Care and Maintenance
EN
Manual cleaning and disinfecting
56
• it is generally suitable for the cleaning of instruments made of metal and plas-
tics.
• an additional, suitable disinfectant with certified efficacy (e.g., VAH/DGHM or
FDA/EPA approval/clearance/registration or CE marking) is used and that this
disinfectant is compatible with the utilized cleaning agent - unless a thermal
disinfection process is applied.
• the chemicals used are compatible with the products (see "material resis-
tance").
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/or disinfectant.
Process
1. Place the products into the cleaning and disinfecting equipment. Make sure
the products do not touch one another. Close all lumina of the products using
the existing Luer lock adapter at the rinsing port of the cleaning and disinfect-
ing equipment.
2. Start the program.
3. Remove the products from the cleaning and disinfecting equipment after the
end of the program.
4. Check and pack the products as soon as possible after removal (see "Inspec-
tion," "Maintenance" and "Packaging," possibly after additional drying in a
clean location).
Documentation of the fundamental suitability of the reusable heating tube sys-
tem for an effective mechanical cleaning and disinfection was prepared by an in-
dependent accredited and recognized (§15 (5) MPG) testing laboratory using the
cleaning and disinfecting equipment type G 7836 CD (thermal disinfection, Miele
& Cie. GmbH & Co., Gütersloh) and the pre-cleaning/cleaning agent neodisher
MediZym (Dr. Weigert GmbH & Co. KG, Hamburg). This was done by taking into
account the procedure described above.
When choosing the cleaning and disinfecting agent to be used, make sure
• they are generally suitable for the cleaning or disinfection of tube systems
made of metal and plastics.
• a disinfectant with certified efficacy (e.g., VAH/DGHM or FDA/EPA approval/
clearance/registration or CE marking) is used and that this disinfectant is com-
patible with the utilized cleaning agent.
• the chemicals used are compatible with the products (see Material resistance).
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 solution, only wa-
ter (e.g., purified water/highly purified water) that is sterile or low-germ
(max. 10 germs/ml) and low in endotoxins (max. 0.25 endotoxin units/ml) and
only a soft, clean and lint-free cloth and/or filtered air for drying.
Cleaning procedure
1. Insert the products into the cleaning solution for the prescribed contact time
and make sure the products are sufficiently submerged. Make sure the prod-
ucts do not touch one another.
2. Rinse all lumina of the products at least five times at the beginning or at the
end of the contact time using a disposable syringe (minimum volume
100 ml). Clean the exterior with a clean, soft cloth and a soft brush that you
use just for this purpose.
3. Remove the products from the cleaning solution and rinse at least three