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Guidance and manufacturer’s declaration – Electromagnetic immunity
Patient coupling port
The Translux Wave device is designed to work in the electromagnetic environment specified below.
The client or user of the Translux Wave device should always make sure that it is used only in such environment.
Phenomenon
Basic EMC standard
or test method
Immunity test levels
Electromagnetic environment – Guidance
Electrostatic
discharge (ESD)
c)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Floors must be wood, concrete or ceramic.
If the floor is lined with synthetic materials,
the relative humidity should be at least
30 %
Conducted distur-
bances induce by
RF fields
a)
IEC 61000-4-6
3 V
b)
0,15 MHz - 80 MHz
6 V
b)
in ISM bands between
0,15 MHz and 80 MHz
80 % AM at 1 KHz
Portable or mobile RF communication
device must not be used in close proximity
of the product, including its cables, except
when these respect the distances of sepa-
ration recommended and calculated from
the equation applicable to the frequency of
the transmitter.
a) The following apply:
– All PATIENT-COUPLED cables shall be tested, either individually or bundled
– PATIENT-COUPLED cables shall be tested using a current clamp unless a current clamp is not suitable. In cases where a current clamp is not suitable, an
EM clamp shall be used.
– No intentional decoupling device shall be used between the injection point and the PATIENT COUPLING POINT in any case.
– Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
– Tubes that are intentionally filled with conductive liquids and intended to be connected to a PATIENT shall be considered to be PATIENT-COUPLED cables.
– If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional test frequency shall be used in the ISM or amateur radio
band. This applies to each ISM and amateur radio band within the specified frequency range.
– The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz
to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0, 15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz,
5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18, 17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to
24,99 MHz, 28,0 MHz to 29, 7 MHz and 50,0 MHz to 54,0 MHz.
b) r.m.s., before modulation is applied
c) Discharges shall be applied with no connection to an artificial hand and no connection to PATIENT simulation. PATIENT simulation may be connected after the
test as needed in order to verify BASIC SAFETY and ESSENTIAL PERFORMANCE.
Summary of Contents for 05100081
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