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Operation Manual MA 25/MA 25e

MA 27/MA 27e

8104818 Rev. 5

28

29/06/2021

6 Technical Data

This section offers you important information about

▪

the MA 25/MA 25e/MA 27/MA 27e hardware specifications

▪

connections

▪

the pin assignment

▪

audiometer calibration values

▪

electromagnetic compatibility (EMC)

▪

electrical safety, EMC and associated Standards

▪

checklist for subjective audiometer testing

6.1 MA 25/MA 25e/MA 27/MA 27e Hardware

The MA 25/MA25e/MA27/MA 27e audiometer is an active,
diagnostic medical product according to the class IIa of the
Medical Device Regulation (EU) 2017/745.

General Information About Specifications
The  performance  and  specifications  of  the  device  can  only  be  guaranteed  if  it  is
subject to technical maintenance at least once every 12 months.
MAICO  Diagnostics  puts  diagrams  and  service  manuals  at  the  disposal  of
authorized service companies.

STANDARDS

Safety Standards

IEC 60601-1: 2012
AAMI ES60601-1:2005+A2+A1
CAN/CSA-C22.2 No. 60601-1:14
Type B applied parts

EMC Standard

IEC 60601-1-2:2014

Audiometer
Standards

Tone: IEC 60645-1:2017/ANSI S3.6-2018 Type 4

DEVICE SPECIFICATIONS

Power supply

Type

UES18LCPU-050200SPA

Input

100 to 240 V AC, 50/60 Hz, 0.5 A

Output

5.0 V DC,

2.0A MAX

Safety

IEC 60601-1, Class II

Mode of Operation

Continuous

Batteries (MA 25/MA 25e)

Battery Type

3 x AA

Battery

operation

Automatic battery on/off switching
Automatic battery status indication

Battery Life

Standby: 6 months, Tone presentations: 70,000

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Содержание MA 25

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

Страница 2: ...nance 11 3 3 Cleaning and Disinfection Recommendations 11 3 4 Disposables 12 3 5 Accessories Replacement Parts 12 3 6 Recycling and Disposal 12 4 Unpacking and Hardware Orientation 13 4 1 Unpacking th...

Страница 3: ...30 70 71 46 99 E mail sales maico biz Internet www maico biz Germany International Copyright 2021 MAICO Diagnostics All rights reserved No part of this publication may be reproduced or transmitted in...

Страница 4: ...loss and the factors that contribute to the occurrence of the hearing loss in the age range of children to adults It is used as part of a total test battery to determine hearing acuity by audiologist...

Страница 5: ...easy communication with the patient while wearing the headphone and or in sound booth installations 1 5 Description The MA 25 MA 25e and MA 27 MA 27e audiometers are designed to be a device for scree...

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: ...ined in this 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...

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

Страница 9: ...epair and or calibration Do 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 MA1234...

Страница 10: ...ormed 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 A Separation...

Страница 11: ...e phones etc If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears Use of this device adjacent to or stacked with other equipment should be avoided b...

Страница 12: ...aintenance In order to ensure that the device works properly it has to be checked and calibrated at least once every 12 months The service and calibration must be performed by your dealer or by a serv...

Страница 13: ...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 Accessories Replacement Parts...

Страница 14: ...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 ensure that a proper claim is made...

Страница 15: ...UES18LCPU 050200SPA MAICO Sessions Kit USB Operation Manual Quick Guide Patient Response Switch Only for MA 25 MA 25e Carrying Bag 3 AA Batteries Applied part according to IEC EN 60601 1 Table 3 Repla...

Страница 16: ...A 27e Only 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 2...

Страница 17: ...9 Figure 8 Figure 9 4 2 4 Establishing a PC Connection MA 25e MA 27e Only To transfer data to a PC establishing a PC connection via USB is required If the MA25e MA 27e is used with office equipment t...

Страница 18: ...Device PC Connection 4 Medical device Laptop battery driven 4 2 5 PC Interface Connecting the Audiometer to a PC for transferring the results is described in section 5 9 2 4 2 6 Storage When the MA 2...

Страница 19: ...fore use Always ensure proper operation of the device by following routine check procedures for audiometric equipment 5 1 2 Where to Setup The MA 25 MA 25e and MA 27 MA 27e should be operated in a qui...

Страница 20: ...iometer press and hold the Hearing Level dB dial 2 and Frequency Hz dial 3 for a few seconds or unplug the device 5 3 Device Layout Figure 10 and Figure 11 show the device layout Table 6 gives further...

Страница 21: ...Warble Warble Off Pure tones will be presented Warble On Warble tones will be presented 5 5 MA 25e MA 27e Special Functions 5 5 1 Talk Forward Figure 12 On the MA 25e MA 27e Talk Forward is activated...

Страница 22: ...Patient response switch is being activated pressed Patient response switch is not activated not pressed 5 6 3 Powering of Device Icon MA 25 MA 25e The icon will change depending on whether the instru...

Страница 23: ...sure that the headphones Figure 17 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 corr...

Страница 24: ...procedure Threshold is defined as 2 out of 3 or 3 out of 5 correct responses obtained at a certain level in a 10 dB decrease and 5 dB increase procedure The device will re test 1000 Hz before moving t...

Страница 25: ...dB 5 dB steps Intensity Steps The decible step size when turning the Hearing Level dB dial Choose between 1 dB and 5 dB Power Off MA 25 MA 25e Battery mode Press Change to toggle between Never and va...

Страница 26: ...requencies 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 or Off Press Save to return to the main Setup menu...

Страница 27: ...dition The HW test can be automated to confirm 2 3 2 out of 3 or 3 5 3 out of 5 correct answers before moving to the next frequency HW Frequencies The HW allows for test frequencies to be deactivated...

Страница 28: ...Results to PC MA 25e MA 27e Only Before transferring data to a PC make sure that you have installed MAICO Sessions properly according to the separately delivered operation manual on the USB Before es...

Страница 29: ...ormance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once every 12 months MAICO Diagnostics puts diagrams and service manuals at the dispo...

Страница 30: ...Talk Forward TF built in talk forward microphone 60 100 dB SPL Continuously adjustable on operation panel Special tests test battery MA 25e MA 27e Automatic recording audiometer according ISO 8253 1 M...

Страница 31: ...25 MA 25e 38 1 mm x 50 8 mm 1 5 in x 2 in Monochrome MA 27 MA 27e 38 1 mm x 76 2 mm 1 5 in x 3 in Monochrome Language Settings English Deutsch Espa ol Fran ais Dutch PC Connection 1 x USB B for PC Con...

Страница 32: ...S USED DURING CALIBRATION DD45 Calibrated using a IEC 60318 3 6cc acoustic coupler Tested in accordance with ANSI S3 6 2010 ISO 389 1 1998 Impedance 10 DD65 v2 Calibrated using a IEC 60318 1 acoustic...

Страница 33: ...0318 3 PTB Report 2018 DTU Report 2018 Coupler IEC 60318 1 DD45 DD65 v2 125 47 5 30 5 250 27 0 17 0 500 13 0 8 0 750 6 5 5 5 1000 6 0 4 5 1500 8 0 2 5 2000 8 0 2 5 3000 8 0 2 0 4000 9 0 9 5 6000 20 5...

Страница 34: ...ecessary instruction for maintaining compliance with regard to EMC can be found in the general maintenance section in this instruction No further steps required To ensure compliance with the EMC requi...

Страница 35: ...ic equipment RF emissions CISPR 11 Class B The MA 25 MA 27 is suitable for use in all commercial industrial business and residential environments Harmonic emissions IEC 61000 3 2 Complies Class A Cate...

Страница 36: ...ronment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or residential environment Voltag...

Страница 37: ...ters 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 vic...

Страница 38: ...uipment Safety Part 1 General Requirements 5 IEC EN 60601 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems 6 IEC EN 60601 1 2 2014 Medical Ele...

Страница 39: ...Operation Manual MA 25 MA 25e MA 27 MA 27e 8104818 Rev 5 38 29 06 2021 6 7 Checklist for Subjective Audiometer Testing...

Страница 40: ...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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