Integra Padgett S Guide De L'utilisateur page 7

Warnings (continued)
To reduce the risk of electrical shock DO NOT remove power supply cover. Do not
disassemble the power supply. Refer maintenance and servicing to the Integra Padgett
Dermatome Repair Center.
The movement of the blade generates heat which may cause a heat related injury to
the patient. Maintain forward movement while the dermatome is in contact with the
patient.
Do not allow the dermatome to operate and be in contact with the patient for a period
exceeding 30 seconds. If multiple grafts are to be taken allow a cool down period of not
less than 5 minutes between grafts.
Do not reuse blades. Blades are designed as single-use, disposable products and should
not be re-sterilized. Re-sterilization and subsequent reuse will dull the blades and may
result in cross-contamination or impaired function of the product. Sharpness of the
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blades is not guaranteed with repeated use. Any blade, once used, should be discarded
according to hospital policy.
Use ONLY with Integra Padgett Dermatome Blades of the correct size. Use only Integra
Padgett part number 3539252 with the Model S dermatome. Use only Integra Padgett
part number 3539602 with the Model S6 dermatome.
It is the sole responsibility of the end-user to validate alternate sterilization methods
and cycles that do not comply with the validated sterilization methods and cycles
specified within this manual. Failure to comply with the validated sterilization methods
may result in ineffective sterilization and damage to the device.
The dermatome is supplied non-sterile and must be sterilized prior to use. Validated
sterilization cycles are provided in the Sterilization section. The dermatome blades
have been sterilized with a minimum dose of 2.5 Mrads (25 kGy) of gamma irradiation,
sterility assurance level of 10 . Prior to use, inspect the blade packaging for damage
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which may compromise sterility. If damaged, or in any way compromised, the
dermatome blade must be assumed to be non-sterile and must not be used.
Do not modify this electromechanical equipment in any manner. The dermatome
system contains no user-serviceable components. Unauthorized modifications,
including the use of replacement components or products servicing not provided by an
authorized Integra Padgett Dermatome Repair Center (IPDRC) can result in serious injury
to patient and/or operator.
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