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Sterilization Instructions (Alternate/CE)
Sterilization Instructions (Alternate/CE)
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 method:
•
Prevacuum Steam (active, dynamic air-removal with saturated steam according to ISO
17665)
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
sterilization. Do not use any other sterilization method.
Caution
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 (Alternate/CE)
Use the following parameters for prevacuum steam sterilization (active, dynamic air-removal with
saturated steam according to ISO 17665-1).
Temperature:
Exposure Time:
Preconditioning
Pulses:
Prevacuum:
Steam (quality):
Wrapping:
Drying Time:
*For CE mark countries in the European Union, sterilization should be performed at 134°C
(273°F). Prevacuum steam sterilization is validated up to an exposure time of 18 minutes and a
temperature of 137°C (279°F), if mandated by local requirements. To avoid product damage, do
not exceed these values.
**Sterilization wraps must be cleared for the prevacuum steam sterilization by the FDA or
approved by equivalent regulatory authority for your country per ISO 11607-1.
28
132° to 137°C (270° to 279°F)*
4 to 18 minutes*
Minimum of 3
340 mBar (254 mmHg)
Use purified water, highly purified water, or sterile water with less than
10 cfu/ml and 0.25 EU/ml
Individually wrapped in two layers of 1-ply polypropylene wrap (Halyard
Health H600) using sequential envelop techniques.**
Minimum of 55 minutes
Sterilizable Internal Defibrillation Paddles Instructions for Use
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