Maico MA 27 Operation Manual Download Page 47

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Operation Manual MA 27 / MA 27e

8104818 Rev.2.0

04/16

Specifications 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:

[email protected]

Internet:

www.maico.biz

Summary of Contents for MA 27

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

Page 2: ......

Page 3: ...MA 27 8 4 2 Standard Accessories 8 4 3 Optional Accessories 9 4 4 Connecting the Accessories 9 5 Function of Buttons and Display 10 5 1 Power On and Power Off 10 5 2 Pure Tone Presentation 10 5 3 Dis...

Page 4: ...Test Setup only on MA 27e 22 8 Warranty Maintenance and After Sales Service Hardware 24 9 Care and Maintenance 25 10 Safety Regulations 26 10 1 Electrical Safety 26 10 2 Measurement Safety 26 10 3 Ins...

Page 5: ...49 30 70 71 46 99 E mail sales maico biz Internet www maico biz Copyright 2016 MAICO Diagnostics All rights reserved No part of this publication may be reproduced or transmitted in any form or by any...

Page 6: ...s simple easy to learn and to understand As all the functions are software controlled upgrading the software and or adding additional functions at a later date will be simple and cost effective By pur...

Page 7: ...ned to be a device for screening for hearing loss Output and specificity of this type of device are based on the test characteristics defined by the user and may vary depending on environmental and op...

Page 8: ...7e incorporates a Hughson Westlake patient controlled automatic threshold test complying with ISO 8253 When the test is completed the results are easily recalled from the internal memory of the MA 27e...

Page 9: ...mperature between 15 C 59 F and 35 C 95 F If the instrument has cooled down during transportation please wait for it to warm up to room temperature before operation The separable mains plug is used to...

Page 10: ...contact with the patient i e earphone cushions should be disinfected using commercial disinfectant after each use Within the European Union it is illegal to dispose electric and electronic waste as u...

Page 11: ...ent 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 curren...

Page 12: ...ld any defects be identified please contact the responsible dealer Keep all original packaging to facilitate any insurance claims against the damages PLEASE KEEP ALL ORIGINAL PACKAGING FOR FUTURE USE...

Page 13: ...e found on the inside compartment of the MA 27 MA 27e All the cables and accessories have to be connected before the instrument is switched on Pos Symbol Function 1 Phones L Socket for left headphone...

Page 14: ...n on the audiometer press the Tone Switch button Power Off To power off the audiometer press and hold the Hearing Level dialer and Frequency dialer for a few seconds or unplug the device 5 2 Pure Tone...

Page 15: ...Response Switch required When using the patient response switch a response is indicated in the middle of the display header Patient response switch is being activated pressed Patient response switch...

Page 16: ...unction of the button is displayed on the bottom of the display screen NOTE The function buttons are dependent upon the version obtained MA 27 MA 27e F1 MA 27 Select the Right ear MA 27e Toggle betwee...

Page 17: ...ting the dial while in the talk forward mode will adjust the level of the talk forward to the patient F Key Functions The following F key functionalities can be accessed by pressing the Frequency Hz r...

Page 18: ...Operation Manual MA 27 MA 27e 8104818 Rev 2 0 14 04 16 F4 Start the Hughson Westlake HW automatic test procedure Please refer to the next chapter for instructions about how to setup the HW test...

Page 19: ...fere with the placement of the earphone cushions on the ear i e hair eyeglasses Ensure that the headphones are positioned correctly red side on the right ear blue side on the left ear Adjust the headb...

Page 20: ...n produce false test results especially at lower frequencies It is important to test in a quiet environment For hygienic reasons it is important to clean the headphone ear cushions after testing 6 4 A...

Page 21: ...right ear blue side 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 Prior to hea...

Page 22: ...that is highlighted F2 Browse up in the setup menu F3 Browse down in the setup menu F4 Save Save settings and Back to previous screen display see below for details 7 1 Standard Menu Setup Power Up Ton...

Page 23: ...intensity when changing ear side is 20 dB Choose between Off 10 dB 5 dB 0 dB 5 dB 10 dB 15 dB 20 dB 25 dB 30 dB 35 dB 40 dB 45 dB and 50 dB Intensity Steps Choose between 1 dB and 5 dB Power Off Setti...

Page 24: ...n 250 msec and 500 msec Language Press Change to toggle between English German Spanish and French LCD Contrast Press Change to toggle between settings ranging from 0 very bright to 6 very dark Frequen...

Page 25: ...000 Press Change to toggle between On or Off Press Save to return to the main Setup menu License Press Change to access the license key of the MA 27 MA 27e Press Change to enter and modify the licens...

Page 26: ...model and version information 7 2 Hughson Westlake Test Setup only on MA 27e MA 27e incorporates the Hughson Westlake test The automation of this test is configured in the Setup Menu Press Change to...

Page 27: ...toggle between 2 correct out of 3 answers and 3 correct out of 5 answers The conditions used before going to the next frequency Select the frequencies to include in the HW test Press Change to toggle...

Page 28: ...so In the event of repair during the guarantee period please enclose evidence of purchase with the instrument In order to ensure that your instrument works properly the audiometer should be checked an...

Page 29: ...it should be ensured that there is no contamination on the parts in connection with the patient General precautions must be observed in order to avoid that disease from one patient is conducted to oth...

Page 30: ...l or equipment 10 2 Measurement Safety In order to ensure safety and quality of the measurement an annual inspection and calibration should be performed The annual check ups can be performed by one of...

Page 31: ...diagnostic medical product in class IIa see also rule 10 of the 93 42 EEC Appendix IX Standards Audiometer EN 60645 1 ANSI S3 6 Type 4 Safety EN 60601 1 Class II Type B applied parts EMC EN 60601 1 2...

Page 32: ...entation Manual or reverse chosen in Setup Menu Multiple pulses 250 or 500 msec chosen in Setup Menu On Off pure tone or warble tone Talk Forward MA 27e Built in talk forward microphone 60 100 dBHL Co...

Page 33: ...y Rise fall Times 35 msec Display Header Indicators Tone On Patient Response Power Status Modulation Warble 5 5 Hz sinusoidal Calibration Air Conduction ISO 389 1 ANSI S3 6 Warm Up Time None Dimension...

Page 34: ...non condensing Transport 20 C 50 C 4 F 122 F Humidity 10 95 non condensing Power Use Only UE24WCP Type 100 240 VAC USB Power from IT equipment in accordance with IEC 60950 1 See also safety notice 5V...

Page 35: ...Operation Manual MA 27 MA 27e 8104818 Rev 2 0 31 04 16 equipment except that the whole system shall comply to safety regulations in IEC 60601...

Page 36: ...acture yyyy Registration Label Address of Manufacturer Registration Label Package Label IFU Return to Authorized Representative Registration Label B Patient Applied Part according to IEC60601 1 Regist...

Page 37: ...l MA 27 MA 27e 8104818 Rev 2 0 33 04 16 Label or International Symbol Reference Placement Logo Front Label EC REP EU Authorized Representative Package Label IFU CE Mark EU Only Directly on Product Pac...

Page 38: ...cers and cables other than those specified with the exception of servicing parts sold by MAICO as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of t...

Page 39: ...EC 60645 series in normal conditions Absence of these performance features can lead to failure in diagnosis which is considered as an unacceptable risk to the patient Temporary loss of essential perfo...

Page 40: ...L 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety 2 IEC EN 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety 3 CAN CSA C22 2 No 60601 1 Medical El...

Page 41: ...t Compliance Electromagnetic environment Guidance RF Emissions CISPR 11 Group 1 The MAICO MA 27 MA 27e uses RF energy only for its internal function Therefore its RF emissions are very low and are not...

Page 42: ...Maximum Output Power of Transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 80 MHz to 800 MHz d 1 17 800 MHz to 2 5 GHz d 2 23 0 01 0 12 0 12 0 23 0 1 0...

Page 43: ...put lines 2 kV for power supply lines 1 kV for input outp ut lines Mains power quality should be that of a typical commercial hospital or residential environment Surge IEC 61000 4 5 1 kV differential...

Page 44: ...an uninterrupted power supply 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 ho...

Page 45: ...equipment should be used no closer to any part of the MA 27 MA 27e including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitte...

Page 46: ...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 fi...

Page 47: ...8104818 Rev 2 0 43 04 16 Specifications 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 mai...

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