Welch Allyn CP 150 Directions For Use Manual
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Welch Allyn CP 150 Directions For Use Manual

Spirometry option
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CP 150 spirometry option
Directions for use
Software version 2.10.XX

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Summary of Contents for Welch Allyn CP 150

  • Page 1 CP 150 spirometry option Directions for use Software version 2.10.XX...
  • Page 2 © 2016 Welch Allyn, Inc. All rights are reserved. 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. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.

  • Page 3: Table Of Contents

    Contents Introduction ..................... 1 About this document ................... 1 Intended use ......................1 Indications for use ....................2 Contraindications ....................2 Description ......................2 Features ....................... 2 Configuration options for CP150 electrocardiograph with spirometry option ..3 Controls, indicators, and connectors ..............4 Symbols .......................
  • Page 4 Contents CP 150 spirometry option Disposing of electronic equipment ..............44 General compliance and standards ............. 45 General radio compliance ................... 45 Federal Communications Commission (FCC) ............ 45 Industry Canada (IC) emissions ................46 EMC guidance and manufacturer’s declarations ..........47 Emissions and immunity information ..............

  • Page 5: Introduction

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

  • Page 6: Indications For Use

    • Incentive graphics for patient coaching • Multiple predictive norms, including NHANES III • 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 •...

  • Page 7: Configuration Options For Cp150 Electrocardiograph With Spirometry Option

    Directions for use Introduction 3 • 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 industry standards, including ATS and NIOSH •...

  • Page 8: Controls, Indicators, And Connectors

    4 Introduction CP 150 spirometry option Controls, indicators, and connectors No. Feature Description LCD screen 800 x 480 pixels color touchscreen provides a graphical user interface. Power switch and LED Power-on/Standby switch. The LED indicates the charging status when connected to AC power: •...
  • Page 9 Directions for use Introduction 5 Back view No. Feature Description 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. Clients USB USB, type "mini B." Provides connection to an enabled host. Host USB USB, type "A."...
  • Page 10 6 Introduction CP 150 spirometry option Spirometry option back view No. Feature Description Bracket Spirometer sensor mounting bracket Thumb screws Thumb screws to attach bracket to device USB cable Provides spirometer sensor connection to device Spirometer sensor USB spirometer sensor Disposable flow transducers Measures patient air velocity.

  • Page 11: Symbols

    Meets essential requirements of the of the DFU is available on this website. A European Medical Device Directive 93/ printed copy of the DFU can be ordered 42/EC from Welch Allyn for delivery within 7 calendar days. Power symbols Power on/standby Battery...
  • Page 12 8 Introduction CP 150 spirometry option Equipotential Ground Connectivity symbols Ethernet Wireless radio symbols Wireless signal strength Non-ionizing electromagnetic radiation • Best (4 bars) • Good (3 bars) • Fair (2 bars) • Weak (1 bar) • No connection (no bars)
  • Page 13 Directions for use Introduction 9 Separate collection of Electrical and China RoHs Electronic Equipment. Do not dispose as unsorted municipal waste. Lithium ion battery Keep away from sunlight IP20 Protected against the ingress of solid Use by Date foreign objects ≥ 12.5 mm diameter, not protected against the ingress of water.

  • Page 14: General Warnings

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

  • Page 15: General Cautions

    Directions for use Introduction 11 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, or loss of data.
  • Page 16 12 Introduction CP 150 spirometry option...

  • Page 17: Setup

    Setup Connect the spirometer WARNING To prevent the spread of infection, use a new flow transducer for each patient. Use protective gloves when replacing used flow transducers, and wash hands after touching them. Discard flow transducers after a single patient use. Connect the spirometer components 1.
  • Page 18 CAUTION Hand-tighten the spirometer sensor and flow transducer connectors to avoid damaging the connectors. The CP 150 software automatically activates the spirometry functions throughout the software. Once the software recognizes the sensor, the Spirometry button appears in the Content area.
  • Page 19 Directions for use Setup 15 WARNING Keep the reusable patient handle clean. Patient contact with contaminated equipment can spread infection. Note Clean the patient handle after each patient use.
  • Page 20 16 Setup CP 150 spirometry option...

  • Page 21: Settings

    Settings View or change 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.
  • Page 22 18 Settings CP 150 spirometry option Touch (Next). 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 Select up to eight parameters to display and print.

  • Page 23: Spirometry Home Screen

    Spirometry home screen Spirometry home screen The Spirometry home screen includes the following areas: Item Area Device status Content Navigation Device status area The Device status area, located at the top of the Spirometry home screen, displays: • Patient Icon and Patient name. Once the patient context is established, the format of the Patient name appears as last name, first name.
  • Page 24 20 Spirometry home screen CP 150 spirometry option • Battery status • Error or information messages. These items are displayed until the condition has been resolved. Content area The Content area includes 2 test selection buttons, a calibrate button, and a button to change the test type: •...
  • Page 25 Directions for use Spirometry home screen 21 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.
  • Page 26 22 Spirometry home screen CP 150 spirometry option Example spirometry report...

  • Page 27: About Calibration

    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 using the new lot number before resuming testing.
  • Page 28 24 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.
  • Page 29 Directions for use About calibration 25 The results display for a single-flow calibration after no air has moved for three seconds. 11. 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.

  • Page 30: Calibrate Multiple Flows

    26 About calibration CP 150 spirometry option Calibrate multiple flows 1. From the ECG home screen touch 2. Touch . The Spirometry calibration screen appears. 3. Touch Calibrate multiple flows. Fill in these fields: • Transducer lot code • Transducer calibration code •...
  • Page 31 Directions for use About calibration 27 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.
  • Page 32 28 About calibration CP 150 spirometry option...

  • Page 33: Prepare The Patient

    Prepare 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 should be 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.
  • Page 34 30 Prepare the patient CP 150 spirometry option...

  • Page 35: Spirometry Tests

    Spirometry tests Overview of the testing process A single test comprises a set of efforts that 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.

  • Page 36: Perform A New Forced Vital Capacity Spirometry Test

    32 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.
  • Page 37 Directions for use Spirometry tests 33 • Birth date*. Touch OK. • Gender*. Touch OK. • Last name*. Touch OK. • First name. Touch OK. • Middle Initial. Touch OK. 4. Touch (Next). 5. Enter the following patient information: Note Required fields are denoted with an asterisk.
  • Page 38 34 Spirometry tests CP 150 spirometry option After each effort, a quality message appears on this screen, Note such as "Blast out harder", “Don’t hesitate,” “Blow out longer,” or “Good effort.” 11. Touch Accept to save the pre test and continue or touch Reject.
  • Page 39 Directions for use Spirometry tests 35 14. Touch Done when you have completed the pre-tests. If the Auto Save setting is turned off, touch Yes and touch Save to save the test. Select one of the following locations: • Local (internal memory) •...

  • Page 40: Continue Saved Test

    36 Spirometry tests CP 150 spirometry option See Performing a new Forced Vital Capacity spirometry test Note for additional details. Perform a spirometry test using the Worklist tab when connected to the Worklist server CAUTION Patient data is not saved until the spirometry test is completed.
  • Page 41 Directions for use Spirometry tests 37 2. Select a patient from the list of saved tests. Touch within the Patient row. 3. Touch Continue test. 4. Touch View or Incentive to select the display information that you want to view during the test.

  • Page 42: Perform A Spirometry Post Test

    38 Spirometry tests CP 150 spirometry option • 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 Perform a spirometry post test Complete the pre-test efforts.

  • Page 43: Work With A Saved Test

    Directions for use Spirometry tests 39 • Workstation • Remote file location Work 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. Alternatively, you can search for All test types. 2.
  • Page 44 40 Spirometry tests CP 150 spirometry option...

  • Page 45: Troubleshooting

    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 Check the connection between flow transducer and sensor transducer and sensor.
  • Page 46 42 Troubleshooting CP 150 spirometry option Symptom Possible cause Suggested action Values are too high (consistently) Pressure connection is partially Remove any foreign substance from the obstructed flow transducer or pressure tubing. Predictive values are blank The selected norm does not support...

  • Page 47: Maintenance

    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.

  • Page 48: Storing The Equipment

    This product and its components must be disposed of according to local laws and regulations. Do not dispose of this product as unsorted municipal waste. For more specific disposal or compliance information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service.

  • Page 49: General Compliance And Standards

    General compliance and standards The CP150 complies with the following standards: ANSI/AAMI EC11** CAN/CSA C22.2 No. 601.1 CAN/CSA C22.2 No. 601.1.2 IEC/EN 60601-1 IEC/EN 60601-1-2 IEC/EN 60601-1-4 CAN/CSA C22.2 No. CAN/CSA C22.2 No. 601.2.25 601.1.4 IEC/EN 60601-1-6 IEC/EN 60601-2-25 *** IEC/EN 60601-2-51* (3x4 report format) ANSI/AAMI EC53 EN 50581...

  • Page 50: Industry Canada (Ic) Emissions

    This booklet is available from the U.S. Government Printing Office, Washington, D.C. 20402. Stock No. 004-000-0034504. Welch Allyn is not responsible for any radio or television interference caused by unauthorized modification of the devices included with this Welch Allyn product, or the substitution or attachment of connecting cables and equipment other than specified by Welch Allyn.

  • Page 51: Emc Guidance And Manufacturer's Declarations

    Directions for use General compliance and standards 47 This radio transmitter (Contains IC ID: 3147A-WB45NBT) has been approved by Industry Canada to operate with the antenna types listed in table above with the maximum permissible gain and required antenna impedance for each antenna type indicated. Antenna types not included in this list, having a gain greater than the maximum gain indicated for that type, are strictly prohibited for use with this device.

  • Page 52: Emissions And Immunity Information

    48 General compliance and standards CP 150 spirometry option • It is not safe to operate the CP150 ELECTROCARDIOGRAPH with SPIROMETER in the presence of high-frequency surgical equipment. Emissions and immunity information Electromagnetic emissions The CP150 with SPIROMETER is intended for use in the electromagnetic environment specified below. The customer or user of the CP150 with SPIROMETER should assure that it is used in such an environment.
  • Page 53 Directions for use General compliance and standards 49 Electromagnetic immunity ± 2 kV common mode ± 2 kV common mode Voltage dips, short Mains power quality should be that of a typical >95% dip in 0.5 cycle >95% dip in 0.5 cycle interruptions and commercial or hospital environment.
  • Page 54 50 General compliance and standards CP 150 spirometry option Electromagnetic immunity applicable RF compliance level above, the CP150 with SPIROMETER should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CP150 with SPIROMETER.

  • Page 55: Specifications

    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...
  • Page 56 52 Specifications CP 150 spirometry option Item Specification Morris 1971, NHANES III 1999, Paoletti 1986, Roca 1986, Schoenberg 1978, Viljanen 1981 Interpretation 1991 ATS interpretation standards Lung age calculation can be enabled or disabled. Automatic interpretation can be enabled or disabled.
  • Page 57 Directions for use Specifications 53 Item Specification Atmospheric air-pressure limits 500 - 1060 hPa Environmental storage conditions Temperature -20° C to +50° C (-4° F to +122° F) Relative humidity 10 - 95% noncondensing Atmospheric air-pressure limits 500 - 1060 hPa Specifications are subject to change without notice.
  • Page 58 54 Specifications CP 150 spirometry option...

  • Page 59: Limited Warranty

    Limited warranty For general information on the limited warranty, see the electrocardiograph manual entitled CP 150 12-lead resting electrocardiograph Directions for use. The following spirometry components have specific warranty periods from date of shipment to customer: • Sensor — 12 months •...
  • Page 60 56 Limited warranty CP 150 spirometry option...

  • Page 61: Service Policy

    Approved Accessories. 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 the manufacturer for calibration verification if necessary.
  • Page 62 58 Service policy CP 150 spirometry option...

  • Page 63: Spirometry Protocols

    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.
  • Page 64 60 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...

  • Page 65: About The Patient Help Sheets

    About the patient help sheets Two patient help sheets are available to print: • 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.

  • Page 66: Adult Smokers Help Sheet

    62 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.

  • Page 67: Asthma Symptoms Help Sheet

    Directions for use About the patient help sheets 63 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.
  • Page 68 64 About the patient help sheets CP 150 spirometry option...

  • Page 69: Predictive Norms And Interpretation

    Predictive Norms and interpretation About Norm extrapolation Extrapolation is the practice of applying a norm’s formula to a patient who is outside of the norm studied. For example, if you were testing an 88-year-old man, and the selected norm was based on males 85 or younger, the predicted values would be extrapolated values.

  • Page 70: About Composite Norm Values

    This value is used primarily to encourage smoking cessation. The CP 150 spirometer calculates lung age values according to the document Short Report Spirometric "Lung Age" Estimation for Motivating Smoking Cessation. (Morris 1995).
  • Page 71 Directions for use Predictive Norms and interpretation 67 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) –...

  • Page 72: List Of Norm-Related Clinical Studies

    68 Predictive Norms and interpretation 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 Reference Berglund 1963 Spirometric Studies in Normal Subjects: Forced Expiratograms in Subjects 7-70 Years of Age, Berglund, et.
  • Page 73 Directions for use Predictive Norms and interpretation 69 Norm Clinical Study Reference NHANES III Spirometric Reference Values from a Sample of the General U.S. Population, John L. Hankinson, John R. Odencrantz, and 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.

  • Page 74: About Quality Feedback

    70 Predictive Norms and interpretation CP 150 spirometry option About quality feedback The spirometer provides two kinds of quality feedback: effort-quality messages and test stage reproducibility, 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.

  • Page 75: Understanding Your Interpretation Results

    Directions for use Predictive Norms and interpretation 71 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.

  • Page 76: References

    72 Predictive Norms and interpretation CP 150 spirometry option References 1. 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.

  • Page 77: Glossary

    Glossary adult Generally, 18 or older. Age limits vary with each norm. 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).
  • Page 78 74 Glossary CP 150 spirometry option curve A graphical display of spirometry data. During SVC testing, only one curve type is available: volume/ time. During FVC testing, two curve types are available: volume/time and flow/volume. effort A single spirometry maneuver, for example, one blow. A single test comprises multiple efforts.
  • Page 79 Directions for use Glossary 75 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.
  • Page 80 76 Glossary CP 150 spirometry option 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.
  • Page 81 Directions for use Glossary 77 Tidal breathing inspiration time (in seconds). See also tidal breathing. Tin/Tex The ratio of Tin and Tex. See also Tin and Tex. 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.
  • Page 82 78 Glossary CP 150 spirometry option...

  • Page 83: Appendix

    Options and software upgrades Part Number Description 406814 CP 50/150 connectivity kit Components of the CP 150 Spirometry Option Part Number Description 410027 Spirometry kit, CP150 410370 Spirometry pressure tube and handle kit, CP150...
  • Page 84 CP150 Cable arm and shelf cart option (compatible with the CP150 office and hospital carts) Literature/Documentation Part Number Description Kit, CD, User Documentation, CP 150 Spirometry Option 106584 106583 Directions for Use, Printed Copy, English Quick Reference Guide, Printed Copy, English...
  • Page 88 Material No. 724176...

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