Welch Allyn CP 200 User Manual

CP 200™ Spirometry Option

Directions for Use

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

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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

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

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

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

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.

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.

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

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.

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

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.

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.

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

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.

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.

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.

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.)

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.

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.

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.

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.

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.

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.

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.

Calibrating the Spirometer

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

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

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

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.

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.

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.

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