Table 2 Guidelines and Manufacturer's Declaration – Electromagnetic emissions for all ME devices
Noise immunity tests
Electrostatic discharge (ESD)
acc. to IEC 61000-4-2
Electrostatic transients / bursts
acc. to IEC61000-4-4
Surge voltage or surges
acc. to 1EC61000-4-5
Voltage dips, short in-terruptions
and voltage variations on power
supply input lines acc. to
IEC 61000-4-11
Magnetic field for the power
frequency (50/60 Hz)
acc. to IEC61000-4-8
Comment: U
is the a.c. supply voltage prior to application of the test level.
T
Recommended working clearances between portable and mobile RF
communication devices and the HEINE OMEGA
The ME device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled.
The user of the ME device can help to prevent electromagnetic faults by
observing the minimum disturbance between portable and mobile RF
communication devices (transmitters) and the ME device, as recommended
in accordance with the output performance of the communication device.
Rated maximum
Working clearance according to transmission frequency [m]
output of
150 kHz to
transmitter [W]
80 MHz
d = 1,2 √P
0,01
0,1
0,1
0,4
1
1,2
10
3,7
Explanation of utilized symbols
The following symbols are used on the device or on the packaging:
The CE marking indicates that the product conforms to the pro-
visions of Directive 93/42/EWG concerning medical products.
REF
Catalogue number
SN
Serial number
Product bearing this symbol may not be disposed of together
with general household waste, but instead requires separate
disposal.
Temperature limitation for storage and transport.
Type BF equipment
Maximum humidity for storage and transport.
Instrument connector
Power supply connector (9VDC)
Please read and follow the instructions for use of and keep
them for future reference.
(Background color blue, foreground color white)
Manufacturer
10/44
Guidance and manufacturer declaration - Electromagnetic emissions
THE ME device is intended to be operated in an electromagnetic environment as specified below.
The customer or use of the ME device must ensure that it is operated in such an environment.
IEC 60601 test level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains cables
± 1 kV for input and output lines
± 1 kV voltage phase – phase,
± 2 kV voltage phase – earth
< 5% U
, (>95% dip in U
)
T
T
for 1/2 period
40% U
, (60% dip in U
)
T
T
for 5 periods
70% U
, (30% dip in U
)
T
T
for 25 periods
<5% U
, (>95% dip in U
)
T
T
for 5 seconds
3 A/m
500
®
80 MHz to
800 MHz to
800 MHz
2,5 GHz
d = 1,2 √ P
d = 2,3 √ P
0,1
0,4
1,2
3,7
Compliance level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains cables
± 1 kV for input and output lines
± 1 kV voltage phase – phase
± 2 kV voltage phase – earth
< 5% U
, (>95% dip in U
T
for 1/2 period
40% U
, (60% dip in U
)
T
T
for 5 periods
70% U
, (30% dip in U
)
T
T
for 25 periods
<5% U
, (>95% dip in U
T
T
for 5 seconds
3 A/m
0,2
0,7
2,3
7,4
Production date
Risk of breakage
Dry storage
"Grüner Punkt" (country-specific)
med 0912
2016-06-30
Electromagnetic environment – Guidelines
Floors should be wood, concrete or covered with
ceramic tiles. If floors are covered with synthetic
material, the relative humidity should be at least
30 %.
The supply voltage quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
)
Mains power quality should be that of a typical
T
commercial or hospital environment. If the user
of the ME device requires continued operation
during power mains interruptions, it is recom-
mended that the EUT be powered by a UPS
(uninterruptible power supply) or a battery.
)
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.