D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US Page 61
6.4 Electromagnetic compatibility (EMC)
• 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.
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