User Manual MUT_RD_009H_GB Page
15
of 43
This symbol means that any equipment emitting radio waves must be OFF when close to the device.
This symbol means that the equipment features a RF transmitter.
Directives and manufacturer’s claim –
electromagnetic emissions
The medical device is intended for use in the electromagnetic environment described below. The
customer or medical device user must ensure that it is used in such an environment.
Emission trials
Compliance
Electromagnetic environment - directives
RF emissions
CISPR 11
Group 1
The medical device uses RF energy only for internal functions.
Consequently, its RF emissions are very low and not liable to
provoke interferences in any neighbouring electronic devices.
RF emissions
CISPR 11
Class A
The medical device is suitable for use in all premises other than
domestic and those directly linked to the public low voltage
supply system feeding domestic use premises.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker
IEC 61000-3-3
Complies
Directives and manufacturer’s claim –
electromagnetic immunity
The medical device is intended for use in the electromagnetic environment described below. The customer
or medical device user must ensure that it is used in such an environment.
Immunity testing
Test level
IEC 60601
Compliance
level
Electromagnetic environment -
directives
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 6 kV in contact
± 8 kV in the air
Complies
Complies
The floor must be made of wood,
concrete or thin set tile. If the ground is
covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast transient
burst
IEC 61000-4-4
± 2 kV for electrical
feed lines
± 1 kV for
input/output lines
Complies
Complies
The quality of the mains supply system
must be that of a typical commercial or
hospital environment.
Transient voltage
surges
IEC 61000-4-5
± 1 kV between
phases
± 2 kV between
phase and ground
Complies
Complies
The quality of the mains supply system
must be that of a typical commercial or
hospital environment.
Voltage dips,
short
interruptions and
voltage variations on
<5 %
U
T
(>95 % dips of
U
T
)
during 0.5 cycle
Complies
The quality of the mains supply system
must be that of a typical commercial or
hospital environment. If the medical
device
user
demands
continuous