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User`s Manual PC Classic PC Classic Plus

1. 12 TD Q oO D 7p PX f MA p 8 n n Ne 4 i 4 N N Ne i Nk o H Y a ap run Fir 1 1 1 h i Ji l k i 1 4 X Je fi A LE gee gt Ar er 12 1 2 3 4 5 6 7 8 Volume Liters m Patient History Cigarettes no Wheezing no Short of Breath no History of Heart Disease no Pain while Breathing no Abnormal X Ray ever no Cough Frequently no Lung Surgery no PC Classic Plus 2 11d 12 30 2002 2 26PM Page 2 Figure 5 24 Two Page Summary Report Page 2 When the necessary predicted normal values are available in the selected normals table the report graphs will contain a predicted curve See the section 6 1 1 Software Customization and the Normals Tables section of the Appendix for more information Feb 04 Chapter 5 Testing 11 Spirometrics PC Classic Classic Plus User s Manual 5 7 TREND ANALYSIS The Trend Analysis option found in both the PC Classic and PC Classic Plus versions allows you to choose tests and plot the values over time This allows you to view graphically the change in the patients lung function over time To prepare a trend analysis do the following 1 Click the Trend button in the Browse Patient List window Alternatively click File to access the pull down menu Click Trend Analysis to display the Trend Analysis window Which Kind of Trend Analysis I
2. place The procedure required to recover lost passwords may f WARNING Store password information in a safe secure result in data loss The steps necessary to add delete or modify user information are as follows 1 Select the Browse Data option in the main menu 2 Click on Maintain Users and the User List window will appear Full Name 2 JOHN John Smith Master Browser El Insert Update Delete Close Figure 7 8 Maintain Users User List Window Feb 04 Chapter 7 Data Management 106 Spirometrics PC Classic Classic Plus User s Manual su Click Insert to add a new user and password or click Update to change a user record The Adding a User s Record or Changing a User s Record window will appear SS Adding a Users Record Iof x User ID 3 User Name Full Hame Create Date JAN 7 2005 Password Reset Administrator es f Ho Cancel Figure 7 9 Adding User Record Window 4 Enter or modify the user s information 5 Click the Reset button to add or modify a password for the user 6 Click OK to continue and save the user entry or changes or Cancel to abort The current window will close and return to the User List window 7 If desired click on Delete to permanently remove a user from the PC Classic user list 7 6 NETWORK OPTION PC CLASsic PLUS ONLY The network option is only available on the PC Classic Plus The network code may be verified in
3. IDH ABC 123 475 10 Date 6422 2001 Test Number 2 Time 14 57PM Indes Meas Pred Pred Var My 115 115 97 13 Rate 4 n a n a 14 Print Forced Expiratory Time 13 1 Figure 5 19 MVV Test Detail Window 12 Click the OK button to return to the MVV Tests window 13 If you have completed testing this patient click Close to return to the Browse Patient List window Feb 04 Chapter 5 Testing 65 Spirometrics PC Classic Classic Plus User s Manual 5 5 1 VIEW OR DELETE TEST To view or delete a test do the following 1 Select the patient whose tests you wish to view or delete by highlighting his or her name in the Browse Patient List window 2 Select the type of test to view or delete by clicking the individual test button FVC Tests Pre Test Meth Chal VC Tests MVV Tests 3 To view a test highlight the specific test then click the Detail button 4 To delete a test highlight it in the desired test window then click the Delete button Confirm Delete x 0 P You ve selected to delete the highlighted record Press OF to confirm 7 deletion of this record OF Figure 5 20 Confirm Delete Window NOTE Completing the delete using this procedure will permanently remove tests from the database A Confirm Delete window will appear to make sure you truly want to delete the test Click OK to delete or click Cancel or the Esc key to cancel the operation These will bring you back to the
4. User s Manual N y io triog k PC Classic PC Classic Plus N aD SPIROMETRICS Software Product License Agreement ATTENTION USE OF THE SOFTWARE IS SUBJECT TO THE SPIROMETRICS SOFTWARE LICENSE TERMS SET FORTH BELOW USING THE SOFTWARE INDICATES YOUR ACCEPTANCE OF THESE LICENSE TERMS IF YOU DO NOT ACCEPT THESE LICENSE TERMS YOU MUST RETURN THE ENTIRE UNUSED PRODUCT FOR A FULL REFUND SPIROMETRICS SOFTWARE LICENSE TERMS The following License Terms govern your use of the accompanying Software unless you have a separate written agreement with SPIROMETRICS License Grant SPIROMETRICS grants you a license to Use one copy of the Software Use means storing loading installing executing or displaying the Software You may not modify the Software or disable any licensing or control features of the Software If the Software is licensed for concurrent use you may not allow more than the maximum number of authorized users to Use the Software concurrently Ownership The Software is owned and copyrighted by SPIROMETRICS or its third party suppliers Your license confers no title or ownership in the Software and is not a sale of any rights in the Software Copies and Adaptations You may only make copies or adaptations of the Software for archival purposes or when copying or adaptation is an essential step in the authorized Use of the Software You must reproduce all copyright notices in the ori
5. 1 Select Browse Data 2 Click on All Calibrations The Saved Calibrations window will appear Feb 04 Chapter 7 Data Management 104 NT n Spirometrics PC Classic Classic Plus User s Manual S Saved Calibrations Sorted by Date and Time 6 30 2002 3 02 3 8 30 2001 8 29 2001 8 28 2001 8 27 2001 8 27 2001 Print Single Calibration Calibration Review Figure 7 7 Calibration Data Detail Review Window Date and time are used to sort all calibration data The data may be reviewed for trending and for evaluation of concerning results The details of a single calibration can also be examined and printed from this window The last date of calibration also prints on each patient report 7 5 MAINTAINING USERS A list of all system users as entered by a program administrator is maintained by the PC Classic PC Classic Plus program A valid username and password is required to run PC Classic PC Classic Plus software when the security option is selected in the Data Options tab of the Customization window See section 6 1 1 Software Customization Feb 04 Chapter 7 Data Management 105 Spirometrics PC Classic Classic Plus User s Manual The user list contains the user name MASTER by default The default password for the MASTER user is master The username and password are NOT uppercase or lowercase character sensitive The MASTER password may be changed or the MASTER user may be deleted entirely if desired
6. 38 Spirometrics PC Classic Classic Plus User s Manual 4 1 3 Deleting Patient Information 40 Chapter 5 Testing 42 5 1 Optional Pre Test Training PC Classic Plus Only 42 DEN O TOS ae nn 45 5 2 1 Warning Messages nennnnnennnnennennennnnnnnenrrrennnnnnnenene 52 DONG TOS ea E 52 5 4 Post Bronchodilator Testing PC Classic Plus Only 56 SAA MONO TEE EEA 56 g4 MENOT 2 era 59 5 5 MVV Test PC Classic Plus Only 61 5 5 1 View or Delete Test 66 5 6 Summary REPOT So 67 5 7 Trend Analysis 72 Chapter 6 Special Features 77 6 1 GUS OMAN a aa a a nue 77 6 1 1 Software Customization cece ceeecceceeeeeeeeeeeeeeeeeeeeeees 77 6 1 2 Data Options 0 0 ccceccccececesseseeeeeeeeessaeeeeeeeeeeeesaaaeeees 79 6 1 3 Report Setup sacra ccnnesszedstoceasdanscteodavatenceavaateedetetseodatecsvedaes 81 6 1 4 Report OPIONS asser este stars 83 6 1 5 Methacholine Challenge Options ccccseseeeeseeeeeees 84 6 16 TICORSROR ns ea a a 86 6 1 7 General Customization Buttons 87 6 2 Performance Verification amp Calibration 87 6 2 1 Performance Verification Routine PC Classic only 88 6 3 Calibration PC Classic Plus Only ccccccccecceeeeeeee ees 91 6 3 1 Calibration Routine cccccececceeeseeeceeeeeeeeeeeeseeetseeeeees 91 6 4 Printer Selection auina 96 Chapter 7 Data Management 99 7 1 Protecting P
7. 75 and PEF Click the Trend button to display the Trend Analysis window with its two 2 tabs The Trend Data tab displays the numeric results with each line showing the date the test was performed the specific test number for that day the respective indices and a column indicating Pre or Post bronchodilator testing results A zero 0 indicates that it was Pre testing a one 1 shows it as a Post test Feb 04 Chapter 5 Testing 73 Spirometrics PC Classic Classic Plus User s Manual Trend Analysis Trend Data TrendGraph Index Mean Std Dey FYC 4 29 0 17 FEW 3 54 0 15 FEW FC 82 62 0 50 FEF25 75 3 68 0 18 9 63 0 40 Testum FYC FEW1 FEV1 2575 PEF Past 1071 9701 gai 9122102 12 210 2 Figure 5 26 Trend Analysis Trend Data Tab The Trend Graph tab will open a graph window and display a plot of the indices Trend Analysis Trend Data TrendGraph 5 PEF oO I K i res L _ PER aa a FEW TFC a0 Test Mumber 1 Figure 5 27 Trend Analysis Trend Graph Tab Feb 04 Chapter 5 Testing 74 SS gt Spirometrics PC Classic Classic Plus User s Manual To print a copy of the trend analysis click the Print button To return to the previous window click the Done button or press the Ese key The test number corresponds to date from the oldest to most recent record Feb 04 Chapter 5 Testing 75 Spirometrics PC Classic Classic Plus User s Manual NOTES Feb 04 Chapte
8. If the sensor is not connected properly check the back of your PC or laptop to make sure that the connection is okay as described in 3 1 2 Connecting the Classic Sensor Follow the instructions in your PC owner s manual to ensure that your serial communications port is enabled When ready click Next or press the Enter key to proceed Feb 04 Chapter 3 Equipment Preparation 13 Spirometrics PC Classic Classic Plus User s Manual Ready Sensor found on COMI Cancel Setup Back Figure 3 3 Sensor Found Window 3 2 4 ADDRESS WINDOW The third window asks you to input the name of the practice clinic or hospital that will be using the spirometer This information will appear on all hard copy reports There are four lines available for inputting the information If you wish to complete or change this information at any time refer to section 6 1 3 Report Setup in this manual which describes the appropriate customization procedure When ready click Next to proceed Feb 04 Chapter 3 Equipment Preparation 14 Spirometrics PC Classic Classic Plus User s Manual First Line airometrics Medical E second Line 2 Shaker Road Third Line Gray ME 04039 Fourth Line 07 657 6700 Back Next Help Figure 3 4 Address Window 3 2 5 AMBIENT CONDITIONS WINDOW The fourth window allows you to change the default ambient conditions This data is used to calculate a correction factor called
9. PC Classic Classic Plus User s Manual SPECIFICATIONS MODELS The PC Classic and the PC Classic Plus consist of a sensor handle and the Classic Windows based software Together these items make up the complete PC Classic system PC Classic Consists of the Classic sensor handle and Classic software configured to measure and compute the following indices at minimum FVC SVC FEV FEV3 FEV 6 FEV FVC FEV FEV6 PEF FEF 5 75 FEF75 35 FEF FEFs9 FEF75 FEF 00 1200 FIVC PIF FIFs0o FEF FIF59 and ET PC Classic Plus The PC Classic Plus adds PRE POST to the standard PC Classic test capabilities and allows the clinician to purchase MVV and or Methacholine Challenge It also allows addition of the network option NOTE The PC Classic can be upgraded to PC Classic Plus without the addition of new hardware The Classic software can be installed in any Windows based desktop or laptop computer that meets the minimum requirements described on the next page Feb 04 Specifications i Spirometrics PC Classic Classic Plus User s Manual GENERAL Weight Size 1 1 Ibs 0 5 kg sensor handle and cord 8 hx4 dx 2 8 w only Computer hardware e 90 MHz Pentium class processor requirements e 8 Mbytes RAM minimum e 7 Mbytes available hard disc space e Compliance to applicable electromagnetic compatibility standards e Compliance to applicable electrical safety standards e SVGA 800X600 scree
10. Race Caucasian FEV1 FEV6 81 5 83 3 80 2 Height 72 inches FEF 2 1 2 V s 9 0 8 5 105 8 7 2 8 Wei nt 0 lbs FEF25 75 V s 3 4 4 7 71 2 8 16 4 oe does FEF75 85 V s 0 8 1 5 53 0 5 35 9 9 y PEF Vs 10 1 10 2 100 9 4 7 2 FEF25 V s 8 3 n a n a 8 4 1 4 FEF50 V s 4 3 5 9 72 3 8 10 8 Normals Composite FEF75 s 1 3 na ma 10 23 1 Ambient Conditions 760 mmHga 72 F FIVC l 3 95 5 84 68 4 40 11 4 Calibrated 12 09 2002 FIF50 V s 6 5 n a n a 7 4 13 3 aan FEF50 FIF50 65 2 n a n a 50 7 22 2 Interpretation PIF l s 6 7 na ma 77 14 8 MMET s 0 65 n a n a 0 80 23 1 FET s 7 74 n a n a 9 40 21 4 MVV VOL m 187 0 Intejpretation Rate Brths m n a n a Spirometric Results Appear Normal VC 5 8 0 s Graph legend ATI VC FVC l Predicted Graph i EN ne lt lt Measured value less than 75 of predicted aF Pre FEV1 Mark X Post FEV1 Mark Volume Time Curve 8 6 2 pe TT E P ee lees 5 7 oeM i H rh D EE e i wy ee Se a ae Lo P see 7 i3 T 7 7 lf cl 2 ij 0 0 1 2 3 4 5 6 7 8 Time Seconds PC Classic Plus 2 11d 12 30 2002 2 26PM Page 1 Figure 5 23 Two Page Summary Report Page 1 Feb 04 Chapter 5 Testing 70 Spirometrics PC Classic Classic Plus User s Manual Spirometrics Medical Equipment Co Summary Report 22 Shaker Road Gray ME 04039 Johnny Doe 207 657 6700 ID 4516156 Test 1 Flow Volume Loop
11. The PRE Tests window will open SS PRE Tests Johnny Doe Oy x FreT ests by Patient Test Num Date Time Stamp IC 1 022 2001 12 40PM EET Delete Perform PRE T est Close Figure 5 1 PRE Tests Window 2 Click the Perform PRE Test button Initially the HOLD SENSOR STEADY box will appear Click OK A full screen display will appear with a graduated scale and an arrow indicating the predicted Inspiratory Capacity IC Feb 04 Chapter 5 Testing 43 SS Spirometrics PC Classic Classic Plus User s Manual Pre Test Exercise Time 9 7 Figure 5 2 Full screen Display PRE Test 3 Instruct the patient to place the sensor into his her mouth making sure to keep a tight seal 4 Ask the patient to breathe quietly and when ready instruct the patient to inhale maximally The display will show a bar moving up as the patient inhales 5 After full inhalation is achieved instruct the patient to exhale passively to the resting position 6 Click the Detail button on each highlighted Test Number A result window will appear showing the measured predicted percent predicted IC value and variance in liters Feb 04 Chapter 5 Testing 44 Spirometrics PC Classic Classic Plus User s Manual S PRE Test Details Johnny Doe of x General ID 4516756 Test Number 1 Indes Meas Pred lt Pred Var IC aff 4 40 06 ha Cancel Figure 5 3 P
12. VC This is only viewable at the initial accept reject window Once the test has been accepted and the details are recalled for viewing the volume time curve is no longer available for the VC test Print Prints a page report with the test results Accept This choice indicates that the test was acceptable and returns to the Browse the VC Tests File window Feb 04 Chapter 5 Testing 55 SS gt Spirometrics PC Classic Classic Plus User s Manual Reject This choice indicates that the test was unacceptable The VC effort was acceptable if the patient put forth a good effort inhaled completely exhaled completely and exhaled smoothly NO COUGHING If you have completed testing this patient for VC close the VC Tests window by either clicking the Close button or pressing the Esc key This will return you to the Browse Patient List window 5 4 POST BRONCHODILATOR TESTING PC CLASSIC PLUS ONLY If you would like to perform post bronchodilator testing there are two ways to enter post bronchodilator testing mode The ATS and AARC have established recommendations for the administration of the bronchodilator and post testing procedures 5 4 1 METHOD 1 If you have performed FVC tests on a patient and you have not closed the FVC Tests window for that patient do the following from the FVC Tests window 1 Click Post Mode button The following window will appear Feb 04 Chapter 5 Testing 56 Spirometri
13. You have purchased a Spirometrics Medical Equipment Company PC Classic Classic Plus spirometer for Windows The PC Classic Classic Plus represents the newest technology in the medical equipment field Its ease of operation and durability will provide years of service Spirometrics is committed to designing products that meet the highest standards of quality instrumentation for pulmonary function testing We have designed the PC Classic Classic Plus to take advantage of the latest developments in computers and software NOTE Federal law restricts this device to use by or on the order of a physician Before setting up please complete the warranty card enclosed at the end of this chapter to ensure that your watranty rights are covered 1 2 PRODUCT DIFFERENCES PC CLassic vs PC CLassic PLUS The PC Classic is a monitoring device designed to be used in screening applications e g early detection of Chronic Obstructive Pulmonary Disease COPD Spirometry is the only test available on the PC Classic Windows is a registered trademark of Microsoft Corporation Redmond Washington Feb 04 Chapter 1 Introduction 1 Spirometrics PC Classic Classic Plus User s Manual The PC Classic Plus is a diagnostic device used in clinical applications such as bronchodilator evaluation and provocation testing that requires a very high standard of accuracy The PC Classic Plus contains routines for calibrating the spiromet
14. new backup now Figure 7 3 Automatic Backup Window Click Yes to backup files PC Classic will close and the PC Classic Back Up amp Restore program will open 7 2 EXPORTING AND IMPORTING FILES The following sections describe how to export and import files 7 2 1 EXPORTING FILES The PC Classic can export patient records to a file To do so 1 From the main menu select File 2 Select Export Data 3 Select Export File Format and specific fields to export The default is checked to Export All Fields If the box is unchecked specific fields may be selected to export Fields selected are tagged with a green circle 4 Enter the dates which start and end the period from which you wish to export data The default starts from 1 01 80 and ends with the current date as read from the computer s current settings Feb 04 Chapter 7 Data Management 101 Spirometrics PC Classic Classic Plus User s Manual PC Classic Export Export File Format PATIL C Flat ASCII Space Del PRS ue C Flat ASCII Tab Del PAT LOCATIDN C DEF PAT SELECT_FLAG PAT STREET PAT CITY v PAT STATE PAT 2IP Export Start Date 1 07 80 PAT BIRTH Export End Date arzal Reset Default Filenames ExportyE spor asc a Figure 7 4 Export Data from PC Classic 5 To proceed with exporting click Export The file will be created and written to your computer s hard drive To abort exporting click Close 7 2 2
15. recommendations but is quick and will print both graphs on a single page Summary Report Options The default is set to Two page ATS graph scaling meets ATS recommendations for hand measurements As in the FVC Test Report Options a single One page condensed report is also available Up to 3 graphs may be included in the pre and post bronchodilator report The graphs may be placed directly on top of each other or slightly offset Flow Volume Loop 1 2 3 4 5 6 7 B PC Classic Plus 2 11d Figure 6 4 Offset Graphs Example When Offset Graphs is selected the graphs will be offset 0 5 liters at Residual Volume RV in the summary report Feb 04 Chapter 6 Special Features 82 Spirometrics PC Classic Classic Plus User s Manual NOTE Spirometrics recommends that at least 3 acceptable graphs should be available for review by the interpreting physician Variability Method The default variability method is set to Actual which will display the absolute differences and will note the FVC or FEV 1 differences from the best to the second best test above 0 20 liters ATS 1994 method Optionally the variability method may be set to Percent which will display percentage differences and will note FVC or FEV1 percent differences from the best to the second best test that are greater than five 5 percent ATS 1987 method 6 1 4 REPORT OP
16. 04 Chapter 4 Test Preparation 33 Spirometrics PC Classic Classic Plus User s Manual Height Enter the patient s measured height without shoes to the nearest one half inch or centimeter 40 89 is designated as inches 90 250 is designated as centimeters This field is required Weight Enter the patient s weight in pounds or kilograms Units are set during customization See Section 6 1 CUSTOMIZATION for specifics This field is optional but weight may impact the interpretation of the results Gender Select the appropriate field for the patient This field is required Predicted normal values are generally based on age height and gender Review all entries for accuracy Press ENTER or click the OK button to accept the entries The patient s first Respiratory History tab will then be displayed S Add a Patient Patient Info Respiratory History Resp Hist cont Motes Reason for Test IEEE Cigarettes Ever Smoked not yes per day 0 Years 0 Phen Quit no yes YearsQutl 0 Short of Breath no r Lung Surgery no Figure 4 3 Add a Patient Respiratory History Tab Feb 04 Chapter 4 Test Preparation 34 Spirometrics PC Classic Classic Plus User s Manual The Respiratory History tab contains default information If the default entries are acceptable press Enter or click the OK button to accept them If one or more of the default entries is not correct you will h
17. 8 1 1 REMOVING THE EASY CLEAN CORE To disassemble the Easy Clean Core do the following 1 Unscrew the core by turning it counterclockwise 2 Continue to turn the core until the threads are disengaged from the handle assembly 3 Pull out the entire Easy Clean Core when it is no longer engaged with the sensor housing Feb 04 Chapter 8 Care and Maintenance 110 Spirometrics PC Classic Classic Plus User s Manual CAUTION DO NOT disassemble the Easy Clean Core After removal from the sensor handle it may be cleaned without further disassembly Easy Clean Core Io 7 Spiro Filter A Handle Assembly To disassemble the Flow sensor unscrew the core assembly counterclockwise To assemble the Flow Sensor screw in the Core Element clockwise JAL Figure 8 1 Flow Sensor Disassembly 8 1 2 CLEANING THE EASY CLEAN CORE To clean the flow sensor s core element do the following 1 Place the core element in cold sterilization fluid a protein dissolving solution Follow the sterilization fluid manufacturer s instructions for disinfecting and sterilizing the core 2 Be sure to rinse in water thoroughly and allow the core to dry completely before attempting to re insert the Easy Clean Core into the handle assembly 8 1 3 INSTALLING THE EASY CLEAN CORE To install the Easy Clean Core insert the Easy Clean Core into the sensor assembly and tighten by turni
18. Composite To change it access the pull down menu by clicking the w button Scroll through the listed studies highlight the author you want to use and click on it The choices are Composite Crapo ECCS Hsu Knudson 1983 Knudson 1976 Lam Morris NHANES III and Polgar Refer to the REFERENCES section in the Appendix for selection guidance Extrapolation The default setting is no indicating that the predicted will not be extrapolated By changing this field to yes the predicted will be reported even though the height or age range was not captured in the author s study The predicted will be identified as being extrapolated when displayed on screen and in the report s Calibration Settings Syringe Volume The default setting is 3 liters To change it use the up and down arrows on the keyboard or highlight the existing number and enter the appropriate number Feb 04 Chapter 6 Special Features 78 Spirometrics PC Classic Classic Plus User s Manual Gauge readings Allows you to change the settings for air temperature and barometric pressure each day of testing To do so highlight the field and enter the appropriate number Temperature values from 10 to 40 are recorded as C and those from 50 to 104 as F Barometric pressure values from 20 to 35 are recorded as inches Hg and from 500 to 900 are recorded as mmHg These values must be accurate for each individual tested FVC Incentive Display The default setting
19. Interpretations Spirometic Results Appear Marmal Indes Meas Pred Pred War Post Chng FWE 4 38 2 04 fa 0 03 4 52 Doe FE 1 3 52 lt 4 75 4 0 04 345 2 0 FE Y6 4 32 5 76 75 0 01 435 O72 FEW AFL 20 4 de 76 3 FEWT FEYE 21 5 03 3 als FEF 26 76 3 4 47 1 0 1 28 16 4 PEF 10 1 10 2 100 0 7 J4 F22 lt lt Measured value less than 75 of predicted Print Summary Figure 5 21 Summary Window The following examples illustrate one page and two page printed summary reports Feb 04 Chapter 5 Testing 68 D NS Spirometrics PC Classic Classic Plus User s Manual Spirometrics Medical Equipment Co Summary Report 22 Shaker Road Best Test is 1 of 3 Tests 3 18 2005 12 37PM Gray ME 04039 Best Post is 5 of 3 Tests 3 18 2005 12 39PM 207 657 6700 Index Unit Meas Pred Pred Post Chng FVC l 4 38 5 84 75 4 52 3 2 Patient Johnny Doe FEV1 3 52 lt lt 4 75 74 3 49 0 9 Dey sai FEV3 40 548 74 407 os Age 29 3 09 5 49 0 0 5 Sex Male FEV1 FVC 80 4 82 1 77 2 i FEV1 FEV6 81 5 83 3 80 2 Race Caucasian FEF 2 1 2 V s 9 0 8 5 105 8 7 2 8 Height 72 inches FEF25 75 Vs 3 4 4 7 71 2 8 16 4 Weight 0 lbs FEF75 85 ls 0 8 15 53 05 35 9 Smoke 0 cigarettes day PEF Vs 10 1 10 2 100 9 4 7 2 FEF25 V s 8 3 n a n a 8 4 1 4 FEF50 V s 4 3 5 9 72 3 8 10 8 Normals Composite FEF75 V s 1 3 n a n a 10 23 1 Ambient Conditions 760 mmHgat 72 F FIVC 3 95 5 84 68 114 Calibrat
20. PATIENT INFORMATION To delete a patient from the system do the following 1 Locate the patient you want to delete 2 Press the Delete key or click the Delete button The following Confirm Delete dialog box will appear Confirm Delete x FP Youve selected to delete the highlighted record Press OK to confirm i deletion of this record Figure 4 7 Confirm Delete Dialog Box 3 Click the OK button to delete the selected patient record Click the Cancel button or press the Esc key to abort the deletion of the patient record Feb 04 Chapter 4 Test Preparation 40 Spirometrics PC Classic Classic Plus User s Manual NOTES Feb 04 Chapter 4 Test Preparation 4 Spirometrics PC Classic Classic Plus User s Manual Chapter 5 TESTING This chapter describes how to perform the various tests available to users of both the PC Classic and the PC Classic Plus After entering information for a new patient or selecting an existing patient select the test to be preformed by clicking on the appropriate test button Pre Test for training FVC Tests VC Tests Post Bronchodilator Tests MVV Tests or Methacholine Challenge Tests Each of these menu options is described in detail in this chapter Options will vary depending upon available modules In its 1994 update to Standards of Spirometry the American Thoracic Society ATS recommends that a minimum of three acceptable Forced Vital Capacity FVC tests
21. Pred Pred War Post Chng FWE 4 38 2 04 ial 0 03 4 52 Ji FE 1 3 52 4 75 4 0 04 345 20 FE Y6 4 32 5 76 75 0 01 435 O72 FEW AFL 20 4 de 76 3 FEWT FEYE 21 5 03 3 False FEF 26 6 3 4 4 7 7 0 1 28 16 44 PEF 10 1 10 2 100 0 7 g4 F22 lt lt Measured value less than 75 of predicted Print Summary Figure 5 14 Bronchodilator Test Results in Summary Window 5 4 2 METHOD 2 After administering a bronchodilator to a particular patient you may wish to perform other tests on other patients If you have returned to the Browse Patient List window after performing FVC tests and before you have entered the post mode by clicking on the Post Mode button you may enter the post bronchodilator testing mode by doing the following from the Browse Patient List window 1 Highlight the patient s name Feb 04 Chapter 5 Testing 59 Spirometrics PC Classic Classic Plus User s Manual De Click the FVC Tests button If you have already performed testing on this patient earlier in the day you will be prompted to set post bronchodilator mode click Yes if all pre bronchodilator testing is complete If all pre bronchodilator testing is not complete click No and complete pre bronchodilator testing before proceeding to post bronchodilator testing Setting Post Mode x k Set Post Bronchodilator Mode Figure 5 15 Setting Post bronchodilator Mode Window Once Post Mode is set for a patient on a p
22. You may also register your warranty by calling 1 800 767 0004 or Feb 04 Chapter 1 Introduction 2 SS gt Spirometrics PC Classic Classic Plus User s Manual faxing the information to 207 657 4123 For software license and warranty information refer to the first 2 pages of this manual Computers printers and products not manufactured by Spirometrics are not covered under the one year warranty These products are covered under the manufacturers warranties which may vary Please consult the appropriate user s manuals for further details Feb 04 Chapter 1 Introduction Spirometrics PC Classic Classic Plus User s Manual NOTES Feb 04 Chapter 1 Introduction Spirometrics PC Classic Classic Plus User s Manual Chapter 2 SAFETY 2 1 INTENDED USE The PC Classic and PC Classic Plus spirometers are intended for use with adult and pediatric patients for the diagnosis and monitoring of pulmonary disorders The company disclaims responsibility for all other uses and the user agrees to assume liability for damages resulting from non intended use or operator error by the user or user s employees The PC Classic is not intended for use as a diagnostic instrument Please upgrade to the PC Classic Plus for diagnostic capability The PC Classic is intended for use at a single facility or location If the instrument is to be used at a different location other than its original setup location the Cl
23. a Patient Patient Info Respiratory History Resp Hist cont Motes Pain while Breathing Wheezing pol peg History of Heart Disease Frequently no C yes not yes Abnormal Chest Aap Ever with Sputum T na B LES pol pes Cancel Figure 4 4 Add a Patient Respiratory History Continued Tab The Resp Hist cont tab contains default information If the default entries are acceptable press Enter or click the OK button to accept them Feb 04 Chapter 4 Test Preparation 36 Spirometrics PC Classic Classic Plus User s Manual If one or more of the default entries is not correct you will have to enter information into the following fields Pain while Breathing The default setting is no and is appropriate if the patient does not experience pain while breathing Select yes if the patient experiences pain Cough frequently The default setting is no and is appropriate if the patient does not cough frequently Select yes if the patient coughs frequently With Sputum The default setting is no and is appropriate if the patient coughs without producing sputum Select yes if the patient produces sputum while coughing Wheezing The default setting is no and is appropriate if the patient does not wheeze Select yes if the patient wheezes History of Heart Disease The default setting is no and is appropriate if the patient does not have a history of heart disease Select yes or click on the
24. be performed Acceptability criteria are defined in the 1994 update After three acceptable trials are performed at least two trials should meet the reproducibility criteria The limits require the two highest acceptable FVC and FEV 1 measurements to agree within 200 mLs To help the clinician achieve this reproducibility target we have included a short routine in the PC Classic Plus called Pre Test that can be done prior to the FVC tests 5 1 OPTIONAL PRE TEST TRAINING PC CLASsic PLUS ONLY For the pre test the patient takes several deep breaths through the spirometer The results are compared to the patient s predicted inspiratory capacity IC This procedure provides two benefits first it maximizes and stabilizes the lungs resting position This is important because many patients particularly those with sedentary lifestyles will exhibit some degree of Feb 04 Chapter 5 Testing 42 Spirometrics PC Classic Classic Plus User s Manual atelectasis 1 e collapsed alveoli The pre test will eliminate a source of variability and enhance the achievement of reproducible maneuvers Second the pre test helps the patient acclimate to the surroundings gain confidence in the clinician s instructions perform the first half of the test with the spirometer and contribute to an overall better testing experience To perform a Pre Test do the following 1 From the Browse Patient List window click the PRE test button
25. e The test lasted a full 12 seconds or more e The patient did not cough or choke e The result is approximately 35 times the FEV 1 Feb 04 Chapter 5 Testing 63 Spirometrics PC Classic Classic Plus User s Manual S Accept or Reject MYY Test 4516156 Test Results vt Graph ID 4516156 Date 3 18 2005 Test Number 2 Time 11 19AM Index Meas Pred Pred Hi Yol 137 1859 8 fe Mi Rate rat n a n a Forced Expiratory Time 12 1 Print amp Accept Figure 5 18 Accept or Reject MVV Test Results Window Options on the MVV Tests window shown in Figure 5 16 are Perform MVV enters MVV testing mode Print prints the numeric test results of the highlighted test when selected later Detail displays the numeric results window Delete deletes the currently highlighted test from the data base Confirmation is required 9 Click the Print amp Accept button to accept and print the test Feb 04 Chapter 5 Testing 64 Spirometrics PC Classic Classic Plus User s Manual If the accepted test is not printed at this time only the numeric test data not the volume time graph will be available for printing later 10 Both window tabs may be clicked for review before making the Accept or Reject determination Once the test is rejected the information for that test is no longer available 11 Click the Detail button to view the MVV Test Details window S MWY Test Details Johnny Doe General
26. following sections 6 2 1 PERFORMANCE VERIFICATION ROUTINE PC CLASSIC ONLY If you purchased the PC Classic the Performance Verification window can be accessed after installation and initial setup of the software at any time by clicking on the Performance Verification button Feb 04 Chapter 6 Special Features 88 Spirometrics PC Classic Classic Plus User s Manual Prepare for Product Verification Before this step can be completed please check these pomts D Easy Clean core is tight 2 sensor is attached to Spirometrics 3 Liter syringe using the adapter provided in such a way as to msure no leaks between the sensor and the syringe 4 Syringe handle is pulled out all the way ready te inject To Perform this maneuver on the syringe display D Wat for the Inject Syringe te appear on the left 2 smoothly push in the handle on the syringe keeping the top display bar between Min and Max 4 Retract syringe handle Two smooth and consistent injections are required Figure 6 9 Prepare for Product Verification Window The following steps describe how to complete the performance verification sequence 1 Click the Perform Verification button The Prepare for Product Verification window will appear 2 Read the instructions carefully 3 Click Go when ready to proceed A full screen display that shows the syringe injection will appear Feb 04 Chapter 6 Special Features 89 OI ano Spirometri
27. is Flow Volume loop FV Loop The choices are FVLoop Flow Volume Loop VTCurve Volume Time Curve and Balloons Weight Units The default setting is Ibs pounds To change it select kgs kilograms Gain Factor This variable is set during calibration It is only displayed on the Setup window and cannot be changed 6 1 2 DATA OPTIONS The Data Options tab allows customization of the security backup and data location settings Feb 04 Chapter 6 Special Features 79 Spirometrics PC Classic Classic Plus User s Manual Ss Customization HIE x Setup Data Options Report Setup Report Options Challenge Licensing Security Require Password to access PC Classic Auto Backup MW Use Auto Back 7 Days before Backup Data Directory CPROGRATTISSPIROMOTIPC CLATT TTC ET AS Change dir Print Customization OF Cancel Figure 6 2 Customization Data Options Security The program can be set to require a password for all individuals to access to the PC Classic software and related patient data in order to ensure patient privacy protection See section 7 5 Maintaining Users to develop a user list and set passwords prior to selecting Require Password to access PC Classic Section 7 5 also has default password information Auto Backup The default setting for automatic backup is for all data to be backed up when exiting the program The interval between each backup may be selected from
28. more information Feb 04 Appendices A 4 Spirometrics PC Classic Classic Plus User s Manual NHANES III AGE HEIGHT HEIGHT FVC FEMALE 8 80 es oe limitation limitation limitation limitation FEV6 FEV 1 FVC FEV 1 FEV6 FEF 25 75 PEF Knudson 1983 SEX AGE HEIGHT HEIGHT Yrs Min max cm Min max in Min max 106 7 147 3 42 58 11 INDICES C FEVI 11 19 132 1 182 9 52 72 FEMALE 20 69 147 3 180 3 58 71 70 87 147 3 167 6 58 66 MALE FEV 1 FVC FEF 25 75 FEF 50 12 24 139 7 193 0 55 76 25 84 157 5 195 6 62 77 Feb 04 Appendices A 5 M Spirometrics PC Classic Classic Plus User s Manual Knudson 1976 AGE HEIGHT HEIGHT limitation limitation limitation limitation FEV3 FEV 1 FVC FEF 25 75 PEF Crapo Yrs min max cm min max in min max FVC FEMALE 17 84 146 178 57 71 FEV 1 MALE 15 91 157 194 61 77 FEV3 FEV 1 FVC FEF 25 75 MVV vol Feb 04 Appendices A 6 M Spirometrics PC Classic Classic Plus User s Manual Polgar Yrs min max cm min max in min max FVC FEMALE 6 18 ee oa limitation limitation FEVI MALE 6 18 ee Nes limitation limitation FEF 25 75 MVV vol ECCS with Knudson 1983 Children ages 18 24 are evaluated as age 25 AGE HEIGHT HEIGHT 25 90 145 0 180 0 56 72 FEVI 106 7 147 3 42 58 CHILDREN 11 female FEV 1 FVC 11 17 132 1 182 9 52 72 FEF 2
29. or change the program Destination Folder Spirometrics recommends accepting the default destination However if you wish to install this program software and data on a server or network location please consult your network administrator Feb 04 Chapter 3 Equipment Preparation 11 Spirometrics PC Classic Classic Plus User s Manual 3 2 1 INITIAL SETUP WIZARD Run PC Classic for the first time by one of the following methods Double click on the newly created PC Classic shortcut icon on your desktop or Select Programs All Programs Spirometrics PC Classic v2 11 PC Classic under the Windows Start menu The PC Classic Wizard takes over to complete the installation The entire process takes only a couple of minutes The first five windows that you will see during installation serve three purposes e They tell the user what is happening e They verify that the sensor is properly connected e They allow you to set the report heading and ambient condition default parameters 3 2 2 WELCOME WINDOW The first window is a welcome message Read the message then click Next or press the Enter key to proceed Feb 04 Chapter 3 Equipment Preparation 12 SS Spirometrics PC Classic Classic Plus User s Manual Welcome to the Spirometrics PC CLASSIC modular spirometry system Figure 3 2 Welcome Window 3 2 3 SENSOR FOUND WINDOW The second window informs you that the sensor has been properly connected
30. previous window Click the Close button or the Esc key to return to the previous window Feb 04 Chapter 5 Testing 66 Spirometrics PC Classic Classic Plus User s Manual 5 6 SUMMARY REPORT This option allows you to display the summary of the results along with an interpretation COPD risk indicator and lung age estimation To learn more about customizing your report summary printing options see sections 6 1 3 Report Setup and 6 1 4 Report Options To prepare a summary report highlight the name of the patient for whom you want a summary and then click the Summary Results button from the Browse Patient List window Options include Test Results tab Displays the test results for testing that day for the individual selected More Test Results tab Displays the second page of test results FVC Graph tab Displays the flow volume loop graph VT Graph tab Displays the volume time curve Print Summary Formats and prints a summary report Comments Allows the clinician to add text comments about this patient The comments are only viewable from the patient summary window and will not be printed on the final report Feb 04 Chapter 5 Testing 67 Spirometrics PC Classic Classic Plus User s Manual SS Summary Johnny Doe Test Results More Test Results FYC Graph VT Graph Best Pre Test Interpretation Best Test is 1 of 3 Tests Date 3 10 2005 Time 12 37PM Forced Expiratory Time r F4
31. the Customization window in the Licensing tab Feb 04 Chapter 7 Data Management 107 Spirometrics PC Classic Classic Plus User s Manual Verify that the data directory path is set to your shared location as desired SS Customization Of x Setup Data Options Report Setup Report Options Challenge Licensing Security Auto Backup M Use AutoBackup 4 2 Days before Backup Reminder Data Directory C PROGRA 1 SSPIROM 1 PC C0L477 174 Change dir Set to default Print Customization Cancel Figure 7 10 Data Directory Path Setting Feb 04 Chapter 7 Data Management 108 Spirometrics PC Classic Classic Plus User s Manual NOTES Feb 04 Chapter 7 Data Management 109 Spirometrics PC Classic Classic Plus User s Manual Chapter 8 CARE AND MAINTENANCE 8 1 MAINTENANCE OF THE PC CLASSIC FLOW SENSOR You must disassemble the flow sensor to clean it Refer to Figure 8 1 Flow Sensor Disassembly below to learn the names of the different parts of the flow sensor CAUTION Do not use alcohol or attempt to autoclave any part of the PC Classic WARNING To reduce the risk of cross contamination you must replace the Spiro Filter after each patient It is also recommended that the sensor be cleaned after any testing Federal and state regulations for infection control must be followed WARNING Always unplug the PC Classic before cleaning to avoid electric shock
32. the ReCheck option to verify the calibration over a wide range of flow rates This option meets the ATS recommendations for calibration verification over a wide flow range Proceed with this step as previously during the calibration routine Each of three syringe injection routines must be completed separately by selecting ReCheck e Inject the syringe at a slow rate lt 2 L second e Inject the syringe at a medium rate 4 to 6 L second e Inject the syringe at a fast rate gt 8 L second The calibration window will appear after each injection It should display in Agreement at all three flows Feb 04 Chapter 3 Equipment Preparation 28 Spirometrics PC Classic Classic Plus User s Manual 13 If Done is selected a Finished window will appear indicating that the calibration process is complete 4 Finishedil Exit PC Classic Figure 3 22 Finished Window Additional calibrations may be performed at any time by selecting the Calibration option on the program window See section 6 3 Calibration PC Classic Plus Only Feb 04 Chapter 3 Equipment Preparation Spirometrics Feb 04 PC Classic Classic Plus User s Manual NOTES Chapter 3 Equipment Preparation 30 Spirometrics PC Classic Classic Plus User s Manual Chapter 4 TEST PREPARATION 4 1 PROCESSING PATIENT DATA Patient information must be entered into the software before testing Patient data is always accessed via B
33. the back of the host computer OT HANDLE ASSEMBLY TO COMPUTER SERIAL PORT A 9 PIN ADAPTER l gt COILED CABLE Figure 3 1 Connection Diagram Feb 04 Chapter 3 Equipment Preparation 10 Spirometrics PC Classic Classic Plus User s Manual If a 25 pin adapter PN 15111F is needed to connect your sensor to a COM port on your computer call Inside Sales 207 657 6700 or 1 800 767 0004 to obtain one or buy a DB9 to DB25 adapter from a local computer supply house The PC Classic Classic Plus for Windows is automatically set to the proper COM port by the Startup Wizard The COM port can also be manually set by accessing the Customization option See Section 6 1 CUSTOMIZATION for details 3 2 SOFTWARE INSTALLATION If you purchased the computer from Spirometrics the PC Classic Classic Plus software will be loaded and configured on your computer If you already have a computer or purchase one from a source other than Spirometrics you will need to install the software To load the software insert the CD into the CD drive The program should load automatically If not do the following 1 Click the START button 2 Select RUN 3 Select or enter lt CD drive letter gt setup exe on the Open command line and click OK 4 Follow the instructions in the PC Classic InstallShield Wizard When asked to confirm
34. to scroll through the printer choices 5 Highlight the printer that you want to use Feb 04 Chapter 6 Special Features 96 Spirometrics PC Classic Classic Plus User s Manual 6 Click OK to save the selection to disk If the print driver supplied by the printer manufacturer gave results that were unacceptable try installing a different driver from that family then retry printing For example the BJ 130 driver prints the lines darker on the graphs than does the native BJC 210 driver to the BJC 210 printer Feb 04 Chapter 6 Special Features g7 Spirometrics PC Classic Classic Plus User s Manual NOTES Feb 04 Chapter 6 Special Features 98 Spirometrics PC Classic Classic Plus User s Manual Chapter 7 DATA MANAGEMENT 7 1 PROTECTING PATIENT DATA It is recommended that the files located in the DATA directory be regularly backed up S PC Classic v 2 10 BEE File Edit Browse Data Batch Reports Window Help Print Setup stomization vA Calibration I Exit S spirometrics com Export Data Import Data Trend Analysis nt List ame by Location ID Backup Restore as Nawe ith Location Exit Johnny Doe 5 05 1945 Jane Doe 5 06 1947 John Smith 5 07 1960 B Summary Results Ej Add Sa Modify X Delete EVC Tests PreTest Meth Chal VC Tests MW Tests X Close Browsing Records Sunday September 1 200
35. verification over a wide flow range Proceed with this step as previously during the calibration routine Each of three syringe injections must be completed separately by selecting ReCheck e Inject the syringe at a slow rate lt 2 L second e Inject the syringe at a medium rate 4 to 6 L second e Inject the syringe at a fast rate gt 8 L second The calibration window will appear after each injection It should display in Agreement at all three flows Feb 04 Chapter 6 Special Features 95 Spirometrics PC Classic Classic Plus User s Manual 6 4 PRINTER SELECTION The PC Classic PC Classic Plus for Windows program uses the default printer selected under Print Manager or Control Panel If your default printer does not supply satisfactory results change your printer selection by doing the following PC Classic PC Classic Plus only determines the Windows system default printer at program start up If you use Windows to change the system default printer you will need to close and restart PC Classic to update the printer selection 1 From the main menu select the File option 2 Click on Print Setup 3 Select the Specific Printer option 2 x Print Setup Printer Name Status Ready Type HP DeskJet 957C Where LPTT Comment Paper Orientation Size Letter f Portrait Ls Source Automatically Select Landscape Figure 6 18 Print Setup Window 4 Click the w button
36. word yes if the patient has a history of heart disease Abnormal Chest X ray The default setting is no and is appropriate if the patient has never had an abnormal chest x ray Select yes if the patient has had an abnormal chest x ray The Notes tab contains a blank page to enter additional pre test information An example of information to include is medications dose frequency time last taken and delivery method Information entered in the Notes tab is NOT printed on the report summary but continues to be available in the patient s file Feb 04 Chapter 4 Test Preparation 37 Spirometrics PC Classic Classic Plus User s Manual SS Add a Patient Patient Info Respiratory History Resp Hist cont Motes Notes Cancel Figure 4 5 Add a Patient Notes Tab After verifying that the information is correct press ENTER or click the OK button to accept the entries The patient record has now been created To begin testing refer to Chapter 5 TESTING in this manual 4 1 2 RETRIEVING AND MODIFYING PATIENT INFORMATION If you have tested a patient previously and the information 1s already stored in the system you can access the patient s data by entering his or her ID number Last Name or Location ID at the Browse Patient List window Feb 04 Chapter 4 Test Preparation 38 Spirometrics PC Classic Classic Plus User s Manual SS Browse Patient List by Patient ID by Patient Name by Loc
37. 1 to 30 days Feb 04 Chapter 6 Special Features 80 NT an Spirometrics PC Classic Classic Plus User s Manual Data Directory The data directory is set to the default location during installation This setting may be changed by selecting the Change Dir button and entering the new data directory location The Set to Default option resets the data path to the data subdirectory of the program directory Both short and long filenames may be used 6 1 3 REPORT SETUP Customization BE x Setup Data Options Report Setup Report Options Challenge Licensing Report Header we Spirometics Medical Equipment Co Line 2 22 Shaker Road Line 3 Gray ME 04039 Line 4 207 657 6700 FYC Test Report Option Summary Report Options C One page condensed C One page condensed Two page ATS Two page ATS 3 Test graphs Vanability Method JActual M Offset Graphs Print Customization Cancel Figure 6 3 Customization Report Setup The Report Setup tab allows customization of the report printout Report Header Allows four 4 lines of text to identify the facility performing the testing Feb 04 Chapter 6 Special Features 81 OI ano Spirometrics PC Classic Classic Plus User s Manual FVC Test Report Option The default setting is Two page ATS graph scaling meets ATS recommendations for hand measurements The other option is a One page condensed report Note condensed graph scaling does not meet ATS
38. 2 7 41PM Figure 7 1 File Options Window To generate a Backup Restore from the main menu 1 Select File 2 Highlight Backup Restore Feb 04 Chapter 7 Data Management 99 Spirometrics PC Classic Classic Plus User s Manual aad A dialog box will appear informing you that the PC Classic program needs to close in order to perform backup and restore procedures Press the Enter key to proceed and PC Classic will close automatically The PC Classic Back Up amp Restore program will open S PC Classic Back Up amp Restore Module Version 4 4 File BackupLog About B z BACKUP RESTORE P LOGFILE EXIT a a Qs Figure 7 2 Backup amp Restore Console You may BACKUP files RESTORE files or review the backup LOG FILE from this screen Choose the appropriate options and follow the on screen instructions in each sub window to perform the desired operation 4 Click BACKUP to back up patient data to floppy or to a directory of your choice 5 Click RESTORE to retrieve patient data from the backup files 6 Click LOG FILE to review all backup and restore history Feb 04 Chapter 7 Data Management 100 Spirometrics PC Classic Classic Plus User s Manual Upon exiting the PC Classic program the following message will appear to allow automatic backup of files Backup 69 days have elapsed since vou last backed up your data files Current Interval is 4 days 2 Would you like to create
39. 3 18 Full screen Display Syringe Injection 6 Wait for the Inject Syringe command to appear on the left 7 Pushin the handle Be sure to use a steady continuous stroke in such a manner that the scroll bar remains between the Min Flow and Max Flow markers 8 Upon successful injection a Verify Calibration dialog box will appear If your injection was too fast or too slow the appropriate dialog box will appear instructing you to repeat the injection Feb 04 Chapter 3 Equipment Preparation 25 Spirometrics PC Classic Classic Plus User s Manual Verify Calibration x Injection DE prepare to CHECK calibration Figure 3 19 Verify Calibration Dialog Box 9 Pull the handle back out to its farthest extent Click OK to proceed 10 Repeat steps 6 through 7 11 Upon successful completion a Flow Calibration Results window will appear denoting that the calibration results are either in agreement or not in agreement The measured ATPS volume will be between 2 91 and 3 09 You may print a copy of the calibration results or proceed to other calibration options Calibration results are also saved in a data file Calibration should be repeated if the results are not in agreement Feb 04 Chapter 3 Equipment Preparation 26 NT Spirometrics PC Classic Classic Plus User s Manual Flow Calibration Results Electronic volume measurement is in agreement with select
40. 3 liter syringe Feb 04 Chapter 3 Equipment Preparation 18 SS SY Spirometrics PC Classic Classic Plus User s Manual Once the syringe is firmly connected follow the installation routine for the software you have purchased as described in the following sections 3 2 6 PERFORMANCE VERIFICATION ROUTINE PC CLASSIC ONLY If you purchased the PC Classic the Performance Verification window will open after the correct access codes have been entered Performance Yeritication Perform Verification Figure 3 8 Performance Verification window The following steps describe how to complete the performance verification sequence 1 Click the Perform Verification button The Prepare for Product Verification window will appear Feb 04 Chapter 3 Equipment Preparation 19 Spirometrics PC Classic Classic Plus User s Manual NOTE A 3 liter syringe is required to perform initial calibration for the PC Classic Classic Plus system Prepare for Product Verification Before this step can be completed please check these points D Easy Clean core is tight 2 sensor is attached to Spirometrics 3 Liter syringe using the adapter provided in such a way as to mesure no leaks between the sensor and the syringe 4 Syringe handle is pulled out all the way ready te inject To Perform this maneuver on the syringe display D Wait for the Inject Syringe te appear on the left 4 smoothly push in the handle on
41. 5 152 3 1107 1136 American Thoracic Society Lung function testing Selection of reference values and interpretative strategies Am Rev Respir Dis 1991 144 1202 1218 American Thoracic Society Guidelines for methacholine and exercise challenge 1999 Am J Respir Crit Care Med 2000 161 309 329 American Association for Respiratory Care Clinical Practice Guideline Spirometry 1996 update Respir Care 1996 41 629 636 American Association for Respiratory Care Clinical Practice Guideline Methacholine Challenge Testing 2001 Revision and Update Respir Care 2001 46 5 523 530 National Committee for Clinical Laboratory Standards HS 4 Approved document A Quality System Model for Respiratory Care Wayne PA NCCLS 2002 ADDITIONAL RESOURCES Eaton T Withy S Garrett JE Mercer J Whitlock RML Rea HH Spirometry in primary care practice The importance of quality assurance and the impact of spirometry workshops Chest 1999 116 416 423 Enright PL Johnson LJ Connett JE Voelker H Buist AS Spirometry in the Lung Health Study methods and quality control Am Rev Respir Dis 1991 143 1215 1223 Feb 04 Appendices A 11 SS gt Spirometrics PC Classic Classic Plus User s Manual American College of Occupational an Environmental Medicine Position Paper Spirometry in the occupational setting ACOEM 2000 Ferguson GT Enright PL Buist AS Higgins MW Office Spirometry for Lung Health Assessment in Adults A C
42. 5 of FVC displays if the patient has a slow start to the test e Early Termination No Plateau in VT displays if a one second 1 plateau was not reached prior to the conclusion of the exhalation maneuver 5 3 VC TEST This test applies to both the PC Classic as well as the PC Classic Plus software In patients with severe obstructive lung disease the Forced Vital Capacity FVC may be reduced due to increased airway resistance or a loss of elastic recoil that results in early closure of the airways and gas trapping Exhaling at much slower flow rates may allow the patient to more fully empty the lungs A higher value for VC Slow Vital Capacity relative to the FVC may help rule out a combined obstructive restrictive disorder but static lung volumes must be measured for a definitive answer The difference between the FVC and VC measurements may estimate how much air is trapped in the lungs during a forced expiration To administer the test perform the following steps NOTE Insert a new Spiro Filter on to the flow sensor if this is a new patient 1 Click the VC Tests button The VC Tests window will display the tests in descending order from the newest to the oldest Feb 04 Chapter 5 Testing 52 Spirometrics PC Classic Classic Plus User s Manual S VC Tests Johnny Doe by Patient ID _ Date Time Test VC 12 09 2002 3 18PM 3 3 21 12 09 2002 12 09 2002 Fertorm C Print Delete
43. 5 75 MALE 25 90 155 0 195 0 58 80 male VC G a A CHILDREN IVC Feb 04 Appendices A 7 M Spirometrics PC Classic Classic Plus User s Manual Morris AGE HEIGHT HEIGHT FEV 1 FVC FEF 0 1 1 2 FEF 25 75 FEF 75 85 HSU 1979 Using Journal of Pediatrics 1979 AGE HEIGHT HEIGHT FEVI MALE 11 100 43 75 FEF 25 75 LAM 1979 Using Journal of Pediatrics 1979 AGE HEIGHT HEIGHT FEMALE 5 74 r ee limitation limitation FEVI MALE 5 74 ee a limitation limitation Feb 04 Appendices A 8 Spirometrics PC Classic Classic Plus User s Manual COMPOSITE This is the Default normals selection These normals provide predicted values for most indices O m MT DIAGNOSTIC INTERPRETATION The PC Classic can make simple diagnostic interpretations of the spirometric test data The interpretation scheme is designed to distinguish normal from abnormal pulmonary function test results without making a diagnosis Spirometry test data cannot stand by itself Itis important to coach patients to their maximal effort WARNING Spirometry tests must be evaluated by a qualified A N physician The interpretations printed by the PC Classic software are suggestive only and should not be considered conclusive Feb 04 Appendices A 9 Spirometrics PC Classic Classic Plus User s Manual The Summary Report which is created by clicking on the Summary Results button in the Browse Patient List wind
44. 7 Figure 5 6 Sample Flow Volume Loop Graph When the necessary predicted normal values are available in the selected normals table the graphs will contain a predicted curve See the section 6 1 1 Software Customization and the Normals Tables section of the Appendix for more information 7 Place nose clips on the patient and instruct in the following manner a Breathe in as deeply as possible then place your mouth securely around the mouthpiece with your tongue under the mouthpiece Feb 04 Chapter 5 Testing 48 Spirometrics PC Classic Classic Plus User s Manual b Blow out as hard and fast as possible until I ask you to breathe in as deeply as possible again Your mouth will still be on the mouthpiece when you breathe in deeply the second time Even if it feels like you have all the air out of your lungs keep squeezing the air out until I ask you to breathe in deeply If only the exhale maneuver is to be performed the sensor must be held steady until the end of test 1s determined the software will wait five 5 seconds from the beginning of the plateau for the beginning of the inhalation to begin A short inhale will immediately trigger the end of test 8 Instruct the patient to begin the procedure whenever he or she is ready As the patient exhales the effort is being displayed on screen This display is used as an incentive for the patient to blow as hard fast and completely as possible
45. Body Temperature and Pressure Saturated BTPS that is applied to the lung volumes measured during patient testing Gas volumes are reduced as they are exhaled from a warm body into a cooler room The BTPS adjusts the lung volumes measured during testing so that they more accurately resemble conditions in the body Ambient conditions should be accurately recorded each day testing is performed This data can also be changed at anytime by accessing the Customization option See section 6 1 1 Software Customization When ready click Next to proceed Feb 04 Chapter 3 Equipment Preparation 15 SS Spirometrics PC Classic Classic Plus User s Manual Ambient Conditions Room Temperature 7 Barometric Pressure 760 Figure 3 5 Ambient Conditions Window 3 2 6 ACCESS CODES WINDOW Enter unique activation codes in the Access Codes Window for the modules that you have purchased You may have up to five license code entries Please refer to the first page of this manual or your PC Classic software CD packaging for a list of license codes that you have purchased Feb 04 Chapter 3 Equipment Preparation 16 SS Spirometrics PC Classic Classic Plus User s Manual Sensor Serial Mumber 01095 Figure 3 6 Access Codes Window e If you have purchased a PC Classic for screening only enter only the first access code e If you have purchased the PC Classic Plus enter the first two access codes e If you have purchased the
46. Figure 5 8 VC Tests 2 The patient should be instructed to breathe in as deeply and completely as possible and then blow all of the air out slowly and completely 3 Click the PerformVC button 4 When the sensor is in the testing position click OK Feb 04 Chapter 5 Testing 53 SS Spirometrics PC Classic Classic Plus User s Manual Vital Capacity test VC Figure 5 9 Vital Capacity Test Graph 5 When the message Begin Slow VC appears on screen the zero point has been established and the system is ready to begin the test 6 Place nose clips on the patient and instruct the patient to do the following a Breathe in as deeply as possible place your mouth tightly around the mouthpiece with your tongue under the mouthpiece b Blow all of the air out of your lungs slowly until I ask you to stop 7 Once the maneuver is complete the following window will appear Feb 04 Chapter 5 Testing 54 Spirometrics PC Classic Classic Plus User s Manual S Accept or Reject VC Test 4516156 Test Results vt Graph ID 4516756 Date 12 09 2002 Test Number 4 Time 2 21PM Index Meas Pred Pred WE aff 2 87 Ed Expiratory Time 16 52 Figure 5 10 Accept or Reject VC Test Window Options on the Accept or Reject VC Test window are Test Results tab This is the default window displayed after the test results are processed VT Graph tab For review of the volume time curve created from the
47. IMPORTING FILES The PC Classic can also import patient records to a file To do SO 1 From the main menu select File 2 Select Import Data 3 Select Import File Format Feb 04 Chapter 7 Data Management 102 NT n Spirometrics PC Classic Classic Plus User s Manual 4 To proceed with importing click Import To abort importing click Close PC Classic Import Import File Format C Classic Subset Set Default Filenames Tab Del Filename Import lmpT ab asc cose Figure 7 5 Import Data from PC Classic 7 3 BATCH REPORTS To generate batch reports from the main menu 1 Select Batch Reports 2 Click on the option that best suits your needs Print Patients by ID Print Patients by Name Print Patients by Location ID or Print the Customization Feb 04 Chapter 7 Data Management 103 Spirometrics PC Classic Classic Plus User s Manual S PC Classic Plus v 2 10 File Edit Browse Data BEE anit Window Help Print Patients by ID Patient C i i Exit i trics RR Lauents dt L Print Patients by Name Rr xI Ss Splrometnics com Print Patients by Location ID Print the Customization a Patient 1 01 1965 1 01 1923 Patient 2 22 1988 Checkup 4 15 1998 Summary Results 25 Delete FVC Tests PreT est Meth Chal VC Tests MYY Tests Report data Wednesday August 22 2001 4 14PM Figure 7 6 Batch Reports Menu 7 4 CALIBRATION REVIEW AND MAINTENANCE
48. Methacholine Challenge Maximum Voluntary Ventilation MVV or Network Data options enter those access codes in addition to the first two codes After entering each code in its appropriate box click the Unlock button on the right If the access code has been entered correctly the lock icons will change from locked to unlocked If at any time you choose to purchase additional license options you may enter those license codes by accessing the Customization option as described in section 6 1 6 Licensing When ready click Next to proceed Feb 04 Chapter 3 Equipment Preparation 17 Spirometrics PC Classic Classic Plus User s Manual 3 2 ATTACHING THE 3 LITER SYRINGE The next window to appear will depend upon whether you have purchased a PC Classic or a PC Classic Plus e If you have the PC Classic you will see the Performance Verification window e If you have the PC Classic Plus you will see the Initial Calibration window In both cases the 3 liter syringe should be connected to the sensor as shown ADAPTER SEAL Spirometrics x CALIBRATION SYRINGE SPIRO FILTER FLOW SENSOR Figure 3 7 Flow Sensor and 3 Liter Syringe To connect the 3 liter syringe to the flow sensor do the following 1 Connect the adapter seal to the end of the 3 liter syringe 2 Connect the flow sensor mouthpiece firmly to the
49. RE Test Details Display 7 Repeat the procedure until a maximal value for IC is achieved 8 Close the IC results window and return to the PRE Tests Browse Patient List window to begin FVC testing 5 2 FVC TEST This Forced Vital Capacity FVC Test applies to both the PC Classic and the PC Classic Plus programs To perform an FVC test do the following 1 Click the FVC Test button The FVC Tests window will display the tests in descending order from the newest to the oldest Feb 04 Chapter 5 Testing 45 Spirometrics PC Classic Classic Plus User s Manual S FVC Tests Johnny Doe by Patient ID _ Date Time Test PVC FEV PEF 8BC 123 475 10 8 22 2002 12 25PM 3o eee oe ABC 123 475 10 8 22 2002 12 21PM 394 323 890 ABC 123 475 10 8 22 2002 12 17PM 439 365 967 ABC 123 475 10 10 19 2001 12 28PM 426 354 987 ABC 123 475 10 10 19 2001 12 27PM 445 368 1018 ABC 123 475 10 1019 2001 12 26PM 442 362 49 54 Perform EVC Print T est Post Mode Figure 5 4 FVC Tests Window 2 Instruct the patient how to perform the FVC maneuver and demonstrate the procedure to the patient Coach the patient to breathe in as deeply as possible place the mouthpiece in their mouth with the tongue placed under the mouthpiece blow out as hard and as fast as possible and breathe in as deeply as possible Explain that nose clips will also be used Insert a new Spiro Filter on to the flow sensor if this
50. TIONS S Customization BE x Setup Data Options Report Setup Report Options Challenge Licensing Automatic Test Printout Weight on report C pegs ho pes f no Diagnostic Interpr tation COPD Risk yes C no C peg ho Respiratory History Lung 4ge ves C ho C pes inc Print Customization Cancel Figure 6 5 Customization Report Options Feb 04 Chapter 6 Special Features 83 Spirometrics PC Classic Classic Plus User s Manual The Report Options window allows you to customize whether listed indices or a list of information will appear on the individual and summary reports The window comprises the following fields Automatic Test Printout The default setting is no Weight on report The default setting is yes Diagnostic Interpretation The default setting is no See the Diagnostic Interpretation section of the Appendix for more information COPD Risk The default setting is no Respiratory History The default setting is yes Lung Age The default setting is no 6 1 5 METHACHOLINE CHALLENGE OPTIONS WARNING Methacholine is an inhaled agent that may cause A N the airways to constrict in susceptible patients The 1999 ATS guidelines for methacholine and exercise testing should be followed See the REFERENCES section in the Appendix Users can customize the methacholine challenge settings at the Challenge tab Feb 04 Chapter 6 Special Features 84 Spirometrics PC Cl
51. To change the number click on the number or press the Tab key repeatedly to reach the appropriate field delete the old value and enter the new value 6 1 6 LICENSING S Customization file x Setup Data Options Report Setup Report Options Licensing Spirometics provides license codes at the time your spirometer was purchased These codes need to be entered here in order to use each module Methacholine Challenge Unlock My Testing Sensor Seral Number Figure 6 7 Customization Licensing The Licensing tab allows entry of a license code for each module purchased Spirometrics has provided each of these codes with the equipment at the time of purchase or upgrade For a list of license codes provided when your system was originally purchased see the first page of this manual or the PC Classic CD packaging Feb 04 Chapter 6 Special Features 86 Spirometrics PC Classic Classic Plus User s Manual Enter each code and click Unlock Notice the padlock symbol turns green when a module is activated 6 1 7 GENERAL CUSTOMIZATION BUTTONS The following buttons are located at the bottom of the Customization window e The Print Customization button allows you to print a copy of the customization settings that you have just made in case you share the equipment with others who might change the settings The default system printer will be used NOTE We recommend that you make a copy of your customi
52. and as feedback to the clinician as to how well the test 1s being performed It is important to observe a sharp immediate peak at the beginning of the test The FV Loop incentive graph is the default setting Refer to Section 6 1 1 SOFTWARE CUSTOMIZATION to change the incentive display Feb 04 Chapter 5 Testing 49 Spirometrics PC Classic Classic Plus User s Manual 9 Once the patient has completed the maneuver the following message window will appear on screen S Accept or Reject FYC Test 4516156 Test Results More Test Results FYC Graph WT Graph IDH 4516156 Date December 9 2002 Test Humber 2 Time z DEF M Indes Meas Pred Pred FYC 4 30 2 07 fa FEW 3 45 4 3 re FET FY O 2 02 5 FEWE 4 26 5 8 fa FEYT FEVE 01 0 93 6 FEF 25 75 3 32 40 69 FEF 10 34 10 2 Forced Expiratory Time Figure 5 7 Test Results Tab The results in the Var column under the Test Results tab will appear as n a if only one test has been performed You may print the current test by clicking the Print button Accept the test and return to the FVC Test window or Reject the test as unacceptable Feb 04 Chapter 5 Testing 50 SS gt Spirometrics 10 11 12 13 PC Classic Classic Plus User s Manual You may review all or any of the tabs prior to accepting rejecting or printing the test To do so click on one of the following e More Test Results displays additional indices e FVC Graph displ
53. articular day it is NOT POSSIBLE to exit the post mode until the next day 4 You will not be prompted to administer a bronchodilator when using this method Administer the bronchodilator if you have not already done so If you have not done testing on this patient earlier in the day and you click on the Post Mode button you will see a dialog box instructing you to perform pre bronchodilator testing Click OK to return to the FVC Tests window 5 Perform FVC tests according to steps 3 through 5 in section 5 4 1 Method 1 above Feb 04 Chapter 5 Testing 60 Spirometrics PC Classic Classic Plus User s Manual 5 5 MVV TEST PC CLaAssic PLUS ONLY The Maximal Voluntary Ventilation MVV is a non specific indicator of respiratory system dysfunction and provides information about the patient s overall breathing ability The MVV is sometimes performed in conjunction with and following FVC testing This test requires considerable effort and motivation on the part of the patient It is fatiguing and patient effort dependent It may induce gas trapping or bronchospasm It is not recommended for routine screening procedures The MVV correlates well with a patient s exercise capacity and is used as a predictor of the maximum ventilatory capacity To perform the MVV test do the following 1 Explain the procedure to the patient so that he or she fully understands what will happen 2 Highlight the patient s name
54. assic Classic Plus User s Manual Customization a x Setup Data Options Report Setup Report Options Challenge Licensing Concentration 1 0 000 Concentration Z mel mg ml Concentration 3 0 062 a aa PE i Breaths Per Concentration Concentration 5 0260 i 5 breaths 1 3 Concentration amp 0 500 j Concentration 1 000 Concentration 8 2000 De E D 4000 1 Lower Limit of Normal Concentration 10 0 2 8 0 mg ml Concentration 11 16 000 i Print Customization Cancel Figure 6 6 Customization Methacholine Options Breaths Per Concentration The default setting is 5 breaths Selection range is one 1 to nine 9 To change the number click on the number or press the Tab key repeatedly to reach the field delete the old value and enter the new one Concentration Concentration 1 is always a baseline diluent The defaults for levels two 2 through eleven 11 are 0 031 0 062 0 125 0 25 0 50 1 2 4 8 16 mg ml breath respectively These are consistent with the 1999 ATS recommendations for dosing protocols To change any of the present values click on the number or press the Tab key repeatedly to reach the appropriate field delete the old value and enter the new value Feb 04 Chapter 6 Special Features 85 Spirometrics PC Classic Classic Plus User s Manual Lower Limit of Normal This is used in the interpretation statement The default setting is 8 0 mg ml
55. assic software must be uninstalled then re installed to insure proper operation 2 2 WARNINGS AND PRECAUTIONS The following warnings and precautions must be heeded at all times Use a genuine Spirometrics filter mouthpiece Spiro Filter to ensure proper accuracy reduce the risk of patient cross contamination and to protect the internal sensor element Replace the Spiro Filter after each patient Feb 04 Chapter 2 Safety 5 Spirometrics ee ee ema emf ema ema em ema em ee PC Classic Classic Plus User s Manual Clean the Easy Clean Core regularly to insure the long term stability and accuracy of the instrument Please refer to Chapter 8 CARE AND MAINTENANCE for proper cleaning procedures Do not attempt to clean the unit with abrasives or solvents Do not autoclave any portion of the unit Never immerse any component of the system in water or other liquids with the exception of the Easy Clean Core Use only a desktop or laptop PC that adheres to the specifications listed in the Specifications section of this document The PC Classic has a built in operation verification feature to insure the operation of the system Establishment of verification procedures and schedule are the responsibility of the user The ATS 1994 spirometry recommendations and the American Association for Respiratory Care AARC 1996 Spirometry Clinical Practice Guideline provide guidance The PC Classic Plus has built in ca
56. at this vital capacity is derived from a forced expiration and dynamic compression of the airways may occur Therefore it may be different from the vital capacity derived from a slow expiration in a VC test Forced Expiratory Volume at One Second FEV is the volume of air exhaled in the first second of the FVC maneuver It may be reduced in obstructive and restrictive processes The FEV FEV ratio and FEV FVC ratio is needed to help determine the reason for the decreased FEV FEV is derived from the volume time curve by finding the volume expired on the Y axis of the curve at exactly one second into the test However if the maneuver had a slow start the PC Classic Plus automatically uses the Back Extrapolation Technique to determine the start of the test One second is measured relative to the extrapolated start of the test Forced Expiratory Volume at Three Seconds FEV is similar to the FEV but is measured at three seconds into the test rather than one second Forced Expiratory Volume at Six Seconds FEV is similar to the FEV but is measured at six seconds into the test rather than one second Feb 04 Appendices A 1 Spirometrics PC Classic Classic Plus User s Manual FEV FVC is a ratio of FEV to FVC It is the FEV divided by the FVC then multiplied by 100 so that it can be expressed as a percentage It is decreased in obstructive processes FEV FEV is a ratio of FEV to FEV It is the FEV divided
57. atient Data 99 7 2 Exporting and Importing Files 101 7 2 1 Exporting Files 101 1 2 2 IMPOMING FICS sas an oo 102 1 39 BACH REDON Sacer np aient 103 7 4 Calibration Review and Maintenance 104 7 5 Maintaining Users 105 7 6 Network Option PC Classic Plus Only 107 Chapter 8 Care and Maintenance 110 Spirometrics PC Classic Classic Plus User s Manual 8 1 Maintenance of the PC Classic Flow Sensor 110 8 1 1 Removing the Easy Clean Core cccecceeceeeeeeeeeeeeees 110 8 1 2 Cleaning the Easy Clean Core ccccccseeeeeeeeneeeeeees 111 8 1 3 Installing the Easy Clean Core cccseeeseeeeeeeeeeeeeeees 111 DC DOU VIC Oat an a nn eu on 113 ADDENOICeS ee ese eteret scutes eevee A 1 SUN MERON ertani pe tree ty tee ciene E E A 1 Normals Tables A 4 Diagnostic Interpretation A 9 Interpretation Table cccccccccssseeceeeeseeeseeesseeeeseeesaeaeeeees A 10 PAC IOV CINCO Sr a ane du A 10 Standards and Guidelines A 10 Additional Resources ccccceccccceeeceeceeseeeeceeceeseeeeeesaaeeees A 11 Spirometry Websites A 12 TOGO tact cr onccsuoeneaeesnobaesneecneseect seer ee enaneeetee A 12 ACCESSOFTIES cccccceecccseececeeseeceeeeeseeecseueessaeeessueeessueeesaneeees A 12 Educational Products cccceccccecececcececececcccececeuaccececeeass A 13 Spirometrics
58. ation ID RL Location ee 006 58 99 10 08 1980 006 58 994lpha Tarn Davis 2821419891 E Add Sa Modify 2 lt Delete EWC Tests Pret est Meth Chal Trend VE Tests MVY Tests Figure 4 6 Browse Patient List Test options will vary depending on whether you have the Classic or Classic Plus version To locate a patient s file do one of the following e To locate the patient by ID click the by Patient ID tab Enter the first digit or letter of the patient ID and use the scrollbar or the arrow keys to scroll through the patient listing e To locate the patient by Name click the by Patient Name tab Enter the first letter of the patient s last name and use the scrollbar or the arrow keys to scroll through the patient listing e To locate a patient by Location ID click the by Location ID tab Enter the first digit or letter of the location and use the scrollbar or the arrow keys to scroll through the patient listing If you need to change patient information accessed through any of these methods do the following 1 Highlight the specific patient Feb 04 Chapter 4 Test Preparation 39 Spirometrics PC Classic Classic Plus User s Manual De Click Modify Enter any necessary change s in each tab 4 After all changes are made press Enter or click the OK button to save immediately The updated information will be stored as part of the patient s record 4 1 3 DELETING
59. ator mode a note at the bottom right of the detail window will indicate Post Mode Test If the test was performed prior to entering the post bronchodilator mode there will be no message at the lower right area of the detail window S FYC Test Details Johnny Doe Test Results More Test Results FYC Graph WT Graph IDH 4516156 Date December 10 2004 Test Number 4 Time 11 424M Early Termination Mo Plateau in YT Indes Meas Pred Pred Var FWE 427 2 54 fa 0 07 FEW 3 43 475 re 0 17 FEY TFC 0 3 de FEWE 4 23 9 FE fa 0 10 FEYT FEYE 1 1 03 3 FEF25 5 3 92 47 fo 0 5 FER 6 80 10 2 BF 15 Forced Expiratory Time Post Mode Test Figure 5 13 Bronchodilator Test Results in Details Window NOTE The 1991 ATS recommendations for interpretation of spirometry discuss limits for an acceptable response Feb 04 Chapter 5 Testing 58 Spirometrics PC Classic Classic Plus User s Manual A To view a testing report close the FVC Tests window and click on the Summary Results button in the Browse Patient List window Post bronchodilator results appear in a separate column on the test report and a percent change from pre bronchodilator results is also given SS Summary Johnny Doe Test Results More Test Results FYC Graph WT Graph Best Pre Test Interpretation Best Testis 1 of 3 Tests Date 3 18 2005 Time 12 37PM Forced Expiratory Time 7 4 Interpretations Spirometic Results Appear Normal Indes Meas
60. ave to enter information into the following fields Reason for Test Access the pull down menu by clicking the button Highlight one of the following choices screening asthma COPD lung fibrosis pre surgery or other Cigarettes Ever Smoked The default setting is no if the patient has never smoked Select yes if the patient has smoked per day Enter the number of cigarettes the patient smokes each day Years Enter the number of years that the patient has smoked Then Quit The default setting is no if the patient has not quit smoking or has never smoked Select yes if the patient has quit smoking Years Quit Enter the number of years since the patient stopped smoking If the patient has not quit smoking leave the default of 0 zero Short of breath The default setting is no If it is not accurate access the pull down menu by clicking the button Highlight one of the following alternate choices on stairs walking or at rest Feb 04 Chapter 4 Test Preparation 35 Spirometrics PC Classic Classic Plus User s Manual Lung surgery The default setting is no If it 1s not accurate access the pull down menu by clicking the button Highlight one of the following alternate choices one lung removed lobectomy biopsy or other After verifying that the information is correct press Enter or click the OK button to accept the entries The patient s Resp Hist cont tab will then be displayed SS Add
61. ays the Flow Volume Loop e VT Graph displays the Volume Time Graph Click Accept to accept the test or Reject to reject the test just performed The effort was acceptable if the patient met all of the following criteria e Started with a full inspiration to Total Lung Capacity TLC e Exhaled with an immediate fast start back extrapolation less than 5 of the FVC or 150 mL whichever is greater e Exhaled with maximal effort observed on the peak flow e Continued smooth continuous exhalation for at least 6 seconds or until there is no change in volume for one second on the volume time curve e No coughing in the first second e Inhaled maximally after the expiration Errors are also displayed on the Test Results tab to assist in re instructing the patient Click Perform FVC to perform another FVC test When testing is complete click Close to return to the Browse Patient List window You may then Select a different type of test for the patient Generate a summary report for the patient Select a previous patient Enter a new patient Modify a patient s biographical information Delete a patient s record Feb 04 Chapter 5 Testing 51 Spirometrics PC Classic Classic Plus User s Manual 5 2 1 WARNING MESSAGES The following warning messages may appear e Test Too Short Expiratory Time lt 6 0 Seconds displays if the patient exhales for less than six seconds e Slow Start Extrapolated Volume gt
62. by the FEV then multiplied by 100 so that it can be expressed as a percentage FEV6i1s used as a Forced Vital Capacity surrogate and 1s recommended by the National Lung Health Education Program NLHEP It is decreased in obstructive processes Forced Mid Expiratory Flow FEF 5 75 is the average forced expiratory flow over the middle 50 of the FVC curve between 25 percent and 75 percent of the FVC Peak Expiratory Flow PEF or maximal expiratory flow is the highest point on the flow volume curve PEF should be at the very beginning of the curve if PEF 1s after the beginning the PC Classic Plus uses the Back Extrapolation Technique to determine the zero second point for the FEV and FEV calculations Forced Expiratory Flow FEF so is the forced expiratory flow after 50 of the FVC has been exhaled Forced Inspiratory Vital Capacity FIVC is a measure of the patient s inspiratory vital capacity the volume of air between a maximal expiration and a maximal inspiration It is derived from a forced inspiration Forced Inspiratory Flow FIF 9 is the forced inspiratory flow after 50 of the FIVC has been inhaled Ratio of FIF 5 to FEF 59 F IF s9 FEF 5 is the Forced Expiratory Flow at 50 as a percentage of the Forced Inspiratory Flow at 50 then multiplied by 100 to express the ratio as a percentage Feb 04 Appendices A 2 Spirometrics PC Classic Classic Plus User s Manual Peak Inspiratory Flow PIF is the ma
63. cs PC Classic Classic Plus User s Manual 2 Set Post Bronchodilator Mode Figure 5 11 Setting Post Mode Window 2 Click Yes if all pre bronchodilator testing 1s complete and to set the patient for Post Mode A dialog box will appear instructing you to administer a bronchodilator Click OK to proceed The FVC Tests window will appear with a title bar that reads FVC Tests patient name Post Bronchodilator Testing The Post Mode button will now be grayed out Once Post Mode is set for a patient on a particular day it is NOT POSSIBLE to exit the post mode until the next day S FYC Tests Johnny Doe Post Brochodilator Testing by Patient ID SS Test OS CS PEF 1414 2003 11 01AM 2 di 35 BA 1 14 2003 1412 2008 1212 2002 12 12 2002 12 11 2002 12 10 2002 12 09 2002 12 09 2002 12 09 2002 12 09 2002 12 09 2002 12 09 2002 3 04 fell 3 39 399 3 55 3 40 3 64 10 33 3 52 J313 3 37 9 46 3 29 3 95 3 47 10 07 3 45 9 82 3 45 10 34 9 67 Perform EWC Print Test Delete Fi Li ee oom Sst st Ps Figure 5 12 FVC Tests Post Mode Window Feb 04 Chapter 5 Testing oF Spirometrics PC Classic Classic Plus User s Manual a Perform post mode FVC tests by clicking on the Perform FVC button 4 To view post mode test details select the desired test and click on the Detail button A FVC Test Details window will appear If the test was performed in the post bronchodil
64. cs PC Classic Classic Plus User s Manual Use Syringe Time 0 7 Flow Rate 2US Min Flow Volume increasing volume gt gt gt gt gt gt Figure 6 10 Full screen Display Syringe Injection 4 Wait for the Inject Syringe command to appear on the left 5 Pull the handle to its farthest extent 6 Pushin the handle Be sure to use a steady continuous stroke in such a manner that the scroll bar remains between the Min Flow and Max Flow markers 7 When done immediately pull the handle back all the way The full screen display will reappear 8 Repeat steps 4 through 6 following the on screen prompts until a window appears reporting the measured results Feb 04 Chapter 6 Special Features 90 Spirometrics PC Classic Classic Plus User s Manual Performance Verification Results x Measured Yolume 3 01 Figure 6 11 Performance Verification Results 9 Click OK to complete the verification procedure 6 3 CALIBRATION PC CLASSIC PLUS ONLY Calibrating your PC Classic Plus ensures accurate test results You should calibrate before you use it for the first time and recalibrate it at routine intervals Spirometrics recommends daily calibrations to insure that the spirometer is working properly For compliance with the American Thoracic Society s 1994 Standards of Spirometry and good quality control procedures it is recommended that the linearity of the flow sensing p
65. eady Dialog Box 4 Pull the handle to its farthest extent 5 When ready click OK to proceed A full screen display will appear Feb 04 Chapter 6 Special Features 92 Spirometrics PC Classic Classic Plus User s Manual Use Syringe Time 0 7 Flow Rate 2US Min Flow Volume increasing volume gt gt gt gt gt gt Figure 6 14 Full screen Display Syringe Injection 6 Wait for the Inject Syringe command to appear on the left 7 Pushin the handle Be sure to use a steady continuous stroke in such a manner that the scroll bar remains between the Min Flow and Max Flow markers 8 Upon successful completion a Verify Calibration dialog box will appear 9 Pull the handle back to its farthest extent Click OK to proceed Verify Calibration x Injection OF prepare to CHECK calibration Figure 6 15 Verify Calibration Dialog Box Feb 04 Chapter 6 Special Features 93 Spirometrics PC Classic Classic Plus User s Manual 10 Repeat steps 6 and 7 11 Upon successful completion a Flow Calibration Results window will appear denoting that the calibration results are either in agreement or NOT in agreement At this point the user can print a copy of the calibration results or proceed to other calibration options Calibration records should be maintained for each day testing is performed Flow Calibration Results x Electronic volume measu
66. ed 12 09 2002 FIF50 V s 6 5 n a n a 7 4 13 3 FEF50 FIF50 65 2 n a n a 50 7 22 2 m Graph legend PIF V s 6 7 n a n a 7 7 14 8 Predicted Graph MMET s 0 65 n a n a 0 80 23 1 Pre Test Best Test is bold FET s 7 74 n a n a 9 40 21 4 e Post Test Best Test is bold MVV VOL I m 187 0 a Pre FEV1 Mark Rate Brths m n a n a x Post FEV1 Mark VC l 5 8 0 ATI VC FVC Flow Volume Loop 16 lt lt Measured value less than 75 of predicted m Interpretation Interpretation Spirometric Results Appear Normal Volume Time Curve 8 1 2 3 4 5 6 7 8 PC Classic Plus 2 11d 12 30 2002 2 32PM Page 1 Figure 5 22 One Page Summary Report Feb 04 Chapter 5 Testing 69 D Spirometrics PC Classic Classic Plus User s Manual Spirometrics Medical Equipment Co Summary Report 22 Shaker Road Best Test is 1 of 3 Tests Gray ME 04039 Best Post is 5 of 3 Tests 3 18 2005 12 37PM 207 657 6700 Index Unit Meas Pred Pred Post Chng i FVC l 4 38 5 84 75 4 52 3 2 Patient Johnny Doe FEV1 l 3 52 lt lt 4 75 74 3 49 0 9 ID 4516156 FEV6 l 4 32 5 76 75 4 35 0 7 Age 29 FEV3 l 4 09 5 49 74 4 07 0 5 Sex Ma FEV1 FVC 80 4 82 1 77 2
67. ed syringe volume Mote Accuracy includes 0 5 for syringe Test syringe volume 3 00 Volurme Error absolute 0 01 Measured ATPS Volume 3 01 Volume error percent 0 3 Ambient Conditions T 0mmHg at T2F ETPS Correction Factors Exhale 1 058 Gain Factor 1 022 Inhale 1 069 Flow Calibration Results Electronic volume measurement is NOT in agreement with selected syringe volume Note Accuracy includes 0 5 for syringe Test syringe volume 3 00 Volume Error absolute 0 50 Measured ATPS volume 3 50 Volume error percent 16 7 Ambient Conditions T dmmHg at T2F BTPS Correction Factors Exhale 1 064 Gain Factor 1 234 Inhale 1 069 Figure 3 20 Flow Calibration Results Feb 04 Chapter 3 Equipment Preparation 21 Spirometrics PC Classic Classic Plus User s Manual Calibration Calibrating Flows Sensor on Comm Port 1 Calibration syringe volume 3 liters Restart Recheck Figure 3 21 Calibrating Flow Sensor Dialog Box 12 When ready to continue click OK A final calibration dialog box appears offering three options e Click Done to proceed to patient testing e Click ReStart to repeat the calibration routine e Click ReCheck to verify the calibration over a wide range of flow rates See Section 6 3 Calibration PC Classic Plus Only for a review of the calibration and recheck procedures necessary to meet the 1994 ATS spirometry recommendations It is important to select
68. er that are not available on the PC Classic These calibration routines meet the 1994 American Thoracic Society ATS recommendations Also networking is only available with the PC Classic Plus The PC Classic can be upgraded to the Classic Plus at any time For more information about the upgrade call our toll free number 1 800 767 0004 1 3 WARRANTY The PC Classic Classic Plus is warranted for one year from delivery date as validated by the return of the warranty card or if the warranty card is not returned one year from the date of manufacture During the warranty period any original parts and or workmanship proven to be defective will be replaced or repaired at an authorized service center provided the equipment has been operated and maintained in accordance with the instructions contained in this manual This warranty applies to the original user only and does not extend to any product or component that has been repaired or altered by anyone other than personnel authorized by Spirometrics This warranty is in lieu of and excludes any warranty as to merchantability and all other watranties expressed or implied and do not cover consequential damages due to improper use or application of the product For the device warranty to be in effect the warranty card packaged with this product must be returned to Spirometrics Medical Equipment Company for warranty registration Please take this time to fill out the postage paid warranty card
69. ginal Software on all copies or adaptations You may not copy the Software onto any bulletin board or similar system No Disassembly or Decryption You may not disassemble or decompile the Software unless SPIROMETRICS prior written consent is obtained In some jurisdictions SPIROMETRICS consent may not be required for disassembly or decompilation Upon request you will provide SPIROMETRICS with reasonably detailed information regarding any disassembly or decompilation You may not decrypt the Software unless decryption is a necessary part of the operation of the Software Transfer Your license will automatically terminate upon any transfer of the Software Upon transfer you must deliver the Software including any copies and related documentation to the transferee The transferee must accept these License Terms as a condition to the transfer Termination SPIROMETRICS may terminate your license upon notice for failure to comply with any of these License Terms Upon termination you must immediately destroy the Software together with all copies adaptations and merged portions in any form Export Requirements You may not export or re export the Software or any copy or adaptation in violation of any applicable laws or regulations License Codes SPIROMETRICS Software Product Limited Warranty One Year Limited Software Warranty SPIROMETRICS warrants for a period of ONE 1 YEAR from the date of the purchase that the software prod
70. he FEV and the FEV timed All flow related indices are affected when a back extrapolation error occurs Feb 04 Appendices A 3 Spirometrics PC Classic Classic Plus User s Manual NORMALS TABLES The principal indication for spirometry testing is to determine whether a patient s pulmonary function is normal or abnormal A predicted normal value for a spirometric test index is a prediction of the value a patient should attain if his her pulmonary function is normal The predictions are based on extensive studies of a population and were often done by leading pulmonologists To obtain predicted values the technologist must enter the height age gender and ethnic background of the patient The spirometric test indices from thousands of people of varying height age gender and ethnicity were analyzed and compiled into an equation Each normals table is named by the pulmonologist who led the study The PC Classic Plus has normals tables from the following seven studies When customizing your spirometer select the table that you want to use See Section 6 1 CUSTOMIZATION The selected normals table should match the population to be tested as closely as possible Note the applicable indices and ranges for each study When the table selected in Customization contains the indices FVC PEF and FEF 25 75 a predicted curve will be generated and displayed during testing and on reports See the section 6 1 1 Software Customization for
71. in the Browse Patient List window 3 Click the MVV Tests button NOTE Insert a new Spiro Filter into the flow sensor for each new patient 4 Have the patient breathe in and out as hard and fast as possible for at least 12 seconds 5 From the MVV Tests window click the Perform MVV button Feb 04 Chapter 5 Testing 61 Spirometrics PC Classic Classic Plus User s Manual Ss MYY Tests Johnny Doe by Patient ID Date Time Test MV Val 3 18 2003 11 10AM 4 153 74 12 13 2002 Perform hay Print Delete Figure 5 16 MVV Tests Window 6 When the Hold SENSOR STEADY window appears click OK 7 Place nose clips on the patient and instruct the patient in the following manner with a Place your mouth on the mouthpiece with your tongue under the mouthpiece b Breathe in and out as hard and fast as possible Continue this forced panting until I tell you to stop It will be about 12 seconds Feb 04 Chapter 5 Testing 62 SS Spirometrics PC Classic Classic Plus User s Manual Maximum Voluntary Ventilation test MYY Figure 5 17 MVV Graph Window The curve moves up and down displaying the volume breathed in and out as well as the respiratory rate This display indicates the breathing pattern during the MVV maneuver 8 After the test is complete the Accept or Reject MVV Test window appears An MVV test is acceptable if e The patient put forth maximal effort
72. ion was too fast or too slow you will be given the opportunity to repeat the injection If several failed injection attempts are made a dialog box will appear instructing you to Keep Trying Product Verification x Setup initialized prepare for one more injection to verity Figure 3 12 Product Verification Dialog Box 11 After your first successful injection a dialog box will appear indicating that one more injection is required to verify the calibration Repeat steps 5 through 10 following the on screen prompts until a Performance Verification Results window appears reporting the measured volume The measured result should be between 2 91 and 3 09 Performance Verification Results x M easured Volume 3 01 Figure 3 13 Performance Verification Results 12 Upon completion of performance verification the Finished window will appear The system 1s ready for patient testing Feb 04 Chapter 3 Equipment Preparation 22 SS Spirometrics PC Classic Classic Plus User s Manual Finished Exit PC Classic Figure 3 14 Finished Window Additional performance verifications may be performed at any time by selecting the Performance Verification option on the program window See section 6 2 Performance Verification 3 2 9 CALIBRATION PC CLASSIC PLUS ONLY If you purchased the PC Classic Plus the Initial Calibration window will open after the correct access codes have been entered Initial Ca
73. is a new patient 3 Click the Perform FVC button to open the FVC test mode window Hold SENSOR STEADY in testing position Mote sensor should remain in this position after patient effort until computer acknowledges end of test press ENTER or OK when steady cancel Figure 5 5 Sensor Steady Warning Feb 04 Chapter 5 Testing 46 Spirometrics PC Classic Classic Plus User s Manual 4 Hold the sensor steady in the testing position and click the OK button or press the Enter key when ready NOTE Clicking the Cancel button returns to the FVC Tests window The sensor s zero point is being established and is not ready until the Begin FVC message is displayed 5 Although a full loop both inhalation and exhalation is preferred and provides the most complete information exhalation only can be obtained a When performing the complete loop after the patient has reached a one second plateau on the exhalation effort he she must forcefully begin the inhalation until full inspiration is achieved b If the full loop is not desired the patient should continue to hold the sensor steady as the computer detects the end of the test Moving the sensor may falsely record as patient effort 6 The flow volume loop graph will appear on screen and testing may begin Feb 04 Chapter 5 Testing 47 SS Spirometrics PC Classic Classic Plus User s Manual Forced Vital Capacity test FVC Time 8
74. les amp Warranty Service 800 767 0004
75. libration Perform Calibration Figure 3 15 Initial Calibration Window Feb 04 Chapter 3 Equipment Preparation 23 Spirometrics PC Classic Classic Plus User s Manual The following steps describe how to complete the calibration sequence 1 Click the Perform Calibration button The Calibration dialog box will appear It displays the syringe volume set to a default value of 3 liters A 3 liter syringe is required to perform initial calibration for the PC Classic Classic Plus system Calibration Calibrating Flow Sensor on comm Port 1 Calibration syringe volume 3 liters Figure 3 16 Calibration Dialog Box 2 Click OK to proceed or Cancel to abort the calibration procedure 3 If you selected OK a second dialog box will appear with an instruction to Hold SENSOR STEADY Hold SEMWSOR STEADY in calibrating postition Mote sensor should remain in thie position after air injection until computer acknowledges end of calibration press ENTER or OK when steady cancel Figure 3 17 Hold Sensor Steady Dialog Box Feb 04 Chapter 3 Equipment Preparation 24 SS Spirometrics PC Classic Classic Plus User s Manual 4 Pull the handle out to its farthest extent 5 When ready press ENTER or click OK to proceed A full screen display will appear Use Syringe Time 0 7 Flow Rate 2U8 Min Flow Volume increasing volume gt gt gt gt gt gt Figure
76. libration capability The 1994 ATS standard on spirometry recommends daily calibration of this instrument or more frequently as appropriate Accurate and effective use of the PC Classic and PC Classic Plus depends on correct application of well established spirometry practices Do not operate the unit in a flammable or explosive atmosphere Insure that the Easy Clean Core is properly installed as described in Chapter 8 CARE AND MAINTENANCE Do not drop the sensor handle The PC Classic handle is a sensitive measurement device Improper handling could affect the accuracy of its reported results Do not disassemble sensor handle There are no user serviceable parts inside Feb 04 Chapter 2 Safety 6 Spirometrics PC Classic Classic Plus User s Manual 2 3 DISPOSAL This instrument contains electronic circuitry and multiple plastics Please dispose of properly at the end of useful life Computer recycling facilities are capable of recycling this instrument 2 4 SYMBOLS AND DEFINITIONS The specific Attention consult directions in this accompanying manual and on the PC documents Classic handle must be observed The system must not be modified or serviced except by authorized personnel Dangerous voltage Class If Equipment Type BF Equipment Feb 04 Chapter 2 Safety 7 Spirometrics PC Classic Classic Plus User s Manual NOTES Feb 04 Chapter 2 Safety Spirometrics PC Classic Classic Plus U
77. mation as follows ID Type the patient s identification number This ID may be any combination of letters and numbers but must be unique to each patient The maximum number of characters is 20 This field is required First Name Type the patient s first name This field is required Feb 04 Chapter 4 Test Preparation 32 Spirometrics PC Classic Classic Plus User s Manual Last Name Type the patient s last name This field is required Street Type the patient s street address This field is optional City Type the city in which the patient lives This field is optional State Prov Type the state in which the patient lives This field is optional Zip Type the patient s zip code This field is optional Birthdate Type the patient s birth date in mm dd yyyy format This field is required Location ID Enter a location ID number in this field Maximum number of digits is 12 This field may be used to identify a specific test site or piece of equipment and is optional It remains optional in network data Ethnic Origin Access the pull down menu by clicking the button Highlight one of the following choices Asian Black Caucasian Hispanic and Non Caucasian After highlighting your selection click the button This field is required Selection of ethnic origin may impact the normal predicted results Consult the Appendix to review the Normals Tables The default reference for spirometry is NHANESIII Feb
78. n resolution or better e Windows compatible printer e Available serial port Operating System Windows 95 or 98 Windows NT Work Station 4 0 Windows ME Windows 2000 Professional and Windows XP Hazardous EQUIPMENT not suitable for Flammable use in the presence of a Environments FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE Mode of Operation Rated for continuous operation Windows 95 98 Windows NT Workstation 4 0 Windows ME Windows 2000 Professional and Windows XP Professional are registered trademarks of Microsoft Corporation Redmond Washington Feb 04 Specifications il Spirometrics PC Classic Classic Plus User s Manual ELECTRICAL Power Derived from the RS 232 port Serial Port RS 232C compliant EMC Compliant with Standard 60601 0 1990 of the Electromagnetic Compatibility Directive OPERATING Meets or exceeds Standards of Spirometry requirements 1994 update American Thoracic Society Medical Section of the American Lung Association Flow Ranges 14 0 to 14 0 liters second ENVIRONMENTAL Operating 17 C 63 F to 40 C 104 F 0 80 Relative Humidity Storage Temperature 18 C 0 F to 50 C 122 F Humidity 0 80 Relative Humidity Feb 04 Specifications iii Spirometrics PC Classic Classic Plus User s Manual NOTES Feb 04 Specifications Spirometrics PC Classic Classic Plus User s Manual Chapter 1 INTRODUCTION 1 1 WELCOME
79. nclude which Tests AIl C Pre BD Only Individual Tests C Post BO Only ATS Best Tests Selected gt lt Mot Selected Date Time Test Pre Post SA B2005 12 59PM Fi i 3162005 12 59PM SN62005 12 35PM 362008 12 55PM BN62005 12 37PM SN82005 12 37PM 1222 2004 12 49PM 1240 2004 11 424M 1240 2004 11 404M 1240 2004 11 204M en Figure 5 25 Trend Analysis Window Ti 4 52 3 45 4 31 3 46 406 3 20 4 35 3 45 4 30 3 54 4 02 3 65 4 27 3 43 4 34 3 60 4 56 3 75 M Li hi D EE om Den OC Qi 2 You may compare individual tests or the best test results from All tests Pre BD Only or Post BD Only Bronchodilator Feb 04 Chapter 5 Testing 12 SS gt Spirometrics PC Classic Classic Plus User s Manual Make selections within the Which Kind of Trend Analysis and Include Which Tests boxes and then highlight the tests from those displayed in the Select area Use the scrollbar press the arrow keys or press the PgUp or PgDn keys to move within the available tests Press the Space Bar or double click to tag tests for trending Tests are tagged to be trended when the icon to the left is a Up to twenty 20 tests maybe selected to trend If you have selected a test that you wish to de select highlight it and press the Space Bar or double click the test The test is not tagged for trending when the icon to the left is an amp Five indices are trended FVC FEV1 FEV1 FVC FEF 25
80. neumotach be checked on a daily basis This can be accomplished by injecting your syringe at three different flow rates during a follow up injection As an example injecting a 3 liter syringe for 1 3 and 6 seconds will create rates of 3 I s 1 l s and 0 5 I s respectively See the following section for instructions 6 3 1 CALIBRATION ROUTINE The following steps describe how to complete the calibration sequence 1 Click the Calibration button The Calibration dialog box will appear It displays the syringe volume Feb 04 Chapter 6 Special Features gi Spirometrics PC Classic Classic Plus User s Manual Calibration Calibrating Flow Sensor on Comm Port 1 Calibration syringe volume 3 liters Figure 6 12 Calibration Dialog Box 2 Click OK to proceed or Cancel to abort the calibration procedure To change the syringe volume the user must access the Customization option from the main menu and change the syringe volume Syringe volumes from 1 to 9 liters may be entered Using a syringe with volume different from the display value will result in calibration errors 3 If you selected OK a second dialog box will appear with an instruction to Hold SENSOR STEADY Hold SENSOR STEADY in calibrating position Mote sensor should remain in this position after air injection until computer acknowledges end of calibration press ENTER or OK when steady cancel Figure 6 13 Hold Sensor St
81. ng until green marker aligns with the pin Feb 04 Chapter 8 Care and Maintenance 111 Spirometrics PC Classic Classic Plus User s Manual Screw in Easy Clean Core Top Pin until seated then tighten in the direction shown until the green band on the core is aligned with the top pin El AANANAMNANAA rci MAMA IS 5 AAYA YAYAYAYAVAVAYA i Figure 8 2 Alignment of Easy Clean Core The figure below shows how to assemble the flow sensor N R Easy Clean Core Screw the Core Element from this Handle Assembly side to assemble Handle Assembly fully assembled Figure 8 3 Flow Sensor Assembly Feb 04 Chapter 8 Care and Maintenance 112 Spirometrics PC Classic Classic Plus User s Manual 8 2 SERVICE If the instrument fails to work do the following l 4 5 Ensure that the power to the computer is on and that all connections are secure Examine the unit for obvious loose broken or damaged components Check that the Easy Clean Core 1s tightened properly See Figure 8 2 Alignment of Easy Clean Core Check that the Easy Clean Core 1s not blocked Check the computer communications port connection If the problem persists and the unit is within the warranty period call Spirometrics at 800 767 0004 Otherwise please contact Spirometrics at 207 657 6700 Our repair personnel can handle many problems over the phone Please be pre
82. onsensus Statement From the National Lung Health Education Program Chest 2000 117 1146 1161 Wanger J Irvin C Office spirometry equipment selection and training of staff in the private practice setting Journal of Asthma 1997 34 2 93 104 SPIROMETRY WEBSITES American Thoracic Society www thoraic org American Association for Respiratory Care www aarc org National Lung Health Education Program www nlhep com National Lung Health Education Program www nlhep com Global Initiative for Chronic Obstructive Lung Disease www goldcopd com PRODUCT LIST ACCESSORIES Item Description Packaging 2195 Spiro Filter Box of 100 2104 Nose Clips Bag of 10 20043 Pediatric Adapter Bag of 1 3014 Pediatric Mouthpiece Bag of 100 Feb 04 Appendices A 12 Spirometrics PC Classic Classic Plus User s Manual EDUCATIONAL PRODUCTS Item Description SP 061973 Spirometry Producing Quality Test Results CDROM SP 040151 Diagnostic Training and Competence Manual Pulmonary and Noninvasive Cardiology CD ROM containing manual SP 111680 Spirometry Quality The Essentials Printed Version SP 081570 Spirometry Quality The Essentials CD ROM Version SP 101201 Spirometry Test Quality Assessment Selecting and Reporting Results Video and Workbook SP 070402 Additional Workbook for SP 101201 Feb 04 Appendices A 13 S gt Spirometrics P O Box 680 22 Shaker Road Gray ME 04039 USA Phone 207 657 6700 Fax 207 657 4123 Sa
83. ow contains a box where interpretation information can be written See section 5 6 Summary Report for more information This box will also optionally contain a brief diagnostic summary generated by the PC Classic software See section 6 1 4 Report Options to enable or disable this option Interpretations are based entirely on two indices FVC and FEV1 The PC Classic uses the best of each of these indices from all test data for a particular patient INTERPRETATION TABLE The following table describes the interpretation scheme and corresponding diagnostic messages of Predicted FVC FEVI FEVI FVC Low FEV1 Suggests lt aaa Obstructive Disorder Low FEV1 Suggests gt aka Ventilatory Disorder Low FVC Suggests Interpretive Message Low FVC Suggests Ventilatory Disorder In all other cases spirometric results appear normal lt 60 lt 75 gt lt 75 a 2 75 Restrictive Disorder REFERENCES STANDARDS AND GUIDELINES American Thoracic Society Pulmonary Laboratory Management and Procedure Manual New York ATS 1998 Updated chapters are available each year Feb 04 Appendices A 10 Spirometrics PC Classic Classic Plus User s Manual American Thoracic Society Standardization of spirometry 1987 update Am Rev Respir Dis 1987 136 1039 1060 Published concurrently in Respir Care 1987 32 11 1039 1060 American Thoracic Society Standardization of spirometry 1994 update Am J Respir Crit Care Med 199
84. pared to provide the information listed on the following page Feb 04 Chapter 8 Care and Maintenance 113 Spirometrics PC Classic Classic Plus User s Manual Product Model Number PC Classic Serial Number of Sensor located on the bottom of the handle Current hardware configuration including CPU Amount of RAM Size of Hard Drive Available Space on Hard Drive Type of mouse installed COM port Current software configuration including Operation system and version Is this computer on a network Is the computer used for other purposes besides spirometry If possible be prepared to work with the device and its program while on the phone with technical support If the problem persists the unit must be returned to Spirometrics for repair e You MUST call for an RGR number before returning your product for repair e Only Spirometrics and its service representatives are authorized to service equipment Feb 04 Chapter 8 Care and Maintenance 114 Spirometrics Feb 04 PC Classic Classic Plus User s Manual NOTES Chapter 8 Care and Maintenance 115 Spirometrics PC Classic Classic Plus User s Manual APPENDICES DEFINITIONS Forced Vital Capacity FVC is a measure of the patient s expiratory vital capacity the volume of air between a maximal inspiration and a maximal expiration FVC indicates the greatest expired volume of air in a person s lungs Note however th
85. r 5 Testing 76 Spirometrics PC Classic Classic Plus User s Manual Chapter 6 SPECIAL FEATURES 6 1 CUSTOMIZATION Spirometrics designed the PC Classic and PC Classic Plus to be as flexible as possible allowing users to customize it to meet their particular needs To customize your software settings open the Customization window by clicking on the Customization option of the main menu 6 1 1 SOFTWARE CUSTOMIZATION The Setup tab contains fields that allow you to customize your software The following variables are included in this window Customization a x Setup Data Options Report Setup Report Options Challenge Licensing COM Port setup Predicteds Flow Sensor Composite gt Extrapolation enabled vues who Calibration Settings syringe Volume 3 o Gauge readings Air Temp rature Lae Barometric Pressure 760 FY Incentive F Loop Fr 7 Weight Units f Ibs kgs Gain Factor 954 Print Customization Cancel Figure 6 1 Customization Setup Feb 04 Chapter 6 Special Features a Spirometrics PC Classic Classic Plus User s Manual COM Port setup Flow Sensor To change the COM Port highlight the number for COM Port Flow sensor and enter the number of the COM port to be used Alternately use the scrollbar or press the up or down arrow keys on the keyboard to arrive at the number you desire Predicteds The default setting is
86. ral with respect to this product Any implied warranty of merchantability or fitness for a particular purpose is limited to the one 1 year duration of this written warranty Some states or provinces do not allow limitations on how long an implied warranty lasts so the above limitation or exclusion may not apply to you This warranty gives specific legal rights and you may also have other rights which vary from state to state or province to province Limitation of Liability and Remedies THE REMEDIES PROVIDED ABOVE ARE CUSTOMER S SOLE AND EXCLUSIVE REMEDIES IN NO EVENT SHALL SPIROMETRICS BE LIABLE FOR ANY DIRECT INDIRECT SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING LOST PROFIT WHETHER BASED ON WARRANTY CONTRACT TORT OR ANY OTHER LEGAL THEORY Some states or provinces do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you Obtaining Warranty Service Warranty service may be obtained by calling Spirometrics customer service at 1 800 767 0004 USA Spirometrics PC Classic Classic Plus User s Manual PC CLASSIC PC CLASSIC PLUS USER S MANUAL Copyright 2003 2004 Spirometrics Medical Equipment Company PO Box 680 22 Shaker Road Gray ME 04039 USA http www spirometrics com IMPORTANT Please send in the attached card to activate your warranty Rev 06 February 2004 Spirometrics PC Classic Classic Plu
87. rement is in agreement with selected syringe volume Mote Accuracy includes 0 5 for syringe Test syringe volume 3 00 Volume Error absolute 0 01 Measured ATPS Volume 3 01 Volume error percent 0 3 Ambient Conditions T dmmHyg st T2F BTPS Correction Factors Exhale 1 058 Gain Factor 1 022 Inhale 1 069 Flow Calibration Results x Electronic volume measurement is NOT in agreement with selected syringe volume Note Accuracy includes 0 5 for syringe Test syringe volume 3 00 folume Error absolute 0 50 Measured ATPS Volume 3 50 Volume error percent 16 7 Ambient Conditions F60mmHe at T2F BTFS Correction Factors Exhale 1 054 Gain Factor 1 234 Inhale 1 069 Figure 6 16 Flow Calibration Results Feb 04 Chapter 6 Special Features 94 Spirometrics PC Classic Classic Plus User s Manual 12 When ready to continue click OK A final calibration dialog box appears offering three options e Click Done to proceed to patient testing e Click ReStart to repeat the calibration routine e Click ReCheck to verify the calibration over a wide range of flow rates Calibration Calibrating Flow Sensor on comm Port 1 Calibration syringe volume 3 liters Restart Recheck Figure 6 17 Calibrating Flow Sensor Dialog Box It is important to select the ReCheck option to verify the calibration over a wide range of flow rates This option meets the ATS recommendations for calibration
88. rowse Patient List window Browse Patient List by Patient ID by Patient Name by Location ID ibe Nee o Brh Location 7 006 58 99 10 08 1980 i 2721 7198 006 58 994lpha Tammy Davis 22141981 __ si Mody 2 Delete EWC Tests Pret est Meth Chal Trend YC Tests MVY Tests Figure 4 1 Browse Patient List Test options will vary depending on whether you have the Classic or Classic Plus versions The following sections describe how to enter retrieve modify and delete patient data 4 1 1 ENTERING A NEW PATIENT From the Browse Patient List window select Add The following window will appear Feb 04 Chapter 4 Test Preparation 31 Spirometrics PC Classic Classic Plus User s Manual S Add a Patient Patient Info Respiratory History Resp Hist cont Notes ID ABC 123 475 10 Red fields required First Hame Jahn Last Name Doe Street 524 Noth 856 City Hooservile State Prov IN Zip 46088 Birthdate 6061945 Location ID Ethnic Origin Mon Caucasian Gender Height eig 62 0 Mali Female weight 185 mea _ Figure 4 2 Add a Patient Patient Info There are three ways of inputting and changing information in this software e Use the Tab key to move sequentially through each field e Use the Enter key to move from one required field to the next o Click the mouse to position the cursor in the desired field Enter patient infor
89. s User s Manual Table of Contents SD CHICANONS 2 i NOGO eeo a ne i GNET aU aE A T N ii EI CINCA oae at lil OS a ee nn lil Envronmenial SE a a nn lil Chapter 1 Introduction 1 1 Fa 606 00 gt a da an 1 1 2 Product Differences PC Classic vs PC Classic Plus 1 To Warranty a nn 2 Chapter 2 Safety 5 2 1 Miended Sa ee ee 5 2 2 Warnings and Precautions ccccccseecseeeseeeeeeeneeenees 5 ZO DEPOS A a a nt noie 7 2 4 Symbols and Definitions cccceccceeeeceeeeseeeseeeeneees 7 Chapter 3 Equipment Preparation 9 3 1 Preparing for Installation 9 SVENO ee aan eau 9 3 1 2 Connecting the Classic Sensor 10 3 2 Software INStallAtiON nd ha 11 3 2 1 Initial Setup Wizard cc eeeeececeeeeeeeeeeeeeeeeeeeeesaaeeeees 12 3 2 2 Welcome Window 12 3 2 3 Sensor Found Window 13 3 2 4 Address Window ccccecccecseecceeceeeeeeeeeeeeeseeeeeeeeaaeeeeeas 14 3 2 5 Ambient Conditions Window ccccseecceeeeeeeeeeeeeeeeees 15 3 2 6 Access Codes Window ccccceeecceeeeeeeeeeeeeeeeeaeeeeeees 16 3 2 7 Attaching the 3 Liter Syringe ccccceeceeeeeeeeeeeeeeeeeees 18 3 2 8 Performance Verification Routine PC Classic only 19 3 2 9 Calibration PC Classic Plus only 23 Chapter 4 Test Preparation 31 4 1 Processing Patient Data 31 4 1 1 Entering a New Patient 31 4 1 2 Retrieving and Modifying Patient Information
90. ser s Manual Chapter 3 EQUIPMENT PREPARATION 3 1 PREPARING FOR INSTALLATION The PC Classic Classic Plus is shipped in a box specifically designed to protect it during shipment Keep the shipping box and packing materials in case you ever need to ship the unit for service or maintenance Common Windows tasks and uses should be familiar to the user before attempting to operate this program Consult the Microsoft Windows user s manual if this is not the case 3 1 1 INVENTORY After unpacking your new PC Classic Classic Plus check each item against the following list Handle Assembly for PC Classic Classic Plus Coiled Cable 9 pin Adapter Program CD User s Manual amp Warranty Card Windows and Microsoft are registered trademarks of Microsoft Corporation Redmond Washington Feb 04 Chapter 3 Equipment Preparation 9 Spirometrics PC Classic Classic Plus User s Manual If anything is missing immediately contact a Spirometrics inside sales representative e Phone 207 657 6700 or 1 800 767 0004 e E mail spiro spirometrics com 3 1 2 CONNECTING THE CLASSIC SENSOR To connect the Classic Sensor do the following 1 Connect one end of the coiled cable to the outlet on the bottom of the Classic Sensor 2 Connect the other end of the coiled cable to the telephone type connector of the 9 pin adapter 3 Plug the 9 pin end of the adaptor into one of the serial ports COM1 COM4 on
91. the syringe keeping the top display bar between Min and Max 4 Retract syringe handle A minimum oftwo smooth injections are required Figure 3 9 Prepare for Performance Verification Window Read the instructions carefully Pull the handle out to its farthest extent Click Go when ready to proceed So a A dialog box will appear instructing you to verify that the syringe is ready Click Ready to continue Feb 04 Chapter 3 Equipment Preparation 20 OI an SS Spirometrics PC Classic Classic Plus User s Manual Make Sure Syringe is ready Are you sure you are ready D No leaks from syringe through the sensor 2 syringe handle pulled all the way out Cancel Figure 3 10 Syringe Ready Dialog Box 6 A full screen display that shows the syringe injection will appear Use Syringe Time 0 7 Flow Rate 2U8 0 Min Flow Max Flow Volume increasing volume gt gt gt gt gt gt Figure 3 11 Full screen Display Syringe Injection 7 Wait for the Inject Syringe command to appear on the left 8 Pushin the handle Be sure to use a steady continuous stroke in such a manner that the scroll bar remains between the Min Flow and Max Flow markers Feb 04 Chapter 3 Equipment Preparation 21 SS gt Spirometrics PC Classic Classic Plus User s Manual 9 When done immediately pull the handle back all the way to prepare for another injection 10 If your inject
92. uct will execute its programming instructions when all files are properly installed SPIROMETRICS does not warrant that the operation of the software will be uninterrupted or error free In the event that this software product fails to execute its programming instructions during the warranty period Customer s remedy shall be a refund or repair Should SPIROMETRICS be unable to replace the media within a reasonable amount of time Customer s alternate remedy shall be a refund of the purchase price upon return of the product and all copies Removable Media If supplied SPIROMETRICS warrants the removable media if supplied upon which this product is recorded to be free from defects in materials and workmanship under normal use for a period of ONE 1 YEAR from the date of purchase In the event the media proves to be defective during the warranty period Customer s remedy shall be to return the media to SPIROMETRICS for replacement Should SPIROMETRICS be unable to replace the media within a reasonable amount of time Customer s alternate remedy shall be a refund of the purchase price upon return of the product and destruction of all other non removable media copies of the software product Notice of Warranty Claims Customer must notify SPIROMETRICS in writing of any warranty claim not later than thirty 30 days after the expiration of the warranty period Limitation of Warranty SPIROMETRICS makes no other express warranty whether written or o
93. ximum inspiratory flow anywhere on the inspiratory portion of the Flow Volume Loop below the zero line PIF is the lowest point on the inspiratory portion of the Flow Volume Loop Expiratory Time ET is the elapsed time expressed in seconds from the beginning of the expiration until the expiration is completed Maximum Voluntary Ventilation MVV is the largest volume of air inhaled or exhaled over a timed period typically 12 to 15 seconds which is then extrapolated to one minute The maneuver done to measure the MVV should imitate rapid breathing during strenuous exercise Vital Capacity VC is the largest volume of exhaled gas measured on a slow complete expiration after a maximal inspiration Air Trapping Index ATI is the difference between the FVC and the VC indices It may reflect how much air becomes trapped in the lungs during a forced expiration Lung Age is an estimate of the age of the subject s lungs based on spirometric measurements The method used to estimate lung age is that described by Morris and Temple Preventive Medicine pp 655 662 1985 COPD Index is a measure of the subject s risk for developing COPD To determine the COPD Index the Tecumseh Index of Risk is calculated using the subject s age gender current smoking habits FEV and height according to the method described by Higgins and Keller Journal of Respiratory Diseases January 1983 Back Extrapolation Technique is necessary for t
94. zation settings and keep it with the user s manual e The OK button allows you to accept all changes that you have made e The Cancel button allows you to cancel the changes that you have made and abort the customization session 6 2 PERFORMANCE VERIFICATION amp CALIBRATION We have included a routine called Performance Verification for PC Classic users and a Calibration routine for PC Classic Plus users to test the long term stability of the system Performance verification or calibration was completed as part of the installation process These procedures can be repeated at any time to validate that the spirometer is working properly ATS standards require daily calibration For more information on the calibration option and ATS requirements see section 6 3 Calibration PC Classic Plus Only Feb 04 Chapter 6 Special Features 87 Spirometrics PC Classic Classic Plus User s Manual ADAPTER SEAL Spirometrics D CALIBRATION SYRINGE SPIRO FILTER 4 To connect the 3 liter syringe to the flow sensor do the following FLOW SENSOR Figure 6 8 Flow Sensor and 3 Liter Syringe 1 Connect the adapter seal to the end of the 3 liter syringe 2 Connect the flow sensor mouthpiece firmly to the 3 liter syringe Once the syringe is firmly connected follow the routine for the software you have purchased described in the

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