Copyright 2005, Welch Allyn, Inc. All rights are reserved. No one is permitted to reproduce or duplicate, in
any form, this manual or any part thereof without permission from Welch Allyn.
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 2005, Welch Allyn, Inc., or its vendors. All rights are reserved. The
software is protected by United States of America copyright laws and international treaty provisions
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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
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For information about any Welch Allyn product, please call Welch Allyn Technical Support:
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+ 1 315 685 4560
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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 UseChapter 1 Introduction3
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 55
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.
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 may be used with patients who are able to understand the instructions for
performing the test. However, normal values and interpretive results are not calculated
for children under the age of six.
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:
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 keySpirometry port
Stacking limitsDo not reuse.
8
Keep away from sunlight.Expiration date
Type BF applied part
200x-xx
Directions for UseChapter 1 Introduction7
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.
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.
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 UseChapter 1 Introduction9
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.
First Name
Second Last Name
Middle Initial
Age/Birth Date
Weight
Medication
History
Comments
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.
Communication
Settings
Auto Send
Directions for UseChapter 2 Reviewing the Spirometry Settings13
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 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 05
3. If desired, change the settings.
SettingDescription
Select ProtocolThe 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 57.
•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 68.
The selected pediatric norm is the primary source of predictive values for pediatric patients.
For details, see “Norm Profiles” on page 68.
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 76.)
• 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.)
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 70.
Directions for UseChapter 2 Reviewing the Spirometry Settings15
Reviewing the Calibration Settings
To review or change the settings that affect calibration — or to calibrate the spirometer —
follow these steps.
The spirometry screen is the first screen that displays after you enter patient data.
For example, see Figure 29 on page 43. To review or change the settings for this screen,
follow these steps.
Select FVC CurvesChoose 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 ScaleChoose which type of scaling (graph resizing) to use in printed volume/time curves.
Print Lung AgeYes 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.
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
AddDeleteExit
9:17AM Oct 16 05
3. Press the desired softkeys.
SoftkeyEffect
AddLets you add statements to the list, up to a total of 50.
DeleteDeletes the highlighted statement.
ExitReturns to the Spirometry Settings screen.
Directions for UseChapter 2 Reviewing the Spirometry Settings21
Reviewing the Auto Send Setting
To review or change the setting for automatically sending all spirometry test records to a
CardioPerfect workstation or to an SD memory card, follow these steps.
1.Press the Menu key .
2. Choose Spirometry Settings > Communication Settings > Auto Send.
The following screen appears.
Figure 8. “Auto Send” Submenu
Spirometry Communication Settings
1 Auto Send
0 Previous Menu
9:17AM Oct 16 05
None
Workstation
Memory Card
3. If desired, change the setting.
For details on these choices, see the CP 200 electrocardiograph manual.
SettingDescription
NoneTest records are not automatically sent.
WorkstationAll spirometry test records are automatically sent to a CardioPerfect workstation.
Memory CardAll spirometry test records are automatically sent to your SD memory card.
24Chapter 3 Calibrating the SpirometerWelch 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 9 on page 25.
For step-by-step calibration instructions, see “Performing a Calibration” on page 26.
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 53.
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