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cos105000-2016-00 en
13.6 Environmental conditions
Operation
Data
Temperature
0 … 40° C
Humidity
20 … 90%, without condensation
Pressure
700 … 1060 hPa
Altitude
max. 3000 m, without pressurization
(altitudes >1000m can cause minor loss of performance)
Oxygen saturation
<= 25%
Exclude danger of explosions or inflammability. Exclude high voltage lines / devices in near vicinity.
Transport & Storage
Data
Temperature
-25°C … 40°C
Humidity
20 … 90%, without condensation
Pressure
700 … 1060 hPa
Altitude
max. 3000 m, without pressurization
When storing for more than 6 months without power connection, the batteries of the MCU may discharge.
Please contact
in case of re-installation after storage.
13.7 Technical and legal requirements
Description
Data
Stationary training equipment
ISO 20957-1, EN 957-6
Medical electrical equipment
IEC 60601-1
Electromagnetic compatibility
IEC 60601-1-2
Usability
IEC 60601-1-6, IEC 62366-1
Software
IEC 62304
Medical device directive
MDD 93/42/EEC
Machinery directive
MD 2006/42/EC
Legal requirements
German medical device act (MPG)
13.8 EMC tests
Description
Data
Measurement of conducted emission
acc. to EN 55011, Group 1, Class B
Measurement of radiated emission
acc. to EN 55011, Group 1, Class B
Electrostatic discharge immunity test
acc. to EN 61000-4-2
Radiated, radio-frequency, electromagnetic field
immunity test
acc. to EN 61000-4-3
Electrical fast transient immunity test
acc. to EN 61000-4-4
Surge immunity test
acc. to EN 61000-4-5
Immunity to conducted disturbances, induced by
radio-frequency fields
acc. to EN 61000-4-6
Power frequency magnetic field immunity test
acc. to EN 61000-4-8
Voltage dips, short interruptions and voltage
variations immunity tests
acc. to EN 61000-4-11
Testing of voltage changes, voltage fluctuations
and flicker in public low-voltage supply systems
acc. to EN 61000-3-3
Variation of mains frequency
acc. to DIN EN 60601-1
