IQspiro®

Version 10.0.0

Operation Manual 3-100-1120 Rev. D

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 Notice
The information in this manual is subject to change without notice.

Midmark Corporation 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 this guide.

This document may contain proprietary information protected by copyright. No part of this document may be
photocopied or reproduced in any form without prior written consent from Midmark Corporation.

IQecg, IQholter, IQspiro , IQvitals, IQmanager, and IQpath are trademarks of Midmark Corporation.

Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries.

Intel and Intel Core are trademarks of Intel Corporation in the United States and other countries.

Citrix and ICA are trademarks of Citrix Systems, Inc. and/or one or more of its subsidiaries, and may be registered in the
United States Patent and Trademark Office and in other countries.

Part number for this Operation Manual: 3-100-1120 Rev. D

Caution
Federal Law restricts this device to sale by or on order of a physician or properly
licensed practitioner.

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 Table of Contents
Related Documents..........................................................................................................6
Precautions..........................................................................................................................6
Contents Checklist...........................................................................................................8
I. General Information......................................................................................................9
A. Introduction.........................................................................................................................9
B. Description........................................................................................................................ 11
C. Product Overview............................................................................................................12
D. Necessary Computer Skills............................................................................................12
E. Configurations..................................................................................................................12
F. Thin Client Configurations...............................................................................................13
G. System Specifications....................................................................................................16
II. System Installation....................................................................................................17
A. Minimum Computer Requirements...............................................................................17
B. Software Installation........................................................................................................18
C. Installation Steps for IQmanager®.................................................................................19
D. Hardware Setup...............................................................................................................20
E. Configuring IQspiro®........................................................................................................21
F. Calibration.........................................................................................................................34
G. Starting a New Calibration.............................................................................................36
III. Operation......................................................................................................................40
A. Starting IQmanager®.......................................................................................................40
B. Opening Screen...............................................................................................................40
C. Creating a New Patient Profile......................................................................................41
D. Pre-Test Preparation.......................................................................................................48
E. Performing an FVC or FVC Loop..................................................................................49
F. Observation Notes...........................................................................................................50
G. Patient Instructions.........................................................................................................51
H. Step-by-Step Spirometry Instructions...........................................................................52
IV. Reviewing Patient Reports....................................................................................58
A. Review Spirometry Reports...........................................................................................58
B. Spirometry Analysis and Reports..................................................................................59
C. Trending............................................................................................................................60
V. Maintenance and Storage.......................................................................................68
Cleaning.................................................................................................................................68

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 VI. Appendices.................................................................................................................70
A. Appendix A - Screen Summary......................................................................................70
B. Appendix B – Troubleshooting IQspiro® and IQmanager®.........................................71
C. Appendix C - Safety and International Symbols.........................................................74
D. Appendix D - Interpretation – ATS................................................................................75
E. Appendix E - Interpretation – NHANES III...................................................................77
F. Appendix F - Reference Values - Adult.........................................................................78
G. Appendix G - Reference Values - Pediatric.................................................................87
H. Appendix H - Adjustments to Reference Values Equations......................................98
I. Appendix I - Spirometry Measurement Parameters.....................................................99
J. Appendix J – COPD Risk Assessment Calculation.....................................................99
K. Appendix K - Lung Age Calculation............................................................................101
L. Appendix L - Performing a Pre/Post FVC Test - Quick Reference User’s Guide.102
M. References.....................................................................................................................104
VII. Customer Support and Warranty Information...........................................106
Warranty..............................................................................................................................106
Return Materials Authorization.........................................................................................106
VIII. EMC Requirements for the IQspiro® Digital Spirometer.......................107
IX. Contact Information............................................................................................... 111

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 Physician’s Responsibility
The interpretations provided by the Midmark IQspiro® Digital Spirometer are for the exclusive use of licensed
physicians or personnel under their direct supervision. The suggested interpretation, including 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. It is the responsibility of the physician to ensure proper administration
of the test, making a diagnosis, obtaining expert opinions on the results, and instituting the correct treatment,
if indicated.

Caution
Federal Law restricts this device to sale by or on the order of a physician.

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 Related Documents
The following documents may be needed in order to operate Midmark diagnostic devices and software
products with the IQspiro® Digital Spirometer:
• IQmanager® Software Operation Manual (Part number: 62-78-0001)
• Setup Manual: Midmark Products over Thin Client using IQpath™ or COM port mapping
(Part number: 61-78-0001)

All documents referenced above are located on the Midmark Operation Manuals CD (part number:
3-100-2000), included with every device. All product Operation Manuals can also be downloaded from
[Link]. For additional information contact Midmark Technical Service at 1-800-624-8950, option 2.

Precautions
Read and observe the following precautions to ensure proper operation of the IQspiro®.
1. Become familiar with the operations and procedures of the instrument prior to use.
2. 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.
3. Installation location and maintenance of the device:
• Avoid installing the device in direct sunlight.
• Install and keep the device away from splashing fluids.
• 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.
4. Prepare the device for operation according to instructions in this operation manual.
5. Observe the patient closely while using the device. If any abnormality is observed, proper action,
which may include stopping the test, should be taken immediately.
6. The software turns off the device power according to programmed procedures.
7. Keep the device clean at all times to ensure trouble-free operation.
8. In case of a malfunction, call Midmark Technical Service and be prepared to describe the problem
precisely.
9. Perform routine inspections on the device.
10. Keep all items in a clean environment.
11. Do not make any modifications to the device; any modifications made will void the warranty.
12. Do not attempt to open the IQspiro® handle. Refer servicing to qualified service personnel.

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 Caution
To ensure accurate patient testing, only use the accessories recommended by Midmark for
this product.

Caution
Electronic devices can be damaged by exposure to liquids. Do not use or store the IQspiro®
near any type of liquids.

Caution
Midmark IQspiro®, when used with specific Midmark disposable mouthpieces, is designed
and tested to meet regulatory and industry standards. Midmark can only warrant product
performance and accuracy if the IQspiro® is used as intended in its unaltered form, and when
recommended practice guidelines are followed. Any modification to the Midmark IQspiro®
mouthpiece, including but not limited to the use of an adapter or filter, is considered an
alteration to the design of the product.

Caution
The American Thoracic Society (ATS) Standardization of Spirometry recommends the use
of gloves when replacing disposable mouthpieces (DMs), and hand-washing after touching
DMs.

Adverse Reactions
The IQspiro® 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.

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 A sitting position is recommended during testing as it may be safer for the patient if they experience syncope
or dizziness while performing the forced expiratory maneuver. Should the patient wish to stand for a
maneuver place a sturdy chair behind them in case they should become dizzy or lightheaded.

If prior testing took place with the patient standing, a new test can be performed with the patient sitting, just
be sure to make a note of the change (see Section III-F, Observation Notes).

Contents Checklist
The IQspiro® shipping box contains the items listed below. Open the package and account for each item
prior to set up. Inspect all items for signs of damage such as dents, cracks, tears or scratches. If an item is
missing or damaged, contact Midmark Technical Service at 1-800-624-8950, option 2, for replacement.

Quantity
Description
Each
1 IQspiro® Digital Spirometer
1 10-pack Disposable Spirometer Mouthpieces

1 10-pack Disposable Nose Clips

1 Mouse Pad

1 Operation Manual CD

1 Quick Reference Guide – IQspiro®

1 Quick Reference Guide – PCP Mode

1 Warranty Registration Card

1 Carrying Case

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 I. General Information
A. Introduction

The information in this Operation Manual is provided for users of Spirometer models Midmark IQspiro®
Digital Spirometer. Future reference of IQspiro® in this document may include the following part numbers:

Model Connection Type Device Part Number Kit Part Number

4-000-0026 w/syringe
USB 1-100-1225
4-000-0025
Midmark IQspiro®
4-000-0021* w/syringe
Serial* 1-100-1205*
4-000-0020*

*No longer in production.

The IQspiro® Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer
for pulmonary function evaluation and data management. The IQspiro® is for use in hospitals and physician/
clinician offices by individuals that have received instruction or training in the administration of spirometry
tests. The IQspiro® operates with a Windows-compatible computer using a serial or USB port connection
and the IQmanager® Software.

Caution
Midmark IQspiro®, when used with specific Midmark disposable mouthpieces, is designed
and tested to meet regulatory and industry standards. Midmark can only warrant product
performance and accuracy if the IQspiro® is used as intended in its unaltered form, and when
recommended practice guidelines are followed. Any modification to the Midmark IQspiro®
mouthpiece, including but not limited to the use of an adapter or filter, is considered an
alteration to the design of the product.

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 The IQspiro® is indicated for use with male and female adult and pediatric patients to evaluate, assess,
describe, measure or monitor:
• Symptoms, signs or abnormal laboratory tests.
• Effects of disease on pulmonary function.
• Individuals at risk for pulmonary disease.
• Preoperative risk.
• Post-surgical prognosis.
• Pre-treatment health status.
• Therapeutic interventions.
• The course of disease affecting lung function.
• Persons exposed to pollutants.
• Adverse reactions to drugs with known pulmonary toxicity.
• Rehabilitation programs.
• Risks as part of an insurance evaluation.
• Individuals for legal reasons.
• Epidemiological surveys.
• Derivation of reference equations.

Note
This list of indications is taken from: American Thoracic Society.
1995. Standardization of Spirometry 1994 Update. Am. J.
Respiratory Crit. Care Med. 152:1108.

Contraindications
The disposable mouthpieces (DMs) 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.

Conformance to Standards
The IQspiro® conforms to the following standards:
• Industry Standards: ATS/ERS 2005, NLHEP, NIOSH, SSD, OSHA, ECCS
• Quality System Regulations: FDA QSR, ISO 10993-5, ISO 10993-10, EN 60601-1-2, CAN/CSA
STD C22.2 601.1-M90
• Product Testing Regulations: IEC 60601-1-1, IEC 601-1, IEC 60601-1-2

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 B. Description

Note
This manual is intended for IQmanager® Diagnostic Workstation
software users. If using the IQspiro® through an EMR, please
contact Midmark Technical Service for assistance with installation,
setup and operation.

The IQspiro® Digital Spirometer is a portable device that performs Forced Vital Capacity (FVC), Vital
Capacity (VC) and Maximal Voluntary Ventilation (MVV) testing. It provides real-time display of flow volume
curves as well as inspiratory and expiratory measurements.

Together with IQmanager®, the IQspiro® makes it easy to record, interpret, and archive spirometry efforts for
future reference.

This manual describes how to use the various IQspiro® features and the operational sequence most
users will follow. This does not mean that a user is restricted to following this particular sequence. There
are certain sequences that must always be followed, such as entering a patient’s medical data prior to
performing a spirometry test. However, this program is designed to be both user-friendly and flexible.

Many of the features are interconnected and can be accessed from more than one screen. 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, click the appropriate button.

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 C. Product Overview
Before conducting any spirometry testing, install IQmanager® on a Windows-compatible computer. Once
IQmanager® has been installed connect the IQspiro® device to the computer via the COM or USB port,
depending on which version is being used.

A Pulmonary Function Test (PFT) is a widely used term for spirometry. People may refer to the IQspiro®
as a PFT machine. A spirometer is a device used by a patient to perform a PFT. In this manual, the words
spirometer and spirometry are used when referring to the Midmark IQspiro® device and its operation.

D. Necessary Computer Skills

This manual is intended for a user capable of using Microsoft® Windows® applications, has some
understanding of PC operations, and is familiar with the basic operations of Windows®.

This Operation Manual is designed as a comprehensive guide, designed to educate the user on the
operation and functions of the IQspiro® device. The information in this manual includes all options that are
available with IQspiro®.

E. Configurations
Typical PC Configuration
The block diagram below (see Figure 1-1) illustrates the standard configuration of the IQspiro® system. The
primary components are a Windows®-based PC, a printer, and the IQspiro® acquisition module. A portable
computer is recommended if mobility is a consideration. Please refer to this block diagram when setting up
the IQspiro® system:

Printer
(optional)

IQspiro Windows-based
module computer

Figure 1-1

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 F. Thin Client Configurations
If working in a thin client environment, install the IQmanager® software on the Terminal Server and operate
the IQspiro® through a thin client terminal.

IQspiro® supports two thin client configurations:

• IQpath™ Software Solution, and
• COM port mapping.

IQpath™ works with either USB or serial port versions of the IQspiro® in high-latency, limited bandwidth
network configurations with Windows-based PC clients. For non-Windows thin client devices on low-latency
high-speed networks, use the serial port versions of the IQspiro® and connect to client devices via COM port
mapping.

Setting up any application in a network environment typically requires special access rights and knowledge
of the network. Please have a system administrator install and configure IQmanager® to the office
environment.

Thin Client Using the IQpath™ Software Solution

IQpath™ utilizes a dedicated flow control scheme to provide the following advantages over COM port
mapping:
• Improved performance on high-latency, low-bandwidth, high-loss networks.
−− Microsoft Terminal Services: Improvement is approximately 10-to-1 in latency tolerance.
−− Citrix® ICA® protocol: Improvement is approximately 40-to-1 in latency tolerance.
• No COM port mapping is required.
• The USB version of the IQspiro® module is compatible.
• Improved device auto-configuration and diagnostics.

Note
IQpath™ has specific requirements for computer hardware,
software and network performance. System administrators should
read Setup Manual: Midmark Products over Thin Client using
IQpath™ or COM port mapping before installing, configuring and
using this software in a thin client environment.

The following block diagram describes IQpath™. In this thin client environment, the client computers must
be running Windows® 10, 8, and 7:

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 Terminal server Windows-based
clients

Network

Windows-based
clients

USB or
IQspiro
serial
module
Figure 1-2

To use IQpath™, load IQmanager® on the terminal server and install one of the following software
components on each client PC that will be used for data acquisition:
• IQpath™ for Microsoft Terminal Services: if using Microsoft Terminal Services (Microsoft RDP).
• IQpath™ for Citrix ICA protocol: if using Citrix software on your clients and servers. These
software products are provided separately and may be obtained by contacting Midmark Technical
Service at 1-800-624-8950, option 2.

Once the software is installed on the client server network and PCs, IQmanager® must be configured as
described in Section II-D, Hardware Setup and Section II-E, Configuring IQspiro®, or refer to the IQmanager
Operation Manual, Section VI-F, Configuring Client Server Networks.

Thin Client Using COM Port Mapping

COM port mapping refers to a configuration in which the IQspiro® connects 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 using non-Windows®-based thin client terminal devices on a low-latency, high-speed network, use the
serial port versions of the IQspiro® and configure the thin client server for COM port mapping.

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 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 Setup Manual: Midmark
Products over Thin Client using IQpath™ or COM port mapping
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 IQspiro® in a thin client environment using COM port
mapping:

Terminal server Clients

Network

Clients

IQspiro Serial
module

Figure 1-3

To use the IQspiro® in this configuration, install IQmanager® 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 Setup Manual: Midmark Products over Thin Client using IQpath™ or COM port mapping.

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 G. System Specifications
IQspiro® Performance Specifications
Category Specification
To provide diagnostic spirometry results that a licensed practitioner can use to
Intended Use
interpret the current condition of a patient’s lungs.
Dimensions 7.75” x 2.5” x 1.75” (191 x 64 x 44mm)

Device style RS232 (serial port) USB

Weight 9.5 oz. 9.0 oz.

Batteries Two 1.5V AAA alkaline N/A

Standard serial port (DB9 or DB25 w/

Connection USB port
adapter)

Anatomical Sites Non-invasive device

Patient Contact Disposable mouthpiece (DM)

Safety Parameters Double-insulated handle

• Fleisch Pneumotach: Differential pressure reading of flow with a DM
Spirometry Acquisition
• Volume determined by flow integration
• Flow: +/- 14 L/s
Ranges
• Volume: +/- 8 L

Environmental Conditions • Temperature: 15°C to 40°C

(temperature and humidity) • Humidity, non-condensing: 10% to 90%
BTPS • Automatic BTPS Correction
• Automatic Back Extrapolation calculation
• Automatic spirometry parameter calculation
Analysis & Measurement • Automatic comparison to published spirometry predicted equations
(Reference Values)
• Automatic interpretation of test results
Parameters Measured • See Appendix I - Spirometry Measurement Parameters
• See Appendix F - Reference Values - Adult and Appendix G - Reference Values
Reference Values Sets
- Pediatric
• ATS (1991): (See Appendix D - Interpretation – ATS)
Interpretations
• NHANES III (NLHEP 1999): (See Appendix E - Interpretation – NHANES III)
Printer • Windows® compatible inkjet or laser printer

Paper • 8.5” x 11” (Letter size) or 210mm x 297mm (A4 size)

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 II. System Installation
Note
Contact Midmark Technical Service before installing and setting
up the IQspiro®. Computers today are more complex with more
software and hardware options than before, making each
computer almost unique. Midmark wants to make sure that your
IQspiro® device is installed and configured as quickly and easily
as possible.

Midmark Technical Service can be reached at 1-800-624-8950, option 2.

A. Minimum Computer Requirements

This section describes the minimum computer resources and hardware components needed when using
new Midmark devices and software. As is the nature of technology to change often, these requirements will
be evaluated and modified periodically. We suggest always referring to the most recent Minimum Computer
Requirements document at [Link], or contact Midmark Technical Service at 1-800-624-8950,
option 2, for additional information.

Note
If updating existing computer systems currently being used with
older Midmark devices and software, please contact Midmark
Technical Service before doing so.

IQspiro® Minimum Computer Requirements

Item Requirement
Windows® 10, Professional and Enterprise, 32-bit and 64-bit
Operating Systems Windows® 8, Professional and Enterprise, 32-bit and 64-bit
Windows® 7, 32-bit and 64-bit
Hardware Requirements Windows® compatible personal computer.
Intel® Core™ 2 Duo Processor E4300 (2M Cache, 1.80 GHz, 800 MHz FSB) (x86)
CPU
or 64-bit (x64) processor or faster
Disk 2 GB of free disk space or greater

Memory Minimum 2GB of system memory

One (1) USB port or one (1) serial port:

• One Universal Serial Bus (USB) port if using USB version of the IQ product

Or
Input/Output Ports
• One RS-232 Serial Port if using serial port version of IQ product.

The above computer port is required for new test acquisitions. It is not required to
review and/or edit a test.

Additional USB ports as needed for keyboard, mouse, printer, etc.

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 IQspiro® Minimum Computer Requirements
Item Requirement
Pointing Device Windows compatible mouse.
®

Keyboard Windows® compatible keyboard.

1024x768 or higher resolutions for the real time acquisition screen. 16-bit color.
Display
Wide-screen (1680x1050) is highly recommended.
Printer Microsoft Windows® compatible inkjet or laser printer.

Surge Protector One (1) hospital-grade power surge protector for the computer system.

Note
The above is the minimum computer requirement specification for
operating the IQspiro® through IQmanager®. A faster CPU and/or
more memory may be required if planning to operate the IQspiro®
through an EMR or install additional software.

Note
USB ports/contacts can become worn with repeated use. The
IQspiro® may not function with a worn USB port.

B. Software Installation

Note
The following software installation information refers to
IQmanager® only. If using the IQspiro® through an EMR, please
contact Midmark Technical Service for assistance with installation
and setup.

IQspiro® uses the IQmanager® software to manage patient records. Other Midmark products can also be
accessed from IQmanager®, such as, IQecg®, IQholter®, IQvitals®, IQvitals® PC and Weight/Scale Interfaces.
Contact the Midmark Sales Department for the latest information on available Midmark products or visit
[Link].

Note
If IQmanager® is already installed on the computer and the user
is now either upgrading or adding a new Midmark product, please
skip this section and refer to the IQmanager® Operation Manual
for installation information.

Before installing IQmanager® on a computer, it is important that the user understand and carry out the
following tasks:

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 Windows Taskbar
IQmanager® is designed to run as a full-screen program. For best results, the Windows Taskbar should not
be displayed in order to provide maximum display area. Place the mouse pointer on the blank portion of the
Taskbar on the bottom of the screen, then right-click and select Properties. Check the Auto-hide the taskbar
box to hide the taskbar when it is not in use; to display the taskbar when it is hidden, move the mouse cursor
over the area where the taskbar is normally set, and it will reappear.

Screen Saver
If a screen saver or any energy saving feature is enabled on the computer, make sure that it does not
activate and interfere with data acquisition during patient testing. Refer to the user’s computer or software
manual for these settings.

Important Computer Date Information

The IQspiro® uses the current date from the computer and the patient’s birth date as entered by the user
to calculate the patient’s age. Since the IQspiro® equations and interpretive analysis use the patient’s age
to produce appropriate diagnostic statements, it is important that the computer’s current date is accurate.
Contact the system administrator if the computer’s date is incorrect.

C. Installation Steps for IQmanager®

Note
Close all Windows programs before running this software
installation. Do not interrupt the installation program while it is
running. The installation should take less than five minutes.

Note
The Midmark IQspiro® requires software to operate. The following
instructions use the IQmanager® software. Please contact
Midmark at 1-800-624-8950 to purchase the required software
license.

1. Do not connect any devices to the computer before running the software installation.
2. Double-click the IQmanager® setup file. The installation starts automatically.
3. Follow the instructions on the screen. For detailed installation, setup and detailed operation
instructions, please refer to the IQmanager® Operation Manual.
4. Once installation is complete connect the IQspiro® module to the computer with the steps outlined in
the following section.
5. If there are any new licenses, add them to the licensing server. For any questions on adding licenses
please refer to the IQmanger® operation manual.

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 D. Hardware Setup
Connecting the Serial-Type IQspiro® Module
If using the serial-type IQspiro®, attach the female end of the 9-pin communication cable to an available
serial port. You may also use a 9-pin to 25-pin adapter as necessary. Secure the connections with the
thumbscrews. Do not over-tighten.

Note
If using a 25-pin serial port, 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.

Battery Installation for Serial (RS232)

• The battery compartment is located at the bottom of the IQspiro®. Hold the IQspiro® upside down so
that the cable is aiming up.
• Press down on the battery door and slide it out until the cover pops up when released.
• Insert two (2) AAA batteries into the battery holder, according to the icon.
• Close the battery compartment door by holding it down while sliding it back in place.

Note
If using a USB version of the IQspiro®, no batteries are needed
and there will be no battery door at the bottom of the unit.

Low Battery Sensor

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 on the IQspiro® to glow RED and sends a LOW
BATTERY message that is displayed on the screen by IQmanager®. The user can complete the current
testing session with confidence but should replace the batteries before starting a new test.

Connecting the USB IQspiro Module

DO NOT plug the USB IQspiro® into the computer until IQmanager® has been installed. Once the software is
installed, plug the USB connector into any available USB port and the software will automatically detect the
device.

Inserting a Disposable Mouthpiece in the IQspiro®

• Open the IQspiro® door by unlatching the door at the side of the spirometer and hold the door open
with one hand, using your index finger.

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 • The following diagram shows the three ports in the top of the IQspiro®. Line the pins of the DM up
with the ports of the IQspiro® and firmly press the DM in place, making sure that the DM is securely
anchored in the ports. Close and latch the IQspiro® door.

Figure 3-1 Inserting the IQspiro® disposable mouthpiece

Note
The DM must be firmly pressed into place to ensure a proper seal.
The DM is not correctly pressed into place it may not seat flush
against the IQspiro® cradle.

E. Configuring IQspiro®
IQmanager® and the IQspiro® can be customized by using the configuration settings. Access the
Configuration Settings by using the following steps:

Click on the SETTINGS button in the upper right side of the IQmanager® opening screen .

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 The IQmanager Settings window appears:

Complete the Institution Name and Address boxes with information about the user’s medical practice.
IQmanager® will display your institution name on each of the procedure screens and on printed reports.
Enter a name that describes your practice or operation to enable other medical personnel to identify your
reports.

Choose between Metric and English units of measurement, 24- and 12-hour time standard. When done,
press Save.

The Spirometry Settings dialog box can be accessed in several ways: it can be accessed by selecting the
spirometer settings button from the Devices tab of the IQmanager Settings;

or by clicking Settings in the New Test or Spirometry Review and Edit screens within IQmanager®. The
following configuration menu will appear:

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 Configuration Tab
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 the IQmanager® Configuration program.

Manage Lists enables the user to modify the Spirometry Indications List and the Bronchodilator List. Add or
delete items from either list.

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 Spirometry Lists Dialog Box

• To add to a list, click Add under the appropriate list box and type a new item.

• To delete an item, highlight the item in the list box and click Delete.

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 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.

Note
The indication list in the spirometry settings are no longer used.
Instead the indications are stored in IQmanager. Refer to the
IQmanager operation manual for details.

Note
For the recommended wait time between bronchodilator
administration and postspirometer testing, refer to the
manufacturer’s package insert.

Reports Tab
Select which reports will be printed when Print is clicked from the Reports tab. For each box checked in any
of the Reports areas, the printed report will include a page for that report.
If the Cover Page box is selected and no boxes within the Reports area are selected, only a onepage report
will print because no additional Reports boxes are selected.
For example, in the Reports tab shown below, the Cover Page box is checked 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 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.

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 Print is clicked.

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 From this tab the user may select the Calibration Report. If this box is checked, every time the user prints 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 left of this tab:

• Vol/Time Predicted Curve,
• Flow/Vol Predicted Curve,
• Use ATS Graph Scales,
• Print Test Quality Statements (only affects the printed reports but not the Cover Page), and
• Print Using Color (affects all reports, including 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. See Section II-E, Configuring IQspiro® for additional information about the cover page.

Cover Page, Best 3 Pre and Best 3 Post Selected

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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.

Use this setting if requested from the user’s carrier or for government agencies.

Enable ATS Graph Scales

Cover Page Settings Tab

The Cover Page Settings tab enables the user to customize the cover page. Selections on this tab only
change the look of the cover page: they do not affect the report pages. The first selection determines
whether the volume-time and flow-volume graphs are printed on this page.

When the check box is selected that states “Table and Graphs (All Measurements)” the user can print out all
selected measurements with the volume-time and flow volume graphs.
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 tab (Print Smoking History, Print COPD Risk, Print Lung Age,
Print Test Quality Statements) determine the additional information to appear in the patient demographics
field and graph section of the cover page.

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 Spirometry Settings – Cover Page Settings Tab

Interpretation Tab
Select which Reference Equations set to use as the default for Adults and Pediatrics from the Interpretation
tab. Not every spirometry measurement (FVC, FEV1, etc) is available in every reference equation. The
secondary reference equations can be used to complete missing measurements. For example, if the user’s
primary reference equation does not have an equation for FEF25, select a secondary reference equation that
does to complete the report.

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 Spirometry Settings – Interpretation Tab

The user can control the Auto. Interpretation feature from this tab, which allows the user to select the ATS
Logic or the NHANES III logic. If the user does 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 selections, as discussed below.

The FVC Settings enable the user 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 and
modifies the test acquisition screen, the test review screen and the printed reports. To set the IQspiro® into
PCP Mode, click on the Configuration tab. Select PCP Mode from the pull-down list In the Configuration
Profile dialog box and click OK.

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 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.

Note
In the PCP mode, the IQspiro® measures the FEV6, but on all
reports and displays it is labeled as the FVC.

After each test maneuver is performed, the software will give a quality control grade for 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 Criteria
At least two acceptable maneuvers with the largest FEV1 values matching within 100 ml and the largest two FEV6
A
values matching within 100 ml.
B At least two acceptable maneuvers with FEV1 measurements that match between 101 and 150 ml.

C 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
D
200 ml.
F 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.

Checking the Primary Care Practitioner (PCP) Mode box with a profile other than PCP Mode selected on the
Configuration tab will enable test grading and remove VC and MVV from the test screen, but will not limit the
measurement parameters displayed. This allows the user to customize the report. To remain in PCP Mode
without customization, select PCP Mode from the Configuration Profile box.

Measurements Tab
The Measurements tab enables the user to customize which measurements to appear on the cover page,
the test screen and the review screen. At least one measurement must be selected.

If the user has selected the Tables and Graphs setting for the Cover Page, only the first 9 measurements
selected will be displayed on the Cover Page. If the Only Table setting is selected, up to 28 measurements
can be displayed.

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 Spirometry Settings – Measurement Tab

Measurements can be placed in any order by clicking Add, Insert, Remove or Clear List. Highlight the
measurement and choose the desired function:
• Add: Move the selected item from the Available Measurements list to the bottom of the Selected
Measurements list.
• Insert: Move the selected item from the Available Measurements list above the highlighted item in
the Selected Measurements list.
• Remove: Moves the selected item from the Selected Measurements list to the Available
Measurements list.
• Clear List: Moves all of the items from the Selected Measurements list to the Available
Measurements list.

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 Incentive/Miscellaneous Tab
The Incentive/Miscellaneous tab enables the user to customize the incentive that the patient will see when
performing a test. The default selection is Candles. Since spirometry is a patient effort-dependent test, these
incentives help some patients complete their exhalation and perform the test properly.

The user can select from the following choices:

• Thermometer
• Tree and Leaves
• Tree, Leaves and Monkeys
• Tree, Leaves and Pinwheel
• Candles
• No incentive (see below)

If the user prefers that no incentive appear during a patient test, un-check the box marked “Use Spirometer
Incentive”. No graphic incentive will display during the test maneuver, however, the following dialog box will
be displayed.

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 Trending Tab
The Trending tab enables you to customize the Trending report. Select which volume, flow and/ or percent
parameters to display. For additional information on this feature, see Section IV-C, Trending.

Spirometry Settings – Trending Tab

Ethnic Adjustments Tab

The Ethnic Adjustments tab enables the user to set what the predicted value equations are adjusted to
when testing a specific ethnic code. When the Use Default Settings box is checked, the program will set
the percentages to the default; when the box is clear, the values may be adjusted. See Appendix H -
Adjustments to Reference Values Equations for the default values and additional information.

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 Spirometry Settings – Ethnic Adjustments Tab

It is highly recommended to use the default ethnic settings for testing.

F. Calibration
Midmark recommends calibrating all spirometers daily before use. The IQspiro® automates this process for
quick and accurate calibration of the instrument.

Calibrating the IQspiro® requires a 3-Liter syringe. Midmark strongly recommends using the Midmark 3-Liter
syringe with the Midmark Syringe Adapter.

Note
The IQspiro® must be calibrated with a DM; the DM must be
calibrated with a syringe adapter that fits over the outside
diameter of the DM. Never calibrate the device with a syringe
that fits inside the DM.

1. Access the Calibration screen from the IQmanager® Opening Screen by selecting the Calibrate

button .
2. A list of devices that support calibration is shown. Select Spirometer from the list by choosing the
calibration icon on the right.

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 Spirometry Calibration Utility Screen

Note
Place the DM into the IQspiro® before opening the Calibration or
Test screens. See Section II-D, Hardware Setup.

3. The following calibration screen is shown:

Calibration Screen

4. Check to see if Sensor: Ready is displayed in the upper-right corner of the graph window. To print the
calibration report, select Print in the bottom left.

Barometric Pressure
The barometric pressure must be set prior to the first time the system is calibrated.
It must be changed only if the location of the instrument is changed and/or the altitude changes.

Click Settings to open the Spirometry Settings dialog box. Select the Calibration tab and enter the
barometric pressure in the Default Barometric Pressure text box. If the barometric pressure is not known,
select Calculate Barometric Pressure From Altitude and enter the altitude. The software will automatically
calculate and store the usual barometric pressure for that altitude.

Note
The proper barometric pressure or altitude MUST be entered to
assure a proper calibration.

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 Spirometry Settings – Calibration Tab

Check the Calibration Reminder box to remind the user when the IQspiro® has not been calibrated for the
interval set in the Calibration Expiration Interval box.

G. Starting a New Calibration

1. Click New Cal on the Calibration screen to begin a new calibration.
2. Attach the 3-Liter syringe to the large end of the syringe adapter then attach the small end of the
adapter to the DM.

Adapter
Plunger handle

Spirometer

Figure 3-1 IQspiro® with a 3-Liter syringe attached

3. Check that the DM is properly attached to the IQspiro®.

4. The first time the IQspiro® is calibrated; the serial numbers for the syringe and the spirometer handle
need to be entered in the appropriate boxes.
5. Click Start Cal. The sensor will zero itself and then the Calibration Pump screen appears:

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 6. Follow the instructions. 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.
7. The plunger handle must be pulled all the way out before proceeding. Once the handle is all the way
out, inject the air from the syringe until the handle is all the way in.

Note
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,
wait for the timer to reset and inject the plunger. This will not affect
the calibration results.

8. If the calibration is performed correctly, the system will prompt to begin a second injection. Repeat
the process, injecting all of the air from the syringe through the spirometer. If the injection is not
performed correctly, the system will discard the attempt and prompt to inject again.
9. After three correctly performed calibrations, the system will automatically calculate a correction
factor and prompt to perform a verification pump. Always verify the calibration. After a verification
injection, the software will display the measured volume and the percentage difference from
3.0 Liters.

Note
The ATS recommends that the verified volume should be between
2.89 and 3.10 (+/- 3.5%) to be accepted. Be sure to check these
numbers before accepting the verification.

10. The verification acceptance dialog box will display those numbers for 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.

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 Verification Acceptance Dialog Box

11. After accepting the verification, the system automatically saves the calibration. To print the calibration
report, click Print and select Print. To view the calibration report, click Print and select Print Preview.
12. After printing or reviewing 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 has incorporated a feature that
requires calibration at 0.5 L/s, 1 L/s and 3.0 L/s.

On the Calibration tab of the Spirometry Settings screen, there is an option for Multi-Flow Calibration; when
checked, you must calibrate at three different flow rates. The program will display the Multi-Flow Calibration
dialog box and will measure the flow rates as the user injects the 3 liters. If the flow is too fast or too slow,
the program will reject the injection and ask the user to try again.

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

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 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:
• Calibration with both spirometer and syringe at the same temperature.
• Proper calibration of the spirometer daily (three different flow rates).
• Calibration for volume and time or flow and time (we provide volume and time).
• Calibration before each shift.
• Calibration whenever the spirometer is transported.
• Calibration after every thirty tests or sooner (2-3 hours) under field test conditions.

Please refer to the Federal Register or your OSHA representative for additional details about occupational
testing.

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 III. Operation
A. Starting IQmanager®
The software application for operating the IQspiro® is called IQmanager® and is located on the computer
desktop as a shortcut icon. Double-click on this icon to start IQmanager®.

Midmark IQmanager®

B. Opening Screen
When starting IQmanager®, the opening screen will appear:

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 Opening Screen Functions
Button Function
Search for patients previously entered into the database; selecting a patient from
the list allows access to, edit, add and delete data from that patient’s records and
view data from previous tests.

Acquire any STAT test before entering patient demographics or selecting a patient.

Register a New Patient. Refer to the appropriate device Operation

Manual for a description of the patient details required for specific tests.

Calibrate a Midmark device.

View patient details from a patient selected from the Search Results screen.

Go directly to the test selection screen for the selected patient, bypassing the
Patient Data screen.

Enable users to configure the program to meet their needs. (See “Configuring
IQmanager®” for more information).

Receive assistance regarding the use, operation and troubleshooting of IQmanager®

and other Midmark products.

Exits the program and returns to the Windows desktop.

C. Creating a New Patient Profile

To create a new patient file, click the New Patient icon on the Opening screen. This opens the Patient
Details screen to enter the patient’s specific data.

Opening Screen

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 Note
A patient name and DOB must be entered to start a new test. It is
highly recommended to enter all information available, including
patient ID.

Click in any text box or press the Tab key on the computer keyboard to enter information and move from field
to field. This information may not be essential for every test performed, however, it is important to complete
each of these fields as accurately as possible. Each diagnostic test has its own patient data requirements,
which may affect the computer-generated interpretation of the test; it is important to refer to each device’s
Operation Manual when completing this screen.

Important Computer Date Information

The IQspiro® uses the current date from the computer and the patient’s birth date (ente red by the user) to
calculate the patient’s age. Since the IQspiro® equations and interpretive analysis use the patient’s age to
produce appropriate diagnostic statements, it is important that computer’s current date is accurate. Contact
the system administrator if your computer’s date is incorrect.

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 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 Diagnostic Role Description
Patient Information
• First Name Required Used for identification purposes.
• Middle Name (except Middle
• Last Name Name) Letters and numbers may be used.
Used for information and diagnostic purposes in ECG and Spirometry.
Date of Birth
Required for ECG IQmanager® uses this data to calculate the age of the patient.
Format: MM/DD/
and Spirometry
YYYY
Format may be changed in the Configuration Settings.
Required for ECG
Gender Used for identification and diagnostic purposes in ECG and Spirometry.
and Spirometry
Used for information and diagnostic purposes in Spirometry.

Select from the pull-down menu one of the following: Unspecified, Caucasian,
Required for Black, Asian, American Indian, Hispanic, African- American, or African-
Race
Spirometry European.

If the patient’s race is not listed, not known, or the patient is of multiracial
origin, select the race as identified by the patient.
Used for identification purposes.
ID # Recommended
Letters and numbers may be used.

Contact Information

Address

Home Phone
Used for identification and/or contacting purposes.
Cell Phone (Contact Info tab)
Letters and numbers may be used.
Work Phone

Email

Smoking History

Year Start Smoking Recommended

for Spirometry For diagnostic purposes in Spirometry.
Year Quit Smoking (Smoking History
tab) Enables the operator to enter smoking history.
Cigarette/Day

Risk Factors

History of Angina

Physical Activity
Used for informational and diagnostic purposes when interpreting test results.
Resting ECG Status
(Risk Factors tab)
The information entered in this tab appears in the Patient Data Report.
• Hypertension
• High Cholesterol
• Obesity
• Diabetes
Medical History

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 Patient Data Fields
Field Diagnostic Role Description
Pacemaker
Physician
(History tab) Used for information purposes.
Referred By

Facility

Medication(s)
• Medications Recommended
• Dosage for Resting ECG
May be used as a diagnostic tool when interpreting test results.
• Schedule and Spirometry
(Medications tab)

Click Save to store the data entered or edited in the New Patient screen in the database.

Click Clear to refresh the New Patient screen and remove all existing information entered or edited.

Click Cancel to exit the New Patient screen without saving any changes.

Upon completion of the Patient Data screen, review all information to ensure that everything is
accurate and up-to-date. Once accuracy is confirmed, proceed with a new patient test.

Vitals
The Vitals drop-down provides a composite of the patient’s most recent day of data. If no vital signs have
been entered, the title of the control group title reads Vital Signs and each field is blank. If vital signs have
been previously entered, the control group title will read Vital Signs as of mm/dd/yy hh:mm:ss indicating the
date and time of data entry, and boxes will be read only. To edit vitals, click New Vitals to overwrite the data.
Additional information about the Vitals section can be found in the IQmanager® Operation Manual.

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 Smoking History Drop-down

• Select the year the patient started smoking from the Year Start Smoking drop-down.
• If the patient has quit smoking, select the year the patient quit from the Year Quit Smoking drop-
down. If the patient has not quit smoking, select Have Not Quit from the drop-down.
• Enter the number of cigarettes the patient smokes per day in the Cigarettes/Day field.

Medications Drop-down
The Medications drop-down displays the current medications assigned to the patient. The available actions
are to add, edit or delete medications from the patient’s profile.

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 Contact Info Drop-down
The Contact Info drop-down provides the patient’s address, phone numbers and email address.

Medical History Drop-down

Selecting the History drop-down on the Patient Details screen enables the operator to select from a number
of common conditions that may play a role in the physician’s final diagnosis.

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 Risk Factors Drop-down
The Risk Factors drop-down lists possible diagnostic factors for the physician’s use including History of
Angina, Physical Activity, Resting ECG Status, Hypertension, High Cholesterol, Obesity and Diabetes. The
data is informational only and will not affect the program’s diagnostic results.

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 D. Pre-Test Preparation
1. Calibrate the IQspiro® daily before use for accuracy.
2. Measure the patient’s height. If the patient can’t stand, measure their arm span from fingertip to
fingertip with arms outstretched against a wall.
3. Wash your hands.
4. Explain to the patient that they will be sitting for the test. If prior testing took place with the patient
standing, have them sit, but make a note of the change or have them continue to stand while being
tested.
5. Ask the patient to loosen any restrictive clothing.
6. Have the patient place loose dentures in a cup.
7. Use of a nose clip is highly suggested during the testing procedure.
8. Avoid cross-contamination by disposing of the DM and replacing it with a new one for each patient.

Note
Always open the package from the end closest to the single pin
on the mouthpiece. This is the exhalation side of the mouthpiece
and is safe to handle. (See figure below).

Open package
from this end.

9. Explain to the patient that they will be performing a minimum of three and a maximum of eight testing
maneuvers.

Caution
Midmark IQspiro®, when used with specific Midmark disposable mouthpieces, is designed
and tested to meet regulatory and industry standards. Midmark can only warrant product
performance and accuracy if the IQspiro® is used as intended in its unaltered form, and when
recommended practice guidelines are followed. Any modification to the Midmark IQspiro®
mouthpiece, including but not limited to the use of an adapter or filter, is considered an
alteration to the design of the product.

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 E. Performing an FVC or FVC Loop
The FVC test is usually the first spirometry test prescribed. Traditionally, the FVC test measures expiratory
flow only; 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, an
FVC test. With IQspiro®, the user can perform a FVC or FVC Loop by selecting FVC.

To start a test, click New Test from the Patient Data screen. Click on the play icon next to IQspiro.

If desired, type the Technician’s name and the Physician’s name or select them from the pull-down list.
The reason for testing the patient can also be selected from the Indication list as shown in the New Test
Selection Screen.

Click on OK to open the test acquisition screen. The Spirometry Data Acquisition (Test) screen appears:

By default, FVC will be selected. For a Pre-BD test, make sure the words Pre-Bronchodilator appear in the
blue box in the middle of the screen. Also notice that Pre and FVC are bold. Do not click Start New Test
until the patient is ready.

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 F. Observation Notes
Observation notes may be added in this section before or right after the patient maneuver. Be sure the
information entered is accurate as once the report screen is clicked, notes and observations cannot be
changed.

To add notes and observations before or right after a test maneuver:

1. Click on the Notes button in the Spirometry Data Acquisition (Test) screen.

2. Enter notes and observations here.

3. Click OK when done.

The observation notes entered can be viewed in the report screen and will appear on the printed report.

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 Note
Text entered in the Observation Notes can only be edited while in
the live testing screen. Observation notes cannot be edited once
the test screen has been exited.

Note
The Sign check box allows users to electronically sign the report
after the report has been reviewed and saved. This feature
prevents any changes to be made to the signed report.

G. Patient Instructions
The accuracy of spirometry testing depends on proper patient instruction and coaching. Therefore, the
technician or nurse is a critical factor in achieving good spirometry results. After patient instruction is given, it
is essential that the clinician demonstrate the correct way to perform the test.
• The purpose of spirometry is to determine how much air the patient can inhale into their lungs and
how hard and fast the patient can blow out that air for at least six seconds. It should be like blowing
out candles on a birthday cake, until there is no air left to exhale.
• The patient should inhale as deeply as possible; when the lungs are completely full, have them
quickly put the DM in their mouth with the tongue under the DM, teeth and lips around it, sealing
the lips around the DM, blast out as hard and fast as possible.

Note
The patient should not block the opening of the DM with their
tongue or teeth.

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 Note
When explaining the maneuver to the patient, instruct them to use
the ridges on the top and bottom of the DM as a guide for how far
to insert the mouthpiece into their mouth. Good practice is for the
patient to rest their teeth gently between the ridges.

Caution
Midmark IQspiro®, when used with specific Midmark disposable mouthpieces, is designed
and tested to meet regulatory and industry standards. Midmark can only warrant product
performance and accuracy if the IQspiro® is used as intended in its unaltered form, and when
recommended practice guidelines are followed. Any modification to the Midmark IQspiro®
mouthpiece, including but not limited to the use of an adapter or filter, is considered an
alteration to the design of the product.

• The use of nose clips helps ensure that no air leaks out through the nose during testing. Air leakage
through the nose can affect the test results.
• The technician will demonstrate the FVC maneuver with the use of a DM.
−− To emphasize to the maneuvers to patient have the technician do the following:
▪▪ Take a very deep breath, and throw the shoulders back, widen their eyes and stand on their
toes.
▪▪ The technician should then stick out their tongue, place the DM on top of their tongue and seal
their lips around it.
▪▪ The technician will then Blast out as hard and fast as possible for at least six seconds. A
vigorous demonstration will help produce a good spirometry test for the patient.
• Explain to the patient that the correct posture during testing is to have the shoulders back, chin up
and do not lean forward during exhalation.

Note
Most patients have a normal tendency to lean forward while
exhaling forcefully. Ask the patient for permission to place a hand
on their shoulder during the test. If they start to lean forward
during the maneuver gently help correct their posture.

Have the patient visually focus on an incentive screen or an object

at eye level to help keep the chin up and posture straight.

For pediatric patients with small hands, instruct them to hold the spirometer with both hands, versus
one hand.

H. Step-by-Step Spirometry Instructions

1. Insert a new DM in the IQspiro®. See Section II-D, Hardware Setup.

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 2. Instruct the patient to hold the IQspiro® in either hand and then hold the device up and to the side of
their face, as illustrated in the photo below.

3. On the Patient Testing screen click Start New Test.

4. 4. The device will zero itself. Be sure that no air is traveling through the mouthpiece during
zeroing. The following box will appear while the IQspiro® is zeroing:

5. Once the zeroing is done, an incentive display appears, if one has been chosen.
6. Instruct the patient to take a maximal inhalation.
7. Instruct the patient to quickly put the DM in their mouth, with their tongue under the DM, teeth and lips
around it, sealing the lips around the DM. Have them Blast out as hard and fast as possible.

Note
The patient’s tongue or teeth should not be blocking the opening
of the DM.

Note
When explaining the maneuver to the patient, instruct them to use
the ridges on the top and bottom of the DM as a guide for how far
to insert the mouthpiece into their mouth. Good practice is for the
patient to rest their teeth gently between the ridges.

8. Encourage the patient to keep blowing out for six seconds, until no air is left to exhale.
−− Optional: Have patient then forcefully inhale until lungs are full.

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 9. Stop the test and instruct the patient to remove DM from their mouth.
10. If necessary, instruct the patient on how to correct any technique problems.
11. Obtain three good maneuvers and two matches. Do not exceed eight maneuvers in one testing
session.
12. The program automatically assigns a quality grade to the test.

Test Accepted Dialog Box

13. After each completed test, the Test Accepted dialog box appears with either Yes or No automatically
selected. After a test is accepted or rejected, click Yes to perform another test or No to stop testing.

Note
The acceptability statements are intended as recommendations
or guidelines and are not mandatory actions. You can override the
software selection and choose Accept or Reject for each test.

Acceptability Statements Seen During FVC Testing

Acceptability Statement Criteria Comment Displayed
Good test Meets all the criteria listed below Good test!
Hesitating start If BEV >150mL Don’t Hesitate
If FET <6.0 sec and EOTV >40 mL
Test too short Blow out longer
(invalid FEV6)
Poor effort If PEF match >1.0 L/s Blast out harder

Poor effort in 1 second

st
If FEV6 match >150mL Deeper breath

Achieve two matches After two acceptable maneuvers match Good test session

Poor effort on PEFT If PEFT >120msec Blast out faster

Interrupted flow Cough or interruption detected Blast out smoothly

No plateau of duration of at least one second
Abrupt stop in which there is less than 0.050 liters of Blast out completely
volume change
Inhalation volume is greater than the Inhale > 1.1 * exhalation if inhalation Inhale deeper before starting
Exhalation Volume performed the test

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 Acceptability Statements Seen During FVC Testing
Acceptability Statement Criteria Comment Displayed
Exhalation volume is greater than the Exhale > 1.1 * inhalation if inhalation Inhale completely at the end
Inhalation Volume performed of the test
This acceptability statement was added by
Volume less than 0.50 Liters Volume Too Low
Midmark

Note
Only one error message is displayed.

Note
Use best judgment when deciding to accept or reject a test.

14. After the patient has completed the number of required tests, click Save Review in the lower-right
corner of the test screen. This will automatically save the test session and display the View Report
screen.

See Section IV, Reviewing Patient Reports for more information about the View Report screen.

Ejecting the DM from the IQspiro®

The IQspiro® eliminates the need to handle the used DM

To eject the DM from the IQspiro®:

1. Open the IQspiro® door and hold open with index finger.

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 2. Hold IQspiro® over trash receptacle and use your thumb to push down on the eject lever.

3. The used DM will eject into the trash receptacle.

Quality of Test Results

Having the patient inhale at the end of the test provides measures to ensure that the patient inhaled fully
before they started the test and expired fully during the test. If a patient performs a FVL, 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 Test
The following instructions assume the Pre-BD test has been done on the patient and the bronchodilator has
been administrated.

Note
To assure validity of the Post-BD test, ample time should be
allowed for the medication to take effect. Refer to manufacturer’s
package insert for further information.

Post-Bronchodilator Testing a Patient

From the View Report screen, select a bronchodilator from the pull-down list then click Post-BD to return
to the testing screen and perform the test. Post-BD FVC tests are performed the same way as Pre-BD FVC
tests. See Appendix L - Performing a Pre/Post FVC Test - Quick Reference User’s Guide.

Vital Capacity or Slow Vital Capacity Tests

Vital capacity (VC) or slow vital capacity (SVC) tests can determine if a patient’s lungs are trapping air during
a FVC test. Air trapping can be an indication of airway obstruction and can also be seen in older patients.
This is a very slow and deliberate test. The patient takes two or three normal tidal breaths then a slow, deep
breath, and then a slow, full exhale.

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 Click VC, which will be bolded. If this is a Pre-BD test, make sure the Pre-Bronchodilator message is
displayed in the blue box in the middle of the test screen. Do not click Start New Test until the patient is
ready to perform the test.

To perform a VC test, the patient must perform the following:

1. Inhale completely before placing the flow sensor mouthpiece into the mouth.
2. Instruct the patient to place the mouthpiece on top of their tongue, with their teeth and lips around the
mouthpiece. The patient must seal their lips around the DM. Let the patient get used to the feeling of
breathing with the DM in their mouth.
3. Inhale as deeply as possible, until the technician observes a plateau at the bottom of the graph.
4. Exhale 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.
5. The technician should stop the test by clicking Stop or pressing Enter.
6. Remove the mouthpiece 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 required, click Save Review and click Yes to save the test efforts.

Maximum Voluntary Ventilation

The Maximum Voluntary Ventilation (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 MVV, which will now be bolded. For a Pre-BD test, make sure the Pre-Bronchodilator message is
displayed in the blue box in the middle of the test screen. Do not click Start New Test until the patient is
ready to perform the test.

To perform the MVV test, the patient must perform the following:
1. Instruct the patient to put DM in their mouth, with their tongue under the DM and lips sealed around it.
Take at least three normal tidal breaths.
2. Inhale and exhale maximally as quickly as possible for 12 to 15 seconds.

Coach and encourage the patient until the test time exceeds 12 seconds. Have the patient remove the DM
from their mouth and allow them to rest.

After the patient has completed the number of tests you require, click Save Review and click Yes to save
the test efforts.

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 IV. Reviewing Patient Reports
IQmanager® allows for the storage of additional patient diagnostic tests including ECG and Holter data. If the
components are being utilized refer to the appropriate manual for information about those devices.

A. Review Spirometry Reports

Once the spirometry session is completed and the test screen has been exited, the View Report Summary
screen appears:

Spirometry View Report Screen - Summary

The test results are displayed in the middle of the display area with other useful information displayed in the
upper sections.

The Sign checkbox is used for signing off the report. If the Sign checkbox is unchecked, it indicates the
report has not been signed and can still be edited. If the Reviewed By box is filled in with a name and the
Sign checkbox is checked and saved when the review screen is exited, the report becomes read-only. If the
user tries to check the Sign checkbox without first typing the reviewer’s name in the Reviewed By box, a
warning message will pop up as follows:

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 Click Settings to select which reports to print; every report checked will be included when the print function
is selected.

In addition to the test results, the Summary tab includes the following information:
• Patient information: Age, Sex, Height, Race, Smoking History
• Lung age
• COPD (Chronic Obstructive Pulmonary Disease) risk
• Pre and Post FVC test session statement (Attemped, Accepted, Matches)

Click on the 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.

Spirometry View Report Screen – FVC Graphs

B. Spirometry Analysis and Reports

Printed reports display patient demographics, test date and time, measurements, graphs, interpretations,
observation notes and additional analysis of the spirometry test results.

COPD Risk Assessment

The 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. See Appendix J – COPD Risk Assessment Calculation for additional
information.

Lung Age
Lung age is a smoking cessation tool that, if enabled, appears on the summary screen and provides an
indication of the health of the patient’s lungs. The program automatically calculates the lung age of the

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 patient from the patient’s sex, height and FEV1. Lung age is calculated only for patients who have been
identified as current or former smokers, from 20 to 84 and will never a value of 25 or less than the patient’s
actual age. It should be emphasized that the lung age parameter is intended to be used solely as a smoking
cessation tool and not as a diagnostic measurement. See Appendix K - Lung Age Calculation for additional
information.

C. Trending
Trending enables the comparison of the best test measurements from two or more of a patient’s spirometry
sessions.

Trending - Main Screen

Use trending to compare different spirometry measurements over time. The changes in a patient’s condition
can be more easily seen in graphical and tabular form.

The following features are standard in the Trending software:

• Date and time of each test performed is displayed
• 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 a maximum of all test
sessions stored for that patient.
• Compare two individual tests, e.g., the best test in one session against the best test in another
session.
• Compare actual and predicted measurements.

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 • View changes over a selected period of time, e.g., the oldest test session against the latest test
session.
• Compare Pre-Bronchodilator tests only or Post-Bronchodilator tests only.
• Display tabular and graphical results for easy comparison.
• Display color-coded graphic results 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.

Selecting Reports to Trend

Click Trending from the View Report screen and the Spirometry Trend Selection dialog box appears:

Spirometry Trend Selection Dialog Box

Report Selection
• All Reports (default): View all the reports in the list.
• Select From List: Select individual reports for trending.

Test Selection
• Pre-Bronchodilator (default): All trended values are taken from the best Pre-BD test of the session.
• Post-Bronchodilator: All trended values are taken from the best Post-BD test of the session.

Action
• View Report (default): Display the Trending screen, from which the user can choose to print the
trending reports.
• Print Report: Click OK to print the trending report to the default printer. The Trending screen
displays briefly then returns to the View Report screen.

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 Spirometry Settings, Trending Tab

Spirometry Settings - Trending

The following actions can be accessed in the Trending tab on the Spirometry Settings:
• Select the parameters to trend,
• Select the type of Flow Volume Loop report to print, and
• Select the default Flow Volume Loop to display

Report Selection
Select which type of Flow Volume Loops to print with the trend report:
• Side By Side F/V Loops: F/V Loops are displayed and printed side-by-side.
• Overlay F/V Loops: F/V Loops are displayed and printed overlaid.

Default F/V Display

Select which type of Flow Volume Loops to review the trend report:
• Side By Side: Click View F/V Loops in the Trending screen to display the Side By Side F/V Loop
screen as the default.
• Overlay: Click View F/V Loops in the Trending screen to display the Overlay F/V Loop screen as
the default.
• Total Selected: Displays the number of parameters selected for printing.
• Maximum Allowed: Displays the maximum number of parameters allowed.

Axis Parameters
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.

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 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: The right axis is for trending flow measurements.
• Percent: The right axis is for trending percentage measurements.
• 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

From the Trending tab on the Spirometry Settings screen, click Select under one of the Measurements
list boxes. The Spirometry Trend Parameters Selections dialog box appears, where the user selects which
parameters to trend. There are six possible sets of parameters:
• Volume measurements
• Volume predicted values
• Percentage measurements
• Percentage predicted values
• Flow measurements
• Flow predicted values

Spirometry Trend Parameter Selection

• Add: Highlight an item in the Available list and click Add. This will place the new item at the bottom
of the Selected list.
• Insert: Highlight an item in the Selected list. The new item will be inserted above this item.
Highlight an item in the Available list and click Insert. This will place the new item above the
highlighted item in the Selected list.
• Remove: Highlight an item in the Selected list and click Remove. This will remove that item from
the Selected list and place it on the Available list.
• Clear List: Removes all the items in the Selected list and places them on the Available list.

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 Trend Display Screen

Trending - Main Screen

The Trending screen is the main screen of the spirometry trending control. It consists of a graphical 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 the cursor is moved from left to right. The software
automatically scrolls the grid and highlights the report to which the current marker points. If on a grid row is
clicked on, the software moves the vertical marker to the data corresponding to the selected report.

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 Trending Buttons

Trending Button Bar

• Save To File: Click to open the File Save dialog box. Enter a valid filename and click OK to saves
the information in the grid in Microsoft Excel file format (*.xls).
• Print: Click to print the trend report to the currently selected printer.
• Print Setup: Click to display the Print Setup dialog 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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 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, showing the session number and report date in
the color that matches the associated F/V loop.

When the vertical marker is moved to a date or a point in the grid is selected, the software highlights the
F/V loop corresponding to that report (if one exists) by drawing the loop in a black. The loop returns to its
previous color when you select another report.

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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 ordered
chronologically, starting with the top left loop, to the bottom right loop. Note that in this screen,
View Side by Side 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.

• Prev: 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 View Overlay to display the F/V loops in an overlay format. Click View Trend to return to the main
Trending screen.

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 V. Maintenance and Storage
Note
For the greatest accuracy, Midmark recommends daily calibration
of the IQspiro® frequently.

• DO NOT REUSE DISPOSABLE MOUTHPIECES.

• For serial devices: Replace the batteries when the device LED turns red or the computer screen
displays the Low Battery message.
• Inspect the IQspiro® and calibration syringe regularly for accuracy.
• Contact Midmark for your annual calibration certifications.

The IQspiro® Digital Spirometer product is designed to operate without adjustment for the lifetime of the
device.

However, electronic equipment can be subject to wear and damage that can cause malfunctions. A
certification policy is the responsibility of the end user and is subject to the end users’ business practices
which may require it. Certification provides peace of mind that the device continues to work within our factory
specifications. Certifications can be purchased directly from Midmark.

Please contact Technical Service at 800-624-8950, option 2, with any questions or to make arrangements for
the certification of your IQspiro® Digital Spirometer device.

Cleaning
Caution
Do not use aromatic hydrocarbons, rubbing alcohol, or solvents for cleaning the IQspiro®.

Preventative Cleaning
Because the IQspiro® uses disposable single-patient use mouthpieces, there is no need to routinely clean
or sterilize any part of the spirometer or cable. To clean the outside of the IQspiro®, use a mild solution of
detergent and water with a soft cloth. Do not use an excessive amount of solution. Be sure not to wet the
ports on the top of the IQspiro® or the battery compartment at the bottom (if applicable). 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.

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 Preventative Inspection
A preventative inspection should be done prior to each use to verify that there is no visible damage to the
unit that may cause it to malfunction. The visual inspection should include the IQspiro® 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 Technical Service.

Storage
Avoid extreme humidity and heat during storage.

For serial connection devices: To prevent damage to the IQspiro® handle due to battery leakage or oxidation,
remove all batteries if the device will not to be used for a long period of time.

Caution
Electronic devices can be damaged by exposure to liquids. Do not use or store the IQspiro®
near any type of liquids.

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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 VI. Appendices
A. Appendix A - Screen Summary

Summary of Screens
Screen Name Screen Summary Main Functions
• Access New Patient screen.
• Access Search Results.
• Configure IQmanager®
Access the main functions of
Opening • Access Help.
IQmanager®.
• Exit to desktop.
• Run a STAT test (If IQecg® or
IQvitals® is installed)
• Enter new patient data.

Enter patient information, including • Edit data for an existing patient

Patient Data name, ID, vital signs, medications, • Initiate a test for a patient
smoking and medical history.
• Access a previously saved rest for
review.
• Acquires FVC, VC and MVV tests.
• Automatically “grades” tests based
Used to acquire spirometry tests. Also on the ATS recommendations.
Spirometry Test used to accept or reject tests and • Compares accepted tests for
assign the best test of a session. reproducibility.
• Enables the user to change the
settings for the IQspiro®.
• View and analyze the spirometry
test numeric and graphic results.
• Enables the user to print preview
Shows the interpretation for the best the test report.
Spirometry Review Pre-FVC test. Allows the user to
confirm the test interpretation. • Enables the user to edit the
interpretation.
• Enables the user to change the
settings for the IQspiro®.
• Select the trending parameters.
• Compare individual tests, Pre-BD
or Post-BD tests only, actual and
Compares the best test measurements
Trending predicted measurements or changes
from two or more spirometry sessions.
over a period of time.
• Display and/or print tabular or
graphic results.

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 B. Appendix B – Troubleshooting IQspiro® and IQmanager®
This Troubleshooting Guide provides a list of solutions or recommendations to problems that may be
encountered with the IQspiro® and IQmanager®. Before calling Midmark Technical 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.

Software Troubleshooting Guide

Error Message or Problem Solution or Recommendation
FAILED TO CREATE EMPTY DOCUMENT All Windows programs must be closed before installing
IQmanager®.
Message appears immediately after initial
software installation and after each attempt • Uninstall IQmanager®, restart computer and reinstall
to start IQmanager®. IQmanager® (refer to the IQmanager® Operation Manual).

The minimum flow required to start a test has been

exceeded or excessive electromagnetic interference is
affecting the instrument.
• Instruct the patient not to move the IQspiro® abruptly, as it
can cause air to flow through the DM and start a test.
• Turn off fans, close heating and air conditioning vents
FVC Test Starts for no apparent reason. near the test area and close doors or windows.
• Delay clicking Start New Test until just prior to beginning
the maneuver.
• Select a different location or find and correct the source of
the interference.
• Contact Midmark Technical Service for additional
assistance.
• Check Patient’s Date of Birth, Height, Sex, and other
information to ensure it is accurately entered.
Incorrect diagnostic interpretation.
• Check which Pre-FVC test is selected as the best test.
• Check which Interpretation logic is selected.
The IQspiro® cannot communicate with the computer
because it is not connected, it is connected to the wrong
MODULE NOT RESPONDING! serial port, or the batteries are dead or installed incorrectly.
or
SENSOR NOT RESPONDING! • Verify the cable is connected to a serial port and that it
is corresponds with what is selected in the Configuration
Message appears after starting a new test. Settings.
No waveform is displayed on the screen. • Check the battery orientation.
• Install new batteries.

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 Software Troubleshooting Guide
Error Message or Problem Solution or Recommendation
• Access the online help by clicking Help on any screen.
Other operation problems • Contact Midmark Technical Service. See Section VII,
Customer Support and Warranty Information.
• Check the patient’s demographics. Race, Age, Sex,
Predicted FEV1/FVC is not available or
and Height (R.A.S.H.) must be entered to calculate a
valid.
Predicted Value.
The Report Locking feature prevents multiple users from
The [test] report dated [test date] for accessing a report simultaneously in a LAN environment
[patient name] is in use by [network where multiple workstations share a central database.
computer name]
Report Locking can also be caused by improperly exiting the
Message appears when trying to open a patient report.
test report. • Close the test report at the [network computer name]
workstation by clicking Review Exit.
The Record Locking feature prevents multiple users
This patient’s record is in use by: from accessing a patient record simultaneously in a LAN
[network computer name] environment where multiple workstations share a central
database. Record Locking can also be caused by improperly
Message appears when trying to open a exiting the patient record.
specific Patient Data screen. • Close the Patient Data screen at the [network computer
name] workstation using Opening Screen.
• Exit IQmanager®.
Unable to create big button • Start MS-DOS Prompt.
• Change directory to c:\windows\system.
Message appears when attempting to
launch/start IQmanager®. • Type regsvr32 [Link] and press Enter.
• Exit MS-DOS Prompt and start IQmanager®.
1. Exit IQmanager®.
2. Start MS-DOS Prompt (command).
3. Change directory to c:\windows\system.
View Report screen does not work
4. Type regsvr32 [Link] and press Enter.
5. Type regsvr32 [Link] and press Enter.
6. Exit MS-DOS Prompt and re-start IQmanager®.
Ambient air pressure or temperature has changed since the
last calibration, the current DM lot is slightly different from the
last one, or the Use Dry Air Conditions option is checked.
Volume numbers appear too high or too low • Calibrate the IQspiro®.
• Deselect the Use Dry Air Conditions option when
performing patient tests. This option disables the BTPS
corrections.

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 Software Troubleshooting Guide
Error Message or Problem Solution or Recommendation
Battery contact damaged.
Battery door will not close
• Call Midmark for RMA; repair IQspiro®.
Leur fitting (pressure port) plugged with plastic from last DM.
Cannot install DM into IQspiro®
• Carefully remove plastic from Leur fitting
Air is flowing through the DM while the software is
attempting to zero the IQspiro® or excessive electromagnetic
interference is affecting the instrument.
A. Instruct the patient to hold the IQspiro® next to their
cheek prior to starting the test and to blow after zeroing is
Cannot zero IQspiro® complete.
B. Select a different location or find and correct the source of
the interference.
C. Contact Midmark Technical Service for additional
assistance.
Batteries are low, the COM port is not communicating, or the
IQspiro® is defective.
• Replace with new batteries.
LED on the IQspiro® glows or flashes red
• Configure the COM port.
• Repair computer COM port.
• Call for RMA. Repair IQspiro®.
The COM port is defective or not compatible with IQspiro®;
the installed USB-to-serial port converter is not compatible
with the IQspiro®.
LED on the IQspiro® will not turn OFF but • Repair COM port
unit functions correctly otherwise.
• Install USB COM Port.
• Install different USB to Serial Port converter.
• Contact Midmark Technical Service.
There are no batteries in the IQspiro®, the IQspiro® is not
plugged into an available COM port, the COM port is not
talking with the IQspiro®, or the IQspiro® is defective.
• Install new batteries
LED on the IQspiro® will not turn on.
• Plug IQspiro® into an available COM port.
• Configure the COM port.
• Call Midmark for RMA; repair IQspiro®.

LED will not turn ON, unit functions Defective LED

correctly. • Call Midmark for RMA; repair IQspiro®.

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 C. Appendix C - Safety and International Symbols
The following symbols are used on Midmark products. Refer to this directory for details concerning the
symbols used on equipment.

Symbol Description

Follow instructions for use.

Date of manufacture.

Do Not Use for More than One Patient – Single-Patient-Use Only, however, 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.

DC VOLTAGE – (USB CONNECTION DEVICES)

This device uses 5 Volt power and consumes 80mA when in use.

DC VOLTAGE AND BATTERY ORIENTATION– (SERIAL CONNECTION DEVICES)

This device uses 3 Volt power and consumes 70mA.
Battery orientation, battery type, and power requirements.

ETL Listing Mark

Equipment displaying this symbol has been tested to comply with the following safety
standards:
• Conforms to UL Std 60601-1;
• Certified to CAN/CSA Std C22.2 No. 601.1

DISPOSAL
Do not dispose of this product as unsorted municipal waste. Dispose this
product in accordance with national requirements per EC Directive 2002/96.

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 D. Appendix D - 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 IQspiro® 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:) Criteria

Physiological variant FEV1 >= 100% Pred. FEV1
Mild obstruction 70% Pred. FEV1 <= FEV1 < 100% Pred. FEV1

Moderate obstruction 60% Pred. FEV1 <= FEV1 < 70% Pred. FEV1

Moderately severe obstruction 50% Pred. FEV1 <= FEV1 < 60% Pred. FEV1

Severe obstruction 34% Pred. FEV1 <= FEV1 < 50% Pred. FEV1

Very severe obstruction 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 Criteria
Mild restriction 70% Pred. FVC <= FVC < LLN
Moderate restriction 60% Pred. FVC <= FVC < 70% Pred. FVC

Moderately severe restriction 50% Pred. FVC <= FVC < 60% Pred. FVC

Severe restriction 34% Pred. FVC <= FVC < 50% Pred. FVC

Very severe restriction FVC < 34% Pred. FVC

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 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.

Ratio of Post-BD / Pre-BD (Post/Pre)

Statement
Post FVC/Pre FVC Post FEV1/Pre FEV1
Markedly improved >= 1.25 >= 1.25
Improved 1.15 to 1.24 1.12 to 1.24

Not clearly improved 1.05 to 1.14 1.05 to 1.11

Not improved < 1.05 < 1.05

Lower Limit of Normal (LLN)

The LLN for FVC, FEV1 and FEV1/FVC is calculated as follows:

LLN = Valuepred − CI95%

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:

CI95% = 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%
LLN = Valuepred x 1−
 100 

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 E. Appendix E - 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 were developed from data collected and we have labeled these equations as
NHANES III.

The NLHEP 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 Section II-E, Configuring IQspiro®).
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 Criteria
Mild obstruction FEV1 >= 60% Pred. FEV1
Moderate obstruction 40% Pred. FEV1 <= FEV1 < 60% Pred. FEV1

Severe obstruction 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 statement: Low vital capacity, perhaps due to restriction of lung volumes

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 F. Appendix F - Reference Values - Adult
IQspiro® provides the following sets of reference equations for adult patients:
• 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

Crapo - Adult
H = Height in centimeters.
A = Age in years.

Parameter Sex Race Age Range Predicted Equation SEE CI95% Source
Predicted VC =
VC M/F W All
Predicted FVC

FVC M W 15–91 0.06H - 0.0214A - 4.650 0.644 1.115 Ref. 4

F W 15–91 0.0491H - 0.0216A - 3.590 0.393 0.676 Ref. 4

FEV0.5 M W 15–91 0.0327H - 0.0152A - 1.914 0.414 0.708 Ref. 4

F W 15–91 0.0238H - 0.0185A - 0.809 0.294 0.506 Ref. 4

FEV1 M W 15–91 0.0414H - 0.0244A - 2.190 0.486 0.842 Ref. 4

F W 15–91 0.0342H - 0.0255A - 1.578 0.326 0.561 Ref. 4

FEV3 M W 15–91 0.0535H - 0.0271A - 3.512 0.587 1.017 Ref. 4

F W 15–91 0.0442H - 0.0257A - 2.745 0.360 0.620 Ref. 4

FEV1/FVC% M W 15–91 -0.13H - 0.152A + 110.49 4.78 8.28 Ref. 4

F W 15–91 -0.202H - 0.252A + 126.58 5.26 9.06 Ref. 4

FEV3/FVC% M W 15–91 -0.0627 - 0.145A + 112.09 2.68 4.64 Ref. 4

F W 15–91 -0.0937H - 0.163A + 118.16 3.11 5.36 Ref. 4

FEF25-75% M W 15–91 0.0204H - 0.038A + 2.133 0.962 1.666 Ref. 4

F W 15–91 0.0154H - 0.046A + 2.683 0.792 1.363 Ref. 4

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 Parameter Sex Race Age Range Predicted Equation SEE CI95% Source

PEF M W 18-25 0.0780H + 0.1660A - 8.060 1.653 2.72 Ref. 14

M W 25-85 0.0940H - 0.0350A - 5.993 2.078 3.42 “

F W 20-87 0.0490H - 0.0250A - 0.735 1.605 2.64 “

FEF25%
M W 18-25 0.0700H + 0.1470A - 7.054 1.530 2.52 Ref. 14
(MEF75%)

M W 25-85 0.0880H - 0.0350A - 5.618 2.012 3.31 “

F W 20-87 0.0430H - 0.0250A - 0.132 1.53 2.52 “

FEF50%
M W 18-24 0.0543H + 0.1150A - 6.3851 1.1196 1.184 Ref. 13
(MEF50%)

M W 25-85 0.0684H - 0.0366A - 5.5409 1.2915 2.12 “

F W 20-70 0.0321H - 0.0240A - 0.4371 0.9778 1.61 “

F W 70-87 0.0118H - 0.0755A + 6.2402 0.7569 1.25 “

FEF75%
M W 18-25 0.0397H - 0.0057A - 4.2421 0.7551 1.24 Ref. 13
(MEF25%)

M W 25-85 0.0310H - 0.0230A - 2.4827 0.6917 1.14 “

F W 20-70 0.0174H - 0.0254A - 0.1822 0.6612 1.09 “

F W 70-90 -0.0172A + 1.8894 0.2409 0.396 “

MVV M W 18-25 1.840H + 1.800A - 192.3 K3

M W 25-85 2.080H - 1.0800A - 168.1 K3

F W 20-87 1.090H - 0.840A - 31.8 K3

Sex Age Range Height Range (cm) Height Range (in)

Male 15 – 91 157 – 194 62 – 76
Female 17 – 84 146 – 178 57 – 70

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 Knudson - Adult

Parameter Sex Race Age Range Predicted Equation SEE CI95% Source
VC M/F W All Predicted VC = Predicted FVC

FVC M W 18-25 0.0590H + 0.0739A - 6.8865 0.4708 0.775 Ref. 13

M W 25-85 0.0844H - 0.0298A – 8.7818 0.6384 1.05 “

F W 20-70 0.0444H - 0.0169A – 3.1947 0.4831 0.795 “

F W 70-90 0.0313H – 0.0296A –0.1889 0.5745 0.945 “

FEV0.5 M W 18-25 0.030H + 0.043A – 3.0540 0.425 0.699 Ref. 14

M W 25-85 0.037H – 0.017A – 2.746 0.474 0.779 “

F W 20-87 0.019H – 0.014A – 0.406 0.388 0.638 “

FEV1 M W 18-25 0.0519H + 0.0636H - 6.1181 0.4458 0.734 Ref. 13

M W 25-85 0.0665H - 0.0292A - 6.5147 0.5241 0.862 “

F W 20-70 0.0332H - 0.0190A - 1.8210 0.3903 0.642 “

F W 70-90 0.143H – 0.0397A + 2.6539 0.3758 0.618 “

FEV3 M W 18-25 0.052H + 0.066A – 5.531 0.589 0.969 Ref. 14

M W 25-85 0.063H – 0.031A – 5.245 0.575 0.946 “

F W 20-87 0.035H – 0.023A – 1.633 0.496 0.816 “

FEV1/FVC% M W 18-25 -0.0813H + 100.4389 6.5752 10.82 Ref. 13

M W 25-85 -0.105A + 86.6862 6.2691 10.31 “

F W 20-89 -0.1852H - 0.1896A + 121.6777 7.5702 12.45 “

FEF25-75% M W 18-25 0.0539H + 0.0749A - 6.1990 0.9861 1.62 Ref. 14

M W 25-85 0.0579H - 0.0363A - 4.5175 1.0825 1.78 “

F W 20-70 0.0300H - 0.0309A - 0.4057 0.8539 1.40 “

F W 70-90 -0.0615A + 6.3706 0.7210 1.19 “

PEF M W 18-25 0.0780H + 0.1660A - 8.060 1.653 2.72 Ref. 14

M W 25-85 0.0940H - 0.0350A - 5.993 2.078 3.42 “

F W 20-87 0.0490H - 0.0250A - 0.735 1.605 2.64 “

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 Parameter Sex Race Age Range Predicted Equation SEE CI95% Source
FEF25%
M W 18-25 0.0700H + 0.1470A - 7.054 1.530 2.52 Ref. 14
(MEF75%)

M W 25-85 0.0880H - 0.0350A - 5.618 2.012 3.31 “

F W 20-87 0.0430H - 0.0250A - 0.132 1.53 2.52 “

FEF50%
M W 18-24 0.0543H + 0.1150A - 6.3851 1.1196 1.184 Ref. 13
(MEF50%)

M W 25-85 0.0684H - 0.0366A - 5.5409 1.2915 2.12 “

F W 20-70 0.0321H - 0.0240A - 0.4371 0.9778 1.61 “

F W 70-87 0.0118H - 0.0755A + 6.2402 0.7569 1.25 “

FEF75%
M W 18-25 0.0397H - 0.0057A - 4.2421 0.7551 1.24 Ref. 13
(MEF25%)

M W 25-85 0.0310H - 0.0230A - 2.4827 0.6917 1.14 “

F W 20-70 0.0174H - 0.0254A - 0.1822 0.6612 1.09 “

F W 70-90 -0.0172A + 1.8894 0.2409 0.396 “

MVV M W 18-25 1.840H + 1.800A - 192.3 K3

M W 25-85 2.080H - 1.0800A - 168.1 K3

F W 20-87 1.090H - 0.840A - 31.8 K3

Notes:
1. CI95% calculated using the equation CI95% = 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 Age Range Height Range (cm) Height Range (in)

Male 18-25 139.7-195.6 55-77
Male 25-85 157.5-195.6 62-77
Female 20-70 147.3-180.3 58-71
Female 70-90 147.3-167.3 58-66

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 European Community For Coal And Steel (ECCS) - Adult
H = Height in meters. A = Age in years.

Parameter Sex Race Age Predicted Equation RSD CI95%

See Note 1 See Note 2

VC M W 18-70 6.10H - 0.028A - 4.65 0.56 0.92

F W 18-70 4.66H - 0.026A - 3.28 0.42 0.69

FVC M W 18-70 5.76H - 0.026A - 4.34 0.61 1.00

F W 18-70 4.43H - 0.026A - 2.89 0.43 0.707

FEV1 M W 18-70 4.30H - 0.029A - 2.49 0.51 0.839

F W 18-70 3.95H - 0.025A - 2.60 0.38 0.625

FEV1/FVC% M W 18-70 -0.18A + 87.21 7.17 11.79

F W 18-70 -0.192A + 89.10 6.51 10.7

FEF25-75% M W 18-70 1.94H - 0.043A + 2.70 1.04 1.71

F W 18-70 1.25H - 0.034A + 2.92 0.85 1.398

PEF M W 18-70 6.14H - 0.043A + 0.15 1.21 1.99

F W 18-70 5.50H - 0.030A - 1.11 0.90 1.48

FEF25% M W 18-70 5.46H - 0.029A - 0.470 1.71 2.81

(MEF75%) F W 18-70 3.22H - 0.025A + 1.60 1.35 2.22

FEF50% M W 18-70 3.79H - 0.031A - 0.35 1.32 2.17

(MEF50%) F W 18-70 2.45H - 0.025A + 1.16 1.10 1.81

FEF75% M W 18-70 2.61H - 0.026A - 1.34 0.78 1.28

(MEF25%) F W 18-70 1.050H - 0.025A + 1.11 0.69 1.14

MVV M W 18-70 1.34H x 100 - 1.26A - 21.40 Kory

F W 18-70 0.807H x 100 - 0.57A - 5.50 Lindall

Notes:
1. If the patient age is between 18 and 25, the program shall use the equation for age = 25.
2. CI95% calculated using the equation CI95% = 1.645 * RSD.

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 NHANES III (Hankinson, NLHEP) - Adult
Male age range : >= 18 years
Female age range: >= 20 years

Parameter Sex Race Intercept Age Age2 Htprd (cm)2 Htlln (cm)2
b0 b1 b2 b3 b3

FVC M W -0.1933 0.00064 -0.000269 0.00018642 0.00015695

M B -0.1517 -0.01821 0 0.00016643 0.00013670

M H 0.2376 -0.00891 -0.000182 0.00017823 0.00014947

F W -0.3560 0.01870 -0.000382 0.00014815 0.00012198

F B -0.3039 0.00536 -0.000265 0.00013606 0.00010916

F H 0.1210 0.00307 -0.000237 0.00014246 0.00011570

FEV1 M W 0.5536 -0.01303 -0.000172 0.00014098 0.00011607

M B 0.3411 -0.02309 0 0.00013194 0.00010561

M H 0.6306 -0.02928 0 0.00015104 0.00012670

F W 0.4333 -0.00361 -0.000194 0.00011496 0.00009283

F B 0.3433 -0.01283 -0.000097 0.00010846 0.00008546

F H 0.4529 -0.01178 -0.000113 0.00012154 0.00009890

FEV6 M W 0.1102 -0.00842 -0.000223 0.00018188 0.00015323

M B -0.0547 -0.02144 0 0.00016429 0.00013499

M H 0.5757 -0.02860 0 0.00017840 0.00015029

F W -0.1373 0.01317 -0.000352 0.00014395 0.00011827

F B -0.1981 0.00047 -0.000230 0.00013497 0.00010848

F H 0.2033 0.00020 -0.000232 0.00014106 0.00011480

PEF M W 1.0523 0.08272 -0.001301 0.00024962 0.00017635

M B 2.2257 -0.04082 0 0.00027333 0.00018938

M H 0.0870 0.06580 -0.001195 0.00030243 0.00021833

F W 0.9267 0.06929 -0.001031 0.00018623 0.00012148

F B 1.3597 0.03458 -0.00847 0.00019746 0.00012160

F H 0.2401 0.06174 -0.001023 0.00022203 0.00014611

FEF25-75 M W 2.7006 -0.04995 0 0.00010345 0.00005294

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 Parameter Sex Race Intercept Age Age2 Htprd (cm)2 Htlln (cm)2
b0 b1 b2 b3 b3

M B 2.1477 -0.04238 0 0.00010461 0.00004819

M H 1.7503 -0.05018 0 0.00014473 0.00009020

F W 2.3670 -0.01904 -0.000200 0.00006982 0.00002302

F B 2.0828 -0.03793 0 0.00008572 0.00003380

F H 1.7456 -0.01195 -0.000291 0.00009610 0.00004594

Use the following equation to calculate the predicted value for a lung function parameter (LFP).
LFP=b0 + b1 * Age + b2 * Age2 + 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 Interceptprd Age Interceptlln

B0 b1 b0

FEV1.0/FEV6.0% M W 87.340 -0.1382 78.372

M B 88.841 -0.1305 78.979

M H 89.388 -0.1534 80.810

F W 90.107 -0.1563 81.307

F B 91.229 -0.1558 81.396

F H 91.664 -0.1670 83.034

FEV1/FVC% M W 88.066 -0.2066 78.388

M B 89.239 -0.1828 78.822

M H 90.024 -0.2186 80.925

F W 90.809 -0.2125 81.015

F B 91.655 -0.2039 80.978

F H 92.360 -0.2248 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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 Morris - Adult

Parameter Sex Race Age Range Predicted Equation SEE CI95% Source

FVC M W 20-84 .0583H – 0.025A – 4.24 0.74 1.22 Ref. 12

F W 20-84 .0453H – 0.024A – 2.85 0.52 0.855 Ref. 12

FEV1 M W 20-84 .0362H – 0.032A – 1.265 0.55 0.905 Ref. 12

F W 20-84 .0350H – 0.025A – 1.93 0.47 0.773 Ref. 12

FEF25-75% M W 20-84 0.0185H – 0.045A + 2.513 1.12 1.84 Ref. 12

F W 20-84 0.0236H – 0.030A + 0.551 0.80 1.316 Ref. 12

Notes:
1. The height ranges are as follows:

Sex Age Range Height Range (cm) Height Range (in)

Male 20-84 147.3-203.2 58-80
Female 20-84 142.2-182.9 56-72

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 Roca - Adult

Parameter Sex Race Age Range Predicted Equation SEE CI95%

FVC M W 20-69 0.0678H – 0.0147A – 6.0548 0.53 0.872

F W 20-69 0.0454H – 0.0211A – 2.8253 0.403 0.663

FEV1 M W 20-69 0.0499H – 0.0211A – 3.837 0.44 0.724

F W 20-69 0.0317H – 0.025A – 1.2324 0.307 0.505

FEV1/FVC% 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 W 20-69 0.0392H – 0.043A – 1.1574 1.0 1.645

F W 20-69 0.023H – 0.0456A + 1.1055 0.68 1.12

PEF M W 20-69 0.0945H – 0.0209A – 5.7732 1.47 2.42

F W 20-69 0.0448H – 0.0304A + 0.3496 1.04 1.71

MEF75% = ALOG(2.113Log(H) –
FEF75% M W 20-69 0.146 0.240
0.01A – 4.136)
MEF75% = ALOG(1.209Log(H) –
FEF75% F W 20-69 0.073 0.120
0.006A – 0.001W – 2.003) – 1

FEF50% M W 20-69 0.0517H – 0.0397A – 2.4 1.3 2.14

(MEF50%) F W 20-69 0.0242H – 0.0418A + 1.6151 0.925 1.52

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 G. Appendix G - Reference Values - Pediatric
The IQspiro® software provides the following sets of reference equations for pediatric patients:
• Wang (1993)
• Knudson (1976 & 1983 compilation)
• Polgar (1971)
• Hsu
• NHANES III
• Zapletal
• Eigen

Wang – Pediatric
Race/ Age InFVC InFEV1 InFEV1/FVC InFEF25.75%
Sex (years) α β α β α β α β
6 -0.024 2.470 -0.109 2.252 -0.078 -0.248 - -
7 -0.018 2.489 -0.104 2.270 -0.086 -0.220 - -
8 0.005 2.443 -0.089 2.257 -0.091 -0.199 0.264 1.505
9 0.017 2.426 -0.063 2.197 -0.086 -0.206 0.308 1.443
10 0.030 2.407 -0.057 2.212 -0.081 -0.209 0.290 1.557
11 0.009 2.468 -0.093 2.324 -0.101 -0.147 0.242 1.738
White Boys

12 -0.061 2.649 -0.161 2.512 -0.101 -0.133 0.165 1.982

13 -0.175 2.924 -0.292 2.843 -0.116 -0.085 0.007 2.396
14 -0.219 3.060 -0.329 2.983 -0.106 -0.087 0.014 2.483
15 -0.079 2.859 -0.141 2.709 -0.060 -0.155 0.241 2.163
16 0.104 2.591 0.062 2.409 -0.045 -0.178 0.503 1.764
17 0.253 2.374 0.262 2.099 0.008 -0.272 0.762 1.368
18 0.296 2.316 0.251 2.129 -0.054 -0.170 0.678 1.528
MSE 0.0121 0.0129 0.0044 0.0502
LLN 83.0% 82.5% 89.0% 67.9%
6 -0.013 2.007 -0.109 1.949 -0.097 -0.055 - -
7 -0.062 2.385 -0.144 2.243 -0.084 -0.132 - -
8 -0.055 2.381 -0.137 2.239 -0.079 -0.152 0.247 1.668
9 -0.039 2.351 -0.123 2.222 -0.084 -0.128 0.254 1.710
10 -0.068 2.458 -0.161 2.364 -0.092 -0.097 0.195 1.933
11 -0.120 2.617 -0.223 2.558 -0.102 -0.061 0.161 2.091
White Girls

12 -0.174 2.776 -0.264 2.709 -0.090 -0.067 0.185 2.120

13 -0.061 2.576 -0.153 2.535 -0.093 -0.040 0.294 1.976
14 0.139 2.208 0.046 2.178 -0.096 -0.026 0.450 1.711
15 0.210 2.099 0.148 2.008 -0.062 -0.093 0.581 1.486
16 0.226 2.097 0.181 1.972 -0.048 -0.120 0.654 1.366
17 0.214 2.146 0.176 1.992 -0.038 -0.154 0.688 1.290
18 0.195 2.179 0.152 2.031 -0.069 -0.096 0.520 1.622
MSE 0.0131 0.0132 0.0040 0.0504
LLN 82.2% 82.2% 89.5% 67.9%

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 Race/ Age InFVC InFEV1 InFEV1/FVC InFEF25.75%
Sex (years) α β α β α β α β
6 -0.088 1.961 -0.166 1.723 -0.091 -0.152 - -
7 -0.040 2.040 -0.122 1.846 -0.091 -0.153 - -
8 -0.094 2.323 -0.225 2.271 -0.118 -0.104 0.097 1.544
9 -0.074 2.308 -0.142 2.059 -0.079 -0.218 0.255 1.248
10 -0.110 2.417 -0.157 2.117 -0.047 -0.303 0.230 1.428
11 -0.138 2.453 -0.176 2.166 -0.048 -0.263 0.256 1.438
Black Boys

12 -0.224 2.710 -0.307 2.548 -0.084 -0.162 0.085 1.936

13 -0.342 2.975 -0.486 2.962 -0.141 -0.018 -0.121 2.476
14 -0.337 3.035 -0.472 3.010 -0.123 -0.050 -0.115 2.536
15 -0.226 2.889 -0.318 2.789 -0.070 -0.140 0.170 2.120
16 0.058 2.425 0.074 2.140 0.018 -0.289 0.663 1.299
17 0.148 2.310 0.053 2.223 -0.095 -0.087 0.505 1.618
18 0.152 2.341 0.130 2.121 -0.041 -0.190 0.859 1.053
MSE 0.0150 0.0157 0.0047 0.0625
LLN 81.9% 81.2% 89.0% 66.8%
6 -0.172 2.117 -0.288 2.182 -0.109 0.059 - -
7 -0.135 2.132 -0.250 2.158 -0.104 -0.030 - -
8 -0.176 2.362 -0.276 2.295 -0.103 -0.066 -0.283 2.990
9 -0.200 2.452 -0.294 2.330 -0.097 -0.104 0.025 2.062
10 -0.230 2.571 -0.344 2.507 -0.120 -0.043 0.051 2.028
11 -0.204 2.526 -0.308 2.460 -0.089 -0.105 0.078 2.006
Black Girls

12 -0.107 2.342 -0.219 2.312 -0.115 -0.021 0.225 1.804

13 -0.042 2.294 -0.117 2.196 -0.051 -0.148 0.418 1.504
14 0.105 2.021 0.041 1.920 -0.063 -0.103 0.574 1.257
15 0.253 1.787 0.203 1.662 -0.043 -0.139 0.599 1.281
16 0.111 2.098 0.129 1.824 -0.022 -0.188 0.653 1.175
17 0.205 1.930 0.273 1.547 0.048 -0.342 0.713 1.067
18 -0.042 2.423 -0.084 2.259 -0.197 0.145 -0.209 2.896
MSE 0.0160 0.0166 0.0038 0.0621
LLN 81.3% 81.0% 90.0% 67.0%

Model: ln(PF) = α + β ln (Ht), where PF is FVC (L), FEV1 (L), FEV1/FVC, or FEF25-75% (L/s), and Ht is height
(m). MSE, means squared error; LLN, lower limit of normal defined as the percent predicted corresponding
to the 5th percentile

See reference 21.

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 Knudson – Pediatric

Parameter Sex Race Age Range Predicted Equation SEE CI95% Source
VC M/F W All Predicted VC = Predicted FVC

FVC M W 6 - 12 0.0409H - 3.3756 0.3503 0.576 Ref. 13

M W 12 - 18 0.0590H + 0.0739A - 6.8865 0.4708 0.774 “
F W 6 - 11 0.0430H - 3.7486 0.3728 0.613 “
F W 11- 20 0.0416H + 0.0699A - 4.4470 0.4973 0.818 “

FEV0.5 M W 6 - 18 0.030H + 0.043A –3.054 0.425 0.699 Ref. 14

F W 6 - 18 0.019H + 0.061A – 1.738 0.364 0.599 “

FEV1 M 6 - 12 0.0348H - 2.8142 0.2734 0.449 Ref. 13

M 12 - 18 0.0519H + 0.0636A - 6.1181 0.4458 0.733 “
F 6 - 11 0.0336H - 2.7578 0.2697 0.444 “
F 11- 20 0.0351H + 0.0694A - 3.7622 0.4223 0.695 “

FEV1/FVC% M 6 - 18 -0.0813H + 100.4389 6.5752 10.82 Ref. 13

F 6 - 20 -0.1909H + 0.6655A + 109.9739 7.8385 12.89 “

FEF25-75% M 6 - 12 0.0338H - 2.3197 0.6263 1.03 Ref. 13

M 12 - 18 0.0539H + 0.0749A - 6.1990 0.9861 1.62 “
F 6 - 11 0.0220H - 0.8119 0.6568 1.08 “
F 11- 20 0.0279H + 0.1275A - 2.8007 0.8653 1.42 “

PEF M 6 - 18 0.078H + 0.1660A - 8.060 1.653 2.72 Ref. 14

F 6 - 20 0.0490H + 0.157A - 3.916 1.339 2.20 “

FEF25%
M 6 - 18 0.0700H + 0.1470A - 7.054 1.530 2.52 Ref. 14
(MEF75%)

F 6 - 20 0.0440H + 0.1440A - 3.365 1.290 2.12 “

FEF50%
M 6 - 12 0.0378H - 2.5454 0.6538 1.08 Ref. 13
(MEF50%)

M 12 - 18 0.0543H + 0.1150A - 6.3851 1.1196 1.84 “

F 6 - 11 0.1846A + 0.7362 0.6689 1.10 “
F 11- 20 0.0288H + 0.1111A - 2.3040 0.9585 1.58 “

FEF75%
M 6 - 12 0.0171H - 1.0149 0.5037 0.829 Ref. 13
(MEF25%)

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 Parameter Sex Race Age Range Predicted Equation SEE CI95% Source
M 12 - 18 0.0397H - 0.0057A - 4.2421 0.7551 1.24 “
F 6 - 11 0.0109H - 0.1657 0.4999 0.822 “

0.0243H + 0.2923A - 4.4009 -

F 11- 20 0.7202 1.18 “
0.0075A2

MVV M 6 - 18 1.840H + 1.800A - 192.3 K3

F 6 - 19 1.090H + 3.40A - 108.1 K3

Notes:
1. The height ranges are as follows:

Sex Age Range Height Range (cm) Height Range (in)

Male 6-12 111.8-154.9 44.01 – 60.98
Male 12-18 139.7-193.0 55.00 – 75.98
Female 6-11 106.7-147.3 42.00 – 57.99
Female 11-20 132.1-182.9 52.00 – 72.00

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 Polgar – Pediatric
H = Height in centimeters.
Parameter Sex Race Age Range Predicted Equation SD%

FVC M W 4-17 0.0000044 x H 2.67

13

F W 4-17 0.0000033 x H2.72 13

FEV1.0 M W 4-17 0.0000021 x H2.80 10

F W 4-17 0.0000021 x H2.80 10

FEV3.0 M W 4-17 FVCpred * 0.98

F W 4-17 FVCpred * 0.98

FEV1/FVC% M W 4-17 47.73 x H0.13 7

F W 4-17 63.63 x H0.08 7

FEF25-75% M W 4-17 0.0437 x H – 3.4616

F W 4-17 0.0437 x H – 3.4616

PEF (L/s) M W 4-17 0.08738 * H – 7.0929 12.8

F W 4-17 0.08738 * H – 7.0929 12.8

MVV (L/min) M W 4-17 1.276 * H – 99.507

F W 4-17 1.276 * H – 99.507

See Reference 19.

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 Hsu – Pediatric

Parameter Sex Race Age Range Predicted Equation SD% Source

FVC M W 7-20 3.58 x 10 x H
-7 3.18
13 Ref. 15
M B 7-20 1.07 x 10 x H
-6 2.93
17 “
M H 7-20 1.06 x 10 x H
-6 2.97
13 “
F W 7-20 2.57 x 10 x H
-6 2.78
14 “
F B 7-20 8.34 x 10 x H
-7 2.98
15 “
F H 7-20 1.25 x 10-6x H2.92 14 “

FEV1 M W 7-20 7.74 x 10-7x H3.00 13 “

M B 7-20 1.03 x 10-6x H2.92 17 “
M H 7-20 1.73 x 10-6x H2.85 13 “
F W 7-20 3.79 x 10-6x H2.68 14 “
F B 7-20 1.14 x 10-6x H2.89 15 “
F H 7-20 1.61 x 10-6x H2.85 14 “

FEF25-75% M W 7-20 7.98 x 10-7x H2.46 26 “

M B 7-20 3.61 x 10 x H
-7 2.60
36 “
M H 7-20 9.13 x 10 x H
-7 2.45
25 “
F W 7-20 3.79 x 10 x H
-6 2.16
28 “
F B 7-20 1.45 x 10 x H
-6 2.34
30 “
F H 7-20 1.20 x 10 x H
-6 2.40
24 “

PEF M W 7-20 3.35 x 10-7x H2.79 18 “

M B 7-20 1.74 x 10 x H
-7 2.92
22 “
M H 7-20 7.69 x 10 x H
-7 2.63
17 “
F W 7-20 2.58 x 10 x H
-6 2.37
18 “
F B 7-20 5.51 x 10 x H
-7 2.68
20 “
F H 7-20 6.97 x 10 x H
-7 2.64
18 “

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.

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 NHANES III (Hankinson, NLHEP) – Pediatric

Parameter Sex Race Intercept Age Age2 Htprd (cm)2 Htlln (cm)2
b0 b1 b2 b3 b3

FVC M W -0.2584 -0.20415 0.010133 0.00018642 0.00015695

M B -0.4971 -0.15497 0.007701 0.00016643 0.00013670

M H -0.7571 -0.09520 0.006619 0.00017823 0.00014947

F W -1.2082 0.05916 0 0.00014815 0.00012198

F B -0.6166 -0.04687 0.003602 0.00013606 0.00010916

F H -1.2507 0.07501 0 0.00014246 0.00011570

FEV1.0 M W -0.7453 -0.04106 0.004477 0.00014098 0.00011607

M B -0.7048 -0.05711 0.004316 0.00013194 0.00010561

M H -0.8218 -0.04248 0.004291 0.00015104 0.00012670

F W -0.8710 0.06537 0 0.00011496 0.00009283

F B -0.9630 0.05799 0 0.00010846 0.00008546

F H -0.9641 0.06490 0 0.00012154 0.00009890

FEV6.0 M W -0.3119 -0.18612 0.009717 0.00018188 0.00015323

M B -0.5525 -0.14107 0.007241 0.00016429 0.00013499

M H -0.6646 -0.11270 0.007306 0.00017840 0.00015029

F W -1.1925 0.06544 0 0.00014395 0.00011827

F B -0.6370 -0.04243 0.003508 0.00013497 0.00010848

F H -1.2410 0.07625 0 0.00014106 0.00011480

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 Parameter Sex Race Intercept Age Age2 Htprd (cm)2 Htlln (cm)2
b0 b1 b2 b3 b3

PEF M W -0.5962 -0.12357 0.013135 0.00024962 0.00017635

M B -0.2684 -0.08016 0.018202 0.00027333 0.00018938

M H -0.9537 -0.19602 0.014497 0.00030243 0.00021833

F W -3.6181 0.60644 -0.016846 0.00018623 0.00012148

F B -1.2398 0.16375 0 0.00019746 0.00012160

F H -3.2549 0.47495 -0.013193 0.00022203 0.00014611

FEF25-75 M W -1.0863 0.13939 0 0.00010345 0.00005294

M B -1.1627 0.12314 0 0.00010461 0.00004819

M H -1.3592 0.10529 0 0.00014473 0.00009020

F W -2.5284 0.52490 -0.015309 0.00006982 0.00002302

F B -2.5379 0.43755 -0.012154 0.00008572 0.00003380

F H -2.1825 0.42451 -0.012415 0.00009610 0.00004594

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 Use the following equation to calculate the predicted value for a lung function parameter (LFP).

LFP=b0 + b1 * Age + b2 * Age2 + 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 Sex Race Interceptprd Age Interceptlln

B0 b1 b0

FEV1.0/FEV6.0% M W 87.340 -0.1382 78.372

M B 88.841 -0.1305 78.979

M H 89.388 -0.1534 80.810

F W 90.107 -0.1563 81.307

F B 91.229 -0.1558 81.396

F H 91.664 -0.1670 83.034

FEV1/FVC% M W 88.066 -0.2066 78.388

M B 89.239 -0.1828 78.822

M H 90.024 -0.2186 80.925

F W 90.809 -0.2125 81.015

F B 91.655 -0.2039 80.978

F H 92.360 -0.2248 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 Sex Race Predicted Equation SEE CI95%

FVC M W 7.9942 – 0.12509 x H + 0.000605 x H2

F W 0.1694 – 0.01217 x H + 0.000605 x H2

FEV1.0 M W 6.6314 – 0.10261 x H + 0.000499 x H2

F W -3.0378 + 0.03640 x H

FEF25% M W -2.3069 + 0.02817 x H

F W -1.8576 + 0.02483 x H

FEF50% M W -4.5848 + 0.05430 x H

F W -3.3655 + 0.04477 x H

FEF75% M W -6.822 + 0.07811 x H

F W -5.1934 + 0.06367 x H

PEF M W -6.9865 + 0.08060 x H

F W -5.3794 + 0.06594 x H

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 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 10.0
1.37 -0.31 0.0608
(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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 H. Appendix H - 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 Scale Factor
FEV1 0.85
FVC 0.85

FEV1/FVC% None

Correction of Reference Values Black Children

Measurement Scale Factor
FEV1 0.88
FVC 0.88

FEV1/FVC% 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,

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: 1101-1108) suggests a
0.93 correction for Asian-American.

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 I. Appendix I - Spirometry Measurement Parameters
FVC FEV0.5 FEV1.0 FEV3.0 FEV6.0 FEV1.0/FVC FEV3.0/FVC FEV1.0/FEV6.0
FEV25% FEV50% FEV75% FEV25-75% FEV75-85% FEV200-1200 FEV0.5/FIV0.5

PEF FIVC FIV0.5 FIF50% PIF Exp Time V ext. MVV

MTV RR AT AT% VC ERV IRV TV

Unless otherwise noted: Volumes (capacity) are expressed in Liters BTPS (L) Flows are
expressed in Liters per second BTPS (L/s)

J. Appendix J – COPD Risk Assessment Calculation

The IQspiro® program calculates the assessment of the likelihood of the patient developing COPD in the
next ten years using the Techumseh Index as follows.

1 
Risk = 1000 * 
1 + 10x Equation 1

Male:
 bestFEV1 
x = −2.1316 + * 10.78 − Age * 0.0914 − cigs * 0.0594
 predFEV1 
Equation 2

If the male patient were to quit smoking…

xquit = x + cigs * 0.0297

Equation 3

Female:
 bestFEV1 
x= * 12.81 − 2.98 − Age * 0.0944 − cigs * 0.1065
 predFEV1  Equation 4

If female patient were to quit smoking…

xquit = x + cigs * 0.0506

Equation 5

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 The program calculates the Risk factor and then uses the criteria shown in the following table to produce a
COPD risk statement.
COPD Risk Statement Criteria
Criteria COPD Risk Statement
If Risk <= 10 Low
If Male and 10 < Risk <= 70 Moderate

If Female and 10 < Risk <= 30 Moderate

If Male and 70 < Risk <= 100 High

If Female and 30 < Risk <= 100 High

If Risk > 100 See Figure 1 below

If the patient is currently smoking, the software will calculate the factor called xquit using Equation 3 or 5 and
calculates the risk using Equation 1. The software then generates a statement indicating the reduced risk if
the patient quits smoking.

Is
Risk > 100
?

Yes

Is
Best FEV1 < 0.65
No
* Pred FEV1
?

Yes

Output:
Is
Risk is very high (Best FEV1/Pred
No
FEV1) > 0.80
?

Yes

Output: Output:

Not Applicable. COPD may exist.

Figure 1 COPD Risk Greater Than 100

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 K. Appendix K - Lung Age Calculation
Reference #18 describes the method to be used for calculating estimated lung age. If the patient is twenty
years old or older but less than eighty-four years old, the IQspiro® program automatically calculates the
estimated lung age provided that the following information is available.
1. Best FEV1 from the FVC tests
2. Patient height in inches
3. Patient sex

For male patients, the estimated lung age shall be calculated as follows:

LAGE = 2.87 * H − 31.5 * BestFEV1 − 39.375

For female patients…

LAGE = 3.56 * H − 40.0 * BestFEV1 − 77.28

LAGE is the estimated lung age in years. H is the patient height in inches.

The IQspiro® program uses the following table to print the lung age statement:
Criteria Lung Age Statement
(Patient’s Age < 20) or (Patient’s Age > 84) N/A
Lung Age > 84 > 84 years

Lung Age < Patient’s Age < #Patient’s Age years

Otherwise #Lung Age years

See reference 18.

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 L. Appendix L - Performing a Pre/Post FVC Test -
Quick Reference User’s Guide
A condensed guide to using the IQspiro® Digital Spirometer.

Note
The ATS recommends that calibration be performed daily before
testing is started.

1. Start IQmanager®.
2. Select the patient:
a. Search for a patient from the Opening Screen and double-click the patient name, or
b. Click New Patient from the Opening Screen.
3. Check the patient data fields to ensure Name, Date of Birth, Weight, Height, Sex and Race fields
have been entered on the Patient Data screen.
a. 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, select New Test.

Click on the play icon next to IQspiro.

5. Prepare the patient for the spirometry test.

a. Explain the procedure to the patient.
b. Demonstrate the procedure to the patient.
c. Insert a new disposable mouthpiece (DM) into the IQspiro®.
d. Instruct the patient to place the DM on top of their tongue, with their teeth and lips around the
mouthpiece, sealing their lips around the DM. Let the patient get used to the feeling of breathing
with the DM in their mouth.

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 6. The type of test 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.
7. When the patient is ready, instruct the patient to hold the IQspiro® up and to the side of their face.
8. Click Start New Test - wait for the zeroing process. Do not allow airflow to pass through the
sensor 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 DM in their mouth.
10. 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.
a. If a flow volume loop is required, have the patient inhale at the end of the expiration.
11. Click Stop or press Enter to conclude the test.
12. Accept or Reject the test based on the patient’s effort.
13. Repeat steps 8 through 11 until the appropriate number of tests has been performed. Performing
more than 8 FVC tests in one sitting will usually return diminished results.
14. Remove and discard the used DM after all tests are completed.
15. Click Save/Review to save the efforts.
16. Use the review screen to review, edit and/or print the results.

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 M. 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 Ap proach”, 2nded., 1996, Williams & Wilkins,
Baltimore.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. “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.

12. “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.

13. 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. 179-187, 1999.

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 14. Polgar G., Promadhat, V. Pulmonary Function Testing In Children: Techniques and Standards, W.B.
Saunders Co., Philadelphia, 1971.

15. 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.

16. 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.

17. Morris, J.F., Temple, W., Spirometric “Lung Age” Estimation For Motivating Smoking Cessation,
Preventative Medicine, 0091-7435/85, 1985.

18. Enright, P. L., Hyatt, E. H., A Practical Guide to the Selection and Use Of Spirometers.

19. 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.

20. Petty TL, Enright PL Simple Office Spirometry for Primary care Practitioners.

21. Wang X, Pulmonary function between 6 and 18 years of Age, Pediatric Pulmonology, 15:75-88,1993.

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 VII. Customer Support and Warranty Information
For immediate help diagnosing problems with this product, refer to the online Help or Appendix B –
Troubleshooting IQspiro® and IQmanager®.

For help diagnosing problems by phone with this product, contact Midmark Technical Service at (800) 624-
8950, option 2, between 6:00 AM to 4:00 PM, Pacific Standard Time.

To contact Midmark Technical Service via email: techsupport@[Link]

Self-help knowledge base and live chat can be accessed at: [Link]

Warranty
Midmark warrants IQspiro® to be free from manufacturing and material defects for 12 months from the date
of purchase. Accessories for IQspiro® are warranted for 90 days. Any misuse or abuse of a Midmark product
voids all applicable warranties.

Please refer to [Link] for the full and current Warranty Terms and Conditions.

Return Materials Authorization

To return any product for repair, a Return Materials Authorization (RMA) number must be obtained from
Midmark Technical Service. This RMA 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, be certain that an RMA number has been issued and that all guidelines
regarding this authorization are followed. We highly recommend following all guidelines for the shipment of
medical products set forth by the shipping company you choose to use. If a question should arise regarding
the appropriate method of shipment, please feel free to ask when calling for your RMA number. It is the
responsibility of the customer when shipping a product to ensure that all packages and their contents get to
Midmark safely. Midmark will not assume responsibility for damage due to improper packaging, shipment or
product use. Such actions will void all applicable warranties.

Midmark Corporation
690 Knox Street, Suite 100
Torrance, California 90502
Tel: (310) 516-6050
(800) 624-8950, option 2
Fax: (310) 516-6517

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 VIII. EMC Requirements for the IQspiro® 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 Appendix.

Portable and mobile RF communications equipment can affect the operation of medical electrical equipment.
The Midmark IQspiro® are medical electrical equipment.

The IQspiro® models comply with sections 36.201 and 36.202 of the EMC Standard EIC60601-1-2 (E).

Use of cables, cable extensions or accessories other than those specified, with the exception of cables and
accessories sold by the manufacturer of the IQspiro® as replacement parts for internal components, may
result in increased EMISSIONS or decreased IMMUNITY of the IQspiro®.

Table 1 – Guidance and manufacturer’s declaration – electromagnetic emissions – for the IQspiro®
Digital Spirometer
Guidance and manufacturer’s declaration – electromagnetic emissions
The IQspiro is intended for use in the electromagnetic environment specified below. The customer or the user of the IQspiro®
®

should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance
The IQspiro uses RF energy only for its internal function. Therefore, its
®
RF emissions
Group 1 RF emissions are very low and are not likely to cause any interference in
CISPR 11
nearby electronic environment.
The IQspiro® is suitable for use in all establishments, including domestic
RF emissions establishments and those directly connected to the public low-voltage
Class B
CISPR 11 power supply network that supplies buildings used for domestic
purposes.
Harmonic Emissions
Not applicable Battery-operated device
IEC 61000-3-2
Voltage fluctuations/flicker
emissions Not applicable Battery-operated device
IEC 61000-3-3

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 Table 2 – Guidance and manufacturer’s declaration – electromagnetic immunity – for the IQspiro®
Digital Spirometer
Guidance and manufacturer’s declaration – electromagnetic immunity
The IQspiro is intended for use in the electromagnetic environment specified below. The customer or the user of the IQspiro® should
®

assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic ±6 kV contact ±6 kV contact
Floors should be wood, concrete or ceramic tile.
discharge (ESD)
If floors are covered with synthetic materials, the
relative humidity should be at least 30%.
IEC 61000-4-2 ±8 kV air ±8 kV air
±2 kV for power supply N/A
Electrical fast
lines
transient/burst
Battery operated device
±1 kV for input/output
IEC 61000-4-4
±1 kV for input/output lines lines
Surge
±1 kV differential mode N/A Battery operated device
IEC 61000-4-5
<5% UT (<95% dip in UT)
for 0.5 cycle
Voltage
dips, short
40% UT 60% dip in UT) for
interruptions and
5 cycles
voltage variations
N/A Battery operated device
on power supply
70% UT (30% dip in UT) for
input lines
25 cycles
IEC 61000-4-11
<5% UT (<95% dip in UT)
for 5 sec
Power frequency
(50/60 Hz) Power frequency magnetic fields should be at
magnetic field 3 A/m 3 A/m 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.

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 Table 3 – Guidance and manufacturer’s declaration – electromagnetic immunity – for the IQspiro®
Digital Spirometer
Guidance and manufacturer’s declaration – electromagnetic immunity
The IQspiro is intended for use in the electromagnetic environment specified below. The customer or the user of the IQspiro® 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 IQspiro®, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.

Recommended separation distance

d = 1.2 √ P
Conducted RF

IEC 61000-4-6
3 Vrms 3 Vrms

Radiated RF 150 kHz to 80 MHz

d = 1.2 √ P 80 MHz to 800 MHz
IEC 61000-4-3 3 V/m
3 V/m d = 1.2 √ P 800 MHz to 2.5 GHz
80 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 IQspiro® is used exceeds the applicable RF Compliance level above, the IQspiro® should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orientating or relocating the IQspiro®.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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 Table 4 – Recommended separation distances between portable and mobile RF communications and
the IQspiro® Digital Spirometer
Recommended separation distances between Portable and mobile RF communications equipment and the IQspiro® Digital
Spirometer
The IQspiro® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of the IQspiro® can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the IQspiro® as recommended below, according to the maximum output
power of the communications equipment.
Separation distance according to frequency of transmitter

Rated maximum output (m)

power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W)

d = 1.2 √ P d = 1.2 √ P 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.

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 IX. Contact Information
Midmark Corporation
690 Knox Street, Suite 100
Torrance, California 90502
Phone: (310) 516-6050
USA: (800) 624-8950, option 2
Fax: (310) 516-6517
Email: techsupport@[Link]
Website: [Link]
Knowledge base: [Link]

Midmark Corporation
690 Knox Street, Suite 100
Torrance, CA 90502 USA
1-800-624-8950
310-516-6050

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