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Operation Manual MA 28

 

 

 

 

 

 

8506915 Rev. 3

 

24 

15/11/2017 

 

5.5.3 Placement of Eartips (for Testing with Insert Phones Only) 

 

Figure 12 

First, place the eartip securely on the white adapter at the 
end  of  the  insert  earphone  tubing.  To  prepare  the  foam 
eartip for insertion in the ear canal, you must compress the 
foam  by  rolling  it  in  your  fingers  to  narrow  its  diameter 
(Figure  12).  Check  to  be  sure  that  the  foam  does  not 
obstruct the opening of the black sound tube.  

 

 

Figure 13 

Quickly,  while  the  foam  is  still  compressed,  grasp  the 
patient’s  ear  and  gently  pull  it  up  and  back  to  open  and 
straighten the ear canal. While holding the canal open, slide 
the compressed foam ear tip into the ear canal. The foam 
should be completely surrounded by the canal with virtually 
none of the foam sticking out of the canal (Figure 13). 

5.6 Performing Tone Audiometric Tests 

5.6.1 Air Conduction Testing 

5.6.1.1 Pretest Set-up and Instructions 

Hearing  threshold  levels  can  be  determined  by  presenting  test  signals  to  the  test 
subject  with  the  included  headphones  (air  conduction 

–  AC).  The  purpose  of  AC 

audiometry 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 Determination 

The test normally starts at 1000 Hz on the patient's better ear. Select 

Right

/

Left

 (

F2

 

key). A procedure of 

“down 10 dB, up 5 dB

” is typically utilized to establish a threshold 

at each frequency. 

NOTE:

 There is a safety feature within the device so that high volumes (i.e. 100 dB or 

more) are not accidently presented to a patient.  When the volume of the tone or noise is 
75 dB or higher and the user changes frequencies or ears, the device will automatically 
reset the level to 70 dB. 

5.6.1.3 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 screened at 
a level of 20 dB HL at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz in each ear. If a patient 
hears all the tones in each ear, the result would be considered a 

Pass

. Failure to hear 

any of the tones in either ear would result in a 

Refer

.  

NOTE

: This is an example of one screening protocol. Each state may have their own 

screening protocol. Contact your state health department for guidelines in your area. 

Содержание MA 28

Страница 1: ...Operation Manual MA 28...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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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