31
Warranty
The Blood Pressure Monitor is guaranteed for 2-year from the date of purchase. If the
Blood Pressure Monitor does not function properly due to defective components or poor
workmanship, we will repair or replace it freely. The warranty does not cover damages to
your Blood Pressure Monitor due to improper handling. Please contact local retailer for
details.
Electromagnetic Compatibility Information
The device satisfies the EMC requirements of the international standard IEC
60601-1-2. The requirements are satisfied under the conditions described in the
table below. The device is an electrical medical product and is subject to special
precautionary measures with regard to EMC which must be published in the
instructions for use. Portable and mobile HF communications equipment can affect
the device. Use of the unit in conjunction with non-approved accessories can affect
the device negatively and alter the electromagnetic compatibility. The device
should not be used directly adjacent to or between other electrical equipment.
Table 1
Table 2
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environm-
ent.
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.
Electromagnetic environment
-guidance
Compliance
level
IEC 60601
test level
IMMUNITY test
±
8 kV
contact
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV air
Electrostatic
discharge (ESD)
IEC 61000-4-2
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Electromagnetic environment
-guidance
Compliance
Emissions test
The device uses RF energy only for
its internal function. Therefore, its
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
Group 1,
class B.
Radiated emission CISPR 11
The device is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic
purposes.
Conducted emission CISPR 11
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Electrostatic
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±0.5kV, ±1kV
(differential
mode)
Voltage dips,
short interrupti-
ons and voltage
variations on p-
ower supply in-
put lines
IEC 61000-4-11
0 % UT;
0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°
, 270° and 315°
0 % UT; 1 cycle
and
70 % UT;
25/30 cycles
Single phase:
at 0°
0 % UT;
250/300 cycle
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m; 50Hz
or 60Hz
Power frequency magnetic fields
should be at levels charactertic of a
typical location in a typical comme-
rcial or hospital environment.
30 A/m; 50Hz
or 60Hz
±
8 kV
contact
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV air
Electromagnetic Compatibility Information
32
33
±
2 kV ,
100kHz, for
AC power port
0 % UT;
0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°
, 270° and 315°
0 % UT; 1 cycle
and
70 % UT;
25/30 cycles
Single phase:
at 0°
0 % UT;
250/300 cycle
±0.5kV, ±1kV
(differential
mode)
±
2 kV ,
100kHz, for
AC power port
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.
Group 1,
class B.
Table 2(continued)
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environm-
ent.
Electromagnetic environment
-guidance
Compliance
level
IEC 60601
test level
IMMUNITY test
Electromagnetic Compatibility Information
34
Radiated RF EM
fields
IEC 61000-4-3
3V/m or 10 V/m
80MHz-2.7
Ghz 80%AM at
1kHz
3V/m or 10 V/m
80MHz-2.7
Ghz 80%AM at
1kHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended seperation distance 80 MHz
to 800 MHz 800 MHz to 2.7 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
metres (m). Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a should be
less than the compliance level in each
frequency range. Interference may occur in
the vicinity of equipment marked with the
following symbol:
Conducted
disturbances
Induced by RF
fields
IEC 61000-4-6
3 V in 0.15
MHz- 80 MHz
6 V in ISM
and/or amateur
radio bands
between 0.15
MHz and 80
MHz 80 %
AM at 1kHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended seperation distance 80 MHz
to 800 MHz 800 MHz to 2.7 Ghz where P is
the maximum output power rating of the
transmitter in watts (W) according to the
transm- itter manufacturer and d is the
recommended separation distance in
metres (m). Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a should be less
than the compliance level in each frequency
range. Interference may occur in the
vicinity of equipment marked with the
following symbol:
3 V in 0.15
MHz- 80 MHz
6 V in ISM
and/or amateur
radio bands
between 0.15
MHz and 80
MHz 80 %
AM at 1kHz