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Technical Specifications

Synergy

RF™

User’s Guide

DFU-0221-6r0_fmt_en-US

Page 22 of 58

3.5

Safety, EMC, and Regulatory Requirements

Table 10

Safety, EMC, and Regulatory Requirements

Parameter

Parameter Value

System

Classification

IEC 60601-1

Class I

(protection against electric shock)

FDA Class

Class II

EU Class

Class IIb

Health Canada Class

Class 3

Safety

Certifications

Domestic Certification

ES60601-1:2005/A1:2012

Canadian Certification

CAN/CSA C22.2 No. 60601-1-08

EU Certification

EN 60601-1:2006/A1:2013

EMC

Certifications

CISPR 11 EMC Class

Class A

CISPR 11 EMC Group

Group 1

EMC Certification

Certification to EN 60601-1-2:2015\

IEC 60601-1-2:2014, 4

edition

Safety

Certification

Marking

Classification

93/42/EEC

Annex IX Rule 9

Class IIb

For all other accessories refer to accompanying DFUs for more information.
Refer to Section 13.0 Electromagnetic Emissions for further details on EMC
Certification

Содержание Synergy AR-9800

Страница 1: ... personnel must read this User s Guide thoroughly prior to using this system and follow all safety warnings cautions and notes Arthrex Inc 1370 Creekside Blvd Naples FL 34108 1945 USA Toll Free 1 800 934 4404 www arthrex com Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 Fax 49 89 909005 280 www arthrex de DFU 0221 6 Revision 0 08 2020 2020 Arthrex Inc All rights r...

Страница 2: ...This page intentionally left blank ...

Страница 3: ...CHNICAL SPECIFICATIONS 21 3 1 Console 21 3 2 Ambient Conditions for Operation 21 3 3 Ambient Conditions for Storage in shipping packaging 21 3 4 SynergyRF Footswitch 21 3 5 Safety EMC and Regulatory Requirements 22 3 6 Power Curves 23 4 0 SETUP 29 4 1 How to Set Up the Console 29 4 2 AC Power Safety Considerations 29 4 3 Replacing the Fuses 30 4 4 Electromagnetic Compatibility 30 4 5 Basic Setup P...

Страница 4: ...46 6 0 CLEANING AND DISINFECTING 47 6 1 Console AR 9800 47 6 2 Footswitches 47 7 0 STERILIZATION 48 7 1 Transmissible Spongiform Encephalopathy Agents 48 8 0 MAINTENANCE 49 8 1 Periodic Maintenance 49 8 2 Service Manual 49 8 3 Annual Calibration 49 9 0 TECHNICAL SUPPORT 50 9 1 How to Display the Software Version 50 10 0 TROUBLESHOOTING 51 10 1 Troubleshooting Interference with Other Devices 51 11 ...

Страница 5: ...Main Screen Display 34 Figure 6 Settings Menu Display Operation 36 Figure 7 Language Selection Display Operation 38 Figure 8 Information Screen Operation 39 Figure 9 Reset Defaults Screen Operation 40 Figure 10 Power Change Button Screen Operation 41 Figure 11 Footswitch Override Selection Screen Operation 43 Figure 12 SynergyRF Footswitch Description 44 Figure 13 ApolloRF probe Description 45 ...

Страница 6: ...play Elements 34 Table 12 Settings Menu Display Operation 36 Table 13 Language Menu Display Operation 38 Table 14 Information Screen Display Operation 39 Table 15 Reset Defaults Display Operation 40 Table 16 Probe Buttons Display Operation 41 Table 17 Footswitch Override Display Operation 43 Table 18 Elements of the SynergyRF Footswitch 44 Table 19 ApolloRF probe Description 45 Table 20 Troublesho...

Страница 7: ...US Page 5 of 58 This is not a warranty document For all warranty information including disclaimers exclusions terms conditions and related provisions refer to the Arthrex U S Product Warranty section of the Arthrex Inc website found at www arthrex com whose provisions are incorporated herein by reference ...

Страница 8: ...dical professional 3 Failure to follow the set up instructions and or continuing to use the console AR 9800 without resolving an alarm could result in a serious patient adverse event 4 Failure to adhere to the set up instructions and use of Arthrex certified devices may result in inaccurate sensing and feedback by the device It is imperative that the user is aware of the potential compromise in pa...

Страница 9: ...ury 11 DO NOT use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide oxygen or endogenous gases All oxygen connections must be leak free for the duration of the surgical procedure 12 Do not have the device in direct contact with the patient if the patient requires defibrillation 13 The safety and effectiveness of the AR 9800 is verified and documented however the AR ...

Страница 10: ...t fuse may increase the risk of electrical shock or fire hazard 8 This device has passed testing for EMI RFI radiation and susceptibility and EMC compatibility This device may cause interference to other devices in the near vicinity if not set up and used as Arthrex instructs 9 Do not attach compatible disposable devices or footswitches during the Self Test or the Programming Modes 10 Do not detac...

Страница 11: ...tive NOTE This identifies information and training that can simplify the setup and operation of this device 1 The user should be experienced in arthroscopic surgical techniques before using the Arthrex SynergyRF System 2 Read this User s Guide thoroughly before operating the device and save it for future reference For additional information and training contact your local Arthrex representative 3 ...

Страница 12: ... First SynergyRF User s Guide DFU 0221 6r0_fmt_en US Page 10 of 58 video and electronic formats The Arthrex website also provides detailed surgical technique information and demonstrations Or contact your Arthrex representative for an onsite demonstration ...

Страница 13: ... or on the order of a physician On Off push push Type CF Equipment The product meets the essential requirements of Medical Device Directive 93 42 EEC Authorized representative in the European Community Precaution of Warning Notice Fragile handle with care Keep dry This side up Electrical hazard dangerous voltages are present Never attempt to repair the equipment Only trained service personnel may ...

Страница 14: ...ion Universal Serial Bus For use ONLY with thumb drive 10101 Serial port Arthrex integration Non Sterile SN Serial number Catalog number RF probe handpiece Do not use if package is damaged IP22 International Protection marking x Square brackets that enclose a letter number or lower case Roman numeral reference a callout on a line drawing Section 2 2 Product Features includes line drawings of produ...

Страница 15: ...amage is not reported within seven 7 business days of receiving the device Refer also to our General Terms of Business The warranty is not valid if modifications are made to the product or repairs are completed outside of Arthrex or an authorized Arthrex distributor Arthrex will answer any questions referring to the quality reliability and or shelf life of any product identified in this User s Gui...

Страница 16: ... output as the tissue characteristics change This will result in a more consistent clinical effect at the surgical site The Supply Main is applied to the console from a detachable power cord The console is activated by a footswitch and or hand switch The front panel display is a touch screen back lit LCD display that is used to select between ABLATE and COAG coagulation and provides a means for po...

Страница 17: ...age 15 of 58 Figure 1 Connection Diagram Table 1 Connection Elements 1 Generator Console 2 Power Cord 3 Footswitch 4 Footswitch Cable Connector 5 RF Ablation Device Probe 6 Probe Cable Connector 7 Suction Tube Connector Save the packaging for later transport of the device 4 1 2 3 5 6 7 ...

Страница 18: ...oot and ankle Contraindications The Arthrex SynergyRF System is contraindicated in any procedure where a conductive solution is not used The System is also contraindicated for patients who have cardiac pacemakers or other electronic implants without specific instructions from the manufacturer of the pacemaker or implant Please refer to the RF Probe Instructions for Use for a comprehensive list of ...

Страница 19: ...f the AR 9800 console The features and symbols are identified in Table 2 below Figure 2 Front Panel of Console Table 2 Front Panel Elements 1 On Off Power Switch 2 Power Switch IEC 60417 5010 symbol On Off 3 Footswitch Symbol 4 Footswitch Connector 5 Touch Screen Display 6 Probe Handpiece Symbol 7 Probe Handpiece Connector 8 Type CF Symbols Electric Shock Protection 1 2 4 7 6 5 3 8 ...

Страница 20: ... 3 below Figure 3 Rear Panel of Console Table 3 Rear Panel Elements 1 Supply main input Plug 2 Equipotential Bonding Pin with Stamped Equipotential Bonding Symbol 3 Address label 4 Fan 5 USB port For use ONLY by service technicians 6 Serial ports for Arthrex integration to only be connected to IEC 60601 1 approved equipment 7 Serial number label 8 Model number label 9 Fuse holder for the Power Ent...

Страница 21: ...e RF device has been lost Check the connection and replace the device if necessary Replace Probe The RF disposable device attached to the console is malfunctioning System Temperature Failure The console temperature is outside of normal parameters contact Arthrex technical support Turn off and let cool down The console has overheated Power off the console for 10 minutes WRAP Footswitch Stuck A butt...

Страница 22: ...ontact Arthrex technical services Relay Failure Power supply self check failure contact Arthrex technical services RF Output Failure Power supply self check failure contact Arthrex technical services Touchscreen Circuit Failure Touch panel failure contact Arthrex technical services Figure 4 Error Screen Display Table 5 Error Screen Display Descriptions 1 Error Message The description of the error ...

Страница 23: ...tting 9 with 218Ω load 3 2 Ambient Conditions for Operation Table 7 AR 9800 Ambient Conditions for Operation Temperature 10 to 40 C 50 to 104 F Relative humidity 20 to 75 Air Pressure 700 hPa to 1060 hPa 21 in Hg to 31 3 in Hg 3 3 Ambient Conditions for Storage in shipping packaging Table 8 AR 9800 Ambient Conditions for Storage Temperature 30 to 70 C 22 to 158 F Relative humidity 10 to 90 non con...

Страница 24: ...ertifications Domestic Certification ES60601 1 2005 A1 2012 Canadian Certification CAN CSA C22 2 No 60601 1 08 EU Certification EN 60601 1 2006 A1 2013 EMC Certifications CISPR 11 EMC Class Class A CISPR 11 EMC Group Group 1 EMC Certification Certification to EN 60601 1 2 2015 IEC 60601 1 2 2014 4th edition Safety Certification Marking CE Classification 93 42 EEC Annex IX Rule 9 Class IIb For all ...

Страница 25: ...Technical Specifications SynergyRF User s Guide DFU 0221 6r0_fmt_en US Page 23 of 58 3 6 Power Curves ...

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Страница 28: ...Technical Specifications SynergyRF User s Guide DFU 0221 6r0_fmt_en US Page 26 of 58 ...

Страница 29: ...Technical Specifications SynergyRF User s Guide DFU 0221 6r0_fmt_en US Page 27 of 58 ...

Страница 30: ...Technical Specifications SynergyRF User s Guide DFU 0221 6r0_fmt_en US Page 28 of 58 ...

Страница 31: ...tioning the console so that it is difficult to disconnect coupler or plug from supply main To prevent electrical shock do not use extension cords or 2 to 3 pronged adaptors NOTE If required by local regulations connect the console to the hospital equalization connector with an equipotential cable Connect the power cord to a wall outlet having the correct voltage Otherwise product damage may occur ...

Страница 32: ...r back into the AC inlet 5 Ensure that fuse holder is fully seated and that the tabs snap back Always use fuses with the correct values to avoid allowing overcurrent to enter the system An incorrect fuse may increase the risk of electrical shock or fire hazard NOTE The AR 9800 console incorporates a universal AC input power supply A voltage selection switch is not required 4 4 Electromagnetic Comp...

Страница 33: ...urface such as the AR 6481 Arthrex Arthroscopy cart 2 Connect the receiver end of the power cord for the AR 9800 into the AC Supply main input socket and the plug end to the facility AC mains supply 3 Power ON console 4 Allow to fully initialize 5 Attach a single use disposable Arthrex ApolloRF Device Probe Note For Probes with suction attach the suction adapter to the standard hospital suction sy...

Страница 34: ...corresponding black dots are not aligned The pins of the footswitch connector may be damaged if the black dots are not aligned before the footswitch is fully inserted The user may experience intermittent operation of the footswitch if the connector is not fully seated into the console receptacle Insert the footswitch connector into the console s footswitch receptacle Align the black dots on the co...

Страница 35: ...nts are metal Do not activate the probe when any portion of the metal tip is in contact with another metal object localized heating of the metal tip and the adjacent metal object may result in product damage to the patient and or operator The probe tip should be completely surrounded by irrigation solution during use A continuous flow of irrigation fluid is recommended Fluid flow assists in removi...

Страница 36: ...ver the AR 9800 must be used with an awareness of the risk of damage to surrounding tissue through iatrogenic injury 5 1 Main Screen Figure 5 Main Screen Display Table 11 Main Screen Display Elements 1 ABLATE Power Setting Ablate means to remove or cut The ABLATE power settings range from 0 9 When an accessory device is plugged into the console it will be recognized and the recommended ABLATE Powe...

Страница 37: ...ng will appear If an alternate setting is desired use the UP and DOWN COAG power adjustment buttons to choose the desired setting 3 Ablate Power Adjustment buttons The yellow up and down arrows adjust the ABLATE power setting An audible tick is emitted from the console for each setting unit changed 4 Coag Power Adjustment buttons The blue up and down arrows adjust the COAG power setting An audible...

Страница 38: ... 1 below 2 Probe Buttons When the Probe Buttons option is pressed the software displays the Power Change Button screen to enable or disable the ablation setting button on the ApolloRF probe handpiece see section 5 2 4 below 3 Reset Defaults button When the Reset Defaults button is pressed the software displays the Reset Defaults Screen which asks for confirmation before resetting all settings to t...

Страница 39: ...Guide DFU 0221 6r0_fmt_en US Page 37 of 58 6 Home button When the Home button is pressed the software displays the Main screen section 5 1 above 7 Info Button When the Info Button is pressed the software displays the Information screen see section 5 2 2 below ...

Страница 40: ...age Selection Display Operation Table 13 Language Menu Display Operation 1 Select Language radio buttons Select the language of choice 2 Menu button When pressed the software stores the selected language and returns to the Menu screen 3 Home button When pressed the software stores the selected language and returns to the Main screen 4 Cancel button When pressed the software returns to the Menu scr...

Страница 41: ...tor has built in intelligent device recognition IDR for Arthrex ApolloRF probes When attached the recommended setting will be automatically applied but individuals that desire an alternate setting can use the ABLATE power COAG power or Ablate power change button see Figure 13 on the device to change the settings Some power settings may be not be allowed depending on the RF probe attached 5 2 3 Res...

Страница 42: ...buttons that allows the user to confirm resetting of factory defaults as described in Table 15 below The defaults that are reset include Language Footswitch Override Volume probe ablation and coag settings Table 15 Reset Defaults Display Operation 1 Prompt to confirm resetting to factory defaults 2 Yes to reset to factory defaults 3 No to exit without resetting 3 1 2 ...

Страница 43: ...mode the ablate power change button is enabled This screen also includes Menu Home and Cancel buttons as described in Table 16 below Figure 10 Power Change Button Screen Operation Table 16 Probe Buttons Display Operation 1 Power Change radio buttons Enable or Disable the ablation setting button on the ApolloRF probe handpiece See Figure 13 2 Menu button When pressed the software stores the selecte...

Страница 44: ...below If both the Footswitch and the Hand Controls are enabled and activated simultaneously whichever button is activated first will take precedence and other inputs will be ignored while that button is activated W A R N I N G When the Footswitch Override function is disabled the disposable RF device Probe hand controls are active Care must be taken not to activate the device inadvertently In the ...

Страница 45: ...switch Override Display Operation 1 Footswitch Override radio buttons When a footswitch is connected select the Footswitch ONLY or Both footswitch and hand controls radio button The factory default is set to Footswitch ONLY mode 2 Menu button When pressed the software stores the selected mode and returns to the Menu screen 3 Home button When pressed the software stores the selected mode and return...

Страница 46: ...e button adjusts the power in the positive direction only Each time the button is pressed the Ablate setting increases by 1 unit When the device is at maximum power setting the user can return to the minimum setting by pressing the Power button one more time An audible tick is emitted from the console for each setting unit changed A different audible tick is emitted from the console when the maxim...

Страница 47: ...nnects to the console to prevent accidental separation during use To avoid damage always disconnect the device by pulling on the cable connector shell plug only Figure 13 ApolloRF probe Description Table 19 ApolloRF probe Description 1 Ablation Power Change button Each time the button is pressed the Ablation setting increases by 1 unit Activation increases ablation in a positive direction only Whe...

Страница 48: ...de for Ablation and Coag is 10 seconds on 30 seconds off 5 6 System Shutdown 1 Turn the power switch to the off position on the console 2 Disconnect the power cord from the wall outlet 3 Disconnect the suction tubing if applicable 4 Disconnect the Probe from the console 5 Dispose of Single Use Probe 6 Disconnect the footswitch if applicable ...

Страница 49: ...oisture on the receptacles remove with dry compressed air ONLY dry connectors should be plugged into the console Do NOT clean the device with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch or damage the device 6 2 Footswitches Clean the footswitch with an enzymatic cleaner without subsequent acid neutralization Rinse the footswitch thoroughly after clean...

Страница 50: ...pongiform Encephalopathy Agents It is outside the scope of this document to describe in detail the precautions that should be taken for Transmissible Spongiform Encephalopathy TSE Agents The agents for transmission of Creutzfeldt Jakob disease are believed to be resistant to normal processes of disinfection and sterilization Therefore the normal processing methods of decontamination and sterilizat...

Страница 51: ... unauthorized repair facility may result in reduced performance of the instruments or instrument failure 8 1 Periodic Maintenance The product should be inspected prior to and after each use to ensure that the there is no damage If it becomes necessary to return the console or accessory devices to Arthrex for service please clean them before shipping If fluid or particles splash on the display clea...

Страница 52: ...y through Friday from 9 00 AM to 5 00 PM EST at 49 89 909005 8800 or techsupport arthrex de from 8 00 AM to 5 00 PM CET 9 1 How to Display the Software Version Technical Support may request the software version of the console Follow these instructions to display the software version 1 Power On the AC mains power switch 1 on the AR 9800 The software version is displayed during the power up sequence...

Страница 53: ... used disconnect and connect footswitch Replace if not functioning properly 4 Open new RF probe Yellow fault message 1 User correction is required 1 Refer to Table 4 for proper disposition Red Fault Message 2 Critical failure 1 Make note of message displayed 2 Call Arthrex Service If the problems persist disinfect the SynergyRF System and send in to Arthrex using the original packaging Always send...

Страница 54: ...pose of WEEE in unsorted municipal waste The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste Instead it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment The separate collection and recycling of your waste equipm...

Страница 55: ...nment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group1 RF emissions CISPR 11 Class A The AR 9800 SynergyRF system is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluct...

Страница 56: ...Cycling Frequency 2 kV for power supply lines 1 kV for input output lines 100khz Cycling Frequency Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrupti...

Страница 57: ...tromagnetic environment guidance Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m 50 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note UT is the AC mains voltage prior to application of the test level ...

Страница 58: ... 7 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 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 o...

Страница 59: ...gnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Model AR 9800 as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz ...

Страница 60: ...3 5553 Arthrex Inc 1370 Creekside Blvd Naples FL 34108 1945 USA www arthrex com Customer Service 1 800 934 4404 Toll Free Technical Support 1 888 420 9393 Monday through Friday 9 00 AM 5 00 PM EST Arthrex GmbH Erwin Hielscher Straße 9 81249 München Germany Tel 49 89 90 90 05 0 www arthrex de All rights reserved ...

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