EnligHTN Model ENL-GEN2 Instructions for Use Released May 2013

State: Released Date: 2013.05.14 15:12 GMT

State: Released Date: 2013.05.14 15:12 GMT

USER Manual

EnligHTN™ RF Ablation Generator - Model ENL-GEN2

State: Released Date: 2013.05.14 15:12 GMT

I

O

~

“ON” (power)

“OFF” (power)

Alternating current

Protective earth ground

Defibrillation-proof type CF applied part

F

Neutral electrode (floating dispersive electrode)

Non-ionizing radiation

Fuse

Dispose of hardware in accordance with local law

SN

Serial number

Keep dry

Fragile, handle with care

Humidity limitations

Temperature limitations

DUTY CYCLE

Duty Cycle

State: Released Date: 2013.05.14 15:12 GMT

RF ABLATION GENERATOR

RF Ablation Generator

INPUT POWER

Input power

OUTPUT POWER

Output power

SOFTWARE VERSION

Software version

Do not use if package is damaged

Foot switch

Transfer image

Write data into store

USB Memory Port

Computer Network connecting terminal

Authorized Representation in the European Community

CONTENTS

Contents

Manufacturer

Manufacturing Facility

Date of manufacture D a te o f m a n u fa

REF

Catalog number

Follow Instructions for Use

State: Released Date: 2013.05.14 15:12 GMT

Caution, consult accompanying documents

General warning

Table of Contents System Description...2 RF GENERATOR DESCRIPTION...2 Indications for Use...2 contraindications...2 WARNINGS...3 Precautions...3 Possible Adverse Events...4 RF Generator CONTROLS AND INPUTS...4 RF Generator and RF Generator touchscreen icons and definitions...5 Touchscreens and definitions...9 Preparation for the Ablation Procedure...13 Touchscreen OPERATION FOR Ablation Procedure...14 Error CODES...16 EVENT TYPE DESCRIPTIONS...18 Disconnecting RF generator cables and electrodes...18 Defibrillation recovery...18 SERVICE AND MAINTENANCE...18 Hardware disposal...19 Technical Data...19 EMC/EMI DECLARATIONS...20 Graphs...23

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English

State: Released Date: 2013.05.14 15:12 GMT

State: Released Date: 2013.05.14 15:12 GMT

CAUTION: The EnligHTN™ RF Ablation Generator should only be used by or under the supervision of physicians 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 (RF generator), the EnligHTN™ Renal Artery Ablation Catheter, the EnligHTN™ Guide Catheter (optional), the EnligHTN™ 1641A Electrophysiology Cable, and the EnligHTN™ Cable Adapter.

RF GENERATOR DESCRIPTION The RF 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 RF generator allows the user to select and de-select active electrodes and control the ablation and diagnostic modes. Each electrode on the ablation catheter is independently controlled by the RF generator. Ablation parameters, including time, temperature, impedance, and power, are pre-programmed. During ablation, real-time values for these parameters are displayed on the RF generator. The RF generator is also pre-programmed with temperature and impedance safety limits. The RF generator will disable power to an electrode if: • The temperature exceeds 75°C for 3 seconds, • The measured impedance falls below 100 Ω or exceeds 400 Ω. • The four electrodes are independently monitored at all times whether in configure, diagnostic or ablation modes. If the generator detects an unexpected rise in temperature on a deactivated electrode, the system will disable all electrodes.

System Components

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

DESCRIPTION

EnligHTN™ Power Cord

Medical grade power supply approved by international safety agencies. This power supply can be used for various line voltages and frequencies without any modifications. Power cords are supplied as required for each geography. If a replacement power cord is needed, contact your SJM representative for the appropriate power cord for each geography.

The following system components are provided separately (availability based on regulatory approval by geography): COMPONENT/REORDER NUMBER

DESCRIPTION

EnligHTN™ Renal Artery Ablation Catheter (Ablation Catheter): Large Basket, reorder number ENL-LG-01 Small Basket, reorder number ENL-SM-01

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

EnligHTN™ 1641A Electrophysiology Cable (Connector Cable), reorder number ENL-CC-02A (or equivalent)

Reusable connector cables to connect the ablation catheter with the RF generator. See the EnligHTN™ 1641A Electrophysiology Cable ENLCC-02 Instructions for Use for resterilization instructions. The connector cable will have no electric breakdown at 500VAC for 60 seconds. Replacement connector cables must be ordered separately.

EnligHTN™ Guide Catheter (Guide Catheter), reorder number ENL-8F55

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

Patient Return Electrode, reorder number PREP-01 (Covidien Model E7506 or 3M or equivalent)

Patient return electrodes used with the EnligHTN™ Renal Denervation System. Replacement patient return electrodes must be ordered separately.

(1) EnligHTN™ Cable Adapter (cable adapter), reorder number ENLADAPT

The cable adapter allows the EnligHTN™ 1641A Electrophysiology Cable to connect into the RF generator. Replacement cable adapters must be ordered separately.

EnligHTN™ Generator Mounting Pole, reorder number POLE-02 (Pryor Products Model 100091714 or equivalent)

The mounting pole supports positioning and placement of the RF generator during treatment. The c-clamp located on the back of the RF generator is used to attach the RF generator to the mounting pole during setup. Note: The mounting pole weight without the RF generator is 25lbs. The mounting pole base has a 22 inch diameter and weighs 22lbs. The maximum height of the mounting pole is 66 inches .

Banded bag (Sterile Drape) (Microtek model 60020S or 3M model 1096 or equivalent)

The sterile drape provides a sterile cover for the RF generator touchscreen while allowing adequate ventilation for the back side of the RF generator.

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 No known contraindications for the EnligHTN™ RF Ablation Generator. Refer to the EnligHTN™ Renal Artery Ablation Catheter Instructions for Use for contraindications.

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WARNINGS • • • • • • •

• • • • • • • • • • • • • • • • • • • •

To avoid the risk of electric shock, this equipment must be connected to an AC power supply with an earth ground. No modification of this equipment is allowed. Do not use the EnligHTN™ RF Ablation Generator in an oxygen rich environment Carefully read instructions for the RF generator, ablation catheter, and all accessories prior to use. The RF generator is intended to be used only with EnligHTN™ Renal Artery Ablation Catheters (ENL-LG-01 or ENL-SM-01), EnligHTN™ 1641A Electrophysiology Cable (ENL-CC-02A), and EnligHTN™ Cable Adapter (ENL-ADAPT). 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. Failure of the RF generator could result in an unintended power output increase. In case of system malfunction, attempt to stop RF delivery by: ○ Using the RF generator’s ABLATION ACTIVATION button. ○ Turning the RF generator’s rocker switch to the off position. ○ Disconnect the power cord from the RF generator. If the RF generator malfunctions discontinue the procedure. Notify a St. Jude Medical representative of the defect, and discontinue use until the RF generator has been repaired or replaced. Verify the corresponding LED is lit for each selected electrode. If the electrode status shown on the touchscreen does not match the status shown by the LEDs, discontinue procedure and consult with SJM representative for corrective action. Ensure the cable adapter, connector cable, and ablation catheter are at room temperature before use to ensure accurate temperature measurement. Do not administer contrast or other agents during energy delivery. Position cables to avoid contact with the patient and contact with other leads. Do not connect any cables or equipment to the RF 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. Do not touch the ablation catheter electrode and the patient return electrode at the same time during energy delivery. Superficial skin burns could occur. Position device such that the power cord connection is easily accessible as a means of disconnecting power from the device. If power outage occurs during use, disconnect power from the device and isolate the patient by disconnecting the ablation catheter and patient return electrodes from the RF generator. All cables may be reconnected after stable power is available. Electric shock hazard. Do not remove the RF generator cover. Refer servicing to qualified personnel. There are no user-serviceable parts inside the RF generator. Do not disassemble the RF generator. This will void the warranty and may cause serious injury to the operator or damage to the unit. Accessory equipment connected to the USB port must comply with IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment. Parties connecting other devices to these ports must ensure compliance to the system requirements of IEC 60601-1. Do not touch any equipment or cables affixed to the USB port and the patient at the same time. 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. If using only one patient return electrode, ensure the unused patient return electrode port cover is closed. The patient’s entire body must be insulated from contact with grounded metal parts. RF generator setup, diagnostics mode, RF generator monitoring, ablation initiation, must be performed by trained personnel.

Precautions • Implantable pacemakers (IPGs) and implantable cardiac defibrillators (ICDs) may be adversely affected by RF signals. It is important to: ○ Have temporary external sources of pacing and defibrillation available during ablation. ○ Deactivate implantable cardiac defibrillators as they could discharge and injure the patient or even damage the ICDs during the ablation procedure. ○ Perform complete analysis on all pacemaker and ICD patients after ablation. • There is a risk of neuromuscular stimulation during RF energy delivery. • RF generator ablation energy delivery should not be active during defibrillation. • Avoid skin-to-skin contact between parts of the patient’s body (e.g. the patient’s arm touching the patient’s abdomen). Use dry gauze where necessary to prevent contact between body parts. • Radiofrequency surgery uses high frequency output. Do not perform procedures if flammable or explosive media are present. Flammable agents used for cleaning, disinfecting, or as adhesive solvents must be allowed to evaporate before beginning the ablation procedure. • A risk of flammable solution pooling under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina exists. Fluids pooled within body depressions and cavities must be mopped up before beginning the ablation procedure. Additionally, there is a risk of igniting endogenous gasses during RF energy delivery. • To avoid a possible shock hazard, do not open the cover for the unused patient return electrode port during ablation or defibrillation. • Do not remove the cover over the Ethernet port and HDMI port. These ports are currently disabled and have not been evaluated for electrical safety. • In the event the RF generator touchscreen breaks, do not touch the sharp edges of the broken screen. • Regularly inspect and test reusable cables and accessories. Refer to instructions for use for cables and accessories. • 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. • See the “EMC/EMI DECLARATIONS” section of this manual for information related to electromagnetic compatibility.

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English

State: Released Date: 2013.05.14 15:12 GMT

State: Released Date: 2013.05.14 15:12 GMT

Possible Adverse Events Refer to the EnligHTN™ Renal Artery Ablation Catheter Instructions for Use for a listing of possible adverse events.

RF Generator CONTROLS AND INPUTS RF Generator Touchscreen The RF generator display is a touch screen which allows the user to select and deselect electrodes, run diagnostic mode, and monitor ablation. RF generator functions are controlled by touching the screen to select and deselect functions. The RF generator also has the following controls and connectors. 1

ELECTRODE INDICATOR LIGHTS

1

Four LED lights indicate which electrodes are selected or deselected. When the LED is lit, it indicates the corresponding electrode is selected. 2

1

ABLATION ACTIVATION BUTTON

2

3

4

Press this to activate and deactivate the ablation cycle.

3

PATIENT RETURN ELECTRODE PORTS Connect up to two patient return electrodes to the RF generator using the 2-pin ports located behind the covers. NOTE: Patient return electrode “Floating Output” is isolated from earth potential. NOTE: This is an applied part.

4

2

ABLATION CATHETER PORT

3

Use this port to connect the cable adapter to the RF generator.

4

NOTE: This is an applied part.

3

RF Generator Side Panel The side panel of the RF generator has the following controls and connectors. 1

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

2

Main Power Connector Used to connect the power cable to the RF generator.

3

EnligHTN™ Footswitch Connector PORT Not supported

4

1

C-CLAMP ADJUSTMENT KNOB Used to adjust the RF generator position on the mounting pole.

2

3

4

4

State: Released Date: 2013.05.14 15:12 GMT

RF Generator Back Panel 1

English

The rear panel of the RF generator has the following controls and connectors. USB PORT Use with USB memory stick. Warning: Accessory equipment connected to the USB port must comply with IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment. Warning: Parties connecting other devices to the port must ensure compliance to the system requirements of IEC 60601-1.

1

Warning: Do not touch any equipment or cables affixed to the port and the patient at the same time. 2

ETHERNET PORT and HDMI PORT (covered)

2

Currently disabled Warning: Do not remove the cover over the Ethernet port and HDMI port. These ports are currently disabled and have not been evaluated for electrical safety.

RF Generator and RF Generator touchscreen icons and definitions The RF generator and the series of touchscreens used to navigate the RF generator operating states incorporate various icons. The icons are described below: ICON

DESCRIPTION

ICON

DESCRIPTION

Time

Temperature

Access Settings Screens

Impedance

W

Confirm Selection

Access Screen Brightness Setting Screen

5

Wattage

State: Released Date: 2013.05.14 15:12 GMT

Status Bar Icons (Not used for navigation. Not selectable.)

CONFIGURE ABLATION SCREEN

RUN ABLATION SCREEN (SHOWN HIGHLIGHTED)

PATIENT ID ENTRY SCREEN

REPORT SCREEN

PATIENT ID #

48953721692

VOLUME ADJUSTMENT

EXIT THIS PATIENT’S PROCEDURE

FOOTSWITCH CONNECTED

(

NO FOOTSWITCH CONNECTED :

)

Configuration Screen Icons

CHOOSE SIDE OF BODY

START SENDING POWER FOR DIAGNOSTIC MODE (FLASHING HALO) STOP SENDING POWER FOR DIAGNOSTIC MODE (SOLID HALO)

1

ELECTRODE THAT HAS BEEN ENABLED FOR ABLATION BY OPERATOR

1

ELECTRODE THAT HAS BEEN DISABLED BY OPERATOR

1

ELECTRODE THAT HAS BEEN DISABLED BY UNIT DUE TO A SAFETY LIMIT

ADVANCE TO REPORT SCREEN

0

NUMBER OF SUCCESSFULY COMPLETED ABLATIONS FOR RIGHT SIDE

0

THIS BUTTON CAN BE PRESSED TO CONFIGURE ALTERNATE SIDE OF BODY

SHOWING LEFT SIDE HAS BEEN SELECTED TO CONFIGURE FOR ABLATION

6

NUMBER OF SUCCESSFULY COMPLETED ABLATIONS FOR LEFT SIDE

Ablation Screen Icons

1

ELECTRODE IN-PROCESS OF ABLATING

ELECTRODE ERROR (PARAMETERS ALSO TURN RED)

1

ELECTRODE THAT HAS BEEN DISABLED BY UNIT DUE TO AN ERROR / POOR CONTACT

CONFIGURE NEXT ABLATION SET

1

ELECTRODE THAT HAS BEEN DISABLED BY OPERATOR

ADVANCE TO REPORT SCREEN

1

ELECTRODE THAT HAS SUCCESSFULLY BEEN ABLATED

SAVE ABLATION REPORT SUMMARY TO USB DRIVE (CURRENTLY DISABLED)

Ablation Screen Icons (continued)

0

NUMBER OF SUCCESSFULY COMPLETED ABLATIONS FOR RIGHT SIDE

#1 : 4

#1 : 4 #2 : 2 #3 : 2

SHOWING RIGHT LIST OF SETS / ELECTRODES SIDE IS CURRENTLY ACTIVATED FOR RIGHT SIDE. BEING ABLATED CIRCULAR ARROWS INDICATE THIS SET IS CURRENTLY IN PROCESS.

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8

LIST OF SETS / ELECTRODES COMPLETED FOR LEFT SIDE

NUMBER OF SUCCESSFULY COMPLETED ABLATIONS FOR LEFT SIDE

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State: Released Date: 2013.05.14 15:12 GMT

State: Released Date: 2013.05.14 15:12 GMT

Ablation Screen Icons (continued) “STATIC” ERROR CODE DISPLAY FOR ERROR CODES THAT SHOULD STAY VISIBLE UNTIL THE OPERATOR ACKNOWLEDGES AND CLOSES.

CONSULT IFU SYMBOL FOR EXPLANATION OF ERROR CODE

ERROR CODE

CLOSE OUT ERROR DISPLAY

TEMPORARY ERROR CODE DISPLAY - FADES AWAY AFTER 3 SECONDS.

2

SHOWING ERROR ON ELECTRODE #2

SHOWS ERROR WAS DUE TO IMPEDANCE

Report Screen (summary section): The following report summary screen and detail screen show total number of successful ablations that ran for the entire 60 seconds according to treatment side.

USER CAN SCROLL DOWN SCREEN EITHER BY FLICKING ANYWHERE IN LEFT WINDOW ON SCREEN, OR USING SLIDER ON SIDE.

GO BACK TO CONFIGURE ANOTHER ABLATION SET

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4

#1 : 4 #2 : 3

#1 : 3 #2 : 1

SAVE PATIENT PROCEDURE INFO TO USB DRIVE

SHOWING TOTAL NUMBER OF SUCCESSFUL ABLATIONS, AS WELL AS HISTORICAL DATA FOR BOTH SIDES.

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ARROWS SHOW USER CAN SCROLL DOWN SCREEN

Report Screen (detail section) The Report detail shows time, average temperature, impedance, and power in addition to monitoring conditions which have caused electrodes to be automatically deactivated.

LABEL FOR EACH TABLE IN TOP LEFT CORNER: KIDNEY SHOWS SIDE OF BODY (LEFT), FOLLOWED BY ABLATION SET NUMBER (#1) AND NUMBER OF ELECTRODES THAT WERE SUCCESSFULLY ABLATED FOR 60 SECONDS ( :3)

#1:4 1 2 3 4 #2:3 1 2 3 4

W 0:60s 0:60s 0:60s 0:60s

68°C 68°C 68°C 68°C

250 Ω 247 Ω 260 Ω 239 Ω

4.9 W 5.2 W 5.1 W 4.8 W

W 0:60s 0:49s 0:60s 0:60s

68°C 68°C 60°C 68°C

261 Ω 4.8 W 8.1WW 248 Ω 8.1 257 Ω 5.1 W 240 Ω 5.0 W

#1:3 1 2 3 4

W 0:60s 0:12s 0:60s 0:60s

70°C 250 Ω 61°C 401Ω 401 Ω 68°C 260 Ω 68°C 239 Ω

#2:1 1 0:60s 70°C 2 0:20s 76°C 3 X X 4 X X

5.0 W 1.0 W 5.1 W 4.8 W

W 250 Ω 5.0 W 243 Ω 4.7 W X X X X

ELECTRODE WAS TURNED OFF BY OPERATOR BEFORE BEGINNING SET (SHOWN WITH RED “X”s)

RED BOX HIGHLIGHTS REASON FOR ERROR RED ELECTRODE SYMBOL SHOWS ERROR OCCURRED

ToUCHSCREEnS anD DEFiniTionS The RF generator navigates between operating states using a series of touchscreens. The RF generator touchscreens are described below: ToUCHSCREEn naME

ToUCHSCREEn DiSplay

ToUCHSCREEn DESCRipTion

Startup/Splash Screen

This screen appears on startup of the RF generator

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State: Released Date: 2013.05.14 15:12 GMT

State: Released Date: 2013.05.14 15:12 GMT

TOUCHSCREEN NAME

TOUCHSCREEN DISPLAY

TOUCHSCREEN DESCRIPTION

Patient Configuration

This screen is used for Patient ID# entry. Enter patient ID# and press the arrow button to advance. SETTINGS screens can be accessed via icon at bottom right.

Orientation Configuration

This screen is used for selecting the side of the body that will be treated. Select side of body by pressing the right or left arrow.

Basket Configuration and Baseline Parameters

This screen is used for configuring the basket by selecting (turn on)/deselecting (turn off) electrodes. Select/Deselect electrodes by pressing each electrode. During Electrode Selection State there are no RF generator outputs. Electrode Selection State allows the user to monitor baseline temperatures for each electrode and select and deselect electrodes in preparation for the ablation procedure. See the “Preparation for the Ablation Procedure” section of this manual for instructions on activating/deactivating individual electrodes.

Diagnostic

The Diagnostic screen shows data for each of the electrodes. Electrodes can be selected/ deselected from this screen by pressing each electrode. During Diagnostic State, the RF generator applies 0.5 watts to each electrode to indicate the electrodes have adequate apposition before starting the ablation procedure. The RF generator will display the temperature, impedance, and power measurements of each active electrode during Diagnostic State.

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TOUCHSCREEN NAME

TOUCHSCREEN DISPLAY

TOUCHSCREEN DESCRIPTION

Ablation/Run Procedure (View 1 of 2)

The Ablation/Run Procedure screen displays active electrodes with data for each electrode and ablation countdown timer. Electrodes can be disabled/turned off during procedure by pressing each electrode.

Ablation Set Complete

The Ablation Set Complete screen shows check marks in each electrode icon for each successful lesion. The countdown timer shows 00 seconds and then the Configure Next Ablation Set and Report Summary icons display.

Ablation/Run Procedure (View 2 of 2)

This version of the Ablation/Run Procedure screen shows 2 active electrodes and 2 disabled electrodes. RF energy is delivered in the Ablation State. In Ablation State, the RF generator delivers power to all activated electrodes, displaying power level, temperature, and impedance measurements for each active electrode. The ablation summary data is displayed at the bottom of the touchscreen during and after ablations. The first number displayed indicates the basket set. The second number indicates the number of activated electrodes.

Report Summary (View 1 of 2)

Report Summary screen shows successful ablation sets and number of successful lesions for each. Report Summary State is entered by selecting the Report Summary icon

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TOUCHSCREEN NAME

TOUCHSCREEN DISPLAY

TOUCHSCREEN DESCRIPTION

Report Summary (View 2 of 2)

(Cont’d) This screen can be scrolled using the vertical slide bar on the right or by swiping a finger on the screen.

Main Settings

The Main Settings screen allows user to adjust brightness.

Brightness Settings

The Brightness Setting screen allows user to adjust the screen brightness using the horizontal slider.

Error (View 1 of 2)

The Error screens display errors during a procedure and play a sound to alert the user. This screen shows an error with the impedance. If an error occurs, it will be displayed at the bottom of the touchscreen. See Error and Information Displays/Screens section for description of errors and error messages.

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TOUCHSCREEN NAME

TOUCHSCREEN DISPLAY

TOUCHSCREEN DESCRIPTION

Error (View 2 of 2)

GUI Sounds

The Error screens display errors during a procedure and play a sound to alert the user. This screen shows error code 24 and directs the user to refer to the IFU for further information.

Various sounds are emitted by the RF generator during the ablation procedure.

The sounds include: Ablation set complete – sound plays when an ablation set is completed Ablation set start - sound plays when ablation is started by pressing the ablation start/stop button on the EnligHTN™ unit (hard button) Ablation set stop - sound plays when ablation is started by pressing the ablation start/stop button on the EnligHTN™ unit (hard button) Alert sound – plays whenever an error occurs that requires user attention Button click – sound plays whenever a button is pressed in the GUI Connection lost – sound plays whenever a cable is disconnected (i.e. patient return electrode cable) Connection made - sound plays whenever a cable is connected (i.e. patient return electrode cable) Boot up / splash screen - sound plays when the RF generator is booted up

Preparation for the Ablation Procedure 1. The RF generator is supplied with a pole clamp and table stand. The pole clamp is used to mount the RF generator to a mounting pole measuring 15mm to 30mm in diameter. When mounting the RF generator to a mounting pole, loosen the clamp, position the RF generator on the mounting pole, and securely tighten the clamp. The RF generator must not be mounted higher than 58.75” to the bottom of generator and 70.5” to the top of the generator. The table stand is used to stand the RF generator upright on any flat stable surface of suitable size. Ensure the table stand is fully extended before placing the RF generator on a table. Caution: Ensure the mounting pole or surface is stable to reduce the risk of tipping. When using a mounting pole, SJM recommends EnligHTN™ Generator Mounting Pole model POLE-02. Do not attach any other items to the mounting pole. Remove generator from mounting pole when transporting generator. 2. Position the RF generator so that the front panel is easily accessible. WARNING: RF generator connections and setup must be performed by trained personnel. 3. The sterile drape can be used with the RF generator to provide a sterile barrier for the RF generator touch screen. The sterile drape should be placed such that the RF generator touch screen is covered. Caution: Ensure the RF generator rear vents are not covered by the sterile drape. 4. Prepare the patient for the ablation procedure using standard procedures for electrosurgery, including appropriate placement of the patient return electrode(s). Warning: If using only one patient return electrode, ensure the unused patient return electrode port cover is closed. Warning: The patient’s entire body must be insulated from contact with grounded metal parts. Warning: Do not apply the patient return electrode where fluid may pool. 5. Connect the patient return electrode to the Patient Return Electrode port on the front panel of the RF generator. Support the RF generator with one hand while gently pushing the patient return electrode fittings straight in until the patient return electrode connector is firmly in place. If needed, two patient return electrodes may be used. 6. Connect the power cord to an AC electrical wall outlet designed for “Hospital Grade” or “Hospital Only.” Warning: To avoid the risk of electric shock, this equipment must be connected to an AC power supply with an earth ground. 7. Turn the RF generator ON by pressing the rocker switch, located on the side panel, to the”I” position. When the RF generator is powered ON the Splashscreen displays. After the Splashscreen briefly displays, the RF generator automatically displays the Patient ID screen. 13

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Warning: Ensure the cable adapter, connector cable, and ablation catheter are at room temperature before use to ensure accurate temperature measurement. 8. Connect the connector cable to the cable adapter. Connect the cable adapter to the RF generator. Connect the ablation catheter to the connector cable. 9. Trained personnel must verify that there are no ablation catheter errors.

Touchscreen OPERATION FOR Ablation Procedure 1. Enter Patient ID

1. Enter the patient ID at the Patient ID screen using the displayed keypad. 2. Press the Selection button on the Patient ID screen.

3. Access the renal artery and position the ablation catheter using standard interventional technique. Refer to the EnligHTN™ Renal Artery Ablation Catheter Instructions for Use for procedure details.

2. Select Patient Treatment Side

1. At the Treatment Selection screen, select the side on which the ablation will be performed by using the Selection Arrow. Note: A check mark will confirm the selection. 2. The Diagnostic Screen displays

3. Perform Diagnostic Test

1. Reference baseline temperatures and perform a diagnostic test by pressing the Diagnostic Mode Selection icon.

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