VRA Screen Instructions for Use Feb 2022

Contents 1

2

Introduction ... 1 1.1

About this manual ... 1

1.2

Intended use... 1

1.3

Contraindications ... 1

1.4

Product description ... 1

1.5

Minimum requirements ... 1

Unpacking and installation ... 2 2.1

Unpacking and inspection... 2

2.2

Reporting imperf ections... 2

2.3

Saf ety precautions ... 2

2.3.1 2.4

Cautions – general... 2 Malf unction... 3

3

Visual reinf orcement audiometry (VRA)... 4

4

Getting started... 5 4.1 4.1.1

PC and connections ... 5

4.1.2

Setup ... 6

4.1.3

Start-up ... 6

4.1.4

Setup window ... 7

4.2

6

The Playlist Creator... 8

4.2.1

PC requirements using the Playlist Creator... 8

4.2.2

Sof tware Installation... 8

4.2.3

Getting started using the Playlist Creator ...10

4.3 5

The VRA system ... 5

Drag and drop...11

Care and maint enance...13 5.1

General maintenanc e procedures ...13

5.2

Repair ...13

5.3

Warranty ...14

General technical specif ication for PC...15

1 Introduction 1.1

About this manual

This manual is valid f or the Interacoustics VRA Screen. This product is distributed by Interacoustics A/S. Interacoustics A/S Audiometer Allé 1 5500 Middelf art Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: inf [email protected] Web: www.interacoustics.com

1.2

Intended use

1.3

Contraindications

1.4

Product description

The Interacoustics VRA Screen is a manually controlled visual reinf orcement system. The system is aimed at giving visual rewards to pediatric patients to keep their f ocus during audiometric assessment.

None known.

The Interacoustics VRA Screen provides the ability to support up to three visual reinf orcement screens where motions and still pictures can be used as rewards. The Playlist Creator sof tware delivered with the VRA system makes it possible to adjust the def ault playlists provided and create playlists of you own. Included parts: • VRA PC • Mouse • USB with VRA playlist creator • Instructions f or Use • 2 HDMI cables Optional parts: If screens with built-in speakers are used f or the setup, then these can be used. If not, separate speakers can be ordered if audio is wanted. • Speakers f or audio rewards (Tabletop active speaker #8104162). • 1 extra HDMI cable • 1 DP to HDMI adaptor Needed in addition: 1-3 screens in accordance with the requirements.

1.5

Minimum requirements

Screens • Resolution 1024x768 (recomended 1920x1080) • HDMI support

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2 Unpacking and installation 2.1

Unpacking and inspection

Check for damage

When you receive the VRA Screen system, please check the shipping box f or rough handling and damage. If the box is damaged, you should keep it until the contents of the shipment have been checked mechanically and electrically. If your VRA Screen is f aulty, please contact your local distributor. Keep the shipping material f or the carrier’s inspection and insurance claim.

Keep carton for future shipment

The instrument comes with shipping cartons, which are specif ically designed f or the components. It is recommended to keep the cartons f or f uture shipments in case of any need f or return or service.

2.2

Reporting imperfections

Inspect before connection Prior to connecting the product, you should inspect it once more f or damage. You should visually check the cabinet and the accessories f or scratches and missing parts. Report any faults immediately Any missing parts or malf unctions should be reported immediately to the supplier of the instrument together with the invoice, serial number, and a detailed report of the problem. At the end of this manual, you will f ind a "Return Report", where you can describe the problem. Please use the "Return Report" Use of the return report provides the service engineer with the relevant inf ormation to investigate the reported issue. Without this inf ormation, there may be dif f iculty in determining the f ault and repairing the device. Please always return the device with a completed Return Report in order to guarantee a satisf actory repair.

2.3

Safety precautions

2.3.1

Cautions – general

Read these instructions caref ully and completely bef ore using the product.

If the system is not f unctioning properly, do not use it until all necessary repairs are made and the unit is tested f or proper f unctioning in accordance with Interacoustics’ specif ications. Do not drop or in any other way cause undue impact to this device. If the instrument is damaged, return it to the manuf acturer f or repair. Do not use the instrument if any damage is suspected. This product and its components will perf orm reliably only when operated and maintained in accordance with the instructions contained in this manual, accompanying labels, and/or inserts. A def ective product should not be used. Make sure all connections to external accessories are secured properly. Parts which may be broken or missing or are visibly worn or distorted should be replaced immediately with clean, genuine replacement parts manuf actured by or available f rom Interacoustics.

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Interacoustics will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other inf ormation that will assist authorized service personnel to repair those parts of this instrument that are designated by Interacoustics as repairable by service personnel. No parts of the equipment can be serviced or maintained while in use with the patient. The instrument is not intended f or use in environments exposed to f luid spills.

2.4

Malfunction

In the event of a product malf unction, it is important to protect patients, users, and other persons against harm. Theref ore, if the product has caused, or potentially could cause such harm, it must be quarantined immediately.

Both harmf ul and harmless malf unctions, related to the product itself or to its use, must immediately be reported to the distributor where the product was acquired. Please remember to include as many details as possible e.g. the type of harm, serial number of the product, sof tware version, connected accessories and any other relevant inf ormation. In case of death or serious incident in relation to the use of the device, the incident must immediately be reported to Interacoustics and the local national competent authority.

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3 Visual reinforcement audiometry (VRA) VRA is a tool that can help keeping young patients stay f ocused during audiometric or other procedures by giving them a visual reward. The test is perf ormed by an audiometer or another medical device. By using visual reinf orcement, the child is trained to move their head to either side and indicate that they have heard the sound, thus giving the clinician an indication of the hearing level. VRA is of ten done in a f ree f ield environment when it is inf ants/very young toddlers, and it is theref ore not possible to determine which side the sound was heard at, at a specif ic sound level. If the child accepts it, headphones or f oam tips with inserts can be used to make an ear specif ic audiometry. In the VRA setup there are usually two screens, one on each side of the child. When the clinician is presenting a sound, the child is prompted to turn its head towards the sound. This can require some training at f irst. When the child moves its head towards the sound heard, the screen is activated by the operator, and an animation or image is presented as a reward. By using the VRA setup it makes it more f un f or the young child to participate in the examination and it does not seem so intimidating getting a hearing test, when cartoons and toys are used.

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4 Getting started The VRA Screen system contains of two parts: the VRA system itself and a VRA Playlist Creator.

4.1

The VRA system

4.1.1

PC and connections

VRA system uses a dedidated PC with Windows IoT operating system. The VRA system is setup the f ollowing way with the PC. 1 2 3 4 5 6 7 8 9 10 11 12 13

14

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Power DP port USB HDMI USB USB USB Ethernet HDMI Power Microphone Headset USB 3.0 USB

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4.1.2

Setup

Screens The VRA Screen PC can have up to three screens connected.

Connect two of the screens directly with HDMI and the last with the HDMI to DP adaptor, as there are only two HDMI ports in the VRA PC. It does not matter what screen is connected to which port, as it is possible to choose the screens position in the settings screen.

4.1.3

Start-up

1. Press the Power button on the VRA Screen PC. A def ault playlist is preloaded on the system. The VRA screens will always start-up with black screens and the only indication f or the system being turned on, is the light in the power button on the PC. Wait f or 30 seconds. The system is now ready f or use. 2. The mouse is now used to control the VRA system. Right click: Shows image or video on the right screen. Left click: Shows image or video on the lef t screen. Wheel click: Show image or video on the center screen. When having more playlists on the VRA PC, it is possible to switch between them by using the mouse wheel. A small indication of the seelcted playlist will appear on screen. Three turns upwards: shif ts to next playlist. Three turn downwards: shif t the image or video to previous one. This can be usef ul in case a reward really caught the attention of the child and you want to reuse it once again. Pressing the respective key f or the screen while the reward is on will result in the reward disapearing immediately.

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4.1.4

Setup window

It is possible to enter the setup window of the VRA system by connecting a USB keyboard. This is done by connecting a keyboard and pressing F1 f or information.

Hardware In this f ield, inf ormation will be available about the screens connected and the USB dongles available in the PC This screen In this area it is possible to adjust the screen setup. Use Screen position to choose what position the screen has in the room. The options are right, lef t or center. Audio output is where the speakers are selected. It is possible to send sound through the PC, or the connected loudspeaker. The play button to the right is to test that the sound is played through the correct media. Audio volume gives the option to control how loud the sounds on the videos should be played. It will be set to 50 % as def ault. Audio muted makes it possible to mute the sound on the videos and it is possible to mute one screen and have the sound on another if this is wanted. About The About box shows the version number and license key. Content From here it is possible to see all the playlists loaded to the PC. In Current scene the next image or video to be shown will be present. In Available scenes all the videos or images of the chosen playlist will be shown. It is then possible to choose what to be shown next. If the child being tested is really f ound of ducks, then it is possible to choose the duck to be shown as the f irst image or video. At start up, the VRA PC will have one playlist available on it as def ault and the system will be ready to use out of the box. If the user wants to create their own playlists, please f ollow the steps in section 4.2.3. To exit the information screen, press F1 again. D-0128588-D – 2022/02 VRA Screen - Instructions for Use - EN

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4.2

The Playlist Creator

4.2.1

PC requirements using the Playlist Creator

When receiving the system, the USB will contain the VRA Playlist Creator which is the program to adjust or create new playlists. From the Playlist Creator you can adjust def ault f actory lists and create and add your own playlists with both motion and still pictures.

PC minimum requirements • Core i3 CPU or better (Intel recommended) • 4GB RAM or more • Hard drive with min 10 GB f ree space (Solid State Drive (SSD) recommended) • Minimum display resolution of 1280x1024 pixels • DirectX 11.x compatible graphics (Intel/NVidia recommended) • One or more USB ports, version 1.1 or higher Supported operating systems • Microsof t Windows® 7 32-bit and 64-bit • Microsof t Windows® 8 32-bit and 64-bit • Microsof t Windows® 10 32-bit and 64-bit • Windows® is a registered trademark of Microsoft Corporation in the United States and other countries. Important: make sure you have the latest service packs and critical updates installed f or the version of Windows® that you are running. NOTICE: Using operating systems where Microsof t have discontinued sof tware and security support will increase the risk f or viruses and malware, which may result in breakdowns, data loss and data thef t and misuse. Interacoustics A/S cannot be held liable f or your data. Some Interacoustics A/S products support or may work with operating systems unsupported by Microsoft. Interacoustics A/S recommends you to always use Microsof t supported operating systems that are kept f ully security updated.

4.2.2

Software Installation

Software installation on Windows® 7, Windows® 8 and Windows® 10 Insert the installation USB and f ollow the steps below to install the VRA playlist Creator sof tware. Click Start, then go to My Computer and double click the USB drive to view the contents of the installation USB. Double click the setup.exe f ile to initiate the installation. Wait f or the dialog shown below to appear, agree to the license terms and conditions, then click Install. NOTICE: As a part of data protection, ensure to be compliant to all the f ollowing points: 1. Use Microsof t supported operating systems 2. Ensure operating systems are security patched 3. Enable database encryption 4. Use individual user accounts and passwords 5. Secure psychical and network access to computers with local data storage 6. Use updated antivirus and f irewall and anti-malware sof tware 7. Implement appropriate backup policy 8. Implement appropriate log retention policy

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Follow the onscreen VRA Playlist Creator Installer instructions until the installation has been completed. Click on Close. The sof tware is now installed and ready to use. During installation, Windows® may: • Ask if you want to allow changes to the computer. Click Yes if this happens • Ask to download and install a new Windows Feature (e.g., .NET Framework 3.5). Download and install new f eatures to ensure that the sof tware works as intended • Warn you that Windows cannot verif y the publisher of this driver sof tware. Install the driver sof tware anyway to ensure the VRA playlist creator works as intended Open the program f rom desktop shortcut or f rom Start. Make sure you have the VRA USB connected to the PC in use. Supported f iles are: • images: .jpeg, jpg, png, bmp • videos: .mp4, .m4a, .m4v Only supported f iles are visible when looking through f olders on the local PC.

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4.2.3

1. 2. 3. 4. 5. 6. 7.

Getting started using the Playlist Creator

Add new playlist: Create new playlists. Add default playlist: The def ault playlists with cartoon animals will be added. Rename the playlist: Choose the name of the playlist. The playlist name will only be visible in the lef t bottom corner of the screen when changing through playlists in use. Time displayed: Set the time to how long the image or video should be visible on screen. From 0 to 99 seconds. Shuffle arrow: Replace the image or video on the playlist. Remove Scene: Remove an image or video f rom the playlist. Remove playlist: Remove entire playlist f rom USB. Def ault playlist can always be removed and added again when needed.

A new playlist is created by using Add new playlist. Open the f olders of the content in the upper lef t corner. The supported f iles in the f older will be available in the lower lef t corner of the screen. Choose the image or video to add to playlist and press Copy to Playlist or drag the content over to the playlist on the right side of the screen.

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Press Copy to playlist or drag the image or video to playlist. When multiple playlists are created, remember to choose the right one bef ore adding images or video to the playlist. This is done by clicking in the line with playlist name and time displayed. The selected playlist will appear dark blue. When dragging the content f rom the media f iles list, the playlist where the image or video will be added will appear light blue. During transf er of the image or video, a box will appear to indicate the status of transf er. If the status bar turns orange during transf er, this means that the image or video is not supported by the system.

When a playlist is created there are multiple options to customize the content. For example, the time shown on screen, which image should appear on what playlist, should a single video or image be shown multiple times in a row etc.

4.3

Drag and drop

It is possible to create as many playlists as needed. When having more playlist, the user can drag images and videos between the dif f erent playlists by holding down on the item and dragging it to the desired place on the playlist or to another playlist. The list the image or video are being dragged to, will be marked by a bold line. To copy an image or video f rom one playlist to another, hold down CTRL when dragging the item. This can also be used f or copying an image or video to the same playlist.

When the desired playlists are added and customized, the USB can be removed f rom the main PC and put in the VRA PC. It is recommended by doing this as a saf ely removal of the USB in Windows. D-0128588-D – 2022/02 VRA Screen - Instructions for Use - EN

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When the USB is placed in the VRA PC, the playlists will be copied to the VRA PC. A process bar appears while the transf er is taking place. Once the transf er is complete the system is ready f or use. Note: If a new playlist is created on the USB, the once on the PC will be removed and replaced by the new once.

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5 Care and maintenance 5.1

General maintenance procedures

• • • • •

Bef ore cleaning, always switch of f and disconnect f rom the power supply Use a sof t cloth lightly dampened with a cleaning solution to clean all exposed surf aces Do not autoclave, sterilize or immerse the instrument or accessory in any f luid Do not use hard or pointed objects to clean any part of the instrument or accessory Do not let parts that have been in contact with f luids dry bef ore cleaning

Recommended cleaning and disinfection solutions: • Warm water and soap • In special cases, e.g., during virus outbreaks should the device be disinf ected using isopropyl alcohol.

5.2

Repair

DGS Diagnostics A/S is only considered to be responsible f or the validity of the CE marking, ef f ects on saf ety, reliability and perf ormance of the equipment if : 1. 2. 3.

assembly operations, extensions, readjustments, modif ications, or repairs are carried out by authorized persons. the electrical installation of the relevant room complies with the appropriate requirements, and the equipment is used by authorized personnel in accordance with the documentation supplied by Interacoustics.

The customer shall reach out to the local distributor to determine the service/repair possibilities including onsite service/repair. It is important that the customer (through local distributor) f ills out the RETURN REPORT every time when the component/product is sent f or service/repair to Interacoustics.

This should also be done every time an instrument is returned to Interacoustics. (This of course also applies in the unlikely worst-case scenario of death or serious injury to a patient or user). This device is manuf actured by: DGS Diagnostics A/S Audiometer Allé 1 5500 Middelfart Denmark

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5.3

Warranty

Interacoustics guarantees that: • The Interacoustics VRA Screen is f ree f rom def ects in material and workmanship under normal use and service f or a period of 24 months f rom the date of delivery by Interacoustics to the f irst purchaser • Accessories are f ree f rom def ects in material and workmanship under normal use and service f or a period of ninety (90) days f rom the date of delivery by Interacoustics to the f irst purchaser If any product requires service during the applicable warranty period, the purchaser should communicate directly with the local Interacoustics service center to determine the appropriate repair f acility. Repair or replacement will be carried out at Interacoustics’ expense, subject to the terms of this warranty. The product requiring service should be returned promptly, properly packed, and postage prepaid. Loss or damage in return shipment to Interacoustics shall be at the purchaser's risk. This shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and Interacoustics shall not be responsible f or, any loss arising in connection with the purchase or use of any Interacoustics product that has been: • repaired by anyone other than an authorized Interacoustics service representative; • altered in any way so as, in Interacoustics opinion, to af f ect its stability or reliability; • subject to misuse or negligence or accident, or that has had the serial or lot number altered; def aced or removed; or • improperly maintained or used in any manner other than in accordance with the instructions provided by Interacoustics. In no event shall Interacoustics be liable f or any incidental, indirect or consequential damages in connection with the purchase or use of any Interacoustics product. This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of Interacoustics. Interacoustics does not give or grant, directly or indirectly, the authority to any representative or other person to assume on behalf of Interacoustics any other liability in connection with the sale of Interacoustics products. INTERACOUS TICS DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION

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6 General technical specification for PC General Operation environment: Transport & storage: Power supply Dimensions

VRA201 weight

Temperature: Relative humidity: Storage temperature: Transport temperature: Rel. humidity: HxWxL

15-35 °C 30-90% 0°C-50°C -20-50 °C 10-95% D18,3 x W17,9 x H3,45 cm (7,2 x 7 x 1,4 inches) 1,32 kg/2,6 lbs.

Copyright© Interacoustics A/S: All rights reserved. Inf ormation in this document is proprietary to Interacoustics A/S. The inf ormation in this document is subject to change without notice. No part of this document may be reproduced or transmitted in any f orm or by any means without a prior written permission of Interacoustics A/S.

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