PneumoCheck Operating Instructions Model 61000

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Welch Allyn

Welch Allyn

Thank you for purchasing the Welch Allyn PneumoCheck. The operating and maintenance instructions found in this manual should be followed to ensure many years of accurate and reliable service. Please read these instructions thoroughly before using your Welch Allyn PneumoCheck Spirometer and Printer/Charger.

CONTENTS Introduction to Spirometry ... Indications for Spirometry ... Parts of the Welch Allyn PneumoCC Preliminary Operating Instructions, The FVC Test ... Quick FVC Reference Chart.. ... Description.. ... Measurement Parameters ... Obtaining Good FVC Results ... Doing an FVC Maneuver ... Doing Multiple Tests on a Patient.. Interpretation of Results ... The MVV Test ... Description ... Measurement Parameters ... Obtaining Good MVV Results.. ... Doing an MVV Maneuver ... Doing Multiple Tests on a Patient.. Interpretation of Results ...

Parts of the PneumoCheck Printer/l Printer/Charger Operating instructi Setting Up.. ... Setting Report Format Options.. ... Predicted Normals.. ... Short Form/Long Form ... Flow/Volume or Volume/Time PI Entering Patient Data ... Printing ... Paper Feed.. ... Paper Jams ... Paper Replacement ... Stopping the Printer ... Error Conditions.. ...

Calibration Check and Flecalibratio **Welch Allyn gratefully acknowleges the assistance of Paul L. Enright, M.D. of the Mayo Clinic in Rochester, Minnesota for his assistance in preparing and reviewing sections of this manual.

The ATS Recommendation ... Calibration Check ... Recalibration ... Quick Calibration Check and Reca

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Welch Allyn

CONTENTS Introduction to Spirometry.. ... .l Indications for Spirometry ... .2 Parts of the Welch Allyn PneumoCheck Spirometer... .3 Preliminary Operating Instructions ... 4 The FVC Test ... .5 Quick FVC Reference Chart ... .5 Description.. ... 6 Measurement Parameters ... .6 Obtaining Good FVC Results ... .8 Doing an FVC Maneuver ... 12 Doing Multiple Tests on a Patient.. ... 14 Interpretation of Results ... 17

The MVV Test ...

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Description ... .20 Measurement Parameters ... .20 Obtaining Good MVV Results.. ... .21 Doing an MVV Maneuver ... .21 Doing Multiple Tests on a Patient ... .22 Interpretation of Results ... .22

Parts of the PneumoCheck Printer/Charger ... 23 Printer/Charger Operating Instructions ... .24 Setting Up ... .24 Setting Report Format Options ... .24 Predicted Normals ... .24 Short Form/Long Form ... .25 Flow/Volume or Volume/Time Plot ... .25 Entering Patient Data ... .26 Printing ... .27 Paper Feed ... .28 Paper Jams ... .28 Paper Replacement ... .28 Stopping the Printer ... .29 Error Conditions.. ... .30

Calibration Check and Recalibration ... 31 The ATS Recommendation ... .31 Calibration Check ... .32 Recalibration ... .34 Quick Calibration Check and Recalibration Reference Charts. . ..3 6

INTRODUCTION TO SPIROM

Battery Maintenance.. ... .37 Battery Recharging ... .37 Battery Replacement ... .39

Cleaning and Sterilization ... 41 Pneumotach ... Body of PneumoCheck ... Printer/Charger ... Charging Transformers.. ...

.41 .42 .42 .42

Accessories ... 43 Warranty ... 44 Repair ... 44 Appendix A . PneumoCheck Messages.. ... .45

The Welch Allyn PneumoCheck is a tally designed to perform FVC and h accurately. In order to properly use y useful test results, you should be fan spirometry: A spirometer is a device that measur breathed into or out of it. To perform a spirometry test, a patie in a prescribed manner over a knowr ent types of spirometry tests can be I of which yields different information t

PneumoCheck Status Messages ... .45 PneumoCheck Error Messages ... .48 PneumoCheck Test Values ... .48

Appendix B - Maneuver Quality Messages ... 49 Appendix C - Predicted Normal Values ... 51 The Ideal Study ... .51 Predicteds Available on Your PneumoCheck ... .51 Racial Differences ... .52 Calculating Predicted Values Manually ... .52

Reference Tables: Knudson, 1983 2121*21 ... .54 Knudson, 1976,13, ... .56 Morris, Crapo, et al., 1981 144 ... 57 European Community for Coal and Steel 166 ... 58 Coefficients for MVV's s ... .58

Appendix D - Technical Specifications ... 59 PneumoCheck ... .59 Printer/Charger ... .60 Standards Compliance ... .60

Appendix E - Glossary ... 61 Appendix F - Bibliography ... .64

1

INTRODUCTION TO SPIROMETRY

The Welch Allyn PneumoCheck is a hand-held spirometer specifically designed to perform FVC and MVV spirometry tests easily and accurately. In order to properly use your PneumoCheck and to obtain useful test results, you should be familiar with the basic principles of spirometry: A spirometer is a device that measures the amount of air that is breathed into or out of it. To perform a spirometry test, a patient breathes into the spirometer in a prescribed manner over a known period of time. Several different types of spirometry tests can be done using a spirometer, each of which yields different information about the patient’s lung function.

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PARTS OF THE WELCH ALLYN PNEUMOCHECK SPIROMETER (#61000) PNEUMOTACH ASSEMBLY

MOUTHPIECE ON/OFF SWITCH

LIQUID ---I CRYSTAL DISPLAY I

BODY OF PNEUMOCHECK

L PNEUMOTACH ASSEMBLY

(ORANGE) SPEAKER FOR AUDITORY SIGNALS

BODY OF PNEUMOCHECK CHARGING JACK DATA/CHARGING CONTACT

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PRELIMINARY OPERATING INSTRUCTIONS

1.

If the instrument has not been stored at room temperature, allow 45 minutes for the temperature of the instrument to stabilize.

2.

Visually check the screen of the PneumoCheck (see p. 41) and check the calibration (see p. 31).

3.

Instruct the patient about what is expected and how to perform a good test (see p. 8 for FVC or p. 21 for MVV).

4.

Ask the adult patient to attach a disposable mouthpiece using a push-and-twist motion to ensure a snug fit. For children, insert a disposable pediatric mouthpiece.

5.

Slide the ON/OFF switch to the right to turn instrument on. The word CLEAR will appear on the liquid crystal display (LCD) and a beep will sound indicating the instrument’s memory has been cleared.

THE FVC TEST /

QUICK FVC REFERENCE CHART How To Use Your PneumoCheck a

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Enter Age, Height, Race, Sex into Printer/Charger

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Instruct and Demonstrate Correci FVC maneuver

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Visually Check Screen of PneumoCh

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When SELECT is displayed, select the type of test by repeatedly depressing the TEST button:

Switch PneumoCheck ON, wait fo SELECT and press TEST

Press once and release to access FVC. Press again and release for MVV. Press again and release for CAL (calibration). Press and release a fourth time to return to SELECT.

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With each selection the appropriate word or abbreviation will appear on the liquid crystal display (SELECT, FVC, MVV, CAL). Within three seconds that particular test will begin.

3 Good Tests?

6.

DoFVC1,2,3...

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Place PneumoCheck into PrinterKha

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Wait for green DATA light to stop

Interpret 1

Results J

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THE FVC TEST

QUICK FVC REFERENCE CHART How To Use Your PneumoCheck and Printer/Charger Enter Age, Height, Race, Sex into Printer/Charger

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Instruct and Demonstrate Correct

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Visually Check Screen of PneumoCheck

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t Switch PneumoCheck ON, wait for SELECT and press TEST

DoFVC1,2,3...

Place PneumoCheck into Printer/Charger 1 Wait for green DATA light to stop flashing, then press PRINT

+ Interpret Results

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DESCRIPTION The most frequently performed spirometry test is the forced expiratory vital capacity test, or FVC. It is commonly used for basic pulmonary function testing as well as managing patients with chronic obstructive pulmonary disease (COPD), asthma, emphysema, bronchitis, or other lung diseases. When doing a single maneuver, the patient inhales as much air as possible, then exhales as rapidly and as completely as possible into the spirometer. To perform a complete FVC spirometry test, the patient should complete three or more acceptable FVC maneuvers with a brief rest between each one. MEASUREMENT PARAMETERS Several characteristics of the FVC maneuver are helpful in evaluating the patient’s lung function. The two most commonly used parameters are FVC and FEV 1 : FVC Forced Expiratory Vital Capacity, the total amount of air (in liters) exhaled during an FVC maneuver. FEVl Forced Expiratory Volume in one second, the volume of air (in liters) exhaled during the first second of the FVC maneuver. FEVl is also the measure of the average flow rate during the first second of the FVC maneuver. Other commonly used FVC parameters include:

PEF Peak Expiratory Flow, the highest rat during the FVC maneuver. Once an acceptable FVC maneuver I results can be compared to establish1 determined. The norms are based OI of the patient. Lung disorders usually fall into one 01 lung diseases or restrictive disorders Obstructive lung diseases are those 1 rates or airflow limitation, such as ast Chronic Obstructive Pulmonary Disc: Restrictive disorders are those that c( reduced, such as congestive heart fa pneumonia, pleural fibrosis, pneumoc In general, it is possible to categorize these two groups and gauge its seve but it is usually not possible to identif further information. The patient’s res ment, response to various bronchodil specific pulmonary tests may be neec disorder. NOTE: During FVC maneuvers in the instrument assumes that air at body 1 saturated with water (BTPS) will be L applied.

FEVl /FVC% (also called RATIO) the ratio of the FEV 1 to the FVC, expressed as a percentage. FEF25%-75% Forced Expiratory Flow between the 25% and 75% volume points (also called Mean Mid Expiratory Flow or MMEF). A measurement of the average rate of flow (in liters/second) during the middle 50% of the FVC maneuver.

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PEF Peak Expiratory Flow, the highest rate of airflow (in liters/second) during the FVC maneuver. Once an acceptable FVC maneuver has been completed, the test results can be compared to established norms and a course of action determined. The norms are based on the height, age, race and sex of the patient. Lung disorders usually fall into one of two categories: obstructive lung diseases or restrictive disorders. Obstructive lung diseases are those that cause a reduction in airflow rates or airflow limitation, such as asthma, chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD) and emphysema. Restrictive disorders are those that cause the lung volume to be reduced, such as congestive heart failure with pulmonary edema, pneumonia, pleural fibrosis, pneumoconiosis and gross obesity. In general, it is possible to categorize a lung disorder into one of these two groups and gauge its severity with a basic spirometry test, but it is usually not possible to identify the specific disorder without further information. The patient’s respiratory history, work environment, response to various bronchodilators, and results from more specific pulmonary tests may be needed to fully diagnose the disorder. NOTE: During FVC maneuvers in the normal operating mode, the instrument assumes that air at body temperature and pressure, fully saturated with water (BTPS) will be used, and a BTPS factor is applied.

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OBTAINING GOOD FVC TEST RESULTS

Unacceptable conditions inc slow or hesitating start air leaking around the m coughing during the first mouthpiece obstruction quitting too soon l

Accuracy of spirometry testing is very dependent on the effort of the patient and is only valid if the patient cooperates and performs the test to the best of his/her ability. Properly instructing and coaching the patient throughout the maneuver is therefore critical. Your Welch Allyn PneumoCheck has a sophisticated monitoring system which will help you in deciding whether a maneuver was a valid effort.

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6.

When the maneuver has been c message. If a message appear: maneuver (see p. 49), instruct ttproblem and repeat the test.

However, you must know how to properly teach your patients to perform good tests or your PneumoCheck will continually find fault with maneuvers and you and your patient will quickly become frustrated. To Obtain a Good FVC Result: 1.

Explain the test and what you expect.

2.

Demonstrate how to place the disposable mouthpiece in the mouth (teeth on the outside, forming a good seal with the lips).

3.

Demonstrate how a maneuver is done by doing one yourself. Make sure your effort is a good one by inhaling all the way and then exhaling as completely and rapidly as possible either into the instrument or simply into the disposable mouthpiece.

4.

Coach your patient throughout the test: “Now blast out hard and fast!! All you can!! More! More! Keep going a little more!”

5.

Learn to recognize poor maneuvers by closely observing the patient: An acceptable maneuver requires: adequate understanding maximal inhalation a rapid start of the effort apparent maximal effort with continuous, steady exhalation at least three seconds of exhalation (the ideal is six to ten seconds) l

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Unacceptable conditions include: slow or hesitating start air leaking around the mouthpiece coughing during the first second of the maneuver mouthpiece obstruction by tongue, lips, or teeth quitting too soon l l l l

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6.

When the maneuver has been completed, observe the quality message. If a message appears indicating an unacceptable maneuver (see p. 49), instruct the patient on how to correct the problem and repeat the test.

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Example of Acceptable (GOOD FVC) Effort: RACE: 2 SEX: M

ACE:23 HEIGHT:7Zin ACTUAL FVC

NORMS :

Examples of Unacceptable Efforts

G o o d FVC

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NORM %NORM RSN

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NORM %NORM ABN

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1983

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NORMS: Slow

7s 108 < VS30P30 >

maneuver.

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FVC

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1983

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COUGH 11

Examples of Unacceptable Efforts: @g:37

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NORMS: Knudson 1983 Slow

FVC

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< VS30P30 > Fugdon t e r m i n a t i o n o f F V C . V too short: blow out longer.

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NORM %NORM RBN

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Knudson

1983

F V C sffort:

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blast

harder.

FVC #l

8.47 SEC ,.

7.44 SEC

COUGH

WEAK TRY 11

DOING AN FVC MANEUVER 1.

Upon selection of FVC, the PneumoCheck first measures zero airflow through the pneumotach to assure maximum accuracy. During this time (no more than seven seconds) the word STEADY is displayed and it is important to hold the PneumoCheck still so that an accurate reference can be made. If the PneumoCheck is moved during this time, the STEADY message will remain until it is held quite still for at least three seconds, or until an UNSTEADY message appears. Should an UNSTEADY message appear, depress the TEST button to start FVC again.

2.

The PneumoCheck then displays the message DO FVC 1, and beeps.

3.

The patient may sit or stand, but position should be noted,,. A sitting position is often preferred for stability.

4.

Instruct the patient to inhale deeply, put the mouthpiece in his/ her mouth and exhale as completely and with as much force as possible.

seal. The mouth should be opened w obstruction by the teeth or tongue. 5.

The PneumoCheck will then disp results. It will then provide a seri message appears automatically, patient’s effort. The message for FVC. For a complete list of the c see p. 49.

6.

Press and release the DATA but additional quality messages and parameters for the maneuver: F FVC%), MMEF (or FEF 25%-759 and discussion of these values, I (P. 17).

7.

Press the TEST button to return

After completely emptying the lungs, the patient removes the instrument from the mouth. The PneumoCheck will beep after about four seconds, indicating it has seen the end of the maneuver. NOTE: Inhalation should not be done through the pneumotach. Back end of pneumotach should not be blocked. In performing an FVC maneuver the patient’s lips and teeth should be placed around the mouthpiece, with the lips forming a

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seal. The mouth should be opened wide enough to avoid any obstruction by the teeth or tongue. 5.

The PneumoCheck will then display BUSY while calculating test results. It will then provide a series of messages. The first message appears automatically, and gives an indication of the patient’s effort. The message for an acceptable effort is GOOD FVC. For a complete list of the other quality control messages see p. 49.

6.

Press and release the DATA button consecutively to see additional quality messages and each of the calculated parameters for the maneuver: FVC, FEW, RATIO (or FEV 1/ FVC%), MMEF (or FEF 25%-75%), and PEF. For a definition and discussion of these values, refer to Interpretation of Results (P. 17).

7.

Press the TEST button to return to SELECT.

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DOING MULTIPLE TESTS ON A PATIENT

ASSESSING ACCEPTABILITY:

According to the American Thoracic Society recommendations for testing,,, the patient should perform at least three acceptable FVC maneuvers, the best two of which must match one another within 5%. The best effort is then used to assess patient status.

The PneumoCheck will determine whl performed should replace the manem as BEST test. In making this determir looks at the quality control messages “good” maneuver is one that has no ic cough in the middle of the maneuver t

No more than eight maneuvers should be obtained to avoid fatiguing the patient. This is easily accomplished with your Welch Allyn PneumoCheck as it will automatically: 1. Assess acceptability. 2. Save the best test. 3. Determine repeatability (“matching”). Following is a description of the specifics: When power is first turned on, the instrument’s memory is empty as indicated by the CLEAR message. The PneumoCheck automatically stores all test data for the best FVC and the best MVV as well as the most recent FVC and MVV maneuvers. To review BEST or LAST test: Press TEST button to access SELECT. Press DATA button once and release to access BEST FVC. Press DATA button again and release to access LAST FVC. Press DATA button and release a third time to return to SELECT. After accessing BEST or LAST memory, wait three seconds for the quality control message. Then, push and release DATA to see calculated values for that test.

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SELECTING BEST TEST: One Acceptable, One Not If the new maneuver is acceptable an maneuver was not, then the previous1 discarded and the new maneuver is s Likewise, if the new maneuver is not I stored BEST maneuver was acceptat BEST maneuver is retained.

Both Acceptable, Both Unacceptab If the stored BEST maneuver and the acceptable or both unacceptable, the mines which is BEST based on the fo

Criterion For Best FVC Maneuver: The larger sum of the FVC and FEVl

Criterion For Best MVV Maneuver: The higher value as expressed in liter DETERMINING REPEATABILITY: In addition to selection of the best tes the tests were reproducible, that is, tc do this the currently stored best test i! test and a message appears after the

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ASSESSING ACCEPTABILITY: The PneumoCheck will determine whether the maneuver just performed should replace the maneuver that was previously stored as BEST test. In making this determination, the PneumoCheck first looks at the quality control messages for the new maneuver. A “good” maneuver is one that has no identifiable faults, such as a cough in the middle of the maneuver or a hesitating start (see p. 8). SELECTING BEST TEST:

One Acceptable, One Not If the new maneuver is acceptable and the previously stored BEST maneuver was not, then the previously stored BEST maneuver is discarded and the new maneuver is stored in its place. Likewise, if the new maneuver is not acceptable while the previously stored BEST maneuver was acceptable, then the previously stored BEST maneuver is retained.

Both Acceptable, Both Unacceptable If the stored BEST maneuver and the new maneuver are both acceptable or both unacceptable, the PneumoCheck next determines which is BEST based on the following criteria:

Criterion For Best FVC Maneuver: The larger sum of the FVC and FEVl

Criterion For Best MVV Maneuver: The higher value as expressed in liters/minute.

DETERMINING REPEATABILITY: In addition to selection of the best test, it is important to know that the tests were reproducible, that is, to know that they matched. To do this the currently stored best test is compared to the most recent test and a message appears after the quality message.

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Match Criteria

INTERPRETATION OF RESULTS

FVC

The PneumoCheck Printer/Charger VI which are abnormal, ,,. If the FEVl/f obstructive disorder is indicated. Use of the obstruction:

The previously stored best maneuver and the new maneuver are compared: l

MATCH will be displayed if both FVC values are within 5% of each other and both FEVl values are within 5% of each other.

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An FEVl above 80% of predicte

Borderline Obstruction. If both FVC values and both FEVl values are not within 5% of each other:

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An FEVl between 60% and 809

Mild Obstruction. l

NO MATCH will be displayed if the new maneuver is 5% less than the previously stored BEST.

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An FEVl between 40% and 609

Moderate Obstruction. l

NEW BEST will be displayed if the new maneuver is 5% greater than the previously stored BEST.

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An FEVl below 40% of predicte

Severe Obstruction. MVV l l

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MATCH will be displayed if the MVV values of the two tests being compared are within 15% of each other. NO MATCH will be displayed if the MVV values compared are not within 15% of each other.

Remember that results displayed at the completion of the maneuver are for the maneuver just completed. See p.14 for instructions on accessing BEST and LAST tests. NOTE: Turn the ON/OFF switch to OFF and back to ON before beginning a test on a new patient, so that the previous patient data memory is cleared.

If the FEVI is below 80% of pre below 80% of predicted, the po: Restriction in addition to the Ob

If the FEVl/FVC ratio is normal, bu strictive disorder is indicated, and severity of the restriction: l

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An FVC between 60% of predic normal indicates a Mild Restric An FVC between 50% and 60%

Moderate Restriction. l

An FVC below 50% of predictec

Severe Restriction. Any patient who has a normal FVC, F considered to be within normal limits obstructive lung disease can be rulec asymptomatic asthmatic who is in rer

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INTERPRETATION OF RESULTS The PneumoCheck Printer/Charger will place a star beside values which are abnormal, ,,. If the FEVl/FVC ratio is abnormally low, an obstructive disorder is indicated. Use the FEVl to grade the severity of the obstruction: l

An FEVI above 80% of predicted indicates a

Borderline Obstruction. l

An FEV1 between 60% and 80% of predicted indicates a

Mild Obstruction. l

An FEVl between 40% and 60% of predicted indicates a

Moderate Obstruction. l

An FEVl below 40% of predicted indicates a

Severe Obstruction. l

If the FEVl is below 80% of predicted and the FVC is also below 80% of predicted, the possibility of a superimposed Restriction in addition to the Obstruction exists.

If the FEVl/FVC ratio is normal, but the FVC is abnormal, a restrictive disorder is indicated, and the FVC is used to grade the severity of the restriction: l

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An FVC between 60% of predicted and the lower limit of normal indicates a Mild Restriction. An FVC between 50% and 60% of predicted indicates a

Moderate Restriction. l

An FVC below 50% of predicted indicates a /

Severe Restriction. Any patient who has a normal FVC, FEVl/FVC, and FEF 2575% is considered to be within normal limits, and clinically significant obstructive lung disease can be ruled out. An exception to this is the asymptomatic asthmatic who is in remission.

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