Algorithm Card
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Radiofrequency Ablation
Algorithm Cards
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