5
Warnings
Danger:
Explosion hazard.
DO NOT
use in the presence of oxygen, nitrous
oxide, or other flammable anesthetics.
This equipment is intended only for professional use in hospital, physical
therapy locations, and similar medical facilities where the patient will be under
the supervision of trained personnel.
To reduce the risk of electrical shock
DO NOT
remove power supply cover. 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.
The Model SB
DOES NOT
have an automatic turn off feature. This product may
cause injury to the user if not operated in accordance with this manual. Handle
the Model SB with care.
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
with Integra Padgett Dermatome Blade part number 3539-252.
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 be assumed to be non-
sterile and must not be used.
