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

Electromagnetic compatibility (EMC) compliance Guidance and manufacturer’s declaration
Welch Allyn CP 50 Electrocardiograph
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 CP 50 Electrocardiograph and accessories comply 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 CP 50 Electrocardiograph near
other equipment.
Electromagnetic emissions
The CP 50 Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or
the user of the CP 50 Electrocardiograph should assure that it is used in such an environment.
Emissions test
Compliance
Guidance
RF emissions
CISPR 11
Group 1
The CP 50 Electrocardiograph 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.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
The CP 50 Electrocardiograph is suitable for use in all
establishments other than domestic and those directly connected to
the public low-voltage power supply network that supplies buildings
used for domestic purposes.
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies
2
Electromagnetic compatibility (EMC) compliance (80017752A)
Welch Allyn CP 50 Electrocardiograph
Electromagnetic immunity
The CP 50 Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or
the user of the CP 50 Electrocardiograph should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Electrostatic discharge ±6 kV contact
(ESD)
±8 kV air
IEC 61000-4-2
Compliance level
±6 kV contact
±8 kV air
Guidance
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 ±2 kV for power
lines
supply lines
±1 kV for input/output Not applicable
lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IED 61000-4-5
±1 kV differential mode ±1 kV differential
±2 kV common mode
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
>95% dip in 0.5 cycle
60% dip in 5 cycles
30% dip in 25 cycles
>95% dip in 5 seconds
>95% dip in 0.5 cycle
60% dip in 5 cycles
30% dip in 25 cycles
>95% dip in 5 seconds
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the CP 50 Electrocardiograph
requires continued operation during a power
mains interruption, it is recommended that
the CP 50 Electrocardiograph 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 CP 50 Electrocardiograph
Electromagnetic compatibility (EMC) compliance (80017752A)
Electromagnetic immunity
The CP 50 Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or
the user of the CP 50 Electrocardiograph 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 CP 50
Electrocardiograph, 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 CP 50 Electrocardiograph is used exceeds the applicable RF compliance level above, the
CP 50 Electrocardiograph should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the CP 50 Electrocardiograph.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
3
4
Electromagnetic compatibility (EMC) compliance (80017752A)
Welch Allyn CP 50 Electrocardiograph
Recommended separation distances between portable and mobile RF communications equipment
and the CP 50 Electrocardiograph
The CP 50 Electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the CP 50 Electrocardiograph can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
CP 50 Electrocardiograph 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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