WORLD OF MEDICINE A127, Инструкция по эксплуатации

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Care and Maintenance
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9.5 Care of the Reusable Tube Set (NOT FOR SALE IN USA)
All reusable inflow tubes must be cleaned, disinfected, and sterilized before use.
This applies in particular to the first use after delivery since the product is delivered
non-sterile. Effective cleaning and disinfection are an essential prerequisite for ef-
fective sterilization.
The device A127 can be used with a reusable tube set listed as an accessory (see
Chapter Accessory List [
} 48]). Please comply with the following information
when using a reusable tube set.
9.5.1 General Notes
WARNING!
Reprocessing
Only reprocess after training has been completed.
The reusable tube set may only be reprocessed by trained personnel.
Within the scope of your responsibility for the sterility of the product in the applic-
ation of material compatibility, please note the following:
• Only cleaning/disinfection and sterilization methods sufficiently validated and
specifically designed for the tube set are to be used.
• The equipment used (washer-disinfector, sterilizer) must be regularly main-
tained and checked.
• Adherence to the validated parameters during each cycle must be ensured.
Please also comply with the legal or statutory requirements applicable to your
country as well as the hygiene rules of the physician's office or hospital. This ap-
plies in particular to the differing requirements regarding effective prion deactiva-
tion.
Products for cleaning and disinfection
WARNING!
Cleaning and disinfection
The reusable tube set (NOT FOR SALE IN USA) consists of silicone, polysulfone (PSU),
POM (Polyoxymethylene) and stainless steel. For cleaning and disinfection, use pH-
neutral or slightly alkaline cleaners and disinfectants approved for the utilized ma-
terials. If using unsuitable substances (e.g., Neodisher® Mediklar rinsing agent), the
tube set and especially connectors made of PSU may become damaged.
Examples for cleaning agents and disinfectants which have been used for valida-
tion by the manufacturer:
Steps Manufacturer Product Concentration [%]
Pretreatment Dr. Weigert Neodisher MediZym 0.5
Automated
Cleaning Dr. Weigert Neodisher MediClean 0.5
Neutralization Dr. Weigert Neodisher Z 0.1
Manual
Cleaning Dr. Weigert Neodisher MediZym 0.5
Disinfection ASP Cidex OPA -
When selecting the cleaning and disinfecting agents, please ensure that the follow-
ing ingredients are not included:
• Organic, mineral, and oxidizing acids with pH-value < 6.5
• Alkalis (pH value > 9.5, neutral/enzymatic or slightly alkaline cleaner recom-
mended)
• Organic solvents (alcohols, ethers, ketones, petroleum)
• Oxidizing agents (such as hydrogen peroxide)
• Halogens (chlorine, iodine, bromine)
• Aromatic/halogenated hydrocarbons
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