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Operation Manual MA 1  

 

8100216 Rev. 5 

15 

09/03/2023 

 

5.5.2 Perform the Hearing Screening 

Once the patient understands the task, continue to the screening process.   

1.  Change the hearing level to 20 dB HL and press the 1000 Hz button 1-2 seconds 

to present the tone to the patient.   

2.  Record  whether  the  patient  responded  by  raising  their  hand.    Present  again  to 

confirm response at 20 dB HL.  

3.  Continue the same procedure for the other frequencies.  Record all results on the 

audiogram card provided.   

4.  Patients are typically screened at a level of 

20 dB HL

 at 

500 Hz

1000 Hz

2000 Hz

and 

4000Hz

 in 

each ear

. If a patient hears all the tones in each ear, the result would 

be considered a 

Pass

. Failure to hear even one of the tones in either 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 responding 
to the actual tone presentation. 

 

Best  practice  is  to  confirm  each  frequencies  response  before  moving  to  the 
next frequency.  Limit testing to no more than 4 presentations to reduce false 
positive responses.  

 

When no response is given at one or more frequencies, reinstruct the patient, 
reposition  headphones  and,  when  possible,  change  examiners.  Continue 
rescreen within the same screening period. 

5.5.3 Results 

PASS

: The screening is considered a pass result if the child responds to all screening 

frequencies in both ears.  

REFER

:  The  child  does  NOT  pass  the  screening and  should  be  referred  for  further 

testing if:  

  child misses any of the frequencies in either ear, even if it is just one, OR  

  cannot complete the screening process.  

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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