Pretreatment; Cleaning And Disinfection - WORLD OF MEDICINE PP110 Mode D'emploi

Care and Maintenance
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9.5.2.2

Pretreatment

Pretreatment must be carried out both during automated and manual cleaning
and disinfection. Please note that the disinfectant used for the pretreatment
serves only personal protection against contamination and cannot replace the
subsequent disinfection carried out after the cleaning step.
Directly after the application (no later than within 2 hrs), large impurities must
be removed from the reusable tube set.
Instruction
1. If necessary, remove the protective caps of the spikes (7) (see Fig. 9-2 "Pres-
sure chamber membrane and its position").
2. Open the tube clamps (8).
3. Rinse the tube set and the membrane for at least 1 min under running water
(temperature < 35 °C/95 °F). Rinse all lumina of the tube set three times using
a disposable syringe filled with water (minimum volume 100 ml).
4. Place the tube set and membrane in a freshly prepared cleaning solution. Ob-
serve relevant requirements as listed in chapter 9.5.1 "General Notes" con-
cerning the selection, concentration, temperature, and exposure time.
5. Rinse all lumina of the tube set three times using a disposable syringe filled
with cleaning solution (minimum volume 100 ml).
6. Manually remove all externally visible particles with a clean soft cloth and
soft brush that is used only for this purpose and that does not scratch the sur-
face.
7. Rinse the tube set and the membrane for at least 1 min under running water
(temperature < 35 °C/95 °F). Rinse all lumina of the tube set three times using
a disposable syringe filled with water (minimum volume 100 ml).
If you use a combined cleaning and disinfecting agent for this purpose - e.g., for
reasons of occupational safety - please take into account the following:
• They should be aldehyde-free (otherwise fixation of blood contamination)
• They must have a tested efficacy (e.g., VAH/DGHM or FDA/EPA approval/ clear-
ance/registration, or a CE marking)
• They must be suitable for disinfecting the product
• They must not contain any of the components listed under chapter 9.5.1 "Gen-
eral Notes" and are compatible with the product.
9.5.2.3

Cleaning and Disinfection

An automated process (cleaning and disinfecting equipment) should be used if
possible. A manual process - even when using an ultrasonic bath - should be used
only if an automated process is not available or not possible due to the signifi-
cantly reduced efficiency and reproducibility.
Suitability of the cleaning device used in the context of automated cleaning and
disinfection, the selected program, and the used cleaning or disinfecting agent,
as well as a guarantee with respect to the attainable hygiene status and material
compatibility are the sole responsibility of the operator!
Automated Cleaning and Disinfection
When selecting a washer-disinfector, make sure of the following:
• The washer-disinfector has a tested effectiveness (e.g., DGHM (German Society
for Hygiene and Microbiology and Compliance with EN ISO 15883-1) - or FDA
approval/ clearance/registration; CE marking according to medical device di-
rective or regulation).
If possible, a tested thermal disinfection program is used (see Vario TD Pro-
gram of Miele & Cie. KG, type: G 7836 CD with mobile injection unit E450 for
MIS instruments; A0 value (scale for the inactivation of microorganisms of a
disinfection process; > 3000 or - for older devices - at least 5 min at 90 °C/
194 °F) (chemical disinfection may leave residues of disinfectant on the prod-