Bowa 932-042 Instrucciones De Uso página 35

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using the fractionate vacuum method (EuroSelectomat from the company:
MMM Münchener Medizin Mechanik GmbH, Planegg). In this connection the
method described above was taken into consideration.
The hot air method for sterilization is basically not to be used
(destruction of the instruments).
The use of other methods of sterilization (e.g. ethylene oxide, formaldehyde,
beam and low temperature plasma sterilization) is outside the responsibility
of the manufacturer. In this case the corresponding valid standards are to be
observed (DIN EN ISO 14937/ ANSI AAMI ISO 14937, resp. standards for
specific methods) and the suitability and principle effectiveness of the
method proved (if necessary, including residue inspection of the sterilization
material) taking the specific product geometry into consideration within the
scope of the validation.
8.
Ambient conditions
8.1 Storage and transport
1.
BOWA recommends storing the products in their original packaging
until their first use. Store the products in a location where they are
protected against:
Strong mechanical stresses such as shock, dropping or impact
Direct exposure to sunlight.
Heat sources (e.g. heat exchanger, air conditioning unit, ...)
2.
Transport and store the instrument in a dry environment.
The storage life of the sterilised products depends on the type of
packaging and storage conditions.
8.2 Operation
The disassembled instruments must be assembled for use.
A visual and functional check must be done before each use.
Use the product at room temperature, protected from mechanical force such
as shock, dropping or impact.
9. Repair / Maintenance
The disassembled instruments are to be assembled according to the corresponding
instructions for use for the application. A visual inspection and function test is to be
carried out before every operation.
All Argon handles and electrodes are to be carefully treated when
transporting and preparation. This especially applies to fine needle tips and
other sensitive areas.
BOWA-IFU-MN030-088-ARGON-HANDLES-AND-ELECTRODES-S6-ML-20230910
The shipping box is not intended for storing the device.
en
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