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Medikro Spiro 2000 Help
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1. Figure 6 7 Show Curves and Show Results button groups For more detailed information see the chapter 8 Analyzing Results The Final Report of each session can also be investigated file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 38 of 81 7 Measurement 7 1 DANnhRWNrE 7 2 Measurement Steps Select patient data or enter new patient data Select measurement view Select measurement type TV VC FEVC FIVC FVC MVV Perform manoeuvres View the results and interpretation Print out the report Getting prepared for the Measurements Please note the following Before starting the actual measurements or calibration it is recommended to allow the spirometer device to have a brief warm up period of 5 10 minutes to reach a thermal equilibrium A spirometer connected to a PC will start to warm up immediately after Windows is started This is a normal and general procedure for most of the high precision measurement devices When the personal information window is open Meas button will open the measurement view Figure 7 1 Title Bar Menu Bar Tool Bar E spiroz000 John FK Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm W 68 kg 20 1 2000 12 00 Bee Session Measure Device Show Help Show Results aa Ea hs Z Maza fest Best Ler me x ete 4 e Flow Lis oo ee foret FV Graph _ _ 107 4 99 95 8 4 79 108
2. 20 Additional Information 21 Disclaimer 22 Trademarks 23 References 24 APPENDIX Variables 25 APPENDIX Reproducibility Indicators 25 1 Introduction 25 2 VC FVC and FEV1 25 3 FEF 5 FEF50 and FEF25 ERS 1993 only 25 4 FEF25 75 ERS 1993 only 25 5 PEF ATS ERS 2005 only 25 6 MVV ATS ERS 2005 only Figure 1 1 Spiro2000 Startup Screen Figure 3 1 Starting of the Spiro2000 program Figure 3 2 Spirometer not found message Figure 3 3 User Identification screen after starting the Spiro2000 program Figure 3 4 The Opening View file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Figure 3 5 Exit Button Figure 4 1 Device Settings Database Figure 4 2 Device Setting General Ambient factors Figure 4 3 Device Settings General Save options Figure 4 4 Device Setting General Units Figure 4 5 Device Settings Spirometry Calibration syringe volume ml Figure 4 6 Device Settings Spirometry Standard recommendations Figure 4 7 Device Settings HIS Figure 4 8 Device Settings Variables Figure 4 9 Device Settings Incentive Figure 4 10 Java not found dialog Figure 4 11 Incentive applet Figure 5 1 Disposable Flow Transducer Figure 5 2 Label for M9228 100 Disposable Flow Transducer Figure 5 3 M9424 Calibration Syringe 3000 m
3. 6 4 99 95 Result Table 11 41 114 47 2 13 27 0 11 0 3 92 2 3 92 9 75 Aa ANN N el oe p 104 12 i MENMEN vit Flow and Duration lee nb ey es ac Ce Ora Indicator 2 vol volume change in last 0 5 s ae dv L 0 00 z VT Graph 24 l Tine 5 Expiration time 4 1 0 1 0 5 10 15 2 2 3 35 40 45 50 55 60 35 0 C Timer Pre None 0 10 le elie E Measurement Manoeuvre Buttons 1013 mbar Time 50 Date 13 06 41 26 1 2004 Post None mo Session Status Summary Timer Time of Day Date Environmental Conditions Figure 7 1 The Measurement View The patient data is now displayed on the top of the screen in the Title Bar All functional buttons are in active state The key features of the Measurement Window are CRPANAMPWNE file C Medikro Spiro2000 Language English Help S piro2000Help htm Title Bar with Patient Information Tool Bar with Functional Buttons Menu Bar with Drop Down Menus Session Status Summary Measurement Manoeuvre Buttons Environmental Conditions Timer Time of Day Date FV Graph VT Graph Result Table Flow and Duration Indicator Reproducibility Indicator appears on display after the measurement has been stopped see Figure 7 8 Figure 8 2 Figure 8 4 and Figure 8 5 11 17 2009 Medikro Windows Spirometer Page 39 of 81 Explain the measurement and prepare the patient for the manoeuvre before the actual measurement T
4. E Settings Database General Spirometry HIS Variables Incentive Result DB DSN MEDIKRO_SPIROMETRY_RESULT z Browse Reference DB DSN Medikro_Spirometry_Reference Default data transfer Folder C Medikro DataTransfer Browse Calibration log file C Medikro Calibration Log SpirometryCalibration xml Browse Final report template Basic Report 1 3 z Ce d e Figure 4 1 Device Settings Database The program allows the operator to define databases also in the LAN environment 4 1 2 The Final Report Template You may choose the default page of the Final Report This page opens first when the final report is selected see the chapter 10 1 Viewing the Final Report To change the default page Figure 4 1 select Device Settings Database Final Report Template file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 13 of 81 4 2 General 4 2 1 Ambient factors The ambient conditions of the operating environment affect the results measured and calculated by the spirometer Due to this fact e room temperature e atmospheric pressure and e relative humidity should be recorded and entered into the program daily and also if they change notably during the day To enter these values Figure 4 2 use the following command path Device Settings General Ambient factors H Settings Database General Spirometry HIS variables Incentive Ambient f
5. Show Curves in flow volume envelope curve format Figure 8 6 Draw a marquee around the interesting view area Applies also to VT6 window Figure 8 7 After drawing a marquee the curve is magnified for more detailed viewing Figure 8 8 Numeric results in tabular format Figure 8 9 Show Best Results Figure 8 10 Trending in a graphical presentation form Figure 8 11 Trending interactive elements Figure 8 12 Trending in relation to reference values Figure 8 13 A separate floating window shows trending in a numeric table presentation Figure 9 1 Ventilation Function Bronchodilatation Test Result and Manual Interpretation Text Figure 10 1 Report Button Figure 10 2 Show the Final Report Figure 10 3 Print Button Figure 10 4 Standard final report Figure 12 1 Log On Screen Figure 12 2 Check Import Person s Identity Window Figure 12 3 Choose a Session Window Figure 14 1 Database Delete Person s or Session s Figure 14 2 Help About Figure 16 1 Calibration Not Accepted message Figure 17 1 EC Declaration of Conformity Figure 17 2 Certificate of Conformity file C Medikro Spiro2000 Language English Help S piro2000Help htm Page 6 of 81 11 17 2009 Medikro Windows Spirometer Page 7 of 81 1 Introductio
6. a Final Report is generated into the folder file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 57 of 81 C Program Files Medikro Temp Report The Final Report contains a minimum of four pages and consists of the following files M8124 3 multi htm page 1 Best Curves png page 1 Trend png page 1 VT6 Curves png page 1 M8124 5 multi htm page 2 PreEnvelopeCurves png page 2 PostEnvelopeCurves png page 2 M8124 6 multi htm page 3 PreFlowVolumes png page 3 PostFlow Volumes png page 3 M8124 7_1 multi htm page 4 M8124 7_n multi htm page n TrendTVarl png page 4 TrendTVarn png n refers to page number Report Logo gif all pages All of these files are needed to display the full final report but you can also choose to select files for certain page s of the final report Drag and drop the files to an e mail message as an attachment and you can send the Final Report in an e mail to the recipient 10 3 2 Receiving the Final Report The report is created in HTML format and can be viewed by any browser such as Internet Explorer or Netscape Navigator When you receive a Final Report via e mail or diskette you can simply double click the file M8124 3 multi htm and the first page of the Final Report will be opened in the browser screen You can also print the file with the browser if you want file C Medikro S piro2000 Language English Help S
7. 00 10 0 11 0 12 0 13 0 14 0 15 1 16 1 17 1 18 1 19 1 20 1 21 1 22 1 23 2 24 2 25 2 15 20 et Pre Nous i g t 9 Sop Post Nove fy 2 02 2 24 2 49 2 75 3 03 3 42 3 83 3 99 4 40 4 42 4 44 4 44 4 44 4 44 4 44 4 43 Figure 8 12 Trending in relation to reference values 30 lumidity 50 Reference models Polg_Z_m Ecs_18_m Ecsc_m Ref Pre 2 19 108 2 39 106 2 62 105 2 93 107 3 24 107 3 69 108 4 04 106 4 30 108 4 69 107 4 74 107 4 73 107 4 72 106 4 80 108 4 81 108 4 80 108 4 73 107 Post 2 22 2 43 2 66 2 97 3 34 3 73 4 22 4 38 4 77 4 79 4 90 4 88 4 79 4 90 4 87 4 84 Post Pre 110 0 03 108 107 108 110 109 110 110 109 108 110 110 0 16 108 0 01 110 0 09 110 0 07 109 0 11 1 2 2 Exclude Sessions 1984 11 14 12 00 1985 11 14 12 00 1986 11 19 12 00 1987 11 24 12 00 1988 11 28 12 00 1989 12 03 12 00 x Axis Variable Age YoreF Table 35 0 C Timer 1013 mbar Time Date 26 1 2004 MEE 95 range Date Age abs abs ref abs ref abs ref min 81 81 81 81 81 81 81 81 81 81 81 81 81 81 81 81 max 124 124 124 124 124 124 124 124 124 124 124 124 124 124 124 124 Printing a Current Window file C Medikro Spiro2000 Lang
8. 141 AEFY L L s FET VEXT Diff of 2 best YC FYC FeE 1 Max diff of all PEF tee ees Ee in 5 20 O gt AW G Pre none MMIII TT lives oise me aes Myv cs Post None MAM O C Humidity f 50 Date 26 1 2004 Figure 8 5 Show Curves in flow volume envelope curve format 8 1 5 Magnification of the Curves The V T VT6 F V and Envel curves can be magnified for more detailed inspection Draw a marquee around the interesting view area of the curve by clicking and dragging from one corner of the area to the opposite corner Figure 8 6 The selected part of the curve will be magnified Note the aspect ratio may not remain the same Figure 8 7 Session Measure Device Show Help Show Curves Post Pre Soref abs ref abs ref 5 50 i 5 20 95 FVC L 5 26 5 41 103 5 57 106 0 15 FEV1 L 4 43 4 73 107 484 109 0 11 FEV6 L 5 26 5 41 103 5 57 106 0 15 FEVI VCFVC 82 68 87 40 106 86 95 105 0 45 PEF Lis 10 00 11 75 118 12 15 122 0 40 MEFSO Lis 5 62 7 76 138 9 32 166 1 55 MEF25 Lis 265 2 59 98 2 98 112 0 38 MMEF Lis 5 07 655 129 7 14 141 0 59 AEFV L L s 35 53 37 52 1 99 FET s 3 98 4 87 0 89 VEXT L 0 13 0 14 0 01 Reproducibility Pre Post abs best abs best Diff of 2 best C FYC L 0 04 1 FEVI L 0 04 1 Max diff of all PEF L s E 0 20 2 35 0 C Timer 1 43 19 Press 1013 mbar Time 14 24 32 os Post None MA C C Humi
9. 17 2 Certificate of Conformity file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 71 of 81 RL e Ayr QUALITY SYSTEM CERTIFICATE Directive 93 42 EEC Manufacturer Medikro Oy Kellolahdentie 27 FI 70460 Kuopio Finland Coverage of Certificate Design manufacture and final inspection Product category Spirometers and their accessories Valid until 22 December 2007 The manufacturer s quality system for the design manufacture and final inspection of the aforesaid product category has been evaluated and mects the provisions of Council Directive 93 42 EEC as set out in Annex II Section 3 This approval is valid until the expiry date provided that the manufacturer fulfils the obligations imposed by Annex II in Directive 93 42 EEC This Certificate is based on decision no TUO 1056 208 P0 Certificate no Notified Body no 0537 VTT Industrial Systems TUO 1056 208 P O Box 1306 Tekniikankatu 1 x a FI 33101 TAMPERE Translated from Finnish original Tel 4358 3 316 3111 Figure 17 2 Certificate of Conformity file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 72 of 81 18 Accessories Product Name Product Code Description Software Upgrade M9832 Use this product code to order an upgrade from your current Spiro2000 software version to the latest version Flow Transducer 100 pcs package
10. 2 4 In the Measurement View The following drop down menus will appear in the Measurement View Figure 7 1 e Session e Measure e Device e Show e Help Session Personal Information Opens the Personal Information window Delete Signal Allows you to delete individual measurements as described earlier in the chapter 7 9 Deleting an Individual Measurement Page Setup Opens the Page Setup window and gives the opportunity to adjust paper settings for printing Print Current Window Prints the current window see the chapter 8 4 Printing a Current Window Exit Opens the Log On window which gives the choice to exit the program or to log on Measure Start Starts the spirometric measurement Note With this selection the measurement begins and curves are drawn on the screen but no results are calculated until you press some of the manoeuvre buttons This is intended mainly for the MVV manoeuvre to monitor the signal before the start of the manoeuvre Stop Stops any spirometry measurement manoeuvre earlier than the maximum time of 60 seconds Device Calibrate Allows you to calibrate the spirometer as described in the chapter 5 Calibration Settings Allows you to define all Spiro2000 settings as described in the chapter 4 Setup Normalize Graph Returns the magnified graph to its original size Show In this menu you will have the following choices e Volume time Curve s file C Medikro S piro2000 Language English Help S piro2000H
11. 2 Bronchodilatation Test Result 9 3 Manual Interpretation Text 10 The Final Report 10 1 Viewing the Final Report 10 2 Printing the Final Report 10 3 Sending and Receiving the Final Report 10 3 1 Sending the Final Report 10 3 2 Receiving the Final Report 11 Sending and Receiving the Session Data 11 1 Sending the Session Data 11 2 Receiving the Session Data 12 The Hospital Information Systems Data Interchange 12 1 Import 12 1 1 Receiving an input file 121 2 Checking Import Person s Identity 12 1 3 Selecting a session for the person imported to the system 12 1 4 Handling errors 121 5 Special Features of GDT Import file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 5 of 81 Figures 13 12 2 Export 12 2 1 XML Export 1222 GDT Export 12 3 Logging Keyboard Shortcuts 14 Drop Down Menus 15 14 1 Inthe Opening View 14 1 1 Database 14 1 2 Device 14 1 3 Help 14 2 Inthe Measurement View 14 2 1 Session 14 2 2 Measure 14 2 3 Device 14 2 4 Show 14 2 5 Help Maintenance 16 17 Trouble Shooting 16 1 Leaks 16 2 Spirometer and Computer Connection 16 3 Operating Environment 16 4 Software Certification 18 17 1 EC Declaration of Conformity 17 2 Certificate of Conformity Accessories 19 Release Information
12. 33 23 1 2004 Zata Temp 350 C Timer E Press 1013 mbar Time Humidity 50 Date The operation of Spiro2000 is easy and fast All the key commands are push buttons that can be selected by a mouse click Alternatively drop down menus are offered At the opening view you can continue with buttons which appear active highlighted 3 2 Exiting the Spiro2000 Software file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 11 of 81 When you want to stop using the Spiro2000 software select the Exit Button Figure 3 5 Figure 3 5 Exit Button The User Identification screen Figure 3 3 appears Now select the Exit button and the program exits to Windows file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer 4 Setup 4 1 Database 4 1 1 Location of Data Page 12 of 81 The operator can define the location of the data generated within a spirometry session The location of following data can be established Description of data Default value Result Database DSN Medikro_Spirometry_Result Reference Database DSN Medikro_Spirometry_Reference only for information the location can t be changed Default data transfer folder C Medikro DataTransfer Calibration log file C Medikro Calibration Log SpirometryCalibration xml To change the setting Figure 4 1 select Device Settings Database
13. 81 16 Trouble Shooting Problems with spirometry measurements are related to instrument failures and erroneous manoeuvres Instrument failures are typically either mechanical or software related 16 1 Leaks The Spirometer can sometimes experience air leakage Leaks may occur if pressure tubing is damaged or if any connection between the flow transducer pressure tube and spirometer is not properly fastened Leaks can be detected by daily calibration of the spirometer If the gain value after calibration is not in the acceptable gain range the software will inform the user with the following message Fig 16 1 EB Information Insp Exp Gain before calibration 1 01 1 04 Gain after calibration 0 75 0 65 Change 26 13 37 74 Acceptable gain range 0 80 1 20 0 80 1 20 Gain after calibration is not in 20 range Calibration not accepted Figure 16 1 Calibration Not Accepted message Make sure that the pressure tube is properly fastened into the transducer and into the spirometer unit 16 2 Spirometer and Computer Connection The Spirometer connection to the computer may be loose Make sure the connector is in place 16 3 Operating Environment The minimum system requirements should be fulfilled to guarantee that the software functions properly The minimum requirements can be found in the Installation Guide 16 4 Software Software related problems are system dependent Memory allocation processor speed operating sys
14. How and What to Export The operator can choose how an output file is created when a session is being closed The choices are Autoexport No Autoexport and No Export Autoexport Will export the output file without reminding you at the end of the session No Autoexport Will remind you to export at the end of the session No Export Export will not happen at the end of the session No reminder will be given For XML HIS and manual XML export see the chapter 11 1 Sending the Session Data the operator can choose also whether the output file has the data of the current session only or all sessions of the current person The latter option is intended especially for sending data for trending You can select how and what to export via menus Figure 4 7 Device Settings HIS Export options Device Settings file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 25 of 81 HIS Export Session Data 4 5 Variables 4 5 1 Variables for display and print Variables can be individually selected for display or print there are altogether 55 variables see APPENDIX Variables To change the setting Figure 4 8 use the following command path Device Settings Variables HE settings Database General Spirometry HIS Variables Incentive Prev Choose variables to be displayed in the program or printed in final report Next as ag as TIME hhimm M V FEV0O 5S FEV6 OO MMEF Lis VV TY 5
15. Session Data from the Database If the automatic proceed into measurement has not been chosen the software leaves the Choose a Session window Figure 12 3 open and waits for the user response file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 61 of 81 E Choose a Session Person Smith demo John F Session Date and Time New Session 20 1 2000 12 00 15 1 1999 12 00 10 1 1998 12 00 5 1 1997 12 00 1 1 1996 12 00 27 12 1994 12 00 22 12 1993 12 00 17 12 1992 12 00 13 12 1991 12 00 Figure 12 3 Choose a Session Window 12 1 4 Handling errors For a successful import the input file must be formally correct the XML file is a valid XML document the GDT file has right check sums Additionally XML input file must have proper values for the variables which determine the predicted values The variables are shown below Height Weight Gender Date of Birth If errors are found in a XML input file they are reported and the file is moved to the Medikro HIS Log Incorrect inputs folder Note if there is a previous input file with the same name it is overwritten without a warning 12 1 5 Special Features of GDT Import The import person s identity is not checked Only personal data is imported directly to the database and the Import mode is always Insert see the chapter 4 4 3 HIS manual Import Mode Incoming session data will be imported only if New session
16. What to Export 4 5 Variables 4 5 1 Variables for display and print 4 6 Incentive 4 6 1 Current Incentive 4 6 2 Show incentive at this PC 4 6 3 Java missing warning 4 6 4 Targeted FET 4 6 5 Incentive size 4 6 6 Data Communication 4 6 7 Success Criteria 5 Calibration 5 1 Flow Transducer and Calibration 5 2 Calibration Procedure and Acceptance file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 4 of 81 6 Personal Information and Session Database 6 1 Personal Information 6 2 Patient Data Entry 6 3 Retrieving Personal Information and Session Data from the Database 7 Measurement 7 1 Measurement Steps ia Getting prepared for the Measurements 7 3 Starting the Measurement 7 4 Stopping the Measurement is Acceptance of the Measurement 7 6 The Flow and Duration Indicator Tel The Reproducibility Indicator 7 8 Session Status Summary 7 9 Deleting an Individual Measurement 7 10 Measurements with the Incentive 8 Analyzing Results 8 1 Curves 8 1 1 VT Volume Time Curves 8 1 2 VT6 6 s Volume Time Curves 81 3 FV Flow Volume Curves 8 1 4 Envel Envelope Curves 8 1 5 Magnification of the Curves 8 2 Numerical Results 8 2 1 Meas Results of all Measurements 8 2 2 Best the Best Results as a Histogram 8 3 Trend 8 4 Printing a Current Window 9 interpretation 9 1 Ventilation Function 9
17. at its favorite pond and waits for strong exhalations that will make it leap to a lily pad on the opposite side of the pond If the exhalation is not effective enough Freddie splashes into the water instead 4 6 2 Show incentive at this PC There are two ways the incentive can be viewed in a local measurement workstation or in external computers that are connected to the network If this check box is selected a web browser of the measurement PC will be automatically opened and the incentive applet will be displayed 4 6 3 Java missing warning Enables a warning dialog if a Java virtual machine is not installed on the system To run the incentive applet a Java virtual machine must be installed and enabled from the browser settings The spirometer software will search for Microsoft Java Virtual Machine and Sun Java Runtime Environment and displays the following warning Figure 4 10 if neither of them is found This dialog can be disabled either by unchecking Warn if Java missing in the dialogue sheet or by selecting the check box Do not show this dialog again in the warning window E Information Microsoft Java irtual Machine MSJ M or Sun Java Runtime Environment is not installed on the system In order to run incentive Java has to be installed and enabled from the browser settings T Do not show this dialog again Figure 4 10 Java not found dialog 4 6 4 Targeted FET A target time of the exhalation Forced Expiratory Time
18. chapter 4 5 1 Variables for display and print you can also affect which manoeuvre buttons are active E g if none of TV manoeuvre variables TV FR or MV is chosen the TV manoeuvre button is deactivated grayed The same principle is applied also to VC FEVC FIVC FVC and MVV manoeuvres The pressing of any manoeuvre buttons starts the measurement Click the appropriate manoeuvre button when the patient is ready The program allows the patient to complete the measurement in 60 seconds Well trained patients can complete several manoeuvre types during the 60 second measurement time You can start a new manoeuvre immediately after another without stopping the measurement by clicking the respective button 7 4 Stopping the Measurement When you start the measurement the Stop button Figure 7 3 will change from a deactivated grayed state into an active state Figure 7 4 Figure 7 4 Choices of Manoeuvres Button Group After Start of Measurement file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 40 of 81 The measurement can be stopped with the Stop button before the 60 seconds are finished The time of the measurement can be monitored from the volume time graph on the screen Figure 7 5 or from the timer The measurement will be stopped automatically after 60 s if not stopped by the button Vol I 4 1 1 I I 1 1 i I Ale 0 5 10 15 2 2 30 35 40 45 50 55 Time
19. in seconds 4 6 5 Incentive size Size of the incentive screen in pixels A default value of 416 x 320 is suitable for most computers since bigger size requires more performance for the computer file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 27 of 81 4 6 6 4 6 6 1 4 6 6 2 4 6 6 3 4 6 6 4 4 6 6 5 4 6 6 6 4 6 7 4 6 7 1 Data Communication HTTP Server Port Port number of the web server A web server is needed to display and run the incentive at a network If the port number is reserved the number is flagged red and an error message will be displayed when exiting Settings by selecting OK In that case a new free HTTP server port can be found by clicking the Find a free port button It is also possible to edit the port number manually Data Server Port Port number of the data server A data server is needed for sending the data to the Java applet If the port number is reserved the number is flagged red and an error message will be displayed when exiting Settings by selecting OK In that case a new free data server port can be found by clicking the Find a free port button It is also possible to edit the port number manually Automatic Host Name Spiro2000attempts to automatically determine the host name of the measurement workstation and uses it as the incentive page net address Please note that the automatic determination process is NOT absolut
20. in use 4 4 2 HIS Input files The operator can define the location of the input file If the XML interface has been chosen the location of the input batch file can also be established The batch file is a small procedure intended to transform the input file to SpiroXML format if necessary You can define the HIS input files using the following command paths Figure 4 7 Device Settings HIS Input file Device Settings HIS Input batch file 4 4 3 HIS manual Import Mode XML HIS and manual XML import see the chapter 11 2 Receiving the Session Data can have three modes which affect how Spiro2000 handles incoming vs database data for GDT HIS interface the mode is always Insert regardless of this selection Bypass The content of the input is not connected to the database in any way Spiro2000 does not write or read the database Instead incoming information is handled in a temporary local database The change back to the use of the normal database requires a new log on to the Spiro2000 software via User Identification window Figure 12 1 Insert The input is discarded in case of a conflict with the database Incoming person information will be rejected if it conflicts with that which already exists for the person in the database Similarly incoming sessions information will be rejected for those sessions in which conflicting information exists in the database This is the only mode for GDT interface Update The input
21. is chosen for the imported person and the session is saved The GDT input file is deleted only after a successful export see the chapter 12 2 2 GDT Export 12 2 Export 12 2 1 XML Export The HIS export will be accomplished when closing a session or it can also be omitted if the export option is No Export The export settings see the chapters 4 4 7 HIS Output files and 4 4 8 How and What to Export define whether and how the output file is produced 12 2 2 GDT Export GDT export is possible only for a new session of the person last imported and Spiro2000 software has not been closed after that Export is accomplished when displaying a report The GDT input file is deleted after the successful export 12 3 Logging This chapter applies only if the XML interface has been chosen for GDT there is no logging All import and export operations are logged to a file located in Medikro HIS Log folder Information older than one week will not be preserved The log file is named SpiroHISLog xml and it will include following information e Date and time file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 62 of 81 Operator Operation type import or export Input or output file name Success info Reason for error in unsuccessful operations file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 63 of 81 13 Ke
22. male Weight 68 0 kg Personal ID Demo3 BMI 21 5 Patient code Ethnic group Co operation Good Comment Operator NN Ref MEASURED VALUES Normal range 95 value Pretest Posttest Difference Pre 0 amp Post x Results range Unit Ecsc_m abs ref abs ref abs ref20 40 60 80 100 120 140 160 180 ref L 0 76 P P I Amin 11 16 l Limin 8 49 5 z x N z L 5 50 6 20 95 S a SeSOsess5 82 124 L 5 26 541103 557 106 0 15 3 L 4 43 4 73107 484 109 0 11 2 L 26 541103 557 106 0 15 3 S Sers ssas g s 82 123 82 68 87 40106 86 95 105 0 45 1 L s 10 00 11 75118 12 15 122 040 4 s Us 562 7 76138 9 32 166 1 55 28 D SSSSSSaessesa O X 62 163 Us 265 2 59 98 2 98 112 038 14 TStSSesrss OnXEasa Hse rsr ts 2 193 Us 507 655129 7 14 141 0 59 12 l ox L s 35 53 37 52 1 99 l s 3 98 4 87 0 89 l L 0 13 0 14 0 01 s L 38 6 43 0 05 L 5 38 5 43 0 05 99 43 97 56 1 87 l Lis 11 44 12 33 0 90 ULis 50 54 52 98 2 44 Unit abs best abs best L 0 01 0 L 0 01 0 0 04 4 k 0 00 O 0 04 1 Lis 0 25 2 0 20 2 VT6 CURVES bead sk 6 5 4 3 2 1 0 1 it L 2 3 4 Time s 10 3 Sending and Receiving the Final Report 10 3 1 Sending the Final Report Page 56 of 81 The report is created in HTML format and can be viewed by any browser such as Internet Explorer or Netscape Navigator When you click the Report button
23. manoeuvres FEVC FVC EYT Curves L O x Figure 8 3 Floating VT6 window showing 6 s volume time curves 8 1 3 FV Flow Volume Curves EB Spiro2000 John FK Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm 68 kg 20 1 2000 12 00 Session Measure Device Show Help Show Curves Show Results Flow Lis Post Pre ref abs ref 103 5 57 106 FEV1 73 107 4 84 109 FEV6 i 41 103 5 57 106 FEV1 VCFYC 7 40 106 86 95 105 PEF A 75 118 12 15 122 MEFSO i 76 138 9 32 166 MEF25 i 5 98 2 98 112 MMEF ji 55 129 7 14 141 AEFY FET Diff of 2 best VC FYC FEV1 Max diff of all PEF EEE oa aso ec timer 423 CS WAN sro _Pre None BEREXOL_ LL 1013 mbar Time 13 45 36 MYY Stoo Post None MA I CCO Humidity s0 Date 26 1 2004 Figure 8 4 Show Curves in flow volume curve format 8 1 4 Envel Envelope Curves file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 47 of 81 E Spiro2000 John FK Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm W 68 kg 20 1 2000 12 00 Session Measure Device Show Help Show Results Post Pre Soref abs ref FYC 57 106 FEV1 i 84 109 FEV6 i 57 106 FEW1 CFVC i E 195 105 PEF i 1S 122 MEFSO Lis i 132 166 MEF25 Lis i j 98 112 MMEF Lis i i 14
24. options No Autosave Units kg cm C L z Language English x lead Figure 4 4 Device Setting General Units 4 2 5 Language You have an option to select the language that your software is using The amount of selectable languages depends on how many languages have been installed on the system More languages can be installed via separate language packs see the chapter 2 1 Installing More Languages To select the language Figure 4 4 use the following command path Device Settings General Language and select the desired language from the list 4 2 6 User Identification To identify the user the software displays a user identification screen where user gives his her user name see Figure 3 3 This is a default procedure and recommended for most operating environments Optionally the user identification can be automated disabled by unselecting the check box Use the following command path see Figure 4 4 Device Settings General Check identification at startup If the user identification is unchecked a default user name will be automatically entered to the user identification screen that is displayed for a short time Default user name can be selected from the Default user name drop down list and it has the following choices e Windows user the user name that is used when logged into the operating system e Last user the user name that has been used previously If the user identification is
25. overrides database information Incoming person information will replace personal information for the file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 23 of 81 persons already existing in the database Similarly incoming sessions information will replace the sessions which exist in the database Sessions not found in the input document remain untouched in the database You can select the import mode using the following command path Figure 4 7 Device Settings HIS Import Mode 4 4 4 HIS manual Import Recalculation For XML HIS and manual XML import see the chapter 11 2 Receiving the Session Data the operator can choose which results to transfer into the local result database There are two choices the results found in the input file or the results recalculated based on signals found in the input file The recalculation is recommended However input file results can also be used if e g the input file does not have signals or if you are sure that the input file results have been calculated with the same Spiro2000 version and same calculation options you have used You can choose the recalculation via menu Figure 4 7 Device Settings HIS Calculate results of imported data 4 4 5 Automatic Proceed into Measurement After the input XML GDT file is opened successfully the software selects automatically the first session included in the import file or a new session i
26. piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 21 of 81 4 3 5 4 4 4 4 1 EC Eu Austrian reference values Forche for adults and children Gulsvik_Z Norwegian reference values Gulsvik for adults Zapletal for children wedish reference values Hedenstrom for adults Zapletal for children Japanese reference values Knudson for adults and children NHANES II_W_ NHANES III Hankinson for 8 80 years old Wang for children below 8 years innish reference values Viljanen for adults Koillinen for children SCZ ropean Coal and Steel Community for adults Zapletal for children The only reference set that takes the ethnic group into account The ethnic groups mentioned in the references are related to the ethnic groups used in Spiro2000 in a following way Reference Ethnic group in the reference Ethnic group in Spiro2000 NHANES III African American African American African descent Mexican American Caucasian All others Black African American African descent White All others Heading of the Final Report HIS The header of the report can be modified to include the name of the establishment clinic or institution as well as the necessary contact information Use the following command path Figure 4 5 Device Settings Spirometry Report Heading Enter the necessary information into the free text field where 3 lines are provided Individual report formats can
27. results You can select the location of this file as defined in the chapter 4 1 1 Location of Data Other calibration settings are explained in the chapter 4 3 1 Calibration Volume Max Variation and Logging 5 1 Flow Transducer and Calibration Medikro spirometers use disposable Flow Transducers Figure 5 1 Figure 5 1 Disposable Flow Transducer Flow Transducers are manufactured to high precision and it is not necessary to calibrate the spirometer system with each Flow Transducer separately It is recommended however that you perform a new calibration when starting to use a new lot of Flow Transducers The lot number is identified at the label of the Flow Transducer package Figure 5 2 he bal RS 4 NB oon F 0099 00001 MEDIKRO OY ae an nu P O Box 54 BEB Bee FIN 70101 Kuopio BEE nnn FINLAND an nu Tel 358 17 2833000 Fax 358 17 2833300 E u MEDIKRO E mail medikro medikro com Home page www medikro com M6153 100 03 U StHHH p 2001 10 n H M9228 100 Disposable Flow Transducer Figure 5 2 Label for M9228 100 Disposable Flow Transducer file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 30 of 81 5 2 Calibration Procedure and Acceptance Please note the following Before starting the actual measurements or calibration it is recommended to allow the spirometer device to have a brief warm up period of 5 10 minutes to reach a therma
28. s Figure 7 5 Volume Time Graph After stopping the measurement the program will show instantly the FEVC FIVC or FVC envelope curve slow VC or MVV curves as well as the measurement results in the measurement window This numerical output includes Reference values Ref results of the current measurement Curr best results of the session Best and the difference between the Current and Best result Curr Best 7 5 Acceptance of the Measurement After stopping the measurement the program will request an acceptance of the measurement Figure 7 6 E Confirmation Do You accept this measurement Figure 7 6 Accept Measurement You can accept the measurement or reject it based on the manoeuvre start extrapolated volume duration see Figure 7 7 and possible manoeuvre artefacts submaximal effort cough glottis closure The Reproducibility Indicator see the chapter 7 7 The Reproducibility Indicator may help in evaluating the magnitude of the artefacts For more details of accepting the manoeuvre see 4 You can start a new measurement with the same or a new manoeuvre as soon as the patient is ready 7 6 The Flow and Duration Indicator During measurement the expiratory and the inspiratory manoeuvres can be monitored from the Flow and Duration Indicator Figure 7 7 Flow and Duration Indicator Volume change in last 0 5 s dy L 0 00 6 Time s Expiration time 4 1 0 50 55 60 E A A ct Temp 35 0 C Tim
29. 000 software was first time installed it automatically also created a patient database MS Access based 6 1 Personal Information All spirometry measurements will start with the identification of the patient Personal information of a new patient can be entered into a database via keyboard or previous session information can be retrieved from the database Database contains the following information e personal information entered by the operator e measurement data from the spirometer unit e session results calculated by the software 6 2 Patient Data Entry Enter personal information via preformatted fields Select Per Info button Figure 6 1 to open Personal Information window Figure 6 2 Perinfo Figure 6 1 Per Info button E Medikro Spiro2000 Mi DataBase Device Help aie Last name Given names dd mm Date of birth f s Age year Personal ID Patient code b Gender No information z Riareranica sat Ethnic group z ECSC_Z 7 Height cm BMI unu AS Profession Smoking No information z Illness Medication Problem Comment Co operation No information z Operator User Yentilation Function Result of bronchodilatation test Interpretation text Ls Temp 35 0 C Timer H Pre Noue 1013 mbar Time 9 57 51 Ree Post None f f i R F Humidty 50 Date 26 1 2004 Figure 6 2 Personal Information window before data entry At least the following fields
30. 2009 Medikro Windows Spirometer Page 78 of 81 24 APPENDIX Variables Abbreviation S vc __ Vitaleapacty__ 10 1 12 13 14 5 i Forced expiratory flow 25 VC 18 FEF25 MEF75 a Forced expiratory flow 50 VC 19 FEF50 MEF50 Forced expiratory flow 75 VC 20 FEF75 MEF25 Forced expiratory flow 25 75 MMEF L s Ca ret koeee Ps Extrapolated volume 29 Fivi__ Forced inspratoy volume at 1 08s L 31 FiV0 5 VC FIVO 5 FIV6 36 FIV1 FIV6 Peak inspiratory flow alee O Forced inspiratory flow 25 VC ie 39 FIF25 MIF75 L s ofm e a 40 FIF50 MIF50 Forced inspiratory flow 75 VC 41 FIF75 MIF25 Forced inspiratory flow 25 75 MMIF e 45 FT Forcedinspiratorytime ts 49 myyt MWtime S s Difference to best VC ie Difference to best FVC file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 T E E E wn n n Medikro Windows Spirometer Page 79 of 81 52 FEV1DIFF Difference to best FEV1 PEFDIFF Difference to best PEF PEFDIFF Difference to best PEF MVVDIFF Difference to best MVV file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 80 of 81 25 APPENDIX Reproducibility Indicators 25 1 Introduction The Spiro2000 software highlights a value in red if its reproducibility criteria are not fulfilled Reproducibility is determined for both single measurements and session b
31. EF calculation criterion I max F C of pre phase x Reference set Ecsc_2 x Report Heading ledikro OY O Box 54 IN 70101 Kuopio ee Figure 4 5 Device Settings Spirometry Calibration syringe volume ml 4 3 2 Linearization File of the Flow Transducer You can check the linearization file of the flow transducer and change it when needed by using Figure 4 5 the following command path file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 17 of 81 Device Settings Spirometry Linearization file The file is identified by the product code of the Flow Transducer for example M9228 and the manufacturing lot number for example lot10 cfg Please note that cfg is the file extension file type of the linearization file In case the lot number in the package of the Flow Transducers is not the same as the chosen linearization file select the right linearization file from the list box If the file is not listed please select New file at the top of the list and follow the instructions given by the Spiro2000 software The linearization file and its file name are provided in the Calibration File Diskette within the Flow Transducers Box 4 3 3 The Spirometry Standard Recommendations You may choose which spirometry standard the Spro2000 software is complying The choices are the ATS 1994 ERS 1993 and ATS ERS 2005 recommendations Figure 4 6 For the selection use the followin
32. M9228 100 Nose Clip 10 pcs M9227 10 Pressure Tube for SpiroStar DX M9220 Pressure Tube for SpiroMaster MX M9230 Calibration Syringe 3000 ml M9424 Outlet Port Adapter M91130 file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer 19 Release Information You most likely are interested to know what is new in your Spiro2000 software Click the link below and you will see e new features e enhancements and e bug fixes for not only this version but for all versions released since the first one ReleaseInformation Spiro2000 htm file C Medikro Spiro2000 Language English Help Spiro2000Help htm Page 73 of 81 11 17 2009 Medikro Windows Spirometer Page 74 of 81 20 Additional Information For additional information please contact us via e mail technicalsupport medikro com or visit our Homepage www medikro com file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 75 of 81 21 Disclaimer Our policy of continuous product improvement makes all Medikro instruments accessories brand names specifications product documentation and model availability subject to change without notice file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 76 of 81 22 Trademarks Windows is a trademark of Microsoft Corporation Redmond WA U
33. Medikro Windows Spirometer Page 1 of 81 Medikro Windows Spirometer User s Manual for Spiro2000 software version 1 8 file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 2 of 81 file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 3 of 81 Table of Contents 1 introduction 1 1 Thank You er Getting the Most Out of This Manual 2 Installation 2 1 Installing More Languages 3 Starting and Exiting the Spiro2000 Software 3 1 Starting the Spiro2000 Software 3 2 Exiting the Spiro2000 Software 4 Setup 4 1 Database 4 1 1 Location of Data 4 1 2 The Final Report Template 4 2 General 4 2 1 Ambient factors 4 2 2 Spirometer Detection 4 2 3 Save Options 4 2 4 Units 4 2 5 Language 4 2 6 User Identification 4 3 Spirometry 4 3 1 Calibration Volume Max Variation and Logging 4 3 2 Linearization File of the Flow Transducer 4 3 3 The Spirometry Standard Recommendations 4 3 4 Calculation Exceptions and Choices 4 3 5 Heading of the Final Report 4 4 HIS 4 4 1 Hospital Information System Interface 4 4 2 HIS Input files 4 4 3 HIS manual Import Mode 4 4 4 HIS manual Import Recalculation 4 4 5 Automatic Proceed into Measurement 4 4 6 Identification of the Imported Person 4 4 7 HIS Output files 4 4 8 How and
34. SA Internet Explorer is a trademark of Microsoft Corporation Redmond WA USA Netscape Navigator is a trademark of Netscape Communications Corporation USA file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 77 of 81 23 References 1 2 American Thoracic Society Standardization of Spirometry 1994 Update Am J Respir Crit Care Med 1995 Vol 152 pp 1107 1136 Quanjer PH Tammeling GJ Cotes JE Pedersen OF Peslin R Yernault JC Lung volumes and forced ventilatory flows Official Statement of the European Respiratory Society Eur Respir J 1993 Vol 6 Suppl 16 pp 5 40 Miller MR Crapo R Hankinson J et al General considerations for lung function testing Eur Respir J 2005 Vol 26 pp 153 161 No 1 in SERIES ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Miller MR Hankinson J Brusasco V et al Standardisation of spirometry Eur Respir J 2005 Vol 26 pp 319 338 No 2 in SERIES ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Pellegrino R Viegi G Brusasco V et al Interpretative strategies for lung function tests Eur Respir J 2005 Vol 26 pp 948 968 No 5 in SERIES ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Sovijarvi A Uusitalo A Lansimies E amp Vuori I Kliininen fysiologia Duodecim Helsinki 1994 file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17
35. Time Curves EB spiroz000 John FK Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm 68 kg 20 1 2000 12 00 Session Measure Device Show Help Show Curves Show Results Ref model Post Pre Ecsc_m ref abs ref TY FR My NC FVC i 41 103 5 57 106 FEV1 7 73 107 4 84 109 FEV6 i 41 103 5 57 106 FEV1 VCFYC 7 87 40 106 86 105 0 PEF i 11 75 118 12 15 122 MEFSO i 7 76 138 9 32 166 MEF25 i 2 59 98 2 98 112 MMEF i 6 55 14 141 AEFY 35 53 FET VEXT Diff of 2 best YC FYC Time s FEY1 Max diff of all PEF 1 I j 1 t 1 i 1 i I 1 I 1 O 5 10 15 20 25 30 35 40 45 50 55 60 ee i P23 4 5 6 7 8 temp 35 0 C Timer 2 35 COTA GD ee none MMMM TT press iors te as Vc_ Feve Five FVC myy Stor Post None ML CCC Humidity 50 Date 26 1 2004 Figure 8 2 Show Curves in volume time curve format file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 46 of 81 8 1 2 VT6 6 s Volume Time Curves Pressing the VT6 button opens a floating window Figure 8 3 which shows envelopes of expiratory 6 s volume time curves Clicking the X button at its upper right corner will close the VT6 window The VT6 window can be kept open during the measurements to help monitor duration at least 6 seconds or 3 s for children aged lt 10 yrs recommended and performance of the expiratory
36. Viv FEVO S VCFYC oo METT s oo FR timin VW FEV1 C Yo Ooo AEFY us VMI my Limin WM FEV1 FYC Yo oo FET s Vi VC L viv FEV1 FEV6 Yo Oo VEXT L Vi FYC L Viv FEVI VCFYC Vi LAGE a Vie FEVO S L oOo PEF Lis Vi FIVC t vi FEV1 L Viv PEF Limin O FIVO S L oo FEV6 L Viv MEF75S Lis oo FIV1 L vi FEVO S C Yo oo MEFSO Lis Viv FIV6 L oo FEVO S FYC Cr mer2s Lis VP FoS oo C es Figure 4 8 Device Settings Variables Note By choosing variables for display you can also affect which manoeuvre buttons are active For example if none of TV manoeuvre variables TV FR or MV is chosen TV manoeuvre button is deactivated grayed The same principle is applied also to VC FEVC FIVC FVC and MVV manoeuvres 4 6 Incentive An incentive screen is a motivator for children and if need be for any test subject to exhale with maximal effort for the spirometry examination An interactive 3 dimensional animation is displayed during the test and it operates by responding to the performed exhale The animation is a Java applet which is run within the web browser and uses a TCP IP protocol for communication To work with the incentive there has to be a TCP IP protocol and a Java virtual machine installed and configured for use We recommend that your system administrator install the communication setup Setup of the incentive screen has been made into the dialogue sheet Incentive Figure 4 9 In most cases it is enough to chec
37. actors User Identification F EEE EONS L25 0 Check identification at startup Vv Pressure mbar 1013 3 Derakon Dame Humidity 50 0 No name Spirometer detection Vv COM Port 1 Save options No Autosave x Units kg cm C L z Language English x Figure 4 2 Device Setting General Ambient factors 4 2 2 Spirometer Detection The default setting of the Spiro2000 program includes an automatic serial port scan for spirometer detection If you are using the software only for viewing database results and do not have a spirometer connected to your PC you may wish the program to omit the automatic search To omit the automatic search Figure 4 2 use the following command path Device Settings General Spirometer Detection file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 14 of 81 Inactivate activate the automatic search by clicking the Spirometer Detection check box 4 2 3 Save Options You have three choices to save the session data The selection Figure 4 3 is made using the following command path Device Settings General Save options EB Settings Database General Spirometry HIS Variables Incentive Ambient factors User Identification Ey Teun S 25 0 Check identification at startup Vv Pressure mbar 1013 3 DAFA pea Humidity 50 0 I Ho nese Spirometer detection Vv COM Port Autosave Save options No Save Units kg cm C L Langu
38. age English x a Figure 4 3 Device Settings General Save options Autosave Will save all information of the session personal information measurement signals and results to the database without reminding you at the end of the session No Autosave Will remind you at the end of the session to save all information of the session personal information measurement signals and results to the database No Save No information of the session will be saved to the database No reminder will be given 4 2 4 Units You may select the units you wish to use from the following two alternatives e metric units kg cm C 1 or kg cm C L or e imperial units Lb Ft In F 1 or Lb Ft In F L The software uses selected units for body weight and height and ambient temperature Body height and sometimes also body weight affects reference values Accordingly ambient conditions affect the results measured and calculated by spirometry To select the units Figure 4 4 use the following command path Device Settings General Units file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 15 of 81 E Settings Database General Spirometry HIS Variables Incentive Ambient factors User Identification n pena 25 0 Check identification at startup Vv Pressure mbar 1013 3 Deraulcitcar mare Humidity 50 0 No name E Spirometer detection Vv COM Port 1 Save
39. al Support to solve a problem it is highly recommended that this information be sent to Technical Support The whole content of the About window can be saved to a separate report file by selecting Save to file from the upper right corner of the window This generates an XML formatted file containing the window information and also the INI file content The file produced can be then easily attached to e mail and sent to Medikro Technical Support should assistance be needed EB About Spiro2000 Ez Figure 1 Medikro Spiro2000 Copyright Medikro Oy 1999 2004 All rights reserved Software Medikro Spiro2000 Type SpiroStar DX Model M9453 Firmware Version 1 Hardware Version 1 Production Lot Number 1 Driver Version 1 26 0 0 Spirometry COM Port coMi Spirometer Status Running Search Restart 0 0in1 mins Calibration Yolume 3000 ml Calibration File M9228 lot 39 cfg Zero 9854 69 Auto Calibration Timer 0 STDEY 1 02984 Sample Interval 10 016690 Ebtps 1 Ibtps 1 04308 EGain 1 0296 IGain 1 1019 Temperature 35 0 C Humidity 50 0 Pressure 1013 3 mbar NS Mame 4 2 Help About hindamise 2000 Save to file file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 66 of 81 14 2 14 2 1 14 2 1 1 14 2 1 2 14 2 1 3 14 2 1 4 14 2 1 5 14 2 2 14 2 2 1 14 2 2 2 14 2 3 14 2 3 1 14 2 3 2 14 2 3 3 14
40. anguage s to install 4 After a successful installation start the spirometry software Default language selected during the language installation will be used when starting the software The language can be changed to any installed one via software settings see the chapter 4 2 5 Language file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 9 of 81 3 Starting and Exiting the Spiro2000 Software 3 1 Starting the Spiro2000 Software In the Windows Start menu point to Programs and then click Medikro Spiro2000 channel guide D i news amp E technology sports business ie entertainment lifestyle amp travel Accessories A CorelDRAW 8 Favorites gt jIntemet Explorer LU StartUp Ns Documents gt K MS DOS Prompt Eh Settings AJ Ena Hep 2 Bun Ly Shut Down As eaw iQ 11 20 Mm Figure 3 1 Starting of the Spiro2000 program After you have started the program you will see the name of the program as well as the version number on the screen while the program is being loaded The program will search for the spirometer attached to your computer serial port and identify the COM port The search can be omitted if you do not use the software for making measurements see the chapter 4 2 2 Spirometer Detection In case the software scan cannot find the spirometer in any of the COM ports the following message will be displayed E Sp
41. as not been calculated yet e A tab with a bright yellow background means that the measured value fulfils the criterion e A tab with a bright red background means that the measured value does not fulfill the criterion Note that the spirometry software makes a prediction for the FVC in the middle part of the exhalation According to the prediction the frog will land in the water on the opposite lily pad However it is possible that the frog will splash into the water even if the FVC succeeds This can happen if the exhalation gets better at the latter half of exhalation A clear indicator of a successful FVC is that the frog will jump up and down and raise its hands after the leap Figure 7 13 file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer F Freddie the Frog Microsoft Internet Explorer Page 44 of 81 BEE Bak gt Q A Qsearch GFavorites BHmedia ye File Edit View Favorites Tools Help Address a http medikro 01 49997 Incentive htm 7 60 Links bal 2 M9836 1 1 0p1 Figure 7 13 Incentive applet after a successful exhalation 24 Freddie the Frog Microsoft Internet Explorer og File Edit View Favorites Tools Help Ea Back gt O A A Reach GFavortes EHmedia Gr Address E http medikro 01 63695 Incentive htm Eao Links izd E M9836 1 1 0p1 E Bone O Local intranet 7 Figure 7 14 Incentive a
42. ate how well the exhalation is performed see the upper part of the incentive applet screen Figure 4 11 For the color status of success flags see the chapter 7 10 Measurements with the Incentive For the preferred comparison there are three choices to select e Reference values When using this setting selected variables of the exhalation are compared to the lower limit of 95 normal range of their reference values e Current session best When using this setting selected variables of the exhalation are compared to their best values of the current session If the current session does not contain any values to compare e g the measurement is the first measurement of the session the comparison will be done to the best values of the previous session If the previous session does not contain any values for comparison it will be done to the lower limit of 95 normal range of their reference values e Prey session best When using this setting selected variables of the exhalation are compared to their best values of the previous session If the previous session does not contain any values where to compare the comparison will be done to the best values of the current session If even they do not exist the comparison will be done to the lower limit of 95 normal range of their reference values file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 28 of 81 Note that in Current sessi
43. be provided at request from Medikro Oy Hospital Information System Interface Spiro2000 software can be connected to a variety of Hospital Information Systems HIS There are two different interfaces GDT and XML GDT Ger te Daten Tr ger is tailored for German standard interface for device data XML is a general interface and can be applied to almost any HIS You can select the Hospital Information System Interface using the following command path Device Settings HIS HIS System file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 22 of 81 E Settings Database General Spirometry HIS Variables Incentive HIS System XML id Input file C Medikro Datatransfer Input xml Browse Input batch file fione Browse Import Mode Import Person Data Insert 3 Check identification Identification Criteria Calculate results of Jy always in a dialog V Personal ID Vv imported data window Patient code O Proceed into Vv Last name Oo measurement Givennames automatically Date of birth 7 Output file C Medikro Datatransfer Output xml Browse Output batch file fione z Browse Export options No Autoexport Export Session Data Current session z a Figure 4 7 Device Settings HIS The options are None GDT and XML Depending on your selection some of the HIS related options shown in the Figure 4 7 and explained below are not
44. ble The number of trending pages depends on how many trending variables the user has selected one at minimum see the chapter 8 3 Trend In more detailed the report pages include the following information Figure 10 2 and Figure 10 4 personal information showing the patient name and ID is selectable on every page smoking history page 1 clinical information page 1 best results as tables and histogram pages 1 reproducibility of the measurements pages 1 3 selectable for the first page numerical values of the individual Pre and Post measurements showing the curves is selectable pages 2 3 numerical values of the selected trending variables from page 4 forward interpretation page 1 envelope curves of the individual Pre and Post measurements page 2 flow volume curves of the individual Pre and Post measurements page 3 On the first page the user can select two graphs to display by selecting two of the following check boxes at the upper left corner of the report page e best curves e trending graph e VT6 curves Note the following details in the representation of figures e A mark in front of reference value for example 60 indicates that the value of the measured variable is outside of the 95 normal range e A mark in front of the Post Pre difference values indicates a significant change of values in bronchodilatation test e Red font color of the figure indicates that the reproducibility
45. dity 50 Date 26 1 2004 Figure 8 6 Draw a marquee around the interesting view area Applies also to VT6 window file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 48 of 81 E Spiro2000 John FK Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm 68 kg 20 1 2000 12 00 Session Measure Device Show Help Show Results Post Pre Soref abs ref 103 5 57 106 0 15 FEV1 i 73 107 4 84 109 0 11 FEv6 i 41 103 557 106 0 15 FEV1 VCFYC Ni 40 106 86 95 105 PEF i 75 118 12 15 122 MEFSO i 76 138 9 32 166 MEF25 98 2 98 112 MMEF i 55 129 7 14 141 AEFY 5 37 52 FET 4 87 VEXT Diff of 2 best YC FYC Fe 1 Max diff of all PEF TS 68 Temp 35 0 C Timer QD ree cu MMSE Terese i015 nber tre Stee Post None BAT C OO Humidity 50 Date Figure 8 7 After drawing a marquee the curve is magnified for more detailed viewing To return to the original graph size select Device Normalize Graph command or click the VT FV Envel or VT6 button Show Curves group 8 2 Numerical Results The following commands will represent the measurement results in numerical formats e Meas will show the results of all measurements e Best will show the results of best measurements and a histogram 8 2 1 Meas Results of all Measurements This choice will show the results of all measure
46. dow a new window is opened and you can select the XML file that you wish to open The data of the session s found in the file is saved to your database according to the HIS import mode options see the chapter 4 4 3 HIS manual Import Mode and the operation after this is similar to HIS Import from step 2 on explained in the chapter 12 1 2 Checking Import Person s Identity Note that if the mode is Bypass incoming information is handled in a temporary local database The change back to the use of the normal database requires a new log in By default the Session Data folder is C Medikro Datatransfer A different default folder can be created as described in the chapter 4 1 1 Location of Data file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 59 of 81 12 The Hospital Information Systems Data Interchange Spiro2000 software can be connected to a variety of Hospital Information Systems HIS This means that data can be interchanged with Spiro2000 and HIS imported exported The operations mentioned below require that either GDT or XML has been chosen for Spiro2000 HIS System see the chapter 4 4 1 Hospital Information System Interface 12 1 Import The import consists of three steps receiving an input file checking imported person s identity and selecting a session for the imported person 12 1 1 Receiving an input file Receiving an input file is semiautomatic The ex
47. e Sessions field Figure 8 11 Several sessions can be selected by pressing SHIFT while making a mouse click New results are calculated automatically for immediate trending inspection X axis variable can be selected from the appropriate field Figure 8 11 There are three choices e Date indicates the date of the session e Age indicates the age of the person at the time of the measurements e Session indicates the sequence number of the sessions The ref button Figure 8 12 activates the inspection of results in relation to reference predicted values The results are expressed as a percentage of reference value provided the selected variable has a reference value file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer 8 4 John FK Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm 68 kg 20 1 2000 12 00 Session Measure Device Show Help FEV1 ref Show Results pre result circle post result square reference line normal range green area 1 1 T 1 t Age 5 10 C_ FEYC FIVC FYC MYY Ei Trending Variables FEV1 mii 1984 11 14 12 00 1985 11 14 12 00 1986 11 19 12 00 1987 11 24 12 00 1988 11 28 12 00 1989 12 03 12 00 1990 12 08 12 00 1991 12 13 12 00 1992 12 17 12 00 1993 12 22 12 00 1994 12 27 12 00 1996 01 01 12 00 1997 01 05 12 00 1998 01 10 12 00 1999 01 15 12 00 2000 01 20 12
48. e program will continue Empty the pump with one stroke Perform at least 3 consecutive fill empty cycles using a flow rate of about 6 L s and after that click the Finish Calibration button see Figure 5 7 The program will show the gain before and after the calibration as well as the change in gain from the previous calibration It will then ask you to accept with OK the new calibration values Typically the gain values during calibration are around 1 00 Should the spirometer system leak the calibration be performed incorrectly or should the operator use incorrect calibration files the absolute gain values after the calibration may lie outside the acceptable gain range In this case the program will instruct Gain after calibration is not in 20 range Calibration is not accepted The default limit for calibration variation is 20 and it determines the acceptable range of gain values range is calculated as follows 1 0 20 0 80 1 20 The limit can be changed as explained in the chapter 4 3 1 Calibration Volume Max Variation and Logging file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 32 of 81 Figure 5 7 Device Calibration End file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 33 of 81 6 Personal Information and Session Database When the Spiro2
49. elp htm 11 17 2009 Medikro Windows Spirometer Page 67 of 81 6 s Volume time Curve s Flow volume Curve s Envelope flow volume Curve s Results of the Measurements Representative Best Results Trend Final Report The functions of these choices are the same as when using Show Curves and Show Results buttons see the chapter 8 Analyzing Results 14 2 5 Help 14 2 5 1 Show Help Displays this Spiro2000 User s Manual 14 2 5 2 About Displays the system summary window see the chapter 14 1 3 2 About file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 68 of 81 15 Maintenance The Flow Transducer is for single use only Change a clean Flow Transducer for every patient Check the pressure tube and replace it if it is leaking or unclean It is recommended to change the pressure tube after 300 patients or four times a year Calibrate the spirometer carefully with a calibration syringe as described earlier in the chapter 5 Calibration Perform a new calibration daily and always when starting to use a new lot of Flow Transducers In addition calibration should be repeated in case there is a notable change during the day in environmental conditions ambient temperature pressure or humidity The spirometer unit does not normally need any maintenance file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 69 of
50. ely correct in all network configurations The automatically determined host name is only a suggestion and may result into an invalid host name In those cases we recommend unselecting this check box and typing the host name manually Host Name Host name of the measurement workstation Can be edited if Automatic Host Name is unchecked This may also be the numeric IP Address of the measurement workstation e g 192 168 64 142 If the incentive is displayed only in a local measurement workstation also the values LocalHost or 127 0 0 1 can be used Please consult your system administrator Incentive page net address The whole address to a net page where the incentive applet is displayed In order to view the incentive at external computers their browsers have to make a connection to this address you can copy this address via the clipboard If the incentive is selected to open at the measurement computer the browser will be opened automatically in this address Incentive buffer Length of the communication buffer in seconds A default value of 0 3 s is recommended for most computers and networks By increasing this value it makes the communication more reliable but adds more delay between the exhalation and the animation Success Criteria Preferred comparison and Success Flags You can choose the preferred comparison and the variables that are monitored within the incentive The monitored variables are called success flags and they indic
51. enabled the selections above are available with an additional choice e Noname file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 16 of 81 If the user identification is enabled the user has a possibility to modify the default name in the user identification screen 4 3 Spirometry 4 3 1 Calibration Volume Max Variation and Logging Before you run the calibration you should verify that the calibration volume specified in the program is the same as the volume of the calibration syringe You may change also maximum variation of the calibration gains and choose if calibration is being logged The settings Figure 4 5 are found using the following command paths Device Settings Spirometry Calibration syringe volume ml Device Settings Spirometry Max calibration variation Device Settings Spirometry Calibration logging HE settings Database General Spirometry HIS Variables Incentive Calibration syringe volume ml 3000 Max calibration variation 20 Calibration logging Vv Linearization file M9228 lot142 cfg x Standard recommendations I ATS ERS 2005 x Exceptions choices 4 Ventilation Function interpretation ATS ERS 2005 Bronchodilatation test interpretation ATS ERS 2005 Bronchodilatation test comparison Pre phase representative 4 4 Best PEF criterion Largest PEF x FEY calculation criterion max F C of each phase x F
52. er 0 10 D Pte i Moue fi Press 1013 mbar Time 13 06 41 top Post None 9 Humidity 50 Date 26 1 2004 Session Status Summary Timer Time of Day Date Environmental Conditions Figure 7 7 Flow and Duration indicator It indicates the volume change in 1 second ATS 1994 or ATS ERS 2005 criteria selected or in 0 5 seconds ERS 1993 file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 41 of 81 criteria selected When there is no horizontal bar to indicate a volume change in specified time the no change criterion to end or reverse the expiratory inspiratory manoeuvre is reached The time of the last expiration is also shown during FEVC and FVC manoeuvres The expiration should last at least 6 seconds 3 s for children aged lt 10 yrs ATS ERS 2005 7 7 The Reproducibility Indicator After the measurement the Reproducibility Indicator will tell you if the measurements will meet the reproducibility criteria for the spirometric test Figure 7 8 Reproducibility Pre Post abs best abs best Diff of 2best VC 010 2 FEVC 0 06 1 002 0 FEV1 001 o O02 0 Max diff of all PEF Is 0 33 3 0 29 3 Figure 7 8 Reproducibility Indicator If the criteria are not fulfilled the program will flag the results in red For more details of reproducibility see APPENDIX Reproducibility Indicators and 4 7 8 Session Status Summary The program mon
53. erpretation Text Interpretation Text is given by a consulting doctor The text is given in the Personal Information window Figure 9 1 and shown in the first page of Final Report Figure 10 4 Note only the five first rows can be printed in a report Last name Given names mith demo Dohn F dd mm Date of birth 14 fll 11974 Age Bs year Meas Personal ID Demo3 Patient code Gender Male z Reference set Exit Ethnic group ECSC_PZ 5 Height 178 0 cm BMI ii ji Yi aa ee Illness Medication Problem ne Co operation Good z Operator NN Ventilation Function Normal Result of bronchodilatation test fo significant change Interpretation text Figure 9 1 Ventilation Function Bronchodilatation Test Result and Manual Interpretation Text file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 54 of 81 10 The Final Report The Final Report summarizes the results and interpretation of the current spirometry session It can also present the summary of patient s background in a form of graphical and numerical trend data The standard final report contains at minimum four pages The first page shows the best representative results The results of individual Pre and Post measurements are shown in the second and third page Pages from number four forward are dedicated to trending with an individual page for each selected trending varia
54. errors see list below Whether the edited information is transferred to a database depends on the Import mode file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer E Check Import Person s Identity You are importing data from the input file to the database Please check the incoming person s identity You may change the identity information to find the corresponding person in the database However the information is used only to select the person and will not replace the person s information in the database Identification Criteria Incoming Person Database Person M Personal ID Demo3 Demo3 Patient Code First Name ohn F John F T LastName Smith Smith dd mm yyyy dd mm Yyyy l DateofBith 14 Ani fisva fhs LRI 11974 Gender Male Male Ethnic Group Hispanic Hispanic Profession Reference Set ECSC_PZ ECSC_PZ Page 60 of 81 Do you accept the identification Figure 12 2 Check Import Person s Identity Window The following identification errors are possible because the database must have unique PID and PatientCode values Several persons found in the database the match must be unique Another person with the given PID exists in the database this is possible if the criteria does not include PID Another person with the given Patient Code exists in the database this is possible if the criteria does not include Patient Code e The input fi
55. est values Note that reproducibility is phase related which means that pre and post measurements are not compared with each other For detailed information see the ATS 1993 1 ERS 1994 2 and ATS ERS 2005 3 5 recommendations 25 2 VC FVC and FEV1 Indicating reproducibility for Session Best values the best value is the largest value for each variable The best value should not exceed the next highest one by more than the criterion If the criterion is not fulfilled the difference between the two largest values is flagged red Indicating reproducibility for single measurements if the VC FVC or FEV1 differs from its largest value by more than its criterion it is flagged red The respective difference VCDIFF FVCDIFF or FEV1DIFF is also flagged red ERS 1993 ATS 1994 ml best ml best vc 100 5 20 i0 Fvc_ 10 5 20 50 Fev 10 5 200 159 100 if FVC lt 1 L 25 3 FEF75 FEF50 and FEF25 ERS 1993 only 25 4 25 5 Indicating reproducibility for Session Best values the best value is the largest value for each variable The chosen flow volume curves for analyzing FEFs should have a PEF within a criterion of the maximal value If the criterion is not fulfilled the maximum difference of all PEF values is flagged red Indicating reproducibility for single measurements if the PEF differs from the maximal value more than a criterion it is flagged red The respective di
56. eter Page 35 of 81 Ventilation function Indicates the status of the ventilation function The program will calculate this after the measurements have been completed Result of Bronchodilatation Test Shows the comparative result of the pre and post phase tests The program will calculate this if post measurements have been accomplished Interpretation Text Interpretation of the session results by consulting doctor Free text format Note only the five first rows can be printed in a report 6 3 Retrieving Personal Information and Session Data from the Database Access the patient database Figure 6 3 by pressing the DataBase button at the Personal Information screen Figure 6 2 Ei Choose a Person and a Session Ez Person search You can search a person by typing first letters to Last name Date of birth Personal ID and or Patient code fields Last name essa ID Date of birth yyyymmdd Patient code Persons in the database Abrahamson demo Abel a Blondin demo Linda Expirator demo Ben Lifebeach demo Michael Smith demo John F Choose the Person s Session Figure 6 3 Database Choose a Person and a Session The selection of the person is made in the list box called Persons in the database which includes a list of the names of all patients in alphabetical order according to family name and then first name The name of a patient can be searched by scrolling down the name
57. f there is no session information coming from the import file The program then automatically proceeds to a measurement ready state If the user finds the automatic proceed impractical it can be disabled by unselecting the check box in the menu Figure 4 7 Device Settings HIS Proceed into measurement automatically 4 4 6 Identification of the Imported Person For XML HIS and manual XML import see the chapter 11 2 Receiving the Session Data the operator can define whether the identification of an imported person is always checked and what the default identification criteria is Persons can be identified by Personal ID PatientCode Last Name First Name and or Date of Birth You can configure the identification via menus Figure 4 7 Device Settings HIS Check identification always in a dialog window file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 24 of 81 Device Settings HIS Identification Criteria 4 4 7 HIS Output files The operator can define the location of the output file If XML interface has been chosen the location of the output batch file can also be established The batch file is a small procedure intended to transform SpiroXML output file to a suitable format applicable to the used HIS if necessary You can define the HIS output files via menus Figure 4 7 Device Settings HIS Output file Device Settings HIS Output batch file 4 4 8
58. fference PEFDIFF is also flagged red ERS 1993 ATS ERS 2005 ml best ml best Lea dl ae Ee eee If the ATS 1994 or ATS ERS 2005 recommendations are selected the best FEFs are obtained from a forced vital capacity manoeuvre which has the largest sum of FVC plus FEV1 FEF25 75 ERS 1993 only Indicating reproducibility for Session Best values the best value is the largest value The reported value should be from a forced vital capacity manoeuvre which differs less than a criterion from the largest FVC If the criterion is not fulfilled FEF25 75 value is flagged red Indicating reproducibility for single measurements if the best value is chosen from the curve which does not fulfill the criterion the FEF25 75 of that curve is flagged red ERS 1993 ATS 1994 ATS ERS 2005 ml best ml best Ce ea e eee a If the ATS 1994 or ATS ERS 2005 recommendations are selected the best FEF25 75 is obtained from a forced vital capacity manoeuvre which has the largest sum of FVC plus FEV1 PEF ATS ERS 2005 only file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 81 of 81 Indicating reproducibility for Session Best values the best value is 1 the largest PEF or 2 PEF obtained from a forced vital capacity manoeuvre which has the largest sum of FVC plus FEV1 Whichever the choice the highest value should not differ next highest one by more than the c
59. g command path Device Settings Spirometry Standard recommendations E Settings Database General Spirometry HIS Variables Incentive Calibration syringe volume ml 3000 Max calibration variation 20 Calibration logging Vv Linearization file ATS 1994 ERS 1993 Standard recommendations Exceptions choices Ventilation Function interpretation ATS ERS 2005 Bronchodilatation test interpretation ATS ERS 2005 Bronchodilatation test comparison Pre phase representative 4 4 4 Best PEF criterion Largest PEF x FEY calculation criterion I max F C of each phase x FEF calculation criterion max FYC of pre phase x Reference set Ecsc_2 x Report Heading ledikro OY O Box 54 IN 70101 Kuopio C Figure 4 6 Device Settings Spirometry Standard recommendations There are generally only minor differences between the American Thoracic Society ATS 1994 1 and the European Respiratory Society ERS 1993 2 recommendations The views of both the ATS and ERS were joined in 2005 3 5 The standard selection affects primarily e how representative values are chosen e start of test criteria extrapolated volume end of test criteria no change in volume exhalation time e repeatability criteria of FVC FEV1 VC PEF and MVV e bronchodilatation response criteria file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 18 of 81 4 3 4 Calculation Excepti
60. gnals with a mouse click Pre Phase 1 WARNING The selected Pre Phase 2 signalis will be 3 permanently deleted and the database results of se 5 the current session will be Post Phase 1 updated Post Phase 2 Post Phase 3 Figure 7 10 Session Delete signal s 7 10 Measurements with the Incentive The incentive screen is a motivator for children to perform an acceptable spirometry study It can be viewed at the measurement computer monitor or at external computers that are connected to the same network Before the first use of the incentive it is recommended to read through the chapter 4 6 Incentive which covers the configuration and setting up of the incentive in details In this chapter we deal with the usage of incentive during the measurement If the incentive settings have been configured properly and the incentive screen has been selected to display at the measurement computer the spirometry software will launch the Internet Explorer web browser Before the measurement is started the incentive applet will be rotating the scenery around the frog see Figure 7 11 F Freddie the Frog Microsoft Internet Explorer OF x File Edit View Favorites Tools Help Back gt Q A Qsearch Favorites media 4 7 Address http medikro 01 56430 1ncentive htm z co Links a M9836 1 1 0p1 Applet FrogApplet started Figure 7 11 Incentive applet in an idle state When t
61. gure 4 6 Device Settings Spirometry FEF calculation criterion There are two choices max FVC of each phase FEFn and FEF25 75 are calculated using the best FVC of Pre or Post phase as a reference volume n 25 50 or 75 The same principle applies to FIFn and FIF25 75 FVC of each manoeuvre FEFn and FEF25 75 are calculated using FVC of each manoeuvre as a reference volume n 25 50 or 75 The same principle applies to FIFn and FIF25 75 4 3 4 7 Reference Set The reference set represents the predicted pulmonary function values for the patient To change the reference set selection 14 alternative reference sets in Spiro2000 v 1 8 use the following command path Figure 4 6 Device Settings Spirometry Reference Set Select the appropriate reference set to change the default value of the set The set includes the predicted values for both genders and all age groups There are several choices for the predicted values of different national or ethnic groups The current reference sets in Spiro2000 are Name of Ref Set Description persons less than 18 years old are regarded as children Berglund for adults Zapletal for children Brazilian reference values Chinese reference values Crapo for adults Knudson for children ECSC_P European Coal and Steel Community for adults Polgar for children ECSC_PZ European Coal and Steel Community for adults Polgar and partly Zapletal for children file C Medikro S
62. he measurement is started see 7 3 Starting the Measurement the incentive applet will set up to a stand by state and the frog will be seen from a side view Figure 7 12 Now it is time to start the study file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 43 of 81 3 Freddie the Frog Microsoft Internet Explorer Afe Es File Edit View Favorites Tools Help Address 4 http medikro 01 56430 Incentive htm M9836 1 1 0p1 hd E Applet Frog pplet started m GE Local intranet h Figure 7 12 Incentive applet in a stand by state During the measurement the frog will react to the ventilation performance by crouching down at the deep inhalation and making a leap at the consecutive exhalation Note that in order to get the frog to crouch and leap the inhalation must be deep enough at least 50 of the current session s pre phase best FVC if the current session does not have FVC the previous session s pre phase best FVC is used instead If even that does not exist the reference value is used The goal for the jump is the opposite lily pad which corresponds a successful FVC Figure 7 13 If the FVC fails the frog will splash into the water Figure 7 14 Small tabs at the upper part of the screen are called success flags and indicate by color if the criteria of the variables have been fulfilled e A tab with a dark yellow background means that the value h
63. he measurement should also be demonstrated to the patient Pay attention to correct posture with head elevated complete inhalation Flow Transducer position and complete exhalation All manoeuvres should be started and finished with resting tidal breathing The actual maximal exhalation effort of FEVC and FVC should last at least 6 seconds 3 s for children aged lt 10 yrs ATS ERS 2005 MVV manoeuvre should be started only after the patient is breathing maximally and the manoeuvre should last 12 15 seconds ATS 1994 amp ATS ERS 2005 or 15 seconds ERS 1993 It is recommended to allow the patient to perform 1 2 sample manoeuvres before the measurement 7 3 Starting the Measurement Select the type of manoeuvre to start a measurement Figure 7 2 Figure 7 2 Choices of Manoeuvres Button Group Before Start of Measurement There are following choices displayed as buttons on the lower left side of the screen Button Manoeuvre Tidal Volume Slow Vital Capacit Forced Expiratory Vital Capacity only expiratory results will be calculated Forced Inspiratory Vital Capacity only inspiratory results will be calculated Forced Vital Capacity FEVC FIVC both expiratory and inspiratory results will be calculated Maximum Voluntary Ventilation If you want to start by only monitoring the signal before any of the manoeuvres you can accomplish it via a menu option see the chapter 14 2 2 1 Start Note by choosing variables for display see the
64. hen NHANES III_W is chosen for the person s reference set see the chapter 4 3 4 7 Reference Set Reference Set Select the appropriate reference set The set represents the predicted pulmonary function values for the patient The selection is valid only during the current session When the session is closed the default reference set becomes valid again The default value of the reference set can be changed as explained in the chapter 4 3 4 7 Reference Set Height Enter the height in centimeters or in feet and inches For example 177 centimeters or 5 feet and 6 inches Weight Enter the weight in kilograms kg or in pounds Ib For example 56 kg or 135 lb BMI The program will calculate automatically the Body Mass Index The formula for BMI is as follows BMI weight kg height m Profession Enter the profession of the patient Smoking Select from the following options Yes No No information Illness The recording of relevant illnesses of the patient Medication The recording of relevant medication of the patient Current problem The recording of any current medical problem Comment Enter any additional observations Co operation Select from the following options Good Satisfactory Poor No information Operator Indicates the operator identification entered at Log On phase of the program file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirom
65. irometer not found or Serial Port can t be opened Check that the sensor is properly connected to the computer Spiro2000 continues autodetecting the sensor and allows to measure when the device is found Figure 3 2 Spirometer not found message This message will appear only once The software will try to detect the spirometer in the background until it is found The personal information can be given and sessions can be studied even before the instrument has been found The following Log On screen will appear file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer EB Medikro Spiro2000 DataBase Device Help Page 10 of 81 e a Se A User name at least two letters please User tg Se are Spiro2000 Spirometry Software 2 L B n 2 n M RO l n 16 28 14 23 1 2004 35 0 C Timer 1013 mbar Time Figure 3 3 User Identification screen after starting the Spiro2000 program You have to type in at least 2 characters initials of your name in the User name field and then click Log On For more information about the user identification options see the chapter 4 2 6 User Identification After the operator has entered the user name the program will activate the opening view EE Medikro Spiro2000 DataBase Device Help BEE Figure 3 4 The Opening View Spiro2000 Spirometry Software sse sas saan ana MEDIKRO E o 15 56
66. istence of the input file is checked by the software after every log on Figure 12 1 If it is found import will start and will proceed via the person identity check up to the measurement view Figure 7 1 The location and name of the input files are defined in the settings see the chapter 4 4 2 HIS Input files EB Medikro Spiroz000 oj DataBase Device Help 3 ser Identification Ez Spi ro2000 User name at least two letters please 4 User Spirometry Software ang Temp 35 0 C Timer Press 1013 mbar Time 16 20 14 23 1 2004 Date Figure 12 1 Log On Screen 12 1 2 Checking Import Person s Identity This chapter applies only if the XML interface has been chosen For GDT the import is always unchecked The import person s identity will be always checked if this has been selected see the chapter 4 4 6 Identification of the Imported Person and the Import mode is not Bypass see the chapter 4 4 3 HIS manual Import Mode However if there is an error in the person s identity the check will be executed despite the settings The check is done in a Check Import Person s Identity dialog window Figure 12 2 The window allows the user to check that the identity of the imported person matches the identity of the person found in the database It is also possible to change identification criteria or edit incoming personal information in order to get the right match or to correct possible
67. itors and reports the number of Pre and Post measurements performed within one session The operator can review the session status from the status summary and activate or inactivate the viewing of curves of any measurement within a session from the respective check box see Figure 7 9 Note this does not affect the calculated results If the user wants to remove a measured curve from the calculations it can be done only by deleting it see the chapter 7 9 Deleting an Individual Measurement The program facilitates up to 8 pre and 8 post measurements as recommended by ATS and ERS Pre indicates Basal Phase and Post indicates Bronchodilatation Phase None all commands will activate or inactivate the viewing of all Pre or Post measurement curves respectively Pre None BIDADI 1 Post None BIRIKI O Figure 7 9 Session Summary Status 7 9 Deleting an Individual Measurement You can delete signals of the current or reviewed session by selecting the following command path Session Delete Signal In order to delete a signal select it from the list and press OK To make a multiple selection press SHIFT while choosing signals with a mouse click from the database list Figure 7 10 file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 42 of 81 Ee Delete Signal s x Select a signal or signals From the list below To make a multiple selection press SHIFT while choosing si
68. k the settings once and start using the incentive without further modifications All the settings that are related to the incentive can be found at Device Settings Incentive file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 26 of 81 E Settings Database General Spirometry HIS Variables Incentive Success Criteria Current Incentive I Frog z Show incentive at this PC v Preferred Comparison I Current Session Best z Warn if Java missing Vv ecurrent prev best 5 Success Flag In use best Targeted FET s 3 0 PEF Lis Vv 97 9 Incentive size pixel I 416 x 320 z f MEF7S Lis Vv 97 97 Data communication ee z 7 MEFSO Ls v 97 97 HTTP Server Port 54581 _ Find a free port n 7 Data Server Port 54079 Find a free port MEF25 Us M LI 97 FEvo 5 L Vv 37 97 Automatic Host Name Vv Host Name fnedikro 01 FEV1 L Vv 97 97 Incentive page net address http medikro 01 54581 Incentive htm gan E M Eld L 97 FYC L Vv 97 97 Incentive buffer s 0 3 Figure 4 9 Device Settings Incentive At the incentive dialogue sheet Figure 4 9 the following settings can be adjusted 4 6 1 Current Incentive This is a main selector from which the incentive is taken into use The default value is none which means that incentive is not in use Currently there is one incentive the Frog Freddie the Frog is an animated frog that spends its time
69. l Figure 5 4 Outlet Port Adapter of Calibration Syringe Figure 5 5 Calibr button Figure 5 6 Device Calibration Start Figure 5 7 Device Calibration End Figure 6 1 Per Info button Figure 6 2 Personal Information window before data entry Figure 6 3 Database Choose a Person and a Session Figure 6 4 Database Choose a Person and a Session Person search Figure 6 5 Database Choose a Session Figure 6 6 Meas button Figure 6 7 Show Curves and Show Results button groups Figure 7 1 The Measurement View Figure 7 2 Choices of Manoeuvres Button Group Before Start of Measurement Figure 7 3 Choices of Manoeuvres Button Group Before Start of Measurement Figure 7 4 Choices of Manoeuvres Button Group After Start of Measurement Figure 7 5 Volume Time Graph Figure 7 6 Accept Measurement Figure 7 7 Flow and Duration indicator Figure 7 8 Reproducibility Indicator Figure 7 9 Session Summary Status Figure 7 10 Session Delete signal s Figure 7 11 Incentive applet in an idle state Figure 7 12 Incentive applet in a stand by state Figure 7 13 Incentive applet after a successful exhalation Figure 7 14 Incentive applet after a failed exhalation Figure 8 1 Show Curves and Show Results button groups Figure 8 2 Show Curves in volume time curve format Figure 8 3 Floating VT6 window showing 6 s volume time curves Figure 8 4 Show Curves in flow volume curve format Figure 8 5
70. l equilibrium A spirometer connected to a PC will start to warm up immediately after Windows is started This is a normal and general procedure for most of the high precision measurement devices A 3000 ml Medikro Calibration Syringe Figure 5 3 product code M9424 is recommended However Spiro2000 software allows the user to enter the volume of the calibration syringe leaving you an option to use other volumes for calibration as well Figure 5 3 M9424 Calibration Syringe 3000 ml Attach the spirometer with the Flow Transducer into the Outlet Port Adapter Figure 5 4 of your Calibration Syringe Figure 5 4 Outlet Port Adapter of Calibration Syringe Empty the syringe Click Calibr button Figure 5 5 Figure 5 5 Calibr button The program will instruct as follows Figure 5 6 Press OK when pump is empty file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 31 of 81 B Medikro Spiro2000 Mi DataBase Device Help Show Results h e PR ya ee ee i A men Porinio _ Meas TA A vel ag Hes i Calibre Flow Ls Press OK when pump is empty Time s 1 1 1 1 1 1 i 1 1 1 5 2 25 0S A045 ol So co 4 Temp 35 0 C Timer Be RH i ess 1013 mbar Time 9 53 47 Stop Posti A Humidity 50 Date 26 1 2004 Figure 5 6 Device Calibration Start After clicking OK the program will instruct Fill the pump with one stroke Th
71. lative difference to the pre phase representative value 4 3 4 4 Best PEF Criterion You can select how best PEF Figure 4 6 is chosen by using the following command path Device Settings Spirometry Best PEF Criterion There are two choices PEF of max FVC FEV1 The best PEF is chosen from the manoeuvre with largest sum of FVC FEV1 Largest PEF The best PEF is the largest PEF of Pre or Post phase manoeuvres 4 3 4 5 FEV calculation criterion You can select how FEV and FIV percentages Figure 4 6 are calculated by using the following command path Device Settings Spirometry FEV calculation criterion file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 20 of 81 There are two choices max FVC of each phase FEVn FVC is calculated by dividing FEVn by the best FVC of Pre or Post phase n 0 5 or 1 The best FEVn is calculated by dividing the best FEVn by the best FVC The same principle applies to FEVn FEV6 FIVn FIVC and FIVn FIV6 FVC of each manoeuvre FEVn FVC is calculated by dividing FEVn by FVC of each manoeuvre n 0 5 or 1 The best FEVn is chosen from the manoeuvre with largest sum of FVC FEV1 The same principle applies to FEVn FEV6 FIVn FIVC and FIVn FIV6 4 3 4 6 FEF calculation criterion You can select how FEFn FEF25 75 FIFn and FIF25 75 n 25 50 or 75 are calculated by using the following command path Fi
72. le has neither Personal ID nor Patient Code for the imported person every person must have either Personal ID or Patient Code in the database The errors are recognized before saving data to the database and they are shown in the dialog window If there is an identification error the acceptance of the person is not possible without corrections After accepted person identification the input data is saved to a database If the input file includes several persons each of them is checked and the data saved separately The XML input file is deleted if all persons were accepted and there were no other errors during import If the identification of a person is not accepted the importing is interrupted and will be started again in the next log on as explained in the previous chapter 12 1 3 Selecting a session for the person imported to the system After the person s identification the software selects automatically the first session of the first person included in the import file or a new session if there is no session information included for the first person If automatic proceed into measurement has been chosen see the chapter 4 4 5 Automatic Proceed into Measurement the selected session is shown in a Choose a Session window only for a short time and the software proceeds automatically to the measurement view Figure 7 1 Session reselection can be done manually afterwards as described in the chapter 6 3 Retrieving Personal Information and
73. list or by using an automatic name search function The name search is straightforward Enter one or more first letters of the last name into the Last name field The list of names displays now the names starting with these specified letters The name search is more accurate the more letters are used in the search Figure 6 4 file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 36 of 81 E Choose a Person and a Session Person search You can search a person by typing First letters to Last name Date of birth Personal ID and or Patient code fields Last name 5 Personal ID Date of birth yyyymmdd 1 974 Patient code Persons in the database Smith demo John F Al Choose the Person s Session Figure 6 4 Database Choose a Person and a Session Person search You can also use person s Date of birth Personal ID and or Patient Code as search criteria The search fields include Date of birth Enter one or more first numbers of the date in an yyyymmdd format For example 19550228 Personal ID Enter one or more first alphanumeric characters of the personal ID For example 1234 Patient code Enter one or more first alphanumeric characters of the code For example A1B2C3D4 The search result is shown in the Persons in the database field After the person has been selected by highlighting the person s name pressing Choose the Person s Session button wi
74. ll open a choose session window This window will show all previous sessions in time sequence Figure 6 5 file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 37 of 81 E Choose a Session x Person Smith demo John F Session Date and Time New Session 20 1 2000 12 00 15 1 1999 12 00 10 1 1998 12 00 i x 5 1 1997 12 00 1 1 1996 12 00 27 12 1994 12 00 22 12 1993 12 00 17 12 1992 12 00 Cancel 13 12 1991 12 00 Figure 6 5 Database Choose a Session The operator can select either a new session or a possible previous session If the operator selects a new session all personal information from the latest session if it exists will be displayed in the Personal Information window The operator can now update the information and start a new measurement by pressing the Meas button Figure 6 6 in the Personal Information window If the operator selects a previous session all personal data and measurement results of the session are displayed in the Personal Information window The operator can now inspect the previous measurement results and curves by pressing first the Meas button Figure 6 6 in the Personal Information window Kieas Figure 6 6 Meas button and then by selecting the needed result or curve layout by pressing one of the buttons in Show Curves or Show Results button groups Figure 6 7 Show Curves Show Results ris
75. m din To make a multiple selection press Expirator Ben SHIFT while choosing persons with Lifebeach Michael a mouse click Smith John F Delete the chosen Person s Delete Session s of the Personfs Figure 14 1 Database Delete Person s or Session s 14 1 1 3 Page Setup Opens the Page Setup window and gives the opportunity to adjust paper settings for printing 14 1 1 4 Exit Opens the Log On window which gives the choice to exit the program or to log on 14 1 2 Device 14 1 2 1 Calibrate file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 65 of 81 Allows you to calibrate the spirometer as described in the chapter 5 Calibration Settings Allows you to define all Spiro2000 settings as described in the chapter 4 Setup Help Show Help Displays this Spiro2000 User s Manual About Displays a system summary window Figure 14 2 The table inside the window contains information about Spirometer hardware and its driver Current status of the spirometer Calibration details System configuration hardware details memory usage Operating system Internet Explorer and Java virtual machine details Communication details and status of the incentive Database details Information of the About window is useful if the user has a problem when using the software Especially when the Spiro2000 software user needs to contact Medikro Technic
76. ments in numerical format Figure 8 8 The list of available variables used in Spiro2000 is described in APPENDIX Variables file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Session Measure hn F Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm W 68 kg 20 1 2000 12 00 Device Show Help Page 49 of 81 Sl he TY FR my ve FVC FEV1 FEVE FEV1 C Pre2 abs FEW1 FYC PEF MEFSO MEF25 MMEF FET VEXT FIVC FI 1 FIVI C Figure 8 8 Numeric results in tabular format Show Results ref 107 103 110 106 118 138 98 129 Pre3 abs ref 107 103 110 106 117 138 98 Up to eight Pre and eight Post measurements are shown Pret abs ref 105 101 108 104 115 133 92 PreS Posti abs ref abs ref 105 108 105 104 120 160 102 134 Temp 24 0 C Timer ress 1013 mbar Time 15 00 13 Humidity 50 Date 4 5 2004 Measurement results include the result of each measured variable as well as percentage comparison to Reference Values 8 2 2 Best the Best Results as a Histogram This choice will show the results of best measurements both in numerical format and as a histogram Figure 8 9 John FK Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm 68 kg 20 1 2000 12 00 Se
77. must be filled before the measurement can be performed Date of Birth Personal ID or Patient Code Gender Reference set file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 34 of 81 e Height e Weight The fields include the following information Last name First name Name of the person If the person has a middle name one can enter either an initial or the middle name into the same field with the first name For example e First name John F e Lastname Smith Date of Birth Enter the data as instructed 2 digits for the day 2 digits for the month and 4 digits for the year The order of the data entry is taken from the regional settings of the PC to reflect the local date format Age The program will calculate the age of the patient automatically Personal ID Enter the ID of the patient In some countries the social security code is used for this purpose For example 1234 Patient Code Open field for any alphanumeric code used by the establishment clinic hospital to identify the patient For example A1B2C3D4 Gender Select from the following options Male Female No information option is just for indicating that the selection has not been done yet Ethnic Group Indicates the ethnic origin of the person Use the drop down menu for a proper selection Ethnic group information does not change the calculation criteria for lung function expect w
78. n 1 1 Thank You We all at Medikro Oy wish to thank you for the purchase of the Medikro spirometer with Spiro2000 software We trust it will serve you well In order to understand better the spirometer system and get most out of it we encourage you to study this manual in detail If you already have used a previous version of Spiro2000 you may want only to have a glance at the additions made in this document since version 1 7 2 The additions are flagged with green color Please note also that the whole text and structure of this document has been revised these changes have not been flagged EE Medikro Spiro2000 DataBase Device Help Spiro2000 Spirometry Software Temp 35 0 C Timer Press 1013 mbar Time 15 56 33 Humidity 50 Date 23 1 2004 Figure 1 1 Spiro2000 Startup Screen 1 2 Getting the Most Out of This Manual Typically an operator will require information on new system installation and operation The installation of the spirometer and related software as well as the system setup is described in the detailed Installation Guide provided with the software We encourage you to study the Installation Guide before you put the spirometer into clinical work This manual covers the use of Spiro2000 software The next chapters will deal with the software setup calibration patient data measurement analyzing and interpreting the results creating a final report sending receiving data and connecti
79. ng to a Hospital Information System HIS There is also important supplementary information at the end of this manual file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 8 of 81 2 Installation The detailed Installation Guide is provided with the Spiro2000 software It contains a description of all procedures to be done before starting the spirometry measurements 2 1 Installing More Languages Additional languages may be installed with separate language packs A language pack is a setup program that will install language files for the Spiro2000 One language pack may contain one or more languages from which the user may select the wanted language s during the installation A standard Spiro2000 software package will supply a language pack with at least one language normally English At the first installation of Spiro2000 you can select which one or more of these languages you want to install It is also possible to install more languages from this language pack afterwards For supplementary languages you can order language packs from Medikro Oy To install additional languages from the Spiro2000 software package follow the next steps 1 Exit the spirometry software if it is running 2 Run the Setup exe that is located at the Spiro2000 installation CD under the X LanguagePack folder where X is the letter of CD ROM drive 3 During the installation you can select the l
80. of the value fails see APPENDIX Reproducibility Indicators 10 1 Viewing the Final Report The final report can be viewed using the Report button Figure 10 1 Feprort Figure 10 1 Report Button file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 55 of 81 Spiro2000 John F Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm W 68 kg 20 1 2000 12 00 Session Measure Device Show Help Show Results fl ie Weng a Q kl Report Pages lt lt Prev 123 Report includes IV Name amp PID l Reproducibility Best Curves l Trend IV VT Curves Medikro OY SPIROMETRY P O Box 54 FIN 70101 Kuopio 20 1 2000 at 12 00 PERSONAL INFORMATION Date of bith 14 11 1974 Height 178 cm Last name Smith demo Age and gender 25 years old male Weight 68 0 kg Given names John F Personal lID Demo3 BMI 21 5 Profession Patient code Ethnic group SMOKING Yes CLINICAL INFORMATION Illness Co operation Good Medication Comment Problem Operator NN xl AASE O re we e e ee TY ve Fevc Five Fve Myv Sop Post Nove A E F F umidity 50 Date 29 3 2004 Figure 10 2 Show the Final Report You may choose which page opens first when viewing the report see the chapter 4 1 2 The Final Report Template Use lt lt Prev 1 2 3 4 and Next gt gt buttons in the upper part of the screen to change the page of
81. on best and Prev session best the comparison limit is determined as a percentage of the current session best or previous session best respectively Each selected variable can have an individual percentage Also note that the comparison is always phase related It means that post phase measurements are always compared to the post phase measurements and pre phase measurements are always compared to the pre phase measurements ZJ Freddie the Frog Microsoft Internet Explorer ofi x File Edit Yiew Favorites Tools Help Bak gt at Search Favorites Media Ey Address i http medikro 01 56430 Incentive htm bd Go Links gt M9836 1 1 0p1 Applet Frog pplet started Figure 4 11 Incentive applet file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 29 of 81 5 Calibration Calibration forms an essential part of good laboratory practice Medikro spirometers should be calibrated daily as outlined in the ATS and ERS recommendations see the chapter 23 References Typically calibration is performed when the spirometer system is switched on In addition calibration should be repeated when starting to use a new lot of Flow Transducers and in case of there is a notable change during the day in environmental conditions ambient temperature pressure or humidity Using a calibration log file is recommended and ensures the reliability of your
82. ons and Choices After choosing the standard you may fine tune the spirometry calculations via exceptions and choices explained in this chapter 4 3 4 1 Ventilation Function Interpretation You can select the how ventilation function is interpreted Figure 4 6 by using the following command path Device Settings Spirometry Ventilation function interpretation There are two choices ATS ERS 2005 With this choice the ventilation function is interpreted according to the ATS and ERS 2005 recommendations 5 The interpretation classifies the spirometry based on the pre phase FEV1 compared to the reference value Ventilation function FEV 1 ref Mild decrease 70 lt x lt 2SD Sovijarvi 1994 With this choice the ventilation function is interpreted according to Sovijarvi 1994 6 The interpretation classifies the per phase spirometry results according to the variable that has the lowest value compared to the reference value The exceptions are VC and FVC of which the classification is accomplished according to the variable having a higher value compared to the reference value Ventilation function Value compared to the reference x gt 2 SD Mild decrease 3 5 SD lt x lt 2 SD 5 5 SD lt x lt 3 5 SD 7 5 SD lt x lt 5 5 SD x lt 7 5 SD SD standard deviation SD 95 confidence limit 4 3 4 2 Bronchodilatation Test Interpretation You can select the method to interpret the results of a bronchodila
83. piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 58 of 81 11 Sending and Receiving the Session Data 11 1 Sending the Session Data The data of a session or sessions can be stored in a file This file is a SpiroXML document The export session data option see the chapter 4 4 8 How and What to Export defines whether only the data of the current session or all sessions of the current person will be exported Exporting all sessions is intended especially to sending data for trending First you have to either perform a new session or retrieve data of an old session from the database When you press the Export button in a personal database window a new window is opened and you can give a name to the data file The session data file has an extension xml By default the session data will be saved into a folder Datatransfer A different default folder can be created as described in the chapter 4 1 1 Location of Data If you want to send the session data as an e mail attachment drag and drop the file on an e mail message Now you are ready to send the e mail to the recipient You can also copy the file to a diskette and send the diskette by mail 11 2 Receiving the Session Data The data of a session or sessions can be stored on a file This file is a SpiroXML document When you receive the SpiroXML document extension XML you can copy it into the Datatransfer folder When you press the Import Button in a personal database win
84. pplet after a failed exhalation file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 45 of 81 8 8 1 8 1 1 Analyzing Results You can analyze the results as graphs or as numeric results or as a combination of both According to your choice select any of the buttons VT VT6 FV or Envel under Show Curves or any of Meas Best or Trend under Show Results Figure 8 1 Show Curves Show Results Meas Figure 8 1 Show Curves and Show Results button groups Note the following details in the representation of figures e A mark in front of reference value for example 60 indicates that the value of the measured variable is outside of the 95 normal range e A mark in front of the Post Pre difference values indicates a significant change of values in bronchodilatation test e Red font color of the figure indicates that the reproducibility of the value fails see APPENDIX Reproducibility Indicators Curves VT will show the Volume Time curve of the measurement s FV will show the Flow Volume curve of the measurement s Envel will show the envelope curve of the measurement s VT6 will open a separate floating window showing the 6 s Volume Time curve of the measurement s The data of the session is displayed as curves and tables Figure 8 2 Figure 8 4 Figure 8 5 Figure 8 3 VT Volume
85. riterion If the criterion is not fulfilled the difference between the two largest values is flagged red Indicating reproducibility for single measurements if PEF differs from its largest value by more than its criterion it is flagged red The respective difference PEFDIFF is also flagged red ERS 1993 ATS 1994 ATS ERS 2005 L s best L s best Per leleda da lor 25 6 MVV ATS ERS 2005 only Indicating reproducibility for Session Best values the best value is the largest MVV No MVV value should differ from the largest value by more than the criterion If the criterion is not fulfilled the MVV difference is flagged red Indicating reproducibility for single measurements if the MVV differs from its largest value by more than its criterion it is flagged red The respective difference MVVDIFF is also flagged red ERS 1993 ATS 1994 ATS ERS 2005 Jbest L min best Ew ee ea 2 file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009
86. s FEV L FEW1 CFVC PEF MEFSO MEF25 MMEF AEFY FET VEXT Exclude Sessions 1984 11 14 12 00 1985 11 14 12 00 1986 11 19 12 00 1987 11 24 12 00 1988 11 26 12 00 1989 12 03 12 00 X Axis Variable Age YoreF Table pre result circle post result square reference line normal range green area Age 1 1 1 1 LI 5 10 15 20 30 O S 35 0 C Timer 1 52 40 WW S reo e 1013 mbar Time 1433 53 vc_ Fevc Five FVC MVV stos Post None I DO Humidity 50 Date 26 1 2004 Figure 8 10 Trending in a graphical presentation form The operator can select one or several variables for the trending inspection from the Choose Variables field Figure 8 11 The selected variables and their dimensions are shown on the top left hand side of the trend graph Several variables can be selected by pressing SHIFT while making a mouse click file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 51 of 81 Choose Yariables FEV1 VCFYC PEF MEFSO MEF25 MMEF AEFY FET VEXT Exclude Sessions 1984 11 14 12 00 PS 1985 11 14 12 00 1986 11 19 12 00 1987 11 24 12 00 1988 11 28 12 00 1989 12 03 12 00 x xis Variable Age x Yor ef Table Figure 8 11 Trending interactive elements The operator can also select the sessions to be excluded from the trending inspection The exclusion of the sessions can be selected from the Exclud
87. ssion Measure Device Show He ref pate 103 5 57 106 107 4 84 109 103 5 57 106 106 86 95 105 118 12 15 122 138 9 32 166 98 2 98 112 129 7 14 141 OE a Show Results Normal range green line ref Pre result blue circle Post result red square l min y AN Post Nove M CLL Figure 8 9 Show Best Results 40 60 80 100 Temp ess 120 140 160 180 95 range max 35 0 C Timer 1 50 49 1013 mbar Time 14 32 02 La Humidity 0 Date 26 1 2004 Best results of the Pre and the Post measurements are compared to Reference Values Also the Post Pre difference is shown file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 50 of 81 The best results are also displayed as a Histogram It will show the 95 normal range for each measured variable as a green bar The best Pre result is indicated with a blue circle and the best Post result with a red square The histogram results will give direct indication on the severity of a limited lung function 8 3 Trend Trend allows the inspection of the trend of each individual variable in a graphical Figure 8 10 and numeric table Figure 8 13 form EB Spiro2000 John FK Smith demo PID Demo3 Born 14 11 1974 25y male H 178 cm W 68 kg 20 1 2000 12 00 Session Measure Device Show Help Show Result
88. tation test Figure 4 6 by using the following command path Device Settings Spirometry Bronchodilatation test interpretation file C Medikro Spiro2000 Language English Help Spiro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 19 of 81 There are three choices ATS ERS 2005 With this choice the bronchodilatation test is interpreted according to the ATS and ERS 2005 recommendations 5 ERS 1993 With this choice the bronchodilatation test is interpreted according to the ERS 1993 recommendations 2 Sovijarvi 1994 With this choice the bronchodilatation test is interpreted according to Sovijarvi 1994 6 4 3 4 3 Bronchodilatation Test Comparison You can select the method to compare the results of a bronchodilatation test Figure 4 6 by using the following command path Device Settings Spirometry Bronchodilatation test comparison There are two choices Reference values With this choice the difference between post and pre results is calculated in relation to the reference value and shown as ref To assess whether the change in the bronchodilatation test is significant Spiro2000 compares the relative difference to the reference value Pre phase representative results With this choice the difference between post and pre results is calculated in relation to the pre phase representative value and shown as pre To assess whether the change in the bronchodilatation test is significant Spiro2000 compares the re
89. tem other devices and applications play a significant role The user is advised either to contact Medikro Oy Technical Support using e mail e mail address technicalsupport medikro com or to search the Medikro Oy homepage www medikro com which also provides useful information file C Medikro Spiro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Page 70 of 81 17 Certification 17 1 EC Declaration of Conformity EC Declaration of Conformity Issued by Medikro Oy P O BOX 54 FIN 70101 Kuopio Finland Equipment Description This declaration of conformity is valid for the following product s M921 SpiroStar DX Spirometer M921 WA D9 W WA OEM Spirometer SpiroPerfect M922 SpiroMaster MX Spirometer M929 SpiroStar USB Spirometer M929 WA D9 W WA USB OEM Spirometer SpiroPerfect M9831 Spiro2000 Spirometer Software M9228 M9242 SpiroSafe Disposable Flow Transducer M9472 Inhalation Trainer Easyhaler PIF meter Serial number all Classification lla Applicable Directives The above products meet the essential requirements of the following directive s 93 42 EEC Medical Device Directive and related laws Following standards are used to fulfil requirements EN 60601 1 EN 60601 1 1 EN 60601 1 2 EN 60601 1 4 Place and Date Kuopio 30 January2909 Lathe AAE Mikko Eloranta Managing Director MEDIKRO Figure 17 1 EC Declaration of Conformity
90. the final report The scroll bar is available on the right margin of the window to allow scrolling the final report page on the screen 10 2 Printing the Final Report When the Final Report window Figure 10 2 is shown you can use the Print button Figure 10 3 to print the Final Report Print Figure 10 3 Print Button file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer Medikro OY P O Box 54 FIN 70101 Kuopio PERSONAL INFORMATION Last name Smith demo Given names John FK Profession SMOKING Yes CLINICAL INFORMATION Illness Medication Problem TEST RESULTS Variable Abbr Tidal volume Tv Breathing frequency FR Minute ventilation My Vital capacity ve Forced vital capacity FYC Forced exp volume at 1 0sFEV4 Forced exp volume at6 0sFEV6 FEW4 max VC FVC FEV4 CVCFVC Peak expiratory flow PEF Max expirat flow 50 VC MEFSO Max expirat flow 25 VC MEF25 Max mean expiratory flow MMEF Area of expirat FV cuwe AEFV Forced expiratory time FET Extrapolated volume VEXT Forced insp vital capac FIVC Forced insp vol at 1 0s FIV FIVA 7 max VC FVC FIVA CVCFVC Peak inspiratory flow PIF Area of inspirat FV curme AIFV Reproducibility Abbr Diff of 2 best VC FVC FEW Max diff of all PEF BEST CURVES Figure 10 4 Standard final report SPIROMETRY 20 1 2000 at 12 00 Date of birth 14 11 1974 Height 178 cm Age and gender 25 years old
91. uage English Help Spiro2000Help htm Figure 8 13 A separate floating window shows trending in a numeric table presentation Page 52 of 81 The Table button opens a floating window that contains a numeric table of trending data Figure 8 13 A drop down selector Variables in the upper left corner of the window shows the list of variables that the operator has chosen from the previous window Figure 8 11 By using this selection the operator can choose the variable of which trend data is being studied at a time Whenever you choose the Print button the software will print the content of the currently shown in a measurement window This allows you to select see the chapter 7 8 Session Status Summary and print any measurement curve individually 11 17 2009 Medikro Windows Spirometer Page 53 of 81 9 Interpretation 9 1 Ventilation Function Spiro2000 interprets the severity of lung function as described in the chapter 4 3 4 1 Ventilation Function Interpretation The result is shown in the Personal Information window Figure 9 1 and in the first page of Final Report Figure 10 4 9 2 Bronchodilatation Test Result Spiro2000 interprets the bronchodilatation test result as described in the chapters 4 3 4 2 Bronchodilatation Test Interpretation and 4 3 4 3 Bronchodilatation Test Comparison The result is shown in the Personal Information window Figure 9 1 and in the first page of Final Report Figure 10 4 9 3 Manual Int
92. yboard Shortcuts Keyboard Shortcut Function in Spiro2000 Ctrl Shift C Ctrl I F F F F8 F FIO Ctrl M Ctrl V Ctrl 6 Ctrl F Ctrl E Ctrl A Ctrl B Ctrl T Ctrl R Ctrl P Ctrl H Ctrl X Enter Positive response Log On OK Yes etc if a dialog window is open Esc 1 Negative response Cancel Close Exit No etc if a dialog window is open 2 Stop Measurement if a measurement is going on 3 Exit otherwise file C Medikro S piro2000 Language English Help S piro2000Help htm 11 17 2009 Medikro Windows Spirometer 14 Drop Down Menus The drop down menus of the Spiro2000 offer you alternative ways to use the program package 14 1 In the Opening View The following drop down menus will appear in the Opening View Figure 3 4 e Database e Device e Help 14 1 1 Database 14 1 1 1 Personal Information Opens the Personal Information window 14 1 1 2 Delete Person s or Session s Page 64 of 81 Allows you to delete persons and or sessions from the database The selection is similar to searching for a patient To make a multiple selection press SHIFT while selecting person s with a mouse click from the database Figure 14 1 E Delete Person s or Session s Person search You can search a person by typing first letters to Last Name Date of Birth Personal ID and or Patient Code fields Last Name Personal ID Date of Birth yypymmdd Patient Code Persons in the database Abel Abrah 3 B o
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