Technical Description - Nissei WS-820 Gebrauchsanweisung

Do not inflate the cuff (start a measurement) when it has not been wrapped
around your wrist. Do not try to stretch or twist the cuff, and do not bring it into
contact with sharp or pointed objects.

TECHNICAL DESCRIPTION

WS-820 complies with the EMC, electromagnetic compatibility, standard, IEC60601-1-2. Refer to the tables below for specific information regarding compliance to the standard. WS-820, as a medical electrical equipment, needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided below. Portable and mobile RF communications equipments can affect the device. The use of accessories other than those specified in this manual may result in increased emissions or decreased immunity of the device. WS-820 should not be used adjacent to or
stacked with other equipment.
Table 201 - Guidance and manufacturer's declaration - electromagnetic emissions -
WS-820 is intended for use in the electromagnetic environment specified below. The customer or the user of WS-820 should assure that it is used in
such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 WS-820 uses RF energy only for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby electronic equipment.
WS-820 is suitable for use in all establishments, including domestic establishments and
RF emissions CISPR 11 Class B those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2 N/A
Voltage fluctuations / flicker emissions N/A
IEC 61000-3-3
Table 204 - Guidance and manufacturer's declaration - electromagnetic immunity -
WS-820 is intended for use in the electromagnetic environment specified below. The customer or the user of WS-820 should assure that it is used in
such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to any part
of WS-820, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms N/A N/A
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m d=1.2√P, 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2,5 GHz 3 V/m 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,
should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following
symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
a
radios broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which WS-820 is used exceeds the
applicable RF compliance level above, WS-820 should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating WS-820.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V
b
d=1.2√P, 800 MHz to 2,5 GHz
a
b
] V/m.
1
Do not disassemble or modify the unit.
Table 202 - Guidance and manufacturer's declaration - electromagnetic immunity -
WS-820 is intended for use in the electromagnetic environment specified below. The customer or the user of WS-820 should assure that it is used in
such an environment.
Immunity test IEC 60601 test level
Electrostatic discharge ±6 kV contact
(ESD) IEC 61000-4-2 ±8 kV air
Electrical fast transient/ ±2 kV for power supply lines
burst IEC 61000-4-4 ±1 kV for input/ output lines
Surge IEC 61000-4-5 ±1 kV differential mode
±2 kV common mode
Voltage dips, short <5% U (>95% dip in U ) for 0,5 cycle
T T
interruptions and voltage 40% U (60% dip in U ) for 5 cycles
T T
variations on power supply 70% U (30% dip in U ) for 25 cycles
T T
input lines IEC 61000-4-11 <5% U (>95% dip in U
T T
Power frequency (50/60 Hz) 3 A/m
magnetic field IEC
61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
Table 206 - Recommended separation distances between portable and mobile RF communications equipment and WS-820 -
WS-820 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of
WS-820 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and WS-820 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power Separation distance according to frequency of transmitter
of transmitter, W 150 kHz to 80 MHz, N/A
0,01
N/A
0,1
N/A
1
N/A
10 N/A
100 N/A
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
-17-
CARE AND MAINTENANCES
Compliance level Electromagnetic environment - guidance
N/A Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30 %.
N/A N/A
N/A N/A
N/A N/A
) for 5 sec
3 A/m Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
m
80 MHz to 800 MHz, d=1.2√P 800 MHz to 2,5 GHz, d=1.2√P
0,12
0,38
1,2
3,8
12
0,23
0,73
2,3
7,3
23