Maico MA 33 User Manual

Operation Manual MA 33
8100092 Rev. 9
81
19/08/2019
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
Manufacturer
Model
Audiometric Headset
Radioear
DD45
Audiometric Headset
Radioear
DD65v2
Patient response switch
Radioear
APS3
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
Length (m)
Screened (Yes/No)
Audiometric Headset
2.0
Yes
Patient response switch
2.0
Yes
Electromagnetic Compatibility (EMC)
Portable and mobile RF communications equipment can affect the MA 33. Install and operate the MA 33 according to the EMC information
presented in this chapter.
The MA 33 has been tested for EMC emissions and immunity as a standalone MA 33. Do not use the MA 33 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 Instrument is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument should
assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The MA 33 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.
RF emissions
CISPR 11
Class B
The MA 33 is suitable for use in all commercial, industrial, business, and
residential environments.
Harmonic emissions
IEC 61000-3-2
Not Applicable
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Not applicable

Maico MA 33 Specifications

General

Brand	Maico
Model	MA 33
Category	Medical Equipment
Language	English