©2018 Medtronic. All Rights Reserved. 02/2018 – US170997 – [WF#1960968]
VALLEYLAB™ FX8
ENERGY PLATFORM
REFERENCES
SPEED
TissueFect™ Sensing Technology
Our smart TissueFect™ technology monitors changes in tissue impedance 434,000 times a second,2 compared to 3,333 times a second on the ForceTriad™ energy platform. And it adjusts energy output accordingly to deliver the appropriate amount of energy for the desired tissue effect.2
REFERENCES
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2. Based in internal report #RE00126471_A, VLFX8GEN Control System Resolution. November 2017.
3. Based on internal memo #R00027952, monopolar and bipolar power control data. October 2015.
4. Based on internal report #RE00058763 Rev A, Verification of monopolar thermal effect for Valleylab™ FX8 generator. June 2017
5. Based on internal report #RE00105221, Comparison testing of the Valleylab™ FT10 and ForceTriad™ generators. The Valleylab™ FT10 energy platform has identical power curves and equivalent power delivery for shared modes to the Valleylab™ FX8 energy platform. July 2017.
6. Based on internal test report #RE00035369, Verification of Captain Hook (LF5637/LF5644) devices: monopolar thermal effect evaluation - 04/2016.
7. Based on internal report #RE0068753, A Quantitative Comparison to Conventional Monopolar Electrosurgery, L-Hook Monopolar Drag Force Measurements. March 2017
8. Based on internal test report #RE00005401, Product validation of Valleylab™ FT10 energy platform surgeon and nurse evaluation in simulated use: 32 surgeons interviewed. January 27 to 30, 2015 and Feb. 24 to 27, 2015.
SPEED
VALLEYLAB™ FX8
ENERGY PLATFORM
TissueFect™ Sensing Technology
Our smart TissueFect™ technology monitors changes
in tissue impedance 434,000 times a second,2 compared to 3,333 times a second on the ForceTriad™ energy platform.
And it adjusts energy output accordingly to deliver the appropriate amount of energy
for the desired tissue effect.2
REFERENCES
1 Based on internal test report #RE00005503, Verification of the Valleylab™ FX8 generator in an acute hemostasis porcine study. January 2015.
2 Based on internal test report #RE00004823 Rev A, Verification – report – tag-on animal lab - LigaSure™ preclinical lymphatic sealing evaluation of the Valleylab™ FX8. March 2015.
3 Based on internal test report #R0064459 Rev B, Verification – report – LigaSure™ pulmonary bench pressure evaluation of the Valleylab™ FX8. March 2015.
4 Based on internal test report #R0064457 Rev A, Verification – report – LigaSure™ renal bench burst pressure evaluation of the Valleylab™ FX8. April 2015.
5 Based on internal test report #RE00005506, Verification of the Valleylab™ FX8 generator in a chronic hemostasis porcine study. February 2015.
6 Based on internal test report #R0064462 Rev B, Verification – report – LigaSure™ thermal profile Valleylab™ FX8. February 2015.
7 Based on internal test report #RE00025819 Rev A, LigaSure™ data sources for VLFX8 white papers: bench testing model used to evaluate sealing time. September 2015.
8 Based on the Valleylab™ FX8 service manual: part number 1079477. January 2015.
9 Based on internal test report #R0064457. Ex‐vivo Renal Burst Pressure report: "Verification ‐ Report ‐ LigaSure™ Renal Bench Burst Pressure Evaluation of the Valleylab™ FX8." May 3, 2015
10 Based on internal test report #RE00005503, Verification – report – GLP acute animal lab – LigaSure™ preclinical evaluation of Valleylab™ FX8. May 19, 2015.
11 Based on internal test report #RE00005401, Product validation of Valleylab™ FX8 surgeon and nurse evaluation in simulated use: 32 surgeons interviewed. January 27-30, 2015; Feb. 24-27, 2015.
12 Based on internal test report #R0064443 Rev A, Verification – report – ex vivo monopolar procedural flow evaluation on the Valleylab™ FX8 Orion. November 2014.
13 Based on internal test report #RE0064455, Autobipolar evaluation – Valleylab™ FX8. February 2015.
14 Based on the Valleylab™ FX8 User guide: part number 1073652. December 2014.
©2018 Medtronic. All Rights Reserved. 02/2018-US170997-[WF#1960968]
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