Affinity Instructions for Use Part 1 Nov 2014

Instructions for Use - EN

Hearing Aid Analyzer Affinity2.0

Table of Contents 1

INTRODUCTION ... 1 1.1 About this Manual ... 1 1.2 Intended Use ... 1 1.3 Product Description ... 1 1.4 Included and Optional Parts and Accessories ... 2 1.5 Warnings ... 3

2

UNPACKING AND INSTALLATION ... 5 2.1 Unpacking and Inspection ... 5 2.2 Marking... 6 2.3 Connection Panel Dictionary ... 7 2.4 Software installation ... 8 2.4.1 Software Installation Windows®7 and Windows®8 ... 9 2.4.2 Software Installation Windows®8.1 ... 12 2.4.3 Software Installation on Windows® XP ... 16 2.5 Driver Installation ... 19 2.6 2.6 Using with Databases ... 22 2.6.1 Noah3 ... 22 2.6.2 Noah 4 ... 22 2.7 Standalone Version ... 23 2.8 License ... 23

3

OPERATING INSTRUCTIONS ... 25 3.1 Using the Tone Screen ... 26 3.2 Using the Speech Screen ... 32 3.2.1 Speech Audiometry in Graph Mode ... 34 3.2.2 Speech Audiometry in Table Mode ... 35 3.2.3 PC Keyboard Shortcuts Manager ... 37 3.3 The REM440 Screen ... 39 3.4 The HIT440 Screen ... 48 3.5 Using the Print Wizard ... 54

4

MAINTENANCE ... 57 4.1 General Maintenance Procedures ... 57 4.2 How to clean Interacoustics Products ... 57 4.3 Concerning Repair ... 58 4.4 Warranty ... 58

5

GENERAL TECHNICAL SPECIFICATIONS ... 59 5.1 Reference Equivalent Threshold Values for transducers ... 60 5.2 Pin Assignments ... 60 5.3 Electromagnetic Compatibility (EMC) ... 60

Affinity Instruction for Use - EN

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1 Introduction 1.1

About this Manual

This manual is valid for the Affinity2.0 . These products are manufactured by: Interacoustics A/S Drejervænget 8 DK 5610 Assens Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: [email protected] Web: www.interacoustics.com

1.2

Intended Use

The Affinity2.0 with AC440 is intended to be used for the detection and diagnosis of suspected hearing loss. The Affinity2.0 with HIT440 is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. The Affinity2.0 with REM440 is intended to be used for Real-Ear Measurement that takes care of all clinical verification needs.

1.3

Product Description

Affinity2.0 are Hearing Aid Analyzers that interfaces with integrated audiologic software modules on a PC. Depending on the installed software modules they can perform:  Audiometry (AC440)  Real Ear Measurements (REM440) including Visible Speech Mapping  Hearing Instrument Testing (HIT)

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1.4

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Included and Optional Parts and Accessories AC440

REM440

HIT440

Included parts:  Affinity2.0 AC440 CD  OtoAccess™ database CD  TDH39 Audiometric headset or DD45 Audiometric headset  MTH400 Headset  EMS400 Talk back microphone  B71 Bone conductor  APS3 Patient response button  Standard USB cable  Power cable 120 or 230V  Mouse pad  Instructions for Use document

Included parts:  Affinity2.0 REM440 CD  OtoAccess™ database CD  IHM60 In-situ headset with probe microphone and reference microphone (double)  Probe tubes, 36 pcs.  Standard USB cable  Power cable 120 or 230V  Mouse pad  Instructions for Use document

Included parts:  Affinity2.0 HIT440 CD  OtoAccess™ database CD  2cc coupler with microphone and adaptors for ITE, BTE and Body Style HA  Coupler seal wax  Reference microphone  Standard USB cable  Power cable 120 or 230V  Mouse pad  Additional Information and Instructions for Use

Optional parts:  DAK70 Audiometer keyboard with live voice mic.  Earphone 3A insert earphones (5As may be substituted)  IP30 insert earphones  B81 Bone Conductor  B71 Bone Conductor  ACC60 Affinity2.0 carrying case  CIR22 Insert masking earphones  Audiocup enclosures  Peltor noise excluding headset  HDA280 Audiometric headset  HDA300 Audiometric headset  KOSS R80 high frequency headset

Optional parts:  SPL60 Transducer kit for RECD measurement including probes and eartips  BET60 Box with eartips for for RECD measurement.  Calibration adaptor for insitu reference  VSP440 Visible Speech Mapping module  Optical USB 1.1 isolation extension cable  ACC60 Affinity2.0 carrying case  Coupler microphone extension cable

Optional parts:  Battery adapters BAA675, BAA13, BAA312, BAA10, BAA5  Couplers 1.2CC and 0.6CC: ITE, BTE, Ear simulator  TBS25M External test chamber incl. cables  ACC60 Affinity2.0 carrying case  Calibration adaptor  Optical USB 1.1 isolation extension cable  SKS10 Skull Simulator with power supply

     

AP70 Power amplifier 2x70 Watt SP90 Loudspeaker SP85A Loudspeaker SP90A Loudspeaker AFC8 Sound cabin installation panel Optical USB 1.1 isolation extension cable

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Optional special tests:  High Frequency audiometry (HF440)  Multi Frequency module (MF440)  Speech from hard-drive (SFH440)  SISI test  Master Hearing Aid (MHA440),  Hearing Loss Simulator (HLS440)  Loudness Scaling (LS440)  QuickSIN  TEN test

1.5 Warnings Throughout this manual the following meaning of warnings, cautions and notices are used:

WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. NOTICE is used to address practices not related to personal injury.

1. The Affinity2.0 are class I medical products and they must only be connected to a power outlet with a functional protective ground. 2. When connecting this device to a computer it is essential to insert a galvanic separation between the device and the computer, unless the computer is battery operated or supplied by a medical approved power supply. 3. If a mains powered computer is used without galvanic separation, it must be supplied from a medical isolation transformer fulfilling the requirements of IEC/ES 60601-1. 4. Although the instrument fulfils the relevant EMC requirements precautions should be taken to 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, e.g. unwanted noise in headphones. If disturbances are observed, try to separate the Affinity2.0 .0/Equinox2.0 from the disturbing device. 5. If this apparatus is connected to one or more other devices with medical CE marking, to make up a system or pack, the CE marking is only valid also for the combination if the supplier has issued a

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declaration stating that the requirements in the Medical Device Directive article 12 are fulfilled for the combination. 6. If connection is made to standard equipment like an active speaker, special precautions must be taken in order to maintain medical safety. If used without galvanic separation, it must be supplied from a medical isolation transformer fulfilling the requirements of IEC/ES 60601-1. 7. Do not disassemble or modify the product as this may impact the safety and/or performance of the device.

1. DO NOT connect the Affinity2.0 hardware to the computer before the software has been installed! 2. The instrument is intended for continued use. However, there is a risk of damaging the transducers if they are operated at the highest intensities for longer periods. 3. To avoid overheating, please observe that cooling vents are unobstructed and that the air can flow freely around the instrument. 4. Within the European Union it is illegal to dispose of electrical and electronic waste as unsorted municipal waste. Electrical and electronic waste may contain hazardous substances and therefore have to be disposed of separately. Such products will be marked with the crossed-out wheelie-bin image shown to the left. User cooperation is important in order to ensure a high level of reuse and recycling of electrical and electronic waste. Failure to recycle such waste products in an appropriate way may endanger the environment and consequently the health of human beings. No installation precautions are necessary to avoid unwanted sound radiation from the audiometer. When connecting the Affinity2.0 to the mains supply and to a computer the following warnings must be observed:

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2 Unpacking and Installation 2.1

Unpacking and Inspection

Check box and contents for damage When the instrument is received please check the shipping box for rough handling and damage. If the box is damaged it should be kept until the contents of the shipment have been checked mechanically and electrically. If the instrument is faulty please contact your local distributor. Keep the shipping material for the carrier’s inspection and insurance claim. Keep carton for future shipment The Affinity2.0 comes in its own shipping carton, which is specially designed for the Affinity2.0 Please keep this carton. It will be needed if the instrument has to be returned for service. If service is required please contact your local distributor. Reporting Imperfections Inspect before connection Prior to connecting the product it should once more be inspected for damage. All of the cabinet and the accessories should be checked visually for scratches and missing parts. Report immediately any faults Any missing part or malfunction should be reported immediately to the supplier of the instrument together with the invoice, serial number, and a detailed report of the problem. In the back of this manual you will find a "Return Report" where you can describe the problem. Please use "Return Report" Please realise that if the service engineer does not know what problem to look for he may not find it, so using the Return Report will be of great help to us and is your best guarantee that the correction of the problem will be to your satisfaction. Storage If you need to store the Affinity2.0 for a period, please ensure it is stored under the following conditions: Temperature; Relative Humidity:

0-50°C 10-95% Non condensing

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2.2 Marking The following marking can be found on the instrument: Symbol

Explanation Type B applied parts. Patient applied parts that are not conductive and can be immediately released from the patient. Refer to instruction manual or WEEE (EU-directive) This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling. Failing to do so may endanger the environment.

0123

The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No. 0123, has approved the quality system. Year of manufacture

Headphones, patient response switches and other accessories shall be plugged into the appropriate connectors as indicated on the rear of the instrument and the overview below:

Affinity Instruction for Use - EN

2.3

Position: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45

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Connection Panel Dictionary

Symbol: FF1 FF2 Left Right Ins. Left Ins. Right Bone Ins. Mask. HF/HLS Talk Back Mic. 1/TF Mic. 2 Ass. Mon. Monitor Pat. Resp. L Pat. Resp. R Inp. Aux. 1 Inp. Aux. 2 Batt. Sim. TB Lsp. TB Loop FF Loop TB Coupler TB Ref.

Sp. 1-4 Power Out FF1 FF2 Sp 1 Sp 2 Sp 3 Sp 4 CD1 CD2 Insitu L. Insitu R. Keyb. DC USB/PC USB Ref.Mic./Ext. Coupler/Ext. Mains Power

Function: Connection of FF1 Connection of FF2 Plug for left AC headphone Plug for right AC headphone Plug for left insert earphone Plug for right insert earphone Plug for bone conductor Plug for insert earphone for masking Plug for High Frequency headphone/Hearing Loss Simulator Plug for talk back microphone Plug for microphone / talk forward Plug for microphone Plug for assistant’s headset Plug for monitor headset Plug for left patient response button Plug for right patient response button Plug for input aux. 1 Plug for input aux. 2 Plug for battery simulator Plug for test box loudspeaker Plug for test box loop Plug for free field loop Plug for test box coupler Plug for test box reference microphone Box for couplers Ground Plug for loudspeaker 1-4 power out Connection of power amplifier FF1 Connection of power amplifier FF2 Connection of loudspeaker 1 Connection of loudspeaker 2 Connection of loudspeaker 3 Connection of loudspeaker 4 Input plug for CD 1 Input plug for CD 2 Connection of Insitu Headset Left Connection of Insitu Headset Right Connection of Keyboard Plug for power supply for optical USB extension cable Plug for USB cable or PC Plug for USB cable Connection of external reference microphone Connection of external coupler Plug for mains cable Turns power on/off.

Affinity Instruction for Use - EN

2.4

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Software installation

To know before you Start Installation You must have administrative rights to the computer on which you are installing the Affinity 2.0/ Equinox 2.0 Suite.

1. DO NOT connect the Affinity2.0 hardware to the computer before the software has been installed! 2. Interacoustics will not make any guarantee to the functionality of the system if any other software is installed, with exception of the Interacoustics measurement (AC440/REM440) modules and AuditBase system4, Otoaccess™, Noah3.7 or Noa4 compatible Office Systems or later releases. What you will need: 1. Affinity2.0 Suite Installation DVD 2. USB Cable 3. Affinity2.0 Hardware Supported Noah Office Systems  Noah 3.7 or Noah 4 (from HIMSA)  AuditBase System 4  Mirage  Practice Navigator  Power Office  AkuWin  He@r-O  Entendre 2  Quasar TM

To use the software in conjunction with a database (e.g. Noah3.7, Noah4 or OtoAccess ), make sure the database is installed prior to the Affinity2.0 Suite installation. Follow the manufacturer’s installation instructions provided to install the relevant database. Note that if you are using AuditBase System 4 you must ensure to launch this office system prior to this installation of the Affinity2.0 Suite. Installation on various Windows® versions Installation on Windows® XP (SP2 or later), Windows Vista and Windows® 7 (32 and 64 bit) and Windows® 8 systems are supported. Note that with Windows® “N” versions, Media Player needs to be installed manually for the software suite to run. Software Installation on Windows® 7 Insert the installation DVD and follow the steps below to install the Affinity2.0 Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD. Double click the “setup.exe” file to initiate the installation.

Affinity Instruction for Use - EN

2.4.1

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Software Installation Windows®7 and Windows®8

Insert the installation DVD and follow the steps below to install the Affinity2.0/Equinox2.0 Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD. Double click the “AffinitySuiteSetup.exe” file to initiate the installation. During the installation process the User 1. Wait for the dialog shown below to appear, then click “Install”.

2. User Account Control may ask if you want to allow the program to make changes to your computer. Click Yes if this happens.

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3. The installer will now copy all the necessary files to the PC. This process may take several minutes.

4. If the dialog box below appears, select “Install” to install this driver software.

Affinity Instruction for Use - EN

5. When the installation is complete, the dialog box below is shown.

6. Click “Close” to finish the installation. The Affinity2.0/Equinox2.0 Suite is now installed.

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Affinity Instruction for Use - EN

2.4.2

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Software Installation Windows®8.1

Insert the installation DVD and follow the steps below to install the Affinity2.0/Equinox2.0 Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD. Double click the “AffinitySuiteSetup.exe” file to initiate the installation. During the installation process the User 1. Wait for the dialog shown below to appear, then click “Install”.

2. User Account Control may ask if you want to allow the program to make changes to your computer. Click Yes if this happens.

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3. The installer will now copy all the necessary files to the PC. This process may take several minutes.

4. If any of the dialogs below are shown, click “Install” to proceed with the installation.

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Affinity Instruction for Use - EN

5. When the installation is complete, the dialog box below is shown.

6. Click “Close” to finish the installation. The Affinity2.0/Equinox2.0 Suite is now installed.

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Affinity Instruction for Use - EN

2.4.3

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Software Installation on Windows® XP

Insert the installation DVD and follow the steps below to install the Affinity2.0/Equinox2.0 Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the DVD/CD-RW drive to view the contents of the installation DVD. Double click the “AffinitySuiteSetup.exe” file to initiate the installation. 1. Wait for the dialog shown below to appear, then click “Install”.

2. The installer will now copy all the necessary files to the PC. This process may take several minutes.

Affinity Instruction for Use - EN

3. If the dialog box below appears, select “Continue Anyway”.

4. If any of the dialogs below appear, click “Yes” to confirm file replace.

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