Version Number: 1.0
Humidity: 10% to 93% RH
Pressure altitude: 70KPa~ 106Kpa
CLASSIFICATION
1. Internally powered equipment; (supplied by Built-in Lithium Ion Polymer Battery)
2. Type BF applied part;
3. IP21;
4. No Sterilize requirement;
5. Not category AP / APG equipment
6. Mode of operation: continuous
EMC Declaration
Guidance and manufacturer’s declaration – electromagnetic immunity
The “Digital Blood Pressure Monitor B61T” is intended for use in the electromagnetic environment specified below. The customer
or the user of the “Digital Blood Pressure Monitor B61T” should ensure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment
–
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for input/output
lines
2 kV for power
supply lines
1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common mode
1 kV differential
mode
2 kV common mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<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 sec
<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 sec
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
“Digital Blood Pressure Monitor B61T” requires
continued operation during power
mains interruptions, it is recommended
that the “Digital Blood Pressure Monitor B61T” be
powered from an uninterruptible power
supply or a battery.
