Go To Table Of Contents OPERATION / SERVICE MANUAL Part Number: 3-100-1025 Revision 8.0 2007 Brentwood Medical Technology Corp.
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Next Back IQmark Digital Spirometer Operation Manual TABLE OF CONTENTS FOREWORD ...........................................................................................................................iv A WORD OF THANKS ........................................................................................................ IV COMPUTER DATE INFORMATION ....................................................................................... V Device Labeling Information.....................................
Next Back IQmark Digital Spirometer Operation Manual E. TESTING A NEW PATIENT.......................................................................................... 36 Vital Signs Tab .....................................................................................................38 Medications tab; History tab..............................................................................40 Contact Info tab; Risk Factors tab.....................................................................
Next Back IQmark Digital Spirometer Operation Manual Polgar – Pediatric ............................................................................................... 82 Hsu – Pediatric .................................................................................................... 83 NHANES III (Hankinson, NLHEP) – Pediatric................................................ 84 Zapletal – Pediatric.............................................................................................
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual IQmark is a registered trademark of Midmark. Windows is a registered trademark of Microsoft Corporation. Pentium is a registered trademark of Intel Corporation. Physician’s Responsibility The IQmark Digital Spirometer can provide test interpretations if the user enables the Auto Interpretation feature. These interpretations are for the exclusive use of licensed physicians or personnel under their direct supervision.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual Computer Date Information The IQmark Digital Spirometer uses the current date from the computer and the patient’s birth date (entered by the user) to calculate the patient’s age. Since the Spirometer’s equations and interpretive analysis use the patient’s age to produce appropriate diagnostic statements, it is important that your computer’s current date is accurate.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Device Labeling Information Indications For Use The IQmark Digital Spirometer is indicated for use with male/female adult patients and male/female pediatric patients to evaluate, assess, describe, measure, or monitor the status of pulmonary health, diseases, or conditions.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual 9. Do not open the device handle. Refer servicing to qualified service personnel. Adverse Reactions The IQmark Digital Spirometer is a non-invasive device and is safe in both construction and use. This has been confirmed by the performance of Verification and Validation Testing, Biocompatibility Testing, Risk Assessment Analysis, and ATS testing. The following minor complications can occur with all diagnostic Spirometers: 1.
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Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual I. General Information A. Description The IQmark Digital Spirometer is a portable device that converts a Microsoft Windowsbased personal computer (PC), be it desktop, laptop, notebook, or pen-based, to a fully functional diagnostic Spirometer with interpretive capability. The device is electronically isolated from the PC and connects to it through the serial port (USB or RS232).
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Thin Client Configurations If you have a thin client environment, you can install the software on the Terminal Server and operate the IQmark Digital Spirometer through a thin client terminal. There are two thin client configurations. The IQmark Virtual Channel Solution is appropriate when using Microsoft Windows based PCs as clients.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual USB Or Serial Terminal Server IQmark Digital Spirometer Windows Client PC Network Windows Client PC Windows Client PC To use the IQmark Virtual Channel Solution, load the IQmark Diagnostic Workstation software on the terminal server and install one of the following software components on each Windows client PC that you intend to use for Spirometry data acquisition. 1.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Thin Client Using COM Port Mapping COM port mapping refers to a configuration in which the Midmark Spirometer devices connect to a serial port of the client and the server is configured so that logical COM ports on the terminal server are mapped to the physical COM ports of the client.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual To use the IQmark products in this configuration, install the IQmark Diagnostic Workstation on the terminal server and configure the server to map to the COM port on the client terminal. System administrators should configure the terminal server for COM port mapping as described in the document entitled Application Note: IQmark Products Over Thin Client Environments.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual D. System Specifications The following are the physical and performance specifications for the Spirometer.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual II. System Installation A. Hardware and Software Requirements Both the Diagnostic Workstation and the IQmark Digital Spirometer are 32-bit Windowsbased software. The software will occupy 90 megabytes (MB) of disk space. Additional disk space is required if you choose to store the results of the Spirometry tests performed. Storing the data is optional.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual 2. For 9-pin (COM) port handles, hold the handle upside down (so that the cable is aiming upward); push the battery compartment cover from the middle of the device towards the edge until the cover slides approximately ¼ of an inch. Remove your finger from the cover, the cover will pop upward when released.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Updating from older Brentwood Diagnostic Workstation versions If you are updating from a version of Brentwood Diagnostic Workstation earlier than version 4.0 and have ECG or Holter records that you would like to retain and transfer to the new version, you must first archive those records. Then you must uninstall the old Diagnostic Workstation version, install this new version and restore the archived records.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual D. Configuring The Spirometer The Diagnostic Workstation can be configured to meet your individual needs. Refer to the Diagnostic Workstation Operation Manual for Workstation configuration questions. Spirometry Settings Within the Spirometry application program, a configuration program is installed that enables you to individualize the Spirometer for your operation. To open this box, click on the Settings button.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual If the profile listed in the Configuration Profile box is Default, highlight Default and click Add New. Create a new name for the profile and click OK. The Default profile cannot be modified. Global settings (Institution Name, etc) must be set in Workstation.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Com Port Spirometer – Auto Detect NOTE: The default Communications Port is COM 1. If you have connected the COM port Spirometry handle to COM 1 on the computer, as is the case for most Laptop or Notebook users, you will not need to change the port setting through the IQmark Configuration program. If COM1 is not available, you can use Auto Detect to locate the Spirometer.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Thin Client Channel Setting The Thin Client Channel setting applies only if you are using the IQmark Diagnostic Workstation in a thin client environment. This setting is ignored when the software is not running in a thin client environment. The drop down combo box contains the following selections. 1. COM port mapping (default) 2. Microsoft RDP 3.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Manage Lists The Manage Lists button enables you to modify the Indications List and the Bronchodilator List. You can add or delete items from either list. To add to a list, click the Add button under the appropriate list and type a new item. To delete an item, highlight the item you wish to delete and click the Delete button.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Reports Tab From this tab, you can select which reports to print whenever Print is selected. For each additional check box selected in any one of the Reports areas, the printed the report will include an additional page. In the Reports Tab shown below, the Cover Page box is selected and three report boxes are selected (Best 3 Pre-BD FVC; Pre and Post BD FVC; Pre and Post BD MVV).
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Cover Page, Best 3 Pre and Best 3 Post Selected Another feature of this tab enables you to select the Calibration Report. If this option is selected, every time you print a patient’s report, the calibration that was performed prior to that test is printed with the report. This is helpful if proof of calibration is required. There are five options at the bottom left of this tab.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual ATS Recommended Graph Size The ATS recommends that a Volume Time graph be at least 20 mm per second and 10 mm per liter when hand measurements are required. Some government agencies and insurance carriers require this for reimbursement. In order to create a one page report, all cover page graphs will not print to this scale size. However, all reports from the Reports tab will if Use ATS Graph Scales is selected here.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Cover Page Settings Tab This tab enables you to customize your cover page. Selections on this tab only change the look of the cover page: they do not affect additional report pages. The first selection determines whether the volume-time and flow-volume graphs are printed on this page.
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Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Interpretation Tab From this tab, you can select which Reference Equations set to use as the default for Adults and Pediatrics. Not every Spirometry measurement (FVC, FEV1, etc) are calculated by every Reference Equation. The Secondary reference equations can be used to “fill in” missing measurements.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual The third area on this tab, FVC Settings, enables you to define the acceptable length of test required. Reducing this number will affect the length of test acceptability error code. The ATS recommends that the minimum length of test be set to 6 seconds. Primary Care Practitioner (PCP) Mode The PCP Mode automatically selects the NHANES III reference equations and interpretation logic.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Placing a check mark in the Primary Care Practitioner (PCP) Mode box with another profile selected (not PCP Mode) will enable test grading, remove VC and MVV from the test screen but will not limit the measurement parameters displayed. This allows you to customize the report if desired. To remain in the PCP Mode without customization, simply select the PCP Mode from the Configuration Profile box.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual Choose the Remove button to remove an item from the Selected Measurements list. To use the Delete button, highlight a measurement from the Selected Measurements list and click the Delete button. The measurement will return to the Available Measurements list.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Incentive/Miscellaneous Tab This tab enables you to customize the incentive that the patient will see when performing a test. Since Spirometry is a patient effort dependant test, these incentives can help some patients perform the test properly and complete their exhalation.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Trending Tab This tab enables you to customize the Trending report. You can select which volume, flow and/or percent parameters to display. For additional information on this feature, please refer to the section on Trending.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Ethnic Adjustments Tab This tab enables you to customize the percentages that the predicted value equations are adjusted when testing a specific ethnic code. These percentages can only be adjusted if the Use Default Settings box in not selected, as show below. When this box is selected, the program will set the percentages as stated in the Adjustments to Reference Values Equations set in the Appendix.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual E. Calibration The ATS recommends daily calibration of any Spirometer. The IQmark Digital Spirometer automates this process for quick and accurate preparation of the instrument. Calibrating the Spirometer requires a 3-Liter syringe. Midmark Diagnostics Group strongly recommends a Midmark Diagnostics Group 3-Liter syringe with the Midmark Diagnostics Group Calibration Adapter.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Clicking on the handle will display the following calibration screen. Calibration Screen Check to see if Sensor: Ready is displayed in the upper right hand corner of the graph window. If you are using a Spirometer with a COM connector (DB9) with a model/serial number beginning with 51xxxx, you must place the DPM in the handle to turn it on. Please note that the handle will remain on whenever the DPM is inserted.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Spirometry Settings – Calibration Tab Select the Calibration Reminder box to remind the user when the Spirometer has not been calibrated for the interval set in the Calibration Expiration Interval box. Starting a New Calibration Click New Cal on the Calibration screen to begin a new calibration. Attach the 3-liter syringe to the Calibration Adapter, and then attach the adapter to the mouthpiece.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Calibration Pump Window Follow the instructions displayed. Use the red dotted line and/or the blue timer arrow as a target flow rate. Try to inject the air from the syringe at a rate close to that of the red line. Remember that the syringe handle attached to the plunger must be pulled all the way out before you inject. Once the handle is all the way out, inject the air from the syringe until the handle is all the way in.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual After you have printed or reviewed the calibration report, click Exit to start testing. Social Security Disability – 3 Flow Calibration SSD and OSHA require a calibration at three different flow rates. Midmark Diagnostics Group has incorporated a feature that requires calibration at 0.5 L/s, 1.5 L/s and 3.0 L/s. On the Calibration Tab of Spirometry Settings, there is a check box for Multi-Flow Calibration.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Please refer to the Federal Register or your OSHA representative for additional details about occupational testing. F. Spirometer Handle There are different versions of the Spirometer handle available. Midmark Diagnostics Group offers USB and COM port versions of the handle. The USB handle is designed to operate with a computer. There are two versions of the COM port handle (COM port handles have a DB9 female connector).
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual III. Operation NOTICE This Spirometer has been designed and tested to meet the appropriate sections of IEC 60601-1-1, IEC 601-1, IEC 60601-1-2, UL 2601-1 and ETL (CSA and UL). A. Introductory Notes This manual describes how to use the various features and the operational sequence most users will follow when operating the IQmark Digital Spirometer. However, you are not restricted to follow this particular sequence.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual performed using a mouthpiece. Remember that Spirometry depends on patient effort – the coaching and enthusiasm displayed towards the patient should emphasize the importance of good performance during the test. C. Starting The Program The application that you will use to start the Spirometer is called the IQmark Diagnostic Workstation and is located on your Windows desktop as a shortcut icon.
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Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual There are six choices on the opening screen: STAT ECG – Please see the IQmark Digital ECG Operation Manual for information on this feature. It is not part of the IQmark Digital Spirometer program. New Patient – Enables you to register and proceed with Spirometry or other installed medical testing for a new patient. Patient List – Enables you to view a list of patients previously tested or previously entered into the database.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Patient Data Screen Each of the data fields on this screen can be accessed by clicking in it with the mouse or pressing the tab key. Although some of this information is not essential for Spirometry, it is important to complete each of these fields as accurately as possible.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Patient Data Fields – Required for Spirometry Field Race Diagnostic Role Yes Description Used for information and diagnostic analysis in Reference Values equations if ethnic reductions are enabled. Select one of several pre-labeled choices from the list. If the patient’s race is not listed, if you do not know the patient’s race, or if the patient is of multiracial origin, use Appendix I for assistance.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Vital Signs Tab Fields Field Weight Diagnostic Role * Description *Used for information and as a diagnostic tool by a physician in some cases. Use only numbers. Data may be entered in either English or Metric units, depending on which option is selected in the IQmark Configuration Settings. Height Yes Used for information and diagnostic analysis in Reference Values equations. BMI * Body Mass Index.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Medications tab; History tab Clicking the Medication tab displays a screen that gives you the option of adding, editing or deleting a medication from the patient’s profile. Clicking the History tab displays a screen that gives you the option of adding, editing or deleting medical history from the patient’s profile. Additional information about these tabs can be found in the Diagnostic Workstation Operation Manual.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual F. Instructions for Performing a Spirometry Test To prepare a patient for any Spirometry test, you must explain to the patient the entire procedure for the type of test you want them to perform. Then you should demonstrate for the patient the correct procedure for performing that test.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual PCP Mode is selected as the configuration profile, only the FVC test is available (see Configuring The Spirometer). FVC or FVC Loop The Forced Vital Capacity (FVC) test is usually the first Spirometry test prescribed. Traditionally, the FVC test measures expiratory flow only and the FVC Loop is a FVC test with the inspiratory portion of the test included.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual Spirometry Data Acquisition Screen (Test Screen) By default, the FVC button will be selected. For a Pre-BD test, make sure the words PreBronchodilator appear in the blue box in the middle of the screen. Also notice that the Pre and FVC buttons are bold. Do not click the Start New Test button until the patient is ready. Once the patient is prepared, you must explain the full procedure of the test.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Inhalation – If a flow volume loop is required, ensure that the patient keeps the DPM in their mouth and takes a maximal inhalation at the end of the forced expiration. Have the patient hold the handle next to their cheek, not in front of their mouth. To start the test, click the Start New Test button. The device will “zero” itself. BE SURE THAT NO AIR IS TRAVELING THROUGH THE MOUTHPIECE DURING ZEROING.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual numbers have stopped rising, instruct the patient to inhale maximally or click the Stop button or press the Enter key to complete the test. Both actions will end the test. The program automatically “grades” the test according to ATS criteria. Test Accepted Dialog Box After each completed test, the Test Accepted dialog box appears. The acceptability statement is also displayed with Yes or No automatically selected.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Poor effort Interrupted flow Abrupt stop Inhalation volume is greater than the Exhalation Volume Exhalation volume is greater than the Inhalation Volume This acceptability statement was added by Midmark Diagnostics Group where X is the Minimum FVC Length configuration setting (default is 6 sec.) PEF not reached within 120 ms. Poor effort: Blast out faster; blast out harder Cough or interruption detected.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual tumor, or an injury due to an accident or intubation or tracheotomy. These are all examples of an extrathoracic airway obstruction.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Once the required number of Post-BD tests is performed, click the Save Review button to display the Pre/Post comparison. VC or SVC This test can determine if a patient’s lungs are trapping air during a forced maneuver (FVC test). Air trapping can be an indication of airway obstruction and is also sometimes seen in older patients. This is a very slow and deliberate test.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual To perform the MVV test, the patient must perform the test according to the following instructions: Correctly place the mouthpiece in their mouth. Take at least 3 normal tidal breaths. Inhale and exhale maximally as quickly as possible. Coach and encourage the patient until the test time exceeds 12 seconds. Have the patient remove the mouthpiece from their mouth and allow them to rest.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Spirometry View Report Screen - Summary Click on the Summary, FVC Graphs, MVV Graphs,or VC Graphs tab to view other data for this patient. Remember that only the information stored is available for viewing, i.e., if no VC tests were performed, no VC tests are available for viewing.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual I. Printed Spirometry Reports – Analysis of results The printed reports display patient demographics, test date and time, measurements, graphs, interpretations, and additional analysis of the Spirometry test results. COPD Risk Assessment The Chronic Obstructive Pulmonary Disease (COPD) Risk Assessment uses the Tecumseh Index. It is helpful in smoking cessation programs.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Multi-Patient Report List Screen This screen lists the patients and tests performed at your facility through the Diagnostic Workstation. It provides ID numbers, the report type, the date of each test, as well as other useful information. Use the horizontal scroll bar to view information about additional reports. The Filter Reports section enables you to select reports by date and type.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual K. Trending Trending enables you to compare the best test measurements from two or more Spirometry sessions. Trending - Main Screen Trending enables you to compare different Spirometry measurements over time so that changes in a patient’s condition can be easily seen in graphical and tabular form.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Selecting Reports to Trend The Spirometry Trend Selection dialog box appears when you click the Trending button when viewing Spirometry reports from the View Report screen. Spirometry Trend Selection Dialog Box The default settings are All Reports, Pre-Bronchodilator Tests, and View Report. Report Selection Select which reports to trend. First select All Reports or Select From List.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual View Report – Select to display the Trending screen. You can then choose to print the trending reports from the Trending screen. Print Report – Select to print the trending report to the default printer when you click the OK button. The Trending screen displays briefly and then returns you to the View Report screen.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Measurements – Lists flow or percentage measurements selected for the right axis. Predicted – Lists predicted values for flow or percentage measurements for the right axis. Selecting Parameters to Trend This dialog box enables you to select which parameters to trend. There are six possible sets of parameters. They are: 1. 2. 3. 4. 5. 6.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Side By Side F/V Loops – If checked, the F/V Loops are displayed and printed side-byside. Overlay F/V Loops – If checked, the F/V Loops are displayed and printed overlaid. Default F/V Display On the Trending Tab, select which type of Flow Volume Loops you want to see when the trend report is displayed.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Print Setup – Click to display the Windows printer setup box. Select Reports – Click to close this screen and return to the Spirometry Trend Selection Screen. Select Items To Trend – Click to display the Trending tab from Spirometry Settings. View F/V Loops – Click to display the Flow/Volume loops using the default screen format or the last screen format used.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Side by Side F/V Loops From the Trending screen, click View Side by Side. This screen shows three F/V loops at a time, with the loop to the left representing the oldest and each newer test to the right and then below. Note that the View Side by Side button will change to View Overlay.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Overlay F/V Loops The Overlay F/V Loop screen consists of a single F/V graphical display of the best FVC loop from each trended session, a chart showing the trended plots, and a tabular grid showing the parameters trended. Overlay Screen The F/V loops are displayed in up to ten different colors. If the number of F/V loops exceeds ten, the control reuses colors.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual IV. Appendix A. Screen Summary Summary of Screens Summary of Screens Screen Name Opening Screen Screen Summary Enables you to access the main functions of the Diagnostic Workstation. Patient Data Entry screen Contains data fields for patient information including name, ID, vital signs, medications, smoking and medical history. Patient List screen Shows a list of all patients in the database.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Summary of Screens Screen Name Report List screen Screen Summary Shows a list of all reports for all patients. Spirometry Test Screen Used to acquire Spirometry tests. Also used to accept or reject tests and assign the best test of a session Spirometry Review Screen Shows the interpretation for the best Pre-FVC test. Allows the user to confirm the test interpretation. 62 Main Functions Select report to review.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual B. Troubleshooting This Troubleshooting Guide provides a list of solutions or recommendations to problems that you may encounter with the Diagnostic Workstation. Before calling Midmark Diagnostics Group for Customer Service, please refer to the following table for help. Error messages are displayed at the center or at the bottom right corner of the screen.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual The [test] report dated [test date] for [patient name] is in use by [network computer name] Message appears when trying to open a specific test report. This Report Locking feature prevents more than one user from accessing the same report at the same time, specifically in a LAN environment where different workstations are sharing the central database.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual C. Maintenance and Storage Cleaning CAUTION Do not use aromatic hydrocarbons, rubbing alcohol, or solvents for cleaning the Spirometer. Preventative Cleaning Clean the outside of the Spirometer handle with a mild solution of detergent and water on a soft cloth. Do not use an excessive amount of solution. Be sure not to wet the connectors on the top or the battery compartment at the bottom.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual D. Safety and International Symbols The following symbols are used on Midmark Diagnostics Group products. Refer to this directory for details concerning the symbols used on equipment. Symbol ! Description ATTENTION – Refer to manual for instructions. Year manufactured. 2000 Do Not Use For More Than One Patient – Single Patient Use Only, but multiple tests can be performed on the same patient with a single mouthpiece.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual E. Interpretation – ATS The American Thoracic Society (ATS) created recommendations for the interpretation of Spirometry tests. Measurements are compared to the Lower Limit of Normal (LLN). The IQmark Digital Spirometer software displays the statement "Normal Spirometry" if the FVC and the FEV1/FVC ratio are within the normal range (i.e., above the LLN).
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Lower Limit of Normal (LLN) The LLN for FVC, FEV1 and FEV1/FVC is calculated as follows: LLN Value pred CI 95% The Valuepred is the predicted value provided by the reference equations. The CI95% is the 95% confidence interval for the predicted value. If the CI95% is not reported for the predicted value, and the Standard Error of the Estimate (SEE) is, then the CI95% shall be calculated as follows: CI 95% 1.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual G. Reference Values - Adult The IQmark Digital Spirometer software provides the following sets of reference equations for adult patients. 1. 2. 3. 4. 5. 6.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Crapo - Adult H = Height in centimeters. A = Age in years. Parameter VC M/F W Age Range All FVC M F W W 15–91 15–91 0.06H - 0.0214A - 4.650 0.0491H - 0.0216A - 3.590 0.644 0.393 1.115 0.676 Ref. 4 Ref. 4 FEV0.5 M F W W 15–91 15–91 0.0327H - 0.0152A - 1.914 0.0238H - 0.0185A - 0.809 0.414 0.294 0.708 0.506 Ref. 4 Ref. 4 FEV1 M F W W 15–91 15–91 0.0414H - 0.0244A - 2.190 0.0342H - 0.0255A - 1.578 0.486 0.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Crapo – Adult, continued Parameter Sex PEF FEF25% (MEF75%) FEF50% (MEF50%) FEF75% (MEF25%) MVV Predicted Equation SEE CI95% Source M M F Race Age Range W 18-25 W 25-85 W 20-87 0.0780H + 0.1660A - 8.060 0.0940H - 0.0350A - 5.993 0.0490H - 0.0250A - 0.735 1.653 2.078 1.605 2.72 3.42 2.64 Ref. 14 “ “ M W 18-25 0.0700H + 0.1470A - 7.054 1.530 2.52 Ref. 14 M F W W 25-85 20-87 0.0880H - 0.0350A - 5.618 0.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Knudson - Adult Parameter Sex Race VC M/F W Age Predicted Equation Range All Predicted VC = Predicted FVC SEE CI95% Source FVC M M F F W W W W 18-25 25-85 20-70 70-90 0.0590H + 0.0739A - 6.8865 0.0844H - 0.0298A – 8.7818 0.0444H - 0.0169A – 3.1947 0.0313H – 0.0296A –0.1889 0.4708 0.6384 0.4831 0.5745 0.775 1.05 0.795 0.945 Ref. 13 “ “ “ FEV0.5 M M F W W W 18-25 25-85 20-87 0.030H + 0.043A – 3.0540 0.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Knudson – Adult, continued FEF25% (MEF75%) FEF50% (MEF50%) FEF75% (MEF25%) MVV M W 18-25 0.0700H + 0.1470A - 7.054 1.530 2.52 Ref. 14 M F W W 25-85 20-87 0.0880H - 0.0350A - 5.618 0.0430H - 0.0250A - 0.132 2.012 1.53 3.31 2.52 “ “ M W 18-24 0.0543H + 0.1150A - 6.3851 1.1196 1.184 Ref. 13 M F F W W W 25-85 20-70 70-87 0.0684H - 0.0366A - 5.5409 0.0321H - 0.0240A - 0.4371 0.0118H - 0.0755A + 6.2402 1.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual European Community For Coal And Steel (ECCS) - Adult H = Height in meters. Parameter Sex A = Age in years. Race Age Predicted Equation RSD CI95% See Note 2 See Note 1 VC M F W W 18-70 18-70 6.10H - 0.028A - 4.65 4.66H - 0.026A - 3.28 0.56 0.42 0.92 0.69 FVC M F W W 18-70 18-70 5.76H - 0.026A - 4.34 4.43H - 0.026A - 2.89 0.61 0.43 1.00 0.707 FEV1 M F W W 18-70 18-70 4.30H - 0.029A - 2.49 3.95H - 0.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual NHANES III (Hankinson, NLHEP) - Adult Male age range : Female age range: Parameter Sex >= 18 years >= 20 years Age b1 0.00064 -0.01821 -0.00891 0.01870 0.00536 0.00307 Age2 b2 -0.000269 0 -0.000182 -0.000382 -0.000265 -0.000237 Htprd (cm)2 b3 0.00018642 0.00016643 0.00017823 0.00014815 0.00013606 0.00014246 Htlln (cm)2 b3 0.00015695 0.00013670 0.00014947 0.00012198 0.00010916 0.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Use the following equation to calculate the predicted value for a lung function parameter (LFP). LFP b0 b1 * Age b2 * Age 2 b3 * Height2 Height is in centimeters and age is in years. Use b3 coefficient from the Htprd column for the predicted value calculation. Use the b3 coefficient from the Htlln column to calculate the LLN. The following table presents the predicted values for FEV1.0/FEV6.0 % and FEV1.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Morris - Adult Parameter Sex Race FVC M FEV1 FEF25-75% W Age Range 20-84 Predicted Equation SEE CI95% .0583H – 0.025A – 4.24 0.74 1.22 F W 20-84 .0453H – 0.024A – 2.85 0.52 0.855 M W 20-84 .0362H – 0.032A – 1.265 0.55 0.905 F W 20-84 .0350H – 0.025A – 1.93 0.47 0.773 M W 20-84 0.0185H – 0.045A + 2.513 1.12 1.84 F W 20-84 0.0236H – 0.030A + 0.551 0.80 1.316 Source Ref. 12 Ref. 12 Ref.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Roca - Adult Parameter Sex Race W W Age Range 20-69 20-69 FVC M F FEV1 FEV1/ FVC% 0.0678H – 0.0147A – 6.0548 0.0454H – 0.0211A – 2.8253 0.53 0.403 0.872 0.663 M F W W 20-69 20-69 0.0499H – 0.0211A – 3.837 0.0317H – 0.025A – 1.2324 0.44 0.307 0.724 0.505 M W 20-69 -0.1902A + 85.58 5.36 8.82 F W 20-69 -0.224A – 0.1126W + 94.88 5.31 8.73 FEF25-75% M F W W 20-69 20-69 0.0392H – 0.043A – 1.1574 0.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual H. Reference Values - Pediatric The IQmark Digital Spirometer software provides the following sets of reference equations for pediatric patients. 1. 2. 3. 4. 5. 6.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Knudson – Pediatric Parameter VC M/F W Age Range All FVC M M F F W W W W 6 - 12 12 - 18 6 - 11 11- 20 0.0409H - 3.3756 0.0590H + 0.0739A - 6.8865 0.0430H - 3.7486 0.0416H + 0.0699A - 4.4470 0.3503 0.4708 0.3728 0.4973 0.576 0.774 0.613 0.818 Ref. 13 “ “ “ FEV0.5 M F W W 6 - 18 6 - 18 0.030H + 0.043A –3.054 0.019H + 0.061A – 1.738 0.425 0.364 0.699 0.599 Ref.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual FEF75% (MEF25%) MVV M 6 - 12 0.0171H - 1.0149 0.5037 0.829 Ref. 13 M F F 12 - 18 6 - 11 11 - 20 0.0397H - 0.0057A - 4.2421 0.0109H - 0.1657 0.0243H + 0.2923A - 4.4009 0.0075A2 0.7551 0.4999 0.7202 1.24 0.822 1.18 “ “ “ M F 6 - 18 6 - 19 1.840H + 1.800A - 192.3 1.090H + 3.40A - 108.1 K3 K3 Notes: 1.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Polgar – Pediatric H = Height in centimeters. Parameter Sex Race W W Age Range 4-17 4-17 FVC M F FEV1.0 0.0000044 x H2.67 0.0000033 x H2.72 M F W W 4-17 4-17 0.0000021 x H2.80 0.0000021 x H2.80 FEV3.0 M F W W 4-17 4-17 FVCpred * 0.98 FVCpred * 0.98 FEV1/FVC % M F W W 4-17 4-17 47.73 x H0.13 63.63 x H0.08 FEF25-75% M F W W 4-17 4-17 0.0437 x H – 3.4616 0.0437 x H – 3.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Hsu – Pediatric Parameter W Age Range 7-20 3.58 x 10-7 x H3.18 13 M M F F F B H W B H 7-20 7-20 7-20 7-20 7-20 1.07 x 10-6 x H2.93 1.06 x 10-6 x H2.97 2.57 x 10-6 x H2.78 8.34 x 10-7 x H2.98 1.25 x 10-6 x H2.92 17 13 14 15 14 Ref. 15 “ “ “ “ “ FEV1 M M M F F F W B H W B H 7-20 7-20 7-20 7-20 7-20 7-20 7.74 x 10-7 x H3.00 1.03 x 10-6 x H2.92 1.73 x 10-6 x H2.85 3.79 x 10-6 x H2.68 1.14 x 10-6 x H2.89 1.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual NHANES III (Hankinson, NLHEP) – Pediatric M M M F F F Race Intercept b0 W -0.2584 B -0.4971 H -0.7571 W -1.2082 B -0.6166 H -1.2507 Age b1 -0.20415 -0.15497 -0.09520 0.05916 -0.04687 0.07501 Age2 b2 0.010133 0.007701 0.006619 0 0.003602 0 Htprd (cm)2 b3 0.00018642 0.00016643 0.00017823 0.00014815 0.00013606 0.00014246 Htlln (cm)2 b3 0.00015695 0.00013670 0.00014947 0.00012198 0.00010916 0.00011570 FEV1.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Use the following equation to calculate the predicted value for a lung function parameter (LFP). LFP b0 b1 * Age b2 * Age 2 b3 * Height2 Height is in centimeters and age is in years. Use b3 coefficient from the Htprd column for the predicted value calculation. Use the b3 coefficient from the Htlln column to calculate the lower limit of normal. The following table presents the predicted values for FEV1.0/FEV6.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Zapletal – Pediatric Age range is from 6 to 18 years. H = Height in centimeters. Parameter FVC Sex M F Race W W Predicted Equation 7.9942 – 0.12509 x H + 0.000605 x H2 0.1694 – 0.01217 x H + 0.000605 x H2 FEV1.0 M F W W 6.6314 – 0.10261 x H + 0.000499 x H2 -3.0378 + 0.03640 x H FEF25% M F W W -2.3069 + 0.02817 x H -1.8576 + 0.02483 x H FEF50% M F W W -4.5848 + 0.05430 x H -3.3655 + 0.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual 87
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual I. Adjustments to Reference Values Equations According to the ATS recommendations specified in Reference 2 and studies cited by Enright (Reference 23), Black and Asian adults have FVC and FEV1 values that are approximately 15% below that of Caucasians. Black children have FVC and FEV1 values that are approximately 12% lower than Caucasian children’s values.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual J. Spirometry Measurement Parameters Defined FVC FEV0.5 FEV1.0 FEV25% FEV50% FEV75% PEF FIVC FIV0.5 MTV RR AT Unless otherwise noted: FEV3.0 FEV6.0 FEV1.0/FVC FEV3.0/FVC FEV1.0/FEV6.0 FEV25-75% FEV75-85% FEV200-1200 FEV0.5/FIV0.5 FIF50% PIF Exp Time V ext.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual FEV0.5 / FIV0.5 – Ratio of the volume of air expired in one-half second to the total volume of air inspired in one-half second during the FV loop test. PEF - Peak Expiratory Flow – Largest expiratory flow achieved with a maximally forced effort from a position of maximal inspiration. Also known at PEFR (Rate) in Spirometry or just PF (Peak Flow) in monitoring devices.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual K. References 1. American Thoracic Society. Standardization Of Spirometry - 1994 Update. Am J Respir Crit Car Med, Vol 152, pp. 1107-1136, 1995 2. American Thoracic Society. Lung Function Testing: Selection Of Reference Values And Interpretative Strategies. Am Rev Respir Dis 1991; 144;1202-1218. 3. American Association for Respiratory Care (AARC). AARC Clinical Practice Guideline Spirometry, 1996 Update.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual 15. Hsu, K. H. K., Jenkins, D. E., Hsi, B. P., Bourhofer, E., et al., Ventilatory Function of Normal Children And Young Adults – Mexican-American, White and Black, Spirometry, Journal Of Pediatrics, July 1979, Vol. 95, No. 1, pp. 14-23. 16.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual L. Technical Service Manual Service Manual Introduction The IQmark Digital Spirometer is a PC based diagnostic instrument that converts an Windows based personal computer to a diagnostic Spirometer with interpretative and data storage capabilities.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Theory of Operation The IQmark Digital Spirometer Handle or data acquisition module is a self contained module for the acquisition and digitalization of pressure data acquired via the DPM. The IQmark Digital Spirometer operating principals are that of the Fleisch Pneumotach. The Disposable Pneumotach Mouthpiece The Pneumotach, also known as the flow sensor, mouthpiece or DPM, is a single piece low cost disposable device.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual detection circuit, and identification device and encodes the data with packets and sends it to the PC through the RS232 interface circuit. Serial port controller The serial signal sent out by the PIC micro controller is relayed to the system through the MAX3232CSE RS-232 transceiver. To provide the maximum safety for the patient the Spirometer hardware and the PC are isolated via double insulation.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual (1) For the greatest accuracy, calibrate the Spirometer frequently. Daily calibration is recommended by the ATS. (2) DO NOT RE-USE Disposable Pneumotach Mouthpieces. (3) Replace the batteries when the device LED turns Red or the computer screen displays the “low battery” indication. (4) Inspect the Spirometer periodically for accuracy. Contact Midmark Diagnostics Group for your annual calibration certifications.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual Can Not Zero Spirometer handle LED on handle glows or flashes Red LED on handle glows or flashes Red even after new batteries have been installed LED on handle will not turn on. LED will not turn ON, unit functions correctly. LED on handle will not turn OFF but unit functions correctly otherwise. Battery door will not close Can not install Pneumotach into Spirometer 1.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual M. Spirometry Testing at a Glance A condensed guide to using the IQmark Digital Spirometer with new patients. The ATS recommends that calibration be performed daily before testing is started. 1) Start the Diagnostic Workstation program. 2) Select New Patient from the opening screen. 3) Complete the Name, Date of Birth, Weight, Height, Sex, and Race fields on the screen.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual N. Performing an FVC Test - Quick Reference User’s Guide 1) Start the Diagnostic Workstation program – double-click the Workstation icon. 2) Select the patient. Either click New Patient and enter the appropriate information or click Patient File (for an existing patient) and double-click the appropriate patient name. 3) Check the patient data fields on the screen. Remember that the R.A.S.H.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual O. Performing a Pre/Post FVC Test - Quick Reference User’s Guide TESTING ONE PATIENT AT A TIME 1) Start the Diagnostic Workstation program – double-click the Workstation icon. 2) Select the patient and check the patient data fields on the screen or add a new patient. Remember that R.A.S.H. (Race; Age; Sex; Height) must be entered to obtain predicted values and interpretations. 3) Click New Test.
Back Go To Table Of Contents Next IQmark Digital Spirometer Operation Manual P. Performing a Pre/Post FVC Test – Quick Reference User’s Guide TESTING MULTIPLE PATIENTS 1) Start the Diagnostic Workstation program – double-click the Workstation icon. 2) Select a patient and check the patient data fields on the screen or add a new patient. Remember that R.A.S.H. (Race; Age; Sex; Height) must be entered to obtain predicted values and interpretations. 3) Click the New Test button.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual Q. Glossary ARCHIVING Placing data into storage where it cannot be damaged or altered. Archived data, such as Spirometer reports, can be retrieved at a later date for review. IQMARK DIAGNOSTIC WORKSTATION (DIAGNOSTIC WORKSTATION) The name of the software application you install on your personal computer in order to use the Spirometer.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual MY COMPUTER A Windows icon that appears on the desktop in the form of a stylized computer. Clicking on My Computer enables you to explore your computer’s disks, printers, Control Panel, etc. PORT A place where data is passed in and out of a computer. Personal computers typically have several ports located on the back panels of the computer. The Spirometer communicates the data it collects from patients through a serial port.
Go To Table Of Contents Back IQmark Digital Spirometer Operation Manual USB 104 Universal Serial Bus. An alternate type of serial connection that can be used to connect your Spirometer to your computer.
Go To Table Of Contents Back Next IQmark Digital Spirometer Operation Manual R. Customer Service and Contact Information For help in diagnosing problems with this product, refer to the online help for immediate assistance. You can also contact Midmark Diagnostics Group Customer Service at (800) 6248950. Office hours are 8:00 AM- 5:00 PM, Pacific Standard Time (PST).
Go To Table Of Contents Back Brentwood Medical Technology Corp. Addendum – EMC Requirements Next IQmark Digital Spirometer Instructions for Use Addendum EMC Requirements for the IQmark Digital Spirometer Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Addendum. Portable and mobile RF communications equipment can affect the operation of medical electrical equipment.
Go To Table Of Contents Back Brentwood Medical Technology Corp. Addendum – EMC Requirements Next IQmark Digital Spirometer Instructions for Use Table 2 – Guidance and manufacturer’s declaration – electromagnetic immunity – for the IQmark Digital Spirometer Guidance and manufacturer’s declaration – electromagnetic immunity The IQmark Digital Spirometer is intended for use in the electromagnetic environment specified below.
Go To Table Of Contents Back Brentwood Medical Technology Corp. Addendum – EMC Requirements Next IQmark Digital Spirometer Instructions for Use Table 3 – Guidance and manufacturer’s declaration – electromagnetic immunity – for the IQmark Digital Spirometer Guidance and manufacturer’s declaration – electromagnetic immunity The IQmark Digital Spirometer is intended for use in the electromagnetic environment specified below.
Go To Table Of Contents Back Brentwood Medical Technology Corp.
