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Faxitron Bioptics TruNode S10, Руководство пользователя

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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; 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  

•

 

Wireless: Bluetooth 4.0BLE 

 

 

Содержание TruNode S10

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 November 2019 Surgical Gamma Probe ...

Страница 2: ...Da Vincilaan 5 1930 Zaventem Belgium Ph 32 27114680 0050 Copyright 2019 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 express priorwritten permission of Faxitron Bioptics LLC The following are trademarks of Faxitron Bioptics LLC TruNode TruNode System TruNode Gamm...

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 DECLARATION 22 12 FCC INFORMATION 277 13 Technical support product complaints 27 ...

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 I 125 radionuclides in a particular organ or body region It can be used in transcutaneous open surgical and laparoscopicprocedures Potential Applications The TruNode Gamma Probe System can be used by...

Страница 5: ...SO 11135 Validation and routine 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 Electromagnetic Compatibility EMC Directive 2004 108 EC Group l Class B EN ISO60601 1 2 2014 Medical Electrical Equipment Part 1 General Requirements For Safety Collateral St...

Страница 6: ...ablet computer and a speaker all enclosed in a protective silicone rubber case An IV pole clamp is attached to the back The tablet computer uses the Android operating system and runs the TruNode Application TruNode T 10 UFU A medical grade power supply is included for re charging the UFU battery Low leakage Medical Grade Power Supply EU Version Shown ...

Страница 7: ...g system The ON OFF control that turns 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 patient use in a TyvekTM peel pouch The pouch is designed for sterile handoff The Probe can also be used in the pouch without breaking the seal prior to setting u...

Страница 8: ...tron Power Supply provided with the UFU for recharging Use of another power supply may increase the risk of electric shock Fully charge the UFU before using the system Do not use the Charger in the operating room Do not use the Charger in the presence of an oxygen enriched environment or in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Keep the UFU off whe...

Страница 9: ...ding its 4 hour life 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 Probe DO NOT drop the Probe It may damage the detector element DO NOT strike the Probe tip against a hard surface It may damage the detector element DO NOT simultaneously use the pr...

Страница 10: ...pleted the Android Home screen will appear after 20 seconds After another 10 seconds the TruNode application will launch and the UFU will be ready to detect the TruNode probe Caution If the battery charge is below 50 turn off the UFU and charge it prior to use Do not use the Charger in the operating room 1 The UFU will announce a greeting followed by its charge status Verify the UFU is at least 50...

Страница 11: ...ight on the Probe keypad flashes This indicates the Probe has been activated The live TruNode application will start when the UFU senses the Probe NOTE The TruNode Probe can be used preoperatively in its sterile pouch prior to sterile deployment Simply press through theclear poly film to access the controls Use care not to damage the pouch seals as this could disrupt its sterile barrier Flashing M...

Страница 12: ...obe will turn off in 30seconds NOTE The useful life of the TruNode Probe is the lesser of 100 minutes of continuous use one patient procedure or 4 hours including preoperative use NOTE The TruNode Probe will hibernate after 10 minutes of inactivity To awaken the probe simply press and hold the M button until the light on the keypad flashes NOTE The UFU will display the life of the probe when 15 mi...

Страница 13: ...uncements 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 icon will be displayed in red To change the mode of the Probe from Scan to Point Click the M button on the Probe handle The selected mode is displayed on UFU To change the mode of the Probe to Seed ...

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 finally the averaged count rate is announced and displayed on Scan Mode Point Mode Seed Mode ...

Страница 15: ...re 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 of gamma photons that are detected produce more rapid count rate feedback information and Scan mode accepts scattered gamma photons with lower energy than Point mode and thus could have emanated fro...

Страница 16: ...erentially 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 TO MATCH THE INCOMING COUNT RATE A range of audio feedback is produced in proportion to the range of detected count rates An increase in pitch and beat frequency indicates an increase in detected cou...

Страница 17: ...h 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 measurement that is more accurate than the instantaneous reading but to less than 10 accuracy with 95 confidence Very low count rates will have much lower accuracy e g 5CPS target 25 accuracy with 95 confide...

Страница 18: ...es 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 ...

Страница 19: ...ensitivity 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 Resolution Point I 125 Seed Count Rate Reporting Count Rate Averaging Audio Feedback Scaling Volume and Mute Probe Life Lesser of 100 min continuous use or 4 hr intermittent use or 1 procedure Use Con...

Страница 20: ...esolution 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 other radio frequency emitter Resolution replace probe Symptom insufficient or complete lack of radiation counts when locating the probe over a known source of high radioactivity Resolution replace prob...

Страница 21: ...ized 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 alkaline battery USA REP USA Representative EC REP EU Authorized Representative Manufacturer Temperature limitation Electronic Waste SN Serial number Date of Manufacturer YYMMDD XX LOT Lot number REF Model Caution consult documen...

Страница 22: ...needs special precautions 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 that it is used in such an environment The following tables provide a guidance and declaration for the electromagnetic emissions and immunity of the TruNode Gamma Probe System which ...

Страница 23: ...uNode 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 Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The TruNode Gamma Probe System uses RF energy only for its internal function Therefore its RF emiss...

Страница 24: ...arth 2 kV 2 kV Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Dips 0 UT for 0 5 cycle 0 UT for 1 cycle 70 UT for 75 cycles Interruptions 0 UT ...

Страница 25: ...rom the equation applicable to the frequency of the transmitter Recommended separation distance d 0 58 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electro...

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 distance between portable and mobile RF communications equipment transmitters and the TruNode Gamma Probe System as recommended below according to the maximum output power of the communications equipmen...

Страница 27: ...ith the instruction manual 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 the interference at his own expense FCC Part 15C Intentional Radiators FCC ID 2ADNA S10 Caution changes or modifications not expressly approved by Faxitron Bioptics LLC could vo...

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