Care and Maintenance
en
Manual disinfection
40
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 9.5.2.4 "Visual Inspec-
tion").
Instruction
1. Place the cleaned and inspected tube set and the membrane in the disinfec-
tion 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 disinfec-
tion 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 9.5.2.4 "Visual Inspec-
tion" and chapter 9.5.2.5 "Subsequent Drying").
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
damaged products (see chapter Reusability 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
further 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
individual components must be dried with a soft, clean and lint-free cloth. Alter-
natively, 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 9.5.2.4
"Visual Inspection".
9.5.2.6
Reinstalling the Membrane
Reinstalling membrane before sterilization (see Fig. Pressure chamber and its po-
sition): Place the lip of the membrane (3) into the ring groove (4) of the pressure
chamber. The strap (6) must be positioned in the notch (5) provided for this
purpose. Press the lip of the membrane into the groove (4). A properly inserted
membrane is flush with the pressure chamber and exhibits no wrinkles.
9.5.2.7
Packaging
Pack the reassembled, dry product (see chapter 9.5.2.6 "Reinstalling the Mem-
brane") in disposable sterilization packaging (single or double packaging) which
meets the following requirements (material/process):
• Conform to EN ISO 11607-1 and -2 /ANSI AAMI ISO 11607-1 and -2.
• Suitable for steam sterilization (temperature resistance up to at least 142 °C