Operation Manual MA 28
8506915 Rev. 5
1
05/05/2021
Table of Contents
1 Introduction ...................................................................................................................... 3
1.1 Intended Use Statement ............................................................................................. 3
1.2 Contraindications of Use ............................................................................................. 3
1.3 Description .................................................................................................................. 3
2 For Your Safety ................................................................................................................. 4
2.1 How to Read this Operation Manual ........................................................................... 4
2.2 Customer Responsibility ............................................................................................. 5
2.3 Manufacturer’s Liability ............................................................................................... 5
2.4 Regulatory Symbols .................................................................................................... 6
2.5 General Precautions ................................................................................................... 7
2.6 Electrical Safety and Measuring Security .................................................................... 7
2.7 Device Control ............................................................................................................ 9
2.8 Electromagnetic Compatibility (EMC) .......................................................................... 9
3 Warranty, Maintenance and After-Sales Service ...........................................................10
3.1 Warranty ....................................................................................................................10
3.2 Maintenance ..............................................................................................................10
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 the System ...............................................................................................13
4.2 Hardware Orientation .................................................................................................15
5 Operating the Device .......................................................................................................19
5.1 Getting started with the MA 28 ...................................................................................19
5.2 Switching On the Device ............................................................................................19
5.3 Switching Off the Device ............................................................................................20
5.4 Device Layout ............................................................................................................20
5.5 Display .......................................................................................................................21
5.6 Function Keys ............................................................................................................22
5.7 Preparing for Testing .................................................................................................23
5.8 Performing Tone Audiometric Tests ...........................................................................24
5.9 Managing Test Results ..............................................................................................26
5.10 Setup Menu .............................................................................................................33
6 Technical Data .................................................................................................................43
6.1 MA 28 Hardware ........................................................................................................43
6.2 Connections ...............................................................................................................45
6.3 Pin Assignment ..........................................................................................................45
6.4 Calibration Values and Maximum Levels ...................................................................46
6.5 Electromagnetic Compatibility (EMC) .........................................................................49
6.6 Electrical Safety, EMC and Associated Standards .....................................................52
6.7 Checklist for subjective Audiometer Testing ...............................................................53
Страница 1: ...Operation Manual MA 28...
Страница 2: ...ations 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 the System 13 4 2 Hardware Orientation 15 5 Operat...
Страница 3: ...s www maico diagnostics com german support resources International https www maico diagnostics com support resources Copyright 2021 MAICO Diagnostics All rights reserved No part of this publication ma...
Страница 4: ...en to adults It is used as part of a total test battery to determine hearing acuity by audiologists ENTs hearing healthcare professionals or other trained technicians in a hospital clinic healthcare f...
Страница 5: ...y 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 screensho...
Страница 6: ...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...
Страница 7: ...manufacture Manufacturer Caution consult accompanying documents Warning consult accompanying documents Return to authorized representative special disposal required Reference number Medical Device Pat...
Страница 8: ...nd 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 MA1234567 The...
Страница 9: ...ed 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 i...
Страница 10: ...quipment 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 verify that they are operating normally Use...
Страница 11: ...ar from date of delivery of the device to the original purchaser The device shall only be repaired and serviced by your distributor or by an authorized service center Opening the device case will void...
Страница 12: ...power supply For cleaning use a lightly dampened cloth with soap water solution Disinfect the plastic housing of the MA 28 and its accessories by wiping the surfaces with wet Sani Cloth Active wipes o...
Страница 13: ...n 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...
Страница 14: ...shortage If any component 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 Imperf...
Страница 15: ...Power Supply UES18LCPU 050200SPA USB Cable DD45 Audiometric Headphones DD65 v2 Audiometric Headphones DD450 High Frequency Headphones IP30 Insert Phones B71 Bone Conduction Headphones B81 Bone Conduc...
Страница 16: ...and a handle to easily carry the device Figure 22 The connections are located in the case Figure 33 Figure 1 Figure 2 Figure 3 NOTE See section 5 4 detailed information about the device layout Adjusti...
Страница 17: ...Insert plugs with care into the appropriate connection Do not wiggle the plug or pull with force while connected Disconnect plugs cautiously Figure 5 Table 4 Connections on Inside Panel of Device CONN...
Страница 18: ...wer supply Printer is only charged when the MA 28 device is plugged in and on 4 2 4 Establishing a PC Connection Infection of the device or the software used with the device can lead to system failure...
Страница 19: ...ction 4 Medical device Laptop battery driven 4 2 5 PC Interface Please refer to the MAICO Sessions operation manual for complete installation instruction and transferring of results to the PC 4 2 6 St...
Страница 20: ...sure proper operation of the device by following routine check procedures for audiometric equipment 5 1 2 Where to Setup The MA 28 should be operated in a quiet room so that the audiometric examinatio...
Страница 21: ...e 10 4 Store NR No Response Press and release to store result Press and hold to display a No Response NR result 5 Hz Press to increase the frequency Hz Press to decrease the frequency Hz 6 Hearing Lev...
Страница 22: ...Displayed on the left side of the screen and indicates the level volume of the tone presented To change rotate the left rotary wheel Hearing Level dB Masking Level Displayed on the right side of the s...
Страница 23: ...Warble P W Type of signal presented Options include Steady Pulse Warble Pulse and Warble P W F4 More To move to the 2nd menu screen 2nd menu screen F1 Delete To delete single stored measurement Set d...
Страница 24: ...scratch the ear canal Always apply a foam eartip before inserting the insert phones into the ear canal Figure 14 First place the eartip securely on the adapter at the end of the insert earphone tubing...
Страница 25: ...ilizing the same method as air conduction testing 5 8 3 Masking Masking is required if there is a notable threshold difference between the left and right ears It is possible for sound to be transmitte...
Страница 26: ...ness levels please push the response switch when you hear a tone and release the button when you no longer hear it The patient response can only be recorded during tone presentation The test is access...
Страница 27: ...active The Save DB is within the third Function Key Menu see section 5 6 Once Save DB is selected the Save to database screen is entered The results can be saved to a default name 1 created by the dev...
Страница 28: ...ction Keys for View Database Function key Label Description F1 Back Return to test screen F2 Edit To update record with patient demographic information F3 Delete Deletes selected patient and all store...
Страница 29: ...ppears to confirm deleting of all sessions 5 9 6 View Results Once you select View F4 from the session list screen the stored results are displayed Figure 21 1 ID and Name are displayed as enterd in t...
Страница 30: ...Caps Lock Activates Caps Lock for internal keyboard F2 Navigate to previous field F3 Navigate to next field F4 Save Saves patient details to database record and returns to the patient list screen To m...
Страница 31: ...More to access these functions See section 5 6 Table 14 Deleting Test Results Function key Description F1 Delete To delete a specific stored result Set the device to the Ear transducer and frequency...
Страница 32: ...f device 2 Facility provides field name to write in facility information after printout 3 Patient data provides the field names Patient ID Last name First name Date of birth and Sex to manually enter...
Страница 33: ...consider the recommendations given in section 4 2 4 in case the MA 28 is connected to a non medical device To transfer the data make sure the device is connected to the PC via USB connection and the...
Страница 34: ...tup menu F3 To browse down in the setup menu F4 Save To save setting and go back to previous screen NOTE A secondary way to manage the setting options is use the Masking Level control to scroll throug...
Страница 35: ...f lines displayed for bone conduction results on the audiogram Choose between Dash Solid No line Display ear side To select the ear side for 2 audiogram displays Choose between L R R L Default level T...
Страница 36: ...o Nederlands Polski Backlight To select the intensity of the Backlight Choose a value between 30 very dark to 100 very bright Air frequencies To select the frequencies to be active during the air cond...
Страница 37: ...to confirm 3 out of 5 or 2 out of 3 correct answers before moving to the next frequency Hughson Westlake familiarization To select if the patient shall be trained with a familiarization test On or not...
Страница 38: ...12 H is chosen a further setting is available for selection of AM PM Time format Select the preferred clock using the 12 or 24 hour time format 5 10 3 Facility info Facility info allows loading of an...
Страница 39: ...Open Paint 5 Press Ctrl e and change Width 560 Height 144 and select OK Figure 33 6 Enter facility information into window size Note The MA 28 printout uses arial narrow bold and font size 14 Anythin...
Страница 40: ...21 7 Select Save as and select BMP picture Figure 35 8 Save to a USB flash drive Save the created file as follows File name FCI bmp Save as type Monochrome Bitmap bmp dib Figure 36 9 A confirming mess...
Страница 41: ...lity information screen reads Image loaded to thermal printout To change a loaded image first Delete loaded image This will allow the Load button to become active 5 10 4 License key The License key sc...
Страница 42: ...ox will display to verify the license key Figure 4139 Contact your local distributor if any problems occur Figure 41 Verification of added licenses is shown in the About screen Figure 4240 Figure 42 5...
Страница 43: ...gate password fields Press Save to continue setting up the database password Press Back to return to the Setup menu without saving the Database password Figure 44 Once Save is selected a message appea...
Страница 44: ...cal maintenance at least once per year MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized service companies STANDARDS Safety Standards IEC 60601 1 2012 ANSI AAMI ES60601...
Страница 45: ...125 Hz 8000 Hz Warble Tone 5 Hz sine 5 modulation Pulse Tone Pulse Length 250 ms or 500 ms Masking Narrow band noise IEC 60645 1 5 12 Octave filter with the same center frequency resolution as pure t...
Страница 46: ...B in USB 2 0 4 Response RI 330R 5 Bone ZA 10 UA 3 Veff 6 Insert Masking Not applicable in actual version 7 Phone L ZA 10 UA 3 Veff 8 Phone R ZA 10 UA 3 Veff 9 AUX input Not applicable in actual versio...
Страница 47: ...32 6000 20 5 25 5 110 95 8000 12 0 17 0 105 95 25 White Noise 0 0 110 Table provides max levels for PSE power only USB power results in reduced max levels Calibration values Insert phones IP30 Couple...
Страница 48: ...00 2 5 8 5 110 95 4000 9 5 14 5 110 95 46 6000 17 0 22 0 100 85 8000 17 5 22 5 100 85 44 White Noise 0 0 110 Table provides max levels for PSE power only USB power results in reduced max levels Calibr...
Страница 49: ...L NBN MAX LEVEL DB HL SOUND ATTENUA TION DB ISO 4869 1 125 30 5 34 5 85 70 8 3 250 17 0 21 0 100 85 15 5 500 8 0 12 0 110 95 26 1 750 5 5 10 5 110 100 1000 4 5 10 5 110 100 32 4 1500 2 5 8 5 110 100 2...
Страница 50: ...metric Headphones Radioear DD45 2 0 Yes Audiometric Headphones Radioear DD65 v2 2 0 Yes High Frequency Headphones Radioear DD450 2 0 Yes Insert Earphone Radioear IP30 2 0 Yes Bone conductor Radioear B...
Страница 51: ...itter manufacturer Note 1 At 80 MHz and 800 MHZ the higher frequency range applies Note 2 These guidelines may not apply to all situations Electromagnetic propagation is affected by absorption and ref...
Страница 52: ...ld 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 e...
Страница 53: ...000 General requirements for safety Collateral standard Safety requirements for medical electrical systems 5 IEC 60601 1 2 2014 Medical Electrical Equipment Part 1 2 General Requirements for Basic Saf...
Страница 54: ...Operation Manual MA 28 8506915 Rev 5 53 05 05 2021 6 7 Checklist for subjective Audiometer Testing...
Страница 55: ...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...
