Vitalograph Spirotrac 7000, Instructions For Use Manual

Page 1: ...ions for Use IFU Part No 07402 Issue 22 _______________________________________________________________________________________________________________ Page 1 of 78 DT_0006 15 Vitalograph Spirotrac MO...

Page 2: ...D 20257 Hamburg Lenexa Kansas 66215 Germany USA Tel 49 40 547391 0 Toll Free 800 255 6626 Fax 49 40 547391 40 Tel 913 730 3200 E mail info vitalograph de Fax 913 730 3232 www vitalograph de E mail con...

Page 3: ...13 User Preferences 28 3 14 Licence Management 29 3 15 Language Variants 29 3 16 Database Management 30 3 17 Vitalograph Spirotrac Fusion 32 3 18 Reference Curve and Data 33 3 19 Health Level 7 Interf...

Page 4: ...3 Install Drivers Vitalograph Pneumotrac Intrac on PC 74 18 4 Install Drivers Vitalograph In2itive Alpha USB on PC 75 18 5 Install Drivers Nonin Pulse Oximeter on a PC 75 18 6 Install Drivers Supplie...

Page 5: ...nnection Tubing 5 Pneumotrac Flowhead 6 Bacterial Viral Filter BVF For other devices see the specific guidance included with the device 1 1 Features of Vitalograph Spirotrac The features are Auto reco...

Page 6: ...device Addition of the Vitalograph Alpha as a device PCF Peak Cough Flow Test Challenge Testing Mannitol ATS 5 breath dosimeter 2 min tidal breathing and Exercise challenge Six Minute Walk Testing In2...

Page 7: ...pirotrac Follow on screen instructions to complete installation This may take some time 5 Close installation and select the Vitalograph Spirotrac icon from the desktop 6 Remove USB drive from USB port...

Page 8: ...s Spirometry Guidelines and Other Manuals 2 2 Network Database Installation Consult with your SQL Server Database Administrator before setup Note A Network Licence must be purchased prior to installat...

Page 9: ...e Appendix 18 1 for setup details on a network database after installation 3 Operating Spirotrac 3 1 Buttons and Icons The following are buttons available on the main toolbar Create a New Subject VC T...

Page 10: ...n with full read write access to the SpirotracV database for upgrades and SpVDefault database If User Logon is enabled a username and password must be entered in order to logon to the application 3 3...

Page 11: ...Subject Data Setup h Date of birth DD MMM YYYY i Height Subject s height in either cm or inches Unit of measurement is configurable see Subject Data Setup j Weight Subject s weight in either kg or lbs...

Page 12: ...the subject list on the main screen 2 The corresponding subject demographics appear for that subject with any previously modified data appearing in green and with all his her sessions appearing in th...

Page 13: ...s 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 h Smoking Information enter smoki...

Page 14: ...chronisation automatically occurs on connecting the Vitalograph In2itive Alpha Touch device Copy Subjects and Tests Both Subject and Test data is copied from the In2itive Alpha Touch device to Spirotr...

Page 15: ...subject s that they wish to send to the Vitalograph device On selecting Upload these subjects are saved to the Vitalograph device Test sessions are not saved If Synchronisation mode is not selected in...

Page 16: ...trac 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 To set 1 Select Tools Options General tab Perform Accuracy Check Dai...

Page 17: ...ration Adjustment from the menu 2 Perform steps 2 9 as per Calibration Verification Check 3 If the accuracy is outside the limits the user is presented with an option to adjust the calibration only af...

Page 18: ...tiple Departments which are managed through the Department Management screen 1 Select Tools Department Management 2 Select New to add new department Enter department details Select OK 3 To switch to a...

Page 19: ...Yes AC12 User Delete User ID ID of deleted user Yes AC14 Session Create Subject ID Subject ID Session Type No AC15 Session Edit Subject ID Subject ID Session Session Date Time Field modified From prev...

Page 20: ...l Cal Acc Temperature Update Manually changed temperature from previous value to updated value No AC26 In2itive Upload Subject s uploaded successfully to In2itive No AC27 In2itive Download Subject s d...

Page 21: ...C42 Delete All Diary Data All Data Deleted for Diary DeviceSerialNumber by User UserName No AC43 Pin Code Reveal PIN Code revealed for Subject SubjectNumber Yes AC43 Pin Code Reveal PIN Code revealed...

Page 22: ...e session which was re opened No AC57 Re Opening AUDIOMETRY Session Subject subject ID Session Date Time Date and time of the session which was re opened No AC58 Export Subject PII Subject ID s list o...

Page 23: ...to save report to PDF 3 11 2 Report configuration Reports may be configured as follows 1 Select Tools Options and then Reports 2 Enter change the headings to appear on VC FVC reports using Report Head...

Page 24: ...3 12 2 Logging into Spirotrac 1 On start up the logon screen requests User ID and Password For Network installations the Database field will show allowing the user to select the server database 2 User...

Page 25: ...Spirotrac prior to continuing 4 To reset a user s password a Select the reset password option b Enter the user s name this must match an existing user c Enter and confirm the new password these must m...

Page 26: ...V YES NO YES Challenge YES NO YES Inhaler YES NO YES ECG YES NO YES ECG View YES NO YES Audiometry YES NO YES Audiometry View YES NO YES SpO2 YES NO YES 6MWT YES NO YES 6MWT Post YES NO YES BP YES NO...

Page 27: ...password YES NO NO Display Print Audit Trail YES YES YES Licence Management YES YES YES Database Management YES YES YES Select YES YES YES Create YES NO NO Backup YES YES YES Restore YES YES YES Conf...

Page 28: ...evice only NO NO Export Email Export data YES YES YES Send Email YES YES YES Setup Email YES YES NO 3 13User Preferences The following preferences may be configured by selecting Tools Options 1 Subjec...

Page 29: ...the Six Minute Walk Test assessment 3 14Licence Management 3 14 1 Manage Licence Keys and Features within Spirotrac Spirotrac can have multiple features enabled via licence keys that are managed thro...

Page 30: ...rotrac will prompt for setup details for the database See Spirotrac Database Setup for more information To create a new database 1 Select Tools Database Management 2 Select Create tab 3 Select Enter t...

Page 31: ...rrently logged on to Spirotrac accessing both the source and destination databases Review the Subject numbers to avoid duplicating subjects Note When duplicate subjects are created during the merge th...

Page 32: ...atabase merge Spirotrac restarted in safe mode Possible Cause This can happen due to timing constraints when larger databases are merged If this happens restart Spirotrac 3 16 4 Automated Database Bac...

Page 33: ...Mail Address The email address of the over reader to which any session data is to be sent 3 The connections button will take the user to the System Dial up connection manager 4 A test button is provid...

Page 34: ...before EMR Requested Testing Subject demographics can be updated before performing EMR requested testing 1 Select the subject from within the Subject List 2 Click Edit button in Subject Demographics w...

Page 35: ...m the menu 4 To close click X in the top right corner of the window 3 20Interpretation Display Spirotrac provides algorithm based interpretations of test results The interpretations are provided for c...

Page 36: ...l 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 5 Check that the...

Page 37: ...rmed on the device by selecting the Bar Chart tab 7 After each blow a quality summary window displays This displays the test acceptability and session quality for the test performed 8 The user may Acc...

Page 38: ...nformation about the overall session such as Session Grade information Repeatability information Session Comments and Interpretations 9 The next test can be performed once the BLOW NOW message re appe...

Page 39: ...r tongue down d Breathe normally e Inhale completely and rapidly with a brief pause when your lungs are completely full f Subjects are instructed to perform a maximal cough after complete inhalation g...

Page 40: ...l between 75 and 85 of the FVC 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 i...

Page 41: ...F50 MVV Maximum Voluntary Ventilation L min VT Average tidal volume L MVV Time The duration of the MVV test MVV Rate The number of full breaths in the MVV test expressed as breaths min MIFR Mean Inhal...

Page 42: ...euvre was less than 3 seconds long No expiratory flow plateau The cumulative change in volume over any 1 second of the test manoeuvre was not less than 0 025L Avoid coughing After PEF was reached a dr...

Page 43: ...Note If the user rejects a curve then that curve is no longer considered as a usable curve 4 1 10 Best Test Criteria All tests in a test session will be saved including unacceptable tests The best te...

Page 44: ...arget 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...

Page 45: ...y selecting the session from the test session list view on the left hand side Note Pulse Oximetry options are configurable on the Options screen 4 3 Challenge Testing Spirotrac includes a Challenge Te...

Page 46: ...determine the baseline FEV1 In the first step the user is instructed to administer a dose to the subject as per the instructions provided in the challenge test wizard When the instructions have been...

Page 47: ...phase is optional and a maximum of three reversibility sessions are possible The user may exit out of the challenge series without performing a reversibility test session A message box displays after...

Page 48: ...otrac includes a Six Minute Walk Test module that measures the distance a subject can walk quickly on a flat hard surface in 6 minutes and reflects an individual s ability to perform daily physical ac...

Page 49: ...nd SpO2 details for the subject by performing a SpO2 test or by entering the SpO2 values manually To perform a SpO2 test select the SpO2 icon The SpO2 testing screen opens and the user can perform a t...

Page 50: ...Mode on the Vitalograph COMPACT Device Prior to obtaining an ECG recording the PC COMPACT running the ECG software and the BT12 device must be paired using a Bluetooth connection 1 Plug Bluetooth don...

Page 51: ...g the electrodes can be found in the user instructions for the BT12 ECG device After switching on the ECG device there should be two short signal beeps which indicate that the device has completed a s...

Page 52: ...roll through different time periods of the recording using the scroll bar with the mouse Alternatively scroll to the left with the Page Up key and to the right with Page Down Select which lead is disp...

Page 53: ...rds for Quantitative Electrocardiography Database 4 6 7 ECG Fault Finding Guide Malfunction Cause of error Rectification The Bluetooth driver requests the entry of a PIN The device was decoupled and i...

Page 54: ...s already paired In this state the device is not visible Reset the device by pressing the button for 20 seconds During recording black bars are displayed in the ECG signal once in a while There are tr...

Page 55: ...relax Place BVF in mouth and close lips around the mouthpiece Seal your lips around the mouthpiece and keep your tongue down Breathe normally When at least 3 resting breaths have been obtained 5 6 Pr...

Page 56: ...ndow and select Tools Advanced from the Main Menu In the Inhaler section click Manage 3 To setup a configuration click New Configuration and enter a name for the configuration in the label field Compl...

Page 57: ...Click OK to exit the Inhaler Options screen On subsequent uses of the Inhaler Test 1 Select a subject by clicking on the subject in the subject list on the main screen 2 Select Test Inhaler Test or c...

Page 58: ...ject list on the main screen 3 Select Test Audiometry or Select the Audiometry icon on the toolbar 4 Select the required audiometry test report template from the list 5 The Audiometry screen opens Ref...

Page 59: ...Present tone to subject 5 Frequency down 6 Hearing level up 7 Frequency up 8 Switch between left and right ear 9 Start automatic test 10 SISI test Only available with Diagnostic device 11 Setup Refer...

Page 60: ...tested on both ears 20 dB random test Only available with Advanced and Diagnostic device A randomised version of the 20 dB test automatic screening test The test starts at default hearing level of 20...

Page 61: ...Present a tone to the subject 3 Afterwards select the direction where the subject perceived the tone most clearly You can carry out this test for the full range of frequencies 4 9 3 5 Ear Protection...

Page 62: ...and volume level Only available with Diagnostic device Fixed tone length Click the check box to set a fixed tone length of 0 3 2 5 seconds Masking assistant Enable or disable the masking assistant Ba...

Page 63: ...69 colour graph Show or hide the ANSI 69 colour graph Klockhoff overlay Show or hide an overlay based on the audiogram classification by Klockhoff Dretner Svedberg Speech banana Show or hide the speec...

Page 64: ...For Weber tests use 08_Weber f For Ear Protection tests use 19_EarProtection_Report_AIR 4 Exit the audiometry screen The selected report is saved with the session 4 9 7 Shadow measurements To compare...

Page 65: ...ectors 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 orde...

Page 66: ...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 inser...

Page 67: ...Spirotrac on the COMPACT device the user will only be allowed to save the log files on a removable storage device 7 Customer Service Service and repairs should be carried out only by the manufacturer...

Page 68: ...20303 2030 Noseclips 200 28554 2820 Eco BVF with Bite Lip 75 28553 2820 Eco BVF with Bite Lip and Disposable Noseclip 75 Accessories 36020 2040 Precision Syringe 3 L 77934 Flow Conditioning Meshes 10...

Page 69: ...t cannot make one Spirometers are also used in non clinical settings such as occupational health screening where no clinical judgment is made suspect findings leading to a referral to a clinician The...

Page 70: ...aph device may compromise product safety and or data and as such Vitalograph cannot be held responsible and the device will no longer be supported 2 For the device to be used as intended there is no r...

Page 71: ...mended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard High levels of electromagnetic disturbances could result in the interruption...

Page 72: ...f 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 i...

Page 73: ...The Company warrants that the software when correctly used in conjunction with the hardware will perform in the manner described in the Company s literature and user manuals The Company undertakes to...

Page 74: ...device The Vitalograph COMPACT is supplied with a full installation of Spirotrac including all device drivers and a test station licence A network licence key is required see 2 2 To gain access to a...

Page 75: ...creen 10 Follow on screen instructions to complete driver installation 18 5Install Drivers Nonin Pulse Oximeter on a PC Note These drivers are installed automatically as part of Spirotrac Installation...

Page 76: ...to the ribbed half of the connector Note If flowhead connection tubing is connected the wrong way around flows will display as inverted on Spirotrac 5 The Pneumotrac device is ready for use 6 USB driv...

Page 77: ...ting Refer to USB driver instructions for details 18 11Connect Device Nonin Pulse Oximeter to PC Vitalograph COMPACT To connect the Nonin Pulse Oximeter 1 Plug one end of USB cable into USB port on PC...

Page 78: ...re Setup to setup automatically b Advanced Setup for manual selection 5 Select the connection method a Connect manually to see a list of available wireless access points b Connect with WPS PIN to conf...