Arthrex SynergyRF AR-9800 Service Manual Download Page 24

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Technical Specifications

Synergy

™

System

Service Guide

DFU-0276-4r0_fmt_en-US

Page 18 of 50

3.5

Safety, EMC, and Regulatory Requirements

Table 13

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

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 10 Electromagnetic Emissions for further details on EMC

Certification

Summary of Contents for SynergyRF AR-9800

Page 1: ...ing personnel must read the User s Guide DFU 0221 XX 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 0276 4 Revision 0 2 2020 2020 Arthrex Inc...

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Page 3: ...SynergyRF Footswitch AR 9800 F 13 2 4 2 ApolloRF probe 14 2 4 3 ApolloRF Service probe 15 3 0 TECHNICAL SPECIFICATIONS 17 3 1 Console 17 3 2 Ambient Conditions for Operation 17 3 3 Ambient Conditions for Storage in shipping packaging 17 3 4 SynergyRF Footswitch 17 3 5 Safety EMC and Regulatory Requirements 18 3 6 Power Curves 19 4 0 SETUP 25 4 1 How to Set Up the Console 25 4 2 AC Power Safety Con...

Page 4: ...31 6 1 How to Display the Software Version 31 7 0 REPAIR POLICY 31 8 0 TROUBLESHOOTING 32 8 1 Troubleshooting Interference with Other Devices 32 9 0 END OF LIFE ENVIRONMENTAL DIRECTIVES 33 10 0 ELECTROMAGNETIC EMISSIONS 34 11 0 BASIC SYSTEM COMMUNICATION PLAN 40 12 0 PREVENTATIVE MAINTENANCE DOCUMENT OPTIONAL 41 ...

Page 5: ...agram 8 Figure 2 Front Panel of Console 9 Figure 3 Rear Panel of Console 10 Figure 4 Error Screen Display 12 Figure 5 Standard Footswitch Description 13 Figure 6 Standard ApolloRF probe Description 14 Figure 7 ApolloRF Service probe Description 15 ...

Page 6: ...ergy Footswitch Specifications 17 Table 13 Safety EMC and Regulatory Requirements 18 Table 14 Troubleshooting Faults their Causes and Solutions 32 Table 15 Guidance and Manufacturer s Declaration Electromagnetic Emissions 34 Table 16 System Cables 34 Table 17 Guidance and Manufacturer s Statement Electromagnetic Immunity 35 Table 18 Guidance and Manufacturer s Statement Recommend Separation 39 Thi...

Page 7: ...re to follow 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 patient safety when an alarm on ...

Page 8: ...de 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 9800 must be used with an awareness of the risk of damage to surrounding tissue through iatrogeni...

Page 9: ...able device or footswitch from the console while the disposable device or footswitch is activated The disposable device will stop functioning if this is attempted 10 Only use footswitches developed by Arthrex specifically for the AR 9800 SynergyRF console 11 Only use disposable devices developed by Arthrex specifically for the SynergyRF console 12 The footswitch cable connects and locks to the con...

Page 10: ...d by local hospital and regulatory requirements 2 The AR 9800 console incorporates a universal AC input power supply A voltage selection switch is not required 3 AR 9800 has been designed to maintain safe operation when subjected to Electromagnetic Interference from other devices within the limitations as described in section 10 4 Setup for a footswitch is the same for all models The console detec...

Page 11: ...by or on the order of a physician On Off push push Type CF Applied Part 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...

Page 12: ... connection Universal Serial Bus For use ONLY with thumb drive 10101 Serial port Arthrex integration Non Sterile SN Serial number Catalog number RF 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 3 Product Layout includes line drawings of produ...

Page 13: ...haracteristics change This will result in a more consistent clinical effect at the surgical site The Mains power supply 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 power adjustment m...

Page 14: ...6 4r0_fmt_en US Page 8 of 50 2 2 Connection Diagram 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 4 1 2 3 5 6 7 ...

Page 15: ...nel of 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 Handpiece Symbol 7 Handpiece Connector 8 Type CF Applied Part Symbol Cardiac Floating 1 2 4 7 6 5 3 8 ...

Page 16: ...le 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 E...

Page 17: ...ed Replace with a new device PROBE Communication Failure Communication with the 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 ha...

Page 18: ...ive Power Power supply is exceeding the power parameters contact 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 ...

Page 19: ...and Accessory Features 2 4 1 SynergyRF Footswitch AR 9800 F Figure 5 shows the SynergyRF Footswitch The features and symbols are identified in Table 6 below Figure 5 Standard Footswitch Description 2 Table 6 Elements of the SynergyRF Footswitch 1 Ablation button 2 Ablate power change button 3 Coag coagulate button 1 3 ...

Page 20: ...e minimum setting by pressing the Ablate Power Change button one more time 2 Ablate button Activates ablation at the tip of the ApolloRF probe 3 Coagulation button Activates coagulation at the tip of the ApolloRF probe The standard ApolloRF probes are utilized in conjunction with the SynergyRF system as a complete system in the resection ablation and coagulation of soft tissue and hemostasis of bl...

Page 21: ...late button Initiates ablation current 3 Coagulation button Initiates coagulation current 4 Red output connector Connects to the red variable load port of electrosurgical analyzer 5 Black output connector Connects to the black variable load port of electrosurgical analyzer 6 Connector Cable Cord Connects the Service probe to the SynergyRF console The ApolloRF Service probe is designed to be used b...

Page 22: ...uipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired 2 The maximum intended operating time of the Service Probe for a single use is 1 minute 3 It is intended for ESU analysis only It is NOT intended for use in surgical applications or to be operated by surgeons or surgical staff ...

Page 23: ... setting 9 with 218Ω load 3 2 Ambient Conditions for Operation Table 10 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 11 AR 9800 Ambient Conditions for Storage Temperature 30 to 70 C 22 to 158 F Relative humidity 10 to 90 no...

Page 24: ... 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 Safety Certification Marking CE Classification 93 42 EEC Annex IX Rule 9 Class IIb For all other accesso...

Page 25: ...Technical Specifications SynergyRF System Service Guide DFU 0276 4r0_fmt_en US Page 19 of 50 3 6 Power Curves ...

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Page 31: ...positioning 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 oc...

Page 32: ...lder 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 C...

Page 33: ...800 on a flat dry surface such as the AR 6481 Arthrex Arthroscopy cart 2 Connect the receiver end of the power cord for the AR 9800 into the AC 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 s...

Page 34: ...te functions The footswitch connector cannot be properly inserted into the console receptacle if the 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 In...

Page 35: ... Do not use the probe as a lever to enlarge the surgical site or gain access to tissue Observe extreme caution when using electrosurgery in close proximity to or in direct contact with metal objects or metal implants The majority of arthroscopes and instruments 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 met...

Page 36: ... the Arthrex SynergyRF Systems accessory devices and foot pedals and will provide competent and efficient service Any services and or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure 5 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 neces...

Page 37: ...arthrex de from 8 00 AM to 5 00 PM CET 6 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 Table 2 item 1 on the AR 9800 The software version is displayed during the power up sequence 2 Refer to Section 5 2 of the User s Manual to show how to display ...

Page 38: ...operly 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 Contact Technical Support If a devise must be returned disinfect the SynergyRF System and send to Arthrex using the original packaging Always send the correspondin...

Page 39: ...se 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 equipmen...

Page 40: ...vironment 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 f...

Page 41: ...khz 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 interr...

Page 42: ...Electromagnetic 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 ...

Page 43: ...put 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 of equipment marked with the following symbol NOTE 1 At...

Page 44: ...IEC 60601 test level Compliance level Electromagnetic environment guidance abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Model AR 9800 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ...

Page 45: ... 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 150 kHz to 80 MHz d 1 2 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d ...

Page 46: ...F System Service Guide DFU 0276 4r0_fmt_en US Page 40 of 50 11 0 Basic System Communication Plan Synergy RF System Basic Block Diagram User Interface Front Panel Display System Controller Power Supply RF System ...

Page 47: ...___________________ __________________________ _____________________________ Each step must be performed in the order provided on this form Sign off each step as it is performed prior to the next step NOTE The SynergyRF console does NOT require annual calibration or preventative maintenance Performing a preventative maintenance inspection is at the discretion of the healthcare facility to verify e...

Page 48: ...ut 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 Entry Module 10 Fuse label ...

Page 49: ...tion Visually inspect the Console and foot pedal to ensure that the cables connectors contacts and display are not damaged or worn If fluid or particles have splashed on the display clean with a microfiber cloth by gently wiping in a circular motion Preparation Initials Action Present Not Present Make sure the SynergyRF Console screen appears when the AC main power switch is activated Connect Serv...

Page 50: ...the yellow ablate Down Button 3 The ablate power 1 will decrease in increments of 1 Make sure the coag coagulation number increases when pressing the blue coag Up Button 4 The coag power 2 will increase in increments of 1 Make sure the coag number decreases when pressing the blue coag Down Button 4 The coag power 2 will decrease in increments of 1 Make sure you are able to press the Menu button 5 ...

Page 51: ...R 9899 T can be utilized to simplify the process First insert the red and black output connectors of the ApolloRF Service probe AR 9899 T into the red and black variable load bank connections of the electrosurgical analyzer Next plug the ApolloRF Service probe AR 9899 T connector into the SynergyRF console AR 9800 The ApolloRF Service probe contains ablate and coagulate buttons to initiate those f...

Page 52: ... A Operating Current N A Ground Impedance Test Measure from Ground on inlet terminal to metal chassis 0 1 ohm Leakage Current Chassis Normal Condition 0 1mA Leakage Current Chassis Single Fault 0 5mA Earth Leakage Current Normal Condition 0 5mA Earth Leakage Current Single Fault 1 0mA Test limits provided are per IEC 60601 1 3rd Edition and IEC 62353 2014 09 Results If all steps have passed or mea...

Page 53: ...probe PROBE Communication Failure Communication with the RF device has been lost Try checking the connection and replace the device if necessary Replace Probe The RF disposable device attached to the console is malfunctioning Try changing the probe System Temperature Failure The console temperature is outside of normal parameters Turn off and let cool down The console has overheated Try powering o...

Page 54: ...Supply PFC Voltage Power supply self check failure contact Arthrex Technical Services Power Supply Excessive Voltage Power supply is exceeding the voltage parameters contact Arthrex technical services Power Supply Excessive Power Power supply is exceeding the power parameters contact Arthrex technical services Relay Failure Power supply self check failure contact Arthrex Technical Services RF Outp...

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Page 56: ...reekside 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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