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Welch Allyn CP 200, Directions For Use Manual

The Welch Allyn CP 200 comes with a comprehensive Directions For Use Manual, ensuring seamless operation. You can easily download the manual for free from our website, allowing you to conveniently access step-by-step instructions and maximize your experience with the product.

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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

Reference 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 
1993

Lung Volumes and Forced Ventilatory Flows: Official Statement of the European Respiratory Society

, Quanjer, et. al., 

European Respiratory Journal, 1993, supplement 16: 5-40.

Falaschetti 2004

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.

Forche II 

Equations acquired from the Spirometry Norm Study from Dr. Günter Forche, Prim. Univ. Doz. 

Gore 1995

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.

Gulsvik 2001

Forced Spirometry Reference Values for Norwegian Adults: The Bronchial Obstruction in Nord-Trondelag Study

, 

Langammer, Gulsvik , et. al., European Respiratory Journal 2001, 18: 770-779.

Hedenström 1986

Reference Values for Lung Function Tests in Men: Regression Equations With Smoking Variables

, Hedenström, et. al., 

Upsala Journal of Medicine Science 91:299-310, 1986.

Hibbert 1989

Lung Function Values From a Longitudinal Study of Healthy Children and Adolescents; Marienne E. Hibbert, Anna 
Lannigan, Louis I. Landau, Peter D. Phelan; Pediatric Pulmonology 7:101-109.

Hsu 1979

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.

Knudson 1976

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.

Knudson 1983

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.

Koillinen 1998

Terveiden suomalaislasten spirometrian ja uloshengityksen huippuvirtauksen viitearvot

, Hannele Koillinen, et. al., Suomen 

Lääkärilehti, 1998, 395-402.

Kory 1961

The Veterans Administration Army Cooperative Study of Pulmonary Function, Clinical Spirometry in Normal Men

, Kory, et. 

al., American Journal of Medicine, February 1961.

Morris 1971

Spirometric Standards for Healthy Non-smoking Adults

, James F. Morris, et. al., American Review of Respiratory Disease, 

volume 103, 1971.

NHANES III

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).

Paoletti 1986

Reference Values for Vital Capacity and Flow-Volume Curves From a General Population Study;

 P. Paoletti, G. Pistelli, P. 

Fazzi, et. al.; Bulletin Européen de Physiopathologie Respiratoire,1986, 22, 451-459.

Polgar 1971

Pulmonary Function Testing in Children: Techniques and Standards

, 

Polgar and Promadhat.1971.

Summary of Contents for CP 200

Page 1: ...CP 200 Spirometry Option Directions for Use ...

Page 2: ...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 ownership of the software remains with Welch All...

Page 3: ...Reviewing the Spirometry Screen Settings 16 Reviewing the Spirometry Print Settings 17 Reviewing the Patient Data Fields Available 19 Reviewing the Interpretation List 20 3 Calibrating the Spirometer 21 About Calibration 22 Performing a Calibration 24 Printing Calibration Reports 29 4 Performing Spirometry Tests 31 Overview of the Testing Process 32 About FVC Efforts 33 About SVC Efforts 34 About ...

Page 4: ...200 Spirometry Option 5 Troubleshooting 49 Problem Solving Suggestions 50 Limited Warranty 51 Service Policy 51 A Specifications 53 B Spirometry Protocols 55 C Patient Help Sheets 61 D Predictive Norms etc 65 Glossary 77 Index 83 ...

Page 5: ... 1 Introduction About This Manual 2 Product Overview 3 Intended Use 4 Indications for Use 4 Features 5 Symbols 6 Using the Spirometer Safely 7 Ordering Information for Replacement Parts 9 Getting Help 10 ...

Page 6: ...reproducibility criteria The hospital s Biomedical IT support staff shall require primary skills including disciplines related to maintenance and servicing computer controls platforms It is recommended that users attend a certified spirometry training course The instructions given here are only a guide and should not be used to train a technician For definitions of specialized terms and abbreviati...

Page 7: ...or Replacement Parts on page 9 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 Conver...

Page 8: ... 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 Assessing health status before a patient begins strenuous physical activity Evaluating the following symptoms signs or abnormal laboratory tests Symptoms dyspnea wheezing orthopnea cough phleg...

Page 9: ...or 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 a...

Page 10: ...ndicates conditions or practices that could lead to illness injury or death Caution In the documentation this symbol indicates conditions or practices that could damage the equipment or other property Caution On the product this symbol means Caution consult accompanying documentation Operation Symbols Spirometry key Spirometry port Stacking limits Do not reuse Keep away from sunlight Expiration da...

Page 11: ...od 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 presence of an acute disease process that might interfere with test performance for example nausea vomiting recent surgery of thorax or abdomen WARNING The spirometer captures and presents data reflecting a ...

Page 12: ...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 If 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...

Page 13: ...to local regulations Item Material Numbers Quantity Disposable flow transducers 703418 703419 25 100 Pressure tubing 2 meters 703415 1 Sensor 703552 1 Nose clip 58550 0000 1 Calibration syringe 3 L 703480 1 Germicidal Sani Cloth canister 26004 0000 1 Product information Spirometry Reference Chart wall poster 71038 3000 1 Spirometry Effort Acceptability Reproducibility wall poster 703337 1 CP 200 S...

Page 14: ...200 spirometry option in a variety of ways beyond this manual Press the Help key from the initial spirometry screen for a list of topics available to print Review the other information that came with the spirometer For list see Product information on page 9 Contact Welch Allyn For phone numbers see page ii ...

Page 15: ...alibration Settings 15 Reviewing the Spirometry Screen Settings 16 Reviewing the Spirometry Print Settings 17 Reviewing the Patient Data Fields Available 19 Reviewing the Interpretation List 20 Note You can access the spirometry settings only if the spirometer is connected See Connecting the Spirometer Components on page 37 ...

Page 16: ...VC Display Parameters Select Efforts Select FVC Curves Select FVC Print Parameters Select Scale Print Lung Age Print Unconfirmed Report Print Reviewed By Print Patient Cooperation Print Quality Grades Print Patient Education Print Physician s Comments Auto Print First Name Second Last Name Middle Initial Age Birth Date Weight Smoke Years Packs Day Medication History Comments Note As part of spirom...

Page 17: ...c norm is the primary source of predictive values for pediatric patients For details see Norm Profiles on page 66 Select Best Effort Formula A patient s best effort is a measurement calculated from a set of efforts To determine the way in which best effort is calculated choose from these options Best Measurement Defines best effort as the single best effort in a set of efforts best FVC pre best FV...

Page 18: ...FVC FIVC FEV1 FEV1 FIVC FEV6 FEV1 FEV1 FEV6 Max FVC FIVC SVC FEV1 FEV1 FVC or FIVC or SVC whichever is largest Enable Predictive Points 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 Enable Predictive Curve Yes or no If yes a curve displays and prints along the predictive points...

Page 19: ...alibration Settings Screen 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 Spirometry Calibr...

Page 20: ... 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 Parameters Choose which FVC test parameters to display during testing Choices up to eight FVC FEV1 FEV1 FEV6 PEF FEF25 75 FEV0 5 FEV2 FEV3 FEV5 FEV1 FEV6 FEV0 5 FEV2 FEV3 FEV5 FEV6 FEF25 FEF5...

Page 21: ...e 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 All efforts All efforts of each type performed Three best efforts The three efforts with the highest sum of FVC FEV1 Only best effort The best effort of each type performed To learn how to change the definition of best effort see Se...

Page 22: ...me curves Auto scale Graph is scaled to a small size 10 mm s X axis time prints at 10 mm s Y axis prints at 10 mm L 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 prin...

Page 23: ...int 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 Note You choose ECG data entry fields separately as described in the CP 200 electrocardiograph manual Spirometry Patient Data Settings 9 17AM Oct 16 08 Several fields Patient ID Last Name Height Gender and Race alw...

Page 24: ...owing screen appears Figure 7 Spirometry Interpretation List Screen 3 Press the desired softkeys Softkey Effect Add Lets you add statements to the list up to a total of 50 Delete Deletes the highlighted statement Exit Returns to the Spirometry Settings screen Spirometry Interpretation List 9 17AM Oct 16 08 Add Delete Exit ATS Obstruction May be a physiological variation ATS Obstruction Mild ATS Ob...

Page 25: ...21 3 Calibrating the Spirometer About Calibration 22 Performing a Calibration 24 Printing Calibration Reports 29 ...

Page 26: ...3 L in 1 second 3 L s 3 L in 3 seconds 1 L s 3 L in 6 seconds 0 5 L s 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 Note If you want to add efforts to a saved test the ca...

Page 27: ...tial screen Continue previous procedure Simulate exhalation inhalation 3x if multiple flow Fill in transducer calibration code etc Calibration report prints if enabled Accept Yes No Retry No Yes Simulate exhalation inhalation Verify Or calibrate Verify Calibrate For step by step procedure see Performing a Calibration on page 24 ...

Page 28: ... and pressure See your local weather reports The temperature must be 10 40 C 50 104 F The atmospheric pressure must be 600 1100 mbar 450 825 mmHg 18 32 inHg 60 110 kPa 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 transducer...

Page 29: ...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 Drawing No 30015257 VER F 8 LOT 2 QTY 100 Disposable Flow Transducers CALIBRATION CODE WKKVDXPB7 0050 200x xx 4341 State Street Road Skaneateles Falls NY 13153 USA www welchallyn com REF 703419 Transducer c...

Page 30: ... 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 Caution Several things may affect calibration 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 t...

Page 31: ...nspired Volume 2 906 L 3 1 Temperature 74 0 F Humidity 57 0 Pressure 739 4 mmHg I Gain 1 19 E Gain 1 09 Legend Measured Adjusted Accept Retry Exit Vol L Time s Errors 3 Curves do not match Calibration is not acceptable Calibration Results 9 17AM Oct 16 08 Syringe Volume 2 998 L Expired Volume 3 010 L 0 4 Inspired Volume 2 936 L 2 1 Temperature 74 0 F Humidity 57 0 Pressure 739 4 mmHg I Gain 1 17 E...

Page 32: ...ion 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 d Press the appropriate softkey Retry to recalibrate or Done if acceptable Caution A poor calibration as shown in...

Page 33: ... 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 ...

Page 34: ...30 Chapter 3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option ...

Page 35: ...31 4 Performing Spirometry Tests Overview of the Testing Process 32 Connecting the Spirometer Components 37 Preparing the Patient 38 Recording a Test 39 Working With a Completed Test 43 ...

Page 36: ...f 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 Optional Calibrate Prompted once daily Enter or search for patient data Accept effort Choose effort type FVC SVC FVC Post SVC Post Perform effort No Yes Another effort Another test No Yes Uninte...

Page 37: ...s 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 Figure 20 FVC Tidal Volume Curve Figure 21...

Page 38: ...thing 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 ...

Page 39: ... 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 Results on page 74 FVC forced vital capacity the maximum volume of air that can be forcibly and rapidly exhaled FEV1 forced expiratory volume 1 the volume of air that is exhaled at one second of a forced expiration T...

Page 40: ...turned off you need to recall the patient s test in progress before continuing About Effort Replacement You can save up to 6 FVC and 6 SVC efforts per test maximum total of 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 ...

Page 41: ...e 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 The CP 200 software automatically activates the spirometry functions throughout the software Figure 26 Connecting the Sensor to the Spirometry Port WARNING To prevent the spread of infection use a new flow transducer fo...

Page 42: ...ures 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 the 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 predic...

Page 43: ...page 13 3 Press The first time this key is pressed each day the prompt Calibrate Now appears 4 Optional Calibrate See Calibrating the Spirometer on page 21 The following screen appears Figure 27 Enter New Patient Screen Note If 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 To le...

Page 44: ...blank because this information varies over time Go to Step b below Continue Test Lets you continue a test in progress This softkey appears only if it is the same day and the calibration is the same Go to Step 6 on page 41 Review Test Lets you recall any of that patient s saved tests and review its data You cannot add new efforts but you can edit the interpretation send the test to a memory card or...

Page 45: ...ffort For tips see Preparing the Patient on page 38 10 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 Note To learn how to change the default FVC curve type and parameters see Reviewing the Spirometry Screen Settings on page 16 FVC 1 9 17AM Oct 16 08 Doe Jane Curve Flow Vol SVC 1 9 17AM ...

Page 46: ...o perform another effort go to Step 6 on page 41 If you are finished with this test press Test Done 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 Quality Messages on page 72 Note The effort numbers increment with each new effort FVC 1 becomes FVC 2 and so on even if some efforts were deleted so the...

Page 47: ...her test for this patient or another patient Go to Step 3 on page 39 Press to exit spirometry mode 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 ...

Page 48: ...ts like a print preview 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 Press or to close the values window Press the next desired softkey View Interp Opens a window containing the interpretation statements that have been saved with th...

Page 49: ...nual statements if you wish 3 Press to cancel or to save your changes The Test Results main 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 de...

Page 50: ...nd Test The following screen appears Figure 33 Send Test Screen 2 Select the desired destination For details on these choices see the CP 200 electrocardiograph manual Memory Card Workstation 3 Press Done The Test Results main screen reappears as shown in Figure 30 on page 43 Send Test 9 17AM Oct 16 08 Doe Jane Memory Card Workstation Done Legend Vol L 3 3 2 4 1 5 Time s Select a destination to beg...

Page 51: ...e 17 To change the definition of best see Select Best Effort Formula on page 13 Curve Cycles through the curve types that are available to print Vol Time Flow Vol Tidal Vol V T and F V None To change the default curve type for printed reports see Reviewing the Spirometry Print Settings on page 17 Print Prints one copy of the test Press Print again for additional copies FVC and SVC efforts print in...

Page 52: ...48 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option ...

Page 53: ...49 5 Troubleshooting Problem Solving Suggestions 50 Limited Warranty 51 Service Policy 51 ...

Page 54: ...ack of the flow transducer causing high back pressure and false reading Patient s lips were not tightly sealed around the flow transducer Spirometer was calibrated with the wrong size syringe Retest Recalibrate with a 3 liter syringe See Calibrating the Spirometer on page 21 Values are too high consistently Pressure connection is partially obstructed Remove any foreign substance from the flow tran...

Page 55: ...vice 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 verifica...

Page 56: ...52 Chapter 5 Troubleshooting Welch Allyn CP 200 Spirometry Option ...

Page 57: ...993 Falaschetti 2004 Forche II Gore 1995 Gulsvik 2001 Hedenström 1986 Knudson 1976 Knudson 1983 Kory 1961 Morris 1971 NHANES III 1999 Paoletti 1986 Roca 1986 Schoenberg 1978 Viljanen 1981 Pediatric 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 Interpr...

Page 58: ...0 FIF50 FET SVC testing SVC ERV IRV VT IC BF MV Tin Tex Tin Tex Quality checks Effort acceptability and test reproducibility checks Effort quality messages and test quality grades Audio and visual incentive for assistance in coaching patients Connectivity Compatible with CardioPerfect workstation Protectionagainstingress of water per IEC 60529 spirometry components IPX0 Protocols PCP primary care ...

Page 59: ...dix 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 ...

Page 60: ...dictive 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 Screen Settings FVC Display Parameters FEV1 FEV6 and FEV1 FEV6 only For details see Reviewing t...

Page 61: ...pretation 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...

Page 62: ...the document noted in Reference 4 on page 75 When this protocol is selected testing and reports are affected as follows 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 values Best Effort Formula Best Measurement Composite Norm Values NO For details see ...

Page 63: ...ree 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 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 R...

Page 64: ...hould be reproducible for both pre bronchodilator tests and if indicated post bronchodilator tests A test is 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 An effort is satisfactory 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 whiche...

Page 65: ...61 C Patient Help Sheets About the Patient Help Sheets 62 Adult Smokers Help Sheet 63 Asthma Symptoms Help Sheet 64 ...

Page 66: ...se 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 p...

Page 67: ...moking 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...

Page 68: ...eathing 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 ...

Page 69: ...files 66 List of Norm Related Clinical Studies 67 About Norm Extrapolation 69 About Race Adjustment 69 About Composite Norm Values 70 About Lung Age 71 About Quality Feedback 72 Understanding Your Interpretation Results 74 References 75 ...

Page 70: ...X X X X No 18 78 X Gulsvik 2001 gu X X X X X X X No M 15 91 F 17 84 M 157 194 F 146 178 X Hedenström 1986 he X X X X X X X X X No 20 70 M 160 196 F 148 183 M 55 109 F 45 94 M 5 55 F 2 53 X Hibbert 1989 hi X X X X X X X X X 6 18 No M 120 190 F 120 176 X Hsu 1979 hs X X X X X X 7 20 No M 111 200 F 111 180 X X X Knudson 1976 k X X X X X X X X 8 90 X Knudson 1983 kn X X X X X X X X 6 M 85 F 88 M 111 8...

Page 71: ...psala Journal of Medicine Science 91 299 310 1986 Hibbert 1989 Lung Function Values From a Longitudinal Study of Healthy Children and Adolescents Marienne E Hibbert Anna Lannigan Louis I Landau Peter D Phelan Pediatric Pulmonology 7 101 109 Hsu 1979 Ventilatory Functions of Normal Children and Young Adults Mexican American White and Black Katharine HK Hsu et al Journal of Pediatrics July 1979 volu...

Page 72: ...e Curves and Spirometry in Healthy Children 7 18 Years of Age L Solymar P H Aronsson B Bake and J Bjure European Journal 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 159 5 20 1981 Wang 1986 Pulmonary Function Between 6 and 18 Years of Age Xiaobin Wang Douglas W Dockery Davi...

Page 73: ...ht 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 the adjustments made by the CP 200 software for the FVC and FEV1 predicted values Where applicable norm values are multiplied b...

Page 74: ... 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 III 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 examp...

Page 75: ...t effort as defined in the settings Lung age results less than 20 years are reported as 20 and results greater than 84 are reported as 84 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 FEF0 2 1 2 Specifically lung age is calculated as follo...

Page 76: ...f 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 Effort Quality Message Criteria Don t hesitate Back extrapolated volume 150 mL or 5 whichever is greater Blast out faster PEF time 120 ms Blow out longer FET 6 0 seconds and...

Page 77: ...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 Grade Number of Acceptable Efforts Reproducibility A 2 or more Largest two FEV1 values match 100 mL Largest two FVC values match 100 mL B 2 or more Largest two FEV1 values match 100 and 150 mL C ...

Page 78: ...retation 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 ...

Page 79: ...ational Respiratory Mortality System National Institute for Occupational Safety and Health NIOSH 5 Short Report Spirometric Lung Age Estimation for Motivating Smoking Cessation James F Morris M D and William Temple Preventive Medicine 14 655 662 1985 6 Standardisation of Spirometry 2005 Update ATS ERS task force This document describes the methods of acquiring the output parameters and the require...

Page 80: ...76 Appendix D Predictive Norms etc Welch Allyn CP 200 Spirometry Option ...

Page 81: ...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 ...

Page 82: ... expiratory flow in L s at 50 of FVC FEF75 Forced expiratory flow in L s at 75 of FVC FEF85 Forced expiratory flow in L s at 85 of FVC FEF0 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 75 and 85 of FVC FET Forced expiratory ti...

Page 83: ...ime t flow The speed at which air is inhaled or exhaled in L s flow 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 ai...

Page 84: ...imary selected norm reporting the results as percentages of the predicted normal values normal Consistent with norm data OSHA Occupational Safety 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...

Page 85: ...um 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 breathing May be used during FVC or SVC testing After measuring tidal brea...

Page 86: ...T 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 tidal volume curve workstation See CardioPerfect workstation ...

Page 87: ...ement 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 ...

Page 88: ...67 Kory norm 66 67 kPa selecting 12 L LLN 42 69 80 loop See flow loop L sec or L min selecting 12 lung age 71 75 M mandatory data fields 40 mbar selecting 12 memory card sending tests to 46 menu tree spirometry settings 12 mmHg selecting 12 Morris norm 66 67 70 multiple flow calibration See calibration MV 80 N NHANES III norm 66 67 70 NIOSH protocol 13 58 75 NLHEP compliance reference 75 norms 13 ...

Page 89: ...on 3 ordering replacements 9 specifications 53 troubleshooting 50 warranty period 51 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 Disability SSD protocol 13 60 75 Soly...

Page 90: ...g 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 ...

Page 91: ......

Page 92: ...Reorder Number multi language CD 401151 Mat Number manual only 708795 Ver E 4341 State Street Road PO Box 220 Skaneateles Falls NY 13153 0220 USA 1 800 535 6663 1 315 685 4560 www welchallyn com ...

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