User manual THERA-Trainer bemo EN
24
Article no. A007-661_Rev 2.0 - Last edited: 2020-06-02
14. Notes on electromagnetic compatibility
14.1. Cables, cable lengths and accessories
Only operate the THERA-Trainer with the original mains supply cable.
14.2. Warning notice regarding installation
Do not use the THERA-Trainer in the immediate vicinity of other devices or stacked with other devices.
If there is no alternative to operation next to or stacked with other devices, observe the THERA-Trainer
to check if the arrangement permits it to work as intended.
14.3. Electromagnetic emission and immunity
‒ The device is classified in Group 1 Class B in accordance with CISPR 11 and designed for interference
immunity testing levels in accordance with EN 60601-2:2016-05 (EN 6060 1-2:2015, IEC 60601-1-2:2014)
for domestic healthcare environments described in Tables 4, 5, 8 and 9.
‒ Deviations or simplifications regarding the above-mentioned immunity test levels are not permitted.
‒ In order to maintain basic safety and the essential performance characteristics within the expected service life
of 10 years, no precautions (maintenance activities) are required with regard to electromagnetic disturbances.
Table 4 - Casing:
Interference immunity test levels
Domestic healthcare environment
Discharge of static electricity
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV Air
High-frequency
electromagnetic fields
10 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
High-frequency
electromagnetic fields in the
immediate vicinity of wireless
communication devices
In accordance with DIN EN 60601-1-2:2016,
EN 60601-2:2016-05 (EN 6060 1-2:2015, IEC 60601-1-2:2014)
for healthcare environments described in Table 9
Magnetic fields with power
rated frequencies