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Breast Biopsy System should ensure that it is
used in such an environment.
Immunity Test
IEC 60601-1-2
Test Level
Compliance Level
(OHFWURPDJQHWLF(QYLURQPHQW±*XLGDQFH
ESD
IEC 61000-4-2
± 8 kV Contact
± 15 kV Air
± 8 kV Contact
± 15 kV Air
)ORRUVVKRXOGEHZRRGFRQFUHWHRUFHUDPLFWLOH,IÀRRUVDUHV\QWKHWLFWKHUHODWLYHKXPLGLW\
should be at least 30%.
EFT
IEC 61000-4-4
± 2 kV Mains
± 1 kV I/O’s
Complies
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV Differential
± 2 kV Common
Complies
Mains power quality should be that of a typical commercial or hospital environment.
Power Frequency
50/60 Hz
Magnetic Field
IEC 61000-4-8
30 A/m
30 A/m
3RZHUIUHTXHQF\PDJQHWLF¿HOGVVKRXOGEHWKDWRIDW\SLFDOFRPPHUFLDORUKRVSLWDO
environment.
Voltage Dips/Dropout
IEC 61000-4-11
> 95% Dip for
0.5 Cycle
Complies
Mains power quality should be that of a typical commercial or hospital environment. If the
user of the E
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mains interruptions, it is recommended that the E
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powered from an uninterruptible power supply or a battery.
> 95% Dip for
1 Cycle
Complies
30% Dip for
25/30 Cycles
Complies
> 95% Dip for
250/300 Cycles
Complies
NOTE:
UT is the A.C. mains voltage prior to application of the test level.
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IEC 60601 Test Level
Compliance Level
(OHFWURPDJQHWLF(QYLURQPHQW±*XLGDQFH
Conducted RF
IEC 61000-4-6
3 V
0.15 MHz – 80 MHz
6 V
in ISM between
0.15 MHz and 80 MHz
80% AM at 1 kHz
3 V
0.15 MHz – 80 MHz
6 V
in ISM between 0.15 MHz
and 80 MHz
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT
Radiated RF
IEC 61000-4-3
3 V/m
0+]±*+]
80% AM at 1 kHz
3 V/m
0+]±*+]
80% AM at 1 kHz
PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT
r.m.s. before modulation is applied.
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Test Frequency
Band ¹
Service ¹
Modulation ²
Maximum Power
Distance
Immunity
Test Level
MHz
MHz
W
Meters
V/m
385
380 – 390
TETRA 400
Pulse modulation ² 18 Hz
1.8
0.3
27
450
430 – 470
*056)56
FM ³ ± 5 kHz deviation 1 kHz
sine
2
0.3
28
710
745
780
704 – 787
LTE Band 13, 17
Pulse modulation ² 217 Hz
0.2
0.3
9
810
870
930
800 – 960
*607(75$L'(1&'0$
850, LTE Band 5
Pulse modulation ² 18 Hz
2
0.3
28
1720
1845
1970
1700 – 1900
*60&'0$*60'(&7/7(
Band 1, 3, 4, 25; UMTS
Pulse modulation ² 217 Hz
2
0.3
28
2450
2400 – 2570
Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE
Band 7
Pulse modulation ² 217 Hz
2
0.3
28
