User Manual

Manufacturer’s Declaration of the EMC
Guidance and manufacturer´s declaration – electromagnetic emission –for all EQUIPMENT AND SYSTEMS
Immunity Test
IEC 60601
Test level
Compliance Level
Electromagnetic Environment -
Guidance
Electrostatic
discharge (ESD)
IEC61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 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 %.
Electrostatic
transient / burst
IEC 61000-4-4
+ 2kV for power
supply lines
+ 1kV for input/output
N/A
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
+ 1kV for differential
mode
+ 2kV common mode
N/A
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
0 % UT; 0,5 cycle g) At 0°,
45°, 90°, 135°, 180°, 225°,
270° and 315° 0 % UT; 1
cycle and 70 % UT; 25/30
cycles at 0°
0 % UT; 250/300 cycle
N/A
Mains power quality should be that of a typical
commercial or hospital environment. If the user of this
device requires continued operation during power mains
interruptions, it is recommended that this device be
powered from an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
NOTE: UT is the a. c. mains voltage prior to application of the test level.
9
Fingertip Pulse Oximeter is intended for use in the electromagnetic environment specified below. The user of this device should assure that
it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions CISPR 11
Group 1
This 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.
RF Emissions CISPR 11
Class B
This device is suitable for use in all establishments, including domestic
establishments and those directly connected to the pubic low-voltage
power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
N/A
Voltage fluctuations /
flicker emissions IEC
61000-3-3
N/A