Welch Allyn CP 200 User Manual

Download

Page 1

CP 200™ Spirometry Option

Directions for Use

Page 2

ii Welch Allyn CP 200 Spirometry Option

Caution: Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed physician.

Welch Allyn assumes no responsibility for any injury, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or indications for use published in this manual.

Welch Allyn is a registered trademark of Welch Allyn, Inc., and CP 200 and CardioPerfect are trademarks of Welch Allyn, Inc.

SD is a trademark of Toshiba.

Software in this product is copyright Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated within this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title and ownership of the software remains with Welch Allyn or its vendors.

For information about any Welch Allyn product, please call Welch Allyn Technical Support:

USA 1 800 535 6663

+ 1 315 685 4560

Canada 1 800 561 8797 China + 86 216 327 9631

European Call Center + 353 46 906 7790 France + 331 6009 3366

Germany + 49 747 792 7186 Japan + 81 33 219 0071

Latin America + 1 305 669 9003 Netherlands + 31 15 750 5000

Singapore + 65 6419 8100 South Africa + 27 11 777 7555

United Kingdom + 44 207 365 6780 Sweden + 46 85 853 6551

Australia + 61 29 638 3000

Reorder Number (multi-language CD): 401151 Mat. Number (manual only): 708795, Ver: E

Welch Allyn 4341 State Street Road, PO Box 220 Skaneateles Falls, NY 13153-0220

Welch Allyn LTD. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Tel.: 353-46-90-67700 Fax: 353-46-90-67755

www.welchallyn.com

Printed in USA

Page 3

Contents

1 - Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

iii

About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Using the Spirometer Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

General Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

General Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Ordering Information for Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Getting Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2 - Reviewing the Spirometry Settings . . . . . . . . . . . . . . . . . . . . . . . . . 11

“Spirometry Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Reviewing the Operation Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Reviewing the Calibration 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

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 the Spirometry Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

About Pre- and Post-Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

About Effort Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Connecting the Spirometer Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Recording a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Working With a Completed Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Page 4

iv Contents Welch Allyn CP 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

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

2 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option

About This Manual

This manual is written for clinical professionals performing pulmonary function testing. Users must be familiar with measurements and the clinical significance of basic spirometry products.

Before using the spirometer, all users and technicians must read and understand this manual and all other information accompanying the CP 200 spirometry option and the CP 200 electrocardiograph.

Caregivers need to know how to properly coach patients, to recognize acceptable waveforms, and to know whether results meet ATS reproducibility criteria.

The hospital's Biomedical/IT support staff shall require primary skills including disciplines related to maintenance and servicing computer 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 abbreviations used in this manual, see “Glossary” on page 77.

Note

This manual supplements the CP 200 electrocardiograph manual, entitled CP 200 12-Lead Resting Electrocardiograph Directions for Use.

See the electrocardiograph manual for procedures that are common to both ECG and spirometry functions, such as how to move through the menus, how to search for patient data, or how to edit the medication list.

Page 7

Directions for Use Chapter 1 Introduction 3

Product Overview

The CP 200 spirometry option performs FVC and SVC testing, including pre- and postbronchodilator testing. It displays flow/volume and volume/time curves in real time, depicting both inspiratory and expiratory measurements.

For details, see the following sections:

• “Features” on page 5

• “Ordering Information for 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. Converts pressure to air flow.

Nose clip

Recommended during testing to avoid leaks.

Three-liter calibration syringe

For daily use to calibrate the spirometer for accuracy.

Page 8

4 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option

Intended Use

The CP 200 spirometry option allows the user to acquire, view, store, and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases.

The spirometer should only be used with patients who are able to understand the instructions for performing the test.

Indications for Use

Spirometry is indicated for use in various common clinical situations:

• Assessing health status before a patient begins strenuous physical activity.

• Evaluating the following symptoms, signs, or abnormal laboratory tests:

Symptoms — dyspnea, wheezing, orthopnea, cough, phlegm production, chest pain

Signs — diminished breath sounds, overinflation, expiratory slowing, cyanosis, chest

deformity, unexplained crackles, shortness of breath

Abnormal laboratory tests — hypoxemia, hypercapnia, polycythemia, abnormal chest radiographs

Page 9

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 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

• Customizable report formats

• Meets ATS/ERS 2005 spirometry standards.

• Single-flow and multiple-flow calibration protocols with automatic printing

• NIOSH, OSHA, and Social Security operation protocols to create reports that meet these agency requirements

• PCP (primary care practitioner) protocol that follows NLHEP guidelines

• Meets all industry standards, including ATS, NIOSH, OSHA, and Social Security

• Integrated into the CardioPerfect workstation for easy analysis, reviewing, storing, printing, and exporting

• Compliant with the National Lung Health Education Program (NLHEP) guidelines for office spirometers. For more information about NLHEP criteria, visit http://www.nlhep.org/spirometer-review-process.html.

Page 10

6 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option

Symbols

The symbols illustrated here may appear on the spirometer components, on the packaging, on the shipping container, or in this manual.

Documentation Symbols

WARNING Indicates conditions or practices that could lead to illness, injury, or 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 date

Type BF applied part

200x-xx

Page 11

Directions for Use Chapter 1 Introduction 7

Using the Spirometer Safely

Before using or servicing the spirometer, you must read and understand the following safety-related information.

General Warnings

The following warning statements apply to spirometer use in general. Warning statements that apply specifically to particular procedures, such as preparing the patient for testing, appear in the corresponding sections of the manual.

Warning statements indicate conditions or practices that could lead to illness, injury, or death.

WARNING Do not perform spirometry tests if any of the following conditions apply to the patient:

• hemoptysis of unknown origin (forced expiratory maneuver may aggravate the underlying condition)

• pneumothorax

• unstable cardiovascular status (forced expiratory maneuver may worsen angina or cause changes in blood pressure)

• recent myocardial infarction

• pulmonary embolus

• thoracic, abdominal, or cerebral aneurysms (danger of rupture due to increased thoracic pressure)

• recent eye surgery (for example, cataract)

• 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 patient’s physiological condition. When reviewed by a trained physician or clinician, this data can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis.

WARNING To minimize chance of a misdiagnosis, it is the physician’s responsibility to assure that spirometry tests are properly administered, evaluated, and interpreted.

WARNING To prevent the spread of infection, do not try to clean the flow transducers and nose clips. Discard these items after a single patient use.

WARNING Read and observe all safety information provided in the flow transducer instructions.

Page 12

8 Chapter 1 Introduction Welch Allyn CP 200 Spirometry Option

General Cautions

The following caution statements apply to spirometer use in general. Caution statements that apply specifically to particular procedures appear in the corresponding sections of the manual.

Caution statements indicate conditions or practices that could damage the equipment or other property.

Caution Do not clean the spirometer or any of its components. Trapped moisture in the pressure tubing or sensor could affect their accuracy. Replace the pressure tubing when it becomes dirty. Replace the sensor when it becomes faulty. Recalibrate the spirometer after replacing any components.

Caution Do not immerse any part of the spirometer into a cleaning liquid or sterilize it with hot water, steam, or air.

Caution Do not use aromatic hydrocarbons, rubbing alcohol, or solvents on the spirometer.

Caution 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 use of accessories other than those specified may result in degraded performance of this device.

Caution When you put the spirometer away, store its pressure tubing in a basket or drawer or other place that prevents compression or kinking.

Caution Avoid installing the spirometer in direct sunlight or in a location where it may be affected by significant changes in humidity, ventilation, or airborne particles containing dust, salt, or sulfur.

Caution Keep the spirometer away from splashing fluids.

Page 13

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. For phone numbers, see page ii.

WARNING Discard all spirometry components according to local regulations.

Item Material Numbers Quantity

Disposable flow transducers 703418

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)

• Spirometry Effort Acceptability & Reproducibility (wall poster)

• CP 200 Spirometry Option Quick Reference (small card)

• CP 200 Spirometry Option Directions for Use 708795 1

• CP 200 product information multi-language CD 401151

703419

71038-3000

703337 1

703977 1

100

Page 14

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 came with the spirometer. For list, see “Product

information” on page 9.

• Contact Welch Allyn. For phone numbers, see page ii.

Page 15

Reviewing the Spirometry Settings

“Spirometry Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Reviewing the Operation Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Reviewing the Calibration 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

12 Chapter 2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option

“Spirometry Settings” Menu Tree

Spirometry

Settings

Operation

Settings

Select Protocol Select Adult Predictive Norm Select Ped. Predictive Norm Select Best Effort Formula Select FVC Reversibility Formula Select FEV1% Formula Enable Predictive Points Enable Predictive Curve Enable ATS Interp. Results Enable Composite Norm Values

Settings

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

Calibration

Settings

Calibrate Spirometer Enable Auto Calibration Report Print Calibration Report

First Name Second Last Name Middle Initial Age/Birth Date Weight Smoke Years Packs/Day Medication History Comments

Patient Data

Settings

Screen

Settings

Select Default FVC Curve Select FVC Display Parameters

Edit

Interpretation

List

Note: As part of spirometry setup, you can also go to the System Settings > Device Configuration menu and select the following spirometry-related units of measure.

• Flow: L/sec or L/min (units for the y-axis on flow/volume curves)

• Pressure: mmHg, mbar, inHg, kPa (units for the calibration menu’s atmospheric pressure values)

• Temperature: Fahrenheit or Celsius (units for the calibration menu’s temperature values)

For details, see the electrocardiograph manual.

Page 17

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 > Operation Settings.

The following screen appears.

Figure 2. “Spirometry Operation Settings” Screen

Spirometry Operation Settings

1 Select Protocol 2 Select Adult Predictive Norm 3 Select Ped. Predictive Norm 4 Select Best Effort Formula 5 Select FVC Reversibility Formula 6 Select FEV1% Formula 7 Enable Predictive Points 8 Enable Predictive Curve 9 Enable ATS Interp. Results A Enable Composite Norm Values

9:17AM Oct 16 08

3. If desired, change the settings.

Setting Description

Select Protocol The selected protocol determines the way the spirometer operates when testing a patient.

Select Adult Predictive Norm

Select Ped. Predictive Norm

Select Best Effort Formula

Applicable for FVC testing only. For details, see “Spirometry Protocols” on page 55.

•None

• PCP (primary care practitioner)

•NIOSH

• OSHA

• SSD (Social Security & Disability)

The selected adult norm is the primary source of predictive values for adult patients. For details, see “Norm Profiles” on page 66.

The selected pediatric norm is the primary source of predictive values for pediatric patients. For details, see “Norm Profiles” on page 66.

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 FVCpost, best SVC). This ATS-recommended method uses the effort with the highest sum of FVC + FEV1, or the effort with the highest SVC value. (For details, see the document noted in Reference 6 on page 75.)

• Best Composite — Defines best effort as a composite of the highest parameter values across all selected efforts (except FVC and FEV1, which are both selected from the highest sum of FVC + FEV1.)

Page 18

14 Chapter 2 Reviewing the Spirometry Settings Welch Allyn CP 200 Spirometry Option

Setting Description (continued)

Select FVC Reversibility Formula

Select FEV1% Formula

Enable Predictive Points

Enable Predictive Curve

Enable ATS Interp. Results

Reversibility is the percentage difference between pre-test and post-test data for FVC testing. This measurement indicates the effect of medication on lung function. Reversibility applies to each parameter separately.

To determine the way in which reversibility is calculated, choose from these options:

• ((Post-Pre)/Pre)*100

• (Post/Pre)*100

• ((Post-Pre)/Predictive)*100

The FEV1% formula determines the calculation method for a test’s (not an effort’s) overall FEV1% value, which affects the automatic interpretation. The variable part of this formula is the denominator. Both the numerator and the denominator represent best effort values.

To determine the way in which FEV1% is calculated, choose from these options:

• FVC (FEV1% = FEV1/FVC

• FIVC (FEV1% = FEV1/FIVC

• FEV6 (FEV1% = FEV1/FEV6

• Max (FVC, FIVC, SVC) (FEV1% = FEV1/FVC

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.

Yes or no. If yes, a curve displays and prints along the predictive points. When the curve is enabled, the points are automatically also enabled.

Yes or no. If yes, ATS interpretative results are included in the test record. For details, see

“ATS interpretive results” on page 77.

)

or FIVC or SVC, whichever is largest)

Enable Composite Norm Values

Yes or no. If yes, any parameters that are not supported in the primary (selected) norm are given predictive values from alternative (composite) norm sources.

If set to no, only the primary norm’s values are used, no composite values. On the screen and in reports, any unsupported parameters appear without predictive values.

For details, see “About Race Adjustment” on page 69.

Page 19

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 following screen appears.

Figure 3. “Spirometry Calibration Settings” Screen

Spirometry Calibration Settings

1 Calibrate Spirometer 2 Enable Auto Calibration Report 3 Print Calibration Report 0 Previous Menu

9:17AM Oct 16 08

3. Change any desired settings.

Setting Description

Calibrate Spirometer Brings up the Spirometer Calibration screen. See “Calibrating the

Enable Auto Calibration Report Yes or no. If yes, a calibration report prints automatically every time you accept

Print Calibration Report Prints the most recent calibration report.

Spirometer” on page 21.

calibration results.

Page 20

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, follow these steps.

1. Press the Menu key .

2. Choose Spirometry Settings > Screen Settings.

The following screen appears.

Figure 4. “Spirometry Screen Settings” Screen

Spirometry Screen Settings

1 Select Default FVC Curve 2 Select FVC Display Parameters 0 Previous Menu

9:17AM Oct 16 08

3. Change any desired settings.

Setting Description

Select Default FVC Curve Choices: volume/time, flow/volume, tidal volume, incentive. The selected default

curve appears first whenever you begin FVC testing.

Select FVC Display 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, FEF50, FEF75, FEF0.2-1.2, FEF75-85, FET, FIVC, FIV1, FIV1%, PIF, FIF50, FEF50/FIF50.

Note: For SVC testing, these parameters always display: SVC, ERV, IRV, VT, BF, Tin/ Te x.

Page 21

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.

Note

FVC and SVC efforts appear in separate print reports, even when they belong to the same test.

1. Press the Menu key .

2. Choose Spirometry Settings > Print Settings.

The following screen appears.

Figure 5. “Spirometry Print Settings” Screen

Spirometry Print Settings

1 Select Efforts 2 Select FVC Curves 3 Select FVC Print Parameters 4 Select Scale 5 Print Lung Age 6 Print “Unconfirmed Report” 7 Print “Reviewed By” 8 Print “Patient Cooperation” 9 Print Quality Grades A Print Patient Education

9:17AM Oct 16 08

3. Change any desired settings.

Setting Description

Select Efforts Choose which efforts are included in printed reports by default. If desired, when printing a

test you can cycle through these choices and change the setting for that one test.

• 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 “Select Best Effort Formula” on page 13.

Page 22

18 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.

• volume/time

• flow/volume

• tidal volume

• V/T & F/V (both volume/time and flow/volume)

• V/T & display (when auto print is selected, prints both volume/time and the displayed curve type if flow/volume or tidal volume; incentive screens do not print.)

•no curves

Note: It is not necessary to select a default SVC curve for printing, because SVC curves are always volume/time.

Select FVC Print Parameters

Select Scale Choose which type of scaling (graph resizing) to use in printed volume/time curves.

Print Lung Age Yes or no. If yes, the estimated lung age is included in printed reports for patients. For

Print “Unconfirmed Report”

Print ”Reviewed By” Yes or no. If yes, “Reviewed By ______________” is included in printed reports, giving

Choose which FVC-test parameters to include in printed reports. You may select as many parameters as you like. If more are selected than fit on a page, the report continues to another page.

Choices: FVC, FEV1, FEV1%, FEV6, PEF, FEF25-75, FEV0.5, FEV2, FEV3, FEV5, FEV1/FEV6, FEV0.5%, FEV2%, FEV3%, FEV5%, FEV6%, FEF25, FEF50, FEF75, FEF0.2-1.2, FEF75-85, FET, FIVC, FIV1, FIV1%, PIF, FIF50, FEF50/FIF50.

Note: It is not necessary to select SVC print parameters, because they all print.

• 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.

•20mm/s X axis (time) prints at 20 mm/s. Y axis prints at 10 mm/L.

details, see “About Lung Age” on page 71.

Yes or no. If yes, “Unconfirmed Report” is included in printed reports.

the clinician a place to sign.

Print “Patient Cooperation”

Print Quality Grades Yes or no. If yes, a test-quality grade is included in each printed report. See “About Test-

Print Patient Education Yes or no. If yes, the patient help sheets on asthma and adult smoking prints

Print Physician’s Comments

Auto Print Yes or no. If yes, a report prints automatically when you press the Test Done softkey.

Yes or no. If yes, “Patient Cooperation _______________” is included in printed reports, giving the clinician a place to comment.

Quality Grades” on page 73.

automatically with every report. For examples of these sheets, see “Patient Help Sheets” on page 61.

Yes or no. If yes, spirometry reports will include an additional blank page (with patient information at the top) for physician to write comments on.

Page 23

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.

Note

You choose ECG data-entry fields separately, as described in the CP 200 electrocardiograph manual.

1. Press the Menu key .

2. Choose Spirometry Settings > Patient Data Settings.

The following screen appears.

Figure 6. “Spirometry Patient Data Settings” Screen

Spirometry Patient Data Settings

1 First Name 2 Second Last Name 3 Middle Initial 4 Age/Birth Date 5 Weight 6 Smoke Years 7 Packs/Day 8 Medication 9 History A Comments

9:17AM Oct 16 08

Several fields — Patient ID, Last Name, Height, Gender, and Race — always appear on the Enter New Patient screen, as shown in Figure 27 on

page 39. Since these fields cannot be disabled or edited, they do not appear on this user-selectable list.

3. Change any desired settings.

For most of these fields, you have two choices: on (enabled) or off (disabled). Disabled fields neither display nor print.

You must choose either Age or Birth Date. This field cannot be disabled.

For more details on these settings, see the description of patient data fields in the electrocardiograph manual.

Page 24

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 Spirometry Settings > Edit Interpretation List.

The following screen appears.

Figure 7. “Spirometry Interpretation List” Screen

Spirometry Interpretation List

ATS Obstruction - May be a physiological variation ATS Obstruction - Mild ATS Obstruction - Moderate ATS Obstruction - Moderately Severe ATS Obstruction - Normal ATS Obstruction - Severe ATS Obstruction - Very Severe ATS Restriction - Mild

Add Delete Exit

9:17AM Oct 16 08

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.

Page 25

Calibrating the Spirometer

About Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Performing a Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Printing Calibration Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Page 26

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 this lot number differs from the lot number used during the most recent calibration, you must recalibrate the spirometer before resuming testing.

There are two types of calibration:

• Single-flow calibration

One inhale/exhale cycle.

• Multiple-flow calibration

Three inhale/exhale cycles at three different rates:

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)

Note

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.

If you want to add efforts to a saved test, the calibration must stay the same. Whenever you recalibrate, you lose the ability to add new efforts to tests that were saved earlier.

Caution For proper performance, the calibration syringe itself must be recalibrated every year. See its calibration certificate for the most recent calibration date. When the syringe is due for recalibration, return it to the manufacturer. For details, see “Service Policy” on page 51.

Page 27

Directions for Use Chapter 3 Calibrating the Spirometer 23

Figure 8. Calibration, Process Diagram

For step-by-step procedure, see

“Performing a Calibration”

on page 24.

Calibrate

Simulate exhalation

& inhalation.

(3x if multiple flow.)

Accept?

Yes

Spirometer Calibration

Go to

initial screen

Fill in transducer

calibration code, etc.

Verify?

Or calibrate?

Verify

Simulate exhalation

& inhalation.

Yes

Retry?

Calibration report prints

(if enabled).

Continue previous

procedure.

Page 28

24 Chapter 3 Calibrating the Spirometer Welch Allyn CP 200 Spirometry Option

Performing a Calibration

WARNING To avoid the risk of cross-contamination, always use a new flow transducer when calibrating the spirometer. Observe all safety information that came with the flow transducers.

Note

When you open a new package of flow transducers, disregard the calibration CD that is shipped with them. The CP 200 spirometer does not use the calibration file on this CD.

1. Go to t h e 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 time you press the Spirometry key each day (as described in Step 3 on page 39).

•Anytime

Press the Menu key , then choose Spirometry Settings > Calibration Settings > Calibrate Spirometer.

Figure 9. “Spirometer Calibration” Initial Screen

9:17AM Oct 16 08

Spirometer Calibration

Transducer Lot Code: 2 Transducer Cal Code: WKKVDXPB7 Syringe Volume (L): 3.000 Temperature (F): 77.00 Humidity (%): 50.00 Pressure (mmHg): 759.06

Last Calibration: 10/15/2005 3:8:39 PM Volumes in/ex (L): -3.000/3.000

Enter the current settings, and then press calibrate.

Verif y

Calibration

Calibrate

1Flow

Calibrate

3 Flows

2. Fill in all fields.

• Transducer lot and “cal” codes appear on the transducer package label, as shown in Figure 10.

• For the syringe volume, see the sticker on the calibration syringe.

• Update the temperature, humidity, 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.

Note

To learn how to change the pressure units, see page 12.

Page 29

Directions for Use Chapter 3 Calibrating the Spirometer 25

Figure 10. Calibration Code on Flow Transducer Package Label

0050

200x-xx

Transducer

REF 703419

Disposable Flow Transducers

“cal” code

CALIBRATION CODE WKKVDXPB7

LOT

Lot code

QTY 100

4341 State Street Road Skaneateles Falls, NY 13153 USA www. welchallyn.com

Drawing No. 30015257 VER. F

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 date that prints on reports will be the last calibration date, not the verification date.

• Calibrate 1 Flow

To calibrate the system using one inhale/exhale cycle.

• Calibrate 3 Flows

To calibrate the system using three inhale/exhale cycles at three different rates.

The “attach flow transducer” prompt appears, as shown in Figure 11.

Figure 11. “Attach Flow Transducer” Prompt

Spirometer Calibration

9:17AM Oct 16 08

Attach the flow transducer

to the syringe,

Pull the plunger out,

Then select continue

BackContinue

At any time, you can press Back to return to the initial calibration screen, as shown in

Figure 9 on page 24.

Page 30

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 tight seal.

Figure 12. Calibration Syringe

Plunger

Port

6. Pull the plunger all the way out.

7. P r e s s Continue.

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 transducer. Place your hand on top of the syringe to prevent movement.

8. Press Start.

9. When the blue bar begins to move, push the plunger all the way in, then pull it all the way out, carefully following the bar’s rate. Use a steady motion in both directions. See

Figure 13.

Figure 13. Simulated Exhalation and Inhalation

Spirometer Calibration

Push plunger in following the bar

Tar g e t Rat e

9:17AM Oct 16 08

Stop

Spirometer Calibration

9:17AM Oct 16 08

Pull plunger out following the bar

Tar get R ate

Stop

Page 31

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.

Otherwise, when no air has moved for three seconds, the following happens:

• For verifications or single-flow calibrations

The results display.

• For multiple-flow calibrations

Another simulated exhalation screen appears. Repeat from Step 8 twice more. The results display.

10. Review your results.

Check the error percentages for the expired and inspired volumes. Both/all must be less than ±3% for your calibration to be acceptable. For single-flow calibrations, the measured and adjusted curves should match. See the following examples.

Figure 14. Single-Flow, Poor Results Figure 15. Single-Flow, Good Results

9:17AM Oct 16 08

Calibration Results

Time (s )

Syringe Volume: 2.998 L Expired Volume: 2.834 L (-5.5%) Inspired 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

Vol (L)

AcceptRetry Exit

Errors > ± 3%. Curves do not match. Calibration is not acceptable.

Calibration Results

Vol ( L)

Time ( s)

Both errors < ± 3%. Curves match. Calibration is acceptable.

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-Gain: 0.99

Legend Measured Adjusted

AcceptRetry Exit

Figure 16. Multiple-Flow, Poor Results Figure 17. Multiple-Flow, Good Results

Calibration Failed

Vol (L)

Time (s )

9:17AM Oct 16 08

Syringe Volume: 2.998 L

Expired Volume

0.5 L/s: 2.83 (-5.8%)

1.0 L/s: 2.98 (-0.7%)

3.0 L/s: 2.81 (-6.2%)

Temperature: 74.0 F Humidity: 57.0 % Pressure: 739.4 mmHg

I-Gain: 1.22 E-Gain: 1.06

Legend Measured Adjusted

Calibration Results

Vol ( L)

Time ( s)

9:17AM Oct 16 08

Syringe Volume: 2.998 L

Expired Volume

0.5 L/s: 3.05 (1.6%)

1.0 L/s: 2.98 (-0.6%)

3.0 L/s: 3.05 (1.6%)

Temperature: 74.0 F Humidity: 57.0 % Pressure: 739.4 mmHg

I-Gain: 1.19 E-Gain: 1.02

Legend Measured Adjusted

Retry Exit

Errors > ± 3%. Calibration is not acceptable.

Retry Exit

All errors < ± 3%. Calibration is acceptable.

Page 32

28 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 and Figure 16) indicates that the system had to make large adjustments to measure the syringe volume accurately. Do not accept poor calibrations, or your spirometry test results may be inaccurate.

• Retry

Discards the results; the calibration data is not saved. Returns to initial calibration screen. Go to Step 2 on page 24. (If you keep retrying and cannot get good results, press Accept, and then calibrate all over again from Step 1 on page 24.)

• Accept

Saves the results. Resumes your original procedure.

If automatic report printing is enabled, a calibration report prints. To learn how to enable or disable automatic printing, see “Reviewing the Calibration Settings” on page 15.

•Exit

Discards the results. Resumes your original procedure.

12. (Optional) Verify the most recent calibration — especially if your calibration results were questionable.

a. Go back to Step 1 on page 24.

b. Select Verify Calibration in Step 3.

c. On your results screen, check the error percentages for the expired and inspired

volumes. Both/all must be less than ±3% for your calibration to be acceptable.

d. Press the appropriate softkey: Retry (to recalibrate) or Done (if acceptable).

Calibration Verification Successful

Vol ( L)

Syringe Volume: 3.00 L Expired Volume: 2.976 L (-0.8%) Inspired Volume: -2.989 L (-0.4%)

Temperature: 74.0 F Humidity: 57.0 % Pressure: 739.4 mmHg

I-Gain: 1.17 E-Gain: 0.99

Legend Measured Adjusted

Time ( s)

Retry Done

Both errors < ± 3%. Calibration is acceptable.

Page 33

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. 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

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

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” on page 34.

A single test comprises a set of efforts — up to 6 efforts of each type (FVC and SVC) for a maximum of 12 efforts (6 FVC and 6 SVC). The 6 efforts of a given type can be a mixture of pre- and post-medication efforts.

For details, see “About Pre- and Post-Testing” on page 36 and “About Effort

Replacement” on page 36.

Figure 18. Spirometry Testing Process Diagram

For step-by-step procedure, see

“Recording a Test” on page 39.

Yes

Enter or search

for patient data.

Choose effort type:

FVC, SVC, FVC-Post, SVC-Post

Perform effort.

Accept effort?

Yes

Another effort?

Yes

Uninterrupted for

< 20 min.?

Test Done

(Optional) Calibrate.

Prompted once daily.

For step-by-step procedure,

see “Working With a

Completed Test” on page 43.

(Optional)

Review test.

Add or edit interpretation.

Send or print test.

Another test?

Yes

Page 37

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 effort, you coach the patient through these steps. (If preferred, you may reverse the order of inhaling and exhaling.)

1. Inhale fully — calmly fill your lungs as much as you can.

2. Place the flow transducer in your mouth.

3. Exhale forcefully — as fast as you can, as long as you can.

4. (Optional) Inhale forcefully — as fast as you can, as long as you can.

For details, see “Preparing the Patient” on page 38.

You can view and print FVC data in three types of curves, as shown in the following figures.

Figure 19. FVC Flow/Volume Curves

Flow (L/s)

Exhaling only

Vol (L)

Figure 20. FVC Tidal Volume Curve

Flow (L/s)

All data from all breaths, including tidal breathing (multiple loops)

Vol ( L)

Figure 21. FVC Volume/Time Curves

Vol (L )

Exhaling only

Flow (L/s)

Exhaling and inhaling (single loop)

Vol (L )

Vol (L)

Exhaling and inhaling

Time (s)

Page 38

34 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option

During FVC testing, an animated incentive screen provides an alternative way to view the data (Figure 22). This screen gives patients, usually children, a fun goal to achieve while exhaling. (If the selected norm does not provide a valid FVC or PEF predicted value, the system tries to use the Polgar norm; if Polgar does not fit the patient’s demographics, the incentive screen is not available.)

Figure 22. FVC Incentive Screen

The more forcefully the patient blows, the more flames are extinguished.

About SVC Efforts

“SVC” stands for slow (relaxed) vital capacity. Sometimes SVC testing is used when forced breathing is impossible. The patient inhales and exhales as completely as possible, as in FVC testing, but the breathing is not forced. The goal of an SVC effort is to measure the volume of air inhaled and exhaled, not the air flow (speed).

When ready to begin an SVC effort, you coach the patient through these steps. (If preferred, you may reverse the order of inhaling and exhaling.)

1. Place the flow transducer in your mouth.

2. Breathe normally several times (tidal breathing).

3. Inhale fully — calmly fill your lungs as much as you can.

4. Exhale fully — calmly empty your lungs as much as you can.

The parameters measured during SVC testing are always displayed in a volume/time curve, as shown in Figure 23.

Figure 23. SVC Curve

Vol ( L)

Time (s)

Tidal breathing

Page 39

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 lung problems are FVC and FEV1. (For a description of how the automatic interpretation software uses these two measurements to determine the degree of obstruction or restriction, see

“Understanding Your Interpretation 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

The following are important parameters for SVC testing:

• VT — tidal volume

• ERV — expiratory reserve volume

• IC — inspiratory capacity

Page 40

36 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option

About Pre- and Post-Testing

If desired, a spirometry test may include both pre- and post-efforts (FVC or SVC) to measure the effectiveness of medication. The “before medication” and “after medication” efforts may be uninterrupted or interrupted.

• Uninterrupted

If there is no interruption between pre- and post-efforts (that is, no other patient has been tested and the electrocardiograph has remained on), the same screen continues to display. You simply continue with the procedure.

• Interrupted

If there is an interruption (that is, another patient has been tested or the electrocardiograph has been turned off), you need to recall the patient’s test-inprogress before continuing.

Pre- and post-efforts must happen on the same day, with the same calibration.

ote

The next day — or after a recalibration — tests become available for review only; you can no longer add efforts to them.

About Effort Replacement

You can save up to 6 FVC and 6 SVC efforts per test (maximum total of 12 efforts). After saving 6 efforts of a given type, the software compares each new effort with the saved efforts. If the new effort is better than the worst saved effort, the worst effort is deleted and the new one is saved. If the new effort is worse than all saved efforts, you are asked whether you want to save it.

If 6 pre-efforts have been saved, the worst pre-effort is deleted when you add a post-effort until you have saved 3 pre- and 3 post-efforts. After that, the “worst” post-effort is deleted.

Page 41

Directions for Use Chapter 4 Performing Spirometry Tests 37

Connecting the Spirometer Components

WARNING To prevent the spread of infection, use a new flow transducer for each patient. Use rubber gloves when replacing used flow transducers, and wash hands after touching them. Discard flow transducers after a single patient use.

1. Verify that the sensor and pressure tubing are clean and undamaged. Look for signs of deterioration, including but not limited to cracks, cuts, discoloration, or oxidation.

If any part exhibits any of these symptoms, replace it. See “Ordering Information for

Replacement Parts” on page 9.

2. Attach a flow transducer to the pressure tubing. See Figure 24.

3. Attach a sensor to the other end of the pressure tubing. See Figure 25.

4. Connect the sensor to the electrocardiograph’s spirometry port. Hand-tighten the sensor connectors. Do not overtighten the connectors, or they may become stripped. See Figure 26.

The CP 200 software automatically activates the spirometry functions throughout the software.

Bacteria filters are unnecessary.

ote

Figure 24. Attaching a Flow Transducer to the Pressure Tubing

Figure 26. Connecting the Sensor to the Spirometry Port

Figure 25. Attaching the Sensor to the Pressure Tubing

Page 42

38 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option

Preparing the Patient

To prepare patients for any spirometry test, explain the entire procedure for the type of effort you want them to perform. Remind patients that the test is painless. Demonstrate at least one effort for the patient.

The accuracy of a spirometry test is highly dependent on the patient's understanding and cooperation. So, be prepared to coach and encourage the patient with your “body language” and your words — for example, ”Blow, blow, blow, keep blowing until you can't blow any more out” — to ensure a good effort with reproducible results.

Instruct patients to do the following:

• Loosen any tight articles of clothing that might constrict lung function, for example, a tight belt, tie, vest, bra, girdle, or corset.

• Remove any foreign objects from the mouth, including loose dentures.

• Use of a nose clip is optional. Patients may also pinch their noses.

• Place your lips and teeth around a new transducer, sealing their lips tightly around the transducer. Grip slightly with your teeth in the groove. If you need to hold 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 prediction value very high (as much as 200% or 300%), and you will need to discard the data.

• Avoid bending forward as you blow. This also creates back-pressure.

• Keep your tongue away from the flow transducer to avoid blocking it.

• Keep your chin up so as not to restrict the airway.

WARNING Patients may become faint, light-headed, dizzy, or short of breath during spirometry testing. Watch patients closely. If they choose to stand during testing, keep a chair immediately behind them. If there is any reason for concern, stop the test and take proper action.

WARNING Patients should not bite on the flow transducer. Biting could result in sharp edges, which could injure the mouth.

Page 43

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.

If the patient has obvious spinal deformities, measure the arm span from

ote

fingertip to fingertip with arms outstretched against a wall. Enter the arm span instead of height.

2. If the patient’s demographics do not match the current spirometry norm, select a more appropriate norm.

To find out how, see “Select Adult Predictive Norm” on page 13 or “Select Ped.

Predictive Norm” on 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

Enter New Patient

Patient ID Last Name Birth Date Height Gender Race Smoke Years

Use up and down arrows to change fields

Search Schedule

ft. in.

yr.

Clear

9:17AM Oct 16 08

MM / DD / YYYY

Done

To learn how to choose which fields display here, see “Reviewing the Patient Data Fields

Available” on page 19.

Page 44

40 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option

5. Enter patient data, or recall saved patient data.

a. To recall saved patient data

Press Search or Schedule, and select the patient. (For details, see CP 200 electrocardiograph manual.) Then press the desired softkey, as described here.

Softkey Function Your Next Action

New Test Returns to the “Enter New Patient” screen. Most of the

patient’s data is automatically filled in. Some data fields — medications, blood pressure, comments, history, height, weight — will be blank because this information varies over time.

Continue Test Lets you continue a test-in-progress. This softkey appears

only if it is the same day and the calibration is the same.

Review Test Lets you recall any of that patient’s saved tests and review

its data. You cannot add new efforts, but you can edit the interpretation, send the test to a memory card or workstation, or print the test.

Go to Step b, below.

Go to Step 6 on page 41.

Go to “Working With a

Completed Test” on page 43.

b. To enter patient data

Fill in the fields. All mandatory fields must be filled in before you can proceed.

Important Fields Description

Patient ID, Last Name

Age/Birth Date, Height, Gender, Race

Always mandatory. The patient must be identified.

Always mandatory. This information determines the automatic interpretation.

Weight Mandatory only when using Schoenberg or Hedenström norm.

Smoke Years Not mandatory. If the patient smokes, enter the number of years the patient

has smoked. If this value is 1 or more for an adult patient, and if patient education is enabled, the smoking help sheet prints after the spirometry test report. See “Patient Help Sheets” on page 61.

When finished entering data, press the desired softkey:

• Clear — deletes the patient data and returns to the Patient ID field.

• Done — accepts the patient data and goes to the initial spirometry screen.

Page 45

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 of the same type.)

7. (FVC testing only) Press Curve as needed to select the curve type that you want to view while testing. See Figure 28.

•Flow/Volume

• Volume/Time

• Tidal Volume

•Incentive

Figure 28. Spirometry Screen, Ready to Start Effort

SVC exampleFVC example (flow/vol curve)

Doe, Jane

FVC #1

Flow (L/s)

Effort Type

FVC

Curve

Flow/Vol

NHANES III 1999 ATS: --

FVC 2.09 -- -FEV1 3.06 -- -FEV1% 80.86 -- -FEV6 3.75 -- -PEF 7.14 -- -FEF25-75 3.00 -- -FEV0.5 2.31 -- -FEV2 -- -- --

Vol ( L)

9:17AM Oct 16 08

Pred Value %Pr ed

Start

Te st

Done

Doe, Jane

SVC #1

Vol ( L)

Select the desired effort type.Select the desired effort type and curve.

Effort Type

SVC

9:17AM Oct 16 08

SVC -ERV -IRV -VT -BF -Tin/Tex --

5 Time (s)

Star t

Valu e

Te st

Done

To learn how to change the default FVC curve type and parameters, see

ote

“Reviewing the Spirometry Screen Settings” on page 16.

8. When ready, press Start.

9. Coach the patient through the effort. 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).

Page 46

42 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option

Figure 29. “Effort Complete” Screen

SVC exampleFVC example (flow/vol curve)

Doe, Jane

FVC #1

Flow (L/s)

NHANES III 1999 ATS : - -

FVC 2.09 3.62 173.5 0 FEV1 3.06 3.08 100.46 FEV1% 80.86 85.01 105.14 FEV6 3.75 0.00 0.00 PEF 7.14 7.18 100.66 FEF25-75 3.00 3.29 1 09.81 FEV0.5 2.31 2.32 100.32 FEV2 -- 3.50 --

Vol ( L)

9:17AM Oct 16 08

Pred Value %Pred

Doe, Jane

SVC #1

Vol ( L)

15 20

9:17AM Oct 16 08

SVC 3.31 ERV 1.35 IRV 1.30 VT 0.66 BF 24.73 Tin/Tex 88.60

Time (s)

Val ue

Curve

Flow/Vol

Effort

Reject

Effort

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 100%.

11. Review the data.

For FVC tests, if desired, press Curve to alternate between curve types.

Decide whether to accept the effort. For help deciding, see the Spirometry Effort Acceptability & Reproducibility poster.

After each effort, a quality message appears on this screen, such as “Don’t

ote

hesitate,” “Blow out longer,” or “Good effort.” For details, see “About Effort-

Quality Messages” on page 72.

12. Press the desired softkey.

• Accept Effort

Saves the effort. See “About Effort Replacement” on page 36.

Reject

Effort

• Reject Effort

Deletes the effort.

In either case, the “ready to start effort” screen reappears (Figure 28 on page 41).

The effort numbers increment with each new effort (FVC #1 becomes FVC

ote

#2, and so on), even if some efforts were deleted, so the test record indicates the patient’s total number of efforts.

13. Determine your next step.

• If you want to perform another effort, go to Step 6 on page 41.

• If you are finished with this test, press Te s t Do n e.

Page 47

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 to recall a saved test for review (Step 5 on page 40).

Figure 30. “Test Results” Main Screen

FVC example (vol/time curve)

Doe, Jane

Test Results

Vol ( L)

9:17AM Oct 16 08

Legend

Time ( s)

All FVC curves, including any pre- and post-efforts, are displayed on one graph. Any SVC curves are

displayed in a separate graph.

Effort Type

FVC

View

Results

Add/Edit

Interps

Send

Te st

Print Te st

You are now ready to work with the completed test. Press the desired softkeys:

Softkey Function

Effort Type Alternates between FVC and SVC efforts, if applicable.

View Results See “To View a Test’s Results” on page 44.

Add/Edit Interp See “To Change a Test’s Interpretation Statements” on page 45.

Send Test See “To Send a Test to a Memory Card or Workstation” on page 46.

Print Test See “To Print a Test” on page 47.

When finished, determine what to do next.

• Press to start another test for this patient or another patient.

Go to Step 3 on page 39.

• Press to exit spirometry mode.

Page 48

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. P r e s s View Results.

The display stays the same. Only the softkeys change, as shown here.

Figure 31. “View Results” Screen

FVC example (vol/time curve)

Doe, Jane

View Results

Vol ( L)

Test C o m p l e t e

Effort Type

FVC

Curve

Vol/Ti me

View

Val ues

9:17AM Oct 16 08

Legend

Time ( s)

View

Interp

Back

2. Press the desired softkeys to view the results in various ways.

Softkey Function Your Next Action

Effort Type Alternates between FVC and SVC efforts, if

applicable.

Curve Alternates between FVC curve types. Press the next desired softkey.

View Values Opens a window containing all of the measured and

calculated parameters across all saved efforts — 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.

View Interp Opens a window containing the interpretation

statements that have been saved with the test.

A test-quality grade appears too. For details, see

“About Test-Quality Grades” on page 73.

Back Returns to the Test Results main screen, as shown in

Figure 30 on page 43.

Press the next desired softkey.

Press or to close the values window.

Press the next desired softkey.

Press or to close the interpretation window.

Press the next desired softkey.

Return to “Working With a Completed

Tes t” on page 43.

Page 49

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. P r e s s Add/Edit Interps.

The following screen appears, displaying any interpretation statements that have been saved with the test.

Figure 32. “Add/Edit Interpretations” Screen

Doe, Jane

Test Results

Interpretation #1:

Interpretation #2:

Interpretation #3:

Interpretation #4:

Add/Edit Interpretations

Cancel = Save =

9:17AM Oct 16 08

Press a right arrow key to see a list of interpretation statements that are available to choose for the highlighted field.

2. Add or edit interpretation statements as desired.

Each test may include up to four statements — either automatically included, or manually added, or a combination. If automatic statements appear, you may replace them with manual statements if you wish.

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 determines the degree of obstruction or restriction, see “Understanding Your Interpretation Results” on page 74.

Page 50

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. P r e s s Send Test.

The following screen appears.

Figure 33. “Send Test” Screen

Doe, Jane

Send Test

Vol ( L)

9:17AM Oct 16 08

Legend

Time (s )

Select a destination to begin sending.

Memory

Card

Workstation

Done

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.

Page 51

Directions for Use Chapter 4 Performing Spirometry Tests 47

To Pr in t a Te s t

From the Test Results main screen (Figure 30 on page 43), follow these steps:

1. P r e s s Print Test.

The following screen appears.

Figure 34. “Print Test” Screen

Doe, Jane

Print Test

Vol ( L)

Press Print to generate a report

Efforts

Best Only

Curve

Vol/ Tim e

9:17AM Oct 16 08

Legend

Time (s )

Back

2. Press the desired softkeys.

Softkey Function Related Information

Efforts Cycles through these print options:

• Best Only

Prints only the best effort of each type that was saved — best FVC, SVC, FVCpre, FVC-post.

• 3 Best

Prints the three best efforts of each type that was saved.

To change the default option, see “Reviewing

the Spirometry Print Settings” on page 17.

To change the definition of best, see “Select

Best Effort Formula” on page 13.

• All

Prints all efforts.

Curve Cycles through the curve types that are

available to print:

To change the default curve type for printed reports, see “Reviewing the Spirometry Print

Settings” on page 17.

•Vol/Time

•Flow/Vol

• Tidal Vol

• V/T and F/V

•None

Print Prints one copy of the test. Press Print again for additional copies.

FVC and SVC efforts print in separate reports.

If “patient education” is enabled in the settings, one or more patient help sheets automatically print along with the test. For details, see

“Patient Help Sheets” on page 61.

Back Returns to the Test Results main screen. See Figure 30 on page 43.

Page 52

48 Chapter 4 Performing Spirometry Tests Welch Allyn CP 200 Spirometry Option

Page 53

Troubleshooting

Problem-Solving Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Service Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Page 54

50 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 ii.

Condition Causes Actions

When printing, text prints correctly but FVC curve does not.

Unable to calibrate. • Poor connection between flow

No sensor detected. Poor connection between the sensor and

Does not print. • Out of paper.

Values are too high (intermittent). • Patient’s fingers obstructed the screen

Values are too high (consistently). Pressure connection is partially obstructed. Remove any foreign substance from the flow

Predictive values are blank. • The selected norm does not support

Print settings Make sure that the desired curve is selected. See “To

Print a Test” on page 47.

transducer and sensor.

• Damage to flow transducer.

• Leak during calibration.

• Uneven calibration strokes.

the electrocardiograph.

• Paper jam.

on the back 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.

certain values, and composite norm values are disabled.

• Check the connection between flow transducer and sensor.

• Replace the flow transducer if it is damaged.

• Ensure that the connection between the calibration syringe and flow transducer is tight with no leaks.

• Use even strokes in calibration.

Disconnect and reconnect the sensor.

• Load paper. See the electrocardiograph manual.

• If paper is jammed, clear it, then reload.

• Retest.

• Recalibrate with a 3-liter syringe. See

“Calibrating the Spirometer” on page 21.

transducer or pressure tubing.

• Re-enter age/birthdate, height, gender, race. See Step b on page 40.

• Enable composite norm values. See “Reviewing

the Operation Settings” on page 13.

The flow sensor has been dropped. Accident. Recalibrate. See “Calibrating the Spirometer” on

page 21.

Report does not print parameters or graphs.

Patient test values differ from values expected by physician.

Improper print settings. Check print settings. See “Reviewing the Spirometry

Print Settings” on page 17.

Various. • If the transducer is contaminated with sputum or

secretions, replace it.

• Verify that proper barometric pressure has been entered. See “Calibrating the Spirometer” on page 21.

• Verify the patient data.

• Eliminate any leaks in the pressure tubing.

• Retest using a nose clip.

• Replace the sensor if damaged.

•Recalibrate.

• Replace the transducer and retest.

Add index entries for each error message, verbatim.

Page 55

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 days

• Sensor — 12 months

• Calibration syringe — 12 months

Service Policy

For general information on the service policy, see electrocardiograph manual.

The following spirometry components have specific service policies. For disposable items, see “Ordering Information for Replacement Parts” on page 9.

• Flow transducer — Disposable.

• Pressure tubing — Disposable.

• Sensor — Return to Welch Allyn for replacement if necessary. Replacement is free

within the warranty period.

• Syringe — Return to Welch Allyn for calibration verification if necessary. Recalibration

is free within the warranty period. Beyond the warranty period, return to the manufacturer:

AM Systems, Inc. 131 Business Park Loop Carlsborg, WA 98324 (800) 426-1306

Page 56

52 Chapter 5 Troubleshooting Welch Allyn CP 200 Spirometry Option

Page 57

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 Pneumotach

Power equipment Powered by CP200 electrocardiograph via serial port (no battery)

Power consumption 5 to 15 mA

Accuracy Compliant with ATS/ERS 2005 guidelines.

Reproducibility Compliant with ATS/ERS 2005 guidelines.

Flow range 0–14 L/s

Predictive norms

Adult Berglund 1963, Crapo 1981, ECCS / Quanjer 1993, Falaschetti 2004, Forche II, Gore 1995,

Pediatric Berglund 1963, Dockery 1983, Forche II, Hibbert 1989, Hsu 1979, Knudson 1976, Knudson

Interpretation 1991 ATS interpretation standards.

Reports

FVC testing Volume/time curve

SVC testing Volume/time curve

Gulsvik 2001, Hedenström 1986, Knudson 1976, Knudson 1983, Kory 1961, Morris 1971, NHANES III 1999, Paoletti 1986, Roca 1986, Schoenberg 1978, Viljanen 1981

1983, Koillinen 1998, NHANES III 1999, Paoletti 1986, Polgar 1971, Schoenberg 1978, Solymar 1980, Wang 1993, Zapletal 1969

Lung age calculation can be enabled or disabled. Automatic interpretation can be enabled or disabled. User-definable interpretation statements are also available to be added manually.

Flow/volume curve Tidal volume Both volume/time and displayed curves No curves

No curve

Page 58

54 Appendix A Specifications Welch Allyn CP 200 Spirometry Option

Feature (continued) Specification (continued)

Parameters

FVC testing FVC, FIVC, FIV1, FIV1%, FEV0.5, FEV1, FEV2, FEV3, FEV5, FEV6, FEV1/FEV6, FEV0.5%, FEV1%,

FEV2%, FEV3%, FEV5%, FEV6%, PEF, FEF25, FEF50, FEF75, FEF0.2-1.2, FEF25-75, FEF75-85, PIF, FIF50, FEF50/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.

Protection against ingress of water, per IEC 60529 (spirometry components)

Protocols PCP (primary care practitioner)

Specifications are subject to change without notice.

IPX0

NIOSH OSHA SSD (Social Security & Disability) None

Page 59

Spirometry Protocols

About the PCP Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

About the NIOSH Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

About the OSHA / Cotton Dust Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

About the SSD Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

This appendix describes the protocols you can select to change the way the CP 200 spirometer operates when testing a patient. Any features that are not specified in the protocol use your own settings.

When a protocol is selected, its settings become uneditable to avoid confusion during setup.

To learn how to review or change the protocol, see “Select Protocol” on page 13.

Page 60

56 Appendix B Spirometry Protocols Welch Allyn CP 200 Spirometry Option

About the PCP Protocol

The PCP (primary care practitioner) protocol is for users who want to make sure that testing meets the requirement of the National Lung Health Education Program (NLHEP). When the PCP protocol is selected, the spirometer automatically performs as described here, regardless of user-defined settings.

For details on PCP requirements, see the document noted in Reference 1 on page 75.

When this protocol is selected, testing and reports are affected as follows:

• Operation Settings

Adult Predictive Norm: NHANES III Ped. Predictive Norm: NHANES III Best Effort Formula: Best Measurement Reversibility Formula: (Post-Pre)/Pre x 100 FEV1% Formula: FEV6 Predictive Points: YES Predictive Curve: YES ATS Interpretation Results: YES Composite Norm Value: NO Automatic Quality Check: NO

(For details, see “Reviewing the Operation Settings” on page 13.)

• Screen Settings

FVC Display Parameters: FEV1, FEV6, and FEV1/FEV6 only

(For details, see “Reviewing the Spirometry Screen Settings” on page 16.)

• Print Settings

Efforts: Only Best Effort FVC Curves: V/T & F/V FVC Print Parameters: FEV1, FEV6, and FEV1/FEV6 only Scale: Auto & 10 mm/L Print Lung Age: YES Print “Unconfirmed Report”: YES Print “Reviewed By”: YES Print “Patient Cooperation”: YES Print Quality Grades: YES Print Patient Education: YES Auto Print: YES

(For details, see “Reviewing the Spirometry Print Settings” on page 17.)

Page 61

Directions for Use Appendix B Spirometry Protocols 57

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.

If the pre or post quality grades are D or F, interpretation states “results should be interpreted with caution.”

If the pre or post quality grade is D and the results are within normal limits, the interpretation states, “normal, but the reported FEV1 and FVC should not be used for comparisons with previous or subsequent tests.”

Interpretation states “airway obstruction” when the FEV1/FEV6 is below the LLN.

Interpretation states “low vital capacity, perhaps due to restriction of lung volumes” if FEV1/ FEV6 is above the LLN, but the FEV6 is below the LLN.

Note

When PCP protocol is selected, no inspiration is recorded.

Page 62

58 Appendix B Spirometry Protocols Welch Allyn CP 200 Spirometry Option

About the NIOSH Protocol

The NIOSH (National Institute for Occupational Safety and Health, U.S.) protocol is for users who want to make sure that occupational testing and reports meet the requirements of NIOSH. The device automatically performs as described here, regardless of user-defined settings.

When using this protocol, the spirometer should be calibrated at three different flows every day before use.

For details on NIOSH requirements, see the document noted in Reference 4 on page 75.

When this protocol is selected, testing and reports are affected as follows:

• 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 “Reviewing the Operation Settings” on page 13.)

• Print Settings

Tests: Three Best Efforts Scale: 20 mm/s & 10 mm/L Curves: V/T & F/V Auto Print: YES

(For details, see “Reviewing the Spirometry Print Settings” on page 17.)

• Calibration Settings

Auto Calibration Report: Yes

(For details, see “Reviewing the Calibration Settings” on page 15.)

Page 63

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 standard. The device automatically performs as described here, regardless of user-defined settings.

When using this protocol, the spirometer should be calibrated at three different flows every day before use.

For details on 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 Race Adjustment logic.)

Composite Norm Values: NO

(For details, see “Reviewing the Operation Settings” on page 13.)

• Print Settings

Tests: Three Best Efforts Scale: 20mm/s & 10mm/L Curves: V/T & F/V

(For details, see “Reviewing the Spirometry Print Settings” on page 17.)

Page 64

60 Appendix B Spirometry Protocols Welch Allyn CP 200 Spirometry Option

About the SSD Protocol

The SSD (Social Security Disability) protocol is for users who want to make sure that testing associated with disability determinations meet the requirement of the Social Security Administration. The device automatically performs as described here, regardless of user-defined settings.

For details on SSD requirements, see the document noted in Reference 2 on page 75.

When this protocol is selected, testing and reports are affected as follows:

• Calibration Settings

Auto Calibration Report: Yes

(For details, see “Reviewing the Calibration Settings” on page 15.)

• Print Settings

Tests: Three Best Efforts Scale: 20mm/s & 10mm/L Curves: V/T & F/V

(For details, see “Reviewing the Spirometry Print Settings” on page 17.)

• Calibrations must be presented in a volume-time format at a speed of at least 20 mm/ sec and a volume excursion of at least 10 mm/L to permit independent evaluation.

• Two of the satisfactory efforts should 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, whichever is greater.

• An effort is satisfactory for measurement of the FVC if maximal expiratory effort continues for at least 6 seconds.

• The device should accurately measure time and volume, the latter to within +/- 1% of a 3 L calibrating volume.

• The testing device must have had a recorded calibration performed previously on the day of the measurement.

• The linearity of the device must be documented by recording volume calibrations at three different flow rates of approximately 3 L/6 sec, 3 L/3 sec, and 3 L/sec.

• These calibrations may be exhale-only since no inhale parameters are reported.

• Whenever the test report is printed, the calibration report shall also be printed.

• If the calibration accuracy is between 1% and 3%, the electrocardiograph applies correction factors to the recorded FVC and FEV1.

Page 65

Patient Help Sheets

About the Patient Help Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Adult Smokers Help Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Asthma Symptoms Help Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Page 66

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:

• Adult Smokers

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

Sheet” on page 63.

•Asthma Symptoms

If “patient education” is enabled, the Asthma Symptoms sheet prints automatically for all patients whenever you print a test. For example, see “Asthma Symptoms Help

Sheet” on page 64.

These help sheets print only if “patient education” is enabled in the settings. To learn how to enable “patient education,” see “Reviewing the Spirometry Print Settings” on page 17.

The patient's name, FEV1%, and date print automatically on both sheets. If “ATS Interpretation” is enabled, the appropriate recommendation is also marked. To learn how to enable “ATS Interpretation,” see “Reviewing the Operation Settings” on page 13.

Note

If no recommendation is marked, the doctor must mark one.

1. Both help sheets come from a booklet entitled Simple Office Spirometry for Primary Care Practitioners, by Thomas L. Petty, MD, and Paul L. Enright, MD. This booklet can be downloaded from the National Lung Health Education Program (NLHEP) home page: www.nlhep.org/resources.html.

Page 67

Directions for Use Appendix C Patient Help Sheets 63

Adult Smokers Help Sheet

Name _________________________

What Your Lung Function Results Mean For Adult Smokers

You have just performed Spirometry, the basic test of how well your lungs are working. The results indicate whether you have developed chronic obstructive pulmonary disease (COPD) due to smoking. COPD occurs in about one of every five smokers after more than 20 years of smoking. COPD slowly “eats away” at the lung's reserves. Affected smokers are often unaware of lung disease until more than half of their lung function has been lost. Spirometry testing can detect COPD many years before symptoms occur.

___ Your test result was within the normal range. You do not appear to be developing COPD. However, as a smoker, you remain at high risk of developing a heart attack, stroke, and/or lung cancer. Call the number at the bottom of this page for help with smoking cessation.

___ Your test result shows mild airways obstruction, suggesting that you are a “susceptible smoker” who already shows signs of early COPD. You are unable to blow out air as quickly as normal (your FEV1/FVC is low). If you continue smoking, you will eventually develop disabling lung disease (in about 10-20 years). If you are able to successfully quit smoking sometime soon, your lung function may return to normal levels and you will probably never develop symptoms of COPD. Call the number at the bottom of this page if you would like information about local resources to help you quit smoking.

___ Your test result shows moderate-to-severe airways obstruction. You have COPD. If you continue smoking, your lung disease will certainly get worse and you will eventually become short of breath while walking, climbing stairs, or doing other exercise. It is very important that you seek help to stop smoking. If you are able to successfully quit smoking sometime soon, you will probably regain a little lung function within three months, and the abnormally rapid decline in your lung function which you have experienced due to smoking will be stopped. Call the number at the bottom of this page for information about local resources to help you quit smoking.

___ Your test shows a low forced vital capacity (FVC). Your FVC is the total amount of air that you exhaled, in liters (similar to quarts). Values below about 80% are abnormally low and suggest that you are unable to inhale or exhale as much air as most healthy persons of your age, height, gender, and race. Obesity may be one of the causes of a mildly decreased FVC, and pneumonia is another. Consider asking your physician to review this report at some time during the next couple of months.

Your result: ______________ FEV1 % predicted

For more information contact:

____________________

Date

Page 68

64 Appendix C Patient Help Sheets Welch Allyn CP 200 Spirometry Option

Asthma Symptoms Help Sheet

Name _________________________

What Your Lung Function Results Mean For Those With Symptoms Suggesting Asthma

You have just performed Spirometry, the basic test of how well your lungs are working. The results may indicate whether you have asthma and its severity.

___ Your test was within the normal range. If you recently had symptoms such as episodes of shortness of breath with wheezing, chest tightness, or cough, you may have asthma, but your lung function is normal today. Consider visiting a physician when you again have asthma symptoms and then repeat this Spirometry test. If you already know that you have asthma, it is in good control.

___ Your breathing test shows mild airways obstruction (some narrowing of your breathing tubes). You are currently unable to blow out air quickly. This result may indicate asthma that is not well controlled. Discuss with your physician medications to better control your asthma.

___ Your breathing test shows moderate-to-severe airways obstruction (narrowing of your breathing tubes). You are currently unable to blow out air quickly. This result usually indicates asthma that is poorly controlled. Discuss with your physician very soon the use of medications that will help to better control your asthma and the value of peak flow monitoring.

___ Your test shows a low forced vital capacity (FVC). Your FVC is the total amount of air that you exhaled, in liters (similar to quarts). Values below about 80% are abnormally low and suggest that you are unable to inhale or exhale as much air as most healthy persons of your age, height, gender, and race. Obesity may be one of the causes of a mildly decreased FVC, and pneumonia is another. Consider asking a physician to review this report at some time during the next couple of months.

Your result: ______________ FEV1 % predicted

Your peak flow after inhaling a bronchodilator was ______ L/s (liters per second). You can compare this value to the peak flow that you measure using your own peak flow meter. The two numbers should match within 1 L/s. If your asthma is currently in good control, today's value may be close to your best peak flow reading at home.

_______________________

Date

Page 69

Predictive Norms, etc.

Norm Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

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.)

Berglund 1963 (be)

Crapo 1981 (cr) X X X X X X X X X No

Dockery 1983 (do)

ECCS/Quanjer 1993 (qu)

Falaschetti 2004 (fa)

Forche II (fo) X X X X X X X X X 5–17 18–90 X

Gore 1995 (go) X X X X X X X No 18–78 X

Gulsvik 2001 (gu) X X X X X X X No

FVC

FEV1

FEV1%

FEV0.5

FEV3

FEV3/FVC

FEV6

FEV1/FEV6

PEF

FEF25-75

FEF75

FEF50

FEF25

FEF0.2-1.2

FEV0.5%

Male

Female

Pediatric

Adult

XXX X X ≥ 7 ≤ 70 X

M:15–91

F:17–84

X X X X 6–11 No 110–160 X X

XXX XXXXX X X No 18–70

X X X X X No 16–94 X

M:15–91

F:17–84

Height (cm)

M:155–195

F:145–180

M:157–194

F:146–178

Weight (kg)

Smoke Years

Caucasian

XX X

Black

Hispanic

Asian

Hedenström 1986 (he)

Hibbert 1989 (hi) X X X X X X X X X 6–18 No

Hsu 1979 (hs) X X X X X X 7–20 No

Knudson 1976 (k) X X X X X X X X ≥ 8 ≤ 90 X

Knudson 1983 (kn)

Koillinen 1998 (kl)

Kory 1961 (ko) X X X X No No 18–66 X

Morris 1971 (mo) X X X X X X No 20–84 X

NHANES III (nh) X X X X X X X X X ≥ 8 ≤ 80 X X X

Paoletti 1986 (pa)

Polgar 1971 (po) X X X X X X 3–19 No 110–170 X

Roca 1986 (ro) X X X X X X X X No 20–70 X

Schoenberg 1978 (sc)

Solymar 1980 (so)

Viljanen 1981 (vi) X X X X

Wang 1993 (wa) X X X X X X 6–18 No X X

Zapletal 1969 (za) X X X X X X X X 6–18 No

X X X X X X X X X No 20–70

XXX XXX X X ≥ 6

XXXX X X X X X 6–16 No X

X X X X X X X 8–17 18–64 X

XXX X XX X X ≥ 7 ≥ 18

XX X XXX X X 7–18 No X

X X X No 18–65 X

M:≤ 85

F:≤ 88

M:160–196

F:148–183

M:120–190

F:120–176

M:111–200

F:111–180

M:111.8–195.6 F:106.7 –182.9

M:118–181

F:107–173

M:5–55

F:45–94

M:55–109

137.2

11.7–

F:2–53

XXX

Page 71

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.,

Crapo 1981 Reference Spirometric Values using Techniques and Equipment that Meet ATS Recommendations, Crapo, et. al., American

Dockery 1983 Distribution of Forced Vital Capacity and Forced Expiratory Volume in One Second in Children 6-11 Years of Age, Dockery,

ECCS/Quanjer 1993

Falaschetti 2004 Prediction equations for normal and low lung function from the Health Survey for England, E. Falaschetti, J. Laiho,

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.

Gulsvik 2001 Forced Spirometry Reference Values for Norwegian Adults: The Bronchial Obstruction in Nord-Trondelag Study,

Hedenström 1986 Reference Values for Lung Function Tests in Men: Regression Equations With Smoking Variables, Hedenström, et. al.,

Hibbert 1989 Lung Function Values From a Longitudinal Study of Healthy Children and Adolescents; Marienne E. Hibbert, Anna

Hsu 1979 Ventilatory Functions of Normal Children and Young Adults — Mexican American, White and Black, Katharine HK Hsu, et.

Acta Medica Scandinavica, volume 173, 1963.

Review of Respiratory Disease 1981, 123:659-664.

et. al., American Review of Respiratory Disease 1983, 128:405-412.

Lung Volumes and Forced Ventilatory Flows: Official Statement of the European Respiratory Society, Quanjer, et. al., European Respiratory Journal, 1993, supplement 16: 5-40.

P. Primatesta, S. Purdon; European Respiratory Journal

Booth, A. Bauman, N. Owen; European Respiratory Journal

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

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

Lannigan, Louis I. Landau, Peter D. Phelan; Pediatric Pulmonology

al., Journal of Pediatrics, July 1979, volume 95, 14-23.

2004; 23: 456–463.

1995. 8: 773-782.

7:101-109.

Knudson 1976 The Maximal Expiratory Flow-Volume Curve Normal Standards, Variability, and Effects of Age, Ronald J. Knudson, Ronald

Knudson 1983 Change in the Normal Expiratory Flow Volume Curve With Growth and Aging, Ronald Knudson, et. al., American Review of

Koillinen 1998 Terveiden suomalaislasten spirometrian ja uloshengityksen huippuvirtauksen viitearvot, Hannele Koillinen, et. al., Suomen

Kory 1961 The Veterans Administration Army Cooperative Study of Pulmonary Function, Clinical Spirometry in Normal Men, Kory, et.

Morris 1971 Spirometric Standards for Healthy Non-smoking Adults, James F. Morris, et. al., American Review of Respiratory Disease

NHANES III Spirometric Reference Values from a Sample of the General U.S. Population, John L. Hankinson, John R. Odencrantz, and

Paoletti 1986 Reference Values for Vital Capacity and Flow-Volume Curves From a General Population Study; P. Paoletti, G. Pistelli, P.

Polgar 1971 Pulmonary Function Testing in Children: Techniques and Standards

C. Slatin, Michael D. Lebowitz, and Benjamin Burrows, et. al., American Review of Respiratory Disease, volume 113, 1976.

Respiratory Disease, 1983, 127, 725-734.

Lääkärilehti, 1998, 395-402.

al., American Journal of Medicine, February 1961.

volume 103, 1971.

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).

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

, Polgar and Promadhat.1971.

Page 72

68 Appendix D Predictive Norms, etc. Welch Allyn CP 200 Spirometry Option

Norm Clinical Study (continued)

Roca 1986 Spirometric Reference Values From a Mediterranean Population; J. Roca, J. Sanchis, et. al.; Bulletin Européen de

Physiopathologie Respiratoire 1986, 22, 217-224.

Schoenberg 1978 Growth and Decay of Pulmonary Function in Healthy Blacks and Whites, Janet B. Schoenberg, Gerald J. Beck, and Arend

Bouhuys, et. al., Respiration Physiology

Solymar 1980 Nitrogen Single Breath Test, Flow Volume Curves and Spirometry in Healthy Children, 7 -18 Years of Age, L. Solymar,

P. H. Aronsson, B. Bake, and J. Bjure, European Journal of Respiratory Diseases, 1980, 61, 275-286.

, 1978, 33, 367-393.

Viljanen 1981 Spirometric Studies in Non-smoking, Healthy Adults, Viljanen, et. al., Journal of Clinical Lab Investigation

Wang 1986 Pulmonary Function Between 6 and 18 Years of Age; Xiaobin Wang, Douglas W. Dockery, David Wypij, Martha E. Fay,

Zapletal 1969 Maximum Expiratory Flow-Volume Curves and Airway Conductance in Children and Adolescents, Journal of Applied

159, 5-20, 1981.

Benjamin G. Ferris, Jr.; Pediatric Pulmonology

Physiology, volume 26, number 3, March 1969.

15:75-85.

, 41 supplement

Page 73

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 85 or younger, the predicted values would be extrapolated values.

• When it takes place, extrapolation is indicated in the test record.

• Pediatric norms do not provide any age, weight, or height extrapolation.

• Adult norms allow extrapolation of age up, but not down.

• Adult norms allow extrapolation of height, weight, and smoke years, up and down.

About Race Adjustment

Although expected values for certain parameters vary significantly between ethnic groups, some norm studies do not include separate regression equations for different races. For those studies, the following table describes 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.

Race Choices FVC & FEV1 Recommendation Source

Caucasian No adjustment —

Black 88% ATS

Asian 94% NIOSH

Hispanic No adjustment None found

Native American 94% NIOSH

Polynesian 94% NIOSH

Aboriginal 94% NIOSH

Indian 94% NIOSH

Note

Race adjustment applies for adults only.

If a race adjustment percentage is used, the same adjustment is applied to the LLN value.

Page 74

70 Appendix D Predictive Norms, etc. Welch Allyn CP 200 Spirometry Option

About Composite Norm Values

When the primary (selected) norm does not support a given parameter — and when composite norm values are enabled in the operation settings — the missing value is filled in from one of the alternative (composite) norm sources, listed here. For example, since the Crapo norm does not support FEV6, this value is filled in from NHANES III.

Composite Norm Source Parameters Filled In When Not Supported in Primary Norm

NHANES III FVC, FEV1, FEV1%, FEV6, FEV1/FEV6, PEF, FEF25-75

Crapo 1981 FEV0.5, FEV3, FEV3/FVC

Morris 1971 FEF0.2-1.2

ECCS/Quanjer 1993 FEF25, FEF50, FEF75

The primary norm takes precedence over the composite source. For example, since the Crapo norm supports the FVC parameter, this value always comes from Crapo, not from the composite source.

Composite values are used when the patient does not fit the demographics of either primary norm (adult or pediatric). For example, if the primary norms are Dockery and Morris, a 14-year-old patient fits neither norm due to age restrictions. The software would use values from the appropriate composite norms, for example, NHANES 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 example, the abbreviation for Polgar is “po.” All norm abbreviations are listed under “Norm Profiles” on page 66.

Also see “Norm Profiles” on page 66 for a listing of the parameters included in each norm.

To learn how to enable or disable composite norm values, see “Reviewing the Operation

Settings” on page 13.

Page 75

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 CP 200 spirometer, calculates lung age values according to the document cited in

Reference 5 on page 75 (Morris 1995). For single-effort tests, lung age is based on the

current effort. Otherwise, it is based on the patient’s “best” effort, as defined in the settings.

Lung age results less than 20 years are reported as “<20,” and results greater than 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 follows:

Gender Lung Age Formula

Men

Women

[5.920 (height) – 40.000 (FVC) – 169.640 +

2.870 (height) – 31.250 (FEV1) – 39.375 +

2.319 (height) – 21.277 (FEF200-1200) + 42.766 +

1.044 (height) – 22.222 (FEF25%-75%) + 55.844 ] / 4

[4.792 (height) – 41.667 (FVC) – 118.833 +

3.560 (height) – 40.000 (FEV1) – 77.280 +

4.028 (height) – 27.778 (FEF200-1200) – 70.333 +

2.000 (height) – 33.333 (FEF25%-75%)+18.367 ] / 4

Page 76

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 testquality grades, as described in the following sections.

About Effort-Quality Messages

One of the following effort-quality messages appears on the screen after each effort is completed. These messages indicate whether an effort was acceptable and reproducible, and if not, what the patient needs to do differently.

For an example of the “effort complete” screen where these messages would appear, see Figure 29 on page 42.

The term “match” here means “variation” or “difference with respect to best test.”

Effort-Quality Message

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 end-of-test volume > 100 mL (invalid FEV6).

Blast out harder PEF is not reproducible (match > 1.0 L/s).

Deeper breath FEV6 match > 150 mL FVC may be substituted for FEV6.

Good effort Effort meets above criteria.

Good test session Two acceptable efforts match.

Criteria

Page 77

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 the values or interpretation of a completed test (as described under “To View a Test’s Results” on page 44).

To learn how to enable or disable this setting, see “Reviewing the Spirometry Print

Settings” on page 17.

Test-Quality

Grade

A 2 or more Largest two FEV1 values match ≤ 100 mL.

B 2 or more Largest two FEV1 values match > 100 and ≤ 150 mL.

C 2 or more Largest two FEV1 values match > 150 and ≤ 200 mL.

D 1 or more Largest two FEV1 values match > 200 mL.

FNone

Number of Acceptable Efforts Reproducibility

Largest two FVC values match ≤ 100 mL.

Page 78

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 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

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 Security Administration SSA publication number 64-039, Office of Disability Programs ICN 468600, January 2003.

See in particular the calibration and reporting sections of this document.

3. Lung Function Testing: Selection of Reference Values and Interpretive Results, American Thoracic Society, March 1991.

This document describes the methods of selecting the reference values and the algorithm for interpretative results.

4. National Occupational 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 required accuracy. For details on ATS/ERS acceptability criteria, see these sections in the standard:

• “Start of Test Criteria,” page 324

• “Manoeuvre repeatability,“ page 325

7. Standardized Lung Function Testing, European Respiratory Journal supplement 16, March 1993.

8. U.S. Pulmonary Function Standards for Cotton Dust Standard, 29 CFR 1910.1043, Appendix D.

9. Lung Function Testing: Selection of reference values and interpretive strategies. American Thoracic Society, American Review of Respiratory Disease (1991).

, volume 6,

, 144:1202-1218

Page 80

76 Appendix D Predictive Norms, etc. Welch Allyn CP 200 Spirometry Option

Page 81

Glossary

adult. Generally, 18 or older. Age limits vary with each norm.

AT S. American Thoracic Society. An organization that provides standards for spirometry common practice

and equipment.

ATS acceptability criteria. Applicable to FVC testing only. (1) Criteria ensuring that an individual effort

started and ended satisfactorily (no leaks or coughs). (2) Criteria ensuring that the patient has made at least two efforts of the same kind (two FVC-pre or two FVC-post), and that these efforts are reproducible. For details, see document noted in Reference 6 on page 75.

ATS interpretive results. The software generates interpretive results as described in the document noted

in Reference 3 on page 75.

baseline. See pre-test.

best effort. A measurement calculated from a set of efforts. The formula for calculating best effort is user-

selectable: (1) the single best effort or (2) a composite of best parameter values.

BF. Breathing frequency. See also MV and tidal breathing.

bronchospasm evaluation. See post-test.

BTPS. B

CardioPerfect workstation. A PC using Welch Allyn CardioPerfect software. Stores ECG and spirometry

composite norm value. A value that is filled in from another norm — a “composite norm source” —

ody 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.

test data. Can communicate with other electronic patient-information systems, such as billing and medical records.

when the primary (selected) norm does not support a given parameter. Applicable only when composite norm values are enabled.

COPD. Chronic obstructive pulmonary disease. Characterized by airflow obstruction that is primarily

caused by smoking. Examples include emphysema, chronic bronchitis, and asthmatic bronchitis.

curve. A graphical display of spirometry data. During SVC testing, only one curve type is available: volume/

time. During FVC testing, four curve types are available: volume/time, flow /volume, tidal volume, and (on screen only) incentive.

Page 82

78 Glossary Welch Allyn CP 200 Spirometry Option

effort. A single spirometry maneuver, for example, one blow. A single test comprises multiple efforts. See

also best effort.

ERS. European Respiratory Society.

ERV. Expiratory reserve volume (in liters). The maximum volume that can be expired from the level of the

functional residual capacity (FRC). See also tidal breathing.

extrapolation. The practice of applying a norm’s formula to a patient who doesn’t fit that norm’s

demographics. For example, if you were testing an 88-year-old man, and the primary (selected) norm were based on males 85 or younger, the predicted values would be extrapolated values.

FEF50/FIF50. The ratio of these two parameters. See FEF50 and FIF50.

FEF25. Forced expiratory flow (in L/s) at 25% of FVC.

FEF50. Forced 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 time (in seconds). The elapsed time from the beginning of expiration until a

specified percentage of FVC.

FEV0.5. Forced expiratory volume (in liters) at 0.5 seconds.

FEV1. Forced expiratory volume (in liters) at 1 second. An important parameter because it reflects the

severity of COPD.

FEV1/FEV6. The ratio of these two parameters. See FEV1 and FEV6.

FEV1/FVC. See FEV1%.

FEV2. Forced expiratory volume (in liters) at 2 seconds.

FEV3. Forced expiratory volume (in liters) at 3 seconds.

FEV5. Forced expiratory volume (in liters) at 5 seconds.

FEV6. Forced expiratory volume (in liters) at 6 seconds.

Page 83

Directions for Use Glossary 79

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.

FEV2%. FEV2 as % of FVC.

FEV3%. FEV3 as % of FVC.

FEV5%. FEV5 as % of FVC.

FEV6%. FEV6 as % of FVC.

FEVt. Timed forced expiratory volume (in liters). Volume of air exhaled in the specified time during an FVC

effort.

FIF50. Forced inspiratory flow (in L/s) at 50% of FIVC.

FIV1. Forced inspiratory volume (in liters) at one second.

FIV1%. FIV1 as % of FIVC.

FIVC. Forced inspiratory vital capacity (in liters). The maximum volume of air that can be inspired during

forced inspiration starting from full expiration.

FIVt. Timed forced inspiratory volume (in liters). Volume of air inhaled in the specified time (t).

flow. The speed at which air is inhaled or exhaled (in L/s).

flow = f(v). See flow/volume.

flow/volume. Same as flow over volume or flow = f(V). A type of data curve available during FVC testing.

The y axis represents flow (L/s); the x axis represents volume (liters).

flow loop. A flow/volume curve that includes inspiratory data (negative values on the y axis).

FRC. Functional residual capacity (in liters). Volume of air remaining in the lungs and airway at the average

end-expiratory level.

FVC. Forced vital capacity. (1) A type of test in which patients inhale fully and exhale forcefully for as long

as they can. The goal: to measure the volume and flow of air. May or may not include forced inhaling. When forced inhaling is included, it may be done either before or after exhaling. See also flow loop. (2) An important parameter (in liters): the maximum volume of air that can be delivered during forced expiration starting from full inspiration.

IC. Inspiratory capacity (in liters). The maximum volume of air that can be inhaled after a normal —

unforced — exhalation. See also tidal breathing.

Page 84

80 Glossary Welch Allyn CP 200 Spirometry Option

incentive screen. An animated screen that gives patients — usually children — a goal to achieve while

exhaling. This screen is listed as a type of “curve” (data display) available during FVC testing.

IRV. Inspiratory reserve volume (in liters). The maximum volume that can be inspired from the average

end-inspiratory level. See also tidal breathing.

LLN. Lower limits of normal. The lowest expected value for a spirometric parameter. The method of

determining this value varies from norm to norm.

loop. See flow loop.

lung age. A calculated value based on a patient’s demographics and spirometric performance that gives a

relative indication of the health of the subject's lungs. This value is used primarily to encourage smoking cessation. Lung age is not available for patients under 20 years of age.

maneuver. See effort.

MV. Minute volume (in liters). MV = BF · VT. See also tidal breathing.

NIOSH. National Institute for Occupational Safety and Health (U.S.).

norm. A research-based spirometry data set with a specific profile for race, gender, age, and height. The

software compares each patient’s results with data in the primary (selected) norm, reporting the 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 results are not available for patients under 3 years of age.

PEF. Peak expiratory flow (in L/s). The largest expiratory flow achieved with a forced effort.

PIF. Peak inspiratory flow (in L/s). The largest inspiratory flow achieved with a forced effort.

post-test. A test that provides data to compare with pre-test data. Sometimes called post-Rx or post-BD

(bronchodilator). A post-test must follow a pre-test within 24 hours. See also reversibility.

predictive curve. A curve that follows a set of predictive points.

predictive points. Key values from the selected norm and from composite norms (if enabled). Applicable

for FVC tests only. For flow/volume curves, predictive values are PEF, FEF25, FEF50, FEF75, and FVC (all represented as points). For volume/time curves, predictive values are FEV1 (represented as a point) and FVC (represented as a horizontal line). If predictive points are enabled, all available predictive values appear on the screen and the printout.

Page 85

Directions for Use Glossary 81

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. The percentage difference between pre-test and post-test data. This measurement indicates

the effect of medication on lung function. Reversibility applies to each parameter separately. The reversibility formula, which determines the way in which reversibility is calculated, is user-selectable.

SVC. Slow (relaxed) vital capacity. (1) A type of test in which patients breathe normally several times, then

inhale maximally and exhale maximally, or vice versa. Sometimes SVC testing is used when forced breathing is impossible. The patient inhales and exhales as completely as possible, as in FVC testing, but the breathing is not forced. The goal of an SVC effort is to measure the volume of air inhaled and exhaled, not the air flow (speed). (2) An important parameter (in liters): the maximum volume of air exhaled from the point of maximum inhalation, or maximum volume of air inhaled from a point of maximum exhalation.

test. A set of efforts — up to 6 efforts of each type (FVC and SVC) for a maximum of 12 efforts (6 FVC and

6 SVC). The 6 efforts of a given type can be a mixture of pre-medication and post-medication efforts.

Tex. Tidal breathing expiration time (in seconds). See also tidal breathing.

tidal breathing. Multiple breaths, normal breathing. May be used during FVC or SVC testing. After

measuring tidal breathing for several seconds, the following parameters can be extrapolated: MV, VE, BF, and Tin/Tex. If you combine a VT measurement with a VC measurement, you can also calculate the ERV, IC, and IRV. For example, COPD patients have a higher ERV and a lower IC and IRV.

tidal volume. See VT.

tidal volume curve. A flow loop that includes all data from all breaths, tidal and forced.

Tin. Tidal breathing inspiration time (in seconds). See also tidal breathing.

Tin/Tex. The ratio of Tin and Tex. See also Tin and Tex .

TV. See VT.

variance. The difference between the best and worst efforts for a parameter (FEV1, FVC, and so on). Pre-

test and post-test variances are reported separately. See also best effort.

VC. Vital capacity. See FVC or SVC.

VE. Ventilation in L/min. See also tidal breathing.

vital capacity. See FVC or SVC.

volume = f(t). See volume/time.

volume/time. Same as volume over time or volume = f(t). A type of data curve available during both FVC

and SVC testing. The y axis represents liters; the x axis represents seconds.

Page 86

82 Glossary Welch Allyn CP 200 Spirometry Option

VT. Tidal volume (in liters). Also called TV, although VT is the preferred abbreviation. The volume of air that

enters the lungs during inspiration and leaves the lungs during expiration in a normal breathing cycle. One of the most important parameters in SVC testing. See also MV, tidal breathing, and tidal volume

curve.

workstation. See CardioPerfect workstation.

Page 87

Index

accessories. See parts and accessories "Add/Edit Interpretations" screen adult

, 77

Adult Smoker help sheet

, 62, 63

Asthma Symptoms help sheet atmospheric pressure units, selecting ATS acceptability criteria ATS/ERS acceptability criteria ATS interpretation. See interpretation automatic calibration reports. See calibration, report printing

, 45

, 62, 64

, 12

, 77

, 75

COPD

, 63, 77

Cotton Dust protocol. See OSHA / Cotton Dust protocol Crapo norm curves

, 66, 67, 70

, 77

Welch Allyn CP 200 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Directions for Use

Introduction

About This Manual

Product Overview

Intended Use

Indications for Use

Features

Symbols

Using the Spirometer Safely

General Warnings

General Cautions

Ordering Information for Replacement Parts

Getting Help

Reviewing the Spirometry Settings

“Spirometry Settings” Menu Tree

Reviewing the Operation Settings

Reviewing the Calibration Settings

Reviewing the Spirometry Screen Settings

Reviewing the Spirometry Print Settings

Reviewing the Patient Data Fields Available

Reviewing the Interpretation List

Calibrating the Spirometer

About Calibration

Performing a Calibration

Printing Calibration Reports

Performing Spirometry Tests

Overview of the Testing Process

About FVC Efforts

About SVC Efforts

About the Spirometry Parameters

About Pre- and Post-Testing

About Effort Replacement

Connecting the Spirometer Components

Preparing the Patient

Recording a Test

Working With a Completed Test

Troubleshooting

Problem-Solving Suggestions

Limited Warranty

Service Policy

Specifications

Spirometry Protocols

Patient Help Sheets

Predictive Norms, etc.

Glossary

Index