Integra Padgett S Guide De L'utilisateur page 20

Integra Padgett
®
Electric Slimline Dermatome Models S and S6
Sterilization (Continued)
Sterrad Sterilization: Dermatome to be processed on STERRAD® 100S unit (short cycle) which
consists of the following steps:
Vacuum
1st Injection Stage
1st Diffusion Stage
1st Gas Plasma Stage
2nd Injection Stage
2nd Diffusion Stage
2nd Gas Plasma Stage
Vent
Total cycle time = ~55 minutes
Note: It is the responsibility of the manufacturer and maintainer of the sterilization equipment
to ensure no chemicals or contaminated waste leak into the environment. Follow facility
guidelines during sterilization.
Environmental Responsibility
Environmental Compliance:
The Integra Padgett Dermatome system, including the hand piece, power supply, disposable
blades and accessories, has been designed and manufactured with the goal to minimize
environmental impact throughout the device life cycle in accordance with the following
standards:
- IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety
and Essential Performance.
- IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Basic
Safety and Essential Performance: Electromagnetic Compatibility.
- Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in
Electrical and Electronic Equipment (RoHS II).
The Dermatomes are constructed of non-hazardous, recyclable materials and/or materials that
are compliant with the safety, performance and hazardous materials standards listed above.
Device servicing and maintenance should be performed by an approved Integra Padgett
Dermatome Repair Center (IPDRC) in accordance with the Maintenance and Servicing section
of this manual.
End of Life Management:
The Dermatome devices have been deemed environmentally non-hazardous and require no
special handling and/or treatment during setup, assembly/disassembly and during normal use,
and are safe for disposal in landfills. At end of life, device recycling and/or disposal should be
performed in compliance with your facility disposal protocol. Waste treatment facilities vary
by locality. Contact your local waste treatment facility as necessary for proper policies and
procedures regarding device disposal in accordance with your facility disposal protocol.
19
®