Publicité
Les langues disponibles
Les langues disponibles
Instructions for use
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.
Warning: Don't near active HF surgical equipment and the RF shielded room of an ME system
for magnetic resonance imaging, where the intensity of EM disturbances is high.
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 equipment (detail model name), including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
If any: a list of all cables and maximum lengths of cables (if applicable), transducers
and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and
that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the
requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may
be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by
MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).
If any: the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be
ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the
ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term
"ESSENTIAL PERFORMANCE" need not be used).
Technical description
1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE
with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer's declaration - electromagnetic emissions and Immunity
Table 1
Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Appendix F: EMC Information
121
www.spengler.fr
Compliance
Group 1
Class A
Class A
Applied
Publicité
