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CP 200 Spirometry Option Directions for Use

1. Item Material Numbers Quantity Disposable flow transducers 703418 25 703419 100 Pressure tubing 2 meters 703415 Sensor 703552 Nose clip 58550 0000 Calibration syringe 3 L 703480 Germicidal Sani Cloth canister 26004 0000 Product information e Spirometry Reference Chart 71038 3000 wall poster e Spirometry Effort Acceptability amp Reproducibility 703337 wall poster e CP 200 Spirometry Option Quick Reference 703977 small card e CP 200 Spirometry Option Directions for Use 708795 e CP 200 product information multi language CD 401151 10 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option Getting Help You can get help with the CP 200 spirometry option in a variety of ways beyond this manual e Press the Help key i from the initial spirometry screen for a list of topics available to print e Review the other information that came with the spirometer For list see Product information on page 9 e Contact Welch Allyn For phone numbers see page ii 2 Reviewing the Spirometry Settings Spirometry Settings Menu Tree 12 Reviewing the Operation Settings 000 cece eee eee eee 13 Reviewing the Calibration Settings 0 0 cece eee 15 Reviewing the Spirometry Screen Settings 00 cece eee ees 16 Reviewing the Spirometry Print Settings 0 00 eee 17 Reviewing the Patient Data Fields Available o ooooooo 19 Reviewing the Interpretation List
2. 20 Note You can access the spirometry settings only if the spirometer is connected See Connecting the Spirometer Components on page 37 11 12 Chapter2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option Spirometry Settings Menu Tree Spirometry Settings Operation Calibration Screen Settings Settings E Settings L Select Protocol Calibrate Spirometer L Select Default FVC Curve Select Adult Predictive Norm Enable Auto Calibration Report Select FVC Display Parameters Select Ped Predictive Norm Print Calibration Report Select Best Effort Formula Select FVC Reversibility Formula Select FEV1 Formula Enable Predictive Points HF Enable Predictive Curve Enable ATS Interp Results Enable Composite Norm Values Print Patient Data Edit tal Settings Settings Interpretation List Select Efforts First Name E Select FVC Curves Second Last Name E Select FVC Print Parameters Middle Initial Select Scale Age Birth Date Print Lung Age Weight Print Unconfirmed Report Smoke Years L Print Reviewed By Packs Day L Print Patient Cooperation Medication Print Quality Grades History Print Patient Education L Comments Print Physicians Comments Auto Print Note As part of spirometry setup
3. Pressure 739 4 mmHg I Gain 1 19 E Gain 1 02 5 10 15 Legend Time d Measured Adjusted Sa Retry Accept Exit All errors lt 3 Calibration is acceptable 28 Chapter3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option 11 Press the appropriate softkey A Caution A poor calibration as shown in Figure 14 and Figure 16 indicates that the system had to make large adjustments to measure the syringe volume accurately Do not accept poor calibrations or your spirometry test results may be inaccurate e Retry Discards the results the calibration data is not saved Returns to initial calibration screen Go to Step 2 on page 24 If you keep retrying and cannot get good results press Accept and then calibrate all over again from Step 1 on page 24 e Accept Saves the results Resumes your original procedure If automatic report printing is enabled a calibration report prints To learn how to enable or disable automatic printing see Reviewing the Calibration Settings on page 15 e Exit Discards the results Resumes your original procedure 12 Optional Verify the most recent calibration especially if your calibration results were questionable a Go back to Step 1 on page 24 b Select Verify Calibration in Step 3 c On your results screen check the error percentages for the expired and inspired volumes Both all must be less than 3 for your calibration to be acceptable
4. Tests Three Best Efforts Scale 20mm s 10mm L Curves V T amp F V For details see Reviewing the Spirometry Print Settings on page 17 60 Appendix B Spirometry Protocols Welch Allyn CP 200 Spirometry Option About the SSD Protocol The SSD Social Security Disability protocol is for users who want to make sure that testing associated with disability determinations meet the requirement of the Social Security Administration The device automatically performs as described here regardless of user defined settings For details on SSD requirements see the document noted in Reference 2 on page 75 When this protocol is selected testing and reports are affected as follows e Calibration Settings Auto Calibration Report Yes For details see Reviewing the Calibration Settings on page 15 e Print Settings Tests Three Best Efforts Scale 20mm s 10mmy L Curves V T amp F V For details see Reviewing the Spirometry Print Settings on page 17 e Calibrations must be presented in a volume time format at a speed of at least 20 mm sec and a volume excursion of at least 10 mm L to permit independent evaluation e Two of the satisfactory efforts should be reproducible for both pre bronchodilator tests and if indicated post bronchodilator tests e Atestis considered reproducible if the two best efforts FVC and FEV1 do not differ by more than 5 percent or 0 1 L whichever is greater e An effort is satisfact
5. d Press the appropriate softkey Retry to recalibrate or Done if acceptable Calibration Verification Successful Vol L Syringe Volume 3 00 L Expired Voli 2 976 K 0 8 0j pesce qM Both errors lt 3 Maca MGE Calibration is acceptable Humidity 57 0 Pressure 739 4 mmHg Gain 1 17 E Gain 0 99 Legend Measured Adjusted Time s Retry Done Directions for Use Chapter3 Calibrating the Spirometer 29 Printing Calibration Reports You can set up your system to print a calibration report automatically every time you accept calibration results You can also print a report manually any time To Turn Automatic Report Printing On or Off 1 Choose Spirometry Settings Calibration Settings Enable Auto Calibration Report 2 Select Yes or No To Print a Report Manually Choose Spirometry Settings Calibration Settings Print Calibration Report 30 Chapter3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option Performing Spirometry Tests Overview of the Testing Process 32 Connecting the Spirometer Components llle 37 Preparing the Patient sues s a dns Rx d eidem d ENEE E E idle EUER eL mace 38 Recording d Test ne RR S DECR OX OR Re ee RR 39 Working With a Completed Test 00 0 64c05 ck RR ERR RR ERR 43 31 32 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option Overview of the Testing Process There are two types of spir
6. presence of an acute disease process that might interfere with test performance for example nausea vomiting e recent surgery of thorax or abdomen WARNING The spirometer captures and presents data reflecting a patient s physiological condition When reviewed by a trained physician or clinician this data can be useful in determining a diagnosis However the data should not be used as a sole means for determining a patient s diagnosis WARNING To minimize chance of a misdiagnosis it is the physician s responsibility to assure that spirometry tests are properly administered evaluated and interpreted WARNING To prevent the spread of infection do not try to clean the flow transducers and nose clips Discard these items after a single patient use WARNING Read and observe all safety information provided in the flow transducer instructions 8 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option General Cautions The following caution statements apply to spirometer use in general Caution statements that apply specifically to particular procedures appear in the corresponding sections of the manual Caution statements indicate conditions or practices that could damage the equipment or other property AN Caution Do not clean the spirometer or any of its components Trapped moisture in the pressure tubing or sensor could affect their accuracy Replace the pressure tubing when it becomes dirty Replace the sensor when it becom
7. loop See flow loop L sec or L min selecting 12 lung age 71 75 M andatory data fields 40 bar selecting 12 emory card sending tests to 46 enu tree spirometry settings 12 mHg selecting 12 orris norm 66 67 70 multiple flow calibration See calibration MV 80 Z33333 N NHANES lll norm 66 67 70 NIOSH protocol 13 58 75 NLHEP compliance reference 75 norms 13 65 75 See also composite norm values and individual norms nose clips 3 9 O Operation Settings menu 13 ordering information 9 OSHA Cotton Dust protocol 13 59 75 P parameters 35 80 See also FVC parameters or SVC parameters parts and accessories 8 9 patient data enabling and disabling fields 19 entering or searching for 40 patient help sheets 18 61 64 PCP protocol 13 56 57 pediatric 80 PEF 80 phone numbers ii physician s comments page 18 PIF 80 pneumotach 53 Polgar norm 34 66 67 posters ordering replacements 9 post testing 36 power specifications 53 predictive curve and points 13 80 Directions for Use predictive norms See norms predictive values 42 50 preparation of patient 38 pressure tubing description 3 37 53 ordering replacement 9 storage 8 warranty period 51 pressure units selecting 12 pre testing 36 print settings 17 Print Test screen 47 protocols 13 55 60 See also individual protocols Q quality grades 17 44 73 quality messages 42 72 Quanjer S
8. 66 67 70 Edit Interpretation List screen 20 effort quality messages See quality messages Enter New Patient screen 39 ERV 35 78 extrapolation of norm values 69 78 F Fahrenheit selecting 12 features 5 FEF parameters 78 FET 78 FEV1 definition 79 included in patient help sheets 62 63 64 selecting formula for 13 FEV parameters 35 78 79 FIF50 79 FIV parameters 79 flow 79 flow loop 33 79 flow transducer description 3 37 53 ordering replacements 9 warranty period 51 84 Index flow units L sec or L min selecting 12 flow volume curve as default 16 18 definition 79 examples 33 42 FRC 79 FVC curve selecting default 16 See also individual curve types FVC parameters 16 35 54 79 See also individual parameters FVC test procedure 31 42 G grades See quality grades graphs See curves Gulsvik norm 66 67 H Hedenstr m norm 40 66 67 help getting 10 help sheets See patient help sheets Hsu norm 66 67 IC 35 79 incentive screen 16 34 indications for use 4 inHg selecting 12 installation 8 37 intended use 4 Internet address ii interpretation adding or editing in a test 45 editing the phrase list 20 enabling 13 and patient help sheets 62 process diagram 74 references 75 IRV 80 K Knudson norms 66 67 Koillinen norm 66 67 Kory norm 66 67 kPa selecting 12 Welch Allyn spirometer Electrocardiograph L LLN 42 69 80
9. FEF25 Forced expiratory flow in L s at 2596 of FVC FEF5O Forced expiratory flow in L s at 5096 of FVC FEF75 Forced expiratory flow in L s at 75 of FVC FEF85 Forced expiratory flow in L s at 8596 of FVC FEFO 2 1 2 Forced expiratory flow average in L s between 0 2 and 1 2 liters of FVC FEF25 75 Forced expiratory flow average in L s during the middle half of FVC FEF75 85 late FEF Forced expiratory flow average in L s between 7596 and 8596 of FVC FET Forced expiratory time in seconds The elapsed time from the beginning of expiration until a specified percentage of FVC FEVO 5 Forced expiratory volume in liters at 0 5 seconds FEV1 Forced expiratory volume in liters at 1 second An important parameter because it reflects the severity of COPD FEV1 FEV6 The ratio of these two parameters See FEV1 and FEV6 FEV1 FVC See FEV1 FEV2 Forced expiratory volume in liters at 2 seconds FEV3 Forced expiratory volume in liters at 3 seconds FEV5 Forced expiratory volume in liters at 5 seconds FEV6 Forced expiratory volume in liters at 6 seconds Directions for Use Glossary 79 FEV0 5 FEVO 5 as of FVC FEV 196 FEV1 as 96 of FVC Same as FEV1 FVC A parameter for a single FVC effort FEV 196 formula A userselectable formula that determines the calculation method for a test s not an effort s overall FEV1 value which affects the automatic interpretation FEV2 FEV2 as of FVC
10. FEV3 FEV3 as of FVC FEV5 FEV5 as of FVC FEV6 FEV6 as of FVC FEVt Timed forced expiratory volume in liters Volume of air exhaled in the specified time during an FVC effort FIF50 Forced inspiratory flow in L s at 5096 of FIVC FIV1 Forced inspiratory volume in liters at one second FIV1 FIV1 as of FIVC FIVC Forced inspiratory vital capacity in liters The maximum volume of air that can be inspired during forced inspiration starting from full expiration FIVt Timed forced inspiratory volume in liters Volume of air inhaled in the specified time t flow The speed at which air is inhaled or exhaled in L s flow z f v See flow volume flow volume Same as flow over volume or flow f V A type of data curve available during FVC testing The y axis represents flow L s the x axis represents volume liters flow loop A flow volume curve that includes inspiratory data negative values on the y axis FRC Functional residual capacity in liters Volume of air remaining in the lungs and airway at the average end expiratory level FVC Forced vital capacity 1 A type of test in which patients inhale fully and exhale forcefully for as long as they can The goal to measure the volume and flow of air May or may not include forced inhaling When forced inhaling is included it may be done either before or after exhaling See also flow loop 2 An important parameter in liters the maximum volume
11. FVC FVC Post SVC SVC Post FVC Post and SVC Post are available only if you have already accepted at least one pre effort of the same type FVC testing only Press Curve as needed to select the curve type that you want to view while testing See Figure 28 Flow Volume Volume Time Tidal Volume Incentive Figure 28 Spirometry Screen Ready to Start Effort FVC example flow vol curve SVC example Doe Jane ML 9 17AM Oct 16 08 Doe Jane ML 9 17AM Oct 16 08 FVC 1 SVC 1 Flow L s NHANES III 1999 Vol L Value ATS svc D 5 4 ERV alge Pred Value Pre IRV Tox FVC 2 09 ap VT 5 FEV1 3 06 BF FEV1 80 86 a nd Tir FEV6 3 75 M PEF 7 14 Be FEF25 75 3 00 ee sg T L FEVO 5 231 f y y FEV2 T T T T 1 ac l Vol oO ER Fime s Select the desired effort type and curve Select the desired effort type Effort Type Curve Start Test Effort Typ Start Test FVC Flow Vol Done SVC Done Note To learn how to change the default FVC curve type and parameters see Reviewing the Spirometry Screen Settings on page 16 When ready press Start Coach the patient through the effort For tips see Preparing the Patient on page 38 When finished you can press Stop but you do not have to The device stops automatically when air stops moving that is when the ATS end of test criteria are met 42 Chapter 4 Performing Spirometry Tests 11 12 13 Welch Allyn
12. P Date page 39 Since these fields cannot be disabled or 6 Smoke Years edited they do not appear on this user selectable list 7 Packs Day 8 Medication 9 History A Comments ll e gt 3 Change any desired settings For most of these fields you have two choices on enabled or off disabled Disabled fields neither display nor print You must choose either Age or Birth Date This field cannot be disabled For more details on these settings see the description of patient data fields in the electrocardiograph manual 20 Chapter2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option Reviewing the Interpretation List To review or change the list of interpretative phrases that you can add to the interpretation area of the screen and reports follow these steps 1 2 Press the Menu key Choose Spirometry Settings gt Edit Interpretation List The following screen appears Figure 7 Spirometry Interpretation List Screen HF 9 17AM Oct 16 08 Spirometry Interpretation List ATS Obstruction May be a physiological variation ATS Obstruction Mild ATS Obstruction Moderate ATS Obstruction Moderately Severe ATS Obstruction Normal ATS Obstruction Severe ATS Obstruction Very Severe ATS Restriction Mild y Add Delete Exit 3 Press the desired softkeys Softkey Effect Add Lets you add statements to the list up to a total of 50 Delete Deletes the hig
13. Rr 51 50 Chapter5 Troubleshooting Problem Solving Suggestions If you try these suggestions and still have problems contact Welch Allyn For phone numbers see page ii Welch Allyn CP 200 Spirometry Option Condition Causes Actions When printing text prints correctly but FVC curve does not Print settings Make sure that the desired curve is selected See To Print a Test on page 47 Unable to calibrate e Poor connection between flow transducer and sensor Damage to flow transducer Leak during calibration Uneven calibration strokes e Check the connection between flow transducer and sensor Replace the flow transducer if it is damaged Ensure that the connection between the calibration syringe and flow transducer is tight with no leaks e Use even strokes in calibration No sensor detected Poor connection between the sensor and the electrocardiograph Disconnect and reconnect the sensor Does not print Out of paper Paper jam Load paper See the electrocardiograph manual If paper is jammed clear it then reload Values are too high intermittent e Patients fingers obstructed the screen on the back of the flow transducer causing high back pressure and false reading e Patient s lips were not tightly sealed around the flow transducer e Spirometer was calibrated with the wrong size syringe e Retest Recalibrate with a 3 liter syringe See Calibrating
14. dag fee er hes odia ies d d eeu had spa odit t od 51 SORVICe POlICV sait A e RO UR RR RC ERE Dese a ance eic AE A 51 a a apes 5 pe I ERIRESAUE IDIAIS A frd Rp Ede RUNS 53 B Spirometry Protocols cuis acce I taba 55 C Patient Help Sheets escitas RAE 61 D Predictive Norms BIOS od eR A ec RR ERE EAE 65 Ee e 77 Introduction About This Manda ooo ciue gore h x uox teste Gok da ata ae aa 2 Product OREA id RD d a ede DAT ade e a deer LAGE 3 intended VSE coros ra ria ir A AA A e aaa 4 Indications Tot Use sico ri eke keds eke RE RE XAR ee ewes 4 SE 5 Ee EE 6 Using the Spirometer Ssatele dece er RR RR RR en 7 Ordering Information for Replacement Parts 9 EI Erol EE 10 2 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option About This Manual This manual is written for clinical professionals performing pulmonary function testing Users must be familiar with measurements and the clinical significance of basic spirometry products Before using the spirometer all users and technicians must read and understand this manual and all other information accompanying the CP 200 spirometry option and the CP 200 electrocardiograph Caregivers need to know how to properly coach patients to recognize acceptable waveforms and to know whether results meet ATS reproducibility criteria The hospital s Biomedical IT support staff shall require primary skills including disciplines related to maintenance and servicing computer cont
15. you can also go to the System Settings Device Configuration menu and select the following spirometry related units of measure Flow L sec or L min units for the y axis on flow volume curves Pressure mmHg mbar inHg kPa units for the calibration menu s atmospheric pressure values e Temperature Fahrenheit or Celsius units for the calibration menu s temperature values For details see the electrocardiograph manual Directions for Use Chapter2 Reviewing the Spirometry Settings 13 Reviewing the Operation Settings To review or change the settings that affect the overall operation of the spirometer reflected both on screen and in print follow these steps 1 2 Press the Menu key Choose Spirometry Settings gt Operation Settings The following screen appears Figure 2 Spirometry Operation Settings Screen HL 9 17AM Oct 16 08 Spirometry Operation Settings 1 Select Protocol 2 Select Adult Predictive Norm 3 Select Ped Predictive Norm 4 Select Best Effort Formula 5 Select FVC Reversibility Formula 6 Select FEV1 Formula 7 Enable Predictive Points 8 Enable Predictive Curve 9 Enable ATS Interp Results A Enable Composite Norm Values fe we Se al el If desired change the settings Setting Description Select Protocol The selected protocol determines the way the spirometer operates when testing a patient Applicable for FVC testing only For details see Spirometry Protocols on
16. 12 efforts After saving 6 efforts of a given type the software compares each new effort with the saved efforts If the new effort is better than the worst saved effort the worst effort is deleted and the new one is saved If the new effort is worse than all saved efforts you are asked whether you want to save it If 6 pre efforts have been saved the worst pre effort is deleted when you add a post effort until you have saved 3 pre and 3 post efforts After that the worst post effort is deleted Directions for Use Chapter 4 Performing Spirometry Tests 31 Connecting the Spirometer Components WARNING To prevent the spread of infection use a new flow transducer for A each patient Use rubber gloves when replacing used flow transducers and wash hands after touching them Discard flow transducers after a single patient use 1 Verify that the sensor and pressure tubing are clean and undamaged Look for signs of deterioration including but not limited to cracks cuts discoloration or oxidation If any part exhibits any of these symptoms replace it See Ordering Information for Replacement Parts on page 9 2 Attach a flow transducer to the pressure tubing See Figure 24 3 Attach a sensor to the other end of the pressure tubing See Figure 25 4 Connect the sensor to the electrocardiograph s spirometry port Hand tighten the sensor connectors Do not overtighten the connectors or they may become stripped See Figure 26 Th
17. 14 Single Flow Poor Results 9 17AM Oct 16 08 Calibration Results Vol L Tao T SyigeVoume2998L Volume 2 998 L Expired Volume 2 834 V 25 5 Inspired Volume 2 908L 3 1 Temperature 74 0 F Humidity 57 0 Pressure 739 4 mmHg I Gain 1 19 E Gain 1 09 Legend Measured Adjusted Time M IEEE Retry Accept Exit Errors gt 3 Curves do not match Calibration is not acceptable Figure 16 Multiple Flow Poor Results 9 17AM Oct 16 08 Calibration Failed Tao Syringe Volume 2999 Vol D Expired Volume 0 5 Lis 2 8 1 0 Lis 2 9 3 0 Lis 2 8 Temperature 74 0 F Humidity 57 0 Pressure 739 4 mmHg l Gain 1 22 E Gain 1 06 Legend Time s Measured Adjusted oe IE Retry Exit Errors gt 3 Calibration is not acceptable Figure 15 Single Flow Good Results 9 17AM Oct 16 08 Calibration Results Vol L Ivana T Syringe Volume 29981 F Volume 2 998 L Expired Volume 3 010 K 0 4 Inspired Volume 2 93 L 2 1 Temperature 74 0 F Humidity 57 0 Pressure 739 4 mmHg l Gain 1 17 E Gain 0 99 Legend Measured Adjusted Time a leen Retry Accept Exit Both errors lt 3 Curves match Calibration is acceptable Figure 17 Multiple Flow Good Results 9 17AM Oct 16 08 Calibration Results Tao TsSwimgeVoume299BL Vol D Expired Volume Temperature 74 0 F Humidity 57 0
18. Asthma Symptoms If patient education is enabled the Asthma Symptoms sheet prints automatically for all patients whenever you print a test For example see Asthma Symptoms Help Sheet on page 64 These help sheets print only if patient education is enabled in the settings To learn how to enable patient education see Reviewing the Spirometry Print Settings on page 17 The patient s name FEV1 and date print automatically on both sheets If ATS Interpretation is enabled the appropriate recommendation is also marked To learn how to enable ATS Interpretation see Reviewing the Operation Settings on page 13 Note f no recommendation is marked the doctor must mark one 1 Both help sheets come from a booklet entitled Simple Office Spirometry for Primary Care Practitioners by Thomas L Petty MD and Paul L Enright MD This booklet can be downloaded from the National Lung Health Education Program NLHEP home page www nlhep org resources html Directions for Use Appendix C Patient Help Sheets 63 Adult Smokers Help Sheet Name What Your Lung Function Results Mean For Adult Smokers You have just performed Spirometry the basic test of how well your lungs are working The results indicate whether you have developed chronic obstructive pulmonary disease COPD due to smoking COPD occurs in about one of every five smokers after more than 20 years of smoking COPD slowly eats away at t
19. BY MEDIKRO FOR LoT 2 om WelcMllyn Lot code Skaneateles Fails NY 13153 USA www welchallyn com Drawing No 30015257 VER F Press the desired softkey as listed here e Verify Calibration To verify the accuracy of the system without recalibrating None of the calibration factors will be saved The date that prints on reports will be the last calibration date not the verification date e Calibrate 1 Flow To calibrate the system using one inhale exhale cycle e Calibrate 3 Flows To calibrate the system using three inhale exhale cycles at three different rates The attach flow transducer prompt appears as shown in Figure 11 Figure 11 Attach Flow Transducer Prompt MF 9 17AM Oct 16 08 Spirometer Calibration Attach the flow transducer to the syringe Pull the plunger out Then select continue At any time you can press Back to return to the initial calibration screen as shown in Figure 9 on page 24 Continue Back 26 Chapter3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option 4 Connect a new flow transducer to the pressure tubing See Connecting the Spirometer Components on page 37 5 Attach the flow transducer to the syringe s port shown here Push the flow transducer all the way in for a tight seal Figure 12 Calibration Syringe Plunger mM Port 6 Pull the plunger all the way out 7 Press Continue Caution Several things may affect calibratio
20. Values for Norwegian Adults The Bronchial Obstruction in Nord Trondelag Study Langammer Gulsvik et al European Respiratory Journal 2001 18 770 779 Reference Values for Lung Function Tests in Men Regression Equations With Smoking Variables Hedenstr m et al Upsala Journal of Medicine Science 91 299 310 1986 Lung Function Values From a Longitudinal Study of Healthy Children and Adolescents Marienne E Hibbert Anna Lannigan Louis Landau Peter D Phelan Pediatric Pulmonology 7 101 109 Ventilatory Functions of Normal Children and Young Adults Mexican American White and Black Katharine HK Hsu et al Journal of Pediatrics July 1979 volume 95 14 23 The Maximal Expiratory Flow Volume Curve Normal Standards Variability and Effects of Age Ronald J Knudson Ronald C Slatin Michael D Lebowitz and Benjamin Burrows et al American Review of Respiratory Disease volume 113 1976 Change in the Normal Expiratory Flow Volume Curve With Growth and Aging Ronald Knudson et al American Review of Respiratory Disease 1983 127 725 734 Terveiden suomalaislasten spirometrian ja uloshengityksen huippuvirtauksen viitearvot Hannele Koillinen et al Suomen L k rilehti 1998 395 402 The Veterans Administration Army Cooperative Study of Pulmonary Function Clinical Spirometry in Normal Men Kory et al American Journal of Medicine February 1961 Spirometric Standards for Healthy Non smok
21. X Gore 1995 go XIX X XIX X X No 18 78 X M 15 91 7157 194 Gulsvik 2001 gu X X X XIX X X No E17 84 F 146 178 X Hedenstr m 160 196 33 8m e I Nt LO 1986 he X X X X X X X X X No 20 70 F 148 183 ER E X zu zu 120 190 Hibbert 1989 hi X X X X X X X X X 6 18 No F 120 176 X 111 200 Hsu 1979 hs XX XIX X X 7 20 No E111 180 XIXIX Knudson 1976 k X X X KA X X gt 8 90 X Knudson 1983 M lt 85 M 111 8 195 6 kn SEXIES Rees X X 26 Pigs F1057 1829 i ee x x x x X X x x X 6 16 No X Kory 1961 ko XIX X X No No 18 66 X Morris 1971 mo X X X X X X No 20 84 X NHANES Ill nh IXI XIX XIXIXIX X X 28 lt 80 XIXIX Paoletti 1986 pa X X X XIX X X 817 18 64 X Polgar 1971 po X X XIX X X3 19 No 110 170 X Roca 1986 ro XIX X XIX X X X No 20 70 X Schoenberg 1978 Mar sc XIXIX X X X X XX om 218 35 XIX SN x x X x x x X x 17 18 Mo X Viljanen 1981 vi X XIX X XIX X X No 18 65 X Wang 1993 wa X X X X X X 618 No XIX M 118 181 Zapletal 1969 za X X X XIX X X X 6 18 No E107 173 X Directions for Use Appendix D Predictive Norms etc 67 List of Norm Related Clinical Studies Each of the following studies provides expected values for various spirometric parameters by measuring significant samples of a particular population Norm Clinical Study Berglund 1963 Referen
22. displays after you enter patient data For example see Figure 28 on page 41 To review or change the settings for this screen follow these steps 1 Press the Menu key 2 Choose Spirometry Settings gt Screen Settings The following screen appears Figure 4 Spirometry Screen Settings Screen ML 9 17AM Oct 16 08 Spirometry Screen Settings 1 Select Default FVC Curve 2 Select FVC Display Parameters 0 Previous Menu Pls 3 Change any desired settings Setting Description Select Default FVC Curve Choices volume time flow volume tidal volume incentive The selected default curve appears first whenever you begin FVC testing Select FVC Display Choose which FVC test parameters to display during testing Parameters Choices up to eight FVC FEV1 FEV1 FEV6 PEF FEF25 75 FEVO 5 FEV2 FEV3 FEV5 FEV1 FEV6 FEVO 5 FEV2 FEV3 FEV5 FEV6 FEF25 FEF50 FEF75 FEF0 2 1 2 FEF75 85 FET FIVC FIV1 FIV1 PIF FIF50 FEF50 FIF50 Note For SVC testing these parameters always display SVC ERV IRV VT BF Tin Tex Directions for Use Chapter2 Reviewing the Spirometry Settings 17 Reviewing the Spirometry Print Settings To review or change the settings that affect printed spirometry reports follow these steps Note FVC and SVC efforts appear in separate print reports even when they belong to the same test 1 Press the Menu key 2 Choose Spirometry Settings gt Print S
23. each type that was saved best FVC SVC FVC pre FVC post e 3Best Prints the three best efforts of each type that was saved e All Prints all efforts To change the definition of best see Select Best Effort Formula on page 13 Print Test volto Legend 1 2 3 4 Time s Press Print to generate a report Efforts Curve Best Only Vol Time ias Back Press the desired softkeys Softkey Function Related Information Efforts Cycles through these print options To change the default option see Reviewing the Spirometry Print Settings on page 17 e Best Only Curve Cycles through the curve types that are available to print To change the default curve type for printed reports see Reviewing the Spirometry Print Settings on page 17 e Vol Time s How Vol e Tidal Vol e V Tand F V e None Print Prints one copy of the test Press Print again for additional copies FVC and SVC efforts print in separate reports If patient education is enabled in the settings one or more patient help sheets automatically print along with the test For details see Patient Help Sheets on page 61 Back Returns to the Test Results main screen See Figure 30 on page 43 48 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option 49 4 Troubleshooting Problem Solving Suggestions 000 cece eee eee ees 50 Limited Warranty 28 ote td ee te ke ee He eee 51 Service Poll
24. electronic patient information systems such as billing and medical records composite norm value A value that is filled in from another norm a composite norm source when the primary selected norm does not support a given parameter Applicable only when composite norm values are enabled COPD Chronic obstructive pulmonary disease Characterized by airflow obstruction that is primarily caused by smoking Examples include emphysema chronic bronchitis and asthmatic bronchitis curve A graphical display of spirometry data During SVC testing only one curve type is available volume time During FVC testing four curve types are available volume time flow volume tidal volume and on screen only incentive 78 Glossary Welch Allyn CP 200 Spirometry Option effort A single spirometry maneuver for example one blow A single test comprises multiple efforts See also best effort ERS European Respiratory Society ERV Expiratory reserve volume in liters The maximum volume that can be expired from the level of the functional residual capacity FRC See also tidal breathing extrapolation The practice of applying a norm s formula to a patient who doesn t fit that norm s demographics For example if you were testing an 88 yearold man and the primary selected norm were based on males 85 or younger the predicted values would be extrapolated values FEF50 FIF50 The ratio of these two parameters See FEF50 and FIF50
25. function within three months and the abnormally rapid decline in your lung function which you have experienced due to smoking will be stopped Call the number at the bottom of this page for information about local resources to help you quit smoking __ Your test shows a low forced vital capacity FVC Your FVC is the total amount of air that you exhaled in liters similar to quarts Values below about 8096 are abnormally low and suggest that you are unable to inhale or exhale as much air as most healthy persons of your age height gender and race Obesity may be one of the causes of a mildly decreased FVC and pneumonia is another Consider asking your physician to review this report at some time during the next couple of months Your result FEV1 96 predicted For more information contact Date 64 Appendix C Patient Help Sheets Welch Allyn CP 200 Spirometry Option Asthma Symptoms Help Sheet Name What Your Lung Function Results Mean For Those With Symptoms Suggesting Asthma You have just performed Spirometry the basic test of how well your lungs are working The results may indicate whether you have asthma and its severity Your test was within the normal range If you recently had symptoms such as episodes of shortness of breath with wheezing chest tightness or cough you may have asthma but your lung function is normal today Consider visiting a physician when you again have asthma symptoms and then repeat this
26. quality grades are D or F interpretation states results should be interpreted with caution If the pre or post quality grade is D and the results are within normal limits the interpretation states normal but the reported FEV1 and FVC should not be used for comparisons with previous or subsequent tests Interpretation states airway obstruction when the FEV1 FEV6 is below the LLN Interpretation states low vital capacity perhaps due to restriction of lung volumes if FEV1 FEV6 is above the LLN but the FEV6 is below the LLN Note When PCP protocol is selected no inspiration is recorded 58 Appendix B Spirometry Protocols Welch Allyn CP 200 Spirometry Option About the NIOSH Protocol The NIOSH National Institute for Occupational Safety and Health U S protocol is for users who want to make sure that occupational testing and reports meet the requirements of NIOSH The device automatically performs as described here regardless of user defined settings When using this protocol the spirometer should be calibrated at three different flows every day before use For details on NIOSH requirements see the document noted in Reference 4 on page 75 When this protocol is selected testing and reports are affected as follows e Operational Setting Adult and Pediatric Norm NHANES III For Asian Americans the reference equations for Caucasians shall be used but a correction factor of 0 94 shall be applied to the predicted val
27. 1991 76 Appendix D Predictive Norms etc Welch Allyn CP 200 Spirometry Option 71 Glossary adult Generally 18 or older Age limits vary with each norm ATS American Thoracic Society An organization that provides standards for spirometry common practice and equipment ATS acceptability criteria Applicable to FVC testing only 1 Criteria ensuring that an individual effort started and ended satisfactorily no leaks or coughs 2 Criteria ensuring that the patient has made at least two efforts of the same kind two FVC pre or two FVC post and that these efforts are reproducible For details see document noted in Reference 6 on page 75 ATS interpretive results The software generates interpretive results as described in the document noted in Reference 3 on page 75 baseline See pre test best effort A measurement calculated from a set of efforts The formula for calculating best effort is user selectable 1 the single best effort or 2 a composite of best parameter values BF Breathing frequency See also MV and tidal breathing bronchospasm evaluation See post test BTPS Body conditions normal body temperature 37 C ambient pressure saturated with water vapor The BTPS correction factor converts ambient conditions temperature humidity and pressure to BTPS CardioPerfect workstation A PC using Welch Allyn CardioPerfect software Stores ECG and spirometry test data Can communicate with other
28. 4 are reported as 284 This limitation is derived from the subject population on which Morris based his research Lung age which is expressed in years is the average of the four formulas in the Morris article FVC FEV1 FEF25 75 and FEFO 2 1 2 Specifically lung age is calculated as follows Gender Lung Age Formula Men 5 920 height 40 000 FVC 169 640 2 870 height 31 250 FEV1 39 375 2 319 height 21 277 FEF200 1200 42 766 1 044 height 22 222 FEF25 75 55 844 4 Women 4 792 height 41 667 FVC 118 833 3 560 height 40 000 FEV1 77 280 4 028 height 27 778 FEF200 1200 70 333 2 000 height 33 333 FEF25 75 18 367 4 72 Appendix D Predictive Norms etc Welch Allyn CP 200 Spirometry Option About Quality Feedback The spirometer provides two kinds of quality feedback effort quality messages and test quality grades as described in the following sections About Effort Quality Messages One of the following effort quality messages appears on the screen after each effort is completed These messages indicate whether an effort was acceptable and reproducible and if not what the patient needs to do differently For an example of the effort complete screen where these messages would appear see Figure 29 on page 42 The term match here means variation or difference with respect to best test Effor
29. CP 200 Spirometry Option Directions for Use WelchAllyn Advancing Frontline Care ii Welch Allyn CP 200 Spirometry Option Copyright 2008 Welch Allyn All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Caution Federal US law restricts sale of the device identified in this manual to or on the order of a licensed physician Welch Allyn assumes no responsibility for any injury or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or indications for use published in this manual Welch Allyn is a registered trademark of Welch Allyn Inc and CP 200 and CardioPerfect are trademarks of Welch Allyn Inc SD is a trademark of Toshiba Software in this product is copyright Welch Allyn or its vendors All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated within this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ow
30. CP 200 Spirometry Option Figure 29 Effort Complete Screen FVC example flow vol curve SVC example Doe Jane MI gt 9 17AM Oct 16 08 Doe Jane MI 9 17AM Oct 16 08 FVC 1 SVC 1 Flow Lis NHANES III 1999 you Value L ATS svc 3 31 ls 5T ERV 1 35 7 Pred Value Pred als IRV 1 30 FVC 2 09 3 62 173 50 VT 0 66 FEV1 3 06 3 08 100 46 BF 24 73 FEV1 80 86 85 01 105 14 FEV6 3 75 0 00 0 00 Tin Tex 88 60 PEF 7 14 7 18 100 66 FEF25 75 3 00 3 29 109 81 FEVO 5 2 31 2 32 100 32 FEV2 3 50 L Time s Curve Accept Reject Accept Reject Flow Vol Effort Effort Effort Effort For FVC efforts the 96 predicted values display in color as follows Red 96 predicted values are below LLN Black predicted values are normal Green predicted values are at least 100 Review the data For FVC tests if desired press Curve to alternate between curve types Decide whether to accept the effort For help deciding see the Spirometry Effort Acceptability amp Reproducibility poster Note After each effort a quality message appears on this screen such as Don t hesitate Blow out longer or Good effort For details see About Effort Ouality Messages on page 72 Press the desired softkey Accept Effort Saves the effort See About Effort Replacement on page 36 e Reject Effort Deletes the effort In either case the ready to start effort screen reappears Figure 28 on page 41 Note T
31. Spirometry test If you already know that you have asthma it is in good control __ Your breathing test shows mild airways obstruction some narrowing of your breathing tubes You are currently unable to blow out air quickly This result may indicate asthma that is not well controlled Discuss with your physician medications to better control your asthma Your breathing test shows moderate to severe airways obstruction narrowing of your breathing tubes You are currently unable to blow out air quickly This result usually indicates asthma that is poorly controlled Discuss with your physician very soon the use of medications that will help to better control your asthma and the value of peak flow monitoring ___ Your test shows a low forced vital capacity FVC Your FVC is the total amount of air that you exhaled in liters similar to quarts Values below about 80 are abnormally low and suggest that you are unable to inhale or exhale as much air as most healthy persons of your age height gender and race Obesity may be one of the causes of a mildly decreased FVC and pneumonia is another Consider asking a physician to review this report at some time during the next couple of months Your result FEV1 96 predicted Your peak flow after inhaling a bronchodilator was L s liters per second You can compare this value to the peak flow that you measure using your own peak flow meter The two numbers should match within 1 L s If your ast
32. Tin Tex Effort acceptability and test reproducibility checks Effort qua Audio and Compatibl IPXO lity messages and test quality grades visual incentive for assistance in coaching patients e with CardioPerfect workstation PCP primary care practitioner NIOSH OSHA SSD Social Security amp Disability None Specifications are subject to change without notice 55 B Spirometry Protocols About the PGP Protocol gases kdo iaaa a RR ac 58 About the NIOSH Protocol scq ico esee neg de t acci d a 60 About the OSHA Cotton Dust Protocol 0 eee eee ees 61 About THE SSD Protool occse ecri tewie ac cac ee d mee Reed c 62 This appendix describes the protocols you can select to change the way the CP 200 spirometer operates when testing a patient Any features that are not specified in the protocol use your own settings When a protocol is selected its settings become uneditable to avoid confusion during setup To learn how to review or change the protocol see Select Protocol on page 13 56 Appendix B Spirometry Protocols Welch Allyn CP 200 Spirometry Option About the PCP Protocol The PCP primary care practitioner protocol is for users who want to make sure that testing meets the requirement of the National Lung Health Education Program NLHEP When the PCP protocol is selected the spirometer automatically performs as described here regardless of user defined settings For det
33. ails on PCP requirements see the document noted in Reference 1 on page 75 When this protocol is selected testing and reports are affected as follows e Operation Settings Adult Predictive Norm NHANES Ill Ped Predictive Norm NHANES III Best Effort Formula Best Measurement Reversibility Formula Post Pre Pre x 100 FEV1 Formula FEV6 Predictive Points YES Predictive Curve YES ATS Interpretation Results YES Composite Norm Value NO Automatic Quality Check NO For details see Reviewing the Operation Settings on page 13 e Screen Settings FVC Display Parameters FEV1 FEV6 and FEV1 FEV6 only For details see Reviewing the Spirometry Screen Settings on page 16 e Print Settings Efforts Only Best Effort FVC Curves V T amp F V FVC Print Parameters FEV1 FEV6 and FEV1 FEV6 only Scale Auto amp 10 mm L Print Lung Age YES Print Unconfirmed Report YES Print Reviewed By YES Print Patient Cooperation YES Print Quality Grades YES Print Patient Education YES Auto Print YES For details see Reviewing the Spirometry Print Settings on page 17 Directions for Use Appendix B Spirometry Protocols 57 Post results are compared 96c column to the pre results only if the test quality grades for both pre and post test sessions are A B or C An ATS interpretation is displayed and printed only if the test session pre and post quality grades are A B or C If the pre or post
34. bility Evaluation Under Social Security the blue book Social Security Administration SSA publication number 64 039 Office of Disability Programs ICN 468600 January 2003 See in particular the calibration and reporting sections of this document Lung Function Testing Selection of Reference Values and Interpretive Results American Thoracic Society March 1991 This document describes the methods of selecting the reference values and the algorithm for interpretative results National Occupational Respiratory Mortality System National Institute for Occupational Safety and Health NIOSH Short Report Spirometric Lung Age Estimation for Motivating Smoking Cessation James F Morris M D and William Temple Preventive Medicine 14 655 662 1985 Standardisation of Spirometry 2005 Update ATS ERS task force This document describes the methods of acquiring the output parameters and the required accuracy For details on ATS ERS acceptability criteria see these sections in the standard e Start of Test Criteria page 324 e Manoeuvre repeatability page 325 Standardized Lung Function Testing European Respiratory Journal volume 6 supplement 16 March 1993 U S Pulmonary Function Standards for Cotton Dust Standard 29 CFR 1910 1043 Appendix D Lung Function Testing Selection of reference values and interpretive strategies American Thoracic Society American Review of Respiratory Disease 144 1202 1218
35. caelo ure tee EDI ER Pup WES 8 Ordering Information for Replacement Parts 9 Getting Helps a aues epe A esr a pon 10 2 Reviewing the Spirometry Settings llle eee eee 11 Spirometry Settings Menu Tree 12 Reviewing the Operation Settings 13 Reviewing the Calibration Setting 15 Reviewing the Spirometry Screen Settings 16 Reviewing the Spirometry Print Settings 17 Reviewing the Patient Data Fields Available o o ooo o 19 Reviewing the Interpretation ier 20 3 Calibrating the Spirometer 0 nnana aaee 21 About Calibration euo or tr tS UNE 22 Pertorming a Calibrador 24 Printing Calibration Reports eee M e e I a n 29 4 Performing Spirometry Tests ccc cece eee eee ees 31 Overview of the Testing Process 32 About FVGETIOLISZ s irs e mal edet eb al rt Rub hes cer Ar dad 33 Abot SVG EON San oss o hn ue cce Meere ce ese aaa eR M a 34 About the Spirometry Parameters nananana aaa narena e 35 About Pre and bDosrjesnng llis ees 36 About Effort Replacement o o o o o o o ooooooooooo eee 36 Connecting the Spirometer Components l l eee 37 Preparing the Patient x esi ee al red ea Me v ep 38 Recordingia Tests cs REOR ERE E e m PEDES 39 Working With a Completed Test 43 iv Contents Welch Allyn CP 200 Spirometry Option 5 Troubleshooting bulo h lent4e X K ER RR eee I1 EE a 49 Problem Solving Suggestions o 50 Limited Warranty
36. ce Spirometric Studies in Normal Subjects Forced Expiratograms in Subjects 7 70 Years of Age Berglund et al Acta Medica Scandinavica volume 173 1963 Crapo 1981 Reference Spirometric Values using Techniques and Equipment that Meet ATS Recommendations Crapo et al American Review of Respiratory Disease 1981 123 659 664 Dockery 1983 Distribution of Forced Vital Capacity and Forced Expiratory Volume in One Second in Children 6 11 Years of Age Dockery et al American Review of Respiratory Disease 1983 128 405 412 ECCS Quanjer Lung Volumes and Forced Ventilatory Flows Official Statement of the European Respiratory Society Quanjer et al 1993 European Respiratory Journal 1993 supplement 16 5 40 Falaschetti 2004 Forche Il Gore 1995 Gulsvik 2001 Hedenstr m 1986 Hibbert 1989 Hsu 1979 Knudson 1976 Knudson 1983 Koillinen 1998 Kory 1961 Morris 1971 NHANES III Paoletti 1986 Polgar 1971 Prediction equations for normal and low lung function from the Health Survey for England E Falaschetti J Laiho P Primatesta S Purdon European Respiratory Journal 2004 23 456 463 Equations acquired from the Spirometry Norm Study from Dr G nter Forche Prim Univ Doz Spirometric standards for healthy adult lifetime nonsmokers in Australia C J Gore A J Crockett D G Pederson M L Booth A Bauman N Owen European Respiratory Journal 1995 8 773 782 Forced Spirometry Reference
37. customer Flow transducer 90 days Pressure tubing 90 days Sensor 12 months Calibration syringe 12 months service Policy For general information on the service policy see electrocardiograph manual The following spirometry components have specific service policies For disposable items see Ordering Information for Replacement Parts on page 9 Flow transducer Disposable Pressure tubing Disposable Sensor Return to Welch Allyn for replacement if necessary Replacement is free within the warranty period Syringe Return to Welch Allyn for calibration verification if necessary Recalibration is free within the warranty period Beyond the warranty period return to the manufacturer AM Systems Inc 131 Business Park Loop Carlsborg WA 98324 800 426 1306 52 Chapter5 Troubleshooting Welch Allyn CP 200 Spirometry Option 53 E Specifications Feature Specification Dimensions amp weights Flow transducer Pressure tubing Sensor Tests Flow technology Power equipment Power consumption Accuracy Reproducibility Flow range Predictive norms Adult Pediatric Interpretation Reports FVC testing SVC testing 24x2 4x2 in 6x6 x5 cm 0 4 oz 12 g 2 2 yd 2 m 0 9 oz 25 g 2 2 x 1 4 x 0 6 in 5 4 x 3 4 x 1 6 cm 0 9 oz 25 g FVC SVC pre and post bronchodilator Pneumotach Powered by CP200 electrocardiograph via serial port no battery 5t
38. dal volume curve workstation See CardioPerfect workstation Index 83 A accessories See parts and accessories Add Edit Interpretations screen 45 adult 77 Adult Smoker help sheet 62 63 Asthma Symptoms help sheet 62 64 atmospheric pressure units selecting 12 ATS acceptability criteria 77 ATS ERS acceptability criteria 75 ATS interpretation See interpretation automatic calibration reports See calibration report printing B baseline See pre testing Berglund norm 66 67 best effort 13 77 BF 77 bronchospasm evaluation See post testing BTPS 77 C calibration procedure 22 28 report printing 15 28 29 settings 15 troubleshooting 50 calibration syringe cleaning 8 description amp illustration 3 ordering replacement 9 warranty period 51 CardioPerfect workstation 46 77 caution symbol defined 6 CD product information ordering replacement 9 Celsius selecting 12 cleaning why to avoid 8 components of spirometer 3 composite best effort 13 composite norm values 13 70 77 connection of spirometry components 37 contact information for Welch Allyn ii COPD 63 77 Cotton Dust protocol See OSHA Cotton Dust protocol Crapo norm 66 67 70 curves 77 See also individual curve types Customer Service ii D data See patient data default FVC curve selecting 16 demographics for norms 66 See also patient data Dockery norm 66 67 E ECCS Quanjer norm
39. e CP 200 software automatically activates the spirometry functions throughout the software Note Bacteria filters are unnecessary Figure 24 Attaching a Flow Transducer Figure 25 Attaching the Sensor to the to the Pressure Tubing Pressure Tubing B Figure 26 Connecting the Sensor to the Spirometry Port 38 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option Preparing the Patient To prepare patients for any spirometry test explain the entire procedure for the type of effort you want them to perform Remind patients that the test is painless Demonstrate at least one effort for the patient The accuracy of a spirometry test is highly dependent on the patient s understanding and cooperation So be prepared to coach and encourage the patient with your body language and your words for example Blow blow blow keep blowing until you can t blow any more out to ensure a good effort with reproducible results Instruct patients to do the following Loosen any tight articles of clothing that might constrict lung function for example a tight belt tie vest bra girdle or corset Remove any foreign objects from the mouth including loose dentures Use of a nose clip is optional Patients may also pinch their noses Place your lips and teeth around a new transducer sealing their lips tightly around the transducer Grip slightly with your teeth in the groove If you need to hold t
40. ee ECCS Quanjer norm quick reference card ordering replacement 9 R race adjustment 69 reference list 75 replacement of saved efforts 36 replacement parts and accessories 9 reports calibration See calibration report printing reports spirometry editing interpretative phrases 20 45 printing 17 47 troubleshooting 50 reproducibility 53 72 73 reversibility 13 81 S safety 7 8 Sani Cloth canister ordering replacement 9 Schoenberg norm 40 66 68 screen settings 16 Send Test screen 46 sensor connecting 37 description amp illustration 3 ordering replacements 9 specifications 53 troubleshooting 50 warranty period 51 Index 85 settings calibration 15 interpretation list 20 operation 13 patient data 19 print 17 screen 16 spirometry menu tree 12 single flow calibration See calibration smoke years 19 40 66 smoking adult patient help sheet 62 63 and lung age 71 packs day 19 studies on 67 Social Security amp Disability SSD protocol 13 60 75 Solymar norm 66 68 specifications 53 54 Spirometry Settings menu tree 12 SSD See Social Security amp Disability protocol supplies 9 SVC curve examples 34 42 SVC parameters 16 35 54 81 See also individual parameters SVC test procedure 31 42 symbols 6 syringe See calibration syringe T Technical Support ii temperature units F or C selecting 12 test procedure See FVC test procedure o
41. effect of medication on lung function Reversibility applies to each parameter separately To determine the way in which reversibility is calculated choose from these options Post Pre Pre 100 e Post Pre 100 e Post Pre Predictive 100 Selec t FEV1 Formula Enab Points e Predictive The FEV196 formula determines the calculation method for a test s not an effort s overall FEV196 value which affects the automatic interpretation The variable part of this formula is the denominator Both the numerator and the denominator represent best effort values To determine the way in which FEV1 is calculated choose from these options e FVC FEV1 FEV1 FVC e FIVC FEV1 FEV1 FIVC e FEV6 FEV1 FEV1 FEV6 Max FVC FIVC SVC FEV1 FEV1 FVC or FIVC or SVC whichever is largest Yes or no If yes predictive points display and print Predictive points may be enabled with or without the predictive curve For details see predictive points on page 80 Enab Curve e Predictive Yes or no If yes a curve displays and prints along the predictive points When the curve is enabled the points are automatically also enabled Enab Resu e ATS Interp ts Yes or no If yes ATS interpretative results are included in the test record For details see ATS interpretive results on page 77 Enab Norm e Composite Values Yes or no If yes any parameters that are not sup
42. es faulty Recalibrate the spirometer after replacing any components Caution Do not immerse any part of the spirometer into a cleaning liquid or sterilize it with hot water steam or air Caution Do not use aromatic hydrocarbons rubbing alcohol or solvents on the spirometer Caution f you choose to clean the calibration syringe wipe its external surfaces as needed with a cloth dampened with water only Caution Use only parts and accessories supplied with the device and available through Welch Allyn The use of accessories other than those specified may result in degraded performance of this device Caution When you put the spirometer away store its pressure tubing in a basket or drawer or other place that prevents compression or kinking Caution Avoid installing the spirometer in direct sunlight or in a location where it may be affected by significant changes in humidity ventilation or airborne particles containing dust salt or sulfur Caution Keep the spirometer away from splashing fluids Directions for Use Ordering Information for Replacement Parts Replace the following parts as noted Chapter 1 Introduction e flow transducers amp nose clips Replace for each new patient e pressure tubing Replace when dirty e sensor Replace when faulty To order parts call Welch Allyn For phone numbers see page ii WARNING Discard all spirometry components according to local regulations 9
43. ess This softkey appears Go to Step 6 on page 41 only if it is the same day and the calibration is the same Review Test Lets you recall any of that patient s saved tests and review Go to Working With a its data You cannot add new efforts but you can edit the Completed Test on page 43 interpretation send the test to a memory card or workstation or print the test b Toenter patient data Fill in the fields All mandatory fields must be filled in before you can proceed Important Fields Description Patient ID Always mandatory The patient must be identified Last Name Age Birth Date Height Always mandatory This information determines the automatic interpretation Gender Race Weight Mandatory only when using Schoenberg or Hedenstr m norm Smoke Years Not mandatory If the patient smokes enter the number of years the patient has smoked If this value is 1 or more for an adult patient and if patient education is enabled the smoking help sheet prints after the spirometry test report See Patient Help Sheets on page 61 When finished entering data press the desired softkey e Clear deletes the patient data and returns to the Patient ID field e Done accepts the patient data and goes to the initial spirometry screen Directions for Use 6 10 Chapter 4 Performing Spirometry Tests 41 Press Effort Type as needed to select the type of effort you want the patient to perform See Figure 28
44. esults on page 74 e FVC forced vital capacity the maximum volume of air that can be forcibly and rapidly exhaled e FEV1 forced expiratory volume 1 the volume of air that is exhaled at one second of a forced expiration The following are important parameters for SVC testing e VT tidal volume e ERV expiratory reserve volume e IC inspiratory capacity 36 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option About Pre and Post Testing If desired a spirometry test may include both pre and post efforts FVC or SVC to measure the effectiveness of medication The before medication and after medication efforts may be uninterrupted or interrupted e Uninterrupted If there is no interruption between pre and post efforts that is no other patient has been tested and the electrocardiograph has remained on the same screen continues to display You simply continue with the procedure e Interrupted If there is an interruption that is another patient has been tested or the electrocardiograph has been turned off you need to recall the patient s test in progress before continuing Note Pre and post efforts must happen on the same day with the same calibration The next day or after a recalibration tests become available for review only you can no longer add efforts to them About Effort Replacement You can save up to 6 FVC and 6 SVC efforts per test maximum total of
45. ettings The following screen appears Figure 5 Spirometry Print Settings Screen HI 9 17AM Oct 16 08 Spirometry Print Settings 1 Select Efforts 2 Select FVC Curves 3 Select FVC Print Parameters 4 Select Scale 5 Print Lung Age 6 Print Unconfirmed Report 7 Print Reviewed By 8 Print Patient Cooperation 9 Print Quality Grades A Print Patient Education ae Se praep 3 Change any desired settings Setting Description Select Efforts Choose which efforts are included in printed reports by default If desired when printing a test you can cycle through these choices and change the setting for that one test e All efforts All efforts of each type performed e Three best efforts The three efforts with the highest sum of FVC FEV1 e Only best effort The best effort of each type performed To learn how to change the definition of best effort see Select Best Effort Formula on page 13 18 Chapter2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option Setting continued Description continued Select FVC Curves Choose which curve type to print for FVC efforts by default If desired you can change the curve type before you print volume time flow volume tidal volume V T amp F V both volume time and flow volume V T amp display when auto print is selected prints both volume time and the displayed curve type if flow volume or tidal vo
46. g May be used during FVC or SVC testing After measuring tidal breathing for several seconds the following parameters can be extrapolated MV VE BF and Tin Tex If you combine a VT measurement with a VC measurement you can also calculate the ERV IC and IRV For example COPD patients have a higher ERV and a lower IC and IRV tidal volume See VT tidal volume curve A flow loop that includes all data from all breaths tidal and forced Tin Tidal breathing inspiration time in seconds See also tidal breathing Tin Tex The ratio of Tin and Tex See also Tin and Tex TV See VT variance The difference between the best and worst efforts for a parameter FEV1 FVC and so on Pre test and post test variances are reported separately See also best effort VC Vital capacity See FVC or SVC VE Ventilation in L min See also tidal breathing vital capacity See FVC or SVC volume f t See volume time volume time Same as volume over time or volume f t A type of data curve available during both FVC and SVC testing The y axis represents liters the x axis represents seconds 82 Glossary Welch Allyn CP 200 Spirometry Option VT Tidal volume in liters Also called TV although VT is the preferred abbreviation The volume of air that enters the lungs during inspiration and leaves the lungs during expiration in a normal breathing cycle One of the most important parameters in SVC testing See also MV tidal breathing and ti
47. he adjustments made by the CP 200 software for the FVC and FEV1 predicted values Where applicable norm values are multiplied by the percentages identified in the following table Race Choices FVC amp FEV1 Recommendation Source Caucasian No adjustment Black 88 ATS Asian 94 NIOSH Hispanic No adjustment None found Native American 94 NIOSH Polynesian 94 IOSH Aboriginal 94 IOSH Indian 94 NIOSH Note Race adjustment applies for adults only If a race adjustment percentage is used the same adjustment is applied to the LLN value 70 Appendix D Predictive Norms etc Welch Allyn CP 200 Spirometry Option About Composite Norm Values When the primary selected norm does not support a given parameter and when composite norm values are enabled in the operation settings the missing value is filled in from one of the alternative composite norm sources listed here For example since the Crapo norm does not support FEV6 this value is filled in from NHANES III Composite Norm Source Parameters Filled In When Not Supported in Primary Norm NHANES III FVC FEV1 FEV19 FEV6 FEV1 FEV6 PEF FEF25 75 Crapo 1981 FEVO 5 FEV3 FEV3 FVC Morris 1971 FEFO 2 1 2 ECCS Quanjer 1993 FEF25 FEF50 FEF75 The primary norm takes precedence over the composite source For example since the Crapo norm supports the FVC parameter this value always comes from Crapo not from the composite source Composite value
48. he effort numbers increment with each new effort FVC 1 becomes FVC 2 and so on even if some efforts were deleted so the test record indicates the patient s total number of efforts Determine your next step e f you want to perform another effort go to Step 6 on page 41 e f you are finished with this test press Test Done Directions for Use Chapter 4 Performing Spirometry Tests 43 Working With a Completed Test If you are looking at the Test Results main screen shown here you arrived here in either of two ways e You pressed Test Done after completing a set of efforts Step 13 on page 42 e You pressed Review Test to recall a saved test for review Step 5 on page 40 Figure 30 Test Results Main Screen FVC example vol time curve Doe Jane T 9 17AM Oct 16 08 Test Results yay Legend 1 All FVC curves including any pre and post efforts 2 are displayed on one graph Any SVC curves are 3 displayed in a separate graph 4 Time s Effort Typ View Add Edit Send Print FVC Results Interps Test Test You are now ready to work with the completed test Press the desired softkeys Softkey Function Effort Type Alternates between FVC and SVC efforts if applicable View Results See To View a Test s Results on page 44 Add Edit Interp See To Change a Test s Interpretation Statements on page 45 Send Test See To Send a Test to a Memory Card or Workstation on page 46 Print Test See To Prin
49. he flow transducer in your hand keep fingers away from the screen on the back Blocking even part of this screen creates back pressure which makes the percent prediction value very high as much as 200 or 300 and you will need to discard the data Avoid bending forward as you blow This also creates back pressure Keep your tongue away from the flow transducer to avoid blocking it Keep your chin up so as not to restrict the airway WARNING Patients may become faint light headed dizzy or short of breath during spirometry testing Watch patients closely If they choose to stand during testing keep a chair immediately behind them If there is any reason for concern stop the test and take proper action A WARNING Patients should not bite on the flow transducer Biting could result in sharp edges which could injure the mouth Directions for Use Chapter 4 Performing Spirometry Tests 39 Recording a Test To record a spirometry test follow these steps 1 Measure the patient s standing height to the nearest half inch or centimeter in stocking feet Accuracy is important height greatly influences the predicted values Note Ir the patient has obvious spinal deformities measure the arm span from fingertip to fingertip with arms outstretched against a wall Enter the arm span instead of height If the patient s demographics do not match the current spirometry norm select a more appropriate norm To find out h
50. he lung s reserves Affected smokers are often unaware of lung disease until more than half of their lung function has been lost Spirometry testing can detect COPD many years before symptoms occur Your test result was within the normal range You do not appear to be developing COPD However as a smoker you remain at high risk of developing a heart attack stroke and or lung cancer Call the number at the bottom of this page for help with smoking cessation Your test result shows mild airways obstruction suggesting that you are a susceptible smoker who already shows signs of early COPD You are unable to blow out air as quickly as normal your FEV1 FVC is low If you continue smoking you will eventually develop disabling lung disease in about 10 20 years If you are able to successfully quit smoking sometime soon your lung function may return to normal levels and you will probably never develop symptoms of COPD Call the number at the bottom of this page if you would like information about local resources to help you quit smoking Your test result shows moderate to severe airways obstruction You have COPD If you continue smoking your lung disease will certainly get worse and you will eventually become short of breath while walking climbing stairs or doing other exercise It is very important that you seek help to stop smoking If you are able to successfully quit smoking sometime soon you will probably regain a little lung
51. hlighted statement Exit Returns to the Spirometry Settings screen Calibrating the Spirometer About Calibration EP RAW A A e Ri 22 Performing a Calibration lere 24 Printing Galibrauon Reports o cias cici e o a a odas 29 22 Chapter3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option About Calibration The American Thoracic Society recommends calibrating a spirometer every day before testing In addition each time you open a new package of flow transducers verify the lot number on the package label If this lot number differs from the lot number used during the most recent calibration you must recalibrate the spirometer before resuming testing There are two types of calibration e Single flow calibration One inhale exhale cycle e Multiple flow calibration Three inhale exhale cycles at three different rates 3 Lin 1 second 3 L s 3 L in 3 seconds 1 L s 3 L in 6 seconds 0 5 L s Note f you want to add efforts to a saved test the calibration must stay the same Whenever you recalibrate you lose the ability to add new efforts to tests that were saved earlier For a diagram illustrating this procedure see Figure 8 on page 23 For step by step calibration instructions see Performing a Calibration on page 24 For information on reviewing or changing the settings that affect calibration see Reviewing the Calibration Settings on page 15 A Caution For proper performance the calibration syringe i
52. hma is currently in good control today s value may be close to your best peak flow reading at home Date Predictive Norms etc a A A Bd ace hs Se PETERET ee 66 List of Norm Related Clinical Studies llle 67 About Norm Extrapolation EEN ngo son kom om Roe e 69 About Race Adjustment ooccocoooccoc lees 69 About Composite Norm Values 0 00 cee eee leeren 70 About Lung Age usse EAR REESEN ene nem emen e EE E e e e 71 About Quality Feedback 72 Understanding Your Interpretation Results 74 Referentes cece NEEN oa oe eee eck ee 3 RD Sad Sg doe oe gee ace ae Rcs ds 75 65 66 Appendix D Predictive Norms etc Welch Allyn CP 200 Spirometry Option Norm Profiles Each predictive norm supports a particular subset of parameters and covers a particular population as shown here Parameters Studied Gender Age Race E FS EN E 5 Z E 2 Norm Name SS elsels iise E a ss E 5 2 Six S c oel gt gt gt gt gt gt S 1 S IDIL c gt E gt 3 ii o B zs o5 Abbrev Sgene ee E E E EES e 2 2 54 Sia z2 Berglund 1963 XIX X X57 70 X be M 15 91 Crapo 1981 cr XIXIX XIX X X X X No E17 84 X aoe x x x x fet No 110 160 x X ECCS Quanjer M 155 195 1993 qu XIXIX XIXIXIX X X X No 18 70 F 145 180 X X X fa KS 2004 X x x X X No 16 94 X Forche Il fo XIXIX X XIXIX X X 5 17 18 90
53. ich appears the first time you press the Spirometry key each day as described in Step 3 on page 39 e Anytime Press the Menu key Es then choose Spirometry Settings gt Calibration Settings gt Calibrate Spirometer Figure 9 Spirometer Calibration Initial Screen 9 17AM Oct 16 08 Spirometer Calibration Transducer Lot Code 2 Transducer Cal Code WKKVDXPB7 Syringe Volume L 3 000 Temperature F 77 00 Humidity 50 00 Pressure mmHg 759 06 Last Calibration 10 15 2005 3 8 39 PM Volumes in ex L 3 000 3 000 Enter the current settings and then press calibrate Verify Calibrate Calibrate Calibration 1 Flow 3 Flows 2 Fill in all fields e Transducer lot and cal codes appear on the transducer package label as shown in Figure 10 e For the syringe volume see the sticker on the calibration syringe e Update the temperature humidity and pressure See your local weather reports The temperature must be 10 40 C 50 104 E The atmospheric pressure must be 600 1100 mbar 450 825 mmHg 18 32 inHg 60 110 kPa Note To learn how to change the pressure units see page 12 Directions for Use Chapter 3 Calibrating the Spirometer 25 Figure 10 Calibration Code on Flow Transducer Package Label MAS C ws TARTE Transducer 70341 9 Disposable Flow Transducers cal code gracie eus AA E CALIBRATION CODE j WKKVDXPB7 MANUFACTURED
54. in an FVC effort you coach the patient through these steps If preferred you may reverse the order of inhaling and exhaling 1 Inhale fully calmly fill your lungs as much as you can 2 Place the flow transducer in your mouth 3 Exhale forcefully as fast as you can as long as you can 4 Optional Inhale forcefully as fast as you can as long as you can For details see Preparing the Patient on page 38 You can view and print FVC data in three types of curves as shown in the following figures Figure 19 FVC Flow Volume Curves Flow L s Flow L s Exiit Exhaling and inhaling m P single loop Vol L Vol L Figure 20 FVC Tidal Volume Curve Flow L s All data from all breaths including tidal breathing multiple loops Vol L Figure 21 FVC Volume Time Curves Vol L Exhaling only Exhaling and inhaling p Vol L XX Time s Time s 34 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option During FVC testing an animated incentive screen provides an alternative way to view the data Figure 22 This screen gives patients usually children a fun goal to achieve while exhaling If the selected norm does not provide a valid FVC or PEF predicted value the system tries to use the Polgar norm if Polgar does not fit the patient s demographics the incentive screen is not available Figure 22 FVC Incentive Screen The more forcefully the patient blows the
55. ing Adults James F Morris et al American Review of Respiratory Disease volume 103 1971 Spirometric Reference Values from a Sample of the General U S Population John L Hankinson John R Odencrantz and Kathleen B Fedan et al Division of Respiratory Disease Studies National Institute for Occupational Safety and Health Centers for Disease Control and Prevention Morgantown West Virginia 1999 The Third National Health And Nutrition Examination Survey NHANES III Reference Values for Vital Capacity and Flow Volume Curves From a General Population Study P Paoletti G Pistelli P Fazzi et al Bulletin Europ en de Physiopathologie Respiratoire 1986 22 451 459 Pulmonary Function Testing in Children Techniques and Standards Polgar and Promadhat 1971 68 Appendix D Predictive Norms etc Welch Allyn CP 200 Spirometry Option Norm Clinical Study continued Roca 1986 Spirometric Reference Values From a Mediterranean Population J Roca J Sanchis et al Bulletin Europ en de Physiopathologie Respiratoire 1986 22 217 224 Schoenberg 1978 Growth and Decay of Pulmonary Function in Healthy Blacks and Whites Janet B Schoenberg Gerald J Beck and Arend Bouhuys et al Respiration Physiology 1978 33 367 393 Solymar 1980 Nitrogen Single Breath Test Flow Volume Curves and Spirometry in Healthy Children 7 18 Years of Age L Solymar P H Aronsson B Bake and J Bjure European J
56. l time flow volume and volume time graphs on full color LCD display Incentive graphic for pediatric patient coaching Multiple predictive adult norms including NHANES lll and pediatric norms Reduced risk of cross contamination with Welch Allyn single use disposable flow transducers Patient education help sheets Instant quality and variability checks for proper test performance Customizable report formats Meets ATS ERS 2005 spirometry standards Single flow and multiple flow calibration protocols with automatic printing NIOSH OSHA and Social Security operation protocols to create reports that meet these agency requirements PCP primary care practitioner protocol that follows NLHEP guidelines Meets all industry standards including ATS NIOSH OSHA and Social Security Integrated into the CardioPerfect workstation for easy analysis reviewing storing printing and exporting Compliant with the National Lung Health Education Program NLHEP guidelines for office spirometers For more information about NLHEP criteria visit http www nlhep org spirometerreview process html 5 6 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option symbols The symbols illustrated here may appear on the spirometer components on the packaging on the shipping container or in this manual Documentation Symbols WARNING Indicates conditions or practices that could lead to illness injury or A death A Caution n the documenta
57. lume incentive screens do not print e no curves Note It is not necessary to select a default SVC curve for printing because SVC curves are always volume time Select FVC Print Parameters Select Scale Choose which FVC test parameters to include in printed reports You may select as many parameters as you like If more are selected than fit on a page the report continues to another page Choices FVC FEV1 FEV1 FEV6 PEF FEF25 75 FEVO 5 FEV2 FEV3 FEV5 FEV1 FEV6 FEVO 5 FEV2 FEV3 FEV5 FEV6 FEF25 FEF50 FEF75 FEFO 2 1 2 FEF75 85 FET FIVC FIV1 FIV1 PIF FIF50 FEF50 FIF50 Note It is not necessary to select SVC print parameters because they all print Choose which type of scaling graph resizing to use in printed volume time curves e Auto scale Graph is scaled to a small size e 10 mm s X axis time prints at 10 mm s Y axis prints at 10 mm L e 20 mm s X axis time prints at 20 mm s Y axis prints at 10 mm L Print Lung Age Yes or no If yes the estimated lung age is included in printed reports for patients For details see About Lung Age on page 71 Print Unconfirmed Report Yes or no If yes Unconfirmed Report is included in printed reports Print Reviewed By Print Patient Cooperation Yes or no If yes Reviewed By is included in printed reports giving the clinician a place to sign Yes or no If yes Patient Cooperation is included in
58. more flames are extinguished About SVC Efforts SVC stands for slow relaxed vital capacity Sometimes SVC testing is used when forced breathing is impossible The patient inhales and exhales as completely as possible as in FVC testing but the breathing is not forced The goal of an SVC effort is to measure the volume of air inhaled and exhaled not the air flow speed When ready to begin an SVC effort you coach the patient through these steps If preferred you may reverse the order of inhaling and exhaling 1 Place the flow transducer in your mouth 2 Breathe normally several times tidal breathing 3 Inhale fully calmly fill your lungs as much as you can 4 Exhale fully calmly empty your lungs as much as you can The parameters measured during SVC testing are always displayed in a volume time curve as shown in Figure 23 Figure 23 SVC Curve Vol L udi Time s Tidal breathing Directions for Use Chapter 4 Performing Spirometry Tests 35 Aboutthe Spirometry Parameters During FVC and SVC testing many parameters are measured and calculated For definitions of these parameters see Glossary on page 77 During FVC testing the two most important parameters in determining lung problems are FVC and FEV1 For a description of how the automatic interpretation software uses these two measurements to determine the degree of obstruction or restriction see Understanding Your Interpretation R
59. n results movement of the syringe movement of the pressure tubing or blockage of air Place the syringe on a hard level surface with at least 1 cubic meter of open air surrounding the flow transducer Place your hand on top of the syringe to prevent movement 8 Press Start 9 When the blue bar begins to move push the plunger all the way in then pull it all the way out carefully following the bar s rate Use a steady motion in both directions See Figure 13 Figure 13 Simulated Exhalation and Inhalation HI 9 17AM Oct 16 08 ME 9 17AM Oct 16 08 Spirometer Calibration Spirometer Calibration Push plunger in following the bar Pull plunger out following the bar Target Rate Target Rate Directions for Use 10 Chapter 3 Calibrating the Spirometer 21 If desired you can press Stop any time Softkeys will change as described in Step 11 on page 28 Otherwise when no air has moved for three seconds the following happens e For verifications or single flow calibrations The results display For multiple flow calibrations Another simulated exhalation screen appears Repeat from Step 8 twice more The results display Review your results Check the error percentages for the expired and inspired volumes Both all must be less than 3 for your calibration to be acceptable For single flow calibrations the measured and adjusted curves should match See the following examples Figure
60. n screen reappears as shown in Figure 30 on page 43 To learn how to change the statements that are available to choose see Reviewing the Interpretation List on page 20 To learn how to enable automatic interpretation see Enable ATS Interp Results on page 14 To learn how the automatic interpretation software determines the degree of obstruction or restriction see Understanding Your Interpretation Results on page 74 46 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option To Send a Test to a Memory Card or Workstation From the Test Results main screen Figure 30 on page 43 follow these steps 1 Press Send Test The following screen appears Figure 33 Send Test Screen Doe Jane MI 9 17AM Oct 16 08 Send Test Kiel Legend 1 2 3 4 Time s Select a destination to begin sending Memory ul Card Workstation Done Select the desired destination For details on these choices see the CP 200 electrocardiograph manual e Memory Card e Workstation Press Done The Test Results main screen reappears as shown in Figure 30 on page 43 Directions for Use To Print a Test Chapter 4 Performing Spirometry Tests From the Test Results main screen Figure 30 on page 43 follow these steps 1 Press Print Test The following screen appears Figure 34 Print Test Screen Doe Jane HL 9 17AM Oct 16 08 41 Prints only the best effort of
61. nding Your Interpretation Results This diagram shows how the automatic interpretation software uses a patient s FVC and FEV1 results in comparison with normal values to determine the degree of obstruction or restriction This diagram follows the American Thoracic Society s example for interpretation For details on interpretative strategies see the document noted in Reference 9 on page 75 Figure 35 Data Interpretation Process Diagram yes REPEAT GOOD FVC een yes Lo Physiologi Mild Mer UN Restriction Mild Moderate Obstruction Restriction Moderately Severe Severe Obstruction Restriction Very Severe Severe Sev Obstruction Restriction Very Severe Obstruction FVC Below 80 of predicted yes o d MANEUVER S Mod Moderately 50 lt FVC lt 60 p Moderate Severe lt yes pr Obstruction Restriction of Predicted 70 lt FVC LLN of Predicted yes 60 lt FVC 70 of Predicted yes 34 lt FVC lt 50 of Predicted no FVC lt 34 of Predicted And low vital capacity cannot rule out superimposed restriction Directions for Use Appendix D Predictive Norms etc 15 References 1 Checklist for Compliance with NLHEP Guidelines for Office Spirometers National Lung Health Education Program www nlhep org resources html review Disa
62. nership of the software remains with Welch Allyn or its vendors For information about any Welch Allyn product please call Welch Allyn Technical Support USA 1800 535 6663 Australia 61 29 638 3000 1 315 685 4560 Canada 1 800 561 8797 China 86 216 327 9631 European Call Center 353 46 906 7790 France 4 331 6009 3366 Germany 49 747 792 7186 Japan 8133 219 0071 Latin America 1 305 669 9003 Netherlands 31 15 750 5000 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Reorder Number multi language CD 401151 Mat Number manual only 708795 Ver E Welch Allyn Welch Allyn LTD Ec ne 4341 State Street Road PO Box 220 Navan Business Park Skaneateles Falls NY 13153 0220 Dublin Road Navan County Meath Republic of Ireland Tel 353 46 90 67700 Fax 353 46 90 67755 www welchallyn com Printed in USA C 0297 WelchAllyn Contents Li STATE OCG TIO Mss oi TIT T MH 1 About his Manual oc vfs a heels tl eee LR 2 Product OVervie Wi oi tor ode pede e E A oe abn AA i 3 Intended SQ i oie ette n ht beth Behar Ghd tees us Eee Auch dea 4 Indications fOr USE zs s era Reha dae we Dead dae ah Sede RA RR 4 Features oes req utu tb o Y e DRE T in da e rediere 5 SVETIDO Sur h Eat ence EH occ Ak OU tg e rd H i ge Ee tard UM IA AR aci 6 Using the Spirometer Safely 0 0 02 eee 7 General Warhilgs 2 e cec da RR RP LER RO CREER S e ERROR 7 General Cautions
63. o 15 mA Compliant with ATS ERS 2005 guidelines Compliant with ATS ERS 2005 guidelines 0 14 L s Berglund 1963 Crapo 1981 ECCS Quanjer 1993 Falaschetti 2004 Forche Il Gore 1995 Gulsvik 2001 Hedenstr m 1986 Knudson 1976 Knudson 1983 Kory 1961 Morris 1971 NHANES III 1999 Paoletti 1986 Roca 1986 Schoenberg 1978 Viljanen 1981 Berglund 1963 Dockery 1983 Forche II Hibbert 1989 Hsu 1979 Knudson 1976 Knudson 1983 Koillinen 1998 NHANES III 1999 Paoletti 1986 Polgar 1971 Schoenberg 1978 Solymar 1980 Wang 1993 Zapletal 1969 1991 ATS interpretation standards Lung age calculation can be enabled or disabled Automatic interpretation can be enabled or disabled User definable interpretation statements are also available to be added manually Volume time curve Flow volume curve Tidal volume Both volume time and displayed curves No curves Volume time curve No curve 54 Appendix A Specifications Welch Allyn CP 200 Spirometry Option Feature continued Specification continued Parameters FVC testing SVC testing Quality checks Connectivity Protection against ingress of water per IEC 60529 spirometry components Protocols FVC FIVC FIV1 FIV1 FEVO 5 FEV1 FEV2 FEV3 FEV5 FEV6 FEV1 FEV6 FEVO 5 FEV1 FEV2 FEV3 FEV596 FEV6 PEF FEF25 FEF50 FEF75 FEF0 2 1 2 FEF25 75 FEF75 85 PIF FIF50 SVC ERV FEF50 FIF50 FET RV VT IC BF MV Tin Tex
64. of air that can be delivered during forced expiration starting from full inspiration IC Inspiratory capacity in liters The maximum volume of air that can be inhaled after a normal unforced exhalation See also tidal breathing 80 Glossary Welch Allyn CP 200 Spirometry Option incentive screen An animated screen that gives patients usually children a goal to achieve while exhaling This screen is listed as a type of curve data display available during FVC testing IRV Inspiratory reserve volume in liters The maximum volume that can be inspired from the average end inspiratory level See also tidal breathing LLN Lower limits of normal The lowest expected value for a spirometric parameter The method of determining this value varies from norm to norm loop See flow loop lung age A calculated value based on a patient s demographics and spirometric performance that gives a relative indication of the health of the subject s lungs This value is used primarily to encourage smoking cessation Lung age is not available for patients under 20 years of age maneuver See effort MV Minute volume in liters MV BF VT See also tidal breathing NIOSH National Institute for Occupational Safety and Health U S norm A research based spirometry data set with a specific profile for race gender age and height The software compares each patient s results with data in the primary selected norm reporting the
65. ometry efforts also called maneuvers e PVC forceful breathing e SVC relaxed breathing For details see About FVC Efforts on page 33 and About SVC Efforts on page 34 A single test comprises a set of efforts up to 6 efforts of each type FVC and SVC for a maximum of 12 efforts 6 FVC and 6 SVC The 6 efforts of a given type can be a mixture of pre and post medication efforts For details see About Pre and Post Testing on page 36 and About Effort Replacement on page 36 Figure 18 Spirometry Testing Process Diagram For step by step procedure see Recording a Test on page 39 HSH mU c NP ee Optional Calibrate Prompted once daily Enter or search for patient data V Choose effort type FVC SVC FVC Post SVC Post V Perform effort For step by step procedure see Working With a Completed Test on page 43 Yes y NA No Optional Review test Add or edit interpretation Send or print test Accept effort Another effort Test Done Uninterrupted for 20 min Yes Another test Directions for Use Chapter 4 Performing Spirometry Tests 33 About FVC Efforts FVC stands for forced vital capacity The goal of an FVC effort is to measure the volume and flow of air Patients inhale fully then exhale forcefully Sometimes they also inhale forcefully When ready to beg
66. ory for measurement of the FEV1 if the expiratory volume at the back extrapolated zero time is less than 5 percent of the FVC or 0 1 L whichever is greater e An effort is satisfactory for measurement of the FVC if maximal expiratory effort continues for at least 6 seconds e The device should accurately measure time and volume the latter to within 1 of a 3 L calibrating volume e The testing device must have had a recorded calibration performed previously on the day of the measurement e The linearity of the device must be documented by recording volume calibrations at three different flow rates of approximately 3 L 6 sec 3 L 3 sec and 3 L sec e These calibrations may be exhale only since no inhale parameters are reported e Whenever the test report is printed the calibration report shall also be printed e fthe calibration accuracy is between 1 and 3 the electrocardiograph applies correction factors to the recorded FVC and FEV1 61 C Patient Help Sheets About the Patient Help Sheet 62 Adult Smokers Help Sheet 63 Asthma Symptoms Help Sheet 64 62 Appendix C Patient Help Sheets Welch Allyn CP 200 Spirometry Option About the Patient Help Sheets Two patient help sheets are available to print e Adult Smokers If patient education is enabled the Adult Smokers sheet prints automatically for all adult smokers whenever you print a test For example see Adult Smokers Help Sheet on page 63 e
67. ournal of Respiratory Diseases 1980 61 275 286 Viljanen 1981 Spirometric Studies in Non smoking Healthy Adults Viljanen et al Journal of Clinical Lab Investigation 41 supplement 158 5 20 1981 Wang 1986 Pulmonary Function Between 6 and 18 Years of Age Xiaobin Wang Douglas W Dockery David Wypij Martha E Fay Benjamin G Ferris Jr Pediatric Pulmonology 15 75 85 Zapletal 1969 Maximum Expiratory Flow Volume Curves and Airway Conductance in Children and Adolescents Journal of Applied Physiology volume 26 number 3 March 1969 Directions for Use Appendix D Predictive Norms etc 69 About Norm Extrapolation Extrapolation is the practice of applying a norm s formula to a patient who doesn t fit that norm s demographics For example if you were testing an 88 yearold man and the primary selected norm were based on males 85 or younger the predicted values would be extrapolated values e When it takes place extrapolation is indicated in the test record e Pediatric norms do not provide any age weight or height extrapolation e Adult norms allow extrapolation of age up but not down e Adult norms allow extrapolation of height weight and smoke years up and down About Race Adjustment Although expected values for certain parameters vary significantly between ethnic groups some norm studies do not include separate regression equations for different races For those studies the following table describes t
68. ow see Select Adult Predictive Norm on page 13 or Select Ped Predictive Norm on page 13 Press Laj 05 The first time this key is pressed each day the prompt Calibrate Now appears Optional Calibrate See Calibrating the Spirometer on page 21 The following screen appears Figure 27 Enter New Patient Screen HI 9 17AM Oct 16 08 Enter New Patient Fi To learn how to choose which fields display Patient ID D m NES A gt Last Name here see Reviewing the Patient Data Fields Birth Date est MM DD YYYY Available on page 19 Height ft in Gender Race CH Smoke Years yr M Use up and down arrows to change fields Search Schedule Clear Done 40 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option 5 Enter patient data or recall saved patient data a To recall saved patient data Press Search or Schedule and select the patient For details see CP 200 electrocardiograph manual Then press the desired softkey as described here Softkey Function Your Next Action New Test Returns to the Enter New Patient screen Most of the Go to Step b below patient s data is automatically filled in Some data fields medications blood pressure comments history height weight will be blank because this information varies over time Continue Test Lets you continue a test in progr
69. p Opens a window containing the interpretation Press or to close the statements that have been saved with the test interpretation window A test quality grade appears too For details see Press the next desired softkey About Test Quality Grades on page 73 Back Returns to the Test Results main screen as shown in Return to Working With a Completed Figure 30 on page 43 Test on page 43 Directions for Use Chapter 4 Performing Spirometry Tests 45 To Change a Test s Interpretation Statements From the Test Results main screen Figure 30 on page 43 follow these steps 1 Press Add Edit Interps The following screen appears displaying any interpretation statements that have been saved with the test Figure 32 Add Edit Interpretations Screen Doe Jane HL 9 17AM Oct 16 08 T wi Add Edit Interpretations at Interpretation Press a right arrow key to see a list of Interpretation 2 3 interpretation statements that are available to choose for the highlighted Interpretation 3 field Interpretation 4 Cancel Save Add or edit interpretation statements as desired Each test may include up to four statements either automatically included or manually added or a combination If automatic statements appear you may replace them with manual statements if you wish Press X to cancel or to save your changes LA LA The Test Results mai
70. page 55 e None e PCP primary care practitioner e NIOSH e OSHA e SSD Social Security amp Disability Select Adult The selected adult norm is the primary source of predictive values for adult patients Predictive Norm For details see Norm Profiles on page 66 Select Ped The selected pediatric norm is the primary source of predictive values for pediatric patients Predictive Norm For details see Norm Profiles on page 66 Select Best Effort A patient s best effort is a measurement calculated from a set of efforts To determine the Formula way in which best effort is calculated choose from these options e Best Measurement Defines best effort as the single best effort in a set of efforts best FVC pre best FVC post best SVC This ATS recommended method uses the effort with the highest sum of FVC FEV1 or the effort with the highest SVC value For details see the document noted in Reference 6 on page 75 e Best Composite Defines best effort as a composite of the highest parameter values across all selected efforts except FVC and FEV1 which are both selected from the highest sum of FVC FEV1 14 Chapter2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option Setting Description continued Selec Reversibility Formula t FVC Reversibility is the percentage difference between pre test and post test data for FVC testing This measurement indicates the
71. ported in the primary selected norm are given predictive values from alternative composite norm sources If set to no only the primary norm s values are used no composite values On the screen and in reports any unsupported parameters appear without predictive values For details see About Race Adjustment on page 69 Directions for Use Chapter2 Reviewing the Spirometry Settings 15 Reviewing the Calibration Settings To review or change the settings that affect calibration or to calibrate the spirometer follow these steps 1 Press the Menu key 2 Choose Spirometry Settings gt Calibration Settings The following screen appears Figure 3 Spirometry Calibration Settings Screen HL 9 17AM Oct 16 08 Spirometry Calibration Settings 1 Calibrate Spirometer 2 Enable Auto Calibration Report 3 Print Calibration Report 0 Previous Menu Viale gt 3 Change any desired settings Setting Description Calibrate Spirometer Brings up the Spirometer Calibration screen See Calibrating the Spirometer on page 21 Enable Auto Calibration Report Yes or no If yes a calibration report prints automatically every time you accept calibration results Print Calibration Report Prints the most recent calibration report 16 Chapter2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option Reviewing the Spirometry Screen Settings The spirometry screen is the first screen that
72. printed reports giving the clinician a place to comment Print Quality Grades Yes or no If yes a test quality grade is included in each printed report See About Test Quality Grades on page 73 Print Patient Education Yes or no If yes the patient help sheets on asthma and adult smoking prints automatically with every report For examples of these sheets see Patient Help Sheets on page 61 Print Physician s Comments Yes or no If yes spirometry reports will include an additional blank page with patient information at the top for physician to write comments on Auto Print Yes or no If yes a report prints automatically when you press the Test Done softkey Directions for Use Chapter2 Reviewing the Spirometry Settings 19 Reviewing the Patient Data Fields Available To review or change the fields that appear during data entry for spirometry patients follow these steps Note You choose ECG data entry fields separately as described in the CP 200 electrocardiograph manual 1 Press the Menu key 2 Choose Spirometry Settings gt Patient Data Settings The following screen appears Figure 6 Spirometry Patient Data Settings Screen BEEN Oct 16 08 Spirometry Patient Data Settings 1 First Name Several fields Patient ID Last Name Height 2 Second Last Name Gender and Race always appear on the 3 Middle Initial Enter New Patient screen as shown in Figure 27 on
73. r SVC test procedure test quality grades See quality grades Test Results screen 43 Tex 81 tidal breathing 33 34 81 tidal volume FVC curve as default 16 18 definition 81 example 33 tidal volume SVC parameter VT 35 82 Tin 81 Tin Tex 81 transducer See flow transducer troubleshooting 49 50 TV 81 U units of measure selecting 12 URL ii 86 Index V VC 81 VE 81 verifying calibration 23 25 28 View Results screen 44 Viljanen norm 66 68 vital capacity See FVC or SVC volume time curve as default 16 18 definition 81 examples 33 43 VT 35 82 W warning symbol defined 6 warranty 51 web site ii Welch Allyn Technical Support ii Z Zapletal norm 66 68 Welch Allyn spirometer Electrocardiograph WelchAllyn 4341 State Street Road PO Box 220 Skaneateles Falls NY 13153 0220 USA 1 800 535 6663 1 315 685 4560 www welchallyn com Advancing Frontline Care Reorder Number multi language CD 401151 Mat Number manual only 708795 Ver E
74. r flow Nose clip Recommended during testing to avoid leaks Three liter calibration syringe For daily use to calibrate the spirometer for accuracy 3 4 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option Intended Use The CP 200 spirometry option allows the user to acquire view store and print measures and waveforms of pulmonary function including but not limited to maximal volume and flow of air that can be moved in and out of a patient s lungs These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with patients who are able to understand the instructions for performing the test Indications for Use Spirometry is indicated for use in various common clinical situations e Assessing health status before a patient begins strenuous physical activity e Evaluating the following symptoms signs or abnormal laboratory tests Symptoms dyspnea wheezing orthopnea cough phlegm production chest pain Signs diminished breath sounds overinflation expiratory slowing cyanosis chest deformity unexplained crackles shortness of breath Abnormal laboratory tests hypoxemia hypercapnia polycythemia abnormal chest radiographs Directions for Use Features Chapter 1 Introduction Automatic interpretation and comparison of best pre bronchodilator effort to best post bronchodilator effort Rea
75. results as percentages of the predicted normal values normal Consistent with norm data OSHA Occupational Safety amp Health Administration U S parameter A commonly defined attribute of a spirometric waveform FVC FEV1 and so on pediatric Generally under 18 years old Age limits vary with each norm Also young children s lung sizes vary greatly Norm values and interpretive results are not available for patients under 3 years of age PEF Peak expiratory flow in L s The largest expiratory flow achieved with a forced effort PIF Peak inspiratory flow in L s The largest inspiratory flow achieved with a forced effort post test A test that provides data to compare with pre test data Sometimes called post Rx or post BD bronchodilator A post test must follow a pre test within 24 hours See also reversibility predictive curve A curve that follows a set of predictive points predictive points Key values from the selected norm and from composite norms if enabled Applicable for FVC tests only For flow volume curves predictive values are PEF FEF25 FEF50 FEF75 and FVC all represented as points For volume time curves predictive values are FEV1 represented as a point and FVC represented as a horizontal line If predictive points are enabled all available predictive values appear on the screen and the printout Directions for Use Glossary 81 pre test A test that provides a baseline for comparison with a po
76. rols platforms It is recommended that users attend a certified spirometry training course The instructions given here are only a guide and should not be used to train a technician For definitions of specialized terms and abbreviations used in this manual see Glossary on page 77 Note This manual supplements the CP 200 electrocardiograph manual entitled CP 200 12 Lead Resting Electrocardiograph Directions for Use See the electrocardiograph manual for procedures that are common to both ECG and spirometry functions such as how to move through the menus how to search for patient data or how to edit the medication list Directions for Use Product Overview Chapter 1 Introduction The CP 200 spirometry option performs FVC and SVC testing including pre and post bronchodilator testing It displays flow volume and volume time curves in real time depicting both inspiratory and expiratory measurements For details see the following sections e Features on page 5 Ordering Information for Replacement Parts on page 9 e Specifications on page 53 Figure 1 Components of the CP 200 Spirometry Option Disposable flow transducer For single patient use Eliminates the need for disinfecting procedures which can be difficult and expensive Minimizes the risk of cross contamination Pressure tubing Connects the flow transducer to the sensor Sensor Connects to the CP 200 electrocardiograph Converts pressure to ai
77. s are used when the patient does not fit the demographics of either primary norm adult or pediatric For example if the primary norms are Dockery and Morris a 14 year old patient fits neither norm due to age restrictions The software would use values from the appropriate composite norms for example NHANES lll or ECCS Quanjer 1993 It would not use values from Dockery or Morris On the screen and in reports an abbreviation identifies the norm source for each composite value used For example the abbreviation for Polgar is po All norm abbreviations are listed under Norm Profiles on page 66 Also see Norm Profiles on page 66 for a listing of the parameters included in each norm To learn how to enable or disable composite norm values see Reviewing the Operation Settings on page 13 Directions for Use Appendix D Predictive Norms etc n About Lung Age Lung age is a calculated value based on a patient s demographics and spirometric performance that gives a relative indication of the health of the subject s lungs This value is used primarily to encourage smoking cessation The CP 200 spirometer calculates lung age values according to the document cited in Reference 5 on page 75 Morris 1995 For single effort tests lung age is based on the current effort Otherwise it is based on the patient s best effort as defined in the settings Lung age results less than 20 years are reported as 20 and results greater than 8
78. st test taken by the same patient Sometimes called pre Rx or pre BD bronchodilator Pre tests and post tests are commonly used to evaluate the effectiveness of medication See also reversibility reversibility The percentage difference between pre test and post test data This measurement indicates the effect of medication on lung function Reversibility applies to each parameter separately The reversibility formula which determines the way in which reversibility is calculated is userselectable SVC Slow relaxed vital capacity 1 A type of test in which patients breathe normally several times then inhale maximally and exhale maximally or vice versa Sometimes SVC testing is used when forced breathing is impossible The patient inhales and exhales as completely as possible as in FVC testing but the breathing is not forced The goal of an SVC effort is to measure the volume of air inhaled and exhaled not the air flow speed 2 An important parameter in liters the maximum volume of air exhaled from the point of maximum inhalation or maximum volume of air inhaled from a point of maximum exhalation test A set of efforts up to 6 efforts of each type FVC and SVC for a maximum of 12 efforts 6 FVC and 6 SVC The 6 efforts of a given type can be a mixture of pre medication and post medication efforts Tex Tidal breathing expiration time in seconds See also tidal breathing tidal breathing Multiple breaths normal breathin
79. t Quality Message Criteria Don t hesitate Blast out faster Blow out longer Blast out harder Deeper breath Good effort Good test session Back extrapolated volume gt 150 mL or 5 whichever is greater PEF time gt 120 ms FET lt 6 0 seconds and end of test volume gt 100 mL invalid FEV6 PEF is not reproducible match gt 1 0 L s FEV6 match gt 150 mL FVC may be substituted for FEV6 Effort meets above criteria Two acceptable efforts match Directions for Use About Test Quality Grades Appendix D Predictive Norms etc 73 Another type of feedback is the test quality grade as described in the following table If Print Quality Grades is enabled in the settings a grade appears on printed reports and also displays on screen when you view the values or interpretation of a completed test as described under To View a Test s Results on page 44 To learn how to enable or disable this setting see Reviewing the Spirometry Print Settings on page 17 Test Quality Number of Acceptable Efforts Reproducibility Grade A 2 or more Largest two FEV1 values match lt 100 mL Largest two FVC values match lt 100 mL B 2 or more Largest two FEV1 values match 100 and x 150 mL C 2 or more Largest two FEV1 values match gt 150 and lt 200 mL D 1 or more Largest two FEV1 values match 200 mL F None 14 Appendix D Predictive Norms etc Welch Allyn CP 200 Spirometry Option Understa
80. t a Test on page 47 When finished determine what to do next e Press to start another test for this patient or another patient Go to Step 3 on page 39 e Press to exit spirometry mode 44 Chapter 4 Performing Spirometry Tests To View a Test s Results Welch Allyn CP 200 Spirometry Option From the Test Results main screen Figure 30 on page 43 follow these steps 1 Press View Results The display stays the same Only the softkeys change as shown here Figure 31 View Results Screen FVC example vol time curve Doe Jane MI 9 17AM Oct 16 08 View Results K Legend 1 2 T 3 4 3 Time s Test Complete Effort Typ Curve View View Back FVC Vol Time Values Interp Press the desired softkeys to view the results in various ways Softkey Function Your Next Action Effort Type Alternates between FVC and SVC efforts if Press the next desired softkey applicable Curve Alternates between FVC curve types Press the next desired softkey View Values Opens a window containing all of the measured and Press J or to close the values calculated parameters across all saved efforts like window a print preview Press the next desired softkey A test quality grade appears too For details see About Test Quality Grades on page 73 The best efforts and parameters display according to the print settings See Reviewing the Spirometry Print Settings on page 17 View Inter
81. the Spirometer on page 21 Values are too high consistently Pressure connection is partially obstructed Remove any foreign substance from the flow transducer or pressure tubing Predictive values are blank e The selected norm does not support certain values and composite norm values are disabled e Re enter age birthdate height gender race See Step b on page 40 e Enable composite norm values See Reviewing the Operation Settings on page 13 The flow sensor has been dropped Accident Recalibrate See Calibrating the Spirometer on page 21 Report does not print parameters or graphs Improper print settings Check print settings See Reviewing the Spirometry Print Settings on page 17 Patient test values differ from values expected by physician Various e fthe transducer is contaminated with sputum or secretions replace it e Verify that proper barometric pressure has been entered See Calibrating the Spirometer on page 21 Verify the patient data Eliminate any leaks in the pressure tubing Retest using a nose clip Replace the sensor if damaged Recalibrate Replace the transducer and retest Directions for Use Chapter 5 Troubleshooting 51 Limited Warranty For general information on the limited warranty see electrocardiograph manual The following spirometry components have specific warranty periods from date of shipment to
82. tion this symbol indicates conditions or practices that could damage the equipment or other property d Caution On the product this symbol means Caution consult accompanying documentation Operation Symbols EJ Spirometry key ch Spirometry port E Stacking limits Do not reuse S e Keep away from sunlight mm Expiration date A Type BF applied part yp pplied p Directions for Use Chapter 1 Introduction 7 Using the Spirometer Safely Before using or servicing the spirometer you must read and understand the following safety related information General Warnings The following warning statements apply to spirometer use in general Warning statements that apply specifically to particular procedures such as preparing the patient for testing appear in the corresponding sections of the manual Warning statements indicate conditions or practices that could lead to illness injury or death A WARNING Do not perform spirometry tests if any of the following conditions apply to the patient e hemoptysis of unknown origin forced expiratory maneuver may aggravate the underlying condition e pneumothorax e unstable cardiovascular status forced expiratory maneuver may worsen angina or cause changes in blood pressure recent myocardial infarction pulmonary embolus thoracic abdominal or cerebral aneurysms danger of rupture due to increased thoracic pressure recent eye surgery for example cataract
83. tself must be recalibrated every year See its calibration certificate for the most recent calibration date When the syringe is due for recalibration return it to the manufacturer For details see Service Policy on page 51 Directions for Use Chapter 3 Calibrating the Spirometer 23 Figure 8 Calibration Process Diagram Go to Spirometer Calibration For step by step initial screen procedure see Performing a Calibration de on page 24 Fill in transducer calibration code etc Verify Calibrate Verify Or calibrate V Simulate exhalation amp inhalation Simulate exhalation 3x if multiple flow amp inhalation No Yes Yes No Calibration report prints if enabled Continue previous procedure 24 Chapter3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option Performing a Calibration A WARNING To avoid the risk of cross contamination always use a new flow transducer when calibrating the spirometer Observe all safety information that came with the flow transducers Note When you open a new package of flow transducers disregard the calibration CD that is shipped with them The CP 200 spirometer does not use the calibration file on this CD 1 Goto the Spirometer Calibration initial screen Figure 9 You can get to this screen in either of two ways e At prompt Press LY in response to the Calibrate Now prompt wh
84. ues Best Effort Formula Best Measurement Composite Norm Values NO For details see Reviewing the Operation Settings on page 13 e Print Settings Tests Three Best Efforts Scale 20 mm s amp 10 mm L Curves V T amp F V Auto Print YES For details see Reviewing the Spirometry Print Settings on page 17 e Calibration Settings Auto Calibration Report Yes For details see Reviewing the Calibration Settings on page 15 Directions for Use Appendix B Spirometry Protocols 59 About the OSHA Cotton Dust Protocol The OSHA Occupational Safety amp Health Administration U S Cotton Dust protocol is for users who want to make sure that occupational testing and reports meet the requirements of OSHAS Cotton Dust standard The device automatically performs as described here regardless of userdefined settings When using this protocol the spirometer should be calibrated at three different flows every day before use For details on OSHA Cotton Dust requirements see the document noted in Reference 8 on page 75 When this protocol is selected testing and reports are affected as follows e Operational Settings Adult and Pediatric Norm Knudson 1976 African American patients shall be adjusted by 0 85 Asian and Hispanic patients shall be adjusted according to General Norm Value Race Adjustment logic Composite Norm Values NO For details see Reviewing the Operation Settings on page 13 e Print Settings

CP 200 Spirometry Option Directions for Use

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