UMF Medical FUSIONONE 3001, Руководство пользователя

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4
Enclosure Port
IMMUNITY TEST LEVELS
Phenomenon
Basic EMC standard
or test method
Professional healthcare
facility environment
Home healthcare
environment
Electrostatic discharge IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM fields a) IEC 61000-4-3
3 V/m f)
80 MHz – 2,7 GHz b)
80 % AM at 1 kHz c)
10 V/m f)
80 MHz – 2,7 GHz b)
80 % AM at 1 kHz c)
Proximity fields from RF
wireless communications
equipment IEC 61000-4-3 See 8.10.
Rated power frequency
magnetic fields
d) e)
IEC 61000-4-8
30 A/m
g)
50 Hz or 60 Hz
Input A.C. Power Port
IMMUNITY TEST LEVELS
Phenomenon
Basic EMC standard
or test method
Professional healthcare
facility environment
Home healthcare environment
Electrical fast
transients / bursts
a) l) o)
IEC 61000-4-4
± 2 kV
100 kHz repetition frequency
Surges
a) b) j) o)
Line-to-line
IEC 61000-4-5 ± 0,5 kV, ± 1 kV
Surges a) b) j) k) o)
Line-to-ground
IEC 61000-4-5 ± 0,5 kV, ± 1 kV, ± 2 kV
Conducted
disturbances induced
by RF fields
c) d) o)
IEC 61000-4-6
3 V
m)
0,15 MHz – 80 MHz
6 V
m)
in ISM bands between 0,15 MHz
and 80 MHz
n)
80 % AM at 1 kHz
e)
3 V
m)
0,15 MHz – 80 MHz
6 V
m)
in ISM and amateur radio bands
between 0,15 MHz and 80 MHz
n)
80 % AM at 1 kHz
e)
Voltage dips
f) p) r)
IEC 61000-4-11
0 % U
T
; 0,5 cycle
g)
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
q)
0 % U
T
; 1 cycle and
70 % U
T
; 25/30 cycles
h)
Single phase: at 0°
Voltage interruptions
f) i) o) r)
IEC 61000-4-11 0 % U ; 250/300 cycle
h)
a) The interface between the PATIENT physiological signal simulation,
if used, and the ME EQUIPMENT or ME SYSTEM shall be located
within 0,1 m of the vertical plane of the uniform field area in one
orientation of the ME EQUIPMENT or ME SYSTEM.
b) ME EQUIPMENT and ME SYSTEMS that intentionally receive
RF electromagnetic energy for the purpose of their operation
shall be tested at the frequency of reception. Testing may be
performed at other modulation frequencies identified by the RISK
MANAGEMENT PROCESS. This test assesses the BASIC SAFETY
and ESSENTIAL PERFORMANCE of an intentional receiver when
an ambient signal is in the passband. It is understood that the
receiver might not achieve normal reception during the test.
c) Testing may be performed at other modulation frequencies
identified by the RISK MANAGEMENT PROCESS.
d) Applies only to ME EQUIPMENT and ME SYSTEMS with
magnetically sensitive components or circuitry.
e) During the test, the ME EQUIPMENT or ME SYSTEM may be
powered at any NOMINAL input voltage, but with the same
frequency as the test signal (see Table 1).
f) Before modulation is applied.
g) This test level assumes a minimum distance between the ME
EQUIPMENT or ME SYSTEM and sources of power frequency
magnetic field of at least 15 cm. If the RISK ANALYSIS shows
that the ME EQUIPMENT or ME SYSTEM will be used closer
than 15 cm to sources of power frequency magnetic field, the
IMMUNITY TEST LEVEL shall be adjusted as appropriate for
the minimum expected distance.
a) The test may be performed at any one power input voltage within
the ME EQUIPMENT or ME SYSTEM RATED voltage range. If
the ME EQUIPMENT or ME SYSTEM is tested at one power input
voltage, it is not necessary to re-test at additional voltages.
b) All ME EQUIPMENT and ME SYSTEM cables are attached during the test.
c) Calibration for current injection clamps shall be performed in a 150 Ω
system.