposable Wipes x Super Sani-Cloth® Germicidal Disposable Wipes x Sani-Cloth® AF3 Germicidal Disposable Wipes x Sani-Cloth® Plus Germicidal Disposable Wipes x CaviWipes TM x CaviWipes1TM Note: If residue is observed, use a dry cloth to remove. Never submerge the Navigator Control Unit. CAUTION: To avoid damage to the control unit, do not use cleaners or other methods not stated in this manual. CAUTION: Do not sterilize the Navigator Control Unit or immerse it in fluids. Attempting to do so will cause permanent damage to the Control Unit. 7 Probe and Cable Cleaning GENERAL WARNINGS: Failure to obey to these safety instructions may cause permanent damage to the systems and/or lead to inadequate cleaning and sterilization. WARNING: Do not drop the Navigator probe. The reusable Navigator probe is a delicate surgical instrument. Mechanical shock can result in permanent damage to the probe. WARNING: Follow universal, generally accepted practices when handling components that have come in contact with blood or tissue. WARNING: The Probes and cables must be cleaned and sterilized only by qualified personnel. WARNING: Do not clean or sterilize when the cap of the wireless probe is missing or not completely tightened. Attempting to do so will cause permanent damage to the probe. WARNING: Do not scratch or abrade the probe when cleaning or sterilizing. Scratching / abrading the probe surface will damage the probe. WARNING: Failure to thoroughly clean the device prior to sterilization may lead to inadequate sterilization. WARNING: Do not use unapproved methods of cleaning or sterilization. Use of cleaning or sterilization methods not listed in the Instructions for Use may cause permanent damage. WARNING: The handling and storing of clean and sterile probes and cables should be conducted per your facility’s guidelines. WARNING: Do not immerse probe and cable in fluids, or place in an automated cleaning system as it may cause permanent damage to the probe and cable. www.Dilon.com 30 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and Service Guide 7.1 Preparation Steps WARNING: To avoid permanent damage of the Navigator Control Unit, do not Preparation of sterilize the Navigator Control Unit or immerse it in fluids. 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. WARNING: To avoid permanent damage to the wireless probe, do not clean with the battery cap open or not securely tightened. PREPARATION STEPS: Ensure the following for wireless probes, wired probes, and cables: 1. The probes are free of any damage. 2. The cables are free of cracks or cuts. 3. The connectors of the probe and cable are completely dry. 4. The cable is detached from the probe and the Navigator Control Unit. 5. (If available) The top gun collimator is removed from the probe. For wireless probe only: 1. Prior to each sterilization or use, insert a new CR2 Duracell battery, part number WP-8500-01. 2. Ensure the cap is securely tightened to the Wireless Pilot Probe. The O-ring on the cap should not be visible. Cleaning Equipment: Enzymatic detergent Instructions: 1. Prepare enzymatic cleaner, suitable for surgical instruments, according to the manufacturer's recommendation. 2. Rinse the outside surfaces of the probe with a brisk stream of lukewarm tap water (98°F to 105°F / 36.5°C to 40.5°C). Wipe with soft cloth or sponge soaked in enzymatic cleaner. Repeat separately for collimator cleaning, if used. 3. Visually inspect device(s) for contaminated areas. 4. Repeat steps 1 & 2 until visual inspection reveals instrument(s) is clean. 5. Rinse equipment with a brisk stream of lukewarm tap water (98°F to 105°F / 36.5°C to 40.5°C) for 30-seconds. 6. Air-dry or dry with clean towel. www.Dilon.com 31 N2-5000-07-001 Rev 16 Navigator 2.0 User Manual and 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: CDC Publication: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update May: 2019 Accessible version : https://www.cdc.gov/infectioncontrol/guidelines/disinfection/ ISO 17664: 2021 Processing of health care products Joint Commission Standards Related to Disinfection and Sterilization Following are instructions for

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