AS Medizintechnik ASIPCO Instrucciones De Uso página 11

AS Medizintechnik GmbH Tel: +49 /74 61/9 66 32-6
Sattlerstraße 15 Fax: +49 /74 61/9 66 32-88
78532 Tuttlingen www.AS-Medizintechnik.de
Germany info@AS-Medizintechnik.de
10.3 Manual cleaning and disinfection
All accessible parts can be cleaned with neutral tenside-based detergents (neutral detergent, dishwashing liquid). pH-neutral disinfectants can be used for
disinfection. The final rinse must be carried out only with demineralised water. No metal brushes or scouring agents must be used for cleaning.
10.4 Mechanical cleaning and disinfection
For mechanical cleaning only pH-neutral or mildly alkaline process chemicals (pH value 8 - 10.5), which are approved by the manufacturer explicitly for the
cleaning of aluminium, should be used. Adding acidic neutralisation agents must be avoided to prevent damage to the aluminium. We recommend disinfecti-
on/final rinse in an RDG at > 90° C with respective exposure time according to A 0 procedure, EN ISO 15883-1, annex B. The final inspection must be carried
out only with demineralised water. The notes of the manufacturers of the automatic cleaning units as well as of the manufacturers of the treatment agents
must be observed. The cleaning unit must be designed for cleaning the containers. Important is here in particular the secure placing in the washing baskets
and the correct layout of the spray nozzles and spray arms.
ATTENTION:
Note on rinsing agent! Due to the plastic components (disc of the microbial barrier, logistics frame at the fitting parts) at the container, the
use of rinsing agent is not recommended, since tenside residue on the surfaces leads to changes in the plastic structure and thus to the
formation of cracks in the subsequent steam sterilisation.
Information on the validation of the sterilisation
We recommend the following cleaning procedure that was validated by AS Medizintechnik GmbH in as suitable cleaning and disinfection device with the
following settings:
Manual pre-cleaning:
Separate the lid and the bottom
(1)
Rinse all parts under cold municipal water (< 40° C) until all visible contamination is removed. Persistent dirt is to be removed with a soft brush. Cavities,
lumen are to be rinsed intensively (> 30 sec) with cold municipal water (< 40° C) using a water pressure gun.
Special instructions of the manufacturers of the automatic cleaning unit must be observed.
Automatic cleaning:
• 1 minute pre-cleaning with cold municipal water < 40° C, water drain
• 3 minutes pre-cleaning with cold municipal water < 40° C, water drain
• 5 minutes cleaning at 55° C ± 5° C with 0.5 % alkaline detergent (neodisher
• 2 minutes intermediate rinsing with cold demineralised water
Automatic disinfection (Miele G7835 CD):
Automatic thermal disinfection in cleaning and disinfection device, taking into consideration the national requirements to the A 0 -3000 value, > 5 minutes at
92° C ± 2° C, demineralised water, water drain.
Automatic drying:
Automatic drying according to automatic drying process of the cleaning and disinfection device 30 minutes at 60° C ± 5° C if required subsequent manual
drying with lint-free cloth and blowing out of lumen using sterile, oil-free compressed air.
The following inspection instructions, materials and machines are used for validation:
Cleaning disinfection device:
Detergent (mechanical):
Details see report:
Should the previously described chemicals and machines not be available, it is for the user to validate its procedure accordingly.
10.5 Removal of residue from the material
Residues or contaminations on the container that cannot be removed in the normal cleaning process (indicator strips, adhesive labels, lettering) must be
removed with the AS Medizintechnik Detergent for Anodised Surfaces, item no. 55-865-00 or other standard agents such as dishwashing liquid, neutral
detergent or alcohol. After this special treatment, the container bottoms or lids must be rinsed again or undergo the usual cleaning routine.
11 Maintenance and repairs
The manufacturer considers himself responsible for the safety and reliability of the sterilisation containers only, if repairs or modifications are carried out
by persons authorised by him and the sterilisation containers are used in accordance with the instruction of use. Only AS Medizintechnik GmbH original
replacement parts must be used for repairs. Only then can guarantees be assumed.
11.1 Replacement of gaskets (7)
The replacement of gaskets can only be carried out by the manufacturer himself and by authorised persons.
11.2 Maintenance plan
Depending on the application conditions, we recommend, in conformity with EN 868-8, to carry out the following maintenance steps after 500 usage cycles
or once yearly:
for the cleaning process. Remove the discs
(5)
Miele G 7835 CD
neodisher MediClean forte; Dr. Weigert
®
No. 1612.0813.1 (Zwisler Laboratorium GmbH)
of the microbial barrier.
(6)
® MediClean forte), water drain
EN
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