Idiomas disponibles
Idiomas disponibles
6 General instructions for reconditioning
6.7.
6.8.
6.9.
14
Argon Handle and Electrodes
The confirmation of the basic suitability of the instruments for
effective steam sterilization was given by an independent accredited
test laboratory 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.
Storage
Store the instruments in a place where they are protected against
strong mechanical forces such as collision, falling or impact, direct
sunlight and X-rays.
Store the instruments in a dry place at room temperature. The
storage life of the sterilized instruments depends on the type of
packaging and the storage conditions.
The shipping box is not intended for storing the device.
Storage conditions
Temperature:
Relative humidity:
Air pressure:
Transport
Observe the stated storage conditions when transporting the
instrument.
Monitoring/inspection/function testing of parts in the operating
theatre
The disassembled instruments have to be assembled for the
application. A visual inspection and function test is to be carried out
before every operation.
-20°C to +50°C
0 - 75%, non-condensing
500 - 1600 hPa
MN030-088-S5
Capítulos
