MDD Welch Allyn Hillrom Diagnostic Cardiology Suite Spirometry User Manual
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MDD Welch Allyn Hillrom Diagnostic Cardiology Suite Spirometry User Manual

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Diagnostic Cardiology
Suite Spirometry
User Manual

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Summary of Contents for MDD Welch Allyn Hillrom Diagnostic Cardiology Suite Spirometry

  • Page 1 Welch Allyn ® Diagnostic Cardiology Suite Spirometry User Manual...
  • Page 2 © 2019 Welch Allyn. 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 Notices ..................... 1 User Safety ....................3 Warnings ......................3 Cautions ....................... 6 Note(s) ......................... 7 Symbols ....................9 General Care ..................13 Precautions ......................13 Inspection ......................13 Cleaning and Disinfecting .................. 13 Introduction ................... 15 Manual Purpose ....................15 Audience ......................
  • Page 4 iv Contents Welch Allyn® Diagnostic Cardiology Suite Spirometry Recording Tab ....................37 Customize the spiro.txt File ................37 Ambient Settings ................... 39 Calibration of Flow Sensor ..............41 The Calibration Process ..................42 View Calibration Results ..................46 Recording Spirometry Tests ..............51 Start a Test Using the Desktop Application ............

  • Page 5: Notices

    Notices Manufacturer's Responsibility Welch Allyn, Inc. is responsible for the effects on safety and performance only if: • Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons authorized by Welch Allyn, Inc. • The device is used in accordance with the instructions for use. Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule.
  • Page 6 2 Notices Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 7: User Safety

    User Safety WARNING Means there is the possibility of personal injury to you or others. CAUTION Means there is the possibility of damage to the device. Note Provides information to further assist in the use of the device. This manual may contain screen shots and pictures. Any screen shots and pictures are provided for reference only.
  • Page 8 4 User Safety Welch Allyn® Diagnostic Cardiology Suite Spirometry WARNING Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care, and adequately trained in the use of this device. Before attempting to use this device for clinical applications, the operator must read and understand the contents of the user manual and other accompanying documents.
  • Page 9 User manual User Safety 5 WARNING Test Welch Allyn Diagnostic Cardiology Suite functions after each Microsoft critical and security update with a simulator prior to patient use. WARNING Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by qualified service personnel prior to continued use.

  • Page 10: Cautions

    6 User Safety Welch Allyn® Diagnostic Cardiology Suite Spirometry WARNING Fire and explosion hazard. Do not operate the spirometer in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched environments; or in any other potentially explosive environment.

  • Page 11: Note(S)

    User manual User Safety 7 Note(s) Note Local Administrator permissions are required for software installation, and application configuration. Local User privileges are required for application users. Roaming and temporary accounts are not supported. Note The application times out automatically after 8 hours of inactivity. Any operation (e.g.
  • Page 12 8 User Safety Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 13: Symbols

    Symbols Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black and white document.
  • Page 14 Symbols Welch Allyn® Diagnostic Cardiology Suite Spirometry Expiration Date To identify a type BF applied part complying with IEC 60601-1. Meets essential requirements of Canadian Standards Association the European Medical Device mark of conformity Directive 93/42/EC -Applies to spirometer hardware By prescription or order of physician or dentist Note...
  • Page 15 User manual Symbols 11 Package Symbol Delineation Fragile Keep dry Keep away from heat / sunlight Temperature limit Atmospheric pressure limitation Humidity limitation...
  • Page 16 Symbols Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 17: General Care

    General Care Precautions • Turn off the device before inspecting or cleaning. • Do not immerse the device in water. • Do not use organic solvents, ammonia based solutions, alcohol, or abrasive cleaning agents which may damage equipment surfaces. Inspection Inspect your equipment daily prior to operation.
  • Page 18 14 General Care Welch Allyn® Diagnostic Cardiology Suite Spirometry CAUTION If you choose to clean the calibrations syringe, clean the outer surface of the syringe with only the following solutions or wipes: • Solution of dish soap and water, ½ tsp per cup of water •...

  • Page 19: Introduction

    Introduction Manual Purpose This manual provides information about the Welch Allyn Diagnostic Cardiology Suite Spirometry software: • Installing Welch Allyn Diagnostic Cardiology Suite Spirometry • Spirometry Display Overview • Customizing the Spirometry Module • Ambient Settings • Calibration of the Flow Sensor •...

  • Page 20: Contraindications

    16 Introduction Welch Allyn® Diagnostic Cardiology Suite Spirometry transmit and print certain physiological signals identified below and provide the data for consideration by a physician.  Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic resting ECG and diagnostic spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system.

  • Page 21: System Description

    System Description Welcome Welch Allyn Diagnostic Cardiology Suite Spirometry is a computer-based program used to record, view and interpret spirometric tests. It can also be used to print and transmit spirometry tests in various formats. The spirometry module meets the requirements of ISO 26782, Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans.
  • Page 22 18 System Description Welch Allyn® Diagnostic Cardiology Suite Spirometry Pressure Tubing Connects the flow transducers to the spirometer sensor. Spirometer Sensor with USB cable Connects to the USB port of your PC. Converts pressure to airflow. Reusable Patient Handle Connects to the disposable flow transducer and pressure tubing for the patient to hold while performing efforts.

  • Page 23: Features

    User manual System Description 19 Features • Automatic interpretation and comparison to best pre-bronchodilator. • Real-time flow/volume and volume/time graphs. • Incentive graphic for pediatric patient coaching. • Multiple predicted norms. • Multiple report formats. • Validated to meet the ISO 26782 spirometry accuracy standards for both ambient and BTPS humidified air.
  • Page 24 20 System Description Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 25: Installation

    Installation Spirometry Application Installer Before installing the Spirometry software, the Welch Allyn Diagnostic Cardiology Suite Manager software must first be installed. For information on the Welch Allyn Diagnostic Cardiology Suite software installation and upgrade processes, please refer to the Welch Allyn Diagnostic Cardiology Suite Manager user manual.

  • Page 26: Software Upgrade

    22 Installation Welch Allyn® Diagnostic Cardiology Suite Spirometry WARNING Multiple socket-outlet or extension cord not to be connected to the Welch Allyn Diagnostic Cardiology Suite to prevent possibility for excessive touch and leakage currents. Software Upgrade When upgrades of the Welch Allyn Diagnostic Cardiology Suite Spirometry software versions become available, the following process should be followed: Prior to the upgrade: •...

  • Page 27: Spirometer Setup

    User manual Installation 23 Spirometer Setup The Welch Allyn Diagnostic Cardiology Suite Spirometry module consists of two elements: the spirometry sensor, and the software that runs on the computer to which the sensor is connected. Two spirometers are supported, the Welch Allyn Diagnostic Cardiology Suite spirometer, and SpiroPerfect spirometer.
  • Page 28 24 Installation Welch Allyn® Diagnostic Cardiology Suite Spirometry After connecting the device, it is recommended to let the spirometer warm up. Setup the spirometer for a new patient Once the device is connected to the PC and a patient is ready to begin a spirometry test, prepare the sensor for use.

  • Page 29: Spirometry Display Overview

    Spirometry Display Overview This section is a guide to the various parts of the Welch Allyn Diagnostic Cardiology Suite Spirometry application. There are two ways to launch the application: 1. If using Welch Allyn Diagnostic Cardiology Suite as a desktop application: •...
  • Page 30 26 Spirometry Display Overview Welch Allyn® Diagnostic Cardiology Suite Spirometry 4. Parameters Area The parameters area displays each effort and up to 6 user- defined measured parameters. Menu Selections Click on the Settings Menu button in the upper-right area of the display to open the menu for deleting an effort, recalculating the prediction norm and reanalyzing the test.
  • Page 31 User manual Spirometry Display Overview 27 Icon Name Description Save Saves the test and assigns an acquired status, or edited status if changes have been made after initial acquisition. Done Ends and exits the data acquisition session. Print Preview Prompts a Print Preview to select the report sections then send to the default printer for the computer.
  • Page 32 28 Spirometry Display Overview Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 33: Customizing The Spirometry Module

    Customizing the Spirometry Module This section indicates how to adjust various settings like selecting prediction schemes, determining which parameters to view, and set various display options. Customize features in the Spirometry settings. To open the Spirometry settings: 1. Open Welch Allyn Diagnostic Cardiology Suite from the desktop. If using the Welch Allyn Diagnostic Cardiology Suite by Note launching from within an EMR, the System Configuration...
  • Page 34 30 Customizing the Spirometry Module Welch Allyn® Diagnostic Cardiology Suite Spirometry Modality settings can be customized for each group. Ensure that the desired group is selected from the drop-down list before proceeding. Select the tab you wish to modify and click on Save Changes to apply or Discard Changes to cancel changes before exiting.

  • Page 35: Modality Settings And Default Values

    Modality Settings and Default Values The following table indicates the Spirometry Modality settings, and possible values. The default value for each setting is indicated in bold. General Tab Setting Notes Options Prediction Sets the default prediction norm presented to the user as Berglund 1963 an option at the start of a spirometry test.
  • Page 36 32 Modality Settings and Default Values Welch Allyn® Diagnostic Cardiology Suite Spirometry Setting Notes Options Forche II 1988 GLI 2012 Hedenstrӧm 1986 Hedenstrӧm / Solymar Hibbert 1989 Hsu 1979 Knudson 1976 Knudson 1983 Koillinen 1998 Kory 1961 Langhammer 2001 Morris 1971 NHANESIII 1999 Polgar 1971 Roca 1986...
  • Page 37 User manual Modality Settings and Default Values 33 Setting Notes Options the highest sum of FVC + FEV1, or the effort with the highest SVC value. Best Complete: Defined as a composite of the highest parameter values across all selected efforts. Calibration Syringe Configures the value for the volume of the calibration 1000 ml...

  • Page 38: Viewing Tab

    34 Modality Settings and Default Values Welch Allyn® Diagnostic Cardiology Suite Spirometry Viewing Tab Setting Notes Options Parameters In Sets the layout of the six-parameter table Columns Rows Show Predictive If Points is checked, predictive points display and print Points in the FVC graph.

  • Page 39: Parameters Tab

    User manual Modality Settings and Default Values 35 Setting Notes Options Display Lung Age If selected, the estimated lung age will be shown Not selected while viewing a test and in the printed reports for patients 20 years or older. Effort Label If Time is selected, each effort is labeled with the Time...
  • Page 40 36 Modality Settings and Default Values Welch Allyn® Diagnostic Cardiology Suite Spirometry Setting Notes Options Tin/Tex VTmvv BFmvv MVmvv DFRC Time Printer Parameters selected in the Printer column are printed on the Default selections in Six reports. Parameters setting WARNING Selecting more than 15 parameters for printing may result in the list of printed parameters being truncated on all but the Best FVC report.

  • Page 41: Recording Tab

    User manual Modality Settings and Default Values 37 Recording Tab Setting Notes Options Calibration Protocol Select the Single Stroke calibration protocol Single Stroke (recommended for Welch Allyn Spiro Perfect) or Three Stroke Select Three Stroke calibration protocol (1, 2 and 3 seconds flow) ATS Sound Enables or disables sound notification after the...
  • Page 42 38 Modality Settings and Default Values Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 43: Ambient Settings

    Ambient Settings When using the Welch Allyn Diagnostic Cardiology Suite spirometer, the flow sensor’s ambient settings are automatically calculated and input. If the SpiroPerfect flow sensor is used, the ambient settings must be input manually. Adjust the ambient settings (the temperature, humidity and air pressure) before calibrating the flow sensor.
  • Page 44 40 Ambient Settings Welch Allyn® Diagnostic Cardiology Suite Spirometry 1. When starting a new spirometry test, select the Ambient settings button in the new spirometry test window. 2. Enter the Temperature value. (The value for the ambient temperature.) 3. Enter the Humidity value. (The value for the ambient air humidity.) 4.

  • Page 45: Calibration Of Flow Sensor

    Calibration of Flow Sensor CAUTION The American Thoracic Society and Welch Allyn recommend calibrating spirometers every day before use Welch Allyn guarantees accurate calibration only with the use of a Welch Allyn 3L calibration syringe. Although the Welch Allyn Diagnostic Cardiology Suite Spirometry application provides other calibration syringe volumes for use, Welch Allyn is not responsible for the system’s accuracy if these syringes are used.

  • Page 46: The Calibration Process

    42 Calibration of Flow Sensor Welch Allyn® Diagnostic Cardiology Suite Spirometry The Calibration Process There are three ways to prompt calibration of the spirometer: • If using Welch Allyn Diagnostic Cardiology Suite as a desktop application, select the syringe icon at the bottom of the screen. •...
  • Page 47 User manual Calibration of Flow Sensor 43 Setting Description Lot Code Enter the lot code for the flow transducers located on the transducers box. Calibration Code Enter the calibration code for the flow transducers located on the transducers box. See example of a schematic cutout of the label from the flow transducers box below where # are the numbers to be entered.
  • Page 48 44 Calibration of Flow Sensor Welch Allyn® Diagnostic Cardiology Suite Spirometry Setting Description Humidity The ambient humidity. Pressure The ambient pressure. WARNING For the ambient settings pressure field please enter the pressure as given by a barometer in the immediate vicinity. Do not enter the normalized sea-level pressure as commonly listed on internet sites on meteorological data resources.
  • Page 49 User manual Calibration of Flow Sensor 45 9. Follow the on-screen instructions. The blue calibration bar is a guideline that indicates the speed at which to push the plunger. For a single flow calibration protocol: Push the plunger entirely in and pull the plunger out as far as possible, while following the blue bar as closely as possible.

  • Page 50: View Calibration Results

    46 Calibration of Flow Sensor Welch Allyn® Diagnostic Cardiology Suite Spirometry If recalibrating, after pressing Recalibrate, press Repeat Calibration in the Note Calibration window and follow the instructions above. If there is trouble getting the results within the Calibration Error Tolerance try: •...
  • Page 51 User manual Calibration of Flow Sensor 47 Insp.% The inspiration deviation percentage. Avg. Vol The averages of inspiration volume and expiration volume. Abs. Avg.% The absolute average deviation percentage between inspiration volume and expiration volume. The average volume should match as close as possible to the volume of the syringe that is being used to calibrate the sensor.
  • Page 52 48 Calibration of Flow Sensor Welch Allyn® Diagnostic Cardiology Suite Spirometry Selection Description Calibration Logs Press Calibration Logs to view previous calibration attempts. Print Log Press Print log to print the currently selected or displayed log. Print Preview Press OK on the Print dialog box to the view the calibration results before printing.
  • Page 53 User manual Calibration of Flow Sensor 49 Calibration Log Use the calibration log to view calibration information of current and previous calibration efforts. Each time the sensor is calibrated, results are stored in the calibration log. The 100 most recent calibrations are stored. Select a calibration effort from the list to see the curve that belongs to it.
  • Page 54 50 Calibration of Flow Sensor Welch Allyn® Diagnostic Cardiology Suite Spirometry Selection Description Calibrated A check mark shows if the sensor was actually calibrated (yes) or only a log entry was saved (no) To view the calibration log: 1. From the main screen select Start Spirometry Calibration, select Calibration Log in the calibration window.

  • Page 55: Recording Spirometry Tests

    Recording Spirometry Tests The following types of efforts can be recorded with the spirometry module: • FVC: Forced Vital Capacity - the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. • MVV: Maximum Voluntary Ventilation - the volume moved in and out of the lungs in a timed interval with voluntary effort.
  • Page 56 52 Recording Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry The following screen appears if a new effort or test is done Note on a patient that has performed a test within 24 hours. To add additional efforts (pre or post) select Add New Effort. To start a new test, select Create New Test, else cancel to return to the Start a Spirometry Exam window.
  • Page 57 User manual Recording Spirometry Tests 53 CAUTION To obtain predictive values for certain parameters, the patient’s age, gender, race and height must be entered into the window, otherwise no predictive data is reported. Note If required data is missing, the parameter labels are displayed red in the New spirometry test window.
  • Page 58 54 Recording Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry 10. If you have selected Post, enter the medication dosage and unit. The medication and dosage fields are only active if a post-effort is selected. 11. Modify the type of curve presented from the drop-down menu located at the bottom of the right graph (Volume/Time, Flow/Time, or Incentive) 12.

  • Page 59: Incentive Screen

    User manual Recording Spirometry Tests 55 Incentive Screen The incentive screen is used to guide patients through the effort and encourage them to blow into the flow transducer the best they can. Note If the patient’s demographics are outside of the prediction norm demographics no prediction values will be calculated.
  • Page 60 56 Recording Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry 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.
  • Page 61 User manual Recording Spirometry Tests 57 Breathe in and out forcefully at a pace of approximate 30 breaths per minute (2 seconds per complete breath) for 15 seconds (the program automatically stops gathering data after 15 seconds). About quality feedback The spirometer provides effort-quality messages as described in the following sections.
  • Page 62 58 Recording Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry 3. Select Save. The Comment editor is also available after recording.

  • Page 63: Viewing Spirometry Tests

    Viewing Spirometry Tests To view a spirometry test when using the desktop application: 1. From the Welch Allyn Diagnostic Cardiology Suite main screen select Exam Search. 2. Double click to select a patient and open the associated spirometry test 3. Use the tabs and the Effort selector (in the toolbar) for selecting information to view. For more information on how to search and sort records in the Exam Search window, see the Welch Allyn Diagnostic Cardiology Suite Manager manual.
  • Page 64 60 Viewing Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry Test Modes and Tabs Description Select to view only the currently selected FVC efforts A flow/volume curve of the current FVC effort and the flow/volume curves of all selected FVC efforts. The dotted line marks the predicted values. Select to view only the currently selected SVC efforts.
  • Page 65 User manual Viewing Spirometry Tests 61 Common Features for each Tab View multiple flow/volume curves of one test It is possible to view and compare multiple efforts previously recorded in one test. The right hand side of the window displays a flow curve of all selected efforts. The left hand side of the window displays the flow curve of the currently selected effort.
  • Page 66 62 Viewing Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry Selection Description • predictive norm • ATS acceptability criteria • predictive values per parameter, followed by the lower limit of normal in parentheses • effort stage & parameter value • final result parameter values •...

  • Page 67: Fvc Tab

    User manual Viewing Spirometry Tests 63 FVC Tab Selection Description Left Graph The left graph always represents the selected effort in the parameters table as a flow volume loop or as tidal volume. Right Graph The right graph displays curves all efforts selected for a particular stage. Different curve views are selected from the drop down menu: •...

  • Page 68: Svc Tab

    64 Viewing Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry SVC Tab SVC test Review results under the SVC tab. Only volume/time (spirogram) graphs are displayed along with six SVC parameters. Calipers mark the beginning and the end of the tidal area. Each effort line displayed on the graph has a different color.

  • Page 69: Trend Tab

    User manual Viewing Spirometry Tests 65 Only volume/time (spirogram) graphs are displayed along with six MVV parameters. Calipers (vertical lines) mark the beginning and the end of the ventilation volume (not the tidal area). Note Calipers can be manually adjusted. If so, affected parameters will automatically be recalculated.
  • Page 70 66 Viewing Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry Selection Description lower or higher percentages in relation to effort 1. (Effort x / Effort 1) x 100. Example with Effort 1 selected Effort 1 Effort 2 Effort 3 Effort 4 Real value of FEV 1% 3.49 3.70...

  • Page 71: Measurements Tab

    User manual Viewing Spirometry Tests 67 Measurements Tab The Measurements Tab contains a number of parameter values for each FVC, SVC and MVV efforts. Each effort is represented by a separate column. • The measurement table only displays the efforts belonging to the selected stage. It only lists the parameters selected in the settings.
  • Page 72 68 Viewing Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 73: Interpreting Spirometry Tests

    Interpreting Spirometry Tests The spirometry module can automatically interpret FVC efforts by offering interpretations based on testing parameters. WARNING A computer generated interpretation cannot replace sound medical reasoning by a trained professional. Therefore, a physician should always review the interpretation. Editing and Confirming an Interpretation To open the interpretation editor, select Interpretation on the toolbar of the review window.
  • Page 74 70 Interpreting Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry To add comments to the interpretation, click in the comment pane and start typing the comment. To add text to the interpretation edit area, click in the interpretation edit area and start typing the text.

  • Page 75: Complete The Editing Process

    User manual Interpreting Spirometry Tests 71 Complete the Editing Process Once analysis and editing is complete, the exam can be saved to the database. The system can be configured to automatically export results or print reports based on the status of the exam – Acquired, Edited, Reviewed or Signed. Refer to the Welch Allyn Diagnostic Cardiology Suite Manager user manual for more information.
  • Page 76 72 Interpreting Spirometry Tests Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 77: Printing Spirometry Reports

    Printing Spirometry Reports Report Viewer To print a test report, select the print icon from the spirometry display screen, or select an exam in the Exam Search and select Print. Icon toolbar Use the printer icon to open a Windows printer dialog and choose defined printers with properties, print range, and number of copies.
  • Page 78 74 Printing Spirometry Reports Welch Allyn® Diagnostic Cardiology Suite Spirometry Use the checkboxes at the left of the display to choose report formats for inclusion or exclusion in the final printout. Select the arrows in the bottom left corner of the display to refresh the displayed report after a change is made.
  • Page 79 User manual Printing Spirometry Reports 75 Print Report Details Example Report Report Area • Date and time of Pre and Post efforts. • Norm profile used to calculate predicted values.
  • Page 80 76 Printing Spirometry Reports Welch Allyn® Diagnostic Cardiology Suite Spirometry • For each selected Pre and Post effort, this section provides quality indication regarding individual effort acceptability. • Variance of best FVC and FEV1 in Pre and Post phases. ATS standards require this variance to be <150 mL. •...

  • Page 81: Configure The Report

    User manual Printing Spirometry Reports 77 Configure the Report It is possible to make minor customizations to reports. This includes: • Adding a custom logo to the report • Enabling and disabling report sections • Adding a practice name to the report To make these customizations open the Windows start menu, navigate to the Hillrom folder and launch the Report Configuration Tool.
  • Page 82 78 Printing Spirometry Reports Welch Allyn® Diagnostic Cardiology Suite Spirometry Add Practice Name Filling in the Practice Name field will cause the entered test to appear on a generated report. Select Next and Finish when done customizing the report.

  • Page 83: Predictions

    Predictions Norm Profiles Each predictive norm supports a particular subset of parameters and covers a specific population, as detailed in the profile charts below.
  • Page 84 80 Predictions Welch Allyn® Diagnostic Cardiology Suite Spirometry...
  • Page 85 User manual Predictions 81 Norm-Related Clinical Studies Each of the following studies provides expected values for various spirometric parameters by measuring significant samples of a specific population.
  • Page 86 82 Predictions Welch Allyn® Diagnostic Cardiology Suite Spirometry Spirometric Studies in Normal Subjects. I. Forced Expirograms in Subjects 7-70 Berglund Years of Age, Berglund E., et. al., Acta Medica Scandinavica, vol. 173(2): 1963 185-192, 1963. Reference Spirometric Values using Techniques and Equipment that Meet ATS Crapo Recommendations, Crapo RO, et.

  • Page 87: Norm Extrapolation

    User manual Predictions 83 Terveiden suomalaislasten spirometrian ja uloshengityksen huippuvirtauksen Koillinen viitearvot, Hannele Koillinen, et. al., Suomen Laakarilehti, 1998, 5 vsk 53, p. 1998 395-402. The Veterans Administration-Army Cooperative Study of Pulmonary Function. I. Kory Clinical Spirometry in Normal Men, Kory RC, et. al., American Journal of 1961 Medicine, February 1961, 243-258.
  • Page 88 84 Predictions Welch Allyn® Diagnostic Cardiology Suite Spirometry Composite Norm Values When the composite norm is selected, predictive parameter values are filled in from one of the alternative (composite) norm sources listed here. NHANESIII FVC, FEV1, FEV1%, FEV6, FEV1/FEV6, FEV6/FVC, PEF, FEF25-75 Crapo 1981 FEV0.5, FEV3, FEV3/FVC Morris 1971...
  • Page 89 User manual Predictions 85 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 90: Understanding Interpretation Results

    86 Predictions Welch Allyn® Diagnostic Cardiology Suite Spirometry Understanding Interpretation Results The following diagram illustrates the process of collecting and interpreting spirometry data. Acceptability of an Effort An individual effort is deemed acceptable by the Spirometry software when: The effort has a good start: •...
  • Page 91 User manual Predictions 87 Effort - Quality Message Criteria Don't hesitate Back Extrapolated Volume (BEV) is > 150 mL Blast out faster PEF time > 120 ms. Blow out longer, No plateau FET < 6 seconds (3 pediatrics) and no plateau Good effort FET <...
  • Page 92 88 Predictions Welch Allyn® Diagnostic Cardiology Suite Spirometry expiratory flow. The Spirometry application finds time zero by taking the largest slope averaged over an 80-ms period at the beginning of an effort, and extrapolation the slope to find the x-intercept, which equals time zero. Z-score For norms that support calculation of the z-score, this value will be shown together with the % Predicted values.
  • Page 93 User manual Predictions 89 9. Anaesthetic and respiratory equipment – Spirometers intended for the measurement of time forced expired volumes in humans, EN ISO 26782:2009, NSAI Standards, 2009.
  • Page 94 90 Predictions Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 95: Maintaining The Spirometer

    Maintaining the Spirometer Maintaining the sensor The spirometer sensor needs little maintenance to stay in good working condition. WARNING Change the flow transducer for each patient. CAUTION Perform the following inspections daily: • Check that all connections are properly aligned and tight. •...
  • Page 96 92 Maintaining the Spirometer Welch Allyn® Diagnostic Cardiology Suite Spirometry WARNING Satisfactory maintenance procedures must be implemented, or equipment failure and health hazards may result. Only qualified service personnel should repair the equipment. To prevent cross-contamination, do not try to clean the flow transducers and nose clips. Discard these items after a single patient use.
  • Page 97 User manual Maintaining the Spirometer 93 Discarding the equipment Dispose of this product and its accessories according to local regulations. Do not dispose of as unsorted municipal waste. For more specific disposal or compliance information, go to www.welchallyn.com/weee or contact Welch Allyn Technical Support at www.welchallyn.com/about/company/locations.htm.
  • Page 98 94 Maintaining the Spirometer Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 99: Troubleshooting

    Troubleshooting Spirometry Errors Symptom Resolution The device (sensor) is not responding Disconnect and reconnect the sensor. Check if the port settings in the settings menu correspond with the used COM-port. Measured values are incorrect Verify LOT number and perform a verification test. Check the flow transducer for potential obstruction.
  • Page 100 96 Troubleshooting Welch Allyn® Diagnostic Cardiology Suite Spirometry Symptom Resolution Select the Reset Calibration icon to reset the calibration factors to factory default. Use even strokes in calibration. Error message: Wait with pushing the plunger in until the blue calibration bar starts moving.
  • Page 101 User manual Troubleshooting 97 Symptom Resolution Accessing Welch Allyn Diagnostic Cardiology Suite Symptom Resolution Login fails. Ensure the correct username and password are used. Contact administrator of Welch Allyn Diagnostic Cardiology Suite to ensure the username being used is registered in the Users Database section of the system configuration.
  • Page 102 98 Troubleshooting Welch Allyn® Diagnostic Cardiology Suite Spirometry Symptom Resolution In the Users Database under System Configurations, ensure that the user logged in has the proper role selected to export exams. Contact IT administrator to ensure the interfaces are setup and connected.

  • Page 103: Appendix A : System Specifications

    Appendix A : System Specifications Spirometry Software Specifications For minimum specifications for client and server PCs, see the Modality Manager user’s manual. Feature Specification* Tests FVC, SVC, MVV, Pre- and Post- bronchodilator Sensor Type Pneumotach Power Equipment None, obtained from USB port Current consumption 50 mA Max (30 mA typical) Accuracy...
  • Page 104 100 Appendix A : System Specifications Welch Allyn® Diagnostic Cardiology Suite Spirometry Feature Specification* User-defined interpretation statements are also available to be added manually. Reports FVC - Volume / Time FVC - Flow / Volume FVC - Both – Volume / Time and Flow / Volume SVC –...
  • Page 105 User manual Appendix A : System Specifications 101 Part Number Description 100680 Nose Clip 703480 3L Calibration Syringe Syringe Calibration service BASIC-LVL-CAL BASIC-LVL2-CAL Manuals Part Number Description 9515-001-51-CD Physician’s Guide Adult & Pediatric User Manual 80023962 Welch Allyn Diagnostic Cardiology Suite Modality Manager User Manual 80023960 Welch Allyn Diagnostic Cardiology Suite Spirometry User Manual 9515-166-50-CD...
  • Page 106 102 Appendix A : System Specifications Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 107: Appendix B: Electromagnetic Compatibility (Emc)

    Appendix B: Electromagnetic Compatibility (EMC) Electromagnetic Compatibility (EMC) The following information on Electromagnetic Compatibility applies to the USB Spirometry flow sensor. Electromagnetic compatibility with surrounding devices should be assessed when using the device. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the device according to the international standard for EMC for medical devices (IEC 60601-1-2).
  • Page 108 104 Appendix B: Electromagnetic Compatibility (EMC) Welch Allyn® Diagnostic Cardiology Suite Spirometry Emissions and immunity information Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The Medikro spirometers are intended for use in the electromagnetic environment specified below. The customer or the user of the Medikro spirometers should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
  • Page 109 User manual Appendix B: Electromagnetic Compatibility (EMC) 105 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The Medikro spirometers are intended for use in the electromagnetic environment specified below. The customer or the user of the Medikro spirometer should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
  • Page 110 106 Appendix B: Electromagnetic Compatibility (EMC) Welch Allyn® Diagnostic Cardiology Suite Spirometry Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The Medikro spirometers are intended for use in the electromagnetic environment specified below. The customer or the user of the Medikro spirometer should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
  • Page 111 User manual Appendix B: Electromagnetic Compatibility (EMC) 107 Recommended separation distances between portable and mobile RF communications equipment and the equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment.
  • Page 112 108 Appendix B: Electromagnetic Compatibility (EMC) Welch Allyn® Diagnostic Cardiology Suite Spirometry...

  • Page 113: Appendix C: Warranty Information

    Appendix C: Warranty Information Your Welch Allyn Warranty Welch Allyn, Inc. (hereafter referred to as “Welch Allyn”) warrants that components within Welch Allyn products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Welch Allyn, or if not otherwise noted, for a period of thirteen (13) months from the date of shipment.
  • Page 114 110 Appendix C: Warranty Information Welch Allyn® Diagnostic Cardiology Suite Spirometry or damage due directly or indirectly to an occurrence or consequence there from relating to the Product/s. If Welch Allyn should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Welch Allyn shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold.

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