EnligHTN Model ENL-T115 User Manual sw ver 3.020

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Contents Inhalt Table des matières Contenuto Contenido Περιεχόμενο Conteúdo Inhoud Innehåll Indhold Innhold Sisältö Batch code Chargenbezeichnung Numéro de lot Codice lotto Número de lote Αριθμός παρτίδας Número de lote Lotnummer Partinummer Batchkode Lot-nummer (produksjonskode) Eränumero Authorized European representative Autorisierte europäische Vertretung Représentant européen autorisé Rappresentante autorizzato per l’Europa Representante autorizado en Europa Εξουσιοδοτημένος αντιπρόσωπος για την Ευρώπη Representante europeu autorizado Erkende Europese vertegenwoordiger Auktoriserad representant för Europa Autoriseret repræsentant i Europa Autorisert europeisk representant Valtuutettu edustaja Euroopassa Manufacturer Hersteller Fabricant Produttore Fabricante Κατασκευαστής Fabricante Fabrikant Tillverkare Producent Produsent Valmistaja Date of manufacture Herstellungsdatum Date de fabrication Data di produzione Fecha de fabricación Ημερομηνία κατασκευής Data de fabrico Productiedatum Tillverkningsdatum Fremstillingsdato Produksjonsdato Valmistuspäivä

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Catalog number Bestellnummer Référence de commande Numero di catalogo Número de referencia Αριθμός καταλόγου Número de catálogo Catalogusnummer Katalognummer Katalognummer Katalognummer Luettelonumero Operating instructions Gebrauchsanweisung Mode d’emploi Istruzioni operative Instrucciones de uso Οδηγίες λειτουργίας Instruções de funcionamento Gebruiksaanwijzing Bruksanvisning Betjeningsvejledning Bruksanvisning Käyttöohjeet

SYSTEM DESCRIPTION ...2 GENERATOR DESCRIPTION ...2 SYSTEM COMPONENTS ...2 INDICATIONS FOR USE ...2 CONTRAINDICATIONS ...2 WARNINGS AND PRECAUTIONS ...2 POSSIBLE ADVERSE EVENTS ...3 OPERATING STATE DEFINITIONS ...4 GENERATOR CONTROLS AND INPUTS...5 PREPARATION FOR THE ABLATION PROCEDURE ...7 ABLATION PROCEDURE ...8 ERROR AND INFORMATION DISPLAYS ...9 DISCONNECTING GENERATOR CABLES AND ELECTRODES ...9 SERVICE AND MAINTENANCE ...10 LIMITED WARRANTY AND GENERAL SERVICE POLICIES ...10 TECHNICAL DATA ...12 EMC/EMI DECLARATIONS ...13

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TABLE OF CONTENTS

CAUTION: The EnligHTN™ RF Ablation Generator should only be used by or under the supervision of physician’s trained in ablation procedures using the EnligHTN™ Renal Denervation System.

SYSTEM DESCRIPTION The EnligHTN Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN RF Ablation Generator, the EnligHTN™ Renal Artery Ablation Catheter, and the EnligHTN™ Guiding Catheter (optional).

GENERATOR DESCRIPTION The EnligHTN RF Ablation Generator delivers RF energy to the EnligHTN Renal Artery Ablation Catheter using a proprietary algorithm developed to produce a consistent, transmural ablation pattern during the renal denervation procedure. The generator allows users to selectively disable ablation catheter electrodes. Each electrode on the ablation catheter has a corresponding display channel on the generator. The generator channels facilitate control and monitoring of the ablation process. Recommended ablation parameters, including time, temperature, impedance, and power, are pre-programmed as generator default settings. During ablation, real-time values for these parameters are displayed on each channel. The generator is also pre-programmed with temperature and impedance safety limits. The generator will automatically power off if: • The temperature exceeds 80°C, • The temperature exceeds the setting by more than 5°C for grater than 3 seconds, or • The measured impedance falls below 50 Ω or exceeds 400 Ω.

SYSTEM COMPONENTS The following system components are provided with the generator: COMPONENT/REORDER NUMBER

DESCRIPTION

(1) EnligHTN™ Power Cable, reorder number ENL-PC-01

Medical grade power supply approved by international safety agencies. This power supply can be used for various line voltages and frequencies without any modifications. Replacement power cables may be ordered separately.

(1) 1641 Connector Cable, reorder number ENL-CC-01

Reusable cables to connect the ablation catheter with the generator. See the ENL-CC-01 Connector Cable Instructions for Use for resterilization instructions. Replacement connector cables may be ordered separately.

The following system components are provided separately: COMPONENT/REORDER NUMBER

DESCRIPTION

EnligHTN Renal Artery Ablation Catheter, reorder number ENL-SM-01 or ENL-LG-01

Ablation catheter required for use with the EnligHTN RF Ablation Generator. See the EnligHTN Renal Artery Ablation Catheter Instructions for Use for product details.

EnligHTN Guiding Catheter, reorder number ENL-8F55

Guiding catheter facilitates percutaneous introduction of the EnligHTN Renal Artery Ablation Catheter.

Patient Return Electrode, reorder number PREP-01

Patient return electrodes used with the EnligHTN Renal Denervation System must be IEC 60601-2-2 compliant. Replacement patient return electrodes must be ordered separately.

INDICATIONS FOR USE The EnligHTN RF Ablation Generator is intended to deliver RF energy to the EnligHTN Renal Artery Ablation Catheter. Refer to the EnligHTN Renal Artery Ablation Catheter Instructions for Use for ablation catheter indications and product details.

CONTRAINDICATIONS Refer to the EnligHTN Renal Artery Ablation Catheter Instructions for Use for contraindications.

WARNINGS AND PRECAUTIONS • Carefully read instructions for the generator, ablation catheter, and all accessories prior to use. • The generator is intended to be used only with EnligHTN Renal Artery Ablation Catheters (ENL-SM-01 and ENL-LG-01). • Pacemakers and implantable cardioverter defibrillators (ICDs) can be adversely affected by RF signals. It is important to: ○ Have temporary external sources of pacing and defibrillation available during ablation. ○ Deactivate implantable cardioverter defibrillators as they could discharge and injure the patient or even damage the ICDs during the ablation procedure. ○ Perform complete system analysis on all pacemaker and ICD patients after ablation. • Hazardous electrical output. The EnligHTN Renal Denervation System is for use only by qualified medical personnel trained in the use of this equipment in adequately equipped labs. • The generator should be powered ON and allowed to complete system Test State before initiating the procedure.

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POSSIBLE ADVERSE EVENTS Refer to the EnligHTN Renal Artery Ablation Catheter Instructions for Use for a listing of possible adverse events.

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• The long-term risks of RF ablation lesions have not been established. • Failure of the generator could result in an unintended power output increase. In case of system malfunction, attempt to stop RF delivery by: ○ Using the control panel’s START/STOP button. ○ Turning the rocker switch to the off position. If these steps do not stop RF power delivery, disconnect the power cord. • If the generator malfunctions discontinue the procedure. Notify a St. Jude Medical representative of the defect, and discontinue use until the generator has been repaired or replaced. • Position connecting cables to avoid contact with the patient and contact with other leads. • Do not connect any cables or equipment to the generator that are not specified by St. Jude Medical. Doing so could potentially damage the system or cause injury. • Do not allow the ablation catheter electrode to come into contact with a metal instrument or surface during energy delivery. Superficial skin burns could occur. • Remove all guidewires from the treatment site before activating the radiofrequency output. • Radiofrequency surgery uses high frequency output. Do not perform procedures if flammable or explosive media are present. Use non-flammable agents for cleaning and disinfection. • Do not touch the ablation catheter electrode and the patient return electrode at the same time during energy delivery. Superficial skin burns could occur. • Regularly inspect and test reusable cables and accessories. • Electric shock hazard. Do not remove the generator cover. Refer servicing to qualified personnel. There are no user-serviceable parts inside the generator. • Do not disassemble the generator. This will void the warranty and may cause serious injury to the operator or damage to the unit. • Safe use of monopolar radiofrequency energy demands proper coupling of the patient return electrode to the patient. Follow the manufacturer’s directions for the placement of the patient return electrode and for proper insulation between the patient and any metal surfaces. • Failure to achieve good skin contact by the entire adhesive surface of the patient return electrode may result in a burn or measured high impedance. The patient return electrode should be placed on the thigh or other non-bony area out of the angiogram field (shave if necessary for good contact). Do not apply the patient return electrode where fluid may pool. • Monitoring electrodes of any physiological monitoring equipment used on the patient at the same time as RF energy delivery should be placed as far as possible away from the lower back region. Needle monitoring electrodes are not recommended. Physiological monitoring equipment incorporating high frequency current limiting devices is recommended. • The EnligHTN Renal Denervation System is not intended for patients with prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts. • The RS-232 data port on the back panel of the generator is only to be used by St. Jude Medical designated personnel using an internally powered St. Jude Medical supplied computer. No other equipment should be connected to the data ports or the St. Jude Medical supplied computer when connected to the generator. • See the “EMC/EMI DECLARATIONS” section of this manual for information related to electromagnetic compatibility.

OPERATING STATE DEFINITIONS The generator navigates between operating states using a combination of software and user inputs. The generator operating states are described below: OPERATING STATE

DESCRIPTION

START/ STOP BUTTON

Test State

When the generator is powered ON, it will automatically enter Test State. In Test State, the RF circuit is tested by delivery of RF power to an internal 100 Ω resistor. Test State will only be performed during cold start. During Test State, the measured impedance value will be displayed. All other digital displays will be blank for the duration of the Test State (approximately 6 seconds). Upon completion of the Test State, pre-programmed generator settings will be applied.

Flashing

The operating system will automatically enter Catheter State (if a valid ablation catheter is not attached), Edit State (if a valid ablation catheter is attached), or Error State (if the generator fails internal Test State routines). Catheter State

Catheter State is entered automatically when the operating system does not detect an ablation catheter, or when an invalid ablation catheter is detected. In Catheter State, the operating system does not allow the user to manually navigate to other states.

Flashing

Edit State

Edit State is entered automatically when the Test State is successfully completed, and a valid catheter is detected.

Flashing

Edit State allows the user to change the time, temperature, impedance or power default values. Edited values will be displayed and retained internally until the generator is powered down. Press the SETUP/MONITOR/EDIT button once to enter Electrode Select State, or press the SETUP/MONITOR/ EDIT button twice to enter Monitor State. Electrode Select State

Electrode Select State allows the user to activate or deactivate electrodes for the ablation procedure. See the “Preparation for the Ablation Procedure” section of this manual for instructions on activating/deactivating individual electrodes.

Monitor State

Monitor State allows the user to confirm that the electrodes are functional before starting the ablation procedure. The Monitor State will display the flashing temperature and impedance measurements of each active electrode, one at a time.

Flashing

Press the SETUP/MONITOR/EDIT button to enter Monitor State. Flashing

Press the SETUP/MONITOR/EDIT button once to return to Edit State, or twice to return to Electrode Select State. Press the START/STOP button to enter Ablation State. Ablation State

RF energy is delivered in the Ablation State. In Ablation State, the generator delivers power to the electrodes in sequential order, displaying power level, temperature, and impedance measurements for each active electrode.

Lit

The operating system will automatically enter Results State when the preset ablation time has elapsed, or the START/STOP button is pressed. The operating system will automatically enter Error State if any measured parameter crosses its respective minimum or maximum operating range. Results State

Results State is entered automatically upon completion of the Ablation State. Results State may be entered manually when the CLEAR button is pressed in Error State.

Flashing

Results State displays the average power delivered, average temperature attained, average impedance measured, and the total elapsed time of ablation. The ablation counter will indicate the number of ablation cycles that were initiated during the procedure. Error State

Error State is entered automatically whenever any measured parameter crosses its respective minimum or maximum operating range. See the “Error and Information Displays” section of this manual for details.

Unlit

Press the CLEAR button to exit the Error State and transition to the Results State.

Operating State Transitions Operating state transitions may be controlled by software or by user inputs, as shown below: BUTTON

CLEAR

SETUP/MONITOR/ EDIT

START/STOP

ARROW

COUNTER RESET

Edit

No effect

Change to Electrode Select State

Change to Ablation State

Value selection

Clears the counter

Electrode Select

No effect

Change to Monitor State

Change to Ablation State

Toggle between active “1” and inactive “0” status of each ablation catheter electrode

No effect

Monitor

No effect

Change to Edit State

Change to Ablation State

No effect

Clears the counter

Ablation

No effect

No effect

Change to Results State

Only Power and Temperature buttons are active for real-time parameter value change

No effect

Results

No effect

Change to Edit State

No effect

No effect

No effect

Error

Change to Results State

No effect

No effect

No effect

No effect

Catheter

No effect

No effect

No effect

No effect

No effect

STATE

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GENERATOR CONTROLS AND INPUTS 8

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Generator Front Panel 1

POWER UP BUTTON The power LED display window will indicate 6 watts when the generator is initially powered ON. The watts value displayed is the maximum RF power that will be delivered to the tissue. Press this button to increase the power set point. Power can be adjusted by 1 watt increments. Pressing and holding the button will cause the displayed value to change (scroll) rapidly until the limit maximum is reached or the button is no longer depressed. The scroll function is disabled during ablation. The power selection range is from 1.0–10.0 W.

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POWER DOWN BUTTON The power LED display window will indicate 6 watts when the generator is initially powered ON. The watts value displayed is the maximum RF power that will be delivered to the tissue. Press this button to decrease the power set point. Power can be adjusted by 1 watt increments. Pressing and holding the button will cause the displayed value to change (scroll) rapidly until the limit minimum is reached or the button is no longer depressed. The scroll function is disabled during ablation. The power selection range is from 1.0–10.0 W.

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TEMPERATURE UP BUTTON The temperature LED display window will indicate 75°C when the generator is initially powered ON. The value displayed is the target electrode temperature that the generator will attempt to achieve. Press this button to increase the temperature set point. Temperature can be adjusted by 1°C increments. Pressing and holding the button will cause the displayed value to change (scroll) rapidly until the limit maximum is reached or the button is no longer depressed. The scroll function is disabled during ablation. The temperature selection range is from 15ºC–75ºC.

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TEMPERATURE DOWN BUTTON The temperature LED display window will indicate 75°C when the generator is initially powered ON. The value displayed is the target electrode temperature that the generator will attempt to achieve. Press this button to decrease the temperature set point. Temperature can be adjusted by 1°C increments. Pressing and holding the button will cause the displayed value to change (scroll) rapidly until the limit minimum is reached or the button is no longer depressed. The scroll function is disabled during ablation. The temperature selection range is from 15ºC–75ºC.

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IMPEDANCE UP BUTTON The impedance LED display window will indicate a default of 400 Ω when the generator is initially powered ON. The value displayed is the maximum impedance limit. Press this button to increase the maximum impedance limit set point. Impedance can be adjusted by 1 Ω increments. Pressing and holding the button will cause the displayed value to change (scroll) rapidly until the limit maximum is reached or the button is no longer depressed. The user cannot change or scroll this parameter during ablation. The maximum impedance selection range is from 50–400 Ω.

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IMPEDANCE DOWN BUTTON The impedance LED display window will indicate a default of 400 Ω when the generator is initially powered ON. The value displayed is the maximum impedance limit. Press this button to decrease the maximum impedance limit set point. Impedance can be adjusted by 1 Ω increments. Pressing and holding the button will cause the displayed value to change (scroll) rapidly until the limit minimum is reached or the button is no longer depressed. The user cannot change or scroll this parameter during ablation. The maximum impedance selection range is from 50–400 Ω. 5

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TIME UP BUTTON The time display window will indicate a default time of 90 seconds when the generator is initially powered on. Press this button to increase the ablation time. Ablation time can be adjusted by 1 second increments. Pressing and holding the button will cause the displayed value to change (scroll) rapidly until the limit maximum is reached or the button is no longer depressed. The user cannot change or scroll this parameter during energy delivery (ablation). The time selection range is from 1–90 seconds.

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TIME DOWN BUTTON The time display window will indicate a default time of 90 seconds when the generator is initially powered on. Press this button to decrease the ablation time. Ablation time can be adjusted by 1 second increments. Pressing and holding the button will cause the displayed value to change (scroll) rapidly until the limit minimum is reached or the button is no longer depressed. The user cannot change or scroll this parameter during energy delivery (ablation). The time selection range is from 1–90 seconds.

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ISOLATED PATIENT CONNECTOR Use this port to connect the ablation catheter to the generator. The 1641 connector cable plugs into this connector.

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INDIFFERENT ELECTRODE PORTS Connect up to two patient return electrodes to the generator using the 2-pin ports. Neutral Electrode “Floating Output” is isolated from earth potential.

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NOT SUPPORTED

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CLEAR BUTTON Press this button to clear error messages when the operating system enters Error State.

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SETUP/MONITOR/EDIT BUTTON Press this button once to enter Electrode Select State. In this state, each of the four ablation electrodes may be activated/deactivated independently. See “Preparation for the Ablation Procedure” for instructions Press this button a second time to enter Monitor State. In this equipment diagnostic state, temperature/impedance information is displayed.

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COUNTER RESET BUTTON Press this button to reset the ablation counter display to “0” (zero). The counter may be reset during Edit State or Monitor State.

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ABLATION COUNTER This counter displays the number of times the user has initiated an ablation cycle. Press the START/STOP button to start the counter. Counter range: 1–99.

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START/STOP BUTTON Press this button once to initiate RF energy delivery. Press this button a second time to stop the delivery of RF energy, and initiate the Results State.

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Generator Rear Panel 1

REMOTE CONTROL CONNECTOR (26 PIN CIRCULAR) This port is not supported.

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TEMPERATURE ANALOG OUTPUT This port is not used.

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SERIAL PORT (PUMP) This port is not supported.

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VOLUME CONTROL This provides the user with volume control for the audible signal that accompanies RF power delivery. To reduce the volume to the minimum level, turn the knob all the way counterclockwise. To increase the volume, turn the knob clockwise.

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EQUIPOTENTIAL GROUND This single contact connector provides connection to the generator frame. This connection is optional and is not required for the proper operation of the generator.

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MAIN POWER SWITCH Turn the generator ON by pressing the rocker switch to the “I” position. Turn the generator OFF by pressing the rocker switch to the “O” position.

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SERIAL PORT (RS232) This port is not used.

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FOOT SWITCH PORT This port is not supported.

PREPARATION FOR THE ABLATION PROCEDURE 1. Prepare the patient for the ablation procedure using standard procedures for electrosurgery, including appropriate placement of the patient return electrode(s). CAUTION: The patient’s entire body must be insulated from contact with grounded metal parts. CAUTION: Do not apply the patient return electrode where fluid may pool. 2. Position the generator so that the front panel is easily accessible. 3. Connect the patient return electrodes to the INDIFFERENT ELECTRODE ports on the front panel of the generator. Gently push the return electrode fittings straight in until they are firmly in place. 4. Connect the 1641 connector cable to the ablation catheter. Gently line up the cable connector pins (green end) with the green ablation catheter socket and push in until the connector fits firmly into the socket. 5. Connect the yellow end of the 1641 connector cable to the yellow generator port labeled ISOLATED PATIENT CONNECTOR. 6. Connect the generator power cord into a properly grounded AC electrical outlet. To ensure proper grounding, the power cord plug must be installed in an AC electrical wall outlet designed for “Hospital Grade” or “Hospital Only.” CAUTION: Never use an outlet without a grounding connection. 7. Turn the generator ON by pressing the rocker switch, located on the back panel, to the”I” position. When the generator is powered ON it will display the software version number briefly and then enter the Test State. When the generator is in Test State, the SETUP/MONITOR/EDIT button will be lit. If, during Test State, any of the tests do not pass, an error message “HELP” will be displayed and the operating system will not respond to user 7

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commands. Refer to “Error and Information Displays” section of this manual for further information. Upon successful completion of the Test State, the generator will load the following default settings for all four ablation catheter electrodes: -Power: 6 W -Time: 90 seconds per electrode for a total of 360 seconds for one ablation cycle -Impedance: 400 Ω -Temperature: 75°C 8. Verify that there are no catheter errors. If the error messages “No id” or “No Cath” are displayed, connect a valid ablation catheter to the generator. Refer to the “Error and Information Displays” section of this manual for further information. 9. Access the renal artery and position the EnligHTN Renal Artery Ablation Catheter using standard interventional technique. Refer to the EnligHTN Renal Artery Ablation Catheter Instructions for Use for procedure details. 10. Confirm the default, temperature, and power, and impedance settings. The pre-programmed default settings (power: 6 W, time: 90 seconds, impedance: 400 Ω, temperature: 75°C) are recommended by St. Jude Medical. 11. Deactivate electrodes, if desired. All four ablation electrodes are, by default, active. To selectively deactivate electrodes, Press the SETUP/ MONITOR/EDIT button to enter Electrode Select State. Channels 1-4 will be displayed on the generator screen. Each channel corresponds to an electrode on the ablation catheter. Channel 1 is displayed in the power window, channel 2 is displayed in the temperature window, channel 3 is displayed in the impedance window, and channel 4 is displayed in the time window. A “-0” or “-1” appears after each channel number; “-0” indicates that the electrode is inactive and “-1” indicates that the electrode is active (Figure 1). Use the up or down arrows below each channel window to activate or deactivate electrodes. channel 1

1 = electrode active

Figure 1 12. Confirm valid impedance and temperature values for active electrodes. Press the SETUP/MONITOR/EDIT button to enter Monitor State. Each active electrode will be monitored on a generator channel, “P1”, “P2”, “P3”, or “P4”, for a period of 3 seconds. The time display window will indicate the active channel. The temperature and impedance windows will display temperature and impedance values for the active electrode. The power window will display “---.” When the monitoring function is complete for the first electrode, the real-time temperature and impedance values will be updated on the respective displays. An audible tone will sound when the generator advances to the next active channel. Impedance values will be approximately 150–300 Ω when the electrode is in stable contact with tissue. Consult the “Error and Information Displays” section of this manual if electrode readings exceed preset temperature or impedance limits.

ABLATION PROCEDURE Press the START/STOP button one time to begin ablation. When RF power is delivered to the ablation catheter, the START/STOP button will be illuminated. In Ablation State, the generator delivers power to the electrodes in sequential order, displaying power level, temperature, and impedance measurements for each active electrode. An audible tone will sound when the generator advances to the next active channel. To disable an ablation catheter electrode at any point during the procedure, see “Preparation for the Ablation Procedure”, step 11. The time display reflects the total elapsed ablation time for all active electrodes. (The time counter does not restart at “0” when the generator activates a new channel. If the user has retained the default ablation time of 90 seconds, and the time display shows 95 seconds, the generator has delivered power to the first electrode for 90 seconds, and the second electrode for 5 seconds.) Power, temperature, impedance, and time may be monitored at all times during RF power delivery, as described below: DISPLAY

MONITORING FUNCTION

POWER

Shows RF power (in watts) delivered to the ablation catheter.

TEMPERATURE

Continuously shows the measured temperature from any electrode during RF delivery.

IMPEDANCE

Shows measured impedance in the range of 50–400 Ω. Values shown will be approximately 150–300 Ω when the electrode is in stable contact with tissue. NOTE: The displayed readings may fluctuate slightly due to variation in the stability of electrode/tissue contact. If the measured value demonstrates significant fluctuation, the ablation catheter should be repositioned. Alternatively, slight pressure on the ablation catheter shaft may minimize ablation catheter motion. CAUTION: If an excessively high impedance value is detected during delivery of RF power, first check that the ablation catheter is correctly connected to the generator. If this is not the cause of the high impedance value, consult the “Error and Information Displays” section of this manual for further instructions.

TIME

Shows elapsed time. When the RF power START/STOP button is pressed, this display will reset to 0 seconds. The elapsed time display will begin to count up to the default (or user-selected) ablation time.

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• • • •

Reaching the targeted ablation time. Pressing the START/STOP button a second time. Exceeding the preset impedance limits (see “Error and Information Displays” section of this manual). Exceeding the preset temperature limits (see “Error and Information Displays” section of this manual).

ERROR AND INFORMATION DISPLAYS Error messages may be observed during generator operation. Error descriptions and suggested actions are described below: ERROR

WINDOW(S)

DESCRIPTION

ACTION

HELP

Power and Temperature

The generator has failed its own internal self-test routines (EPROM, RAM, and 100 Ω internal load resistor).

Turn the generator on and off via the power switch. If the HELP error remains activated, do not use the generator and contact a St. Jude Medical representative immediately.

No Cath

Power and Temperature

The EnligHTN Renal Artery Ablation Catheter is not connected to the generator.

Connect the ablation catheter to the generator.

No id

Power and Temperature

One or more EnligHTN Renal Artery Ablation Catheter thermocouple connections are broken.

Obtain a replacement ablation catheter, and connect the replacement catheter to the generator.

EE

Temperature

“EE” flashes alternately with temperature value when the temperature has gone out of range.

Before attempting to proceed with the ablation, confirm that the ablation catheter is in the desired treatment location.

Power delivery is terminated when temperature limits are exceeded.

It may be necessary to turn off the ablation electrode that resulted in the “EE” error, and repeat all or part of the ablation cycle.

Observed impedance has exceeded the impedance set point.

The following actions may be used to correct impedance errors:

HI

Impedance

Power delivery is terminated when impedance limits are exceeded.

LO

Impedance

“LO” flashes alternately with impedance valve when observed impedance is less than 50 Ω. Power delivery is terminated when impedance limits are exceeded.

PE

Power

The measured power has reached 10 W. Power delivery is terminated when measured power reaches 10 W.

Press the CLEAR button to advance to Results State.

Press the CLEAR button to advance to Results State. • Confirm that the ablation catheter is correctly connected to the generator. • Confirm that patient return electrode conductivity is acceptable. In some circumstances, it may be necessary to connect a second patient return electrode. • Confirm that the ablation catheter is in the desired treatment location. • Deflect or straighten the ablation catheter tip. • Collapse and expand the basket while maintaining the basket position. • Collapse the basket, reposition the ablation catheter, and expand the basket. If these actions do not resolve the impedance errors, it may be necessary to turn off the ablation electrode that resulted in the “HI” error, and repeat all or part of the ablation cycle. Press the CLEAR button to advance to Results State. Before attempting to proceed with the ablation, confirm that: • The ablation catheter is correctly connected to the generator. • The ablation catheter is in the desired treatment location. It may be necessary to turn off the ablation electrode that resulted in the “LO” error, and repeat all or part of the ablation cycle. Press the CLEAR button to advance to the Results State. If the PE error remains activated, do not use the generator and contact a St. Jude Medical representative immediately.

DISCONNECTING GENERATOR CABLES AND ELECTRODES Turn off and unplug the generator before disconnecting cables and electrodes. To unplug the patient return electrode, grasp the fitting and gently pull it out of the port. CAUTION: Do not disconnect the patient return electrode connector by pulling on the cable. Gently disconnect the 1641 connector cable from the ablation catheter and the generator. The 1641 connector cable may be cleaned and sterilized as described in the ENL-CC-01 Connector Cable Instructions for Use.

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The START/STOP button remains illuminated until RF power delivery is discontinued by any of the following methods:

SERVICE AND MAINTENANCE The generator requires no routine service or maintenance. If the generator fails to operate when plugged into a proper AC power receptacle and the power switch is turned ON, check the fuse (see “Replacing the Fuses”). If a second failure occurs, notify St. Jude Medical for service. The generator contains no user-serviceable parts. Disassembly and attempted repair by unqualified personnel may create a hazardous condition and will void the warranty. CAUTION: DO NOT remove the cover of the generator. Removing the cover may result in personal injury and/or damage to the generator. Contact your local St. Jude Medical representative for limited warranty and general service policy information.

Cleaning The outer surfaces of the generator and its accessories may be cleaned with a mild soapy solution. Do NOT immerse the generator or its accessories in any liquid. Avoid caustic or abrasive cleaners. If disinfections are required, isopropyl alcohol may be used to clean the outer surfaces.

Replacing the Fuses CAUTION: Before replacing fuses, disconnect the main power cord from the generator.

Replacing Main Fuses Using a slotted screwdriver, pull the fuse holder out of the power entry module. Replace the fuse with another fuse of the same type and rating. Refer to the back panel label. Insert the new fuse in the fuse holder, and reinsert the fuse holder in the power entry module. When replacing the fuse holder, ensure that it is inserted in the correct orientation for the operational voltage level.

Replacing Auxiliary Power Outlet Fuses Use a slotted screwdriver to rotate the fuse holder counterclockwise 1/8th turn. The fuse holder will jut out approximately ¼ inch. Remove the fuse holder and the fuse. Replace the fuse and return the fuse holder to the original position. If there appears to be a problem with the generator, please contact St. Jude Medical.

LIMITED WARRANTY AND GENERAL SERVICE POLICIES Initial Warranty Period St. Jude Medical (“SJM” or “we”), warrants that its EnligHTN catheter products and EnligHTN RF Ablation Generator shall be free from defects in materials and workmanship under normal use and service for a period of twelve (12) months from the date of transfer of ownership to the customer (as specified in the sales terms and conditions). Regarding sterile products, the warranty will not extend beyond the expiration date stated on any product labeling and will only be accepted if the original packaging is intact. Optimal functionality of the EnligHTN RF Ablation Generator requires annual preventive maintenance on request of the user, and to be provided no earlier than one year after the Generator’s first usage. The preventive maintenance is not part of the standard warranty coverage and is typically offered under a separate Maintenance Service Agreement.

Notification; RGA Number; and Return of Defective Products (Warranty and Out-of-Warranty) Should the distributor or customer discover a defect in one of our catheter products or our RF Ablation Device, whether or not the discovery occurs during the Initial Warranty Period and whether or not the catheter products or the RF Ablation Device is subject to this limited warranty or a Maintenance Service arrangement, our distributor or customer should promptly advise a SJM representative of the scope and nature of the problem, the conditions under which the problem was noticed, and request a “Returned Goods Authorization” (RGA) and/or “Field Experience Report” (FER) number. The FER and RGA number can only be provided by SJM. SJM will provide decontamination, packaging and shipping return instructions. At the same time, SJM will provide estimated repair and return timing. After obtaining the RGA and/or FER number, the distributor or customer should display it prominently on the carefully packaged product shipping carton, and send it to the indicated return address (with prepaid postage) for inspection. Shipments arriving without an RGA and/or FER number will not be accepted and will be returned to the sender. Inside the package, enclose a document explaining the scope and nature of the problem, the conditions under which the problem was noticed, and the name of a contact person and a phone number. Loss or damage in shipment to SJM shall be at the distributor or customer’s risk and cost.

Warranty Repairs In addition to the notification instructions above, claims for warranty repairs must also be accompanied by a copy of the original invoice. SJM will evaluate the product that is returned with an RGA/FER number and (I) if subject to the terms and conditions of this limited warranty or any other applicable agreement, at SJM’s expense, replace or repair (at its sole discretion) any product that proves to be defective and (ii) return it to the customer (with freight prepaid). Loss or damage in shipment to the distributor or customer shall be at the distributor or customer’s risk. SJM will provide a written report to the distributor or customer listing the repairs made. If SJM determines that the product is not defective, that no repair of the product is required, or that it is not covered by this limited warranty or any other applicable agreement, it will be returned to the customer, freight collect including customs duties. Loss or damage in shipment to the distributor or customer shall be at the distributor or customer’s risk and cost. The terms of SJM’s repair limited warranty shall apply to the repaired portion of the RF Ablation Device except that the duration of such repair limited warranty is ninety (90) days or the balance of the Initial Warranty period or applicable agreement period-whichever is greater.

No User-Serviceable Components There are no user-serviceable components within our products. Do not attempt to perform any repair work or attempt to open the RF Ablation device or footswitch enclosures. This limited warranty is null and void if the product is misused, abused, modified, or tampered with in any way.

Disclaimers SJM’s catheter products are designed as single-use devices and are not intended for reuse. Furthermore, the authorized uses and approved methods of use of each of our catheter products and RF Ablation devices are set forth in the related “Directions/Instructions for Use” that accompany each of our catheter products and RF Ablation devices. SJM disclaims any responsibility and liability for the use of its catheter products and RF Ablation Devices in a manner that has not been authorized or approved. SJM HEREBY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY OF QUALITY, OTHER THAN AS EXPRESSLY SET FORTH HEREIN OR IN THE PRODUCT LABELING, INCLUDING THE APPLICABLE USER DIRECTIONS/INFORMATION. SJM WILL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES OF ANY TYPE ARISING OUT OF THE USE OF 10

Out-of-Warranty Service and Repairs Requests for out-of-warranty service also require an RGA/FER number, which must be prominently displayed on the outside of the shipping carton. Shipments arriving without an RGA/FER number will not be accepted and will be returned to the sender. Should a problem occur, enclose a document inside the package explaining the scope and nature of the problem, the conditions under which the problem was noticed, and the name of a contact person and a phone number. If a customer requests service for an RF Ablation Device that is not subject to a Maintenance Service arrangement or this limited warranty or another applicable agreement, and returns the RF Ablation Device with an RGA/FER number, SJM will provide a non-binding repair cost estimate and a repair plus shipping timing estimate for customer’s acceptance. SJM will use reasonable efforts to repair the device at standard rates for Maintenance Service Repair. SJM will provide a written report to the distributor or customer listing the repairs made and will return the RF Ablation Device to the distributor or customer, freight collect, plus any applicable customs charges and taxes. Loss or damage in shipment to the distributor or customer shall be at the distributor or customer’s risk and cost. Notwithstanding the above, SJM reserves the right not to repair any RF Ablation Device that, in its sole discretion, it deems is beyond reasonable repair. Furthermore, on a project-by-project basis and subject to notice prior to the commencement of repair services, SJM reserves the right to vary its then-current, standard rates and terms on any specific out-of-warranty repairs. The terms of SJM’s repair limited warranty shall apply to the repaired portion of the RF Ablation Device except that the duration of such repair limited warranty is ninety (90) days or the balance of the Initial Warranty period or applicable agreement period-whichever is greater.

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English

THE PRODUCT BY THE CUSTOMER. IN NO EVENT SHALL SJM’S LIABILITY EXCEED THE PURCHASE PRICE PAID FOR THE DEFECTIVE PRODUCT. Furthermore, this limited warranty shall not apply to, and SJM shall not be responsible for, any loss arising in connection with the purchase or use of any SJM product that has been repaired by anyone other than SJM or altered in any way that might, in SJM’s sole judgment, affect its stability or reliability, or that has been subject to misuse, negligence, or accident, or that has been used otherwise than in accordance with the directions/instructions for use furnished by SJM. This is a limited warranty and is exclusive and in lieu of all other warranties, express or implied, and of all other obligations or liabilities on SJM’s part and SJM neither assumes nor authorizes any representative or other person to assume for it any other liability in connection with SJM’s products.

TECHNICAL DATA Supply Voltage

100-120 VAC, 60 Hz 200-240 VAC, 50Hz

Current Rating

T2.0 A (IBI P/N 180620-001) / 250 V (220-240 VAC)

Fuse Rating

T3.15 A (IBI P/N 180620-002) / 250 V (100-120 VAC)

Operating Duration

Standby: Continues until start button is activated Ablation: Continues from 1-90 second maximum

Safety Class

Class I. Type CF according to IEC 60601-1

Operating Frequency

485 kHz

Operating Parameters

Values are digitally displayed on the generator front panel.

PARAMETER

UNITS

OPERATING RANGE

ADJUSTMENT STEPS ACCURACY

RF Output Power

watts

1-10

1W

± 20% (1-4 W) ± 10% (5-10 W)

Temperature

°C

15-75

1°C

Impedance

ohms

50-400

1Ω

± 10% @ 100 Ω

Time

seconds

1-90

1 second

Internal clock

Temperature Monitoring

4-channel independent and simultaneous display

Operating Modes

Temperature Control Mode

Input/Output

- 14 pin socket for the ablation catheter - Socket for the foot switch (not supported) - RS.232 serial interface - Analog output BNC connector

Dimensions

362 mm x 153 mm x 317 mm (W x H x D without handle)

Weight

9.75 kg

Environmental Specifications Storage

- Temperature: -40°C to 70°C - Relative humidity: 10% to 100%, non-condensing - Atmospheric pressure: 500 to 1060 millibar

Operation

- Temperature: 10°C to 40°C - Relative humidity: 30% to 75%, non-condensing - Atmospheric pressure: 700 to 1060 millibar

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± 3°C

The generator may cause harmful RF energy interference with other devices in the vicinity. To determine potential interference, turn the generator off and on in the presence of auxiliary electronic devices. If interference is noted, correct the problem by: 1. Reorienting or relocating one or both of the devices. 2. Increasing the separation between the devices. 3. Connecting the generator to an outlet on a different circuit. 4. Contacting St. Jude Medical for help. Declaration-Electromagnetic Emissions The generator is intended for use in the electromagnetic environment specified below. The customer or the user of the generator should assure that it is used in such an environment. EMISSION TEST

COMPLIANCE

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

RF emission CISPR 11

Group 2

The generator must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF emission CISPR 11

Class A

Harmonics emissions IEC 6100-3-2

Not Applicable

Voltage fluctuations/flicker emissions IEC 6100-3-3

Not Applicable

The generator is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purpose.

Declaration-Electromagnetic Immunity The generator is intended for use in the electromagnetic environment specified below. The customer or the user of the generator should assure that it is used in such an environment. IMMUNITY TEST

IEC 60601 TEST LEVEL

COMPLIANCE LEVEL

ELECTROMAGNETIC ENVIRONMENT-GUIDANCE

Electrostatic discharge (ESD)

±6 kV contact

±6 kV contact

EN61000-4-2 (IEC 1000-4-2)

±8 kV air

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material the relative humidity should be at least 30%.

Electrical fast transient/burst

±2 kV for power supply lines

±2 kV

EN61000-4-4 (IEC 1000-4-4)

±1 kV for input/output lines

±1 kV

Surge

±1 kV differential mode

±1 kV

EN61000-4-5 (IEC 1000-4-5)

±2 kV common mode

±2 kV

<5 % UT (>95 % dip in UT) for 0.5 cycle

>95 % dip in VNOM for 0.5 line cycle

40 % UT (60 % dip in UT) for 5 cycles

60 % dip in VNOM for 5 line cycles

70 % UT (30 % dip in UT) for 25 cycles

30 % dip in VNOM for 25 line cycles

IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 5 sec

>95 % of VNOM for 5 sec

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Voltage dips, short interruptions and voltage variations on power supply input lines.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the generator requires continued operation during power mains interruptions, it is recommended that the generator be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level. The generator was tested at 230 VAC.

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English

EMC/EMI DECLARATIONS

Declaration-Electromagnetic Immunity Recommended separation distances between portable and mobile RF communications equipment and the generator The generator is intended for use in the electromagnetic environment specified below. The customer or the user of the generator should assure that it is used in such an environment. IMMUNITY TEST

IEC 60601 TEST LEVEL

COMPLIANCE LEVEL

ELECTROMAGNETIC ENVIRONMENT-GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the generator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

d [ Conducted RF

3 Vrms

3 Vrms

EN61000-4-6

150kHz to 80 MHz

[V1 = 3]

d  1.2 P

(IEC 1000-4-6)

d [

Radiated RF

3 V/m

3 V/m

EN61000-4-3

80 MHz to 2.5 GHz

[E1 = 3]

3.5 ] P V1

3.5 ] P E1

80 MHz to 800 MHz

d  1.2 P

(IEC 1000-4-3)

d [

7 ] P E1

800 MHz to 2.5 GHz

d  2.3 P 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 surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

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)

b)

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 generator is used exceeds the applicable RF compliance level above, the generator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the generator. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1 ] V/m.

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The generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the generator as recommended below, according to the maximum output power of the communications equipment. RATED MAXIMUM OUTPUT POWER OF TRANSMITTER

SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER m

W

150 kHz to 80 MHz

80 MHz to 800 MHz

3.5 d [ ] P V1

3.5 d [ ] P E1

800 MHz to 2.5 GHz

d [

7 ] P E1

0.01

0.117

0.117

0.233

0.10

0.369

0.369

0.737

1

1.167

1.167

2.33

10

3.69

3.69

7.37

100

11.67

11.67

23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture. 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.

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English

Recommended separation distances between portable and mobile RF communications equipment and the generator

INHALTSVERZEICHNIS SYSTEMBESCHREIBUNG...2 BESCHREIBUNG DES GENERATORS ...2 INDIKATIONEN ...2 KONTRAINDIKATIONEN ...2 WARNHINWEISE UND VORSICHTSMASSNAHMEN...2 MÖGLICHE UNERWÜNSCHTE EREIGNISSE ...3 BETRIEBSZUSTÄNDE – DEFINITIONEN ...4 BEDIENELEMENTE UND EINGÄNGE DES GENERATORS ...5 VORBEREITUNG FÜR DAS ABLATIONSVERFAHREN ...7 ABLATIONSVERFAHREN...8 FEHLER- UND INFORMATIONSANZEIGEN ...9 ABTRENNEN VON GENERATORKABELN UND -ELEKTRODEN ...9 SERVICE UND WARTUNG ...10 TECHNISCHE DATEN ...11 EMV/EMI-ERKLÄRUNGEN ...12

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Deutsch

SYSTEMKOMPONENTEN ...2

SISÄLLYSLUETTELO JÄRJESTELMÄN KUVAUS...2 GENERAATTORIN KUVAUS ...2 JÄRJESTELMÄN OSAT ...2 INDIKAATIOT...2 KONTRAINDIKAATIOT ...2 VAROITUKSET JA VAROTOIMET ...2 MAHDOLLISET HAITTAVAIKUTUKSET ...3 TOIMINTATILAN MÄÄRITELMÄT ...4 GENERAATTORIN OHJAINPAINIKKEET JA SYÖTTEET...5 ABLAATIOTOIMENPITEEN VALMISTELU ...7 ABLAATIOTOIMENPIDE ...8 VIRHEILMOITUKSET JA VIESTIT ...9 GENERAATTORIN KAAPELEIDEN JA ELEKTRODIEN IRROTTAMINEN ...9 HUOLTO JA YLLÄPITO ...10 TEKNISET TIEDOT ...11

Suomi

SÄHKÖMAGNEETTINEN YHTEENSOPIVUUS / SÄHKÖMAGNEETTISET HÄIRIÖT – VALMISTAJAN ILMOITUKSET ...12

1

St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345-2126 USA +1 800 544 1664 +1 651 490 4410 sjm.com

St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11

0086 EnligHTN, SJM, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. © 2012 St. Jude Medical. All rights reserved. AFD IFU: 100071428B CVD IFU: ARTMT100069276B

05/2012