PC-10 User Manual

Spiro-Master
PC-10
Spirometry System
Operation Manual
REV. 2.0
For software versions 1.26 or later
Warning Information
WARNING
The user should read and understand all product literature, labeling and
warnings prior to operation PC-10 spirometry system
Throughout this manual, the following indicators are used as follows;
WARNING
Warning alerts the user to potential serious outcomes (including injury or

adverse events) to the patient or user. It also alerts the user to potential serious
damages to the stored data or the unit.
Important information for the safe, effective, and convenient use of PC-10
NOTE
spirometer.
-1- Rev.2.0
Table of Contents
1. Precautions .... 3
2. Introduction (Spirometry / Intended use) . 5
3. Configuration (Standard accessories / Parts description) ... 6
4. System Installation (Hardware attachment) .... 7
5. Basic Operation (Operational procedure) ........ 8
6. Pre-measurement Settings (General settings / Factory defaults setting) ... 12
7. Calibration .... 17
8. Patient (ID) Information Input ... 19
9. Spirometry Tests (SVC / FVC / MVV / MV) ... 21
10. BD [Bronchodilator] Test (FVC) .. 36
11. Challenge Test (FVC) . 40
12. Interpretation (Spirometry / COPD / QC check) .. 45
13. Patient Database (Database / Data batch processing) ... 48
14. Trending .... 50
15. Description of the Measured Parameters (SVC / FVC/ MVV/ MV) .... 52
16. Predicted Formula 58

(Prediction / Predicted Curve)
17. Maintenance (Cleaning / Safety check) .... 65
18. Troubleshooting .... 67
19. Glossary of Spirometry Terms . 69
20. Technical References (Product specifications) 73
21. Print Forms ... 75

(COPD+SVC+FVC / SVC+FVC+MVV+MV / FVC / with BD / Challenge test)
22. Accessories ..... 76
(Optional accessories / Spirobank software / Optional measurements)
23. Limited Warranty . 77
24. Contact Information EC representative / Manufacturer / Your local dealer 78
-2- Rev.2.0
1. Precautions
WARNING
Please read this operation manual carefully, and operate PC-10 spirometry system
properly and safely.
1. Precautions
1.1 Contraindication and prohibition
Precautions
Prepare the device for operation according to instructions in this operation manual.
Check to be sure that all the cords are connected correctly and firmly.
When the device is used with other equipment, check to be sure that they can be used safely without
causing mutual interference.
Observe the patient closely. If any abnormality is observed, proper action, which may include stopping
the test, should be taken immediately.
Do not allow the patient to touch the device directly.
The software turns off the device power according to programmed procedures.
When disconnecting the cords, do not apply excessive force.
Clean the accessories, cords, and flow sensor after use. Keep them in a clean environment.
Use the Spiro-filter, C-2F to reduce the risk of patient cross contamination.
If any abnormality is found in the device, exit the PC-10 software and plug off the Flow sensor cord.
In case of malfunction, mark the device with the notice, "FAILURE" or "DON'T USE". And contact our
sales office, our authorized representative, or medical dealer in your area as quickly as possible.
Bronchial inhalation testsBD test and Challenge testshould be carried by a physician. Prepare
bronchodilator before the tests
Strong electromagnetic waves in the surrounding may cause noise in the curve or malfunction. If any
unexpected malfunction occurs during operation, check the electromagnetic environment and take
appropriate measures.
Examples:
1) Use of a cellular phone
The electromagnetic wave may cause unexpected malfunction.
Turn off the power source of cellular phones and radio equipment in the room or building where electrical
equipment for medical equipment is installed.
2) When high-frequency noise generated by other equipment enters through the socket for power source
Identify the source of noise, and take countermeasures such as installing a noise limiter in the circuit.
If possible, stop the operation of the equipment that generates the noise.
Connect the power cord to another power supply socket.
3) Electrostatic effect (caused by electrical discharge in the device or in the surrounding)
Completely remove the electrostatic charge from the operator and patient.
Humidify the room.
4) Effect of thunderbolt
An excessive voltage may be induced in the device when a thunderbolt occurs in the neighborhood. In such a
case, operate the device using an uninterrupted power supply.
5) Noise generation
If noise is caused to a receiver of radio or television by the device, move the receiver to a distant place from
the device.
Avoid placing the device in the following places.
1) A place likely to be splashed with water.
2) A place with the direct sun light, high temperature, high humidity, dust, and air containing salt or sulfur.
3) A place with inclination, vibration, or shock (same during transportation.)
4) A place where chemical substances are stored or gasses are generated.
IEC 60950 acceptable PC is required. (Do not use other type of PC.)
Do not make any modifications to the devices; any modifications made will void the warranty.
Do not disassemble the device, anytime.
Perform routine maintenance and inspection on the device.
1.2 Standards and Compliance

This equipment meet the following standards
1.2.1 Electrical, Safety Standards
IEC60601-
IEC60601-1, IEC60601-
IEC60601-1-1 (Electrical, Safety),
Safety), IEC60601-
IEC60601-1-2 : 2001 (EMC)
(EMC)
1.2.2 EMC COMPLIANCE
Guidance and manufacturer's declaration - electromagnetic emissions
PC-10 is intended for use in the electromagnetic environment specified below.
The customer or the user of PC-10 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
-3- Rev.2.0
RF emissions Group 1 PC-10 uses RF energy only for its internal function.
CISPR11 Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
CISPR11 Class B PC-10 is suitable for use in all establishments, including domestic
CISPR11 establishments and those directly connected to the public low-voltage
Harmonic emissions IEC61000-3-2 Class B power supply network that supplies buildings used for domestic
Voltage fluctuations/ flicker emissions IEC61000-3-3 Complies purposes.
Guidance and manufacturer's declaration - electromagnetic immunity

Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic 2kV,4kV, 2kV,4kV, Floors should be wood, concrete or ceramic tile. If floors are
discharge(ESD) 6kV Contact 6kV Contact covered with synthetic material, the relative humidity
2kV,4kV, 2kV,4kV, should be at least 30%.
IEC61000-4-2 8kV air 8kV air
2kV,4kV, 2kV,4kV,
6kV Indirect 6kV Indirect
Electrical fast 2kV for power 2kV for power Main power quality should be that of a typical commercial or
transient/burst supply lines supply lines hospital environment.
IEC61000-4-5 (without PE) (without PE)
Surge 1kV for power 1kV for power Main power quality should be that of a typical commercial or
IEC61000-4-5 supply lines supply lines hospital environment.
Voltage dips, short 0% UT 0% UT Main power quality should be that of a typical commercial or
interruptions and (100% dip in UT) (100% dip in UT) hospital environment. If the user of PC-10 requires
voltage variations for 0.5 cycle for 0.5 cycle continued operation during power mains interruptions, it is
on power supply recommended that PC-10 be powered from an
input lines <40% UT <40% UT uninterruptible power supply or a battery.
(>60% dip in UT) (>60% dip in UT)
for 5 cycle for 5 cycle
IEC61000-4-11 <70% UT <70% UT
(>30% dip in UT) (>30% dip in UT)
for 25 cycle" for 25 cycle"
Power frequency 3 A/m 3 A/m If image distortion occurs, it may be necessary to position
(50/60Hz) PC-10 further from sources of power frequency magnetic
magnetic field fields or to install magnetic shielding. The power frequency
IEC61000-4-8 magnetic field should be measured in the intended
installation location to assure that it is sufficiently low.

Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no
closer to any part of PC-10, including cables, than the recommended
separation distance calculated from the equation applicable to the
frequency of
the transmitter. Recommended separation distance
d=[3.5/V1]P 150kHz to 80MHz

3 Vrms 3 Vrms
Conducted RF 150kHz to 80MHz [V1] d=[3.5/E1]P 80MHz to 800MHz
IEC61000-4-6 outside ISM bands
3 V/m d=[7/E1]P 00MHz to 2.5GHz
Radiated RF 3 V/m [V1]
IEC61000-4-3 80MHz to 2.5GHz 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 fixed RF
transmitters,
as determined by an electromagnetic site survey, should be less than the
compliance level in each frequency range
interference may occur in the vicinity of equipment marked with the

following symbol:

PC-10 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of
PC-10 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and PC-10 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter M
W 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
d=[3.5/V1]P d=[3.5/E1]P d=[7/E1]P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
List of external device

Devices Manufacturer and Model Note
Personal Computer TOSHIBA PSJ1225CXG11K Windows XP
AC Adapter (for PC) TOSHIBA ADP-60RHA
Printer HP Deskjet 5551
AC Adapter (for Printer) HP 0950-4082
Cables Length Shielding

USB cable (PC-10) 2.0m Yes
Printer cable 1.0m Yes
AC power cable for PC 1.7m None
DC power cable for PC 1.8m Yes
AC power cable for Printer 1.8m None
DC power cable for Printer 0.8m Yes
The EMC of PC-10 had been tested based on the specifications described in the above table.
-4- Rev.2.0
2. Introduction
The SpiroMaster, PC-10 is a device that converts a Microsoft Windows based PC to a fully
functional diagnostic spirometer, which measures a patients pulmonary function parameters.
PC-10 spirometer consists of mainly two parts. One is a flow sensor, the other one is a
computer software, provided in CD ROM. PC-10 offers you a fast, efficient, and accurate
spirometry. Spirometry results can be compared to any of several predicted normal values.
PC-10 also performs Bronchodilator test as well as Bronchoconstrictor test (Challenge test).
PC-10 is suitable in early detection of respiratory impairments, such as Asthma and COPD.
We trust our product will become your ideal office-based Spirometer to diagnose and enhance
your patients pulmonary health.
Please remember that it is to be used by physicians or by trained personnel on a physician

responsibility.
Spirometry testing
Spirometry is used to measure the rate at which the lung changes volume during forced
breathing maneuvers. The most commonly performed test procedure uses the forced
expiratory vital capacity (FVC) maneuver, in which the subject inhales maximally and then
exhales as rapidly and completely as possible. The FVC test is the most important. Generally,
it provides most of the information that is to be obtained from pulmonary function testing.
(Interpretation of Pulmonary Function Tests by Robert Hyatt et al) The FVC test shows how fast he
can blow (flow) and how much he can blow (volume). These parameters are compared to
normal values derived from Predicted formula based upon the patients age, height and sex.
Depending on the results, it is decided whether the patient is normal, or has an obstructive or
a restrictive lung disease.
Scope of this manual

This manual will show you how to use the SpiroMaster, PC-10 Spirometry system.
Read and understand the entire manual before trying to use this device.
Intended use
SpiroMaster, PC-10 Spirometry system is an electrical medical device designed to perform
pulmonary function tests. It is to be used by physicians or by trained personnel on a
physicians responsibility. It is intended for use with pediatric and adult patients in hospitals,
physicians offices, and occupational health testing environments.
-5- Rev.2.0
3. Configuration
The block diagram below illustrates the configuration of the system. The primary components
are a Windows-based PC, a printer, and PC-10 spirometer module (flow sensor).
(1) PC-10 flow sensor with USB cable

(2) Windows based PC (not supplied), with PC-10 software, installed
(3) Windows compatible printer (not supplied)
PC-10 Flow sensor PC (Not supplied) Printer (Not Supplied)
Standard Accessories
When you get your SpiroMaster PC-10, carefully open the box and unpack the system. Make
sure that you have all the parts listed below and that nothing looks damaged. Included with
this system are the following:
# Description Qty
1. Flow sensor body 1 pc
2. Flow sensor head 1 pc
3. Software (CD Rom) 1 pc
4. Nose clip 2 pcs
5. Spiro-Filter (C-3F) 1 pc
6. Paper mouthpiece (50pcs/box) 1 box
7. Carrying case 1 pc
8. Operation manual 1 copy
(1) (2) (3)
(4) (5) (6)
(7) (8)
-6- Rev.2.0
4. System Installation
In order to install and successfully use the spirometer, your computer must meet the following
requirements;
1. Windows-based PC with Windows 98, 2000, XP, and 7 OS

2. Keyboard, mouse, and a CD-Rom drive
3. VGA display accommodating 800x600, 1024x786, 1280x1024, or higher resolution
4. At least one USB port
Installing the PC-10 Software

Close all Windows programs before running this software installation. Once the installation
program is started, it should not be interrupted until completed.
1 Plug the USB cable of flow sensor in to the computer.

2 Unknown device. Message will be displayed.
3 Insert the PC-10 software CD into the CD-ROM drive.
4 Open the Windows My Computer or Explorer with which you can see the contents on
the CD ROM. You can find Driver and PC-10 folders in the CD Rom.
5 Click Driver folder. And install the USB driver.
6 After the USB driver installation, PC-10 software is also installed continuously.
7 Open the PC-10 holder. You can find PC-10\setup.exe icon.
8 To start the installation process, just double click on PC-10\setup.exe. The installation
program will be started automatically.
9 Follow the instructions on the screen. The program will load up a dialog box and ask for a
directory where to be installed. When the installation is over, the program will advise you
with a message indicating that the installation has been successfully completed.
10) It is recommended to put the program icon on your Windows Desktop to short cut next
time.
Program shortcut Icon on your Desktop
Setting the flow sensor
-7- Rev.2.0
5. Basic Operation
The basic procedure from switching ON the power supply to finishing measurement is as follows
-8- Rev.2.0
1 Confirm that a flow sensor cable is connected properly.
2 Startup the "PC -10" program by double-clicking "PC-10 icon" on your desktop.
3 <Main Menu> screen is displayed.
When Flow sensor is not connected is displayed, Click [Configuration] and choose
[Spirometry] tab. The [Sensor Port] entry (COM1 to COM20) may be found in the lower right
corner on the screen. Choose the correct USB port number of your PC, where the Flow sensor
USB cable is connected to.
USB port #
How to find the right USB port.

1. Open Control Panel
2. Click System Properties
3. Choose Hardware tab
4. Press Device Manager
5. Open Port (COM & LPT)
6. USB Serial Port (COM XX) is displayed.
XX is the number of USB port, which the flow sensor is connected.
-9- Rev.2.0
4 Click the [FLOW SENSOR CALIBRATION] button and perform calibration if necessary.
See 7. Calibration for details.
5) Click the [PATIENT INFORMATION] button and enter the patient information.
See 8. Patient (ID) Information Input for details.
-10- Rev.2.0
6) In order to obtain the COPD interpretation of the patient, click the [COPD SYMPTOMS]
button and enter the patient COPD information.
Questionnaire screen for <COPD diagnosis by Gold>
7) When Pre-measurement setting is needed, go back to [Main Menu] and click

[Configuration] and enter the necessary information.
8) Select the measurement mode by clicking [SVC], [FVC], [MVV], [MV] ,or [Challenge test]
button.
9) Perform the measurement according to the procedure specified for each measurement
mode.
Start the measurement by clicking [START] and finish it by clicking the [STOP] button.
When the flow sensor mesh ring gets deeply wet by patients exhalation after continuous
measurements, replace the sensor mesh ring (or flow sensor head). The wet sensor mesh
ring may negatively affect the accurate test result.
When patients sputum and/or spit are stuck on the sensor mesh ring, high
accurate test result may not be expected. In this case, replace the sensor mesh
NOTE
ring (or flow sensor head) immediately. Using Spiro-filter, C-2F is recommended
to avoid sticking sputum in the flow sensor.
10) After the necessary measurements are done, confirm the data, and print or save it by
clicking [Data Save] and/or [Print Out] buttons.
11) In order to exit the program after the tests, go back toMain Menuand click [Exit] button.
12) Turn off the PC by exiting Windows, and plug off the USB cable of flow sensor.
-11- Rev.2.0
6. Pre-Measurement Settings
SpiroMaster, PC-10 can be configured to meet your individual needs. You can change the
default settings, such as Spirometry test protocols, items to display or print, print format,
predicted formula, last test data transaction, etc as you want.
Click [Configuration] on the [Main Menu] screen. [Settings] screen will be displayed.
Tab Blue Square
[Spirometry] tab
Best data selection Set the best data selection method. Manual or Auto. When
Auto is chosen, always the one with largest SVC value is
taken.
SVC # of Rest ventilation Choose the number of rest ventilation before SVC test is started.
VC<FVC selection SVC: Always his best SVC value is taken as his SVC.
FVC: FVC value is taken as his SVC value when his FVC value
is bigger than his SVC value.
Best data selection Choose the best data selection method from Manual, Auto, or
ATS protocol. When Auto is chosen, all parameters are taken
from the one largest SVC, FVC+FEV1, MVV, and MV tests.
When ATS is chosen, the largest FVC and FEV1 are taken
among the tests, even if they do not come from the same
curve. All other measuring items of FVC are taken from the
FVC largest sum of FVC+FEV1 test.
FVC Predicted Choose Yes when you need the Predicted waveform in the FVC
waveform graph to compare with his actual waveform at a glance.
Flow zero position In the Flow/Volume graph, Zero position for X axis can be
changed. Choose Point C normally. If no inspiratory
information is needed (only exhalation) in FVC test, choose
Point E.
MVV Auto is chosen, always the one with largest MVV value is
taken.
MV Auto is chosen, always the one with largest MV value is taken.
-12- Rev.2.0
Predicted FVC waveform
Actual Patients FVC waveform
F/V graph in (Point E) F/V graph in (Point C)
No predicted waveform is shown, if the predicted formula to be chosen does not

NOTE
have PEF prediction.
Measuring items do display in SVC, FVC, MVV, and MV can

be manually chosen. Click the Blue Square to open the
Items to display window. Move cursor on the measuring items to move up or
down. Or Yes or No to display in SVC, FVC, MVV, and MV
respectively.
Best data: Always only the best data is displayed.
Data selection: All the test data (up to 5 tests) are displayed
Data display
to compare in the same graph with different color of
waveforms.
Number of measurement data Up to 5 test data can be saved to choose the best test data.
Choose the correct flow sensor port number, which PC-10 flow
Flow sensor port sensor USB cable is connected to. When the wrong port
number is chosen, test can not be done.
Evaluation Standard Set the lower limit of Normal (LLN) if other than 80% for
SVC and 70% for FEV1 are preferred.
[Print/CSV file] tab

When marked in Data Save and/or CSV File, automatically data is
Print/Batch process saved, and CSV (Comma Separated Values) file is created after
printing.
Printer selection When Yes is chosen, <Print setting> window
is always opened at printing is preferred.
Print form selection When Yes is chosen, <Print form selection>
window is always opened at printing. When
Print No is chosen, click the Blue Square and
choose one or more print forms. The print form
samples are shown at the end of this manual.
Color printing Choose Color if printing in colors is preferred.
(It has to be connected to the color printer.)
If CSV File is needed, choose Yes. Click the Blue Square on the
CSV file
right to choose the items for the output to CSV file.
The CSV (or comma-separated values) file format is a delimited data format that
NOTE
has fields separated by the comma character and records separated by newlines
-13- Rev.2.0
Items to
Display
<Print form selection> window
[Unit] tab
Height Choose either cm or inch as the measurement unit in height.
Weight Choose either kg or lbs as the measurement unit in weight.
Temperature Choose either C or F as the measurement unit of temperature.
Atm. Pressure Choose either mmHg or hPa as the measurement unit of Atmospheric
Pressure.
[Patient information/Prediction] tab

Reservation # Choose Yes if the Reservation Number entry is needed
on the Patient Information input.
Test Date Format Choose preferred date format.
Patient Birthdate Choose Yes if the Birthdate of the patient entry is
Information needed on the Patient Information input.
Race Choose Yes if the Race of the patient entry is needed on
the Patient Information input. Click the Blue Square to
edit (add, delete, and/or revise) the race table.
Physician Choose Yes if the name of Physician entry is needed on
edit (add, delete, and/or revise) the physician table.
Department Choose Yes if the name of Department entry is needed
on the Patient Information input. Click the Blue Square
to edit (add, delete, and/or revise) the Department table.
Hosp. Ward Choose Yes if the name of Hospital Ward entry is
needed on the Patient Information input. Click the Blue
Hospital
Square to edit (add, delete, and/or revise) the Hospital
Information
Ward table.
Hosp. Room Choose Yes if the name of Hospital Room entry is
needed on the Patient Information input. Click the Blue
Square to edit (add, delete, and/or revise) the Hospital
Room table.
Technician Choose Yes if the name of Technician entry is needed on
edit (add, delete, and/or revise) the Technician table.
Choose Yes if the Smoking Status of the patient entry is
Smoking Status
needed on the Patient Information input.
Choose Yes if the Diagnostic Report (free memorandum
Diagnostic Reports
space) entry is needed on the Patient Information input.
-14- Rev.2.0
Choose one test mode from SVC, FVC, MVV, or MV, which
Initial Screen
appears after the Patient Information input.
Click the Blue Square to edit (add, delete, and/or revise)
Diagnostic Comments
the Diagnostic comment table.
Choose one predicted formula from Crapo-Hsu, ECCS,
ITS, Knudson, Korean, Morris, NHANES III,
Polgar, Thai and Asia1 to Asia6. You can review the
Predicted Formula Setting each predicted equation in the below table. (You may also
revise or edit the equations although we do not recommend
doing so.) Your own Predicted formula may be added on the
table if it is needed (Press Add New).
<Physician Table Setting> screen <Diagnostic Comments> screen
Patients measured values are compared to their predicted values as one way of
judging the degree of abnormality of their lung function. The patients height, age,
and sex must be entered or no predicted values are available. The Predicted
NOTE formula used for the calculation of predicted values are dependent upon the
Country/Area. Generally, ECCS is the most popular in Western Europe. In North
America, Knudson is the most popular. For Asian people, Japanese Respiratory
Society may be recommended.
No Predicted formula covers all spirometry measuring items, (such as FEV1, PEF,
MMEF, etc) for all age, height, and sexes group of patients. For your convenience,
the secondary Predicted formula may be used to complete it. For example,
Knudson does not have predicted equation for FEF75-85. In order to complete it
NOTE
ITS predicted equation for FEF75-85 is used. ECCS does not have the predicted
equations for 17 or younger people. For the age group, Quanjer & Tammeling
Comparisons Predicted formula is used. Please refer the Predicted formula table
at the end of this manual for details.
-15- Rev.2.0
[Last test data] tab
The last test data of the patient can be displayed for comparison. Last test
data is tracked by the patients ID number. (Once it is recalled, patient ID
information do not have be filled again.)
*Please note that no last test data is appeared on display if no last test
Last test data display data of the patient (searched by Patient ID #) is stored.
Manual: Only when Last test data button is clicked, it appears.
Auto: It always appears on display.
No: It does not appear on display.
Last test data Last one only Only the last test data of the patient is displayed.
selection Show all The list of the patient test data in the past is displayed.
Manual On Measurement mode screen, when Last test data
button is clicked, the last data and its waveform appear.
Last test waveform
Auto On Measurement mode screen, the last data and its
data display
waveform appear. (It disappeared by clicking Last data
non-display button.
<Last test data display comparison> screen
-16- Rev.2.0
7. Calibration
In order to keep high degree in accuracy, it is recommended to calibrate the flow sensor
periodically. PC-10 automates this process quickly and easily
The American Thoracic Society (ATS) recommends a daily calibration of any

NOTE
Spirometer, using a calibrated syringe with a minimum volume of 3L.
Performing calibration once a day after the power is turned ON is recommended.

Perform calibration when the flow sensor (and/or sensor mesh ring) is cleaned or
replaced.
1) Click the [Flow Sensor Calibration] button on the <Main menu> screen
2)
2) Click the [Settings] button on the < Flow Sensor Calibration> screen.
3) Enter the Flow sensor number (1-10) and Syringe capacity (1L to 6L) to be used.
The calibration factor for each flow sensor head can be stored in memory. If you
calibrate multiple flow sensor heads at a time before the test, the flow sensor
head can be changed anytime during the test without calibration. (Click Sensor
NOTE
selection button on <Patient Information> screen to change the flow sensor
head.) It would be useful to mark on each flow sensor head to distinguish one
from another. (The extra flow sensor heads can be purchased optionally.)
-17- Rev.2.0
4) Connect the flow sensor and the syringe with the silicone adapter.
5) Press the [Calibration Start] button to start. The following messages will be displayed.
Flow zero adjustment

Hold the sensor still
As long as the above message is displayed, do not move the syringe plunger. Hold the flow
sensor without moving.
6) After the Flow Zero message, move the syringe plunger back and forth repeatedly.
Followed by the flow sensor calibration, Volume Checking (Volume Verification) is
performed continuously. Keep moving the syringe plunger until it is automatically (and
completely) stopped.
Move the calibration syringe plunger to reach the upper and lower lines
NOTE
(+/-3L/S) on the graph.
7) Be sure that OK signs are appeared both in Ex (Expiration) and In (Inspiration) at

the Judgment of <Volume Verification>. (If NG is appeared, click Calibration start to
repeat the calibration procedure again. Usually OK signs are appeared in one or two
trials of calibration.)
OK or NG signs
Technically and physically, it is not necessary to perform calibration so

frequently as long as it is well maintained. However, in order to secure the high
NOTE accuracy, we also strongly recommend doing it once a day of use as the ATS
recommend. Allow more than 10 minute heat-run in order to stabilize the
electrical system before calibration.
8) Click the Verification start for volume checking (without performing Calibration). It is
recommended to check the volume accuracy periodically.
-18- Rev.2.0
8. Patient (ID) Information Input
1) Click the [Patient Information] button on the <Main menu > screen.
2) Click the [New Patient] button in the lower left corner to clear the form. Move the cursor
and fill the necessary information of the patient and hospital. (If needed, customize the
<Patient information> screen. See 6. Pre measurement Settings, [Patient
information/Prediction] tab for more details.
[New Patient] to clear the form
Since air volumes varies with temperature and pressure (Boyles law), Input
correct value in both Temperature and Air Pressure to obtain accurate
NOTE
measuring result.
(Standard Air Pressure (Atm)
(Atm) : 1013.3 hPa or 760mmHg at sea level.)
3) Click the [COPD Symptoms] button for COPD diagnosis. Click the [Comment] button for
diagnostic comment. (Comments have to be registered beforehand, See 6. Pre
measurement Settings, [Diagnostic Comments] for more details.)
-19- Rev.2.0
Comment
Free write-in Space

Data Save
COPD symptoms entry Sensor # Selection
Free Write in space is provided at the lower left corner. Move cursor to the Diagnostic
Reports and fill in. In order to start new line, press Ctrl + Enter keys on your keyboard.
<COPD Symptoms entry> window
<Comment entry> window
4) Click the [Sensor selection] button on the bottom to choose the right flow sensor head #.
(See 7 Calibration for more information.)
5) Click the [SVC], [FVC], [MVV], [MV], or [Challenge Test] buttons (or [F2] to [F6] buttons)
to start the measurement.
-20- Rev.2.0
9. Spirometry Tests
Preparation for the measurement

1) Attach the mouthpiece (and Spiro-Filter, C-2F, Option) to the flow sensor, and apply the
nose clip to the patient as he may blow out or inhale through the nose during the test.
2) Plug the USB cable of flow

sensor in to the right USB port of your computer.
Spirometry procedure checklist (Excerpt from NIOSH SPIROMETRY TRAINING GUIDE

GUIDE)
3) Prepare the patient.

Explain the purpose of spirometry: I want to learn how hard and fast you can breathe.
Note the previous position used (sitting or standing) in past Spirometric tests and use the
same position if possible. Record the position to be used in the chart.
Instruct the patient to loosen tight clothing, elevate the chin, and extend the neck
slightly.
Show the patient how to apply a nose clip and check to see that it is on properly.
4) Perform the test

Explain how to position the mouthpiece (in mouth without obstruction from teeth or
tongue, with a tight lip seal).
Explain and demonstrate how to perform the forced expiratory maneuver. (e.g., FVC
test): When you are ready, take the deepest possible breath, place your mouth firmly
around the mouthpiece, and without further hesitation, blow into the spirometer as hard,
fast and completely as possible, without stopping until I tell you.
Actively and forcefully coach the patient as he/she performs the maneuver! (Now BLAST
it out hard and fast! All you can. More! More! More! Keep on going! Blow, blow, blow!)
Keep coaching until a plateau is reached.: ATS 1994 (Less than 25ml volume change in
0.5 seconds.)
-21- Rev.2.0
5) Check the acceptability of each tracing before continuing the test
Acceptable spirograms are free from:
1. Hesitation or false starts
2. Cough
3. Variable effort
4. Glottis closure
5. Early termination, before a plateau is reached
6. Leaks
7. Baseline error
Review causes of errors with the patient if needed.
Continue testing until three acceptable tracings have been obtained, allowing the patient
to recover between tests, up to a maximum of eight trials.
6) After confirming the test result, save data by clicking the [Data Save] button, and/or print
by clicking the [Print out] button.
Data save Print
WARNING
Occasionally, a patient may become lightheaded or dizzy. Such patients should

be asked to rest or lie down, and should not be tested until after the symptoms
subside. In rare cases, the patient may experience pneumothorax, intracranial
hypertension, chest pain, or uncontrolled coughing. In such cases, additional
care directed by a physician may be required.
-22- Rev.2.0
SVC (Slow Vital Capacity) measurement
The patient should breathe normally a few times and then inhale maximally to total lung
capacity and then exhale maximally.
<SVC measurement> screen
-23- Rev.2.0
1) Click the [SVC] button to display <SVC> measurement screen.
nose clip to the patient.
3) Have the patient hold the flow sensor still.
4) Click the [Start] button. The following message will be displayed.

As long as the above message is displayed, the flow sensor must be held quite still and no air
should be breathed into the flow sensor. Otherwise, the zero adjustment can not be completed,
and the measurement can not be started.
5) After the message, instruct the patient to place the lips and teeth around the mouthpiece,
sealing lips around it firmly so that there are no air leaks. Take care not to block its
opening with teeth or tongue or bite it excessively.
6) Then, ask the patient to;

A) Breath normally a few times. (Breathe normally.)
B) Then, inhale as much as possible. (Now, deep breath. Pull it all in!)
C) Then, exhale slowly and completely. (Now, exhale completely. Squeeze it out!)
D) Breath normally again. (OK. Breathe normally again.)
7) Click the [Stop] button to finish the measurement.
8) Review the test result. If it is not acceptable, repeat the test until it is correctly performed.
(The ATS recommends perform minimum of 3 trials, but not more than 8 trials.) Click the
[Start] button to repeat the test. Up to 5 measurements can be saved. (No.5 measurement
data is pushed out after 6th measurement. In order to keep No.5 data, take the following
steps shown below.)
9) If you want to choose the best data manually, choose the one best data by clicking one
from [1] [5] buttons. The selected data becomes No.1 data. Only one best data at No.1
can be printed. (The selected data can be also deleted manually by pressing
[Delete] key on your keyboard.)
<Data selection> screen Data Selection
-24- Rev.2.0
10) After the all measurements, click the [Data Save] and/or [Print out] buttons if necessary.
Data Save Print
When the measured value is

lower than normal limit,
the value is displayed in red,
and printed with * indication.
-25- Rev.2.0
FVC (Forced Vital Capacity) measurement
The patient should breathe normally a few times and then inhale maximally to total lung
capacity and then exhale as quickly and as much as possible. Then, inhale again as quickly as
possible.
<FVC measurement> screen in Flow/Volume graph
-26- Rev.2.0
Besides, the Flow/Volume graph screen, Volume/Time graph screen, and Patient incentive
animation screen for kids can be chosen by clicking the [FVC (V/T)] or [FVC (Kids)] buttons.
(Animation screen will be appeared, after [Start] button is pressed.)
Flow/Volume or Volume/Time Graph Selection
Animation
<FVC measurement> screen <Patient incentive animation> screen

in Volume/Time graph
1) Click the [FVC] button to display <FVC> measurement screen.



C) Then, exhale as quickly as possible without hesitation, and continue exhaling until all
the air has been out. (Now, blow out quickly, harder! Keep blowing completely)
D) Then, inhale as much and as quickly as possible. (OK now, deep breath quickly!
Quickly!)
E) Breath normally again. (OK. Breathe normally again.)
-27- Rev.2.0
When the EOT indicator, which is displayed at the upper right corner of the
graph, turns blue, it means no change in volume for more than 1 sec. And it
indicates the time to press STOP.
End of test criteria by ATS are as follows;

1) The subject cannot or should not continue further exhalation. The
technician should terminate the test if a patient is becoming
NOTE uncomfortable.
2) The Volume/Time curve shows no change in volume (<0.025L) for 1 second
or more, and the subject has tried to exhale for 3 sec(or more) in children
aged < 10 yrs and 6 sec or more in subjects aged > 10 yrs.
Please remember that it is only recommendations and not requirements. Please

use your own judgment when deciding to accept or reject a test. See page 64 for
more details of test Quality checks.
EOT (End of Test) indicator
8) Review the test result. If it is not acceptable, repeat the test until it is correctly performed.
(The ATS recommends perform minimum of 3 trials, but not more than 8 trials.) Click the
[Start] button to repeat the test. Up to 5 measurements can be saved. (No.5 measurement
data is pushed out after 6th measurement. In order to keep No.5 data, take the following
steps shown below.)
can be printed. (The selected data can be also deleted manually by pressing [Delete] key
on your keyboard.)
-28- Rev.2.0
Data Selection
<Data selection> screen
Data Save Print

the value is displayed in red,
When the FIVC is smaller

than 90% of his FVC, all
Inspiratory measurements
become null and indicated
----- .
-29- Rev.2.0
MVV (Maximal Voluntary Ventilation) measurement
The patient should breathe as deeply and as quickly as possible over a period of 12 seconds.
<MVV measurement> screen
-30- Rev.2.0
WARNING
Occasionally, a patient may become lightheaded or dizzy. Such patients should
be asked to rest or lie down, and should not be tested until after the symptoms
subside. In rare cases, the patient may experience pneumothorax, intracranial
hypertension, chest pain, or uncontrolled coughing. In such cases, additional
care directed by a physician may be required.
1) Click the [MVV] button to display <MVV> measurement screen.


6) Then, ask the patient to start breathing as deeply and as quickly as possible.
(Breathe out and in deeply and quickly!)
7) As soon as his breathing becomes stable, click the [Start] button again.
(Double start, the 2nd Start has to be clicked in 12 second after the 1st Start.).
8) Then, ask the patient to keep breathing as deeply and as quickly as possible for 12
seconds. (Breathe out and in deeply and quickly. Keep going!)
9) After 12 seconds, it automatically stopped.
11) Review the test result. If it is not acceptable, repeat the test until it is correctly
performed. Click the [Start] button to repeat the test. Up to 5 measurements can be saved.
(No.5 measurement data is pushed out after 6th measurement. In order to keep No.5 data,
take the following steps shown at 11).
on your keyboard.)
-31- Rev.2.0
Data Selection
Data Save Print
-32- Rev.2.0
MV (Minute Volume) measurement
The patient should keep breathing normally for up to 60 seconds.
<MV measurement> screen
-33- Rev.2.0
1) Click the [MV] button to display <MV> measurement screen.

6) Then, ask the patient to start breathing as normally as possible.

(Keep breathing normally.)
7) When his breathing becomes stable, click the [Start] button again. (Double start, the 2nd
Start has to be clicked in 60 second after the 1st Start.).
8) Then, ask the patient to keep breathing as normally as possible for 60 seconds.
(Keep breathing normally and stably.)
9) After 60 seconds, it automatically stopped.
performed. Click the [Start] button to repeat the test. Up to 5 measurements can be
saved. (No.5 measurement data is pushed out after 6th measurement. In order to keep
No.5 data, take the following steps shown below.)
on your keyboard.
Data Selection
-34- Rev.2.0
Data Save Print
-35- Rev.2.0
10. BD (Bronchodilator) Test
The BD test is performed when an obstruction is identified by the initial spirometry tests. The
goal of this test is to identify how much if any of a patients obstructive disease can be
reversed by a bronchodilator. This information is used both to clarifying diagnosis and to help
decide on medication for treatment.
The BD test is done by treating the patient with a bronchodilator after the initial spirometry
tests (Pre-BD). Approximately 10 to 20 minutes after the medication (when bronchodilator
shows effect) Post-BD test is performed.
Increase of 10 to 15% in FEV1 or FVC values are considered significant and indicate some
degree of reversibility. (Interpretation of Pulmonary Function Test
Test by R.E.Hyatt, P.D.Scanlon,
M.Nakamura)
The test maneuver is identical to the regular SVC, FVC, MVV, and MV tests, respectively.
* BD test is normally done in FVC test.
<BD measurement> screen
-36- Rev.2.0
Before BD test, perform the pre-medication spirometry tests (SVC, FVC, MVV, and/or MV).
Ex.) BD test on FVC measurement.

1) Click the [FVC] button to display <FVC> measurement screen.
2) Confirm the pre-medication test data is displayed.
3) Click the [BD Test] button to display the BD test measurement screen.
BD Test
<BD measurement screen> on FVC
-37- Rev.2.0


D) Then, inhale as much and as quickly as possible.
(OK now, deep breath quickly! Quickly!)

performed. (The ATS recommends perform minimum of 3 trials, but not more than 8
trials.) Click the [Start] button to repeat the test. Up to 5 measurements can be saved.
(No.5 measurement data is pushed out after 6th measurement. In order to keep No.5
data, take the following steps shown below.)
on your keyboard.)
<Data selection> screen Data Selection
-38- Rev.2.0
Data Save Print

value is displayed in red
-39- Rev.2.0
11. Challenge Test
The Challenge test is one method of assessing airway responsiveness. In this test, the patient
inhales an aerosol of one or more concentrations of bronchoconstrictor. FVC test performed
before and after the inhalations are used to quantitate response.
Results of the test are expressed by an index of responsiveness, the provocating dose (PD20)
or concentration (PC20) producing a 20% fall of FEV1.
WARNING
The challenge tests should be performed under the direction of a physician

trained in pulmonary function testing and experienced in bronchial provocation.
WARNING
The challenge test is designed to provoke a mild asthma attack in patients who
have airways hyperreactivity. It is not prudent to perform the test in patients in
whom the diagnosis of asthma or airways hyperreactivity has already been
established.
WARNING
During the test procedure, a physician knowledgeable in challenge testing
procedure and trained must be close enough to the patient to treat acute
bronchospasm and use resuscitation equipment in an emergency.
WARNING
Follow the operational instruction of the bronchoconstrictor inhalation

equipment to be used, such as a nebulizer correctly.
-40- Rev.2.0
1) Click the [Challenge test] button to display <Challenge test> measurement screen.
2) Click the [Protocol] button to confirm the test protocol.
<Challenge Test measurement> screen Test <Protocol> window
-41- Rev.2.0
3) Choose the protocol for Adult or Child, and if necessary, change the name of broncho-
constrictor, and the concentration schedule.
<Challenge test measurement> screen

Test #
* For your reference

American Thoracic Society guidelines recommend two different methods of methacholine
challenge testing: the 2-min tidal breathing method with twofold increases in concentration,
and the five-breath dosimeter method with fourfold increases. Guidelines for Methacholine
and Exercise challenge testing -1999 by American Thoracic Society.
Here are Dilution Schemes for the two recommended methacholine dosing schedule by ATS.
-42- Rev.2.0
For further information, please refer Guidelines for Methacholine and Exercise challenge
testing -1999 by American Thoracic Society.
4) The test is started with C (Control) to assess the patient for non-specific responses to
the Diluents, or Saline. If the measurement with Saline is not needed, you may skip it.
You can choose the test #1 or any test # manually.
5) Administer the prescribed protocol of saline or bronchoconstrictor solutions to the patient
to inhale.


D) Then, inhale as much and as quickly as possible.
(OK now, deep breath quickly! Quickly!)
12) Repeat the above procedure 3) to 9). The test # is automatically counted up every time
[Start] button is switched.
13) Discontinue the Challenge Test when a positive response (PC20 and/or PD20) is
observed.
Threshold
PC20 (PD20)
-43- Rev.2.0
14) Review the test result. If it is not acceptable, you may repeat the test until it is correctly
performed with close attention. Regarding the Frequency, following guideline is
released from AARC (American Association for Respiratory Care), Methacholine
Challenge Testing: 2001 Revision & Update:
To ensure that a previous methacholine challenge test does not affect a later test, 230
minutes should be allowed to elapse before the test is repeated. Tolerance of methacholine
may occur in patients who are not asthmatic when tests are repeated at less than 24-hour
intervals. When a test is to be repeated, medications, exposures, time of day, and nebulizer
employed should be held constant, if possible.
Data Save Print
Following
Following official statements
statements may be useful for the Challenge test.
ATS: Guidelines for Methacholine and Exercise Challenge Testing-1999
NOTE (Am J Respir Crit Care Med Vol161. pp309-329, 2000)
AARC Methacholine Challenge Testing: 2001 Revision & Update
(Respiratory Care May 2001, Vol46 No.5)
-44- Rev.2.0
12. Interpretation
Interpretation of the test results are displayed upon completion of SVC and FVC
measurements. Measurements are compared to the Lower Limit of Normal (LLN). COPD
Classification of Severity and QC Check for test maneuver are also displayed.
<Interpretation> screen
Click the [Interpretation] button upon completion of SVC and FVC measurements.
Interpretation
Spirometry Evaluation
Spirometry Evaluation is determined by the combination of %SVC and FEV1%.

(LLN Default Setting: 80% predicted for %SVC, 70% predicted for FEV1%)
%SVC FEV1% Judgment
LLN or more and LLN or more Normal
LLN or more and Less than LLN Obstructive pulmonary disease
Less than LLN and LLN or more Restrictive pulmonary disease
Less than LLN and Less than LLN Mixed pulmonary disease
-45- Rev.2.0
COPD Classification of Severity
COPD (Chronic Obstructive Pulmonary Disease) is a disease state characterized by airflow

limitation that is not fully reversible. The airflow limitation is usually both progressive and
associated with an abnormal inflammatory response of the lungs to noxious particles or gases.
Chronic cough and sputum production often precede the development of airflow limitation by
many years, although not all individuals with cough and sputum production go on to develop
COPD. (Cited from Global Initiative for Chronic Obstructive Lung Disease by National Institute of Health and
National Heart, lung, and Blood Institute, July 2003)
Classification Severity Characteristics

Normal Spirometry
Normal
No chronic symptoms.
Chronic cough and sputum production; Normal Spirometry.
Stage 0:
lung function is still normal. Chronic symptoms.
At Risk
Exposure to risk factors.
Mild airflow limitation and usually, but
not always, chronic cough and sputum
FEV1/FVC < 70%
Stage I: production.
FEV1 > or = 80%
Mild COPD *At this stage, the individual may not be
With or without symptoms.
aware that his or her lung function is
abnormal.
Worsening airflow limitation, and usually
FEV1/FVC < 70%
Stage II: the progression of symptoms, with
50% < or = FEV1 < 80%
Moderate COPD shortness of breath typically developing
on exertion.
Further worsening of airflow limitation,
increased shortness of breath, and
repeated exacerbations which have an
FEV1/FVC < 70%
Stage III: impact on patients quality of life.
30% < or = FEV1 < 50%
Severe COPD *Exacerbations of symptoms, which have
an impact on a patients quality of life and
prognosis, are especially seen in patients
with FEV1<50% predicted.
Severe airflow limitation or the presence
of chronic respiratory failure. Patients
may have very severe (Stage IV) COPD FEV1/FVC < 70%
Stage IV: even if the FEV1 is >30% predicted, FEV1 < 30% or
Very Severe COPD whenever these complications are present. FEV1 < 50% plus chronic
*At this stage, quality of life is very respiratory failure
appreciably impaired and exacerbations
may be life-threatening.
-46- Rev.2.0
COPD Classification of Severity is provided based upon Global Initiative for Chronic
Obstructive Lung Disease (GOLD, updated Dec. 2006) by NHLB/WHO workshop report.
Classification is based on Post-Bronchodilator FEV1.
For more details of COPD, visit official GOLD site at http://www.goldcopd.com
QC Check (Test quality check)

Acceptability and Reproducibility of FVC Test maneuver are displayed.
GOOD TEST !
Dont hesitate, Start faster!

Blast out harder!
harder!
Blow out longer!
longer!
Take a deeper breath!

Blow out faster!
faster!
Acceptability
Description Suggestion as to NG Criterion
ExtrapV Start faster back-extrapolated volume > 5% of FVC and > 150 mL
PEF Time Blast out harder time to peak expiratory flow > 85 ms
FET Blow out longer forced expiratory time < 6 s
Expiration limit Blow out more air flow > 0.2 L/s within 20 mL of FVC end point
Reproducibility
Description Suggestion as to NG Criterion
FVC Take a deeper breath FVC > 200 mL and > 5% best FVC
FEV1.0 Blow out faster FEV1 > 100 mL and > 5% best FEV1
Spirometry in the Lung Health Study. 1. Methods and quality control. by Enright PL, Johnson LR, Connett JE, Voelker H,
Buist AS. Am Rev Respir Dis 1991; 143: 1215-1223.
The acceptability checks are only recommendations and not requirements.

NOTE
Please use your own judgment when deciding to accept or reject a test.
Not every patient can exhale to comply with the criteria.

NOTE Suboptimal efforts may be adequate to assist clinical decisions, where it can be
judged what the recorded values underestimate true lung function.
-47- Rev.2.0
13. Patient Database
Patient test reports can be effectively managed with the database. You can view a list of
patients previously tested or previously entered into the database. Select a patient from the
list to access that patients records and data from previous tests.
1) Click the [Patient Database] button to display <Patient Database> screen.
<Patient Database> screen
2) Move cursor to the patient on the list to access his previous tests and data. Then, click one
from [Patient Info], [SVC], [FVC], [MVV], [MV], or [Challenge Test] to view his ID
information or previous tests. (Or double click to the [Patient info]).
In order to sort the database by categories,

Click Test date, ID number, Name, Sex, Age or Measurement mode buttons.
[O
O] indicates that the patient had the test.
Remember that only the test stored is available for viewing. If no SVC test was performed, no
SVC test is available for viewing.
-48- Rev.2.0
4) Or Click the [Trend Graph] (to see his previous tests in one graph), [Print Out] (to print
his last test record) or [Data Delete] (to delete the patient data from the list).
Search Filter Data Delete
Trend Graph Print out

(See 14. Trend Graph)
5) You may easily find the patient on the list by search filter. Click the [Search Filter] and
enter the patient search conditions, such as Test date (or period), ID #, Name, Sex,
and/or Age. And Click the [Search] button.
<Search Filter> Window
6) After the designated data search, click the [Show All] buttons to view all the tests in the
database again.
-49- Rev.2.0
14. Trending
Trending enables you to compare the patients best test measurements over time. Changes in
patients condition can be easily seen in the Trend graph.
<Trend Graph> Screen
1) On the Database screen, move cursor to the patient on the list to access his previous tests
and data. Then, click the [Trend Graph] button.
Trend Graph
2) Then, <Trend Graph> screen appears.
Graph 2
(Dotted line)
Graph 1
(Solid line)
Time Scale
-50- Rev.2.0
3) Two different spirometry measurements over time can be appeared in the graph.
Following spirometry measurements can be appeared in the trend graph.
Unit Item
Volume SVC, FVC, FEV1
Flow PEF, MMEF
% FEV1/SVC, FEV1/FVC
Select one to two different Spirometry measurements to trend at one time.

Measurement in Graph1 (Solid line) can be chosen in the Window of the lower left corner.
First, choose Unit (Volume, Flow, or %), then, choose Item.
Measurement in Graph2 (Dotted line) can be chosen in the Window of the lower right corner.
First, choose Unit (Volume, Flow, or %), then, choose Item.
If one spirometry measurement to trend in the graph is preferred, choose Unspecified.
4) Select the length of time to compare by arrow keys on the lower right of the graph.
5) Graph scale can be changed by clicking the arrow keys on the upper right (for Graph 1)
and left corners (for Graph 2).
-51- Rev.2.0
15. Description of the Measured Parameters
SVC
Analysis
Description Unit Remarks
Item
SVC (VC) Difference between peak inhalation and peak L (Slow) vital capacity
expiration
IC IRV + TV L Inspiratory capacity
TV Average ventilation at rest before VC measurement L Tidal volume
ERV Max. volume of expiration beyond expiration at rest L Expiratory reserve volume
IRV Max. volume of inhalation beyond inhalation at rest L Inspiratory reserve volume
-52- Rev.2.0
FVC
Analysis
Item
FVC Vital capacity with forced expiratory effort L Forced vital capacity
FEV0.5 Volume of air exhaled in first 0.5 second of L Forced expiratory
forced expiration volume in 0.5 second
FEV1.0 Volume of air exhaled in first 1 second of forced L Forced expiratory
expiration volume in 1 second
FEV6.0 Volume of air exhaled in first 6 second of forced L Forced expiratory
expiration volume in 3 second
FEV0.5% (FEV0.5/FVC)100 %
FEV1.0/FVC (FEV1.0/FVC)100 % (Geansler)
FEV1.0/SVC (FEV1.0/SVC)100 % (Tiffeneau)
FEV6.0/FVC (FEV3.0/FVC)100 %
FEV1/VCpr (FEV1.0/(Predicted VC))100 %
MMEF Mid forced expiratory flow from the point at L/s Maximal
(FEF25-75) which 25% to 75% of the FVC. mid-expiratory flow
PEF Peak expiratory flow L/s Peak expiratory flow
FEF25 Flow speed of expired air by 25% of the FVC L/s
FEF50/FEF75 FEF50/FEF75 Expiratory flow ratio
FEF75-85 Mean flow from 75% and 85% of FVC L/s
FEF200-1200 Mean flow from 200 and 1,200cc after exhaling L/s
PEF TIME Time required from zero to peak expiratory flow sec
FET Exhaling time sec
Extrap V Extrap Volume L
-53- Rev.2.0
Analysis
Item
Extrap V% Extrap V/FVC100 %
FIVC Forced inspiratory vital capacity L
FIV0.5 Volume of air inhaled in first 0.5 second of L Forced inspiratory
forced inspiration after forced expiration volume in 0.5 second
FIV1.0 Volume of air inhaled in first 1 second of forced L Forced inspiratory
inspiration after forced expiration volume in 1 second
FIV1/FVC (FIV1.0/FVC)100 %
FIV1/FIVC (FIV1.0/FIVC)100 %
PIF Peak inspiratory flow L/s
FIF50 Forced inspiratory flow at 50% of FIVC L/s
FEF50/FIF50 FEF50/FIF50
FIF50/FEF50 FIF50/FEF50
CVI FEV0.5/FIV0.5 Check valve index
-54- Rev.2.0
MVV
Analysis
Item
MVVVolume of air expired in one minute during L/min Maximum voluntary
repetitive maximal respiratory effort ventilation
RR Respiratory frequency in one minute C/min Respiration rate
TV Mean value of several quiet breathing L Tidal volume
MVV/BSA MVV/BSA L/min/m2
AVI %MVV/%VC Air velocity index
-55- Rev.2.0
MV
Analysis
Description Unit
Unit Remarks
item
MV Volume of air ventilated in 1 minute L/min Minute ventilation
TV Mean value of the volume of one respiration L Tidal volume
during the measurement
RR Number of respiration in 1 minute C/min Respiratory frequency
BR MVVMV L Breathing reserve
VR (MVVMV)MVV100 % Ventilation reserve rate
-56- Rev.2.0
Challenge test (MCT)
Analysis
item
PC20 The solution density that FEV1 value mg/ml Provocation
inhaled when 20% fell than a FEV1 Concentration producing
standard value a 20% fall in FEV1
PD20 The accumulation density that it seems mg/ml Provocation Dose
decreases 20% than a FEV1 standard value producing a 20% fall in
FEV1
Threshold The solution density that it seems mg/ml
decreases 20% than a FEV1 standard value
FEV1 Degree of leaning of FEV1 decrease rate %
12% - 20%
-57- Rev.2.0
16. Predicted Formula
-58- Rev.2.0
-59- Rev.2.0
-60- Rev.2.0
-61- Rev.2.0
References
Ref.# References
[1] Naoyuki, Ishida, Respiratory and Circulation Vol.14 No.9, 718-721
[2] Toshiaki Ebina et al, Respiratory and Circulation Vol. 6 No. 13, 999-1013, Dec 1958
[3] Baldwin, E. de F., Cournand, A., and Richards, D.W., Jr.: Pulmonary Insufficiency. I. Physiological Classification,
Clinical Methods of Analysis, Standard Values in Normal Subjects. Medicine, 27: p.243-278, 1948.
[4] Marion L.Dickman et.al. Spirometric Standards for Normal Children And Adolescents
( Ages 5 Years through 18 Years ) Am. Rev. Resp. Dis. Vol.104,1971 680-687
[5] C.DuWayne Schmidt et.al. Spirometric Standards for Healthy Elderly Man and Women
Am. Rev. Resp. Dis. Vol.108,1973 933-939
[6] Dubois D, Dubois E.F. - Clinical Calorimetry : Tenth paper : A Formula to Estimate the Approximate Surface
Area if Height and Weight are known. Arch.Intern.Med.,1916 , 17, 863-871
[7] Knudson R.J.,Lebowits M.D., Holberg C.J.,and Burrows, B.: Change in the Normal Maximal Expiratory Flow -
Volume Curve with Growth and Aging., Am.Rev.Resp.Dis.,Vol.127,p725-734, 1982
[8] Knudson R.J., Slatin, R.C., Lebowits M.D., and Burrows, B.
The maximal Expiratory Flow Volume Curve . Am.Rev.Resp.Dis.,vol.113.p.587-600, 1976
[9] Morris, J.F., Koski A, Johnson LC.: Spirometric standards for healthy nonsmoking adults.
Am.rev.Resp.Dis. , 1971 103,57-67
[10] G.Polgar and V.Promadhat: Pulmonary Function Testing in Children. Techniques and Standards, 1971,
W.B.Saunders Company. table 44 , P.254 Summary Equations
[11] R.C.Kory, R.Callahan, H.G.Boren, and J.C.Syner: The Veterans Administration - Army Cooperative Study of
Pulmonary Function. 1. Clinical Spirometry in Normal Men Amer.J.Med. vol.30 , pp243-258 , 1961
[12] G.Grimby and B.Soderholm: Spirometric studies in Normal Subjects. III. Static Lung Volumes and maximum
Voluntary Ventilation in Adults with a Note on Physical Fitness, Acta Med.Scand., vol.173,p.199-206 , 1963
[13] G.Polgar and V.Promadhat: Pulmonary Function Testing in Children. Techniques and Standards, 1971,
W.B.Saunders Company. Equations obtained from referenced graphs by linear approximation.
[14] Hollis.G.Boren, M.D., Ross C.Kory, M.D., and Lt. Col.James C.Syner, MC The Veterans Administration - Army
Cooporative Study of Pulmonary Function. II. The Lung Volume and Its Subdivision in Normal Men
Amer.J.Med. vol.41 ,pp96-114 , 1966
[15] Morris, J.F. Spirometry in the Evaluation of Pulmonary Function, Medical Progress, West J.Med. 125 :110-118
Aug. 1976
[16] Robert O.Crapo, Alan H.Morris, and Reed M.Gardner: Reference Spirometric Values Using Techniques and
Equipment that Meet ATS Recommendations, Am.Rev.Respir.Dis. 1981 ; 123:659-664
[17] Ph.H Quanjer et.al. LUNG VOLUMES AND FORCED VENTILATORY FLOWS Report Working Party
Standardization of Lung Function Tests European Community for Steel and Coal Official Statement of The
European Respiratory Society Eur Respir J, 1993,6,Suppl. 16,5-40
[18] The JapanSociety for Diseases of the Chest, 31(3), 1993
[19] Nishima, The Japanese Journal of Clinical and Experimental Medicine Vol. 54 No. 2
[20] Quanjer & Tammeling Comparisons
[21] The Japanese Respiratory Society, April, 2001
[22] A.Zapletal, E.K.Motoyama, K.P.Van de Woestijne, V.R.Hunt, and A.Bouhuys; Maximum expiratory flow-volume
curves and airway conductance in children adolescents: Journal of Applied Physiology, Vol.26, No.3, March
1969, p306-316
[23] Tetsuro Yokoyama, M. D., F.C.C.P., and Makoto Mitsufuji, M. D.; Statistical Representation of the Ventilatory
Capacity of 2,247 Healthy Japanese Adults; CHEST, VOL.61, NO.7, JUNE 1,P655-661.
[24] Respiration and Circulation, Vol.30, No.5, May 1982 p463
[25] E. Berglund, G. Birath, J. Bjure, G. Grimby, I. Kjellmer, L. Sandqvist and B. Sderholm; Spirometric Studies in
Normal Subjects I. Forced Expirograms in Subjects Between 7 and 70 Years of Age; Acta Medica Scandinavica.
Vol. 173, fasc. 2, 1963.
-62- Rev.2.0
[26] R. M. Cherniack, M. B. Raber; Normal standards for ventilatory function using an automated Wedge Spirometer;
Am.Rev.Respir.Dis.1972 ; Vol.106:p.38-46.
[27] A. J. Nunn, I. Gregg; New regression equations for predicting peak expiratory flow in adults; Br. Med. J. Vol.
298, p1068-1070, 22 April 1989.
[28] Kanner RE, Morris AH, Crapo RO, Gardner RM (eds); Clinical Pulmonary Function Testing. A Manual of
uniform laboratory procedures for the Intermountain Area, 2nd Ed. Salt Lake City, Utah, Intermountain Thoracic
Society, 1984
[29] Lindall A, Medina A, Grismer JT. A re-evaluation of normal pulmonary function measurements in the normal
female, Am.Rev.Respir.Dis. Vol.95:p1061-1064, 1967
[30] Jinpai shinsa handbook by Ministry of labor of Japan, 4th Edition, 1987
[31] Gen Tamura, Japanese Respiratory Society, Vol.44, No.12, p916-922, Dec.,2006
[32] Hisamichi Aizawa, Kokyu Vol.25, No.12 p1104-1115, Dec., 2006
[33] Normal predictive values of Spirometry in Korean population, Jung Keun Choi, The Korean Academy of
Tuberculosis and Respiratory Diseases, 2005, 58: p230-242
[34] Wang X, Dockery DW, Wypij D, Fay ME, Ferris BG Jr. Pulmonary function between 6 and
18 years of age. Pediatr Pulmonol 1993; 15: 75-88.
[35] J. L.. Hankinson, J. R. Odencrantz, and K. B. Fedan; Spirometric Reference Values from
a Sample of the General U.S. Population; Am J Respir Crit Care Med 1999;159:179187.
[36] Dejsomritrutai W, Nana A, Maranetra N, et al. Reference spirometric values for healthy lifetime nonsmokers in
Thailand. J Med Assoc Thai 2000; 83: 457-466
No Predicted formula covers all spirometry measuring items, (such as FEV1, PEF,
MMEF, etc) for all age, height, and sexes group of patients. For your convenience,
the secondary Predicted formula may be used to complete it. For example,
Knudson does not have predicted equation for FEF75-85. In order to complete it
NOTE
ITS predicted equation for FEF75-85 is used. ECCS does not have the predicted
equations for 17 or younger people. For the age group, Quanjer & Tammeling
Comparisons Predicted formula is used. Please refer the Predicted formula table
at the end of this manual for details.
Some predicted equations do not have SVC prediction. In this case, SVC
predicted value is replaced by FVC predicted value.
For your convenience, the predicted values are shown for all ages. For
NOTE Example, applicable age range for FEF25-75 of NHANES is 8 to 80 yrs old,
but using NHANES predicted equations, predicted values for 7 yr or 81 yr old
patients are displayed and saved. Please use the prediction as just one
reference to help your diagnosis.
-63- Rev.2.0
Predicted Curve
PEFpr
FEF25pr
FEF50pr
Predicted
Curve
FEF75pr
FVCpr
Position on Y axis Position on X axis

Description Sex
(L/S) (L)
PEF Male : FVCpr x 0.052
PEF prediction
Female : FVCpr x 0.061
FEF25 Male & Female FEF25 prediction : FVCpr x 0.25
-64- Rev.2.0
17. Maintenance
Cleaning the Flow Sensor

Clean the flow sensor at the end of the day. Follow the below steps for cleaning.
1) Detach the sensor head from 2) Disassemble the sensor head.

from the sensor body.
3) Immerse the mesh holders (A and B), mesh ring, and O-rings in the solution for
sterilization.
Sterilizing solution Density Immersing time

Glutaral 2.25W/V% More than 1 hour
Chlorhexidine gluconate 0.5% More than 30 min
Benzalkonium chloride 0.1% More than 30 min
Sodium hypochlorite 0.1% More than 1 hour
* Please read carefully the instruction of the sterilizer before use.
4) After the sterilization, rinse them fully with water.

*Do not brush the mesh ring to clean. It may be damaged.
5) After rinsing, shake water off and dry them naturally.
6) Be sure all parts are fully dried before assembling.
Mesh Holders (A and B) can be also sterilized by autoclave. Please let it run at 121 degrees in
Celsius (or 250 degrees in Fahrenheit) for 20 minutes. They may be autoclavable approx.10
times. When cracks are found or after 10 time autoclave sterilization, please do not use it.
Only Mesh Holders (A and B) are autoclavable. Both Mesh ring and O ring are
NOTE
NOT autoclavable.
-65- Rev.2.0
After sterilizing / cleaning the flow sensor parts, performing calibration before
NOTE
use is highly recommended.
NOTE Do not immerse the sensor body for sterilization.
Replacing the Sensor mesh

Replace the sensor mesh when the following symptoms are observed.
The sensor mesh is damaged, or stains cannot be removed by cleaning.
The sensor mesh is bent by heat.
* When the sensor mesh has been replaced, be sure to perform calibration.
Safety check
Perform the safety check while the sensor is connected.
Measure the enclosure leakage current, patient leakage current I (DC), and patient leakage
current I (AC) under the normal condition and the single fault condition. Confirm that these
measured values do not exceed the permissible values shown in the table below. The
measured values should be recorded.
Permission value
Item Permissible values under Permissible values under
normal condition the single fault condition
1 Enclosure leakage current 0.1 mA or less 0.5 mA or less
2 Patient leakage current I, (DC) 0.01 mA or less 0.05 mA or less
3 Patient leakage current I, (AC) 0.1 mA or less 0.5 mA or less
Disposal of equipment and consumables

When disposing of PC-10, accessories, and consumables, pay proper attention to the
environmental protection. Following procedures are recommended.
* Recording paper: Discard as usual paper.

* Paper mouthpiece: Discard as flammable medical waste.
* Flow sensor and its components: Discard as industrial waste after sterilization.
* Other accessories: USB cable and nose clip can be discarded as industrial waste.
-66- Rev.2.0
18. Troubleshooting
Before requesting for repair, please refer to the following table for help.
Trouble? Check Point
Program software can not be Is your PC a WINDOWS based?
installed. Did you read and follow the steps in this manual?
Calibration error is more than +/-3%. Did you input the temperature and PB correctly?
Did you start calibration after the flow zero adjustment?
Did you input the correct volume capacity of a syringe?
No air leakage is found in the air circuit?
Perform the calibration repeatedly (at least a few times).
Predicted values seem to be strange. One predicted formula never cover all the age, sex, height,
(for example; FEV1pr is larger than and race of people for all spirometry parameters. For the
FVCpr. FVCpr for 17 year old girl is sake of convenience, other predicted formulas by different
larger than 18 year old girl.) authors are mixed to make it complete. At the boundary
between two, some contradictions may occur. (For
example, ECCS predicted formula doesnt have predicted
formula for 17 or younger people. Then, Quanjer &
Tammeling predicted formula for 17 or younger people is
used to complete ECCS predicted formula.)
No predicted values are available for The author of the prediction may not provide the
specific measurement items or all predicted formula for the measurement item(s). Check the
items. table of predicted formula of the author.
Predicted formula has age (or height) range. If it is out of
range, no predicted values are available.
ZERO Adjustment cannot be done. Did you blow into the flow sensor or move the flow
sensor while the ZERO Adjustment?
Hold the sensor still during the zero adjustment.
Measurement cannot be performed. Flow sensor cable is connected securely to the USB
connection port of your PC?
Verify the USB cable is connected to the right USB port?
Is the flow sensor damaged?
The waveform is going up (or down) Did you input the right temperature?
naturally. Did you input the right air pressure?
Did you hold the sensor still in the upright position during
zero adjustment?
Do you use the nose clip? Patients may breathe through
the nose.
Make sure no leaks around the mouthpiece.
Did you calibrate the flow sensor recently?
-67- Rev.2.0
Trouble? Check Point
Abnormal measurement data (too Do you calibrate the flow sensor recently?
large or too small) is observed. Do you input the temperature and PB correctly? Normal
PB values are around 1013hPa or 760mmHg. (approx.
10hPa goes down every 100m altitude change. For
example, in Johannesburg, South Africa, whose altitude
is1800M, it is approx.830hPa)
Do you keep using the damaged or not-cleaned flow
sensor head? Water drops or sputum on the mesh screen?
If so, replace the flow sensor head and/or mesh screen.
Too much humidity contained in the flow sensor head? If
so, replace the flow sensor head and/or let it dry.
Did the patient start breathing during Flow zero
adjustment?
Do you use the nose clip? Patients may breathe through
the nose.
Use a calibration syringe and confirm the volume error.
No inspiratory measurement items, Inspiratory measurement items are NOT analyzed when
such as FIVC, FIV1, PIF, FIVC (Forced Inspiratory Vital Capacity) is smaller than
FIF50/FEF50, etc are printed but 90% of FVC. Theoretically, Patients FIVC must be as
marked ---*---. much as FVC. If his FIVC is much smaller than his FVC,
it means he did not do their best during inhalation.
Without patients full effort, the measurement values do
not have any meaning. In this case ------- is appeared on
the print-out. ATS recommend not to show the inspiratory
data when FIVC is smaller than 90% of FVC as the FIVC
value is considered as faulty value.
No BD test data is available. Pre-medicine-inhalation measurements (SVC, FVC,

MVV) were performed beforehand?
Always NG is appeared in Quality Follow the suggestion as to NG. The acceptability
Control check. checks are only recommendations, and not requirements.
Some patients really can not exhale to comply with the
ATS criteria. Please use your own judgment when
deciding to accept the test.
Printer does not work. Printer paper is set in the printer?

Is the printer turned on?
Your PC is connected to the printer?
Waveforms are too large or too short Adjust the graph scale on the display.
on the print out.
Measurement data was disappeared Was the ID number changed after the measurements?
after the measurements. If you changed the ID number and had a test before
storing the previous data in memory, the previous data is
gone.
The data can not be transmitted. PC-10 does not send the data to other PC.
-68- Rev.2.0
19. Glossary of Spirometry Terms
AARC The American Association for Respiratory Care is the professional

society for respiratory therapists in hospitals and with home care
companies, managers of respiratory and cardiopulmonary
services, and educators who provide respiratory care training. The
useful information, guideline, recommendations for Respiratory
Care may be available at their web-site at http://www.aarc.org.
ATS The American Thoracic Society is the scientific branch of the
American Lung Association. They promote the improvement of
Spirometry through the use of their recommendations. Visit their
web-site at http://www.thoracic.org for more information.
Back Extrapolation The method for determining zero time from a spirogram,
particularly important when the exact starting point of a forced
expiatory maneuver is not obvious. Since the FEV1 is affected by
the point on the graph that is selected as the start, a uniform way
to determine this must be used.
BD Test Bronchodilator. Administration of a bronchodilator is indicated if

baseline Spirometry shows airway obstruction or asthma is
suspected (Office Spirometry). The BD test is performed to
determine the response on bronchodilator by performing FVC test
before (Pre) and after (Post) medication. When bronchodilator
shows effect a second FVC is performed. Also known as
Bronchodilator test, Post Bronchodilator test, etc.
Brinkman Index The Brinkman index (BI) is defined as numbers of cigarette

smoked per day times smoking years.
BTPS Body Temperature and Pressure Saturated with water vapor. A

volume of gas will shrink when cooled. The volume of air exhaled
into a spirometer from the lungs will contract because the lungs
are warmer than the spirometer. Therefore, it is necessary to
adjust the recorded values with a BTPS conversion factor to
determine the actual volume of air exhaled before it contracted.
This corrects the volume of air saturated with water vapor to body
temperature for various spirometer temperature.
Calibration Periodic determination of a spirometers ability to make accurate
measurements of volume and time.
Challenge test Challenge test is one method of assessing airway responsiveness

to diagnose asthma patients. Challenge test is performed to
determine the airway hyperresponsiveness on bronchoconstrictor
by performing FEV1 test before (Pre) and after (Post) medication.
Also known as Methacholine challenge test, Bronchial challenge
test, Bronchial provocation test, Provocation test, BC test,
Broncho-provocation test, Inhalation challenge,
Broncho-constrictor test etc.
-69- Rev.2.0
COPD Chronic Obstructive Pulmonary Disease is a disease state
characterized by airflow limitation that is not fully reversible. The
airflow limitation is usually both progressive and associated with
an abnormal inflammatory response of the lungs to noxious
particles or gases. Chronic cough and sputum production often
precede the development of airflow limitation by many years,
although not all individuals with cough and sputum production go
on. COPD is a major cause of chronic morbidity and mortality
throughout the world. COPD is currently the fourth leading cause
of death in the world (WHO, 2000).
ERS The European Respiratory Society (ERS) with members in over
100 countries aims to alleviate suffering from respiratory disease
and to promote lung health through research, knowledge sharing,
medical and public education. Visit their web-site at http://
http://dev.ersnet.org/ for more information.
ERV Expiratory Reserved Volume. The maximal amount of air
forcefully exhaled after a normal inspiration and expiration.
Expiratory time The time required for the subject to reach his largest volume
(FVC). For quality control process, total expiratory time is the
time from the beginning of exhalation to the end of the subjects
expiratory maneuver. As a rule of thumb, total expiratory time
should be greater than 6 seconds.
Expiratory volume The volume that was determined by a perpendicular line drawn
from the point where time equals zero to where it intersects the
FVC curve. The extrapolated volume must be les than 150ml (for
FVCs less than 3L) or less than 5% (for FVCs greater than 3L) for
the tracing to be acceptable. A high extrapolated volume is due to a
slow start or hesitation in the start of the maneuver.
FEF25% Flow speed of the expired air by 25% of the FVC. Also known as
MEF75% or V75.
MEF50% or V50.
MEF25% or V25.
FEF25-75% It is mid forced expiratory flow measured from the point at which
25% of the FVC to the 75% point (during the middle half of the
FVC). Also called Maximum Mid-Expiratory Flow and abbreviated
MMEF, MMFR, or MMF.
FEF25-75/FVC FEF25-75/FVC is recently considered as a surrogate measure of
airway size relative to lung size, which is significantly associated
with airway responsiveness.
FEF 200-1200 Equivalent to FEF x, but computed for 200cc and 1200cc rather
than at 25% and 75%, infrequently used. Also written as
FEF.2-1.2.
FEV1 Forced Expiratory Volume in 1 second. The volume of air exhaled
during the first second of a forced expiratory maneuver. It may
also be considered the average flow during the first second of the
FVC maneuver.
-70- Rev.2.0
FEV6 Forced Expiratory Volume in 6 seconds. According to some theses,
it can be an acceptable alternative to forced vital capacity (FVC)
for diagnosing airway obstruction in adults.
FEV1/FVC The ratio of the FEV1 to the FVC expressed as a percentage. Also
written as FEV1% or FEV1% (G), or FEV1/FVC ratio.
FEV1/VC The ratio of the FEV1 to the SVC expressed as a percentage. Also
written as FEV1% or FEV1% (T), or FEV1/SVC ratio.
FIVC Forced Inspiratory Vital Capacity. The maximum volume of air
inspired with a maximally forced effort from a position of
maximum expiration. PC-10 does not calculate FIVC when it is
smaller than 90% of FVC as it is considered that the patient does
not do his very best in inhalation.
Flow/Volume graph A tracing of flow rate (on the Y or vertical axis) against volume
(on the X or horizontal axis) for a forced expiratory maneuver
followed by a maximal inhalation. Also known as Flow/Volume
curve, Flow/Volume loop.
FVC Forced Vital Capacity. The maximal volume of air which can be
exhaled forcefully after maximal inspiration. NOTE: the Vital
Capacity is the amount of air that can be exhaled by an individual
after taking the deepest breath possible, whether or not the air is
exhaled forcefully (FVC) or slowly (VC)
GOLD Global initiative for chronic Obstructive Lung Disease program

was conducted in 2001 in collaboration with the US National
Heart, Lung, and Blood Institute and the World Health
Organization to increase awareness of COPD among health
professionals, public health authorities, and the general public,
and to improve prevention and management through a concerted
worldwide effort. Publications are available on the Internet at
www.gold-copd.com
IRV Inspiratory Reserve Volume. The maximal amount of air forcefully
inhaled after a normal inhalation.
JRS The Japanese Respiratory Society promotes the study of
respiratory diseases by disseminating information and promoting
academic achievements in this field.
LLN Lower Limit of Normal. The point which is considered to be the
lower limit of the normal patient for a given parameter. This point
is defined in the various referenced studies. The default setting of
LLN for PC-10 is 80% for FVC, and 70% for FEV1 against
predictions.
MMEF See FEF25-75%
MMFR See FEF25-75%
MMF See FEF25-75%
MV Minute Volume. The volume of air expired in 1 minute during rest
ventilation.
MVV Maximum Voluntary Ventilation. The volume of air expired in 1
minute during repetitive maximum respiratory efforts at
maximum repetition rate. (Usually measured for 15 sec and
multiplied by 4, or 12 sec and multiplied by 5.)
-71- Rev.2.0
NIOSH The National Institute for Occupational Safety and Health, a US
government agency.
Obstructive lung disease Diseases that reduce flow from the lungs. These diseases include
asthma, chronic bronchitis, and emphysema.
PC 20 (Challenge test) The concentration of the agonist in the inhaled aerosol leading to a
fall in FEV1 of 20%
PD 20 (Challenge test) The administered dose of a substance in the inhaled aerosol which
causes the FEV1 to fall by 20%
PEF Peak Expiratory Flow. Maximum expiratory flow recorded during
a forced expiratory maneuver. Also known as PEFR or PF.
Pneumotacho flow PC-10 uses a pneumotacho meter to sense airflow. A pneumotacho
sensor meter, a differential pressure transducer measures the pressure
difference across a flow resistor as the air stream passes through
it. The resulting pressure change is converted to a signal
proportional to the airflow rate.
Predicted value Expected values for various lung volumes and flow rates, derived
from healthy non-smoking populations. The values are adjusted
for sex, age, height, and race. Also known as Reference values, or
Normal values.
Reproducibility The ability of a test to obtain the same result from an individual
when it is repeated several times. Reproducibility is determined
by checking for excess variability between the two largest values
for FVC and FEV1 obtained from three acceptable spirograms.
Restrictive lung disease Diseases that reduce the ability of the lungs to expand fully but do
not necessarily affect air flow. Asbestosis and silicosis, two of the
most common of the occupationally caused restrictive diseases, are
caused by the development of fibrotic tissue in the lungs.
RR Respiration Rate. Breath per minute.
TV Tidal Volume. The volume of air inhaled and exhaled during quiet,
normal breathing.
VC Vital Capacity. The maximum amount of air that can be exhaled

after the fullest inhalation possible. The sum of tidal volume,
expiratory reserve volume, and inspiratory reserve volume. May
be measured either during inhalation or exhalation. Also known as
SVC.
Volume/Time graph A tracing of volume rate (on the Y or vertical axis) against time
(on the X or horizontal axis) for a maximal (or forced) expiratory
maneuver followed by a maximal inhalation.
Zero time point In the measurement of the FEV1, the point selected as the start of
the test, obtained using back extrapolation.
-72- Rev.2.0
20. Technical References
Specifications
Flow sensor (PC-
(PC-10)
Flow Detection method Lilly-type pneumotacho sensor
Detection range 0.05 to 14.0 L/S
Resolution 0.01L/S
Accuracy +/-5% or 0.2 L/S, whichever is greater
Volume Detection method Flow integration type
Detection range 0.01 to 10.0 L
Resolution 0.01L
Accuracy +/-3% or 0.05 L, whichever is greater
Measurement items SVC, FVC, MVV, MV+BD test, and
Spirometry
Challenge test
Dimensions: (Approx) W/D/H (mm) 74.8 x 87.7 x 223 excluding USB cable
Weight: (Approx) kg 0.25
Power supply 5V(DC) Supply from the USB port of a PC
Type and degree of Type of protection Depend on the PC
protection against
electric shock Degree of protection B
Environmental Temperature 15 to +40
Conditions for use Humidity 10% to 85% , non-condensing
Atmospheric pressure 700 to 1060 hPa
Environmental Temperature -10 to +60
Conditions
Humidity 10% to 95% , non-condensing
for transportation and
storage Atmospheric pressure 700 to 1060 hPa
* The performance and specifications may change for improvement without prior notification.
Flow sensing method
Pneumotacho Sensor is used for SpiroMaster, PC-10 to sense airflow. A differential pressure
transducer measures the pressure difference across a flow resistor (Sensor mesh ring) as the
air-stream passes through it. The resulting pressure change is converted to a signal
proportional to the airflow rate.
Flow sensor mesh ring (Resistive element)
-73- Rev.2.0
System Requirements
Hardware and Software Requirements (IBM

(IBM PC/AT compatible Windows-
Windows-based personal
computer)
computer)
PC OS Windows98se, Me, 2000, XP
(IEC60950 CPU Same as Intel Celeron 800MHz or faster
acceptable) HDD At least 10 MG of disk space for the software
Additional disk space is required for storing test
data.
Memory More than 128MB
USB USB port for flow sensor connection (buss
powered)
CD Rom drive For software installation
Display LCD, CRT ResolutionMore than 1024768 dot
ColorsMore than 16bit
Printer A4 or letter size Compatible with the above OS (Color or BW)
Input device Mouse/Keyboard Compatible with the above OS
Backup unit Device for data backup
Classification
Class.Internally powered equipment (Followed IEC60601-1).

Type B applied part.
Equipment not suitable for use in the presence of a FLAMABLE ANAESTHETIC MIXTURE WITH
AIR or WITH OXYGEN or NITROUS OXIDE INTERMITTENT OPERATION
Electromagnetic Compatibility
PC-10 is designed to comply with EN 60601-1-2 : 1995, Electromagnetic Compatibility

Requirements and Tests. Move PC-10 away from other electronic equipment if you suspect the
electronic equipment is interfering with the operation of PC-10 or conversely PC-10 is interfering with
the operation of other electronic equipment.
Applicable Standards
American Thoracic Society Standardization of Spirometry, 1994 Update

EN 60601-1 (IEC 601-1) 1995, Medical electrical equipment Part 1 : General requirement for safety
EN 60601-1-2 (IEC 601-1-2) 1995, Electromagnetic Compatibility Requirements and Tests
-74- Rev.2.0
21. Print Forms
Standard Form (COPD+SVC+FVC)
1) COPD Classification
2) Spirometry Evaluation
3) SVC waveform
4) FVC (F/V) waveform
5) SVC +FVC data
6) Your Memo
SVC+FVC+MVV+MV FVC COPD+SVC+SVC (BD)
SVC+FVC+MVV+MV (BD) FVC (BD) Challenge Test
-75- Rev.2.0
22. Accessories
Optional Accessories
# Description Part Number Unit
1. Paper mouthpiece (100pcs/box) 03-6111-010211 10 boxes
2. Reusable plastic mouthpiece (100pcs/box) 03-6111-060101 1 box
3. Silicon mouthpiece (Re-usable, for adult) 03-6111-020402 1 pc
4. Silicon mouthpiece (Re-usable, for child) 03-6111-020401 1 pc
5. Nose clip (Metal) 03-4511-010101 1 pc
6. Nose clip (Plastic, 10pcs/pack) 04-4511-020101 1 pack
7. Spiro-Filter (C-3F, 100pcs/box) 03-5311-010301 1 box
8. Flow sensor mesh ring (10pcs/pack) 03-2421-020201 1 pack
9. Flow sensor O ring 04-1450-110301 1 pc
10. Sensor mesh holder (A+B) 04-1480-110401 1 pair
11. 1L Calibration syringe + Silicon adapter 04-1350-150101 1 pc
12. 3L Calibration syringe + Silicon adapter 05-9601-060103 1 pc
(1) (3/(4) (5)/(6)
(7) (8) (9)
(10) (11)/(12)
Flow Sensor Head Assembly
-76- Rev.2.0
23. Limited Warranty
Each new PC-10 is warranted to be free from defects in material or workmanship for a period
of twelve (12) months from the initial date of purchase. For the purpose of this Limited
Warranty, the initial date of purchase shall be the date of shipment from the manufacturer to
the initial owner of record. Should the Unit be defective in material or workmanship during
the term of this Limited Warranty, an official local dealer, at its option, repair or replace the
defective system or component part. Replacement Units and/or parts do not carry a new
warranty and shall only be warranted for the unexpired portion of the original Limited
Warranty or six (6) months, whichever is longer.
The manufacturer will not assume any responsibility for damages;
1) If PC-10 is not installed and connected in accordance with the instructions furnished by
the manufacturer.
2) If the serial number or any component part thereof has been altered, defaced or removed,
or if purchaser cannot produce a bill of sale or other evidence to verify the initial purchase
of the Unit.
3) If the defects arising from misuse, abuse, negligence or accident or from repair,
maintenance, adjustment, modification or replacement made by anyone other than
authorized personnel.
The manufacturers and local dealers responsibilities hereunder are limited to repair and
replacement only. To obtain service under this warranty, the owner of PC-10 must promptly
notify a local dealer of any defect in material or workmanship, and the serial number as well
as the date of purchase.
-77- Rev.2.0
24. Contact Information
Medical Device Safety Service GmbH

Schiffgraben 41
D-30175 Hannover, Germany
CHEST M.I., Inc.

3-6-10 Hongo, Bunkyo-ku,
Tokyo, 113-0033, Japan
Tel: +81-3-5804-5031 (M-F 9 to 5 in Japan time, in Japanese language only)

Fax: +81-3-3812-7220 (24hrs. English, Chinese, and Japanese are acceptable)
To place an order for consumables, for repair, or for general inquiries,

NOTE
please contact your local dealer.
-78- Rev.2.0
When contacting your local dealer for service & maintenance, prepare the
NOTE
Software version of your PC-10 as well as the serial number to report.
Serial #
Software
Version
<Configuration> screen
*Serial number is shown on

the flow sensor body
Your Local Dealer
REV. 1.26
April 1, 2012
-79- Rev.2.0

PC-10 User Manual

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Spiro-Master

Throughout this manual, the following indicators are used as follows;

Warning alerts the user to potential serious outcomes (including injury or

2. Introduction (Spirometry / Intended use) . 5

3. Configuration (Standard accessories / Parts description) ... 6

4. System Installation (Hardware attachment) .... 7

5. Basic Operation (Operational procedure) ........ 8

6. Pre-measurement Settings (General settings / Factory defaults setting) ... 12

8. Patient (ID) Information Input ... 19

9. Spirometry Tests (SVC / FVC / MVV / MV) ... 21

10. BD [Bronchodilator] Test (FVC) .. 36

11. Challenge Test (FVC) . 40

12. Interpretation (Spirometry / COPD / QC check) .. 45

13. Patient Database (Database / Data batch processing) ... 48

14. Trending .... 50

16. Predicted Formula 58

18. Troubleshooting .... 67

19. Glossary of Spirometry Terms . 69

20. Technical References (Product specifications) 73

21. Print Forms ... 75

24. Contact Information EC representative / Manufacturer / Your local dealer 78

1.2 Standards and Compliance

Guidance and manufacturer's declaration - electromagnetic immunity

Guidance and manufacturer's declaration - electromagnetic immunity

d=[3.5/V1]P 150kHz to 80MHz

interference may occur in the vicinity of equipment marked with the

Guidance and manufacturer's declaration - electromagnetic immunity

List of external device

Cables Length Shielding

Please remember that it is to be used by physicians or by trained personnel on a physician

Scope of this manual

(1) PC-10 flow sensor with USB cable

PC-10 Flow sensor PC (Not supplied) Printer (Not Supplied)

(1) (2) (3)

(4) (5) (6)

1. Windows-based PC with Windows 98, 2000, XP, and 7 OS

Installing the PC-10 Software

1 Plug the USB cable of flow sensor in to the computer.

Program shortcut Icon on your Desktop

Setting the flow sensor

How to find the right USB port.

XX is the number of USB port, which the flow sensor is connected.

Questionnaire screen for <COPD diagnosis by Gold>

7) When Pre-measurement setting is needed, go back to [Main Menu] and click

Tab Blue Square

F/V graph in (Point E) F/V graph in (Point C)

No predicted waveform is shown, if the predicted formula to be chosen does not

Measuring items do display in SVC, FVC, MVV, and MV can

[Print/CSV file] tab

<Print form selection> window

[Patient information/Prediction] tab

<Physician Table Setting> screen <Diagnostic Comments> screen

<Last test data display comparison> screen

The American Thoracic Society (ATS) recommends a daily calibration of any

Performing calibration once a day after the power is turned ON is recommended.

Flow zero adjustment

7) Be sure that OK signs are appeared both in Ex (Expiration) and In (Inspiration) at

Technically and physically, it is not necessary to perform calibration so

[New Patient] to clear the form

Free write-in Space

COPD symptoms entry Sensor # Selection

<COPD Symptoms entry> window

<Comment entry> window

Preparation for the measurement