Evaluation: ConMed/Buffalo Filter VisiClear Portable Surgical Smoke Evacuator

August 21, 2019 | Evaluations & Guidance


  • This device is used to capture and filter surgical smoke during open and laparoscopic surgical procedures in which there is thermal destruction of tissue or bone.
  • Major device components and software features:

    • Console: A 7.7 kg (17 lb) device with touchscreen display that allows the surgical team to select between three procedure-based modes, as well as to adjust flow rate, manually activate suction via a rotating fan icon, and assess filter status either as a countdown clock or as a percentage of remaining life. The console also offers an optional occlusion alarm that will suspend suction when an obstruction is detected and intermittently attempt to resume the set level of suction until the obstruction has been cleared.
      • Available modes, each with adjustable suction control from 10% to 100% at 10% increments:
        • Open mode, represented as an open tubing icon on the home screen i) Filter life: 18 hours ii) Default suction level: 80% iii) Occlusion alarm available? Yes
        • Electrosurgical/diathermy mode, represented as an electrosurgical unit (ESU) pencil and plug icon on the home screen i) Filter life: 21 hours ii) Default suction level: 80% iii) Occlusion alarm available? Yes
        • Laparoscopic mode, represented as a trocar icon on the home screen i) Filter life: 35 hours ii) Default suction level: 10% iii) Occlusion alarm available? No
      • Extended time: The unit can be set to run up to an additional 10 seconds after electrosurgical handpiece activation has ceased. The user selects the extended time from the touchscreen settings menu.
      • Noise level of 54.2 ±1.2 dBA at maximum suction, as measured by ECRI Institute. When the device is in standby mode, it does not contribute any additional sound to the ambient room noise.
      • Available top stacking surface area: 32.4 × 37.8 cm (12.8 × 14.9 in), as measured by ECRI Institute.
    • ViroSafe VisiClear Filter: An ultra-low-penetration air (ULPA) filter with integrated charcoal filter. The VisiClear instructions for use (IFU) list the filter as having 99.999% efficiency for particles of 0.1 to 0.2 micrometers.
      • The filter weighs approximately 1.25 kg (2.75 lb) and has dimensions of 16.5 × 13.4 × 27.9 cm (6.5 × 5.25 × 11 in).
      • The estimated remaining filter life is automatically adjusted based on the selected mode.
      • The system will warn the surgical team when the maximum filter life for the selected mode has been reached. Six hours of extended operational time following the warning are built into the filter, which can allow the surgical team to continue normal operation, if necessary. Once the warning is given, the system will not function without filter replacement after powering down or at the end of the six hours.
      • There are three ports on the filter for tubing connections of 22, 10, and 6 mm (7/8, 3/8, and 1/4 in) diameter. When not in use, the ports have a SafePort cover that slides over their outlets to prevent the loss of suction or contamination of fluids that may have been introduced into the filter during the course of a procedure.
    • EZLink Automatic Activation Device: A radio-frequency sensing device that can be affixed to the ESU generator, and that, when the ESU pencil wire is clipped into it, will automatically begin suction whenever the pencil electrode is activated. The EZLink gives the user the option to extend the evacuation duration after activation has ceased up to 10 seconds beyond the console setting.
    • Electrosurgical pencils. See the table below for a description of the features available on the two Buffalo Filter pencils we evaluated. Surgeon preference and procedure type may dictate pencil selection—for example, whether or not a telescoping nozzle will be required to access a hard-to-reach surgical site. Note that ConMed/Buffalo Filter has other electrosurgical pencils available for purchase, but ECRI Institute did not assess them as part of this Evaluation, as the two we evaluated were presented as the most commonly used from the manufacturer.

    Features of ConMed/Buffalo Filter ESU Pencils​ ​ ​Feature PlumePen Elite PlumePen Pro Weight, g (lb) 252.6 (0.56) 144.1 (0.32) Holster included? Yes Yes Circumference of widest grip, mm (in) 50 (2.0) 45 (1.8) Telescoping nozzle? Yes—85 mm (3.3 in) with 30° slant for visual access of site; manual positioning required (does not move with blade) No Telescope lock? No—different blade electrode required for telescoped position Not applicable Cord management: wire encapsulated in tubing? Yes, for 91 cm (3 ft) Yes, for 152 cm (5 ft) Swivel at tubing connection? Yes Yes Hinge at tubing connection? No No 130° bend? Yes Yes Push button or rocker switch? Push button Push button Fluid ingress protection around buttons? Yes Yes Grip Rubber Textured plastic Blade centered within or seated below nozzle? Below Centered Smooth tubing beyond wire exit? Yes No Standard or proprietary tubing connection? Standard, removable to allow threaded connection to other proprietary...

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