Instructions for use: Ikus - Berlin Heart

14.3 Electromagnetic immunity - Part 2
Electromagnetic immunity - Part 2
The EXCOR stationary Driving Unit Ikus system is intended for operation in the electromagnetic
environment described below. The customer or user of the EXCOR stationary
Driving Unit Ikus system must ensure that it is used in such an environment.
Noise immunity tests IEC 60601 testing level Compliance level
Derived HF disturbance
variable according to
IEC 61000-4-6
Irradiated HF disturbance
variable according to
IEC 61000-4-3
3 V eff
150 kHz to 80 MHz
outside of the ISM
bands a
10 V eff
150 kHz to 80 MHz
within the ISM bands a
10 V/m
80 MHz to 2.5 GHz
[V 1]=10 V
[V 2]=10 V
[E 1 ]=10 V/m
Electromagnetic environment -
guidelines
Wearable and mobile radio devices
should not be used at a shorter distance
from the EXCOR stationary Driving Unit
Ikus system including its cables than the
recommended protection distance
calculated according to the appropriate
equation for the transmission
frequencies.
Recommended protection distance
d = 0,
35
d = 1,
2
d = 1,
2
d =
2,
3
80 MHz to 800 MHz
800 MHz to 2.5 GHz
With P as the maximum rated power
of the transmitter in watts (W)
according to the data from the
transmitter manufacturer and d as the
recommended protection distance in
meters (m). b The field strength of
stationary radio transmitters should,
at all frequencies according to an
on-site investigation, c be less than
the compliance level. d Interference is
possible in the vicinity of devices that
bear the following pictogram.
• NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
• NOTE 2 These guidelines may not be applicable to all cases. The propagation of electromagnetic variables is influenced by
absorption and reflections from the building, objects and people.
• a) The ISM frequency bands (for industrial, scientific and medical applications) between 150 kHz and 80MHz are 6,765 MHz
to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz and 40,66MHz to 40,70MHz.
• b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz to
2.5 GHz are set in order to reduce the probability of mobile/wearable communication devices causing interference if they
are inadvertently brought into the vicinity of the patient. For this reason, the additional factor of 10/3 is applied when calculating
the recommended protection distances in these frequency ranges.
• c) The field strength of stationary transmitters, e.g. base stations for cellular telephones and mobile terrestrial radio devices,
amateur radio stations, AM and FM radio and television transmitters can theoretically not be predetermined precisely.
To determine the electromagnetic environment with respect to the stationary transmitter, a study of the site should be considered.
If the measured field strength at the location exeeds the above conformance level, the normal operation for the
EXCOR stationary Driving Unit Ikus system must be monitored at each site of use to demonstrate proper function. If unusual
performance features are observed, additional corrective action may be required, e.g. a modified orientation or another
site for the EXCOR stationary Driving Unit Ikus system .
• d) Over the frequency range 150 kHz to 80 MHz, the field strength should be less than 10 V/m.
1000002 Rev. 4.9.1 103
P
P
P
P