Midmark IQmark Digital SpiroPDA Service manual

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OPERATION / SERVICE MANUAL
Part Number: 3-100-1025 Revision 8.0 2007 Brentwood Medical Technology Corp.
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TABLE OF CONTENTS
FOREWORD ...........................................................................................................................iv
A WORD OF THANKS ........................................................................................................ IV
COMPUTER DATE INFORMATION ....................................................................................... V
Device Labeling Information...................................................................................................vi
INDICATIONS FOR USE ...................................................................................................... VI
Intended Use ......................................................................................................... vi
I. General Information ..............................................................................................................1
A. DESCRIPTION ...............................................................................................................1
B. NECESSARY COMPUTER SKILLS ...................................................................................1
C. CONFIGURATION ..........................................................................................................1
Thin Client Configurations .................................................................................. 2
D. SYSTEM SPECIFICATIONS .............................................................................................6
II. System Installation.............................................................................................................7
A. HARDWARE AND SOFTWARE REQUIREMENTS .............................................................7
B. HARDWARE INSTALLATION..........................................................................................7
C. SOFTWARE INSTALLATION ...........................................................................................8
Updating from older Brentwood Diagnostic Workstation versions................. 9
Installing the IQmark Digital Spirometer (and Diagnostic Workstation)...... 9
D. CONFIGURING THE SPIROMETER ...............................................................................10
Spirometry Settings............................................................................................. 10
Com Port Spirometer – Auto Detect .................................................................. 12
USB Spirometer – Auto Detect........................................................................... 12
Thin Client Channel Setting ............................................................................... 13
Configuration Profile.......................................................................................... 13
Reports Tab .......................................................................................................... 15
Cover Page Settings Tab..................................................................................... 18
Interpretation Tab............................................................................................... 20
Primary Care Practitioner (PCP) Mode............................................................ 21
Measurements Tab............................................................................................... 22
Incentive/Miscellaneous Tab .............................................................................. 24
Trending Tab........................................................................................................ 25
Ethnic Adjustments Tab ...................................................................................... 26
E. CALIBRATION .............................................................................................................27
Starting a New Calibration ................................................................................ 29
Social Security Disability – 3 Flow Calibration............................................... 31
OSHA Regulations............................................................................................... 31
F. SPIROMETER HANDLE ................................................................................................32
III. Operation .........................................................................................................................33
A. INTRODUCTORY NOTES .............................................................................................33
Prescription Device............................................................................................. 33
B. PATIENT PREPARATION..............................................................................................33
C. STARTING THE PROGRAM ..........................................................................................34
D. OPENING SCREEN ......................................................................................................34
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E. TESTING A NEW PATIENT.......................................................................................... 36
Vital Signs Tab .....................................................................................................38
Medications tab; History tab..............................................................................40
Contact Info tab; Risk Factors tab.....................................................................40
Smoking History tab ............................................................................................40
F. INSTRUCTIONS FOR PERFORMING A SPIROMETRY TEST ............................................ 41
FVC or FVC Loop.................................................................................................42
Acceptability Statements .....................................................................................45
Flow Volume Loops – Why Inhale?.....................................................................46
Post-Bronchodilator Tests ..................................................................................47
VC or SVC.............................................................................................................48
MVV .......................................................................................................................48
G. REVIEWING PATIENT REPORTS ................................................................................. 49
H. REVIEW SPIROMETRY REPORTS ................................................................................ 49
I. PRINTED SPIROMETRY REPORTS – ANALYSIS OF RESULTS ...................................... 51
COPD Risk Assessment........................................................................................51
Lung Age ...............................................................................................................51
J. REVIEWING DATA FOR OTHER PATIENTS.................................................................. 51
K. TRENDING.................................................................................................................. 53
Selecting Reports to Trend..................................................................................54
Volume Parameters ..............................................................................................55
Flow and Percentage Parameters .......................................................................55
Report Selection ...................................................................................................56
Default F/V Display..............................................................................................57
Trend Display Screen...........................................................................................57
Side by Side F/V Loops ........................................................................................59
Overlay F/V Loops................................................................................................60
IV. Appendix ........................................................................................................................ 61
A. SCREEN SUMMARY.................................................................................................... 61
B. TROUBLESHOOTING ................................................................................................... 63
C. MAINTENANCE AND STORAGE .................................................................................. 65
Cleaning................................................................................................................65
D. SAFETY AND INTERNATIONAL SYMBOLS .................................................................. 66
E. INTERPRETATION – ATS............................................................................................ 67
Lower Limit of Normal (LLN) .............................................................................68
F. INTERPRETATION – NHANES III.............................................................................. 68
G. REFERENCE VALUES - ADULT ................................................................................... 69
Crapo - Adult ........................................................................................................70
Knudson - Adult....................................................................................................72
European Community For Coal And Steel (ECCS) - Adult ..............................74
NHANES III (Hankinson, NLHEP) - Adult ........................................................75
Morris - Adult .......................................................................................................77
Roca - Adult ..........................................................................................................78
H. REFERENCE VALUES - PEDIATRIC............................................................................. 79
Knudson – Pediatric ............................................................................................80
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Polgar – Pediatric ............................................................................................... 82
Hsu – Pediatric .................................................................................................... 83
NHANES III (Hankinson, NLHEP) – Pediatric................................................ 84
Zapletal – Pediatric............................................................................................. 86
Eigen – Pediatric................................................................................................. 86
I. ADJUSTMENTS TO REFERENCE VALUES EQUATIONS .................................................88
J. SPIROMETRY MEASUREMENT PARAMETERS DEFINED ..............................................89
K. REFERENCES ..............................................................................................................91
L. TECHNICAL SERVICE MANUAL ...................................................................................93
Service Manual Introduction ............................................................................. 93
Theory of Operation............................................................................................ 94
System Maintenance and Obtaining Service .................................................... 95
M. SPIROMETRY TESTING AT A GLANCE ........................................................................98
N. PERFORMING AN FVC TEST - QUICK REFERENCE USER’S GUIDE ............................99
O. PERFORMING A PRE/POST FVC TEST - QUICK REFERENCE USER’S GUIDE ...........100
TESTING ONE PATIENT AT A TIME ............................................................. 100
P. PERFORMING A PRE/POST FVC TEST – QUICK REFERENCE USER’S GUIDE ...........101
TESTING MULTIPLE PATIENTS.................................................................... 101
Q. GLOSSARY ...............................................................................................................102
R. CUSTOMER SERVICE AND CONTACT INFORMATION ................................................105
Warranty............................................................................................................. 105
Return Goods Authorization ............................................................................ 105
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS ............2
EMISSIONS TEST ..................................................................................................................2
COMPLIANCE........................................................................................................................2
ELECTROMAGNETIC ENVIRONMENT – GUIDANCE ..................................................................2
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY .............3
IMMUNITY TEST .......................................................................................................................3
IEC 60601 TEST LEVEL ............................................................................................................3
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY .............4
IMMUNITY TEST .......................................................................................................................4
IEC 60601 TEST LEVEL ............................................................................................................4
RECOMMENDED SEPARATION DISTANCE .........................................................................................4
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE IQMARK DIGITAL SPIROMETER..............................5
W .............................................................................................................................. 5
80 MHz to 800 MHz ................................................................................................. 5
800 MHz to 2.5 GHz ................................................................................................ 5
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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. The suggested interpretation and
the numerical and graphical results should be examined with respect to the patient’s
overall clinical condition. Final analysis should always be determined and verified by a
physician.
Spirometry is an effort dependent test. Proper administration of the test is the physician’s
responsibility, as is making a diagnosis, obtaining expert opinions on the results, and
implementing the correct treatment, if indicated.
FOREWORD
A Word of Thanks
Thank you for purchasing the IQmark Digital Spirometer and IQmark Diagnostic
Workstation. Midmark Diagnostics Group has used the latest microelectronic and
computer software technology to develop a fast, efficient, and accurate Spirometry
system. We trust our product will enable you to use office-based Spirometry tests to
diagnose and enhance your patient’s pulmonary health.
Midmark Diagnostics Group provides a range of diagnostic products, including ECG and
Holter, which are accessed using the Diagnostic Workstation program.
We believe you will be pleased with the user-friendly operation of our product and with
your results. As your partner in patient care, we look forward to working with you in the
coming years as we develop even more sophisticated diagnostic technology for the
medical field. Your thoughts, questions and comments about our product and direction
are welcomed.
Midmark Diagnostics Group PH (800) 624-8950.
www.midmarkdiagnostics.com
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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. Contact your
system administrator if your computer’s date is incorrect.
Notice
The information in this operation manual is subject to change without notice.
Brentwood Medical Technology Corp. (dba Midmark Diagnostics Group) shall not be
liable for technical or editorial omissions made herein, nor for incidental or consequential
damages resulting from the furnishing, performance, or use of information in this
operation manual.
This document contains proprietary information protected by copyright. No part of this
document may be photocopied or reproduced in any form without prior written consent
from Brentwood Medical Technology Corp.
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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.
Intended Use
The IQmark Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic
Spirometer for pulmonary function evaluation and data management. The Spirometer is for use
in hospitals or physician/clinician offices.
Contraindications
The Disposable Pneumotach Mouthpieces are clean but not sterile and should not be placed over
open wounds that are prone to infection. There are no other known medical contraindications
other than the physical limitations of the patient.
Warnings
To ensure accurate patient testing, you must replace the Midmark Diagnostics Group accessories
used with this device with accessories manufactured by Midmark Diagnostics Group.
The American Thoracic Society (ATS) Standardization of Spirometry recommends the use of
rubber gloves when replacing Disposable Pneumotach Mouthpieces (DPM), and hand washing
after touching DPMs.
Precautions
Read and observe the following precautions to ensure the proper operation of this device.
1. Familiarize yourself thoroughly with the operational procedures of the device prior to use. It
is recommended that the user be trained in the methods of administrating Spirometry tests to
a patient by an organization that is certified by a recognized agency.
2. Installation location and maintenance of the device.
a) Avoid installing the device in direct sunlight. Install and keep the device away from
splashing fluids.
b) Do not install the device where it may be affected by significant or extreme changes in
humidity, ventilation, airborne particles containing dust, salt, sulfur, etc.
3. Prepare the device for operation according to instructions in this operation manual.
4. Precaution while using device - Observe the patient closely. If any abnormality is observed,
proper action, which may include stopping the test, should be taken immediately.
5. Precaution after using device - The software turns off the device power according to
programmed procedures. Keep the device clean at all times to ensure trouble-free operation.
6. In case of a malfunction, call Customer Service and precisely describe the problem.
7. Perform routine inspection on the device. Keep all items in a clean environment.
8. Do not make any modifications to the device; any modifications made will void the warranty.
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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. Infection or injury due to the use of a non-sterile mouthpiece over open wounds
2. Skin or mucous membrane abrasion caused by prolonged rubbing or excessive use of the
mouthpiece (not related to biocompatibility issues)
3. Nasal, oral, or dental pain
4. Drying of oral or pharyngeal mucosa
5. Congestion or irritation of Eustachian tubes
6. Gastric distention or flatulence from ingested air
7. Slight discomfort during test procedures
8. Decreased secretion clearance during test procedures
9. Aspiration of secretions
10. Hyperventilation and possible dizziness
Patients may become light-headed, dizzy, or even faint during a test maneuver. Be sure to watch
the patient closely and place a chair behind the patient before beginning any procedure.
Electrical, Safety, Biocompatibility Standards
This Spirometer has been tested to comply with the following standards:
UL STD 2601-1
CAN/CSA STD C22.2 601.1-M90
IEC 601-1 (Electrical)
IEC 60601-1-1 (Safety)
EN 60601-1-2 (EMC, 2nd Ed. 2001)
ISO 10993-5 (Cytotoxicity)
ISO 10993-10 (Irritation and Sensitization)
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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).
Together with the Diagnostic Workstation, the Spirometer makes it easy to record
Spirometry efforts, interpret them, and archive them for future reference.
B. Necessary Computer Skills
This manual assumes that you are already capable of using Windows-based applications,
that you have some understanding of how a PC works, and that you are familiar with the
basic operations of Windows. If this is true, you will have no problem using the product.
However, in the event that you have any technical questions or problems, please refer to
the Troubleshooting Guide (Appendix B) or the Technical Service Manual (Appendix L)
of this manual for immediate troubleshooting assistance. Customer Service contact
information is listed in Appendix R.
C. Configuration
Block Diagram
The block diagram below illustrates the configuration of the system. The primary
components are a Windows-based PC, a printer, and the IQmark Digital Spirometer
handle. A portable computer is recommended if mobility is a consideration.
Figure 1.0
Block Diagram for the IQmark Digital Spirometry system
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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. In this configuration,
you can use either the USB or serial port versions of the IQmark Digital Spirometer
product in high latency, limited bandwidth network configurations. The following section
describes the virtual channel solution. The second possible configuration is to use the
serial port version of the IQmark Digital Spirometer product and connect it to client
devices via COM port mapping. This configuration is appropriate when using nonWindows thin client devices on low latency high-speed networks. The section entitled
Thin Client Using COM Port Mapping discusses this solution.
Setting up any application on a network environment typically requires special access
rights and knowledge of the network. Please have your network administrator install and
setup the software to fit your office environment.
Thin Client Using the IQmark Virtual Channel Solution
The IQmark Thin Client Virtual Channel software provides the following advantages over
COM port mapping.
1. Operation over high latency, low bandwidth, high loss networks. For Microsoft
Terminal Services, the virtual channel provides a 10 to 1 improvement in
performance in latency tolerance over COM port mapping. For Citrix ICA the
performance improvement is approximately 40 to 1 in latency tolerance.
2. No COM port mapping is required.
3. It is possible to use the USB versions of the Spirometer module.
4. Improved device auto-configuration and diagnostics.
 NOTE:
The IQmark Virtual Channel Solution has specific requirements for
computer hardware, software and network performance. System
administrators must read the document entitled Application Note: Using
the IQmark Thin Client Virtual Channel Software before installing,
configuring and using this software in a thin client environment.
The following block diagram describes the IQmark Virtual Channel Solution. In this thin
client environment, the client computers must be running Windows XP SP2 or Windows
Vista.
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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. IQmark Virtual Channel Client for Microsoft Terminal Services (part number 4100-1420) if you are using Microsoft Terminal Services (also called Microsoft
RDP).
2. IQmark Virtual Channel Client for Citrix ICA (part number 4-100-1430) if you are
using Citrix software on your clients and servers.
The above software products are provided separately and may be obtained by contacting
Midmark Diagnostic Group’s customer service department at (800) 624-8950.
Once you have installed the software on the server and client computers, you must
configure the software for virtual channel operation as described in the “Configuring the
IQmark Diagnostic Workstation” section of the IQmark Diagnostic Workstation
Operation Manual and in section II-D Configuring the Spirometer in this manual.
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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.
If you are using non-Windows based thin client terminal devices on a low-latency, highspeed network you must use the serial port versions of the IQmark Digital Spirometer and
configure the thin client server for COM port mapping.
 NOTE:
In order to use the COM port mapping solution in a thin client
environment, the computer hardware and software as well as the network
must meet stringent performance requirements. System administrators
must read the document entitled Application Note: IQmark Products
Over Thin Client Environments before installing, configuring and using
this software in a thin client environment using COM port mapping.
The following block diagram illustrates the use of the IQmark Digital Spirometer product
in a thin client environment using COM port mapping.
Serial
Term inal Server
Client
IQmark Digital Spirometer
Network
Client
4
Client
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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.
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D. System Specifications
The following are the physical and performance specifications for the Spirometer.
Spirometer Specifications
Performance Specifications
Category
Intended Use
Physical Characteristics
(Handle)
Anatomical Sites
Patient Contact
Safety Parameters
Spirometry Acquisition
Ranges
Environmental Conditions
(temperature and humidity)
BTPS
Analysis & Measurement
Parameters Measured
Reference Values Sets
Interpretations
Printer
Paper
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Specification
 To provide diagnostic Spirometry results that a
licensed practitioner can use to interpret the
current condition of a patient’s lungs.
 Approximately 7” (178mm) x 2 1/4” (57mm) x
1.5” (38mm) (HxWxD)
RS232 (serial)
USB (serial)
Weight – 10 oz. (w/batteries)
8.5 oz.
Batteries – Two 1.5V AAA alkaline
N/A
 Plugs into standard serial port
USB
DB9 or DB25 w/adapter
 Non-invasive device
 Disposable Pneumotach Mouthpiece (DPM)
 Double insulated handle
 Fleisch Pneumotach – differential pressure
reading of flow with a DPM
 Volume determined by flow integration
 +/- 14 L/s – Flow
 +/- 8 L – Volume
 30 s – Maximum Measuring Time
 15C to 40C
 10% to 90% Humidity, non-condensing
 Automatic BTPS Correction
 Automatic Back Extrapolation calculation
 Automatic Spirometry parameter calculation
 Automatic comparison to published Spirometry
Predicted Equations (Reference Values)
 Automatic interpretation of test results
 See Appendix J
 See Appendix G & H
 ATS (1991) - Appendix E
 NHANES III (NLHEP 1999) - Appendix F
 Windows supported ink jet or laser printer
 8.5” x 11” (Letter size) or
210mm x 297mm (A4 size)
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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. This software shall run on a personal computer using a
Pentium 500 MHz or faster processor, running Windows 2000, Windows XP or Windows
Vista. For each operating system listed, the Spirometry program will run on the minimum
RAM requirements as recommended by Microsoft:
Windows 2000
Windows XP
Windows Vista
128 MB of RAM
256 MB of RAM
512 MB of RAM
In order to install and successfully use the Spirometer, your computer must meet the
following minimum requirements:
1. Windows-based PC with Windows 2000, Windows XP or Windows Vista.
Precaution: The Workstation and Spirometer have been tested for proper function with the
Off-The-Shelf (OTS) Operating Systems (OS) specified in this manual. Do not operate the
Workstation and Spirometer with an operating system other than the OTS OS specified.
Future releases of currently approved operating systems should not be used until Midmark
Diagnostics Group has had an opportunity to test the Spirometer with them. Before
updating your operating system, contact Midmark Diagnostics Group for the latest OTS
OS information.
2. Keyboard, mouse, and a CD-ROM drive.
3. VGA display accommodating 800x600, 1024x768, 1280x1024, or higher resolution.
Minimum 256 colors (16-bit color recommended).
4. One (1) serial port (RS232C port, usually COM1 or COM2) or a USB port (use a USB
to Serial Port adapter for the Spirometer handle with the 9-pin connector).
B. Hardware Installation
1. Remove the items from the packaging and verify that you have the following:
 IQmark Digital Spirometry software installation CD
(Diagnostic Workstation software is included on CD)
 IQmark Digital Spirometer Handle with built-in serial cable (USB or 9-pin)
 10 Single Patient Use, Disposable Pneumotach Mouthpieces and nose clips
 Four (4) AAA alkaline batteries (Spirometers provided with a USB connector do
not require batteries, so none are supplied).
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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. Insert two (2) AAA
batteries into the battery holder, negative end in first, making sure to follow the
battery polarity diagram (negative end towards the top) located on the lower side of
the handle. Close the battery compartment cover.
3. For COM port handles, attach the female end of the 9-pin communication cable to an
available PC serial port. You may also use a 9-pin-to-25-pin adapter as necessary (see
note below). Secure the connections with the thumbscrews. Do not over-tighten.
If using a 25-pin serial port (e.g., COM 2), connect the 25-pin (female) -to- 9-pin
(male) adapter to the port on back of the computer. Then connect the female end of
the 9-pin connector on the communication cable to the 9-pin port on the adapter.
4. If you received a USB Spirometer, no batteries are needed. DO NOT plug the USB
Spirometer in to the computer until the Workstation and Spirometry software has
been installed. Once the software is installed, simply plug the USB connector into any
available USB port and the software will automatically detect the Spirometer.
 NOTE:
For IQmark Holter and ECG users only: If one of these IQmark
programs is already installed and its security key on the same PC, you will
not need to adjust the security key.
C. Software Installation
Before installing the IQmark Digital Spirometry software on your computer, it is
important that you understand and carry out the following tasks appropriately.
Windows Taskbar
The Diagnostic Workstation is designed to run as a full-screen program. For best results,
the Windows Taskbar should be set to Auto hide to provide maximum display area. To
do so, position the mouse pointer on the gray portion of the Taskbar on bottom of the
screen. Press on the right mouse button and select Properties. Make sure the Auto hide
box is checked. Click OK.
Screen Saver
If screen saver or any energy saving feature is enabled on the computer, disable it. Refer
to your computer or software manual to find and change these settings.
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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.
Refer to the Diagnostic Workstation Operation Manual for instructions on updating.
Installing the IQmark Digital Spirometer (and Diagnostic Workstation)
Close all Windows programs before running this software installation. Once the
installation program is initiated, it should not be interrupted until completed. The
approximate installation time is five minutes.
1. Insert the Midmark Diagnostics Group software CD into the CD-ROM drive.
2. Follow the instructions on the screen.
Refer to the Diagnostic Workstation Operation Manual if you have any questions. The
installation CD will install both Workstation and Spirometry software.
You can access the online IQmark Digital Spirometer Operation Manual from the
Windows Task Bar through the following sequence:
 Start  Programs  Midmark Diagnostics  IQmark Spirometry Manual
3. The installation program adds at least three shortcuts to your Windows desktop: one
for the IQmark Workstation; one for the IQmark Configuration; one for the
Spirometry Calibration. You can use the IQmark Configuration or the
Spirometry Calibration program to set the communications port that the Spirometer
uses or to set up your network database. If you installed the Adobe Reader, this icon
is also added to your Windows desktop.
 NOTES:
 The IQmark Digital Spirometer application uses the IQmark Diagnostic
Workstation to manage patient records. When you install or upgrade the
Spirometer, the IQmark Diagnostic Workstation is automatically installed or
upgraded accordingly.
 You may also access other Midmark Diagnostics Group PC-based products, such
as the Holter or ECG, from the IQmark Diagnostic Workstation, if the product
is installed on the same computer. Call Midmark Diagnostics Group for the latest
information on additional PC-based diagnostic products.
 The IQmark Diagnostic Workstation is called the Diagnostic Workstation or
Workstation for the remainder of this manual.
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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.
The Settings button can be found in several locations. It can be accessed through the
Spirometry Calibration icon, IQmark Configuration icon, the New Test screen, and
the Spirometry Review and Edit screen within the Workstation program. Click the
Settings button to display the following configuration menu.
Spirometry Settings – Configuration Tab
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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.
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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.
Click the Auto Detect button to find the port that the Spirometry handle is connected to.
To use Auto Detect, you must have the Spirometry Module connected to an available
serial port on the computer and then click the Auto Detect button. If Auto Detect
cannot find the Spirometer, the following screen will appear:
Auto Detect Screen
Check the items listed and click OK. When the software finds the Spirometry handle,
click OK to select the correct port.
USB Spirometer – Auto Detect
If you ordered a Spirometer with a USB connector, the Auto Detect button will not
display. The USB driver for the Spirometer is installed when the software is installed. The
software will detect the USB Spirometer automatically when it is connected. DO NOT
connect the USB Spirometer until the Workstation and Spirometry software is
successfully installed. The software must be installed before the Spirometer is connected.
USB Spirometer Connected
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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. Citrix
Select “COM port mapping” if you are using the IQmark Diagnostic Workstation product
in a thin client and are not using the IQmark Virtual Channel Solution. If you are using
the IQmark Virtual Channel Solution, select Microsoft RDP if your clients and servers are
using Microsoft Terminal Services or select Citrix if your clients and servers are using
Citrix software. Please refer to the document entitled “Application Note: Using the
IQmark Thin client Virtual Channel Software” for more information.
Configuration Profile
Click the Add New button in the Configuration Profile area of this tab. Assign a name,
e.g. My Config, and click OK. You can now modify the selections in the setup menu.
Changing the Institution Name and Institution Address will change the header of your
reports. Both fields are optional.
 NOTE:
The original configuration profile may be set to Default. The Default
profile cannot be changed. You must click the Add New button to create
a new profile to change these settings. Once a new profile is added, you
can change the settings on the other tabs. Other preset profiles are shipped
with the instrument. Any of the other profiles can be modified or deleted.
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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.
Managed Lists Dialog Box
For example, if a doctor uses only Albuterol for a bronchodilator, this list can be modified
so that Albuterol is the only selection available. The list always appears in alphabetical
order.
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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).
If a test session only contains Pre-BD FVC tests, clicking on Print will print a three page
report. The first page is the Cover Page, the second page is the Best 3 Pre-BD FVC tests
performed and the third page is the best Pre-BD test.
If the Cover Page box is selected and no boxes within the Reports area are selected,
only a one-page report will print because no additional Reports boxes are selected.
Spirometry Settings – Reports Tab
If the patient has Pre- and Post-Bronchodilator, FVC, VC and MVV tests saved, all
applicable selected reports will print when the Print button is clicked.
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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. Four of these selections – Vol/Time
Predicted Curve, Flow/Vol Predicted Curve, Use ATS Graph Scales, Print Using
Color, affect all reports, including the cover page. Print Test Quality Statements only
affect the reports selected in the Report areas – they do not affect the cover page.
For example, if the Predicted Curve boxes are selected, the predicted Volume/Time and
predicted Flow/Volume graphs for the patient are printed on the secondary report pages
and will also print on the cover page graphs.
The Cover Page Settings tab has separate selections for Smoking History, COPD
Risk, Lung Age and Test Quality Statements. Please see the Cover Page Settings
tab section for additional information about the cover page.
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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. These graphs will print on the pages following the cover page.
Please use this setting if requested from your carrier or for government agencies.
Enable ATS Graph Scales
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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.
The Pre and Post BD Table Format selections determine whether the report includes
only the Best Pre and Best Post BD test or the Best 3 Pre and Best 3 Post BD tests. This
option is available when both Pre and Post BD tests have been saved.
If the patient has performed only Pre or only Post BD tests, the Pre Or Post BD Table
Format selections will take effect.
The check box selections at the bottom of this page (Print Smoking History; Print COPD
Risk; Print Lung Age: Print Test Quality Statements) determine what additional
information appears in the patient demographics field and graph section of the cover
page. These selections do not affect any of the additional report pages.
Spirometry Settings – Cover Page Settings Tab
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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. For example, if your primary reference equation does
not have an equation for FEF25, you can select a secondary reference equation that does
to “fill in” your report.
Spirometry Settings – Interpretation Tab
You can also turn on or off the Auto. Interpretation feature. If the Auto. Interpretation
box is selected, you can select the ATS Logic or the NHANES III logic. If you do not
wish to have the software automatically interpret the Spirometry tests, clear the Auto.
Interpretation box. The Primary Care Practitioner (PCP) Mode overrides Reference
Equation and Interpretation selection. It is discussed on the next page.
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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. It also modifies the test acquisition screen, the test review screen and
the printed reports. To set the Spirometer into the PCP Mode, the user selects PCP
Mode from the pull-down list in the Configuration Profile box and clicks OK.
As recommended by the National Lung Health Education Program (NLHEP), this mode
simplifies the test procedure, measurements displayed and report options. For the test
procedure, it eliminates the inhalation side of the flow volume loop and stops the test at 6
seconds of exhalation. It also eliminates the VC and MVV test selection.
For the measurements and reports, it only displays values for FEV1, FEV6 and
FEV1/FEV6 and limits the number of digits displayed to two (FEV1 and FEV6 is
displayed as X.X Liters and FEV1/FEV6 is displayed as YY %). Any measured values
that fall below the Lower Limit of Normal (LLN) will be displayed in red (bold in black
and white).
After each test maneuver is performed, the software will grade the test session. The
quality control grade displayed will be A, B, C, D, or F. A test session must be graded A,
B, or C to generate an interpretation and the results of Pre-FVC and Post-FVC tests are
only compared if both the Pre and Post sessions are graded A, B, or C. To have the
software display “Good Test Session”, you must acquire two acceptable tests that match
according to the criteria listed here.
QC Grade
A
B
C
D
F
Criteria
At least two acceptable maneuvers with the largest FEV1 values matching
within 100 ml and the largest two FEV6 values matching within 100 ml.
At least two acceptable maneuvers with FEV1 measurements that match
between 101 and 150 ml.
At least two acceptable maneuvers with FEV1 measurements that match
between 151 and 200 ml.
Only one acceptable maneuver or more than one acceptable maneuver,
but the FEV1 values don’t match within 200 ml.
No acceptable maneuvers
If the FVC maneuver is less than 6 seconds (because the operator ended the test) but the
end of test volume is less than 100 ml during the last 0.5 seconds, then the software will
set the FEV6 value equal to the FVC value (if the FVC measurement is valid).
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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.
Measurements Tab
This tab enables you to customize which measurements you want to appear on the cover
page, the test screen and the review screen. You must select at least one measurement.
If you have selected the Tables and Graphs setting for your Cover Page, the cover
page report displays only the first 9 measurements selected. If Table Only is selected, the
cover page displays up to 28 measurements.
Spirometry Settings – Measurement Tab
You can place the measurements in any order you wish by using the Add, Insert, and
Remove buttons. Highlight the measurement with your mouse and then choose the
desired function.
 Choose the Add button to place the newly selected Available Measurements
at the bottom of the Selected Measurements list.
 Choose the Insert button to place the newly selected Available
Measurements above the currently highlighted item in the Selected
Measurements list.
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 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.
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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.
Spirometry Settings – Incentive/Miscellaneous Tab
The user can select from the following choices:
Thermometer
Tree and Leaves
Tree, Leaves and Monkeys
Tree, Leaves and Pinwheel
Candles
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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.
Spirometry Settings – Trending Tab
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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.
It is highly recommended that you use the default ethnic settings for testing.
Spirometry Settings – Ethnic Adjustments Tab
Additional information on these percentages is discussed in the Adjustments To
Reference Values Equations appendix.
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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.
 NOTE:
The Spirometer handle must be calibrated with a Disposable Pneumotach
Mouthpiece (DPM). The DPM must be calibrated with a Calibration
Adapter that fits OVER the outside diameter of the mouthpiece. Never
calibrate the device with a syringe that fits within the DPM.
You can access the Calibration program from the Windows Task Bar through the
following sequence:
 Start  Programs  Diagnostic Workstation  Spirometry Calibration
or
Double-click the Spirometry Calibration icon:
The following screen is displayed. Click the handle icon in the upper left corner to start
calibration. Clicking OK will close this screen and return to the desktop. It is
recommended that you place the DPM into the handle before you enter the Calibration or
Test screen.
Spirometry Calibration Utility Screen
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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. Be sure to
remove the DPM after calibration or testing to conserve the life of your batteries.
Barometric Pressure
The Pressure must be set prior to the first time you calibrate the system. It must be
changed only if you change the location of the instrument and the altitude changes. Click
the Settings button to open Spirometry Settings. Select the Calibration tab and enter
the Barometric Pressure in the Default Barometric Pressure box. If you do not know the
barometric pressure, you can select Calculate Barometric Pressure From Altitude and
enter your altitude. The software will automatically calculate and store the usual
barometric pressure for that altitude.
 NOTE:
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The proper Barometric Pressure or altitude MUST be entered
to assure a proper calibration.
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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. Check
that the mouthpiece is properly attached to the handle. The first time you calibrate your
Spirometry handle, you must type your name in the Performed by box, the Syringe SN
(serial number) and Spirometer SN (handle serial number) in the appropriate boxes.
Click Start Cal. The sensor will zero itself and then the following screen appears.
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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. PUSH THE HANDLE IN AND DRAW THE HANDLE OUT
SMOOTHLY – TRY NOT TO “BANG” THE PLUNGER AS YOU PERFORM THE
MANEUVER. “Banging” the plunger can cause the timer arrow to start to count. If it
does, just wait for the timer to reset and inject the plunger. This will not affect the
calibration results.
If the pump is performed correctly, the program will prompt you to begin a second
injection. Repeat the process, injecting all of the air in the syringe. If the injection is not
performed correctly, the system will discard the attempt and prompt you to inject again.
After three correctly performed injections, the system will automatically calculate a
correction factor and prompt you to perform a verification pump. ALWAYS VERIFY
YOUR CALIBRATION. After a verification injection, the software will display the
measured volume and the percentage difference from 3.0 Liters. The ATS recommends
that the verified volume should be between 2.91 and 3.09 (+/- 3.0 %) to be accepted. Be
sure to check these numbers before accepting the verification.
The verification acceptance dialog box will display those numbers for quick and easy
comparison. Click Yes if the verification flow is within the recommended parameters. If
the flow is not within the parameters, click No and repeat the verification flow.
Verification Acceptance Dialog Box
After you accept the verification, the system automatically saves the calibration. To print
the calibration report, click Print and select PRINT from the menu. To view the
calibration report, click Print and select PRINT PREVIEW from the menu.
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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. If this box is selected, you must calibrate at three different flow rates. The
program will display the Multi-Flow Calibration window and will measure the flow rates
as the user injects the 3 liters. If the flow is too fast, the program will reject the injection
and ask the user to try again with a slower injection. If the flow is too slow, the program
will reject the injection and ask the user to try again with a faster injection.
When injecting the 3 liters, try to keep the graph on the left hand side in line with the
dotted red line, or, on the right hand side, try to keep the bar moving at the same speed as
the blue arrow.
Multi-Flow Calibration Window
OSHA Regulations
OSHA Regulations are outlined in the Recommended Standardized Procedures for
Pulmonary Function Testing published in the Federal Register. At a minimum, OSHA
requires:






Calibrate with both Spirometer and syringe at the same temperature.
Proper calibration of the Spirometer daily. (three different flow rates)
Calibrate for volume and time or flow and time (we provide volume and time).
Calibrate before each shift.
Calibrate whenever the Spirometer is transported.
Calibrate after every thirty tests or sooner (2-3 hours) under field test conditions.
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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). One version is designed to operate with a Pocket PC device (like a
Compaq/HP iPAQ) and the other version is designed to operate with a computer.
The model/serial number is listed on the label on the top of the Spirometer handle (under
the DPM). This should be used to identify the version of the handle.
The model/serial number defines the handle as follows:
03xxx
COM port handle for use with a desktop or laptop computer
50xxxx
COM port handle for use with a desktop or laptop computer
51xxxx
COM port handle for use with a Pocket PC, hand-held device
52xxxx
USB port handle for use with a desktop or laptop computer
 NOTE:
51xxxx handles are switched on when the DPM is in place. To
conserve the life of your batteries, be sure to remove the DPM after
calibration or testing. In addition, place the DPM in the handle
BEFORE entering the test or calibration screen. This will turn the
handle on and allow the software to detect the handle.
Please contact Midmark Diagnostics Group Customer Service at 800-624-8950, if you
have any questions about which handle you have.
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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. The bottom or right side of each screen has a
menu bar that lists other screens that may be accessed. To visit any of these screens,
simply click the appropriate button.
Of course, certain sequences must always be followed, such as entering a patient’s
demographics and medical data prior to performing a Spirometry test. For your
convenience, a condensed guide to the operation of the Spirometer with new patients is
listed in the Appendix under Spirometry Testing at a Glance. Use this guide until you
become more familiar with the use and operation of the program. Appendix N, O, and P
can be used for more advanced users and for Pre/Post testing.
Pulmonary Function Test or PFT is another term widely used for Spirometry. You may
hear people refer to this device as a PFT machine. Technically, a Spirometer is a device
used by a patient to perform a PFT. In this manual, the words Spirometer or Spirometry
are used when referring to the Midmark Diagnostics Group device and its operation.
Prescription Device
“Caution: Federal law restricts this device to sale by or on the order of a medical
practitioner licensed by the law of the state in which that person practices.”
B. Patient Preparation
 NOTE:
The ATS recommends daily calibration of Spirometers using a 3-liter
syringe. See Calibration in the Installation section for instructions.
Each patient must be prepared for the Spirometer test procedure. It is essential that you
comply with the following instructions on patient preparation as closely as possible.
Otherwise, the integrity of the Spirometry data may be compromised.
Show every patient the proper way to perform a test. It is recommended that the user
perform at least one forced expiratory maneuver to demonstrate the procedure to the
patient. This test does not have to be performed on this Spirometer but it should be
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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. Double click
on this icon to start the Diagnostic Workstation program.
OR
Starting from the Windows Task Bar, go through the following
sequence:
 Start  Programs 
Midmark Diagnostics

IQmark Workstation
D. Opening Screen
When you start the Diagnostic Workstation application, an opening screen appears. The
IQmark Products Available will list the products installed on your computer. Hardware
modules are required for operation of each product. Call Midmark Diagnostics Group
Sales for information about available add-on products.
IQmark Diagnostic Workstation Opening Screen
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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. Selecting a patient from the list enables
you to access that patient’s records and data from previous tests.
Configuration – Displays what database is currently selected and enables the
user to configure the program to meet their needs. See Configuring The
Spirometer and Configuration in the Diagnostic Workstation manual.
Help – Provides on-line assistance regarding the use, operation and
troubleshooting of the IQmark Diagnostic Workstation and other products.
Return to Windows – Exits the program and returns you to the Windows
desktop.
E. Testing A New Patient
For a new patient, click the New Patient button in the opening screen. This opens the
Patient Data Entry screen.
The Patient Data screen enables you to enter the data that is specific to your patient.
Some of this data is of diagnostic value and is used by the Spirometer’s interpretive
program when the program analyzes the patient's data.
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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. The accuracy of,
Date of Birth, Sex, Height, and Race, is essential since this data is used by the
Spirometer interpretive analysis program to produce predicted measurements and
preliminary diagnostic statements. All four digits of the year must be entered for the
Date of Birth. The Height is located on the Vital Signs tab.
The following table provides a brief description of the function for each field. Fields that
play a diagnostic role in the interpretive program are noted.
Patient Data Fields
Field
Last Name
First Name
Middle Initial
ID
Diagnostic
Role
Description
Used for identification. Providing complete
information facilitates easier retrieval of patient data at
later dates.
Letters and/or numbers may be used.
Used for identification.
Letters and/or numbers may be used.
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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.
Date of Birth
Yes
(age)
Enter using a month/day/year format (this order may
be changed in IQmark Configuration settings). Enter 2
digits each for month and day and all four digits for
the year. The Spirometer interpretive program uses
this data to calculate the age of the patient.
( mm/dd/yyyy
i.e. 02/14/1961 )
Sex
Used for information and diagnostic analysis in
Reference Values equations.
Yes
Used for information and diagnostic analysis in
Reference Values equations.
Select the appropriate gender.
Height
Yes
Used for information and diagnostic analysis in
Reference Values equations (in Vital Signs tab).
Use only numbers. Data may be entered in either
English or Metric units, depending on which option is
selected in the IQmark Configuration Settings.
Vital Signs Tab
The Vital Signs tab displays on top when the Patient Data screen is opened. This tab
enables the user to enter and track the patient’s vital signs over time. The user can enter
the vital signs when entering new patient information. After the patient has been saved,
the user can enter additional vital signs by clicking on the New Vital Signs button. This
clears the BP, Pulse, Temperature and SpO2 and enables you to enter new vital signs
readings.
After vital sign measurements are entered, click the Review Vital Signs button to
display all previously entered vital signs. These measurements will be display in a table as
well as on a user defined graph.
The following table provides a brief description of the function for each field. Fields that
play a diagnostic role in the interpretive program are noted. Additional information about
the Vital Signs tab can be found in the Diagnostic Workstation Operation Manual.
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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. Automatically calculated from
Height and Weight. Refer to the Workstation
Operation Manual for additional information.
BP (Blood Pressure)
*
*Used for information and is used as a diagnostic tool
by a physician in some cases. Enter numbers only.
Pulse
*
*Used for information and is used as a diagnostic tool
by a physician in some cases. Enter numbers only.
Temp.
*
*Used for information and is used as a diagnostic tool
by a physician in some cases. Enter numbers only.
SpO2 (Pulse Oximetry)
*
*Used for information and is used as a diagnostic tool
by a physician in some cases. Enter numbers only.
Vital Signs tab
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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.
Contact Info tab; Risk Factors tab
Clicking the Contact Info tab displays a screen that gives you the option of adding,
editing or deleting the patient’s contact information (Address and Phone Number).
Clicking the Risk Factors tab displays a screen that gives you the option of selecting risk
factors for the patient (does not effect Spirometry results). Additional information about
this tab can be found in the Diagnostic Workstation Operation Manual.
Smoking History tab
Clicking the Smoking History tab displays a screen that gives you the option of adding
the smoking history to the patient’s profile. To add this information, select the Smoker
box and then enter the number of cigarettes the patient smokes per day and the number
of years they have been smoking.
Smoking History tab
If the patient used to smoke and has since quit, select Smoker as above and then select the
Quit box and enter the number of years since they quit.
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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. The American Thoracic
Society (ATS) states in their Standardization of Spirometry 1994 Update: “Perhaps the
most important component in successful Spirometry is a well-motivated, enthusiastic
technician.” Coaching and encouraging the patient with body language and with verbal
language like “blast out hard and fast”, “continue to blast out”, and “squeeze the air out”
will help to ensure a good FVC maneuver with reproducible results.
Throughout of this manual, the user or technician refers to the person instructing the
patient and operating the Spirometer.
The Disposable Pneumotach Mouthpiece (DPM) is designed for a single patient use.
Multiple tests can be performed on one patient during one testing session. Use new DPM
for each future test session on the same patient. Do not attempt to sterilize or disinfect
the DPM. Any such attempts would have a high chance of affecting the results of a
Spirometry test. Do not attempt to re-use the DPM.
 NOTE:
PHYSICIAN’S RESPONSIBILITY: It is the physician’s responsibility
to ensure that the test is properly administered, evaluated and interpreted.
The technician administrating the test should be trained in Spirometry by
completing a certified Spirometry Training course. The instructions listed
here are only a guide and should not be used to train a technician.
Prepare by requiring the patient to:
 Loosen any tight clothing that might constrict lung function.
 Remove any foreign objects from the mouth, including dentures if they are
likely to become dislodged.
 Select a new DPM and place it in the Spirometer handle.
Once you are both ready to perform a test, require the patient to:
 Place the lips and teeth around the DPM (not near the end), using their lips to
seal their mouth to the DPM prior to performing any Spirometry test.
 Be careful not to block the flow tube with the tongue.
 Follow the instructions of the technician.
Allow the patient to place the mouthpiece in their mouth and breathe through it before
performing a test. This will help reduce the anxiety of catching their breath and show
them there is no resistance when breathing through the DPM.
This Spirometer enables you to choose among FVC, VC, and MVV tests in both the PreBronchodilator (Pre-BD) and Post-Bronchodilator (Post-BD) modes. Remember, if the
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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. However, a full expiratory and
inspiratory loop is often referred to as a Flow Volume Loop, an FVC Loop or
occasionally as an FVC test. On this Spirometer, the user can perform a FVC or FVC
Loop by simply selecting FVC.
To start a test, click New Test from the Patient Data screen. Click on the lungs icon next
to Spirometry. If desired, enter the Technician’s name and the Physician’s name or select
them from the list. The reason for testing the patient can also be selected from the
Indication list as shown in the New Test Selection Screen below.
The Spirometry Profile section is used to select different Configuration Profiles, if desired.
For example, if the practice has physicians that required different measurement
parameters on their report, a different Configuration Profile can be created and name for
each physician.
New Test Selection Screen
Click on OK to open the test acquisition screen. The Spirometry data acquisition, or test,
screen appears.
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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. Tell the
patient to take 2 or 3 normal tidal breaths and then to inspire as deeply as possible. After
a complete inhalation, tell the patient to place the mouthpiece in their mouth (as described
earlier) and enthusiastically encourage them to blast out the air quickly and completely.
Continue to encourage with voice and body language until a visible plateau is evident on
the Flow-Volume scale or until the program indicates that no additional flow is being
measured (displays: Inhale Now). If a full loop is required, instruct the patient to breathe
in quickly and fully to take in as much air as possible.
Demonstrate this procedure for the patient. Let the patient see the effort required for a
good test. The technician should carefully watch the entire maneuver ensuring:
 Maximal inhalation before starting
 Forced expiration - Quick, strong and without hesitation
 Continued expiration – Encourage the patient to blow out as long as possible
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 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. The
following box will appear while the Spirometer is zeroing.
Zeroing The Sensor
Once this is done, the following incentive display appears (or the one selected by the
user). Have the patient, inhale fully, move the handle sideways towards their mouth,
insert the mouthpiece into their mouth and start the test.
Thermometer Incentive Display
For this incentive, note that the color of the “mercury” in the thermometer changes with
the percentage of the patient’s predicted FVC value. It will remain red from 0 to 49%,
yellow from 51% to 79%, green from 80% to 100% and bright green above 100%. The
percentage of their predicted value is also displayed above the thermometer. After the
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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.
IMPORTANT – The acceptability statements are to be used as recommendations or
guidelines and do not mean that a test must be accepted or rejected. It is up to you to
decide if the effort performed is acceptable. You can override the software selection and
choose Accept if you determine the effort is good. After deciding to accept or reject a
test, click Yes to perform another test or No to stop testing.
These acceptability statements are based on the recommendations of the ATS.
Acceptability Statements
The following table lists the acceptability statements you might see during FVC testing.
Please remember, these are recommendations and not requirements. Please use your own
judgment when deciding to accept or reject a test.
ATS Acceptability Statement
Criteria
Comment Displayed
Good test
Meets all the criteria listed
below.
Extrapolated volume > 5% of
FVC, or greater than 0.150
liters, whichever is greater.
Good test!
Test did not last at least X
seconds from start of expiration
Blow out longer
Hesitating start
Test too short
Hesitation detected:
Blast out faster; blast
out harder
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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. Blast out smoothly
No plateau of duration of at
least one second in which there
is less than 0.050 liters of
volume change.
Inhale > 1.1 * exhalation if
inhalation performed.
Exhale > 1.1 * inhalation if
inhalation performed.
Volume less than 0.50 Liters
Blast out completely
Inhale deeper before
starting the test.
Inhale completely at
the end of the test.
Volume Too Low
After the patient has completed the number of tests you require, click the Save Review
button in the lower right corner of the test screen. This will automatically save the test
session and display the review screen.
See section G, Reviewing Patient Reports, later in this manual for more information about
the View Report screen.
If a patient’s FVC is below expectations or if you suspect airway obstruction, you might
require the patient to perform a slow vital capacity (SVC) or VC test.
Flow Volume Loops – Why Inhale?
Diagnostic Reasons
The inhalation side of the flow volume loop can be used to determine if an Upper Airway
Obstruction (UAO) is fixed or dynamic (variable). A fixed UAO decreases rates in both
expiratory flow and inspiratory flow. A variable UAO decreases rates in expiratory flow
or inspiratory flow, not both.
Extrathoracic (outside the chest area, i.e. in the throat) airway obstruction decreases rates
in the inspiratory flow.
Intrathoracic (inside the chest area, i.e. in the airway tubes leading directly to the lungs)
airway obstruction decreases rates in the expiratory flow.
Typically a patient will present with stridor (crowing or wheezing breathing sounds)
and/or dyspnea (shortness of breath) on exertion. The common causes are vocal cord
paralysis, swelling of the upper airway or voice box, enlarged thyroid gland or goiter, a
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tumor, or an injury due to an accident or intubation or tracheotomy. These are all
examples of an extrathoracic airway obstruction.
If the flow volume loop shows signs of UAO, the obstruction should be assessed and
located using flexible bronchoscopy (to view the obstruction)
Quality of Test Results
If you do not have the patient inhale at the end of the test, how can you be assured that
the patient expired fully or that the patient inhaled fully before they started the test? If a
patient performs a flow volume loop, the results of their expiratory volume and their
inspiratory volume should be within 10% of each other. If they are not, the appropriate
acceptability statement will display after the test is completed.
Post-Bronchodilator Tests
The following instructions assume you have already performed the Pre-BD test on the
patient and have administrated the bronchodilator.
Testing one patient at a time
From the View Report screen, you can select a bronchodilator from a list and then click
Post-BD to perform tests. Selecting Post-BD returns you to the testing screen. Post-BD
FVC tests are performed the same way as Pre-BD FVC tests. See Appendixes P and Q.
Testing more than one patient at a time
Select a patient from the patient list. Click New Test. Select Spirometry and click OK.
If you have performed a Pre-BD test on this patient, the program will display a list of test
type selections. To attach a Post-BD test to the existing Pre-BD test, use the default
setting (select the first choice) and click OK. This will open the testing screen. Post-BD
FVC tests are performed the same way as a Pre-BD FVC tests. See Appendix O.
Existing Pre-Bronchodilator Test Dialog Box
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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. The patient takes 2 or 3
normal tidal breaths and then a slow, deep breath, and then a slow, full exhale.
Click the VC button. The VC button appears bold. If this is a Pre-BD test, make sure the
Pre message is displayed in the blue box in the middle of the test screen. Do not click the
Start New Test button until the patient is ready to perform the test.
To perform a VC test, the patient must perform the test according to the following
instructions:
 Inhale completely before placing the flow sensor mouthpiece into the mouth.
 Insert the mouthpiece just past the front teeth and seal the mouth to the flow
sensor mouthpiece with the lips.
 Take 3 or 4 tidal breaths with the mouthpiece in the mouth.
 Inhale as deeply as possible, until the technician observes a plateau at the
bottom of the graph.
 Blow out slowly and evenly until the technician observes a plateau at the top
of the graph or the device signals that the end of test criteria has been met.
 The technician should stop the test with the mouse or the ENTER key.
 Remove the mouthpiece from their mouth when instructed by the technician.
The patient must exhale at a faster rate during the “Blow out” phase than during the tidal
breaths. After the patient has completed the number of tests you require, click the Save
Review button and click Yes to save the test efforts.
MVV
The Maximum Voluntary Ventilation, or MVV, is the measurement of a patient’s
breathing when the patient inhales and exhales maximally and rapidly for 12 to 15
seconds. The software takes this result and extrapolates the results for a period of one
minute. MVV is expressed in liters per minute (L/min). This is a very demanding test
and patients must be allowed to rest between efforts. The MVV test is required to qualify
some patients for Social Security Disability benefits.
Click the MVV button. The MVV button now appears bold. For a Pre-BD test, make
sure the Pre message is displayed in the blue box in the middle of the test screen. Do not
click the Start New Test button until the patient is ready to perform the test.
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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.
After the patient has completed the number of tests you require, click the Save Review
button and click Yes to save the test efforts.
G. Reviewing Patient Reports
The Diagnostic Workstation software allows for the storage of additional patient
diagnostic tests including ECG and Holter data (only if you have purchased these
options). Please refer to the appropriate manual for these procedures.
H. Review Spirometry Reports
Once you have completed the Spirometry session and exited the test area, View Report
screen appears. The test results are displayed in the middle of the display area with other
useful information displayed in the upper sections as shown in the Spirometry View
Report Screens on the following page.
The name of attending technician should be entered in this screen if they have not
previously been entered. Entering the Reviewed By information will CONFIRM this
report. Until the Reviewed By is entered, the report is unconfirmed.
To edit or review a report, display the desired view by clicking the Summary, FVC
Graphs, MVV Graphs, or VC Graphs tab. These tabs display the tests performed in
the session under review. You can edit (Technician and Reviewed By), review and
print the Spirometry reports. Clicking the Settings button (upper right) enables you to
select which reports to print. Remember that every report checked will print when you
click the Print button and select Print.
Click the Print button and click Print Preview to display reports before they are printed.
In addition to the test results, the Summary tab includes the following information:
Patient’s Age, Lung Age, Sex, Height, Race, Smoking History and COPD Risk.
Pre and Post FVC test session statement (Attemped, Accepted, Matches).
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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.
Spirometry View Report Screen – FVC Graphs
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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. If the patient is a current
smoker and that fact is entered into the Patient Data screen, the printed report will indicate
the curent COPD Risk and the reduced COPD risk to the patient if they quit smoking.
The COPD Risk statements are: Low, Moderate, High, Risk is very high, COPD may
exist.
Lung Age
The program automatically calculates the Lung Age of the patient. The Lung Age is
calculated from the patient’s Sex, Height and FEV1. This estimate is also useful in
smoking cessation programs. Lung Age is calculated only for patients from 20 to 84.
J. Reviewing Data for Other Patients
Patient reports can be effectively managed with the Diagnostic Workstation. You can
access other patients test data by selecting the Patient List from the Patient Data screen
and then clicking on Go To Report List Screen.
For additional information on the Report List screen and patient data management, refer
to the Diagnostic Workstation Operation Manual.
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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.
In the Show Range area, select Show All to display tests from the earliest report to the
current date. Select Show Today to display only those reports prepared on the current
date according to the computer calendar. You can also indicate a range of dates using the
From and To fields. The default setting is Show All.
 NOTE:
The From box will not accept dates before 01/01/97.
The Show Reports area enables you to select one or more of the following reports for
display: ECG, RR Variability, Holter, and Spirometry. Selecting Show All will display all
available types of reports. For example, remove the check box from ECG, RR Variability
and Holter to display Spirometry tests only.
When the selection is completed, the Report List screen is updated with the new data
and selection ranges.
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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.
The following features are standard in the Trending software:
 Select one to ten different Spirometry measurements to trend at one time.
 Select the length of time to compare, from a minimum of two sessions, to any
number of sessions, to all test sessions stored for a patient.
 Provide comparison between two individual tests, e.g., the best test in one session
against the best test in another session.
 Provide comparison between actual and predicted measurements.
 Provide changes over a selected period of time, e.g., the oldest test session against
the latest test session.
 Choose Pre-Bronchodilator tests only or Post-Bronchodilator tests only.
 Provide tabular and graphical displays for easy comparison.
 Provide color-coded graphic displays for easy identification.
 Print and display trend measurement in tabular format.
 Print and display graphical Flow/Volume (F/V) reports in overlay or side-by-side
formats.
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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.
Select All Reports to view all the reports in the list. This is the default selection.
Select Select From List to select individual reports. If this option is selected, you can
pick and choose which sessions to trend.
Test Selection
Select the type of tests to trend. You can trend Pre test results against Pre test results or
Post test results against Post test results.
Pre-Bronchodilator – If checked, all trended values are taken from the best Pre-BD test
of the session.
Post-Bronchodilator – If checked, all trended values are taken from the best Post-BD
test of the session.
Action
This selection tells the program what to do with the trend after the above selections are
chosen and the OK button is clicked.
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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.
The Trending tab in Spirometry Settings enables you to select the parameters to trend,
the type of Flow Volume Loop report to print and the default Flow Volume Loop to
display.
The left axis and right axis scales are independent of each other. The left axis always
displays volume parameters in liters. The right axis displays either percentage parameters
or flow parameters.
Spirometry Settings - Trending
Volume Parameters
Measurements – Lists volume measurements selected for the left axis.
Predicted – Lists predicted values for volume measurements for the left axis.
Flow and Percentage Parameters
None – Disables the right axis trend.
Flow – If selected, the right axis is for trending flow measurements.
Percent – If selected, the right axis is for trending percentage measurements.
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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.
Volume measurements
Volume predicted values
Percentage measurements
Percentage predicted values
Flow measurements
Flow predicted values
Spirometry Trend Parameter Selection
From the Trending tab in Spirometry Settings, click the Select button. The Spirometry
Trend Parameters box displays. To add an item to the Selected box, select the item in
the Available box and click the Add button. This will place the new item at the bottom
of the list.
To insert an item between or above items in the Selected box, select the item in the
Selected box above which want to place a new item, select an item from the Available
box, and click the Insert button.
To remove an item from the Selected box, select the item to be removed and click the
Remove button.
To start a new list with no items selected, click the Clear List button.
Report Selection
On the Trending Tab, select which type of Flow Volume Loops you want to print when
the trend report is printed.
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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.
Side By Side – If selected, the Side By Side F/V Loop screen is displayed as the default
when you click on the View F/V Loops button in the Trending screen.
Overlay – If selected, the Overlay F/V Loop screen is displayed as the default when you
click on the View F/V Loops button in the Trending screen.
Total Selected – Indicates the total number of parameters selected for printing.
Maximum Allowed – Displays the maximum number of parameters allowed.
Trend Display Screen
The Trending screen is the main screen of the Spirometry trending control. It consists of
a graphical trending chart, a tabular measurement grid, and trending button bar.
The graphical chart plots volume parameters on the left axis. The right axis is optional
and can display either percentage parameters or flow parameters, depending on the
settings. The horizontal axis represents time, spanning from the earliest session to the
latest session.
Each parameter trended is a data series and is built from the values from the best Pre-BD
or best Post-BD test of the Spirometry sessions selected. The graph created for each
parameter is represented by a different color line.
A vertical marker on the display moves left or right as you move the cursor from left to
right. The software automatically scrolls the grid and highlights the report to which the
current marker points. Also, if you click on a grid row, the software moves the vertical
marker to the data corresponding to the selected report.
Trending Buttons
Save To File – Click to open the File Save dialog box. If a valid filename is entered and
the OK button is clicked, the software saves the information in the grid to a file in
Microsoft Excel file format (*.xls).
Print – Click to print the trend report to the currently selected printer.
Trending Button Bar
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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.
View Patient Info – Click to display the patient’s information for the current highlighted
test.
Patient Information
Help – Click to open the Help file.
Review/Exit – Click to exit this screen and return to the View Report screen.
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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.
Side By Side Screen
Immediately below the display are buttons that provide fast navigation:
First – Display the first, second, and third F/V loops.
Previous – Shift the display to show the previous series of F/V loops.
Next – Shift the display to show the next series of F/V loops.
Last – Display the last F/V loops.
Click the View Overlay button to display the F/V loops in an overlay format.
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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. The same color scheme is used in the grid control,
showing the session number and report date in the color that matches the associated F/V
loop.
When you move the vertical marker to a date or select a point in the grid, the software
highlights the F/V loop corresponding to that report (if one exists) by drawing the loop in
a darker color. The loop returns to its previous color when you select another report.
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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.




Main Functions
Access New Patient
screen.
Access Patient List
screen.
Access online Help.
Exit to Windows
desktop.
Enter essential patient
data.
Edit data for an existing
patient.
Initiate test for a new
patient.
Update patient data for
selected patient.
Register a new patient.
Search for specific
patient using their name,
ID and other criteria.
Delete selected patient
records.
Restore archived
reports.
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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.
 Print one or more
selected reports.
 Restore and archive
reports.
 Search for a patient
using name or ID.
 The File button enables
you to:
o Delete currently
viewed report.
o Restore (retrieve)
archived reports.
o Archive reports.
o Send currently
viewed report by
email.
 Acquires FVC, VC and
MVV tests.
 Automatically “grades”
tests based on the ATS
recommendations.
 Compares accepted
tests for reproducibility.
 Enables the user to
change the settings for
the Spirometer.
 View and analyze the
Spirometry test numeric
and graphic results.
 Enables the user to print
preview the test report.
 Enables the user to edit
the interpretation.
 Enables the user to
change the settings for
the Spirometer.
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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.
Troubleshooting Guide
Troubleshooting Guide
Error Message or Problem
View Report screen does not work
Solution or Recommendation
1. Exit Diagnostic Workstation.
2. Start MS-DOS Prompt (command).
3. Change directory to c:\windows\system
4. Type
regsvr32 msflxgrd.ocx and press Enter
5. Type
regsvr32 oleaut32.dll and press Enter
6. Exit MS-DOS Prompt and re-start Workstation.
MODULE NOT RESPONDING!
Or
SENSOR NOT RESPONDING!
Message appears after starting New
Test. No waveform is displayed on
the screen.
IQmark Digital Spirometer cannot communicate with
the computer because the handle is not connected to
the computer, the handle is connected to the wrong
serial port, or the batteries are completely dead or
installed incorrectly.
 Verify the cable is connected to a serial port and
that it is the correct serial port (COM1 or COM2).
 Check battery orientation or install new batteries.
FAILED TO CREATE EMPTY
DOCUMENT
All Windows programs must be closed before the
installation of Diagnostic Workstation.
Message appears immediately after
initial software installation and after
each attempt to start the Diagnostic
Workstation.
 Uninstall the Diagnostic Workstation; restart
computer and reinstall the Diagnostic Workstation
(refer to the Diagnostic Workstation Operation
Manual).
Incorrect diagnostic interpretation.
 Check Patient’s Date of Birth, Height, Sex, and
other demographics to ensure the information is
accurately entered.
 Check which Pre-FVC test is selected as the best
test.
 Check which Interpretation logic is selected.
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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. Report
Locking can also be caused by improperly exiting the
patient report from any workstation.
 Close the desired test report for the specific patient
at the [network computer name] workstation using
the Review Exit button
This patient’s record is in use by:
[network computer name]
Message appears when trying to
open a specific Patient Data screen.
This Record Locking feature prevents more than one
user from accessing the same patient record at the
same time, specifically in a LAN environment where
different workstations are sharing the central database.
Record Locking can also be caused by improperly
exiting the Patient Data screen from any workstation.
 Close the specific Patient Data screen at the
[network computer name] workstation using the
Opening Screen button.
Unable to create big button
Message appears when attempting to
launch/start Diagnostic Workstation.
 Click on the ‘X’ close button on the top right
corner to exit Diagnostic Workstation.
 Start MS-DOS Prompt.
 Change directory to c:\windows\system
 Type
regsvr32 threed32.ocx
and press Enter
 Exit MS-DOS Prompt and start Diagnostic
Workstation.
Predicted FEV1/FVC is not
available or valid.
 Check patient demographics. Race, Age, Sex, and
Height (R.A.S.H.) must be entered to calculate a
Predicted Value.
Other operation problems…
 Please refer to the online help by clicking on the
Help button at any screen.
 Contact Midmark Diagnostics Group Customer
Service. See contact information at the end of this
manual.
 Additional Troubleshooting Guide is included in
the Technical Service Manual appendix at the end
of that manual.
.
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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. If necessary, use a mild
sterilizing detergent with low alcohol content generally used in hospitals. Verify that all
equipment, including accessories, is completely dry before using.
Preventative Inspection
A preventative inspection should be done prior to each use. This is done to verify that
there is no visible damage to the unit that may cause it to malfunction.
Visual inspection should include the handle and the cable for signs of damage and
deterioration, including but not limited to cracks, cuts, discoloration, or oxidation. If a
cable or other accessory exhibits any of these symptoms, call Midmark Diagnostics
Group Customer Service.
Storage
To prevent damage to the Spirometry Module due to battery leakage or oxidation, remove
all batteries if the Spirometry Module is not to be used or is to be stored for long period of
time. Avoid extreme humidity and heat during storage.
Radio and Television Interference
This equipment does not generate or use radio frequency energy. It will not cause
interference to radio or television reception.
This equipment has been tested and proved to be in compliance with the limits for a
medical device in accordance with the IEC 60601 rules, which are designed to provide
reasonable protection against such interference in a medical or hospital environment.
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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.
IEC 601-1 Medical Electric Equipment - Type BF Equipment
Equipment displaying this symbol provides the patient protection by
providing isolation from earthed parts and other accessible parts of the
equipment.
Battery orientation, battery type, and power requirements.
ETL Listing Mark
Equipment displaying this symbol has been tested to comply with the
following safety standards: UL STD 2601-1;
CAN/CSA STD C22.2 601.1-M90
CE Mark.
Equipment displaying this symbol has passed specific safety tests and
adheres to international quality standards originated from the European
Community.
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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).
Airway Obstruction - If the FEV1/FVC ratio is below the LLN, the software displays
one of the following statements regarding obstruction.
Statement
Obstruction may be a
physiological variant.
Mild obstruction.
Moderate obstruction.
Moderately severe obstruction.
Severe obstruction.
Very severe obstruction.
Criteria
FEV1 >= 100% Pred. FEV1
70% Pred. FEV1 <= FEV1 < 100% Pred. FEV1
60% Pred. FEV1 <= FEV1 < 70% Pred. FEV1
50% Pred. FEV1 <= FEV1 < 60% Pred. FEV1
34% Pred. FEV1 <= FEV1 < 50% Pred. FEV1
FEV1 < 34% Pred. FEV1
If the FVC is below the LLN, the software will add, "with low vital capacity" to the above
obstruction statements.
Lung Restriction - If there is no suggested airway obstruction, the program displays one
of the following statements pertaining to lung restriction.
Statement
Mild restriction.
Moderate restriction.
Moderately severe restriction.
Severe restriction.
Very severe restriction.
Criteria
70% Pred. FVC <= FVC < LLN
60% Pred. FVC <= FVC < 70% Pred. FVC
50% Pred. FVC <= FVC < 60% Pred. FVC
34% Pred. FVC <= FVC < 50% Pred. FVC
FVC < 34% Pred. FVC
Pre/Post Bronchodilator Comparison - If both pre and post bronchodilator tests have
been performed, the software performs and reports automatic interpretation for both sets
of test data.
Statement
Markedly improved
Improved
Not clearly improved
Not improved
Ratio of Post-BD / Pre-BD (Post/Pre)
Post FVC/Pre FVC Or Post FEV1/Pre FEV1
>= 1.25
>= 1.25
1.15 to 1.24
1.12 to 1.24
1.05 to 1.14
1.05 to 1.11
< 1.05
< 1.05
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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%  1.645 x SEE
If the SEE is not reported and the SD% (Standard Deviation of the error) is, then the
software shall calculate the LLN as follows:
2
 SD% 

x

LLN Value 1
100


pred
F. Interpretation – NHANES III
The 3rd National Health And Nutrition Examination Survey (NHANES III) created a
number of medical recommendations including some directed at Spirometry. A new set
of predicted equations as well as new calculations for LLN (lower limit of normal) were
developed from data collected and we have labeled these equations as NHANES III.
The National Lung Health Education Program (NLHEP www.nlhep.org) published an
Interpretation table using NHANES III. We have labeled this interpretation logic as
NHANES III (or by selecting PCP Mode as the Configuration Profile, see Configuring
The Spirometer). It determines results as follows:
The software displays a statement that reads "Normal Spirometry" if the FEV1 and the
FEV1/FEV6 ratio are within the normal range (i.e. above the LLN).
If the FEV1/FEV6 ratio and the FEV1 are below the LLN, the software will display one of
the following statements regarding obstruction.
Statement
Mild obstruction.
Moderate obstruction.
Severe obstruction.
Criteria
FEV1 >= 60% Pred. FEV1
40% Pred. FEV1 <= FEV1 < 60% Pred. FEV1
FEV1 < 40% Pred. FEV1
In addition, if the FEV1/FEV6 ratio is above the LLN but the FEV6 measurement is below
the LLN, the software will output the following statement:
"Low vital capacity, perhaps due to restriction of lung volumes"
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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.
Crapo (Crapo/Knudson compilation, aka ITS, ATS)
Knudson (1976 & 1983 compilation)
European Community For Coal And Steel (ECCS) (1993)
NHANES III (aka NLHEP, Hankinson)
Morris
Roca
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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
0.326
0.842
0.561
Ref. 4
Ref. 4
FEV3
M
F
W
W
15–91
15–91
0.0535H - 0.0271A - 3.512
0.0442H - 0.0257A - 2.745
0.587
0.360
1.017
0.620
Ref. 4
Ref. 4
FEV1/FVC%
M
F
W
W
15–91
15–91
-0.13H - 0.152A + 110.49
-0.202H - 0.252A + 126.58
4.78
5.26
8.28
9.06
Ref. 4
Ref. 4
FEV3/FVC%
M
F
W
W
15–91
15–91
-0.0627 - 0.145A + 112.09
-0.0937H - 0.163A + 118.16
2.68
3.11
4.64
5.36
Ref. 4
Ref. 4
FEF25-75%
M
F
W
W
15–91
15–91
0.0204H - 0.038A + 2.133
0.0154H - 0.046A + 2.683
0.962
0.792
1.666
1.363
Ref. 4
Ref. 4
70
Sex
Race
Predicted Equation
SEE
CI95%
Source
Predicted VC =
Predicted FVC
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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
0.0430H - 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
1.2915
0.9778
0.7569
2.12
1.61
1.25
“
“
“
M
W
18-25
0.0397H - 0.0057A - 4.2421
0.7551
1.24
Ref. 13
M
F
F
W
W
W
25-85
20-70
70-90
0.0310H - 0.0230A - 2.4827
0.0174H - 0.0254A - 0.1822
-0.0172A + 1.8894
0.6917
0.6612
0.2409
1.14
1.09
0.396
“
“
“
M
M
F
W
W
W
18-25
25-85
20-87
1.840H + 1.800A - 192.3
2.080H - 1.0800A - 168.1
1.090H - 0.840A - 31.8
Sex
Male
Female
Age
Range
15 – 91
17 – 84
Height Range (cm)
Height Range (in)
157 – 194
146 – 178
62 – 76
57 – 70
K3
K3
K3
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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
0.037H – 0.017A – 2.746
0.019H – 0.014A – 0.406
0.425
0.474
0.388
0.699
0.779
0.638
Ref. 14
“
“
FEV1
M
M
F
F
W
W
W
W
18-25
25-85
20-70
70-90
0.0519H + 0.0636H - 6.1181
0.0665H - 0.0292A - 6.5147
0.0332H - 0.0190A - 1.8210
0.143H – 0.0397A + 2.6539
0.4458
0.5241
0.3903
0.3758
0.734
0.862
0.642
0.618
Ref. 13
“
“
“
FEV3
M
M
F
W
W
W
18-25
25-85
20-87
0.052H + 0.066A – 5.531
0.063H – 0.031A – 5.245
0.035H – 0.023A – 1.633
0.589
0.575
0.496
0.969
0.946
0.816
Ref. 14
“
“
FEV1/FVC%
M
M
F
W
W
W
18-25
25-85
20-89
-0.0813H + 100.4389
-0.105A + 86.6862
-0.1852H - 0.1896A + 121.6777
6.5752
6.2691
7.5702
10.82
10.31
12.45
Ref. 13
“
“
FEF25-75%
M
M
F
F
W
W
W
W
18-25
25-85
20-70
70-90
0.0539H + 0.0749A - 6.1990
0.0579H - 0.0363A - 4.5175
0.0300H - 0.0309A - 0.4057
-0.0615A + 6.3706
0.9861
1.0825
0.8539
0.7210
1.62
1.78
1.40
1.19
Ref. 14
“
“
“
PEF
M
M
F
W
W
W
18-25
25-85
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
“
“
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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
1.2915
0.9778
0.7569
2.12
1.61
1.25
“
“
“
M
W
18-25
0.0397H - 0.0057A - 4.2421
0.7551
1.24
Ref. 13
M
F
F
W
W
W
25-85
20-70
70-90
0.0310H - 0.0230A - 2.4827
0.0174H - 0.0254A - 0.1822
-0.0172A + 1.8894
0.6917
0.6612
0.2409
1.14
1.09
0.396
“
“
“
M
M
F
W
W
W
18-25
25-85
20-87
1.840H + 1.800A - 192.3
2.080H - 1.0800A - 168.1
1.090H - 0.840A - 31.8
K3
K3
K3
Notes:
1. CI 95% calculated using the equation CI 95% = 1.645 * SEE.
2. Race: W = white. Sex: M = male, F = female.
3. A = age in years. H = height in centimeters.
4. Height ranges are as follows
Sex
Male
Male
Female
Female
Age
Range
18-25
25-85
20-70
70-90
Height Range (cm)
Height Range (in)
139.7-195.6
157.5-195.6
147.3-180.3
147.3-167.3
55-77
62-77
58-71
58-66
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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 - 0.025A - 2.60
0.51
0.38
0.839
0.625
FEV1/VC% M
F
W
W
18-70
18-70
-0.18A + 87.21
-0.192A + 89.10
7.17
6.51
11.79
10.7
FEF25-75%
M
F
W
W
18-70
18-70
1.94H - 0.043A + 2.70
1.25H - 0.034A + 2.92
1.04
0.85
1.71
1.398
PEF
M
F
W
W
18-70
18-70
6.14H - 0.043A + 0.15
5.50H - 0.030A - 1.11
1.21
0.90
1.99
1.48
FEF25%
(MEF75%)
M
F
W
W
18-70
18-70
5.46H - 0.029A - 0.470
3.22H - 0.025A + 1.60
1.71
1.35
2.81
2.22
FEF50%
(MEF50%)
M
F
W
W
18-70
18-70
3.79H - 0.031A - 0.35
2.45H - 0.025A + 1.16
1.32
1.10
2.17
1.81
FEF75%
(MEF25%)
M
F
W
W
18-70
18-70
2.61H - 0.026A - 1.34
1.050H - 0.025A + 1.11
0.78
0.69
1.28
1.14
MVV
M
F
W
W
18-70
18-70
1.34H x 100 - 1.26A - 21.40
0.807H x 100 - 0.57A - 5.50
Kory
Lindall
Notes:
1. If the patient age is between 18 and 25, the program shall use the equation for age = 25.
2. CI 95% calculated using the equation CI 95% = 1.645 * RSD.
74
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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
0.00011570
FVC
M
M
M
F
F
F
Race Intercept
b0
W
-0.1933
B
-0.1517
H
0.2376
W
-0.3560
B
-0.3039
H
0.1210
FEV1
M
M
M
F
F
F
W
B
H
W
B
H
0.5536
0.3411
0.6306
0.4333
0.3433
0.4529
-0.01303
-0.02309
-0.02928
-0.00361
-0.01283
-0.01178
-0.000172
0
0
-0.000194
-0.000097
-0.000113
0.00014098
0.00013194
0.00015104
0.00011496
0.00010846
0.00012154
0.00011607
0.00010561
0.00012670
0.00009283
0.00008546
0.00009890
FEV6
M
M
M
F
F
F
W
B
H
W
B
H
0.1102
-0.0547
0.5757
-0.1373
-0.1981
0.2033
-0.00842
-0.02144
-0.02860
0.01317
0.00047
0.00020
-0.000223
0
0
-0.000352
-0.000230
-0.000232
0.00018188
0.00016429
0.00017840
0.00014395
0.00013497
0.00014106
0.00015323
0.00013499
0.00015029
0.00011827
0.00010848
0.00011480
PEF
M
M
M
F
F
F
W
B
H
W
B
H
1.0523
2.2257
0.0870
0.9267
1.3597
0.2401
0.08272
-0.04082
0.06580
0.06929
0.03458
0.06174
-0.001301
0
-0.001195
-0.001031
-0.00847
-0.001023
0.00024962
0.00027333
0.00030243
0.00018623
0.00019746
0.00022203
0.00017635
0.00018938
0.00021833
0.00012148
0.00012160
0.00014611
FEF25-75
M
M
M
F
F
F
W
B
H
W
B
H
2.7006
2.1477
1.7503
2.3670
2.0828
1.7456
-0.04995
-0.04238
-0.05018
-0.01904
-0.03793
-0.01195
0
0
0
-0.000200
0
-0.000291
0.00010345
0.00010461
0.00014473
0.00006982
0.00008572
0.00009610
0.00005294
0.00004819
0.00009020
0.00002302
0.00003380
0.00004594
75
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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 FEV1.0/FVC %
Parameter
Sex
Race
FEV1.0/FEV6.0 %
M
M
M
F
F
F
W
B
H
W
B
H
Interceptprd
B0
87.340
88.841
89.388
90.107
91.229
91.664
FEV1/FVC %
M
M
M
F
F
F
W
B
H
W
B
H
88.066
89.239
90.024
90.809
91.655
92.360
Age
b1
-0.1382
-0.1305
-0.1534
-0.1563
-0.1558
-0.1670
Interceptlln
b0
78.372
78.979
80.810
81.307
81.396
83.034
-0.2066
-0.1828
-0.2186
-0.2125
-0.2039
-0.2248
78.388
78.822
80.925
81.015
80.978
83.044
Use the following equation to calculate the lung function parameter (LFP).
LFP  b0  b1 * Age
Use the b1 coefficient from the Interceptprd column to calculate the predicted value. Use the b1
coefficient from the Interceptlln column to calculate the lower limit of normal.
76
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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.
12
Ref.
12
Ref.
12
Ref.
12
Notes:
1. The height ranges are as follows:
Sex
Male
Female
Age
Range
20-84
20-84
Height Range (cm)
Height Range (in)
147.3-203.2
142.2-182.9
58-80
56-72
77
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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
0.023H – 0.0456A + 1.1055
1.0
0.68
1.645
1.12
PEF
M
F
W
W
20-69
20-69
0.0945H – 0.0209A – 5.7732
0.0448H – 0.0304A + 0.3496
1.47
1.04
2.42
1.71
FEF75%
M
W
20-69
0.146
0.240
FEF75%
F
W
20-69
MEF75% =
ALOG(2.113Log(H) – 0.01A
– 4.136)
MEF75% =
ALOG(1.209Log(H) – 0.006A
– 0.001W – 2.003) - 1
0.073
0.120
FEF50%
(MEF50%)
M
F
W
W
20-69
20-69
0.0517H – 0.0397A – 2.4
0.0242H – 0.0418A + 1.6151
1.3
0.925
2.14
1.52
78
Predicted Equation
SEE
CI95%
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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.
Knudson (1976 & 1983 compilation)
Polgar (1971)
Hsu
NHANES III
Zapletal
Eigen
79
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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. 14
“
FEV1
M
M
F
F
6 - 12
12 - 18
6 - 11
11 - 20
0.0348H - 2.8142
0.0519H + 0.0636A - 6.1181
0.0336H - 2.7578
0.0351H + 0.0694A - 3.7622
0.2734
0.4458
0.2697
0.4223
0.449
0.733
0.444
0.695
Ref. 13
“
“
“
FEV1/FVC%
M
F
6 - 18
6 - 20
-0.0813H + 100.4389
-0.1909H + 0.6655A + 109.9739
6.5752
7.8385
10.82
12.89
Ref. 13
“
FEF25-75%
M
M
F
F
6 - 12
12 - 18
6 - 11
11 - 20
0.0338H - 2.3197
0.0539H + 0.0749A - 6.1990
0.0220H - 0.8119
0.0279H + 0.1275A - 2.8007
0.6263
0.9861
0.6568
0.8653
1.03
1.62
1.08
1.42
Ref. 13
“
“
“
PEF
M
F
6 - 18
6 - 20
0.078H + 0.1660A - 8.060
0.0490H + 0.157A - 3.916
1.653
1.339
2.72
2.20
Ref. 14
“
FEF25%
(MEF75%)
M
6 - 18
0.0700H + 0.1470A - 7.054
1.530
2.52
Ref. 14
F
6 - 20
0.0440H + 0.1440A - 3.365
1.290
2.12
“
M
6 - 12
0.0378H - 2.5454
0.6538
1.08
Ref. 13
M
F
F
12 - 18
6 - 11
11 - 20
0.0543H + 0.1150A - 6.3851
0.1846A + 0.7362
0.0288H + 0.1111A - 2.3040
1.1196
0.6689
0.9585
1.84
1.10
1.58
“
“
“
FEF50%
(MEF50%)
80
Sex
Race
Predicted Equation
Predicted VC = Predicted FVC
SEE
CI95%
Source
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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. Height ranges are as follows:
Sex
Male
Male
Female
Female
Age
Range
6-12
12-18
6-11
11-20
Height Range (cm)
Height Range (in)
111.8-154.9
139.7-193.0
106.7-147.3
132.1-182.9
44.01 – 60.98
55.00 – 75.98
42.00 – 57.99
52.00 – 72.00
81
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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 – 3.4616
PEF (L/s)
M
F
W
W
4-17
4-17
0.08738 * H – 7.0929
0.08738 * H – 7.0929
MVV (L/min)
M
F
W
W
4-17
4-17
1.276 * H – 99.507
1.276 * H – 99.507
See Reference 19.
82
Predicted Equation
SEE
CI95%
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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
1.61 x 10-6 x H2.85
13
17
13
14
15
14
“
“
“
“
“
“
FEF25-75%
M
M
M
F
F
F
W
B
H
W
B
H
7-20
7-20
7-20
7-20
7-20
7-20
7.98 x 10-7 x H2.46
3.61 x 10-7 x H2.60
9.13 x 10-7 x H2.45
3.79 x 10-6 x H2.16
1.45 x 10-6 x H2.34
1.20 x 10-6 x H2.40
26
36
25
28
30
24
“
“
“
“
“
“
PEF
M
M
M
F
F
F
W
B
H
W
B
H
7-20
7-20
7-20
7-20
7-20
7-20
3.35 x 10-7 x H2.79
1.74 x 10-7 x H2.92
7.69 x 10-7 x H2.63
2.58 x 10-6 x H2.37
5.51 x 10-7 x H2.68
6.97 x 10-7 x H2.64
18
22
17
18
20
18
“
“
“
“
“
“
FVC
Sex
Race
M
Predicted Equation
SD%
Source
Notes:
1. Race: W = white, B = black, H = Hispanic or Mexican-American
2. The original equations provide volume in milliliters and flow in milliliters per
second. The above equations are a modification of the original equations and
provide volume in liters and flow in liters per second.
3. Height (H) range is from 110.0 to 190.0 cm for male and 110.0 to 180.0 for female.
83
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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
FEV1.0
M
M
M
F
F
F
W
B
H
W
B
H
-0.7453
-0.7048
-0.8218
-0.8710
-0.9630
-0.9641
-0.04106
-0.05711
-0.04248
0.06537
0.05799
0.06490
0.004477
0.004316
0.004291
0
0
0
0.00014098
0.00013194
0.00015104
0.00011496
0.00010846
0.00012154
0.00011607
0.00010561
0.00012670
0.00009283
0.00008546
0.00009890
FEV6.0
M
M
M
F
F
F
W
B
H
W
B
H
-0.3119
-0.5525
-0.6646
-1.1925
-0.6370
-1.2410
-0.18612
-0.14107
-0.11270
0.06544
-0.04243
0.07625
0.009717
0.007241
0.007306
0
0.003508
0
0.00018188
0.00016429
0.00017840
0.00014395
0.00013497
0.00014106
0.00015323
0.00013499
0.00015029
0.00011827
0.00010848
0.00011480
PEF
M
M
M
F
F
F
W
B
H
W
B
H
-0.5962
-0.2684
-0.9537
-3.6181
-1.2398
-3.2549
-0.12357
-0.08016
-0.19602
0.60644
0.16375
0.47495
0.013135
0.018202
0.014497
-0.016846
0
-0.013193
0.00024962
0.00027333
0.00030243
0.00018623
0.00019746
0.00022203
0.00017635
0.00018938
0.00021833
0.00012148
0.00012160
0.00014611
FEF25-75
M
M
M
F
F
F
W
B
H
W
B
H
-1.0863
-1.1627
-1.3592
-2.5284
-2.5379
-2.1825
0.13939
0.12314
0.10529
0.52490
0.43755
0.42451
0
0
0
-0.015309
-0.012154
-0.012415
0.00010345
0.00010461
0.00014473
0.00006982
0.00008572
0.00009610
0.00005294
0.00004819
0.00009020
0.00002302
0.00003380
0.00004594
Parameter
Sex
FVC
84
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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/FEV6.0 % and FEV1.0/FVC %
Parameter
FEV1.0/
FEV6.0 %
FEV1.0/
FVC %
Sex
Race
W
Interceptprd
B0
87.340
M
Age
b1
Interceptlln
-0.1382
b0
78.372
M
M
F
F
F
B
H
W
B
H
88.841
89.388
90.107
91.229
91.664
-0.1305
-0.1534
-0.1563
-0.1558
-0.1670
78.979
80.810
81.307
81.396
83.034
M
W
88.066
-0.2066
78.388
M
M
F
F
F
B
H
W
B
H
89.239
90.024
90.809
91.655
92.360
-0.1828
-0.2186
-0.2125
-0.2039
-0.2248
78.822
80.925
81.015
80.978
83.044
Use the following equation to calculate the lung function parameter (LFP).
LFP  b0  b1 * Age
Use the b1 coefficient from the Interceptprd column to calculate the predicted value. Use the b1
coefficient from the Interceptlln column to calculate the lower limit of normal.
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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 + 0.04477 x H
FEF75%
M
F
W
W
-6.822 + 0.07811 x H
-5.1934 + 0.06367 x H
PEF
M
F
W
W
-6.9865 + 0.08060 x H
-5.3794 + 0.06594 x H
SEE
CI95%
Eigen – Pediatric
The age range is from 3-6 years and the height range is 87-127 cm (34.3 to 50 inches).
Parameter
Intercept (α)
Slope (β)
SEE
CI95%
FVC
-13.63
2.95
0.1167
0.192
FEV1
-12.26
2.63
0.1124
0.185
FEF25-75
-8.13
1.81
0.2393
0.394
FEV1/FVC
1.37
-0.31
0.0608
10.0
(see Note 1)
(see Note 2)
PEF
-10.99
2.54
0.1509
0.248
Notes:
1. The FEV1/FVC predicted equation generates a fraction instead of a
percentage so the software must convert this number to a percentage.
2. The FEV1/FVC predicted equation generates a fraction instead of a
percentage so the CI95% value has been converted to a percentage value
Patient gender was not considered in the regression analysis. The Knudson Pediatric
predicted equations will not be used for missing parameters because that study does not
cover children less than 6 years old. In addition, the Eigen equations should not be used as
the default pediatric equations because of the limited age range.
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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.
The software makes the following adjustments to the reference values for Asian and Black
patients if the reference equations are only for a white patient population.
Correction Of Reference Values For Blacks And Asians
Measurement
FEV1
FVC
FEV1/FVC %
Scale Factor
0.85
0.85
None
Correction Of Reference Values For Black Children
Measurement
FEV1
FVC
FEV1/FVC %
Scale Factor
0.88
0.88
None
The software does not use the above correction factors if the reference equations in use
include the patient’s race, e.g., Hankinson.
Not all race scale factors have been documented. At the time of this printing, many races
have had some published recommendations. The latest recommendations are as follows:
1.00 - American Indian, Caucasian, Eskimo, European-American, Hawaiian, Hispanic,
Indian, Italian, Iranian, Jordanian, Polynesian, Saudi Arabian, South American, Spanish,
White
0.85 - Asian, African, African-American, Black, Cambodian, Chinese, East Indian Pakistani,
Filipino, Jamaican, Japanese, Korean, Laotian, Vietnamese
However, a recent paper by Korotzer et al (Am. J. Respir. Crit. Care Med. 2000 161: 11011108) suggests a 0.93 correction for Asian-American.
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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.
MVV
AT%
VC
ERV
IRV
TV
Volumes (capacity) are expressed in Liters BTPS (L)
Flows are expressed in Liters per second BTPS (L/s)
AT – Air Trapping – Calculated if an accepted FVC and an accepted VC test is saved in the
same session. Displayed in Liters, it is the difference of the VC and the FVC.
AT% – Air Trapping Percentage – Calculated if an accepted FVC and an accepted VC test is
saved in the same session. Displayed as a percentage it is the difference of the VC and the
FVC divided by the VC.
FVC – Forced Vital Capacity – The total volume of air exhaled during a forced expiration
(maximally forced effort) starting from a position of full inspiration and ending at complete
expiration. Expiration must be made as forcefully and completely as possible. A decrease in
FVC is common to restrictive disorders and severe obstructive disease.
FEVX – Forced Expiratory Volume at X (0.5, 1.0, 3.0, 6.0) second(s) – The volume of air
exhaled during a set value of time. The FEV at the first second of the FVC maneuver is the
most common. Back extrapolation is used to determine the beginning of the FVC maneuver.
A decrease in the FEV1 value is common in obstruction of large to mid-sized airways.
FEV1.0 / FVC – Ratio of the volume of air expired in one second to the total volume of air
expired during the FVC test. An obstruction can cause a decrease in this ratio.
FEV3.0 / FVC – Ratio of the volume of air expired in three seconds to the total volume of air
expired during the FVC test.
FEV1.0 / FEV6.0 – Ratio of the volume of air expired in one second to the total volume of air
expired in six seconds during the FVC test.
FEFXX% – Forced Expiratory Flow where XX could be 25, 50 or 75. This is the expiratory
flow rate at a certain percentage of the total FVC.
FEF25-75% – Forced Expiratory Flow from 25% of expiration to 75% of expiration, the middle
half of the FVC. Also known as the MMEF (maximal mid-expiratory flow). Decreases can
be an indicator of early stages of lung disease.
FEF75-85% – Forced Expiratory Flow from 75% of expiration to 85% of expiration.
FEF200-1200 – Forced Expiratory Flow from 200 ml of expiration to 1200 ml of expiration.
Mostly used in the European Union.
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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.
FIVC – Forced Inspiratory Vital Capacity – The volume of air inhaled from a position of full
expiration to full inspiration.
FIV0.5 – Forced Inspiratory Volume at one-half second after the start of inspiration.
FIF50% – Forced Inspiratory Flow at 50 percent of inspiration.
PIF – Peak Inspiratory Flow – The maximum inspiratory flow rate measured during the force
inspiratory portion of the FV Loop.
Exp time – Total expiratory time for the forced expiratory maneuver.
V ext – Volume of air from the beginning of expiration to the zero point of the FVC due to
back extrapolation.
MVV – Maximal Voluntary Ventilation – The volume of air expired with continual maximal
expiration and inspiration measured over a 12 second duration. Volumes are then
extrapolated to one minute.
MTV – Mean Tidal Volume – The mean volume of air expired within the tidal breath during
the continual maximal expiration and inspiration measured over a 12 second duration.
Expressed in Liters/Breath.
RR – Respiration Rate – The respiration frequency (Breath/Minute) measured during a MVV
maneuver.
VC – Vital Capacity – The maximum volume of air exhaled from the point of maximal
inhalation or the maximal volume of air inhaled from a point of maximal exhalation can be
measured with a slow exhalation or inhalation, respectively. It is the volume change at the
mouth between the positions of full inspiration and complete expiration. Previously called
the “slow” vital capacity (SVC).
ERV – Expiration Reserve Volume – The volume of air that can be expired by a forceful
expiration after the end of a normal tidal expiration.
IRV – Inspiration Reserve Volume – The volume of air that can be inspired by a forceful
inspiration after the end of a full expiration.
TV – Tidal Volume – The volume of air inspired and expired with each normal breath.
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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. Respir Card 1996; 41(7);629-636.
4. Clinical Pulmonary Function Testing - A Manual Of Uniform Laboratory Procedures,
Second Edition, 1984. Intermountain Thoracic Society. Salt Lake City, Utah.
5. Wanger, J., “Pulmonary Function Testing, A Practical Approach”, 2nd ed., 1996, Williams
& Wilkins, Baltimore.
6. Spiroscan 4000 Operator’s Manual. Brentwood Medical Technology Corp.
7. Spiroscan 5000 Operator’s Manual. Brentwood Medical Technology Corp.
8. Reichl, PH. Brentwood Diagnostic Workstation Product Requirements Specification.
9. Reichl, PH. Brentwood Diagnostic Workstation User Interface Design Document.
10. Reichl, PH. Preliminary Spirometer Serial Port Communications Protocol.
11. Siafakas, N., et al. Optimal Assessment And Management Of Chronic Obstructive
Pulmonary Disease (COPD); A Consensus Statement of the European Respiratory
Society (ERS), European Respiratory Journal, ISSN 0903-1936, 1995.
12. Morris, J.F., Koski, Al, Johnson L.C. Spirometric Standards For Healthy Nonsmoking
Adults, American Review Of Respiratory Disease. Volume 103,1971. Pages 57-67.
13. Knudson, R. J., Lebowitz M.D., Holberg, C. J., Burrows, B., Changes in the Normal
Maximal Flow-Volume Curve With Growth And Aging, AM REV RESPIR DIS 1983;
127;725-734.
14. Knudson, R. J., Slatin R. C., Lebowitz, M. D., Burrows, B., The Maximal Expiratory
Flow-Volume Curve – Normal Standards, Variability, and Effects of Age, AM REV
RESPIR DIS, 1976 113;587-600.
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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. “Lung Volumes And Forced Ventilatory Flows – Report Working Party –
Standardization of Lung Function Tests – European Community For Coal And Steel –
Official Statement Of The European Respiratory Society”, European Respiratory Journal,
ISBN:87-16-15024-4, 1993.
17. “Guide To Pulmonary Function Studies Under The Social Security Disability Programs”,
Social Security Administration Office Of Disability, SSA Pub. No. 64-055, ICN 953760,
June 1999.
18. Hankinson, J.L., Odencrantz, J.R., Fedan, K.B. Spirometric Reference Values From a
Sample of the General U.S. Population, Am J Respir. Crit. Care Med., Vol. 159. pp. 179187, 1999.
19. Polgar G., Promadhat, V. Pulmonary Function Testing In Children: Techniques and
Standards, W.B. Saunders Co., Philadelphia, 1971.
20. Zapletal, A., Motoyama E.K., Van de Woestijne, K.P., Hunt, V.R., Bouhuys, A.
Maximum Expiratory Flow-Volume Curves and Airway Conductance in Children And
Adolescents, Journal of Applied Physiology, Vol. 26, No. 3, March 1969.
21. Ferguson, G.T., Enright P.L., Buist, A.S., Higgins, M.W. Office Spirometry For Lung
Health Assessment in Adults: A Consensus Statement from the National Lung Health
Education Program, unpublished draft of Aug. 17, 1999.
22. Morris, L.F., Temple, W., Spirometric “Lung Age” Estimation For Motivating Smoking
Cessation, Preventative Medicine, 0091-7435/85, 1985.
23. Enright, P. L., Hyatt, E. H., A Practical Guide to the Selection and Use Of Spirometers.
24. A 66-Year-Old Woman with Longstanding Dyspnea on Exertion; Niranjan Seshadri MD
and Atul C Mehta MD, Department of Pulmonary and Critical Care Medicine, The
Cleveland Clinic Foundation, Cleveland, Ohio, Dec 1999.
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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. A complete IQmark Digital Spirometry system usually consists of the
Spirometer data acquisition module (handle), the PC system, which includes a monitor and a
printer, one of the Microsoft Windows operating systems (Windows 2000, Windows XP or
Windows Vista), and the IQmark Workstation software program. Additional testing
modalities such as the IQmark Digital ECG and Vital Statistics acquisition devices can be
incorporated simultaneously utilizing the IQmark Diagnostic Workstation software.
This section is provided to assist with the troubleshooting of some commonly experienced
problems and service of the IQmark Digital Spirometer data acquisition module. For
information regarding the service and operation of the PC system you have selected, consult
the documents provided by your PC manufacturer.
Flow Sensor / Mouth Piece
Diff Amp
Handle
Orientation
Compensation
Ckt.
IC Pressure
Transducer
16 Bit A/D
Temperature
Sensing Circuit
Temp Sensor
Battery In
Power
Supply
+5, +5 Ref,
+2.5 Ref
Low
Battery
Sensor
Ckt.
Micro
Controller
Power
On / Off
To Com
Port
Serial Port
Controller
Serial Data Out
Block Diagram
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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. Its primary components are the pressure ports, mouthpiece and
laminar flow element (LFE). During pulmonary function testing (PFT) air is expelled and
travels through the LFE. The LFE smoothes the airflow and provides a consistent resistance
in the path of the air. Two pressure ports sense pressure changes on either side of the LFE.
The pressure ports are connected to a precision differential pressure transducer. The
differential pressure signal is digitized and sent via the serial port to the Spirometry program
running on the PC. The Spirometry program computes flow using the pressure data then
calculates volume by integrating flow data over time.
IC Pressure Transducer
A precision piezio electric transducer takes differential pressure measurements from the
disposable pneumotach mouthpiece. Differential measurements produce more accurate
results as opposed to comparing a single measurement to estimated ambient air pressure.
Handle Orientation Compensation Circuit
An orientation compensation circuit stabilizes the Spirometer during PFT testing. This circuit
eliminates artifacts generated by motion in the X, Y and Z axis as well as allowing a short
enclosed hose path from the pneumotach to the transducer.
16 bit A/D
The A/D converter used is a programmable 2 channel Sigma Delta 16 bit A/D converter. The
A/D converter provides the 12Hz low pass filtering for the Spirometry pressure signal. The
effective sampling rate is 48 Hz. The digitized pressure signal is sent serially to the micro
controller.
Temperature Sensor
An LM34 temperature sensor relays ambient temperature information to the Spirometer
program. Ambient temperature is utilized to produce more accurate BTPS calculations. The
A/D converter converts the temperature signal when the Spirometer handle is powered up
and then passes it along to the Spirometer program through the micro controller and serial
interface.
Micro controller
The micro controller is a PIC16C66 chip produced by Microchip Technology. The micro
controller receives the digitized data from the A/D converter, temperature sensor, low battery
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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.
Power Supply
The IQmark Digital Spirometer uses two AAA batteries for power. A step up DC-DC
converter is used to provide a 6.2 V power source. Two 5.0 V regulators are used to provide
power sources for the analog and digital circuits. A 2.5 V reference voltage is derived with a
voltage divider and current amplifier to provide the Spirometer’s pressure signal baseline and
A/D reference voltage. The IQmark Digital Spirometer’s power is switched ON or OFF by
software control via the DTR bit of the RS232 port.
Low Battery Sensor Circuit
The low battery detection circuit monitors the battery voltage and alerts the micro controller
when the energy in the batteries is low. The micro controller causes the LED in the handle to
glow RED and sends a LOW BATTERY message that is displayed on the screen by the
Spirometer software. The user can complete the current testing session with confidence but
should replace the batteries before starting a new test session.
System Maintenance and Obtaining Service
The IQmark Digital Spirometer is a battery powered, portable device, which requires little
maintenance and contains no user adjustable or serviceable components inside. There are no
fuses in the Spirometer handle. In the event that the Spirometer hardware does not appear to
function correctly and the remedies offered in the troubleshooting guide do not correct the
problem, contact Midmark Diagnostics Group Customer Service. In the event that Repairs are
required our staff will provide complete instructions on returning the Spirometer.
DO NOT send your Spirometer without first contacting a Customer Service representative. A
return authorization is required prior to the return of the device. Help us to service you better
and minimize your down time. Obtain a Return Materials Authorization (RMA) number prior
to returning your Spirometer.
Midmark Diagnostics Group
1125 W. 190th Street
Gardena, CA 90248
Tel: (800) 624-8950
www.midmarkdiagnostics.com
To obtain optimum benefits and to ensure the best performance of this device, the user
should read and understand all information offered in this Operation Manual.
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(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.
Troubleshooting
Problem
Volume numbers appear
too high or too low
FVC Test Starts for no
apparent reason
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Cause
1. Ambient air pressure or
temperature has changed
since the last calibration.
2. The current lot of
pneumotach is slightly
different from the last lot.
3. The “Use Dry Air
Conditions” option was
checked.
1. The minimum flow
required to start a test has
been exceeded.
Solution
1. Calibrate the Spirometer.
2. Calibrate the Spirometer.
3. De-select the “Use Dry Air
Conditions” option when
performing patient tests.
This option disables the
BTPS corrections.
1. Instruct the patient not to
move the handle abruptly,
which can cause air to flow
through the pneumotach
and start a test.
Turn off fans or close
heating and air
conditioning vents near the
test area. Close doors or
windows.

Delay pressing the “Start
New Test” button until just
prior to beginning the
2. Excessive electromagnetic
maneuver.
interference is affecting
2. Select a different location
the instrument.
or find and correct the
source of the interference.
Contact Midmark
Diagnostics Group
Customer Service for
additional assistance.
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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. Air is flowing through the
pneumotach while the
software is attempting to
zero the Spirometer.
1. Instruct patient to hold
handle next to their cheek
prior to starting the test.
Instruct them to blow after
zeroing is complete.
2. Excessive electromagnetic
interference is affecting the
instrument.
2. Select a different location
or find and correct the
source of the interference.
Contact Customer Service.
1. Replace with new batteries.
1. Batteries are low
1. The Com port is not
1. Configure the Com port.
communicating.
2. The Com port can not drive
the Spirometer.
2. Repair computer Com port
3. The Spirometer is defective. 3. Call for RMA. Repair
Spirometer.
1. No batteries in the handle.
1. Install new batteries
2. The handle is not plugged
into an available Com port 2. Plug Spirometer into an
3. The Com port is not talking
available Com port.
with the handle.
3. Configure the Com port.
4. If after steps 1-3, LED does 4. Call Midmark Diagnostics
not turn on, Spirometer is
Group for RMA, Repair
defective
Spirometer.
1. Defective LED
1. Call for RMA, Repair
Spirometer.
1. Com port is defective.
1. Repair Com port
2. Com port not compatible
2. Install USB Com Port.
with Spirometer.
Contact Midmark
Diagnostics Group
3. Installed USB to Serial port
Customer Service
converter is not compatible 3. Install different USB to
with the Spirometer.
Serial Port converter.
Contact Midmark
Diagnostics Group
Customer Service.
1. Battery contact damaged.
1. Call Midmark Diagnostics
Group for RMA, Repair
Spirometer.
1. Leur fitting (pressure port) 1. Carefully remove plastic
plugged with plastic from
from Leur fitting.
last pneumotach.
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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.
4)
When the Patient Data screen is complete, select New Test
5)
Select Spirometry and then click OK.
6)
Prepare the patient for the Spirometry test. Select a new disposable mouthpiece.
7)
The type of test currently selected is displayed in bold in the upper right corner of the
screen. If this is not the type of test required, select the required test by clicking the
appropriate button – FVC, VC, MVV, and either Pre or Post.
8)
When the patient is ready, click Start New Test.
9)
Wait while the sensor automatically zeros the sensor – DO NOT ALLOW AIRFLOW TO
PASS THROUGH THE SENSOR DURING THIS PROCESS.
10) When the incentive box displays “Start When Ready” instruct the patient to begin the test.
11) Encourage the patient with verbal and body language to perform the test properly. For an
FVC test, you can ask them to blast out fast and blow out long.
12) Click the Stop button to conclude the test and review the current data.
13) Repeat steps 7 through 12 until you have acquired the number of tests desired.
14) Click on Save/Review to save tests and review or print the data.
15) Discard the used mouthpiece after all tests are completed.
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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. (Race; Age; Sex; Height)
must be entered for each patient to obtain predicted values and interpretations.
4) When the Patient Data screen is complete, click New Test.
5) Select Spirometry and then click OK to enter the test screen.
6) Prepare the patient for the Spirometry test.
a) Explain the procedure to the patient
b) Demonstrate the procedure to the patient
c) Instruct the patient to select a new disposable mouthpiece and to insert it into the handle
d) Instruct the patient to place the mouthpiece on top of their tongue, with their teeth and
lips around the mouthpiece. The patient must seal the outer part of the mouthpiece with
their lips. Let the patient get used to the feeling of breathing with the mouthpiece in their
mouth.
7) When the patient is ready, instruct the patient to hold the handle close to but not in front of their
mouth. Be sure that the patient is not breathing through the mouthpiece when you start the test.
8) Click Start New Test - wait for the zeroing process – DO NOT ALLOW AIRFLOW TO PASS
THROUGH THE MOUTHPIECE DURING THIS PROCESS.
9) When the incentive box displays “Start When Ready” instruct the patient to perform a full
inspiration and then to place the mouthpiece in their mouth. Instruct the patient to Blast out the air.
Encourage the patient with verbal and body language to blast out fast and blast out long. Ask the
patient to continue to blow out until a plateau is reached on the volume-time curve. If a flow
volume loop is required, have the patient inhale at the end of the expiration.
10) Click the Stop button or press the ENTER key to conclude the test. Accept or Reject the test
based on the patient’s effort. Repeat steps 7 through 9 until the appropriate number of tests has been
performed. Performing more than 8 forced vital capacity tests in one sitting will usually return
diminished results.
11) Click the Save/Review button to save the efforts. Use the review screen to review, edit and/or
print the results.
12) Instruct the patient to remove and discard the used mouthpiece after all tests are completed.
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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.
4) Click Spirometry and then click OK to enter the test screen.
5) Prepare the patient for the Spirometry test.
6) When the patient is ready, click on Start New Test.
7) Wait for the zeroing process and instruct the patient to perform the test.
8) Click the Stop button or press the ENTER key to conclude the test. Accept or Reject the test
based on the patient’s effort. Repeat steps 6 and 7 until the appropriate number of tests has been
performed.
9) Click the Save/Review button to save the efforts. Use the review screen to review, edit and/or
print the results.
10) Administer the bronchodilator (BD). Wait the appropriate amount of time for the BD to take
effect.
11) Select the correct BD from the Bronchodilator list and click the Perform Post-BD button.
Click on Yes to save the addition of the BD to the report.
12) Repeat steps 5 through 9.
13) Instruct the patient to remove and discard the used mouthpiece after all tests are completed.
14) Review the Interpretation, edit if desired, then click Print and choose Print.
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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.
4) Select Spirometry and then click OK to enter the test screen.
5) Prepare the patient for the Spirometry test.
6) When the patient is ready, click Start New Test.
7) Wait for the zeroing process to finish and then instruct the patient to perform the test.
8) Click the Stop button or press the ENTER key to conclude the test. Accept or Reject the test
based on the patient’s effort. Repeat steps 6 and 7 until the appropriate number of tests has been
performed.
9) Click the Save/Review button to save the efforts. Use the review screen to review, edit and/or
print the results.
10) Administer the bronchodilator (BD). Wait the appropriate amount of time for the BD to take
effect. Instruct the patient to remove the mouthpiece and to hold on to it until after all tests are
completed.
11) Click the Patient List button. Select the next patient. Click Yes to save modifications.
12) Repeat steps 2 through 10 for the next patient.
13) Select the first patient from the Patient List and click the View Report button.
14) Select a BD from the Bronchodilator list and click the Perform Post-BD button.
15) Have the patient place the mouthpiece in the Spirometry handle. Repeat steps 5 through 9.
16) Instruct the patient to remove and discard the used mouthpiece after all tests are completed.
Review the Interpretation, edit if desired, then click Print and choose Print.
17) Repeat steps 11 through 16 for the next patient.
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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.
BTPS
Body conditions; normal body Temperature (37°C); ambient
Pressure; Saturated with water vapor.
CLICK
In this manual, Click refers to tapping a mouse button once –
quickly and firmly. For example, if you want to pull down the
Medications list, you will click on the list name. Double Click
refers to performing this task twice, and is generally used to
start programs.
DATABASE
A collection of data arranged into methodically organized
categories. In this manual, the term refers to the collection of
reports that the Diagnostic Workstation stores on your hard
drive.
DESKTOP
The background that appears on your computer screen behind
the application windows.
DIALOG BOX
An on-screen form you complete to provide the Diagnostic
Workstation with information that it needs to accomplish a
task, such as the Medications window.
ECG
See electrocardiogram.
ELECTROCARDIOGRAM
A graphic recording that displays the electrical activities of the
heart. Contact Midmark Diagnostics Group for additional
information.
F OLDER
Folders, which function like the drawers in a filing cabinet, are
used by Windows to organize files and applications. The
Diagnostic Workstation application resides in a folder named
“Brentwood”, which is located in your hard drive.
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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.
PREDICTED VALUES
Also known as Reference Values or Predicted Equations Sets.
A value for a parameter is calculated and estimated as “normal”
for the age, height, sex, and sometimes the ethnic background
of the patient. These values are compared to a patient’s actual
values to evaluate a patient’s lung condition.
SERIAL P ORT
A 9- or 25- pin port that is used by a computer to communicate
serial data, typically labeled COM1 or COM2. The Spirometer
connects to a 9-pin serial port or a 25-pin serial port if an
adapter is used. Consult your computer owner's manual for
more information on configuration and capability.
SHORTCUT ICON
Generally appearing on the desktop, shortcut icons enable you
to open a document, application, or folder simply by double
clicking on them.
SPIROMETER
Midmark Diagnostics Group’s Module for converting a
personal computer into a Spirometer with interpretive
capability. The Spirometer is operated using the Diagnostic
Workstation software application.
START BUTTON
Appears at the left end of the Windows Taskbar, and enables
you to start applications, open files, get to the Control Panel
and exit Windows. Consult your Windows owners’ manual
for more information.
TASKBAR
A gray bar that typically appears at the bottom of the screen. In
Windows, the Taskbar provides rapid access to the Start Button
and open applications. The Diagnostic Workstation requires
the taskbar be set to Auto hide in order for the Workstation to
display properly.
TEXT BOX
A box where you type in text relative to an application or task.
Select the text box by clicking in it and start typing.
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USB
104
Universal Serial Bus. An alternate type of serial connection that
can be used to connect your Spirometer to your computer.
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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).
Warranty
All Midmark Diagnostics Group Products are warranted free from manufacturing and
material defects for 12 months from the date of purchase. Any misuse or abuse of the
product voids all warranties.
Return Goods Authorization
To return any product for repair, an RMA (Return Materials Authorization) number must be
obtained from Midmark Diagnostics Group Customer Service. This number should be
referenced on the package(s) containing the items to be returned and in any correspondence
regarding the return.
Shipping
Before shipping any unit to Midmark Diagnostics Group, be certain that an RMA (Return
Materials Authorization) number has been issued and that all guidelines regarding this
authorization are followed. We highly recommend that you follow all guidelines for the
shipment of a medical product set forth by the shipping company of your choice. If a
question should arise regarding an appropriate method of shipment, please feel free to ask
when calling for your Return Goods Authorization Number. It is ultimately the responsibility
of the customer when shipping a product to ensure that all packages and their contents get to
Midmark Diagnostics Group safely.
Midmark Diagnostics Group will not assume any responsibility for damage due to
improper packaging, shipment or use of a product. Such actions will result in all
warranties being void. It is the customer’s responsibility to ensure proper packaging
and shipment of the product. Packaging and shipping costs associated with the return
of the product to Midmark Diagnostics Group are also the customer’s responsibility.
Midmark Diagnostics Group
1125 W. 190th Street
Gardena, California, USA 90248
PH
800-624-8950
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Addendum – EMC Requirements
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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. The IQmark Digital Spirometer is medical electrical equipment.
The following is a list of the IQmark Digital Spirometer cables and other accessories that are used as
part of the IQmark Digital Spirometer that comply with sections 36.201 and 36.202 of the EMC
Standard EIC60601-1-2 (E):

Hand piece, Model number(s): IQmark Digital Spirometer
Use of cables, cable extensions or accessories other than those specified, with the exception of cables
and accessories sold by the manufacturer of the IQmark Digital Spirometer as replacement parts for
internal components, may result in increased EMISSIONS or decreased IMMUNITY of the IQmark
Digital Spirometer.
Table 1 – Guidance and manufacturer’s declaration – electromagnetic emissions – for the
IQmark Digital Spirometer
Guidance and manufacturer’s declaration – electromagnetic emissions
The IQmark Digital Spirometer is intended for use in the electromagnetic environment specified below. The
customer or the user of the IQmark Digital Spirometer should assure that it is used in such an environment.
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Not applicable
The IQmark Digital Spirometer uses RF energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic environment.
IQmark Digital Spirometer is suitable for use in
all establishments, including domestic
establishments and those directly connected to the
public low-voltage power supply network that
supplies buildings used for domestic purposes.
Battery operated device
Not applicable
Battery operated device
Emissions Test
Harmonic Emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Addendum to 3-100-1025 Revision 8.0
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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. The
customer or the user of the IQmark Digital Spirometer should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 60601 test level
Compliance level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
±2 kV for power
supply lines
N/A
±1 kV for input/output
lines
±1 kV differential
mode
Electromagnetic environment –
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic materials, the relative
humidity should be at least 30%.
Battery operated device
±1 kV for input/output
lines
N/A
Battery operated device
N/A
Battery operated device
IEC 61000-4-5
<5% UT
(<95% dip in UT)
for 0.5 cycle
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(<95% dip in UT)
for 5 sec
Power frequency
(50/60 Hz)
magnetic field
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
IEC 61000-4-8
NOTE: UT is the A.C. mains voltage prior to application of the test level.
Addendum to 3-100-1025 Revision 8.0
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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. The
customer or the user of the IQmark Digital Spirometer should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment – guidance
Portable and mobile RF Communications equipment
should be used no closer to any part of the IQmark
Digital Spirometer, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80
MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5
GHz
3 Vrms
Recommended separation distance
d = 1.2 √ P
3 V/m
d = 1.2 √ P 80 MHz to 800 MHz
d = 1.2 √ P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from the fixed RF transmitters, as
determined by an electromagnetic site survey, a should
be less than the compliance level in each frequency
range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the IQmark Digital Spirometer
is used exceeds the applicable RF Compliance level above, the IQmark Digital Spirometer should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorientating or relocating the IQmark Digital Spirometer.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Addendum to 3-100-1025 Revision 8.0
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IQmark Digital Spirometer
Instructions for Use
Table 4 – Recommended separation distances between portable and mobile RF communications
and the IQmark Digital Spirometer
Recommended separation distances between Portable and mobile RF communications
equipment and the IQmark Digital Spirometer
The IQmark Digital Spirometer is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the IQmark Digital Spirometer can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the IQmark Digital Spirometer as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
d = 1.2 √ P
d = 1.2 √ P
800 MHz to 2.5 GHz
d = 2.3 √ P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Addendum to 3-100-1025 Revision 8.0
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