Maico MA 2 Series Скачать руководство пользователя страница 36

Operation Manual MA 25/MA 25e   

MA 27/MA 27e 

 

 

 

 

8104818 Rev. 4

 

35 

19/10/2017 

 

Surge 
 
IEC 61000-4-5

 

+1 kV differential mode 
 
+2 kV common mode 

+1 kV differential mode 

+2 kV common mode 

Power supply quality should be that of 
a typical commercial or residential 
environment.

 

Voltage dips, short 
interruptions and voltage 
variations on power 
supply lines  
 
IEC 61000-4-11 

 

< 5% 

U

T  

(>95% dip in 

U

T) for 0.5 cycle 

 
40% 

U

T  

(60% dip in 

U

T) for 5 cycles 

 
70% 

U

T  

(30% dip in 

U

T) for 25 cycles 

 
<5% 

U

T  

(>95% dip in 

U

T) for 5 sec

 

< 5% UT (>95% dip in UT) 

for 0.5 cycle 

40% UT (60% dip in UT) for 

5 cycles 

70% UT (30% dip in UT) for 

25 cycles 

<5% U

Power supply quality should be that of 
a typical commercial or residential 
environment. If the user of the 
MA 25/MA 25e/MA 27/MA 
27erequires continued operation 
during power supply interruptions, it is 
recommended that the MA 25/MA 
25e/MA 27/MA 27ebe powered from 
an uninterruptable power supply or its 
battery. 

 

Power frequency (50/60 
Hz) 
 
IEC 61000-4-8

 

3 A/m

 

3 A/m

 

Power frequency magnetic fields 
should be at levels characteristic of a 
typical location in a typical commercial 
or residential environment.

 

Note: U

T is the A.C. supply voltage prior to application of the test level. 

 

Guidance and manufacturer’s declaration — electromagnetic immunity 

The MA 25/MA 25e/MA 27/MA 27eis intended for use in the electromagnetic environment specified below. The customer or the user 
of the MA 25/MA 25e/MA 27/MA 27eshould assure that it is used in such an environment, 
Immunity test 

IEC / EN 60601 
test level 

Compliance level 

Electromagnetic environment 

– 

guidance 

 
 
 
 
 
 
 
 
 
Conducted RF 
IEC / EN 61000-4-6 
 
 
Radiated RF 
IEC / EN 61000-4-3 
 

 
 
 
 
 
 
 
 
 
 
3 Vrms 
150kHz to 80 MHz 
 
 
3 V/m 
80 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 distance calculated from 
the equation applicable to the 
frequency of the transmitter. 
 
Recommended separation distance 

P

d

2

,

1

 

P

d

2

,

1

  

80 MHz to 800 MHz

 

P

d

3

,

2

 

800 MHz to 2,5 GHz

 

Where 

P

 is the maximum output 

power rating of the transmitter in watts 
(W) according to the transmitter 
manufacturer and 

d

 is the 

recommended separation distance in 
meters (m). 
 
Field strengths from fixed RF 
transmitters, as determined by an 
electromagnetic site survey, (a) 
should be less than the compliance 
level in each frequency range (b) 
 
Interference may occur in the vicinity 
of equipment marked with the 
following symbol: 

 

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies 
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from 
structures, objects and people. 

(a)   

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, 

amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the 
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 
strength in the location in which the MA 25/MA 25e/MA 27/MA 27e is used exceeds the applicable RF compliance level above, the 
MA 25/MA 25e/MA 27/MA 27eshould be observed to verify normal operation, If abnormal performance is observed, additional 
measures may be necessary, such as reorienting or relocating the MA 25/MA 25e/MA 27/MA 27e. 

(b)  

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 

 

Содержание MA 2 Series

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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