Radiofrequency Ablation Needle Electrodes. Procedural Algorithms and Lesion Geometry
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1 Radiofrequency Ablation Needle Electrodes Procedural Algorithms and Lesion Geometry
2 Radiofrequency Ablation Needle Electrodes O R D E R I N G I N F O R M A T I O N Array Cannula UPN Order Number Diameter Length (cm) LeVeen Needle Electrodes M M M M M M M M M M M LeVeen SuperSlim Needle Electrodes M M M M LeVeen CoAccess Needle Electrode System M M M Soloist Single Needle Electrode Active Electrode Length (cm) M RCS Nanterre B Boston Scientific Corporation or its affiliates. All rights reserved. DINONC2008ED/PSST IC 1727RevB
3 Soloist Single Needle Electrode Treatment Algorithm Check needle position to verify if still in target tissue. Introduce Soloist device into tissue with or without CoAccess Cannula 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 min. Refer to Target Power table for recommended minimum setting during Ramp Up period. Treatment Target Power Time Point During Ramp Up (min:sec) (Watts) 0:00 2 1:00 3 2:00 4 3:00 5 4:00 6 5:00 7 6:00 8 7:00 9 8: : : : : : : :00 17 Stop treatment. Total time of treatment; 0-4 minutes Time to indication > 4-15 minutes Stop and wait approx seconds. Phase 2: Restart in place at approx. 70% of highest set power (i.e. 10W = 7W). If 5 minute mark reached, increase power by 1 Watt every minute Continue treatment until indication indication Auto stop after 15 minutes Relocate 0.5 cm. Restart at 70% of highest set power. Increase 1W per minute Indication Power 70% (Watts) Watts Treatment Complete The RF energy should be applied until a rise in impedance and corresponding drop in delivered power ( Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result. NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. t a diagnostic or treatment referral tool.
4 Soloist Single Needle Electrode Lesion Geometry * mm cm 4.0 3mm 5.0 1cm *These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types. RCS Nanterre B Boston Scientific Corporation or its affiliates. All rights reserved. DINONC2008ED/PSST IC 1727RevB
5 2.0cm Treatment Algorithm Deploy 2.0cm (20mm) LeVeen Electrode Indication Power 70% Start treatment: Set Radiofrequency (RF) power to 30W. Increase 10W per minute to 60W, maintain until 5 minutes and restart power at 50% of 5 minutes? Maintain 60W of power After 5 minutes increase power 10W per minute to 60W and maintain and restart power at 70% of 15 minutes? Immediately restart at 60W Continue treatment until Indication Treatment Complete The RF energy should be applied until a rise in impedance and corresponding drop in delivered power ( Indication) is achieved.this condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result. NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. t a diagnostic or treatment referral tool.
6 Lesion Geometry * mm cm 1.5cm cm *These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types. RCS Nanterre B Boston Scientific Corporation or its affiliates. All rights reserved. DINONC2008ED/PSST IC 1727RevB
7 3.0cm Treatment Algorithm Deploy 3.0cm (30mm) LeVeen Electrode Indication Power 70% Start treatment: Set Radiofrequency (RF) power to 40W. Increase 10W per 30 seconds to 80W, maintain until 5 minutes and restart power at 50% of 5 minutes? Increase 10W per 30 seconds to 150W After 5 minutes increase power 10W per 30 seconds to 150W and maintain and restart power at 70% of 15 minutes? Immediately restart at 150W Continue treatment until Indication Treatment Complete The RF energy should be applied until a rise in impedance and corresponding drop in delivered power ( Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result. NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. t a diagnostic or treatment referral tool.
8 Lesion Geometry * mm cm 2.5cm cm *These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types. RCS Nanterre B Boston Scientific Corporation or its affiliates. All rights reserved. DINONC2008ED/PSST IC 1727RevB
9 3.5cm Treatment Algorithm Deploy 3.5cm (35mm) LeVeen Electrode Indication Power 70% Start treatment: Set Radiofrequency (RF) power to 50W. Increase 10W per 30 seconds to 90W, maintain until 5 minutes and restart power at 50% of 5 minutes? Increase power 10W per 30 seconds to 180W After 5 minutes increase power 10W per 30 seconds to 180W and maintain and restart power at 70% of 15 minutes? Immediately restart at 180W Continue treatment until Indication Treatment Complete The RF energy should be applied until a rise in impedance and corresponding drop in delivered power ( Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result. NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. t a diagnostic or treatment referral tool.
10 Lesion Geometry * mm cm 3.0cm cm *These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types. RCS Nanterre B Boston Scientific Corporation or its affiliates. All rights reserved. DINONC2008ED/PSST IC 1727RevB
11 4.0cm Treatment Algorithm Deploy 4.0cm (40mm) LeVeen Electrode Indication Power 70% Start treatment: Set Radiofrequency (RF) power to 80W. Increase 10W per 30 seconds to 130W, maintain until 5 minutes and restart power at 50% of 5 minutes? Increase power 10W per 30 seconds to 190W After 5 minutes increase power 10W per 30 seconds to 190W and maintain and restart power at 70% of 15 minutes? Immediately restart at 190W Continue treatment until Indication Treatment Complete The RF energy should be applied until a rise in impedance and corresponding drop in delivered power ( Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result. NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. t a diagnostic or treatment referral tool.
12 Lesion Geometry * mm cm 3.3cm cm *These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types. RCS Nanterre B Boston Scientific Corporation or its affiliates. All rights reserved. DINONC2008ED/PSST IC 1727RevB
13 5.0cm Treatment Algorithm Preset the time on the RF 3000 Generator to 20 minutes Indication Power 70% Fully deploy the 5.0cm (50mm) array Start treatment: Set Radiofrequency (RF) power to 100W. Increase 10W per 30 seconds to 150W, maintain until 5 minutes and restart power at 50% of 5 minutes? Increase power 10W per 30 seconds to 200W After 5 minutes increase power 10W per 30 seconds to 200W and maintain and restart power at 70% of Impedance rise before 15 minutes? Retract array to marking on handle, reinsert blue retention clip, and reset generator power to 130W Hold until a 5 ohm increase occurs. Fully deploy array. After 30 seconds, increase power 10W per 30 seconds to 200W. 20 minutes? Immediately restart at 200W Continue treatment until Indication Treatment Complete The RF energy should be applied until a rise in impedance and corresponding drop in delivered power ( Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result. NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. t a diagnostic or treatment referral tool.
14 Lesion Geometry * cm cm 3.0cm cm *These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types. RCS Nanterre B Boston Scientific Corporation or its affiliates. All rights reserved. DINONC2008ED/PSST IC 1727RevB
15 WARNING The 2 arrows to the left (shown in blue on this illustration) measure the distance between the base of the umbrella and the top of the tines. top of tines base of umbrella
16 European Distribution Centre - The Netherlands T: F: European Headquarters - Paris T: F: Argentina (Freephone) T: F: Australia/New Zealand T: F: Austria T: F: Belgium (Freephone) T: F: Brazil T: F: Canada T: F: Chile T: F: China Beijing T: F: China Guangzhou T: F: China Shanghai T: F: Colombia T: F: Czech Republic T: F: Denmark (Freephone) T: F: Eire (Freephone) T: F: Finland T: F: France T: F: Germany (Freephone) T: F: Greece T: F: Hong Kong T: F: Hungary T: F: India Bangalore T: /9 F: India Chennai T: F: India Delhi T: F: India Mumbai T: F: Italy T: F: Korea T: F: Mexico T: F: Middle East /Gulf/rth Africa T: F: The Netherlands T: F: rway (Freephone) T: F: Poland T: F: Portugal T: F: South Africa T: F: South East Asia Malaysia T: F: South East Asia Philippines T: F: South East Asia Singapore T: F: South East Asia Thailand T: F: South East Europe T: F: Spain - Barcelona T: F: Spain - Madrid T: F: Sweden T: F: Switzerland T: F: Taiwan T: F: Turkey Istanbul T: F: UK (Freephone) T: F: Uruguay T: F: Venezuela T: F: Content and illustrations are provided for information purposes only - not indicative of actual clinical outcome. Treatments are under the sole responsiblity of practicing physican. 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 labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. PSST IC 1727RevB Printed in France by creativeservices. RCS Nanterre B Boston Scientific Corporation or its affiliates. All rights reserved. DINONC2008ED
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