Declaration of Conformity for EN 60601-1-2
Recommended separation distances between
portable and mobile RF communications equipment and the ME equipment
for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Finger-tip pulse oximeter
can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
tip pulse oximeter as recommended below, according to the maximum output power of the communications
Rated maximum output
power of transmitter
W
Separation distance according to frequ
150 kHz to 80 MHz
d=
1
5,3
V
P
80 MHz to 800 MHz
d=
1
5,3
E
P
800 MHz to 2.5 GHz
d=
1
7
E
P
Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING and
are specified for use only in a shielded location
system is intended for use in the electromagnetic environment specified below.
The customer or the user of the
system should assure that it is used in such a
Immunity test IEC 60601 test level
Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
Portable and mobile RF communications equipment should be
used no closer to any part of the E
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
Interference may occur in the vicinity of equipment marked
with the following symbol.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3V/m
Declaration – electromagnetic immunity
tip pulse oximeter system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Finger-tip pulse oximeter system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
＜
＜＜
＜
(＞
＞＞
＞95 % dip in UT) for 0.5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
＜
＜＜
＜5 % UT
(＞
＞＞
＞95 % dip in UT) for 5 sec
＜
＜＜
＜
(＞
＞＞
＞95 % dip in UT) for 0.5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
＜
＜＜
＜5 % UT
(＞
＞＞
＞95 % dip in UT) for 5 sec
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the EQUIPMENT or SYSTEM
requires continued operation during power
mains interruptions, it is recommended th
the EQUIPMENT or SYSTEM be powered
from an uninterruptible power supply or a
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
cal commercial or hospital environment.
Declaration – electromagnetic emissions
is intended for use in the electromagnetic environment specified below. The customer or the user of
the Finger-tip pulse oximeter should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
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
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.
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