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Standards

The

TruNode®

system complies with the following standards:

Safety

•

IEC 60601-1 (2014) 4th 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; externally
communicating device; <24hrs exposure

Sterilization

•

ISO 11135: Validation and routine control of ethylene oxide
sterilization

•

ISO 11607-1:2009+A1:2014: Packaging for Terminally Sterilized
Medical Devices

Regulatory

•

Medical Devices Directive 93/42/EEC amendment 2007/47/EC,
Class IIa

Electromagnetic Compatibility

•

EMC Directive 2004/108/EC Group l, Class B

•

EN ISO 60601-1-2:2014 Medical Electrical Equipment - Part 1: General

Requirements For Safety - Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests

Wireless Operation

•

Radio Equipment Directive 2014/53/EU

•

FCC Part 15C: Intentional Radiators

–

FCC ID 2ADNA-S10 (Probe)

& QISCPN-W09 (Huawei Tablet) or ZCASMT-290 (Samsung
tablet)

•

Wireless: Bluetooth 4.0BLE

Содержание TruNode S-10

Страница 1: ...User Manual Caution Federal USA law restricts this device to sale by or on the order of a physician User Manual P N 110015 August 2020 User Manual P N MAN 07510 Revision 002 December 2020...

Страница 2: ...pyright 2020 Faxitron Bioptics LLC All rights reservedworldwide The work herein is owned exclusively by Faxitron Bioptics LLC No parts may be reproduced transmitted or otherwise used without the expre...

Страница 3: ...N 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 AFTER SURGERY 17 8 SPECIFICATIONS 19 9 TROUBLESHOOTING 20 10 SYMBOLS 21 11 EMC DECLARA...

Страница 4: ...radiation from Tc 99m and I 125 radionuclides in the body or tissues Indications for Use The TruNode Gamma Probe System can be used in non imaging procedures to quantify relative amounts of Tc 99m or...

Страница 5: ...control of ethyleneoxide sterilization ISO 11607 1 2009 A1 2014 Packaging for Terminally Sterilized Medical Devices Regulatory Medical Devices Directive 93 42 EEC amendment 2007 47 EC Class IIa Elect...

Страница 6: ...ablet computer and custom speaker all enclosed in a custom protective silicone rubber case An IV pole clamp is attached to the back The tablet computer uses the Android operating system and runs the T...

Страница 7: ...s launches the TruNode application is located on the top of the UFU enclosure TruNode Probe The wireless TruNode Probe is battery powered 4 5V It is completely sealed and supplied sterile for a single...

Страница 8: ...ing Use of another power supply may increase the risk of electric shock Fully charge the UFU before using thesystem Do not use the Charger in the operating room Do not use the Charger in the presence...

Страница 9: ...e window DO NOT reuse the Probe It can be used on a single patient in a single surgical procedure only Reuse poses a risk of cross infection and cross contamination DO NOT attempt to re sterilize the...

Страница 10: ...e NOTE A full charge for a fully discharged UFU takes about three hours Unless the UFU is fully depleted the Android Home screen will appear after 40 seconds After another 30 seconds the TruNode appli...

Страница 11: ...tion that is easy to see by the user 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 th...

Страница 12: ...dy state nearby a flashing light indicates the battery is not discharged If no UFU is detected the probe will turn off in 30seconds NOTE The useful life of the TruNode Probe is the lesser of 100 minut...

Страница 13: ...ncements cannot be adjusted To mute the audio feedback volume Repeatedly click the button on the Probe until the UFU announces Muting Probe The audio level slider bar will be minimized and the speaker...

Страница 14: ...the instantaneous count rate To get an averaged count rate Hold the C button for 2seconds at which time Recording Counts will be announced then a countdown to Zero while the integration completes and...

Страница 15: ...e gamma photons that have been scattered while in transit from their source to the probe s detector This allows the user to survey wider areas more quickly than Point mode The relatively higher number...

Страница 16: ...rentially accepts photons from I 125 while rejecting the majority of photons from nearby Tc 99m This can be useful for detecting I 125 seeds or other sources of I 125 isotope CHANGING THE AUDIO SCALE...

Страница 17: ...accuracy e g 1 000CPS target 2 seconds counting time 10 accuracy with 99 confidence Or For count rates below 40 counts per second The system will count for 10 seconds and return a count rate measurem...

Страница 18: ...s 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 U...

Страница 19: ...nsitivity in Air Point Mode 18 000CPS MBq max 3 400 MBq 1cm Sensitivity in Air Scan Mode 27 000CPS MBq max 4 800CPS MBq 1cm Probe Mounted Controls Activate Connect to UFU Mode Hi Sensitivity Scan Hi R...

Страница 20: ...solution move electrocautery device cable or other radio frequency emitter away from probe Symptom spurious radiation counts not associated with radiation contamination or electrocautery device or oth...

Страница 21: ...structions STERILE EO Sterilized using ethylene oxide Not to be used in case package is damaged 2 Re use is not allowed 2 Sterilize Do not re sterilize Does not contain natural rubber latex Contains a...

Страница 22: ...ions regarding EMC and needs to be installed and put into service according to the EMC information provided in this User Manual The customer or user of the TruNode Gamma Probe System should assure tha...

Страница 23: ...SK modulation The effective radiated power of the transmitter is 1 2mW The Trunode Gamma Probe System may be interfered with by other equipment even if that other equipment complies with CISPR EMISSIO...

Страница 24: ...e 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply inp...

Страница 25: ...closer to any part of the TruNode Gamma Probe System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended...

Страница 26: ...gnetic environment in which radiated RF disturbances are controlled The customer or the user of the TruNode Gamma Probe System can help prevent electromagnetic interference by maintaining a minimum di...

Страница 27: ...LTE Band 5 Pulse modulation b 18 Hz 2 0 3 28 870 930 1720 1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1845 1970 2450 2 400 2 570 Bluetooth W...

Страница 28: ...al may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct t...

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