iHealth BP5 Owner's Manual - Page 12

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iHealth BP5 Owner's Manual
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer's declaration - electromagnetic immunity
The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer
or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.
IMMUNITY test
IEC 60601test level
Compliance level
Electrostatic
± 6 kV contact
± 6 kV contact
discharge (ESD)
± 8 kV air
± 8 kV air
IEC 61000-4-2
Electrical fast
± 2 kV for power
± 2 kV for power
transient/burst
supply lines
supply lines
IEC 61000-4-4
Surge
± 1 kV line(s) to
± 1 kV line(s) to
IEC 61000-4-5
line(s)
line(s)
± 2 kV line(s) to earth
± 2 kV line(s) to earth
<5 % U
Voltage dips, short
<5 % U
T
T
interruptions and
(>95 % dip in U
)
(>95 % dip in U
T
voltage variations
for 0.5 cycle
for 0.5 cycle
on power supply
40 % U
40 % U
T
T
input lines
(60 % dip in U
)
(60 % dip in U
T
IEC 61000-4-11
for 5 cycles
for 5 cycles
70 % U
70 % U
T
T
(30 % dip in U
)
(30 % dip in U
T
for 25 cycles
for 25 cycles
<5 % U
<5 % U
T
T
(>95 % dip in U
) for 5 s
(>95 % dip in U
T
Table 2
Electromagnetic environment - guidance
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 a typical
)
commercial or hospital environment. If the user of
T
theBP5 requires continued operation during power
mains interruptions, it is recommended that theBP5 be
)
powered from an uninterruptible power supply or a
T
battery.
)
T
) for 5 s
T
21
Power frequency
3 A/m
3 A/m
(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
Guidance and manufacturer's declaration - electromagnetic immunity
The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user
of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.
IMMUNITY test
IEC 60601test level
Compliance level
Conducted RF
3 Vrms 150
3 V
IEC 61000-4-6
kHz to 80 MHz
Radiated RF
3 V/m 80 MHz
3 V/m
IEC 61000-4-3
to 2.5 GHz
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Table 3
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the BP5, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance：
d
1
2 .
P
=
d
1
2 .
P
=
80 MHz to 800 MHz
d
2
3 .
P
=
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
22