Page 9 of 58 Pages
3.2 Operating Conditions
The autoclave is intended to work in ‘indoor’ conditions only.
Only autoclavable materials shall be used.
The ambient temperature shall not exceed 40ºC and a relative
humidity up to 85%.
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.
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
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:
3.3.1 Technical Directives
1. Pressure Equipment Directive 97/23/EC.
2. Council Directive for voltage limits 73/23/EEC.
3. Electromagnetic Compatibility Requirements Directive
89/336/EC.
3.3.2 Technical Standards
1. ASME code (models 2540, 3150, 3850, 3870).
2. EN 13445 (models 5050, 5075).
3. IEC-61010-1 & IEC-61010-2-040 - Safety requirements for
medical device.
4. EN 61326 – EMC Requirements .
3.3.3 Quality standards
The manufacturing plant meets the following quality standards:
1. EN ISO 9001:2008– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices.
3.4 Environment Emission Information
A. Peak sound level generated by the sterilizer is « 70 / dBA with a back
sound level of 60 dBA.
B. Total heat transmitted by the sterilizer is < 100 W/h
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