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2.2
Operating Conditions
•
The autoclave is for “Indoor use” only.
•
Only autoclavable materials shall be used.
•
The ambient temperature shall be in the range of 50°F - 104°F (10°C -
40°C) and a relative humidity up to 85%.
•
The operation altitude of this autoclave is restricted to 6600ft
(2000m).The ambient pressure shall not be lower than 11.6psi (80kPa)
•
The autoclave shall not be used in a manner not specified in this
manual!
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!
2.3
Directives and Standards
Every autoclave meets the following Standards:
2.3.1
Technical Standards
1.
The pressure vessel is an integral part of the equipment
and complies with the ASME code, Section VIII div.1 for
unfired pressure vessels
2.
UL-61010–2-041 & UL-61010–1: Safety requirements for
medical device.
3.
UL
–
1998 Software in Programmable Components
2.3.2
Quality standards
The manufacturing plant meets the following quality standards:
1.
EN ISO 9001:2000– Quality System
2.
ISO 13485-2003 – Quality systems – Medical devices.
2.4
Environment Emission Information
A. Peak sound level generated by the sterilizer is
less than 70 / dBA with
a back sound level of 60 dBA.
B. Total heat transmitted by the sterilizer is less than 300 W/h
