Spirotrac Model 7000 User Manual Issue 10

Vitalograph Ltd. Maids Moreton Buckingham MK18 1SW England Tel: +44 (0) 1280 827110 Fax: +44 (0) 1280 823302 e- mail: [email protected] Vitalograph Inc. 13310 West 99th Street Lenexa Kansas 66215 USA Tel: (913) 888 4221 Fax: (913) 888 4259 e-mail: [email protected]

Vitalograph GmbH Rellinger Straße 64a 20257 Hamburg Deutschland Tel.: +49 40 547391-0 Fax: +49 40 547391-40 E-Mail: [email protected] Vitalograph (Ireland) Ltd. Gort Road Business Park Ennis Co Clare Ireland Tel: (065) 6864100 Fax: (065) 6829289. e-mail: [email protected]

Internet: www.vitalograph.co.uk © Copyright Vitalograph 2011 Current Edition (Issue 10) Cat. No. 07402 Vitalograph is a registered trademark

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Table of Contents DESCRIPTION OF THE VITALOGRAPH SPIROTRAC

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BUTTONS AND ICONS USED IN SPIROTRAC

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FEATURES OF THE VITALOGRAPH SPIROTRAC

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GETTING THE VITALOGRAPH SPIROTRAC READY FOR USE

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LOADING THE SPIROTRAC SOFTWARE NETWORK DATABASE INSTALLATION INSTALLING THE VITALOGRAPH PNEUMOTRAC USB DRIVERS INSTALLING THE VITALOGRAPH IN2ITIVE AND ALPHA USB DRIVERS INSTALLING THE USB AND BLOOD PRESSURE MONITOR DRIVER CONNECTING THE SERIAL VITALOGRAPH PNEUMOTRAC TO YOUR PC CONNECTING THE SERIAL VITALOGRAPH 2120 TO YOUR PC CONNECTING THE VITALOGRAPH IN2ITIVE AND ALPHA TO YOUR PC STARTING SPIROTRAC FOR THE FIRST TIME

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OPERATING THE VITALOGRAPH SPIROTRAC

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START-UP / LOGON Logging into Spirotrac Application Lock (Autolock) / Unlock SUBJECT MANAGEMENT Creating a Subject Editing a Subject Selecting/Viewing a Subject Finding a Subject Deleting a Subject Subject Data Setup PREDICTED VALUES Population Group Setup SPIROMETRY TESTING Checks to Make before Performing VC, FVC and Post Tests VC Testing Performing FVC Testing Post Testing PCF Testing ATS Waveforms Parameter Definition Test Quality Information System Acceptability Best Test Criteria Copyright Vitalograph 2011

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Session Grades Incentive Device Setup SUBJECT UTILITY SENDING SESSIONS Fusion Sending sessions to Over-Read Viewing sent sessions Setup mail settings PULSE OXIMETRY TESTING CHALLENGE TESTING Challenge Test Procedure SIX MINUTE WALK TESTING BLOOD PRESSURE MEASUREMENT WEIGHT MEASUREMENT ACCURACY CHECKING Accuracy Checking in Spirotrac Checking Accuracy Calibration update Viewing/Printing accuracy log INSTITUTE AND DEPARTMENT Viewing Institution or Department Details Editing Institution or Department Details Department Management AUDIT TRAIL Audit Trail Codes Viewing/Printing The Audit Trail PRINTING Printer Setup Report configuration Printing a Test Report. Printing a Trend Report. USERS User Management USER PREFERENCES LICENCE MANAGEMENT Manage Licence Keys and Features within Spirotrac. Online Updates LANGUAGE VARIANTS FAULT FINDING GUIDE

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TECHNICAL SPECIFICATIONS

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CE NOTICE

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FDA NOTICE

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DECLARATION OF CONFORMITY

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GUARANTEE

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DESCRIPTION OF THE VITALOGRAPH SPIROTRAC Vitalograph Spirotrac is a Microsoft Windows based computerized Spirometry system that is intended for use as a lung function testing application in conjunction with Vitalograph Spirometry devices. The application will interface with the Vitalograph Pneumotrac, Vitalograph In2itive, Vitalograph Alpha, Vitalograph Alpha Touch, Vitalograph 2120, Vitalograph 2160 and asma-1 Spirometry devices. Spirotrac also includes Pulse Oximetry, Challenge Test, Blood Pressure, Weight and Six Minute Walk Test modules. Spirotrac is intended for use in occupational health centres, hospitals, pharmaceutical research centres, physicians' and GPs' offices, and wherever else advanced PC-based spirometry is required. Spirotrac is not intended for use for vital signs monitoring in a critical-care setting. Spirotrac provides a system for adding and recalling subjects, testing their lung function, saving the results to its own database and printing reports. To obtain help on a specific function within the application select a topic in the left panel, type a keyword in the index tab or search for a word in the search tab. To launch the Help file: 1. Select Contents from the Help menu Information about the software can be obtained from the About box. This information can be used if any queries are made to Vitalograph or a service agent. To access the About box: 1. Select About from the Help menu

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Buttons and Icons Used in Spirotrac The following buttons are visible on the main toolbar:

Create a New Subject

Perform VC Testing

Perform FVC Testing

Select Post Mode Testing

Perform a PCF Test

Select Pulse Oximetry Testing

Challenge Test

Measure Blood Pressure

Measure Weight Test

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Six Minute Walk Test

Print test reports

Send sessions to over-read

Perform an Pneumotrac

Accuracy

Check

on

the

Vitalograph

Launch the Help file

FEATURES OF THE VITALOGRAPH SPIROTRAC Vitalograph Spirotrac offers a number of sophisticated features that further enhance the functionality of the acclaimed existing software. These features include: • • • • • • • • • • • •

New User Friendly Interface Automatic FEV1 Trending FVC single or multi-breath testing with auto-recognition VC single or multi-breath testing New child incentive displays (optional) Improved test quality information, including test session grades, test repeatability and test acceptability Enforceable accuracy check facility Individual user logon by password Audit Trail (optional) Configurable Subject Demographics Plug-in regression set architecture New spirometry report layouts

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• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Print preview facility Ability to change test acceptability Ability to add comments to any test session Communications port auto-detect feature for connected Vitalograph Pneumotrac device Data storage in Microsoft SQL Server 2005 Express edition View/Print previous accuracy check/calibration update sessions Print audit trail logs and accuracy logs Send test sessions to Vitalograph Over-Read system Comprehensive subject demographic information Automatic storage of all test data Configurable Spirometry Reports Accuracy Checking for Vitalograph Pneumotrac device ATS 24 Waveforms Support for the GDT data interchange standard Post mode for bronchodilation testing Full networked database / Multi User Support (via Microsoft SQL Server 2005) Comprehensive Network Database Management (for DB Administrators) Subject Data Migration from Spirotrac 4 Improved user interface(s) Improved testing functionality In2itive Subject Utility module In2itive integration with Spirotrac as a dumb flow-head Improved report configuration options Standard deviation score on screen and on reports 14 new predicted sets Configurable subject entry screens Ability to link external documents to subject info. as attachments Fixed Vitalograph technical support user Backup and restore functionality added to DB admin tool Enhanced Post session display in session tree Implementation of latest ATS guidelines on Test QA Maximum number of blows increased to 20 Full parameter list enabled Pulse Oximetry Testing (Sp02)

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• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Ability to move subjects to different departments Automatically uninstall Spirotrac before installing new Spirotrac release Language Variants – German, French, Spanish, Dutch, Portuguese, Swedish, Norwegian, Japanese. Ability to send the audit logs to Over-Read Automatic and manual test acceptance Addition of the Vitalograph 2120 as a device Addition of the Vitalograph Alpha as a device Addition of the option to prompt the user to send all unsent spirometry sessions when the application is closed. Addition of Swedish and Norwegian ID functionality when those variants are selected. Addition of a motorcycle jumping over a canyon incentive PCF (Peak Cough Flow) Test Challenge Testing Six Minute Walk Testing Alpha Touch Subject Utility Module Alpha Touch integration with Spirotrac as a dumb flow head asma-1 Subject Utility Module Addition of new predicted sets Simulation of ATS/ISO waveforms with incentive Biometric Utility Manual Data Entry Utility Blood Pressure Monitor measurement Weighing Scales measurement Device as a Dongle License Option Export of previous sessions in GDT mode Download of In2itive Accuracy Log Model 2160 Gold Standard Plus Subject Utility Module Enhanced Visit Summary View Multi-Breath testing in VC Test Manoeuvre Inspiratory before expiratory on FVC Test Manoeuvre Option to display Best Test/Best 3 Tests/Best 8 Tests on a onepage report. Allows the user to switch on/off the ‘Export Previous Sessions’ GDT option. GDT option to recognise either decimal points (.) or commas (,)

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GETTING THE VITALOGRAPH SPIROTRAC READY FOR USE Loading the Spirotrac Software NOTE: • Spirotrac must be installed by a User with Administrative privileges. To install Spirotrac, do the following: 1. Place the Spirotrac CD in the DVD/CD-ROM disk drive. After a moment, the installer application will automatically run. 2. When the installer starts click “Install Spirotrac” to start the installation of Spirotrac. 3. Click the Next button to begin the installation. 4. Read the Licence Agreement and if you are satisfied with the terms agree to it. If you do not, the installation will not continue. 5. Click the Next button. 6. If necessary, make changes to the install location by selecting the Browse button. Click the Next button when finished. 7. The files are copied to the selected drive and directory. An error message is displayed if there is insufficient space on the drive. If this occurs, you should click on the OK button. Create space by deleting or backing up files and then start installing again from step 1. 8. A virtual PDF printer driver is installed onto the system. This allows the user to select this printer when printing, which allows the user to print to an Adobe Acrobat compatible PDF file. 9. When the installation has completed, a message is displayed on the screen informing the user of same. Click on the Close button. 10. The program name appears in the ‘START’ menu under Start-> All Programs -> Vitalograph ->Spirotrac along with a Shortcut icon which is placed on the desktop. 11. Setup Spirotrac by starting the Spirotrac application. A Set-up dialog is displayed. 12. The user is prompted to select from the following options:
Single-device installation – provides the ability to lock Spirotrac to one specific device and perform spirometry Copyright Vitalograph 2011

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tests with that device only, saving results to a local database on this personal computer.
Full installation – provides the ability to use more than one Vitalograph device for testing (see step 14 for setup) 13. When the user selects to perform a Single-device installation the user is prompted to enter a Spirotrac licence key and once validated, a database dialog is displayed. (go to step 18 ) 14. When the user selects to perform a Full Installation the user is prompted to select from the following options:
Test Station – provides the ability to connect to Vitalograph devices, perform new tests and review existing tests.
Review Station – Allows user to review existing data in the database only.
Local Database – Save test data to a local database on this personal computer. To set-up Spirotrac as a stand-alone application or if the current pc is database server pc, then choose this option.
Multi-User Database – Save test data to a multi-user networked database. To set-up Spirotrac using a network database and the current pc is client pc, then choose this option.
15. Click the Continue button. If a Test Station is selected the user is prompted to enter the relevant Licence key exactly as printed, and activate that key using one of the following methods:
Online Activation – This requires an Internet connection and requires a valid email address.
Manual Activation – This requires an additional computer bound key to have been obtained from Vitalograph. 17. Once Licence Key(s) have been entered and the relevant activation method selected, select the Activate button to activate the licence key. 18. A Database / Server Set-up dialog is displayed. Ensure details are correct. If the current pc is a client pc, enter the server name/instance of the database. Select Continue and the database is created.

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Note: For additional information see Network Database Installation 19.

Next: • Setup the Spirotrac System Administrator user when prompted. The id for this user will be ‘Administrator’ and the password which is case sensitive must be at least 6 characters in length. • You will have the option to set-up other users at this stage. To set-up another user, select the ‘Add User’ button or users can be added later from within the application if you wish, so select the ‘Continue’ button. • The user will then be prompted to set-up the Institution and Department details. • Next, user is prompted to log on to the SpirotracV application. (See Starting Spirotrac for the first time for next steps) Note: The user may select to cancel out of the set-up at any time. However, as the above details are required prior to launching the application, the application will not be launched until all the details are provided. Only then will the application actually launch. Once, the application is launched, checking the configuration settings is recommended, to ensure that user preferences are set-up as required. Additional documentation is available on the CD as support. These can be found under the following headings on the installer: ‘Release Notes’, ‘Spirometry Guidelines’ and ‘Other Manuals’. 20.

Network Database Installation • • •

Initially the user will be asked to select either a Local Database or a Multi-User Database. For a Local Installation, leave the default values present (localhost) and click ‘Continue’. For a Networked Installation, select the ‘Multi-User Database’ option. Enter the name or I.P. address of the SQL Server 2005 host. Enter the SQL Server 2005 Instance name if required (default SQLEXPRESS). Consult with your SQL Server Database Administrator for these settings.

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If the Database already exists Spirotrac will simply connect to and use this Database. • If the Database does not exist Spirotrac will create this Database automatically. The User must have the appropriate privileges to perform this action. Consult with your SQL Server Database Administrator for these privileges. • If a Database from a previous version of Spirotrac exists, Spirotrac will automatically migrate the data to the current version of the Database. • The user will be prompted to supply the ‘Administrator’ password. This account should later be used to setup other Spirotrac users. • The user will be prompted to add other users to Spirotrac (optional). • The user will be prompted to supply details of the Institution. • The user will be prompted to supply details of the Department. Note: At any point during the Spirotrac Setup Wizard the User may click the ‘Setup Later’ button. The Wizard will pick up from where it left off during next run. •

Installing the Vitalograph Pneumotrac USB drivers Note: These drivers are installed automatically as part of the Spirotrac Installation. To install Vitalograph Pneumotrac USB drivers manually, do the following: 1. Place the Spirotrac CD in the DVD/CD-ROM disk drive. After a moment, the installer application will automatically run. 2. When the installer starts click “Install USB Pneumotrac” 3. A WinZip self-extracting file will automatically execute and display a “Vitalograph USB Pneumotrac Installer” dialog – click the Next button. 4. The USB Pneumotrac drivers will be installed at this point and you will be presented with a Finish button. Click this button.

Installing the Vitalograph In2itive and Alpha USB drivers Note: These drivers are installed automatically as part of the Spirotrac Installation.

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To install Vitalograph In2itive and Alpha USB drivers manually, do the following: 1. Make sure the Spirotrac CD is inserted in the CD/DVD drive of the PC. If not, insert it now. (Note: When the CD is inserted, the installation wizard will start.) 2. Click on the “Install USB Device Driver” option. The USB drivers will be installed at this point and you will be presented with a Finish button. Click this button. 3. Connect one end of the USB cable into an available USB port on the PC. 4. Power Up the Vitalograph In2itive/Alpha device. 5. Connect to the other end of the USB cable into the Vitalograph In2itive/Alpha device. 6. The PC will detect that new hardware has been connected and a “Found New Hardware” installation wizard shall be displayed. This dialog will ask, “Can Windows connect to Windows Update to search for Software?” Select “No, not this time” and click the “Next” button. 7. Follow the default options on the screen until you are asked where to install your hardware from and choose “install the software automatically” – click the Next button. 8. You may be presented with an information dialog in relation to Windows Logo checks. Choose “Continue Anyway” on this screen. 9. The In2itive/Alpha drivers will be installed at this point and you will be presented with a “Finish” button. Click this button.

Installing the USB AND Blood Pressure monitor driver Note: These drivers are NOT installed automatically as part of the Spirotrac Installation and must be installed manually. To install USB AND Blood Pressure driver manually, do the following: 1. Make sure the Spirotrac CD is inserted in the CD/DVD drive of the PC. If not, insert it now. (Note: When the CD is inserted, the installation wizard will start.) 2. Click on the “Install USB Blood Pressure Driver” option. The USB drivers will be installed at this point and you will be presented with a Finish button. Click this button. Copyright Vitalograph 2011

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3. Connect one end of the USB cable into an available USB port on the PC. 4. Connect to the other end of the USB cable into the Blood Pressure device. 5. The PC will detect that new hardware has been connected and a “Found New Hardware” installation wizard shall be displayed. This dialog will ask, “Can Windows connect to Windows Update to search for Software?” Select “No, not this time” and click the “Next” button. 6. Follow the default options on the screen until you are asked where to install your hardware from and choose “install the software automatically” – click the Next button. 7. You may be presented with an information dialog in relation to Windows Logo checks. Choose “Continue Anyway” on this screen. 8. The USB driver will be installed at this point and you will be presented with a “Finish” button. Click this button.

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Connecting the USB Vitalograph Pneumotrac to your PC The following simple steps need to be carried out to get the Vitalograph Pneumotrac ready for use. For safety, it is recommended that the PC is fully powered off before you start this procedure. 1.

Plug one end of the USB cable into an available USB port at the back of the PC (usually marked with the symbol).

2.

Plug the other end of the USB cable into the USB port at the side of the Vitalograph Pneumotrac (marked with the symbol). If you connect additional equipment (not produced by Vitalograph) to the USB interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g. EN60950 for data equipment, EN60601 for medical equipment. Non-medical equipment must be kept outside the patient environment i.e. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons touching parts of the system can occur. (Contact your distributor if you have any queries.)

3.

Unwrap the white twin tubing from its packaging and connect one end to the Vitalograph Pneumotrac device. Ensure that the ribbed side of the tubing is connected to the ribbed half of the connector.

4.

Unwrap the flowhead from its packaging and connect the other end of the twin tubing to it. Ensure that the ribbed side of the tubing is connected to the blue tapping on the flowhead connector.

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Take one of the flowhead filters from its packaging and place in the flowhead holder on the Vitalograph Pneumotrac device.

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The Vitalograph Pneumotrac device is now ready for use.

7.

The USB driver must be installed on the PC to begin testing. Refer to the USB driver instructions for details. Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph Pneumotrac comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.

Connecting the Serial Vitalograph Pneumotrac to your PC The following simple steps need to be carried out to get the Vitalograph Pneumotrac ready for use. For safety, it is recommended that the PC is fully powered off before you start this procedure. 1.

Plug one end of the serial cable into an available serial port at the back of the PC (usually marked with the symbol). If the PC has a 25 pin serial port connector use a 9 pin to 25 pin port adapter.

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Plug the other end of the serial cable into the serial port at the side of the Vitalograph Pneumotrac (marked with the symbol). If you connect additional equipment (not produced by Vitalograph) to the serial interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g. EN60950 for data equipment, EN60601 for medical equipment. Non-medical equipment must be kept outside the patient environment i.e. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons touching parts of the system can occur. (Contact your distributor if you have any queries.)

3.

Unwrap the white twin tubing from its packaging and connect one end to the Vitalograph Pneumotrac device. Ensure that the ribbed side of the tubing is connected to the ribbed half of the connector.

4.

Unwrap the flowhead from its packaging and connect the other end of the twin tubing to it. Ensure that the ribbed side of the tubing is connected to the blue tapping on the flowhead connector.

5.

Take one of the flowhead filters from its packaging and place in the flowhead holder on the Vitalograph Pneumotrac device.

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The Vitalograph Pneumotrac device is now ready for use.

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Connecting the Serial Vitalograph 2120 to your PC The following simple steps need to be carried out to get the Vitalograph 2120 ready for use. 1. 2.

3.

Make sure that the PC is turned off. Connect the serial cable supplied with the Vitalograph 2120 and following the instructions supplied with it, ensure that the power supply is connected to it unless the battery is already charged. Connect the 9 pin ‘D’ serial connector on the other end of the 2120 cable to the appropriate serial ‘COM’ port on the back of the PC.

Connecting the Vitalograph In2itive and Alpha to your PC The following simple steps need to be carried out to get the Vitalograph In2itive and Vitalograph Alpha devices ready for use. For safety, it is recommended that the PC is fully powered off before you start this procedure. 1. Plug one end of the USB cable into an available USB port on the PC (usually marked with the symbol). 2. Plug the other end of the USB cable into the USB port at the side of the Vitalograph In2itive/Alpha (marked with the symbol). If you connect additional equipment (not produced by Vitalograph) to the USB interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g. EN60950 for data equipment, EN60601 for medical equipment. Non-medical equipment must be kept outside the patient environment i.e. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons Copyright Vitalograph 2011

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