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13.6 Environmental conditions
Operation
Temperature
Humidity
Pressure
Altitude
Oxygen saturation
Exclude danger of explosions or inflammability. Exclude high voltage lines / devices in near vicinity.
Transport & Storage
Temperature
Humidity
Pressure
Altitude
When storing for more than 6 months without power connection, the batteries of the MCU may discharge.
Please contact
service@h-p-cosmos.com
13.7 Technical and legal requirements
Description
Stationary training equipment
Medical electrical equipment
Electromagnetic compatibility
Usability
Software
Medical device directive
Machinery directive
Legal requirements
13.8 EMC tests
Description
Measurement of conducted emission
Measurement of radiated emission
Electrostatic discharge immunity test
Radiated, radio-frequency, electromagnetic field
immunity test
Electrical fast transient immunity test
Surge immunity test
Immunity to conducted disturbances, induced by
radio-frequency fields
Power frequency magnetic field immunity test
Voltage dips, short interruptions and voltage
variations immunity tests
Testing of voltage changes, voltage fluctuations
and flicker in public low-voltage supply systems
Variation of mains frequency
Data
0 ... 40° C
20 ... 90%, without condensation
700 ... 1060 hPa
max. 3000 m, without pressurization
(altitudes >1000m can cause minor loss of performance)
<= 25%
Data
-25°C ... 40°C
20 ... 90%, without condensation
700 ... 1060 hPa
max. 3000 m, without pressurization
in case of re-installation after storage.
Data
ISO 20957-1, EN 957-6
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6, IEC 62366-1
IEC 62304
MDD 93/42/EEC
MD 2006/42/EC
German medical device act (MPG)
Data
acc. to EN 55011, Group 1, Class B
acc. to EN 55011, Group 1, Class B
acc. to EN 61000-4-2
acc. to EN 61000-4-3
acc. to EN 61000-4-4
acc. to EN 61000-4-5
acc. to EN 61000-4-6
acc. to EN 61000-4-8
acc. to EN 61000-4-11
acc. to EN 61000-3-3
acc. to DIN EN 60601-1
page 50
cos105000-2016-00 en
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