Electromagnetic Emissions - Canary CanarE System Instructions For Use Manual

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the pins using the rounded tip finger of the ESD generator. The exception is that the
only connector pins that are tested are those that can be contacted or touched,
under conditions of INTENDED USE, by the standard test finger illustrated in Figure
6 of the general standard, applied in a bent or straight position.
Capacitive coupling shall be used.
If the frequency stepping skips over an industrial, scientific and medical (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.
r.m.s., before modulation is applied.
The ISM bands between 150 kHz 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.

16.3. Electromagnetic Emissions

The CTE implant and CanarE device are intended for use in the electromagnetic environment
specified in Table 9. Make sure that the transmitter is used in such an environment.
Phenomenon
Conducted and
radiated RF Emissions
Harmonic distortion
Voltage fluctuations
and flicker
This test is not applicable in this environment unless the ME EQUIPMENT and ME
SYSTEMS used there will be connected to the PUBLIC MAINS NETWORK and the
power input is otherwise within the scope of the Basic EMC standard.
ME EQUIPMENT and ME SYSTEMS intended for use in aircraft shall meet the RF
EMISSIONS requirements of ISO 7137. The conducted RF EMISSIONS test is
applicable only to ME EQUIPMENT and ME SYSTEMS that are intended to be
connected to aircraft power. ISO 7137 is identical to RTCA DO-160C:1989 and
EUROCAE ED- 14C:1989. The latest editions are RTCA DO-160G:2010 and
EUROCAE ED-14G:2011. Therefore, use of Section 21 (and category M) of a more
recent edition, e.g., [39] or [40], should be considered.
Standards applicable to other modes or EM ENVIRONMENTS of transportation for
which use is intended shall apply. Examples of standards that might be applicable
include CISPR 25 and ISO 7637-2.
Page | 32
Table 9: Electromagnetic Emissions
Professional Healthcare
Facility Environment
CISPR 11
See IEC 61000-3-2
b)
See IEC 61000-3-3
b)
Instructions for Use
Rev. 4
Home Healthcare
a)
Environment
CISPR 11
c), d)
See IEC 61000-3-2
See IEC 61000-3-3
CanarE System

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