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Operation Manual MA 28

 

 

 

 

 

 

8506915 Rev. 3

 

38 

15/11/2017 

 

Voltage dips, short 
interruptions and voltage 
variations on power 
supply lines  
 
IEC 61000-4-11 

 

< 5% 

U

T  

(>95% dip in 

U

T) for 0.5 cycle 

 
40% 

U

T  

(60% dip in 

U

T) for 5 cycles 

 
70% 

U

T  

(30% dip in 

U

T) for 25 cycles 

 
<5% 

U

T  

(>95% dip in 

U

T) for 5 sec

 

< 5% UT (>95% dip in UT) 

for 0.5 cycle 

40% UT (60% dip in UT) for 

5 cycles 

70% UT (30% dip in UT) for 

25 cycles 

<5% U

Power supply quality should be that of 
a typical commercial or residential 
environment. If the user of the MA 28 
requires continued operation during 
power supply interruptions, it is 
recommended that the MA 28 be 
powered from an uninterruptable 
power supply or its battery. 

 

Power frequency (50/60 
Hz) 
 
IEC 61000-4-8

 

3 A/m

 

3 A/m

 

Power frequency magnetic fields 
should be at levels characteristic of a 
typical location in a typical commercial 
or residential environment.

 

Note: U

T is the A.C. supply voltage prior to application of the test level. 

 

Guidance and manufacturer’s declaration — electromagnetic immunity 

The MA 28 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 28 should 
assure that it is used in such an environment, 
Immunity test 

IEC / EN 60601 
test level 

Compliance level 

Electromagnetic environment 

– 

guidance 

 
 
 
 
 
 
 
 
 
 
Conducted RF 
IEC / EN 61000-4-6 
 
 
Radiated RF 
IEC / EN 61000-4-3 
 

 
 
 
 
 
 
 
 
 
 
3 Vrms 
150kHz to 80 MHz 
 
 
3 V/m 
80 MHz to 2,5 GHz 

 
 
 
 
 
 
 
 
 
 
3 Vrms 
 
 
 
3 V/m 

Portable and mobile RF 
communications equipment should be 
used no closer to any parts of the 
MA 28, including cables, than the 
recommended separation distance 
calculated from the equation 
applicable to the frequency of the 
transmitter. 
 
Recommended separation distance 

P

d

2

,

1

 

P

d

2

,

1

  

80 MHz to 800 MHz

 

P

d

3

,

2

 

800 MHz to 2,5 GHz

 

 
Where 

P

 is the maximum output 

power rating of the transmitter in watts 
(W) according to the transmitter 
manufacturer and 

d

 is the 

recommended separation distance in 
meters (m). 
 
Field strengths from fixed RF 
transmitters, as determined by an 
electromagnetic site survey, (a) 
should be less than the compliance 
level in each frequency range (b) 
 
Interference may occur in the vicinity 
of equipment marked with the 
following symbol: 

 

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies 
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from 
structures, objects and people. 

(a)   

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, 

amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the 
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 
strength in the location in which the MA 28 is used exceeds the applicable RF compliance level above, the MA 28 should be observed 
to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or 
relocating the MA 28. 

(b)  

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 

 

Summary of Contents for MA 28

Page 1: ...Operation Manual MA 28...

Page 2: ...Maintenance 11 3 3 Cleaning and Disinfection Recommendations 12 3 4 Disposables 13 3 5 Accessories Replacement Parts 13 3 6 Recycling and Disposal 13 4 Unpacking and Hardware Orientation 14 4 1 Unpac...

Page 3: ...ico biz Copyright 2017 MAICO Diagnostics All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of MAICO Diag...

Page 4: ...different MAICO MA 28 functions as quick and as easy as possible Should you encounter any problems or have ideas for any further improvements we are only a phone call away Please do not hesitate to co...

Page 5: ...intensities to test for hearing loss It features pure tone audiometric testing with or without masking for measuring audibility thresholds MA 28 is meant to be used with headphones that are calibrate...

Page 6: ...y information as well as maintenance and cleaning recommendations READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this manual All images and screensho...

Page 7: ...uctions contained in this 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 m...

Page 8: ...of manufacture Manufacturer Caution consult accompanying documents Warning consult accompanying documents Return to authorized representative special disposal required Reference number Patient applied...

Page 9: ...e device if any damage is suspected Calibration of the device The audiometer and the transducers complement each other and share the same serial number i e 7663252 Therefore the device shall not be us...

Page 10: ...comply with the requirements If in doubt contact qualified medical technician or your local representative If the device is connected to a PC IT equipment forming a system ensure not to touch the pati...

Page 11: ...nment To avoid the risk of electric shock this equipment must only be connected to the power supply delivered by MAICO The device fulfills the relevant EMC requirements Avoid unnecessary exposure to e...

Page 12: ...ar from date of delivery of the device to the original purchaser The device shall only be repaired and serviced by your distributor or by an authorized service center Opening the device case will void...

Page 13: ...of the MA 28 and its accessories by wiping the surfaces with wet Sani Cloth Active wipes or a comparable product Follow the instructions on the specific disinfection product o Wipe before and after ea...

Page 14: ...riate for your MA 28 device configuration Ask your authorized local distributor when accessories need to be replaced 3 6 Recycling and Disposal Within the European Union it is illegal to dispose of el...

Page 15: ...shortage If any component 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 Imperf...

Page 16: ...ble Components Base Unit Database Software with Audiometry Module CD and USB Power Supply UE10WCP1 050200SPA USB Cable DD45 Audiometric Headphones DD65 Audiometric Headphones DD450 High Frequency Head...

Page 17: ...as it may lead to incorrect test results The test room must be at a normal temperature usually from 15 C 59 F to 35 C 95 F and the device should be switched on approximately 10 minutes before the firs...

Page 18: ...ugs with care into the appropriate connection Do not wiggle the plug or pull with force while connected Disconnect plugs cautiously Figure 5 Table 4 Connections on Inside Panel of Device CONNECTIONS 1...

Page 19: ...be used exception a battery driven laptop is used PC CONNECTIONS PC Connection 1 Medical device Medical Device PC Connection 2 Medical device Non Medical Device PC Connection 3 Medical device Non Med...

Page 20: ...ore use If the device has been stored in a colder environment even for shorter time allow the device to become acclimatized This can take a long time depending on the conditions like environmental hum...

Page 21: ...result Press and hold to display a No Response NR result 5 Hz Press to increase the frequency Hz Press to decrease the frequency Hz 6 Hearing Level dB Turns the volume of the tone up down 7 Tone Swit...

Page 22: ...switch is being activated pressed Patient response switch is not activated not pressed Level Hearing Level Displayed on the left side of the screen and indicates the level volume of the tone presente...

Page 23: ...l at the time of selecting Store button Air Level of air conductor transducer Mask Air Non test ear noise level Bone Level of bone conductor transducer Mask Bone Non test ear noise level Figure 10 5 4...

Page 24: ...stlake automatic air conduction threshold test F2 No function F3 No function F4 Back Returns the function key selection to the 1st menu screen 5 5 Preparing for Testing 5 5 1 Preparing the Patient The...

Page 25: ...iometry is to establish the hearing sensitivity at various frequencies The test can specify the AC loss but cannot distinguish between conductive versus a sensorineural abnormality 5 6 1 2 Threshold D...

Page 26: ...hones or inserts based on the test ear selected The masking is turned on by rotating the Masking Level dB level control dial to the right The masking sound should be continuously presented for effecti...

Page 27: ...ncorporated into the test process See section 5 7 for more information on this setting 5 7 Tone Setup Menu To access the MA 28 Tone Setup menu press F1 and F4 simultaneously for 2 3 seconds Once in th...

Page 28: ...ensity To select the default intensity when the noise is turned on using the Masking Level dB level control dial Choose between 0 dB to 50 dB Masking type To select between Narrowband NB and White noi...

Page 29: ...00 Hz 750 Hz 1500 Hz 2000 Hz 3000 Hz 4000 Hz 6000 Hz and 8000 Hz Bone Frequencies To select the frequencies to be active during the bone conduction test by setting them On Off Press Change to toggle b...

Page 30: ...00 Hz 750 Hz 1500 Hz 2000 Hz 3000 Hz 4000 Hz 6000 Hz 8000 Hz Press Save to return to the main Hughson Westlake Tests Setup Menu 5 7 1 Transferring Test Results to PC Before transferring data to a PC m...

Page 31: ...Function key Description Delete To delete the current selection set by the device controls i e Transducer Ear and Frequency Delete All To delete the entire transducer selection set by the device contr...

Page 32: ...nce at least once per year MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized service companies STANDARDS Medical CE mark Yes Safety Standards IEC 60601 1 2012 ANSI AAMI...

Page 33: ...one 5 Hz sine 5 modulation Pulse Tone Pulse Length 250 ms or 500 ms Masking Narrow band noise IEC 60645 1 5 12 Octave filter with the same center frequency resolution as pure tone Synchronous masking...

Page 34: ...B in USB 2 0 4 Response RI 330R 5 Bone ZA 10 UA 3 Veff 6 Insert Masking Not applicable in actual version 7 Phone L ZA 10 UA 3 Veff 8 Phone R ZA 10 UA 3 Veff 9 AUX input Not applicable in actual versio...

Page 35: ...0 110 105 15 1500 8 0 14 0 110 105 2000 8 0 14 0 110 105 26 3000 8 0 14 0 110 105 4000 9 0 14 0 110 105 32 6000 20 5 25 5 110 95 8000 12 0 17 0 105 95 25 White Noise 0 0 110 Calibration values Insert...

Page 36: ...95 32 3000 2 5 8 5 110 95 4000 9 5 14 5 110 95 46 6000 17 0 22 0 100 85 8000 17 5 22 5 100 85 44 White Noise 0 0 110 Calibration values AC Headphone Radioear DD65 Coupler IEC 60318 3 FREQUENCY HZ TONE...

Page 37: ...ler IEC 60318 6 mastoid placement FREQUENCY HZ REFERENCE EQUIVALENT THRESHOLD FORCE LEVEL FOR TONE AIR RADIATION MAX LEVEL ISO 389 3 ANSI S3 6 DB RE 1 N MIN MAX DB TONE DBHL 250 67 0 35 500 58 0 55 75...

Page 38: ...f the MA 28 can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MA 28 as recommended below acc...

Page 39: ...o any parts of the MA 28 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P d 2 1 P...

Page 40: ...General requirements for safety Collateral standard Safety requirements for medical electrical systems 5 IEC 60601 1 2 2014 Medical Electrical Equipment Part 1 2 General Requirements for Basic Safety...

Page 41: ...Operation Manual MA 28 8506915 Rev 3 40 15 11 2017 6 7 Checklist for subjective Audiometer Testing...

Page 42: ...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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