Maico MA 2 Series Operation Manual Download Page 10

Operation Manual MA 25/MA 25e   

MA 27/MA 27e 

 

 

 

 

8104818 Rev. 4

 

19/10/2017 

 

 

To transfer data to a PC, establishing a PC-connection via USB 
is  required.  See  section  4.2.5  on  how  to  safely  establish  a 
connection  with  a  power  supplied  PC  or  laptop  (medical 
device/non-medical device) or to a battery-driven laptop. 

This  equipment  is  intended  to  be  connected  to  other 
equipment  thus  forming  a  Medical  Electrical  System. 
External equipment intended for connection to signal input, 
signal  output  or  other  connectors  shall  comply  with  the 
relevant product standard e.g. IEC 60950-1 for IT equipment 
and the IEC 60601-series for medical electrical equipment. 
In  addition,  all  such  combinations 

–  Medical  Electrical 

Systems 

– shall comply with the safety requirements stated 

the general standard IEC 60601-1, edition 3, clause 16. Any 
equipment  not  complying  with  the  leakage  current 
requirements  in  IEC  60601-1  shall  be  kept  outside  the 
patient  environment  i.e.  at  least  1.5  m  from  the  patient 
support or shall be supplied via a separation transformer to 
reduce  the  leakage  currents.  Any  person  who  connects 
external  equipment  to  signal  input,  signal  output  or  other 
connectors has formed a Medical Electrical System and is 
therefore  responsible  for  the  system  to  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 patient while operating the PC. 

If the device is connected to a PC (IT equipment forming a 
system) assembly and modifications shall be evaluated by 
qualified medical technician according to safety regulations 
in IEC 60601. 

 

The  device  is  not  intended  for  operation  in  areas  with  an 
explosion hazard. 

Never short-circuit the terminals. 

 

To avoid the risk of electric shock, this equipment must only 
be  connected  to  the  medical  power  supply  originally 
delivered by MAICO. Using another power supply can also 
lead to electrical damage on the device. 

 

In order to maintain a high level of safety and to ensure the 
device works properly, it is necessary to have the device and 
its power supply checked according to the medical electrical 
safety standard IEC 60601-1 by a qualified service technician 
at least once a year. For more information see section 3.2. 

The use of non-calibrated devices can lead to incorrect test 
results and is not advisable. 

Prevent cable breakage: cables must not be bent or buckled. 

WARNING 

WARNING 

WARNING 

CAUTION 

Summary of Contents for MA 2 Series

Page 1: ...Operation Manual MA 25 MA 25e MA 27 MA 27e...

Page 2: ...s Service 11 3 1 Warranty 11 3 2 Maintenance 11 3 3 Cleaning and Disinfection Recommendations 11 3 4 Disposables 12 3 5 Accessories Replacement Parts 12 3 6 Recycling and Disposal 13 4 Unpacking and H...

Page 3: ...et Eden Prairie MN 55344 United States Tel 1 888 941 4201 Fax 1 952 903 4100 E mail info maico diagnostics com Internet www maico diagnostics com Copyright 2017 MAICO Diagnostics All rights reserved N...

Page 4: ...ning and understanding the different MAICO MA 25 MA 25e and MA 27 MA 27e functions as quick and as easy as possible Should you encounter any problems or have ideas for any further improvements we are...

Page 5: ...d automatic threshold test complying with ISO 8253 When the test is completed the results are easily recalled from the internal memory of the device Talk Forward function allows easy communication wit...

Page 6: ...ding safety 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...

Page 7: ...when operated and maintained in accordance with the instructions contained in this manual accompanying labels and or inserts A defective product should not be used Make sure all connections to extern...

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

Page 9: ...not use the 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...

Page 10: ...or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements If in doubt contact qualified medical technician or your local r...

Page 11: ...nment To avoid the risk of electric shock this equipment must only be connected to power supply with protective earth The device fulfills the relevant EMC requirements Avoid unnecessary exposure to el...

Page 12: ...quipment is allowed In the event 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 b...

Page 13: ...ents 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 Discard single use equipme...

Page 14: ...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...

Page 15: ...attempt to use any component or device that appears to be damaged Reporting Imperfections Notify the carrier immediately if any mechanical damage is noted This will insure that a proper claim is made...

Page 16: ...iometric test room shall not exceed the values specified in the norm ISO 8253 1 2010 or ANSI S3 1 1999 For use in noisier environments headphones with optional sound insulation muffs are available Dev...

Page 17: ...This can take a long time depending on the conditions like environmental humidity You can reduce the condensation by storing the device in its original packaging If the device is stored under warmer...

Page 18: ...g feet height Figure 5 To adjust the height turn the device over Adjust the two feet by turning them in a counter clockwise to increase height or in a clockwise direction to decrease height Figure 5 4...

Page 19: ...battery driven use of the MA 25 MA 25e 3x AA batteries have to be placed in the battery compartment on the backside of the device Figure 8 and Figure 9 Figure 8 Figure 9 4 2 6 Only for MA 25e MA 27e...

Page 20: ...e requirements of IEC 60950 If a non medical device is used within the patient environment 1 5 m from patient as defined in IEC 60601 a voltage transformer must be used exception a battery driven lapt...

Page 21: ...kets as shown in section 4 2 3 Plug the power cord into a grounded outlet 5 1 2 Device Layout Figure 10 and Figure 11 show the device layout Table 6 gives further explanation Figure 10 Figure 11 Table...

Page 22: ...igure 10 and Figure 11 4 as well as Table 7 for the selections available for each function key in the testing mode NOTE The function buttons are dependent upon the version obtained MA 25 MA 25e and MA...

Page 23: ...c test procedure Refer to the section 5 6 on how to setup the HW test 5 4 Screens 5 4 1 General Figure 15 shows the main screen See the explanation of the screen areas below Figure 15 Tone A tone pres...

Page 24: ...yed on the screen reflects the intensity volume presented to patient To change rotate the Hearing Level dB dial 5 4 5 Frequency Frequency displayed on the screen reflects the frequency presented to th...

Page 25: ...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...

Page 26: ...e to toggle between Right and Left as the default ear for Power Up Default Intensity The default intensity when changing ear side is 20 dB Choose between Off and values between 10 dB and 50 dB 5 dB st...

Page 27: ...efault frequency range from 125 Hz to 8000 Hz 10 frequencies are available to change 125 Hz 250 Hz 500 Hz 750 Hz 1500 Hz 2000 Hz 3000 Hz 4000 Hz 6000 Hz and 8000 Hz Press Change to toggle between On o...

Page 28: ...set to On or Off 125 Hz 250 Hz 750 Hz 1500 Hz 3000 Hz 6000 Hz 8000 Hz Press Save to return to the main Hughson Westlake Tests Setup Menu 5 7 Managing Test Results 5 7 1 Deleting Test Results MA 25 MA...

Page 29: ...A 25 MA 25e MA 27 MA 27e 8104818 Rev 4 28 19 10 2017 Request Measurement Figure 14 1 button appears Click on Request Measurement and the tone audiometry values are transferred and displayed on the PC...

Page 30: ...pecifications The performance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once per year MAICO Diagnostics puts diagrams and service manua...

Page 31: ...ch MA 25e MA 27e One push button Patient communication MA 25e MA 27e Talk Forward TF built in talk forward microphone 60 100 dBSPL Continuously adjustable on operation panel Special tests test battery...

Page 32: ...h PC Connection 1 x USB B for PC Connection comparable with USB 1 1 and later Warm up time 10 minutes incl boot up time Store Function MA 25e MA 27e only Soft key function key store button and interna...

Page 33: ...ordance with ANSI S3 6 2010 ISO 389 1 1998 Impedance 10 DD65 Calibrated using a IEC 60318 3 6cc acoustic coupler Tested in accordance with ANSI S3 6 2010 ISO 389 1 1998 Impedance 10 Holmco 8103 Calibr...

Page 34: ...0 35 5 45 0 250 28 0 25 0 25 5 500 13 0 12 5 11 5 750 6 5 8 0 7 5 1000 6 0 7 0 7 0 1500 7 5 9 0 6 5 2000 7 5 5 0 9 0 3000 8 0 4 5 10 0 4000 7 0 7 8 9 5 6000 20 0 20 0 15 5 8000 11 0 12 0 13 0 Table 16...

Page 35: ...Harmonic emissions IEC 61000 3 2 Complies Class A Category Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Recommended separation distances between portable and mobile RF communications...

Page 36: ...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 25 MA 25E MA 27 MA 27E including cables than the recommended separation dist...

Page 37: ...eneral Requirements 4 IEC EN 60601 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems 5 IEC EN 60601 1 2 Medical Electrical Equipment Part 1 2 G...

Page 38: ...Operation Manual MA 25 MA 25e MA 27 MA 27e 8104818 Rev 4 37 19 10 2017 6 7 Checklist for subjective Audiometer Testing...

Page 39: ...Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E mail sales maico biz Internet www maico biz Diagnostic Group LLC DBA MAICO Diagnostics 10393 West 70th Street Eden Prairie MN 55344 United States...

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