Medel SENSE Instrucciones De Uso página 107

IEC 60601-1-2-2014 ME EQUIPMENT and ME SYSTEMS
identification, marking and documents for Class B
product
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 equip-
ment 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 (inclu-
ding peripherals such as antenna cables and external anten-
nas) should be used no closer than 30 cm (12 inches) to any
part of the MEDEL SENSE 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 EQUIP-
MENT or ME SYSTEM with the requirements of Clause
7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSO-
RIES may be specified either generically (e.g. shielded
cable, load impedance) or specifically (e.g. by MANUFAC-
TURER and EQUIPMENT OR TYPE REFERENCE).
If any: the performance of the ME EQUIPMENT or ME
SYSTEM that was determined to be ESSENTIAL PERFOR-
MANCE 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).
1.All necessary instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electroma-
gnetic disturbances for the excepted service life.
2. Guidance and manufacturer's declaration -electromagne-
tic emissions and Immunity
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