Welch Allyn CP 200 - Manual

Directions for Use Chapter 1 Introduction 3 Product Overview The CP 200 spirometry option performs FVC and SVC testing, including pre- and post-bronchodilator testing. It displays flow/volume and volume/time cur ves in real time, depicting both inspiratory and expiratory measurements. For details, s...

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 pati...

Directions for Use Chapter 1 Introduction 5 Features • Automatic interpretation and comparison of best pre-bronchodilator effort to best post-bronchodilator effort • Real-time flow/volume and volume/time graphs on full-color LCD display • Incentive graphic for pediatric patient coaching • Multiple p...

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, inju...

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...

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 cond...

Directions for Use Chapter 1 Introduction 9 Ordering Information for Replacement Parts Replace the following parts as noted: • flow transducers & nose clips — Replace for each new patient. • pressure tubing — Replace when dirty. • sensor — Replace when faulty. To order parts, call Welch Allyn. F...

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. • Press the Help key from the initial spirometry screen for a list of topics available to print. • Review the other information that...

11 2 Reviewing the Spirometry Settings “Spirometry Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Reviewing the Operation Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Reviewing the Calibration Settings . . . . . . . . . ....

12 Chapter 2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option “Spirometry Settings” Menu Tree Spirometry Settings Operation Settings Calibration Settings Screen Settings Print Settings Patient Data Settings Edit Interpretation List Select ProtocolSelect Adult Predictive NormSel...

Directions for Use Chapter 2 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. Press the Menu key . 2. Choose Spirometry Settings &g...

Directions for Use Chapter 2 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 > Calibration Settings . The fo...

16 Chapter 2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option Reviewing the Spirometry Screen Settings The spirometry screen is the first screen that displays after you enter patient data. For example, see Figure 28 on page 41. To review or change the settings for this screen, ...

Directions for Use Chapter 2 Reviewing the Spirometry Settings 17 Reviewing the Spirometry Print Settings To review or change the settings that affect printed spirometry reports, follow these steps. 1. Press the Menu key . 2. Choose Spirometry Settings > Print Settings . The following screen appe...

Directions for Use Chapter 2 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. 1. Press the Menu key . 2. Choose Spirometry Settings > Patient Data Settings . T...

20 Chapter 2 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. Press the Menu key . 2. Choose Sp...

21 3 Calibrating the Spirometer About Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Performing a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Printing Calibration Reports . . . . . ...

22 Chapter 3 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...

24 Chapter 3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option Performing a Calibration 1. Go to the Spirometer Calibration initial screen ( Figure 9 ). You can get to this screen in either of two ways: • At prompt Press in response to the Calibrate Now? prompt, which appears the first...

Directions for Use Chapter 3 Calibrating the Spirometer 25 Figure 10. Calibration Code on Flow Transducer Package Label 3. Press the desired softkey, as listed here. • Verify Calibration To verify the accuracy of the system (without recalibrating). None of the calibration factors will be saved. The ...

26 Chapter 3 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 ...

Directions for Use Chapter 3 Calibrating the Spirometer 27 If desired, you can press Stop any time. Softkeys will change, as described in Step 11 on page 28. Other wise, when no air has moved for three seconds, the following happens: • For verifications or single-flow calibrations The results displa...

Directions for Use Chapter 3 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. Choo...

31 4 Performing Spirometry Tests Overview of the Testing Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Connecting the Spirometer Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . ...

32 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option Overview of the Testing Process There are two types of spirometry efforts (also called maneuvers): • FVC — forceful breathing • SVC — relaxed breathing For details, see “About FVC Efforts” on page 33 and “About SVC Efforts...

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 begin an FVC ef...

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 no...

Directions for Use Chapter 4 Performing Spirometry Tests 35 About the 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 lu...

36 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option About Pre- and Post-Testing If desired, a spirometr y 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 unint...

Directions for Use Chapter 4 Performing Spirometry Tests 37 Connecting the Spirometer Components 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...

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 fo...

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. 2. ...

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, a...

Directions for Use Chapter 4 Performing Spirometry Tests 41 6. Press Effort Type as needed to select the type of effort you want the patient to perform. See Figure 28 . • FVC • FVC Post* • SVC • SVC Post* *FVC Post and SVC Post are available only if you have already accepted at least one pre-effort ...

42 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option Figure 29. “Effort Complete” Screen For FVC efforts, the “% predicted” values display in color as follows: Red: % predicted values are below LLN. Black: % predicted values are normal. Green: % predicted values are at least...

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: • You pressed Test Done after completing a set of efforts ( Step 13 on page 42). • You pressed Review Test...

44 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option To View a Test’s Results 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”...

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 sa...

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 2. Select the d...

Directions for Use Chapter 4 Performing Spirometry Tests 47 To Print a Test 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 2. Press the desired softkeys. Softkey Function Related Inform...

49 5 Troubleshooting Problem-Solving Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Service Policy . . . . . . . . . . . . . . . . . . . . . ....

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 customer: • Flow transducer — 90 days • Pressure tubing — 90 da...

53 A Specifications Feature Specification Dimensions & weights Flow transducer 2.4 x 2.4 x 2 in. (6 x 6 x 5 cm)0.4 oz (12 g) Pressure tubing 2.2 yd (2 m)0.9 oz (25 g) Sensor 2.2 x 1.4 x 0.6 in. (5.4 x 3.4 x 1.6 cm)0.9 oz (25 g) Tests FVC, SVC, pre- and post-bronchodilator Flow technology Pneumot...

55 B Spirometry Protocols About the PCP Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 About the NIOSH Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 About the OSHA / Cotton Dust Protocol . . . . . . . . ...

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, ...

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 automa...

Directions for Use Appendix B Spirometry Protocols 59 About the OSHA / Cotton Dust Protocol The OSHA (Occupational Safety & Health Administration, U.S.) Cotton Dust protocol is for users who want to make sure that occupational testing and reports meet the requirements of OSHA’s Cotton Dust stand...

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 devic...

61 C Patient Help Sheets About the Patient Help Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Adult Smokers Help Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Asthma Symptoms Help Sheet . . . . . . . . . . . . . . . . ....

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: 1 • Adult Smokers If “patient education” is enabled, the Adult Smokers sheet prints automatically for all adult smokers whenever you print a test. For ...

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 c...

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 r...

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 Norm Name (Abbrev.) FVC FEV1 FEV1% FEV0. 5 FEV3 FEV3/FVC FEV6 ...

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...

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-year-old man, and the primary (selected) norm were based on males ...

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 alternativ...

Directions for Use Appendix D Predictive Norms, etc. 71 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 ...

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-q...

Directions for Use Appendix D Predictive Norms, etc. 73 About Test-Quality Grades 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 ...

74 Appendix D Predictive Norms, etc. Welch Allyn CP 200 Spirometry Option Understanding 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 restrict...

Directions for Use Appendix D Predictive Norms, etc. 75 References 1. Checklist for Compliance with NLHEP Guidelines for Office Spirometers , National Lung Health Education Program, www.nlhep.org/resources.html#review . 2. Disability Evaluation Under Social Security (the “blue book”), Social Securit...

77 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...

83 Index 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 interp...