12
EMC Declaration
IEC 60601-1-2
：
2014 ME EQUIPMENT and ME SYSTEMS identification, marking and
documents for Class B product
Instructions for Use
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warning
：
Do not use 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 thermometer,
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).