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Operation Manual MA 1  

 

8100216 Rev. 5 

20 

09/03/2023 

 

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 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 accessories listed in the following table. Conformance to the 
EMC  requirements  as  specified  in  IEC  60601-1-2  is  ensured  if  the  cable  types  and 
cable lengths are as specified. 

 
 

Guidance and manufacturer’s declaration - electromagnetic emissions 

The 

MA 1 

is intended for use in the electromagnetic environment specified below. The customer or the user of the 

MA 1 

should 

assure that it is used in such an environment. 

Emissions Test

 

Compliance

 

Electromagnetic environment - guidance 

RF emissions 
CISPR 11 

Group 1 

The 

MA 1 

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 1 

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 
 

 
 

Recommended separation distances between 

portable and mobile RF communications equipment and the MA 1.

 

The 

MA 1 

is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or 

the user of the 

MA 1 

can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile 

RF communications equipment (transmitters) and the 

MA 1 

as recommended below, according to the maximum output power of the 

communications equipment.  

Rated Maximum 

output 

power of transmitter 

[W]

 

Separation distance according to frequency of transmitter 

[m] 

150 kHz to 80 MHz 

= 1.17

√𝑃

 

80 MHz to 800 MHz 

= 1.17

√𝑃

 

800 MHz to 2.7 GHz 

= 2.23

√𝑃

 

0.01

 

0.12 

0.12 

0.23 

0.1

 

0.37 

0.37 

0.74 

1

 

1.17 

1.17 

2.33 

10

 

3.70 

3.70 

7.37 

100

 

11.70 

11.70 

23.30 

For transmitters rated at a maximum output power not listed above, the recommended separation distance 

in meters (m) can be 

estimated using the equation applicable to the frequency of the transmitter, where 

is the maximum output power rating of the 

transmitter in watts (W) according to the transmitter manufacturer. 

Note 1 

At 80 MHz and 800 MHZ, the higher frequency range applies. 

Note 2 

These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from 

structures, objects and people. 

 

 

 

 

 

Summary of Contents for MA 1

Page 1: ...Operation Manual MA 1...

Page 2: ......

Page 3: ...ng and Disinfection Recommendations 8 3 4 Disposables 9 3 5 Components Replacement Parts 9 3 6 Recycling and Disposal 9 4 Unpacking and Installation 10 4 1 Unpacking the System 10 4 2 Hardware Orienta...

Page 4: ...www maico diagnostics com german support resources International https www maico diagnostics com support resources Copyright 2023 MAICO Diagnostics All rights reserved No part of this publication may...

Page 5: ...ENTs hearing healthcare professionals or other trained technicians in a hospital clinic or healthcare facility 1 3 Contraindications of Use The patient is too young sick or uncooperative to perform th...

Page 6: ...ystem including safety information as well as maintenance and cleaning recommendations READ THIS ENTIRE OPERATION MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this...

Page 7: ...is manual accompanying labels and or inserts A defective product should not be used Make sure all connections to external accessories are snug and secured properly Parts which may be broken or missing...

Page 8: ...tion consult accompanying documents Warning consult accompanying documents Return to authorized representative special disposal required Reference number Medical Device Global Trade Item Number Patien...

Page 9: ...calibration Do not use the device if any damage is suspected Calibration of the device The device and the transducers complement each other and share the same serial number i e MA7663252 Therefore the...

Page 10: ...device adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this device and the other equipment should be observed to v...

Page 11: ...t of repair during the guarantee period please enclose evidence of purchase with the device 3 2 Maintenance In order to ensure that the device works properly it has to be checked and calibrated at lea...

Page 12: ...lies that are supplied with your device Ear cushion covers are intended for single use only These should be discarded after use They cannot be cleaned In case of re use of the single use disposables y...

Page 13: ...onent appears to be damaged in shipment contact your distributor immediately to report it Do not attempt to use any component or device that appears to be damaged Reporting Imperfections Notify the ca...

Page 14: ...iometric Headset 2x AA Batteries Carrying Case Operation Manual Quick Guide Audiogram Pad Applied parts according to IEC 60601 1 As download from the download center see accompanying leaflet Table 3 R...

Page 15: ...attery life The device will power off after 90 s of inactivity When batteries get too low to produce the proper signal remaining battery power of 2 1 V or lower the device will shut off and will not t...

Page 16: ...condensation by storing the device in its original packaging If the device is stored under warmer conditions than the use conditions no special precaution are required before use Always ensure proper...

Page 17: ...r Conduction Testing 5 4 1 Screening A hearing screening utilizes a Pass or Refer result and is used to determine if further testing is required as a hearing problem may exist Patients are typically s...

Page 18: ...ither ear would result in a Refer Note When presenting tones be sure to vary the timing of the tone presentation This is to prevent the patient from routinely raising his her hand instead of respondin...

Page 19: ...e disposal of authorized service companies STANDARDS Safety Standards IEC 60601 1 2005 Cor 2006 Cor 2007 A1 2012 Internally powered Type B Applied Parts EMC Standard IEC 60601 1 2 2014 The MA 1 is not...

Page 20: ...ansducers Headband tension DD45 Headband Static Force 4 5 N 0 5 N DD65 v2 Headband Static Force 10 0 N 0 7 N Inputs Tone Accuracy Level 4 dB Precision 5 dB level steps Outputs Left Right Stimuli Prese...

Page 21: ...al MA 1 8100216 Rev 5 18 09 03 2023 6 2 Connections Figure 5 CONNECTIONS No Connection socket Specification 1 Phone ZA 10 UA 7 Veff 6 3 Pin Assignment SOCKET CONNECTOR PIN 1 PIN 2 Phone 3 5 mm Mono Gr...

Page 22: ...lent threshold sound pressure level RETSPL dB re 20 Pa DD45 DD65 v2 500 7 0 26 1 1000 15 0 32 4 2000 26 0 43 6 4000 32 0 43 8 Table 7 Reference Values for Stimulus Calibration REFERENCE VALUES FOR STI...

Page 23: ...o cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The MA 1 is suitable for use in all commercial industrial business and residential environments Harmonic emissions...

Page 24: ...the electromagnetic environment specified below The customer or the user of the MA 1 should assure that it is used in such an environment Immunity test IEC EN 60601 test level Compliance level Electr...

Page 25: ...equirements for Basic Safety and Essential Performance Collateral Standard Electromagnetic Compatibility Requirements and tests 3 DIN EN ISO 14971 2012 Application of risk management to medical device...

Page 26: ...Operation Manual MA 1 8100216 Rev 5 23 09 03 2023 6 7 Checklist for Subjective Device Check...

Page 27: ...ecifications are subject to change without notice MAICO Diagnostics GmbH Sickingenstr 70 71 10553 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E mail sales maico biz Internet www maico b...

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