3
Reprocessing
ese 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.
is normally requires validation and routine
monitoring of the process.
Warnings
• isdevicemustbecleanedandsterilizedprior
to the rst use and aer every subsequent use.
• Useonlythesterilizationcyclesoutlinedinthis
document. Using unspecied sterilization cycles
may damage the device or result in incomplete
sterilization.
• Wearappropriateprotectiveequipment:gloves,
eye protection, etc.
Cautions
• Sterilizethedeviceonlywhennecessary,since
sterilization accelerates normal product aging.
• Donotusebrushesorpadswithmetal
orabrasive tips during manual cleaning,
aspermanent scoring or damage could result.
• Useanon-oilcleanerormildsoap.
• DONOTusesyntheticdetergentsoroil-based
soaps. ese soaps may be absorbed by the
device and leach out causing a tissue reaction.
• edeviceisnotautoclavable.Donotautoclave
the device or damage will result.
• Flashsterilizationisnotapreferredmethod.
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.
• Inspectthedevicebeforesoakingforcutsand
breaks. Replace if any cuts or breaks are found.
• Separatetheextensioncableandcamerahead
cable prior to disinfection. Always install the
soaking caps prior to disinfection to protect
theconnector pins.