Physio Control 805355, Cleaning And Sterilization Manual

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Physio-Control internal handles and electrodes are capable of withstanding the following sterilization methods and cycles.
* When used with either monophasic or biphasic defibrillators.
** When used only with biphasic defibrillators.
Prevacuum Steam Sterilization (Wrapped in two layers of KIMGUARD
®
KC600 or equivalent
polypropylene wrap)
Physio-Control has tested and approved the internal defibrillation handles and electrodes listed above using the following
prevacuum steam sterilization settings:
STERRAD
®
100S Hydrogen Peroxide Gas Plasma Sterilization
Physio-Control has tested and approved the internal defibrillation handles and electrodes listed above for peroxide gas plasma
sterilization (STERRAD 100S System), in two layers of KIMGUARD KC600 or equivalent polypropylene wrap.
General Precautions
• These sterilization parameters are valid only with equipment properly maintained and calibrated.
• Sterilization cycle times and efficacy vary depending on equipment, wrapping, and load configuration.
The instructions provided above have been validated by the medical device manufacturer as being CAPABLE of preparing a
medical device for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed
using equipment, materials and personnel in the processing facility achieve the desired result. This requires validation and
routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly
evaluated for the effectiveness and potential adverse consequences.
Sterilization Method LIFEPAK 12/ LIFEPAK 20
Internal Handles
PN 3010901
LIFEPAK 9
Internal Handles
PN 805249
Internal Electrodes
PN 805355
Prevacuum Steam (wrapped) 25 cycles 25 cycles 10 cycles**
Prevacuum Steam (wrapped) 25 cycles 25 cycles 1 cycle*
STERRAD 100S (wrapped) 100 cycles 100 cycles 1 cycle**
Prevacuum (Wrapped)
Sterilization Temperature 132 °-135°C (270°-275°F)
Preconditioning Pulses 4 pulses
Prevacuum 254 mmHg (10.0 inHg) minimum
Sterilization Exposure Time 4 minutes
Dry Time Up to 30 minutes
Physio-Control, Inc.
11811 Willows Road NE
Post Office Box 97006
Redmond, WA 98073-9706 USA
Telephone: 425.867.4000
Toll Free (USA only): 800.442.1142
Fax: 425.867.4121
Internet: www.physiocontrol.com
PHYSIO-CONTROL and LIFEPAK are registered trademarks of Physio-Control, Inc. STERRAD is a registered trademark of Advanced Sterilization Products. KIMGUARD is a registered trademark of Kimberly-Clark
Corporation. Enzol is a registered trademark of Advanced Sterilization Products. Specifications subject to change without notice. Printed in USA.
© 2010 Physio-Control, Inc.
01/2010
MIN 3011886-009