RF 3000 Algorithm Card Feb 2014

Treatment Time Point (min:sec)

Target Power during Ramp ™Up (Watts)

Soloist

Single Soloist™ Needle Electrode Single Needle Electrode 2 0:00 1:00 3 2:00 4 Target 3:00 5 Treatment Power during Time4:00 Point 6 Ramp Up (min:sec) 5:00 7 (Watts) 6:00 8 0:00 2 7:00 9 1:00 3 8:00 2:00 4 10 3:00 5 11 9:00 4:00 6 10:00 12 5:00 7 11:00 6:00 8 13 7:00 9 14 12:00 8:00 10 15 13:00 9:00 11 14:00 16 10:00 12 15:00 11:00 13 17

12:00 13:00 14:00 15:00

Roll-Off Indication Roll-Off Power Indication (Watts) Power

11 12

Start treatment, set RF power at 2W

At 1 minute mark, if power is under 3W, increase to 3W

At 2 minute mark, if power is under 4W, increase to 4W

Continue to increase power at 1W per minute. Refer to Target Power table for recommended minmum setting during Ramp Up period

14 15 16 17

Time to Roll-Off indication

70% Watts

70% Watts

(Watts)2 23 3 4 4 55 66 7 7 8 98 10 9 11 10 12

Introduce Soloist Needle into tissue with or without CoAccess™ Cannula

2 2 3 4 4 5 6 6 7 8 8

2 2 3 4 4 5 6 6 7 8 8

Relocated 0.5 cm and restart at 70% of highest set power Increase the 1W per minute

Continue Treatment until Roll-Off indication

Soloist and CoAccess are registered or unregistered trademarks of Boston Scientific Corporation or its affilaites. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

Soloist™ Single Needle Electrode (16.5ga) UPN

M001262500

Order Number

Active Electrode Length (cm)

Cannula Length (cm)

26-250

0.9

18.0

Soloist is a registered or unregistered trademak of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen Electrode ™ 2.0 cm

LeVeen Electrode 2.0 cm Roll-Off Indication Power 50 60

70% 35 42

LeVeen is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen™ SuperSlim™ Needle Electrode System UPN

Order Number

Array Diameter (cm)

Cannula Length (cm)

M001262270

26-227

2.0

25.0

M001262260

26-226

2.0

15.0

LeVeen and SuperSlim are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen Electrode™3.0 cm

LeVeen Electrode 3.0 cm Roll-Off Indication Power 50 60 70 80 90 100 110 120 130 140 150

70% 35 42 49 56 63 70 77 84 91 98 105

LeVeen is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen™ Standard Needle Electrode System UPN

Order Number

Array Diameter (cm)

Cannula Length (cm)

M001262040

26-204

3.0

12.0

M001262050

26-205

3.0

15.0

LeVeen SuperSlim™ Needle Electrode System UPN

Order Number

Array Diameter (cm)

Cannula Length (cm)

M001262290

26-229

3.0

25.0

M001262280

26-228

3.0

15.0

LeVeen CoAccess™ Needle Electrode System UPN

M001262220

Order Number

Array Diameter (cm)

Cannula Length (cm)

26-222

3.0

15.0

LeVeen, SuperSlim and CoAccess are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen Electrode 3.5 cm

LeVeen™ Electrode 3.5 cm Roll-Off Indication Power 50 60 70 80 90 100 110 120 130 140 150 160 170 180

70% 35 42 49 56 63 70 77 84 91 98 105 112 119 126

LeVeen is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen™ Standard Needle Electrode System UPN

Order Number

Array Diameter (cm)

Cannula Length (cm)

M001262020

26-202

3.5

12.0

M001262030

26-203

3.5

15.0

M001262150

26-215

3.5

25.0

LeVeen CoAccess™ Needle Electrode System UPN

M001262230

Order Number

Array Diameter (cm)

Cannula Length (cm)

26-223

3.5

15.0

LeVeen and CoAccess are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen Electrode ™ 4.0 cm

LeVeen Electrode 4.0 cm Roll-Off Indication Power 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190

70% 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133

LeVeen is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen™ Standard Needle Electrode System UPN

Order Number

Array Diameter (cm)

Cannula Length (cm)

M001262130

26-213

4.0

15.0

M001262310

26-231

4.0

25.0

LeVeen CoAccess™ Needle Electrode System UPN

M001262240

Order Number

Array Diameter (cm)

Cannula Length (cm)

26-224

4.0

15.0

LeVeen and CoAccess are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen Electrode 5.0 cm

LeVeen™ Electrode 5.0 cm Roll-Off Indication Power 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200

70% 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133 140

LeVeen is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

LeVeen™ Standard Needle Electrode System UPN

Order Number

Array Diameter (cm)

Cannula Length (cm)

M001262160

26-216

5.0

15.0

M001262170

26-217

5.0

25.0

LeVeen is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014

The LeVeen Needle Electrode Family Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Prior to use, please see the complete “Directions for Use” for more information on Indications, contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. Indications for Use: The LeVeen™, SuperSlim™, and Soloist™ Needle Electrode Families are intended to be used in conjunction with the RF 3000™ Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. Contraindications for Use: None Known Warning: Do not use in main biliary ducts, gallbladder or during pregnancy. Do not use in MR Suite. Use of the electrode without the colored insulated cannula may result in serious burns to the patient and./or user. Damage to the insulation of the introducer may result in serious burns to the patient and/or user. Precautions: The LeVeen, SuperSlim, and Soloist Needle Electrode Families must be used in conjunction with the Boston scientific RF 3000 Generator. Potential Complications: Potential complications include, but are not limited to: Abscess, ARDS, Ascites, Arterial Fibrillation, Biloma, Bowel Perforation, Burn, Death, Delayed hemorrhage into ablated tissue, Diarrhea, Electric Shock, Fistula including biliary fistual, Hematoma, Hemorrhage, Infection, Liver Failure, Liver Insufficiency, Pain, Peritonitis, Persistent Fever >39˚C, Pleural Effusion, Pneumothorax, Renal Failure, Tumor recurrence, Tumor Seeding, Ventricular Fibrillation. Prior to use, please consult device DFU for full indications, contraindications, warnings, precautions, adverse events and operating instructions. RF 3000, LeVeen, SuperSlim, CoAccess and Soloist are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates.

Peripheral Interventions One Boston Scientific Place Natick, MA 01760-1537 USA www.bostonscientific.com To order product or for more information contact customer service at 1.888.272.1001. © 2014 Boston Scientific Corporation or its affiliates. All rights reserved. PI-220603-AA FEB2014