Applicable where phthalates are identified on the product label: Due to the presence of phthalates in the product, the clinician must weigh the medical benefits of product use against the drawbacks of phthalate exposure for male children and pregnant or nursing women.Reuse, reprocessing, or re-sterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
Do not reuse, reprocess, or re-sterilize this product. This device was designed for single patient use only.Release compressed CO2/medical air in a controlled fashion, by pointing the tip of device away from the wound or surgical site before turning the device on.The shunt, tether, and tag should remain intact.Use only PVC tubing to connect the airline to the device.Each surgeon must, of course, evaluate the appropriateness of the procedure based on their own medical training and experience, and the type of surgical procedure. The described procedure is furnished for information purposes only. Proper surgical procedures are necessarily the responsibility of the medical profession.Use caution when moving the tip of the device closer than 3 cm (1.18 in) to the surgical site.Do not exceed inlet pressure of 60 psi (414 kPa).Do not use where the effects of an air stream or irrigation mist are contraindicated.This device is not intended for use except as indicated above.This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means to improve visibility at the site.
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