Tuttnauer 2540 - Technical Standards and Electrical Data

Page 10 of 66 Pages
3.7 Environment Emission Information
1. The peak sound level generated by the autoclave is less than 70 dBa
with background noise of 60 dBa.
2. The total heat per hour transmitted by the autoclave is < 100 W/h for
all models.
3.8 Directives and Standards
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:
3.8.1 Technical Directives
1. Pressure Equipment Directive 97/23/EC.
2. Council Directive for low voltage equipment 73/23/EEC.
3. Electromagnetic Compatibility Requirements Directive
89/336/EC.
3.8.2 Technical Standards
1. ASME code (models 2540, 3150, 3850, 3870, 5050, 5075).
2. EN 13445 (models 5050, 5075).
3. IEC-61010-1 & IEC-61010-2-041 - Safety requirements for
medical device.
4. EN 61326 – EMC Requirements .
3.8.3 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.
3.9 Electrical Data
Model
Power
consumption
Supply Voltage
Line
current
Protection against
electrical shock
2540
4 x 550W 1Ph, 230V/50Hz 9.6A
Class I
(IEC 60601-1)
3150
4 x 600W 1Ph, 230V/50Hz 10.4A
3850
4 x 800W 3Ph, 400V/50Hz 7.0A
4 x 800W 1Ph, 230V/50Hz 13.9A
3870
6 x 800W 3 Ph, 400V/50Hz 7.0A
5050
4 x 1100W 3 Ph, 400V/50Hz 9.6A
4 x 1100W 3 Ph, 230V/50Hz 12.0A
5075
6 x 1100W 3 Ph, 400V/50Hz 9.6A