User's Manual

Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
± 2 kV be-
tween
line(s) to
earth
± 2 kV be-
tween
line(s) to
earth
Magnetic field
at industrial rat-
ed frequency
(IEC61000-4-8)
30 A/m 30 A/m Professional health care establishment.
Voltage dips
(IEC
61000-4-11)
0% UT
For 0.5 cy-
cle
A 0°, 45°,
90°, 135°,
180°, 225°,
270° and
315°
0% UT for 1
cycle
and
70% UT for
25 cycles,
50Hz
30 cycles,
60 Hz,
Monophase:
0°
0% UT
For 0.5 cy-
cle
A 0°, 45°,
90°, 135°,
180°, 225°,
270° and
315°
0% UT for 1
cycle
and
70% UT for
25 cycles,
50Hz
30 cycles,
60 Hz,
Monophase:
0°
Professional health care establishment. If op-
eration of the system requires continued use
during power cuts, it is recommended that
the medical device be powered by a sepa-
rate power source (UPS, etc.)
Voltage Inter-
ruptions
(IEC
61000-4-11)
0 % UT;
For 250 cy-
cles, 50 Hz
For 300 cy-
cles, 60 Hz
0 % UT;
For 250 cy-
cles, 50 Hz
For 300 cy-
cles, 60 Hz
Professional health care establishment. If op-
eration 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: UT is the a.c. mains voltage prior to application of the test level.
ELECTROMAGNETIC IMMUNITY, PORTABLE RADIO FREQUENCY
EQUIPMENT
The programmer is intended for use in the electromagnetic environment specified below. The
customer or the user of the programmer should ensure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic
environment -
guidance
WARNING: Portable RF communication devices (including peripherals such as antenna cables and
external antennas) should not be used closer to 30 cm (12 inches) to any part of the Smart touch
programmer, including the specified cables. Otherwise, the performance of this device may be im-
paired.
12.6.
12. GUIDANCE AND MANUFACTURER'S DECLARATION
28 SmartTouch – UA10412A