Birmingham Hip Resurfacing - Literature Review

• Implant components are supplied sterile to a Sterility Assurance Level (SAL) of 10-6. Metal components are sterilized to a minimum of 25 kiloGrays of gamma irradiation. All components are supplied in protective packaging. Inspect packages for punctures or other damage prior to surgery.
   

• Instruments used to implant the device system are supplied non-sterile and must be sterilized prior to use using one of the following validated, recommended methods:
  * Prevacuum Flash Cycle: 4 pulses (Maximum = 26.0 psig (2.8 bars) & Minimum = 10.0 inHg (339  millibars)) with a minimum exposure time of 4 minutes at 270°F to 275°F (132°C to 135°C), followed by a 1 minute purge.
  * High Temperature Gravity Cycle: 270°F to 275°F (132°C to 135°C) with a minimum exposure time of 10 minutes, followed by a 1 minute purge and at least 15 minutes of vacuum drying.
  * Prevacuum Cycle: 4 pulses (Maximum = 26.0 psig (2.8 bars) & Minimum = 10.0 inHg (339 millibars)) with a minimum exposure time of 4 minutes at 270°F to 275°F (132°C to 135°C), followed by a 1 minute purge and at least 15 minutes of vacuum drying.
   

• DO NOT RESTERILIZE implant components. Contact your local Smith & Nephew, Inc. Sales Representative regarding procedures to return components.

The product is not labeled “pyrogen free”.

The BHR components are packaged in a TyvekTM vacuum peel pouch to maintain sterility. The product has a five (5) year sterile shelf-life.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
 

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2/4/2007

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