Evaluation: IC Medical Crystal Vision 450D Portable Surgical Smoke Evacuator
December 11, 2020 | Evaluations & Guidance
Preview
- 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: a) Console: A 7.7 kg (17 lb) device that allows the surgical team to select between open and laparoscopic modes. The modes have adjustable flow level and suction time settings, accessible via two numerical digital displays controlled by up and down arrows; a third numerical display provides the "flow reading," which is an estimated flow level that the device is delivering. Upon start-up, the system will default to laparoscopic mode, with the last flow and time settings used; additionally, the unit will evacuate at these flow and time settings once, immediately upon start-up. Users also have the option to manually activate suction. The console offers an alarm that sounds in the event of occlusion, overpressurization, and no patient/tubing connected, and another alarm if the filter requires replacement. The occlusion alarm 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:
- Open mode. Flow setting: 40 to 90 L/min, adjustable in 1 L/min increments
- Laparoscopic mode. Flow setting: 4 to 18 L/min, adjustable in 1 L/min increments
- Extended time: The unit can be set to run an additional 2 to 30 seconds after handpiece activation has ceased. The user selects the extended time under the digital "Time Setting" display.
- Noise level of 56.2 ±1.5 dBA at maximum suction, as measured by ECRI . When the device is in standby mode, it outputs a noise level of approximately 45.0 dBA.
- Available top stacking surface area: 31.8 × 35.6 cm (12.5 × 14.0 in), as measured by ECRI. The top surface is actually larger than the provided measurement, but its usable area is limited by the device's protruding "filter release" button.
- Available modes: