MA 28 Operation Manual Rev 3 Nov 2017

Operation Manual MA 28 Table of Contents 1 Introduction ... 3 1.1 General ... 3 1.2 Intended Use Statement ... 3 1.3 Contraindications of Use ... 4 1.4 Essential Performance ... 4 1.5 Description ... 4 2 For Your Safety... 5 2.1 How to Read this Operation Manual ... 5 2.2 Customer Responsibility ... 6 2.3 Manufacturer’s Liability ... 6 2.4 Regulatory Symbols ... 7 2.5 General Precautions ... 8 2.6 Electrical Safety and Measuring Security ... 8 2.7 Device Control ...10 2.8 Electromagnetic Compatibility (EMC) ...10 3 Warranty, Maintenance and After-Sales Service ...11 3.1 Warranty ...11 3.2 Maintenance ...11 3.3 Cleaning and Disinfection Recommendations ...12 3.4 Disposables ...13 3.5 Accessories/Replacement Parts ...13 3.6 Recycling and Disposal ...13 4 Unpacking and Hardware Orientation ...14 4.1 Unpacking the System ...14 4.2 Hardware and Accessories ...16 5 Operating the Device...19 5.1 Getting started with the MA 28 ...19 5.2 Use of Equipment After Transport and Storage ...19 5.3 Device Layout ...20 5.4 Function Keys ...22 5.5 Preparing for Testing ...23 5.6 Performing Tone Audiometric Tests ...24 5.7 Tone Setup Menu ...26 6 Technical Data ...31 6.1 MA 28 Hardware ...31 6.2 Connections ...33 6.3 Pin Assignment ...33 6.4 Calibration Values ...34 6.5 Electromagnetic Compatibility (EMC) ...37 6.6 Electrical Safety, EMC and Associated Standards ...39 6.7 Checklist for subjective Audiometer Testing ...40

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Operation Manual MA 28

Title: Operation Manual MA 28 Date of issue/last revision: 15/11/2017

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

Copyright © 2017 MAICO Diagnostics All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of MAICO Diagnostics. The information in this publication is proprietary to MAICO Diagnostics.

Compliance MAICO Diagnostics GmbH is an ISO 13485 certified corporation.

Caution for USA: Federal Law restricts this device to sale by or on the order of a licensed medical professional

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Operation Manual MA 28 1 Introduction This section offers you important information about:     

the intended use of the device indications and contraindications of use essential performance features and benefits a description of the device

1.1 General Thank you for selecting one of our quality products from the MAICO family range. The MA 28 is designed and manufactured to meet all quality and safety requirements. Particular attention has been taken during the designing phase of the MA 28 to ensure its user-friendliness, meaning that its operation is 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 purchasing the MAICO MA 28, you have made a decision towards long-term investment. This operating manual aims to make learning and understanding the different MAICO MA 28 functions as quick and as easy as possible. Should you encounter any problems or have ideas for any further improvements, we are only a phone call away. Please do not hesitate to contact us. Your MAICO-Team

1.2 Intended Use Statement The MA 28 audiometer is designed to be a portable device for testing 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 operating conditions. Testing for hearing loss using this type of audiometer requires interaction with the patient. Indications for Use: The MA 28 is a portable or standalone audiometer intended to be used for the identification of hearing 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 audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in ISO 8253-1 or ANSI S3.1 or equivalent.

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Operation Manual MA 28 1.3 Contraindications of Use The patient is too young, sick or uncooperative to perform the tasks.

1.4 Essential Performance There is no essential performance as defined in IEC 60601-1.

1.5 Description The MA 28 is an electroacoustic test device that produces sounds through a range of frequencies and intensities to test for hearing loss. It features pure tone audiometric testing with or without masking for measuring audibility thresholds. MA 28 is meant to be used with headphones that are calibrated to the specific audiometer and are not interchangeable with other devices. 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 operating conditions. The testing for hearing loss using this kind of audiometer depends on the interaction with the patient.

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Operation Manual MA 28 2 For Your Safety This section offers you important information about:     

how to read the operation manual where to spend special attention the customer responsibility the explanation of all regulatory symbols used important cautions and warnings that have to be considered during the whole time handling and operating your device

2.1 How to Read this Operation Manual This Operation Manual contains information pertinent to the use of the MAICO device system including 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 screenshots are only examples and may differ in appearance from the actual device settings. In this manual, the following two labels identify potentially dangerous or destructive conditions and procedures: WARNING

The WARNING label identifies conditions or practices that may present danger to the patient and/or user.

CAUTION

The CAUTION label identifies conditions or practices that could result in damage to the equipment

NOTE: Notes help you identify areas of possible confusion and avoid potential problems during system operation.

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Operation Manual MA 28 2.2 Customer Responsibility All safety precautions given in this operation manual must be observed at all times. Failure to observe these precautions could result in damage to the equipment and injury to the operator or subject. The employer should instruct each employee in the recognition and avoidance of unsafe conditions and the regulations applicable to his or her work environment to control or eliminate any hazards or other exposure to illness or injury. It is understood that safety rules within individual organizations vary. If a conflict exists between the material contained in this manual and the rules of the organization using this device, the more stringent rules should take precedence. WARNING

This product and its components will perform reliably only 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 external accessories are snug and secured properly. Parts which may be broken or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from MAICO.

NOTE: Customer responsibility includes proper maintenance and cleaning of the device (see sections 3.2 and 3.3). Breach of the customer responsibility can lead to limitations of Manufacturer’s Liability and Warranty (see sections 2.3 and 3.1). NOTE: In the unlikely case of a serious incident, inform MAICO as well as your local distributor.

2.3 Manufacturer’s Liability Usage of the device in a way deviant from the intended use will lead to a limitation or termination of the manufacturer’s liability in case of damage. Improper use includes disregarding the operation manual, the operation of the device by underqualified personnel as well as making unauthorized alterations on the device.

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Operation Manual MA 28 2.4 Regulatory Symbols The following Table 1 gives an explanation of the symbols used on the device itself, on the packaging and the accompanying documents including the Operation Manual. Table 1 Regulatory Symbols

REGULATORY SYMBOLS SYMBOL DESCRIPTION Serial number Date of manufacture Manufacturer Caution, consult accompanying documents Warning, consult accompanying documents Return to authorized representative, special disposal required Reference number Patient applied part type B according to IEC 60601-1 Refer to instruction manual (mandatory) Keep away from rain Transport and storage temperature range Transport and storage humidity limitations Voltage transformer Electrostatic sensitive devices Do not reuse Conforms to 93/42/EEC

European

Medical

Device

Directive

ETL listed mark Logo

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Operation Manual MA 28 2.5 General Precautions WARNING

Before starting a measurement make sure, that the device works properly. Use and store the device indoors only. For operation, storage and transport conditions see table in section Technical Data.

WARNING

No modification of this equipment is allowed. Equipment is not user repairable. Repairs must be performed by a qualified service representative only. No modifications of the equipment are allowed by anyone other than a qualified MAICO representative. Modification of the equipment could be hazardous. No part of the equipment can be serviced or maintained while in use with the patient. Do not drop or otherwise cause undue impact to this device. If the device is dropped or otherwise damaged, return it to the manufacturer for repair and/or calibration. Do not use the device if any damage is suspected.

WARNING

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 not be used with any other transducer prior to recalibration. Recalibration also needs to be conducted, when a defected headphone is replaced. Uncalibrated devices may lead to faulty measurements and sometimes even damage the hearing of the examinee.

2.6 Electrical Safety and Measuring Security This icon indicates that patient applied parts of the device conform to IEC 60601-1 Type B requirements. WARNING

In case of emergency, disconnect the device from the computer.

In Case of Emergency WARNING In Case of Emergency

In case of emergency, disconnect the device from power supply. Do not position the device in a way that it is difficult to operate the disconnection device. The power supply and the power socket shall be accessible at all times. Do not use the device if the power supply and/or the outlet is damaged.

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Operation Manual MA 28 WARNING

To transfer data to a PC, establishing a PC-connection via USB is required. See section 4.2.4 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 60601-1shall 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-series.

WARNING

WARNING

CAUTION

The device is not intended for operation in areas with an explosion hazard. Do NOT use the MA 28 in a highly oxygen-enriched environment, such as a hyperbaric chamber, oxygen tent, etc. If the device is not used switch it off and disconnect it from the power supply. 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.

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Operation Manual MA 28 2.7 Device Control The user of the device should perform a subjective device check once a week according ISO 8253-1. See section 6.7 for a checklist. For annual calibration please see sections 2.5 and 3.1

2.8 Electromagnetic Compatibility (EMC) Electrostatic discharge (ESD) according to IEC 61000-4-2. Use the device only in an electrostatic controlled environment. To avoid the risk of electric shock, this equipment must only be connected to the power supply delivered by MAICO.

WARNING

The device fulfills the relevant EMC requirements. Avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears. The use of the accessories, transducers and cables with medical equipment/system other than the MA 28 may result in increased emissions or decreased immunity of the medical equipment/system. Please also refer to EMC consideration in section 6.5.

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Operation Manual MA 28 3 Warranty, Maintenance and After-Sales Service This section offers you important information about:       

warranty conditions maintenance cleaning and disinfection recommendations accessory and replacement parts handling disposables troubleshooting recycling and disposal of the device

3.1 Warranty The MAICO device is guaranteed for at least one year. Ask your authorized local distributor for more information. This warranty is extended to the original purchaser of the device by MAICO through the distributor from whom it was purchased and covers defects in material and workmanship for a period of at least one year 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 the warranty. WARNING

No modification of this equipment 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 be checked and calibrated at least once a year. The service and calibration must be performed by your dealer or by a service center authorized by MAICO. When returning the device for repairs or calibration it is essential to send the acoustic transducers with the device. Please include a detailed description of faults. In order to prevent damage in transit, please use the original packing when returning the device.

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Operation Manual MA 28 3.3 Cleaning and Disinfection Recommendations It is recommended that parts (device and accessories like headphones, ear cushions) which come in direct contact with the patient be subjected to standard cleaning and disinfecting procedure between patients. Recommendations for cleaning and disinfection of MAICO device presented in this document are not intended to replace or contradict policies in effect or procedures required for infection control at the facility. If there is not a high infection potential, MAICO recommends: 

Before cleaning always switch off and disconnect the device from the 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 or a comparable product. Follow the instructions on the specific disinfection product. o Wipe before and after each patient o After contamination o After infectious patients CAUTION

To avoid damage of the device and its accessories, please mind the following: 

Do not autoclave or sterilize.



Do not use the device in the presence of fluid that can come into contact with any of the electronic components or wiring.

Should the user suspect fluids have contacted the system components 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. WARNING

Discard single-use equipment after use! In case of re-use of the single-use equipment you enhance the risk of cross contamination!

For more detailed cleaning recommendations see the following sections 3.3 to 3.5.

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Operation Manual MA 28 3.4 Disposables Operating the MA 28 with insert phones will require the use of Insert Foam Eartips. They are intended for singleuse only. These should be discarded after use. They cannot be cleaned. WARNING

In case of re-use of the single-use equipment you enhance the risk of cross contamination!

In case you want to purchase further disposables, please, contact MAICO or your local distributor.

3.5 Accessories/Replacement Parts Some reusable components are subject to wear with use over time. MAICO recommends that you keep these replacement parts available (as appropriate for your MA 28 device configuration). 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 municipal waste. According to this, all MAICO products sold after August 13, 2005, are 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 distribution costs we assign the responsibility for the proper collection and treatment according to legal regulations to our customers. Non-European countries Outside the European Union, local regulations should be followed when disposing of the product after its useful life.

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Operation Manual MA 28 4 Unpacking and Hardware Orientation This section provides information on:    

unpacking the system components becoming familiar with the hardware inclusive connections how to store the device

4.1 Unpacking the System Check Box and Contents for Damage    

It is recommended that you unpack your MA 28 carefully making sure that all components are removed from the packing materials. Verify that all components are included as shown on the packing slip included with your shipment. If any component is missing, contact your distributor immediately to report the 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 Imperfections Notify the carrier immediately if any mechanical damage is noted. This will insure that a proper claim is made. Save all packaging material so the claim adjuster can inspect it as well. Report Immediately any Faults Any missing part or malfunction should be reported immediately to the supplier of the device together with the invoice, serial number, and a detailed report of the problem. Keep Packaging for Future Shipment Save all the original packing material and the shipping container so the device can be properly packed if it needs to be returned for service or calibration (see section 3.2).

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Operation Manual MA 28 The MA 28 comes with different components (see Table 2). The availability of configurations with the following components are country specific. Contact your local distributor for more information. See also Table 3 for replacement parts and disposables. Table 2 List of Components

Available Components Base Unit Database Software with Audiometry Module (CD and USB) Power Supply UE10WCP1-050200SPA USB Cable DD45 Audiometric Headphones* DD65 Audiometric Headphones* DD450 High Frequency Headphones* IP30 Insert Phones* B71 Bone Conduction Headphones* B81 Bone Conductor Headphones* Patient Response Switch* Operation Manual Quick Guide *Applied part according to IEC 60601-1.

Table 3 Replacement Parts and Disposables

Replacement Parts and Disposables Ear Cushion Cover Foam Eartips** Audiogram Pad **Only for use with Insert Phones.

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Operation Manual MA 28 4.2 Hardware and Accessories 4.2.1 Where to Setup The MA 28 should be operated in a quiet room, so that the audiometric examinations are not influenced by outside noises. Ambient sound pressure levels in an audiometric test room shall not exceed the values specified in the norm ISO 8253-1 or ANSI S3.1. For use in noisier environments, headphones with optional sound insulation muffs are available. Electro-medical devices, which emit strong electromagnetic fields (e.g. microwaves or radiotherapy devices), can influence the function of the audiometer. Therefore, it is not recommended to use these devices in close proximity to the audiometer as it may lead to incorrect test results. The test room must be at a normal temperature, usually from 15° C/59 °F to 35° C/ 95 °F, and the device should be switched on approximately 10 minutes before the first measurement. If the device has been cooled down (e.g. during transport), please wait until it has warmed to room temperature before using. WARNING

External devices such as a computer, printer or Ethernet which are connected to the device must meet electrical safety requirements, such as ANSI/AAMI ES/IEC/EN 60601-1. This is to avoid electrical shock to the user or the patient.

4.2.2 MA 28 Device Figure 1 shows the MA 28 device. The device has a main device layout, a case to store headsets and cables and a handle to easily carry the device (Figure 2). The connections are located in the case (Figure 3).

Figure 1

Figure 2

Figure 3

NOTE: See section 5.3 detailed information about the device layout.

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Operation Manual MA 28 Adjusting feet height 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 4.)

Figure 4

4.2.3 Connections for Headphones, Power Supply and USB Devices Figure 5 shows the connections on the inside panel of the device. The connections are explained in Table 4. Insert the plugs before turning on the device.

CAUTION

1

Insert plugs with care into the appropriate connection. Do not wiggle the plug or pull with force while connected. Disconnect plugs cautiously.

2

3

4

5

6

7

8

9

Figure 5

Table 4 Connections on Inside Panel of Device

CONNECTIONS 1 2 3 4 5 6 7 8 9

Power Supply UE10WCP1-050200SPA USB Host USB Device for PC Communication Patient Response Switch Bone Conduction No Function in Actual MA 28 Version Left Phone or Left Insert Right Phone or Right Insert No Function in Actual MA 28 Version

4.2.4 Establishing a PC-Connection To transfer data to a PC, establishing a PC-connection via USB is required. If the MA 28 is used with office equipment that is not a medical device itself (see Table 4,

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Operation Manual MA 28 PC-Connection 1), make sure to establish the PC-connection in one of the following ways (see Table 4, PC Connection 2, 3 or 4).

WARNING

Make sure you use only office equipment with the device that is a medical device itself or meets the requirements of IEC 60950. If a non-medical device is used within the patient environment (1.5 m from patient as defined in IEC 60601series) a voltage transformer must be used (exception: a battery driven laptop is used).

PC CONNECTIONS PC Connection 1

PC Connection 2

Medical device – Medical Device

Medical device – Non Medical Device

PC Connection 3

PC Connection 4

Medical device – Non Medical Device

Medical device –Laptop (battery driven)

4.2.5 PC-Interface Please refer to the Audiometry Module operation manual for transferring of results to the PC. 4.2.6 Storage When the MA 28 is not in use, store it in a location where it will be safe from damage to sensitive components such as the acoustic transducers and cables. Store according to the recommended temperature conditions described in section 4.2.1. 8506915 Rev. 3

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Operation Manual MA 28 5 Operating the Device This section offers you information about:      

how to get started with the MA 28 the device layout the display the function keys performing Tone Audiometric testing changing settings in the setup menu

5.1 Getting started with the MA 28 Place the MA 28 on a stable counter or table. Plug the power cord into the power socket. Connect all accessories with the appropriate sockets as shown in Section 4.2.3. Plug the power cord into a grounded outlet.

5.2 Use of Equipment After Transport and Storage Make sure the device is functioning correctly before use. If the device has been stored in a colder environment (even for shorter time) allow the device to become acclimatized. 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 conditions than the use conditions no special precaution are required before use. Always ensure proper operation of the device by following routine check procedures for audiometric equipment. 5.2.1 Switching On the Device NOTE: The warm up time for the device including boot up process takes about 1 minute. Briefly press the Power key on the MA 28 to turn on the device (Figure 6). Figure 6

5.2.2 Switching Off the Device The device can be shut down by pressing the Power key for about 3 seconds.

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