43
2. Visually inspect the external surface of the device for cleanliness, focusing
on hard-to-reach areas. If visible soil remains, repeat cleaning and
disinfection until all visible soil is removed.
1
Cleaning and disinfection were validated using PDI® Super Sani-Cloth® Germicidal Disposable Wipes.
Cleaning, Disinfecting, and Sterilizing the Camera Head
These reprocessing instructions are provided in accordance with
ISO 17664, ISO 15883, AAMI TIR12, and AAMI TIR30. 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 device involves manual or automated cleaning with
either an enzymatic or a non-enzymatic detergent, optional disinfection,
and sterilization.
•
Step 1
(required): Cleaning with Enzymatic or Non-Enzymatic
Detergent
•
Step 2
(optional): Disinfection
•
Step 3
(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 (when used with 1688210105 and
1688710105 only), and endoscope prior to cleaning, disinfection, or
sterilization. Failure to follow this instruction will render the devices
non-sterile. (Refer to the coupler and endoscope 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.
•
The sterilization parameters presented in this document apply only
when the device is sterilized outside of a sterilization tray. When using a
Summary of Contents for 1688 Series
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