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CardioPerfect Workstation SpiroPerfect Module, User Manual

1. 66 12 2 Norm Related Clinical Studies 68 t23 N riiiExtiqpolalloli u uu uuu 70 12 4 Composite Norm Values 70 DIR 80012334 Ver H 6 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 9 LUNO AOO RU 70 12 5 Grou COM SCHON u u uuu uuu uu u oe 71 12 7 Understanding Interpretation Results 72 12 8 Acceptability ofan qa Baa obtenu CR Bae Cb ER 73 12 9 Reproducibility of a test stage 73 12 10 Reversibility Bronchodilator 74 2 TT Z u uu 74 12 12 FANE TNC CS etc ayer ceive tye cet oye 74 13 Maintaining the Spirometer Welch Allyn 75 13 1 Maintaining the Senso a uu E casas TO 75 13 2 Cleaning the 75 13 3 Cleaning the Calibration Syringe 76 13 4 Ordering Information for Replacement Parts 76 14 Troubleshooting ROTE oom 78
2. haeo cede 31 Calibration of Flow Sensor 33 Preparing calibration 33 CG a 33 View Calibration Results sao pti 38 Error Messages Associated with Failed Calibration 39 AIF ATION uuu T 40 Recording Spironmielry 55 uuu u u uu u u uu uu u u u u u uu uu uu 41 DIR 80012334 Ver H 5 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 8 1 Record a Spirometry Test a 41 8 2 D 44 8 3 Patient ado oU EET 45 8 4 Del dp 46 8 5 Add or Change Information in the Comment Editor 47 9 Viewing Spirometry tests 48 9 1 View a Spirometry test nennen nnns 48 9 2 OIG D ET STET TO 48 9 3 View and Add Information to a Test 49 9 4 NESE and NAS awama kanaa 49 9 5 Common Features for each Tab 51 9 5 1 Parameters e T 52 9 5 2 Interpretation Area
3. a 13 S C I I sss 13 General information 15 VV nn Sun masu 2 usss 15 Intended Use Indications for Use 15 GontraindicallOfiS Lu v Aun itp quite 15 Important Considerations 16 Installing the SpiroPerfect Spirometer 17 Configuring the Welch Allyn CardioPerfect Workstation 18 The Spirometer Window 19 Customizing the Spirometry Module 21 u gt x u 21 WICWINICT IL u T 23 Farameters D L 25 PUI bu nu a 2 u 27 Recording Tab a a 29 Customize the spiro txt file 30 Ambient Settings Temperature Humidity and Pressure 31 Why the Workstation needs Ambient Setting Information 31 When to Adjust the Ambient Settings 31 Adjusung ihe Ambient SENGS u UU uas te aeg ub be odd do
4. HH 2 50 54 patient procedures 46 Mr O 9 troubleshooting 78 warranty 2 3 93 93
5. Units GLI 2012 LLN Final FinalzPred z _ ATS I Selected iL 5 71 4 58 5 50 198 2 0 16 FI 4 65 3 70 4 70 101 0 08 FEVIFVC 82 71 84 102 0 35 FEV6 L 5 60 L s l 1111 14 FEF25 75 4 61 2 82 5 06 110 0 36 Selection Description Parameters The Parameters area holds the parameters table It is displayed under the area FVC SVC MVV and Trend tabs The Parameters table lists up to six user defined parameters See page 24 to select the parameters The following information is displayed in the table predictive norm ATS acceptability criteria predictive values per parameter followed by the lower limit of normal in parentheses effort stage amp parameter value final result parameter values predictive followed by the z score in parentheses for the norms that support z score change in All efforts and Post view Effort The color in front of the effort name corresponds to the color of the curve in the graph Select the check box in the selected row or column and the curve is displayed in the graph You can select to show the parameters in rows or columns in the settings menu viewing tab see page 22 Deselect a check box and the curve is hidden 9 5 2 Interpretation Area The interpretation area displays automatic or confirmed interpretation medications comments lung age if enabled in the settings and reprod
6. 811 971 901 77 761 191 N LELF 09 IN LO CO NIN O gt gt gt gt gt gt gt gt L L 2 W LLI LLI LLI LLI LLI LU LLI LLI LLI LL LL LL LL LL LL CL ILL LL peipnis sJojeuieJed FEFO 2 1 2 FEV0 5 Male Female Adult Height cm Weight kg Asian Native American FEF50 FEF25 years old Caution Pediatric use in the US gt 6 adult population only 66 93 DIR 80012334 Ver H WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Knudson 1976 Knudson 1983 Koillinen 1998 Schoenberg Viljanen 1981 X X X FEVO5 FE3 FEV3 FEV1 FEV6 PE FEES FEF50 MEN TERNI l Male gt lt Female Adult co QD Su i X X Caucasian X X Parameters Studied mem 112 196 107 183 8 B M 118 181 F 107 173 M 155 195 F 145 180 i d J Hispanic Asian Aneren _ Caution Pediatric use in the US gt 6 years old O O p ES E NEN ER E RENE NE x gt 2 PEN NN E dmm DIR 80012334 Ver 67 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 12 2 Norm Related Clinical Studies Each of th
7. Trend Measurements 12 12 e 10 8 j 8 j 8 4 2 a i eim c P M B 1 z 3 amp 5 B 2 2 B E 8 4 E 10 Within normal limits am Flow alume Loop Selected Flow alume Interpretation Effort RENS E r nm FEVE Pre FVC 5 6L FEVI 4 7L FEVI FVC 83 92 Within normal limits Units LLCs ee Albuterol Beclomethasone Fro Ph w T U T ad 5 50 14 Interpretation Confirmed on 8 4 2006 1 22 22 P awam TN 160 EN SEE 14 FmazPed hos norz 03x View multiple flow volume curves of one test It is possible to view and compare multiple efforts previously recorded in one test The right hand side of the window displays a flow curve of all selected efforts The left hand side of the window displays the flow curve of the currently selected effort To view multiple efforts in one flow volume graph 1 In the Spirometer window move the mouse arrow to the Parameters table 2 Check the box of each effort to view in the Selected row column 3 Uncheck the boxes of each effort to hide it from view DIR 80012334 Ver H 51 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 9 5 1 Parameters Area Figure 9 7 Parameters Table
8. 10 3 View Interpretation History When making changes in an interpretation the original interpretation is not changed but a new one is created A copy of all interpretations is kept in the interpretation history Figure 10 2 Interpretation History screen Interpretation history Interpretations Date E ditedB y 3 3 2005 10 57 24 Unknown Mild restictrye abnormality To view the interpretation history 1 Choose Tools 2 Select Interpretation history The Interpretation history window is displayed The left hand pane displays the interpretations sorted by date The right hand pane DIR 80012334 Ver H 60 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual displays the content of each interpretation including the date time and editor 3 Select a date to view an interpretation 10 4 Reanalyze a Spirometry Test Retrieve overwritten automatic interpretations by reanalyzing the spirometry test To reanalyze a spirometry test e Choose Actions e Select Reanalyze test Reanalyzing the test will result in the following e Anew interpretation is appended to the test containing the automatic interpretation statements e The state of the interpretation is set to unconfirmed e All parameter values are re calculated 10 5 Recalculate prediction With this option you can re calculate the predicted values for the test with a different Prediction norm To recalculate a prediction 1
9. FERE K 1 3 5 6 8 K Calibration instructions and messaqe window Follow the blue bar Do not stop between a push and a pull ofthe plunger 1040 mbar 20 0 e 60 Syringe volume 3000 ml Protocol Single Flow Calibrating Expiratior Attempt 1 For a single flow calibration protocol Push the plunger entirely in and pull the plunger out as far as possible while following the blue bar as closely as possible The calibration procedure will stop automatically and inform you of the results For multiple stroke calibrations Push the plunger entirely in and pull the plunger out as far as possible three times while following the blue bar as closely as possible At the end of each stroke a message appears you can either choose to accept the calibration stroke or redo the last stroke DIR 80012334 Ver H 36 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 7 5 Accept stroke x d Press YES to accept this stroke and perform the next one reda the stroke press MO and to stop calibrating press CANCEL The following options apply e Yes Continue to the next stroke or show calibration results e No Redo the current stroke with the same speed e Cancel Stop calibrating The sensor will not be calibrated 9 If the calibration was successful this will be displayed You can either accept the results or recalibrate If the ATS
10. guidance RF emissions CISPR 11 RF emissions Class A CISPR 11 Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable DIR 80012334 Ver H The Welch Allyn SpiroPerfect uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Welch Allyn SpiroPerfect is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the Welch Allyn SpiroPerfect or shielding the location 83 93 WelchAllyn Electromagnetic Immunity CardioPerfect Workstation SpiroPerfect Module User Manual The Welch Allyn SpiroPerfect is intended for use in the electromagnetic environment specified below The customer or the user of the Spirometer should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transien
11. Show an increase from Pre to Post of 12 or more AND Have an absolute increase from Pre to Post of 200 mL or more 12 11 Z score For norms that support calculation of the z score this value will be shown together with the 96 Predicted values 12 12 References 1 Disability Evaluation Under Social Security the blue book Social Security Administration SSA publication number 64 039 Office of Disability Programs ICN 468600 January 2003 oee in particular the calibration and reporting sections of this document 2 Lung Function Testing Selection of Reference Values and Interpretive Results American Thoracic Society March 1991 This document describes the methods of selecting the reference values and the algorithm for interpretative results 3 National Occupational Respiratory Mortality System National Institute for Occupational Safety and Health NIOSH 4 Short Report Spirometric Lung Age Estimation for Motivating Smoking Cessation James F Morris M D and William Temple Preventive Medicine 14 655 662 1985 5 ATS ERS Task Force Standardisation of Lung Function Testing European Respiratory Journal Volume 26 Number 2 319 338 2005 This document describes the methods of acquiring the output parameters and the required accuracy For details on ATS ERS acceptability criteria see these sections Start of Test Criteria page 324 Manoeuvre repeatability page 325 6 Standardized Lung
12. nennen nnne nnne nnn nnn nnns 52 9 6 53 9 7 sasana s sss 54 9 8 V 55 9 9 Trend 56 9 10 Measurements ab 57 SIr ua eee eee E eee eee 58 10 Interpreting Spirometry Tests 59 10 1 Editing and Confirming an Interpretation 59 10 2 Automatic Interpretation rsisi iaia 60 10 3 View Interpretation History 60 10 4 Reanalyze Spirometry Test 61 10 5 Recalculate prediction 61 VT Printing Spirometry ISIS III III 62 11 1 Prinung uuu uuu uuu uu uuu a T OT TT TT 62 Pi S u cect ete ace dere oat ee Lau eal Rael tnt Leet oath 63 11 3 Print PreviewW a nennen nares 63 11 4 Print Report Details 64 12 21 S u u His ua d xo UOCE OK OD I aaa 66 12 1
13. 6 seconds 3 pediatrics and has plateau FET is 6 seconds 3 seconds pediatrics 8 4 Deleting an Effort You can easily delete an effort after recording it To delete an effort DIR 80012334 Ver H 46 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Option 1 In the Recording Test window 1 Select Delete The following screen appears Figure 8 6 Confirmation dialog box Confirmation 2 Are vou sure you want to delete the current effort 2 Select Option 2 While viewing the test Highlight the effort to delete in the Parameters area located in the lower right side of the of workspace window See Figure 4 1 Main Window 1 Select Action gt Delete Effort or Ctrl D located on the menu bar the confirmation dialog box appears See Figure 8 6 2 Select OK 8 5 Add Change Information in the Comment Editor When creating a new spirometry test the SpiroPerfect offers space for adding or changing comments while recording To add or change comments 1 Choose Patient and start a new Spirometry test 2 Select Next 3 Selectthe Comment button from the toolbar Note The Comment editor is displayed containing previously added comments 4 Selectinterpretations and or medication from the statement tree on the left side or type in comments in the comment pane 5 Select Save The Recording Test window will appear again The comment editor is also a
14. Best SVC Best Three FVC Measurements MVV Measurements SVC Measurements FVC Social Security Trend Each format contains the patient s personal information test information interpretation parameter table and all but the measurement report contain a graphs section Please refer to the Workstation manual for further information on printing a test 11 3 Print Preview To Preview a Test e Select File gt Print Preview The print dialog box appears See Figure 11 1 e Select type of report to preview The name of the report type appears at the top of the dialog box The print preview window appears Figure 11 2 Print preview dialog box 15 x Setup Page Width 100 lt Close Print preview Best Name of the report type DIR 80012334 Ver 63 9 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 11 4 Print Report Details Example Report Welch Allyn CardioPerfect Workstation Normal Spirometry Report etn 1115 2007 11 59 10 AM 1 Patent Information Test Information ID CCNV 018 Pre Time 11 58 AM 9121333 Age 74 years Nom Reference GU 2012 Heignt 63inch Weight 185 0 Ibs Pre 4 Blow out longer No Plateau 2 Blow out longer No Plateau 1 Bicw out longer Plateau Packs Day ee Post 7 Glow nut longer No Plateau amp Blaw out longer Plateau Cooper ee eee 5 Bicw out longer
15. No Plateau Test Results Lung age 63 years Pre Post Var 77 mi 4 56 F10 mi 0 FEV1 Pred 102 x FVC Pre Post Var 138 5 32 mi 1 FEV1 80 ATS Improwement 5 FEV1 3 Post Pre Pre 100 Pre NOT lt 3 acceptable efforts Not Significant Response Post WOT 3 acceptabile efforts Test interpretation UNCONFIRMED REPORT Test Comment Pre FVC 2 641 2 71 115 2007 12 01 34 PML Within normal limite Post FVC 2 51 5 4 k 2404 3 55 79 9 1 98 2 50 FEVT FVC 2 195 120851 PML Within normal limits East Effort Parameter Units Pred 4 Pre 7 Post Praed iL 2 62 1 88 2 64 101755 0 04 2 50 20 27 F 40 14 FEW L 202 1 45 207 0 13 1 38 0 08 M5 0 071 FEVUFVC 7B 019 0 061 80 102 0 27 2 2 FEV amp iL 264 2 F 40 14 PEF Lis 7 14 D 4 63 FEF25 F5 Lis 1 59 75 1 75 10356 0 08 1 75 104 0 09 0 0 01 Means below LLN Ja 7 N xm 2 2 1 1 8 L 1 1 Ll 1 1 I W 1 6 at 14 14 1 0 8 0 6 5 0 2 F T T T T T T 1 2 3 4 2 7 Post 4 Pre Effort 7 Post 4 Pre Reviewed By Se U Last Callbrationr TIHS2DI 7 53 11 Device Info 1 66 1142 DIR 80012334 Ver H 64 93 CardioPerfect Workstation WelchAllyn Report Area SpiroPerfect Module Us
16. 1040mbe 20 0 60 Syringe volume 3000 mi Protocol Singe Flow Sage Attempt 1 Beneath the Calibration window the calibration instruction and message window is displayed giving instruction for the calibration procedure Note Please check the calibration and lot code if you cannot continue to the Calibration window Connect the syringe to the new flow transducer Fill the syringe by pulling the plunger completely out Press the Calibrate button in the window Wait until the messages Initializing sensor Opening sensor please wait disappears DIR 80012334 Ver H 35 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 7 3 Start Calibration xj Aiya This iz single flow calibration Please attach new flow transducer to the syringe Stark with the syringe filled illustrated in this picture and press when ready to start the calibration Cancel 7 Verify the syringe is completely filled and press the OK button Note f the syringe was emptied before calibration the No valid stroke recorded message will appear 8 Follow the instruction on screen The blue calibration bar can be used as a guide line by giving you an indication of the speed Figure 7 4 Calibration bar E e 4 Abort Calibration Results Calibration Logs Print Log Print Preview Help Done 6 5 5 E d
17. 2 2003 11 52 26 lt 822000161511 4 7401996121551 Hi 13 6 1995 15 28 33 126 1995 9 02 33 i 2951995121533 Note This action is not available if Best composite is set as Final result in the Spirometry General Settings Select Ok The Spirometry settings window closes Set the effort selector to Pre or Post see Figure 9 4 This feature will not function if you have selected All Efforts or Final Results All Efforts view and compare all efforts of current test Figure 9 2 Effort selector All efforts All efforts Pre view and compare only the pre Final Result efforts of current test Post view and compare only post efforts of current test Final Best result view and compare only the best effort final result of current test Select the pre effort you consider best DIR 80012334 Ver H 48 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 10 Next from the menu bar select Action Set Current Effort As Best 11 Repeat steps 8 10 for the post effort selection 9 3 View and Add Information to a Test To view and or add information to a test e Select Tools gt Information The following screen appears Figure 9 3 Information dialog box Information Retering physician Recorded by Location Comment To enter comments 1 Type comments in the Comment section 2 Select OK 9 4 Test Modes and Tabs There are four
18. 23 2987 0 43 2997 0 10 Averages 2999 0 03 2990 0 33 2994 018 2 3004 0 13 3008 027 3006 10 20 2992 0 27 3057 1 90 3024 0 82 Averages 3001 0 03 3017 057 3009 0 30 Calibrated results table Selection Description Calibrate Press the Calibrate icon when you are ready to start the calibration process After one calibration the icon label changes to Repeat Calibration It is recommended to repeat the calibration more than once Calibration Press the Calibration Results icon to view the results of the calibration Results This can only be viewed between calibration attempts Calibration Press the Calibration Logs icon to view previous calibration attempts Logs Print Log Press Print log icon to print the currently selected or displayed log Print Preview Press Print Preview The Print dialog box appears Press OK on the Print dialog box to the view the calibration results before printing Done Press Done to exit the Calibration window 7 4 Error Messages Associated with Failed Calibration Figure 7 9 No valid stroke recorded x valid calibration stroke recorded Please press OK to redo this stroke CANCEL to abort Cancel When the calibration attempt was not valid or if the volume read back by the sensor is not within 35 of the selected syringe volume the calibration fails This message also appears if the calibration attempt was performed in the wrong order first emptyin
19. Goto the Action menu 2 Select Recalculate Prediction 3 Select the preferred Prediction norm from the list Note for a more elaborate description of the Prediction norms see section Norm Profiles 12 1 4 Press the OK button DIR 80012334 Ver H 61 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 11 Printing Spirometry tests 11 1 Printing reports To print a particular report for the test currently on your screen Select File gt Print or Press Ctrl P The Print dialog box appears Figure 11 1 Print dialog box Copies All plus best effort FYE SES Number of capies lest Collate Measurements hy Measurements SWE Measurements Social Security Page rang All pages Curent page Cancel Select the desired print report type The report type corresponding with the current view is already selected If you should so desire you can select another report type Press the OK button to start printing To print multiple reports for the test currently on your screen Select File gt Print selected formats or Press Ctrl Alt P To control which reports will be printed see page 26 DIR 80012334 Ver H 62 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 11 2 Print Report Formats The SpiroPerfect module prints the following report formats All plus best effort FVC Best FVC Best MVV
20. Printing The following screen appears DIR 80012334 Ver H 27 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 5 5 Spirometry Printing tab ap Settings BE m x Modules sh Spirometry I E Default repart template Selected All plus best effort Best Best Best SVC Best Three Measurements MV Measurements SWC Measurements FWE Social Security Trend Exercise ECG S pirametry Show Graph scalin v Unconfirmed C Fixed Iv Confirmed bu Auto scale pn Iw Print in calor Cancel Apply Help Setting Description Default report A list of available templates used for printing reports templates To print multiple reports select the preferred formats from the list Show on Unconfirmed If checked Unconfirmed is printed on the reports if the Report test is not yet confirmed Confirmed By If checked Confirmed By is printed on the reports It provides a space for the clinician s signature Print in color If checked the spirometry reports are printed in color when using a color printer Graph scaling Select the type of scaling graph resizing to use when printing volume time curves Fixed scale volume 10 mm L time 20 mm sec flow 5mm L s Auto scale both x and y axes volume and time scale automatically DIR 80012334 Ver H 28 93 We
21. Printing these reports with a monochrome printer or in black and white can lead to confusion as it is not easy to identify which curve is a Pre and which is a Post effort Verify sensor calibration information Verify the barometric pressure Recalibrate Replace transducer Verify the patient data The norm selection is dependent upon accurate input of patient data in the SpiroPerfect database Eliminate any leaks in the pressure tubing Replace the sensor if damaged Make sure the patient remains still during recording Recalibrate 79 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 15 Specifications Specification Description opiroPerfect Computer based full diagnostic spirometer Tests FVC SVC MVV Pre Post BD sensor Type Pneumotach Power Equipment None obtained from USB port Accuracy Meets or exceeds_ATS ERS 2005 standard Reproducibility Meets or exceeds_ATS ERS 2005 standard ssi Volume Range 0 14 Flow Rane 40 Predictive Norms For Predictive Norms included see 12 2 Additional predictive norms can be added upon customer request Interpretation 1991 ATS Interpretation Standards Automatic interpretation can be disabled Manual Interpretation available Lung Age calculation Reports FVC Volume Time FVC Flow Volume FVC Both Volume Time and Flow Volume SVC Volume Time Incentive graphic Fireman Parameters FVC FIVC FI
22. Return Material Authorization RMA number lt is recommended that all returned goods be insured Claims for loss or damage to the product must be initiated by the sender DIR 80012334 Ver H 3 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Limited Warranty Statement Welch Allyn Inc warrants that the SpiroPerfect computer based Spirometer you have purchased the Product meets the labeled specifications of the Product and will be free from defects in materials and workmanship that occur within 1 year after the date of purchase Accessories used with the Product are warranted for 90 days after the date of purchase Such accessories include disposable flow transducers pressure tubing and nose clip The date of purchase is 1 the date specified in our records if you purchased the Product directly from us 2 the date specified in the warranty registration card that we ask you to send to us or 3 if you don t return the warranty registration card 120 days after the date on which the Product was sold to the dealer from whom you bought the Product as documented in our records This warranty does not cover damage caused by 1 handling during shipping 2 use or maintenance contrary to labeled instructions 3 alteration or repair by anyone not authorized by Welch Allyn and 4 accidents You assume all responsibility for use of the Product with any hardware or software that does not meet the system requir
23. races but most others do not In the latter case Welch Allyn CardioPerfect applies ethnic group correction to all non Caucasian adult patients in the prediction formulas The interpretation area will state if the norm values are extrapolated The ATS for blacks or NIOSH for Asians recommendations will be used for extrapolation Race Choices FVC amp FEV1 Recommendation Source Caucasian No adjustment Black 88 ATS Asian 94 NIOSH Hispanic No adjustment None found Native American No adjustment None found Note Race adjustment applies for adults only and applies to all supported parameters within the norm study If a race adjustment percentage is used the same adjustment is applied to the LLN value DIR 80012334 Ver H 71 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 12 7 Understanding Interpretation Results The following diagram illustrates the process of collecting and interpreting spirometry data For details see the document noted in reference 8 Figure 12 1 Data Interpretation Process 6000 FVC T L3 REPEAT MANEUVER S BEST OF 3 RATIO ABNORMAL 0 5 yes NORMAL SPIROMETRY May bea Physiological Mid yes 70 FVC lt LLN Variant Restriction of Predicted no Mild Moderate 60 lt FVC lt 70 Obstruction Restriction of Predicted no Moderately ENUN Moderate Severe lt FVC lt Obstruction Restriction of Predicted no Moderately S
24. standard has not been met you have to recalibrate e See the following section on how to deal with the results e f you have pressed the Recalibrate button Press the Repeat Calibration button in the Calibration window and follow the instructions above from step 6 Note If you have trouble getting the results within the Calibration Error Tolerance try e waiting 1 second between emptying and filling the syringe e asingle flow calibration before the three flow calibration if the three flow calibration is unsuccessful DIR 80012334 Ver H 37 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 7 3 View Calibration Results After calibration the Verify Calibration Results window will appear Figure 7 6 Verify Calibration Results Exp IInsp 2 Abs Avg Verify Calibration Results Syringe Volume 3000 ml 50 Humidity 34 X Pressure 1100 00 bar L s Exp Vol InspVol Insp AvgVol AbjAvgX 1 05 3013 3021 2 1 3015 053 2994 0 20 3005 10 37 3 3 3011 037 2934 2 20 2972 1 28 Averages 3013 0 43 2983 0 57 2998 Note Abs Avg should be lt 1 to meet the social security standard lt 3 to meet ATS standard Social security standard has been met lt 1 ATS standard has been met lt 3 Each row gives the result of a stroke the last row gives the Averages The following columns are given L s Results per str
25. tab is disabled DIR 80012334 Ver H 55 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 9 9 Trend Tab Figure 9 12 Trend Tab Patient Test date CCNV 003 John Doe M 3 27 1967 8 23 2006 9 23 24 AM svc Trend Measurements Reference 6 23 2006 10 19 33 4M 8 23 2008 10 18 27 AM 6 23 2006 10 18 11 8 23 2006 _ 10 17 51 6 23 2006 10 17 34 4M m O elve xl FEV1 B e rvix v The Trends tab displays trends of e the FVC efforts of the test or e best pre and best post efforts of the several different tests of the same patient There is no limit to the number of tests that you can trend You can simultaneously view three parameters and see how the parameters evolve during the test The interpretation area shows the interpretation of the most recent test Figure 9 13 Parameters menus FYE E FEVS FEY E Selection Description Parameters Three parameters are always trended The choice of parameters trended depends on the selected parameters in the settings File gt Settings Spirometry gt Parameters tab Six parameter column When you exit the trend view SpiroPerfect remembers the last three parameters selected and recalls them when you enter the trend view again Axes The horizontal axis displays the date amp time of the efforts The vertical axis displays the parameter
26. the Measurement table Information on test reproducibility is displayed in the reproducibility table that is placed below the Measurements Table In particular the FVC and FEV1 absolute value variance difference between the best effort and the second best effort is analyzed for both pre and post tests When a value is in bold red text that value is below the lower prediction limit 9 11 Compare Tests With SpiroPerfect you can compare final results from different tests recorded for the same patient Selecting various tests 1 Choose Action 2 Select Comparison The following screen appears Figure 9 16 Comparison dialog box x Date T ime 3 6 2006 9 09 43 2 8 2000 4 15 11 C Inverted Cancel Click the check box in front of each test to select tests The best pre and best post efforts of the patient s selected tests are compared Available views are e FVC e Measurements e Trend The trend view displays a graphical overview of the patient s performance over time DIR 80012334 Ver H 58 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 10 Interpreting Spirometry Tests The Spirometer module can automatically interpret FVC efforts A computer generated interpretation cannot replace sound WARNING medical reasoning by a trained professional Therefore physician should always review the interpretation 10 1 Editing and Confirming an Interp
27. typing the comment Adding text to the interpretation edit area Click in the interpretation edit area and start typing the text DIR 80012334 Ver H 59 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Adding an interpretation statement to the interpretation edit area using the statement tree 1 Select a category to display the statements 2 Inthe statement tree look up the statement to include in the interpretation 3 Click on the statement to add it to the interpretation edit area Deleting an interpretation statement from the interpretation edit area Select the statement text and press BACKSPACE or DEL to delete it Deleting a comment from the comment pane Select the comment and press BACKSPACE or DEL to delete it Tips for editing and confirming an interpretation e Automatically insert the current date and time by selecting the Date time button e Clear the interpretation editor by selecting the Clear button e The statement tree can be changed Please consult your system administrator or local dealer for new or changed statements 10 2 Automatic Interpretation The spirometer module automatically calculates interpretive results as described in the document noted in reference 2 on page 74 The automatic interpretation is shown in the interpretation area if the interpretation is not confirmed If the interpretation is confirmed the confirmed interpretation is shown in the interpretation area
28. who doesn t fit that norm s demographics For example if you were testing an 88 year old man and the primary DIR 80012334 Ver H 88 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual selected norm were based on males 85 or younger the predicted values would be extrapolated values FEF50 FIF50 The ratio of these two parameters See FEF50 and FIF50 FEF25 Forced expiratory flow in L s at 2596 of FVC FEF50 Forced expiratory flow in L s at 5096 of FVC FEF75 Forced expiratory flow in L s at 7596 of FVC FEF85 Forced expiratory flow L s at 85 of FVC FEFO0 2 1 2 Forced expiratory flow average L s between 0 2 and 1 2 liters of FVC FEF25 75 Forced expiratory flow average in L s during the middle half of FVC 75 85 late FEF Forced expiratory flow average in L s between 75 and 85 of FVC FET Forced expiratory time in seconds The elapsed time from the beginning of expiration until a specified percentage of FVC FEVO 5 Forced expiratory volume in liters at 0 5 seconds FEV1 Forced expiratory volume in liters at 1 second An important parameter because it reflects the severity of COPD FEV1 FEV6 The ratio of these two parameters See FEV1 and FEV6 FEV1 FVC See FEV1 FEV2 Forced expiratory volume in liters at 2 seconds FEV3 Forced expiratory volume in liters at 3 seconds FEV5 Forced expiratory volume in liters at 5 seconds FE
29. 1 1 WARNING A color printer and a color printout are recommended for printing opirometry reports Printing these reports with a monochrome printer or in black and white can lead to confusion as it is not easy to identify which curve is a Pre and which is a Post effort CAUTION Do not clean the pressure tubing or sensor Trapped moisture could affect their accuracy Replace the pressure tubing when it becomes dirty Replace the sensor when it becomes faulty CAUTION You cannot clean the spirometer or any of its components CAUTION If you choose to clean the calibrations syringe clean the outer surface of the syringe with only the following solutions or wipes Solution of dish soap and water 2 tsp per cup of water Solution of bleach and water 1 part bleach 6 sodium hypochlorite with 9 parts water Isopropyl Alcohol and water 70 by volume PDI Sani Cloth Plus wipes 14 85 Isopropanol Cavi Wipes 17 2 Isopropanol CAUTION Use only parts and accessories supplied with the device and available through Welch Allyn The use of accessories other than those specified my result in degraded performance of the device CAUTION When you put the spirometer away store its pressure tubing ina basket or drawer or other place that prevents compression or kinking CAUTION Avoid installing the spirometer in direct sunlight or in a location where it may be affected by significant changes in humidity ventilation or airborne particle
30. 13 2 Cleaning the Spirometer 1 Caution cannot clean the spirometer or any of its components DIR 80012334 Ver H 75 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual If you choose to clean the calibrations syringe clean the outer surface of the syringe with only the following solutions or wipes Solution of dish soap and water 2 tsp per cup of water Solution of bleach and water 1 part bleach 6 sodium hypochlorite with 9 parts water Isopropyl Alcohol and water 70 by volume PDI Sani Cloth Plus wipes 14 8596 Isopropanol Cavi Wipes 17 296 Isopropanol equipment failure and health hazards may result Only qualified service personnel should repair the equipment See Limited Warranty and Service Policy page 4 JA Cte FI To prevent cross contamination do not try to clean the flow transducers and nose clips Discard these items after a single patient use Wear gloves when replacing flow transducers and wash hands after touching them AN Caution Donotclean the pressure tubing or sensor Trapped moisture could affect accuracy e Replace the pressure tubing when it becomes dirty Recalibrate after replacement e Replace the sensor when it becomes faulty See section 13 4 Ordering Information for Replacement Parts on page 76 13 3 Cleaning the Calibration Syringe Clean the outer surface of the syringe with any of the following solutions or wipes Solu
31. 15 80 16 Statutory and Regulatory Requirements 82 17 Guidance and Manufacturer s Declarations 83 TO lt E EE REEE aE Ea 87 GOO Siya u u ee eee ua sau Da 88 DIR 80012334 Ver H 7 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 1 Introduction 1 1 About This Manual This manual is written for clinical professionals performing pulmonary function testing Users must be familiar with measurements and the clinical significance of basic spirometry products Caregivers need to know how to properly coach patients recognize acceptable waveforms and know whether results are reproducible or not and whether they meet ATS criteria or not The hospital s Biomedical IT support staff shall require primary skills including disciplines related to maintenance and servicing computer controls platforms It is recommended that users attend a certified spirometry training course The instructions given here are only a guide and should not be used to train a technician For definitions of specialized terms and abbreviations related to spirometry see the Glossary Before using the spirometer all users and technicians must read and understand this manual and all other information accompanying the SpiroPerfect spirometry option and the CardioPerfect workstation Note This manual supplements the CardioPerfect workstation ma
32. 3 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 2 4 Important Considerations The Spirometer should not be used if any of the following conditions exist or are thought to exist e he spirometer is not regularly calibrated e hemaintenance instructions listed in section 13 are not satisfactorily completed e Any part of the equipment or system is known or suspected to be defective DIR 80012334 Ver H 16 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 3 Installing the SpiroPerfect Spirometer The SpiroPerfect Spirometer consists of two elements the spirometry sensor and the software that runs on the computer to which the sensor is connected Before you can start recording spirometry tests you need to e Connect the sensor to the computer CAUTION Always use the USB extension cable The USB extension cable prevents damage to the spirometer ca c pr V LUE _ miem Ma NIHU AH ee az en T E EA E Im e Configure the software Warm up the Spirometer After connecting the device it is recommended to let the Spirometer warm up 1 Connect the Spirometer to the computer 2 Open the Spiro module The sensor starts to warm up as soon as the SpiroPerfect module is opened 3 Wait for at least 5 minutes before starting a new test Flo
33. 3 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 15 The status bar of the Recording window displays ATS acceptability criteria met duration of the effort number of FVC SVC and MVV efforts completed in a test and if the reproducibility criteria are met 16 When the patient finishes testing select Done The Spirometry view appears displaying all the efforts 8 2 Incentive Screen The incentive screen is used to encourage pediatric patients to blow into the flow transducer the best they can Note If the patient s demographics are outside of the Prediction norm demographics no prediction values will be calculated The incentive screen will not operate without predicted values To display the Incentive screen Select the Incentive button from the Recording Test toolbar Or Select Incentive from the Type of Curve drop down menu The following screen appears Figure 8 5 Recording window with incentive screen selection Recording Test E E inl D x F amp gt Record FYC SVC MYV Incentive Comment Delete Done Pe Medication Dosage amp Unit Note ncentive screen The fireman extinguishes the fire if the patient s effort reaches 80 of the predicted for PEF amp FVC values If the patient s effort is below 80 the fire is not extinguished Parameters FEVO5S FEV3 FEV6 L IL L L 1 Crapo 1981
34. 5 31 4 80 3 73 5 65 Reproducibility Pre not met To remove the Incentive screen select Volume Time or Flow Time from the Type of Curve drop down menu or select the FVC SVC or MVV button DIR 80012334 Ver H 44 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 8 3 Patient Procedures Patients may become faint light headed dizzy or short of breath during spirometry testing Watch patients closely If they WARNING choose to stand during testing keep a chair immediately behind them If there is any reason for concern stop the test and take proper action Recommendations Practice the procedure with the patient before recording the effort American Thoracic Society recommends ending recording after eight successful FVC efforts to avoid fainting To prepare patients for any spirometry test explain the entire procedure for the type of effort you want them to perform Remind patients that the test is painless Demonstrate at least one effort for the patient The accuracy of a spirometry test is highly dependent on the patient s understanding and cooperation So be prepared to coach and encourage the patient with your body language and your words for example Blow blow blow keep blowing until you can t blow out any more to ensure a good effort with reproducible results Instruct patients to do the following e Loosen any tight articles of
35. Allyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 6 1 The Ambient settings dialog box Ambient settings Ambient settings Temperature 20 Humidity Pressure 1040 mbar Cancel Enter the Temperature value The value for the ambient temperature Enter the Humidity value The value for the ambient air humidity Enter the Pressure value The value for the ambient barometric pressure ee Tip In the spirometry settings the ambient units for temperature and pressure can be changed Tip There is an additional option available to update the Ambient settings 1 Select Calibrate located on the Toolbar or press F10 2 Enter the ambient setting information in the Pre Calibration dialog box Updating ambient settings is recommended when a calibration is going to be performed DIR 80012334 Ver H 32 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 7 Calibration of Flow Sensor 1 CAUTION The American Thoracic Society and Welch Allyn recommend calibrating spirometers every day before use Welch Allyn guarantees accurate calibration only with the use of a Welch Allyn 3L calibration syringe Although SpiroPerfect provides other calibration syringe volumes for use Welch Allyn is not responsible for the system s accuracy if these syringes are used Flow Transducers Flow Transducers are manufactured to high precision and it is not necessar
36. B Saunders 1971 Spirometric Reference values from a Mediterranean population J Roca J Sanchis A Agusti Vidal F Segarra D Navajas R Rodriguez Roisin P Casan S Sans Bull Eur Physiopathol Respir 1986 22 217 224 Growth and Decay of Pulmonary Function in Healthy Blacks and Whites Janet B Schoenberg Gerald J Beck and Arend Bouhuys Respiration Physiology 1978 33 367 393 Nitrogen Single Breath Test Flow Volume Curves and Spirometry in Healthy Children 7 18 Years of Age L Solymar P H Aronsson B Bake and J Bjure European Journal of Respir Dis 1980 61 275 286 Spirometric Studies in Non smoking Healthy Adults AA Viljanen et al The Scandinavian Journal of Clinical Lab Investigation 41 supplement 159 5 20 1981 Wang X Dockery DW Wypij D Fay ME Ferris BG Jr Pulmonary function between 6 and 18 years of age Pediatric Pulmonology 1993 15 75 88 Maximum Expiratory Flow Volume Curves and Airway Conductance in Children and Adolescents A Zapletal EK Motoyama KP Van De Woestijne VR Hunt and A Bouhuys Journal of Applied Physiology vol 26 no 3 308 316 March 1969 69 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 12 3 Norm Extrapolation Extrapolation is the practice of applying a norm s formula to a patient whose profile doesn t fit that norm s profile For example if you were testing an 88 year old man and the primary selected norm wa
37. Best effort Best composite Cancel Apply Help 5 1 General Tab To display the General tab 1 Choose File 2 Select Settings gt Spirometry gt General The following screen appears DIR 80012334 Ver H 21 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 5 2 Spirometry General Tab Settings E el x 5 Spirometry 1 General Viewing Parameters Printing Recording General Prediction Calibration syringe ECCS Quanjer 1993 3000 ml VIC Paramete Wal FC Best composite only Calibration reminder Ever Day Week Month Exercise ECG Heverzibilit Post Pre Past Pre zPre 5 pirometry Ambulatory blood Final resul rezsure pile Best effort Best composite as Recallect Flow Lis Temperatur 7 m PostFre Pred Cancel Apply Help Setting Description Prediction Select the prediction to use The list contains all supported predictions VC Parameter VC parameters FEV1 formula The FEV1 formula determines the calculation method for the FEV1 value which affects the automatic interpretation The variable part of this formula is the denominator the numerator is always the best effort s FEV 1 value To determine the way in which FEV1 is calculated choose from these options e FVC FEV1
38. Equipment General Requirements for safety Safety requirements for medical electrical systems IEC EN 60601 1 Medical Electrical Equipment General Requirements for Safety IEC 60601 1 2 Medical Electrical Equipment Safety Requirements EMC IEC EN 60601 1 4 Collateral Standard for Programmable Medical Systems CAN CSA C22 2 No 601 1 M90 UL 60601 1 Medical Electrical Equipment General Requirements for Safety Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road Navan County Meath Republic of Ireland 4341 State Street Road WelchAllyn Skaneateles Falls NY 13153 USA Tel 800 535 6663 North America Only or 315 685 4560 Fax 315 685 3361 www welchallyn com DIR 80012334 Ver H 82 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 17 Guidance and Manufacturer s Declarations Caution The Welch Allyn SpiroPerfect spirometer needs special precautions regarding EMC and needs to be installed and put into service according to the following EMC information provided Portable and mobile RF communications equipment can affect the Welch Allyn SpiroPerfect spirometer Electromagnetic Emissions The Welch Allyn SpiroPerfect is intended for use in the electromagnetic environment specified below The customer or the user of the Spirometer should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment
39. FEV1 FVC e FIVC FEV1 FEV1 FIVC e FVC FIVC SVC FEV1 FEV1 FVC or FIVC or SVC the largest Note The SVC parameter is only included if Final Result is set to Best composite Reversibility Reversibility is the percentage difference between pre test and post test data This measurement indicates the effect of medication on lung function Reversibility applies to each parameter separately DIR 80012334 Ver H 22 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Final Result A patient s best effort is a measurement calculated from a set of efforts To determine the method in which best effort is calculated choose from these options Best effort Defines best effort as the single best effort in a set of efforts per effort type best FVC pre best FVC post best SVC This ATS recommended method uses the effort with the highest sum of FVC FEV1 or the effort with the highest SVC value For details see the document noted in reference 5 Best Composite Defines best effort as a composite of the highest parameter values across all selected efforts Calibration Default value for the volume of the calibration syringe Select the Syringe syringe Volume from the list Calibration Check this box to receive a calibration reminder pop up daily weekly or reminder monthly Pressure Determines the unit of Pressure Check the preferred unit Flow Determines the unit of Flow on the axis of the gra
40. Function Testing European Respiratory Journal volume 26 supplement number 16 April 2005 7 U S Pulmonary Function Standards for Cotton Dust Standard 29 CFR 1910 1043 Appendix D 8 Lung Function Testing Selection of reference values and interpretive strategies American Thoracic Society American Review of Respiratory Disease 144 1202 1218 1991 DIR 80012334 Ver H 74 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 13 Maintaining the Spirometer Welch Allyn 13 1 Maintaining the Sensor The Spirometer sensor needs little maintenance to stay in good working condition N WARNING Change the flow transducer for each patient Check that all connections are properly aligned and tight Visually check the pressure tubing for leaks and kinks Check for irreversible bending or compression of the pressure tubing between flow transducers and device Caution Perform the following inspections daily Ensure spirometer is calibrated and that the proper lot code and calibration code is used The lot code and calibration code can be found on the flow transducer package For more detailed information please refer to chapter 7 the Calibration chapter of this manual Caution void placing spirometer and any of its components in direct sunlight or in a dusty environment To make reliable recordings calibrate the sensor on a daily basis Keep track of the calibrations in the calibration log
41. S CP200 Package includes Lot code and Calibration code V Pressure Tubing 703415 1 CPWS CP200 2m Sensor 703554 1 Spirometer USB Kit Nose Clip 100680 1 Calibration Syringe 703480 1 3L CPWS CP200 SPIRO Syringe Calibration BASIC LVL CAL 1 Service BASIC LVL2 CAL 1 DIR 80012334 Ver H 77 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 14 Troubleshooting Condition The Device sensor is not responding Measured values are incorrect Values are too high intermittent Flow data is out of range measured flow has exceeded the allowable limits The program does not predict values or the values appear incorrect Unable to calibrate DIR 80012334 Ver H Solution Disconnect and reconnect the sensor Check if the port settings in the settings menu correspond with the used COM port Verify LOT number and perform a verification test Check the flow transducer for potential obstruction Do a volume calibration to check the gain factor and to recalibrate the device if necessary Check to ensure that the patient s lips form a tight seal around the flow transducer Use a nose clip on the patient Retest with fingers positioned properly around the flow transducer Do not block the end of the flow transducer with your fingers or hand Check the flow transducer for obstruction caused by patient saliva or phlegm Replace the flow transducer Check to ensu
42. V1 FIV1 FEV0 5 FEV1 FEV2 FEV3 FEV5 FEV6 FEV0 5 FEV0 5 FEV1 FEV1 FVC FEV2 FEV3 FEV5 FEV6 PEF FEF25 FEF50 FEF75 FEF0 2 1 2 FEF25 75 FEF75 85 PIF FIF50 FEF50 FIF50 FEV1 FEV6 FET MEF25 MEF50 MEF75 SVC ERV IRV VT IC BF MV Tin Tex Tin Tex MVV MV VT BF DFRC Quality Checks ATS Acceptability and ATS Reproducibility checks Audio and visual incentive for assistance in coaching patients Connectivity Compatible with CardioPerfect Workstation Export compatible with most electronic medical records programs Available in multi user network Telemedicine option for e mail transfer Storage and e Temperatures between 20 C 4 F and 50 C 122 F Environment e Relative humidity between 15 and 95 non condensing e Atmospheric Pressure of 500 hPa mbar to 1 060 hPa DIR 80012334 Ver H 80 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Specification Description Operation Environment e Temperatures between 10 C 50 F and 40 C 104 F e Relative humidity between 15 and 90 non condensing e Atmospheric Pressure of 700 hPa mbar to 1 060 hPa mbar e Warm up period of 5 minutes Mode of Operation Continuous DIR 80012334 Ver H 81 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 16 Statutory and Regulatory Requirements MDD Medical Device Directive MDD 93 42 EEC IEC EN 60601 1 Medical Electrical
43. V6 Forced expiratory volume in liters at 6 seconds FEV0 5 FEVO0 5 as 96 of FVC FEV1 FEV1 as of FVC Same as FEV1 FVC A parameter for a single FVC effort FEV1 formula A user selectable formula that determines the calculation method for a test s not an effort s overall FEV1 value which affects the automatic interpretation FEV2 FEV2 as of FVC FEV3 FEV3 as of FVC FEV5 FEV5 as of FVC FEV6 FEV6 as of FVC FEVt Timed forced expiratory volume in liters Volume of air exhaled in the specified time during an FVC effort DIR 80012334 Ver H 89 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual FIF50 Forced inspiratory flow in L s at 5096 of FIVC FIV1 Forced inspiratory volume in liters at one second FIV196 FIV1 as of FIVC FIVC Forced inspiratory vital capacity in liters The maximum volume of air that can be inspired during forced inspiration starting from full expiration FIVt Timed forced inspiratory volume in liters Volume of air inhaled in the specified time t flow The speed at which air is inhaled or exhaled in L s flow z f v See flow volume flow volume Same as flow over volume or flow f V A type of data curve available during FVC testing The y axis represents flow L s the x axis represents volume liters flow loop A flow volume curve that includes inspiratory data negative values on the y axis FRC Functional residual cap
44. WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual REP Regulatory Affairs Representative Welch Allyn Inc Welch Allyn Limited 4341 State Street Road Navan Business Park Skaneateles Falls NY Dublin Road 13153 USA Navan County Meath www welchallyn com Republic of Ireland 901051 SPIROMETER 80012334 Ver H Revision date 2015 05 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Copyright Copyright 2015 Welch Allyn All rights are reserved To support the intended use of the product described in this publication the purchaser of the product is permitted to copy this publication for internal distribution only from the media provided by Welch Allyn No other use reproduction or distribution of this publication or any part of it is permitted without written permission from Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of Welch Allyn to provide accurate and up to date information to users and operators alike Welch Allyn CardioPerfect Workstation and SpiroPerfect are registered trademarks of Welch Allyn Soft
45. acity in liters Volume of air remaining in the lungs and airway at the average end expiratory level FVC Forced vital capacity 1 A type of test in which patients inhale fully and exhale forcefully for as long as they can The goal to measure the volume and flow of air May or may not include forced inhaling When forced inhaling is included it may be done either before or after exhaling See flow loop 2 An important parameter in liters the maximum volume of air that can be delivered during forced expiration starting from full inspiration IC Inspiratory capacity in liters The maximum volume of air that can be inhaled after a normal unforced exhalation See also tidal breathing incentive screen An animated screen that gives patients usually children a goal to achieve while exhaling This screen is listed as a type of curve data display available during FVC testing IRV Inspiratory reserve volume in liters The maximum volume that can be inspired from the average end inspiratory level See also tidal breathing LLN Lower limit of normal The lowest expected value for a spirometric parameter The method of determining this value varies from norm to norm LLN is displayed together with the predicted value lung age A calculated value based on a patient s demographics and spirometric performance that gives a relative indication of the health of the subject s lungs This value is used primarily to encourage smoki
46. age the equipment Single Use Do Not Reuse mm diameter not protected against the ingress of water Shipping Storing and Environment Symbols Expiration Date Keep away from sunlight Stacking limits Fragile Keep away from rain Certification Symbols C CE Mark for Class Is Im 16 amp III 0297 Authorized Representative in the European Community DIR 80012334 Ver H 9 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Conventions Serial Number Product Identifier Manufacture Date YYYY MM DD Temperature Range Number Do not dispose of in trash for devices Pe Consult operating instructions directions for use DFU A copy of d the DFU is available on this website A printed copy of the DFU welchallyn com can be ordered from Welch Allyn for delivery within 7 calendar days Global Trade Number 2 B X By prescription or order of physician or dentist Atmospheric pressure limitation Humidity limitation DIR 80012334 Ver H 10 93 WelchAllyn CardioPerfect Workstation 1 3 SpiroPerfect Module User Manual Using the Spirometer Safely Before using or servicing the spirometer you must read and understand the following safety related information N WARNING Do not perform spirometry test if any of the following conditions apply to the patient e hemoptysis of unknown origin forced ex
47. assess the effort for signs of cough during the initial second glottis closure early termination effort that is not maximal throughout leak obstructed mouthpiece Refer to the effort acceptability poster that shipped with your product for examples of efforts that are acceptable The poster also contains examples of inaccurate results Delete any efforts exhibiting signs of inaccurate results See section 8 4 Deleting an Effort on page 46 The poster is also accessible in the Help menu Go to Help Spirometry Acceptability Poster 12 9 Reproducibility of a test stage Within a test stage i e either Pre or Post medication an assessment will be made of the acceptability and reproducibility of the overall test stage The test stage will be deemed by the software to be acceptable if there are at least 3 acceptable efforts and reproducible if within the acceptable efforts the best two FVC measurements and the best two FEV1 measurements are within 150 mL DIR 80012334 Ver H 73 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 12 10 Reversibility Bronchodilator response For any spirometry test that has Pre and Post efforts significance of the BD response will be shown in the interpretation text area stating either Not Significant BD Response or Significant BD Response as appropriate opiroPerfect will deem the Bronchodilator response to be significant if either FVC or FEV1
48. ce between portable and mobile RF communications equipment transmitters and the Welch Allyn SpiroPerfect as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of transmitter 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people DIR 80012334 Ver H 86 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 18 Function keys The Welch Allyn CardioPerfect module is just like all Windows applications designed for working with the mouse However there might be situations in which working with the keyboard can be quicker Therefore a number of functions within the Welch Allyn CardioPerfect module can also be selected directly using the keyboard Here is a list of all available keyboard shortcuts in this module for a more gen
49. clothing that might constrict lung function for example a tight belt tie vest bra girdle or corset e Remove any foreign objects from the mouth including loose dentures e The use of a nose clip is highly recommended If used check for proper fit e Place lips and teeth around a new flow transducer sealing their lips tightly around the transducer Grip slightly with teeth in the groove e Keep tongue away from the flow transducer to avoid blocking it e Keep the rear of the Flow sensor free e Keep chin up so as not to restrict the airway Always check the interior of the flow transducer to ensure that no foreign objects are present WARNING Once the patients have the transducer in place ask them to perform the effort using the guide below for the patients predicted performance effort breathing instructions Note Place the mouthpiece in the patient s mouth after stabilization DIR 80012334 Ver H 45 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual For an FVC effort instruct the patient to 1 Breathe in until the Total Lung Capacity is reached 2 Blow out forcefully until the Residual Volume is reached Allow sufficient time For an FVC loop instruct the patient to 1 Breathe in until the Total Lung Capacity is reached 2 Exhale forcefully until the Residual Volume is reached 3 Breathe in forcefully until the Total Lung Capacity is reached Allow suff
50. d parameters will trend as a percentage of predictive values Manual If checked you are allowed to manually select the best effort when the selection of Final Result is set to Best Effort best effort Display ATS If checked a row or column appears in the Parameter and Measurement Acceptability tables displaying whether or not each individual effort meets the ATS 2005 per effort acceptability criteria Superimpose If checked curves are offset on the graph If unchecked all curves are FV Curves superimposed DIR 80012334 Ver H 24 93 WelchAllyn CardioPerfect Workstation Display Lung Age Effort Label X Axis Position Table Color Scheme Scheme Editor SpiroPerfect Module User Manual If checked the estimated Lung Age will be shown while viewing a test and in the printed reports for patients of 20 years or older For details see Lung Age page 70 Time or Number If Time is selected each effort is labeled with the time it was recorded If Number is selected each effort is labeled with a number and stage For example FVC Pre3 means it is the 3rd effort of a FVC test Bottom or Top If Bottom is selected spirograms are displayed with the horizontal axis at the bottom of the graph If Top is selected spirograms are displayed with the horizontal axis at the top of the graph Defines the background color and font type and color of the Spirometry module The default setting is Welch Allyn To customize the settin
51. e following studies provides expected values for various spirometric parameters by measuring significant samples of a specific population Berglund 1963 Crapo 1981 Dockery 1983 ECCS Quanjer 1993 Falaschetti 2004 Forche ll 1988 GLI 2012 Spirometric Studies in Normal Subjects l Forced Expirograms in Subjects 7 70 Years of Age Berglund E et al Acta Medica Scandinavica vol 173 2 185 192 1963 Reference Spirometric Values using Techniques and Equipment that Meet ATS Recommendations Crapo et al American Review of Respiratory Disease 1981 123 659 664 Distribution of Forced Vital Capacity and Forced Expiratory Volume in One Second in Children 6 11 Years of Age Dockery DW et al American Review of Respiratory Disease 1983 128 405 412 Lung Volumes and Forced Ventilatory Flows Official Statement of the European Respiratory Society Quanjer Ph H et al European Respiratory Journal 1993 vol 6 Suppl 16 5 40 Prediction equations for normal and low lung function from the Health Survey for England Falaschetti E et al European Respiratory Journal 2004 23 456 463 Neue spirometrische Bezugswerte fur Kinder Jugendliche und Erwachsene Forche G Harnoncourt K Stadlober E Osterreichische Arztezeitung 48 15 16 1988 Multi ethnic reference values for spirometry for the 3 95 year age range the global lung function 2012 equations Quanjer P H Stanojevic S Cole T J Bau
52. ements described in the Product documentation If a Product or accessory covered by this warranty is determined to be defective because of defective materials components or workmanship and the warranty claim is made within the warranty period described above Welch Allyn will at its discretion repair or replace the defective Product or accessory free of charge You must obtain a return authorization from Welch Allyn to return your Product before you send it to Welch Allyn s designated service center for repair THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WELCH ALLYN S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THEWARRANTY DIR 80012334 Ver H 4 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Table of Contents 1 1 1 1 2 1 3 1 4 1 5 2 1 2 2 2 3 2 4 3 1 5 1 5 2 5 3 5 4 5 5 5 6 6 1 6 2 6 3 7 1 rav 7 3 7 4 res 8 Odi CIIOi ftem c 8 TEAS asume 8 ne 9 Using the Spirometer Safely 11 Product OVverviewW
53. er Manual Test Information Pre Time Past time Norm Reference 11 59 12 07 NHANESIII 1999 Quality Messages Pre 4 Blow out longer 2 Blow out longer 1 Blow out longer Post 7 Blow out longer 6 Blow out longer 5 Blow out longer FEV1 Pre Post Var 79 ml 4 FVC Pre Post Var 138 ml 5 ATS Reproducibility Pre NOT MET Post NOT MET 10 ml 0 95 32 ml 1 3 acceptable efforts 3 acceptable efforts Test Results Lung age 63 years FEV 19sPred 101 95 FEV 195 TTo Improvement FVG 95 FEV1 97 Post Pre 100 Not Significant BD Response Test interpretation Pre FVG 2 64L FEV1 2 07L FEV 1 77 5 2 07 2 67 FEV1 Max FVC FIVC SVG 11 15 2007 12 01 34 PM Within normal limits UNCONFIRMED REPORT Post FVC 2 5L 5 4 FEV1 2 0L 8 595 FEV1 71 096 8 4 11 15 2007 12 08 51 PM Within normal limits Best Effort Pred LLN 4 Pre 2 62 1 88 2 02 1 45 78 64 Parameter Units FVC L FEV1 L FEV1 FVC 96 FEV6 L PEF L s FEF25 75 L s Pred z 7 Post 10196 0 04 2 50 102 0 13 10196 0 06 Pred z Change 95 0 27 5 0 14 99 0 08 3 0 07 103 0 27 2 2 5 0 14 9 0 69 104 0 09 0 0 01 1 69 0 75 103 0 08 DIR 80012334 Ver H Date and time of Pre and Post efforts Norm Profile used to calculate predicted values For each selected Pre and Post effort this section p
54. eral function key description please refer to the Workstation manual pirometry functions Key Function O SHIFT 4 CTRL 4 S CTRL H Opens the Interpretation Histor CTRLTI D Delete current effort CTRL H T puncion gt O DIR 80012334 Ver H 87 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 19 Glossary adult Generally 18 or older Age limits vary with each norm ASS American Security Society ATS American Thoracic Society An organization that provides standards for spirometry common practice and equipment ATS acceptability criteria Applicable to FVC testing only 1 Criteria ensuring that an individual effort started and ended satisfactorily no leaks or coughs 2 Criteria ensuring that the patient has made at least two efforts of the same kind two FVC pre or two FVC post and that these efforts are reproducible For details see document noted in reference 5 ATS interpretive results The software calculates interpretive results as described in the document noted in reference 2 baseline See pre test best effort A measurement calculated from a set of efforts The formula for calculating best effort is user selectable 1 the single best effort or 2 a composite of best parameter values BF Breathing frequency See also MV and tidal breathing bronchospasm evaluation See post t
55. est BTPS Body conditions normal body temperature 37 C ambient pressure saturated with water vapor The BTPS correction factor converts ambient conditions temperature humidity and pressure to BTPS CardioPerfect workstation A PC using Welch Allyn CardioPerfect software Stores ECG and spirometry test data Can communicate with other electronic patient information systems such as billing and medical records composite norm value A value that is filled in from another norm a composite norm source when the primary selected norm does not support a given parameter Applicable only when composite norm values is enabled COPD Chronic obstructive pulmonary disease Characterized by airflow obstruction that is primarily caused by smoking Examples include emphysema chronic bronchitis and asthmatic bronchitis curve A graphical display of spirometry data During SVC testing only one curve type is available volume time During FVC testing three curve types are available volume time flow volume and flow time effort A single spirometry maneuver for example one blow A test typically comprises multiple efforts See also best effort and test ERS European Respiratory Society ERV Expiratory reserve volume in liters The maximum volume that can be expired from the level of the functional residual capacity FRC See also tidal breathing extrapolation The practice of applying a norm s formula to a patient
56. evere 34 lt FVC lt 50 Os Restriction of Predicted no Very Severe lt 34 Restriction of Paqta Very Severe Obstruction FVC Below 80 of predicted And low vital capacity cannot rule out superimposed restriction DIR 80012334 Ver H 72 1 9 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 12 8 Acceptability of an effort See section 12 11 references 2 5 and 8 for details of the ATS standards An individual effort is deemed acceptable by the SpiroPerfect software when The effort has a good start extrapolated volume lt 5 of FVC or 150 mL whichever is greater If this criterion is not met the effort quality message Don t hesitate or Blast out faster displays The effort exhibits satisfactory exhalation duration gt 6 seconds gt 3 seconds for children under 10 years of age OR 1 second plateau in the volume time curve occurs If this criterion is not met then the effort quality message Blow out longer No plateau displays See the Effort Quality Message table below for further detail Effort Quality Message Don t hesitate Back Extrapolated Volume BEV is 150 mL Blast out faster PEF time 120 ms Blow out longer No plateau FET 6 seconds 3 pediatrics and no plateau Good effort DE 6 seconds 3 pediatrics and has plateau FET is 6 seconds 3 seconds pediatrics In addition the clinician administering the test should
57. fore calibrating the flow sensor If N the ambient settings are not adjusted before calibration the CAUTION device will not be properly calibrated and could give false readings You must recalibrate if there is a significant change in the ambient settings Ambient settings are stored locally by the program and passed on to the flow sensor before each measurement This means that when using different PC s with the same flow sensor you have to set the ambient settings on each PC before starting the measurements Also when another person logs in to the PC he she needs to enter the ambient settings 6 1 Why the Workstation needs Ambient Setting Information Ambient settings information is necessary for calculating the Ambient Temperature Pressure Saturation ATPS to Body Temperature Pressure Saturation BTPS correction in the Flow sensor 6 2 When to Adjust the Ambient Settings Adjust the ambient settings e Daily the first time logging into the Spirometry module e When ambient settings have changed significantly during the day e When the same flow sensor is used on different computers In this case adjust the ambient settings on each computer e Before calibration takes place in the pre calibration window 6 3 Adjusting the Ambient Settings 1 Make sure the SpiroPerfect module is loaded 2 Press F9 or choose Ambient settings from the Tools menu The following screen appears DIR 80012334 Ver H 31 93 Welch
58. g the syringe instead of filling it before starting the calibration DIR 80012334 Ver H 39 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual A Caution the users responsibility to determine whether to accept or reject failed calibration data If the device does not pass calibration it could give false readings 7 5 Calibration log Figure 7 11 Calibration log window cs ini il Date User Locaton Device ID Insp CF SD Exp CF Exp SD Calibrated 28 4 2005 17 10 45 CARDIONJor wi 0 8842 N A 0 5935 N A 28 4 2005 17 10 30 28 4 2005 17 05 49 CARDIONJ 28 4 2005 17 05 33 CARDIO 33 dio Welch Alin 1 3345 N A 1 1682 N A ando Welch Alyn 11900 NAA 11971 Go ch UA 01 39 N A de gii Use the Calibration log to view calibration information of current and previous calibration efforts Each time the sensor is calibrated results are stored in the calibration log Select a calibration effort from the list to see the curve that belongs to it Calibration Log Selection Description Date amp time Date and time of the calibration User Name of the user that performed the calibration Location Location specified in the general settings Device ID The spirometry sensor hardware used Insp CF The Calibration Factor of the inspiratory strokes Insp SD The stroke difference between the inspiratory strokes Exp CF The Calibration Factor of
59. gs select User Defined from the drop down menu Select the User Defined option from the Table Color Scheme drop down menu Once selected the Scheme Editor button becomes highlighted Click on the Scheme Editor button The Styles properties editor dialog box appears You can customize the properties for the Spirometry module in the Styles properties editor dialog box 5 3 Parameters Tab To display the Parameters tab 1 Choose File 2 Select Settings gt Spirometry gt Parameters The following screen appears DIR 80012334 Ver H 25 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 5 4 Spirometry Parameters tab Settings O x 5 Spirometry Measurements Sis parameters Printer Selection General All Inverted Default Exercise ECG Spirometry Ambulatory blood Pressure 2 4 4 4 Cancel Apply Help Select parameters for three categories Setting Description Measurements Parameters selected in the Measurements column are displayed in the Measurements Tab of the SpiroPerfect module Six parameters Parameters selected in the Six parameters column are displayed in the six parameters table of the module s Parameter area A maximum of six parameters can be selected per test type For FVC a minimum of three parameters is required Printer Parameters selected in the Printer column are printed
60. he predicted value The z score will be shown together with the 96 predicted values for the norms that support z score calculation DIR 80012334 Ver H 92 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Index add test information 49 ambient Settings 31 ATS acceptability criteria 24 best composite 23 DEST SION onsec uicem sd 23 manual selection 24 calibration of flow sensor 39 comment editor 30 add or change comments 47 compare 48 49 51 58 composite norm values 70 delete effort 46 flow transducer disposable 13 77 incentive screen 44 interpretation 59 20 52 56 DIR 80012334 Ver automatic 22 59 60 en 59 lil 0 60 72 Interpretation BONOT nasa 59 60 Uno OG ious suu 70 patient procedures effort uuu u 46 PVG OOD uu u u ua aaa 46 MVV effort 46 CMON 46 1 0
61. he right of the title bar can be used to maximize minimize and close CardioPerfect Workstation Menu bar The menu bar contains the File Edit Mail View Action Tools and Help menus When a menu is grayed out you cannot access its functionality Toolbar The toolbar contains the Patient Exercise ECG Recollect Spirometry ABP Print and Print Preview buttons It provides easy access to other CardioPerfect Workstation applications and most common tasks in the SpiroPerfect module Search area The search area on the left hand side contains search and display functionality In the search area you can find a patient see the date and type of tests recorded for a patient You can create search patterns so you can easily locate frequently needed information DIR 80012334 Ver H 19 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Workspace The workspace displays tests and test related data such as graphs and measurements This is where you record view and interpret the data The workspace is divided into three elements e Graph area This area displays spirograms and flow curves e Interpretation The interpretation area displays the automatic or area confirmed interpretation for the test lung age and ATS reproducibility data e Parameters The parameters area displays each effort and up area to 6 user defined measured parameters Shortcut Menu In the workspace you can use shortcut menus to acces
62. hould be at levels characteristic of a typical location in a typical commercial or hospital environment 84 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Electromagnetic Immunity The Welch Allyn SpiroPerfect is intended for use in the electromagnetic environment specified below The customer or the user of the Welch Allyn SpiroPerfect should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Portable and mobile RF communications equipment should be used no closer to any part of the Welch Allyn SpiroPerfect including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 12 JP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz 1 2 8010 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At80 MHz and 800 the higher frequency range appl
63. icient time 1 Start normal breathing tidal breathing 2 Breathe out until the Residual Volume is reached 3 Breathe in forcefully until the Residual Volume is reached Allow sufficient time 4 Exhale forcefully until the Total Lung Capacity is reached For an SVC effort instruct the patient to 1 Start normal breathing tidal breathing 2 Breathe in calmly until the Total Lung Capacity is reached 3 Exhale calmly until the Residual Volume is reached Allow sufficient time 4 f necessary repeat steps and 4 Steps 3 amp 4 can be reversed meaning a maximum expiration followed by a maximum inspiration For an MVV effort instruct the patient to Breathe in and out forcefully at a pace of approximate 30 breaths per minute 2 seconds per complete breath for 15 seconds the program automatically stops gathering data after 15 seconds About Quality Feedback The spirometer provides effort quality messages as described in the following sections About Effort Quality Messages One of the following effort quality messages appears on the screen after each effort is completed These messages indicate whether an effort was acceptable and if not what the patient needs to do differently Effort Quality Message Don t hesitate Back Extrapolated Volume BEV is gt 150 mL Blast out faster PEF time gt 120 ms Blow out longer No plateau FET lt 6 seconds 3 pediatrics and no plateau Good effort po lt
64. ies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Welch Allyn SpiroPerfect is used exceeds the applicable RF compliance level above the Welch Allyn SpiroPerfect should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Welch Allyn SpiroPerfect Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m DIR 80012334 Ver H 85 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Recommended separation distances between portable and mobile RF communications equipment and the Welch Allyn SpiroPerfect The Welch Allyn SpiroPerfect is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Welch Allyn SpiroPerfect can help prevent electromagnetic interference by maintaining a minimum distan
65. ioPerfect Workstation SpiroPerfect Module User Manual Figure 8 2 New spirometry test window New spirometry test B x Patient information Height Weight Birth date 70 inches 207 2 lps 872 92 Gender Male Caucasian Smoker Asthmatic Test information Referring physician Speciality Any l Prediction norm ELLS Luanjer 1993 Ambient settings 3 Complete Patient information fields in the New spirometry test window Check the omoker and or Asthmatic boxes if applicable 4 Select the Specialty and Referring physician by whom the test was ordered Select the Prediction Norm for the test gender race and height must be entered into the Patientcard dialog box Choose Edit gt patientcard or Alt P otherwise no predictive data is reported The patient s weight is only obligatory for certain prediction norms Note f patient data is missing these will be displayed in red in the New spirometry test window You must fill in the blanks before you are able to continue 5 J W ee The Norm Profiles see section 12 1 indicate valid demographic ranges for each norm 6 Select Ambient Settings If the humidity temperature or pressure have changed since the last calibration adjust as necessary DIR 80012334 Ver H 42 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 7 Select Next The following screen appears Figure 8 3 Recording windo
66. irometer calculates lung age values according to the document cited in Reference 4 Morris 1985 For single effort tests lung age is based on the current effort Otherwise it is based on the patient s best pre effort as defined in the settings Lung age calculations are provided only for patients 20 and older For patients older than 84 years the lung age is extrapolated This limitation is derived from the subject population on which Morris based his research The lung age is one floating point number in years the DIR 80012334 Ver H 70 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual average of the 4 formulas in the Morris article FVC FEV1 FEF25 75 FEFO 2 1 2 opecifically lung age is calculated as follows Gender Lung Age Formula Men 5 920 height 40 000 FVC 169 640 2 870 height 31 250 FEV1 39 375 2 319 height 21 277 FEF200 1200 42 766 1 044 height 22 222 FEF25 75 55 844 4 Women 4 792 height 41 667 FVC 118 833 3 560 height 40 000 FEV1 77 280 4 028 height 27 778 FEF200 1200 70 333 2 000 height 33 333 FEF25 75 18 367 4 height in inches 12 6 Ethnic group correction otudies have demonstrated that expected values for certain spirometric parameters can vary significantly from one ethnic group to another Some norm studies include separate regression equations for different
67. lchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 5 5 Recording Tab To display the Recording tab 1 ChooseFile 2 Select Settings gt Spirometry gt Recording The following screen appears Figure 5 6 Spirometry Recording tab Settings lO x maaa Modules 5 Spirometry 1 ET Sensor typ Spiro Perfect VET 400 Welch Allyn SpiroPerfect Calibration Single calibration stroke protocol xa Evercise ECG Three calibration stroke protocol 1 2 and 3 seconds flow Calibration Error Tolerance Social Security 1 Standard 3 Incentive Fil APR GRA71 SCARDID715MD Vv Modules Fireman svt Ambulatory blood prezzure Sensor calibration informatio Lot Code 24 Calibration Code IVP WOMHY Contirn Code Re ATS sound notification 5 pirametry Cancel Apply Help DIR 80012334 Ver H 29 93 WelchAllyn Setting Sensor Type Connected To Calibration protocol Calibration Error Tolerance Incentive file Sensor calibration information 5 6 CardioPerfect Workstation SpiroPerfect Module User Manual Description Select Welch Allyn SpiroPerfect Welch Allyn SpiroPerfect The port to which the Welch Allyn SpiroPerfect sensor is connected is automatically detected When operating in a thin client environment the application displays an additional option called PerfectLi
68. lume and volume time graphs Incentive graphic for pediatric patient coaching Multiple predicted norms WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual e Customizable report formats e Validated to meet the American Thoracic Society spirometry accuracy standards for both ambient and BTPS humidified air e Instant quality and variability check for proper test performance e Single stroke and multiple stroke calibration protocols e Reduced risk of cross contamination with Welch Allyn single use disposable flow transducers e Meets all industry standards including ATS NIOSH OSHA and Social Security e Trending of several different tests from the same patient DIR 80012334 Ver H 14 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 2 General information 2 1 Welcome Welcome to the SpiroPerfect module of the Welch Allyn CardioPerfect Workstation With this module you can record view and interpret spirometric tests You can also use it to print spirometry tests in various formats The SpiroPerfect module exceeds the recommendations for spirometry of the American Thoracic Society ATS This manual contains specific information about the SpiroPerfect module of the Welch Allyn CardioPerfect Workstation For all general information about the workstation software please refer to the Workstation manual which describes e Creating and editing Patient cards e General i
69. m When calling please be prepared to provide e Product name and model number and complete description of the problem e The serial number of your product if applicable e The complete name address and phone number of your facility e For out of warranty repairs or spare parts orders a purchase order or credit card number e For parts order the required spare or replacement part number s Repairs If your product requires warranty extended warranty or non warranty repair service please call first the nearest Welch Allyn Technical Support Center A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone avoiding potential unnecessary return In case the return cannot be avoided the representative will record all necessary information and will provide a Return Material Authorization RMA number as well as the appropriate return address A Return Material Authorization RMA number must be obtained prior to any return Note Welch Allyn does not accept returned products without an RMA Packing Instructions If you have to return goods for service follow these recommended packing instructions e Remove all hoses cables sensors power cords and ancillary products as appropriate before packing unless you suspect they are associated with the problem e Wherever possible use the original shipping carton and packing materials e Include a packing list and the Welch Allyn
70. mends using gloves when replacing disposable flow transducers and washing hands after touching them WARNING No modification of this equipment is allowed WARNING Fire and explosion hazard Do not operate the spirometer in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide in oxygen enriched environments or in any other potentially explosive environment DIR 80012334 Ver H 11 93 WelchAllyn CardioPerfect Workstation N SpiroPerfect Module User Manual WARNING The CardioPerfect family of devices is an integral part of a personal computer based diagnostic system The user shall adhere to warnings in order to ensure safe and reliable performance of the system The personal computer non medical electrical equipment shall be situated outside the patient environment reference IEC 60601 1 The personal computer used should adhere to the appropriate safety standard for non medical electrical equipment IEC 60950 or its national variants and use of an isolation transformer is recommended The personal computer used should adhere to the appropriate electromagnetic compatibility EMC standard for non medical electrical equipment CISPR 22 24 FCC Part 15 CE or related national variants If it is required for the personal computer to be situated within the patient environment it is the responsibility of the user to ensure that the system provides a level of safety in compliance with IEC 6060
71. n select a line from the Trends graph by clicking on one of the points in the line The percentage deviation for each point is shown when you move the mouse over a point in the line By clicking on a different colored point you select the line of that color and the percentage deviation for that line is displayed when moving over the points of that line 9 10 Measurements Tab Figure 9 15 Measurement Tab Patient CCNV 003 John Doe M 3 27 1967 svc Trend Measurements Test date 8 23 2006 9 23 24 AM ECCS Quanijer FYC Pre 1 FYC Pre 2 FYC Pre 3 FYC Pre 4 FYC Post 1 Final 1993 FinalZPred No No No No No 473 2 99 2 94 2 97 2 99 2 98 294 62 Z 3 90 2 63 2 94 2 58 2 47 2 82 294 75 x 80 x 78 X 86 X 78 X 74 X 88 X 86 2 108 2 2 33 2 34 2 37 2 33 2 38 234 E 2 99 2 94 2 97 2 99 2 98 294 be lt 922 3 62 11 24 10 50 6 78 8 79 11 24 122 2 DIR 80012334 Ver H 57 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual The Measurements Tab contains a number of parameter values for each FVC SVC and MVV efforts Each effort is represented by a separate column he measurement table only displays the efforts belonging to the selected stage It only lists the parameters selected in the settings See page 24 to select parameters for display in
72. nfigure the calibration process DIR 80012334 Ver H 33 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 7 1 The Pre calibration dialog box x Selected Flow Sensor Welch Allyn SproPerfect Lot Code 24 Calibration Code Springe Volume Liter S000 Current Calibration F actor 0 990495 Calibration Error Tolerance f Social Security 1 X Standard 3 X Temperature 20 Humidity Pressure 1040 mbar od Fill in the appropriate settings For a description of the options see the following table Setting Description Lot code Enter the Lot code for the Flow transducers located on the box the Transducers came in Calibration Enter the Calibration code for the Flow transducers located on the box the code Transducers came in See example of a schematic cutout of the label from the Flow transducers box below CALIBRATION CODE LOT QTY 100 III Note the sensor calibration information can also be set in the Spirometry settings recording tab Please make sure that Lot code and Calibration code are still accurate before calibrating Syringe Volume Select the appropriate Syringe Volume Tip See page 20 on how to change the default setting Current This value cannot be changed and indicates the correction factor applied Calibration to the calibration data from the previous session Once the calibra
73. nformation about printing For further information on installation and configuration please refer to the Workstation Installation manual 2 2 Intended Use Indications for Use Using the optional spirometry module and associated accessories to acquire view store and print measures and waveforms of pulmonary function The spirometer should only be used with patients able to understand the instructions for performing the test Indications for spirometry include but are not limited to the following shortness of breath Chronic cough Occupational exposure to dust and chemicals Assist in the diagnosis of Bronchitis Assist in the diagnosis of Asthma Wheezing Assist in the monitoring of bronchodilators 2 3 Contraindications Relative contraindications to performing spirometry are AARC Clinical Practice Guideline Spirometry 1996 Update e hemoptysis of unknown origin forced expiratory maneuver may aggravate the underlying condition e pneumothorax e unstable cardiovascular status forced expiratory maneuver may worsen angina or cause changes in blood pressure or recent myocardial infarction or pulmonary embolus e thoracic abdominal or cerebral aneurysms danger of rupture due to increased thoracic pressure e recent eye surgery e g cataract e presence of an acute disease process that might interfere with test performance e g nausea vomiting e recent surgery of thorax or abdomen DIR 80012334 Ver H 15 9
74. ng cessation Lung age is not available for patients younger than 20 years maneuver See effort MV Minute volume in liters The volume of air expired per minute measured over at least one minute MV BF VT See also tidal breathing norm A research based spirometry data set with a specific profile for race gender age and height The software compares each patient s results with data in the primary selected norm reporting the results as percentages of the predicted normal values normal Consistent with norm data DIR 80012334 Ver H 90 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual parameter A commonly defined attribute of a spirometric waveform FVC FEV1 and so on pediatric Generally under 18 years old Age limits vary with each norm Also young children s lung sizes vary greatly Norm values and interpretive results are not available for patients under 3 years of age Pediatric use in the US for ages 6 and above PEF Peak expiratory flow in L s The largest expiratory flow achieved with a forced effort PIF Peak inspiratory flow in L s The largest inspiratory flow achieved with a forced effort post test A test that provides data to compare with pre test data Sometimes called post Rx or post BD bronchodilator A post test must follow a pre test within 24 hours See also reversibility predictive curve A curve that follows a set of predictive points predictive point
75. nk This option allows the use of the Welch Allyn SpiroPerfect sensor in thin client environments Select the Single calibration stroke protocol this is recommended for the Welch Allyn Spiro Perfect or Select Three calibration stroke protocol 1 2 and 3 seconds flow Select Social Security 1 for increased accuracy required by US Social Security Administration guidelines or Standard 3 Select the file that is used for the incentive screen for testing the pediatric population Enter the Lot code and the Calibration code and Confirm For more information see 32 If the Spiro Perfect 400 is selected this area is not applicable Customize the spiro txt file Statements used in the Comment editor can be customized Please refer to the Workstation manual for general instructions on editing this file Medication list In addition to the pre defined comment and interpretation statements this file also contains the medications shown in the medication list These items are immediately followed by an asterisk in the spiro txt file Note spiro_cmt txt file is available the spiro txt file is used DIR 80012334 Ver H 30 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 6 Ambient Settings Temperature Humidity and Pressure Adjust the Ambient Settings the temperature humidity and air pressure before calibrating the flow sensor Adjust ambient settings be
76. nual entitled CardioPerfect Workstation User Manual For information that the workstation and spirometry functions share for example instructions for moving through the menus searching for patient data see the CardioPerfect workstation manual Please take note of all safety precautions and warnings provided with this device before using this device and the accompanying software We at Welch Allyn are dedicated to provide safe products to our customers It is the user s responsibility to follow the rules of safety as established for their protection and for the protection of their patients as described in this manual Please take special note of the safety and precautions as described in Using the Spirometer Safely on page 11 DIR 80012334 Ver H 8 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 1 2 Symbols The symbols shown below may appear on the spirometer components on the packaging on the shipping container or in this manual Safety Symbols A safety symbol used on the device to highlight the fact that there are specific warnings or precautions associated with the device which are not otherwise found on the device label WARNING A WARNING in this manual indicates conditions or practices that if not corrected immediately could lead to illness injury or CAUTION 22th A CAUTION in this manual indicates conditions or practices that if continued or not corrected immediately could dam
77. oke The speed in the L s plunger should be moved as indicated by the blue calibration bar during the strokes Exp Vol The expiration volume reached by pushing in the plunger The expiration deviation from the actual volume in percent Insp Vol The inspiration volume reached by pulling out the plunger The inspiration deviation percentage Avg Vol The averages of inspiration volume and expiration volume Abs Avg The absolute average deviation percentage between inspiration volume and expiration volume The Averages row gives the averages reached for all strokes Please refer to this row for improving the calibration results After you have accepted the results you can view these values in the table below the graph by selecting the Calibrate Results button DIR 80012334 Ver H 38 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 7 7 Single stroke calibration window with calibrated results rahbration D J x e 4j Repeat Calibration Calikesion Results Calibration Logs Piri Log Print Preview Help Done 1040 20 0 C 60 Syrings volume 3000 ml Protocol Sings Flow Figure 7 8a Single stroke calibration Figure 7 8b Three stroke calibration Stroke Nr Lis Exp Vol Exp Insp Vol Insp Ava Vol Ava Stroke L s Exp Vol Exp Insp Vol Insp Avg Vol Avg 1 1 2993 0 03 2990 0 33 2994 0 18 05 3007 0
78. on the reports Selecting more than 15 parameters for WARNING printing may result in the list of printed parameters being truncated on all but the Best FVC report Parameters Measured FVC testing FVC FIVC FIV1 FIV196 FEVO 5 FEV1 FEV2 FEV3 FEV5 FEV6 FIVO 5 0 5 FEV1 FEV1 FVC FEV2 FEV3 FEV5 FEV6 PEF FEF25 FEF50 FEF75 FEFO 2 1 2 FEF25 75 FEF75 85 PIF FIF50 FEF50 FIF50 FEV1 FEV6 FET DIR 80012334 Ver H 26 93 WelchAllyn CardioPerfect Workstation MEF25 SVC testing SVG MV MVV testing MVV Selection None All Inverted Default SpiroPerfect Module User Manual MEF50 MEF75 ERV IRV VT IC BF Tin Tex Tin Tex MV VT BF DFRC Blanks all previously selected parameters boxes in the Measurements and Printer columns It does not affect the Six parameters column Selects all parameters in the Measurements and Printer columns It does not affect the Six parameters column Deselects the selected parameters and selects the parameters that are not for the Measurements and Printer columns It does not affect the Six parameters column Selects factory Default parameter selections for the Measurement Six parameters and Printer columns 5 4 Printing Tab WARNING Printing these reports with a black and white printer can lead to contusion as it is not easy to identify which curve is a Pre and which is a Post effort To display the Printing tab 1 Choose File 2 Select Settings gt Spirometry gt
79. or liters per minute based on settings DIR 80012334 Ver H 53 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 9 7 SVC Tab Figure 9 10 SVC Tab Patient Test date CCNV 003 John Doe M 3 27 1967 2 8 2000 4 15 11 PM SWE MYA Trend Measurements SVC Test Review results under the SVC tab Only volume time spirogram graphs are displayed along with six SVC parameters Calipers mark the beginning and the end of the tidal area Each effort line displayed on the graph has a different color Note Calipers can be manually adjusted If so affected parameters will automatically be recalculated If no SVC test is performed the SVC tab is disabled DIR 80012334 Ver H 54 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 9 8 MVV Tab Figure 9 11 MVV Tab Patient Test date CCNV 003 John Doe M 3 27 1967 2 8 2000 4 15 11 PM FYE SYE Muy Trend Measurements 1 2 3 4 3 B T 3 10 11 12 13 MVV Test Review the results under the MVV tab Only volume time spirogram graphs are displayed along with six MVV parameters Calipers vertical lines mark the beginning and the end of the ventilation volume not the tidal area Note Calipers can be manually adjusted If so affected parameters will automatically be recalculated Tip You can select or deselect a curve in the parameters table If no MVV test is performed the MVV
80. ph possible options are L s or L m Temperature Determines the unit of Temperature possible options are C or F 5 2 Viewing Tab To display the Viewing tab 1 Choose File 2 Select Settings gt Spirometry gt Viewing The following screen appears DIR 80012334 Ver H 23 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 5 3 Spirometry Viewing tab Settings iol st Spirometry 1 E Parameters Columns Rows Show Predict w Points Iw Curve xa Exercise ECG t Bottom Table Color Scheme Welch Allyn Trending Spirometry Ambulatory blood pressure Manuallselection of the best effort w Display ATS Acceptability per effort X reference value predicted Scheme editor gt Iv Superimpose FY curves Recallect Display Lung Age Cancel Apply Help Setting Description Parameters in Columns or Rows Changes the layout of the six parameter table Show Points and or Curve Predictive If Points is checked predictive points display and print in the FVC graph Predictive points definition see page 94 If Curve is selected a prediction curve will be displayed in the FVC graph Trending Reference Value 95 Predicted When 96 Reference Value is selected parameters values are graphed as a percentage of the selected reference value When predicted is selecte
81. piratory maneuver may aggravate the underlying condition e pneumothorax e unstable cardiovascular status forced expiratory maneuver may worsen angina or cause changes in blood pressure or recent myocardial infarction or pulmonary embolus e thoracic abdominal or cerebral aneurysms danger of rupture due to increased thoracic pressure e recent eye surgery e g cataract e presence of an acute disease process that might interfere with test performance e g nausea vomiting e recent surgery of thorax or abdomen WARNING The spirometer captures and presents data reflecting a patient s physiological condition When reviewed by a trained physician or clinician this data can be useful in determining a diagnosis However the data should not be used as a sole means for determining a patient s diagnosis WARNING To minimize chances of a misdiagnosis it is the physician s responsibility to assure that spirometry tests are properly administered evaluated and interpreted WARNING People may become light headed dizzy or even faint during a spirometry effort Watch patients closely If they choose to stand during testing keep a chair immediately behind them If there is any reason for concern stop the test and take appropriate action WARNING To prevent cross contamination do not try to clean the flow transducers and nose clips Discard these items after a single patient use WARNING The American Thoracic Society ATS recom
82. r X Hall G L Enright P L Hankinson J L lp M S Zheng J Stocks J on behalf of the ERS Global Lung Function Initiative 2012 European Respiratory Journal 2012 40 1324 1343 Langhammer Forced Spirometry Reference Values for Norwegian Adults The Bronchial Obstruction in 2001 Nord Trondelag Study Langammer A Gulsvik A et al European Respiratory Journal 2001 18 770 779 Hedenstr m Reference Values for Lung Function Tests in Men Regression Equations With Smoking 1986 Variables Hedenstr m H et al Upsala Journal of Medicine Science 91 299 310 1986 Reference Values for Lung Function Tests in Females Regression Equations With Smoking Variables Hedenstr m H et al Bull Eur Physiopathol Respir 1985 21 551 557 Lung function values from a longitudinal study of healthy children and adolescents Hibbert ME Lanigan A Landau LI Phelan PD Pediatric pulmonology 7 101 109 1989 Ventilatory Functions of Normal Children and Young Adults Mexican American White and Black 1 Spirometry Katharine HK Hsu et al The Journal of Pediatrics volume 95 1 14 23 July 1979 The Maximal Expiratory Flow Volume Curve Normal Standards Variability and Effects of Age Honald J Knudson Ronald C Slatin Michael D Lebowitz and Benjamin Burrows American Review of Disease volume 113 587 600 1976 Hibbert 1989 Hsu 1979 Knudson 1976 Knudson 1983 Changes in the Normal Maximal E
83. re that the patient s airways are not restricted by excessive bending Correct the patient s posture Recalibrate with a 3 liter syringe Check in the settings menu to see if the correct author is selected Verify that the date of birth gender race and the height of the patient are correctly entered in the patient card these are needed for the calculation of the predicted values For some prediction norms the patient s weight is also obligatory Verify sensor calibration information Check the connection between flow transducer and sensor 78 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Condition Error message No valid stroke recorded Report does not print parameters or graphs Indistinguishable Pre and Post curves on printed reports Patient test values differ from values expected by physician The flow sensor has been dropped Loss of network connection during spirometry test DIR 80012334 Ver H Solution Replace the flow transducer Check that the connection between the syringe and the flow transducer is tight and without leaks Use even strokes in calibration Wait with pushing the plunger in until the blue calibration bar starts moving Pull the plunger completely out before pressing the OK button on the start calibration window Check print and parameters settings A color printer and a color printout are recommended for printing Spirometry reports
84. retation Figure 10 1 Interpretation editor Interpretation Medication editor Li Confirm E Cancel Clear D atertime Best Effort FYE Interpretation Comment Medications Pre 5 60L 4 701 83 30 F Bronchodilator 22822000 4 15 12 Within normal limits H Corticosteroids l Interpretation nterpretation Within normal limits edit area E Restrictive abnormalities E Obstructive abnormalities x kaybe a physiological variant Comment Ma interpretation possible 8 2 00 16 12 Comment pane Statement Tree In the Interpretation editor text or interpretation statements are added to the interpretation area Once an interpretation is edited confirm it Otherwise the edits are not saved Opening the interpretation editor Choose Tools and select Interpretation or Select Interpretation on the Toolbar see Figure 4 1 Main Window Automatically generated interpretation The generated interpretation is shown in the interpretation editor automatically if the interpretation is unconfirmed You can keep this interpretation and add text to it or replace it The automatic interpretation statements can be inserted by clicking the Best effort FVC interpretation button Confirming an interpretation and closing the interpretation editor Select Confirm to save your comments and to return to the spirometry window Adding comments to the interpretation Click in the comment pane and start
85. rovides quality indication regarding individual effort acceptability Variance of best FVC and FEV1 in Pre and Post phases ATS standards require this variance to be lt 150 mL Indication of Pre and Post effort repeatability being met If criteria is not met the reason why is orovided Main results of the Spirometry test See section 5 for settings that influence the amount of information shown here Spirometry interpretation area Tabular presentation of a subset of measurement data 65 93 CardioPerfect Workstation WelchAllyn SpiroPerfect Module User Manual 12 Predictions Norm Profiles 2 1 Each predictive norm supports a particular subset of parameters and covers a specific population as detailed in the profile charts below 1 _ 9 1 021 3 e 7 81 871 d 41545 xxx x 961 091 _ 8l 8rl d X X ON 08 02 06 434 X X _ 96 gt 1 33 10 g lt OAS gt gt 061 OtI 3InpeJ 281 011 949 0 S 00Z tr 8861 I 945104 gt lt gt lt x X 961 601 PIIUOW meuesere eT TPP SERES MET 081 6 1 1961 5661 Ger a s lejejdez So03 gt lt x gt x x x x gt lt 81 81 gt gt 0861 5661 0 61 081 91 isd JeuAS SOO3 gt gt 961 991 661 ueni 081 691 4 JeluenD SO93 4541 1111 961 991 N LL 091 011 Hispanic
86. s Key values from the selected norm and from composite norms if enabled Applicable for FVC tests only For flow volume curves predictive values are PEF FEF25 FEF50 FEF75 and FVC all are represented as points For volume time curves predictive values are FEV1 represented as point and FVC represented as horizontal line If predictive points are enabled all available values appear on the screen and the printout pre test A test that provides a baseline for comparison with a post test taken by the same patient Sometimes called pre Rx or pre BD bronchodilator Pre tests and post tests are commonly used to evaluate the effectiveness of medication See also reversibility reversibility The percentage difference between pre test and post test data This measurement indicates the effect of medication on lung function Reversibility applies to each parameter separately The reversibility formula which determines the way in which reversibility is calculated is user selectable SVC Slow relaxed vital capacity 1 A type of test in which patients breathe normally several times then inhale maximally and exhale maximally or vice versa 2 An important parameter in liters the maximum volume of air exhaled from the point of maximum inhalation or maximum volume of air inhaled from a point of maximum exhalation test A set of efforts at least 1 and no more than 12 various possible combinations of FVC efforts SVC efforts or both Te
87. s based on males 85 or younger the predicted values are extrapolated values e When it takes place extrapolation is indicated in the test record e Pediatric norms do not provide any age weight or height extrapolation e Adult norms allow extrapolation of age up but not down e Adult norms allow extrapolation of height weight up and down 12 4 Composite Norm Values When the Composite norm see tables in section 12 1 is selected predictive parameter values are filled in from one of the alternative composite norm sources listed here NHANESIII FEV1 FEV1 FEV6 FEV1 FEV6 FEV6 FVC PEF FEF25 75 Crapo 1981 FEVO 5 FEV3 FEV3 FVC Morris 1971 FEFO0 2 1 2 ECCS Quanjer 1993 FEF25 FEF50 FEF75 Note an adult norm is selected but pediatric patient data is used no prediction value will be calculated and displayed The following combinations of norms are supported Predicition Norm Solymar 7 18 ECCS 19 70 ECCS Solymar Zapletal 6 18 Solymar 7 18 Hedenstr m 20 70 Hedenstr m Solymar The Composite of Hedenstrom Solymar cannot be used for age 19 For a listing of the parameters included in each norm see section 12 1 Norm Profiles 12 5 Lung Age Lung age Is a calculated value based on a patient s demographics and spirometric performance This provides a relative indication of the health of the patient s lungs This value is used primarily to encourage smoking cessation The SpiroPerfect sp
88. s containing dust salt or sulfur CAUTION Keep the spirometer away from splashing fluids DIR 80012334 Ver H 12 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 1 4 Product Overview SpiroPerfect performs FVC SVC and MVV testing including pre post testing It instantly displays flow volume curves and depicts inspiratory and expiratory measurements For details see the following sections e Features page 13 e Ordering Information for Replacement Parts page 76 e Specifications page 80 Figure 1 1 Components of the SpiroPerfect Spirometer Disposable Flow Transducer For single patient use only to minimize the risk of cross contamination Pressure Tubing Connects the flow transducers to the Spirometer sensor USB Sensor Connects to the USB port of your PC Converts pressure to airflow Assembled SpiroPerfect Spirometer Consists of Disposable Flow transducer Pressure tubing and USB Sensor h Nose Clip Highly recommended during testing to avoid air leaks Unless medical condition makes it uncomfortable or N unpractical to use it in which case the clinician should NM Y record that the nose clip was not used 3 liter Calibration syringe For daily use to calibrate the Welch Allyn SpiroPerfect spirometer for accuracy 1 5 Features DIR 80012334 Ver H 13 93 Automatic interpretation and comparison to best pre bronchodilator Real time flow vo
89. s the most common tasks You can access these tasks by clicking on the workspace with your right mouse button Shortcut menus are context sensitive meaning that they show only relevant tasks for the area clicked Status bar The status bar at the bottom of the window shows the name of the user currently logged on the patient s race height weight and the Prediction norm used in the Spirometry test currently viewed DIR 80012334 Ver H 20 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 5 Customizing the Spirometry Module This chapter shows how to adjust various settings like selecting prediction schemes determining which parameters to view and print and set various display options Customize features in the Spirometry settings To open the Spirometry settings 1 ChooseFile 2 Select Settings Spirometry The following screen appears Figure 5 1 Settings Screen ELT MEN emo ch Spirometry 1 xn Generali Viewing Parameters Printing Recording General Prediction Calibration syringe ECCS Quanjer 1993 3000 ml VIC Paramete Best composite only Calibration reminder Ever C Day Week Month T Exercise ECG Heverzibilit PostPre Past Pre zPre S pirometry Flow Lis Temperature D Lm Fost Fre Fred Ambulatory blood Final resul r
90. sts may include pre and post efforts FVC or SVC to measure the effectiveness of medication Tex Tidal breathing expiration time in seconds See also tidal breathing tidal breathing Spontaneous or normal breathing See also Tin and Tex tidal volume See VT Tin Tidal breathing inspiration time in seconds See also tidal breathing Tin Tex The ratio of these two parameters See also Tin and Tex TV See VT variance The difference between the best and second best effort s parameter for FEV1 and FVC Pretest and post test variance are reported separately See also best effort VC Vital capacity See also FVC and SVC DIR 80012334 Ver H 91 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual volume f t See volume time volume time Same as volume over time or volume f t A type of data curve available during both FVC and SVC testing The y axis represents liters the x axis represents seconds VT Tidal volume in liters Also called TV although VT is the preferred abbreviation The volume of air that enters the lungs during inspiration and leaves the lungs during expiration in a normal breathing cycle See also MV and tidal breathing workstation See CardioPerfect workstation z A dimensionless value that indicates how many standard deviations a measurement is away from the predicted value For example z 1 means that the measured parameter value is one standard deviation below t
91. t burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 5 UT 95 96 dip in Ur for 0 5 cycle 40 96 UT 60 dip in Ur for 5 cycles 70 UT 30 dip in Ur for 25 cycles b UT gt 95 dip in Ur for 5 sec Compliance level 6 kV contact 8 kV air Not Applicable Not Applicable Not Applicable NOTE Uris the AC mains voltage prior to application of the test level DIR 80012334 Ver H Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Welch Allyn SpiroPerfect requires continued operation during power mains interruptions it is recommended that the Welch Allyn SpiroPerfect be powered from an uninterruptible power supply or a battery Power frequency magnetic fields s
92. the expiratory strokes Exp SD The stroke difference between the expiratory strokes Calibrated A check mark shows if the sensor was actually calibrated yes or only a log entry was saved no To view the calibration log 1 Choose Tools 2 Select Calibration log DIR 80012334 Ver H 40 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 8 Recording Spirometry Tests Various types of efforts can be recorded with the Spirometer module e FVC Forced Vital Capacity e MVV Maximum Voluntary Ventilation e SVC Slow Vital Capacity The following tags can be assigned to each effort e Pre e Post When recording a post stage effort the medication administered to the patient can be entered 8 1 Record a Spirometry Test Follow these steps to record a test 1 In the Workstation find or create a patient see the Workstation manual for instructions Spirometry 2 Choose Spirometry located in the toolbar at the top of the screen Tip The following screen appears if a new effort or test is being added to the patient s profile within 24 hours since the last test or effort Figure 8 1 Warning window WARNING Patient has already recorded spiro test today How do you want ta proceed Create New Test Cancel AN Caution Use numerals only to set the date format Alpha characters cannot be used in the date field DIR 80012334 Ver H 41 93 WelchAllyn Card
93. tion is Factor performed this value will be updated The factor displayed is the average of the inspiration and expiration calibration factor Calibration Select the measured calibration accuracy to be within 1 or 3 of the Error Tolerance syringe volume DIR 80012334 Ver H 34 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Setting Description Tip See page 28 on how to change the default setting Temperature The ambient temperature See Operating Environment Specifications on page 80 Humidity The ambient humidity See Operating Environment Specifications on page 80 Pressure The ambient pressure N 2 See Operating Environment Specifications on page 80 For the ambient settings pressure field please enter the pressure as given by a barometer in the immediate vicinity WARNING Do not enter the normalized sea level pressure as commonly listed on internet sites on meteorological data resources Press the Next button to continue The following screen appears depending on your setup Figure 7 2 Calibration window ioj x e 3j d Calibrate Calibration Logs Done Cabeaton and message window This is single flow calibration protocr ou will need to push the plunger in and pull the plunger out one time Do not stop before you have completed a full stroke Press the Calibrete bution when you are ready to start the calbration process and follow the instruction
94. tion of dish soap and water 12 tsp per cup of water oolution of bleach and water 1 part bleach 696 sodium hypochlorite with 9 parts water Isopropyl Alcohol and water 70 by volume PDI Sani Cloth Plus wipes 14 85 Isopropanol Cavi Wipes 17 296 Isopropanol Discarding the Equipment dispose of as unsorted municipal waste For more specific disposal or compliance information go to www welchallyn com weee or contact Welch Allyn Technical 13 4 z Dispose of this product and its accessories according to local regulations Do not Support at www welchallyn com about company locations htm 13 5 Ordering Information for Replacement Parts The following parts must be replaced as noted e flow transducers amp nose clips Replace for each new patient e pressure tubing Replace when dirty e sensor Replace when faulty DIR 80012334 Ver H 76 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual To order parts call the Welch Allyn Technical Support Center N Warning Discard all spirometry components according to local regulations Use of components other than those recommended by Welch Allyn may compromise product performance The Welch Allyn warranty can only be honored if you use Welch Allyn approved components and replacement parts Figure 13 1 Ordering Information for Replacement Parts Item Part Numbers Order Quantities Disposable Flow 703418 25 pk Transducer i 703419 100 pk CPW
95. ucibility information See page 59 for more information DIR 80012334 Ver H 52 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Figure 9 8 Interpretation Area Interpretation Pre 5 60L 4 701 FEW 83 307 2 8 2000 4 75 72 within normal limits Interpretation Mat Confirmed Comment 9 2 00 16 18 Lung Age 35 years ATC Coker 9 6 FVC Tab Figure 9 9 FVC Tab Patient Test date CCNV 003 John Doe M 3 27 1967 2 8 2000 4 15 11 PM FWE SWC Trend Measurements s 12 1 el 1 8 j 8 j 4 j 4 2 2 jM MC M pa si SS B 1 2 3 amp 5 B 2 2 4 4 E 10 10 ol Within normal limits 25 Flow alumne Loop Selected Flow olume Selection Description Left Graph The left graph always represents the selected effort in the parameters table as a flow volume loop or as tidal volume Right Graph The right graph displays curves all efforts selected for a particular stage Different curve views are selected from the drop down menu Flow Volume Volume Time Flow Time Axes In a flow volume graph the flow is plotted against the volume In a volume time graph the volume is plotted against time Units e Volume is expressed in liters e Time is expressed in seconds e Flow is expressed in liters per second
96. ure 4 1 Main Window Search area Toolbar Workspace Welch Allyn CardioPerfect Menu bar Ir Title bar All efforts v Test date 232000 4 15 11 PM Mail ta Pocket PC Patient Patients Search CCNV 003 John Doe M 3 27 1 Search Go Effort Brady T achy CCNV 002 Ceasar J selector CCNV 003 Doe John CCNV 013 Fainting attacks CCNV 001 Jongmans Stella CCNV 010 Nodal tachycardia CCNV 008 Onymous Ann Shortcut CCNV 009 Pacing problern men 004 Recording Long enu 1234 testnumber1 WPW Graph area Flow volume Loop E Interpretation Effort ATS Selected 1 FEV1Z FEV3 Pre F C 5 60L FEV1 4 70L FEV1 FYC 83 90 Unite 2 8 2000 4 15 12 Within normal limits ECCS Quanie 6 22872000 4 15 11 Xu Quanie 10 7 1996 12 15 51 PM 6 13 1995 3 28 33 PM Interpretation Not Confirmed Comment 8 2 00 16 18 6 12 1995 9 02 33 5 23 1385 12 16 33 PM Final 1470 847 Lung FinalZPred 105 107 103 35 years FINAL 5 60 4 70 84 51562 El D A ii ea admin Caucasian 1185 2 165 72 inches ECCSIQuanjer 1993 Status bar Interpretation area Parameters area Title bar The title bar displays the name of the program Three buttons located on t
97. vailable form the menu bar select Edit comment from the Action menu or type CTRL T DIR 80012334 Ver H 47 93 WelchAllyn 9 9 1 CardioPerfect Workstation SpiroPerfect Module User Manual Viewing Spirometry tests View a Spirometry test To view a spirometry test 1 2 9 2 Select a patient The patient s previously recorded tests appear in the test list From the test list select a spirometry test to view Note Spirometry tests are indicated with a I SpiroPerfect launches and the test is displayed in the workspace Use the tabs and the Effort selector in the toolbar for selecting information to view Setting the Best Effort Follow these steps for setting the Best Effort Choose File Select Settings gt Spirometry Select the General tab Under the Final result check Best effort Select the Viewing tab Check Manual selection of the best effort Figure 9 1 Patient list database zz Search Search Go Name Birthdate CCNV 012 Brady Tachy 2171962 CCNV 002 Ceasar J 12 8 1921 CCNV 003 Doe John 1 1 1990 CCNV 020 Doe Jane Pocket Doe John 1 1 1968 CCNV 013 Fainting attacks CCNV 001 Jongmans Stella 17 5 1371 CCNV 010 Nodal tachycardia CCNV 008 Onymous Ann 29 9 1951 CCNV 009 Pacing problem CCNV 004 Recording Long 1 1 1963 amp 2972003105321 29 7 2003 10 32 11 A 5
98. values e As a of Predictive effort x pred value x 100 e As a percentage of a reference value The value of the parameters is a relative value It depends on the currently selected effort For example if a test has three efforts and effort 1 is selected all parameter values for effort 1 are set to 10096 The values for other efforts are expressed as lower or higher percentages in relation to effort 1 Effort x Effort 1 x 100 Example with Effort 1 currently selected Effort 1 Effort 2 Effort 3 Effort 4 Real value of FEV1 Relative value of FEV1 as displayed in trends 10096 106 108 DIR 80012334 Ver H 56 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual To view trends 1 Select three parameters from the drop down menus located beneath the Trends graph The curve for these parameters is displayed in the Trends graph Select or deselect efforts by checking the boxes beneath the efforts listed in the parameters area The efforts are added or removed from the Trends graph Select which effort is used as the reference point by clicking on one of the efforts located in the parameters area The parameter value of this effort is set to 100 in the Trend graph and the parameter values of all other efforts are expressed as a percentage proportional to the reference value The percentage of deviation is given in the parameters area Figure 9 14 Parameters Area FEVB PEF You ca
99. views available from the Effort selector in the toolbar All Efforts view and compare all efforts of current test Figure 9 4 Effort selector Pre view and compare only the pre efforts of current test Post view and compare only post DIR 80012334 Ver H 49 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual AI efforts efforts of current test All efforts iei Final Best result view and compare only the best Post effort final result of current test Final Result Figure 9 5 Five tabs SVE Trend Measurements Tab Description FVC Select to view only the currently selected FVC efforts A flow volume curve of the current FVC effort and the flow volume curves of all selected FVC efforts The dotted line marks the predicted values SVC Select to view only the currently selected SVC efforts A spirogram for the current SVC effort MVV Select to view only the currently selected MVV efforts A spirogram for the current MVV effort Trend Select to view only the trends to a maximum of six parameters Trends of the FVC effort of the test Measurements Select to view all the parameters calculated of all effort types All parameters values based on user settings for each stage and effort DIR 80012334 Ver H 50 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 9 5 Features for each Tab Figure 9 6 Tab overview Sv
100. w D x Tip Double click on the left graphic to expand it to full window size Double click again to reduce it to half window size 1 2 3 4 5 5 8 9 10 11 12 Volume Time Parame ters FEV1 FEW1 il L L 2 L L Reproducibility 8 Select the effort type to perform by selecting the FVC SVC or MVV 9 Select the effort stage If you have selected Post enter the medication dosage and unit Note The medication and dosage fields are only active if a post effort is selected Post effort is only available after a pre effort has been recorded 10 Select the type of curve from the drop down menu located at the bottom of the right graph Figure 8 4 Type of Curve menu Volume Time Volume T ime Flow T Ime Incentive 11 Instruct the patient to hold the SpiroPerfect sensor still Note Make sure the rear of the flow tube is not blocked The extra resistance will result in faulty measurements 12 Select Record to start recording 13 Ask the patient to perform the effort according to the appropriate procedures See section 8 3 14 When the patient has completed the test select Done The recording window closes and the main view displays all efforts of the recorded effort stage Pre Post Note The effort along with six corresponding parameter values are displayed in the parameters area DIR 80012334 Ver H 43 9
101. w sensor with USB connection SpiroPerfect from Welch Allyn OEM SpiroPerfect manufactured by Medikro Oy Finland for Welch Allyn Inc USA For information on connecting the Flow sensor with USB connection see section 3 Installing the SpiroPerfect Spirometer DIR 80012334 Ver H 17 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Flow sensor with serial connection SpiroPerfect from Welch Allyn OEM SpiroPerfect manufactured by Medikro Oy Finland for Welch Allyn Inc USA 0537 The Flow sensor with serial connection is ready for use after plugging it into the computer No further driver needs to be installed 3 1 Configuring the Welch Allyn CardioPerfect Workstation After connecting the spirometry sensor you need to configure Welch Allyn CardioPerfect Workstation To configure Welch Allyn CardioPerfect Workstation for use with the sensor otart Welch Allyn CardioPerfect Workstation In the File menu click Settings and click Spirometry Click the Recording tab Select Welch Allyn SpiroPerfect Click OK to save the settings h P o ws DIR 80012334 Ver H 18 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual 4 TheSpirometer Window This section guides you through the various parts of SpiroPerfect The structure of the workspace is similar to the other Welch Allyn CardioPerfect Workstation modules and conforms to the Microsoft Ul guidelines Fig
102. ware in this product is Copyright 2015 Welch Allyn All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software provided on the original distribution medium The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ownership of the software remains with Welch Allyn The information contained in this manual is subject to change without notice All changes will be in compliance with regulations governing manufacture of medical equipment User responsibility This product is designed to perform in conformity with the description thereof contained in this manual and accompanying labels and inserts when assembled operated maintained and repaired in accordance with the instructions provided A defective product should not be used Parts that are broken plainly worn missing or incomplete distorted or contaminated should be replaced immediately Should any repair or replacement become necessary we recommend that service be performed at the nearest approved service center The user of the product shall have the sole responsibility for any malfunction which results from improper use faulty maintenance improper repair damage or alteration b
103. xpiratory Flow Volume Curve With Growth and Aging Ronald J Knudson et al American Review of Respiratory Disease 1983 127 725 734 Koillinen Terveiden suomalaislasten spirometrian ja uloshengityksen huippuvirtauksen viitearvot 1998 Hannele Koillinen et al Suomen Laakarilehti 1998 5 vsk 53 p 395 402 Kory The Veterans Administration Army Cooperative Study of Pulmonary Function 1 Clinical 1961 Spirometry in Normal Men Kory RC et al American Journal of Medicine February 1961 243 258 Morris Spirometric Standards for Healthy Nonsmoking Adults James F Morris et al American 1971 Review of Respiratory Disease 103 57 67 1971 DIR 80012334 Ver H 68 93 WelchAllyn CardioPerfect Workstation NHANES I 1999 Polgar 1971 Hoca 1986 T Schoenberg 1978 Solymar 1980 Viljanen 1981 Wang 1993 Zapletal 1969 DIR 80012334 Ver H SpiroPerfect Module User Manual Spirometric Reference Values from a Sample of the General U S Population John L Hankinson John R Odencrantz and Kathleen B Fedan Division of Respiratory Disease Studies National Institute for Occupational Safety and Health Centers for Disease Control and Prevention Morgantown West Virginia 1999 The Third National Health And Nutrition Examination Survey NHANES Am J Respir Crit Care Med Jan 1999 159 179 187 Pulmonary Function Testing in Children Techniques and Standards Polgar G and Promadhat V Philadelphia W
104. y anyone other than Welch Allyn or their authorized service personnel Accessories The Welch Allyn warranty can only be honored if you use Welch Allyn approved accessories and replacement parts Caution Use of accessories other than those recommended by Welch Allyn may compromise product performance DIR 80012334 Ver H 2 93 WelchAllyn CardioPerfect Workstation SpiroPerfect Module User Manual Warranty Service and Spare Parts Warranty All repairs on products under warranty must be performed or approved by Welch Allyn Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall exclusively be performed by Welch Allyn certified service personnel Assistance and Parts If the product fails to function properly or if assistance service or spare parts are required contact the nearest Welch Allyn Technical Support Center USA 1 800 535 6663 Canada 1 800 561 8797 Latin America 41 305 669 9003 South Africa 27 11 777 7555 European Call Center 353 46 90 67790 Australia 61 2 9638 3000 United Kingdom 44 207 365 6780 Singapore 65 6419 8100 France 33 1 55 69 58 49 Japan 81 42 703 6084 Germany 49 695 098 5132 China 86 21 6327 9631 Netherlands 31 202 061 360 Sweden 46 85 853 65 51 Before contacting Welch Allyn it is helpful to attempt to duplicate the problem and to check all accessories to ensure that they are not the cause of the proble
105. y to calibrate the spirometer system with each Flow Transducer separately Consult Accompanying Documents CAUTION Perform a new calibration when using a new lot of Flow Transducers 7 1 Preparing calibration Calibration Protocol SpiroPerfect supports two calibration protocols e Single Stroke Calibration e Three Stroke Calibration The calibration protocol can be set on the Recording tab in the Spirometry Settings See section 5 5 Recording Tab To calibrate the Welch Allyn SpiroPerfect flow sensor it is strongly recommended to use the Single Stroke Calibration Protocol while calibrating This method will increase the accuracy of the flow sensor To calibrate the Spiro Perfect VCT 400 use the Three Stroke Calibration Protocol for the best results The protocol can be changed in the spirometry settings Warm up the Spirometer Before calibrating it is recommended to let the Spirometer warm up If the Spirometer has already been used shortly before calibration this warm up period is not needed 1 Connect the Spirometer to the computer 2 Open the Spiro module The sensor starts to warm up as soon as the spirometer module is opened 3 Wait for at least 5 minutes before starting the calibration process 7 2 Calibration Process Make sure the Spirometer is plugged in before continuing 1 start the calibration select the Calibrate button located on the Toolbar or press F10 The following dialog box will be presented to co

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