Integra Padgett B, Руководство пользователя

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Integra
®
Padgett
®
Electric Dermatome Models B and PI
Atmospheric pressure limitation. The atmospheric pressure values in hPa
units are shown adjacent to the symbol. (Ref. ISO 7000-2621)
Humidity limitation. The relative humidity values are shown adjacent to
the symbol. (Ref. ISO 7000-2620)
Electrical Fuse. Fuse designation per IEC 60127 is shown adjacent to the
symbol (Ref. IEC 60417-5016)
Warnings
Explosion Hazard: Do not use in the presence of oxygen, nitrous oxide, or other
flammable anesthetics.
These instruments are intended only for professional use in hospitals, physical therapy
locations, and similar medical facilities where the patient will be under the supervision of
trained personnel.
To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
To reduce the risk of electric shock, do not remove cover. Refer maintenance and
servicing to the Integra Padgett Dermatome Repair Center.
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
blades is not guaranteed with repeated use. Any blade, once used, should be discarded
according to hospital policy.
Use only Integra Padgett Dermatome Blades of the correct size. Use only Integra Padgett
part number 3539252 with the Model B dermatome. Use only Integra Padgett part
number 3539602 with the Model PI 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
-6 . Prior to use inspect the blade packaging for damage which may
compromise sterility. If damaged, or in any way compromised, the dermatome blade must
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