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RF Generator User Manual - STOCKERT medical solutions

1. The ablation created a steam pop The catheter was pushed suddenly into the tissue The spike cut off value is too low Indicators V Visual S Sound Alert V A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary and catheter receptacle flashes red for 5 seconds S Ablation stop tone Ablation Stop Reason V A and Ablation Summary and catheter receptacle flashes red for 5 seconds S Ablation stop tone 7 Troubleshooting Page 76 What To Do Impedance below minimum If the catheter is connected through an additional system such as a navigation system try replacing the system parts that are between the generator and the catheter or connect the catheter directly to the generator If the problem persists contact Customer Support It is not recommended but if you know the reason for the low impedance and still want to perform an ablation you can disable this cut off by setting its value to Off See Section 6 3 3 Editing a Preset Impedance spike cut off Consider possible clinical reasons If you suspect that there is no reason for the impedance to spike try increasing the cut off to avoid getting this message due to measurement noise If the problem persists contact Customer Support If it is clinically appropriate you can disable this cut off by setting its value to Off See Section 6 3 3 Editing a Preset RF Gener
2. Connection status Type of catheter selected on PRESET screen Connection status Action N A Foot pedal test for the foot pedal connected to the generator N A N A N A Action Description N A Press the foot pedal connected to the generator to verify that it is working During the foot pedal test a tone is emitted and the image changes toa pressed foot pedal RF energy is not delivered during the foot pedal test while the Foot Pedal device screen is displayed N A N A See Section 6 3 2 Selecting a Preset 6 Operation Connections Page 37 RF Generator User Manual Table 4 System Settings Screen Options In Oo ma tio n Dis o aye fo Action Date Press a gray date button and use the Data Entry Knob O to change the date Time Press a gray time button and use the Data Entry Knob O to change the time Language Select a language if supported by the software version Calibrate Touch Screen Press Calibrate Touch Screen to improve the performance of the touch button screen see Section 7 5 Calibrating the Touch Screen Service button This button is for use by service technicians Export to USB button Press Export to USB to export ablation and event log data to a USB flash drive see Section 6 5 1 Exporting Ablation and Event Log Data to a USB Flash Drive P 6 Operation Connections Page 38 RF Generator User Manual 6 3 Presets PRESET Screen ThermoCo
3. When catheters with cooled ablation electrodes are used the temperature measurement reflects the temperature of the cooled electrode not the temperature of the tissue The temperature of the tissue may be distinctly higher and the risk of pop explosion of steam bubbles may increase Therefore use only moderate RF power output Follow the recommendations in the instructions for use provided with the therapeutic catheters that are used with the system 3 Warnings and Precautions Page 10 RF Generator User Manual SMART 4 Keepin mind when setting the temperature that only the temperature of the electrode and not the temperature of the heart tissue is measured Because of the cooling effect of blood flow the temperature of the heart tissue may be higher than the temperature measured at the ablation electrode 5 Avoid sudden increases in impedance to minimize charring at the ablation electrode Charring at the ablation electrode can result in reduced RF energy delivery and or an embolism 6 Make sure that the active RF electrode of the ablation catheter is not in contact with another catheter or with another metallic conductor such as an implanted pacemaker lead This could lead to uncontrolled conduction of the RF energy to other parts of the body or to an uncontrolled increase in the effective size of the active RF electrode 7 Do not set any extreme unrealistic limit values The limit values serve to trigger an alarm when a
4. Products Law UL 60601 1 Medical electrical equipment Part 1 General requirements for safety 8 11 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 SMART BLATE RF Generator as replacement parts for internal components may result in increased emissions or decreased immunity of the SMaRTABLATE RF Generator Electromagnetic Emissions The SMARTABLATE RF Generator is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE RF Generator should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The SMARTABLATE RF Generator 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 RF Generator is suitable for use in all establishments other than Harmonic emissions Class A 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 8 Technical Data Page 92 RF Generator User Manual Electromagnetic Immunity The
5. The SMARTABLATE RF Generator meets the requirements of the following standards Standard ANSI AAMI HF 18 CAN CSA C22 2 No 601 1 B 90 CMDR DIN EN 980 DIN EN 1041 DIN EN ISO 14971 EU Dir 2002 96 EC EU Dir 2006 66 EC IEC 60812 IEC EN 60601 1 IEC EN 60601 1 1 IEC EN 60601 1 2 IEC EN 60601 1 4 IEC EN 60601 1 6 IEC EN 60601 1 8 IEC EN 60601 1 9 IEC EN 60601 2 2 IEC EN 62304 Title Electrosurgical devices Medical electrical equipment Part 1 General requirements for safety Canadian Medical Devices Regulations Symbols for use in the labeling of medical devices Information supplied by the manufacturer of medical devices Medical devices Application of risk management to medical devices EU Directive 2002 96 EC of 27 January 2003 on waste electrical and electronic equipment WEEE Directive 2006 66 EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91 157 EEC Analysis techniques for system reliability Procedure for failure mode and effects analysis FMEA Medical electrical equipment Part 1 General requirements for basic safety and essential performance Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems Medical electrical equipment Part 1 2 General requirements for basic safe
6. V A and Ablation Summary S none Foot pedal released Remote The pressed foot pedal that is connected to the remote control was released Ablation Stop Reason V A and Ablation Summary S none Disconnect the foot pedal from the remote control then reconnect it If the problem persists either use a different foot pedal or operate the generator using the Ablation Start and Stop buttons on the generator or remote control To resume ablation press and hold the foot pedal To resume ablation press and hold the foot pedal 7 Troubleshooting Page 74 RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Indicators What To Do Reasons V Visual S Sound Impedance above maximum Theimpedance exceeded Alert Verify that the catheter is properly the maximum cut off V A and Alarm indicator turns inserted in the body and is out of value set in the preset on orange the sheath Possible reasons are Disconnect the catheter and the The catheter is out of zur indifferent electrode from the the patient s body oris Ablation Stop Reason generator then reconnect them covered by a sheath Improve the contact of the V Ablation Summary and catheter receptacle flashes red for indifferent electrode with the patient s skin or use a different The indifferent electrode has become 5 d a disconnected from the m indifferent electrode See gene
7. When using a split indifferent electrode the contact quality with the patient s skin has deteriorated since the indifferent electrode was applied to the patient Bubble The pump sensor identified a bubble in the irrigation tubing The temperature of the catheter ablation electrode exceeded the cut off value set in the preset Possible reasons are The ablation electrode is too hot The cut off value is too low Indicators V Visual S Sound Bad contact indifferent electrode Alert V A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary and both indifferent electrode receptacles flash blue for 5 seconds S Ablation stop tone Alert V A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary S Ablation stop tone Catheter temperature above maximum Alert V A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary and catheter receptacle flashes red for 5 seconds S Ablation stop tone 7 Troubleshooting Page 69 What To Do When using a split indifferent electrode improve the contact of the indifferent electrode with the patient s skin See 3 4 Handling Indifferent Electrodes If the problem persists use a different indifferent electrode ora different cable Patient Danger Press the Stop button on the pump Flush th
8. Data Entry Knob 4 System Overview and Setup Page 15 RF Generator User Manual 4 3 Controls on the Back of the Generator DEVICE LABEL Item Description 1 Remote Control Receptacle for SMARTABLATE Remote Control cable 2 USB port 3 Serial data port 1 for electrophysiology recording system 4 Mains rating label 5 Fiber optic ports not implemented 6 Mains socket 7 Fuse cover 8 Potential equalization port 9 Serial data port 2 for Carto System 10 Ethernet port not implemented 11 Pump Receptacle for SMARTABLATE Irrigation Pump cable 12 Foot Pedal Receptacle for SMARTABLATE System foot pedal cable 13 Device label 4 System Overview and Setup Page 16 RF Generator User Manual 4 4 Functional Test and On Site Training The SmarTABLATE RF Generator is a medical device In some countries in order to comply with local regulations the generator may not be put into service until the distributor has subjected the generator to a functional test on site and has trained the person responsible for operating the device in the handling of the generator per this user manual All applicable requirements of local regulations must be followed A functional test of the generator can be performed using a STOCKERT test box for the SMARTABLATE RF Generator which is available for purchase see Section 5 2 Accessory Lists See the instructions for use that are provided with the test box 4 5 Setup 4 5 1 Setting U
9. Edit the Preset Follow the instructions in Section 6 3 3 Editing a Preset 3 Save the Preset Temporarily Press the ABLATION workflow button or another workflow button or Press Save O then press Save temporarily Notes 1 When you save temporarily EDITED PRESET is displayed above the list of presets and none of the presets in the list is selected To understand which preset has been temporarily edited look at the name of the preset on the PRESET workflow button the name will be followed by an asterisk Temporary changes are in effect only until a different preset is selected or the system is turned off When a different preset is selected the temporary changes to the previous preset are discarded The most common time to perform a temporary save is when you are preparing to start ablation or during a pause in ablation when you determine that a permanently saved preset does not contain the exact settings that you want To save the temporary preset as a new preset follow the instructions in Section 6 3 5 Creating a New Preset All changes made at the ABLATION screen are temporary see Section 6 4 3 Making Temporary Changes to Ablation Settings 6 Operation Presets Page 44 RF Generator User Manual 6 3 5 Creating a New Preset Keyboard Screen PHYSICIAN jum lt Backspace erases one character OK closes keyboard and saves physician name and preset name Escape c
10. The Ethernet port on the back of the generator see Item 10 in Section 4 3 Controls on the Back of the Generator is provided for future use DODDDDDD 4 5 9 USB Connection Only USB mass storage devices such as USB flash drives may be connected to the USB port on the back of the generator see Item 2 in Section 4 3 Controls on the Back of the Generator Do not connect any other USB devices such as a printer mouse or scanner these other devices are not supported by the generator Note The USB ports on the back of the tilting front panel of the generator are for use by service technicians only 4 5 10 Serial Data Connections lOlOll Devices that exchange data with the generator such as the Carto 3 System the CARTO XP System compatible electrophysiology recording systems and other external compatible monitoring systems can be connected to the serial data ports on the back of the generator see Items 3 and 9 in Section 4 3 Controls on the Back of the Generator 4 5 11 Fiber Optic Connections The fiber optic ports on the back of the generator see Item 5 in Section 4 3 Controls on the Back of the Generator are provided for future use 4 5 12 Setting Up Irrigated Catheters with the Irrigation Pump and Tubing Connect the SmarTABLATE RF Generator to the SMARTABLATE Irrigation Pump by plugging one end of the connection cable into the Pump receptacle on the back of the generator see Item 11 in Section
11. the increase will be determined from a baseline measurement taken just before ablation Impedance Settings Pane Max Cut Off The maximum impedance measurement between the ablation electrode and the indifferent electrode above which RF energy will automatically shut off Spike Cut Off If the impedance spikes higher than the number set here in any half second interval the RF energy will automatically shut off Min Cut Off The lowest impedance measurement between the ablation electrode and indifferent electrode below which the RF energy will automatically shut off Irrigation Control Settings Pane This pane appears only when an irrigated catheter type is selected see Section 6 3 10 Irrigation Control Other Audio Settings 2 See Section 6 3 11 Changing Audio Settings Display Settings See Section 6 3 12 Selecting Ablation Display Settings a 6 Operation Presets Page 43 RF Generator User Manual 6 3 4 Editing a Preset Temporary Save EDITED PRESET indicates temporary save Asterisk after preset name indicates temporary save of that preset PRESET Screen After Temporary Save 4mm Standard D a Edit Set Default 4mm 8mm ThermotCool ThermoCool SF Preset 4mm Standard Quick Steps 1 Display the Edit Preset Screen Press the PRESET workflow button Select the preset to edit Press Edit or When the ABLATION screen is displayed press Edit on the Navigation Bar 2
12. the safety of the device and system is not guaranteed 5 2 1 Devices SMARTABLATE Irrigation Pum p Worldwide except USA Japan China M4900103 USA M490003 Japan M4900203 China M4900403 5 Accessories Page 23 RF Generator User Manual SMART BLATE Remote Control Worldwide except USA Japan China M4900104 USA M490004 Japan M4900204 China M4900404 STOCKERT Testbox III 39F45X 5 2 2 Foot Pedal Foot Pedal length of connection cable 3 m Worldwide except China M490005 China M4900405 ES Foot Pedal Extension Cable length 7 m M490026 Redel 6 gt Redel 6 black 5 2 3 SMARTABLATE Cables Connection Cable from SMARTABLATE RF Generator to SMARTABLATE Remote Control Redel 10 gt Redel 10 yellow length 10 m M490010 length 15 m M490029 length 25 m M490012 length 30 m M490013 Connection Cable from SMARTABLATE RF Generator to SMARTABLATE Irrigation Pump Redel 10 gt Redel 10 blue length 1 m M490027 length 3 m M490016 length 5 m M490028 length 10 m M490030 5 Accessories Page 24 RF Generator User Manual Item Mains Cable length 3 m Australia Brazil China EU India South Africa Israel Japan Russia Switzerland Taiwan UK Singapore Hong Kong USA Grounding Cable length 3 m Worldwide except Japan Japan ECG Connection Cable length 3 m Redel 16 gt 4x 2 mm tip pins green Serial Da
13. Bar CONNECTIONS screen Navigation Bar Manual Section 6 3 11 Changing Audio Settings The icon is gray if this feature is not supported by the software version Press the icon to close the screen 6 3 7 Deleting a Preset 6 3 12 Selecting Ablation Display Settings Press the icon to close the screen without saving changes 6 2 Connections 6 3 10 Irrigation Control The icon is gray until the ABLATION workflow button is pressed 6 4 1 Starting a New Procedure The icon is gray until the ABLATION workflow button is pressed Press the icon to close the screen and save changes 6 3 3 Editing a Preset 6 4 3 Making Temporary Changes to Ablation Settings 6 3 5 Creating a New Preset 6 7 System Control 6 8 Volume Brightness and Foot Pedal Test 6 2 Connections 7 2 Warnings Alerts and Ablation Stop Reasons 6 Operation Icons on the Screens Page 62 RF Generator User Manual Name Icon Where Manual Section System Status Navigation Bar 7 2 Warnings Alerts and Ablation Warning or Alert Stop Reasons System Status Navigation Bar 7 3 System Errors System Error USB To USB PRESET screen 6 3 Presets Also see 6 5 1 Exporting Ablation and Event Log Data to a USB Flash Drive The icon is gray if this feature is not supported by the software version USB From USB PRESET screen 6 3 Presets The icon is gray if this feature is not supported by the software version Wait
14. Do not modify accessories Visually inspect all accessories on a regular basis Make sure that the connected cables are not damaged When using sterile accessories be sure to maintain the sterility of those accessories 3 Warnings and Precautions Page 6 RF Generator User Manual SMART 10 Place the generator on a secure non slip surface such as the CarTo System cart If the generator is placed on a mounting plate make sure it is securely fastened Do not place the generator directly above another device and do not place any other device directly on the generator Make sure that there is enough free space on all sides of the generator to allow the heat created by the generator to escape 11 The entire surface of the indifferent electrode must be as close as possible to the operating field and must have fully reliable contact with the patient s body The skin surface must be free of excessive oil and body hair See Section 3 3 Warnings and Precautions During an Ablation Procedure 12 The generator is equipped with a contact quality monitoring feature for split indifferent electrodes If the contact quality falls below a defined value the generator displays an alert message However if two split indifferent electrodes are used at the same time and one loses contact quality but the other maintains contact quality no alert is triggered If a solid indifferent electrode detaches from the patient s skin no alert is triggered When usin
15. Generator User Manual SMART Preface The SMARTABLATE Radiofrequency RF Generator is a highly specialized device intended for use during RF ablation therapy of the human heart This device is used in conjunction with specialized therapeutic catheters and a dispersive pad indifferent electrode to create a closed electrical circuit capable of delivering specified doses of RF energy The RF energy is delivered to cardiac tissue that forms unwanted electrical pathways that either drive or maintain arrhythmias The RF energy heats the tissue such that it becomes denatured and no longer functional This interrupts and or destroys the unwanted electrical pathways thereby restoring normal heart function The SmarTABLATE RF Generator actively generates specified doses of RF energy and continuously monitors displays and coordinates the amount of RF energy the temperature of the catheter s ablation electrode and the tissue impedance during ablation therapy The temperature of the catheter s ablation electrode is measured by a sensor in the electrode and is transmitted to the generator Simultaneously high resolution impedance measurement circuits built into the generator measure the heart tissue impedance allowing detection of small tissue changes prior to during and after treatment Before and during treatment electrical signals generated by the heart are also detected and transmitted by the catheter through the generator to connected moni
16. M4900615 M4900616 A E LE Indifferent Electrodes and Cables available from STOCKERT GmbH Other indifferent electrodes that meet the requirements specified in Section 3 4 Handling Indifferent Electrodes are also compatible with the SMARTABLATE RF Generator Item Erbe Indifferent Electrode for Children reusable 17x 11cm Erbe Indifferent Electrode for Adults reusable 17 5 x 29 5 cm Connection Cable for 3M Indifferent Electrode with Clip length 3 m Connection Cable for Erbe Indifferent Electrode with 4 mm Phone Jack length 3 m Catheters Part 39D 15X a 39D 19X M490034 Eim For recommended catheters contact Customer Support Note The UL mark on this generator is only valid with accessories tested by Underwriters Laboratories See http www stockert de hleadmin downloads Tested_accessories_by_UL pdf 5 Accessories Page 26 RF Generator User Manual 5 3 Caring for Accessories ann Do not modify any accessories 5 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 generator or other apparatus Coiling the connection cables during normal operation of the generator creates inductive components which can lead to measurement errors The values indicated in error can lead to misinterpretations When plugging in a cable or unplugging a cable hold the cable by
17. Mapping Physician System Presets System Er eS a Te S a oo Ablation Summary Ablation Setting Serr Pane ee een bot Warnings and eee Alerts Window Remote eee eee eee Control Temperature Di m ee Se en Settings Pane Foot Pedal oo wer ee Esophageal Temperature Indifferent Settings Pane Electrode HERREN Impedance 7 Esophageal Settings Pane probe N rain Gr u DZ ee ze Irrigation Control Catheter Settings Pane System Irrigation Settings Control High Flow Audio Settings Display Settings The Esophageal Probe and the Esophageal Temperature Settings Pane shown above are not applicable for the US and JP versions of the generator N S 3 N O za Wr 6 Operation Flowchart of the Screens Page 61 RF Generator User Manual 6 10 Name Audio Settings Close Delete Display Settings Escape Front Back Irrigation Control New Procedure OK Save Save As System Control System Settings System Status Ready for Ablation Icons on the Screens Icon pu ESG Where Edit Preset screen Top right corner of many screens PRESET screen Edit Preset screen Many screens CONNECTIONS screen Navigation Bar Also appears on the ABLATION screen when fluid is low during ablation Navigation Bar Many screens Edit Preset screen Edit Preset screen Navigation
18. Save Notes 1 The ablation values that are displayed when you first access the ABLATION screen are determined by the selected preset for the catheter tyoe either the default preset or a preset that you selected see Sections 6 3 2 Selecting a Preset and 6 3 3 Editing a Preset 2 When Power Control Mode is selected in the preset Power Control is displayed at the top of the screen See the sample screen in Section 6 4 Ablation 3 Onthe ABLATION screen before or during ablation you can change the time s and power W values In Temperature Control Mode you can also change the temperature set point C For irrigated catheters you can also change the flow rate mL min These changes take effect immediately without confirmation 4 When you change the flow rate on the ABLATION screen AUTO at the top of the screen changes to MAN It reverts to AUTO at the end of the current ablation 5 All changes made as described above are temporary An asterisk appears after the preset name on the PRESET workflow button to indicate that temporary changes have been made but have not been saved The changes stay in effect until a different preset is selected or until the system is turned off If you want to save these settings in a new preset follow the steps in Section 6 3 5 Creating a New Preset 6 Operation Ablation Page 53 RF Generator User Manual 6 The catheter type selected for the preset im
19. ablation catheter or to the indifferent electrode that are not approved by the manufacturer 7 Troubleshooting Page 79 RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons No low standby flow An irrigated catheter preset is selected the catheter temperature and the impedance indicate that the catheter is in the patient but the pump is stopped Power output too high The generator was trying to deliver a power output that was beyond its intended capability Possible reasons are There is a compatibility problem between the generator and external devices There is an internal problem in the generator Pump door open The pump door is open Indicators V Visual S Sound Warning V A and orange border around Irrigation Control icon flashes for 20 seconds S Warning tone Ablation Stop Reason V A and Ablation Summary and catheter receptacle flashes red for 5 seconds S Ablation stop tone Alert V A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary S Ablation stop tone 7 Troubleshooting Page 80 What To Do Press START Low Flow on the generator s Irrigation Control screen or press Low Standby Flow SA on the pump to start the pump flowing at the low standby flow rate See Section 6 3 10 Irrigation Control Disconnect any devices connected to the ab
20. by other equipment even if that other equipment complies with CISPR EMISSION requirements The SmarTABLaTE RF Generator internally generates RF electromagnetic energy for the purpose of its operation The following frequency bands are used e 45 kHz 1 kHz is used for impedance measurement between the catheter and the indifferent electrode e 480 kHz 1 kHz is used for impedance measurement between the catheter and the indifferent electrode e 100 kHz 1 kHz is used for impedance measurement of the split indifferent electrode ECG signals have very small amplitudes 0 1 mV For this reason the SMARTABLATE RF Generator uses a sensitive measurement unit for the ECG signals This measurement unit is also sensitive to externally radiated RF energy and can be disturbed by other systems placed close to the SMARTABLATE RF Generator Possible sources of interference are for example neon lamps and power transformers The following instructions must be followed to avoid disturbance of the measurement quality e The SmarTABLATE RF Generator may be operated only with cables provided by or recommended by the manufacturer e The SmartABLATE RF Generator must be connected with the grounding cable to a separate grounding point e All devices in the patient area that are connected to the SMaARTABLATE RF Generator must be on the same mains e All devices in the patient area that are connected to the SMARTABLATE RF Generator mu
21. connect a pump with a flushed tubing set see the instructions for use for the SMARTABLATE Irrigation Pump the instructions for use for the SMARTABLATE Irrigation Tubing Set and Section 6 6 Flushing to Eliminate Air in the Tubing and Catheter 6 1 8 Typical Procedure Process Full Quick Steps Turn on the generator and remote control 6 1 1 System Startup Atthe CONNECTIONS screen review the device 6 2 Connections connections Physically connect all applicable devices to the generator Physically connect all applicable devices to the patient Atthe PRESET screen select or create a preset 6 3 Presets Go to the ABLATION screen then position the catheter at the first ablation site Press Ablation Start or press and hold the foot 6 4 Ablation pedal to start ablation Notes 1 Ata minimum connect a catheter and an indifferent electrode to the generator For an irrigated catheter also connect a pump and a flushed tubing set see the instructions for use for the SMARTABLATE Irrigation Pump the instructions for use for the SMARTABLATE Irrigation Tubing Set and Section 6 6 Flushing to Eliminate Air in the Tubing and Catheter 2 Optionally connect other devices shown on the CONNECTIONS screen 3 You can also start ablation by pressing Ablation Start on the front of the remote control or by pressing the foot pedal connected to the remote control when the remote control is the sys
22. in Radiofrequency Catheter Ablation Circulation 86 No 5 1648 1650 Wittkampf FHM Hauer RNW Robles de Medina EO 1989 Control of Radiofrequency Lesions by Power Regulation Circulation 80 962 968 Wittkampf FHM Nakagawa H Yamanashi W Imai S Jackman WM 1996 Thermal Latency in Radiofrequency Ablation Circulation Vol 93 No 6 1083 1086 Wittkampf FHM Simmers TA Hauer RNW Robles de Medina EOR 1995 Myocardial Temperature Response during Radiofrequency Catheter Ablation Pace Vol 18 307 317 SSS 11 References Page 102 RF Generator User Manual Manufactured By 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 Biosense Webster A Division of Johnson amp Johnson Medical NV SA Leonardo da Vincilaan 15 1831 Diegem Belgium Tel 32 2 7463 401 Fax 32 2 7463 403 In USA Biosense Webster Inc 3333 Diamond Canyon Road Diamond Bar California 91765 USA Tel 1 866 473 7823 Fax 1 909 468 2786 http www biosensewebster com Carto CeLsius SMARTABLATE and THERMOCOOL are trademarks of Biosense Webster Inc The third part
23. mapping system of the connected mapping system The mapping system image on the CarTo 3 CONNECTIONS screen will change system when this screen closes CARTO XP System or Other Pi 6 Operation Connections Page 35 RF Generator User Manual Device Recording System Pump Table 3 Device Screens Information Displayed Action After selecting the TRANSMIT mapping system images and values appear for verifying transmission of impedance data STOP Image of generatorand TRANSMIT recording system Values for verifying transmission of data STOP Active flow rate or Flush dashes if the pump is active when not connected the pump is Serial number or connected dashes if the pump is not connected Message to connect the pump and select an irrigated catheter preset if the pump is not connected or if a non irrigated catheter preset is selected START Low Flow visible when the pump is connected and is stopped STOP visible when the pump is connected and is running Action Description Press TRANSMIT to test the communication on the mapping system connection port see Item 9 in Section 4 3 Controls on the Back of the Generator The color in the arrow moves from left to right to indicate that the test is running The number on the screen is the impedance value being sent to the mapping system Press STOP to stop the transmission test Press TRANSMIT to test
24. open the System Control screen Volume Press the volume bar then turn the Data Entry Knob 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 generator 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 This screen is displayed only on the local unit generator or remote control and the settings affect only the local unit The local unit can be the system Master or the System monitor when you access this screen See Section 6 7 System Control for information about the system Master 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 3 When the generator is the system Master you can also perform the foot pedal test on the Foot Pedal device screen which is accessible from the CONNECTIONS screen see Table 3 Device Screens in Section 6 2 Connections 6 Operation Volume Brightness and Foot Pedal Test Page 60 RF Generator User Manual 6 9 Flowchart of the Screens PRESET ABLATION POST
25. remove the Warnings and Alerts window from the screen A There is a System Error or a Fatal System Error The Event window appears See Sections 7 3 1 System Error and 7 3 2 Fatal System Error Ablation Summary with Ablation Stop Reason ABLATION SUMMARY RF time total 60s Power max 10W Power avg 9 9W Energy total Temp max Temp avg Imp max Imp drop Ablation Stop Imp min 1000 Irrigation 19mL Reason Ablation Stop Reason Timer completed Ablation a on Kr System Status icon When ablation stops because the preset ablation time has been reached or because ablation has been intentionally stopped the A System Status icon is displayed The Ablation Summary appears displaying an Ablation Stop Reason such as Timer completed When ablation stops because an Alert has occurred the A System Status icon is displayed and the Ablation Summary screen appears displaying an Ablation Stop Reason that explains the Alert You also have the option of pressing the icon to display the Warnings and Alerts window Resolve the Alert see Table 8 Warnings Alerts and Ablation Stop Reasons below and then press Close to remove the Warnings and Alerts window from the screen 7 Troubleshooting Page 68 RF Generator User Manual Table 8 describes the Warnings Alerts and Ablation Stop Reasons that may appear on the screen Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons
26. the Generator Verify that you are using the correct catheter connection cables for the selected catheter type and for the selected mapping system See Section 5 2 3 SMARTABLATE Cables Replace the catheter and or connection cable s with new ones Warnings and Alerts Ablation Active WARNINGS No active warnings Active ALERTS Warnings Pump not connected an d A e rts window System Status icon The System Status icon is visible on the Navigation Bar whenever ablation is not being performed There are three different System Status icons A A A A Ablation can be performed and there are no active Warnings or Alerts 7 Troubleshooting Page 67 RF Generator User Manual A There is aWarning or an Alert A Warning indicates a condition that is not critical Ablation can be performed even when there is a Warning For example Low fluid An Alert indicates a condition that is critical and must be fixed before ablation can be performed An Alert may occur when ablation is not being performed or it may stop ablation For example Catheter temperature above maximum The System Status icon changes from A to A when a Warning or an Alert occurs Press the icon to display the Warnings and Alerts window Resolve the Warning or Alert see Table 8 Warnings Alerts and Ablation Stop Reasons in this section As each Warning or Alert is resolved it disappears from the screen Press Close to
27. to drop before the cut off value set on orange restarting ablation in the preset Possible See the instructions in this table I aves a One for Esoph temperature above The ablation is heating Ablation Stop Reason maximum Warning the esophagus V Ablation Summary and esophageal probe receptacle flashes red for 5 seconds The cut off value is too low S Ablation stop tone Esoph temperature above maximum not applicable for the US and JP versions of the generator The esophageal probe Warning Reduce the power setting used for temperature exceeded A the ablation or stop the ablation the warning value set u punpa an re Ifitis clinically appropriate in the preset Possible An reposition the catheter farther reasons are orange border flashes away from the esophagus The ablation is heating S Warning tone Ifthe problem persists contact the esophagus Customer Support The warning value is You can disable this warning too low by setting its value to Off See Section 6 3 3 Editing a Preset 7 Troubleshooting Page 72 RF Generator User Manual SMART Table 8 Warnings Alerts and Ablation Stop Reasons Message Indicators What To D Reasons V Visual S Sound Se Esophageal temperature invalid not applicable for the US and JP versions of the generator The generator did Alert Verify that the esophageal probe not recognize a valid V A and Alarm indicator turns is co
28. 4 3 Controls on the Back of the Generator and the other end of the cable into the appropriate receptacle on the back of the pump Connect a SMARTABLATE Irrigation Tubing Set with the pump and with an irrigated catheter as described in the SmarTABLATE Irrigation Pump user manual Also see Section 6 6 Flushing to Eliminate Air in the Tubing and Catheter 4 5 13 Tilting the Generator s Front Panel Generators with a Tilt Panel button After the generator has been turned on see Section 6 1 1 System Startup the front panel can be tilted for easier viewing Press the Tilt Panel button see Item 7 in Section 4 2 Controls on the Front of the Generator to release the lock and gently pull the bottom of the front panel forward Note The generator s front panel cannot be adjusted when the generator is off Before moving the generator make sure that the front panel is closed 4 System Overview and Setup Page 19 RF Generator User Manual SMART 4 5 14 Tilting the Generator s Front Panel Generators without a Tilt Panel button The front panel can be tilted for easier viewing the generator does not have to be turned on Gently pull the bottom of the front panel forward until it is at the desired angle then release it The front panel will lock into place To lower the front panel gently pull the front panel forward slightly and then let it glide backward 4 6 Cleaning and Disinfecting the Generator Pens e The SmarTABLAT
29. 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 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 4 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 RF Generator is used exceeds the applicable RF compliance level above the SMARTABLATE RF Generator should be observed to verify normal operati
30. Aa SS on N OE AIOE E E AONT 17 4 5 4 Potential Equalization eesesesesesesesesssenenenenenennnnnnnnnnenennnnnenennnennnnnnnnnnnnnnnnnnnnnnnnnenenenenenennenne 18 4 5 5 Girc lar Plug CONNEENONS nennen 18 4 5 6 Connection Cables and Catheters s ssesssessesseeseessessesseessesseessesseoseessesseoseeseessessesseeseess 18 4 5 7 Indifferent Electrode Connections neun 18 458 Ethernet COMME ELON een rahenlseurn 19 A39 NSB OM CIO Aes ee ee 19 4 5 10 Serial Data CONNECTIONS usesesesesesesenenenenenenenenenenenenenenennenenenenenenenenenenennenenennnnnenenensnnenenenene 19 ASIT FIDEROBUCCONDECHOm Lo een ee ee 19 4 5 12 Setting Up Irrigated Catheters with the Irrigation Pump and Tubing 19 4 5 13 Tilting the Generator s Front Panel Generators with a Tilt Panel button 19 4 5 14 Tilting the Generator s Front Panel Generators without a Tilt Panel button 20 4 6 Cleaning and Disinfecting the Generator cscsscssessssccscssessessesseseesssssssessessessesessessesseassesseaeens 20 A7 Protecting Against Damage tate rosea scncaseaseuschtaceats eaeshsnchsacvstesteancschsansasesccheagestuniesecschtace lt tisaeseacentartenegeds 20 Ao PEDO 7 cape sz ceeccceccctec A E eierarsiaversceieneisedeostneint 21 RF Generator User Manual 5 ACCESSORIES 22 5 1 Diagram of the Generator and ACCeSSOrieS ssesseessseesssesssessseesseesssessseesseesserosseessseenserssersseeossee 22 FCS OL een ee
31. D Many screens This icon appears when the system is busy 6 Operation Icons on the Screens Page 63 RF Generator User Manual 7 Troubleshooting 7 1 Device Connections The CONNECTIONS screen see Section 6 2 Connections displays 9 to indicate that a device is properly connected and bd to indicate a problem with the connection Table 7 describes the specific meaning of these icons for each device Table 7 Device Connections Device Meaning of Icons Pump Communication between the generator and the SMARTABLATE Irrigation Pump was established and is functional The pump is now controlled by the generator 1 Possible Reasons What To Do The pump is not connected to the Connect the pump to the generator generator The pump is powered off Turn on the power to the pump There are communication Replace the communication cable between problems between the generator the generator and the pump and the pump The pump has a software version Check the software version on the pump that is not compatible with the and on the generator See Table 3 Device generator s software version Screens in Section 6 2 Then consult Customer Support There may bea problem with the See the SmartABLaTe Irrigation Pump User pump for example the pump Manual door may be open or there may be a bubble in the irrigation tubing 7 Troubleshooting Page 64 RF Generator User Manual Table 7 Device Connections Devic
32. E RF Generator must be turned off and the mains cable must be disconnected from the generator before cleaning and disinfecting the generator e The SMART BLATE RF Generator mains cable grounding cable serial connection cable and the indifferent electrode cable must not be sterilized Note Some accessories may need sterilization follow the instructions for use that are provided with the accessories Use a dry microfiber cloth to clean the generator 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 generator Use only non flammable and non explosive substances Water or soapy water is recommended for cleaning Make sure that no liquid penetrates the inside of the generator The following disinfectants may be used for disinfecting the generator 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 generator lodine or disinfectants containing dyes cause discoloration of the housi
33. Not valid for versions JP and US D z Q Q O 0 50 100 150 200 250 300 350 400 450 500 Load Impedance ohms Maximum Output Voltage vs Output Control Setting Load Impedance ohm 300 250 200 gt 150 5 2 100 Limit of versions JP and US v 50 rms 100 110 sel Control Me W 8 Technical Data Page 88 RF Generator User Manual Output Power vs Output Control Setting Load Impedance 100 200 ohm W Output Power T of gt Tolerance max versions Nominal JP and US e Tolerance min I HE HE m Control Be W 8 7 Safety Inspections To ensure the safety of the SMART BLATE RF Generator inspect the generator before each use Perform the following verifications e Verify that all of the visual and audible indicators available on the generator are functional see Section 6 1 1 System Startup e Verify that preventive maintenance for the SmarRTABLATE RF Generator is not overdue see the description of the generator screen in Table 3 Device Screens in Section 6 2 Connections 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 the description of the foot pedal screen in Table 3 Device Screens in Section 6 2 Connections e Verify that the connections to all accesso
34. OLINA T CTRL 40DEG ZHANG 20W ThermoCool ThermoCool SF Provides access to selecting editing creating and deleting presets Provides access to the Irrigation Control screen the Audio Settings screen and the Display Settings screen ABLATION 6 4 Ablation When the ABLATION screen is displayed you can press Ablation Start and Stop or the foot pedal to start or stop ablation The screen displays ablation measurement information and provides the ability to change common settings while viewing the ABLATION screen When the Navigation Bar is displayed with the ABLATION screen before or after ablation you can press Edit on the Navigation Bar to change additional settings You can press Irrigation Control to modify irrigation settings for an irrigated catheter You can press System Control to change the volume or the brightness of the screen and to indicate whether the generator or remote control has control of the system When ablation stops the Ablation Summary appears 6 Operation Quick Overview Page 30 RF Generator User Manual Table 1 Screens Screen Description POST Section 6 5 Post Procedure 1 Procedure Jate 06 September 2010 Total Ablation Time 00 03 13 The Max Esophageal temperature shown above is not applicable for the US and JP versions of the generator Displays the POST Post Procedure screen 6 1 4 Screen Features Sample Screen PRESET Screen Butto
35. SMART RF Generator User Manual SAG_UM_04 00_EN Manufactured by Distributed by Stockert GmbH gd Biosense Webster a fohwonGohwren company RF Generator User Manual Table of Contents PREFACE IV 1 FUNCTIONAL PRINCIPLES 1 1 1 Functional Principles of RF Ablation reed 1 1 2 Power Controlled Ablation Method nennen 2 1 3 Temperature Controlled Ablation Method an cc essesesesesesesesesesssssssesssssesssssesssssessssssssssesseseeees 2 1 4 Unipolar Application Method ersehen ee 3 1 5 Measuring Impedance ernennen 3 2 INDICATIONS 5 3 WARNINGS AND PRECAUTIONS 6 31 Warnings Generator Usage arena innen ne ehe statuses ae aaa 6 3 2 Warnings System Safety and CONNECTIONGS ccccscssssssssessssssecsssssscsssssecssssscsssesscassscassesscssseesessess 9 3 3 Warnings and Precautions During an Ablation Procedure uusssssssssssesseesesenenenenenenenenenenenene 10 3 4 Handling Indifferent Electrodes 0 esessssssessssssscsssscscsesessescsesscsescsesesesseseseseseeseseseseescacseesesesesessess 11 4 SYSTEM OVERVIEW AND SETUP 14 4 1 Structure and Features ou esessssssssssesssscscscscscsessssssssesssescsesescscseseseseseseacacsesesssesseseseseseacacecsseseseseseacacs 14 42 Controls on the Front of the Genese 15 AS Controls on the Back of the Generator ansehe 16 4 4 Functional Test and On Site Training euere 17 Ia OU ea A A A EA A EE EE T 17 4 5 1 Setting Up the Generator sssss EHE 17 452 Malhs COIS TOM esc een cent 17
36. SMARTABLATE RF Generator is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE RF Generator 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 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 1 kV 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 1 kV 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 tha
37. Visual S Sound aie See the Troubleshooting section in the user manual for the pump Ifthe problem persists contact Customer Support S Ablation stop tone If an irrigated catheter is being used connect the pump to the generator Ifa non irrigated catheter is being used select an appropriate preset Disconnect the remote control and operate the generator directly from the generator s user interface To resume ablation press Ablation Start or press and hold the foot pedal S none RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons Stop button Remote The Stop button on the remote control was pressed System overheating The internal hardware temperature of the system is too high Timer completed The ablation time has reached the set value on the ABLATION screen Voltage output too high The setup is causing the generator to deliver higher voltage than it was designed for Indicators V Visual S Sound Ablation Stop Reason V A and Ablation Summary S none Alert Vo A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary S Ablation stop tone Ablation Stop Reason V A and Ablation Summary S none Ablation Stop Reason V A and Ablation Summary and catheter receptacle flashes red for 5 seconds S Ablation stop tone What To D
38. 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 10 3 Product Liability Product liability is assumed by STOCKERT GmbH under the following conditions e The generator has been operated only with the original accessories provided by or recommended by the manufacturer see Chapter 5 Accessories e Repairs to the generator 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 10 Warranty Page 100 RF Generator User Manual SMART 11 References Dorwarth U Mattke S Muller D Hoffmann E Steinbeck G 1993 Temperaturkontrollierte Raidofrequenz Katheterablation Vergleich Mono und Bipolarer Nekrosebildung Z Kardiol 82 Suppli 12 Hoffmann E Bach P Haberl R Mattke S Steinbeck G 1992 Antiarrhythmische und Pro arrhythmische Effekte einer Oralen Cibenzolintherapie bei Anhaltenden Ventrikul ren Tachykardien Z Kardiol 81 389 393 Hoffmann E Dainat C Mattke S Dorwarth U Steinbeck G 1989 Optimized Radiofrequency Catheter Ablation by Temperature Controlled Bipolar Asymmetrical Coagulation Eur Heart J 10 Suppl 221 Hoffmann E Dorwarth U Pulter R Gok
39. ances temperature measurement may not prevent overheating The temperature indicator is a guide not an absolute measurement 1 Functional Principles Page 2 RF Generator User Manual SMART The difference between actual tissue temperature and the temperature measured by the integrated temperature sensor moreover depends greatly on the relevant catheter technology When standard catheters that are not irrigated are used the deviation in temperature is proportional to the electrode size due to passive cooling by blood flow The larger the ablation electrode the larger the temperature difference Regardless of the electrode used the actual tissue temperature is the same as or higher than the indicated temperature When an actively cooled ablation electrode is used for example an irrigated electrode cooled with saline solution the electrode no longer provides a basis for accurate tissue temperature In this case the temperature measurement is an indicator of the irrigation function and is completely dissociated from the tissue temperature 1 4 Unipolar Application Method To perform ablation with RF current a closed circuit is required The RF current flows from the generator via the connection cable to the catheter s ablation electrode tip electrode The current then passes through the biological tissue and is passed back to the generator through a second electrode indifferent electrode In order for the tissue heating to occur
40. at only the interface between the ablation electrode and the tissue the second electrode must have a considerably larger surface area than the ablation electrode This arrangement is known as a unipolar application Because the current density is highest at the smaller ablation electrode most of the RF energy is converted into heat in the area of this electrode The second considerably larger RF electrode is preferably a skin adhesive electrode This second electrode is known as an indifferent electrode or a neutral electrode For safety reasons care must be taken to ensure that the area of the indifferent electrode is considerably larger than the area of the ablation electrode If the ratio between the electrodes is too small severe skin burns can occur at the site of the indifferent electrode With this type of application the information provided by the manufacturer of the indifferent electrode and the information in Chapter 3 Warnings and Precautions must be heeded 1 5 Measuring Impedance Measurement of tissue impedance the electrical resistance in the tissue is used for two purposes 1 To differentiate between the various types of tissue so that the ablation electrode can be positioned correctly 2 To confirm that a lesion is being formed during RF current application The SMARTABLATE RF Generator measures impedance between the surface of the ablation electrode and the indifferent electrode 1 Functional Principles Pa
41. ated with that name see Section 6 3 9 Adding a Name to the Physician Presets List 6 Operation Presets Page 46 RF Generator User Manual 6 3 9 Adding a Name to the Physician Presets List Quick Step Create a new preset containing the physician s name see Section 6 3 5 Creating a New Preset Note When you create a new preset you are prompted to select an existing physician s name or type a new physician s name If there are fewer than 10 physician names in the Physician Presets list when you type a new physician s name that name will appear automatically in the list the next time that you press the button in the Physician Presets pane see Section 6 3 8 Displaying One Physician s Presets 6 3 10 Irrigation Control Irrigation Control Screen Monitor Low Flow N High Flow gt gt 17 30 mL min Low Flow gt 2 mL min Pre RF Time Post RF Time Monitor Fluid f Low Fluid Warning mL 1000 mL Volume Remaining 8 5mL Quick Steps 1 Display the Irrigation Control Screen Press the PRESET workflow button Select an irrigated catheter type Select a preset to edit Press Edit Press the gray rectangle in the Irrigation Control Settings pane or Press the ABLATION workflow button Press the Irrigation Control gt icon on the Navigation Bar 2 Change Settings Use the Data Entry Knob O to change values see Section 6 1 5 Data Entry Knob Press OK ey See Table 6 Irri
42. ator User Manual Table 6 Irrigation Control Settings Setting Description Flush Press Flush When a message appears press and hold the Data Entry Knob O to flush air bubbles from the irrigation tubing and the catheter Use this function carefully For details see Section 6 6 Flushing to Eliminate Air in the Tubing and Catheter START Low Flow Press START Low Flow to start the pump rotation at the Low Flow standby flow visible only when rate the pump is stopped STOP Press STOP to stop the pump visible only when the pump is running 6 3 11 Changing Audio Settings Quick Steps Press the PRESET workflow button Press Edit Press Audio Settings D Select the options that you want Press OK 07 Note This feature is not available in some software versions 6 3 12 Selecting Ablation Display Settings Display Settings Screen Impedance 0 v i Voltage v M 999 999 999 999 99 f 99 MA 99 mL 99 E C Eoo BE z Irrigation delivered mL M 1 ee ae see ee i Grid Lines M All Values White M Setpoint Lines M Impedance 4 i Separate or Ex The Esophageal C selection shown above is not applicable for the US and JP versions of the generator 6 Operation Presets Page 49 RF Generator User Manual Quick Steps Press the PRESET workflow button Press Edit Ir Select the options that you want Press OK ey Notes 1 The options that you select determine what i
43. ator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Incompatible catheter cable The catheter connection Alert If using an incompatible catheter cables have an electrical V A and Alarm indicator turns connection cable replace it identification component on orange with a cable that was provided that the system uses to by or recommended by the verify that an approved S none manufacturer type of cable is being used This alert appears when the system does not detect the identification data Possible reasons are If using a compatible catheter connection cable replace it with a new compatible connection cable If the problem persists contact Customer Support The cable was not provided by or recommended by the manufacturer The cable was damaged during re sterilization The cable is faulty There is a system problem 7 Troubleshooting Page 77 RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Indicators Reasons V Visual S Sound What To Do Incompatible esophageal probe cable not applicable for the US and JP versions ofthe generator The esophageal probe Alert connection cables have V A and Alarm indicator turns an electrical identification on orange component that the S none system uses to verify that an approved type of cable is being used This alert appears when the system does not detect the identi
44. can endanger the patient s life Make sure that the leakage current of the connected system in any combination never exceeds the maximum permissible value patient leakage current lt 0 05 mA Take into account that the system s RF leakage current can be negatively influenced by other system components The maximum allowable values are specified in IEC EN 60601 2 2 Displacements of the ECG baseline surface signals is a sign of uncontrolled RF current leakage through the body surface ECG electrodes Heating of these electrodes gives rise to a shift in direct current voltage which in turn leads to a displacement of the baseline In this case check the whole system combination to avoid uncontrolled current leakage It may also be the case however that the electrocardiograph is unsuitable for this use or that the body surface ECG electrodes have too high a contact impedance Make sure that the ECG device is appropriate for this application Skin burns at the body surface ECG electrodes can be a sign of uncontrolled current leakage 7 There are many electrocardiographs to which a stimulator can be directly connected The stimulator must be galvanically isolated or physically disconnected before the RF current is turned on The reason for this is the parallel connection between the output of the generator and the stimulator If the connection is not isolated the stimulator s patient interface and safety insulation may be damaged The transf
45. ching it even when wearing surgical gloves or by tapping it with a pen The generator features redundant protection circuits if one safety mechanism fails a second safety mechanism indicates the failure to ensure safety A central computer processor operates the device Several other microprocessors control the various functions such as RF power output and calculation of impedance The generator is equipped with a memory unit that stores the settings even after the generator has been turned off These settings are active when the generator is turned on again Operating errors and defects in the attached devices are detected and error messages are issued For a list of possible error messages see Sections 7 2 Warnings Alerts and Ablation Stop Reasons and 7 3 System Errors ET 4 System Overview and Setup Page 14 RF Generator User Manual 4 2 Controls on the Front of the Generator Item 1 WM P WIN O 10 12 13 Description RF On indicator Ablation Start button Stop button Catheter 1 receptacle for ablation catheter cable Catheter 2 receptacle for esophageal probe cable not functional in the US and JP versions of the generator Receptacles for indifferent electrode cables Tilt Panel button on side of front panel not available on some models Receptacle for ECG cable external stimulator electrophysiology recording system Touch screen Alarm indicator Stand by button Stand by indicator
46. communication through the recording system port see Item 3 in Section 4 3 Controls on the Back of the Generator The color in the arrow moves from left to right to indicate that the test is running The numbers on the screen are the values being sent to the recording system Press STOP to stop the transmission test Press Flush When a message appears press and hold the Data Entry Knob O to flush air bubbles from the irrigation tubing and the catheter Use this function carefully For details see Section 6 1 5 Data Entry Knob Press START Low Flow to start the pump flowing at the low standby flow rate see Section 6 3 10 Irrigation Control Press STOP to stop the pump 6 Operation Connections Page 36 RF Generator User Manual Device Remote Foot Pedal Indifferent Electrode Esophageal Probe not applicable for the US and JP versions ofthe generator Catheter Table 3 Device Screens Information Displayed Device name Serial number or dashes if the remote control is not connected Image of foot pedal Green bar and number s indicating impedance if indifferent electrode is connected and is functioning properly Red bar and dashes if indifferent electrode is not connected Red bar and number s if split indifferent electrode is connected but contact quality is below the threshold Temperature of esophageal probe or dashes if there is no probe attached
47. d all new data is logged as part of the new procedure The POST screen summarizes the activities see Section 6 5 Post Procedure 2 Ifthe generator is off for more than 6 hours a new procedure starts automatically when you turn on the generator and start ablation 6 4 2 Starting and Stopping Ablation Quick Steps Press the ABLATION workflow button To start ablation press Ablation Start on the front of the generator or remote control or press and hold the foot pedal To stop ablation press Stop on the front of the generator or remote control or release the foot pedal Notes 1 Either the generator or the remote control can be the system Master see Section 6 7 System Control When the remote control is the system Master ablation can still be started from the generator 2 When you start ablation the RF On indicator on the generator and on the remote control light up and a continuous tone is emitted These turn off when you stop ablation 3 Ifa Pre RF time has been set for fluid control RF energy will not start until after the fluid has flowed for the Pre RF amount of time see Section 6 3 10 Irrigation Control 4 lf ablation does not stop when you press Stop try any of these alternatives If you pressed Stop on the generator press Stop on the remote control If you pressed Stop on the remote control press Stop on the generator Press and release the foot pedal on the generator Pre
48. d external devices S Ablation stop tone There is an internal problem in the generator For a dual sensor DS catheter the difference between the measurements of the two sensors is too high This may be caused by a problem with the catheter or the cables Catheter temperature warning The temperature measured by the catheter may have exceeded the warning value set in the preset Current output too high The generator was trying to deliver a current output that was beyond its intended capability Warning V A appears near temperature reading and its orange border flashes S Warning tone Ablation Stop Reason V A and Ablation Summary and catheter receptacle flashes red for 5 seconds S Ablation stop tone 7 Troubleshooting Page 71 Reduce the power setting used for the ablation or stop the ablation If it is clinically appropriate modify the temperature warning value for the preset that was used See Section 6 3 3 Editing a Preset See the instructions in this table for Power output too high RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Indicators What To D Reasons V Visual S Sound Se Esoph temperature above maximum not applicable for the US and JP versions of the generator The esophageal probe Alert Wait a few seconds for the temperature exceeded V A and Alarm indicator turns temperature
49. d on the back of the generator see Item 2 in Section 4 3 Controls on the Back of the Generator 2 Ifyou press Today all data from the current day will be exported If you press Last 7 Days all data from the last 7 days will be exported If you press All all data on the generator will be exported These buttons change from blue to gray during the export process 3 A light green dot appears on the export status line and continually gets darker as the export process progresses It changes to when the export status is 100 complete It changes to if you press Cancel export or if the export fails Any files that have already been exported to the USB flash drive will remain on the flash drive Any file that was only partially exported will be completely exported the next time the export process is started 4 The export process may take minutes or more than an hour depending on the amount of data 6 Operation Post Procedure Page 57 RF Generator User Manual 6 6 Flushing to Eliminate Air in the Tubing and Catheter mn e Irrigated catheters must be flushed before they are inserted in the patient e When flushing a catheter the catheter must not be inside the patient When flushing the SMARTABLATE Irrigation Tubing Set either the catheter must be outside the patient or the 4 way stopcock on the tubing set must be turned so that the fluid is not routed to the catheter Quick Steps Ensure that the catheter is not in th
50. de or a different cable RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons Insufficient irrigation High ablation flow was stopped Possible reasons are The Stop button on the pump was pressed The Low Standby Flow button on the pump was pressed The foot pedal on the pump was released Low fluid The generator has calculated that the amount of fluid in the irrigation bag is low Measurement integrity error The generator has two independent measurement channels for critical parameters this message will appear if the two channels do not agree Possible reasons are The cable is faulty There is a compatibility problem between the generator and external devices There is an internal problem in the generator Indicators V Visual S Sound Ablation Stop Reason V A and Ablation Summary S Ablation stop tone Warning V A and orange border around Irrigation Control icon flashes for 20 seconds S Warning tone Alert V A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary S Ablation stop tone What To Do Restart the flow Check the fluid level If it is low change the bag and after the ablation update the fluid bag size on the Irrigation Control screen See Section 6 3 10 Irrigation Control Disconnect any devices connected to the
51. des and electrodes of low quality can impair contact quality and increase the risk of a skin burn e Heat produced by thermal blankets or other sources of heat adds to the heat arising under the indifferent electrode This increases the risk of skin burns Do not use such sources of heat in immediate proximity to the indifferent electrode Feen An unsuitable indifferent electrode or an incorrectly applied indifferent electrode can lead to burns on the skin surface Check the indifferent electrode and the connection cable before use Do not use these if they are damaged or modified 3 Warnings and Precautions Page 13 RF Generator User Manual SMART YSTEM 4 System Overview and Setup The SmarTABLaTE RF Generator is a radiofrequency generator designed for use in cardiac ablation procedures The generator can be configured to work with a variety of other devices and meets the highest standards for safety precision and ease of operation u recording System LAR TOR 3 Be Remote System en FF Catheter Foot Fedal Esophageal Frobe Connections gt The Esophageal Probe shown above is not applicable for the US and JP versions of the generator The generator is compatible with a large number of catheters and devices For a listing of devices and accessories see Section 5 2 Accessory Lists The generator is operated via an easy to use user interface Selections can be made on the screen by tou
52. e Do not use any contact gel with single use electrodes Use the single use electrode for only one procedure If the indifferent electrode becomes loose or needs to be moved use a new indifferent electrode Repeated use of an already applied electrode can mean a loss of adhesiveness and thus lead to distinctly poorer contact quality e Forareusable electrode Make sure that the electrode contact surface is not dry If it is dry use a small evenly distributed quantity of conductive gel Kr 3 Warnings and Precautions Page 12 RF Generator User Manual e Carefully select the contact area Choose a muscular area on the back of the patient that is as near the heart as possible and that has sufficient blood flow Do not place the indifferent electrode near wounds e Carefully prepare the contact area Prepare the contact area on the patient and on the indifferent electrode according to the instructions for use provided with the indifferent electrode Place the indifferent electrode closer to the ablation site than any ECG electrode or other products that could represent an alternative lead Shave and degrease the skin e Carefully apply the indifferent electrode to the contact area Make sure that the whole surface of the indifferent electrode forms a closed contact with the patient s back There should be no pockets of air between the skin and the indifferent electrode Oil hair dirt repeatedly used adhesive electro
53. e Brightness and FOOT Pedal TeSticsscscssscovesssessasscsconessnansncovssceseisescisssssessdessavcanensosveseecsesesssss 60 89 FOwcChart othe SCLC SING nen ee eh 61 6 10 Tons On LS CS een are 62 7 TROUBLESHOOTING 64 Al DOCE OM SCIONS senn r ER E E EE E E 64 7 2 Warnings Alerts and Ablation Stop Reasons cscesssesesssscssscsesessssssssesesescscscsesesssssessescacscsesees 67 13 Sy ENON porra R 83 Pek VOM EN OT gen a E errs rea E ere rer 83 732 FP E aa AA E seeanaen 83 74A Other Troubleshooting sera nenne 84 7 93 Calibrating the TOuUcHSereen een 84 8 TECHNICAL DATA 85 3 1 SIDS CEM CUO 1 Seien een ee ee O E es 85 82 Storage and Shipping ONG One eareensenane 86 8 gt Operating Condi nennen ernennen 86 8 4 THERMOCOOL Catheter Preset RANGES cscsssessessssessessessssessessssesssssssesssssssessessssessessssssaesecsesseeseeees 86 85 Alarm and Touch Specifications e ssesseseeessessesseessessesseeseesseessensesseessesseoseeseesseoseoseesseeseesesseeseeseesesss 87 39 OUUU PEE OE nee een een 88 er Salat LASSE OIG ee E ENSE S AE AES 89 88 MONONA O E E E r E ORE 90 o R O r A A E E E AS 90 8 10 Conformance to Standards na 91 8 11 EMC Information and Technical Description eseseseseseseesesesesenenenenenenenenennnnnnnnnnenenennnnnnnnnnnnenenene 92 9 SYMBOLS 97 10 WARRANTY 100 101 Transit Damage era 100 1O N enian EE een ee ns 100 103 Produc OaD co seer arroen a SEE ET A AAAA 100 11 REFERENCES 101 RF
54. e Meaning of Icons Remote Communication between the generator and the SMART BLATE Remote Control was established and is functional Possible Reasons The remote control is not connected to the generator The remote control 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 remote control has a software version that is not compatible with the generator s software version What To Do Connect the remote control to the generator Turn on the power to the remote control Replace the communication cable between the generator and the remote control Replace the communication cable between the generator and the remote control The software version on the remote control needs to be updated Contact Customer Support Foot Pedal The foot pedal is connected to the generator and has passed the foot pedal test 1 Possible Reasons The foot pedal is not connected to the generator or has become disconnected The foot pedal test has not been performed The foot pedal has failed the foot pedal test The foot pedal automatic ID check failed What To Do Connect the foot pedal to the generator Perform the foot pedal test See Table 3 Device Screens in Section 6 2 or Section 6 8 Volume Brightness and Foot Pedal Test Press the image of the foot pedal and perform the foo
55. e patient or that the 4 way stopcock on the tubing is turned so fluid is not routed to the catheter Open the Pump device screen or the Irrigation Control screen Press Flush on the screen or Flush on the pump When a message appears press and hold the Data Entry Knob Release the Data Entry Knob Notes 1 The Flush button is available on the generator s Pump device screen see Table 3 Device Screens in Section 6 2 and on the Irrigation Control screen see Section 6 3 10 Irrigation Control 2 Toensure that all bubbles have been flushed from the catheter or tubing set flush for at least 5 additional seconds after an image appears on the pump s display indicating that no bubbles were detected and after there are no visible bubbles in the tubing see the instructions for use provided with the pump 3 Opening the door ofthe pump can move the tubing slightly causing the bubbles to move out of the bubble sensor area Inspect the tubing carefully 6 Operation Flushing to Eliminate Air in the Tubing and Catheter Page 58 RF Generator User Manual 6 7 System Control When you first turn on the generator the generator is the system Master and the remote control is the Monitor The Master controls all system functions except the volume brightness and foot pedal testing of the Monitor At the remote control you can request that it become the Master the generator then becomes the Monitor When you want the gen
56. e stimulator are galvanically connected with the ablation catheter Only cables and plugs approved for a CF type of device CF safety classification may be used see Section 5 2 Accessory Lists 2 All devices with these cables and plugs must fulfill the requirements stated in MDD MPG for class 1 devices Fulfillment of the requirements stated in IEC EN 60601 1 1 and MDD 93 42 EEC must be monitored and documented in a suitable way 3 The person who connects the generator and accessories to each other or who uses the generator and accessories is responsible and liable for installation and operation that complies with IEC EN 60601 1 1 4 All system components must comply with all applicable requirements and standards and be labeled pursuant to these standards 5 If there are any concerns regarding the use of a component contact the distributor of the component to obtain further information 6 If several devices are connected to the generator and 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 All devices and accessories when located within the patient area must comply with IEC EN 60601 1 and its sub standards 3 Warnings and Precautions Page 9 RF Generator User Manual SMART Keep in mind that the ECG connection cable for the generator creates a direct electrical connection to the patient s heart Incorrect use of this connection
57. e tubing See Section 6 6 Flushing to Eliminate Air in the Tubing and Catheter Resume low standby flow Wait a few seconds for the temperature to drop before restarting ablation If the problem persists modify the temperature cut off value in the preset that was used See Section 6 3 3 Editing a Preset Consider possible clinical reasons for the ablation electrode to overheat If the problem persists contact Customer Support RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons Indicators V Visual S Sound Catheter temperature change The catheter temperature changed at a rate that was greater than 20 degrees within 200 ms This may occur when there is electrical interference between the ablation electrode and the temperature sensor Ablation Stop Reason V A and Ablation Summary for 5 seconds S Ablation stop tone Catheter temperature invalid The generator does Alert not recognize a valid V A and Alarm indicator turns temperature reading on orange Possible reasons are S none A catheter is not connected or is connected to the wrong receptacle Ablation Stop Reason V Ablation Summary and catheter receptacle flashes red for The cable or catheter is 5 seconds faulty There isa compatibility Ablation stop tone problem between the generator and external devices There is an
58. ed from the generator by performing the steps in Section 6 5 1 Exporting Ablation and Event Log Data to a USB Flash Drive Alarm Tones and Alarm Indicator Al Light See Sections 7 2 Warnings Alerts and Ablation Stop Reasons and 7 3 System Errors Warning Fatal Ablation Stop Reason System Error System Error Comment Information tone Information tone High priority alarm Pulse Pattern ti ti ti ti ti ti ti ti ti ti ti ti ti ti Frequency 600 Hz 900 Hz 1000 Hz Duration 600 ms 400 ms 4 25 Repetition None 20s 10s Al Off On orange Flashes red f 2Hz duty cycle 50 Note All alarms are technical alarms Signal Lights See Section 7 2 Warnings Alerts and Ablation Stop Reasons Indicator Color Frequency Duration Indifferent electrode receptacles Blue 5 Hz 55 Catheter receptacle Red 5Hz 55 Esophageal probe receptacle not functional Red 5 Hz 55 in the US or JP versions of the generator Duration of warning Border of System Control icon Orange 0 5 Hz Border of Irrigation Control icon Orange 0 5 Hz Duration of warning Border of System Status icon Orange 0 5 Hz Touch Screen Tones Duration of warning Duration Event Frequency Touch is recognized and button is valid 4 kHz 40 ms 20 ms Touch is recognized but button or area is not valid 2 kHz 8 Technical Data Page 87 RF Generator User Manual 8 6 Output Specifications Output Power vs Load Impedance pf ff of ff ff IN ee ee HE
59. ee 23 ZI eer ee ee ae esse en 23 522 TOPCO graces ce se cacy contacter E E A 24 523 SWARTABLEIE Cable ee rer 24 5 2 4 Indifferent Electrodes and Cables available from STOCKERT GmbH 26 323 CNS SMe een ae ee ee Teen 26 53 MIO CS 5 SS een 27 5 3 1 Connection Cables ss sesesseesseesseesseessesseesseesseosseoseesseesseosseesseoseeoseroseenseoseesseesseoserosereseeoseeosee 27 3 32 naderen ISCO CGS cueir eana EEN sneunteswaarts 27 33 OO POGI eaa een 27 5 4 Cleaning Disinfecting and Sterilizing Accessories esenssesesesenesensenenenenennenenenennnnenenenennenenenennene 27 6 GENERATOR OPERATION 28 Bl EOV IO aan ar ee ee 28 5 1 SYE U e E AE E E E 28 612 E E E a E E ee 29 SM ie 6 ee E 29 0 14 Scieen l 9 u a 31 6 15 Boll BAY KN0D een 32 5 10 Foot Pedal een ee 32 6 1 7 Typical Procedure Process Quick csssssssssscsssecessssssssecscsssssssecscsssssesesscssseccsssesesecseens 33 6 1 8 Typical Procedure Process Full aaa ana 33 5 2 ONEC DONS een ren 34 OS ass crear EBEN EEE esc case cme vacate ccs ELDER EERIEESNOEENEENEE OO ENCEULIERERREERRERIE DIENEN EIERN SPREGEEIER 39 081 PIESELOVEV Wesen ae er 39 632 SOUS CBAC a PIE ee ee 39 63 EAN a PrE O aE E anne 40 6 3 4 Editing a Preset Temporary Save 44 035 CAEN eS OI ernennen een 45 6 3 6 Designating a Default Preset ceesesscscsscesscsescsssssssscssssssesesssesessesssesseescseseesescseseseeseees 46 6 3 7 Deleting a Preset
60. efore the generator is turned on Beware of flammable endogenous gases Materials such as cotton and gauze when saturated with oxygen can be ignited by sparks that arise even during normal use of the generator The foot pedal is suitable for use in operating rooms 20 Be aware during ablation procedures that in patients with cardiac pacemakers or pacemaker leads there is a risk of interference with the pacemaker function or damage to the pacemaker In case of doubt consult the manufacturer of the device 21 The electromagnetic radiation emitted by the generator can interfere with the function of other electrical devices Conversely other electrical devices can influence the function of the generator if they are operated at the same time in the immediate vicinity of the generator 22 The plugs on the catheter and the catheter connection cable must not be brought into contact with parts that have high voltage such as mains outlets or metallic objects This can lead to the patient s death by electrocution 23 To avoid damage to the connection cables do not wrap the cables around the generator or other apparatus Coiling the connection cables during normal operation of the generator creates inductive components which can lead to measurement errors The values indicated in error can lead to misinterpretations 24 Special safety measures with regard to electromagnetic compatibility EMC must be taken with electrical medical devices This
61. el M Steinbeck G 1992 Bedeutung Physikalischer Parameter fur die Effektivitat der Radiofrequenz Katheterablation Biomed Technik 37 62 68 Hoffmann E Gerth A Remp T Muller D Steinbeck G 1992 Linksventrikul re Katheterablation des AV Uberleitungssystems mit Radiofrequenzstrom Z Kardiol 81 378 384 Hoffmann E Haberl R Pulter R Dainat C 1987 Phase Displacement between Voltage und Current during Radiofrequency Catheter Ablation Circulation 76 Suppl IV 278 Abstract Hoffmann E Haberl R Pulter R Gokel M Steinbeck G 1992 Biophysical Parameters of Radiofrequency Catheter Ablation Inter J Cardiol 37 213 222 Hoffmann E Mattke S Dorwarth U et al 1989 Temperature Controlled Impedance Guided Radiofrequency Catheter Ablation in Swine Circulation 80 Suppl II 4 Abstract Hoffmann E Mattke S Dorwarth U Muller D Haberl R Steinbeck G 1993 Temperature Controlled Radiofrequency Ablation with a New Electrode Catheter First Clinical Experience Eur Heart J 14 57 64 Hoffmann E Mattke S Knecht M et al 1990 Predictors of Successful Temperature Controlled Radiofrequency AV Ablation Eur Heart J 11 155 Abstract Hoffmann E M ller D Gerth A Remp T Steinbeck G 1992 Bedeutung des Impedanz Monitoring wahrend Radiofrequenz Katheterablation Z Kardiol 81 Suppl 1 142 Abstract Hoffmann E Muller D Remp T Gerth A Steinbeck G 1992 Radiofrequenzablation der La
62. equipment generates uses and can radiate radiofrequency energy and if not installed and used in accordance with this user manual may cause harmful interference to radio communications Similarly portable and mobile communication devices may cause harmful interference to the functioning of the generator 25 If error messages repeatedly appear stop using the generator and contact Customer Support 26 To avoid damage to the generator and its accessories use only appropriate cleaning agents see Sections 4 6 Cleaning and Disinfecting the Generator and 5 4 Cleaning Disinfecting and Sterilizing Accessories 27 To avoid the risk of electric shock connect the mains cable from the generator mains socket see Item 6 in Section 4 3 Controls on the Back of the Generator to a 3 prong outlet that meets the specifications in Section 8 1 Specifications 28 The generator may be opened only by persons authorized by the manufacturer When the generator is open parts that have high voltage or are very hot are accessible and can cause injury If the generator is opened by an unauthorized person any claims on the warranty are void No modification of the generator is permitted 29 If fluid penetrates into the generator stop using the generator and contact Customer Support 3 Warnings and Precautions Page 8 RF Generator User Manual SMART 30 Inthe unlikely event that there is a fatal system error the system will stop and the Alarm
63. er of RF energy into the electrodes connected to the stimulator can also cause injury to the patient 8 Only classified electrical medical devices may be connected to the generator 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 3 3 Warnings and Precautions During an Ablation Procedure 1 Blood vessel perforation is a risk inherent in the placement of an electrophysiology catheter The catheter needs to be moved carefully to avoid damage or perforation of blood vessels 2 When performing ablation of the posterior wall of the left atrium beware of the risk of forming a lesion in the esophagus 3 Avoid high ablation temperatures High ablation temperatures can lead to clot formation charring of the heart tissue or blood and or evaporation of interstitial intracellular fluid Note The temperature indicated on the generator is not the tissue temperature The indicated temperature is the temperature of the catheter s ablation electrode which does not necessarily represent the tissue temperature This applies especially when catheters with saline cooled ablation electrodes are used
64. erator to take control again make it the Master as described in this section Note Screen calibration also affects only the Master see Section 7 5 Calibrating the Touch Screen System Control Screen When Generator Is Monitor Device status Become Master MONITOR Volume Brightness Foot Pedal Gen Press to test f COOUNEEOEE 4 Automatic no RF energy will be delivered Manual Net y pressed 3 TEP l j Preset THERMOCOOL Standard 6 7 1 Making the Generator the System Master Quick Steps Press System Control WES on the Navigation Bar Press Become Master Notes 1 The Ablation Start button on the generator and the foot pedal on the generator can be used to start ablation regardless of whether the generator is the Master or the Monitor Similarly the Stop button and the foot pedal on the generator can be used to stop ablation regardless of whether the generator is the Master or the Monitor 2 When the remote control is the Monitor it can only be used to stop ablation 6 Operation System Control Page 59 RF Generator User Manual 6 8 Volume Brightness and Foot Pedal Test System Control Screen Device status Become Master MASTER Volume Brightness Foot Pedal Gen Press to test ef COOUREEEEE 4 Automatic no RF energy will be delivered Manual Not pressed 3 TT x al j u Quick Steps Press System Control on the Navigation Bar to
65. es At least once a year verify that the SMARTABLATE RF Generator and its accessories are installed per Section 4 5 Setup At least once a year perform the touch screen calibration per Section 7 5 Calibrating the Touch Screen The SmarTABLaTe RF Generator contains measurement circuitry To ensure that the generator stays in compliance with its performance specifications the generator s calibration must be maintained Every other year and any time that loss of accuracy is suspected contact Customer Support and schedule preventive maintenance that includes calibration and a full functional test The calibration and the full functional test may be performed only by the manufacturer a service engineer certified by the manufacturer or a service center certified by the manufacturer At any time if any problems are found report them to Customer Support and send the generator or broken accessory for repair If desired a service contract can be arranged Contact Customer Support 89 Repairs There are no parts in the SMARTABLATE RF Generator that may be serviced by the user Exception The fuses may be replaced per Section 4 5 3 Fuses Repairs or any changes to the generator and the accessories must be performed only by the manufacturer a service engineer certified by the manufacturer or a service center certified by the manufacturer 8 Technical Data Page 90 RF Generator User Manual 8 10 Conformance to Standards
66. etting Descriptions in this section Use the Data Entry Knob O to change the value see Section 6 1 5 Data Entry Knob Press Save O then press In selected preset or Press Escape Mis then press No to exit the screen without changing the preset Notes 1 If you don t see the preset that you want to edit select a different catheter type see Section 6 3 2 Selecting a Preset or display the presets for a different physician see Section 6 3 8 Displaying One Physician s Presets 2 The choices in each pane vary depending on the catheter type you select 3 Before making changes select Temperature or Power in the Ablation Settings pane to select Temperature Control Mode or Power Control Mode The selections in the panes vary depending on the mode Temperature Control Mode is not available for all catheter types and is not applicable for the US and JP versions of the generator 4 The lrrigation Control Settings pane appears only when you select an irrigated catheter 5 When you press Save a message appears asking whether to save In selected preset or Save temporarily Select In selected preset See Section 6 3 4 Editing a Preset Temporary Save for information on Save temporarily 6 When you press Save O and then press In selected preset the selected preset is saved with the revised values If you want to save the revisions as a different preset press Save As and follow the instructions in Section 6 3 5 Creat
67. fication data Possible reasons are The cable was not provided by or recommended by the manufacturer The cable was damaged during re sterilization The cable is faulty There is a system problem Indifferent electrode not detected No indifferent electrode Alert was detected V A and Alarm indicator turns A split indifferent on orange electrode is connected to S none the generator but is not applied to the patient Ablation Stop Reason V Ablation Summary and both indifferent electrode receptacles flash blue for 5 seconds S Ablation stop tone 7 Troubleshooting Page 78 If using an incompatible esophageal probe connection cable replace it with a cable that was provided by or recommended by the manufacturer If using a compatible esophageal probe connection cable replace it with a new compatible connection cable If the problem persists contact Customer Support If a split indifferent electrode is connected to the generator apply it to the patient Disconnect the indifferent electrode from the generator then reconnect it Check all other connections to the indifferent electrode such as the connection between the cable and the electrode itself Plug the indifferent electrode into the other indifferent electrode receptacle on the front of the generator Contact Customer Support even if the problem is resolved If the problem persists use a different indifferent electro
68. g a solid indifferent electrode the hospital staff is responsible for ensuring proper contact of the electrode with the patient s skin 13 The patient must not be in contact with grounded metal components or with metal components that have a large grounded area for example the operating table supports For this purpose the use of sufficiently insulating antistatic covers on the operating table is recommended Electrostatic discharge ESD can give rise to extremely high current densities at the catheter tip which can injure the patient Therefore do not touch the pins in the plug at the end of the catheter or the pins in the plug at the end of the cable after the catheter has been placed in the patient s body 14 Skin contact between parts of the patient s body for example between the arms and the body should not occur Such contact can be avoided by using dry gauze for example 15 Ifthe generator and physiological monitoring devices are used on a patient at the same time all monitoring electrodes without protective resistances or RF filters should be applied to the patient s body as far away as possible from the ablation electrodes Needle electrodes are not recommended for monitoring purposes In all cases it is appropriate to use monitoring electrodes and other monitoring devices that limit the RF current 16 Position the connection cables of the ablation electrodes in such a way that they do not touch either the patient or othe
69. gation Control Settings in this section 6 Operation Presets Page 47 RF Generator User Manual SMART Setting Monitor Low Flow Use automatic flow adjustment High Flow Low Flow Pre RF Time Post RF Time Monitor Fluid Low Fluid Warning New Bag Volume Remaining Table 6 Irrigation Control Settings Description Select Monitor Low Flow if you want the system to warn you when either the catheter is in the patient and the pump hasn t started working yet or the flow is stopped Select Use automatic flow adjustment if you want the rate at which fluid flows during ablation to be automatically adjusted by the system When Use automatic flow adjustment is selected you will see AUTO automatic next to the set flow rate on the ABLATION screen When Use automatic flow adjustment is not selected you will see MAN manual next to the set flow rate on the ABLATION screen See Section 6 4 Ablation for a sample screen Note If the flow rate is changed manually during ablation as described in Section 6 4 3 Making Temporary Changes to Ablation Settings all system controls over the flow rate are disabled The user is responsible for ensuring that the flow rate is appropriate for the power setting The rate at which fluid flows during Pre RF Post RF and ablation If Use automatic flow adjustment is selected press High Flow to access the High Flow screen where you can set the flow for each powe
70. ge 3 RF Generator User Manual RF heating of the tissue changes the impedance because of the heating and dehydration of the tissue During the increase in tissue temperature the tissue impedance first falls to a minimum value and remains at this level for some time Then the impedance rises based on the supplied power see Figure 4 Impedance should be monitored during ablation A rapid increase in impedance is an indicator that there is a problem and ablation should be stopped One possible cause for the rapid increase is char formation another possible cause is that the electrode has become buried in the tissue Figure 4 a 1 Functional Principles Page 4 RF Generator User Manual 2 Indications The use of the SMARTABLATE RF Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures Read and follow the instructions for use that are provided in this user manual before using the system in a clinical application Also refer to instructions for use that are supplied with the accessories and with the compatible therapeutic catheters USE 2 Indications Page 5 RF Generator User Manual SMART 3 Warnings and Precautions 3 1 Warnings Generator Usage 1 Read this user manual carefully before using the SMARTABLATE RF Generator for the first time Note especially the instructions in Section 4 5 Setup 2 Cardiac ablat
71. heter type that you selected when you created the preset 8 See Section 6 3 4 Editing a Preset Temporary Save for an explanation of a temporary save Designating a Default Preset Quick Steps Select the preset that you want as the default Press Set Default Notes 1 The default preset is the preset that is automatically selected after you select a catheter type 2 D appears after the name of the default preset Deleting a Preset Quick Steps Select the preset to delete Press Delete Ea Press Yes Notes 1 The standard presets that come with the generator cannot be deleted 2 If you delete all of the presets for one physician the physician s name will be deleted from the Physician Presets list see Section 6 3 8 Displaying One Physician s Presets Displaying One Physician s Presets Quick Steps Press the PRESET workflow button Select the catheter type In the Physician Presets pane press the button Select the physician whose presets you want to see Notes 1 When the button in the Physician Presets pane says All all of the presets for the catheter type that you selected appear in the Preset pane When the button says the name of a physician only the presets for that physician for the selected catheter type and the standard preset for the selected catheter type appear 2 Ifa physician s name is not listed on the Physician Presets screen there are no presets associ
72. ific location in the tissue This current density is a factor not only of the generator output but also of the ablation electrode surface area and the contact between the ablation electrode and the cardiac tissue In order to assess the effect of the RF power the user must watch for intracardiac ECG signal reduction in the area of the ablation 1 3 Temperature Controlled Ablation Method The temperature of the ablation electrode is measured by a temperature sensor In the case of non irrigated ablation catheters the temperature of the ablation electrode is an indication of the temperature of the tissue in contact with the electrode During temperature controlled ablation the RF power output is regulated automatically by the generator so that the temperature selected by the user is reached and maintained at the desired level see Figure 3 Thus the risk of charring tissue adhesion or pop is greatly reduced Figure 3 The size of a lesion is determined primarily by the ablation time and temperature With the temperature controlled ablation method it is not necessary to set the initial RF power level manually Note Because the ablation electrode measures only the temperature of the electrode with its integrated temperature sensor and not the actual tissue temperature deep inside the myocardium tissue overheating can still occur Therefore temperature measurement is suitable only for limiting overheating However in some physical circumst
73. indicator will flash red immediately disconnect the mains cable from the generator 31 Electrodes and probes for monitoring and stimulation devices can be electrical conductors of RF current Reduce the risk of burns by placing the electrodes and probes as far away as possible from the site of ablation and from the indifferent electrode 32 To avoid possible injury to patients and medical personnel do not start RF power application before the catheter is positioned in the intended ablation area 33 To minimize electrical noise on the ECG recordings position catheter connection cables so that they do not touch either the patient or other cables For an optimal ECG trace keep unused active surface electrodes at a distance from the patient 34 To prevent fluid from impairing system performance ensure that sterile catheters and cable plugs are completely dry 35 To prevent a system malfunction inspect all reusable accessories regularly Do not use damaged cables 36 Ablation data stored electronically must not be used for diagnosis or therapy The intended use is for archiving or research only 3 2 Warnings System Safety and Connections The SmarTABLaTe RF Generator can be connected directly or indirectly to many other devices and accessories The generator and the connected group of devices and accessories are referred to in the following warnings as the system 1 The generator connections for the ECG signals and for th
74. ing a New Preset 7 You cannot save changes to the standard presets that come with the generator If you make changes to a standard preset and want to save the changes press Save As and follow the instructions in Section 6 3 5 Creating a New Preset 6 Operation Presets Page 41 RF Generator User Manual Table 5 Preset Setting Descriptions Setting Ablation Settings Pane Time Max Power Power Power Ramp Duration Temperature Settings Pane Target Warning Cut Off Control Algorithm Description The time limit for a single ablation Ablation will stop automatically after this time only in Temperature Control Mode Upper power limit for the temperature control algorithm The temperature control algorithm will automatically set the power without exceeding this value Consult the instructions for use for the catheter to determine the appropriate power setting for the catheter only in Power Control Mode The output power to be maintained by the generator during the ablation Consult the instructions for use for the catheter to determine the appropriate power setting for the catheter only in Power Control Mode The time it will take the generator to increase power from OW to the value set in the Power field only in Temperature Control Mode The temperature that you want the ablation electrode to reach The generator will generate power up to the Max Power setting in an attempt to reach the Targe
75. ings pane 20 Off Tem peratu re Temperature Power Irrigation Control Settings pane IRRIGATION CONTROL SETTINGS 43 High Flow G gt Settings pane Low Flow Normal and Fast re Re appears only i Post RF Time 5 for irri ated are only available ESOPHAGEAL TEMPERATURE SETTINGS Erland wenn r for 4mm catheters Max warning OCut Off catheters Esophageal Rise Warning Cut Off Temperature orecer THERMOCOOL Standard Settings pane The Esophageal Temperature Settings pane shown above is not applicable for the US and JP versions of the generator Edit Preset Screen in Temperature Control Mode Non Irrigated Catheter OD Temperature EO O Normal ESOPHAGEAL TEMPERATURE SETTINGS Max Warning OCut Off Rise Warning OCut Off Preset 4mm Standard Temperature Control Mode is not available for some irrigated catheters Temperature Control Mode for irrigated catheters and the Esophageal Temperature Settings pane are not applicable for the US and JP versions of the generator 6 Operation Presets Page 40 RF Generator User Manual EDITING A PRESET continued Quick Steps 1 Display the Edit Preset Screen Press the PRESET workflow button Select the preset to edit Press Edit 2 Change the Control Mode not available for all catheter types Inthe Ablation Settings pane select Temperature or Power 3 Change Settings Press a displayed value see Table 5 Preset S
76. internal problem in the generator and catheter receptacle flashes red What To Do Try a different cable or catheter If the problem persists contact Customer Support Verify that the catheter is connected to the appropriate cable and that the cable is connected to the red Catheter 1 receptacle on the front of the generator See Item 4 in Section 4 2 Controls on the Front of the Generator Verify that you are using a catheter and a cable or cables that are compatible with the generator Try a different cable or catheter If the problem persists contact Customer Support 7 Troubleshooting Page 70 RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons Indicators What To D V Visual S Sound ann Catheter temperature measurementerror The generator recognizes Alert Verify that you are using a a valid temperature V A and Alarm indicator turns catheter and a cable or cables that reading but the on orange are compatible with the generator redundant eaS ANENA Try a different cable or if you system reflects a reading S none are using a dual sensor DS catheter try a different catheter If the problem persists contact Customer Support Possible reasons Ablation Stop Reason V Ablation Summary and catheter receptacle flashes red for 5 seconds The cable is faulty There is a compatibility problem between the generator an
77. ion procedures should be performed only by physicians who have been thoroughly trained in RF catheter ablation techniques Catheter ablations should be performed only in medical rooms in compliance with IEC EC 60601 1 Annex A 4 Clause 16 3 In catheter ablation procedures fluoroscopy is commonly used When using fluoroscopy there is the risk of exposure to considerable radiation The intensity of the X rays and the duration of the radiation can lead to acute radiation damage or to an increased risk of a physical or genetic defects for both patients and medical personnel Therefore perform catheter ablations only after carefully considering the potential radiation dose The advantages and disadvantages of X ray exposure should be considered carefully before catheter ablation is performed in pregnant women Also the long term risk of prolonged X ray imaging has not been researched Therefore the advantages and disadvantages should be considered carefully before this procedure is performed in prepubertal children Consider using a navigation system without fluoroscopy to reduce exposure to X rays 4 Do not apply RF energy while a stimulator is connected to the generator unless specifically indicated by the stimulator s instructions for use Doing so might induce ventricular fibrillation 5 Always verify that the generator s visual and acoustic alarms are working before using the generator see Section 6 1 1 System Startup 6 When the ge
78. king 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 greater and is protected against vertically falling water drops Certificate of origin in Germany Hardware revision number Mode of operation Indication of duty cycle giving the maximum activation ON time and the minimum deactivation OFF time 9 Symbols Page 99 RF Generator User Manual 10 Warranty 10 1 Transit Damage The SMARTABLATE RF Generator and accessories must be examined for transit damage immediately after receipt If the generator 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 generator you can use this form to record any damage 10 2 Warranty The warranty for the SmarTABLATE RF Generator warrants that the generator 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 normal 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
79. lates the amount of fluid delivered and estimates the remaining fluid amount based on the bag size you select When you press New Bag the remaining fluid level is reset to be the same as the bag size you select Because the volume remaining calculation is affected by the preset you select the value of the remaining volume may not correctly reflect the actual volume remaining if you select a different preset during an ablation When you turn off the generator and turn it on again within 6 hours the volume remaining value is retained If you turn the generator on again after 6 hours the volume remaining is reset to the selected bag size Before you start ablation the Irrigation Control Edo icon is available on the Navigation Bar After you start ablation the Navigation Bar disappears During ablation if the fluid level reaches the warning limit set on the Irrigation Control screen the Irrigation Control icon appears at the bottom of the ABLATION screen with a flashing orange border If you press Irrigation Control Ego when the ABLATION screen is displayed and you then make changes on the Irrigation Control screen an asterisk appears after the name of the preset on the PRESET workflow button to indicate that temporary changes have been made see Section 6 4 3 Making Temporary Changes to Ablation Settings The Irrigation Control screen indicates the volume remaining in the selected bag size When you press New Bag this number resets
80. lation catheter or to the indifferent electrode that are not approved by the manufacturer If the problem persists try disconnecting any other devices connected to the patient that are not mandatory Ifthe problem still persists turn the generator off Let it cool down for 5 seconds then turn it on again Contact Customer Support even if the problem is resolved Close the pump door RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons Pump error There is an internal error in the pump Pump not connected An irrigated catheter preset is being used and no pump connection was detected Remote disconnected The remote control that had control of the generator is disconnected or there isa communication error between it and the generator Stop button Generator The Stop button on the generator was pressed Indicators Alert V A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary Alert V A and Alarm indicator turns on orange S none Ablation Stop Reason V Ablation Summary S Ablation stop tone Warning V A and orange border around System Control icon flashes for 20 seconds S Warning tone Ablation Stop Reason V Ablation Summary S Ablation stop tone Ablation Stop Reason V A and Ablation Summary 7 Troubleshooting Page 81 What To Do V
81. limit value is exceeded If unrealistic values are set important alarm functions will be triggered too late or not at all 8 To minimize the risk to the patient keep the ablation duration to one minute or less 9 When using the usual operating settings a low output RF power or a problem with the ablation device can be a sign that the indifferent electrode is not correctly positioned or has poor contact with its connection cable 10 Continuously monitor the generator s impedance measurement during RF energy application If a sudden increase in impedance is observed stop the RF energy delivery Remove the catheter from the patient s body and clean the ablation electrode of the catheter with a sterile cloth to remove any adherent materials 11 If there is any doubt about an unintended increase in RF energy or the proper functioning of the touch screen Data Entry Knob foot pedal or remote control during RF delivery immediately stop the RF energy delivery by pressing the Stop button on the generator releasing the foot pedal or pressing the Stand by button If none of these measures stops the RF energy delivery disconnect the mains cable from the generator 3 4 Handling Indifferent Electrodes An indifferent electrode is used for unipolar ablations see Section 1 4 Unipolar Application Method The indifferent electrode is monitored at all times by the generator e To ensure patient protection the generator prevents unipola
82. loses keyboard without saving Press the PRESET workflow button In the Catheter pane select the catheter type for which you want to create a preset In the Preset pane select a preset with settings similar to those you want Press Edit Change the settings see Section 6 3 3 Editing a Preset ip Press Save As vw Select a physician s name then type a preset name or Press Create New type a physician name press PRESET NAME then type a preset name Press OK ga NAME PRESET NAME Quick Steps Notes 1 2 3 4 5 6 The physician s name can be a maximum of 9 characters The maximum number of physician names is 10 The preset name can be a maximum of 13 characters The maximum number of presets is 80 You cannot use the same preset name for two catheter types For example you cannot create an 8mm preset named 20W POWER LIMIT if you already created one with the same name for 4mm For this reason it is a good idea to include a catheter description such as 4MM in the preset name If there are fewer than 10 physician names in the Physician Presets list the physician s name that you type when you create a new preset will be added to the Physician Presets list see Section 6 3 8 Displaying One Physician s Presets 6 Operation Presets Page 45 RF Generator User Manual 6 3 6 6 3 7 6 3 8 7 When you create a new preset it will be available only for the cat
83. n 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 generator 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 Stop to continue After you press Stop O the ABLATION screen will appear If the progress dots 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 7 4 Other Troubleshooting 4 Always wait until the automatic self test has been successfully completed before starting the first steps of the procedure on the patient for example before anesthesia or before creating percutaneous access Also if using a remote control a pump a CARTO System or an electrophysiology recording system 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
84. n y ThermoCool Standard D P wa 20w Edit N A H Button owas Set Default MOLINA T CTRL 40DEG Icon ZHANG 20W Selection buttons Pane ThermoCool SF N avi g atio n Ba r Dre ThermoCool Standard EEE ee a Workflow buttons Icons System Status icon Table 2 Screen Features Name Description How to Use Button Blue raised Press the button to display another screen or perform an action Selection button Gray flat white when selected Press one button to make a selection from a group of buttons ee 6 Operation Quick Overview Page 31 RF Generator User Manual Table 2 Screen Features Name Description How to Use Workflow button Black flat Press the button to display the screen named on the button on Navigation Bar The workflow button for the displayed screen has an orange underscore Icon Image Press the icon to perform the action represented by the image on the icon see Section 6 10 Icons on the Screens System Status Image triangle See Sections 7 2 Warnings Alerts and Ablation Stop Reasons icon and 7 3 System Errors Pane Rectangular gray Provides visual grouping of related buttons and information section of the screen Note When raised buttons are gray and when icons are gray either they are not available for use on the screen that is displayed or their functions are not supported by the software version 6 1 5 Data Entry Knob The Data Entry Knob O is used
85. nerator on If the problem persists contact Customer Support See Section 7 5 Calibrating the Touch Screen Verify that the power supply meets the specifications in Section 8 1 Specifications and then check to see whether a fuse is broken If a fuse is broken replace it see Section 4 5 3 Fuses If the fuse is not broken or if a new fuse breaks contact Customer Support 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 Press the CONNECTIONS workflow button Press System Settings sa Press Calibrate Touch Screen Press each target after it appears a total of 6 targets Press Stop Notes 1 You can only calibrate the generator s screen when the generator is the system Master see Section 6 7 System Control 2 Atany time during the calibration process you can press Stop Y to exit calibration 3 Ifthe calibration is successful you will see Result f if the calibration is unsuccessful you will see Result ol If the calibration is unsuccessful repeat the steps until a successful calibration is achieved If the problem persists contact Customer Support 4 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 targe
86. nerator User Manual rc amp JGRU22EBNKNAO69 O c UL Jus C E0366 4 Description Alternating current Serial data port Ethernet port Output signal Input signal USB port Remote control receptacle Foot pedal receptacle Pump receptacle Manufacturer Manufacturing date Serialnumber Lot number Japanese version of the SMARTABLATE RF Generator United States version of the SMARTABLATE RF Generator Worldwide version of the SMARTABLATE RF Generator except the United States and Japan Medical applied current energy equipment as to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 NO 601 1 IEC 60601 2 2 2006 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 NO 60601 1 2008 IEC 60601 2 2 2009 40GF CE marking with the number of the notified body The device is radiating non ionizing electromagnetic radiation See Section 8 11 EMC Information and Technical Description Separate collection for electrical and electronic equipment 9 Symbols Page 98 RF Generator User Manual RoHS y IP21 Made in Germany Description The device does not contain phthalates The device is latex free RoHS compliant Directive 2002 95 EC of the European Parliament and ofthe Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS compliant mar
87. nerator has been turned off power continues to be supplied to the generator through the mains cable To completely cut off power to the generator disconnect the mains cable from the generator To allow easy disconnection in the event of severe power failure make sure that the generator is located where there is easy access to the mains cable on the back of the generator 7 After turning on the generator always wait until the automatic self test has been successfully completed before starting the first steps of the procedure on the patient for example before anesthesia or before creating percutaneous access Also if using a remote control a pump a CarTo System or an electrophysiology recording system 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 5 3 Caring for Accessories 8 Use only catheters that have been approved for use with the maximum voltage specified in this user manual see Section 8 1 Specifications 9 Use only accessories that have been provided by or recommended by the generator s manufacturer see Chapter 5 Accessories The use of other accessories can have a negative effect on the technical specifications
88. ng and should not be used Perform disinfection by wiping not by spraying Avoid condensation If cleaning or disinfecting the generator with flammable or explosive substances cannot be avoided make sure these substances have completely evaporated before the generator is turned on Check the vents on the bottom and sides of the generator regularly for excessive deposits of dust and foreign bodies Carefully brush or wipe off the unwanted material 4 7 Protecting Against Damage In addition to being operated and maintained per the instructions in this user manual the SMARTABLATE RF Generator must also be protected against damage This includes installing the generator in a safe location and protecting the generator 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 4 System Overview and Setup Page 20 RF Generator User Manual Make sure that the front panel of the generator is closed before moving the generator Hold the sides of the generator not the front panel when lifting the generator Carry the generator with two hands To transport the generator over long distances or to send the generator for service use the original packaging If the original packaging is not available contact the manufacturer or distributor for a replacement 4 8 Disposal Inadequately treated electrical and electronic wa
89. ngen einer Dosierten Hochfrequenzkoagulation bei Stereotaktischen Hirnoperationen Zentralbl fur Chir 85 1051 1062 Nakagawa H Yamanashi WS Pitha JV Arruda M Wang X Ohtomo K Beckmann KJ McClelland JH Lazzara R Jackman WM 1995 Comparison of In Vivo Tissue Temperature Profile and Lesion Geometry for Radiofrequency Ablation with a Saline Irrigated Electrode versus Temperature Control in a Canine Thigh Muscle Preparation American Heart Association Remp T Hoffmann E Gerth A Mattke S Ebeling F Steinbeck G 1994 Bedeutung des Impedanzabfalles w hrend Radiofrequenz Katheterablation Z Kardiol 83 Suppl 118 Remp T Hoffmann E Gerth A Mattke S Ebeling F Steinbeck G 1994 Drop in Impedance and Safety during Catheter Ablation Validation of a Predictive Marker for Impedance Rise Eur Heart J 15 Suppl 286 Steinbeck G 1983 Differentialdiagnose der Herzrhythmusst rungen Tachykarde Rhythmus St rungen In Herzrhythmusst rungen Springer Berlin Heidelberg New York Handbuch der Inneren Medizin Bd IX 1 S 617 642 Steinbeck G 1986 Intrakardiale Ableitung und Programmiierte Stimulation In L deritz B Hrsg Herzschrittmacher Springer Berlin Heidelberg New York Tokyo S 120 161 Steinbeck G Doliwa R Bach P 1988 Treatment of Paroxysmal Atrial Fibrillation with Digoxin Alone or Digoxin Plus Antiarrhythmic Drugs Dtsch Med Wschr 113 1867 1871 Wittkampf FHM 1992 Temperature Response
90. ngsamen Bahn bei AV Reentry ohne Anderung der Normalen AV Uberleitung Z Kardiol 81 Suppl 1 142 Abstract Hoffmann E Remp T Gerth A Mattke S Steinbeck G 1993 Does Preablation Impedance Measurement Improve the Safety of Radiofrequency Catheter Ablation Eur Heart J 14 Suppl 34 Hoffmann E Remp T Gerth A Mattke S Steinbeck G 1993 Does Impedance Monitoring during Radiofrequency Catheter Ablation Reduce the Risk of Impedance Rise Circulation 88 I 165 Hoffmann E Remp T Gerth A Mattke S Steinbeck G 1993 Preablation 50 kHz Impedance a New Parameter for Assessing Myocardial Wall Contact before Radiofrequency Catheter Ablation J Am Coll Cardiol 21 49A Abstract 11 References Page 101 RF Generator User Manual SMART Hoffmann E Steinbeck G 1993 Elektrotherapie Supraventrikul rer Tachykardien Vorhof flimmern Vorhofflattern Innere Medizin 48 446 452 Hoffmann E Steinbeck G 1994 Katheterablation Supraventrikul rer Tachykardien Springer Verlag ISBN 3 540 60301 8 Hoffmann E Steinbeck G 1999 Interventionelle Kardiale Elektrophysiologie Springer Verlag ISBN 3 540 65684 7 Moringlane JR Koch R Schafer H Ostertag ChB 1989 Experimental Radiofrequency Coagulation with Computer Based Online Monitoring of Temperature and Power Acta Neurochirurgica 96 126 131 Mundinger F Riechert T Gabriel E 1960 Untersuchungen zu den Physikalischen und Technischen Voraussetzu
91. nnected to the appropriate temperature reading on orange cable and that the cable is Possible reasons are connected to the red Catheter An esophageal probe S none 2 receptacle on the front of the is not connected or Ablation Stop Reason generator See Item 5 in Section connected tothe 4 2 Controls on the Front of the wrong receptacle V Ablation Summary and Generator The cable is faulty esophageal probe receptacle Verify that you are using a probe flashes red for 5 seconds and a cable that are compatible S Ablation stop tone with the generator Try a different cable or probe If the problem persists contact Customer Support In order to continue with the procedure you can disable the esophageal monitoring feature by setting the warning and cut off values to Off See Section 6 3 3 Editing a Preset Esophageal temperature rise not applicable for the US and JP versions of the generator The esophageal probe Ablation Stop Reason See the instructions in this table temperature rise for Esoph temperature above exceeded the cut off v A and ablation Summary maximum Alert and Ablation value set in the preset and esophageal probe receptacle Stop Reason flashes red for 5 seconds S Ablation stop tone Esophageal temperature rise not applicable for the US and JP versions of the generator The esophageal probe Warning See the instructions in this table temperature rise A for Esoph temperature ab
92. nufacturer Other catheters may be used only after consultation with the distributor For recommended accessories see Section 5 2 Accessory Lists To connect an ablation catheter use a sterile cable and connect one end to the Catheter 1 receptacle on the front of the generator see Item 4 in Section 4 2 Controls on the Front of the Generator and the other end to the catheter Alternatively if the ablation catheter is connected to an additional system such as the CarTo System connect the cable from the system to the Catheter 1 receptacle To connect an esophageal probe connect the appropriate cable to the Catheter 2 receptacle on the front of the generator see Item 5 in Section 4 2 Controls on the Front of the Generator An esophageal probe cannot be used with the US or JP versions of the generator The Catheter 2 receptacle is not functional 4 5 7 Indifferent Electrode Connections The receptacles on the front of the generator for the indifferent electrodes see Item 6 in Section 4 2 Controls on the Front of the Generator can be used to connect both solid and split indifferent electrodes Some of the indifferent electrodes recommended for use with the SMARTABLATE RF Generator are available with cables that have the appropriate mating component For other indifferent electrodes appropriate adapter cables are available 4 System Overview and Setup Page 18 RF Generator User Manual SMART 4 5 8 Ethernet Connection
93. o To resume ablation press Ablation Start or press and hold the foot pedal Make sure that the vents on the bottom and sides of the generator are not blocked Wait for a few minutes without turning on the RF energy and then try to operate the system again Contact Customer Support even if the problem is resolved To resume ablation press Ablation Start or press and hold the foot pedal See the instructions in this table for Power output too high 7 Troubleshooting Page 82 RF Generator User Manual 7 3 System Errors Event Window Displaying System Error Codes EVENT code Active WARNINGS l System error 2213 10 28 No active warnings i Active ALERTS atheter temperature invalid mnpedance above maximum Event WI ndow displaying System Error codes System Status icon 7 3 1 System Error When a System Error occurs the A System Status icon is displayed and the Event window appears displaying the System Error codes NThe Alarm indicator is orange and the warning tone is emitted Manually record the codes displayed in the Event window If you want to save the ablation files and event log insert a USB flash drive containing a data transfer indicator into the back of the generator and wait for the data to transfer Then press Stand by SUB for approximately 3 seconds to turn the generator off and press Stand by 49 again to turn the generator on Contact Customer Support to
94. ol Standard ol P nya 20w a Edit DAVIS 30W N A Set Default Physician Presets pane MOLINA T CTRL 40DEG 4mm ZHANG 20 W smm Preset pane ThermoCool SF Catheter pane 6 3 1 Preset Overview e Apreset is a named group of settings to use during ablation e The SmART BLATE RF Generator comes with one standard preset for each catheter type listed in the Catheter pane This preset is always the first in the list and it cannot be deleted e You can create new presets for each physician e You can view alist of all of the presets for a selected catheter type or you can view only the presets for a selected physician for the selected catheter type e When you select a catheter type the default for that catheter type is automatically selected You can designate one of the displayed presets to be the new default for the catheter type 6 3 2 Selecting a Preset Quick Steps Press the PRESET workflow button Select the catheter type Select a preset Notes 1 The currently selected preset is highlighted white background 2 The PRESET workflow button displays the name of the selected preset 3 Forinstructions on displaying the presets for only one physician see Section 6 3 8 Displaying One Physician s Presets 6 Operation Presets Page 39 RF Generator User Manual 6 3 3 Editing a Preset Edit Preset Screen in Power Control Mode Irrigated Catheter Ablation Impedance Settings pane i 60 Sett
95. on If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SMARTABLATE RF Generator b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m NSS Tee GG 8 Technical Data Page 94 RF Generator User Manual SMART Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the SmART BLATE RF Generator The SMARTABLATE RF Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the SmarRTABLATE RF Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SMARTABLATE RF Generator 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 17 233 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 din 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
96. ove exceeded the warning V appears near esophageal maximum Warning value set in the preset temperature reading and its orange border flashes S Warning tone 7 Troubleshooting Page 73 RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons Indicators V Visual S Sound What To Do Foot pedal disconnected Generator or Foot pedal disconn Generator The foot pedal that was connected to the generator when ablation started became disconnected during ablation Warning V A and orange border around System Control icon flashes for 20 seconds S Warning tone Ablation Stop Reason V Ablation Summary S Ablation stop tone Disconnect the foot pedal from the generator then reconnect it If the problem persists either use a different foot pedal or operate the generator using the Ablation Start and Stop buttons on the generator or remote control Foot pedal disconnected Remote or Foot pedal disconn Remote The foot pedal that was connected to the remote control when ablation started became disconnected during ablation Warning V A and orange border around System Control icon flashes for 20 seconds S Warning tone Ablation Stop Reason V Ablation Summary S Ablation stop tone Foot pedal released Generator The pressed foot pedal that is connected to the generator was released Ablation Stop Reason
97. p the Generator The SMARTABLATE RF Generator may be used only in medical rooms in compliance with IEC EN Annex A 4 Clause 16 Place the generator on a secure non slip surface such as the Carto System cart If the generator is placed on any other surface make sure it is securely fastened Do not place the generator directly above another device and do not place any other device directly on the generator Make sure that there is enough free space on all sides of the generator to allow the heat created by the generator to escape 4 5 2 Mains Connection The SMART BLATE RF Generator automatically adjusts for the necessary mains 620 voltage and frequency To avoid the risk of electric shock connect the mains cable from the generator mains socket see Item 6 in Section 4 3 Controls on the Back of the Generator to a 3 prong outlet that meets the specifications in Section 8 1 Specifications Use only the mains cable supplied by the manufacturer or distributor for the country where the generator is being used 4 5 3 Fuses BEE Externally accessible fuses for the SmarTtAsLate RF Generator are located under the fuse cover see Item 7 in Section 4 3 Controls on the Back of the Generator Use only fuses approved by the manufacturer 4 System Overview and Setup Page 17 RF Generator User Manual SMART 4 5 4 Potential Equalization To avoid differences in potential between the generator and other devices with power ope
98. perform a visual inspection of the accessories see Section 5 3 Caring for Accessories 6 Operation Quick Overview Page 28 RF Generator User Manual 6 1 2 System Shutdown Quick Steps Stop ablation see Section 6 4 2 Starting and Stopping Ablation Press and hold Stand by for approximately 3 seconds to turn off the generator Turn offthe remote control For irrigated catheters turn off the pump Note You can turn off the pump and remote control before or after you turn off the generator 6 1 3 Screens The SMART BLATE RF Generator has four primary screens represented by the first four buttons on the Navigation Bar See Section 6 9 Flowchart of the Screens for a chart that lists other screens that can be accessed from these primary screens Table 1 Screens Screen Description Section CONNECTIONS 6 2 Connections The Esophageal Probe shown above is not applicable for the US and JP version ofthe generator Shows all devices that you can connect to the SMART BLATE RF Generator Indicates which devices are currently connected and functioning properly Provides access to information about the connected devices Provides access to the System Settings screen 6 Operation Quick Overview Page 29 RF Generator User Manual SMART Table 1 Screens Screen Description Section PRESET 6 3 Presets ThermoCool Standard D e nA 20w Edit DAVIS 30W N A Set Default M
99. poses restrictions on the flow rate and the ranges of power Consult the instructions for use for the catheter to determine the appropriate flow rate and power 6 4 4 Ablation Summary Ablation Summary ABLATION SUMMARY Ablation RF time total 60s Summa ry Power max 10W Power avg 9 ON Energy total 595J Tem p max 44 C Temp avg 391C Imp max 1010 Imp drop Imp min Irrigation 13mL Ablation Sto p Reason Ablation Timer completed Stop Ablation i J er Rea son Notes 1 Afew seconds after ablation stops the Ablation Summary appears 2 Atthe bottom of the Ablation Summary an Ablation Stop Reason is displayed see Section 7 2 Warnings Alerts and Ablation Stop Reasons 3 To remove the trend lines and the Ablation Summary either wait for them to disappear or press anywhere on the screen 4 To view a summary of the entire procedure press the POST workflow button see Section 6 5 Post Procedure 6 4 5 Low Fluid Level Quick Steps To Change the Fluid Level Settings for a Preset See Section 6 3 10 Irrigation Control To Indicate Replacement of the Fluid Bag Wait until ablation stops or press Stop Press Irrigation Control Sul If the bag size changed select the new bag size see Section 6 3 10 Irrigation Control Press New Bag Press OK 07 Press the ABLATION workflow button 6 Operation Ablation Page 54 RF Generator User Manual Notes 1 The generator calcu
100. principles of various methods of applying RF energy and the principles of power and temperature control that are presented in this manual Proper application of RF energy leads to desired tissue denaturation to correct arrhythmias incorrect application of RF energy can lead to excessive tissue denaturation RF Generator User Manual The SmarTABLaTE RF Generator may be used only by medical personnel trained and experienced in the techniques of electrophysiology Before using this generator for the first time in a clinical application the user should thoroughly read this user manual To become familiar with operation of the generator and to avoid damaging it the user should practice using the generator and all accessories by simulating ablation in a container of saline solution or by using a STOCKERT test box for the SMarRTABLATE RF Generator The user should also become familiar with all accessories and other devices connected to the generator by reading and following the instructions for use for the accessories and devices For information on training and a STOCKERT test box for the SMARTABLATE RF Generator please contact Biosense Webster We will gladly answer any questions that you may have Yours truly STOCKERT GmbH RF Generator User Manual SMART 1 Functional Principles 1 1 Functional Principles of RF Ablation Cardiac RF ablation is the destruction of the electro mechanical function heart beat conduction of cardiac ti
101. r ablation in the absence of an indifferent electrode e Ifthe indifferent electrode is not correctly connected to the generator the generator immediately stops RF energy delivery and displays a message e The generator is equipped with a contact quality monitoring feature for split indifferent electrodes When a split indifferent electrode is used the generator displays an alert message as soon as skin contact with the electrode surface decreases by an unacceptable amount After the indifferent electrode is applied to the patient the generator continuously monitors the contact quality and updates an internal value for best achieved contact quality the minimum 3 Warnings and Precautions Page 11 RF Generator User Manual SMART contact impedance of the split indifferent electrode This value is reset every time the indifferent electrode is disconnected from the patient The alert message appears when the contact impedance of the split indifferent electrode increases by 40 from the best achieved contact quality If a solid non split indifferent electrode is used and the electrode partially detaches itself no alert is triggered The danger of a skin burn under the indifferent electrode is thus increased Place the indifferent electrode within the operating field on the patient s back Solid indifferent electrode Split indifferent electrode The generator provides the option of connecting two separate indifferent electrode
102. r cables Keep active electrodes that are temporarily not in use at a Safe distance from the patient 17 Set the RF power at only moderate output to avoid charring and clotting at the catheter ablation electrode 18 When the SmART BLATE RF Generator is used with irrigated catheters monitor the irrigation flow rate to avoid hazards caused by insufficient irrigation flow The approximate flow rate can be estimated by observing the drip speed in the drip chamber The hospital staff is responsible for determining and monitoring the flow rate to avoid insufficient flow of the irrigation solution The hospital staff is responsible for monitoring the total amount of solution delivered to the patient to avoid an excessive loading of the irrigation solution in the patient For recommended flow rates refer to the catheter s instructions for use 3 Warnings and Precautions Page 7 RF Generator User Manual SMART 19 Avoid using flammable anesthetics or oxidizing gases such as nitrous oxide NO and oxygen O if the procedure is being performed in the region of the thorax or head unless the gases are being aspirated off or an anesthesia safe device is being used Before starting RF ablation allow time for flammable substances that are used as cleaning agents disinfectants or solvents to evaporate There is a risk associated with flammable liquids under the patient or in the patient s body cavities Wipe away the liquid in these places away b
103. r increment displayed on a graph If Use automatic flow adjustment is not selected press High Flow and turn the Data Entry Knob to change the value Consult the instructions for use for the catheter to determine the appropriate flow rate for the catheter The standby rate at which fluid flows before the Pre RF period and after the Post RF period The length of time after Ablation Start is pressed that fluid flows at the High Flow ablation flow rate without RF After this Pre RF Time RF turns on A tone is emitted during the Pre RF time The length of time after RF turns off that fluid flows at the High Flow ablation flow rate After the Post RF Time flow returns to the Low Flow standby flow rate A tone is emitted during the Post RF time Select Monitor Fluid if you want the generator to issue a warning when the fluid level is low Then specify the size of the bag that you are using Press 500 mL 1000 mL or 2000 mL Or press User then press the size that appears under User and then use the Data Entry Knob o to set a different bag size The fluid level at which a warning will occur Low Fluid Warning is only available when Monitor Fluid is selected After you attach a new bag to the pump and select the new bag size on the screen press New Bag After you press New Bag the generator s fluid level monitor will reset and the new bag size will appear after Volume Remaining 6 Operation Presets Page 48 RF Gener
104. rate effective RF power setting A lesion conversion of the soluble protein in the tissue into a denatured coagulated state arises when the tissue is exposed to RF current densities At low current densities the tissue is heated slowly and contracts as a result of fluid loss When the tissue is exposed to excessively high RF current densities the tissue fluid evaporates so rapidly that the resulting steam pressure in the cells destroys the cell membrane If this process occurs suddenly superheating it is perceptible as a steam explosion Since this phenomenon is audible in certain cases and under some circumstances can be felt at the catheter handle it is also known as pop In extreme cases this can lead to undesirable tissue changes such as tears craters and holes A suitable choice of RF energy output and sufficient contact between the ablation electrode and the myocardial wall avoids this pop effect LOG 1 Functional Principles Page 1 RF Generator User Manual 1 2 Power Controlled Ablation Method As described in Section 1 1 Functional Principles of RF Ablation a high RF current can rapidly heat the tissue With the power controlled ablation method the RF power output can be manually adjusted on the basis of values known from experience The power adjusted by the user in this mode is the power output from the generator The user should be aware that the lesion formation is dependent on the RF current density in the spec
105. ration the SmarTABLATE RF Generator must be connected to a grounding line as specified in IEC EN 60601 1 Connect one end of the green and yellow potential equalization cable provided with the generator to the grounding connection on the back of the generator see Item 8 in Section 4 3 Controls on the Back of the Generator Connect the other end to the room s central grounding line To avoid radiation interference noise in the ECG signal always use the same grounding line for connection of all devices involved electrocardiograph Carto System generator 4 5 5 Circular Plug Connections Ki The circular plugs on the accessory cables are the same color as the O receptacles on the front and back of the generator see Sections 4 2 Controls on the Front of the Generator and 4 3 Controls on the Back of CE the Generator To connect an accessory cable to the generator align the arrow on the plug with the mark on the 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 4 5 6 Connection Cables and Catheters Use only ablation catheters with temperature sensors and connection cables supplied by or recommended by the ma
106. rator S Ablation stop tone Section 3 4 Handling Indifferent The indifferent Been Oge gt electrode contact with Consider applying the indifferent the patient is not good electrode to a different place on the patient s body to avoid oil hair and dirt that increase the impedance If the catheter is connected through an additional system such as a navigation system make sure that this system is not intentionally disconnecting the generator from the tip of the catheter Try replacing the system parts that are between the generator and the catheter or connect the catheter directly to the generator If the problem persists contact Customer Support It is not recommended but if you know the reason for the high impedance and still want to perform an ablation you can disable this cut off by setting its value to Off See Section 6 3 3 Editing a Preset CE u 7 Troubleshooting Page 75 RF Generator User Manual Table 8 Warnings Alerts and Ablation Stop Reasons Message Reasons The impedance was below the minimum cut off value set in the preset Possible reasons are There is a compatibility problem between the generator and external devices There is an internal problem in the generator Rarely such as in pediatric cases the patient has low body impedance and there is no problem The impedance change exceeded the spike cut off value set in the preset Possible reasons are
107. report the codes even if the problem is resolved 7 3 2 Fatal System Error N The Alarm indicator flashes red and the high priority tone is emitted Immediately turn off the generator If pressing Stand by 49 does not turn off the generator remove the mains cable from the generator Contact Customer Support CE u 7 Troubleshooting Page 83 RF Generator User Manual 7 4 Other Troubleshooting Problem Bubbles are detected in the irrigation tubing during standby On startup the progress dots do not appear or the logo screen does not disappear On startup after you press Stop in response to the message that appears the ABLATION screen does not appear Nothing happens when you press a button on the screen The generator won t turn on 7 5 What To Do Immediately turn the 4 way stopcock on the SMART BLATE Irrigation Tubing Set so that the fluid is not routed to the catheter Then flush the tubing see Section 6 6 Flushing to Eliminate Air in the Tubing and Catheter After flushing turn the 4 way stopcock to allow fluid to be routed to the catheter again Press and hold Stand by for approximately 3 seconds to turn off the generator Then press Stand by again to turn the generator 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 generator Then press Stand by again to turn the ge
108. ries are functional 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 and the grounding cables 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 8 Technical Data Page 89 RF Generator User Manual Because the generator is a medical device some countries require an electrical safety test If local regulations require a safety test have the generator tested by a technician certified by the local governing agency N Important Notice To ensure the safety of the SmarTABLATE RF Generator repairs may be performed only by the manufacturer a service engineer certified by the manufacturer or a 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 8 8 Maintenance Perform the safety inspections specified in Section 8 7 Safety Inspections Regularly clean and disinfect the SMARTABLATE RF Generator per Section 4 6 Cleaning and Disinfecting the Generator Regularly clean the accessories per the instructions for use provided with the accessori
109. s Both split and solid indifferent electrodes can be connected In this case as well the contact quality monitoring feature works only with split indifferent electrodes However if two split indifferent electrodes are used at the same time and one loses contact quality but the other maintains contact quality no alert is triggered The use of two indifferent electrodes doubles the size of the contact surface on the patient s skin The use of two indifferent electrodes is recommended especially for heavy patients with a low muscle mass in ablations with high output gt 50 watts and in the case of prolonged RF energy delivery gt 60 seconds If two indifferent electrodes are used apply one electrode to the left side of the ablation site and the other electrode to the right side of the ablation site both at approximately the same distance from the ablation site The two indifferent electrodes must not overlap Guide to the Use of Indifferent Electrodes with the SMART BLATE RF Generator Use only indifferent electrodes with a surface area of gt 124 cm that conform with either IEC EN 60601 2 2 or ANSI AAMI HF 18 e Read the instructions for use for the indifferent electrodes carefully and take special note of the warnings and precautions sections Fora single use electrode Make sure that the electrode contact surface is not dry If it is dry replace it with a new unused electrode before continuing with the ablation procedur
110. s displayed on the screen during ablation see Section 6 4 Ablation 2 The Irrigation Delivered option is displayed only for irrigated catheters This value is the total irrigation delivered during the procedure excluding flushing 3 The Dual Temp option is displayed only for dual sensor DS 8mm catheters 6 3 13 Copying Presets to a USB Flash Drive Quick Steps Press the PRESET workflow button Press To USB zZ Note This feature is not available in some software versions 6 Operation Presets Page 50 6 4 Ablation Item COIN ISA WM P WIN ABLATION Screen in Power Control Mode before ablation starts 1 234 5 6 7 i 9 Temperature Control Mode for irrigated catheters is not applicable for the US and JP versions of the generator Description Impedance measurement Set time Time since start of ablation Flow rate control indicator AUTO automatic MAN manual Set flow rate Set temperature displayed only in Temperature Control Mode Measured temperature Set power in Power Control Mode Max power in Temperature Control Mode Measured real power output 6 Operation Ablation Page 51 RF Generator User Manual 6 4 1 Starting a New Procedure Quick Steps Press the ABLATION workflow button Press New Procedure L on the Navigation Bar Press Yes On the PRESET screen select a preset Notes 1 When you start a new procedure any accumulated parameters are reset an
111. sesssssssssssssssssssssssssescsesessssssssssesesesesescscsesssssseseseseseassssseseseseseseacaceeseeses 46 6 3 8 Displaying One Physician s Preseis uuenee ae 46 6 3 9 Adding a Name to the Physician Presets List sssesscsssssssecscssssssessssssecscesssseseescens 47 6 3 10 oan COMMON mern ee ana 47 63 11 Changing AUdiO Settings area ae ENA 49 6 3 12 Selecting Ablation Display SettingS s sseessesssesssesseesssesseesseessesseesseesseossesseesseesseesseessee 49 6 3 13 Copying Presets to a USB Flash Drive ssessesssesssesseesseesseesseenseoseesseesseosseoseesseesseosseessee 50 CA ABITO a E 51 6 4 1 Starting a New Procedure se ssesseessesseessessesseeseessesseoseessesseosecoseoseesseoseoseessesseoseeseessesseeseesss 52 642 Starting and Stopping Ablation werner un 52 6 4 3 Making Temporary Changes to Ablation SettingS ss sssesseesseessesssesseesseessesseesseessee 53 GAA PPO Mis UMMA een 54 6 4 5 Low Fluid Level sse ssesssesssesseessesssesssesseesseesseesseesseossesseesseosseoseeoseesseoseeosseossesseesseesseoseeoseessee 54 RF Generator User Manual 03 POTRO OU ee nee eee 56 6 5 1 Exporting Ablation and Event Log Data to a USB Flash Drive 56 6 6 Flushing to Eliminate Air in the Tubing and Catheter uu esesssscscsesssssssssssssesessssssssssssssesees 58 STI GOAT ON ee een ae 59 6 7 1 Making the Generator the System Mastel sssssssesscsssssssecssssssesesscsssecscesesseseescees 59 6 8 Volum
112. ss and release the foot pedal on the remote control Press Stand by on the generator If the remote control is the system Master press Stand by on the remote control Disconnect any of the following cables catheter connection cable indifferent electrode connection cable mains cable 6 Operation Ablation Page 52 RF Generator User Manual 5 During ablation the Navigation Bar disappears After ablation the Navigation Bar reappears 6 Forirrigated catheters if the fluid level reaches the Low Fluid Warning level the Irrigation Control Ego icon appears at the bottom of the ABLATION screen as a warning After ablation stops and the Navigation Bar appears press the Irrigation Control 29 icon to access the Irrigation Control screen see Sections 6 3 10 Irrigation Control and 6 4 5 Low Fluid Level 7 Ablation stops if conditions are not right for ablation see Section 7 2 Warnings Alerts and Ablation Stop Reasons 8 A few seconds after you stop ablation the Ablation Summary appears see Section 6 4 4 Ablation Summary 9 Tominimize the risk to the patient keep the ablation duration to one minute or less 6 4 3 Making Temporary Changes to Ablation Settings Quick Steps To Change Values at the Top of the Ablation Screen Press the displayed value Turn the Data Entry Knob to change the value To Change Values at the Edit Preset Screen See Section 6 3 4 Editing a Preset Temporary
113. ssue through the application of RF energy The term radiofrequency RF is used to refer to an alternating current that flows through a conductor In the case of ablation RF current flows through biological tissue that contains free ions The saline solution present in the tissue provides the electrical conductivity The tissue conductivity can be represented by the tissue impedance Low impedance represents high conductivity and high impedance represents low conductivity The application of RF current to biological tissue causes heating of the tissue The higher the RF current density in the biological tissue current per unit area the higher the resulting temperature The tissue stops reacting to electrical stimulation when heated above a threshold over a minimal period of time The extent of heating is proportional to the RF power current density output A low RF power output causes slow heating to the tissue See Figure 1 Figure 1 Figure 2 At high RF power output the tissue can heat rapidly Excessively high RF power output can overheat the tissue causing evaporation of the water bound in the tissue see Figure 2 This can result in charring of the tissue Therefore excessively high RF power output is not recommended Charring reduces the energy delivery to the heart tissue which can cause other side effects such as thrombosis or adhesions on the ablation electrode It is recommended that ablation be performed using a mode
114. st be connected to separate ground points with their own grounding cables See Section 5 1 Diagram of the Generator and Accessories for an illustration of the typical configuration and the cables required for undisturbed measurement quality 8 Technical Data Page 96 RF Generator User Manual 9 Symbols Symbol Distributed by Manufactured by gt lm gt gt gt gt Ba kb O lwo i al U ie l 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 To electrophysiology recording system ECG Press the button to release the lock and allow the front panel of the generator to be tilted up not available on some models Indifferent electrode The indifferent electrode and catheter connections on the device have zero voltage Connections identified with this symbol are floating are not grounded All patient connections of the device are defibrillation proof type CF applied parts Radiofrequency Potential equalization port Fuses 9 Symbols Page 97 RF Ge
115. ste poses environmental and health risks Follow local regulations for disposal of the SMARTABLATE RF Generator 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 generator and its accessories aaa lease SSS aaa 4 System Overview and Setup Page 21 RF Generator User Manual 5 Accessories 5 1 Diagram of the Generator and Accessories Patient Area Front View Outside Patient Area Outside Patient Area 5 Accessories Page 22 RF Generator User Manual 1 SMARTABLATE RF Generator 2 Catheter 3 CARTO 3 System 4 Catheter 5 CARTO XP System 6 Catheter 7 Esophageal probe not applicable for the US and JP versions of the generator 8 ECG connection 9 Split indifferent electrode 10 Split indifferent electrode 11 Erbe indifferent electrode 12 SMARTABLATE Irrigation Pump 13 SMARTABLATE Remote Control 14 Foot pedal 15 Grounding cable 16 Mains cable 17 Personal computer or CARTO System 18 Electrophysiology recording system 5 2 Accessory Lists The following is a list of accessories for the SMARTABLATE RF Generator emia Use only the original accessories provided by or recommended by the manufacturer of the SMARTABLATE RF Generator If you use accessories that are not authorized by the manufacturer
116. stem The temperature is not within a reasonable range The esophageal probe or connection cable is defective connection cable See Section 5 2 3 SMARTABLATE Cables Verify that the esophageal probe connection cable is connected to the red Catheter 2 receptacle on the front of the generator See Item 5 in Section 4 2 Controls on the Front of the Generator Verify that the esophageal probe is compatible with the generator Verify that the connection cable is correct for the type of esophageal probe Replace the esophageal probe and or connection cable with a new one 7 Troubleshooting Page 66 RF Generator User Manual Table 7 Device Connections Device Meaning of Icons Catheter e The catheter is connected to the generator and the temperature is within a and Ablation reasonable range for the room or for the patient Cable to Mapping Possible Reasons What To Do System if The catheter is not connected to Verify that the CONNECTIONS screen reflects applicable the generator the mapping system that you are using The wrong cable type is being used The catheter or a cable is defective 7 2 Warnings Alerts and Ablation Stop Reasons CaRTO 3 System CARTO XP System or other Verify that the catheter is connected to the appropriate cable and that the cable is connected to the red Catheter 1 receptacle on the front of the generator See Item 4 in Section 4 2 Controls on the Front of
117. t 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 RF Generator requires continued operation during power mains interruptions it is recommended that the SMARTABLATE RF Generator be powered from an uninterruptible 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 in a typical commercial or hospital environment Note U is the AC mains voltage prior to application of the test level The SMARTABLATE RF Generator was tested at 100 and 230 VAC 8 Technical Data Page 93 RF Generator User Manual SMART Electromagnetic Immunity The SMARTABLATE RF Generator is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE RF Generator 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 IEC 61000 4 6 150 kHz to equipment should be used no closer to any part of 80 MHz the SmartABLaTe RF Generator including cables Radiated RF 3V m 3V m men u n erp rena IEC 61000 4 3
118. t pedal test Replace the foot pedal with a good foot pedal and perform the foot pedal test In this case although the foot pedal may have passed the foot pedal test it cannot be used Replace the foot pedal with a good foot pedal and perform the foot pedal test 7 Troubleshooting Page 65 RF Generator User Manual Table 7 Device Connections Device Meaning of Icons Indifferent Solid indifferent electrode Indicates that the indifferent electrode is connected to Electrode the system Split indifferent electrode Indicates that the indifferent electrode is connected to the system and contact with the patient is good enough for ablation 1 Possible Reasons Solid or split indifferent electrode The indifferent electrode is not connected to the generator Split indifferent electrode The contact quality on the patient is not good enough for ablation What To Do Connect the indifferent electrode to the generator Improve the contact of the indifferent electrode on the patient See Section 3 4 Handling Indifferent Electrodes Esophageal The esophageal probe is connected to the generator and the temperature is within Probe not a reasonable range for the room or for the patient applicable for ym the US andJP S Possible Reasons What To Do versions of the The esophageal probe is not Verify that the esophageal probe is connected generator connected to the generator to the appropriate SMARTABLATE Sy
119. t temperature only in Power Control Mode The temperature of the ablation electrode at which a warning will occur RF energy will remain on The temperature of the ablation electrode at which RF energy will automatically shut off only for Amm catheters in Temperature Control Mode The sensitivity of the temperature control algorithm to changes in temperature how fast it reacts how aggressively it changes the power to reach the target temperature Esophageal Temperature Settings Pane not applicable for the US and JP versions ofthe generator Max Warning Cut Off Select either Warning or Cut Off If you select Warning then select the temperature of the esophageal probe at which you want a warning to occur RF energy will remain on If you select Cut Off then select the temperature ofthe esophageal probe at which RF energy will automatically shut off 6 Operation Presets Page 42 RF Generator User Manual Table 5 Preset Setting Descriptions Setting Description Rise Select either Warning or Cut Off Warning Cut Off l If you select Warning then select the increase of temperature of the esophageal probe at which you want a warning to occur during ablation the increase will be determined from a baseline measurement taken just before ablation RF energy will remain on If you select Cut Off then select the increase of temperature of the esophageal probe at which RF energy will automatically shut off
120. t with the tip of a pen instead of your finger 7 Troubleshooting Page 84 RF Generator User Manual 8 8 1 Technical Data Specifications Impedance Unit Measurement current Measurement range Indifferent electrode monitoring current Measurement range Ablation Unit Temperature Measurement range Preset time RF frequency RF output Measurement range RF maximum voltage Modes Interface Interface Mains Voltage Frequency Power consumption Fuses 6 5 uA 45 kHz sinusoidal 0 500 Q max 5 3 Q 1 Q resolution 4 uA 100 kHz sinusoidal 0 390 Q 20 User configurable target up to 90 C 1 C increments User configurable cut off up to 95 C 10 C 60 C 1 C 61 C 100 C 2 C catheter 10 C 50 C 1 C esophageal probe esophageal probe temperature is not available for US and JP versions Up to 999 sec non linear increments 5 to 30 sec 480 kHz 1 kHz 100 W 1009 version WW 70W 100 Q versions JP and US software limits output depending on catheter type selected 0 150 W max 8 2W 60 150 290 V FY Temperature Control Power Control manually set power RS 232 USB max current 300 mA 115 120 V 230 V versions US and WW 100 V version JP 50 60 Hz 350 VA T3 15 AH 250 V 8 Technical Data Page 85 RF Generator User Manual Acoustic Error Signal Sound pressure Greater than 65 db A Operational Limits 6 hour con
121. ta Communication Cable for CARTO Systems or Electrophysiology Recording Systems Redel 9 gt Dsub 9 gray length 3 m length 5 m length 15 m Connection Cable for Smiths Esophageal Probe Rectangular 2 pin length 3 m not applicable for the US and JP versions of the generator Connection Cable for Philips Esophageal Probe accepts mini 1 8 phone plug length 3 m not applicable for the US and JP versions of the generator Connection Cable from STOCKERT Testbox III to an indifferent electrode Part M4900601 M4900609 M4900410 M4900108 M4900604 M4900606 M4900210 M4900603 M4900605 M4900607 M4900602 M490024 M490014 M490015 M490018 M490021 M490025 M490023 M490019 M490020 M490017 5 Accessories Page 25 0 en eal SED i p E f mme RF Generator User Manual 5 2 4 5 2 5 Item Connection Cable for CELSIUS Catheters TC THR Redel 26 gt Redel 10 red length 3m Connection Cable for CELSIUS Catheters DS Redel 26 gt Redel 10 green length 3 m Connection Cables from SMARTABLATE RF Generator to ablation catheters available in Europe length 3 m APTMedical Triguy D Boston Scientific EPT Osypka Osypka Easy TC Osypka Plus Flutter Bard St Jude Medical IBI St Jude Medical DAIG Biotronik Medtronic Part D130302 F E E D130303 A E M4900622 M4900610 M4900611 M4900620 M4900619 M4900612 M4900613 M4900614
122. tem Master see Section 6 7 System Control 6 Operation Quick Overview Page 33 RF Generator User Manual 6 2 Connections CONNECTIONS Screen Displaying Carto 3 System Recording System Mapping Pump System Remote Control Catheter Esophageal Foot Pedal Probe ECG Indifferent Electrodes The Esophageal Probe shown above is not applicable for the US and JP versions of the generator Quick Steps Press the CONNECTIONS workflow button Press the image for any device except the ECG cable to view information about the device and or to test the interface between the generator and the device see Table 3 Device Screens in this section Press Front Back to view the connections on the back of the generator Press System Settings Ba to open the System Settings screen see Table 4 System Settings Screen Options in this section Note See Section 7 1 Device Connections for an explanation of the meaning of and for each device connection Fi 6 Operation Connections Page 34 RF Generator User Manual Sample Device Screen START Lo ur F Di Serial Number Table 3 Device Screens Information Displayed Actior Generator Device name N A N A Manufacturer Serial number Software and hardware versions Last and next preventive maintenance dates Customer name and number Mapping Image of generatorand Change Press Change then press the image System
123. the plug housing not by the cable itself 5 3 2 Indifferent Electrodes Follow the instructions in Section 3 4 Handling Indifferent Electrodes and the instructions for use that are provided with the indifferent electrodes 5 3 3 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 5 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 5 Accessories Page 27 RF Generator User Manual 6 Generator Operation 6 1 Quick Overview 6 1 1 System Startup Quick Steps Connect the generator to the mains supply Press Stand by to turn on the generator At the message press Stop Optionally turn on the remote control For irrigated catheters set up and turn on the pump Notes 1 When you press Stand by ATB make sure that Ablation Start and Stop and the foot pedal are not pressed 2 When you turn on the generator the generator 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 scree
124. tinuous operation with intermittent ablations Maximum 75 of the time performing ablations at maximum of 100 W output Maximum continuous ablation time at full power less than 30 minutes Other Classifications Class land defibrillation proof type CF as defined in IEC EN 60601 1 Class Ilb as defined in MDD 93 42 EEC Class 3 FDA Weight 18 5 kg Dimensions 399 mm wide x 178 mm high x 344 mm deep IP rating IP21 8 2 Storage and Shipping Conditions Ambient temperature 30 to 65 C Relative humidity 10 to 90 non condensing Atmospheric pressure 500 to 1060 mbar 8 3 Operating Conditions Ambient temperature 10 to 40 C Relative humidity 10 to 85 non condensing Atmospheric pressure 700 to 1060 mbar 8 4 THERMOCooL Catheter Preset Ranges THERMOCOOL Catheter THERMOCOOL SF Catheter Power Pump Default Power Pump Default W mL min W mL min 1 10 17 1 10 8 11 20 17 11 20 8 21 30 17 21 30 8 31 40 30 31 40 15 41 50 30 41 50 15 8 Technical Data Page 86 RF Generator User Manual 8 5 Alarm and Touch Specifications After an alarm event occurs there may be a delay of not more than 500 ms before the related sound light and or message are produced All alarm events are recorded and stored in the SMARTABLATE RF Generator If power is lost alarm event data is maintained on the generator for a minimum of 30 days This data can be exported copied to a USB flash drive and delet
125. to change values on the generator screens When you press a displayed value on the touch screen the ring around the Data Entry Knob O turns on The color of the ring matches the color of the value or the color of the background surrounding the value When you turn the Data Entry Knob O the value changes Press the knob to save the new value The ring around the knob will turn off You can also save the new value by pressing a different displayed value or by waiting until the ring around the knob turns off by itself Note At the ABLATION screen the changed values take effect immediately it is not necessary to press the knob 6 1 6 Foot Pedal If a SMARTABLATE System foot pedal is connected to the generator the foot pedal can be used to start and stop ablation see Section 6 4 2 Starting and Stopping Ablation Note If a SMARTABLATE Irrigation Pump is connected to the generator and a SMARTABLATE System foot pedal is connected to the pump that foot pedal controls only the pump 6 Operation Quick Overview Page 32 RF Generator User Manual 6 1 7 Typical Procedure Process Quick Quick Steps Physically connect devices to the generator Turn on the generator Press the PRESET workflow button Select a preset Press the ABLATION workflow button Press Ablation Start s to start ablation Note Ata minimum connect a catheter and an indifferent electrode to the generator For an irrigated catheter also
126. to the selected bag size 6 Operation Ablation Page 55 RF Generator User Manual 6 5 Post Procedure POST Screen Procedure 1 Date 06 September 2010 Total Ablations 4 Total Ablation Time 00 03 13 Total Total Energy Total Irrigation The Max Esophageal temperature shown above is not applicable for the US and JP versions of the generator Quick Step Press the POST workflow button Notes 1 The POST screen displays a summary of the data collected by the generator during an entire procedure To indicate the start of a new procedure to restart data collection press New Procedure see 6 4 1 Starting a New Procedure 2 The Total Irrigation value shown on the POST screen is the total irrigation delivered during the procedure excluding flushing 6 5 1 Exporting Ablation and Event Log Data to a USB Flash Drive Export Ablation and Event Log Data Insert USE flash drive then select the amount of data to export Today Last 7 Days Export status complete Time remaining Cancel Export 6 Operation Post Procedure Page 56 RF Generator User Manual Quick Steps Insert a USB flash drive into the USB port on the back of the generator Press the CONNECTIONS workflow button Press System Settings aa Press Export to USB Press Today Last 7 Days or All When the export status is 100 complete remove the USB flash drive Notes 1 The USB port is locate
127. toring instruments These signals in combination with the temperature of the ablation electrode tissue impedance and RF energy information are used by the operator to control the safe delivery of RF energy to locations within the heart that require treatment The SmarTABLaTE RF Generator was designed to ensure simple intuitive and user friendly operation This device features a touch screen for making selections and setting parameters Among the features of the screen is a display that shows power temperature and impedance in color coded real time continuous graphics during ablation The generator features redundant protection circuits if one safety mechanism fails a second safety mechanism indicates the failure to ensure safety 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 The SmarTABLaTE RF Generator is connected to the SmarTABLATE Irrigation Pump by a communication interface that allows both devices to be controlled from the user interface of the generator If an error occurs in either of these devices the necessary notification and recovery steps are initiated simultaneously in both devices This user manual describes the operation of the SMARTABLATE RF Generator It is important that the user understand the functional
128. ty and essential performance Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 4 General requirements for safety Collateral Standard Programmable electrical medical systems Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability Medical electrical equipment 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 Medical electrical equipment Part 1 9 General requirements for basic safety and essential performance Collateral Standard Requirements for environmentally conscious design 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 Medical device software Software life cycle processes 8 Technical Data Page 91 RF Generator User Manual Standard Title 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 MDD 93 42 EEC Medical Device Directive MDD Council Directive 93 42 EEC of 14 June 1993 MPG Medical concerning medical devices
129. 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 objects 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 RF Generator as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of the SmartABLaTE RF Generator AN Warning The SMARTABLATE RF Generator may be operated in the immediate vicinity of the SMARTABLATE Irrigation Pump However do not operate the generator in the immediate vicinity of devices that are not approved for electromagnetic compatibility EMC with the generator If such operation is unavoidable regularly monitor the generator to ensure proper functioning 8 Technical Data Page 95 RF Generator User Manual N Warning The SMARTABLATE RF Generator may be interfered with
130. y 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 RF Generator Firmware 1 XX XX Biosense Webster Inc 2012 2013 January 2013 SAG_UM_04 00_EN

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