CP 150 spirometry option Directions for use
© 2014 Welch Allyn, Inc. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. Caution: Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed physician.
iii Contents Introduction ............................................................................................. 1 About this document ........................................................................................... 1 Intended use ........................................................................................................ 1 Indications for use ................................................................................................ 2 Contraindications .................
iv Contents CP 150 spirometry option Specifications ........................................................................................ 43 Spirometry protocols ............................................................................ 45 About the PCP protocol ..................................................................................... 45 About the NIOSH protocol ................................................................................. 45 About the patient help sheets ...........
1 Introduction About this document 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 150 spirometry option and the CP 150 electrocardiograph.
2 Introduction CP 150 spirometry option Indications for use The spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed to test pulmonary function and obtain spirometric indices for • adult and pediatric patients 12 years and older, • hospital and clinic use only.
Directions for use Introduction • Meets ATS/ERS 2005 spirometry standards • Single-flow and multiple-flow calibration protocols • NIOSH protocols to create reports that meet agency requirements • PCP (primary care practitioner) protocol that follows NLHEP guidelines • Meets all industry standards, including ATS and NIOSH • Transfer results into the CardioPerfect workstation for easy analysis, reviewing, storing, printing, and exporting • Compliant with the National Lung Health Education Progr
4 Introduction CP 150 spirometry option Controls, indicators, and connectors No. Feature Description 1 LCD screen 800 x 480 pixels color touchscreen provides a graphical user interface. 2 Power switch and LED Power-on/Standby switch. The LED indicates the charging status when connected to AC power: • Green: The battery is charged. • Amber: The battery is charging. 3 Patient cable connector Provides connection for patient cable.
Directions for use Introduction 5 Back view No. Feature Description 1 Ethernet connector Provides a hardwired connection to the computer network. The LEDs indicate active network status when the ethernet cable is connected to a network. 2 Clients USB USB, type "mini B." Provides connection to an enabled host. 3 Host USB USB, type "A." Provides four host USB connections for optional accessories. 4 Power connection Provides an external AC power connection.
6 Introduction CP 150 spirometry option Spirometry option back view No. Feature Description 1 Bracket Spirometer sensor mounting bracket 2 Thumb screws Thumb screws to attach bracket to device 3 USB cable Provides spirometer sensor connection to device 4 Spirometer sensor USB spirometer sensor 5 Disposable flow transducers Measures patient air velocity. Connects to pressure tubing.
Directions for use Introduction 7 Symbols Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Caution The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. This definition applies to both yellow and black and white symbols. Consult Directions for Use, Electronic version available at Welchallyn.
8 Introduction CP 150 spirometry option Expiration date 20XX-XX IP20 Protected against the ingress of solid foreign objects ≥ 12.5 mm diameter, not protected against the ingress of water. Miscellaneous symbols Manufacturer Type BF applied part Reference/Model number Serial number Reorder/Catalog number Batch code Professional use only Do not reuse Conforms with IEC/UL/CSA/EN 60601-1 Intertek ETL listed General warnings The following warning statements apply to spirometer use in general.
Directions for use Introduction 9 WARNING Read and observe all safety information provided in the flow transducer instructions. 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. Cautions indicate conditions or practices that could damage the equipment or other property. CAUTION Do not clean the spirometer or any of its components.
10 Introduction CP 150 spirometry option
11 Setup Connecting the Spirometer 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. Connecting the spirometer components 1. Attach the right side of the spirometer mounting bracket to the device using one of the thumb screws. Tighten the thumbscrew. 2. Insert the spirometer sensor into the mounting bracket.
12 Setup CP 150 spirometry option 4. Insert the mini USB cable connector into the spirometer sensor mini USB port. a. Insert the USB cable into the spirometer sensor mounting bracket groove to secure the cable. b. Insert the USB cable connector into the device's first USB port, furthest to the right. Note The mounting bracket is designed to protect the spirometer sensor and USB cable and only accepts the USB cable mini connector when the spirometer sensor label faces outward. 5.
Directions for use Setup 6. Push the flow transducer down onto the patient handle until it is secure. WARNING Keep the reusable patient handle clean. Patient contact with contaminated equipment can spread infection. Note Clean the patient handle after each patient use.
14 Setup CP 150 spirometry option
15 Settings Viewing or changing the spirometry settings • The spirometry settings control the predictive norms, parameters, formulas, and content of your report. To view or change the settings 1. Touch the Settings tab. The ECG tab and the vertical ECG configuration tab appear. 2. Touch the Spirometry tab. The vertical Spirometry configuration tab appears. Modify the settings as desired: The following settings are saved as they are selected.
16 Settings CP 150 spirometry option • Pressure unit • Flow unit Touch the FVC report tab. Modify the settings as desired: • Efforts • Lung age • Quality grades • Print “ATS Reproducibility Not Met” Touch the (Next) button. Modify the settings as desired: • First name • Smoke years • Packs/day • Age or Birth date • Middle initial • Weight • Comments Touch the Parameters tab. Modify the settings as desired: Note Touch the Select up to eight parameters to display and print.
17 Spirometry home screen Spirometry home screen The Spirometry home screen includes the following areas: Item Area 1 Device status 2 Content 3 Navigation Device status area The Device status area, located at the top of the Spirometry home screen, displays: • Time and date • Battery status • Error or information messages. These items are displayed until the condition has been resolved.
18 Spirometry home screen CP 150 spirometry option Content area The Content area includes 2 test selection buttons, a calibrate button, and a button to change the test type: • Forced Vital Capacity test • Continue saved test • Calibrate • Change test type The content area also provides shortcuts to several controls. About the test types FVC Perform new Forced Vital Capacity test “FVC” stands for forced vital capacity. The goal of an FVC effort is to measure the volume forcefully.
Directions for use Spirometry home screen 19 Navigation area The Navigation area includes the following tabs: • Spirometry home: Displays spirometry test types and provides shortcuts to several controls. • Manage worklist: Includes patient data entered manually or orders downloaded when connected to a hospital information system. • Saved tests: Accesses the patient spirometry and ECG tests. • Settings: Accesses device configuration settings.
20 Spirometry home screen Example spirometry report CP 150 spirometry option
21 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.
22 About calibration CP 150 spirometry option Note Obtain the transducer lot and calibration codes from the transducer package label. Note For the syringe volume, see the sticker on the calibration syringe. Note Humidity (%), Temperature, and Pressure are set through the USB spirometer sensor and are not editable fields. 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. 4. Touch the (Next) button. 5.
Directions for use About calibration The results display for a single-flow calibration after no air has moved for three seconds. 10. Review the results. Note Check the error percentages for the expired and inspired volumes. Both volumes must be less than ±3.5% for the calibration to be acceptable. For single-flow calibrations, the measured and adjusted curves should match. Note The syringe used to check the volume calibration of spirometers must have an accuracy of 15 mL for a 3-L syringe. 11.
24 About calibration CP 150 spirometry option Calibrate multiple flows 1. From the ECG Home screen touch the 2. Touch the (Spirometry) button. (Calibrate) button. The Spirometry calibration screen appears. 3. Touch the Calibrate multiple flows button. Fill in these fields: • Transducer lot code • Transducer calibration code • Syringe Vol. (in ml) Note Obtain the transducer lot and calibration codes from the transducer package label.
Directions for use About calibration 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. Touch the Start button to begin the calibration. 9.
26 About calibration CP 150 spirometry option
27 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.
28 Preparing the patient CP 150 spirometry option
29 Spirometry tests Overview of the testing process A single test comprises a set of efforts — up to 6 FVC efforts. The 6 efforts of a given type can be a mixture of pre- and post-medication efforts. 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.
30 Spirometry tests • CP 150 spirometry option FEV1 — forced expiratory volume 1, the volume of air that is exhaled at one second of a forced expiration About pre- and post-testing If desired, a spirometry test may include both pre- and post-efforts to measure the effectiveness of medication. The “before medication” and “after medication” efforts may be uninterrupted or interrupted.
Directions for use Spirometry tests 31 • First name. Touch the OK button. • Middle Initial. Touch the OK button. 4. Touch the (Next) button. 5. Enter the following patient information: Required fields are denoted with an asterisk. Note • Gender* • Race* • Height*. Touch the OK button. • Weight. Touch the OK button. • Smoke Years. Touch the OK button • Packs/day. Touch the OK button • Comments. Touch the OK button 6. Touch the (Next) button. 7.
32 Spirometry tests CP 150 spirometry option Note After each effort, a quality message appears on this screen, such as "Blast out harder", “Don’t hesitate,” “Blow out longer,” or “Good effort.” 11. Touch the Accept button to save the pre test and continue or touch the Reject button. If the test is accepted or rejected, the next pre-test will increment in number. Even if some efforts were deleted, the test record indicates the patient’s total number of efforts. 12.
Directions for use Spirometry tests 33 14. Touch Done when you have completed the pre-tests. If the Auto Save setting is turned off, touch the Yes button and touch Save to save the test. Select one of the following locations: • Local (internal memory) • USB mass storage device (Any tests that you save to a USB mass storage device can be retrieved only from a CardioPerfect workstation.
34 Spirometry tests CP 150 spirometry option 4. When the patient is ready, touch the Start pre #1 button to perform the spirometry test. See Performing a new Forced Vital Capacity spirometry test for additional details. Note Performing a spirometry test using the Worklist tab CAUTION Patient data is not saved until the spirometry test is completed. The spirometry configuration settings can be changed in the Settings tab.
Directions for use Spirometry tests 35 2. Select a patient from the list of saved tests. Touch Patient ID, Patient name, Birth date, or Efforts. 3. Touch the Continue test button. 4. Touch the View or Incentive button to select the display information that you want to view during the test. a. Modify the View settings as desired: • View Flow/Volume. (View FV curve) • View Volume/Time. (View VT curve) • View Flow/Volume and Volume/Time. (View FV & VT) • View Parameters. b.
36 Spirometry tests CP 150 spirometry option • Local (internal memory) • USB mass storage device (Any tests that you save to a USB mass storage device can be retrieved only from a CardioPerfect workstation.) • Workstation • Remote file location Performing a spirometry post test Complete the pre-test efforts. See Performing a new Forced Vital Capacity spirometry test. Note Pre- and post-efforts must happen on the same day.
Directions for use Spirometry tests 37 12. Touch the Yes button and touch Save to save the test. Select one of the following locations: • Local (internal memory) • USB mass storage device (Any tests that you save to a USB mass storage device can be retrieved only from a CardioPerfect workstation.) • Workstation • Remote file location Working with a Saved test To view Saved tests: 1. From the Spirometry home tab, touch the Saved tests tab. Search for tests by Date, Last name, or Patient ID.
38 Spirometry tests CP 150 spirometry option View and Print options include test efforts with color-coded legend, parameters with norm profile, efforts summary, and ATS Interpretive results.
39 Troubleshooting Symptoms and solutions Problem-solving suggestions: If you try these suggestions and still have problems, contact Welch Allyn. Symptom Possible cause Suggested action Unable to calibrate Poor connection between flow transducer and sensor Check the connection between flow transducer and sensor. Damage to flow transducer Replace the flow transducer if it is damaged. Leak during calibration.
40 Troubleshooting CP 150 spirometry option Symptom Possible cause Suggested action Values are too high (consistently) Pressure connection is partially obstructed Remove any foreign substance from the flow transducer or pressure tubing. Predictive values are blank The selected norm does not support certain values, and composite norm values are disabled Re-enter age/birthdate, height, gender, race. (Fill in the fields. All mandatory fields must be filled in before you can proceed.
41 Maintenance Cleaning the spirometer, calibration syringe, and patient handle WARNING Change the flow transducer for each patient. WARNING Satisfactory maintenance procedures must be implemented, or equipment failure and health hazards may result. Only qualified service personnel should repair the equipment. CAUTION You cannot clean the spirometer or any of its components. CAUTION Do not clean the pressure tubing or sensor. Trapped moisture could affect accuracy.
42 Maintenance CP 150 spirometry option CAUTION When cleaning the patient handle, avoid using cloths or solutions that include quaternary ammonium compounds (ammonium chlorides) or glutaraldehyde-based disinfectants. Note Disinfect according to your facility's protocols and standards or local regulations. Limited warranty For general information on the limited warranty, see the electrocardiograph manual entitled CP 150 12-lead resting electrocardiograph Directions for use.
43 Specifications Item Specification Dimensions and weights Flow transducer 1.5 x 1.2 x 3.3 in. (37 mm x 30 mm x 85 mm) 0.4 oz (12 g) Pressure tubing 2.2 yd (2 m) 0.9 oz (25 g) Sensor 1.2 x 4.3 x 0.6 in (31 mm x 108 mm x 14 mm) 0.9 oz (25 g) Tests FVC, pre- and post-bronchodilator Flow technology Pneumotach Power equipment Powered by CP150 electrocardiograph via USB port (no battery) Current consumption 50 mA Max (30 mA typical) Accuracy Compliant with ATS/ERS 2005 guidelines.
44 Specifications CP 150 spirometry option Item Specification Reports FVC testing Volume/time curve Flow/volume curve Both volume/time and displayed curves No curves None 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 Quality checks Effort acceptability and test reproducibility checks.
45 Spirometry protocols This manual describes the protocols you can select to change the way the CP 150 spirometer operates when testing a patient. Any features that are not specified in the protocol use your own settings. Protocol settings are uneditable after selection to avoid confusion during setup. To learn how to review or change the protocol, see Viewing or changing the spirometry settings.
46 Spirometry protocols CP 150 spirometry option When this protocol is selected, testing and reports are affected as follows: Operation Settings • Norm: NHANES III 1999 (Adult) • Best Effort Formula: Best Measurement • Composite norms: False • Efforts to be printed: Three best efforts
47 About the patient help sheets Two patient help sheets are available to print:1 • Adult smokers If Smoke Years is enabled in the FVC report settings, the Smokers' education sheet option can be printed for adult smokers. • Asthma symptoms These help sheets print only if patient education is selected. To enable patient education touch the Print patient's education button after the FVC efforts have been performed. Touch the checkbox next to Asthma education or Smokers' education.
48 About the patient help sheets CP 150 spirometry option 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.
Directions for use About the patient help sheets 49 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.
50 About the patient help sheets CP 150 spirometry option
51 Predictive Norms, etc. 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 was based on males 85 or younger, the predicted values would be extrapolated values. • Norm extrapolation is indicated in the test record. • Adult norms allow extrapolation of age up, but not down.
52 Predictive Norms, etc. CP 150 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.
Directions for use Predictive Norms, etc. Gender Lung Age Formula 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 Women [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.
54 Predictive Norms, etc. CP 150 spirometry option List of Norm-related clinical studies Each of the following studies provides expected values for various spirometric parameters by measuring significant samples of a particular population. Norm Clinical Study Berglund 1963 Reference Spirometric Studies in Normal Subjects: Forced Expiratograms in Subjects 7-70 Years of Age, Berglund, et. al., Acta Medica Scandinavica, volume 173, 1963.
Directions for use Predictive Norms, etc. Norm Clinical Study Viljanen 1981 Spirometric Studies in Non-smoking, Healthy Adults, Viljanen, et. al., Journal of Clinical Lab Investigation, 41 supplement 159, 5-20, 1981.
56 Predictive Norms, etc. CP 150 spirometry option About quality feedback The spirometer provides two kinds of quality feedback: effort-quality messages and test quality grades, as described in the following sections. About effort-quality messages One of the following effort-quality messages appears on the screen after each effort is completed. These messages indicate whether an effort was acceptable and reproducible, and if not, what the patient needs to do differently.
Directions for use Predictive Norms, etc. 57 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.
58 Predictive Norms, etc. CP 150 spirometry option 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.
59 Glossary adult. Generally, 18 or older. Age limits vary with each norm. ATS. American Thoracic Society. An organization that provides standards for spirometry common practice and equipment. ATS acceptability Applicable to FVC testing only. (1) Criteria ensuring that an individual effort started and ended criteria. satisfactorily (no leaks or coughs).
60 Glossary CP 150 spirometry option 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. effort.
Directions for use Glossary 61 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).
62 Glossary CP 150 spirometry option 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 x VT. See also tidal breathing. NIOSH. National Institute for Occupational Safety and Health (U.S.). norm.
Directions for use Glossary 63 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.
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