Instructions for Use - EN. OtoAccess 1.0 D B /06

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Instructions for Use - EN OtoAccess 1.0 D-0107872-B - 2016/06

Contents 1 Introduction... 1 1.1 Intended use of OtoAccess... 1 2 Precautions... 2 3 OtoAccess Installation guide... 3 3.1 PC Minimum Requirements... 3 3.2 Installation... 4 3.3 Remove installation... 6 3.3.1 Uninstall SQL Server... 6 3.4 Copy IaBaseII data to OtoAccess TM... 7 3.4.1 Precautions... 7 4 OtoAccess User Manual... 8 4.1 OtoAccess Introduction... 8 4.2 OtoAccess User Interface... 8 4.2.1 The Toolbar... 9 4.3 Create Client... 9 4.4 Add/delete Client Picture... 10 4.5 Search for a Client... 10 4.6 Change Client Information... 10 4.7 Delete Client... 10 4.8 Client Options... 11 4.8.1 The Client Journal... 11 4.8.2 View / Print Sessions... 11 4.8.3 Booking Clients... 11 4.9 Launching Instruments... 12 4.10 Import/Export... 12 4.10.1 XML Format... 12 4.10.2 GDT Format... 12 5 Setup... 13 5.1 General... 13 5.1.1 Search Options... 13 5.1.2 Logging... 13 5.1.3 Client Picture... 13 5.1.4 Startup... 13 5.2 Import/Export... 13 5.2.1 GDT Import... 13 5.3 Permissions... 14 5.3.1 Password Renewal... 14 5.4 Client information view... 14 5.4.1 Required Fields to be typed... 14 5.4.2 Enabled/Disable Fields to type... 14 5.5 Addins... 15 5.5.1 Installed addins, to launch from OtoAccess... 15 5.6 Clinic Information... 15 5.6.1 Clinic Info... 15 5.7 Examiners... 16 5.7.1 Create / Update Examiners... 16 5.8 Instruments... 16

5.8.1 Create Instrument... 16 5.9 Database... 17 5.9.1 SQL Server Credentials... 17 5.10 Backup... 17 6 Troubleshooting... 18 6.1 Network Connection Problems... 18 6.1.1 Windows Firewall Settings (only relevant for the IT Administrator)... 19 6.1.2 Backup Failed... 20 7 GDT Interface description... 21 7.1 Description:... 21 7.2 General information... 21 7.3 Transferring patient information (6301)... 21 7.4 Opening a module (6302)... 22 7.5 Reopen a historical session (6311)... 22 7.6 Results (6310)... 23 8 Error Log... 24 80600601 - ver. 09/2008 80600602 - ver. 11/2008 80600603 ver. 03/2010 80600604 ver. 04/2010 80600605 ver. 11/2010 D-0107872-A ver. 07/2015 D-0107872-B ver. 2016/05

1 Introduction OtoAccess is an SQL database application designed to support audiological Windows modules and for easy management of client information and recordings/sessions. OtoAccess can be installed in three different ways: 1. OtoAccess Server and Network Client. 2. OtoAccess Network Client. 3. OtoAccess Standalone. OtoAccess TM uses Microsoft SQL server but can also use existing database servers as long as they support common SQL techniques. OtoAccess TM can hold as many clients as your storage facilities allow you and without becoming slow at high number of stored clients. New audiological software modules can easily be installed and OtoAccess TM features import and export possibilities for XML and GDT formats. OtoAccess TM has a specially designed Journal feature that allows you to enter comments to each session and a schedule planner for managing a day list of sessions. The high degree of data safety ensures that OtoAccess TM meets HIPAA requirements for handling patient databases. 1.1 Intended use of OtoAccess The OtoAccess database is used for storage of data recordings. The recordings are made with connected audiologic instruments. The recordings are primarily used in the audiologic/neurologic evaluation, documentation and diagnosis of ear disorders. This is of particular interest to Ear, Nose and Throat Specialists, Neurologists, Audiologists and other health professionals concerned with the measurement of auditory function. Without a connected instrument it is not possible to create any recordings, but previously stored recordings do not require a connected instrument to be viewed for diagnosis or comparison. The OtoAccess database can also be used for scheduling/booking of patients during the day. This task can be carried out by the secretary at the office in the hospital or private clinic. 1

2 Precautions Follow these precautions in order to handle patient data correctly. 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 To avoid client information being captured during network transmission the communication to the SQL database must be secure (encrypted). Store backup of client data in a safe manner. Create backup of patient s data regularly (for example once a week). To avoid data from being misused, if stolen, the data must be encrypted. To avoid unwanted data transfer from PC to the network, make sure that an appropriate Virus & Spyware scanner is installed, updated and effective; please contact your local administrator for help and guidance. All users must have their own login to the database to ensure traceability and identification of data updated or deleted from the database. 2

3 OtoAccess Installation guide 3.1 PC Minimum Requirements - Processor of 1 GHz or higher (Pentium III or better) - 1 gigabyte (GB) for 32-bit or 2 GB for 64-bit - Hard drive with 50MB free space for software installation and at least 44MB while running. - Minimum display of 1024x768 pixels with 16bit color or more. - One or more USB ports, version 1.1 or higher.! Note See Instrument Module: equipment concerning communication part(s) requirements - Network LAN card (if connecting to database over the network) - CD-ROM drive - Supported operating systems : o Microsoft Windows 7 SP1 o Microsoft Windows 8 o Microsoft Windows 8.1 o Microsoft Windows 10 - Software requirements: o Microsoft Internet Explorer 5.01 or later o Microsoft Data Access Components 2.8; o Microsoft.NET Framework version 2.0 Important: make sure you have the latest service packs and critical updates for the version of Windows that you are running. The OtoAccess software will install the following if not already installed:.net Framework 2.0 Microsoft SQL Server 2014 Express OtoAccess Database Windows is a registered trademark of Microsoft Corporation in the United States and other countries 3

3.2 Installation Please insert the OtoAccess CD-ROM. If auto run is disabled double click on the setup.exe file on the CD-ROM. OtoAccess TM is the client part of the database and is always installed no matter what type of installation you select. If only the Network Client is installed make sure that an SQL server is installed before proceeding. Accept the invitation to install OtoAccess TM and type in the Serial Number placed on the back of the CD sleeve in the following screen. 4

OtoAccess can be installed with or without SQL server. 1. Stand-alone installation If you are going to run OtoAccess as standalone on one pc, let the Installer install the client and SQL server. 2. Install Client Application Choose this installation type when you already have an OtoAccess TM Server installation on another machine. Both the Stand-alone and the Server version will require Microsoft SQL Server 2014 Express. Press the Link Label of your choice. Hint! If the setup doesn t start automatically, please run D:\Setup.exe (in case D: is your CD drive) Note! Some anti spy ware applications may prompt you when installing the Microsoft SQL server. Please allow the application to proceed. First logon The first time the database is launched you will be prompted for a Login Name and a Password. Login: admin as login name Password: password. The default Login and Password should be changed in the OtoAccess TM setup shortly after installation. 5

3.3 Remove installation Run the installer from the CD and choose Uninstall The operation will remove the installed items. Note! Make sure a backup is created before the installation is removed. Note! Backups are not affected by uninstalling OtoAccess TM or the Microsoft SQL Server. 3.3.1 Uninstall SQL Server When uninstalling OtoAccess standalone or server then the SQL server will not be uninstalled automatically. To uninstall the SQL server go to program files and choose uninstall. Note! The Microsoft SQL server is a shared component and might be used by other programs. 6

3.4 Copy IaBaseII data to OtoAccess TM The OtoAccess TM software can copy patient data and sessions/recordings from IaBaseII to OtoAccess. 3.4.1 Precautions Please make sure that a backup of patient data is made before running this application! Please be aware that only IaBaseII version 4.10 is supported by this application! If you have an older version of IaBaseII then you must upgrade to IaBaseII version 4.10 before copying data to OtoAccess TM. Note! IaBaseII and its data will not be affected by this operation and IaBaseII can still be used after the data copy. 7

4 OtoAccess User Manual 4.1 OtoAccess Introduction OtoAccess is designed to manage large numbers of clients and their individual test sessions. Test sessions are measurements performed on audiologic instruments and stored in the OtoAccess database. OtoAccess does not perform any measurement; it only communicates with audiologic instruments. OtoAccess collects measurement data from instruments. The data is stored in the OtoAccess database for review and easy retrieval of client data. In the OtoAccess setup, an instrument list can be created to simplify the communication between the instrument and OtoAccess software. 4.2 OtoAccess User Interface The OtoAccess main screen is shown below. The user interface consists of a Menu, a Toolbar, and Client Information as highlighted below: 8

The Menu The Menu has five selections and the options of each selection are listed below: File - Find New Client, Save Client, Open last session, Import/Export, Setup and Quit. Edit - Search and Delete. View - Fields (data grid fields), client or journal view when expanding View. Help Help Topics and About OtoAccess. Login Logout. 4.2.1 The Toolbar The Toolbar provides short-cuts to important Menu items (shown from left to right) Search, New Client, Save Client, Delete Client and Edit Client. 4.3 Create Client To create a new client, the Client Tab must be open. To open, click on the Client Tab or select the Client Tab in the View-selection of the Menu. Then click on the New Client icon in the toolbar or select File, New in the Menu. Required fields are highlighted with a red dot and data entry is required in each of these fields. Hint! Required fields may be chosen in the Setup view. A minimum of 3 1 fields are mandatorily required for safe client identification. Administrator rights are necessary to enter Setup. Each field must be completed before continuing to the next field. Use the Tab key/shift+tab to move between fields Use Backspace to delete text, the Delete key to delete a client, and Enter for searching. Hint! Birth date can be entered directly in the field instead of using the calendar. Open the calendar and hit Enter. Now you can manually change the date of birth When completed click on the Save Client icon in the toolbar or select File, Save in the Menu. The new client is now added to the Client Table. 1 Date of birth, First Name, Last name 9

4.4 Add/delete Client Picture To add a picture to a Client simply select the folder icon to the right of the picture field in the Client tab. When done, click the Save Client icon in the toolbar picture is now saved with client information. The picture will be resized before it is added to Client information. or select File, Save in the Menu. The Hint! The quality and size of the picture can be changed in Setup General. You need to have administrator rights to enter the setup. The picture may be deleted by selecting the trash bin icon next to the picture field. 4.5 Search for a Client To search for a client, the Client Tab must be open. To open, click on the Client Tab or select the Client Tab in the View-selection of the Menu. Click on the Search Icon to start the search. Enter the characters to search for and press the Enter key. The Client Table will update with the clients that match the information entered. If more than one client appears in the table, select the desired entry and all information will appear in the Client Information Area. Hint! If you want to see all clients simply press will appear. and leave the search field blank and all clients 4.6 Change Client Information To change client information, the Client Tab must be open. To open, click on the Client Tab or select the Client Tab in the View-selection of the Menu. Find the client where changes are required Change desired client information fields and then click on the Save Client icon in the toolbar select File, Save in the Menu. Revised client information is now saved. or 4.7 Delete Client To delete a client or selected client information, the Client Tab must be open. To open, click on the Client Tab or select the Client Tab in the View-selection of the Menu. Use the Search function to find the client you want to delete. Click on the Delete Client icon in the toolbar client is now deleted. or select Edit, Delete in the menu and accept. The 10

4.8 Client Options Client Options are additional features available for each client, providing the examiner with extended data storage and editing opportunities. 4.8.1 The Client Journal OtoAccess allows the creation of a journal for each client and each client session. The session window provides an overview of all sessions for the selected client. The Journal window provides a toolbar (see below) with all the standard text tools to create or change the client or session journal information. The created journals may be printed or converted into Rich Text Format (RTF) for easy transfer to most word processing software. Hint! Measurement data must be opened and printed in the corresponding instrument software. 4.8.2 View / Print Sessions View: Historical sessions are displayed in the Session Window below the Journal tab. Data from these sessions may be displayed by expanding and clicking on the measurement. Print: To print measurement data, open the instrument software used for the required session. Printing is then controlled by the instrument software. 4.8.3 Booking Clients OtoAccess features a simple day list. In the journal tab you will find calendars for each client and by right clicking on a day you can add the selected client to the selected day. In the data grid on the client tab a watch will appear in front of a client if he is booked for today s list. Hint! Clients who are not on Today s list can be removed from the data grid by enabling the with schedule today and clicking search 11

4.9 Launching Instruments The instrument software must be installed on the same computer that holds OtoAccess TM Once the instrument software has been installed, OtoAccess TM will recognise it and the instrument/software can be added to the OtoAccess TM instrument list. This is done in the Setup - Instruments in the setup menu. Hint! OtoAccess TM must be closed during installation of instrument software All instrument software modules installed should be added to the OtoAccess TM instrument list. To launch the instrument software, double click on the relevant instrument software icon in the client tab. 4.10 Import/Export OtoAccess TM can import and export to XML files and the GDT file format. 4.10.1 XML Format Select Import/Export in the file menu and Clients. When exporting please define whether data should be encrypted into XML or normal XML format, and whether client sessions should be added. Please note that only an OtoAccess TM application can read encrypted XML files. 4.10.2 GDT Format To export in GDT format select Export and Client in GDT format. Type in a name and press save. To import please follow the steps below 1. Close OtoAccess TM 2. Copy the GDT file into C:\IABASE2000\GDT 3. Start OtoAccess TM GDT data will now be imported into OtoAccess TM. 12

5 Setup 5.1 General 5.1.1 Search Options This option enables you to limit search returns to a specific number to minimize search time when a large number of clients are stored in the database. 5.1.2 Logging Logging information, for development and troubleshooting. 5.1.3 Client Picture These options determine the quality of the picture. All pictures are stored in JPG format in the database. 5.1.4 Startup OtoAccess TM will normally start up in resizable window. Enable this option to use maximized view as default. 5.2 Import/Export 5.2.1 GDT Import Prompt user before clients are imported into OtoAccess TM. 13

5.3 Permissions 5.3.1 Password Renewal When a high level of safety is required OtoAccess TM can be set to prompt examiners to renew their password. Renewal intervals can be set between 30 and 300 days. 5.4 Client information view 5.4.1 Required Fields to be typed Required fields 2 are key fields that must be filled out when entering client information. These fields are marked with a red dot in the client information area. 5.4.2 Enabled/Disable Fields to type Fields can be toggled on/off, so that deactivated fields are removed from the client information view. 2 First name, Last name and Birth date are always required and can not be disabled 14

5.5 Addins 5.5.1 Installed addins, to launch from OtoAccess This is not the instruments list but a display of the various addins that have been loaded with OtoAccess TM. Most addins are interfaces to the Software modules. The list is only for information. The statement True next to an addin indicates that is has been installed and is enabled. 5.6 Clinic Information 5.6.1 Clinic Info Clinic Information. 15

5.7 Examiners 5.7.1 Create / Update Examiners There are 3 levels of examiners in OtoAccess TM 1 Examiner is not a user on this system 2 Examiner is a normal user 3 Examiner is a user with administrator rights Level 1 and 2 examiners do not have access to the setup 5.8 Instruments 5.8.1 Create Instrument Once an instrument is installed on the same computer as OtoAccess TM it is possible to create it as an Instrument in OtoAccess TM. Type in a name for the instrument and select the instrument you just installed in the drop down list below software modules. Select hardware and setup type of communication. Please see service manual for the selected hardware to get information concerning communication. 16

5.9 Database 5.9.1 SQL Server Credentials Fill in requested information and test your connection. Information on how to encrypt the connection to the database, please read the following pages from the Microsoft Support site: http://msdn2.microsoft.com/enus/library/ms191192.aspx How to: Enable Encrypted Connections to the Database Engine (SQL Server Configuration Manager) http://msdn2.microsoft.com/enus/library/ms189067.aspx Encrypting Connections to SQL Server 5.10 Backup OtoAccess TM enables you to backup and restore your data in an easy way. Simply click backup and type a name and location for the backup file. To restore, please click Restore and select the file to be restored. restore operation. Precaution Please note that all previous data will be deleted by the After a restore operation please restart the application to refresh all content. 17

6 Troubleshooting 6.1 Network Connection Problems Problems may arise when connecting to the database. The following checklist may be helpful to overcome the most common errors: - Check the physical network cabling, do you have access to other network resources? - Is the Machine running and is the Database turned on? - Are you able to ping the Machine name of the PC/Server running the database. This is done by running the ping.exe from a command prompt. >ping hostname Where hostname is the name or IP address of the Server. - Security programs (Firewall, Antispy ware software, Antivirus etc.) running on Client and/or Server machine may be disabled temporarily. If you are uncertain whether any security programs are running on your computer, please contact your local IT support. - Sometimes the Client is unable to resolve the Server name. To solve this problem run clientcfg.exe from the Start menu: Type in Cliconfg.exe in the Run dialog box and click on OK: Choose the General tab and enable the TCP/IP protocol to connect to the server: 18

Click on the Alias tab and add a new alias for the server. Enter the server IP address as server name. Remember to select the TCP/IP protocol: The alias should be used as the Server name under a Network Client installation of OtoAccess. For more information on how to use the Client Netwok Utility see: http://support.microsoft.com/kb/265808/en-us 6.1.1 Windows Firewall Settings (only relevant for the IT Administrator) To get access to the SQL Server the Server Executable must have rights to receive and send packages on the network. Create exceptions in Windows Firewall These steps apply to Windows. If you use another firewall system, please see your firewall documentation for more information. If you run a firewall on the computer that runs SQL Server 2014, external connections to SQL Server 2014 will be blocked unless SQL Server 2014 and the SQL Server Browser service can communicate through the firewall. You must create an exception for each instance of SQL Server 2005 that you want to accept remote connections and an exception for the SQL Server Browser service. SQL Server 2005 uses an instance ID as part of the path when you install its program files. To create an exception for each instance of SQL Server, you must identify the correct instance ID. To obtain an instance ID, follow these steps: 1. To open Windows Firewall, click Start, click Run, type firewall.cpl, and then click OK. 19

Create an exception for SQL Server 2014 in Windows Firewall To create an exception for SQL Server 2014 in Windows Firewall, follow these steps: 1. In Windows Firewall, click the Exceptions tab, and then click Add Program. 2. In the Add a Program window, click Browse. 3. Click the C:\Program Files\Microsoft SQL Server\MSSQL.1\MSSQL\Binn\sqlservr.exe executable program, click Open, and then click OK. Note! The path may be different depending on where SQL Server 2014 is installed 4. Repeat steps 1 through 3 for each instance of SQL Server 2014 that needs an exception. Create an exception for the SQL Server Browser service in Windows Firewall To create an exception for the SQL Server Browser service in Windows Firewall, follow these steps: 1. In Windows Firewall, click the Exceptions tab, and then click Add Program. 2. In the Add a Program window, click Browse. 3. Click the C:\Program Files\Microsoft SQL Server\90\Shared\sqlbrowser.exe executable program, click Open, and then click OK. Note! The path may be different depending on where SQL Server 2014 is installed. For more information on how to enable network access to the Database see: http://support.microsoft.com/default.aspx?scid=kb;en-us;914277 6.1.2 Backup Failed Backup can only be made to the default backup folder due to SQL server permissions. If you change folder please make sure that the user networkservice has write permission to the new folder. Alternatively copy or move the backup file after backup. The backup folder will not be deleted during removal of OtoAccess or the MS SQL server. 20

7 GDT Interface description Technical Note no. : 0819 Date : 2008.10.27 Instrument : OtoAccess 1.0.1 Subject 7.1 Description: : GDT Interface description This document describes the GDT interface implemented in OtoAccess version 1.0.1. The used GDT interface definition is version 2.1 and protocols are (6301, 6302, 6310, 6311). The GDT interface is implemented as separate module that is loaded into OtoAccess. The current version 1.3.0.0 7.2 General information GDT files are placed in the folder c:\iabase2000\gdt\ GDT files must have the extension.gdt Settings for the input and output folder are stored in the file c:\iabase2000\gdt\settings.xml GDT input files (6301,6302,6311) are processed when OtoAccess is started and when OtoAccess is already running. OtoAccess will monitor the folder specified in the settings for files being added. 7.3 Transferring patient information (6301) The 6301 is placed in the input folder. If the patient exists in the database then OtoAccess will search for and select that client. If not the client will be added to the database and selected. Example 6301 file: 01380006301 0128100177 011300016 0193101Mustermann 0153102Martin 017310305091900 0123104Dr. 01931051234567890 022310681679 München 0273107Mustermann Str. 34 21

01031101 7.4 Opening a module (6302) The 6302 is placed in the input folder. If the patient exists in the database then OtoAccess will search for and select that client and try to start the instrument specified in the file. If not, the client will be added to the database and selected. If the instrument specified in the GDT file exists then OtoAccess will open it with the selected client. It the instrument does not exist then nothing will happen. Example 6302 file: 01380006302 014810000235 01392182.00 011300016 0193101Mustermann 0153102Martin 017310305091900 0123104Dr. 01931051234567890 022310681679 München 0273107Mustermann Str. 34 01031081 01031101 01036220 01036230 0138402BERA 7.5 Reopen a historical session (6311) The 6311 is placed in the input folder. If the patient exists in the database then OtoAccess will search for and select that client. If not, the client will be added to the database and selected. If a session exists for the session date specified in the GDT file then OtoAccess will specify that session to load. It the instrument specified in the GDT file exists then OtoAccess will start that instrument. If not, nothing will happen. 22

Example 6311 file: 01380006311 014810000176 01392182.00 011300016 0193101Mustermann 0153102Martin 017310305091900 0123104Dr. 0138402BERA 017620024042007 017843224042007 0158439140805 7.6 Results (6310) The 6310 is placed in the output folder specified in the settings.xml file (Default c:\iabase2000\gdt\) If anything is measured the 6310 will contain the session date & time and the module name. If nothing is measured the 6310 is skipped. Example 6310 file: 01300006310 0128100117 01392182.00 0148402ABRIS 011300014 017843224042007 0158439102521 0146221ABRIS 23

8 Error Log If you encounter a problem with this product please open the following file:..\[program Folder]\IA\OtoAccess \Error.log..\the drive letter where OtoAccess is installed. Note! The text file is not generated before an error occurs. 24