FDA Requirements for Pneumatic Tourniquets | 合法醫療器材資訊網

2018年1月3日—AreyouusingapneumatictourniquetcuffthatmeetsFDArequirementsasaClassImedicaldevice?...Figure1:Pneumatictourniquetsystem ...

A pneumatic tourniquet is a medical device consisting of a pressure-regulating unit which can be operated manually or automatically, connecting tubing, and an inflatable cuff. Pneumatic tourniquets are intended to reduce or totally occlude circulation to a patient’s limb to enable a licensed healthcare practitioner to perform a therapeutic function. Note that this definition covers pneumatic tourniquets intended to restrict blood flow to a limb, as well as pneumatic tourniquets intended to completely occlude or stop blood flow to the limb.

For patient safety, the design of inflatable tourniquet cuffs is fundamentally different than the design of other cuffs such as blood pressure cuffs. The special design of tourniquet cuffs allows a user to safely and accurately apply a desired pressure level and...