EMC GUIDANCE & MANUFACTURER’S DECLARATION
52
OTOWAVE 302+ INSTRUCTION FOR USE
8.
EMC GUIDANCE &
MANUFACTURER’S DECLARATION
•
This instrument is suitable in hospital environments except for near active HF surgical equipment and RF
shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic
disturbance is high
•
Use of this instrument adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this instrument and the other equipment should be observed
to verify that they are operating normally
•
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. The list of accessories, transducers and cables can be found in
this appendix
•
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 this instrument, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment could result
NOTICE
•
ESSENTIAL PERFORMANCE for this instrument is defined by the manufacturer as:
This instrument does not have an ESSENTIAL PERFORMANCE Absence or loss of ESSENTIAL PERFORMANCE
cannot lead to any unacceptable immediate risk
•
Final diagnosis shall always be based on clinical knowledge There are no deviations from the collateral standard
and allowances uses
•
This instrument is in compliance with IEC60601-1-2:2014, emission class B group 1
NOTICE:
There
are
no
deviations
from
the
collateral
standard
and
allowances
uses
NOTICE: All necessary instruction for maintaining compliance with regard to EMC can be found in the general
maintenance section in this instruction. No further steps required.
CAUTION
Содержание Otowave 302+
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