Potential Complications - Integra Revize Bedienungsanleitung

Potential Complications

General risks may include, but are not limited to: infection, allergic reactions, pain, swelling or bruising,
foreign body reactions, acute or chronic inflammatory reactions, adhesions, seromas, and hematomas�
The patient should be made aware of these risks and others associated with general surgery and the
use of anesthesia�
Instructions for Use
Note:
• Revize-X collagen matrix is designed to expand to approximately twice its initial area�
• Consider the mechanical properties and load environment when deciding the appropriate
configuration of the device�
• Revize-X collagen matrix is more conformable but has less mechanical strength, compared to
Revize collagen matrix�
• For more information, refer to the Revize collagen matrix Application Guide for breast
reconstruction�
Application
• Inspect packaging and discard the device if packaging is previously damaged or opened�
• Rinse surgical gloves, if necessary, to remove any glove powder prior to touching the device�
• Peel open the outer foil package and aseptically deliver inner, sterile package to sterile field�
• Remove the device from package using sterile, atraumatic forceps or gloved hand�
• Submerge the device in sterile, room temperature, 0�9% saline to ensure that it is completely
hydrated (typically about 1-3 minutes)� Hydration is indicated by a color change from white (dry) to
gray (wet)�
• To facilitate hydration, pressure can be applied with gloved fingers across the surface of the device
until it has a uniform gray, wet appearance�
• Revize-X collagen matrix expands at a 2:1 ratio when hydrated with 0�9% saline� After hydration,
manually pull both length and width three times; the size of the expanded device will be
approximately twice the initial area� See Figure 1�
• While dry, or following soaking in sterile, room temperature, 0�9% saline, cut the device to the
size and shape needed�
• Keep the device immersed in sterile, room temperature, 0�9% saline until ready for use�
• For best results, place the hydrated device in close approximation with host tissue�
• The device should be fixed in place using standard suturing techniques encompassing both graft
and host tissue� Adequate overlap of device to healthy host tissue is recommended�
• Discard any unused pieces of the device�
Safety
The device is manufactured from bovine skin� The source material is processed and solely derived from
cattle in compliance with United States and European regulatory requirements�
Storage
• Store at room temperature: 15 - 30°C (59 - 86°F)�
• Keep away from excessive heat and direct sunlight�
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