6.4 Electromagnetic Compatibility (EMC)
ESSENTIAL PERFORMANCE for this device is defined by the manufacturer as:
• This device 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.
This device is in compliance with IEC 60601-1-2:2014+AMD1:2020, 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.
To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is
essential to use only the following accessories (see Table 6). Conformance to the EMC
requirements as specified in IEC 60601-1-2 is ensured if the cable types and cable
lengths are as specified in Table 6.
Table 6 EMC Requirements – Accessories
Portable and mobile RF communications equipment can affect the easyTone. Install and operate the device
according to the EMC information presented in this chapter.
The device has been tested for EMC emissions and immunity as a standalone device. Do not use the device
adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should
verify normal operation in the configuration.
The use of accessories, transducers and cables other than delivered from MAICO, with the exception of servicing
parts sold by MAICO as replacement parts for internal components, may result in increased emissions or decreased
immunity of the device.
Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601-
1-2 standard.
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