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™ CP 200 Spirometry Option Directions for Use...
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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.
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.
Directions for Use Chapter 1 Introduction 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 curves in real time, depicting both inspiratory and expiratory measurements. For details, see the following sections: •...
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.
• Incentive graphic for pediatric patient coaching • Multiple predictive adult norms, including NHANES III, 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 •...
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 death.
Directions for Use Chapter 1 Introduction 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.
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.
& nose clips — Replace for each new patient. • pressure tubing — Replace when dirty. • sensor — Replace when faulty. To order parts, call Welch Allyn. For phone numbers, see page WARNING Discard all spirometry components according to local regulations. Item Material Numbers...
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.
Directions for Use Chapter 2 Reviewing the Spirometry Settings 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. Press the Menu key 2.
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Chapter 2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option Setting Description (continued) Select FVC Reversibility is the percentage difference between pre-test and post-test data for FVC Reversibility Formula testing. This measurement indicates the effect of medication on lung function. Reversibility applies to each parameter separately.
Directions for Use Chapter 2 Reviewing the Spirometry Settings Reviewing the Calibration Settings To review or change the settings that affect calibration — or to calibrate the spirometer — follow these steps. Press the Menu key 2. Choose Spirometry Settings > Calibration Settings. The following screen appears.
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, follow these steps.
Directions for Use Chapter 2 Reviewing the Spirometry Settings Reviewing the Spirometry Print Settings To review or change the settings that affect printed spirometry reports, follow these steps. FVC and SVC efforts appear in separate print reports, even when they belong to Note the same test.
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Chapter 2 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.
Reviewing the Patient Data Fields Available To review or change the fields that appear during data entry for spirometry patients, follow these steps. You choose ECG data-entry fields separately, as described in the CP 200 Note electrocardiograph manual. Press the Menu key 2.
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.
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.
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Directions for Use Chapter 3 Calibrating the Spirometer Figure 8. Calibration, Process Diagram Go to Spirometer Calibration For step-by-step initial screen procedure, see “Performing a Calibration” on page 24. Fill in transducer calibration code, etc. Calibrate Verify Verify? Or calibrate? Simulate exhalation Simulate exhalation &...
When you open a new package of flow transducers, disregard the calibration CD Note that is shipped with them. The CP 200 spirometer does not use the calibration file on this CD. Go to the Spirometer Calibration initial screen...
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Directions for Use Chapter 3 Calibrating the Spirometer Figure 10. Calibration Code on Flow Transducer Package Label 0050 200x-xx REF 703419 Transducer Disposable Flow Transducers “cal” code CALIBRATION CODE WKKVDXPB7 QTY 100 Lot code 4341 State Street Road Skaneateles Falls, NY 13153 USA www.
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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 tight seal.
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Directions for Use Chapter 3 Calibrating the Spirometer 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: • For verifications or single-flow calibrations The results display.
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Chapter 3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option 11. Press the appropriate softkey. Caution A poor calibration (as shown in Figure 14 Figure 16) indicates that the system had to make large adjustments to measure the syringe volume accurately.
Directions for Use Chapter 3 Calibrating the Spirometer 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 Choose Spirometry Settings >...
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”...
Directions for Use Chapter 4 Performing Spirometry Tests 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.
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.
Directions for Use Chapter 4 Performing Spirometry Tests 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 lung problems are FVC and FEV1.
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”...
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. Figure The CP 200 software automatically activates the spirometry functions throughout the software. Bacteria filters are unnecessary.
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.
Directions for Use Chapter 4 Performing Spirometry Tests Recording a Test To record a spirometry test, follow these steps. 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 If the patient has obvious spinal deformities, measure the arm span from fingertip to fingertip with arms outstretched against a wall.
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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...
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Directions for Use Chapter 4 Performing Spirometry Tests 6. Press Effort Type as needed to select the type of effort you want the patient to perform. See Figure • • FVC Post* • • 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.
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Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option Figure 29. “Effort Complete” Screen FVC example (flow/vol curve) SVC example 9:17AM Oct 16 08 Doe, Jane 9:17AM Oct 16 08 Doe, Jane SVC #1 FVC #1 Vol (L)
Directions for Use Chapter 4 Performing Spirometry Tests 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).
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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: Press View Results. The display stays the same. Only the softkeys change, as shown here.
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Directions for Use Chapter 4 Performing Spirometry Tests To Change a Test’s Interpretation Statements From the Test Results main screen (Figure 30 on page 43), follow these steps: Press Add/Edit Interps. The following screen appears, displaying any interpretation statements that have been saved with the test.
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Time (s) Select a destination to begin sending. Memory Workstation Done Card 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.
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Directions for Use Chapter 4 Performing Spirometry Tests To Print a Test From the Test Results main screen (Figure 30 on page 43), follow these steps: Press Print Test. The following screen appears. Figure 34. “Print Test” Screen Doe, Jane 9:17AM Oct 16 08 Print Test Vol (L)
Chapter 5 Troubleshooting Welch Allyn CP 200 Spirometry Option Problem-Solving Suggestions If you try these suggestions and still have problems, contact Welch Allyn. For phone numbers, see page Condition Causes Actions When printing, text prints correctly but Print settings Make sure that the desired curve is selected. See “To...
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.
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...
......... . 62 This appendix describes the protocols you can select to change the way the CP 200 spirometer operates when testing a patient.
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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).
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Directions for Use Appendix B Spirometry Protocols Post results are compared (%c 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.
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.
Directions for Use Appendix B Spirometry Protocols 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 standard.
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.
Patient Help Sheets About the Patient Help Sheets ........62 Adult Smokers Help Sheet .
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Appendix C Patient Help Sheets Welch Allyn CP 200 Spirometry Option About the Patient Help Sheets Two patient help sheets are available to print: • Adult Smokers If “patient education” is enabled, the Adult Smokers sheet prints automatically for all adult smokers whenever you print a test.
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Directions for Use Appendix C Patient Help Sheets 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.
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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.
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 Race Norm Name (Abbrev.) Berglund 1963 ≥ 7 ≤...
Directions for Use Appendix D Predictive Norms, etc. 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.
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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 Européen de Physiopathologie Respiratoire 1986, 22, 217-224. Schoenberg 1978 Growth and Decay of Pulmonary Function in Healthy Blacks and Whites, Janet B.
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 by the percentages identified in the following table.
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.
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.
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.
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Directions for Use Appendix D Predictive Norms, etc. 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 the values or interpretation of a completed test (as described under “To View a Test’s Results”...
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 restriction.
Directions for Use Appendix D Predictive Norms, etc. References 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 Security Administration SSA publication number 64-039, Office of Disability Programs ICN 468600, January 2003.
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Appendix D Predictive Norms, etc. Welch Allyn CP 200 Spirometry Option...
The BTPS correction factor converts ambient conditions — temperature, humidity, and pressure — to BTPS. CardioPerfect workstation. A PC using Welch Allyn CardioPerfect software. Stores ECG and spirometry test data. Can communicate with other electronic patient-information systems, such as billing and medical records.
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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).
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Directions for Use Glossary FEV0.5%. FEV0.5 as % of FVC. FEV1%. FEV1 as % of FVC. Same as FEV1/FVC. A parameter for a single FVC effort. FEV1% formula. A user-selectable formula that determines the calculation method for a test’s (not an effort’s) overall FEV1% value, which affects the automatic interpretation.
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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.
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Directions for Use Glossary pre-test. A test that provides a baseline for comparison with a post-test taken by the same patient. Sometimes called pre-Rx or pre-BD (bronchodilator). Pre-tests and post-tests are commonly used to evaluate the effectiveness of medication. See also reversibility. reversibility.
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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.
CD (product information), ordering replacement FIV parameters Celsius, selecting flow cleaning, why to avoid flow loop components of spirometer flow transducer composite best effort description composite norm values ordering replacements connection of spirometry components warranty period contact information for Welch Allyn...
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Index Welch Allyn spirometer Electrocardiograph flow units (L/sec or L/min), selecting flow/volume curve as default loop. See flow loop definition L/sec or L/min, selecting examples lung age FVC curve, selecting default See also individual curve types FVC parameters mandatory data fields...
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Directions for Use Index predictive norms. See norms settings predictive values calibration preparation of patient interpretation list pressure tubing operation description patient data ordering replacement print storage screen warranty period spirometry (menu tree) pressure units, selecting single-flow calibration. See calibration pre-testing smoke years print settings...
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Index Welch Allyn spirometer Electrocardiograph verifying calibration "View Results" screen Viljanen norm vital capacity. See FVC or SVC volume/time curve as default definition examples warning symbol defined warranty web site Welch Allyn Technical Support Zapletal norm...
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4341 State Street Road, PO Box 220, Skaneateles Falls, NY 13153-0220 USA 1 800 535 6663, + 1 315 685 4560 www.welchallyn.com Reorder Number (multi-language CD): 401151 Mat. Number (manual only): 708795, Ver: E...
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