Welch Allyn ProBP 2400 User Manual page 36

Annex of Report
Manufacturer's Declaration of the EUT
(altogether 5 pages)
Report No.: TRE14120020
Guidance and manufacturer's declaration – electromagnetic emission –
for all EQUIPMENT AND SYSTEMS
1
Guidance and manufacturer's declaration – electromagnetic emission
The ProBP 2400 Digital Blood Pressure Device is intended for use in the
2 electromagnetic environment specified below. The customer or the user of ProBP 2400
Digital Blood Pressure Device should assure that it is used in such an environment.
3
Emissions test Compliance
RF emissions
4
Group 1
CISPR 11
RF emissions
5 Class B
CISPR 11
Harmonic emissions
6 Class A
IEC 61000-3-2
Voltage fluctuations
/
7
flicker emissions Complies
IEC 61000-3-3
36
A 2 Issued: 2014-12-15
Electromagnetic environment - guidance
The ProBP 2400 Digital Blood Pressure
Device 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.
The ProBP 2400 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.
Guidance and manufacturer's declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer's declaration – electromagnetic immunity
The ProBP 2400 Digital Blood Pressure Device is intended for use in the electromagnetic environment specified
below. The customer or the user of the ProBP 2400 Digital Blood Pressure Device should assure that it is used
in such an environment.
IEC 60601
Immunity test
test level
Electrostatic
± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
± 2 kV for power
Electrostatic supply lines
transient / burst
± 1 kV for input/
IEC 61000-4-4 output
lines
± 1 kV differential
Surge mode
IEC 61000-4-5 ± 2 kV common
mode
< 5 % U
T
(>95 % dip in U )
T
for 0.5 cycle
Voltage dips, short 40 % U
T
interruptions and (60 % dip in U )
T
voltage variations for 5 cycles
on power supply
input lines 70 % U
T
(30 % dip in U )
T
IEC 61000-4-11 for 25 cycles
< 5 % U
T
(>95 % dip in U )
T
for 5 sec
Power frequency
(50/60 Hz)
magnetic field 3 A/m
IEC 61000-4-8
NOTE U is the a. c. mains voltage prior to application of the test level.
T
Electromagnetic environment -
Compliance level
guidance
Floors should be wood, concrete or
± 6 kV contact
ceramic tile. If floors are covered
with synthetic material, the relative
± 8 kV air
humidity should be at least 30 %.
± 2 kV for power
Mains power quality should be
supply lines
that of a
typical commercial or hospital
± 1 kV for input/output
environment.
lines
Mains power quality should be
± 1 kV differential mode
that of a
typical commercial or hospital
± 2 kV common mode
environment.
< 5 % U
T
(>95 % dip in U )
Mains power quality should be
T
for 0.5 cycle
that of a
typical commercial or hospital
40 % U
environment. If the user of the
T
(60 % dip in U )
ProBP 2400 Digital Blood Pressure
T
for 5 cycles
Device requires continued
operation during power mains
70 % U
interruptions, it is recommended
T
(30 % dip in U )
that the ProBP 2400 Digital Blood
T
for 25 cycles
Pressure Device be powered from
an uninterruptible power supply
< 5 % U
or a battery.
T
(>95 % dip in U )
T
for 5 sec
Power frequency magnetic fields
should be at levels characteristic
3 A/m of a typical location in a
typical commercial or hospital
environment.