and optimal for the detergent used. A minimum of ten (10) minutes is recommended.
NOTES:
• Separate stainless steel instruments from other metal instruments during
ultrasonic cleaning to avoid electrolysis.
• Fully open hinged instruments.
• Use wire mesh baskets or tray designed for ultrasonic cleaners.
• Regular monitoring of sonic cleaning performance by means of an ultrasonic
activity detector, aluminum foil test, TOSI™ or SonoCheck™ is recommended.
6. Remove the instruments from the ultrasonic bath and rinse in purified water for
a minimum of one (1) minute or until there is no sign of residue detergent or
biologic soil. Actuate all moveable and hinged parts while rinsing. Thoroughly and
aggressively flush lumens, holes, cannulas, and other difficult to access areas.
7. Dry instruments with a clean, absorbent, non-shedding lint free cloth. Clean, filtered
compressed air may be used to remove moisture from lumens, holes, cannulas, and
difficult to access areas.
Automated Cleaning Procedure
A validation study for Automatic Cleaning has not been performed for these
instruments. Please consult an appropriate responsible person or hospital protocol for
direction.
Disinfection
Disinfection is only acceptable as an adjunct to full sterilization for reusable surgical
instruments. See sterilization section below.
Inspection / Functional Testing
1. Carefully inspect each device to ensure that all visible blood and soil has been
removed.
2. Visually inspect for damage and/or wear.
3. Check the action of moving parts (such as hinges and box-locks) to ensure smooth
operation throughout the intended range of motion.
4. Check instruments with long slender features (particularly rotating instruments) for
distortion.
5. Where instruments form part of a larger assembly, check that the devices
assemble readily with mating components.
6. Inspect edges of the case, tray and cassette to ensure there aren't any sharp edges
which might cut sterilization wrap. Inspect lid to assure there isn't any cracking,
bending or warping. Verify lid continues to fit case tightly.
* Note: If damage or wear is noted that may compromise the function of the
instrument, do not use the instrument and notify the appropriate responsible person.
Sterilization
Instruments and the instrument kit must be cleaned prior to sterilization. Instruments
must be arranged per the specified tray configuration. Additional instruments not
included in the specified tray configuration shall not be added to the tray for sterilization.
With instruments secured within, the kit must be wrapped using CSR (sterilization wrap)
following the AAMI double wrap method (ANSI/AAMI ST46), or equivalent. The trays and
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