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Operation Manual MA 1  

 

8100216 Rev. 5 

09/03/2023 

 

If there is not a high infection potential, MAICO recommends: 

  For cleaning use a lightly dampened cloth with soap water solution. 

  Disinfect  the  plastic  housing  of  the  MA  1  and  its  accessories  by  wiping  the 

surfaces  with  disinfectant  wipes  or  a  comparable  product.  Follow  the 
instructions on the specific disinfection product.  

o

  Wipe before and after each patient  

o

  After contamination 

o

  After infectious patients 

 

 

 

To avoid damage of the device and its accessories, please mind 
the following: 

  Do not autoclave or sterilize. 

  Do not use the device in the presence of fluid that can come into 

contact with any of the electronic components or wiring.  

 

 

 

Should  the  user  suspect  fluids  have  contacted  the  system 
components  or  accessories,  the  unit  should  not  be  used  until 
deemed safe by a MAICO certified service technician.  

Do not use hard or pointed objects on the device or its accessories. 

Use 70 % isopropyl alcohol only on hard cover surfaces. 

3.4 Disposables 

Use only the Sanibel Supply disposable supplies 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, you enhance 
the risk of cross-contamination! 

3.5 Components/Replacement Parts 

Some reusable components are subject to wear with use over time. MAICO recommends 
that  you  keep  these  replacement  parts  available  (as  appropriate  for  your  MA  1  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 electric and 
electronic waste as unsorted municipal waste. According to this, 
all MAICO products sold after August 13, 2005, are marked with 
a  crossed-out  wheeled  bin.  Within  the  limits  of  Article  (9)  of 
DIRECTIVE  2002/96/EC  on  waste  electrical  and  electronic 
equipment (WEEE), MAICO has changed their sales policy. To 
avoid additional distribution costs we assign the responsibility 
for  the  proper  collection  and  treatment  according  to  legal 
regulations to our customers.  

Non-European countries  Outside  the  European  Union,  local  regulations  should  be 

followed when disposing of the product after its useful life.  

CAUTION 

CAUTION 

WARNING 

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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