Stryker 0700010000, Руководство пользователя

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Cleaning, Disinfecting, and Sterilizing the Camera Head
These reprocessing instructions are provided in accordance with
ISO 17664, ISO 17665, AAMI TIR12, AAMI ST79, and AAMI ST81. The
instructions have been validated by Stryker as being capable of preparing
the device for re-use. To achieve the desired result, the processor shall
ensure that the following instructions are performed as written in their
entirety and as appropriate in the processor’s facility. This normally
requires routine monitoring and validation of the facility’s reprocessing
procedures. Stryker recommends users observe these standards when
reprocessing medical devices.
Overview
Reprocessing the camera head involves manual or automated cleaning
with two different detergents, optional disinfection, and sterilization.
• Step 1
(required): Cleaning with Enzymatic Detergent
• Step 2
(required): Cleaning with Non-Enzymatic Detergent
• Step 3
(optional): Disinfection
• Step 4
(required): Sterilization
Warnings
• This device must be cleaned and sterilized prior to the first use and
after every subsequent use.
• Separate the camera head, coupler, and scope prior to cleaning,
disinfection, or sterilization. Failure to follow this instruction will
render the devices non-sterile. (Refer to the coupler and scope product
manuals for reprocessing instructions for those devices.)
• Wear appropriate protective equipment: gloves, eye protection, etc.
• To avoid health risks from aerosol contamination, brush the device only
when it is submerged in liquid.
• Use only the sterilization cycles outlined in this document. Using
unspecified sterilization cycles may damage the device or result in
incomplete sterilization.
• Only camera heads marked AUTOCLAVE can withstand steam
sterilization. Autoclaving camera heads that do not bear this marking
will result in non-sterile product and permanent device damage. Refer
to the “Product Description and Intended Use” section for the location
of the AUTOCLAVE marking on the Precision AC Camera.