Remote Control User Manual - STOCKERT medical solutions
Contents
1. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the SmMarRTABLATE Remote Control The SmarTABLATE Remote Control is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the SMARTABLATE Remote Control can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SMARTABLATE Remote Control as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17VP d 1 17 VP d 2 33 VP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures object2. The device is latex free ROHS compliant Directive 2002 95 EC of the European Parliament and of the RoHS VY Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment ROHS compliant marking according to Chinese Administration on the Control of Pollution Caused by Electronic Information Product ACPEIP standard SJ 11364 2006 The device is protected against solid foreign objects of 12 5 mm diameter and IP 21 Made in Germany greater and is protected against vertically falling water drops Certificate of origin in Germany q Hardware revision number Speaker receptacle 8 Symbols Page 26 Remote Control User Manual 9 Warranty 9 1 Transit Damage The SMARTABLATE Remote Control and accessories must be examined for transit damage immediately after receipt If the remote control and accessories are damaged notify Customer Support Damage claims can be validated only if the seller or the shipping agent is informed immediately For your convenience an Error Report form is shipped with the remote control you can use this form to record any damage 9 2 Warranty The warranty for the SmarTABLaTe Remote Control warrants that the remote control will conform to its product specifications for a period of one year from the date of shipment or for the period of time defined in the purchase contract The warranty does not cover n
3. Biosense Webster Biosense Webster Inc A Division of Johnson amp Johnson Medical NV SA 3333 Diamond Canyon Road Leonardo da Vincilaan 15 Diamond Bar California 91765 USA 1831 Diegem Belgium Tel 1 866 473 7823 Tel 32 2 7463 401 Fax 1 909 468 2786 Fax 32 2 7463 403 http www biosensewebster com CARTO and SMmaRTABLATE are trademarks of Biosense Webster Inc The third party trademarks listed herein are trademarks of their respective owners Caution Federal USA law restricts this device to sale by or on the order of a physician SMARTABLATE Remote Control Firmware 1 XX XX Biosense Webster Inc 2012 2013 January 2013 SARC_UM_04 00_EN
4. The upper portion of the remote control can be tilted for easier viewing Hold the top or side of the remote control while you release the handle behind it Tilt the remote control to the desired angle and then push the handle back into place Verify that the handle is completely closed and that the remote control is locked in place before you release your hold of the remote control 3 4 6 Connection to the SMARTABLATE RF Generator Plug the connection cable from the SmarTABLaTE RF Generator into the receptacle for the generator cable see Item 8 in Section 3 2 Controls on the Back of the Remote Control as described in Section 3 4 3 Circular Plug Connections 3 5 Cleaning and Disinfecting the Remote Control Pome e The SmMARTABLATE Remote Control must be turned off and the mains cable must be disconnected from the remote control before cleaning and disinfecting the remote control e The SMARTABLATE Remote Control and mains cable must not be sterilized Use a dry microfiber cloth to clean the remote control s touch screen If damp cleaning is necessary moisten a soft cotton or linen cloth with commercial glass cleaner that does not contain alcohol and wipe the screen Do not spray the cleaner directly onto the screen Use a soft damp lint free cloth to clean and disinfect the housing of the remote control Use only non flammable and non explosive substances Water or soapy water is recommended for cleaning Make sure that
5. Remote Control User Manual 3 Remote Control Overview and Setup 3 1 Controls on the Front of the Remote Control RF ON if ABLATION START lt p gt Pi 8 Manufactured by Stockert GmbH Ostrbutod by Fi M Biosense Webster ji a pinmafoiaasrpar ji 7 4 a oo 1 RF On indicator 2 3 4 5 6 7 8 Ablation Start button Stop button Touch screen Alarm indicator Stand by button Stand by indicator Data Entry Knob 3 Remote Control Overview and Setup Page 4 Remote Control User Manual 3 2 Controls on the Back of the Remote Control 9 100V 240V 50 60HZ 40VA Item Description 1 Mains socket and mains rating information Handle for tilting the remote control Speaker receptacle not implemented USB port for use by service technicians only Serial data port 1 for electrophysiology recording system Serial data port 2 for CARTO System Receptacle for SMARTABLATE System foot pedal cable Receptacle for SMARTABLATE RF Generator cable Oo OI NI nn wm BW N Device label 3 3 Functional Test and On Site Training The SMARTABLATE Remote Control is a medical device In some countries in order to comply with local regulations the remote control may not be put into service until the distributor has subjected the remote control to a functional test on site and has
6. Remote Control User Manual 4 2 Accessory Lists The following is a list of accessories for the SMARTABLATE Remote Control A WARNING Use only the original accessories provided by or recommended by the manufacturer for the SMARTABLATE Remote Control If you use accessories that are not authorized by the manufacturer the safety of the device and system is not guaranteed 4 2 1 Foot Pedal Item Foot Pedal length of connection cable 3 m Worldwide except China China Foot Pedal Extension Cable length 7 m Redel 6 gt Redel 6 black 4 2 2 SmartTABLaTe Cables Item Connection Cable from SMARTABLATE RF Generator to SMARTABLATE Remote Control Redel 10 gt Redel 10 yellow length 10 m length 15 m length 25 m length 30 m Mains Cable length 3 m Australia Brazil China EU India South Africa Israel Japan Russia Switzerland Taiwan UK Singapore Hong Kong USA Part M490005 M4900405 M490026 Part M490010 M490029 M490012 M490013 M4900601 M4900609 M4900410 M4900108 M4900604 M4900606 M4900210 M4900603 M4900605 M4900607 M4900602 M490024 4 Accessories Page 10 oo cii E E a E Remote Control User Manual Item Part Serial Data Communication Cable for Carto Systems or Electrophysiology Recording Systems Redel 9 gt Dsub 9 gray length 3 m M490021 HAE Li l length 5 m M490025 length 15 m M490023 4 3 Caring for Acc
7. no liquid penetrates the inside of the remote control The following disinfectants may be used for disinfecting the remote control and its cables e Lysoformin spezial e Kodan e Meliseptol e Commercial disinfectants that do not contain ethyl alcohol Caution The following substances must not be used acetone benzene acids of any kind including acetic acid and citric acid scouring agents nitro dilutions and other organic solvents Do not use any agent containing ethyl alcohol to clean the remote control lodine or disinfectants containing dyes cause discoloration of the housing and should not be used Perform disinfection by wiping not by spraying Avoid condensation If cleaning or disinfecting the remote control 3 Remote Control Overview and Setup Page 7 Remote Control User Manual SMART with flammable or explosive substances cannot be avoided make sure these substances have completely evaporated before the remote control is turned on 3 6 Protecting Against Damage In addition to being operated and maintained per the instructions in this user manual the SMARTABLATE Remote Control must also be protected against damage This includes installing the remote control in a safe location and protecting the remote control against moisture contamination and contact with flammable or explosive substances Make sure that all cables to devices and accessories are arranged in a way that prevents tripping Make sure that th
8. trained the person responsible for operating the device in the handling of the remote control per this user manual All applicable requirements of local regulations must be followed 3 Remote Control Overview and Setup Page 5 Remote Control User Manual SMART 3 4 Setup 3 4 1 Setting Up the Remote Control The SmarTABLaATE Remote Control may be used only in medical rooms IEC EN 60601 1 1 AAA 1 201 Place the remote control on a secure non slip surface If the remote control is placed ona mounting plate make sure that it is securely fastened Do not place the remote control directly above another device Make sure that there is enough free space on all sides of the remote control to allow the heat created by the remote control to escape Make sure that the cable to the SmarTABLATE RF Generator is properly connected see Section 3 4 3 Circular Plug Connections and the remote control can be moved easily without disconnecting it from the generator If the cable to the generator is disconnected when the remote control is the system Master ablation is automatically stopped 3 4 2 Mains Connection The SmarTABLaTE Remote Control automatically adjusts for the necessary mains Kg voltage and frequency To avoid the risk of electric shock connect the mains cable from the remote control mains socket see Item 1 in Section 3 2 Controls on the Back of the Remote Control to a 3 prong outlet that meets the specifications in Se
9. 4 Remote Control User Manual 8 Symbols Symbol Distributed by Manufactured by LUPE Qe O BB IOIOI LERNA Description The device is distributed by The device is manufactured by Quantity Catalog number Alarm Rotational adjustment Clockwise rotation increases value Follow operating instructions Follow operating instructions Upper and lower temperature limits storage and shipping conditions Upper and lower humidity limitation storage and shipping conditions Upper and lower atmospheric pressure limitation storage and shipping conditions Keep dry Caution Radiofrequency Alternating current Serial data port USB port Generator receptacle Foot pedal receptacle Manufacturer Manufacturing date 8 Symbols Page 25 Remote Control User Manual Description Serial number Lot number Japanese version of the SMARTABLATE Remote Control United States version of the SMARTABLATE Remote Control Worldwide version of the SMARTABLATE Remote Control except the United States and Japan Medical General medical equipment as to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 NO 601 1 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 NO 60601 1 2008 40GF CE marking with the number of the notified body Separate collection for electrical and electronic equipment The device does not contain phthalates
10. 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6 kV contact 8 kV air 2 kV for power supply lines 1kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec 3 A m Compliance Level 6 kV contact 8 kV air 2 kV for power supply lines 1kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec 3 A m Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the SMARTABLATE Remote Control requires continued operation during power mains interruptions it is recommended that the SMARTABLATE Remote Control be powered from an uninterruptibl
11. AAMI HF 18 Electrosurgical devices CAN CSA C22 2 No 601 1 Medical electrical equipment Part 1 General requirements for safety B 90 CMDR Canadian Medical Devices Regulations DIN EN 980 Symbols for use in the labeling of medical devices DIN EN 1041 Information supplied by the manufacturer of medical devices DIN EN ISO 14971 Medical devices Application of risk management to medical devices EU Dir 2002 96 EC EU Directive 2002 96 EC of 27 January 2003 on waste electrical and electronic equipment WEEE IEC 60812 Analysis techniques for system reliability Procedure for failure mode and effects analysis FMEA IEC EN 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC EN 60601 1 1 Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems IEC EN 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests IEC EN 60601 1 4 Medical electrical equipment Part 1 4 General requirements for safety Collateral Standard Programmable electrical medical systems IEC EN 60601 1 6 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability IEC EN 60601 1 8 Medical electrical equipmen
12. ABLATE RF Generator from outside the patient area The SmarTABLATE Remote Control was designed to ensure simple intuitive and user friendly operation This accessory features a touch screen for making selections and setting parameters Critical safety functions are controlled by buttons that are operated independently of the touch screen A prominent red Stop button has priority over all other functions and connected devices thus immediately stopping RF energy delivery when pressed Use of the SMARTABLATE Remote Control requires familiarity with the device and its operation Before using the remote control the user should read this user manual and the user manual for the SMARTABLATE RF Generator For more information on training options please contact Biosense Webster We will gladly answer any questions that you may have Yours truly STOCKERT GmbH Remote Control User Manual 1 Indications See the SmarTABLaTE RF Generator User Manual for indications that apply to the SmarTABLATE RF Generator and the SmarTABLaTE Remote Control 1 Indications Page 1 Remote Control User Manual SMART 2 Warnings Note The warnings in this section cover the SMaRTABLATE Remote Control specifically See the SMARTABLATE RF Generator User Manual for additional warnings 1 Read this user manual carefully before using the SMARTABLATE Remote Control for the first time Note especially the instructions in Secti
13. ShA aii Remote Control User Manual SARC_UM_04 00_EN Manufactured by Distributed by Stockert GmbH K Biosense Webster a fofmonafolmon company Remote Control User Manual Table of Contents PREFACE II 1 INDICATIONS 1 2 WARNINGS 2 3 REMOTE CONTROL OVERVIEW AND SETUP 4 3 1 Controls on the Front of the Remote Control sesssesseesssesssesseesseessesseesseesseesecoseesseesseesseesseeseeeseesse 4 3 2 Controls on the Back of the Remote Control ssesssesseesssesssesseesseessesseesseesseesecoseeoseeeseesseesseesseeseesse 5 3 3 Functional Test and On Site Training s ssessesssessessesseessesseessessesseessesseoseeseessesseoseesessersseoseoseessesseosees 5 A U E A EAA sgucotovataieotansianacnaetts 6 3 4 1 Setting Up the Remote Control es ssesseessessesseesseeseessesseeseessessesseeseesseoseeseesscessesseoseessesseosees 6 BAZ Mains COnnectiOn sessesessessessesessessesessessesessessesesseseesesseosessesesseoseseoseseesesseseoseoseseoseosesseseesesse 6 243 Circular Plug COnNECtiONS zessin ninss veseni aar NEEE CSEG RS 6 344 Serial Data COMMS CUO ING serseriye issii orian inea Naaa E NE 6 3 4 5 Tilting the Remote Control ssesseessessesseessessesseessessesseeneesseesseoseoseeseesseoseeseesseoseeseessesssesseosees 7 3 4 6 Connection to the SMARTABLATE RF Generator seseesseseessesecssssecessseecessseeessseeessseeessseeee 7 3 5 Cleaning and Disinfecting the Remote COntrol eeesseesssesssesseesseesse
14. an have a negative effect on the technical specifications Do not modify accessories Visually inspect all accessories on a regular basis Make sure that the connected cables are not damaged 6 Make sure that the cable to the SmarTABLATE RF Generator is properly connected and that the remote control can be moved easily without disconnecting it from the generator see Sections 3 4 1 Setting Up the Remote Control and 3 4 3 Circular Plug Connections 7 Place the remote control on a secure non slip surface as described in Section 3 4 1 Setting Up the Remote Control Make sure that there is enough free space on all sides of the remote control to allow the heat created by the remote control to escape 8 Other electrical devices can influence the function of the remote control if they are operated at the same time in the immediate vicinity of the remote control 9 To avoid damage to the connection cables do not wrap the cables around the remote control or other apparatus Coiling the connection cables during normal operation of the remote control creates inductive components which can lead to interruption of the operation of the remote control 2 Warnings Page 2 Remote Control User Manual SMART 10 Special safety measures with regard to electromagnetic compatibility EMC must be taken with electrical medical devices This equipment generates uses and can radiate radiofrequency energy and if not installed and used in accordance
15. cations e Verify that all of the visual and audible indicators available on the remote control are functional see Section 5 1 Remote Control Startup e Verify that the Data Entry Knob O is not loose and that the values on the screen change as expected when the knob is turned e Verify that the foot pedal is not damaged and that it functions correctly see Section 5 4 Volume Brightness and Foot Pedal Test e fusing accessories that connect to the remote control verify that the connections to those systems are functional 7 Technical Data Page 17 Remote Control User Manual Once a year perform the verifications listed above as well as those below e The device label is present and readable e The cable connection receptacles are not damaged and are not loose e The accessory cables especially the mains cable are not damaged e The remote control can function as the system Master Make the remote control the system Master and then perform ablation using a STOCKERT test box for the SMARTABLATE RF Generator Because the remote control is a medical device some countries require an electrical safety test If local regulations require a safety test have the remote control tested by a technician certified by the local governing agency Important Notice To ensure the safety of the SmarTABLATE Remote Control repairs may be performed only by the manufacturer a service engineer certified by the manufacturer or a
16. cniscnsstesteesecosnstessovisnysieisdcusteseovioscsesthanesessnosealeaneniareens 15 6 3 Calibrating the Touch Screen a cscrevseseasanescusssustesstves cncgbesscnvscsdhancaseussegscesbacnsassscshooveteasantscentonssteaninesactes 16 Remote Control User Manual 7 TECHNICAL DATA ZA SPEM arinn ee ee eee eee ee ee ee eee ee 7 2 Storage and Shipping Conditions visssscccereseccssssvsecxsvenseconsanoncsuencacunsssncen dose sdieosaeneevoessesosseuaeasesevencsesees 43 Operating COMI OIG sesoses neerpen EAE E SNE AEE TENEN ENE NE EA ENAN EAN ERRE ERREN ONEEN TA SAVIE OS aa aman oe Lo WOVE ANC O srein eni eier nerie NEEN Enia ENE EA T NEEE PE IDEATE Se VE e E E ANS E EA E E AEA E A E E EE E exes 74 Conformanc to Standards ieesteercn cae ee enetiesttccnicsceentntieniatitnn 8 uaerciatereinenctieachewtrtieacies 7 8 EMC Information and Technical Description ssssccsisidscesicctsssicteldscssastvsbscstivatasarsetbscesdesivslacent avesevests 8 SYMBOLS 9 WARRANTY AE TTAR O N aia E A eZ E E A T A E A A cn A A E A 23 Produc Gan Y eaaa A NEEN E EAE E E Remote Control User Manual Preface The SMARTABLATE Remote Control is an accessory for the SMARTABLATE RF Generator The physical appearance and the user interface of the two devices are almost identical However the remote control is not designed to connect to patient cables such as catheter cables and indifferent electrode cables The SMARTABLATE Remote Control allows remote control of the SMART
17. ction 7 1 Specifications Use only the mains cable supplied by the manufacturer or distributor for the country where the remote control is being used 3 4 3 Circular Plug Connections ON The circular plugs on the accessory cables are the same color as the Q receptacles on the back of the remote control see Section 3 2 Controls i on the Back of the Remote Control To connect an accessory cable to 7 the remote control align the arrow on the plug with the mark on the Ce receptacle and push in without unnecessary force until a click indicates that the connector is locked in the receptacle If the plug does not fit in the receptacle verify that the color coding matches and that the number of pins in the plug is appropriate for the receptacle To remove the plug gently pull back the sleeve on the plug and pull the plug out of the receptacle 3 4 4 Serial Data Connections lOlOll Devices that exchange data with the generator such as the Carto 3 System the CARTO XP System electrophysiology recording systems and other external compatible monitoring systems can be connected to the serial data ports on the back of the remote control see Items 5 and 6 in Section 3 2 Controls on the Back of the Remote Control These connections can be tested following instructions available in the SMARTABLATE RF Generator User Manual 3 Remote Control Overview and Setup Page 6 Remote Control User Manual 3 4 5 Tilting the Remote Control
18. displayed at the bottom of the screen This indicates that from the remote control you can only observe system activities or stop ablation When you want to control the system from the remote control make the remote control the Master as described in this section System Control Screen When Remote Control Is Monitor Device status Become Master MONITOR Volume Brightness Foot Pedal Rem Press to test of ELELEE 4 Automatic no RF energy will be delivered Manual Not Ay pressed Ee SLE x oe j Preset THERMOCOOL Standard Quick Steps Press System Control gt on the Navigation Bar Press Become Master Notes 1 Even when the remote control is the Monitor you can stop ablation by pressing Stop on the remote control or by releasing the foot pedal 2 Ifthere is a problem with the connection to the generator the System Control screen will display the message shown below Follow the instructions in the message to resolve the problem Also see Section 6 1 Problems with Connection to the Generator No connection detected to SMARTAELATE RF Generator Check the following the cable is free of cuts or kinks the cable is properly connected and the SMARTABLATE RF Generator is on The remote control software may be incompatible Rernote control SW Ver 1 0 5 Remote Control Operation Page 13 Remote Control User Manual 5 4 Volume Brightness and Foot Pedal Test Quick Steps P
19. do not appear or if the number of dots stops increasing and the logo remains on the screen or if the confirmation message does not appear there could be a problem see Section 6 2 Other Troubleshooting 4 Always wait until the automatic self test has been successfully completed and the remote control has been made the Master of the system see Section 5 3 Assigning the System Master before starting the first steps of the procedure on the patient for example before anesthesia or before creating percutaneous access Also if using accessories that connect to the remote control s serial data ports verify that the connections to those systems are functional prior to starting the first steps of the procedure Doing this helps to detect problems with the device before the patient is in a phase of the intervention in which interruption could lead to an increased risk to the patient s health Also perform a visual inspection of the accessories see Section 4 3 Caring for Accessories 5 Remote Control Operation Page 12 Remote Control User Manual 5 2 Remote Control Shutdown Quick Steps Stop ablation Press and hold the Stand by button for approximately 3 seconds to turn off the remote control Note You can turn off the remote control before or after you turn off the generator 5 3 Assigning the System Master When you first turn on the remote control see Section 5 1 Remote Control Startup the word MONITOR is
20. e cable to the SmarTABLATE RF Generator is properly connected see Section 3 4 3 Circular Plug Connections and that the remote control can be moved easily without disconnecting it from the generator Always carry the remote control with two hands To transport the remote control over long distances or to send the remote control for service use the original packaging If the original packaging is not available contact the manufacturer or distributor for a replacement 3 7 Disposal Inadequately treated electronic waste poses environmental and health risks Follow local regulations for disposal of the SmaRTABLATE Remote Control and its electrical or electronic accessories To ensure proper disposal there is also the option of contacting your Biosense Webster representative regarding return of the remote control and its accessories 3 Remote Control Overview and Setup Page 8 Remote Control User Manual 4 Accessories 4 1 Diagram of the Remote Control and Accessories 7 8 9 Front of SMARTABLATE Remote Control Back of SmarRTABLATE Remote Control Front of SmaRTABLATE RF Generator Back of SmarTABLATE RF Generator Connection cable to SMaRTABLATE RF Generator Mains cable Serial data communication cable for electrophysiology recording system Serial data communication cable for Carto System O OI NI ND WM Bl Wl nN Foot pedal SSS 4 Accessories Page 9
21. e power supply Note that a 5 second removal of power as tested results in the device shutting down and requires user intervention to restart There was no interruption of operation for other tests Power frequency magnetic fields should be at levels characteristic of a typical location ina typical commercial or hospital environment Note U is the AC mains voltage prior to application of the test level The SMARTABLATE Remote Control was tested at 100 and 230 VAC 7 Technical Data Page 21 Remote Control User Manual SMART Electromagnetic Immunity The SMARTABLATE Remote Control is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE Remote Control should ensure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Conducted RF 3 Vrms 3V Portable and mobile RF communications equipment IEC 61000 4 6 150 kHz to should be used no closer to any part of the 80 MHz SMARTABLATE Remote Control including cables Radiated RF EA 3V m than the recommended separation distance IEC 61000 4 3 80 MHz to calculated from the equation applicable to the 25 GHz frequency of the transmitter Recommended separation distance d 1 17VP 150 kHz to 80 MHz d 1 17VP 80 MHz to 800 MHz d 2 33 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the
22. ergy delivery by pressing the Stop button on the remote control or generator releasing the foot pedal or pressing the Stand by button on the remote control or generator If none of these measures stops the RF energy delivery disconnect the mains cable from the remote control 17 Take care when using the SmarTABLaTE Remote Control and accessories Although ablation cannot be started from the remote control when it is the system Monitor ablation is automatically stopped when the Stop button is pressed or the foot pedal is released 18 The person who connects the remote control and accessories to each other or who uses the remote control and accessories is responsible and liable for installation and operation that complies with IEC EN 60601 1 1 19 If several devices are connected to each other they should be as safe both individually and together as specified in IEC EN 60601 1 and its sub standards and IEC EN 60601 1 2 20 Only classified electrical medical devices may be connected to the remote control If a PC system does not fulfill the requirements of IEC EN 60601 1 UL 60601 1 and their sub standards the distance between the PC system and the patient must be at least 1 83 m 6 ft and the PC system must fulfill the requirements of IEC 950 UL 60950 1 All medical devices that are connected electrically to the generator must fulfill the requirements of IEC EN 60601 1 1 the standard for medical systems 2 Warnings Page 3
23. essories FP NVAANING Do not modify any accessories 4 3 1 Connection Cables Visually inspect all connection cables before each use Do not use damaged cables To avoid damage to the connection cables do not wrap the cables around the remote control or other apparatus Coiling the connection cables during normal operation of the remote control creates inductive components which can lead to interruption of the operation of the remote control When plugging in a cable or unplugging a cable hold the cable by the plug housing not by the cable itself 4 3 2 Foot Pedal Never pick up the foot pedal by its cable Do not coil the cable closely around the foot pedal Check the cable regularly for visible damage Do not use a damaged foot pedal 4 4 Cleaning Disinfecting and Sterilizing Accessories To ensure that the accessories are safe to use follow the cleaning disinfecting and sterilizing instructions in the instructions for use provided with the accessories Make sure that any liquid is removed from electrical contacts after cleaning disinfecting or sterilizing 4 Accessories Page 11 Remote Control User Manual SMART 5 Remote Control Operation The SMARTABLATE Remote Control is operated in the same manner as the SMARTABLATE RF Generator except as described below See the SMARTABLATE RF Generator User Manual for instructions on features that the remote control shares with the generator 5 1 Remote Control Startu
24. he foot pedal is released 5 Remote Control Operation Page 14 Remote Control User Manual 6 Troubleshooting 6 1 Problems with Connection to the Generator If there is a problem with the connection between the SmMaARTABLATE Remote Control and the SMARTABLATE RF Generator the System Control screen will appear with an explanatory message see Section 5 3 Assigning the System Master Possible Reasons for Connection Problem The remote control is not connected to the generator The generator is powered off There are communication problems between the generator and the remote control The communication cable between the generator and the remote control is damaged The generator had a fatal system error The remote control has a software version that is not compatible with the generator s software version 6 2 Other Troubleshooting Problem On startup the progress dots do not appear or the logo screen does not disappear On startup after you press Stop z in response to the message that appears the screen currently displayed on the generator does not appear Nothing happens when you press a button on the screen The remote control won t turn on What To Do Connect the remote control to the generator Turn on the power to the generator Replace the communication cable between the generator and the remote control Replace the communication cable between the generator and the remote con
25. ion 5 3 Assigning the System Master At any time during the calibration process you can press Stop to exit calibration If the calibration is successful you will see Result O If the calibration is unsuccessful you will see Result 3 If the calibration is unsuccessful repeat the steps until a successful calibration is achieved If the problem persists contact Customer Support When you perform calibration be careful to press directly on the center of the target If the calibration fails try touching the center of the target with the tip of a pen instead of your finger 6 Troubleshooting Page 16 Remote Control User Manual 7 Technical Data 7 1 Specifications Mains Voltage 100 240 V Frequency 50 60 Hz Power consumption 40 VA Other Classifications Class as defined in IEC EN 60601 1 Class Ilb as defined in MDD 93 42 EEC Class 3 FDA There are no applied parts Weight 4 5 kg Dimensions 395 mm wide x 220 mm high x 170 mm deep IP rating IP21 7 2 Storage and Shipping Conditions Ambient temperature 30 to 65 C Relative humidity 10 to 90 non condensing Atmospheric pressure 500 to 1060 mbar 7 3 Operating Conditions Ambient temperature 10 to 40 C Relative humidity 10 to 85 non condensing Atmospheric pressure 700 to 1060 mbar 7 4 Safety Inspections To ensure the safety of the SMARTABLATE Remote Control inspect the remote control before each use Perform the following verifi
26. nal components may result in increased emissions or decreased immunity of the SMaRTABLATE Remote Control Electromagnetic Emissions The SMARTABLATE Remote Control is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE Remote Control should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The SMARTABLATE Remote Control uses CISPR 11 RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A CISPR 11 The SmarTABLaTE Remote Control is suitable a for use in all establishments other than Harmonic emissions Class A i domestic and those directly connected to the IEC 61000 3 2 public low voltage power supply network Voltage fluctuations flicker Complies that supplies buildings used for domestic emissions purposes IEC 61000 3 3 7 Technical Data Page 20 Remote Control User Manual Electromagnetic Immunity The SMARTABLATE Remote Control is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE Remote Control should ensure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000
27. on 3 4 Setup 2 Always verify that the remote control s visual and acoustic alarms are working before using the remote control see Section 5 1 Remote Control Startup 3 When the remote control has been turned off power continues to be supplied to the remote control through the mains cable To completely cut off power to the remote control disconnect the mains cable from the remote control To allow easy disconnection in the event of severe power failure make sure that the remote control is located where there is easy access to the mains cable on the back of the remote control 4 After turning on the remote control always wait until the automatic self test has been successfully completed and the remote control has been made the Master of the system see Section 5 3 Assigning the System Master before starting the first steps of the procedure on the patient for example before anesthesia or before creating percutaneous access Also if using accessories that connect to the remote control verify that the connections to those systems are functional prior to starting the first steps of the procedure Doing this helps to detect problems with the device before the patient is in a phase of the intervention in which interruption could lead to an increased risk to the patient s health 5 Use only accessories that have been provided by or recommended by the remote control s manufacturer see Chapter 4 Accessories The use of other accessories c
28. ormal wear and tear damage due to improper handling accessories connection cables and disposable parts Repairs or any changes may be performed only by the manufacturer a service engineer authorized by the manufacturer or a service center authorized by the manufacturer The warranty is voided if improper modifications or repairs are performed or if the device is not maintained according to the instructions in this user manual The warranty is not extended or renewed by services performed under warranty 9 3 Product Liability Product liability is assumed by STOCKERT GmbH under the following conditions e The remote control has been operated only with the original accessories provided by or recommended by the manufacturer see Chapter 4 Accessories e Repairs to the remote control and to the accessories have been performed only by the manufacturer a service engineer authorized by the manufacturer or by a service center authorized by the manufacturer 9 Warranty Page 27 Remote Control User Manual Manufactured By ad STOCKERT GmbH B tzinger Stra e 72 79111 Freiburg Germany Fax 49 761 20716 20 Email info stockert de http www stockert de Customer Support In USA Biosense Webster Inc Tel 1 866 4SERVCE 1 866 473 7823 toll free in USA Email complaint bwius jnj com Customer Support Outside USA Biosense Webster Tel 32 2 7463 463 Email techsupport its jnj com Distributed By Outside USA In USA
29. p Quick Steps Connect the remote control to the mains supply and to the generator Verify that the generator is on Press the Stand by button to turn on the remote control At the message press the Stop button on the front of the remote control Notes 1 When you press Stand by Mi make sure that Ablation Start oy and Stop and the foot pedal are not pressed 2 When you turn on the remote control the remote control s audible and visual indicators are tested to allow you to verify that they are functional The Stand by indicator lights up and the SMARTABLATE System logo appears on the screen The Alarm indicator flashes alternately red and orange for a short time to indicate that the Alarm indicator is working Also the RF On indicator flashes orange and an audible RF tone is played briefly If the indicators listed above do not perform as described there is a problem with the remote control and you should contact Customer Support 3 Progress dots in the bottom left corner of the screen indicate that the system is performing a self test When the self test is successfully completed a confirmation message appears asking you to press the Stop Y button to continue After you press the Stop button the screen currently displayed on the SmarTABLATE RF Generator will be displayed on the remote control If the generator is not on the System Control screen will be displayed on the remote control If the progress dots
30. ress System Control on the Navigation Bar to open the System Control screen see the image in Section 5 3 Assigning the System Master Volume Press the volume bar then turn the Data Entry Knob O to change the volume of the audio output Brightness Select Automatic to have the system determine the screen brightness Select Manual then press the brightness bar and turn the Data Entry Knob O to adjust the screen brightness manually Foot Pedal Press the foot pedal connected to the remote control to verify that it is working During the foot pedal test a tone is emitted and the image changes to a pressed foot pedal RF energy is not delivered during the foot pedal test while the System Control screen is displayed Notes 1 When you press System Control on the remote control the System Control screen appears only on the remote control not on the generator The volume and brightness changes that you make affect only the remote control and the foot pedal test applies only to the foot pedal connected to the remote control 2 The volume setting affects the RF tone and all alarm and informational tones Make sure that you select the appropriate volume so that you can hear the tones or turn off the volume if you do not want to hear these tones on the remote control 3 Take care when using the remote control and accessories When the remote control is the system Monitor ablation is automatically stopped when Stop is pressed or t
31. s and people EMC Information and Technical Description MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this user manual Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT N Warning The use of ACCESSORIES transducers and cables other than those specified with the exception of transducers and cables approved by the manufacturer of the SMARTABLATE Remote Control as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of the SMARTABLATE Remote Control A Warning Do not operate the remote control in the immediate vicinity of devices that are not approved for electromagnetic compatibility EMC with the remote control If such operation is unavoidable regularly monitor the remote control to ensure proper functioning Warning The SmarTABLaTE Remote Control may be interfered with by other equipment even if that other equipment complies with CISPR EMISSION requirements 7 Technical Data Page 23 Remote Control User Manual The SmarTABLATE Remote Control may be operated only with cables provided by or recommended by the manufacturer See Section 4 1 Diagram of the Remote Control and Accessories for an illustration of the typical configuration and the cables required for undisturbed operation 7 Technical Data Page 2
32. service center certified by the manufacturer The safety inspections must be performed at least once a year and after every repair according to IEC EN 60601 1 and its sub standards and IEC EN 62353 7 5 Maintenance Perform the safety inspections specified in Section 7 4 Safety Inspections Regularly clean and disinfect the SmARTABLATE Remote Control per Section 3 5 Cleaning and Disinfecting the Remote Control Regularly clean the accessories per the instructions for use provided with the accessories At least once a year verify that the SMARTABLATE Remote Control and its accessories are installed per Section 3 4 Setup At least once a year perform the touch screen calibration per 6 3 Calibrating the Touch Screen At any time if any problems are found report them to Customer Support and send the remote control or broken accessory for repair If desired a service contract can be arranged Contact Customer Support 7 6 Repairs There are no parts in the SMARTABLATE Remote Control that may be serviced by the user Repairs or any changes to the remote control and the accessories must be performed only by the manufacturer a service engineer authorized by the manufacturer or service centers certified by the manufacturer 7 Technical Data Page 18 Remote Control User Manual 7 7 Conformance to Standards The SMARTABLATE Remote Control meets the requirements of the following standards Standard Title ANSI
33. sseesseesseesscoseessseoseesseesseeseeeseesse 7 36 Protecund Against Damage sessissio nR EE EERE ERRE 8 a DEPO ee iaae A REEE EET EAEE AEE EE ATE ES 8 4 ACCESSORIES 9 4 1 Diagram of the Remote Control and Accessories csssssesesscsssesssecsescsssessesesesessesescseeseseseseeeeseees 9 W PCC OSS OU L S E AEE 10 BZA POOP OO I eana E E E 10 Jo NATARE SAO CS aeara EEEE 10 4 3 Caring for ACCeSsSorieS eRe ene ene ene etna rT ne ner ee erento 11 4 3 1 CONNECTION Cables 0 eessssssssssssssscscscscscscsessssssssesesescscsesssssssseseseseseacsesesssesscseseseacsesesssseseseas 11 dod FOO P Oc RE re ER ete ene N EE Tre mnie arn er ee tere trent enone rte 11 44 Cleaning Disinfecting and Sterilizing Accessories cccesessssesesesssscsessssssessseseesesssesesseaeseseeseees 11 5 REMOTE CONTROL OPERATION 12 S REMOTE ON Ol SU OUD saene nnana A caetaneeensnsenise eens 12 5 2 Remote Control SNUtTdOWT os ceccescencvesesseseae cu csenen conssaswonstasesase cacazsestecasacwsatasesdeeonecsesahsatactsssucevsesateesseens 13 53 Assigning the Systemi Master sssssrredsrsikossrrri spiren pa a a EOE IN RISA EA E R 13 5 4 Volume Brightness and Foot Pedal TeSt ss ssesseessessesseessessesseesseoseessesseoseeneessesseoseessesseoseessesse 14 6 TROUBLESHOOTING 15 6 1 Problems with Connection to the Generator ssesssessesseessessesseesecoseessesseoseeseessesseoseessesseoseeseeese 15 6 2 Other GU SS OO ANG causes sossanasesavossesessareszrsveustves
34. t Part 1 8 General requirements for basic safety and essential performance Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC EN 60601 1 9 Medical electrical equipment Part 1 9 General requirements for basic safety and essential performance Collateral Standard Requirements for environmentally conscious design IEC EN 60601 2 2 Medical electrical equipment Part 2 2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC EN 62304 Medical device software Software life cycle processes IEC EN 62353 Medical electrical equipment Recurrent test and test after repair of medical electrical equipment IEC EN 62366 Medical devices Application of usability engineering to medical devices 7 Technical Data Page 19 Remote Control User Manual Standard Title MDD 93 42 EEC MPG Medical Device Directive MDD Council Directive 93 42 EEC of 14 June Medical Products Law 1993 concerning medical devices UL 60601 1 Medical electrical equipment Part 1 General requirements for safety 7 8 EMC Information and Technical Description The use of accessories transducers and cables other than those specified with the exception of transducers and cables approved by the manufacturer of the SmarRTABLATE Remote Control as replacement parts for inter
35. 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a 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 If the measured field strength in the location in which the SMARTABLATE Remote Control is used exceeds the applicable RF compliance level above the SMARTABLATE Remote Control should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SMARTABLATE Remote Control b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m eee 7 Technical Data Page 22 Remote Control User Manual SMART
36. trol Follow the instructions in the SmartAblate RF Generator User Manual for troubleshooting a fatal system error The software version on the remote control needs to be updated Contact Customer Support What To Do Press and hold Stand by for approximately 3 seconds to turn off the remote control Then press Stand by again to turn the remote control on If the problem persists contact Customer Support Unplug the foot pedal and plug it in again Then press and hold Stand by for approximately 3 seconds to turn off the remote control Then press Stand by again to turn the remote control on If the problem persists contact Customer Support See Section 6 3 Calibrating the Touch Screen Verify that the power supply meets the specifications in Section 7 1 Specifications If the problem persists contact Customer Support 6 Troubleshooting Page 15 Remote Control User Manual 6 3 Calibrating the Touch Screen Over time the buttons on the touch screen may move a little and the location that you press on the screen may no longer be exactly where the button is If this happens follow the steps below Quick Steps Notes 1 2 J 4 Press the CONNECTIONS workflow button Press System Settings Ba Press Calibrate Touch Screen Press each target after it appears a total of 6 targets Press Stop You can only calibrate the remote control s screen when the remote control is the system Master see Sect
37. with the user manual may cause harmful interference to radio communications Similarly portable and mobile communication devices may cause harmful interference to the functioning of the remote control 11 If error messages repeatedly appear stop using the remote control and contact Customer Support 12 To avoid damage to the remote control and its accessories use only appropriate cleaning agents see Sections 3 5 Cleaning and Disinfecting the Remote Control and 4 3 Caring for Accessories 13 To avoid the risk of electric shock connect the mains cable from the remote control mains socket see Item 1 in Section 3 2 Controls on the Back of the Remote Control to a 3 prong outlet that meets the specifications in Section 7 1 Specifications 14 The remote control may be opened only by persons authorized by the manufacturer When the remote control is open parts that have high voltage or are very hot are accessible and can cause injury If the remote control is opened by an unauthorized person any claims on the warranty are void No modification of the remote control is permitted 15 If fluid penetrates into the remote control stop using the remote control and contact Customer Support 16 If there is any doubt about an unintended increase in RF energy or the proper functioning of the remote control s touch screen Data Entry Knob Or foot pedal or the functioning of the generator during RF delivery immediately stop the RF en
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