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3.
Technical Data
3.1
Storage Conditions
The packed or unpacked autoclave shall be retained in indoor
conditions!
3.2
Operating Conditions
▪
The autoclave is intended to work in ‘indoor’ conditions only.
▪
Only autoclavable materials shall be used.
•
The environment shall not exceed an ambient temperature range of
5
º
C (41
º
F)-40
º
C (104
º
F) and a relative humidity of 85% respectively.
•
The operation altitude shall not be over 2000 meters (6561 feet)
(ambient pressure shall not be lower than 80 kPa (11.6 psi)).
•
The autoclave shall not be used in a manner not specified in this
manual!
•
Do not use the autoclave in the presence of dangerous gases.
•
The packed or unpacked device shall be
stored in ‘indoor’ conditions.
•
Operate the autoclave only in the manner specified in the manual. If
the equipment is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.
Caution!
Waste water should be brought into the public net in accordance
with the local rules or requirements i.e. only non-hazardous
liquids shall be disposed in public sewage!
3.3
Directives and Standards
EN ISO
13485:2012 (Quality Systems for Devices)
ISO
9001:2008 (Quality Systems)
MDD
93/42/EEC (Device Directive)
Tuttnauer. Ltd. company also works in conjunction with and refers to:
AAMI/ANSI-ST8
Hospital sterilizers