WORLD OF MEDICINE A127, Instructions For Use Manual

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Care and Maintenance
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• A disinfectant with tested effectiveness (e.g. VAH/DGHM or FDA/EPA approva/
clearance/Registration or CE marking) is used which is compatible with the
cleaning agent used.
• The chemicals used are compatible with the products.
Combined cleaning/disinfecting agents should not be used if possible. Combined
cleaning/disinfecting agents can be used only in cases of very low contamination
(no visible impurities).
It is imperative to comply with the concentrations, temperatures, and exposure
times, as well as the post-rinsing requirements specified by the manufacturer of
the cleaning agent and disinfectant. Use only freshly prepared solutions, only
sterile or low-germ (max. 10 germs/ml) and low endotoxin (max. 0.25 endotoxin
units/ml) water (e.g., purified water/high-purity water), or only a soft, clean and
lint-free cloth and/or filtered air for drying.
Manual cleaning Instruction
1. Place the tube set and the membrane in the cleaning bath for the specified ex-
posure time of the cleaning agent so that they are sufficiently covered and do
not touch each other.
2. Rinse all lumina of the products at least five times at the beginning and at the
end of the exposure time using a disposable syringe filled with the cleaning
agent (minimum volume 100 ml). Clean the exterior surfaces with a clean, soft
cloth and a soft brush that is only used for this purpose.
3. Remove the tube set and the membrane from the cleaning bath and rinse
them at least three times thoroughly (at least 1 min) with water.
4. Rinse all lumina of the tube set at least five times using a disposable syringe
filled with water (minimum volume 100 ml).
5. Inspect the tube set and the membrane (see Chapter Visual Inspection [
}
43]).
Manual disinfection Instruction
1. Place the cleaned and inspected tube set and the membrane in the disinfection
bath for the specified exposure time so that they are sufficiently covered and
do not touch each other.
2. Rinse all lumina of the tube set at least five times at the beginning and at the
end of the exposure time using a disposable syringe filled with the disinfection
solution (minimum volume 100 ml).
3. Remove the tube set and the membrane from the disinfecting bath and rinse
at least five times thoroughly (at least 1 min) with water.
4. Rinse all lumina of the tube set at least five times using a disposable syringe
filled with water (minimum volume 100 ml).
5. Inspect and dry the product if necessary (see Chapter Visual Inspection [ } 43]
and Chapter Subsequent Drying [ } 43]).
9.5.2.4 Visual Inspection
After cleaning or cleaning/disinfecting, inspect the tube set and the membrane for
corrosion, damaged surfaces, splinters, dirt and discoloration, and inspect for dam-
aged products (see Chapter Reusability [
} 45] for numerical restrictions on reuse).
If the chrome-plated components of the Luer lock adapter or the spike are dam-
aged (scratches, detachments), the product must be replaced immediately (no fur-
ther use permitted).
A product that is still dirty must be cleaned and disinfected again.
9.5.2.5 Subsequent Drying
After cleaning, the tube set and membrane must be dried before packing. For this
purpose, the tube set and membrane must be placed in an appropriate tray and
drained or dried with an air pistol and filtered compressed air; if necessary, the in-
dividual components must be dried with a soft, clean and lint-free cloth. Alternat-
ively, the components can be treated in an air dryer (10 minutes at 100 °C/212 °F).
Check the tube set and the membrane after drying as described in Chapter Visual
Inspection [
}
43].
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