Sterilization Instructions (Us/Fda) - Physio Control 11131-000040 Instrucciones De Uso

Sterilization Instructions (US/FDA)

Sterilization Instructions (US/FDA)
Follow the instructions in this document. Any deviation by the processor from the instructions
provided should be evaluated for effectiveness and potential adverse consequences.
The internal defibrillation paddles may be sterilized using the following sterilization methods:
•
Prevacuum Steam
• Hydrogen Peroxide Vapor
Sterilization containers must be large enough to accommodate the size of the internal paddles
and cable. The diameter of the coiled cable should be at least 15 cm (6 in).
Ensure the electrodes are positioned so that water cannot pool in the spoons during the
sterilization cycle.
The useful life of internal defibrillation paddles is affected by the number of sterilization cycles
rather than by the age of the paddles. The number of sterilization cycles should be tracked as
described in Sterilization Tracking (on page 28).
Warning
Possible Ineffective Sterilization. These internal paddles may be sterilized using Prevacuum Steam
or Hydrogen Peroxide Vapor sterilization methods. Do not use any other sterilization method.
Cautions
• Possible Damage to Internal Paddles. Use only one of the recommended sterilization
methods for the life of each internal paddles set. Using more than one sterilization method may
invalidate the product certifications.
• Possible Damage to Internal Paddles. Coil the cable loosely away from the internal paddles for
sterilization. Damage or ineffective sterilization may occur if the cable has tight bends or is
wrapped around the handles. The diameter of the coiled cable should be at least 15 cm (6 in).
Prevacuum Steam Sterilization (US/FDA)
Use the following parameters for prevacuum steam sterilization.
Temperature and Exposure
Time:
Preconditioning Pulses:
Prevacuum:
Wrapping:
Drying Time:
Note: After sterilization is complete, inspect the packaging for signs of moisture on or within the
packaging. Moisture on or within sterile packaging may signify a compromised sterile barrier
and/or sterilization process failure. If moisture is observed on or within a sterile pack, repackage
and re-sterilize with a longer dry time.
*Sterilization wraps must be cleared for the prevacuum steam sterilization by the FDA or
approved by equivalent regulatory authority for your country.
24
132°C (270°F) for 4 minutes
Minimum of 3
340 mBar (254 mmHg)
Individually wrapped in two layers of 1-ply polypropylene wrap
(Halyard Health H600) using sequential envelop techniques.*
Minimum of 55 minutes (see note below).
Sterilizable Internal Defibrillation Paddles Instructions for Use