Summary of Contents for Faxitron Bioptics TruNode S10
- Page 1 ® Surgical Gamma Probe User Manual Caution: Federal (USA) law restricts this device to sale by or on the order of a physician User Manual P/N: 110015 November 2019...
- Page 2 0050 Copyright © 2019 Faxitron Bioptics, LLC. All rights reserved worldwide. The work herein is owned exclusively by Faxitron Bioptics, LLC. No parts may be reproduced, transmitted, or otherwise used without the express prior written permission of Faxitron Bioptics, LLC.
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Page 3: Table Of Contents
® TruNode Gamma Probe System User Manual Table of Contents 1. INTRODUCTION ................4 2. SYSTEM OVERVIEW ................6 3. WARNINGS and CAUTIONS ............... 8 4. USING THE SYSTEM ................ 10 5. USING THE CONTROLS ..............13 6. IN SURGERY ..................15 7. -
Page 4: Introduction
1. INTRODUCTION Description The TruNode® Gamma Probe System is designed to detect and quantify Technetium-99m (Tc-99m) and Iodine-125 (I-125) in radio- guided localization medical procedures. A numeric display and audible signal convey the relative amount of radiation detected, allowing the user to localize radiolabeled tissue or structures. The system is battery-powered, wireless, and portable. - Page 5 Standards The TruNode® system complies with the following standards: Safety • IEC 60601-1 (2005) 3rd Ed. Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance Biocompatibility • ISO 10993 (including ETO residuals): Biological evaluation of medical devices: cytotoxicity, sensitization, irritation;...
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Page 6: System Overview
2. SYSTEM OVERVIEW The TruNode® T-10 User Feedback Unit is used with the TruNode® S-10 Probe. TruNode® User Feedback Unit (UFU) The UFU is comprised of a tablet computer and a speaker all enclosed in a protective silicone rubber case. An IV pole clamp is attached to the back. - Page 7 The UFU communicates bi-directionally with the TruNode® Probe over a Bluetooth Low Energy (‘BLE’) wireless link. It provides the visual display, sound feedback, and redundant controls for operating the probe. The rate of gamma photons entering the Probe is displayed on the UFU in digits and with a log-scale meter.
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Page 8: Warnings And Cautions
• Remove the Charger when the UFU is fully charged. • The UFU and Charger are non-sterile. Do not sterilize these components. • If liquid is spilled on the UFU, remove it from service and contact Faxitron Bioptics for instructions to return for inspection. Ph: 1.520.399.8180. - Page 9 • Securely mount the UFU to an IV pole. • After connecting to a probe, the UFU must be turned ‘off’ then back ‘on’ before attempting to connect to a new probe. Probe • DO NOT activate the Probe until it is ready to be used. It is designed to be used immediately after activation.
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Page 10: Using The System
4. USING THE SYSTEM Setting up the UFU (to be done prior to starting the procedure) 1. Turn on the UFU by pressing down on the ON-OFF control switch located on its top-left edge for approximately 5 seconds, until the boot screen appears. If only the battery-charge ICON appears, the battery is fully depleted and the UFU must be recharged prior to use. - Page 11 Flashing ‘M’ button on UFU indicates ready to link NOTE: After connecting to a probe, the UFU must be turned ‘off’ then back ‘on’ before attempting to connect to a new probe. Deploying the Probe 1. Remove the Probe from the sterile peel-pouch, using aseptic technique.
- Page 12 Note: The battery charge in the TruNode® Probe can also be tested as in step 2 by first assuring that there is no UFU in ‘Ready’ state nearby – a flashing light indicates the battery is not discharged. If no UFU is detected, the probe will turn off in 30 seconds. NOTE: The useful life of the TruNode®...
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Page 13: Using The Controls
5. USING THE CONTROLS NOTE: Each button can be: 1) momentarily ‘clicked’ or 2) held down for ~2 seconds to initiate a function. The UFU will announce the function. To adjust the audio count-rate feedback volume: Click the ‘+’ or ‘-‘ button on the probe. A slider bar on the UFU displays the volume. - Page 14 Scan Mode Point Mode Seed Mode To announce the instantaneous count rate: Click the ‘C’ button. The UFU continuously displays the instantaneous count rate. To get an averaged count rate: Hold the ‘C’ button for 2 seconds – at which time “Recording Counts” will be announced – then a countdown to “Zero”...
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Page 15: In Surgery
the UFU. Up to 6 of the most recent average count rates can be displayed, and they can be removed by touching the stored count rate on the display. To change the audio scale to match the count range: Hold the ‘+’... - Page 16 Point mode provides higher-spatial resolution because it rejects low energy gamma photons that have been scattered while in transit from their source to the probe’s detector. This allows the user to more precisely locate the source of the gamma photons: only those photons that have been minimally-scattered between their source and the probe’s detector are counted, so the influence of background and scattered radiation is reduced.
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Page 17: After Surgery
OBTAINING AN AVERAGED COUNT RATE The user can initiate the acquisition of an averaged, statistically- significant count-rate to improve the accuracy of the count rate reading for an exact target region. The user must hold the probe perfectly steady during this acquisition. When this feature is initiated, the TruNode®... - Page 18 • Wipe the surfaces of the UFU with a damp cloth or disinfectant wipe if they are soiled. Clean the display screen with a dry cloth to remove smudges. • Charge the UFU. For maximum battery life, remove the charger when the UFU is fully charged.
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Page 19: Specifications
® TruNode Gamma Probe System User Manual 8. SPECIFICATIONS TruNode® S-10 Probe Overall Dimensions: 17mm X 226mm Reach: 103mm, Operative Diameter: 10mm Weight: 70g ® Wireless: Bluetooth Smart Integrated Tungsten Collimator External Materials: Stainless Steel, Tungsten, Silicone Rubber Shielding Efficiency: >99.9% Energy Resolution: 10% FWHM (Tc-99m) Selectable Energy Windows: Tc-99 ‘Point’... -
Page 20: Troubleshooting
® TruNode Gamma Probe System User Manual 9. TROUBLESHOOTING Symptom: radiation count rate greater than zero even when no radiation present after contacting radioactive tissue Resolution: decontaminate probe tip of radioactive material using sterile process Symptom: spurious radiation counts in conjunction with energizing electrocautery device or other radio-frequency emitter Resolution: move electrocautery device cable or other radio-... -
Page 21: Symbols
® TruNode Gamma Probe System User Manual 10. SYMBOLS Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Only Splash-proof IPX4 Type BF Applied Part Bluetooth® Use by date Read usage instructions Sterilized using ethylene oxide STERILE EO Not to be used in case package is damaged... -
Page 22: Emc Declaration
® TruNode Gamma Probe System User Manual 11. EMC DECLARATION 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. It has been certified and tested by 3rd party testing facilities. - Page 23 ® TruNode Gamma Probe System User Manual stacked with other equipment. If adjacent or stacked use is necessary, the TruNode® Gamma Probe System should be observed to verify normal operation in the configuration in which it will be used. The Trunode® Gamma Probe System transmitter and receiver use Bluetooth technology, with a frequency band of 2.400 GHz- ®...
- Page 24 ® TruNode Gamma Probe System User Manual Guidance and declaration – electromagnetic immunity The TruNode® Gamma Probe System is intended for use in the electromagnetic environment specified below. The customer or the user of the TruNode® Gamma Probe System should assure that it is used in such an environment. –...
- Page 25 ® TruNode Gamma Probe System User Manual Guidance and declaration – electromagnetic immunity The TruNode® Gamma Probe System is intended for use in the electromagnetic environment specified below. The customer or the user of the TruNode® Gamma Probe System should assure that it is used in such an environment. IEC 60601 Compliance Immunity test...
- Page 26 ® TruNode Gamma Probe System User Manual Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
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Page 27: Fcc Information
® TruNode Gamma Probe System User Manual 12. FCC INFORMATION 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.