Depuy Synthes VIPER PRIME Gebrauchsanweisung Seite 22

Step 6: Maintenance and Inspection
Instruments should be visually inspected under ambient lighting, to verify that the devices do not
have visible soil, damage or moisture.
Inspect devices for:
• Lack of moisture. If moisture is detected, manually drying should be performed.
• Cleanliness. If any residual soil is discovered during inspection, repeat the cleaning steps on those
devices until all visible soil is removed from the device.
• Damage, including but not limited to, corrosion (rust, pitting), discoloration, excessive scratches,
flaking, cracks and wear
• Proper function, including but not limited to, sharpness of cutting tools, bending of flexible devices,
movement of hinges/joints/box locks and moveable features such as handles, ratcheting and
couplings and missing or removed part numbers
Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed
off) part numbers, damaged and worn devices should be discarded.
Disassembled devices should be reassembled prior to sterilization when specified.
Lubricate any moving parts with a water-soluble surgical instrument lubricant. The lubricant should
be approved for use on medical devices and provided with data to ensure biocompatibility and
compatibility with steam sterilization.
Step 7: Packaging
Place cleaned, dry devices into the specified locations within the cases provided, if applicable.
Only legally marketed, and locally approved sterilization barriers (e.g. wraps, pouches or containers)
should be used for packaging terminally sterilized devices, in compliance to the manufacturer's
instructions.
Step 8: Sterilization
Steam (moist heat) sterilization shall be performed in a locally approved, pre-vacuum (forced air
removal) cycle. The steam sterilizer should be validated to the requirements of any local standards
and guidance such as EN 285 or AAMI/ANSI ST8. The steam sterilizer should be installed and
maintained in compliance to manufacturer's instructions and local requirements. Ensure that the
steam sterilizer cycle is chosen that is designed to remove air from porous or lumened device loads
in accordance to manufacturer's instructions and does not exceed the criteria for sterilizer load.
The following steam sterilization cycles are examples of validated cycles:
Conditioning Phase
Prevacuum
Prevacuum
Extended steam exposure cycle can be used to meet local requirements such as 134°C (274°F)
for 18 minutes.
Minimum Sterilization
Exposure Time (minutes)
4
3
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Minimum Sterilization
Exposure Temperature
132°C (270°F)
134°C (274°F)
Dry Time*
30 minutes
30 minutes