Appendix B: Electromagnetic Compatibility (Emc) - Interacoustics Sera Instructions For Use Manual

Appendix B: Electromagnetic Compatibility (EMC)

This equipment is suitable in hospital and clinical 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.
NOTICE: ESSENTIAL PERFORMANCE for this equipment is defined by the manufacturer as:
This equipment 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.
Use of this equipment adjacent to 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.
Use of accessories 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 and cables can be found in this section.
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 equipment, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result in
improper operation.
This equipment complies 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 instructions for maintenance comply with EMC and can be found in the general
maintenance section in this instruction. No further steps required.
To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use only
the following accessories as applicable:
Item
Preamplifier
OWA Probe
Snap Probe
IP30 50Ohm stereo ID earphone
IP30 50Ohm earcup stereo ID
headset
Anyone connecting additional equipment is responsible for making sure the system complies with the IEC
60601-1-2 standard.
Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and cable
lengths are as specified below:
Description
Power Supply
Wireless charger/cradle
Audiometric Insert-Headsets (IP30)
Ear Probes (OWA / Snap)
Preamplifier
Electrode cables
The use of the accessories, transducers and cables with medical equipment/system other than this
equipment may result in increased emissions or decreased immunity of the medical equipment/system.
D-0113323-F – 2020/11
Sera™ - Instructions for Use - US
Manufacturer
Interacoustics
RadioEar
RadioEar
RadioEar
RadioEar
Length (meter)
1,5
-
0,25
0,50
1,15
0,51
Model
-
-
-
IP30
IP30
Screened (Yes/No)
N
-
Y
Partial
Partial
N
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