Stryker AIM HD Guia Del Usuario página 7

3. Use acetone or alcohol on a clean cotton swab to remove the
paste residue.
4. Clean and sterilize the laparoscope before its next use.
Caution: Polishing optical surfaces should not be part of routine
cleaning procedures. Repeated application of polishing paste
to the laparoscope lens can cause damage. It should only be
performed when the laparoscope image is cloudy due to deposits
that cannot be removed in normal cleaning practices.
Reprocessing
These reprocessing instructions are provided in accordance
with ISO 17664, AAMI TIR 12, AAMI ST79, and AAMI ST81.
While they have been validated by Stryker 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. Stryker
recommends users observe these standards when reprocessing
medical devices.
Warnings
• These reprocessing instructions apply to AIM HD
laparoscopes and included adapters when reprocessed
disassembled from each other.
• This device must be cleaned and sterilized prior to the first
use and after every subsequent use.
• The sterilization parameters presented in this document
apply only to laparoscopes and included adapters sterilized
outside of a sterilization tray. When using a sterilization tray,
consult the instructions provided with the tray for proper
sterilization parameters. Stryker recommends sterilizing
device inside of a sterilization tray.
• Use only the sterilization cycles outlined in this document.
Using unspecified sterilization cycles may damage the device
or result in incomplete sterilization.
• Do not sterilize the device using 134°C for 18 minutes
pre-vacuum cycle, as it may damage the device.
• Failure to follow cleaning instructions may result in
inadequate sterilization.
• Prior to cleaning, disinfection, or sterilization, remove
any protective sheathing that was used to protect the
laparoscope during shipment. These include rubber caps on
the distal and proximal end of the laparoscope as well as a
plastic cover on the light post.
• Prior to cleaning, disinfection, or sterilization, disassemble
the laparoscope from the camera head, coupler, and
adapter, which may come pre-attached to the laparoscope.
If any of these components are cleaned, disinfected, or
sterilized as a single unit, disconnecting the devices during use
will compromise the sterility of the products. (Refer to the
camera head and coupler product manuals for reprocessing
instructions.)
• Unwrapped immediate-use ("flash") steam sterilization
is not recommended because it may reduce the optical
performance and shorten the expected service life of the
device.
• Wear appropriate protective equipment: gloves, eye
protection, etc.
Cautions
• Do not use brushes or pads with metal or abrasive tips
during manual cleaning, as permanent scoring or damage
could result.
• To minimize galvanic corrosion, avoid soaking dissimilar
metals in close proximity.
• Allow the device to air cool following steam sterilization.
Rapid cooling or "quenching" in a liquid could damage the
device and void the warranty.
Limitations on Reprocessing
• Using multiple sterilization methods may significantly reduce
the performance of the device and is not recommended.
• Proper reprocessing has a minimal effect on this device. End of
life is normally determined by wear and damage due to use.
• Damage incurred by improper reprocessing will not be
covered by the warranty.
Instructions for Reprocessing
Point of Use
• Wipe excess soil from the device using disposable paper
towels or lint free cloth.
• If an automated reprocessing method will be used, rinse any
channels in the device with 50 mL of sterile distilled water
immediately after use.
Containment and Transportation
• Reprocess the device as soon as reasonably practical
following use.
• Transport the device in a sterilization tray to avoid damage.
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