Contraindications; Warnings And Precautions - Integra Revize Bedienungsanleitung

For use outside the USA only
Revize / Revize
™
Collagen Matrix for Soft Tissue Reconstruction
Description
Revize / Revize -X collagen matrix is an acellular dermal tissue matrix derived from bovine dermis� The
™ ™
device is available in solid (Revize) and meshed (Revize-X) configurations, and is supplied sterile in various
sizes� The meshed device is designed to expand at a 2:1 ratio when hydrated with 0�9% saline�
Indications
Revize / Revize-X collagen matrix is intended for implantation to reinforce soft tissue where weakness
exists and for surgical repair of damaged or ruptured soft tissue membranes� Revize / Revize-X collagen
matrix is specifically indicated for plastic and reconstructive surgery, including breast reconstruction�

Contraindications

• Revize / Revize-X collagen matrix should not be used for patients with a known history of
hypersensitivity to collagen or bovine products�

Warnings and Precautions

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare
practitioner�
• Excessive heat can damage collagen� Do not hydrate in 0�9% saline warmed above room
temperature� If, when hydrated, the product shrinks in size, DO NOT use the device�
• The device should be used with caution in regions where infection exists or is suspected� Treat
any existing infection appropriately� If used in contaminated or infected wounds, collagen- based
implants can weaken or break down�
• The device is for single patient use only�
• Do not use the device if the foil seal is broken�
• Discard all opened and unused portion(s) of the device�
• Do not resterilize the device�
• The device has not been evaluated for use in pregnant women�
• The patient's medical condition may adversely impact healing of the deficient tissue� These
conditions may include, but are not limited to: obesity, smoking, diabetes, insufficient blood supply
at the implant site, and exposure of the implant site to radiotherapy and chemotherapy�
• Do not use the device past the expiration date�
• Do not mesh or fenestrate the Revize-X collagen matrix�
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