Electromagnetic Compatibility (Emc) - Interacoustics AD629 Instructions For Use Manual

5.4 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 accessories specified in section 1.3
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
Monitor Headset
w. microphone
Bone Conductors
Audiometric Headsets
Talk Back Microphone Clip-On
Free field speakers
Patient response switch
USB cable
D-0133833-A – 2022/09
AD629 - Instructions for Use - EN
Length (m)
2.9
2.0
2.0
1.9
0.6+0.9
2.0
1.9
Screened (Yes/No)
Yes
No
Yes
Yes
Yes
Yes
Yes
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