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(14) INFORMATION ABOUT ELECTROMAGNETIC
COMPATIBILITY (EMC)
All the information given below comes from standard requirements to which electromedical devices are
subject as defined by the IEC60601-1-2 standard.
The device radio-frequency emissions are very low and are not therefore likely to cause interference with
electronic equipment installed nearby (radios, computers, phones, etc.). Nevertheless, users will make sure
that possible electromagnetic interferences do not create an additional risk, such as from radio-frequency
emitters or other electronic devices.
The device is designed to withstand foreseeable interferences from electrostatic discharges, magnetic fields
from mains power supplies or radio-frequency emitters. Nevertheless, some types of mobile
telecommunications devices such as mobile phones may interfere with the medical device. The separation
distances recommended in this section must therefore imperatively be respected.
In this section, you will find the information required to guarantee the installation and commissioning of your
medical device in the best conditions in terms of electromagnetic compatibility.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
WARNING: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the Dr Aktive® Cryo Pro,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
• Electromagnetic emissions
The device is designed for use in the electromagnetic environment described in the table below.
The user and installer must make sure the device is used in the environment described below.
Emissions tests
Compliance
Electromagnetic radiation
interference
Group 1
(radiated emissions)
CISPR 11
Interference voltage at the supply
terminals
(conducted emissions)
CISPR 11
Harmonic current emissions
IEC 61000-3-2
Voltage variations, voltage
fluctuations and flicker
Compliant
IEC 61000-3-3
• Magnetic and electromagnetic immunity
The device is designed for use in the magnetic and electromagnetic environment described in the table
below.
Users and installers must guarantee the compliance of the electromagnetic environment.
Test level as per
Immunity tests
IEC60601
±8 kV in contact
Electrostatic
discharges (ESD)
±2,4,8,15kV in the
±2,4,8,15kV in the
IEC 61000-4-2
air
Fast electric
±2 kV for
transients / bursts
electricity supply
IEC 61000-4-4
lines
±0.5, 1 kV
in differential
Shock waves
mode
IEC 61000-4-5
±0.5, 1, 2 kV
in common mode
Magnetic field at the
assigned industrial
30A/m
frequency
IEC 61000-4-8
0% U
for 0.5
T
cycles
at 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
Voltage dips, short
0% U
for 1 cycle
T
power cuts and
voltage variations
70% U
T
IEC 61000-4-11
for 25 cycles at
50Hz
for 30 cycles at
60Hz
single phased at
0°
0% U
T
Voltage
for 250 cycles at
interruptions
50Hz
IEC 61000-4-11
for 300 cycles at
60Hz
REMARK: U
corresponds to the alternating network voltage before application of the test level.
T
Electromagnetic environment - Remarks
The device only uses radio-frequency energy for
its internal operation. As a result, its radio-
frequency emissions are very low and are not
likely to create any interference with neighbouring
equipment.
Class B
The device is suitable for use in a home healthcare
environment and in a professional healthcare
Class A
establishment environment.
Compliance level
Electromagnetic environment - Remarks
±8 kV in contact
The device is suitable for use in a home
healthcare environment and in a
professional healthcare establishment
air
environment.
The quality of the electricity supply grid must
±2 kV for
be equivalent to that of a home healthcare
electricity supply
environment and a professional healthcare
lines
establishment environment.
±0.5, 1 kV
in differential
The quality of the electricity supply grid must
mode
be equivalent to that of a home healthcare
environment and a professional healthcare
±0.5, 1, 2 kV
establishment environment.
in common mode
The magnetic field intensity must be of the
same level as that of a home healthcare
30A/m
environment and a professional healthcare
establishment environment.
0% U
for 0.5
T
cycles
at 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
The quality of the electricity supply grid must
0% U
for 1 cycle
T
be equivalent to that of a home healthcare
environment and a professional healthcare
70% U
T
establishment environment.
for 25 cycles at
50Hz
If the use of the device requires continued
for 30 cycles at
use during mains power outages, it is
60Hz
recommended to supply the medical system
single phased at
using a separate power source (UPS, etc.)
0°
0% U
T
for 250 cycles at
50Hz
for 300 cycles at
60Hz
• Electromagnetic immunity, portable RF equipment
The device is designed for use in the magnetic and electromagnetic environment described in the table
below.
Users and installers must guarantee the compliance of the electromagnetic environment.
Immunity tests
Test level
3V/m from 80MHz to
2.7GHz
Radiated radio-
80%MA at 1kHz
frequency
electromagnetic fields
10V/m from 80MHz to
IEC 61000-4-3
2.7GHz
80% MA at 1kHz
9 V/m
710MHz,745MHz,
780MHz,5240MHz,
5550MHz,5785MHz
Proximity fields emitted
by wireless radio-
27 V/m
frequency
385MHz
communications
devices
28 V/m
IEC 61000-4-3
450MHz,810MHz,
870MHz,930MHz,
1720MHz,1845MHz,
1970MHz,2450MHz
3V from 150kHz to 80MHz
Conducted interference
6V in the ISM band and
induced by radio-
band included between
frequency fields
0.15MHz and 80MHz,
IEC 61000-4-6
including the amateur
radio band
80%MA at 1kHz
The electromagnetic field intensity of static radio-frequency emitters as determined by an electromagnetic
environment measurement (a), must be less than the conformity level for each frequency range.
Interference can occur near equipment identified by the following symbol.
REMARK: These specifications may not apply in all situations. Electromagnetic propagation is influenced by
the absorption and reflection of structures, objects and persons.
(a) The electromagnetic field intensity of static radio-frequency emitters such as mobile phone base
stations (cell / cordless), mobile radios, amateur radios, AF/FM radio emissions and TV emissions
cannot be accurately determined by the theory.
To assess the electromagnetic environment due to the static radio-frequency emitters, an
electromagnetic environment measurement must be carried out. If the measured intensity of the
radio-frequency field in the immediate product use environment exceeds the radio-frequency
conformity level specified above, the product performances must be tested to check that they are
compliant with specifications. If abnormal performances are found, additional measurements may be
needed, such as reorienting or moving the product.
EN
Electromagnetic
Compliance level
environment - Remarks
3V/m from 80MHz to
The device is suitable
2.7GHz
for use in a home
80%MA at 1kHz
healthcare
environment and in a
10V/m from 80MHz to
professional healthcare
2.7GHz
establishment
80% MA at 1kHz
environment.
9 V/m
710MHz,745MHz,
780MHz,5240MHz,
5550MHz,5785MHz
The device is suitable
for use in a home
27 V/m
healthcare
385MHz
environment and in a
professional healthcare
28 V/m
establishment
450MHz,810MHz,
environment.
870MHz,930MHz,
1720MHz,1845MHz,
1970MHz,2450MHz
3V from 150kHz to 80MHz
The device is suitable
for use in a home
6V in the ISM band and
healthcare
band included between
environment and in a
0.15MHz and 80MHz,
professional healthcare
including the amateur
establishment
radio band
environment.
80%MA at 1kHz
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