megadyne™ smoke evacuation portfolio · 2020. 12. 9. · 14. ethicon, eng-rpt-704 filter physical...

Megadyne™

Value analysis summary MEGADYNE™ Smoke Evacuation Portfolio

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MEGADYNE™ Smoke Evacuation Portfolio

Executive overviewThe MEGADYNE™ Smoke Evacuation Portfolio delivers all-around flexibility by providing multiple smoke evacuation pencils and a versatile smoke evacuator. 1

MEGADYNE™ MINI VAC™ Smoke Evacuator

The MEGADYNE™ MINI VAC™ Smoke Evacuator is designed with an ultra-quiet, high-suction, high-flow-rate vacuum motor.4

MEGADYNE™ Telescoping Smoke Evacuation Pencil

The adjustable length of the MEGADYNE™ Telescoping Smoke Evacuation Pencil helps position the smoke evacuation tip closer to the surgical site, which may provide more efficient smoke evacuation.2-4*

MEGADYNE™ ZIP PEN™ Smoke Evacuation Pencil

The ZIP PEN™ has three ergonomic grip positions to provide surgeons with choice, flexibility and comfort all in one device.7

MEGADYNE™ Smoke Evacuator

MEGADYNE™ Smoke Evacuator is designed to have effective and quiet performance for open and laparoscopic procedures.1,5,6**

*May provide more efficient smoke evacuation by capturing smoke at the source. **Efficiently captures and filters 99.999% of particulates and microorganisms of 0.1 to 0.2 microns and performs quiet at 50 +/- 10 dBa per IEC 60601-1 at 1 m, with [59.2 dBA in open mode] [and/or] [51.9 dBA in lap mode] at 1 m

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Hydrogen cyanide34,35

Dead and live cellular material, including blood fragments and

viruses 8-10

Carbon monoxide34,35

Formaldehyde34,35

Benzene34,35

Acrylonitrile34,35

Irritant, carcinogenic

and neurotoxic compounds11,12


What’s in electrosurgery smoke?

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The effects of surgical smoke on health and visibility

Potential health risks of surgical smoke How smoke impacts visibility

CDC*: “Exposure to surgical smoke can cause both acute and chronic health effects ranging from eye,

nose and throat irritation to emphysema, asthma or chronic bronchitis" 13*

Surgical site without smoke

Surgical site with smoke

*Centers for Disease Control and Prevention

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MEGADYNE™ Smoke Evacuator

Designed to be intuitive and simple to use16

Enables automatic activation with electrosurgical generators that deliver monopolar, bipolar, ultrasonic, and advanced bipolar energy16

Filter is designed to capture particulate and microorganisms of 0.1-0.2 microns at 99.999% efficiency16

Connect cable

Automatically detects energy device activation to trigger smoke evacuation

Manual start/stop button

Push button to start or stop smoke evacuation

RF sensor

Automatically detects monopolar device activation to trigger smoke evacuation

Flexible

• Allows users to adjust run time

• Supports continuous smoke evacuation under Manual Mode16

3 ways to activate

Comprehensive

• Has an adjustable flow rate to accommodate insufflation air flow to maintain peritoneum pressure in laparoscopic procedures16

*Efficiently captures and filters 99.999% of particulates and microorganisms of 0.1 to 0.2 microns and performs quiet at 50 +/- 10 dBa per IEC 60601-1 at 1 m, with [59.2 dBA in open mode] [and/or] [51.9 dBA in lap mode] at 1 m

MEGADYNE™ Smoke Evacuator is designed to have effective and quiet

performance for open and laparoscopic procedures.14-16*

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MEGADYNE™ MINI VAC™ Smoke Evacuator

User-friendly design

• The electronic controls on the face panel have been designed to be user-friendly and facilitate setup and operation*

• Filter Life Indicator provides a clear signal of the status of the life of the filter in use (filters have up to 35 hours of life*)

Efficient

• The MEGADYNE™ Smoke Evacuator filter is designed to capture particulates and micro-organisms of 0.1-0.2 microns at 99.999% efficiency17

• The MEGADYNE™ RF Sensor allows smoke removal to automatically turn on and off with the smoke evacuation pencil*

Quiet

• Is designed with an ultra-quiet, high-suction, high flow-rate vacuum motor.17

MEGADYNE™ Micro Safe Filter

MEGADYNE™ EZ Link RF Sensor

Footswitch (included with evacuator)

*As Per Instructions For Use

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MEGADYNE™ Telescoping Smoke Evacuation Pencil

Has a telescoping shaft for access to deep surgical pockets 18-20

Has full 360 degree swivel designed for maximum procedural flexibility18,21,22

Visibility

• The adjustable length of the Megadyne™ Telescoping Smoke Evacuation Pencil helps position the smoke evacuation tip closer to the surgical site, which may provide more efficient smoke evacuation.18,23,24*

Surgeon comfort

• Cord in tubing may enhance comfort and ease of use25

• Features tactile buttons for high user feedback.18,26

Efficiency

• The adjustable shaft of the Megadyne™ Telescoping Smoke Evacuation Pencil minimizes the need to exchange electrodes of varying lengths.25

• E-Z Clean electrodes with PTFE produce 68% less smoke compared to uncoated stainless steel blades.27**

Secure telescoping shaft length at any position from fully extended to fully retracted

Fully compatible with more than 16 different smoke evacuators from 12 manufacturers28 # ¥

*May provide more efficient smoke evacuation by capturing smoke at the source.

**In a preclinical porcine model at 60W vs. uncoated stainless steel blades at 60W (p

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MEGADYNE™ ZIP PEN™ Smoke Evacuation Pencil

Surgeon comfort

• The ZIP PEN™ has three ergonomic grip positions to provide surgeons with choice, flexibility and comfort all in one device31

The clear suction sleeve of the ZIP PEN™ encapsulates the electrode for more efficient smoke capture and should not inhibit surgical site visibility30

The ZIP PEN™ has large activation buttons that were designed for ease of use.29

Efficiency

• E-Z Clean electrodes with PTFE produce 68% less smoke compared to uncoated stainless steel blades.32**

“Traditional” grip method

Tubing can be kept in the full upright position (as shown) to emulate a traditional pencil

“Trigger” grip method

The ZIP PEN™ eliminates 100% of the torque off the back end of the pencil for improved surgeon ergonomics33#

“Over the hand” grip method

This grip reduces torque by draping the tubing over the surgeon’s thumb or back of the hand

3 ergonomic, non-slip grip positions

*Comparing a 15 foot ZIP PEN™ against UltraVac™ 2110-10 using four different smoke evacuator boxes

**In a preclinical porcine model at 60W vs. uncoated stainless steel blades at 60W (p

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Product codesMEGADYNE™ Smoke Evacuation Pencils and Shrouds

Description Catalog number Quantity

MEGADYNE™ Telescoping Smoke Evacuation Pencil, 10-Foot (3m) Tubing 251010J 20/box

MEGADYNE™ Telescoping Smoke Evacuation Pencil, 15-Foot (4.5m) Tubing 251015J 20/box

MEGADYNE™ ZIP PEN™ Smoke Evacuation Pencil, 10-Foot 3m Tubing 252510 20/box

MEGADYNE™ ZIP PEN™ Smoke Evacuation Pencil, 10-Foot 3m Tubing with 22mm Connector 252510EC 20/box

MEGADYNE™ Attacha Vac Smoke Evacuation Shroud 212009J 25/box

MEGADYNE™ Attacha Vac Smoke Evacuation Shroud with 22mm Connector 212009EC 25/box

MEGADYNE™ Smoke Evacuators and Accessories

Description Catalog number Quantity

MEGADYNE™ Smoke Evacuator MESE1 1 EA

MEGADYNE™ Filter 2550J 1/box

MEGADYNE™ Fluid Trap 2555J 10/box

MEGADYNE™ RF Sensor 2255J 1 EA

MEGADYNE™ Connect Cable, 1m 2403J 1 EA

MEGADYNE™ Connect Cable, 2.1m 2406J 1 EA

MEGADYNE™ Laparoscopic Tubing 2390J 25/box

MEGADYNE™ Speculum Tubing 2395J 25/box MEGADYNE™ MINI VAC™ Smoke Evacuator, 210V ECVV220 1 EA

EZ Link RF Sensor for MINI VAC™ Smoke Evacuator MGEZLINK01 1 EA MEGADYNE™ Micro Safe Filter 1 pk MGVS353 1 EA

MEGADYNE™ Micro Safe Filter 2 pk MGVS35302 2/box Fluid Trap for MINI VAC™ Smoke Evacuator MGVSFT10 10/box

Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

Ethicon Endo-Surgery (Europe) GmbH

Hummelsbütteler Steindamm 7122851 Norderstedt, Germany

www.jnjmedicaldevices.com

© Ethicon Endo-Surgery (Europe) GmbH 2020, 152280-200908 EMEA

References: 1. As Per Instructions For Use (133887-200303, 131252-200127, 131119-200124) 2. Ethicon, 14012019, Design Claims Memo for Telescoping Pencils, Dec 2019, Data on File (131500-200727)

3. Ethicon, 6020195-01, Sub-Assy, Megadyne Telescoping Smoke Evacuation Pencil, 10 foot, Dec 2019, Data on File (131500-200727)


5. Ethicon, ENG-RPT-704 Filter Physical characteristics comparison with predicate device filter, Oct 2019, Data on File ((131252-200127)

6. Ethicon, ENG-RPT-753, MESE1 competitive sound test report, Feb 2020, Data on File (131252-200127)

7. (131695-200204)

8. OSHA: Surgical Suite – Common Safety and Health Topics (E932) (119490-200214)

9. CDC NIH: Control of Smoke from Laser/Electric Surgical Procedures (E933) (119490-200214)

10. NIOSH: Control of Smoke from Laser/Electric Surgical Procedures (E934) (119490-200214)

11. Al Sahaf, Chemical composition of smoke produced by high-frequency electrosurgery Ir J Med Sci; 2007;176;229 (121417-190822)

12. Gates. Operating room nursing and lung cancer risk in a cohort of female registered nurses, J Work Environ Health;2007;33(2);140-147 (121417-190822)

13. NIOSH Study Finds Healthcare Workers’ Exposure to Surgical Smoke Still Common. Nov 3, 2015 available at https://www.cdc.gov/niosh/updates/upd-11-03-15.html [accessed 19.02.2020] (132927-200819)

14. Ethicon, ENG-RPT-704 Filter Physical characteristics comparison with predicate device filter, Oct 2019, Data on File (131252-200127)

15. Ethicon, ENG-RPT-753, MESE1 competitive sound test report, Feb 2020, Data on File (131252-200127)

16. As Per Instructions For Use (131252-200127, 131337-200128, 131317-200128, 131256-200127, 131392-200129, 131334-200128)

17. As Per Instructions For Use (131337-200128, 131119-200124)

18. Ethicon, 14012019, Design Claims Memo for Telescoping Pencils, Jan 2019, Data on File (131625-200203, 131496-200721, 131500-200727, 131758-200205)

19. Ethicon, 6010145-01, Nozzle/Collet Assy, Megadyne Telescoping Pencil, Sept 2019, Data on File (131625-200203)

20. Ethicon, 5800138-01, Lock Nut, Extension, Megadyne Telescoping Pencil, Sept 2019, Data on File (131625-200203)

21. Ethicon, 5800134-01, Straight Swivel, Female, Ultra Vac 2, Nov 2016, Data on File (131496-200721)

22. Ethicon, 5800141-01, Swivel Insert, Male, Megadyne Telescoping Smoke Evacuation Pencil, Nov 2019, Data on File (131496-200721)



25. As Per Instructions For Use (131437-200721, 131621-200721)

26. Ethicon, X4010343, Dome Switch, 6mm, Aug 2019, Data on File (131758-200205)

27. Kisch et al, Electrocautery Devices With Feedback Mode and Teflon- Coated Blades Create Less Surgical Smoke for a Quality Improvement in the Operating Theater Medicine;2015;94;e1104 (125295-200205)

28. Ethicon, ENG-RPT-710 Universal Smoke Connector Compatibility Summary Report, March 2020, Data on File (144286-200622)

29. Ethicon, ENG-RPT-418, Zip Pen Product Specification Verification Test Report, Feb 2018, Data on File (131696-200204)

30. Ethicon, ENG-RPT-403, Zip Pen Flow Evaluation Test Report, Dec 2014, Data on File (138067-200423)

31. (131695-200204)

32. Kisch et al, Electrocautery Devices With Feedback Mode and Teflon-Coated Blades Create Less Surgical Smoke for a Quality Improvement in the Operating Theater Medicine;2015;94;e1104 (125295-200205)

33. Ethicon, ZIP PEN™ Instructions for Use, Data on File (123063-190912)

34. Pierce JS, Lacey SE, Lippert JF, Lopez R, Franke JE, Laser-generated air contaminants from medical laser applications: a state-of-thescience review of exposure characterization, health effects, and control;2011;8;447;446

35. Barrett WL, Garber SM, Surgical smoke:a review of the literature,Surg Endosc:2003:17:979-98

megadyne™ smoke evacuation portfolio · 2020. 12. 9. · 14. ethicon, eng-rpt-704 filter physical...

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