Cleaning And Sterilization - Invuity St2B Gebrauchsanweisung

Cleaning and Sterilization

Clean the sterilization tray as indicated before first use. Use the cleaning methods as indicated in
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these instructions. Other cleaning methods may prevent proper sterilization of the equipment.
Do not use Sterrad® or other sterilization processes that contain chlorine (bleach) or enzymatic
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solutions.
Warnings/
It is recommended to use the appropriate Invuity Sterilization Tray to help protect any Invuity
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Precautions
Fiber Optic Cable or Retractor from damage during transport, decontamination, sterilization, and
storage.
Do not process instruments of different metals during sterilization, oxidation due to electrolytic
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effects may occur.
1. Use an enzymatic solution or a neutral pH detergent according to hospital protocol for pre-soak
cleaning. Pay close attention to instructions for correct detergent dilution, temperature, and soak
time.
2. Scrub the entire Invuity Sterilization Tray thoroughly using a soft brush and a neutral pH (7.0-8.5)
detergent. An alkaline cleaning agent (neat, up to pH 11) is allowable, but not preferred. Alkaline
cleaning agents may cause cosmetic damage or reduce the life of the product. The Invuity
Cleaning
Sterilization Tray may be submerged when scrubbing. Take special care to thoroughly clean and
remove all debris from the aeration holes.
Note: Do not use a stiff bristle brush or metal type brush to clean the tray. Avoid contact with
other metal instruments or object which may dent, ding, scrape or otherwise damage the
surface of the Sterilization Tray.
3. Rinse the Sterilization Tray to remove residual debris and cleaning agents.
WARNINGS:
Use appropriate water quality for each stage of the cleaning process. Mineral residues from hard
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water can stain the equipment and/or prevent effective cleaning and decontamination.
Use utility water for flushing, washing, and rinsing the equipment. Utility water is water that
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comes from the tap.
Use potable water for diluting cleaning agents. Potable water is water that is treated and delivered
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in a matter so that it meets United Sates (US) Environmental Protection Agency (EPA) or local
guidelines as suitable for drinking.
Use critical water for final rinsing of the equipment prior to sterilization. Critical water is water
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that is extensively treated usually by a multistep treatment process that could include a carbon
Water
bed, softening, deionization, and reverse osmosis or distillation to ensure that the microorganisms
Quality
and the inorganic and organic material are removed from the water. A final submicron filtration
could also be part of the treatment process.
CAUTION: Poor water quality can adversely affect the life of medical devices. ALWAYS follow the
water quality requirements per Association for the Advancement of Medical Instrumentation (AAMI)
TIR 34.
Warm water with an optimum temperature range of 27 to 44 °C [80 to 110 °F] is recommended for
manual cleaning. The water should not exceed 60 °C [140 °F] and should be warm to the touch.
Disinfection Disinfection processes do not ensure the margin of safety associated with sterilization processes.
(Optional) Therefore, disinfection is optional.
IFU 14466 Rev A 4