Electromagnetic Compatibility
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12.3
Guidelines and Manufacturer's Statement - Electromagnetic
Interference Immunity
The device A127 is intended for use in an electromagnetic environment as de-
scribed below. The user/operator of the device A127 should make sure the device is
operated within such an environment.
Electromagnetic inter-
ference immunity tests
IEC 60601 test level
Compliance levels
Electromagnetic environment guidelines
Electrostatic discharges
(ESD) IEC 61000-4-2
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
Floors should be made from wood or concrete or
covered with ceramic tiles. If the floor covering
consists of synthetic material, the relative humid-
ity should be at least 30 %.
Electrical fast transi-
ents/bursts according to
IEC 61000-4-4
± 2 kV for power lines
Modulation 100 kHz
± 2 kV for power lines
Modulation 100 kHz
The quality of the supply voltage should be the
same as the voltage of a typical business or hos-
pital environment.
Surges
according
to
IEC 61000-4-5
±1 kV line(s) to line(s)
± 2 kV line(s) to earth
±1 kV line(s) to line(s)
± 2 kV line(s) to earth
The quality of the supply voltage should be the
same as the voltage of a typical business or hos-
pital environment.
Blackouts,
brownouts,
and fluctuations of the
power supply according
to IEC 61000-4-11
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % UT; 1 cycle and
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 1 cycle and
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycles
0 % UT; 250/300 cycles
Supply
frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
30 A/m
30 A/m
Magnetic fields of the mains power frequency
should comply with the typical values of business
and hospital environments.
Conducted RF
IEC 61000-4-6
3 Vrms
0.15 MHz to 80 MHz
6 Vrms in ISM bands
between 0.15 MHz and
80 MHz
80 % AM at 1 kHz
3 Vrms
0.15 MHz to 80 MHz
6 Vrms in ISM bands
between 0.15 MHz and
80 MHz
80 % AM at 1 kHz
Transients RF
IEC 61000-4-3
3 V/m 0.15 MHz to
80 MHz
80 % AM by 1 kHz
3 V/m 0.15 MHz to
80 MHz
80 % AM by 1 kHz
IMMUNITY to proximity fields from RF wireless communications equipment
Test method IEC 61000-4-3
Test
frequency
(MHz)
Band
(MHz)
Service
Modulation Maximum power
(W)
Distance
(m)
IMMUNITY TEST LEVEL (V/m)
385
380-390
TETRA 400
Pulse modu-
lation
18 Hz
1.8
0.3
27
450
430-470
GMRS 460, FRS
460
FM
±5 kHz devi-
ation
1 kHz sinus
2
0.3
28
710
704-787
LTE Band 13, 17
Pulse modu-
lation
217 Hz
0.2
0.3
9
745
780
810
800-960
GSM
800/900,
TETRA 800, IDEN
820, CDMA 850,
LTE Band 5
Pulse modu-
lation
18 Hz
2
0.3
28
870
930
en
Содержание A127
Страница 1: ...A127 Pump for Arthroscopy A127 Instructions for Use en...
Страница 56: ...Appendix 56 62 15 Appendix 15 1 Test log Date Result Comment Signature en...
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