Electromagnetic compatibility (EMC) compliance Guidance and manufacturer’s declaration

Electromagnetic compatibility (EMC) compliance Guidance and manufacturer’s declaration
Welch Allyn ProBP 3400 digital blood-pressure device
Electromagnetic compatibility (EMC) compliance
Guidance and manufacturer’s declaration
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment.
•
All medical electrical equipment must be installed and put into service in
accordance with the EMC information provided in this document.
•
Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
The ProBP 3400 digital blood-pressure device complies with all applicable and required
standards for electromagnetic interference.
•
It does not normally affect nearby equipment and devices.
•
It is not normally affected by nearby equipment and devices.
•
It is safe to operate it in the presence of high-frequency surgical equipment;
however, it is good practice to avoid using the ProBP 3400 digital blood-pressure
device near other equipment.
Electromagnetic emissions
The ProBP 3400 digital blood-pressure device is intended for use in the electromagnetic environment specified below.
The customer or the user of the ProBP 3400 digital blood-pressure device should assure that it is used in such an
environment.
Emissions test
Compliance
Guidance
RF emissions
CISPR 11
Group 1
The ProBP 3400 digital blood-pressure device uses RF energy only for its
internal function.a Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The ProBP 3400 digital blood-pressure 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.
Harmonic emissions
IEC 61000-3-2
Class B
The ProBP 3400 digital blood-pressure device is intended for use by
healthcare professionals only. It may cause radio interference or
may disrupt operation of nearby equipment. It may be necessary to take
mitigation measures, such as reorienting or relocating the CVSM or
shielding the location.
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
a.
Complies
The ProBP 3400 digital blood-pressure device contains either a 5-GHz orthogonal frequency-division multiplexing transmitter or a
2.4-GHz frequency-hopping spread-spectrum transmitter for the purpose of wireless communication. The radio is operated according
to the requirements of various agencies, including FCC 47 CFR 15.247 and R&TTE Directive (1995/5/EC). The radio is excluded from
the EMC requirements of 60601-1-2:2001, but should be considered when addressing possible interference issues between this and
other devices.
2
Electromagnetic compatibility (EMC) compliance (80017751A)
Welch Allyn ProBP 3400 digital blood-pressure device
Electromagnetic immunity
The ProBP 3400 digital blood-pressure device is intended for use in the electromagnetic environment specified below.
The customer or the user of the ProBP 3400 digital blood-pressure device should assure that it is used in such an
environment.
Immunity test
IEC 60601 test level
Compliance level
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 line(s) to line(s)
±2 kV line(s) to line(s)
±1 kV line(s) to line(s)
±2 kV line(s) to line(s)
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
>95% dip for 0.5 cycle
60% dip for 5 cycles
30% dip for 25 cycles
>95% dip for 5 seconds
>95% dip for 0.5 cycle
60% dip for 5 cycles
30% dip for 25 cycles
>95% dip for 5 seconds
Mains power quality should be that of a
typical commercial or hospital environment. If
the user of the ProBP 3400 digital
blood-pressure device requires continued
operation during a power mains interruption,
it is recommended that the ProBP 3400 digital
blood-pressure device be powered from an
uninterruptible power supply or battery.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Welch Allyn ProBP 3400 digital blood-pressure device
Electromagnetic compatibility (EMC) compliance (80017751A)
3
Electromagnetic immunity
The ProBP 3400 digital blood-pressure device is intended for use in the electromagnetic environment specified below.
The customer or the user of the ProBP 3400 digital blood-pressure device should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Compliance
level
Guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the ProBP 3400 digital
blood-pressure device, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1.2
P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2
P
d = 2.3
P
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts according to the transmitter
manufacturer and d is the recommended separation distance
in meters.
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site surveya, should be less than the
compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked
with the following symbol:
Note 1
At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio 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 the ProBP 3400 digital blood-pressure device is used exceeds the applicable RF compliance
level above, the ProBP 3400 digital blood-pressure device should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating the ProBP 3400 digital blood-pressure device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
4
Electromagnetic compatibility (EMC) compliance (80017751A)
Welch Allyn ProBP 3400 digital blood-pressure device
Recommended separation distances between portable and mobile RF communications equipment
and the ProBP 3400 digital blood-pressure device
The ProBP 3400 digital blood-pressure device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ProBP 3400 digital blood-pressure device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the ProBP 3400 digital blood-pressure device as recommended below, according to the
maximum output power of the communications equipment.
Separation distance (meters) according to frequency of transmitter
Rated maximum output
power (watts) of transmitter
150 kHz to 80 MHz
d = 1.2 P
80 MHz to 800 MHz
d = 1.2 P
800 MHz to 2.5 GHz
d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(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.
Note 1
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
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