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Operation Manual MA 1  

 

8100216 Rev. 5 

14 

09/03/2023 

 

5.3 Preparing for Testing  

5.3.1 Preparing the Patient 

The  patient  should  sit  with  back  to  device  and  examiner  so  they  do  not  see  any 
pressing of the buttons. 

Prior  to  hearing  threshold  level  measurements,  the  following  instructions  should  be 
given: 

"You will now hear a variety of tones with various loudness levels, raise your 

hand as soon as you hear the tone in either ear“.

 

5.3.2 Placement of Headphones  

 

Figure 4 

Eliminate  any  obstructions  which  will  interfere  with  the 
placement  of  the  ear  cushions  on  the  ear  (i.e.  hair, 
eyeglasses).  

Ensure  that  the  headphones  (Figure  4)  are  positioned 
correctly: red phone on the right ear, blue phone on the left 
ear.  Adjust  the  headband  of  the  headphones  so  that  the 
earphones  are  positioned  at  the  correct  height  (i.e.  the 
sound output grid exactly facing the ear canal). 

 

5.3.3 Test Environment   

Excessive sounds or noises in the chosen test environment can produce a masking effect 
and  therefore  affect  test  results.  The  selected  site  should  be  away  from  conversations, 
hallway traffic, outside auto traffic, and other noise producing environments.  

5.4 Performing Tone Tests with MA 1 (Air 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 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

: 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. 

5.5 Conducting a Hearing Screening 

5.5.1 Familiarize the patient with the test procedure 

1.  Press the black right/left button to turn on the MA 1. 

2.  Use this same button to select the right ear (red LED).  

3.  Press the up or down arrow keys to select 50 dB HL.   

4.  Press the 1000 Hz button 1-2 seconds to present the tone to the patient.  The tone 

will be presented as long as the corresponding frequency key is held down.  (This 
level is loud enough that a normal hearing patient should hear the tone clearly in a 
quiet setting.) 

5.  The patient should raise their hand when the tone is played.  Play the tone a second 

time to make sure they understand the task.  If not, re-instruct and try again.  If no 
response is obtained, change to the left ear to confirm unresponsiveness. 

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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