BZ4212

Indications, Safety, and WarningsIndicationsThe BiZact™ device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

The tissue fusion of the device can be used on vessels (arteries and veins) and lymphatics up to and including 3 mm diameter.

It is also indicated for adult, children, and adolescent ENT procedures (3 years of age and above), including tonsillectomy, for the ligation and division of vessels, tissue bundles, and lymphatics 2–3 mm away from unintended thermally sensitive structures.

The BiZact™ device has not been shown to be effective for tubal sterilization procedures. Do not use for these procedures.

Warnings

This product cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse, and is therefore intended for single-use

This instrument is intended for use only with Covidien equipment.

Cautions

Do not use the BiZact™ system unless properly tranined to use it in the specific procedure being undertaken.

Use the system with caution in the presence of internal or external pacemaker or other implanted devices.

See the insturctions for use (IFU) for full list of warnings and cautions.

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