Use Instructions

IFU-EUA Rev. 01
Date: 01Sep2020
Page 14 of 17
Guidance and Declaration – Electromagnetic Immunity
(For ME equipment ME system that are not life-supporting)
The Cardi/o
®
Sensor is intended for use in the electromagnetic environment specified below. The end user of the
device should assure that it is used in such an environment.
Immunity test Compliance level
Electromagnetic environment- guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 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%.
Radiated RF [24.0 – 24.25 GHz]
IEC 61000-4-3
5 mW/cm
2
(uncontrolled )
1 mW/cm
2
(uncontrolled )
Portable and mobile RF communications equipment
should be used no closer to any part of the Cardi/o
®
Sensor device than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter. Recommended
separation distance:
Pd = (Pout*G) / (4*pi*r
2
Where:
Pd = power density in mW/cm2
Pout = output power to antenna in mW
G = gain of antenna in linear scale
Pi = 3.1416
R = distance between observation point and center
of the radiator in cm)
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should
be less than the compliance level in each frequency
range. Interference may occur in the vicinity of
equipment marked with the following symbol:
Electrical fast transient/burst
IEC 61000-4-4
+ 2kV for power
supply lines
Mains power quality should be that of a typical home
healthcare environment.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Voltage Dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
Mains power quality should be that of a typical home
healthcare environment. If the user of the N507
requires continued operation during power mains
interruptions, it is recommended that the Cardi/o
®
Sensor device be powered from an uninterruptible
power supply.
Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people. Note 2: Over the frequency range 1,500 MHz to 1,500-100,000 MHz,
field strengths should be less than 5 mW/cm
2
for uncontrolled environments and less than 1 mW/cm
2
for controlled
environments. Note 3: UT is the a.c. mains voltage prior to application of the test level. (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 device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the device.