AS Medizintechnik ASIPCO Instrucciones De Uso página 12

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Instruction of use
Sterilizing-Container System
53-110-10-01 - 53-315-20
53-320-01
- 53-355-03
Gasket:
(7)
Container lid:
(1)
Microbial barrier:
(6)
Container bottom:
(5)
12 Dimensions
The asipco
Sterilizing-Container comply in their dimensions with the recommendations of EN 868-8 (nominal dimensions). The dimensions can be found in
®
the AS Medizintechnik brochure. The technical dimensions can be found in the AS measurement chart.
13 Safety regulations
The contents of a sterilisation container can only be regarded as sterile, if the disc(s)
lid
(1)
is closed, the container was sterilised, the seal is intact (visual check) and all container components are undamaged. The successful sterilisation
exposure is recorded by the steriliser and documented.
The sterilisation container is hot after successful sterilisation!
WARNING: Risk of burns! Wear protective clothing!
To avoid hazards and material damage, containers must not be stacked higher than 550 mm (2 container units). Suitable installations are to be used for
transport and storage that prevent falling over or falling down of containers. All product manufacturer's instructions must be adhered to.
The container is not suited for the sterilisation of medicinal products or biological products.
14 Replacement parts
asipco
Microbial barrier disc, PPSU, orange, Ø 144 mm
®
asipco
Logistic-frame, PPSU, Unit = 4 pieces
®
asipco
Coding tag, PPSU, white, 57 x 40 mm
®
Item numbers for the asipco
Container lids and bottoms can be found in the current asipco
®
Replacement parts are also available from AS Medizintechnik GmbH.
ATTENTION: Only approved AS Medizintechnik original parts may be combined.
15 General
The general guidelines and hygiene principles on the handling with contaminated, goods to be sterilised and already sterilised goods must be observed. To
exclude possible recontamination risks, the above mentioned instruction of use must be adhered to. If when opening the sterilisation container deviations
from the above mentioned desired state are detected, the contents of the sterilisation container must be regarded as non-sterile and the treatment process
must be repeated.
Note:
The sterilisation containers must only be used by trained personnel.
16 Other applicable standards and literature
DIN EN 285
DIN EN ISO 17665-1
DIN EN ISO 11607-1
DIN EN ISO 11607-2
DIN EN 868-8
DIN 58953-9
DIN 58952-3
17 Manufacturer information according to EN 868-8
Specification of the essential components: see chapter 4 "Structure and function of the container" and chapter 2 "Product overview"
Manner of inspection and maintenance and/or use: see chapter 5.11, .13 and .14
Useful life of the sterilisation container (usage cycles) according to EN 868-8
Useful life of the gaskets according to EN 868-8
Cleaning procedure: see chapter 10 "Disinfection, cleaning and care"
18 Disposal container
18.1 Purpose
The disposal container is used for storage and the safe transport of contaminated materials until reprocessing.
ATTENTION:
The disposal container must not be sterilised with the lid in place! The bottom and the lid must be sterilised separately in the sterilisation
chamber of the steriliser!
18.2 Material
Lid and bottom of the asipco
®
disposal container are made from anodised aluminium and can be treated according to chapter 10 "Disinfection, cleaning and
care" . The asipco
®
disposal container does not have a microbial barrier. With the exception of the notes on these systems, all notes of these instruction of
use also apply to the lid of the asipco
Page 12 of 32
Revision status: B
File name:
Inspection for integrity. Visual check for damage. If required replace the seal as a measure.
Check for integrity. Visual check for damage. If required replace the lid as a measure.
Check for integrity. Visual check of the contour and the locking mechanism. Replace if required.
Check for integrity. Visual check of the contour and the locking with the lid. If required, repair or replace.
®
disposal container.
GA_asipco® Sterilisations-Container System_M_A5_B
(6)
were affixed properly, the
REF: 53-325-00
REF: 53-320-01 - 53-320-07
REF: 53-321-00 - 53-321-01
Sterilizing-Container brochure.
®
Issued at:
13.02.2017
Issued from:
Revised at:
25.09.2017
Revised from: WS / NS
WS / NS
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