- Is this product registered and approved by the Food and Drug Administration (FDA)?
Yes to both questions. It is approved as a 510 (k) product and classified as a Class II sterile device.
- How do I apply the miniSQUAIR®?
Complete the surgical prep and dry. If you use a surgical barrier drape, apply that next; if not, then remove the white “release paper” and apply the miniSQUAIR® to the skin (or drape). Pass the end of the tubing to the circulating nurse for attachment to the ULPA filter or directly to the suction source. Complete the sterile field with towels and/or drapes as per protocol.
- Can I use retractors as needed?
Yes, everything from simple springs and rakes to heavy “ring” retractors can be used. As long as there is exposed cell foam, the product will continue to capture smoke.
- Can I use wall suction for the miniSQUAIR® as I do for the ESU?
No. Wall suction will not provide the volume of air flow needed to effectively capture the smoke which is 25-35 cfm.
- Can small biopsy specimens or sponges be sucked into the miniSQUAIR®?
No. The reticulated foam, because of the small “cell” size, will not allow unwanted removal of tissue or sponges. In fact, particulates such as hair, dust or fabric debris from masks or caps will be trapped by the cell foam core of the miniSQUAIR®.
- Can moistened lap sponges interfere with removal of the plume?
Yes, but it is best to avoid covering the edge of the open cell foam. The smoke will not pass through wet towels if used to cover the edges of an incision.
- What if body fluids or saline irrigation gets sucked up by the miniSQUAIR®? Will the fluids prevent bioaerosol capture?
No. The miniSQUAIR® is non-porous to fluids as well as to smoke, so both will be carried to the source of suction. To prevent damage to the in-line filter(s) by the fluid, attach the hose to dual non-collapsible canisters or to a fluid-bioaerosol management system. If canisters are needed, you will also need an additional length of 25 mm I.D. tubing to connect the second canister to a surgical suction; wall suction will not provide enough air flow. During wound irrigation, shut off the suction to prevent filter damage. Some fluid will accumulate in the tubing.
- Why use the wider 1 1/4” tubing instead of the standard 7/8” tubing?
The tubing we have provided for use allows greater air flow than the standard tubing. The enhanced flow is one of the reasons why the miniSQUAIR® does a superior job of smoke capture while also increasing the efficiency of your surgical suction.
- Is the miniSQUAIR® “fireproof?”
No, but it has been specially treated with fire retardant to earn a UL94RH-1 rating. This means that should it be set on fire, the device will self-extinguish.
- Why was it constructed with a cell foam core?
The core allows no significant resistance to air flow while providing an excellent pathway for the removal of surgical plume, bone dust and chemical odors without eduction of tissue biopsies.
- What if I have additional questions? With whom and how can I contact a person knowledgeable about the product?
Nascent Surgical is happy to put you in touch with an experienced clinician. Please call 952-345-1112 or e-mail email@example.com. We will promptly respond to your inquiry.