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Reprocessing
These reprocessing instructions are provided in
accordance with ISO 17664. While they have been
validated by the manufacturer of the medical device
as being capable of preparing the device for re-use,
it remains the responsibility of the processor to
ensure that the reprocessing as actually performed,
using equipment, materials, and personnel in the
reprocessing facility, achieves the desired result.
This normally requires validation and routine
monitoring of the process.
Warnings
• This device must be cleaned and sterilized prior
to the first use and after every subsequent use.
• Use only the sterilization cycles outlined in this
document. Using unspecified sterilization cycles
may damage the device or result in incomplete
sterilization.
• Wear appropriate protective equipment: gloves,
eye protection, etc.
Cautions
• Sterilize the device only when necessary, since
sterilization accelerates normal product aging.
• Do not use brushes or pads with metal
or abrasive tips during manual cleaning,
as permanent scoring or damage could result.
• Use a non-oil cleaner or mild soap.
• DO NOT use synthetic detergents or oil-based
soaps. These soaps may be absorbed by the
device and leach out causing a tissue reaction.
• The device is not autoclavable. Do not autoclave
the device or damage will result.
• Flash sterilization is not a preferred method.
Repeated Flash sterilization may break down
the device insulation, compromising the overall
safety and performance of the device. If time
permits, use a wrapped sterilization method
instead.
• Inspect the device before soaking for cuts and
breaks. Replace if any cuts or breaks are found.
• Separate the extension cable and camera head
cable prior to disinfection. Always install the
soaking caps prior to disinfection to protect
the connector pins.
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