Midmark IQmark Digital SpiroPDA Service Manual

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Summary of Contents

Page 1 - OPERATION / SERVICE MANUAL

OPERATION / SERVICE MANUAL Part Number: 3-100-1025 Revision 8.0 2007 Brentwood Medical Technology Corp. NextGo To Table Of Co

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NextBackGo To Table Of Contents

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IQmark Digital Spirometer Operation Manual 90FEV0.5 / FIV0.5 – Ratio of the volume of air expired in one-half second to the total volume of air in

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IQmark Digital Spirometer Operation Manual 91 K. References 1. American Thoracic Society. Standardization Of Spirometry - 1994 Update. Am J R

Page 5 - IEC 60601

IQmark Digital Spirometer Operation Manual 9215. Hsu, K. H. K., Jenkins, D. E., Hsi, B. P., Bourhofer, E., et al., Ventilatory Function of Normal

Page 6 - FOREWORD

IQmark Digital Spirometer Operation Manual 93 L. Technical Service Manual Service Manual Introduction The IQmark Digital Spirometer is a PC bas

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IQmark Digital Spirometer Operation Manual 94 Theory of Operation The IQmark Digital Spirometer Handle or data acquisition module is a self contai

Page 8 - Device Labeling Information

IQmark Digital Spirometer Operation Manual 95detection circuit, and identification device and encodes the data with packets and sends it to the P

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IQmark Digital Spirometer Operation Manual 96 (1) For the greatest accuracy, calibrate the Spirometer frequently. Daily calibration is recommended

Page 10 - Go To Table Of Contents

IQmark Digital Spirometer Operation Manual 97 Can Not Zero Spirometer handle 1. Air is flowing through the pneumotach while the software is atte

Page 11 - I. General Information

IQmark Digital Spirometer Operation Manual 98 M. Spirometry Testing at a Glance A condensed guide to using the IQmark Digital Spirometer with n

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IQmark Digital Spirometer Operation Manual 99 N. Performing an FVC Test - Quick Reference User’s Guide 1) Start the Diagnostic Workstation pro

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IQmark Digital Spirometer Operation Manual 1I. General Information A. Description The IQmark Digital Spirometer is a portable device that conve

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IQmark Digital Spirometer Operation Manual 100 O. Performing a Pre/Post FVC Test - Quick Reference User’s Guide TESTING ONE PATIENT AT A TIME

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IQmark Digital Spirometer Operation Manual 101 P. Performing a Pre/Post FVC Test – Quick Reference User’s Guide TESTING MULTIPLE PATIENTS 1)

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IQmark Digital Spirometer Operation Manual 102 Q. Glossary ARCHIVING Placing data into storage where it cannot be damaged or altered. Archive

Page 17 - II. System Installation

IQmark Digital Spirometer Operation Manual 103MY COMPUTER A Windows icon that appears on the desktop in the form of a stylized computer. Clicki

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IQmark Digital Spirometer Operation Manual 104USB Universal Serial Bus. An alternate type of serial connection that can be used to connect your

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IQmark Digital Spirometer Operation Manual 105R. Customer Service and Contact Information For help in diagnosing problems with this product, r

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Brentwood Medical Technology Corp. IQmark Digital Spirometer Addendum – EMC Requirements Instructions for Use Addendum to 3-100-1025 Revision

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Brentwood Medical Technology Corp. IQmark Digital Spirometer Addendum – EMC Requirements Instructions for Use Addendum to 3-100-1025 Revision

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Brentwood Medical Technology Corp. IQmark Digital Spirometer Addendum – EMC Requirements Instructions for Use Addendum to 3-100-1025 Revision

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Brentwood Medical Technology Corp. IQmark Digital Spirometer Addendum – EMC Requirements Instructions for Use Addendum to 3-100-1025 Revision

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IQmark Digital Spirometer Operation Manual 2 Thin Client Configurations If you have a thin client environment, you can install the software on the

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IQmark Digital Spirometer Operation Manual 3 NetworkTerminal ServerWindows Client PCWindows Client PCUSBOrSerialIQmark Digital SpirometerWindows C

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IQmark Digital Spirometer Operation Manual 4 Thin Client Using COM Port Mapping COM port mapping refers to a configuration in which the Midmark Spi

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IQmark Digital Spirometer Operation Manual 5 To use the IQmark products in this configuration, install the IQmark Diagnostic Workstation on the te

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IQmark Digital Spirometer Operation Manual 6 D. System Specifications The following are the physical and performance specifications for the Spiro

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IQmark Digital Spirometer Operation Manual 7 II. System Installation A. Hardware and Software Requirements Both the Diagnostic Workstation and

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IQmark Digital Spirometer Operation Manual 82. For 9-pin (COM) port handles, hold the handle upside down (so that the cable is aiming upward); pus

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IQmark Digital Spirometer Operation Manual 9Updating from older Brentwood Diagnostic Workstation versions If you are updating from a version of Br

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NextBackGo To Table Of Contents

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IQmark Digital Spirometer Operation Manual 10 D. Configuring The Spirometer The Diagnostic Workstation can be configured to meet your individual

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IQmark Digital Spirometer Operation Manual 11If the profile listed in the Configuration Profile box is Default, highlight Default and click Add Ne

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IQmark Digital Spirometer Operation Manual 12 Com Port Spirometer – Auto Detect  NOTE: The default Communications Port is COM 1. If you have con

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IQmark Digital Spirometer Operation Manual 13 Thin Client Channel Setting The Thin Client Channel setting applies only if you are using the IQmark

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IQmark Digital Spirometer Operation Manual 14 Manage Lists The Manage Lists button enables you to modify the Indications List and the Bronchodilato

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IQmark Digital Spirometer Operation Manual 15 Reports Tab From this tab, you can select which reports to print whenever Print is selected. For ea

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IQmark Digital Spirometer Operation Manual 16 Cover Page, Best 3 Pre and Best 3 Post Selected Another feature of this tab enables you to select t

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IQmark Digital Spirometer Operation Manual 17 ATS Recommended Graph Size The ATS recommends that a Volume Time graph be at least 20 mm per second

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IQmark Digital Spirometer Operation Manual 18 Cover Page Settings Tab This tab enables you to customize your cover page. Selections on this tab on

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IQmark Digital Spirometer Operation Manual 19 NextBackGo To Table Of Contents

Page 43 - III. Operation

IQmark Digital Spirometer Operation Manual iTABLE OF CONTENTS FOREWORD...

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IQmark Digital Spirometer Operation Manual 20 Interpretation Tab From this tab, you can select which Reference Equations set to use as the default

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IQmark Digital Spirometer Operation Manual 21The third area on this tab, FVC Settings, enables you to define the acceptable length of test require

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IQmark Digital Spirometer Operation Manual 22Placing a check mark in the Primary Care Practitioner (PCP) Mode box with another profile selected (no

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IQmark Digital Spirometer Operation Manual 23 Choose the Remove button to remove an item from the Selected Measurements list. To use the Delete

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IQmark Digital Spirometer Operation Manual 24 Incentive/Miscellaneous Tab This tab enables you to customize the incentive that the patient will see

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IQmark Digital Spirometer Operation Manual 25 Trending Tab This tab enables you to customize the Trending report. You can select which volume, fl

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IQmark Digital Spirometer Operation Manual 26Ethnic Adjustments Tab This tab enables you to customize the percentages that the predicted value equa

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IQmark Digital Spirometer Operation Manual 27 E. Calibration The ATS recommends daily calibration of any Spirometer. The IQmark Digital Spirom

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IQmark Digital Spirometer Operation Manual 28 Clicking on the handle will display the following calibration screen. Calibration Screen Check to

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IQmark Digital Spirometer Operation Manual 29 Spirometry Settings – Calibration Tab Select the Calibration Reminder box to remind the user when

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IQmark Digital Spirometer Operation Manual iiE. TESTING A NEW PATIENT...

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IQmark Digital Spirometer Operation Manual 30Calibration Pump Window Follow the instructions displayed. Use the red dotted line and/or the blue t

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IQmark Digital Spirometer Operation Manual 31After you have printed or reviewed the calibration report, click Exit to start testing. Social Secur

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IQmark Digital Spirometer Operation Manual 32Please refer to the Federal Register or your OSHA representative for additional details about occupati

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IQmark Digital Spirometer Operation Manual 33III. Operation NOTICE This Spirometer has been designed and tested to meet the appropriate section

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IQmark Digital Spirometer Operation Manual 34performed using a mouthpiece. Remember that Spirometry depends on patient effort – the coaching and

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IQmark Digital Spirometer Operation Manual 35 NextBackGo To Table Of Contents

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IQmark Digital Spirometer Operation Manual 36 There are six choices on the opening screen: STAT ECG – Please see the IQmark Digital ECG Operation

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IQmark Digital Spirometer Operation Manual 37 Patient Data Screen Each of the data fields on this screen can be accessed by clicking in it with

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IQmark Digital Spirometer Operation Manual 38Patient Data Fields – Required for Spirometry Field Diagnostic Role Description Race Yes Used for

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IQmark Digital Spirometer Operation Manual 39 Vital Signs Tab Fields Field Diagnostic Role Description Weight * *Used for information and as a

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IQmark Digital Spirometer Operation Manual iiiPolgar – Pediatric ...

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IQmark Digital Spirometer Operation Manual 40 Medications tab; History tab Clicking the Medication tab displays a screen that gives you the option

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IQmark Digital Spirometer Operation Manual 41 F. Instructions for Performing a Spirometry Test To prepare a patient for any Spirometry test, yo

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IQmark Digital Spirometer Operation Manual 42PCP Mode is selected as the configuration profile, only the FVC test is available (see Configuring Th

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IQmark Digital Spirometer Operation Manual 43 Spirometry Data Acquisition Screen (Test Screen) By default, the FVC button will be selected. Fo

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IQmark Digital Spirometer Operation Manual 44 Inhalation – If a flow volume loop is required, ensure that the patient keeps the DPM in their mou

Page 71 - IV. Appendix

IQmark Digital Spirometer Operation Manual 45numbers have stopped rising, instruct the patient to inhale maximally or click the Stop button or pr

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IQmark Digital Spirometer Operation Manual 46where X is the Minimum FVC Length configuration setting (default is 6 sec.) Poor effort PEF not reac

Page 73 - Troubleshooting Guide

IQmark Digital Spirometer Operation Manual 47tumor, or an injury due to an accident or intubation or tracheotomy. These are all examples of an e

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IQmark Digital Spirometer Operation Manual 48 Once the required number of Post-BD tests is performed, click the Save Review button to display the

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IQmark Digital Spirometer Operation Manual 49To perform the MVV test, the patient must perform the test according to the following instructions:

Page 76

IQmark Digital Spirometer Operation Manual iv IQmark is a registered trademark of Midmark. Windows is a registered trademark of Microsoft Corpor

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IQmark Digital Spirometer Operation Manual 50 Spirometry View Report Screen - Summary Click on the Summary, FVC Graphs, MVV Graphs,or VC Graphs

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IQmark Digital Spirometer Operation Manual 51 I. Printed Spirometry Reports – Analysis of results The printed reports display patient demogra

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IQmark Digital Spirometer Operation Manual 52 Multi-Patient Report List Screen This screen lists the patients and tests performed at your facili

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IQmark Digital Spirometer Operation Manual 53 K. Trending Trending enables you to compare the best test measurements from two or more Spirometr

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IQmark Digital Spirometer Operation Manual 54 Selecting Reports to Trend The Spirometry Trend Selection dialog box appears when you click the Tren

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IQmark Digital Spirometer Operation Manual 55View Report – Select to display the Trending screen. You can then choose to print the trending repo

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IQmark Digital Spirometer Operation Manual 56Measurements – Lists flow or percentage measurements selected for the right axis. Predicted – Lists p

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IQmark Digital Spirometer Operation Manual 57Side By Side F/V Loops – If checked, the F/V Loops are displayed and printed side-by-side. Overlay

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IQmark Digital Spirometer Operation Manual 58Print Setup – Click to display the Windows printer setup box. Select Reports – Click to close this s

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IQmark Digital Spirometer Operation Manual 59Side by Side F/V Loops From the Trending screen, click View Side by Side. This screen shows three F

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IQmark Digital Spirometer Operation Manual v Computer Date Information The IQmark Digital Spirometer uses the current date from the computer and t

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IQmark Digital Spirometer Operation Manual 60 Overlay F/V Loops The Overlay F/V Loop screen consists of a single F/V graphical display of the best

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IQmark Digital Spirometer Operation Manual 61 IV. Appendix A. Screen Summary Summary of Screens Summary of Screens Screen Name Screen Summar

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IQmark Digital Spirometer Operation Manual 62Summary of Screens Screen Name Screen Summary Main Functions Report List screen Shows a list of al

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IQmark Digital Spirometer Operation Manual 63B. Troubleshooting This Troubleshooting Guide provides a list of solutions or recommendations to p

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IQmark Digital Spirometer Operation Manual 64 The [test] report dated [test date] for [patient name] is in use by [network computer name] Message

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IQmark Digital Spirometer Operation Manual 65C. Maintenance and Storage Cleaning CAUTION Do not use aromatic hydrocarbons, rubbing alcohol, o

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IQmark Digital Spirometer Operation Manual 66D. Safety and International Symbols The following symbols are used on Midmark Diagnostics Group pr

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IQmark Digital Spirometer Operation Manual 67E. Interpretation – ATS The American Thoracic Society (ATS) created recommendations for the inter

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IQmark Digital Spirometer Operation Manual 68Lower Limit of Normal (LLN) The LLN for FVC, FEV1 and FEV1/FVC is calculated as follows: CIValueLLNpr

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IQmark Digital Spirometer Operation Manual 69 G. Reference Values - Adult The IQmark Digital Spirometer software provides the following sets of

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IQmark Digital Spirometer Operation Manual vi Device Labeling Information Indications For Use The IQmark Digital Spirometer is indicated for use wi

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IQmark Digital Spirometer Operation Manual 70Crapo - Adult H = Height in centimeters. A = Age in years. Parameter Sex Race Age Range Predicted

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IQmark Digital Spirometer Operation Manual 71 Crapo – Adult, continued Parameter Sex Race Age Range Predicted Equation SEE CI95% Source PE

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IQmark Digital Spirometer Operation Manual 72 Knudson - Adult Parameter Sex Race Age Range Predicted Equation SEE CI95% Source VC M/F W A

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IQmark Digital Spirometer Operation Manual 73 Knudson – Adult, continued FEF25% (MEF75%) M W 18-25 0.0700H + 0.1470A - 7.054 1.530 2.52 Re

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IQmark Digital Spirometer Operation Manual 74 European Community For Coal And Steel (ECCS) - Adult H = Height in meters. A = Age in years. Pa

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IQmark Digital Spirometer Operation Manual 75NHANES III (Hankinson, NLHEP) - Adult Male age range : >= 18 years Female age range: >= 20 y

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IQmark Digital Spirometer Operation Manual 76Use the following equation to calculate the predicted value for a lung function parameter (LFP). 2322

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IQmark Digital Spirometer Operation Manual 77Morris - Adult Parameter Sex Race Age Range Predicted Equation SEE CI95% Source FVC M W 20-8

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IQmark Digital Spirometer Operation Manual 78 Roca - Adult Parameter Sex Race Age Range Predicted Equation SEE CI95% FVC M W 20-69 0.0678

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IQmark Digital Spirometer Operation Manual 79H. Reference Values - Pediatric The IQmark Digital Spirometer software provides the following set

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IQmark Digital Spirometer Operation Manual vii9. Do not open the device handle. Refer servicing to qualified service personnel. Adverse Reactio

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IQmark Digital Spirometer Operation Manual 80 Knudson – Pediatric Parameter Sex Race Age Range Predicted Equation SEE CI95% Source VC M/F W

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IQmark Digital Spirometer Operation Manual 81 FEF75% (MEF25%) M 6 - 12 0.0171H - 1.0149 0.5037 0.829 Ref. 13 M 12 - 18 0.0397H - 0.

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IQmark Digital Spirometer Operation Manual 82 Polgar – Pediatric H = Height in centimeters. Parameter Sex Race Age Range Predicted Equation S

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IQmark Digital Spirometer Operation Manual 83Hsu – Pediatric Parameter Sex Race Age Range Predicted Equation SD% Source FVC M W 7-20 3.5

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IQmark Digital Spirometer Operation Manual 84NHANES III (Hankinson, NLHEP) – Pediatric Parameter Sex Race Intercept Age Age2 Htprd (cm)2 Htl

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IQmark Digital Spirometer Operation Manual 85 Use the following equation to calculate the predicted value for a lung function parameter (LFP). 23

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IQmark Digital Spirometer Operation Manual 86Zapletal – Pediatric Age range is from 6 to 18 years. H = Height in centimeters. Parameter Sex Ra

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IQmark Digital Spirometer Operation Manual 87NextBackGo To Table Of Contents

Page 118

IQmark Digital Spirometer Operation Manual 88I. Adjustments to Reference Values Equations According to the ATS recommendations specified in Ref

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IQmark Digital Spirometer Operation Manual 89 J. Spirometry Measurement Parameters Defined FVC FEV0.5 FEV1.0 FEV3.0 FEV6.0 FEV1.0/FVC FEV3.0/

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