AS Medizintechnik ASIPCO Instrucciones De Uso página 9

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 [email protected]
3. Intended purpose
The AS Medizintechnik asipco Sterilizing-Container is used for packaging, sterilisation, transporting and for sterile provision of sterile materials, as well as
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for the recirculation of the contaminated sterile materials. The designs correspond in all, for the container applicable components, with the requirements of
the international and national standards ISO 11607-1, ISO 11607-2, EN 868-8 and DIN 58953-9.
3.1 Sterilisation
The AS Medizintechnik asipco Sterilizing-Container is suited for steam sterilisation. It must be ensured that the sterilisation is carried out in a validated
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steam sterilisation procedure (e.g. in a steriliser according to EN 285 and validated according to ISO 17665-1). The use of other sterilisation procedures must
be agreed upon with AS Medizintechnik GmbH.
Information on the validation of the sterilisation
Sterilisation of the products 3-fold fractionated pre-vacuum procedure (e.g. steam steriliser: Tuttnauer EHS 3870) according to ISO 17665-1 under considera-
tion of the respective national requirements.
Validated procedure:
Pre-vacuum: 3 x
Temperature: 134° C / 273° F
Pressure: 3 ± 0.5 bar
Holding time: 5 minutes
Drying time: 20 minutes
The instruction of use of the autoclave manufacturer and the recommended guidelines for the maximum load with sterilisation material must be observed.
The autoclave must be installed, serviced, validated and calibrated appropriately.
Details see report: No. 1610.2161.1 (Zwisler Laboratorium GmbH)
4. Structure and function of the asipco
4.1 Microbial barrier with optimised Pasteur's loop
The microbial barrier consists of an orange coloured plastic disc and the subsystem integrated on the inside of the lid. Disc and subsystem are simply locked
by means of a bayonet locking mechanism. Prior to the steam sterilisation, the disc must be connected to the subsystem integrated on the lid. The system
works permanently and does not require any consumables.
4.2 Visual check of the microbial barrier from the outside
Even with the lid closed it can be seen and checked at any moment, if the system is used properly, e.g. during approval.
4.3 Lid gasket (7)
On the inside of the lid there is a firmly anchored silicone gasket, which ensures the germ-proof fit of the lid on the bottom after having put the lid on the
bottom and after successful sterilisation. The gasket can easily be checked visually for any wear as a routine measure. Damaged gaskets must be replaced
(see chapter 11.2 maintenance plan).
4.4 Container lock / lid locking mechanism
Closing the container:
• The lid is placed onto the bottom and locked by means of noticeable locking (pressing on) of the catch fasteners at the end sides of the container.
Opening the container:
• This is done in reverse order. By lifting the catch fasteners the lock is released. The lid can now be removed easily. If seals were affixed, they will be
forcibly destroyed and must then be removed.
4.5 Inclusion of seals (8)
The standard requires that the unintentional or unauthorised opening of the container after its sterilisation must be made visible. Therefore, the container
must be sealed on both end sides prior to sterilisation. Due to the operating principle of the catch fasteners, the seal is forcibly destroyed when opening the
container.
4.6 Handles (4)
On the end sides of the container the wide handle is integrated in the fitting part. After opening the closure, the lid can be removed easily and comfortably
since the entire fitting part can be lifted "as a handle" . The resilience of the handles complies with the requirements of EN 868-8, annex C.
4.7 Identification tags / document cards or labels
On both end sides of the container there are 2 fields integrated in each of the handle plates, which serve in connection with the logistics frames to accom-
modate identification tags and document cards / labels. The identification tags can be marked by AS Medizintechnik GmbH with the text provided by the
user (Set contents / destination). The fields integrated in the handle plate are equipped with a logistics frame. The logistics frames are available in 7 different
colours and can be used for logistics purposes.
5. Initial commissioning
The container must be cleaned prior its placement and the first sterilisation (see chapter 10 "Disinfection, cleaning and care"). The assembly of the container
is done according to chapter 4 "Assembly and function of the container" . The functional test must be carried out according to chapter 6.1 "Functional test
Sterilizing-Container.
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