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User Manual - Vitalograph

1. 07402 Issue 10 AC22 Test Performed Subject ID Subject ID No Outside Temp Session Session Date Time AC23 Calibration Pneumotrac Device Yes Update Outside ID device serial number Temp AC24 Manual Test Temperature modified No Temperature From lt previous value gt To Update lt updated value gt AC25 Manual Cal Acc Manually changed No Temperature temperature from Update lt previous value gt to lt updated value gt AC26 In2itive Upload Subject s uploaded No successfully to In2itive AC27 In2itive Subject s downloaded No Download AC28 In2itive Subject s successfully No Synchronisation synchronised AC29 2120 Upload Subject s uploaded No successfully to 2120 AC30 2120 Download Subject s downloaded No Source 2120 AC31 Subject Move From department lt old Yes dept gt To department lt new department gt Subject Number s lt list of subject numbers moved AC32 Model 4000 Test s Downloaded No Download AC33 MDE Subject Subject ID subject id No Create AC34 MDE Subject Subject ID subject id No Edit AC35 MDE Test Subject ID subject id No Addition AC36 Alpha Accuracy ALPHA accuracy log No Log Download downloaded AC37 Alpha Touch Subject s uploaded No Upload successfully Copyright Vitalograph 2011 55 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 AC38 Alpha Touch Subject s downloaded N
2. User ID as above Device ID the serial number of the device The device type Syringe volume Syringe reference User comment if the device was updated The log may be filtered by User device serial number the date time of the accuracy check To remove all filters and show all entries click the Show All entries button Select the Report icon to print the accuracy log You may view an individual accuracy check and flow volume curves by double clicking on an individual check or selecting one in the list and clicking on the View button The following window shall be displayed The accuracy check results may be printed by selecting the Report button Institute and Department Viewing Institution or Department Details 1 2 3 4 Select Institution Details or Current Department in the View menu The institution or department information will be displayed Modifications will not be allowed here Click on the OK button when finished Editing Institution or Department Details 1 2 3 4 In order to edit institution or department details select Institution Details or Department Details in the Edit menu The institution or department information will be displayed Make the changes required any non editable fields will be greyed out Select OK to save changes or Cancel to ignore changes Copyright Vitalograph 2011 52 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Depart
3. First Name the Subject s first name can be up to 20 characters in length Middle Name the Subject s middle name Last Name the Subjects last name can be up to 20 characters in length Subject date of birth DD MMM YYYY Gender the gender of the subject can be male or female drop down list Height the height of the subject in either cm or inches Can be 3 numeric characters Unit of measurement is user configurable see Subject Data Configuration Copyright Vitalograph 2011 23 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Weight the weight of the subject in either kg or lbs Unit of measurement is user configurable and also whether this field can be entered for Subject or not see Subject Data Configuration Population group drop down list with predicted values associated with each group It is user configurable whether this field is entered for Subject s or not see Subject Data Configuration Smoking Information the Smoking status of the subject This can be Smoker Non smoker or Ex smoker via a drop down list Notes notes comments can be entered for the subject Attachments External documents can be linked to subject information as attachments Select Tools gt Options gt Subject Entry to enable disable User Field1 Field added for extra information The Label is configurable see Subject Data Configuration The label can be up to 20 characters in length the data associated w
4. The following language variants are available English UK English US German French Spanish Dutch Portuguese Swedish Norwegian Japanese To switch to another language do the following 1 2 3 4 Select Tools gt Options gt Advanced In the Language Configuration section select the required language from the list provided Select the Ok button The system will prompt the user to restart the application Fault Finding Guide Problem Fault e Not measuring flow Symptoms Possible Causes e Ensure tubing is connected correctly Ribbed In probable side of the tubing should be connected to the order ribbed half of the connector on the Vitalograph device Problem Fault e Incorrect or no volume measurements Copyright Vitalograph 2011 60 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Symptoms Possible Causes In probable order Ensure tubing is connected correctly Ribbed side of the tubing should be connected to the ribbed half of the connector on the Vitalograph device Ensure that the connectors are clear of obstruction or dirt and that they are inserted fully Ensure the tubing is not kinked or squeezed Problem Fault Symptoms Excessive calibration drift Possible Causes In probable order Clean the flow head thoroughly Contact the nearest dealer for replacement Problem Fault Symptoms Test performe
5. 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 gt symbol 2 Plug the other end of the USB cable into the USB port at the side of the Vitalograph Pneumotrac marked with the O amp gt symbol A 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 Copyright Vitalograph 2011 17 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 5 Take one of the flowhead filters from its packaging and place in the flowhead holder o
6. manually perform a sync by selecting Tools gt Subject Utility gt In2itive Selecting Multiple Sync allows the user to synchronise with multiple In2itive devices in sequential order Each In2itive device is switched off on synchronisation completion Sending Sessions On selecting the Send Sessions Send All Unsent options from the File menu or by selecting the Send sessions to over read button the user will be presented with a dialog informing them that the Vitalograph Fusion Quality Assured Spirometry System is not currently enabled On selecting Yes they will be presented with a dialog informing them about the system This dialog contains a link that allows the user to contact Vitalograph regarding more information about Fusion Copyright Vitalograph 2011 39 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Fusion Vitalograph Spirotrac Fusion is an integrated easy to use Quality Assured Spirometry System providing expert over reading of spirometry in primary care occupational health or post training environments The expert over readers can be your own experts or provided as an optional service by Vitalograph Spirotrac Fusion supports you in the delivery of good and cost effective Clinical governance by providing assurance backed up by hard data that the quality of your entire group s spirometry meets acceptable standards Where an individual operator s spirometry quality is less than optimum th
7. DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Ability to download calibration accuracy check data from Vitalograph In2itive Alpha Touch 2120 devices Ability to upload subject history to Vitalograph In2itive Alpha Touch devices Ability to delete tests and subjects from Vitalograph In2itive Alpha Touch 2120 2160 devices Ability to set the date time on the In2itive Alpha Touch device Ability to connect to a USB serial or Bluetooth asma 1 device Ability to copy data from an asma 1 device Ability to delete tests from an asma 1 device Subject Utility Options are configurable Select Tools gt Options and click the Communications Icon The user is provided with the following options In2itive Synchronisation Mode When selected synchronisation automatically occurs on connecting the Vitalograph In2itive device Copy Subjects and Tests Both Subject and Test data is transferred from the In2itive device to Spirotrac and the original data remains stored on the In2itive device Move Tests Test data is transferred from the In2itive device to Spirotrac and the original test data is deleted from the In2itive device This is the default mode Move Subjects and Tests Subject and Test data is transferred from the In2itive device to Spirotrac and both the original subject and test data is deleted from the In2itive device 2120 2160 Detect COM Port button Automatically detects the COM port that the Vitalo
8. Record baseline heart rate and Sp02 details for the subject by performing an Sp02 test or by entering the Sp02 values manually To perform an Sp02 test select the Sp02 icon provided On selecting the Sp02 icon the user will be brought to the Sp02 testing screen where they can perform a test See Pulse Oximetry Testing Enter test values or perform an Sp02 test Select Next to Continue Step 6 Record baseline fatigue and dyspnoea levels It is optional to enter the Blood pressure and rest period Select Next to Continue Record and enter the lap length in metres Select OK to Continue Note The walking course should be marked every 3 meters and the turnaround points should be marked for example with a cone A starting point should also be marked Step 7 Instruct the user to start the 6 minute walk test by positioning the subject at the starting line The technician should also stand near the starting line during the test The technician should not walk with the patient As soon as the patient starts to walk start the timer Each time the subject returns to the starting line click the lap counter once On completion of the 6 minute walk test the distance walked on the final lap if not completed should be measured and entered in the appropriate dialog Select OK to Continue Select Next to Continue to step 8 Copyright Vitalograph 2011 46 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Step 8 Record the Final
9. 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 one page report e Allows the user to switch on off the Export Previous Sessions GDT option e GDT option to recognise either decimal points or commas Copyright Vitalograph 2011 10 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 dis 2 Place the Spirotrac CD in the DVD CD ROM disk drive After a moment the installer application will automatically run When the installer starts click Install Spirotrac to start the installation of Spirotrac Click the Next button to begin the installation Read the Licence Agreement and if you are satisfied with the terms agree to it If you do not the installati
10. b Edit user password c Delete an existing user 4 Click on the Close button to return to the main screen User Preferences The following information is available to the user for configuration by selecting Options from the Tools menu 1 Subject data information settings i Data to be entered for a subject see Subject Data Setup ii Population Group configuration see Population Group Setup 2 Spirometry Testing settings see Checks to Make before Performing VC FVC and Post Tests Copyright Vitalograph 2011 58 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Parameter Selection Subject posture during testing Session comment settings Incentive Device settings see Incentive Device Setup Device Selection Accuracy Check settings Check the Perform Accuracy Check Daily checkbox to enforce an accuracy check each day before testing can be performed Security settings Automatic Application Lock settings For Lock application after select the number of minutes from the drop down list Password expiration settings For Expire passwords after select the number of minutes from the drop down list Licence Management Manage Licence Keys and Features within Spirotrac Spirotrac can have multiple features enabled via licence keys that are managed through the Licence Management screen 1 2 Select Tools gt Licence Management A dialog is displayed listing all the features avail
11. been dropped The equipment used to perform the accuracy check should itself be certified and traceable to national or international standards All measuring equipment should be checked for accuracy on an annual basis Although it is not a specified requirement a routine annual service on this equipment is strongly recommended Mandatory daily accuracy checking can be switched on and off as follows Inthe Tools gt Options gt General tab Copyright Vitalograph 2011 49 DT_0006 9 Note Vitalograph Spirotrac User Manual 07402 Issue 10 When this option is on the user will not be able to proceed to testing until an accuracy check has been performed for that day If it is the first time the Pneumotrac device has been used in the system the user must perform a check with this device before proceeding to FVC testing It is recommended that the Vitalograph 3 Litre Syringe be used This has an accuracy of 0 5 Checking Accuracy Follow these steps to perform an accuracy check 1 2 10 Attach the Vitalograph Pneumotrac device flow head to the precision syringe Select the Accuracy Check from the Tools menu Alternatively select the Accuracy Check button on the main toolbar Enter the syringe reference and the syringe volume in L 1 9 in the dialog displayed Click on the Check button and a message shall appear prompting you to pump air through the flow head in order to ensure that the flowhead i
12. different subject may be selected from the drop down list if required 4 Select the session s to be sent from the list and then select the Add selected session s to send list button j 5 To remove any session s from the send list select the relevant session and then select the Remove selected pending session s from send list button 5 6 Once all session s for the subject s have been added to the send list select the Send button to send the sessions or select the Cancel button to cancel To send all unsent sessions to over read do the following 1 Select Send Send All Unsent from the File menu or click the Send All Unsent Sessions option from the send button on the main toolbar 2 All unsent session s will be sent to over read Viewing sent sessions 1 Select the subject whose sent session s are to be viewed 2 Select View Sent Session s from the main menu 3 All sent FVC sessions for that subject will be displayed 4 To view sent sessions for another subject select that subject from the drop down list 5 Select the Close button to return Setup mail settings In addition to access to the Vitalograph Fusion Quality Assured Spirometry System in order to send data to an Over Reader Spirotrac needs to be setup with a suitable mail server 1 Select Tools Options from the main menu and then select Mail Setup 2 Enter the details required as follows a SMTP Server this is the mail server nam
13. is inserted the installation wizard will start 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 15 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 Copyright Vitalograph 2011 16 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 A For safety
14. italograph Spirotrac MODEL 7000 User Manual Copyright Vitalograph 2011 1 DT_0006 9 Vitalograph Ltd Maids Moreton Buckingham MK18 1SW England Tel 44 0 1280 827110 Fax 44 0 1280 823302 e mail sales vitalograph co uk Vitalograph GmbH Rellinger StraBe 64a 20257 Hamburg Deutschland Tel 49 40 547391 0 Fax 49 40 547391 40 E Mail info vitalograph de Vitalograph Inc 13310 West 99 Street Lenexa Kansas 66215 USA Tel 913 888 4221 Fax 913 888 4259 e mail vitcs vitalograph com Vitalograph Ireland Ltd Gort Road Business Park Ennis Co Clare Ireland Tel 065 6864100 Fax 065 6829289 e mail sales vitalograph ie Internet www vitalograph co uk Copyright Vitalograph 2011 Current Edition Issue 10 Cat No 07402 fitalographi is a registered trademark Copyright Vitalograph 2011 2 DT_0006 9 Table of Contents DESCRIPTION OF THE VITALOGRAPH SPIROTRAC BUTTONS AND ICONS USED IN SPIROTRAC FEATURES OF THE VITALOGRAPH SPIROTRAC GETTING THE VITALOGRAPH SPIROTRAC READY FOR USE 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
15. no usable tests rejected tests shall be used When performing a Post test session the best pre test is associated with the Post test session Session Grades Each test series can be graded in relation to its reproducibility between system usable acceptable manoeuvres Grades are displayed in the session information tab Grades are calculated based on the type of blow achieved of which there are two e Usable Blow This is a blow that meets start of test criteria and does not contain a cough artefact e Acceptable Blow This is a blow that meets start of test and end of test criteria Quality Grade At least 3 acceptable blows with the largest 2 FEV1 values within 150mL and largest 2 FVC values within 150mL At least 3 usable blows with the highest two of the FEV1 values within 150mL C At least 2 usable blows Only one usable blow _ o Z o Z o Only one usable blow F No usable blows Copyright Vitalograph 2011 36 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Incentive Device Setup Spirotrac can be set to show a graphical incentive during FVC and VC testing To setup the incentive device follow these steps 1 9 Select Tools gt Options gt Incentive The Incentive Device configuration screen is displayed To switch on the Incentive device ensure the Show Incentives check box is checked Likewise to switch off the Incentive device un check this Select the incentive dev
16. the following provisions of Annex II 0086 of the Medical Devices Directive as per Article 11 section 3a excluding point 4 of Annex II Canadian Medical Device Regulation CMDR FDA Quality System Regulation QSR 21 CFR 820 EN ISO 13485 2003 Medical devices Quality management systems Requirements for regulatory purposes Certifying Body for 93 42 EEC and CMDR British Standards Institute BS I Certificate Nos CE 00772 MD 82182 FM 83550 Signed on behalf of Vitalograph Ireland Ltd B R Garbe Group Managing Director Copyright Vitalograph 2011 65 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 GUARANTEE V talograph Guarantee Terms of Guarantee Subject to the conditions listed below Vitalograph Ltd and its associated companies hereinafter called the Company guarantee to repair or at its option replace any component thereof which in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials The conditions of this guarantee are 1 This Guarantee shall only apply to hardware defects which are notified to the Company or to its accredited distributor within 1 year of the date of purchase of the equipment unless otherwise agreed in writing by the Company Software meaning computer software or user installable modules is guaranteed for 90 days from the date of purchase The Company warrants that the software when correc
17. updated value gt Copyright Vitalograph 2011 53 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 ACO9 Subject Delete Subject Number Subject Yes ID AC10 User Create User ID D of new user No ACH User Edit User ID Yes lt Password Change gt AC12 User Delete User ID D of deleted user Yes AC14 Session Create Subject ID Subject ID No Session Type AC15 Session Edit Subject ID Subject ID Yes Session Session Date Time Field modified From lt previous value gt To lt updated value gt AC16 Calibration Device Name Device Yes Update ID device serial number AC17 Add Population lt Regression Set Map No Group Population Group Name New Population Groups Name Regression Set Regression Set Name Correction Factor Correction Factor gt AC18 Edit Population Field modified From Yes Group lt previous value gt To lt updated value gt AC19 Delete lt Regression Set Map Yes Population Population Group Name Group name ofthe deleted population group Regression Set name of the regression set the deleted population group was mapped to Correction Factor the correction factor of the deleted population group gt AC21 Date Time No Change AC20 Software No Update Copyright Vitalograph 2011 54 DT_0006 9 Vitalograph Spirotrac User Manual
18. 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 Copyright Vitalograph 2011 8 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 In2
19. 0 Selecting Tools gt Options gt Advanced Switch User Send Sessions Send All Unsent Sessions Edit Institution Edit Department Changing Device Post Testing 1 2 3 Select a subject by clicking on the Subject in the subject list on left hand side of main screen Once the required subject has been selected from the list select Post from the Test menu or click on the Post button A list of all previous FVC test sessions for that subject will be displayed Select the appropriate test session from the list and click Select The post test session will be associated with this selected test session and the FVC test screen is displayed see Performing FVC Testing Alternatively when the list of all previous FVC test sessions is displayed select Cancel to cancel Post testing and return to the main screen PCF Testing The PCF Peak Cough Flow is the velocity of air expelled from the lungs during a cough manoeuvre Testing may be performed either in the sitting or standing position The standing position may not be appropriate in some circumstances such as in hospitals where many subjects may not be able to tolerate the standing position especially when making forced manoeuvres If the standing position is used an appropriately shaped chair should be placed behind the subject so he she can quickly and easily be eased into a sitting position if he she becomes light headed during the manoeuvres The posture typ
20. 58 User Management 58 USER PREFERENCES 58 LICENCE MANAGEMENT 59 Manage Licence Keys and Features within Spirotrac 59 Online Updates 60 LANGUAGE VARIANTS 60 FAULT FINDING GUIDE 60 CUSTOMER SERVICE 62 Copyright Vitalograph 2011 4 DT_0006 9 TECHNICAL SPECIFICATIONS CE NOTICE FDA NOTICE DECLARATION OF CONFORMITY GUARANTEE 63 63 64 65 66 Copyright Vitalograph 2011 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 he
21. 7 If you wish to abort the login process at this stage click on the Cancel button Copyright Vitalograph 2011 22 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Application Lock Autolock Unlock Spirotrac will automatically lock after defined periods of inactivity The default is 45 minutes Only the currently logged on user or the Administrator user can unlock Spirotrac Automatic application locking can be configured to different time intervals See Configure Application Lock Timeout While the application is locked all active windows amp dialogs will be hidden they will be restored to their current state upon unlock To unlock the application enter User ID and Password in the Unlock screen and click OK 1 2 Subject Management Creating a Subject Select New gt Subject in the File menu or click the new subject button on the main toolbar Enter details for each field as follows a Subject ID a unique number for each subject this will be 1 2 generated automatically but the user may change this ID if required This field is mandatory Note1 To create a new subject the Subject ID is mandatory All other details are optional Note2 On Swedish and Norwegian variants Swedish and Norwegian ID formats are supported here Alternative Subject ID an alternative identifier for the subject It is configurable as to whether this field is displayed or not see Subject Data Configuration
22. ALPHA TO YOUR PC STARTING SPIROTRAC FOR THE FIRST TIME OPERATING THE VITALOGRAPH SPIROTRAC 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 3 DT_0006 9 Session Grades 36 Incentive Device Setup 37 SUBJECT UTILITY 37 SENDING SESSIONS 39 Fusion 40 Sending sessions to Over Read 40 Viewing sent sessions 4 Setup mail settings 4 PULSE OXIMETRY TESTING 42 CHALLENGE TESTING 43 Challenge Test Procedure 43 SIX MINUTE WALK TESTING 45 BLOOD PRESSURE MEASUREMENT 47 WEIGHT MEASUREMENT 48 ACCURACY CHECKING 49 Accuracy Checking in Spirotrac 49 Checking Accuracy 50 Calibration update 5I Viewing Printing accuracy log 5 INSTITUTE AND DEPARTMENT 52 Viewing Institution or Department Details D2 Editing Institution or Department Details 52 Department Management 53 AUDIT TRAIL 53 Audit Trail Codes 53 Viewing Printing The Audit Trail 56 PRINTING 57 Printer Setup 57 Report configuration 57 Printing a Test Report 58 Printing a Trend Report 58 USERS
23. Fatigue and Dyspnoea levels Select Next to Continue Step 9 Record final heart rate and Sp02 details for the subject by performing an Sp02 test or by entering the Sp02 values manually To perform an Sp02 test select the Sp02 icon provided On selecting the Sp02 icon the user will be brought to the Sp02 testing screen where they can perform a test See Pulse Oximetry Testing Select Next to Continue Step 10 Record any Walk test comments by entering free text in the space provided Select Finish to end the 6 minute walk test The user is returned to the main screen where a summary of the test information is displayed Blood Pressure Measurement Spirotrac includes a Blood Pressure module that will interface with the A amp D Blood Pressure Monitor allowing the measurement of a subject s blood pressure in millimetres of mercury mm Hg and pulse rate in beats per minute BPM The Spirotrac Blood Pressure module is intended to provide a quick and easy way to monitor a subject s blood pressure In order to take a blood pressure measurement 1 Select a subject by clicking on the Subject in the subject list on the left hand side of the main screen 2 Instruct the subject to sit comfortably at a table resting their arms on the table 3 The subject should relax for five minutes before the measurement 4 If the A amp D Blood Pressure Monitor is a USB device attach the cable to the PC 5 Attach the blood pressure cuff to t
24. OK button to save the settings or Cancel to ignore 4 The user can choose to reset the Subject Data entry settings by selecting the Reset Subject Settings button Copyright Vitalograph 2011 26 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Predicted Values Population Group Setup 1 2 3 Select Tools gt Options from Main Menu and select General In the Population Groups amp Regression Sets section select the Manage button To add a new population group do the following Select the New button enter the name Select the corresponding Regression Set from the drop down list Enter the correction factor the to multiply the predicted value by Select OK to save the new population group or Cancel to cancel To rename a population group do the following Select the Edit button Enter the new name Select OK to save changes or Cancel to ignore To Edit a population group do the following Select the Population Group from the list Select the Edit button Select the new Regression Set from the drop down list Enter the new correction factor Select OK to save changes or Cancel to ignore To Delete a population group do the following Select the Population Group from the list Select the Delete button Select Yes to delete the population group or No to cancel Spirometry Testing Checks to Make before Performing VC FVC and Post Tests Before commencing a test routine check that
25. able on the system indicating which are enabled through presence of a licence key and also provides details about the features The user can update an existing licence key or add a new licence key to enable a new feature as follows Select the feature from the list Select the Update button A dialog is displayed to prompt the user to activate the new licence key The user is prompted to enter the relevant Licence key exactly as received from Vitalograph 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 Copyright Vitalograph 2011 59 DT_0006 9 4 Vitalograph Spirotrac User Manual 07402 Issue 10 iv Once Licence Key s have been entered and the relevant activation method selected select the Activate button to activate the licence key Click on the Close button to return to the main screen Online Updates Spirotrac users with a valid Technical Support and Maintenance plan can check and download minor updates to the software as a follows 1 2 3 4 Select Help gt Check for Updates A dialog is displayed click the Next button When an update is available the user can download and install the update to the pc Click on the Finish button to return to the main screen Language Variants
26. ber required for the test and the ATS test is performed AWN Parameter Definition Slow Vital capacity L Inspiratory Vital capacity L Forced Vital capacity L Forced expiratory volume after n second s L FEV1 FVC Ratio of FEV1 versus FVC Copyright Vitalograph 2011 32 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 FEVn FVC Ratio of Forced Expiratory Volume after n second s L versus FVC Ratio of Forced Expiratory Volume after n second s L versus VC Peak expiratory flow L sec or L min FEFO 2 1 2 Mean forced expiratory flow in the volume interval between 0 2 L and 1 2 L of the ren FEF25 75 Maximal mid expiratory flow the mean FEF in the time interval between 25 and Bere ofthe FVC L sec FEF75 85 Forced late expiratory flow the mean FEF in the time interval between 75 and Br ofthe FVC L sec FEF25 Forced expiratory flow at 25 of the FVC L sec FEF50 Forced expiratory flow at 50 of the FVC L sec FEF75 Forced expiratory flow at 75 of the FVC L sec FIVC Forced inspiratory vital capacity L FIVC FVC IV1 Forced inspiratory volume after 1 second L IF Peak inspiratory flow L sec or L min FIF25 Forced inspiratory flow at 25 of the FVC L sec or FIVC whichever is greater FIF50 Forced inspiratory flow at 50 of the FVC L sec or FIVC whichever is greater FIF75 Forced inspiratory flow at 75 of the FVC L sec or FIVC whichever is greater FIF50 FEF50 MVVInd Maximum voluntary ventila
27. contains information on the quality of the session so far The messages that may appear in this section and what they mean are outlined in the table below displayed FVC is not The largest FVC and second largest FVC or FEV6 repeatable from the acceptable blows in the current session vary by more than 0 15 L FEV1 is not The largest FEV1 and the second largest FEV1 repeatable from the acceptable blows in the current session vary by more than 0 15L System Acceptability The System Defined Usable Acceptable results are defined as follows Represents a curve which passed all test acceptability criteria Represents a curve which passed Start of Test and Artefact free acceptability criteria only X Represents a curve which did not pass both the Start of Test and Artefact free acceptability criteria A Usable curve is any curve which passes the Start of Test acceptability criteria and which is artefact free i e no cough detected by system Copyright Vitalograph 2011 35 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Note If the user rejects a curve then that curve is no longer considered as a usable curve Best Test Criteria All tests in a test session will be saved including unacceptable tests The best test criteria is as follows The highest volume paramaters from usable tests All other parameters shall be taken from the usable test with the largest FVC FEV1 sum If there are
28. ct the Six Min Walk Test menu item from the Test menu or Select the Six Minute Walk test icon from the toolbar Step 1 A six minute walk test instruction dialog is displayed Read the instructions carefully and select Next to continue Step 2 A Medication dialog is displayed Select Add to record a list of any medication that the subject may be taking at the present time Add a medication if applicable Select Next to continue Copyright Vitalograph 2011 45 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Step 3 Dyspnoea is a measure of shortness of breath and is a sign of serious disease of the airway lungs or heart The user selects a dyspnoea grade for the subject using the Modified Medical Research Council Dyspnoea Scale or MMRC This uses a simple grading system to assess a patient s level of dyspnoea The MMRC is used to help calculate the BODE Index which is a tool for predicting life expectancy of someone with COPD Select the appropriate dyspnoea grade for the subject Select Next to continue Step 4 Record Spirometry details for the subject either by performing a FVC test or by entering the parameter values manually To perform a FVC test select the FVC icon provided On selecting the FVC icon the user will be brought to the FVC test screen where they can perform a test See Spirometry Testing Performing FVC Testing Enter test values or perform a FVC test Select Next to Continue Step 5
29. d but does not show on screen Possible Causes In probable order Ensure correct device is selected from Tools gt Device Ensure device is connected to PC correctly Ensure tubing is connected between flow head and device correctly same colour connector at both ends Problem Fault Symptoms Report does not print all tests Report does not print some parameters Possible Causes In probable order Ensure the correct report settings are set up in Tools Options Reports Ensure the parameters you require are selected from Tools Options Parameters NOTE If a particular parameter is selected but has no measurement for any test then it will not appear on the printout Problem Fault Symptoms Communication error message appears when entering the Test screen the Accuracy Check screen or the Calibration Update screen Copyright Vitalograph 2011 61 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Possible Causes In probable order Ensure that the Vitalograph device is attached correctly Problem Fault Symptoms Accuracy check variations gt 3 Possible Causes In probable order Recheck Calibration with reference to section Checking Accuracy Was the correct syringe volume entered Ensure that the tubing connectors are clear of obstruction or dirt and that they are inserted fully Ensure the tubing is not kinked or squeezed Ensure
30. d 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 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 Take one of the flowhead filters from its packaging and place in the flowhead holder on the Vitalograph Pneumotrac device The Vitalograph Pneumotrac device is now ready for use Copyright Vitalograph 2011 19 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 Make sure that the PC is turned off 2 Connect the serial cable supplied with the Vitalograph 2120 and following the instructions supplied with it ensure tha
31. dical Devices Directive of the European Community 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 product 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 Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided Portable and mobile RF communications equipment can affect medical electrical equipment Copyright Vitalograph 2011 63 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 FDA NOTICE Caution Federal Law restricts this device to sale by or on the order of a physician Copyright Vitalograph 2011 64 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 DECLARATION OF CONFORMITY Product ifalographi Spirotrac Vitalograph hereby ensures and declares that the above product associated with this user manual is designed and manufactured in accordance with the following QMS regulations and standards European Medical Devices Directive MDD 93 42 EEC This device classified as 2a as per Annex IX of MDD 93 42 EEC meets
32. e must be selected prior to testing Select a subject by clicking the Subject in the Subject list Copyright Vitalograph 2011 31 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Once the required Subject has been selected select Test gt PCF or click on the PCF Test button If the device is connected correctly the PCF test screen will be shown Wait for the Cough Now message to appear on screen Read the following instructions to the Subject to ensure testing is performed properly e Keep the flow head away from your mouth e Inhale as deeply as possible and insert the Bacterial Viral Filter into your mouth clamping it between your teeth e Close your lips around the mouthpiece e Perform a PCF manoeuvre e Again wait for the Cough Now message to appear on screen before performing the next PCF manoeuvre e When all blows are complete click the return button to return to the Main screen ATS Waveforms ATS waveforms may be displayed to simulate the results of FVC testing by selecting values on the screen instead of performing physiological tests 1 Check that the device is set at ATS Waveforms Tools gt Device gt ATS Waveforms Select subject from the subject list Select FVC from the Test menu or click on the FVC test button Once the test screen is displayed the user can select which ATS wave curve to run from ATS 24 Waveforms menu item in test screen 5 Click on the waveform num
33. e the following a b Unit of Height the user can select to enter height in cm or inches Enter subject s weight the user can select to enter weight as part of subject demographics or not When checkbox is ticked weight can be entered displayed printed for subjects Unit of Weight the user can select to enter weight in kg or Ibs Alternative Subject ID the user can select to enter an alternative subject number as part of subject demographics When Display Report On this alternative number will be displayed printed for the subject Population Group the user can select to enter Population Group as part of subject demographics When Select Population Group for Subject is ticked then a Population Group can be selected for a subject and therefore displayed and printed When it is not ticked it will not be possible to select a population group for a subject Extra Subject Information The user can select to enter extra subject information as part of the subject demographics dialog When Display Subject Attachments is ticked the New Subject dialog will contain a section allowing the user to associate attachments with the subject The Extra Subject Information section also provides the user with the ability to add two additional fields to the New Subject dialog by ticking the enabled checkboxes for User Field 1 and User Field 2 Names can be specified for each of these fields in the spaces provided 3 Click on the
34. e with your Internet Service Provider ISP Copyright Vitalograph 2011 41 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 b SMTP Port this is the mail server port number with your Internet Service Provider ISP typically port 25 however this can be different c Connection this is the dialup connection to establish during transmission if required d SMTP Username this is the user ID of your account with the ISP if a login is required e SMTP Password this is the user password of your account with the ISP if a login is required f Over Read E Mail Address this is the email address of the over reader to which any session data is to be sent 3 A connections button is provided which will take the user to the System Dial up connection manager 4 A test button is provided to check your settings Pulse Oximetry Testing Spirotrac includes a Pulse Oximetry module that will interface with the Nonin Model 3212 IPOD oximeter DF2 W USB connector allowing the measurement of a subject s pulse rate in beats per minute BPM and oxygen saturation levels SpO2 The Spirotrac Pulse Oximetry module is intended for use for spot checking subjects Pulse Oximetry measurements up to one hour max in an environment where little sensor motion is expected For additional information on the indications for use for the Nonin Model 3212 IPOD oximeter DF2 W USB connector please refer to Nonin Medical s directi
35. elect Start Pre Challenge Testing The user is brought to the FVC test screen The user performs blows reference Spirometry Testing FVC Test and on completion of these blows the user should select the return button to exit the test screen and return to the challenge test wizard When the Pre challenge testing results are displayed to continue to the next phase select Next gt to proceed Dosing Step 1 of 9 This stage is used to determine the baseline FEV1 In the first step the user is instructed to administer a dose to the subject as per the instructions provided The instructions may be read by selecting the Dose Instructions link in the challenge test wizard When the instructions are read and the dose administered the user should select the Dose Administered button This will start the 60 second count down timer On completion of this timer the application shall enter the FVC test screen where the subject must perform two repeatable FEV1 measurements These measurements must be within 0 15L 150ml variability If there is greater than 0 15L variability between readings the subject will be instructed to perform another FEV1 The highest FEV1 reading is recorded as the baseline FEV1 If the highest FEV1 is gt 10 drop from the pre challenge FEV1 the challenge test should be discontinued To exit the FVC test screen press the return button and the results of the Dose Step 1 Phase will be displayed The user can proceed
36. erform a Re Check step 3 3 9 as per Checking Accuracy will be performed again but this time the user will not be prompted to re check if a calibration adjustment is recommended If three consecutive strokes are reproducible within 3 but the overall difference is greater than 25 the user shall not be allowed adjust the calibration This may be as a result of the following e Faulty equipment e Faulty technique It is possible for the user to enter comments on the results pop up dialog The user may view and print the results at the end of the procedure Viewing Printing accuracy log 1 2 3 4 Spirotrac maintains an accuracy check log The accuracy check Log is updated each time that an accuracy check is performed with the Pneumotrac in Spirotrac Select the Accuracy Check Log from the View menu You will be prompted to select the device ID from a drop down list or alternatively select All Devices to view the entire accuracy log A screen is displayed with the following information Date Time Volume that the device measured Percentage difference from syringe volume Copyright Vitalograph 2011 51 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 If the accuracy was updated or not User ID the user who performed the check Temperature that accuracy check was performed The following extra information is shown when the individual accuracy check is selected
37. est Only Print the ATS ERS Best Test only b Best 3 Tests Print the best three tests from the session c Best 8 Tests Print the best eight tests from the session 5 An Economode option is available for selection When selected all test session reports printed will have any shaded areas removed 6 The user can choose to reset the Report configuration settings by selecting the Reset Report Settings button Copyright Vitalograph 2011 57 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 7 Select OK to save change or Cancel to discard Note When the One Page Report is printed a default list of parameters is printed regardless of the parameters selected Printing a Test Report To print a test report for any test session do the following 1 Select the Subject to which the test session belongs 2 Select the session to be printed 3 Select File gt Report gt Test Report OR alternatively select the Print button Printing a Trend Report To print a Trend Report for a subject do the following 1 Select the Subject to view the Trend Graph 2 Select File gt Report gt Trend Report Users User Management Spirotrac can have multiple Users that are managed through the User Management screen 1 Select Tools gt User Management 2 A dialog is displayed listing all the users available on the system with the current user highlighted in Bold 3 The following actions are available a Add anew user
38. flow head is clean Problem Fault Symptoms Test begins automatically Volume accumulates automatically without the subject blowing Very small VC or FVC test displayed Possible Causes Flowhead and or tubing not stationary at the In probable start of test Hold them steady until the Blow order Now prompt appears Return to Main Menu and re enter the test routine CUSTOMER SERVICE Service and repairs should be carried out only by the manufacturer the approved importer or by Service Agents specifically approved by Vitalograph For the names and addresses of approved Vitalograph Service Agents or to arrange spirometry workshops please refer to the contact information at the start of this manual Copyright Vitalograph 2011 62 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 TECHNICAL SPECIFICATIONS Product Vitalograph Spirotrac Model 7000 Flow detection principle Fleisch type pneumotachograph Maximum test duration 45 seconds Maximum displayed volume 10L Volume accuracy 3 Flow accuracy when operated in operating 10 temperature range conditions Operating temperature range ATS ERS limits 17 37 C Design limits 10 40 C Parameters measured Varies by country Note All values displayed by the Vitalograph Spirotrac are expressed as BTPS values CE NOTICE Marking by the symbol gS indicates compliance of Vitalograph Spirotrac to the Me
39. g is displayed prompting the user for their ID and password These will have been set up during installation See Logging into Spirotrac OPERATING THE VITALOGRAPH SPIROTRAC Start up Logon Note In order to use the application Spirotrac requires that the PC user adhere to one of the following e User must have full administrative rights on the PC or e User must be added to the SQLServer2005MSSQLUser group or e User must be added to the SQLServer s Security Login with full read write access to the SpirotracV database for upgrades and SpVDefault database Logging into Spirotrac 1 Users who have been successfully added to the Spirotrac software reference the Users section will have their own User ID and Password 2 The logon screen will be presented on start up prompting for User ID and Password to be entered For Network installations the Database field will be enabled allowing the user to select the server database 3 The User ID will be pre populated with the User ID of the last person who logged into the Spirotrac software application If appropriate enter your own User ID 4 Enter your password and click the OK button or press Enter on your keyboard 5 If the login is successful your user criteria is accepted by the system you will be presented with the application desktop 6 If the login is not successful your user criteria is rejected by the system you will be presented with the Login screen again
40. graph 2120 2160 device is connected to Displays an error message if no 2120 2160 device connected Copy Subjects and Tests Both Subject and Test data is transferred from the 2120 2160 device to Spirotrac and the original data remains stored on the 2120 device Copyright Vitalograph 2011 38 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 e Move Tests Test data is transferred from the 2120 2160 device to Spirotrac and the original test data is deleted from the 2120 2160 device This is the default mode e Move Subjects and Tests Subject and Test data is transferred from the 2120 2160 device to Spirotrac and both the original subject and test data is deleted from the 2120 2160 device Click the OK button to save changes or the Cancel button to discard them On selecting Download Tests Spirotrac connects to the appropriate device downloads subject and test session data and presents a dialog containing a list of Subjects and tests downloaded On selecting the save option the Subject s selected and associated test sessions are saved to the Spirotrac database Selecting Upload Subjects presents the user with a list of all subjects in the Spirotrac database The user can then select the subject s that they wish to send to the Vitalograph device On selecting the upload button these subjects are saved to the Vitalograph device Test sessions are not saved If Synchronisation mode is not selected in Options the user can
41. he subject as per the manufacturer s guidelines 6 Select the Blood Pressure menu item from the Test menu or Select the Blood Pressure icon from the toolbar 7 A Blood Pressure screen is displayed This screen displays the following Copyright Vitalograph 2011 47 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 a The date and time of the test b The systolic reading in mmHg c The diastolic reading in mmHg d The pulse rate in BPM 8 Record the arm that is used and the subject s posture 9 Click Start on the Blood pressure monitor to inflate the cuff and record the measurement 10 The measurements shall be displayed on the screen after the device goes into standby mode Depending on the number of measurements stored on the device the time it takes to transmit the measurement to Spirotrac may be increased Weight Measurement Spirotrac includes a Weight measurement module that will interface with the A amp D Weighting Scales allowing the measurement of a subject s weight in kilograms or pounds depending on the configuration chosen The Spirotrac Weighting Scales is intended to provide a quick and easy way to monitor a subject s weight In order to take a weight measurement 1 Select a subject by clicking on the Subject in the subject list on the left hand side of the main screen 2 Select the Weight menu item from the Test menu or Select the Weight icon from the toolbar 3 In
42. he user will be prompted to supply details of the Institution The user will be prompted to supply details of the Department 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 2 3 Place the Spirotrac CD in the DVD CD ROM disk drive After a moment the installer application will automatically run When the installer starts click Install USB Pneumotrac A WinZip self extracting file will automatically execute and display a Vitalograph USB Pneumotrac Installer dialog click the Next button 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 Copyright Vitalograph 2011 14 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 s
43. ice to be displayed from the Current Incentive drop down list Enter the Target of Predicted Valid values are 80 150 This represents the percentage of the predicted volume of the lungs which must be reached for the incentive to play out fully i e for birthday cake this represents volume at which all candles will blow out Next enter the Target of Best Test Valid values are 80 150 This represents a percentage of the best FVC value of the tests done which must be reached for the incentive to play out fully This may be used to encourage the child to try harder The user can change the opacity of the Incentive display window by editing the Window Opacity value Valid values are 50 100 The user can also re set the incentive settings to the default installation at any stage by selecting the Reset Incentive Device Settings button Click on the OK button to save settings 10 Click on the Cancel button to cancel Note If the required subject information is not entered to calculate the predicted values the incentive device will not be displayed Subject Utility This provides the user with the following functionality Ability to download subjects from Vitalograph In2itive Alpha Touch 2120 2160 devices Ability to upload subjects to Vitalograph In2itive Alpha Touch 2120 2160 devices Ability to download tests parameters and curves from Vitalograph In2itive Alpha Touch 2120 2160 devices Copyright Vitalograph 2011 37
44. ions are configurable on the Options screen Challenge Testing Vitalograph Spirotrac includes a Challenge Test module Challenge testing is used as an aid in determining the degree of narrowing of a subject s airways A bronchorestricting agent is given to the subject and the response to that agent is monitored by repeated Spirometry Challenge Test Procedure Enter the subject s details in Spirotrac as applicable age height race date of birth gender etc or select a subject from the subject list Select the Challenge Test icon from the main screen The Challenge testing screen is displayed along with the Challenge test wizard This wizard will guide the user through the Challenge test procedure It is important that the user reads the Instructions provided by the wizard before proceeding Once the instructions are read the Copyright Vitalograph 2011 43 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 user should indicate this by clicking on the check box provided This enables the next button in the wizard screen Pre Challenge Test Phase The Challenge test procedure consists of multiple phases The pre challenge test phase is used to determine the baseline prior to the issuing of a diluent or dose In this phase the user should perform a spirometry test with a minimum of two blows that meet repeatability criteria of 150 ml The subjects FEV1 should be gt 70 predicted To determine the pre challenge FEV1 s
45. is automated feedback data enables identification of specific training needs by the project manager Requiring only Internet access or a mail client Spirotrac Fusion is very easy to use e Simply perform spirometry as normal e At the end of the days testing press the send all icon e Encrypted blind spirometry test sessions are sent securely to our web server e The expert over reader logs in daily to review all spirometry sessions e Routine monthly and or daily exception reports make the identification of areas of excellence or deficiencies transparent On receiving access to the Vitalograph Fusion Quality Assured Spirometry System the user will be provided with the following Over Read functionality Sending sessions to Over Read Spirotrac provides the ability to send FVC session data to an Over Reader through two options a Send Sessions which allows the user to select which sessions are to be sent b Send All Unsent which sends all session data which have never been sent to any over reader To select sessions to send to over read do the following Copyright Vitalograph 2011 40 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 1 Select the subject whose session s are to be sent to over read 2 Select Send Send Session s from the File Menu or click the Send Sessions to Over Read button on the main toolbar 3 All FVC session s for the currently selected subject are listed however a
46. ith the label can also be up to 20 characters in length User Field2 Field added for extra information The Label is configurable see Subject Data Configuration The label can be up to 20 characters in length the data associated with the label can also be up to 20 characters in length Click on the OK button to save this subject to the database Click on the Cancel button to discard new subject and return to the application desktop Editing a Subject In order to edit a subject a user may a Right click on the subject in the subject list on the left panel and select edit subject b Select the subject from the subject list on the left panel and select the edit button in the subject demographics panel c Select the subject in the subject list on the left panel and select the Subject Details from the Edit menu The subject information is displayed See Creating a Subject for details on fields Click on the OK button to save the changes Click on the Cancel button to undo the changes and return to the application desktop 1 m Copyright Vitalograph 2011 24 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Note If the date of birth gender height or population group of the subject is changed the predicted values for the subject shall be re calculated Selecting Viewing a Subject 1 Select the subject in the subject list on the left panel The subject becomes the current subject You may perform a Spiromet
47. itive 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 Copyright Vitalograph 2011 9 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 e Ability to move subjects to different departments e Automatically uninstall Spirotrac before installing new Spirotrac release e 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
48. lected prior to testing see Checks to Make before Performing VC FVC and Post Tests 1 Select a subject by clicking on the Subject in the subject list on left hand side of main screen 2 Once the required subject has been selected from the list select FVC from the Test menu or click on the FVC test button 3 If the Pneumotrac In2itive is connected correctly the correct COM port is selected and the device is within temperature operating limits the FVC test screen shall be displayed 4 If the device is not within temperature testing may still continue but results may not be valid This will be indicated by displaying a warning message to the user 5 If the test screen is left idle for two minutes or more Spirotrac will suspend the test 6 Wait for the BLOW NOW message to appear on screen before beginning the test 7 After each blow a quality summary window is displayed The test acceptability and session quality for the test performed is displayed to the user see Test Quality Information 8 It is possible for the user to Accept Reject or keep the Copyright Vitalograph 2011 29 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 automatic interpretation for the test at any time using the User Acceptability drop down list Changing the acceptability of a test will automatically update the best test reproducibility and quality information 9 Session information Quality information Acceptability a
49. 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 Copyright Vitalograph 2011 12 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Note For additional information see Network Database Installation 19 20 Next e 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 e 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 e The user will then be prompted to set up the Institution and Department details e 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 documenta
50. lp 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 Copyright Vitalograph 2011 6 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 Bn le ko ie E Select Pulse Oximetry Testing P Challenge Test Measure Blood Pressure Measure Weight Test Copyright Vitalograph 2011 DT_0006 9 Fam Vitalograph Spirotrac User Manual 07402 Issue 10 F Six Minute Walk Test L Print test reports Send sessions to over read Pneumotrac Launch the Help file a gE DD Perform an Accuracy Check on the Vitalograph 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
51. ment Management The Institute can have multiple Departments which are managed through the Department Management screen 1 Select Tools gt Department Management 2 To add a new department select New enter department details and then press the OK button 3 To switch to another department select the department name from list and then press Select button When prompted for confirmation select Yes to switch departments or No to keep the current department active 4 Click on the Close button to return to the main screen Audit Trail Audit Trail Codes Note The user will only be prompted to enter a reason for a change on versions of the software which include audit trail activities and where User Annotation below is indicated with a Yes Activity Activity System Annotation User Code Description Annotation ACO1 User Logon No AC02 User Logoff Switch User No Application exit only when user is logged off due to a switch in user ACO3 Institute Create Institute ID No AC04 Institute Edit Institute Name Field No modified From lt previous value gt To lt updated value gt AC05 Department Department Name No Create AC06 Department Edit Department Name Field Yes name modified From lt previous value gt To lt updated value gt AC07 Subject Create Subject ID Subject ID No AC08 Subject Edit Subject ID Yes Field name modified From lt previous value gt To lt
52. n the Vitalograph Pneumotrac device 6 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 Copyright Vitalograph 2011 18 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 2 Plug the other end of the serial cable into the serial port at the side of the Vitalograph Pneumotrac marked with the 10101 symbol A If you connect additional equipment not produce
53. nd Usability information can be viewed at any time during testing by selecting the relevant tab on the test screen The Parameters tab contains the parameter values and also includes System Acceptability information and User Acceptability information The Test QA tab contains information on the status of all test acceptability criteria for each test The Info tab contains information about the overall session such as Session Grade information Repeatability information Session Comments and Interpretations 10 The next test can be performed once the BLOW NOW message re appears on screen 11 The maximum number of blows that a subject should perform in any one session is eight 12 You may leave the test screen at any time by selecting Return This brings you back to the main screen but the test session remains open Selecting the test button again returns you to the test screen and testing can continue 13 A test session will remain open until one of the following occurs and at that point you will be prompted whether or not you wish to close the session Selecting a Different Subject Selecting the Post Mode testing Closing Spirotrac Add Subject Editing a Subject Performing a Calibration Update Performing Department Management Changing Password Performing Database Management Invoking the Subject Utility Copyright Vitalograph 2011 30 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 1
54. o Download Source Alpha Touch AC39 Alpha Touch Subject s successfully No Synchronisation synchronised Viewing Printing The Audit Trail Spirotrac records an entry in an audit trail each time certain events occur within the application For a list of these events see Audit Trail Codes All Users can view and print reports of the Audit Trail Note This only applies to versions of the software that include this functionality 1 Select Audit Trail from the View menu 2 All entries are sorted by date time initially The User can change the sort order by clicking any of the column headers 3 The following information is shown a b C User ID the user who performed this action Date Time when the action was performed Annotation Code the type of action performed AC code System Annotation details of the change will be recorded by Spirotrac e g previous and new values etc User Annotation the comment the user entered at the time of the change if required 4 The following extra information is shown for individually b C selected audit entries Annotation Type a description of this type of annotation record e g User Logon etc System Annotation as above User Annotation as above 5 The Entries can be filtered by User A Date BEI and or Annotation Type Click any of the corresponding filter buttons and enter your criteria The matching rec
55. on the Vitalograph In2itive Alpha device 4 The Vitalograph In2itive Alpha device is now ready for use The In2itive Alpha driver must be installed on the PC to begin testing Refer to the USB driver instructions for details 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 Medical Devices may be affected by cellular telephones Note This equipment may be affected by electromagnetic interference Also the Pneumotrac In2itive Alpha 2120 may affect other electrical equipment in the close vicinity If such effects are suspected either switch off the offending equipment or increase the distance between the affected equipment and that suspected of causing the interference or shorten connecting leads Connecting the AND Blood Pressure Monitor to your PC Consult the user manual accompanying the blood pressure monitor for information about connecting the device to the PC Copyright Vitalograph 2011 21 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Starting Spirotrac for the first time On starting Spirotrac for the first time a Logon dialo
56. on will not continue Click the Next button If necessary make changes to the install location by selecting the Browse button Click the Next button when finished 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 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 When the installation has completed a message is displayed on the screen informing the user of same Click on the Close button The program name appears in the START menu under Start gt All Programs gt Vitalograph gt Spirotrac along with a Shortcut icon which is placed on the desktop Setup Spirotrac by starting the Spirotrac application A Set up dialog is displayed 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 11 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 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 de
57. ons for use for the device 1 Ensure that the Pulse Oximetry device is connected to a USB port on the machine 2 Select a subject by clicking on the Subject in the subject list on left hand side of main screen 3 Attach the Pulse Oximetry measuring device to the subject as per the manufacturer s guidelines 4 Select the Pulse Oximetry menu item from the Test menu or Select the Pulse Oximetry icon from the toolbar 5 A Pulse Oximetry screen is displayed This screen displays the following a SpO2 measurement SpO2 Copyright Vitalograph 2011 42 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 b Heart Rate in Beats Per Minute BPM c Plethysmograph X Axis showing up to 5 seconds of data 6 The measurements shall be displayed on the screen immediately but shall not be recorded until the user requests that test recording commence 7 Monitor the subject s readings and if necessary wait until they are stable before commencing the test recordings Select Start Recording to begin the test Select Stop Recording to end the test 0 A session can contain multiple Pulse Oximetry tests up to a maximum of 20 11 Select Exit and Close Session to end the session and return to the main screen 12 The user can recall a Pulse Oximetry session by selecting the session from the test session list view on the left hand side of the application main screen OO Note Pulse Oximetry opt
58. or FVC for blows less than 6 seconds long the following is true Either the measured value is greater than 0 15L and the extrapolated volume is greater than 5 of the measured value Or the measured value is less than or equal 0 15L and the extrapolated volume is greater than 0 15L Min exhalation timelA longer test manoeuvre was expected Either the subject is greater than 10 years of age and the test manoeuvre was less than 6 seconds long Or the subject is less than or equal to 10 years of age and that test manoeuvre was less than 3 seconds long No expiratory flow The cumulative change in volume over any 1 plateau second of the test manoeuvre was not less than 0 025L Me RS PEF was reached a drop in the flow value of at least 50 and a recovery of at least 1L s occurred within the first second of exhalation Copyright Vitalograph 2011 34 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 During FVC testing the test quality criteria information can be viewed by selecting the Test QA tab as follows e A marks that the test passed the specific acceptability criteria e An indicates that the acceptability did not pass for this criteria Note User Defined Artefact free will remain blank until the User Acceptability on the Parameters tab is selected it will be populated with a if Accept is selected or a if Reject is selected Session Quality Reproducability Information This section
59. ords will Copyright Vitalograph 2011 56 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 automatically be shown To remove all filters and show all m entries click the Show All entries button 6 The current entries can be printed by clicking the Report button Note Only the entries displayed on screen will be printed i e if data is filtered by a user ID then only the entries belonging to that user id will be printed on the report Printing Printer Setup Spirotrac offers a facility for printing various reports such as audit trail reports accuracy log reports trend reports and test session reports Spirotrac shall save the current selected printer and it shall be possible to change printer setup from within the application 1 Select Printer Setup from the File menu 2 Select the desired printer and click OK Report configuration Spirotrac provides the user with the option to configure reports as follows 1 Select Tools gt Options and then Reports 2 The user can enter change the headings to appear on VC FVC reports Report Header and Post Test Reports Post Report Header 3 The user can select whether the application will print spirometry reports in full Full Report format or limit them to one page One Page Report format 4 When the Full Report is selected the user can configure which tests will be printed on the report The following print options are available a Best T
60. quipment 8 This Guarantee is offered as an additional benefit to the Consumer s statutory rights and does not affect these rights in any way Copyright Vitalograph 2011 67 DT_0006 9
61. ry test on this subject view his her sessions select a session for print and or view his her trend data The corresponding subject demographics appear for that subject with any previously modified data appearing in green and with all his her sessions appearing in the lower left panel Note Click on to expand tree and view sessions A trend of all the best FEV1 values from subject s sessions is displayed on the lower main panel Finding a Subject An automatic search facility is available on the main desktop for finding subjects 1 2 3 Using the radio buttons select to search for a subject by either ID or Last name Begin typing the relevant search information in the space provided The search arrow will automatically move to the Subject beginning with the first character entered in the search field If an exact match is made the Subject will be highlighted in blue Note When searching by ID if subject with matching Subject ID is not found the application will search for a subject with a matching Alternative ID Deleting a Subject 1 Select the Subject to be deleted from subject list 2 Right click this Subject and select Delete Subject 3 Select Yes to delete the subject or No to cancel Copyright Vitalograph 2011 25 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Subject Data Setup 1 Select Tools gt Options from Main Menu and then select Subject Entry 2 The user can configur
62. s at ambient temperature before an accuracy check is performed Once you have pumped air through the flow head click OK Follow the instructions on the screen Make sure the plunger is out fully and inject the syringe when prompted Press in the syringe with a smooth firm stroke not too slowly Follow the instructions on the screen and repeat step 5 and 6 Three repeatable syringe strokes are required If the accuracy is outside the limits it is suggested that you perform another check before updating the device If three consecutive strokes are not reproducible within 3 an error message is displayed It is possible for the user to enter comments for an accuracy check on the results pop up dialog Copyright Vitalograph 2011 50 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 11 It is possible to view and print the Accuracy Check results at the end of the procedure To re check the accuracy select the Re Check button Calibration update Follow these steps to perform a Calibration Update 1 2 3 4 Attach the flowhead to the precision syringe Select the Calibration Adjustment from the Tools menu Perform steps 3 9 as per Checking Accuracy If the accuracy is outside the limits the user is presented with the option to Adjust the calibration or not Select Yes to adjust the calibration Select No to go back to result screen where a re check can be performed if desired If user selects to p
63. struct the user to step on the weighing scales 4 A Weight screen is displayed This screen displays the following a The measured weight b The date and time of the test c The measured weight at last weigh in d The last weigh in date and time The calculated BMI Note BMI will only be calculated where a subject has height information oO Copyright Vitalograph 2011 48 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Accuracy Checking Accuracy Checking in Spirotrac All spirometry standards e g ATS ERS BTS ANZRS recommend checking the accuracy of lung function measuring devices at least daily with a 3 L syringe to validate that the instrument is measuring accurately The system should never be outside accuracy limits unless the measuring device is damaged or in a fault condition In this event see the corresponding faultfinding guide In normal use calibration traceability certification is recommended as a part of the routine annual service ATS recommendations require that the difference between the volume measured by the spirometer and the volume pumped into the spirometer from a syringe is within 3 Routine user accuracy checking on the measuring equipment should be performed e before the instrument has been dismantled e after the instrument has been dismantled e after cleaning e if damage is suspected e after annual maintenance checks e after adjusting calibration e if the flow head has
64. t the power supply is connected to it unless the battery is already charged 3 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 OP 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 OS 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 20 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 touching parts of the system can occur Contact your distributor if you have any queries 3 Take one of the flow head filters from its packaging and place in the flow head holder
65. tart 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 Connect one end of the USB cable into an available USB port on the PC Power Up the Vitalograph In2itive Alpha device Connect to the other end of the USB cable into the Vitalograph In2itive Alpha device 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 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 You may be presented with an information dialog in relation to Windows Logo checks Choose Continue Anyway on this screen 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
66. the options for testing are set up correctly as follows 1 Check that the Vitalograph spirometer device is connected correctly See the appropriate Connecting the Vitalograph device to your PC Copyright Vitalograph 2011 27 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 2 Check that the correct device is selected Select Tools gt Device Select the appropriate device from the list 3 Check that the accuracy of the device was checked recently 4 Check that the parameters to be measured are selected as required Select Tools gt Options and then choose Parameters Select the parameters to be displayed printed and click OK Note All the results of tests are calculated and stored automatically so that the user can later recall a test and display any additional parameters that have been selected from this window Note The user can reset the parameter selection at any time by selecting the Reset Parameter List button 5 Check that the correct subject is selected 6 Check that the correct posture is selected Select Tools gt Options from Main Menu and then select General Select the appropriate Posture from the drop down list and click OK Note When performing Spirometry testing it is recommended by the joint International ATS ERS standard on Spirometry that the subject is in a seated position for the duration of the test s VC Testing 1 Select a subject by clicking on the Subject in
67. the subject list on left hand side of main screen 2 Once the required subject has been selected from the list select VC from the Test menu or click on the VC test button 3 Wait for the BLOW NOW message to appear on screen 4 Read the following instructions to the patient so that testing is performed properly Keep the flow head away from your mouth Inhale as deeply as possible and insert the mouthpiece into your mouth clamping it between your teeth Close your lips round the mouthpiece Copyright Vitalograph 2011 28 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Exhale normally for as long as possible 5 Alternatively select the Volume Time Graph tab where multi breath testing is required 6 Again wait for the BLOW NOW message to appear on screen before performing the next blow 7 When all blows are complete click on the Return button to return to the previous screen Performing FVC Testing Testing may be done either in the sitting or standing position The standing position may not be appropriate in some circumstances such as in hospitals where many subjects may not be able to tolerate the standing position especially when making forced manoeuvres If the standing position is used an appropriately shaped chair should be placed behind the subject so he she can quickly and easily be eased into a sitting position if he she becomes light headed during the maneuvers The posture type must be se
68. tion indirectly calculated from the FEV L min It is the measured FEV1 values 37 5 Forced mid expiratory flow time s Forced expiratory time s Volume Expired between 0 seconds and start time according to the back extrapolated volume L Functional residual capacity L Residual volume L Total lung capacity L Inspiratory reserve volume L Expiratory reserve volume L Tidal Volume L Inspiratory Capacity L Ratio of FEV1 to Height in meters squared Airways Resistance Indirect Time to PEF ms Time from start of test to back extrapolated time zero ms End of test volume L Ratio of FEV1 versus FIVC Ratio of FEV1 versus IVC Ratio of FIV1 versus FIVC Ratio of FIV1 versus FVC Copyright Vitalograph 2011 33 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 Test Quality Information After every test manoeuvre a quality control window is displayed which is intended to increase or maintain maximum performance throughout a session Two types of information will be displayed acceptability information for that test and session reproducibility information for the session to date as follows Test Acceptability This section contains information on the acceptability of this single blow The messages that may appear in this section and what they mean are outlined in the table below displayed Looking at the measured value of either FEV6 for blows at least 6 seconds long
69. tion 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 Network Database Installation e Initially the user will be asked to select either a Local Database or a Multi User Database e Fora Local Installation leave the default values present localhost and click Continue e 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 Copyright Vitalograph 2011 13 DT_0006 9 Note Vitalograph Spirotrac User Manual 07402 Issue 10 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 T
70. tly used in conjunction with the hardware will perform in the manner described in the Company s literature and user manuals The Company undertakes to rectify at no expense to the customer any software failure notified within the period stated above provided that the failure can be recreated and the software has been installed and used in accordance with the user manual Notwithstanding this clause the software is not warranted to be free of errors This Guarantee does not cover any faults caused by accident misuse neglect tampering with the equipment use of consumable items or parts not approved by the Company or any attempt at adjustment or repair other than by personnel accredited by the Company nor does it cover reinstatement of any configuration changes caused by the installation of any software If a defect occurs please contact the supplier from whom it was purchased for advice The Company does not authorize any person to create for it any other obligation or liability in connection with Vitalograph equipment This Guarantee is not transferable and no person firm or company has any authority to vary the terms or conditions of this guarantee Copyright Vitalograph 2011 66 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 7 To the maximum extent permitted by law the Company does not accept liability for any consequential damages arising out of the use of or inability to use any Vitalograph e
71. to the next and subsequence phase s by selecting Next gt then administering the dose for the current phase as per the dose instructions and then selecting the Dose administered Copyright Vitalograph 2011 44 DT_0006 9 Vitalograph Spirotrac User Manual 07402 Issue 10 button They then perform repeatable FEV1 manoeuvres as per the guidelines provided and exit the test screen to move to the next phase Challenge Outcomes When a subject achieves a fall in FEV1 of 10 or greater between dose phases or a15 fall from the baseline FEV1 a positive result is achieved The Challenge test procedure is completed and the user is given the option to perform a recovery phase Recovery Phase A bronchodilator is administered and the subject is monitored for 15 minutes to ensure their FEV1 has returned to within 5 of pre challenge level In the case of a negative result you may or may not wish to give a bronchodilator Six Minute Walk Testing Vitalograph Spirotrac includes a Six Minute Walk test module that measures the distance a patient can walk quickly on a flat hard surface in 6 minutes and reflects an individual s ability to perform daily physical activities To perform a six minute walk test do the following Select a subject by clicking on the Subject in the subject list on left hand side of the main screen or Create a new subject by selecting the New Subject icon on the main screen and entering the relevant subject details Sele
72. vice 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 16 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

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