RF 3000 Product In Service Sept 2014

Contents

• Product Overview

• Device Preparation • RF3000 Generator: Operation • Product Offering : Matrix Overview

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Product Overview RFA Soft Tissue Ablation

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Simple & Predictable thermal ablation

LeVeen electrode are to designed to provide Spherical ablation and Good fixation into the tissue Self-balancing tines with 1-cm spacing enable optimal energy conduction and creation of an progressive and homogenous coagulative necrosis

Development

Progression

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Expansion

Completion

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Broad LeVeenTM Probes Portfolio Array Diameters 2.0-5.0cm

Shaft Lengths 12, 15, 25cm

Printed cm Length Markings

LeVeen™ SuperSlim™ Electrode 17G* shaft**

*17G=1,149mm

** SuperSlim Shaft and handle profile designed to improve puncturability and decrease movements during procedure Boston Scientific ConfidentialCorporation -- For Internal Use Do Not Copy, Distribute Externally © Boston Scientific or Only. its affiliates. AllDisplay rightsorreserved 5 2014

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Broad LeVeenTM Probes Portfolio LeVeen™ CoAccess™ Needle Electrode

Soloist™ Needle Electrode

LeVeen CoAccess Needle must be used with CoAccess Introducer

• • •

Pre-Procedural mapping ablation zone of large or complex lesions Cannula may be used as procedural and biopsy access port Fit into CT Gantry

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Designed for improved puncturability • Small diameter ablation • Lesions close to vital structures PI- AA 268001 SEPTEMBER 2014

Product Overview: Generator

RF 3000™ Generator • Constant Voltage • Frequency: 460 kHz (no muscular contraction) • Power set up (Max 200 watts) • Visual & audible monitoring of Impedance (Roll-Off) • Time display

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Impedance As a Procedural Endpoint • Application of electrical current results in tissue heating above 50⁰C • Cellular destruction impacts tissue’s ability to conduct current => tissue’s resistance to conduct electrical current = Impedance • A rise in impedance can be used to indicate the completion of a thermal ablation

The RF3000™ Generator Monitors and Displays Impedance Levels Real-time

Measurement of total target tissue destruction Constant Voltage System

™

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Displays Illuminates Impedance Levels Throughout The Procedure

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Device Preparation RFA Soft Tissue Ablation

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Grounding Pads Placement

RF 3000 is a monopolar system, therefore patients must be grounded Boston Scientific ConfidentialCorporation -- For Internal Use Do Not Copy, Distribute Externally © 2014 Boston Scientific or Only. its affiliates. AllDisplay rightsorreserved 10

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Return Pads: Selection & Placement Pad Placement Proper Orientation & Pad Alignment Place the return pads on each leg and align them parallel on the lateral and median part of the thights. The return pads must not ovelap, nor be in contact. Check that they duction properly.

There is a potential for superheating if the return electrodes are placed over an implanted metal prostheses. Return electrodes should not be placed over superficial metal implants. Improper Orientation & Misalignment

Boston Scientific recommends the use of Megadyne™ 0850C Disposable Electrosurgical Patient Return Electrodes (Pads) Boston Scientific ConfidentialCorporation -- For Internal Use Do Not Copy, Distribute Externally © 2014 Boston Scientific or Only. its affiliates. AllDisplay rightsorreserved 11

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Pacemakers and ICD’s

For patients with permanent pacemaker and Implantable Cardiac Defibrillators (ICD) additional precautions should be taken. These precautions include, but are not limited to: o Checking with manufacturer of the pacemaker and the patient’s cardiologist regarding functioning of the pacemaker during Radiofrequency Ablation (RFA). o Ensuring that the current path from the RFA site to the disposable patient return electrodes does not pass through the vicinity of the patient’s heart, the implanted pacemaker or the Implantable Cardiac Defibrillator (ICD). o Keeping all RFA cords and cables away from patient’s pacemaker and leads. o Continuous evaluation of the patient’s cardiac rhythm and pacemaker function. o Having a magnet available and a pacemaker programmer present. o Having an external pacemaker available and ready to be activated in the event of prolonged inhibition of the permanent pacemaker.

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RF3000™ Generator Operation RFA Soft Tissue Ablation

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P4

P3

P2

P1

RF 3000 Generator overview

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RF 3000 Generator overview

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Generator: Operation

Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Time Display – In Ready mode, displays the time duration for which RF energy will be applied, as entered by the operator. In Operating mode, displays the total elapsed time. Default time is 15:00.

Power Display – During Operating mode, displays the power output. The unit operates as a constant voltage source during Operating mode, so output power will vary as load impedance changes. During Ready mode, this display is blank. Boston Scientific ConfidentialCorporation -- For Internal Use Do Not Copy, Distribute Externally © 2014 Boston Scientific or Only. its affiliates. AllDisplay rightsorreserved 16

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Generator: Operation Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Impedance Display – In Operating mode, this display shows both the currently measured impedance and a 10element display of the value relative to the initially measured impedance. During Ready mode, this display is blank.

Active Indicator– Illuminates during Operating mode indicating active RF output (2W or more of RF power). When this indicator is on, measured power and elapsed time are also displayed

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Product Offering RFA Soft Tissue Ablation

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LeVeen

LeVeen

CoAccess™ SuperSlim™ Electrode Electrode

LeVeen™ Needle Electrodes

Product Offering: Matrix Overview

Soloist™

UPN

Order Num.

Array Dia. (cm)

Cannula Length (cm)

M001262160

26-216

5.0

15

M001262170

26-217

5.0

25

M001262130 M001262310

26-213 26-231

4.0 4.0

15 25

M001262020 M001262030

26-202 26-303

3.5 3.5

12 15

M001262150

26-215

3.5

25

M001262040

26-204

3.0

12

M001262050

26-205

3.0

15

M001262290

26-229

3.0

25

M001262280

26-228

3.0

15

M001262270

26-227

2.0

25

M001262260 M001262220

26-226 26-222

2.0 3.0

15 15

M001262230 M001262240

26-223 26-224

3.5 4.0

15 15

M001262250 M001262500 M001262200

26-225 26-250 26-220

CoAccess Introducer 0.9 18 Generator

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LeVeen Needle Electrode

LeVeen CoAccess™ Electrode System

RF 3000 Generator

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All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations." Boston Scientific ConfidentialCorporation -- For Internal Use Do Not Copy, Distribute Externally © 2014 Boston Scientific or Only. its affiliates. AllDisplay rightsorreserved 20

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