SPIRARE 3 Installation Guide

SPIRARE 3 Installation Guide SPIRARE 3 Installation Guide Version 2.11 2010-03-29 Welcome to the Spirare 3 Installation Guide. This guide documents the installation of Spirare 3 and also the separate license installation/renewal. It is recommended that you read this document before installing Spirare 3. Contents 1 Spirare Support... 3 2 General information... 3 3 Installation requirements... 4 4 Starting Spirare setup... 5 5 Automatic upgrade... 7 6 New installation... 7 6.3 Standard database... 8 6.4 Client / Server database... 9 6.4.1 Server... 10 6.4.6 Client... 12 6.4.14 Backup... 14 6.4.15 Restore... 15 7 Advanced setup mode... 16 8 Upgrade from standard database to Client / Server database... 19 9 License installation/renewal... 19 Spirare is developed by DIAGNOSTICA AS Sondreveien 1 N-0378 Oslo Norway Tel (+47) 22 92 40 00 Fax (+47) 22 92 40 09 DIAGNOSTICA AS Sondreveien 1 N-0378 Oslo Norway Tel (+47) 22 92 40 00 Fax (+47) 22 92 40 09 Copyright DIAGNOSTICA Email: diag@diag.no Web: www.spirare.com Spirare 3 Installation Guide Page 2 of 21

1. Spirare Support For further information, please contact Spirare Support by email diag@diag.no, fax (+47) 22 92 40 09 or by phone: Region Spirare Support phone no. Norway 22 92 40 00 Sweden 08 756 6820 Other (+47) 22 92 40 00 2. General information Spirare 3 is a 32-bit Windows program for spirometry, ergometry and ECG. It interfaces several different types of medical equipment to a PC. Spirare is available with two different database systems, a standard database for small installations, and a client/server database for medium to large installations. The Spirare software is delivered via the internet or on a CD-ROM as a single Spirare setup program. It may be necessary to install the license separately, see section 8. The Spirare setup program is used to: Perform a new installation Upgrade an existing Spirare 3 installation Upgrade an old Spirare 2 installation with database conversion Upgrade database Move database* Merge databases Delete database* Repair database files* Change Integration* Encrypt and send database to Spirare Support* Convert and merge CardioBase database to Spirare 3* 3. Installation requirements Spirare 3 requires a PC with Microsoft Windows 2000/XP/2003/Vista/7 or newer, with at least 50MB free disk space. Important: It is required that the installation is performed with system administrator rights. The first time Spirare is started from a workstation where Spirare was not originally installed, it is required that Spirare is started as a local administrator with write permissions to the registry in HKEY_LOCAL_MACHINE. The end users of Spirare need write/change permissions to the client files and database files (standard database only). System requirements Database options Supported networks Operating system: Windows 2000/XP/2003/Vista/7 or Mac OSX (with VMware). Processor: Pentium III 500MHz or faster USB support for Spirare Sensor SPS310 or Spirare SPE100 ECG recorder Resolution: 800 600 or better, 32-bit colour recommended. Free disk space: 50MB minimum (depending on no. of tests) Standard (1-15 users on LAN) or Client/Server (15+ users, WAN or terminal server installations) Standard database: Single workstation, LAN, Linux server with Samba Client/Server database: LAN, WAN, NT Terminal Server / Citrix MetaFrame The Spirare Sensor SPS310 / SPS320 is in accordance with directive 93/42/EEC and is CE and EN60601-1-1 2nd ed (2000) certified. It is required that the computer, to which the Spirare Sensor SPS310 is connected, is certified/approved according to the IEC/EN60601-1 if the patient is to be located less than 1.5 meters from the computer when using the Spirare Sensor SPS310. If the the patient is to be located outside this area, the Spirare Sensor SPS310 can be used with any IEC60950 approved computer. * Not a part of this guide, please contact Spirare Support for further information Spirare 3 Installation Guide Page 3 of 21 Spirare 3 Installation Guide Page 4 of 21

4. Starting Spirare setup 4.1. Please terminate all other programs and log on Windows as the local and network administrator (or equivalent). 4.2. Start the Spirare setup. If you have the Spirare 3 CD-ROM, please insert the CD and wait for automatic startup of Spirare setup. If autorun is disabled, or if Spirare 3 was delivered over the internet, start the file SPSetup.exe (license included) or SPSetupn.exe (license not included, requires separate license installation). 4.3. Select language (Norwegian or English) for the setup session. 4.4. The license agreement for DIAGNOSTICA software Please be aware that you must accept the terms of the License Agreement for DIAGNOSTICA Software to install and use Spirare 3, and that installation and/or use of Spirare 3 constitutes acceptance of these terms. The License Agreement is included for reference at the end of this document. Available setup modes: Automatic Upgrade. This option is only available if an existing installation is detected on your workstation. New Installation is used to perform a new, first-time installation. Do not use this to upgrade an existing installation. Advanced is used to o Upgrade an old Spirare 2 installation with database conversion o Upgrade database o Move database o Merge databases o Delete database o Repair database files o Change Integration o Encrypt and send database to Spirare Support o Convert and merge CardioBase database to Spirare 3 4.5. Select setup mode Spirare 3 Installation Guide Page 5 of 21 Spirare 3 Installation Guide Page 6 of 21

5. Automatic upgrade 5.1. Select Automatic Upgrade, see section 4.5. 5.2. The Spirare program files will be upgraded automatically. 5.3. The first time Spirare is started after an upgrade, you may get a one-time message indicating that the database needs to be upgraded (answer Yes), or that an automatic table validation has been started. Please wait for this process to complete before you continue. 6. New installation 6.1. Select New installation, see section 4.5. Select the Electronic Patient Journal system; EPJ (or Hospital Information System; HIS) for integration. You may be prompted to specify the network location of the EPJ. Select No integration for a stand-alone installation. 6.2. Select database system, according to your purchased Spirare license 6.3. Standard database installation Spirare client program and database should be installed on a network file server Spirare should be started either from the EPJ (integrated) or by a shortcut (stand-alone) 6.3.1. Specify installation directory. The default Spirare data directory is placed directly under the specified program location. It is normally not recommended that you change the default data directory. Note: A technical description of the integration protocol is available from Spirare Support upon request. Spirare 3 Installation Guide Page 7 of 21 Spirare 3 Installation Guide Page 8 of 21

6.3.2. Verify the settings before you proceed 6.3.3. The program and database will now be installed. Depending on the EPJ selected for integration (see 6.1), you may receive further instructions on how to complete the integration. 6.3.4. You will need an authorization key the first time Spirare 3 is started after a new installation. Please call Spirare Support when the authorization dialog is shown. 6.3.5. Please be sure to test Spirare together with the sensor to verify that Spirare 3 is functioning properly. 6.3.6. The Spirare database directories, as well as the client directory, should be included in existing backup routines. 6.4.1. Spirare Database Server installation. Note: make sure that you start the Spirare setup program locally on the file/database server. 6.4. Client / Server database installation The Spirare database server should be installed locally on the file/database server. It is not necessary for the end users to have access to this area (share). A service named SpirareDbService is created. Note: To establish a backup routine, please see section 6.4.12. The Spirare client should be installed on a common (shared) area of a file server. Spirare should be started either from EPJ (integrated) or by a shortcut (stand-alone) Spirare requires no system dll s, ODBC/MDAC drivers or registry settings. Normally no files are installed on local workstations. 6.4.2. Specify the location of server program files and database files. Note: It is important that you specify a directory local to the server. Installing the database on a network share outside of the server may result in degraded performance and loss of data. The default (recommended) directory is C:\Spirare3\Server. 6.4.3. Verify the settings before proceeding with the installation. Spirare 3 Installation Guide Page 9 of 21 Spirare 3 Installation Guide Page 10 of 21

6.4.4. In the next step, select Yes to create the service SpirareDbService on the server. The service will start automatically. It is highly recommended that the Spirare database runs as a service. 6.4.6. Spirare Client installation: start the setup from a network workstation or on the file/database server and follow the steps in section 4. The client depends on a successful server installation with a running database service. Select Client (workstation) in the setup 6.4.5. The server installation is now complete. Please refer to section 6.4.14 for installation of backup routines. The next step is to install the Spirare Client. 6.4.7. Depending on your network layout, there are two possible options for the Spirare Client installation: On a standard localarea network (LAN), select File-server to install the client on a file server. In an NT Terminal Server/Citrix Metaframe environment, please consult Spirare Support for further instructions. Spirare 3 Installation Guide Page 11 of 21 Spirare 3 Installation Guide Page 12 of 21

6.4.8. Specify the location for the Spirare Client files. It is recommended that Client files are placed on a common network share, rather than on the local workstations, although both options are available. 6.4.14. Backup for Client/Server database The Spirare database directories, as well as the client directory, should be included in existing backup routines. To backup a running database, it is necessary to run a scheduled task that will make a backup of the open database file. This is achieved using the supplied program SpBackup.exe which is automatically installed on the Spirare database server. To see an explanation of the available parameters, invoke SpBackup.exe /? : 6.4.9. Verify the settings before you proceed An example batch file backup.bat is automatically created by the installation of the server software, and can be used as a template. Remember to test and validate the backup routine. 6.4.10. The client file installation will now take place. Depending on the EPJ selected for integration (see section 6.1), further instructions may be given on how to complete the integration. 6.4.11. Important: The client communicates with the server on TCP and UDP port 2638. If there are any active firewalls between the client and the server, it will be necessary to allow this traffic. 6.4.12. You will need an authorization key the first time Spirare 3 is started after a new installation. Please call Spirare Support when the authorization dialog is shown. 6.4.13. Please be sure to test Spirare together with the sensor to verify that Spirare 3 is functioning properly. Spirare 3 Installation Guide Page 13 of 21 Spirare 3 Installation Guide Page 14 of 21

6.4.15. Restore of Client/Server Database Procedure to restore a backup of the client/server database: 6.4.15.1. Stop the database service SpirareDbService. 6.4.15.2. Open the folder containing the Spirare client/server database files (default: C:\Spirare3\Server\Sp3Data). 6.4.15.3. As a precaution, make an additional file backup (copying the files) of the data file, Spirare3.db, and the corresponding transaction log, Spirare3.log. Remove both the Spirare3.db and Spirare3.log files from the Spirare data directory. 6.4.15.4. Copy the Spirare3.db file from the backup medium to the Spirare data directory. 6.4.15.5. Run the recover database procedure from the command line. Example (remember to change the paths according to the installation): C:\Spirare3\Server\dbsrv6.exe C:\Spirare3\Server\Sp3Data\Spirare3.db -f The database server will display a console window during the recovery process. This window will close automatically when the procedure has been completed successfully. 6.4.15.6. Start the database service SpirareDbService. 6.4.15.7. The restored database is now ready for use. Spirare 3 Installation Guide Page 15 of 21 7. Advanced setup mode 7.1. Select Advanced in section 4. The Spirare Advanced Installation Utility will be started. 7.2. To specify existing Spirare installations, select Show all installations to perform a search of the workstation/network for all available databases. Or click Add installation and specify the Spirare database file manually. To specify a Spirare client/server database that is not running locally, you will have to use Add installation. 7.3. Advanced setup options: Upgrade database (see 7.4) Move database Merge databases (see 7.5) Delete database Repair database files Change integration Send database to Spirare Support Convert and merge CardioBase database to Spirare 3 7.4. Upgrade database: This option is only available for existing Spirare 2 installations, and Medikro Spiro2000 installations. You may only upgrade and convert one database at a time. Check the database entry in the leftmost column and select Upgrade. 7.5. Merge databases: To merge existing Spirare databases, check two or more database entries in the leftmost column and select Merge. You can choose whether to merge the data into a new installation, or into one of the selected installations. Spirare 3 Installation Guide Page 16 of 21

7.6. Verify the installation settings before you continue 7.7. During a conversion of Spirare 2 data, a visual indicator will display conversion progress. The conversion process may take a few minutes. You will need an authorization key, please call Spirare Support. 7.9. During merging of databases, the merging process is visualised by a progress bar. The merging process may take a few minutes 7.10. After the merging has completed successfully, a summary will be shown 7.8. Spirare setup will display patient records that may be duplicate entries of the same patient. These entries will be displayed in the Patient Duplicate Record Management window (see below). Please read the displayed list carefully and where the red and green patient records refer to the same patient, confirm by checking the rightmost column. Remove the check to indicate that the red and green patient records belong to different patients. It is recommended that a printout of this list is made for reference. 7.11. The conversion/merge is now completed Spirare 3 Installation Guide Page 17 of 21 Spirare 3 Installation Guide Page 18 of 21

8. Upgrade from standard database to client/server database (checklist) 8.1. Install Spirare client/server database (see above) 8.2. Install Spirare client files on a network file/application server 8.3. Create user profiles as necessary 8.4. Configure global configuration settings in Spirare 8.5. Get access to the Spirare database files that are to be merged into the client/server database, and temporarily disable use of the Spirare program 8.6. Start the Spirare setup program, select Advanced and merge the client/server database with one or several standard databases 8.7. Verify duplicate patient records as necessary 8.8. When the merge has completed, start Spirare and verify data integrity 8.9. Assign all users to their proper user profiles 8.10. Update all Spirare startup paths, and enable Spirare for all users 8.11. Make a backup of all the standard database files and remove them from the application server(s). 9. License installation/renewal 9.1. The Spirare license is delivered via the internet or on a CD-ROM as setup program. Insert the CD or start the setup program manually and follow the on-screen instructions. The Spirare setup program spsetup.exe is copied into the installation directory after a successful installation. This copy of the Spirare setup program can be used later in case the original media is no longer available. Spirare 3 Installation Guide Page 19 of 21 License Agreement for DIAGNOSTICA AS Software IMPORTANT: Please carefully read the License Agreement below before installing the Software Product. The right to use this Diagnostica Software Product is sold only on the condition that the customer/wholesaler/dealer/supplier ("Customer"), agrees to the following License. If you do not agree to the terms of the License, you may return the uninstalled Software Product for a full refund. HOWEVER, INSTALLING THE SOFTWARE PRODUCT INDICATES YOUR ACCEPTANCE OF THESE TERMS AND CONDITIONS. LICENSE AGREEMENT In return for payment of the license fee for the software Product, the Customer receives from Diagnostica a license to use the Product subject to the following terms and conditions: 1. The Product license is limited for a period of up to 1 (one) year for use on one personal computer or workstation. 2. A separate license and fee is required for each personal computer or workstation on which the Product is used, and/or for each location or address where the Product is to be used or distributed over a network, and/or if the licensee is divided into two or more entities using the Product. The Product is licensed as a single Product and its component parts including the Product database, may not be separated for use on more than one computer. A license for the Product may not be shared or used concurrently on different computers and/or rented or leased. The Customer/user is unasked obliged to pay said fees to fulfil this agreement. 3. The Product may not be duplicated or copied except for archive purposes, program error verification, or to replace defective media, and all copies made must bear the copyright notices contained in the original. Reverse engineering, decompiling or disassembling of the Product is prohibited, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation. 4. The Customer may permanently transfer all of his/her Product rights under this agreement, provided that the Customer retains no copies, except for customary archive purposes, and transfer all of the Product (including all component parts and the product database, the media and printed materials, any upgrades, this agreement, and if applicable, the Certificate(s) of Authenticity provided the recipient agrees to the terms and conditions of this agreement. If the Product is an upgrade, any transfer must include all prior versions of the Product. 5. 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In the event the Customer modifies the Product or includes it in/connects it to any other software program, upon termination of this license, the Customer agrees to remove and destroy the Product or any component part thereof as stated above. For the LIMITED WARRANTIES and SPECIAL PROVISIONS pertaining to the Customer's particular jurisdiction, please refer to the provisions below or on a separate page included with this agreement or provided with the Product. LIMITED WARRANTY and SPECIAL PROVISIONS This agreement shall be governed by the laws of Norway. If the Customer acquire the Product in another jurisdictions, local law may apply. SOFTWARE: Diagnostica warrants for period of NINETY (90) DAYS from the date of purchase that the software Product will execute its programming instructions when properly installed on the personal computer or workstation indicated in the owner's manual. Diagnostica does not warrant that the operation of the software will be uninterrupted or error free. In the event that this software Product fails to execute its programming instructions during the warranty period, Customers remedy shall be to return the diskette(s), CD-ROM or tape cartridge(s) ("media") to Diagnostica for Spirare 3 Installation Guide Page 20 of 21

replacement. Should Diagnostica be unable to replace the media within a reasonable amount of time, Customer's alternate remedy shall be a refund of the purchase price upon return of the Product and all copies. MEDIA: Diagnostica warrants the media upon which this Product is recorded to be free from defects in materials and workmanship under normal use for a period of NINETY (90) DAYS from the date of purchase. In the event any media prove to be defective during the warranty period, Customer's remedy shall be to return the media to Diagnostica for replacement. Should Diagnostica be unable to replace the media within a reasonable amount of time, Customers alternate remedy shall be a refund of the purchase price upon return of the Product and all copies. Delivery via modem/internet/etc. takes place EX Diagnostica's WEB SITE/HOME PAGE (corresponding to EXW (Incoterms 1990)). NOTICE OF WARRANTY CLAIMS: Customer must notify Diagnostica in writing of any warranty claim not later than thirty (30) days after the expiration of the warranty period. LIMITATION OF WARRANTY: Diagnostica makes no other express warranty, whether written or oral with respect to this Product. Any implied warranty of merchantability or fitness is limited to the 90-day duration of this written warranty. Some jurisdictions do not allow limitations on how long an implied warranty lasts, so the above limitation or exclusion may not apply to you. This warranty gives specific legal rights, and you may also have other rights which vary from jurisdiction to jurisdiction. EXCLUSIVE REMEDIES: The remedies provided above are Customer's sole and exclusive remedies. In no event shall Diagnostica be liable for any direct, indirect, special, incidental, or consequential damages (including lost profit) whether based on warranty, contract, tort, or any other legal theory. Some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. WARRANTY SERVICE: Warranty service may be obtained from the nearest Diagnostica sales office or other location indicated in the owner's manual. Spirare 3 Installation Guide Page 21 of 21