WARNING!
Use the tear-off tabs attached to the tube to keep track of the number of steril-
ization cycles. The heating tube may not be sterilized after the last tab has been
removed.
Please check the reusable tube for signs of damage after sterilization and before
use. Never use a tube showing signs of damage, especially brittleness and perfo-
ration.
9.5.1
Cleaning and Disinfecting
A mechanical process (cleaning and disinfecting equipment) should be used if
possible. A manual process - even when using an ultrasonic bath - should be used
only if a mechanical method is not available or not possible due to the signifi-
cantly reduced efficiency and reproducibility. Pretreatment is required in both
cases.
Directly after use (within maximum 2 h) large impurities must be removed from
the reusable tube system:
Process
• Rinse the products at least 1 min under running water (temperature <35 °C/
95 °F). Rinse all lumina of the products three times using a disposable syringe
(minimum volume 100 ml).
• Place the products in a freshly prepared cleaning solution
requirements as listed in Manual cleaning and disinfecting concerning the se-
lection, concentration, temperature, and exposure time. Use only freshly pre-
pared solutions. Rinse all lumina of the products three times using a disposable
syringe (minimum volume 100 ml).
• Manually remove all externally visible particles with a clean soft cloth and soft
brush, which you are using only for this purpose.
• Rinse the products at least 1 min under running water (temperature <35 °C/
95 °F). Rinse all lumina of the products three times using a disposable syringe
(minimum volume 100 ml).
1
If your are using a combination cleaner and disinfectant for this step - e.g., for rea-
sons of occupational safety and health - please keep in mind that this product
should be free of aldehyde (otherwise blood particles may become permanently de-
posited), should have a certified efficacy (e.g., VAH/DGHM or FDA/EPA approval/
clearance/registration or CE marking), is suitable for the disinfection of products,
and is compatible with the products being cleaned and disinfected (see "material
resistance"). Please keep in mind that the disinfectant used for the pre-treatment
serves only personal protection and cannot replace the subsequent disinfection car-
ried out after the cleaning step.
When selecting a cleaning and disinfecting equipment, make sure
• this device has a certified efficacy (e.g., DGHM or FDA approval/clearance/reg-
istration or CE marking according to DIN EN ISO 15883).
• to use a certified program for thermal disinfection (A0 value > 3000 or - for old-
er devices - at least 5 min at 90 °C/194 °F), if possible (with chemical disinfec-
tion risk of disinfectant residues on the products).
• the used program for the products is suitable and contains sufficient rinsing
cycles.
• rinsing is done only with water (e.g., purified water/highly purified water) that
is sterile or low-germ (max. 10 germs/ml) and low in endotoxins (max. 0.25 en-
dotoxin units/ml).
• the air used for drying is filtered (oil-free, low in particles and germs).
• the cleaning and disinfecting equipment will be regularly maintained and
checked.
When choosing the cleaning agent system, make sure
Basics
Pretreatment
1
. Observe relevant
Mechanical cleaning/disinfecting (cleaning
and disinfecting equipment)
Care and Maintenance
EN
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