Electromagnetic Compatibility - EMS AIRFLOW Prophylaxis Master Instructions For Use Manual

9.2. Electromagnetic Compatibility

The use of parts other than those supplied or listed as accessory may negatively affect EMC performance.
The device has embedded a low power, 8 dBm EIRP max, Bluetooth 2.4 GHz module, for communication with the
wireless pedal. This radio module is disabled when a wired pedal is connected (device reboot required).
The Bluetooth module complies with all the restrictions foreseen by the ERC recommendations 70-03 for the CEPT
countries concerning the Annex 3 (Wideband Data Transmission System band A 2400-2483.5 MHz) without requiring any
modifications of the products by the user.
The product is intended for use and Basic Safety is maintained in the electromagnetic environment specified below.
The customer or the user of this product should assure that it is used in such an environment.
Electromagnetic immunity compliance
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3
Notes:
- UT is the a. c. mains voltage prior to application of the test level.
- At 80 MHz and 800 MHz, the higher frequency range applies.
- These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
6
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 product is used exceeds the applicable RF compliance level above, the product should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
product.
7
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
ENGLISH
IEC 60601 test level Compliance level
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines 100 kHz repetition
frequency
± 1 kV for input/output lines 100 kHz repetition
frequency
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<5 % UT (>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
0 % UT for 0,5 cycle at 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % UT for 1 cycle single phase
<5 % UT (>95 % dip in UT) for 5 s
0% UT for 250 cycles
30 A/m 30 A/m (50 Hz or 60
3 V
150 kHz to 80 MHz
6V in ISM bands
150kHz and 80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
See Table below
FB-618/AU – rev.E – ed.2019/08
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, relative humidity should be > 30%.
Mains power quality should be that of a typical commercial or
hospital environment.
Mains power quality should be that of a typical commercial or
hospital environment.
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the product requires continued
operation during power mains interruptions, it is recommended that
the product be powered from an uninterruptible power supply or a
battery.
Power frequency magnetic fields should be at levels characteristic
Hz) of a typical location in a typical commercial or hospital
environment.
3 V Portable and mobile RF communications equipment should be
used no closer to any part of the product, including cables, than
the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.17 √P, d = 1.17 √P 80 MHz to 800 MHz, d = 2.4 √P 800
MHz to 2.7 GHz
3 V/m where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey
level in each frequency range
Interference may occur in the vicinity of equipment marked with the
following symbol:
, should be less than the compliance
6
.
7
or
45/48