User's Manual

Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Voltage
Interruptions
(IEC 61000-4-11)
0 % U
T
;
For 250 cycles,
50 Hz
For 300 cycles,
60 Hz
0 % U
T
;
For 250 cycles,
50 Hz
For 300 cycles,
60 Hz
Mains power quality should be that of a Home health care
environment or Professional health care establishment
If operation of the system requires continued use during
power cuts, it is recommended that the medical device be
powered by a separate power source (UPS, etc.).
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
14.4. ELECTROMAGNETIC IMMUNITY, PORTABLE RADIO FREQUENCY EQUIPMENT
WARNING: Portable RF communication devices (including peripherals such as antenna cables and
external antennae) should not be used closer than 30 cm (12 inches) on any part of the Smart Spot,
including the cables specified by the manufacturer. Otherwise, the performance of these devices may
be impaired.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment
- guidance
Electromagnetic fields
Radiated RF
( IEC 61000-4-3)
10 V/m
80 MHz – 2,7
GHz
80 % MA at 1 kHz
10 V/m
80 MHz – 2,7
GHz
80 % MA at 1 kHz
Home health care environment
and Professional health care
establishment.
Proximity fields emitted by RF wireless
communication devices IEC 61000-4-3
(provisional method)
9 V/m
710 MHz,
745 MHZ,
780 MHz,
5240 MHz,
5550 MHz,
5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz,
810 MHz,
870 MHz,
930 MHz,
1720 MHz,
1845 MHz,
1970 MHz,
2450 MHz
9 V/m
710 MHz,
745 MHZ,
780 MHz,
5240 MHz,
5550 MHz,
5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz,
810 MHz,
870 MHz,
930 MHz,
1720 MHz,
1845 MHz,
1970 MHz,
2450 MHz
Home health care environment
and Professional health care
establishment.
Conducted disturbances, IEC 61000-4-6 3 V
150 kHz to
80 MHz
6V in ISM Band
between
0.15 MHz -
80 MHz
80% MA to 1 KHz
Amateur band
includes 80% MA
at 1 KHz
3 V
150 kHz to
80 MHz
6V in ISM Band
between
0.15 MHz -
80 MHz
80% MA to 1 KHz
Amateur band
includes 80% MA
at 1 KHz
Home health care environment
and Professional health care
establishment.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
10 Smart Spot – UA10275A