Electromagnetic Compatibility (Emc) - Maico PILOT TEST Operation Manual

6.5 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, emission class B group
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:
Item
Audiometric Headset
Audiometric Headset
Patient response switch
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
Audiometric Headset
Patient response switch
Electromagnetic Compatibility (EMC)
Portable and mobile RF communications equipment can affect the PILOT TEST. Install and operate the PILOT TEST according to the
EMC information presented in this Section.
The PILOT TEST has been tested for EMC emissions and immunity as a standalone device. Do not use the PILOT TEST 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 those specified, 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.
Guidance and manufacturer's declaration - electromagnetic emissions
The PILOT TEST is intended for use in the electromagnetic environment specified below. The customer or the user of the
PILOT TEST should assure that it is used in such an environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Rev.
8504660 3
Operation Manual PILOT TEST
Manufacturer
Radioear
Radioear
Radioear
Length (m)
2.0
2.0
Compliance
Group 1
Class B
Complies
Class A Category
Complies
Model
DD45
DD65 V2
APS3
Electromagnetic environment - guidance
The PILOT TEST uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The PILOT TEST is suitable for use in all commercial, industrial,
business, and residential environments.
40
Screened (Yes/No)
Yes
Yes
06/11/2019