iHealth BP7 Benutzerhandbuch - Seite 14

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iHealth BP7 Benutzerhandbuch
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
The Wireless Blood Pressure Wrist Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of the Wireless Blood Pressure Wrist Monitor should assure
that it is used in such an environment.
IMMUNITY
IEC 60601test level
test
Electrostatic
± 6 kV contact
discharge
± 8 kV air
(ESD)
IEC 61000-4-2
Electrical fast
± 2 kV for power
transient/burst
supply lines
IEC 61000-4-4
Surge
± 1 kV line(s) to
IEC 61000-4-5
line(s)
± 2 kV line(s) to
earth
Voltage dips,
<5 % U
short
(>95 % dip in U
interruptions
for 0.5 cycle
and
40 % U
voltage
(60 % dip in U
variations
for 5 cycles
on power
70 % U
supply
(30 % dip in U
input lines
for 25 cycles
IEC 61000-4-11
<5 % U
(>95 % dip in U
for 5 s
Power
3 A/m
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: U
is the a.c. mains voltage prior to application of the test level.
T
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
nearby electronic equipment.
The monitor is suitable for use in all establishments,
Class B
including domestic establishments and those directly
connected to the public low-voltage power supply network
Class A
that supplies buildings used for domestic purposes.
Complies
Table 2
For all ME EQUIPMENT and ME SYSTEMS
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
<5 % U
T
)
(>95 % dip in U
T
for 0.5 cycle
40 % U
T
)
(60 % dip in U
T
for 5 cycles
70 % U
T
)
(30 % dip in U
T
for 25 cycles
<5 % U
T
)
(>95 % dip in U
T
for 5 s
3 A/m
Table 3
Electromagnetic environment -
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30 %.
Mains power quality should be that of
a typical commercial or hospital
environment.
Mains power quality should be that of
a typical commercial or hospital
environment.
Mains power quality should be that of
T
)
a typical commercial or hospital
T
environment. If the user of the monitor
requires continued operation during
T
)
power mains interruptions, it is
T
recommended that the monitor be
powered from an uninterruptible
T
)
power supply or a battery.
T
T
)
T
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
guidance
13