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PC Spirometry PC Spirometry

Measurement and Analysis Program Measurement and Analysis Program


for Spirometry for Spirometry
*2.510368*

*2.510368*
Art. no.: 2.510368 Rev.: d

Art. no.: 2.510368 Rev.: d

User Guide User Guide


Sales and Service Information Sales and Service Information
The SCHILLER sales and service centre network is world-wide. For the address of your The SCHILLER sales and service centre network is world-wide. For the address of your
local distributor, contact your nearest SCHILLER subsidiary. In case of difficulty a local distributor, contact your nearest SCHILLER subsidiary. In case of difficulty a
complete list of all distributors and subsidiaries is provided on our internet site: complete list of all distributors and subsidiaries is provided on our internet site:

www.schiller.ch www.schiller.ch

Sales information can also be obtained from: Sales information can also be obtained from:
sales@schiller.ch sales@schiller.ch

Address Headquarters Address Headquarters


SCHILLER AG Tel: +41 (0) 41 766 42 42 SCHILLER AG Tel: +41 (0) 41 766 42 42
Altgasse 68 Fax: +41 (0) 41 761 08 80 Altgasse 68 Fax: +41 (0) 41 761 08 80
CH-6341 Baar, Switzerland E-Mail: sales@schiller.ch CH-6341 Baar, Switzerland E-Mail: sales@schiller.ch
Web: www.schiller.ch Web: www.schiller.ch

Article No: 2.510368 Rev.: d Article No: 2.510368 Rev.: d


Issue date: 15.12.05 Issue date: 15.12.05
PC Spirometry User Guide

1 Safety Notes .............................................. 7


1.1 Responsibility of the User .................................................. 7
1.2 Intended Use ........................................................................ 7
1.3 Organisational Measures ..................................................... 8
1.4 Terms of Warranty ................................................................ 8
1.5 Safety Symbols and Pictograms ......................................... 9
1.5.1 Used symbols in this document ......................................................... 9

2 Introduction ............................................ 10

3 Installation .............................................. 11
3.1 Requirements...................................................................... 11
3.2 Mechanical Installation ...................................................... 12
3.2.1 Splitter Cable.................................................................................... 12
3.2.2 USB Converter ................................................................................. 13
3.3 Software Installation .......................................................... 14
3.3.1 USB Driver Software (USB Converter Box only).............................. 14
3.3.2 SDS104 software ............................................................................. 14

4 Flow Sensors .......................................... 15


4.1 SP-250 Sensor .................................................................... 15
4.2 SP-260 Sensor .................................................................... 16
4.3 Sterilising ............................................................................ 17

5 Program Overview .................................. 18


5.1 Login .................................................................................... 18
5.2 The Patient Screen ............................................................. 19
5.2.1 Patient Screen Function Overview................................................... 20
5.3 Entering / Editing Patient and Recording Data ................ 22

6 Calibration ............................................... 24
6.1 Procedure............................................................................ 24
6.2 Calibration Information ...................................................... 25

7 Taking a Spiro Measurement ................ 26


7.1 Procedure............................................................................ 26
Art. no.: 2.510368 Rev.: d

7.2 Displaying the Results ....................................................... 27


7.2.1 Screen Information........................................................................... 27
7.3 Pulmonary Test Overview.................................................. 28
7.3.1 Forced Vital Capacity (FVC) ............................................................ 28
7.3.2 Slow Vital Capacity (SVC)................................................................ 28
7.3.3 Maximum Voluntary Ventilation (MVV) ............................................ 28
7.3.4 Post-Medication Tests...................................................................... 28
7.4 Viewing Stored Recordings ............................................... 29
7.4.1 Interpretation .................................................................................... 30
7.4.2 Quad Graphic................................................................................... 30
7.4.3 Result table ...................................................................................... 31
7.4.4 Trend................................................................................................ 31

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PC Spirometry

8 Spiro References ....................................32


8.1 Definition of Best ................................................................ 32
8.2 Predicted Values................................................................. 32
8.2.1 Ethnic Influences on Predicted Values ............................................ 33
8.3 Measured Values ................................................................ 34
8.4 Diagnosis............................................................................. 35
8.4.1 International ..................................................................................... 35
8.4.2 American.......................................................................................... 36
8.4.3 Air Obstruction Categories............................................................... 36
8.4.4 Chest Restriction Categories ........................................................... 37
8.4.5 Ratio of Post (Pre/Post) ................................................................... 37
8.5 Norm Values........................................................................ 38
8.5.1 Ethnic Influences on Norm Value..................................................... 38
8.5.2 Tobacco Influences on Norm Values ............................................... 38
8.5.3 International Norm Standards .......................................................... 39
8.5.4 Norm Values for the USA and Canada ............................................ 43

9 Program Settings ....................................48


9.1 Defining Users, Departments and Institutions................. 48
9.2 System Configuration ........................................................ 49
9.3 User Configuration ............................................................. 51
9.4 Printer Defaults ................................................................... 52
9.5 PDF Defaults ....................................................................... 53
9.6 Convert, Transfer and Export Settings............................. 53
9.7 Filter Settings...................................................................... 56
9.8 Directories ........................................................................... 56
9.9 Texts .................................................................................... 57
9.10 Options and Unit Software................................................. 58
9.11 Spiro Settings ..................................................................... 58

Art. no.: 2.510368 Rev.: d

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PC Spirometry User Guide

10 Other Program Functions ...................... 60


10.1 Deleting a Recording / Deleting a Patient ........................ 60
10.2 Assigning a Recording ...................................................... 60
10.3 Sending a Recording by e-mail ......................................... 60
10.4 Archiving ............................................................................. 61
10.4.1 Archive ............................................................................................. 61
10.4.2 Archive Maintenance........................................................................ 62
10.5 Importing a Recording ....................................................... 63
10.6 Restoring the Database ..................................................... 63
10.6.1 What to do if you cannot see imported files ..................................... 63
10.7 Exporting ............................................................................. 64
10.8 Sending Patient Data.......................................................... 65
10.9 Refreshing the Database ................................................... 66
10.10 Generating a PDF file ......................................................... 66
10.11 Adding a Program Icon ...................................................... 67
10.12 Audit Trail............................................................................ 68
10.12.1 Viewing the Audit Trail ..................................................................... 68
10.13 Technical Data .................................................................... 70

11 Index ........................................................ 71
Art. no.: 2.510368 Rev.: d

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Page 6
PC Spirometry

Art. no.: 2.510368 Rev.: d


Safety Notes 1
PC Spirometry User Guide Responsibility of the User 1.1

1 Safety Notes
1.1 Responsibility of the User
V This software must only be used by qualified doctors or trained medical person-
nel.
V The numerical and graphical results and any interpretation given must be exam-
ined with respect to the overall clinical condition of the patient and the general re-
corded data quality.
V Ensure that personnel have read and understood this user guide. In particular this
section “safety notes" must be read and understood.

1.2 Intended Use


V The Spirometry program is designed to carry out pulmonary function tests on
persons of all races and sex, from the age of 6 years. The objective of these tests
is to diagnose a lung disease and find the extent of the abnormality by following
a patient during the course of his/her disease to determine the efficiency of
treatment or the need for supplemental oxygen and mechanical ventilation. It is
also useful in determining if pre-operative patients can withstand any intended
surgery, to assess disability and to decide whether an individual can perform an
occupational task requiring a certain workload.
V Routine pulmonary function tests can be used to determine if a patient
complaining of dyspnea (shortness of breath) or fatigue has a lung disease and,
if so, whether it is an obstructive, restrictive, or vascular disease or a disease of
the control of ventilation.
V The Spirometry option can be used to measure Forced Vital Capacity (FVC),
Forced Expiratory Volume in one second (FEV1), FEV 1.0 / FVC, FEF 0.2-1.2, FEF 25-
75%, FEF 75-85% , PEF, FEF 25%, FEF 50%, FEF 75%, FIVC, FIV 1.0, FIV 1.0 / FIVC, PIF, FIF

50%, SVC, ERV, IRV, TV, MVV, MV, RR, TV, in patients 6 years of age or older.
Art. no.: 2.510368 Rev.: d

Page 7
1 Safety Notes
1.3 Organisational Measures PC Spirometry

1.3 Organisational Measures


V Before using the software, ensure that an introduction regarding the functions
and the safety precautions has been provided by a medical product representa-
tive.
V Keep this user guide in an accessible place for reference when required. Make
sure that they are always complete and legible.
V For correct predicted values and diagnosis, it is important that all patient data is
entered correctly. In particular gender, date of birth, ethnic, height and weight
must be entered.
V The unit must be calibrated at the beginning of every day, or after a significant
change in temperature.
V False measurements can result when the sensor is not held vertically - always
ensure that the sensor is held upright at all times.
V If using the SP-250 sensor - The disposable mouthpiece of the SP-250 spiro
sensor is designed for one-time use to eliminate the danger of cross contamina-
tion - do not use the mouthpiece for more than one patient. Do not attempt to
clean the mouthpiece.
V If using the SP-260 sensor - The mouthpiece of the SP-260 spiro sensor is
reusable. Thoroughly disinfect the mouthpiece assembly before using for
another patient. Replace the filter after every patient - do not use the filter for
more than one patient.

1.4 Terms of Warranty


The SCHILLER pc spirometry program disks and the spirometry flow sensor are
warranted against defects in material and manufacture for the duration of three
months (as from date of purchase). Excluded from this guarantee is damage caused
by an accident or as a result of improper handling. The warranty entitles free
replacement. Any liability for subsequent damage is excluded. The warranty is void if
unauthorized or unqualified persons attempt to make repairs.

There are no Express or implied warranties which extend beyond the warranties here-
inabove set forth. SCHILLER makes no warranty of merchantability or fitness for a
particular purpose with respect to the product or parts thereof.

Art. no.: 2.510368 Rev.: d

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Safety Notes 1
PC Spirometry User Guide Safety Symbols and Pictograms 1.5

1.5 Safety Symbols and Pictograms


1.5.1 Used symbols in this document
The safety level is classified according ANSI Z535.4. The following overview shows
the used safety symbols and pictograms used in this manual.

For a direct danger which could lead to severe personal injury or to death.

For a possibly dangerous situation, which could lead to heavy bodily injury or to death.

For a possibly dangerous situation which could lead to personal injury. This symbol is
also used to indicate possible damage to property.

For general safety notes as listed in this chapter.

Used for electrical dangers, warnings and other notes in regarding operation with elec-
tricity.

Note For possibly dangerous situations, which could lead to damages to property or
system failure. Important or helpful user information

Reference to other guidelines


Art. no.: 2.510368 Rev.: d

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2 Introduction
1.5 Safety Symbols and Pictograms PC Spirometry

2 Introduction
The spirometry option features four pulmonary function testing modes for the meas-
urement of inspiratory and expiratory values as follows:

• FVC Forced Vital Capacity


• SVC Slow Vital Capacity
• MV Expired or Minute Ventilation
• MVV Maximum Voluntary Ventilation
The monitor shows real time pulmonary test results and provides a clear and
comprehensive result analysis in a number of different formats.

Two flow sensors are available with the software as follows:

SP-250 This sensor has a disposable combined mouthpiece and filter assem-
bly designed for one-time use only and replaced as a complete assem-
bly.
SP-260 The mouthpiece of this sensor must be sterilised, and the filter replaced
after every patient.

The program includes the SDS104 data management function for the storage,
archiving and diagnosis of recordings. The program can also accept and send data
from a SCHILLER unit or a network or hospital data storage system. These functions
are detailed in system settings (see page 32).

Art. no.: 2.510368 Rev.: d

Page 10
Installation 3
PC Spirometry User Guide Requirements 3.1

3 Installation
3.1 Requirements
Read the SOFTWARE LICENSE AGREEMENT enclosed in the package. By
breaking the seal of the package you are agreeing to be bound by the terms of the
agreement. To install the SDS104 program you must have the following:

• Pentium processor PC compatible computer (>1GHz, >256MB RAM) with approx-


imately 1Gbyte or more of free disk space.
• Windows operating system ( Windows 2000 or XP).

The SCHILLER PC Spirometry comprises the following:

• The SDS-104 software (on SCHILLER CD).


• One of the following flow sensors:
– The SP-250 flow sensor with disposable, single patient mouthpiece or
– The SP-260 flow sensor with reusable mouthpiece but disposable, single pa-
tient filter.
• Because the flow sensors require more power than can be supplied from the stand-
ard RS connector on the computer, one of the following (flow sensor) converters
must also be used when connecting the flow sensor:
– Splitter cable assembly - for use when your computer has an RS-232 connector.
– USB / RS232 converter box and USB driver software (on SCHILLER CD) - for
use when your PC does not have an RS-232 connector (e.g. laptop), or when
you also have an AT-104 ECG unit and/or other external units.
Art. no.: 2.510368 Rev.: d

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3 Installation
3.2 Mechanical Installation PC Spirometry

3.2 Mechanical Installation


The PC pictures given here are for guidance only and may differ from the connector
location on your PC. If you are uncertain consult the handbook for your PC.

3.2.1 Splitter Cable


1. Remove the keyboard connector from the PC and plug the PS/2 connector of the
Splitter cable into the keyboard connector of the PC.
2. Plug the connector from the keyboard into the splitter cable connector.
3. Plug the double RS-232 connector into the RS-232 connector of the PC.
4. Plug the flow sensor into the double RS-232 connector on the splitter cable
assembly.

Plug the RS-232 Plug the RS-232


connector into COM 1 (or connector to the
COM 2 if COM 1 is flow sensor.
occupied) on the back of
the PC.
Plug the removed
Keyboard cable into
this connector.

Plug into the keyboard


connector (PS/2) of the
PC.

Keyboard
Connector

RS-232 connector
Art. no.: 2.510368 Rev.: d

(to Flow sensor)

To Keyboard

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Installation 3
PC Spirometry User Guide Mechanical Installation 3.2

3.2.2 USB Converter


• The USB driver software must be installed before connecting the USB converter
box. Do not install the driver software supplied with the packaging of the con-
verter box. Use the USB driver software supplied on the SCHILLER CD.

1. Connect the USB cable assembly between a free USB connector on the compu-
ter, and the USB converter box.
2. Connect the Flow sensor to the left hand connector on the USB converter box.
3. (If you have an AT-104 unit as well connect to the right hand connector.

USB Connector
(computer)

To flow sensor (port 4)


Art. no.: 2.510368 Rev.: d

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3 Installation
3.3 Software Installation PC Spirometry

3.3 Software Installation


3.3.1 USB Driver Software (USB Converter Box only)
Do not install the USB driver supplied with the converter box. Only install the
driver software supplied on the SCHILLER CD.

1. Go to the SDS104 (AT-104) folder and install the USB RS232 Converter software
- follow the instructions on the screen.
2. Reboot the PC.
3. After installation four new ports are defined in the device manager (Control
Panel>System>Hardware). Make a note of the COM port defined so that it can
be defined when the SDS104 software in installed.

3.3.2 SDS104 software


Go to the SDS104 (AT-104) folder and install the SDS104 software - follow the
instructions on the screen.

Notes:

« Check `PC-Spirometry with SP-250` box - if the spirometry program is to be


installed in conjunction with the AT-104 PC ECG unit, check the `ECG-
Acquisition with AT-104` as well. Full details are given in the AT-104 PC ECG
Handbook.
« Select Port - This refers to the RS-232 communication ports on the back of your
computer where the Spirometry sensor is connected. In most cases this can be
left at the default. In case of difficulty after installation the port can be checked
and/or changed in the program settings (see page 49).
« When the USB converter box (driver software) is installed more COM ports are
given. The COM port is found in system configuration (see above).
« The program is installed in the location specified. If you are updating an older
version the new program overwrites the older version automatically. Stored
recordings will not be lost and can be accessed with the new version.
« The sentinel driver option (install/ don’t install) is a driver software for the flow
Art. no.: 2.510368 Rev.: d

sensor. It must be installed when first installing the software. It is unnecessary to


reinstall the sentinel driver if already installed.
« The Advantage database is used by the program. If an advantage database is
already installed on your computer, select the version already installed. If an
advantage database is not installed, select the latest version given here.
« The program commences installation and creates a new folder on your hard disk
called SDS-104. A progress screen is displayed during installation.
« For best viewing the screen resolution should be set to 1024 x 768.

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Flow Sensors 4
PC Spirometry User Guide SP-250 Sensor 4.1

4 Flow Sensors
4.1 SP-250 Sensor
V The disposable mouthpiece is designed for one-time use to eliminate the danger
of cross contamination - do not use the mouthpiece for more than one patient.
Do not attempt to clean the mouthpiece.

1. Remove the disposable mouthpiece (if not already disposed) by gently but firmly
pulling it away from the handle.
2. Discard the complete mouthpiece.
3. Position a new disposable mouthpiece - align with guide slot in the sensor handle
and gently but firmly click it in position.

The disposable mouthpiece can only be positioned in one direction and no force is
necessary to insert it on the handle. Ensure that the orientation is correct by checking
the guide protrusion in the mouthpiece against the guide slot in the handle.
Art. no.: 2.510368 Rev.: d

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4 Flow Sensors
4.2 SP-260 Sensor PC Spirometry

4.2 SP-260 Sensor


V The filter is not reusable - replace the filter after every patient - never use the
filter for more than one patient.
V The mouthpiece is reusable - thoroughly disinfect the mouthpiece assembly
before using for another patient.

1. Remove mouthpiece by gently but firmly pulling it away from the handle

2. Unscrew the mouthpiece counter clockwise

3. Discard the filter. Thoroughly disinfect the two parts of the mouthpiece as-
sembly.

4. Position a new filter (Part No. 2.100123) in the threaded half of the mouthpiece
as shown, and screw the two halves of the mouthpiece together. Ensure the filter
is firmly held with no air gaps.

5. Insert the mouthpiece in the handle. The mouthpiece can only be inserted in one
Art. no.: 2.510368 Rev.: d

direction. A moulded lip in the mouthpiece prevents incorrect insertion.

6. The sensor is now ready for the next patient.

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Flow Sensors 4
PC Spirometry User Guide Sterilising 4.3

4.3 Sterilising
• The cable and handle of the flow sensors can be wiped with a damp cloth to clean.
• Standard hospital disinfectant can be used to sterilise the mouthpiece (SP260 sen-
sor). The following disinfectants have been tested and approved.

Disinfectant Maximum Immersion Concentration


Time
Sekusept Extra N 1 Hr. 2%
30 mins 3%
Sekusept Forte 1 Hr. 1.5%
Sekusept Plus 1 Hr. 1.5%
Sekusept Powder 1 Hr 2%
Sekudrill 15 min. 100%
Velicin forte 15 min. 25%
Aseptisol 15 min. 2.5%
30 min. 1.5%
1 Hr 1.0%
Gigasept 4 Hr 10%
Lysetol V 4 Hr 10%
Cidex 10 Hr 100%
Art. no.: 2.510368 Rev.: d

Page 17
5 Program Overview
5.1 Login PC Spirometry

5 Program Overview
5.1 Login
Click the desktop icon to open the program.

The Login screen is displayed:

For the first time only (or if ID or password has been forgotten), the following can be
typed to open the program:

User ID: default


Password: system

The user 'rights' given to the default user (when first logged on) are limited, and will
not allow editing, validation, or give access to system settings. This means that some
menu options and function icons may not be displayed or may be dimmed. If a menu
Art. no.: 2.510368 Rev.: d

item or function described in this user guide is not available, check the user rights.
These are defined in system settings Settings > Users, departments, Institutes
(see page 48).

Page 18
Program Overview 5
PC Spirometry User Guide The Patient Screen 5.2

5.2 The Patient Screen


The patient screen is the first screen displayed after logging in. In the patient screen
you can:

• Select data management functions.


• Enter the system settings and user setting screens.
• Make patient and recording selection.
• Edit patient data.
• Enter the search screen.
• View a recording.
• Send / export / receive recordings.
• Print a recording.

If any of the options detailed on the following pages are not available (icons not
shown, menu options greyed etc.), check the user rights (see page 48).
Art. no.: 2.510368 Rev.: d

Page 19
5 Program Overview
5.2 The Patient Screen PC Spirometry

5.2.1 Patient Screen Function Overview

7 8 9 10

1
2

3
4

(1) Program Menus - the menu options will change according to the screen dis-
played.
(2) Function icons.
(3) The data base icon updates the database. This can be used for example, if the
program is in a network and/or SEMACOMM is installed. When this icon is
clicked, the data base is updated and externally edited recordings, received
since the program was opened, are referenced.
– Full details of the SEMACOMM program are available for the service depart-
ment.
(4) List of all patients - highlight a patient to list all recordings for that patient.
– To list all patients by name, click on the column title - Name.
– To list all patients by ID, click on the column title - Patient ID.
Art. no.: 2.510368 Rev.: d

Right click functions in the patient column


When a patient is highlighted right clicking provides patient editing functions. These
functions are as follows:

New Patient
Edit Patient (see next page).
Delete Patient Deletes selected Patient - you are prompted to confirm. If the
patient has recordings you are prompted to delete the record-
ings first.

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Program Overview 5
PC Spirometry User Guide The Patient Screen 5.2

(5) All recordings of the highlighted patient. Highlight a recording and double click
to open the recording. A tick against a recording in the lettered columns indi-
cates the following:
Column Meaning
V Validated - Recording has been validated.
P Printed - Recording has been printed.
S Sent - Recording has been sent to external
device (not used in this version).
E Exported - Recording has been exported (or
transferred) to file server (when the program is
networked), or folder, drive etc.
A Archived - Recording has been stored on an
archiving medium CD, server, Tape, optical disk,
etc.).

Right click functions in the record column


When a recording is highlighted right clicking provides recording editing functions.
These functions are as follows:

Edit Recording The height, weight, BP, etc., can be changed for the recording.
Note that data applicable to the recording only can be changed.
This means that name, date of birth, etc., cannot be changed.
This is changed in the edit screen (see next page).
Assign Recording If the recording has accidentally been recording under the incor-
rect patient, the recording can be assigned to another patient
(see page 60).
Delete recording Deletes selected recording - you are prompted to confirm. Go
into the Patient menu to delete a patient.
(6) General and recording Information.
(7) A search can be initiated by patient identification number or by patient name. It
is possible to search for a patient either by name or by patient identification
(record number). To search for a patient:
– Click on the title bar of the list - `Name` or `Patient ID` (4).
– To search for a category of patients, for example all patients with ID beginning
with '2', or all patients with surname beginning with 'w', simply type '2' or 'w' in
the Patient ID and click the search icon. Enter as many characters as you wish
to identify the (group of) patient(s). All patients beginning with entered charac-
ter(s) are listed.
– To again display all patients, clear the box
(8) Edit predefined patient or define a new patient (see next page).
Art. no.: 2.510368 Rev.: d

(9) Export selected recording/send patient details (see page 53).


(10) Print icons to print the recording according to the default values or to select spe-
cific data for printing. The default print settings are defined in system settings
(see page 52).

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5 Program Overview
5.3 Entering / Editing Patient and Recording Data PC Spirometry

5.3 Entering / Editing Patient and Recording


Data
Recording specific data such as weight, height, blood pressure etc.) are changed for
a specific recording only. General patient data such as gender, data of birth etc., are
changed for all patient recordings.

Patient data
Enter the patient screen by highlighting the patient / recording in the patient and
clicking edit patient icon. Define a new patient with the New Patient icon. The following
is displayed:

Recording data (Patient)


Highlight the patient and the recording in the patient screen and click the edit patient
icon or Edit Recording in the patient menu. The following is displayed:

Art. no.: 2.510368 Rev.: d

• The edit patient screen can also be entered by ‘right clicking‘ on the patient in the
patient screen.
• The edit recording screen can also be entered by ‘right clicking‘ on the recording
in the patient screen by (see page 19).

Page 22
Program Overview 5
PC Spirometry User Guide Entering / Editing Patient and Recording Data 5.3

Pat ID The patient ID is an easily identifiable short form of identifying a patient - a maximum
of 20 characters can be entered.

The patient ID format can be user defined. For example BC-123-1122 (two letters
followed by three digits followed by four digits). This is defined in system settings (see
page 49).

Last Name Enter patients name (maximum 30 characters).

First Name Enter patients first name (maximum 15 characters).

Second last name Enter patients second name (maximum 30 characters).

Sex Enter the patient‘s gender - M or F.


1
Date of Birth Enter patient‘s date of birth dd-mm-yy.

For a quick and easy way of doing this click the icon to the right of the field to display
a calendar. The years and months are scrolled with the arrows (1).

Weight Enter patient‘s weight between 0.5 and 250kg (5 and 500 lbs).

Height Enter patient‘s height between 20 and 250cm (10 and 80 inches).

Ethnic The setting here can affect the predicted values. This is detailed in the reference
section (see page 32).

Note that the ethnic field is only displayed (in the patient data entry) when enabled in
system settings > Settings > System Configuration > tick the show ethnic box (see
page 49).

Pacemaker Not applicable for spirometry.

Insurance Select the patient’s insurance.

Insurance Type Select the insurance type.

To make an entry in the individual tables proceed as follows:

1. Click the ‘write‘ icon (2) in the edit screen.


2
Art. no.: 2.510368 Rev.: d

2. Select the type of table (3).

3. Click new (4) to enter the data.

3 4

Page 23
6 Calibration
6.1 Procedure PC Spirometry

6 Calibration
V The unit must be calibrated with the first pulmonary function test of the day and
after every significant temperature change.

6.1 Procedure
1. To calibrate the unit proceed as follows:
2. Press the Calibration icon from the spiro screen.

3. The calibration screen is displayed as shown.


4. Position a new mouthpiece in the sensor.
5. Connect the calibration pump to the mouthpiece. Ensure that there are no air
1 leaks.
6. Enter the ambient temperature (1)
2
7. Enter the reference volume of air (2) - depending on the size of the calibration
pump and times of pumping; e.g. a 2 litre pump pumped 3 times = 6 litres.
3 8. Click the start icon (3).

Make sure that the flow sensor is kept still during the pumping operation.

The message Make Measurement appears on the screen. Pump 3 to 6 litres of air
through the sensor

While pumping, the unit records the volume being pumped through the flow sensor
and indicates it on the display.

9. Press the Stop key when finished pumping.

Art. no.: 2.510368 Rev.: d

10. The message Calibration OK appears on the display

Page 24
Calibration 6
PC Spirometry User Guide Calibration Information 6.2

If the message Please change the sieve ! appears on the screen after a calibration,
it indicates that the difference between the measured volume and the entered vol-
ume is too great (>12%). Check the temperature setting, the syringe volume and the
entered syringe volume. If these are all correct change the mouthpiece (SP-250), or
filter (SP-260), and re-calibrate.

6.2 Calibration Information


Last Calibration Date of last calibration

BTPS Factor BTPS (=> Body Temperature, Ambient Pressure, Saturated with water vapour) val-
ue. This value compensates for the difference in inhaled and exhaled humidity. The
unit is set for measuring exhaled volume (100% humidity, Temp 36.8o), and so when
inhaled volume is measured this factor is applied. The software uses ambient tem-
perature to calculate the BTPS factor. This is sufficient for accurate FIVC calculation.
The formula used is as follows:

Pb - PH2O 273.15 + 37
BTPS =
Pb - 47 * 273.15 + Tu

Where: -273.15oC = 0o absolute ( 0o K)


Pb =716mmHg (at 500 metres above sea level)
PH2O = the vapour pressure of water (mmHg)
Tu = the ambient temperature in degrees centigrade

Calibration Factor Calculated value between measured and effective calibration air volume.

Temperature Ambient temperature in oC (or oF) dependent on device setting.

Measured Volume Air volume measured by the system from the calibration pump.

Reference Volume Entered air volume (volume of the calibration pump x number of pumps).
Art. no.: 2.510368 Rev.: d

Page 25
7 Taking a Spiro Measurement
7.1 Procedure PC Spirometry

7 Taking a Spiro
Measurement
V It is important that all patient data is entered correctly. In particular gender, date
of birth, ethnic (see page 33), height and weight must be entered for correct
predicted values and diagnosis.
– Note that the ethnic field is only displayed (in the patient data entry) when ena-
bled in system settings > Settings > System Configuration > tick the show eth-
nic box (see page 49).
V Calibrate the unit if carrying out the first test of the day, or after a significant
change in temperature.
V False measurements can result when the sensor is not held vertically - ensure
that the sensor is held upright at all times during tests.

7.1 Procedure
1. From the main screen press the spiro icon to enter the spirometry screens.
2. Edit patient data if required (see page 22).
– Note: If show smoking variables and Hedenstom / Solymar normal values
have been selected in the Spiro settings (see page 58), the smoke consumtion
entry screen is displayed.
3. Calibrate the unit (see previous page).
4. Select test - FVC, SVC, MVV or MV

Art. no.: 2.510368 Rev.: d

5. For all tests the procedure is the same:


6. Press the Start key.

Page 26
Taking a Spiro Measurement 7
PC Spirometry User Guide Displaying the Results 7.2

– The flow sensor must be held quite still and no air should be breathed into the
sensor for at least one second before and after the Start key is pressed.
– Patient blows into the mouthpiece.
– As soon as the patient starts to breathe into the mouthpiece, the unit begins to
record the expiratory flow. The corresponding curve is represented on the dis-
play. The break-off point for the expiration measurement is reached automati-
cally (or the Stop key is pressed).

7. On completion of the test press on the Stop key.


8. Repeat as many times as required.

We recommend that a minimum of three measurements be taken.

7.2 Displaying the Results


7.2.1 Screen Information
Once the stop key is pressed, the curve of the last test taken is shown on the centre
of the screen along with the measurement results which are displayed on the left of
the screen.

Following a series of patient measurements the best two results are stored along
with the last test made. That is, the two measurements with the highest FVC + FEV1
values will be saved and given as Meas 1 and Meas 2 along with the last measure-
ment taken (Meas 3). These three results can then be printed in graphical and tabu-
lar form.

When American/ITS standards are stipulated, the following message is given on the
printout if the deviation (as stipulated by the American Thoracic Society) between the
best and second best measurements is <200ml.

ATS criteria met

When the difference is greater than 200ml, the following message is given:

ATS criteria not met

The measurement table is displayed giving the three highest measured values from
all the tests taken, and the predicted values (calculated from the entered patient da-
ta).

The result displayed is in accordance with ATS recommendations. When subse-


Art. no.: 2.510368 Rev.: d

quent tests are made, the result with the highest value will always be saved and giv-
en in the measurement columns.

For definition of best (see page 29).

Details of interpretation and normal calculations are given later in this section.

Page 27
7 Taking a Spiro Measurement
7.3 Pulmonary Test Overview PC Spirometry

7.3 Pulmonary Test Overview


7.3.1 Forced Vital Capacity (FVC)
For this test the patient must exhale as quickly as possible from the time of starting
the test.

The FVC test employs the `Back extrapolation` method. If the extrapolated volume
is too large (>0.15 litres or 5% of FVC), then a warning appears on the display.

The patient must exhale as quickly as possible from the time of starting the test so
be sure that he/she understands what is required. If inspiratory measurements are
required, the exhalation can be immediately followed by a maximum inhalation. The
inspiration results will be given on the printout.

The coordinates represent the graph on which the curve will be drawn with the res-
piratory volume in litres being represented on the vertical axis and the time in sec-
onds on the horizontal axis.

The flow can be shown as a loop if desired (see above). Define loop in the Setup
menu (see page 59).

7.3.2 Slow Vital Capacity (SVC)


The patient should breathe normally 3 times and then inhale as much as possible to
maximum lung capacity, and then exhale as fully as possible. Make sure that the pa-
tient understands what is required.

7.3.3 Maximum Voluntary Ventilation (MVV)


The patient should breathe as deeply and as rapidly as possible over a period of 6
to 12 seconds.

SVC Graph V Care should be exercised when performing this test as there is a danger of hy-
perventilation. Ensure that the patient is sitting down.

7.3.4 Post-Medication Tests


To carry out post-medication tests for comparison,

• press the Post softkey Art. no.: 2.510368 Rev.: d

The post-medication tests are carried out in the same way as the premedication tests
(three measurements stored). The printout following post-medication tests will give
the curves of both pre and post-medication tests. The measurement results are
shown as the best results (pre/post), results as a percentage of those predicted,
(both pre and post) and the percentage change (i.e. difference) between pre and
post-medication results. The diagnosis resulting from the premedication test is also
given on this printout if set.

If a patient has spiro recording(s), and the spiro screen is entered, you are prompted
if the recording is to be a pre or post recording.

Page 28
Taking a Spiro Measurement 7
PC Spirometry User Guide Viewing Stored Recordings 7.4

7.4 Viewing Stored Recordings


Spiro recordings are indicated in the patient recording list by the lung symbol.
1 2 3 4 5 6

7 8 9

(1) Patient Data


(2) Click on the FVC, SVC, MVV and MV icons to display spiro graphs. Note that if
no measurements have been taken in a category, the icon is dimmed and can-
not be selected.
(3) Graph Scale, click to a scale of 3 litres, 6 litres or 12 litres
(4) Display graph as:
– Flow = f(vol) - that is flow (Litres/second) against volume (litres)
– Vol. =f(t) - volume (litres) against time (seconds)
(5) Display first, second, third or all measurements
Art. no.: 2.510368 Rev.: d

(6) Legend of selected waveforms


(7) Display Pre, Post or all (Report) graphs
(8) Interpretation
(9) Table of measurements

Page 29
7 Taking a Spiro Measurement
7.4 Viewing Stored Recordings PC Spirometry

7.4.1 Interpretation

1 2

The list of statements to the right (2), is only displayed after the acronyms icon has
been clicked (1).

The interpretation can be manually entered via the keyboard. Additionally standard
interpretation statements and acronyms can be selected for inclusion in the
interpretation statement. To display the standard statement click on the `acronyms`
icon at the bottom of the screen. A list of all statements are displayed. Click on a
statement to enter the interpretation statement.

To save an interpretation statement after editing click on the `Save` icon. When you
click on the `Close` icon before saving you are asked if you wish to save the changes
or not.

Click on yes to exit and save the currently displayed interpretation statement, or no to
exit this screen without saving the changes.

7.4.2 Quad Graphic

Art. no.: 2.510368 Rev.: d

This screen can be superimposed on the main screen at any time.

The standard quad interpretation graph is shown.

Page 30
Taking a Spiro Measurement 7
PC Spirometry User Guide Viewing Stored Recordings 7.4

7.4.3 Result table

This screen can be superimposed on the main screen at any time and gives the
measurements for all pre and post tests in tabular form. When three measurements
are taken the percentage difference is between the best and the worst.

The measurements highlighted in yellow are the best pre and post results for the test.

The final column gives the percentage change between the pre and post
measurements.

Click `OK` to remove the measurements screen and any changes in the first column.
Click `Cancel` to remove the screen without saving any changes made.

7.4.4 Trend
Art. no.: 2.510368 Rev.: d

When the patient has two or more spiro recordings taken at different times, the trend
can be displayed.

The trend screen gives the measurements of up to 10 selected categories of test in


graphical format. The tests for display are selected to the right of the screen by
checking the box. The trend graph can be displayed either as a bar graph or as a line
graph and either the pre measurements or the post measurements can be displayed.
The dates of the recordings are displayed on the graph and on the tabs at the bottom
of the screen.

Page 31
8 Spiro References
8.1 Definition of Best PC Spirometry

8 Spiro References
8.1 Definition of Best
In accordance with the American Thoracic Society (ATS) Spirometry Standard
(March 1987), the best measurement is defined as the highest value from the calcu-
lation:

Best = FVC + FEV1

The Spirometry Program takes the best value from a test according to the above
equation and defines this as Meas. 1. When ' Best' is selected (see page 58) this def-
inition is also used with the exception of FVC and FEV1 which takes the highest ab-
solute value from the three measurements, (Meas 1, Meas 2 or Meas 3).

8.2 Predicted Values


The predicted values (%) given on the printout may differ slightly from the values that
would be obtained if manually calculated. The reason is that the measured and pre-
dicted values on the printout are rounded to two decimal places, the processor how-
ever, uses the actual values - measured to three decimal places - to calculate the %
of predicted value. This can account for a possible variation. Where a difference ex-
ists, the values given on the printout are always the more accurate.

The norm values are defined in unit setup (Menu > Setup > Spiro Settings (see
page 59). The predicted values are modified by the ethnic origin (defined under `eth-
nic` in the patient data entry) as follows.

Art. no.: 2.510368 Rev.: d

Page 32
Spiro References 8
PC Spirometry User Guide Predicted Values 8.2

8.2.1 Ethnic Influences on Predicted Values


Note that the ethnic field is only displayed (in the patient data entry) when enabled in
system settings > Settings > System Configuration > tick the show ethnic box (see
page 49).
According to the setting of the patient`s ethnic origin, the predicted values will differ.
The differences are (according to Intermountain Thoracic Society (ITS) recommen-
dations) as follows:

Setting Predicted Value


Caucasian / White « values are calculated according to the given
formulas (= 100%)
Black « 85% of the given formulae
Oriental « 85% of the given formulae
Hispanic « values are calculated according to the given
formulas (= 100%)
Asian « 85% of the given formulae

The 85% ethnic compensation is calculated only when the following norm values are
selected:

• Composite
• Knudson
• Crapo
• Morris
• Polgar
• ECCS / Quanjer
The complete diagnostic criteria and reference data is given later in this book (see
page 60).
Art. no.: 2.510368 Rev.: d

Page 33
8 Spiro References
8.3 Measured Values PC Spirometry

8.3 Measured Values


Parameter Unit Explanation
FVC [l] Forced (expiratory) Vital Capacity. Volume achieved by the quickest
possible exhalation after a maximal inhalation.
FEV0.5, FEV1, FEV3 [l] Forced Expiratory Volume. Lung volume in litres, measured after
0.5, 1, or 3 seconds forced expiration.
FEV0.5 / FVC [%] Forced expiratory air volume measured in the first half second as a
percentage of forced vital capacity.
FEV1 / FVC [%] Forced expiratory air volume measured in the first second as a per-
centage of forced vital capacity.
FEV3 / FVC [%] Forced expiratory air volume measured in the first three seconds as a
percentage of forced vital capacity.
FEF [l/s] Forced Expiratory Flow. Flow in terms of differing lung volumes
measured in litres per second.
FEF25-75% [l/s] Flow speed of the expired air at 25 to 75% of the forced vital capacity
(FVC).
FEF75-85% [l/s] Flow speed of the expired air at 75 to 85% of the forced vital capacity
(FVC).
FEF0.2-1.2 [l/s] Averaged flow between 0.2 and 1.2 litres of the forced vital capacity
(FVC)
PEF [l/s] Peak Expiratory Flow.
MEF75% [l/s] Flow speed of the expired air at 25% of the forced vital capacity (FVC).
MEF50% [l/s] Flow speed of the expired air at 50% of the forced vital capacity (FVC).
MEF25% [l/s] Flow speed of the expired air at 75% of the forced vital capacity (FVC).
MEF75% = FEF25%
MEF50% = FEF50%
MEF25% = FEF75%
ERV [l] Expiratory Reserve Volume. Possible further expiration starting from
the normal expiration level.
IRV [l] Inspiratory Reserve Volume. Possible further inspiration starting
from the normal inspiration level.
TV [l] Tidal Volume. Expiration and inspiration volumes during normal res-
piration.
SVC [l] Slow Vital Capacity. Lung volume measured from a complete expira-
tion following a deep inspiration.
MV [l/min] Expired or Minute Ventilation. Volume of expired air in litres per
minute measured over a minimum of one minute.
MVV [l/min] Maximum Voluntary Ventilation. Maximum volume of air which can
be moved on expiration while breathing as deeply and as rapidly as
possible.
Art. no.: 2.510368 Rev.: d

RR [l/min] Respiration Rate. Number of breaths per minute.


FIVC [l] Forced Inspiratory Vital Capacity. Inspiration volume achieved be-
tween a maximal expiration and a maximal inspiration.
FIV 1 [l] Forced inspiratory air volume in litres measured in the first second.
FIV 1 / FIVC [%] Forced inspiratory air volume measured in the first second as a per-
centage of forced inspiratory vital capacity.
FIV1 / FVC [%] Forced inspiratory air volume measured in the first second as a per-
centage of forced expiratory vital capacity.
PIF [l/s] Peak Inspiratory Flow. Maximum inspiratory flow speed in litres / sec-
ond.
FIF50% (=MIF50%) [l/s] Flow speed by 50% of the forced inspiratory vital capacity.

Page 34
Spiro References 8
PC Spirometry User Guide Diagnosis 8.4

8.4 Diagnosis
8.4.1 International
The diagnostic interpretation is dependent upon country. The following diagnosis cri-
teria are applicable when the spiro standard (see page 58) is set to International.

Diagnostic norms are predicted using the VC value (if taken). If VC values are not
recorded, FVC is used. That is:

• %VC = 100 * VC/VC predicted (when VC measurement taken),


otherwise
• 100 * FVC/FVC predicted

• FEV% = 100 * FEV1/VC (when VC measurement taken),


otherwise
• 100 * FEV1/FVC

Possible respiratory problems are diagnosed on evaluation of the following factors:

Diagnosis %FVC (%SVC) FEV1%


Normal Condition 80% >70%
Restrictive <80% -
Obstructive - <70%
Combined <80% <70%

The measurement FEV1/FVC or FEV1/VC is adapted on the screen and on the print-
out .

The diagnostic settings are selected in spirometry settings (see previous page).
Art. no.: 2.510368 Rev.: d

Page 35
8 Spiro References
8.4 Diagnosis PC Spirometry

8.4.2 American
For the USA and Canada, diagnosis of possible respiratory problems is based on the
ITS interpretation standard which uses the LLN (Lower Limits of Normal) calcula-
tions. These calculations apply to patients between the ages of 5 and 85. The LLN
FEV1% value is calculated as shown on the following pages.

Diagnosis of possible respiratory problems is based on the ITS interpretation stand-


ard. These calculations apply to patients between the ages of 5 and 85.

The following diagnosis criteria are applicable when the spiro standard (see page 58)
is set to American.

8.4.3 Air Obstruction Categories


Predicted Value Minus Measured Value (%)
Category Women Men
FEV1/FVC FEV3/FVC FEV1/FVC FEV3/FVC
Normal (<1 C.I.) <9.1 and.. <5.4 <8.3 and .. <4.6
Airway Obstruction Suggested <9.1 and .. <5.4 <8.3 and .. <4.6
Mild (>1 to 2 C.I.) 9.1 to .. 18 18.3 to .. 16.5
Moderate (>2 to 4 C.I.) 18.2 to .. 36.3 16.6 to .. 33.1
Severe (>4 C.I.) >36.4 >33.2

• If FEV 0.5/FEV 1 < 0.60, then state:


Upper airway obstruction suggested

• If SVC/FVC> 1.10 or FIVC/FVC > 1.10,then state:


Air trapping may be present

• If obstruction and expiration time < 5 sec, then state:


Airway Obstruction may be underestimated

• If FEV0.5/FVC < 0.56 sec, then state:


Poor initial effort suggested

Art. no.: 2.510368 Rev.: d

Page 36
Spiro References 8
PC Spirometry User Guide Diagnosis 8.4

8.4.4 Chest Restriction Categories


Predicted VC Minus Measured VC (Litres)
Category Women Men
Normal (<1 C.I.) <0.68 <1.12
Mild Restriction (>1 to 1.75 C.I.) 0.68 to 1.18 1.12 to 1.95
Moderate Restriction (>1.75 to 2.5 C.I.) 0.68 to 1.18 1.12 to 1.95
Severe Restriction (>2.5 C.I.) >1.7 >2.80

• If FVC > SVC, then SVC = FVC


• If FIVC > SVC, then SVC = FIVC

8.4.5 Ratio of Post (Pre/Post)


or
FEV 0.5 Post/ Pre (1) or
Category FVC Post / Pre
or FEF25-75%Post/Pre (2)
FEV 1.0 Post/Pre
Markedly Improved >1.25 >1.25 >2
Improved 1.15 to 1.24 1.12 to 1.24 1.45 to 1.99
Not clearly Improved 1.05 to 1.14 1.05 to 1.11 1.10 to 1.44
Not Improved <1.05 <1.05 <1.10

1)
If expiratory time post/pre is > 1.10, then FVC is not used because increased
FVC may be due to the increased expiratory time, and not increased flow.
2) If expiratory time post/pre is < 0.90 and the FVC post/pre is not between 0.96
and 1.04, then the FEF25-75% is not used because reduced expiratory time
and reduced FVC can increase the FEF25-75% without change in the flow it-
self.
Art. no.: 2.510368 Rev.: d

Page 37
8 Spiro References
8.5 Norm Values PC Spirometry

8.5 Norm Values


The norm values used for the calculation of predicted values are dependent upon the
country.

• For Great Britain, Italy, Spain and Switzerland, the ECCS and Quanjer standards
are used.
• For Sweden, the Swedish (Berglund) and Quanjer standards are used.
• In Finland the Finnish and Quanjer standards are used.
• In Austria the Austrian standards are used.
• In India the Indian norm values are used.
• In America and Canada the norm values that are used are Knudson, Knudson76,
Crapo, Morris, Composite and Polgar. The American norm values are extended
with values taken from the ITS (Intermountain Thoracic Society) recommenda-
tions.
The factors used in the evaluation for diagnosis and the specific norm values are in-
cluded in the software and are described on the following pages.

Due to great differences in the size of the lungs of children, there are no standard
values for children under 6 years of age

8.5.1 Ethnic Influences on Norm Value


The ethnic influence on predicted values and norm values are given in predicted
values (see page 33).

8.5.2 Tobacco Influences on Norm Values


Tobacco influence on predicted values and norm values are only calculated when
Hedenstom / Solymar Standard is selected (see page 42 and see page 58).

Art. no.: 2.510368 Rev.: d

Page 38
Spiro References 8
PC Spirometry User Guide Norm Values 8.5

8.5.3 International Norm Standards


ECCS
The safety standards of the European Coal and Steel Community Standards (ECCS)
are valid for adults of at least 25 years of age. Patients between the ages of 18 and
25 are calculated on the basis of a 25 year old. The calculation equations are as fol-
lows:

Male Female
SVC 6.103 x H - 0.028 x A - 4.654 4.664 x H - 0.024 x A - 3.284
FVC 5.757 x H - 0.026 x A - 4.345 4.426 x H - 0.026 x A - 2.887
FEV1 4.301 x H - 0.029 x A - 2.492 3.953 x H - 0.025 x A - 2.604
FEV1/SVC -0.179 x A + 87.21 -0.192 x A + 89.10
MEF 1.944 x H - 0.043 x A + 2.699 1.252 x H -0.034 x A + 2.924
PEF 6.146 x H - 0.043 x A + 0.154 5.50 x H -0.030 x A - 1.106
MEF75 5.459 x H - 0.029 x A - 0.470 3.218 x H -0.025 x A + 1.596
MEF50 3.794 x H - 0.031 x A - 0.352 2.450 x H -0.025 x A + 1.156
MEF25 2.605 x H - 0.026 x A - 1.336 1.050 x H -0.025 x A + 1.107

H = Height in meters A = Age in years

Quanjer and Tammeling


The Quanjer and Tammeling comparison is valid for children between the ages of 6
and 17 as follows:

Boys Girls
SVC = FVC 1.00 x H 2.7 0.95 x H2.7
FEV1 0.84 x H2.7 0.81 x H2.7
FEV1/SVC 0.84 0.84
MEF = PEF 8.2 x H -6.8 6.6 x H -5.3
MEF50 5.6 x H -4.4 4.6 x H -3.3

H = Height in metres
Art. no.: 2.510368 Rev.: d

Page 39
8 Spiro References
8.5 Norm Values PC Spirometry

Austrian Standard
Boys 5 - 17.99 years (1.09 - 1.96m) Males 18 - 91years (1.44 - 2.00m)
In(FVC) = -1.142 + 1.259H + 0.004070A √W FVC = - 11.606 + 8.172H - 0.0339A x 1.2869In (A)

In(FEV1) = -1.178 + 1.221H + 0.003841A √W FEV1 = -8.125 + 6.212H - 0.0300A x H + 0.9770In (A)
In(PEF) = -0.214 + 0.921H + 0.0467A + 0.0020W √PEF = 1.798 + 2.311In (H) + 0.0159A - 0.000248A 2
In (PEF75) = -0.077 + 0.770H + 0.0373A + 0.0025W √PEF75 = 1.581 + 1.854In (H) + 0.0213A - 0.000283A 2
In(PEF50) = -0.322 + 0.843H + 0.0300A + 0.0035W √PEF50 = 1.490 + 1.290In (H) + 0.0125A - 0.000218A 2
In(PEF25) = -1.576 + 1.166H + 0.0219A + 0.0021W √PEF25 = 1.314 + 0.898In(H) - 0.0083A - 0.000026A 2
FEV1 %CVF = 101.99 - 1.191H 2 - 3.962In (A) FEV1 % FVC = 101.99 - 1.191H 2 - 3.962In (A)

Girls 5 - 15.99 years (1.10 - 1.82m) Females 16 - 91 years (1.40 - 1.90m)


In(FVC) = -3.842 + 4.1632 √H + 0.1341√A - 1.614Fi FVC = -10.815 + 6.640H - 0.0408A x H + 1.7293In (A)

In(FEV1) = -3.877 + 3.9809 √H + 0.1485√A - 1.322Fi FVC1 = -6.995 + 5.174H - 0.0314A x H + 1.0251In (A)
In(PEF) = 0.411 + 1.793In(H) + 0.4251In(A) - 0.910Fi √PEF = 1.832 + 1.838In (H) + 0.0078A - 0.0001722 A 2
In(MEF75) = 0.455 + 1.616In(H) + 0.3738In(A) - 0.861Fi √PEF75 = 1.779 + 1.421In (H) + 0.0096A - 0.000179A 2
In(MEF50) = 0.256 + 1.643In(H) + 0.3481In(A) - 1.089Fi √PEF50 = 1.561 + 1.177In (H) + 0.0045A - 0.000140A 2
In(MEF25) = -0.772 + 2.002In(H) + 0.3063In(A) - 0.409Fi √PEF25 = 1.372 + 0.938In(H) - 0.0152A - 0.000036A 2
FEV1 % FVC = 92.33 FEV1 % FVC = 118.993 - 3.0320H 2 - 6.9053In (A)

H = Height in metres A = Age in years


W = Weight in Kg Fi = Body fat index = H/ 3 W

Swedish Standard (Berglund)


The Swedish (Berglund) standard is valid for adults between the ages of 18 and 75
years as follows:

Male Female
FEV% 91.79 - (0.373 x A) 92.11 - (0.261 x A)
SVC 1.09 [ (4.81 x H) - (0.020 x A) - 2.81] 1.09 [ (4.04 x H) - (0.022 x A) - 2.35]
FEV 1.09 [ (3.44 x H) - (0.033 x A) -1.00] 1.09 [ (2.67 x H) - (0.027 x A) - 0.54]

H = Height in metres A = Age in years

Art. no.: 2.510368 Rev.: d

Page 40
Spiro References 8
PC Spirometry User Guide Norm Values 8.5

Finnish Standard
The Finnish standard is valid for adults from the age of 18 years as follows:

Male Female
SVC exp [(-0.00833 x A) + (0.6309 x log A) + exp [(-0.01016 x A) + (0.6995 x log A) +
(-1.4750 / H) + 0.9047] (-1.4518 / H) + 0.7763]
FEV1 exp [(-0.00587 x A) + (0.2756 x log A) + exp [(-0.00920 x A) + (0.4772 x log A) +
(-1.1655 / H) + 1.0980] (-1.3284 / H) + 0.9296]
FVC exp [(-0.00827 x A) + (0.5860 x log A) + exp [(-0.00982 x A) + (0.6358 x log A) +
(-1.4468 / H) + 0.9461] (-1.4137 / H) + 0.8320]
MEF 50 exp [(0.00041 x A) + (-0.30870 x log A) + exp [(0.00741 x A) + (-0.34710 x log A) +
(-0.0148 / H) + 1.34150] (-0.8581 / H) + 0.9336
MEF 25 exp [(0.00771 x A) + (-0.28190 x log A) + exp [(0.01548 x A) + (-0.34310 x log A) +
(-0.0252 / H) + 1.05970] (-0.8498 / H) + 0.7966]
FEV1 / FVC exp [(0.00240 x A) + (-0.3104 x log A) + exp [(0.00062 x A) + (-0.1586 x log A) +
(0.2813 / H) + 2.1519] (0.0853 / H) + 2.0975]
PEF exp [(-0.00211 x A) + (0.1049 x log A) + exp [(-0.00677 x A) + (0.4017 x log A) +
(-0.6774 / H) + 1.3255] (-0.7422 / H) + 0.9661]

H = Height in metres A = Age in years


log = Logarithm to base 10

Indian Standard
The Indian equations are valid for patients from the age of 7 years as follows:

Males Females
<30 years old:
FVC 0.055 x H + 0.019 x A -6.058 0.030 x H + 0.006 x A - 2.284
FEV1 0.039 x H - 0.010 x A -3.266 0.025 x H - 0.011 x A - 1.424
>=30 years old:
FVC 0.054 x H - 0.018 x A -4.832 0.043 x H - 0.010 x A - 3.755
FEV1 0.037 x H - 0.022 x A -2.650 0.032 x H - 0.012 x A - 2.580
>30 years old:
FEV1/FVC -0.1756 x H - 0.2457 x A -119.346 -0.0334 x H - 0.2146 x A - 94.8867
SVC 0.0522 x H - 0.0114 x A -4.859 0.0587 x H - 0.0296 x A - 5.927
FEV3 0.0485 x H - 0.0183 x A -4.138 0.0533 x H - 0.0105 x A - 5.660
FEF25-75% 0.0173 x H - 0.0407 x A -1.6108 0.0245 x H - 0.0336 x A - 0.1399
PEF 0.0850 x H - 0.0187 x A -6.2083 0.0497 x H - 0.0018 x A - 2.7154
FEF50 0.0195 x H - 0.0365 x A -1.7383 0.0272 x H - 0.0279 x A - 0.2704
FEF75 0.0088 x H - 0.0301 x A -1.0402 0.0113 x H - 0.0288 x A - 0.5012
Art. no.: 2.510368 Rev.: d

MVV 1.3052 x H - 0.5228 x A -93.2102 0.7149 x H - 0.3624 x A - 25.0208

H = Height in metres A = Age in years

Page 41
8 Spiro References
8.5 Norm Values PC Spirometry

Hedenstrom Standard
The Hedenstrom normals are valid for patients over 18 years as follows:

Males Females
VC -0.000686 x Age + 0.0471 x Age + 0.0752 x Height -0.000145 x Age2 + 0.0119 x Age + 0.0552 x Height
2

- 0.0069 x SmokeYears - 8.56 - 4.329


FVC -0.000705 x Age2 + 0.0467 x Age + 0.0744 x Height -0.000118 x Age2 + 0.0143 x Age + 0.0545 x Height
- 0.0065 x SmokeYears - 8.44 - 4.205
FEV1 -0.000406 x Age + 0.0145 x Age + 0.0509 x Height -0.0281 x Age + 0.0258 - 0.0052 x SmokeYears +
2

- 0.0081 x SmokeYears - 4.67 0.130


FEV1/FVC -0.2251 x Age - 0.1286 x Height - 0.0568 x Smoke- -0.2371 x Age - 0.2809 x Height - 0.1694 x Pack-
Years + 109.4 Years + 136.4
PEF -0.000342 x Age2 + 0.0169 x Age + 0.0885 x Height -0.001206 x Age2 + 0.0647 x Age + 0.0195 x Weight
- 0.0139 x SmokeYears - 5.8 - 0.0140 x SmokeYears + 6.554
MEF75 -0.000508 x Age2 + 0.0193 x Age + 0.0678 x Height --0.001302 x Age2 + 0.0736 x Age + 0.0339 x Weight
- 0.0173 x SmokeYears - 3.73 - 0.0121 x SmokeYears + 4.088
MEF50 -0.000639 x Age2 + 0.0245 x Age + 0.0375 x Height -0.000132 x Age2 + 0.0509 x Age + 0.0337 x Weight
- 0.0167 x SmokeYears - 1.71 - 0.0219 x SmokeYears + 4.073
MEF25 -0.000216 x Age2 + 0.0513 x Age + 0.0193 x Height -0.000768 x Age2 + 0.1013 x Age + 0.0054 x Weight
- 0.0076 x SmokeYears - 0.19 - 0.0086 x SmokeYears + 3.970
MVV -0.7629 x Age + 1.5524 x Height - 0.3045 x Smoke- 0.7806 x Age + 0.8124 x Height - 0.1368 x Smoke-
Years - 102.5 Years + 2.550

Height = Height in metres


Age = Age in years
Weight = Weight in Kg
SmokeYears = Number of years smoked
Tobacco = Tobacco consumption in grammes per day
PackYears = A calculated value of SmokeYears x Tobacco

Solymar Standard
The Solymar normals are valid for patients 18 years and under as follows:
Boys Girls
log(FVC) 0.008 + 2.695 x log(height) -0.052 + 2.857 x log(height)
log(FEV1) -0.053 + 2.710 x log(height) -0.114 + 2.942 x log(height)
log(PEF) 0.236 + 2.592 x log(height) 0.225 + 2.671 x log(height)
log(MEF75) 0.613 + 2.792 x log(height) 0.173 + 2.790 x log(height)
log(MEF50) 0.089 + 2.482 x log(height) 0.055 + 2.815 x log(height)
log(MEF25) -0.251 + 2.762 x log(height) -0.260 + 3.066 x log(height)
Art. no.: 2.510368 Rev.: d

log(FIV1) -0.032 + 2.754 x log(height) -0.101 + 2.977 x log(height)


log(PIF) 0.210 + 2.525 x log(height) 0.189 + 2.669 x log(height)
log(MIF50) 0.162 + 2.696 x log(height) 0.196 + 2.469 x log(height)

Page 42
Spiro References 8
PC Spirometry User Guide Norm Values 8.5

8.5.4 Norm Values for the USA and Canada


Morris
The Morris equations are valid for women between 56 and 72 inches tall and within
the age range 20 to 90 years, and for men between 58 and 80 inches tall and within
the age range 20 to 90 years.

Male Female
FVC 0.1480 x H - 0.0250 x A - 4.241 0.1150 x H - 0.0240 x A - 2.852
FEV1 0.0920 x H - 0.0320 x A - 1.260 0.0890 x H - 0.0250 x A - 1.932
FEV1/FVC -0.3118 x H - 0.2422 x A + 107.120 -0.0679 x H - 0.1815 x A + 88.700
FEF.2 - 1.2 0.1090 x H - 0.0470 x A + 2.010 0.1450 x H - 0.0360 x A - 2.532
FEF25 - 75 0.0470 x H - 0.0450 x A + 2.513 0.0600 x H - 0.0300 x A + 0.551
FEF75 - 85 0.0130 x H - 0.0230 x A + 1.210 0.0250 x H - 0.0210 x A + 0.321

The Morris normals are extended with the following: ITS equations

Male Female
FEV0.5 0.0831 x H - 0.0152 x A -1.914 0.0605 x H - 0.0185 x A - 0.809
FEV3 -0.1359 x H - 0.0271 x A -3.512 -0.1123 x H - 0.0257 x A - 2.745
FEV3/FVC -0.1593 x H - 0.1450 x A +112.090 -0.2380 x H - 0.1630 x A + 118.160
MVV 3.4040 x H - 1.2600 x A -21.400 2.0500 x H - 0.5700 x A - 5.500

H = Height in inches A = Age in years

Crapo
The Crapo equations are valid for men between 61 and 77 inches tall and within the
age range 18 to 89 years, and for women between 57 and 71 inches tall and within
the age range 18 to 89 years:

Male Female
FVC 0.1524 x H - 0.0214 x A -4.650 0.1247 x H - 0.0216 x A - 3.590
FEV1 0.1052 x H - 0.0244 x A -2.190 0.0869 x H - 0.0255 x A -1.578
FEV3 0.1359 x H - 0.0271 x A -3.512 0.1123 x H - 0.0257 x A - 2.745
FEV1/FVC -0.3302 x H - 0.1520 x A +110.490 -0.5131 x H - 0.2520 x A + 126.580
FEF25 - 75 0.0518 x H - 0.0380 x A +2.133 0.0391 x H - 0.0460 x A + 2.683
MVV Vol. 3.4040 x H -1.2600 x A -21.400 2.0500 x H - 0.5700 x A - 5.500

The Crapo normals are extended with the following ITS equations:

Male Female
Art. no.: 2.510368 Rev.: d

FEV0.5 0.0831 x H -0.0152 x A - 1.914 0.0605 x H - 0.0185 x A - 0.809


FEV3.0/FVC -0.1593 x H -0.1450 x A + 112.090 -0.2380 x H - 0.1630 x A + 118.160

H = Height in inches A = Age in years

Page 43
8 Spiro References
8.5 Norm Values PC Spirometry

Morris and Crapo Norm Values for Children


The following equations are valid for children within the age range 7 to 17.99 years:

Boys 7 - 17.99 years (1.09 - 1.96m) Girls 7 - 17.99 years (1.09 - 1.96m)
White / Caucasian / Hispanic White / Caucasian / Hispanic
FVC(ml) = 3.58 x 10-4 x H3.18 FVC(ml) = 2.57 x 10-3 x H2.78
SD = 13% SD = 14%
FVC1(ml) = 7.74 x 10-4 x H3.0 FVC1(ml) = 3.79 x 10-3 x H2.68
SD = 13% SD = 14%
PEF(l/min) = 3.35 x 10-4 x H2.79 PEF(l/min) = 2.58 x 10-3 x H2.37
SD = 13% SD = 18%
FEF25-75% (l/min) = 7.98 x 10-4 x H2.46 FEF25-75% (l/min) = 3.79 x 10-3 x H2.16
SD = 13% SD = 28%

Boys 7 - 17.99 years (1.09 - 1.96m) Girls 7 - 17.99 years (1.09 - 1.96m)
Black / Asian Black / Asian
FVC(ml) = 1.07 x 10-3 x H2.93 FVC(ml) = 8.34 x 10-4 x H2.98
SD = 17% SD = 15%
FVC1(ml) = 1.03 x 10-3 x H2.92 FVC1(ml) = 1.14 x 10-3 x H2.89
SD = 17% SD = 15%
PEF(l/min) = 1.74 x 10-4 x H2.92 PEF(l/min) = 5.51 x 10-4 x H2.68
SD = 22% SD = 20%
FEF25-75% (l/min) = 3.61 x 10-4 x H2.60 FEF25-75% (l/min) = 1.45 x 10-3 x H2.34
SD = 36% SD = 30%

H = Height in inches A = Age in years

Art. no.: 2.510368 Rev.: d

Page 44
Spiro References 8
PC Spirometry User Guide Norm Values 8.5

Knudson
The Knudson equations are valid for both children and adults in specific groups ac-
cording to age and height as shown following:

Male Female
H = 44 to 61 inches, A = 6 to 11 years H = 42 to 58 inches, A = 6 to 10 years
FVC 0.1039 x H + 0.0 x A -3.376 0.1092 x H + 0.0 x A -3.749
FVC0.5 0.0760 x H + 0.0430 x A -3.050 0.0480 x H + 0.0610 x A -1.740
FEV1 0.0884 x H + 0.0 x A - 2.814 0.0853 x H + 0.0 x A - 2.758
FEV1/FVC -0.2065 x H + 0.0 x A + 100.439 -0.4849 x H + 0.6655 x A + 109.974
FEF25 - 75 0.0859 x H + 0.0 x A - 2.320 0.0559 x H + 0.0 x A - 0.812
PEF 0.1980 x H + 0.1660 x A - 8.061 0.1240 x H + 0.1570 x A - 3.920
FEF50 0.0960 x H + 0.0 x A - 2.545 0.0 x H + 0.1846 x A + 0.736
FEF75 0.0434 x H + 0.0 x A - 1.015 0.0277 x H + 0.0 x A - 0.166
MVV 4.6800 x H - 1.8 x A - 192.32 2.7600 x H + 3.4000 x A - 108.120
H = 55 to 76 inches, A = 12 to 25 years H = 52 to 72 inches, A = 11 to 20 years
FVC 0.1499 x H + 0.0739 x A - 6.887 0.1057 x H + 0.0699 x A - 4.447
FVC0.5 0.0760 x H + 0.0430 x A - 3.050 0.0480 x H + 0.0610 x A - 1.740
FEV1 0.1318 x H + 0.0636 x A - 6.118 0.0892 x H + 0.0694 x A - 3.762
FEV1/FVC -0.2065 x H + 0.0 x A + 100.439 -0.4849 x H + 0.6655 x A + 109.974
FEF25 - 75 0.1369 x H + 0.0749 x A - 6.199 0.0709 x H + 0.1275 x A - 2.801
PEF 0.1980 x H + 0.1660 x A - 8.061 0.1240 x H + 0.1570 x A - 3.920
FEF50 0.1379 x H + 0.1150 x A - 6.385 0.0732 x H + 0.1111 x A - 2.304
FEF75 0.1008 x H - 0.0057 x A - 4.242
MVV 4.6800 x H + 1.8000 x A - 192.320 2.7600 x H + 3.4000 x A - 108.12

For patients over 18 years the following equations apply:

Male Female
FEV3 0.1359 x H - 0.0271 x A - 3.512 0.1123 x H - 0.0257 x A - 2.745
FEV3/FVC -0.1593 x H - 0.1450 x A + 112.090 -0.2380 x H - 0.1630 x A + 118.160
H = 62 to 77 inches, A = 26 to 91years H = 58 to 71 inches, A = 21 to 91years
FVC 0.1524 x H - 0.0214 x A - 4.650 0.1247 x H - 0.0216 x A - 3.590
FVC0.5 0.0831 x H - 0.0152 x A - 1.914 0.0605 x H - 0.0185 x A - 0.809
FEV1 0.1052 x H - 0.0244 x A - 2.190 0.0869 x H - 0.0255 x A - 1.578
FEV3 0.1359 x H - 0.0271 x A - 3.512 0.1067 x H - 0.0257 x A - 2.745
FEV1/FVC 0.0 x H - 0.1050 x A + 86.686 -0.4704 x H - 0.1896 x A + 121.678
FEF.2 - 1.2 0.1090 x H - 0.0470 x A + 2.010 0.1450 x H - 0.0360 x A - 2.532
FEF25 - 75 0.1471 x H - 0.0363 x A - 4.518 0.0531 x H - 0.0344 x A + 1.128
Art. no.: 2.510368 Rev.: d

FEF75 - 85 0.0130 x H - 0.0230 x A + 1.210 0.0250 x H - 0.0210 x A + 0.321


PEF 0.2390 x H - 0.0350 x A - 5.990 0.1240 x H - 0.0250 x A - 0.740
FEF25 0.0900 x H - 0.0200 x A + 2.726 0.0690 x H - 0.0190 x A + 2.147
FEF50 0.1737 x H - 0.0366 x A - 5.409 0.0681 x H - 0.0289 x A + 0.609
FEF75 0.0787 x H - 0.0230 x A - 2.483 0.0244 x H - 0.0259 x A + 1.118
MVV 3.0300 x H - 0.8160 x A - 37.900 2.1400 x H - 0.6850 x A - 4.870

In addition there are the following ITS equations:

Male Female
FEV3/FVC -0.1593 x H - 0.1450 x A + 112.090 -0.2380 x H - 0.1630 x A + 118.160

Page 45
8 Spiro References
8.5 Norm Values PC Spirometry

Knudson 76
The Knudson 76 equations are valid for both males and females in specific age
groups as follows:

Male Female
Age <25 years Age <20 years
FVC 0.1270 x H + 0.078 x A -5.508 0.0838 x H + 0.092 x A -3.469
FVC0.5 0.0762 x H +0.043 x A -3.054 0.0483 x H + 0.061 x A -1.738
FEV1 0.1168 x H + 0.045 x A - 4.808 0.0686 x H + 0.085 x A - 2.703
FEV3 0.1321 x H + 0.066 x A - 5.531 0.0838 x H + 0.086 x A - 3.417
FEV1/FVC -0.2210 x H - 0.140 x A + 103.64 -0.2819 x H - 0.109 x A + 107.38
FEF25 - 75 0.1499 x H + 0.0 x A - 5.334 0.0635 x H + 0.121 x A - 1.893
PEF 0.1981 x H + 0.166 x A - 8.060 0.1245 x H + 0.157 x A - 3.916
FEF25 0.1778 x H + 0.147 x A - 7.054 0.1118 x H + 0.144 x A + 3.365
FEF50 0.1295 x H + 0.081 x A - 4.975 0.0864 x H + 0.120 x A + 2.531
FEF75 0.0813 x H + 0.0 x A - 2.455 0.0 x H + 0.139 x A - 0.692

Age >25 years Age >20 years


FVC 0.1651 x H - 0.029 x A - 5.459 0.0940 x H - 0.022 x A - 1.774
FVC0.5 0.0940 x H - 0.017 x A - 2.746 0.0483 x H - 0.014 x A - 0.406
FEV1 0.1321 x H - 0.027 x A - 4.203 0.0686 x H - 0.021 x A - 0.794
FEV3 0.1600 x H - 0.031 x A - 5.245 0.0889 x H - 0.023 x A - 1.633
FEV1/FVC -0.2210 x H - 0.140 x A + 103.64 -0.2819 x H - 0.109 x A + 107.38
FEF25 - 75 0.1143 x H - 0.031 x A - 1.864 0.0533 x H - 0.024 x A - 1.171
PEF 0.2388 x H - 0.035 x A - 5.993 0.1245 x H - 0.025 x A - 0.735
FEF25 0.2235 x H - 0.035 x A - 5.618 0.1092 x H - 0.025 x A + 0.132
FEF50 0.1753 x H - 0.015 x A - 5.400 0.0889 x H - 0.013 x A - 0.444
FEF75 0.1118 x H - 0.012 x A - 4.143 0.0 x H - 0.014 x A - 3.042

H = Height in inches A = Age in years

Composite Norm Values


Selection of the Composite normals provides selected equations taken from other ta-
bles as follows:

Value Equation Reference


FVC Knudson
FEV1 Knudson
FEV3 Crapo
Art. no.: 2.510368 Rev.: d

FEF25 - 75 Knudson
FEF75 - 85 Morris
FEF.2 - 1.2 Morris
MVV Crapo
SVC Knudson (same as FVC)

Page 46
Spiro References 8
PC Spirometry User Guide Norm Values 8.5

Polgar Norm Values


The Polgar equations are valid for both children and adults in specific groups accord-
ing to age as follows:

Male Female
Age under 18 years Age under 18 years
FVC 3 2
H * 0.0000071 + H * 0.00057 - H * 0.0123 + 0.14 H3 * 0.0000076 + H2 * 0.00048 + H * 0.0112 + 0.13
FVC0.5 H * 0.076 + A * 0.043 -3.05 -
FEV1.0 H3 * 0.00000087 + H * 0.00035 - H * 0.0086 + 0.1 H3 * 0.0000086 + H2 * 0.00035 - H * 0.0086 + 0.1
FEF25 - 75% H * 0.1109 - 3.46 H * 0.1109 - 3.46
PEF H * 0.2219 - 7.09 H * 0.2219 - 7.09
MVV H * 4.68 - A * 1.8 - 192.32 H * 2.76 - A * 3.4 - 108.12

Age 18 to 25 years Age 18 to 20 years


FVC H * 0.1499 + A * 0.0739 - 6.887 H * 0.1057 + A * 0.0699 - 4.447
FVC0.5 H * 0.0760 + A * 0.0430 - 3.050 H * 0.0480 + A * 0.00610 - 1.740
FEV1.0 H * 0.1318 + A * 0.0636 - 6.118 H * 0.0892 + A * 0.0694 - 3.762
FEF25 - 75 H * 0.1369 + A * 0.0749 - 6.199 H * 0.0709 + A * 0.1275 - 2.801
PEF H * 0.1980 + A * 0.1660 - 8.061 H * 0.1240 + A * 0.1570 - 3.920
FEF50 H * 0.1379 + A * 0.1150 - 6.385 H * 0.0732 + A * 0.1111 - 2.304
FEF75 H * 0.1008 - A * 0.0057 - 4.242 H * 0.0617 + A * 0.2923 - 4.401
MVV H * 4.68 + A * 1.8 - 192.32 H * 2.76 + A * 3.4 -108.12

Age over 25 years Age over 20 years


FEF3.0 - H * 0.1067 - A * 0.0257 - 2.745
FEF0.2-1.2 H * 0.1090 - A * 0.0470 + 2.010 H * 0.1450 - A * 0.0360 - 2.532
FEF25 - 75% H * 0.1471 - A * 0.0363 - 4.518 H * 0.0531 - A * 0.0344 + 1.128
FEF75 - 85% H * 0.0130 - A * 0.0230 + 1.210 H * 0.0250 - A * 0.0210 + 0.321
PEF H * 0.2390 - A * 0.0350 - 5.990 H * 0.1240 - A * 0.0250 - 0.740
FEF25 H * 0.0900 - A * 0.0220 + 2.726 H * 0.0690 - A * 0.0190 + 2.147
FEF50 H * 0.1737 - A * 0.0366 - 5.409 H * 0.0681 - A * 0.0289 + 0.609
FEF75 H * 0.0787 - A * 0.0230 - 2.483 H * 0.0244 - A * 0.0259 + 1.118
MVV H * 3.03 - A * 0.816 -3 7.9 H * 2.14 - A * 0.685 - 4.87

H = Height in inches A = Age in years


The remaining values are taken from the ITS equations.
Art. no.: 2.510368 Rev.: d

Page 47
9 Program Settings
9.1 Defining Users, Departments and Institutions PC Spirometry

9 Program Settings
This section details the various general and miscellaneous functions and settings
available to the user in the settings menu.

9.1 Defining Users, Departments and


Institutions
Settings The three tabs at the top of the screen allow the modification, deletion and new entry
Users, Departments, Institutes. of Institutions, Departments and Users. These are used in various locations and can
System Configuration
User Configuration
be given on the printout of a recording.
Printout
PDF settings
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print

Art. no.: 2.510368 Rev.: d

Enter the relevant data and tick the required boxes.

Assign rights to individual users as required. The User ID and the password defined
for a user must be remembered. These are required when first opening the program
and when a 'new login' is requested.

The maximum number of characters that can be entered in the ID field of all sections
is 8. The maximum number of characters that can be entered in the address fields is
40.

Page 48
Program Settings 9
PC Spirometry User Guide System Configuration 9.2

9.2 System Configuration


Settings made in the System configuration are universal and apply to all users.

Settings Formats
Users, Departments, Institutes.
System Configuration
User Configuration
Printout
PDF settings
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print

Lead Order Select Standard or Cabrera - not applicable to spirometry.

Units This defines the units that will be used for entering patient data and on the printout.
Select between Metric (kg/cm) and US (lbs / ins).

Patient ID Format The format of the patient identification is defined here. A number of format options
exist to fit into your system. The number of characters, the case (upper/lower), the
type of character (letters only, numbers only) along with other attributes can all be
defined. The patient ID is defined in this field by a series of characters. The maximum
number of characters is 20. Characters that can be used are as follows:

• ‘X` (upper case X) - any character


• `x` (lower case x) - any character - initial letter upper case
• `!`(exclamation mark) - any character upper case
• `L` (upper case L) - any character lower case
• `a` (lower case a) - alpha characters only
• `A`( upper case A) - alpha characters only upper case
• `1 ` ( number 1) - alpha characters only lower case
Art. no.: 2.510368 Rev.: d

• `9` (number 9) - number or space


• `i`( lower case i) - number or space or ‘-‘ (dash or minus)
• `#‘(hash) - number or space or ‘.‘(period)

Date Format Select dd.mm.yyyy or mm/dd/yyyy

Time Format Select hh.mm.ss or hh.mm

Limit Number of Full disclosures - not applicable to spirometry

Show ethnic Check this box to show race in the patient data field.

Edit patient before Check this box to display the patient data field for editing purposes before a recording
is made.

Page 49
9 Program Settings
9.2 System Configuration PC Spirometry

Show Checklist after Check this box to display the data tables checklist (users, institutions etc.) when the
unit is switched on or a new login.

Device name This is for use only when your computer is connected to a GDT system. Enter your
device (computer) identification. Up to 8 characters can be entered. Note that the
GDT system requires that the first four characters must be unique.

Program Directories
Not applicable for spirometry.

Other System
In the `Other System` page the RS-232 ports on the PC can be defined. The ports are
defined for connection of the following:

• The AT-104 unit (defined on installation of the SDS104 software but can be
changed here if required).
• An RS-232 controlled ergometer for exercise testing.
• A blood pressure unit.
• Spiro sensor (SP250).

If any of these units are not used, a port must not be specified and ‘--‘ (double dash)
must be placed in the field.

The tabs Ergo Device, Holter Settings, BR-102 plus setting tabs are not applicable for
spirometry.

Electronic Audit Trail


To enable an audit trail an Advantage data base must be installed either locally of in
a server. Settings can only be defined while the ADS is running. When in a network,
the settings defined for the audit trail apply to all SEMA programs connected to the
same Advantage database.

Define here all the data categories that are recorded in the database. Recovering and
Art. no.: 2.510368 Rev.: d

viewing the audit trail is described in Miscellaneous Program functions (see page 68).

Page 50
Program Settings 9
PC Spirometry User Guide User Configuration 9.3

9.3 User Configuration


• The settings made in this screen apply to the individual user and are automatically
set when the user logs in.
• The Start Forms tab is not applicable for spirometry.

Settings Colours
Users, Departments, Institutes.
System Configuration
User Configuration
Printout
PDF settings
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print

In this screen colour preferences can be defined for grid (background and
foreground), leads, and lead designation text. To set a colour:

1. Click on the relevant box on the left of the display. The colour palette is displayed.
2. Select the desired colour and click OK. The grid on the display changes to the
selected colour.

View Spirometry
Art. no.: 2.510368 Rev.: d

Main Form (Reference) When this box is checked reference marks will appear on the loop graph of the spiro
recording detailing:

• horizontal line giving the predicted PEF value


• the measured values of MEF25, MEF50 and MEF75
• the predicted value of FVC

FVC Curve Check to view the FVC value as flow against time or flow against volume.

Line Thickness and Colour Choose colour and thickness of both pre and post measurements. As the settings are
defined the sample graph (right) shows the colour and line thickness.

Trend In this section select the default measurements and graph settings that are used when
the trend view is requested (Trend icon clicked in the view screen).

Page 51
9 Program Settings
9.4 Printer Defaults PC Spirometry

9.4 Printer Defaults


Settings made here are universal and apply to all users.

Defaults are defined for Spirometry and other recording categories not applicable to
Settings spirometry.
Users, Departments, Institutes.
System Configuration
User Configuration
Printout
1
PDF settings
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print

Various print options are available but the following is always given:

• Patient Data (short version)


• Date and Time of Recording
• Measurements
• Interpretation Statement (if selected)
• Software version
• User name
Display the print options for each type of recording by selecting and clicking with the
mouse on the required page (tab) at the top of the screen (1). Interpretation, grid
background, reference beat, average format and other dedicated options etc. can be
defined individually for each record type.

Print Image Alignment (2) If you wish to change the position of the image on the printout, this can be achieved
by changing the x and y alignment setting (2). The printout image can be shifted left/
right and up/down.

Printer Setup (3) If problems are experienced in printing e.g. no printout obtained, no readable data
Art. no.: 2.510368 Rev.: d

given or the wrong printer is defined the printer settings must be checked or changed,
click on the `Setup` icon (3). The screen displayed will vary according to the printer
connected to your system. Ensure that the correct printer is specified and that the
correct settings are detailed.

Any changes made in printer setup apply until the unit is switched off. Enter
Windows® control panel (printer and faxes) to made changes that are remembered.

Page 52
Program Settings 9
PC Spirometry User Guide PDF Defaults 9.5

9.5 PDF Defaults


Settings made here are universal and apply to all users.

Settings Defaults are defined for the printing of spirometry recordings and other recordings not
Users, Departments, Institutes. applicable to spirometry.
System Configuration
User Configuration
Printout
PDF settings
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print

Various print options are available and are broadly the same as the print options
detailed previously.

9.6 Convert, Transfer and Export Settings


Settings Conversion
Users, Departments, Institutes.
System Configuration
User Configuration
Printout
PDF settings
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print
Art. no.: 2.510368 Rev.: d

This refers to the format of imported recordings (on for example floppy disk, CD
ROM), which have been recorded on a SCHILLER machine where the date format
and other settings may vary. This may be for example, because the recording has
been made on an older unit.

When the old date format is entered it is automatically converted to the current data
format specified on the previous page. Similarly the data entered on the imported
record under medication, Remarks, User ID and MTA can be automatically
reassigned to the headings specified here.

Page 53
9 Program Settings
9.6 Convert, Transfer and Export Settings PC Spirometry

Address Book
In this menu option RS232, network and other transmission options can be defined.

To enter a new destination click on the New icon. The entries are as follows:

Conn Name and Full Name Under 'Conn Name' enter the designation of the communication channel to which the
modem or line is connected (it must be the same designation defined for 'port name'
in the SEMACOMM program.

Details of the SemaComm program, installation and settings are provided in the
SemaComm installation Guide available from the SCHILLER service department.
• The ConnName is specific to the device and COM port and must be in the follow-
ing format:
• xxxxxx-y (maximum 8 characters) where xxx is the location ID of the device and
Y is the COM port starting with 0, (i.e. ‘0‘ = COM 1, ‘1‘ = COM 2 etc.).
• Between xxxx and y there must be a hyphen ‘-‘.

Type Select between modem, line, export or file.

• Modem is for transmitting over a modem to a remote computer/ unit.


• Line is for direct connection to a local PC or other device.
• Export is to transfer a recording to another system e.g. a hospital record system
HL7 or GDT.
• File is to transfer a recording to a backup medium e.g. floppy disk.

Phone number This is only applicable when Modem is selected above. If it is necessary to enter a
pause in the dialling sequence enter a comma (,) in the number. The comma gives a
one second pause. If a longer pause is required, two or more commas can be entered.
This may be required for example, if you have to wait for an outside line.
Art. no.: 2.510368 Rev.: d

Protocol The options given here depend directly on the `Type` selected above.

• Line - for direct export over an RS232 port.


• Modem - for export over a serial modem.
• Export - for export to a third party management system (SEMA1, SEMA2, ADTS
or GDT). Details of these settings can be obtained from your SCHILLER distribut-
er.

Device The options given here are only applicable when Line or Modem is selected in `Type`
above. The device options available are as follows:

• SCP (Standard Communication Protocol)


• ASCII (default)
• IBMPC - use this setting for transmitting to a PC.

Page 54
Program Settings 9
PC Spirometry User Guide Convert, Transfer and Export Settings 9.6

Transfer

Validation Export (1) Tick Data Export Enabled box to automatically export a file (recording) after it has
been validated. When this is ticked the file can be exported as an RST-file (SDS104/
SEMA format) or PDF file. When validation export is specified the Export address
must be defined

Reception Export (2) Tick Data Export Enabled box to automatically export a file (recording) after it has
been recorded or imported. When this is ticked the file can be exported as an RST-
file (SDS format) or PDF file. When validation export is specified the Export address
must be defined.

• The options given in `Export Address` are specified in Address Book (previous
item). Addresses only appear when at least one `Export' address has been en-
tered.
• The transfer / export procedure is detailed earlier in this book (see page 64).

The Call Export DLL (3), is a specialised application and is used for research
purposes. This setting can be left unticked. Similarly, the TCP setting (4) is a
customised settings used for dedicated networks. This should also be left unchecked.

SEMA 2 and GDT settings

2
Art. no.: 2.510368 Rev.: d

SEMA 2 Settings In the SEMA2 Settings (1), select use import file name as export file name to use
the same file name (and format for name, date, ID format) when again exporting
patient data that has been imported. For example imported patient data may have the
file name XYZ.imp. If the file is again exported, for example after validation, the export
file name will be XYZ.exp.

GDT Settings If transferring to a GDT system tick the measurement in GDT (2) box. If you wish to
have a user defined file extension tick the Use static file extension for exported
GDT files and define the extension. If this function is not selection the extension will
could up for each recording. This must be set according to the system used.

Page 55
9 Program Settings
9.7 Filter Settings PC Spirometry

9.7 Filter Settings


Not applicable for spirometry.

9.8 Directories
Settings Two Directories are defined. The Normal defines the directories during normal
Users, Departments, Institutes. working and the Emergency defines the directories that are used when the normal
System Configuration
User Configuration
locations are not available for any reason, e.g. the network is down, etc. For this
Printout reason the Emergency locations are usually set to a local drive. Select Directories
PDF settings from the System menu. The following is displayed:
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print

Recordings This defines the default location (folder) where recordings (data files) are stored.

Full Disclosure Files Not applicable for spirometry.

Database This defines the location of the SDS104 database. This is where the program is stored
including the index for all ancillary information (patient data, drugs tables, institution/
department/ user data, etc.) and reference to the directory (volume and disk etc.)
where patient data files are stored. Note that this is not where the data files are stored.

Archive This defines the default location that will be used when archiving recordings for long
term storage or for backup. For example you may wish to store on a server, optical
disk or tape streamer. A sub-directory can also be specified.

Import This is the default directory used by the program when importing patient data - not
ECG data files themselves), from another system (GDT, SEMA etc.). To enter the
imported patient data on the SDS104 system the import option on the system menu
must be selected and the `Patient data from interfaces` option clicked. Specify the
Art. no.: 2.510368 Rev.: d

location (directory) that is the default when importing recordings.

Export Specify the default location (directory) that can be selected when sending recordings.

Texts This is the location of the program text file used by the program. This is mainly used
in larger network installations where text can be edited in one location (server) and
then the same text used by all PCs on the network.

Log This is the location of the program file used by the program to log all transactions.

Page 56
Program Settings 9
PC Spirometry User Guide Texts 9.9

Search Drives This defines the drives, and the order of drives that are accessed when making a
recording search. All the drives that contain data are to be defined here. When the
SDS104 program is asked to display a specific file the data location (including drive)
is stored in the data base - but not the data file. The program searches all drives
specified here in the order given. It is important therefore, that all drives where data
files are stored are specified and that the most commonly used drive(s) is (are) named
first otherwise speed may suffer. If the program is asked to view a recording the
location of which is not specified here an error message appears

9.9 Texts
Settings Select Texts from the System menu and the following texts can be edited
Users, Departments, Institutes.
System Configuration
User Configuration Editing a text field
Printout
PDF settings 1. Position the cursor where you wish to edit/insert text.
Convert, Transfer, Export.
Filters. 2. Enter the desired text.
Directories 3. Save the edited text by either:
Texts
Drug Classes and Drugs
AT-104
Individual Tables
– pressing function key F2 or
Resting ECG
System Text – enter the file menu at the top of the screen and select save.
Exercise ECG
Acronyms
Rhythm ECG
Break Reasons
exit by clicking on the cross in the top right of the screen.
Direct Print
Events

Drug Classes and Drugs The drugs entered in the drug table are available for entry against patient data for a
recording.

Individual Tables In these tables the information that can be entered in for example the patient data and
analysis tables, can be defined. To enter any data proceed as follows:

1. Select the table category - these include insurance type, cost type and indication
(diagnosis summation) - select and click with the mouse.
2. Click on the `New Type` icon on the bottom of the display - the top section of the
screen is highlighted.
3. Enter text and ID as prompted.
4. Click OK to confirm the entry.
Statements entered in the ' individual table' are available, for example, in the patient
screen. By clicking the arrow (to the right of the data entry field), statements are
displayed and can be selected to accompany a stored recording. In this way typical
individual commonly used statements can be entered against a patient recording.

System Text The program text is provided for reference only. In this screen it is possible to edit the
text that appears in the program. It is recommended that no modifications are made
Art. no.: 2.510368 Rev.: d

to this entry field. If modifications are made and you wish to revert to the default the
program must be reinstalled. If this is necessary, no recordings will be lost.

Interpretation Acronyms Acronym tables are provided for spiro recordings and other recordings. In these
tables all the standard interpretation statements are listed. These can be inserted in
the interpretation screen. Any statements can be edited or new statements added.

Note: Acronyms are limited to 255 characters. If more than 255 characters are
entered, an access violation is registered.

Page 57
9 Program Settings
9.10 Options and Unit Software PC Spirometry

9.10 Options and Unit Software


Settings Select AT-104 from the System menu. A tick indicates that the parameter is installed.
Users, Departments, Institutes.
System Configuration
User Configuration
Printout
PDF settings
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print

9.11 Spiro Settings


Settings Select Direct Print from the System menu. The following is displayed:
Users, Departments, Institutes.
System Configuration
User Configuration
Printout
PDF settings
Convert, Transfer, Export.
Filters.
Directories
Texts
AT-104
Resting ECG
Exercise ECG
Spirometry
Rhythm ECG
Direct Print

Report Type This defines the measurement on which the interpretation is to be based. When
Meas. 1 is set, the interpretation is based on the measured values when FVC + FEV1
is the maximum value. When Best is selected, the values are again defined from the
FVC + FEV1 formula above with the exception that when the FVC or FEV1 value is
higher in either Meas 2 or Meas 3, the highest FVC or FEV1 value taken from Meas
2 or Meas 3. (see previous page).

Sensor Select the sensor type used for measurement. The type is written on the sensor.
Select between:

• SP-20
• SP-250
Art. no.: 2.510368 Rev.: d

Normals Select between:

• Knudson 76/ ITS


• Crapo / ITS
• Morris / ITS
• Polgar/ ITS
• Composite / ITS
• ECCS / Quanjer
• Austria
• Berlund / Quanjer
• Finnish / Quanjer
• India

Page 58
Program Settings 9
PC Spirometry User Guide Spiro Settings 9.11

Spiro Standard This defines the standard and terms used by the interpretation in assessing the
diagnosis. Set to International for all countries outside the USA or to American for
the USA and Canada (see page 32).

FVC View Select between flow against time or volume against time.

Loop Check this box to display the graph in loop form.

FVC Volume = V(t) FVC Flow = f(V) FVC Flow = Loop

Auto Interpretation Check this box to give an interpretation of the results automatically.

Show Smoking Variables Dialogue Tick this option to display the following smoking input dialogue when the lung function
test is started.

Note that the Show Smoking Variables dialogue is only available when Hedenstom /
Solymar Normal standard is set. When any other normal standard it defined, the
Show Smoking Variables dialogue option is disabled.
Art. no.: 2.510368 Rev.: d

Page 59
10 Other Program Functions
10.1 Deleting a Recording / Deleting a Patient PC Spirometry

10 Other Program Functions


10.1 Deleting a Recording / Deleting a Patient
To delete a recording:

1. In the main patient screen, highlight the specific recording with the mouse.
2. Select the ‘Delete Recording’ option in the patient menu.
A confirmation message is displayed. You must confirm that you wish to delete.

To delete a patient:

Before a patient entry can be deleted, all recordings associated with that patient must
have been deleted. If delete is selected and the patient has recordings, a message is
displayed that the recording(s) must be deleted first.

1. Highlight the specific patient with the mouse as previously described.


2. Select the ‘Delete Patient’ option in the patient menu.

10.2 Assigning a Recording


A recording assigned to the incorrect patient can be reassigned. All recordings must
be assigned individually - it is not possible to assign a group of recordings. To assign
a recording, proceed as follows:

1. In the Patient screen highlight the recording that is to be reassigned.


2. Select 'assign record' from the patient menu.
3. Enter the new patient ID number and click the find icon.
4. When the number is found click the 'OK' icon to reassign the selected recording
to the new patient.
If the number cannot be found the 'OK' icon remains dimmed and a message is
displayed indicating this. Check the number entered and click find again.

Patient and Recording editing and defining a new patient is detailed earlier in this
book (see page 22).

10.3 Sending a Recording by e-mail


Art. no.: 2.510368 Rev.: d

To send a recording by e-mail proceed as follows:

1. In the patient screen, highlight the recording that you wish to send.
2. In the patient menu select `send mail`.
3. Your default browser opens with the selected recording already as an
attachment. Define the recipient and message, and send in the usual way.

Recordings sent by E-mail are not indicated by an `S` (sent) in the recordings section
of the patient screen.

Page 60
Other Program Functions 10
PC Spirometry User Guide Archiving 10.4

10.4 Archiving
Archiving is not to be confused with backup, which we strongly recommend is carried
out on a daily basis.
Archiving is carried out when a recording is no longer required for active access.
Archiving is normally carried as a batch process i.e. a number of recordings are
archived together. Dependent on your system methodology we recommend that you
archive on regular basis (monthly, 6-monthly, yearly etc.). When the archive function
is selected data files are moved or copied to an archive directory. This can be to
another hard disk, to another directory on the same hard disk, or an archive medium,
optical disk, CD ROM, zip drive, etc.

When a recording is archived the reference to the patient and the recording remains
in the database and it is displayed in the patient screen. The recording can still be
opened in the normal way. If an attempt is made to open an inaccessible recording
(stored for example, on an optical disk, server etc.), a message is displayed to mount
the archived disk.

Although archived recordings continue to be displayed in the patient screen, it is not


possible to:

• edit an archived recording


• export an archived recording
• validate an archived recording
• carry out an advanced search

10.4.1 Archive
In the patient data screen, select the 'Archive' option from the function menu:

At the top of the archive menu screen, 2 pages can be selected indicated by tabs;
these are Archive and Settings. A second menu item 'archive maintenance' gives
further setting which are described later. The current page is highlighted bold.

Archive Directory
Specify the drive and directory on which you wish to archive. The default storage
medium (drive) can be preprogrammed in the submenu DIRECTORIES (archive) of
the system menu (see later). It is recommended that no more than approximately
1000 recordings are stored in a sub- directory. When more than this number is stored
access speed can suffer.
Art. no.: 2.510368 Rev.: d

Click on the Start icon to archive the defined recordings (see following for defining
recording type).

The following fields are displayed after archiving.

Err The number of recordings that could not be archived.


Totals This box is a counter indicating the total number of re-
cordings being archived.
in Dir This box indicates the total number of recordings in the
archive directory.

Page 61
10 Other Program Functions
10.4 Archiving PC Spirometry

Archive Settings
Archive Conditions Tick the boxes of all classifications of recordings that you
wish to archive.
incl. full disclosure files Check the full disclosure box to archive the saved full
disclosure recordings. Note that a full disclosure file may
be very large. Ensure that you have enough disk space
when selecting this option.
Delete Files Automatic If you wish to automatically delete the original recordings
after archiving, check the automatic deletion box.
Note:If this box is not checked the data file remains in the
original file location. This means that the same recording
can appear twice in the patient screen. The archived ver-
sion is indicated by the archived flag in the patient
screen.
Recordings can also be deleted manually - see 'special
tasks' on the next page.
Log Check this box to keep a log of all archived records and/
or errors. The directory where the log file will be gener-
ated is specified in the Directories (logs) submenu of
the system menu (see page 56).

10.4.2 Archive Maintenance

Rebuild Archive
Read Directory Select archive maintenance to retrieve archived record-
ings and for further special archive settings.
When recordings have been manually moved into an ar-
chive directory, or if an error in the database occurs,
some files in the archive directory may not be available
for view until 'mapped' by the database. Other archive di-
rectories can also be made available (for example from
another hospital/practitioner) for view in the database.
To make these recordings available, select the archive
directory form the read directory field and click the start
icon. The number of updated files and the number of pa-
tients updated are displayed. The total number of re-
cordings in the archive directory is given at the bottom of
the screen.

Special Tasks
Art. no.: 2.510368 Rev.: d

Delete Original Check this box to manually delete all recordings after ar-
chiving. Note that recordings can also be deleted auto-
matically after archiving.
Delete Recording Ref. When this box is checked a date can be defined. All ar-
chived recording references before the date specified
are deleted in the data base.
Note: With this function only the index reference to the
recordings are deleted. The actual recordings are not
deleted. If at a later stage you wish to have access to the
archived data select 'rebuild archive` above.
Reset Archive Flag This is a special function that resets the archive flag on
archived recordings. This allows you for example, to re-
archive recordings in another directory.

Page 62
Other Program Functions 10
PC Spirometry User Guide Importing a Recording 10.5

10.5 Importing a Recording


This function imports recording from an external source or folder. When this function
is selected all imported recordings are placed in the SDSRECS folder and are
available for viewing directly. To import a recording or group of recordings, proceed
as follows:

1. In the patient data screen function menu, select the 'Import' and select the data
to be imported.

2. Select the drive in the top field of where the files to be imported are located. (Click
on the 'browse' icon (1) to the right of the field to display the drives connected to
your system and select the file(s).
3. Click on the Start icon (2).
1
All recordings on the disk/medium selected will be copied to the SDSRECS file and
will be available for view directly. If the recordings are not available for view select
`restore database` from the function menu.
2

10.6 Restoring the Database


10.6.1 What to do if you cannot see imported files
The database contains a reference index (pointer) to the directory (volume and disk
etc.) where recordings are stored. Sometimes when recordings are imported, the
database `pointer`, must be set so that the database knows where the recording are
stored (directory, folder etc.). To do this the restore database option must be selected
as follows:

1. In the main screen select the 'restore database' option in the system menu.
2. Select the drive where the recordings are stored - click on the 'browse' icon to the
right of the field to display the drives connected to your system and select the file.
3. Click on the START icon.
Art. no.: 2.510368 Rev.: d

All recordings in the specified directory will be available for view directly.

The ‘Refresh DB‘ icon in the patient data screen has a slightly different function and
is used when the SemaComm is installed to import any recordings that have been
received.

Page 63
10 Other Program Functions
10.7 Exporting PC Spirometry

10.7 Exporting
The export function copies and renames a validated recording to a specific directory
/ folder. This can then be accessed by for example, a hospital network.

The export function is automatic when a recording has been validated. Recordings
can also be exported manually (when not validated), but the setting must be
‘validation export‘ as detailed following, to enable the export icon on the patient
screen.

To export a recording proceed as follows:

1. In the address book in the system settings, define an export address where the
recording will be sent. This is described in system settings (see page 53).

2. In the transfer tab in the system settings, define the data to be exported i.e. pat
data, and/or recording (1).

2
1

3. Select the address that you wish to export (2), - defined in address book.
The `Validation Export` (step 2 above), must be checked to make the `Export` icon on
the patient screen active.

Manually Exporting a Recording


In the patient screen, highlight the recording that you wish to export and click the
Art. no.: 2.510368 Rev.: d

export icon.

Page 64
Other Program Functions 10
PC Spirometry User Guide Sending Patient Data 10.8

10.8 Sending Patient Data


The send patient data function sends a patient data to the data base of an external
device. At the time of press the only the SCHILLER AT-10 can accept patient data.
To send patient data proceed as follows:

1. In the address book in the system settings, define the address where the record-
ing will be sent (see page 53). The following must be observed when defining the
address:

– The ConnName is specific to the device and COM port and must be in the fol-
lowing format:
– xxxxxx-y (maximum 8 characters) where xxx is the location ID of the device
and Y is the COM port starting with 0, (i.e. ‘0‘ = COM 1, ‘1‘ = COM 2 etc.).
– Between xxxx and y there must be a hyphen ‘-‘.
– In this example an AT-10 in room 5 is connected to COM port 1.

2. Select the patient from the patient screen and click the send PatData icon.

3. A list of all addresses is shown. Select required address and time to send.
Art. no.: 2.510368 Rev.: d

Page 65
10 Other Program Functions
10.9 Refreshing the Database PC Spirometry

10.9 Refreshing the Database


If the software is networked and the program is open, any externally edited recordings
are not automatically updated in the database.

To refresh the database click the DB icon in the patient screen.

Additionally, the SemaComm program is automatically opened when the computer is


switched on and all received recordings are stored on the import directory (defined
during installation). These recordings are transferred to the database when the
program is first opened i.e. all recordings stored in the import directory are
automatically transferred to the database. However, when the program is already
open, transfer is not automatic and to view these files click the DB icon.

Details of the SemaComm program, installation and settings are provided in the
SemaComm installation guide available from the SCHILLER service department.

10.10 Generating a PDF file


PDF files can be generated from the patient screen and an open recording. To
generate a PDF (to the settings defined in system settings (see page 53), select
Generate PDF Report (1) in the function menu (highlight the recording first when in
the patient screen).

To define the setting before generating the PDF file, select Generate PDF report ..
1 (2).
2
When the PDF file has been generated, it can be viewed, stored, send by email, etc.,
in the normal manner.

Art. no.: 2.510368 Rev.: d

Page 66
Other Program Functions 10
PC Spirometry User Guide Adding a Program Icon 10.11

10.11 Adding a Program Icon


An extra program icon can be added to the icon bar in the patient screen. This icon
can be defined so that it open any program installed on your PC. For example word
can be opened for writing patient notes, or excel can be opened for reference data,
etc. To add an extra program icon, proceed as follows:

1. In the root directory of the program (usually SDS104 on your local harddisk),
open the file ExternalApp.ini. The following is displayed:

2. Enter the following:


Name: A suitable label for the application. This is used by the program
for access only.
Hint: Write any text here that will appear in a box when the cursor is
positioned over the icon.
Button: The name that appears on the icon in the program
Exe: The full path of the program that is to be opened when the icon
is clicked.
Parameter: Leave this as default, system
Icon: If you wish a symbol on the icon define the full path here. The
size must be 20 x 20 pixels and can be bmp, jpg, or any other
standard symbol format.

Save the file (File > Save). When the Program is again opened the icon will appear in
Art. no.: 2.510368 Rev.: d

the icon bar and when clicked, the selected program will open.

Page 67
10 Other Program Functions
10.12 Audit Trail PC Spirometry

10.12 Audit Trail


To be able to follow up and prove defined operations important actions can be
recorded in a database. This enables for example, proof of patient / recording editing
/ deletion or, history checking that a recording has been printed, mailed or exported,
etc.

To enable an audit trail an Advantage data base must be installed either locally of in
a server. This is not supplied with the SEMA-200 program and must be purchased
separately from the SEMA-200 program.

Settings can only be defined while the ADS is running. When in a network, the settings
defined for the audit trail apply to all SEMA programs or CS-200 units connected to
the same Advantage database. The settings are defined under Settings > System
Configuration > Electronic Audit Trail (see page 50).

10.12.1 Viewing the Audit Trail


Settings can only be defined and the menu options given when the ADS (Advantage
database is running.

The audit trail is viewed and printed from the function menu in the patient
screen Function menu > Show Audit Trail. The following is displayed:

Art. no.: 2.510368 Rev.: d

Page 68
Other Program Functions 10
PC Spirometry User Guide Audit Trail 10.12

Searching for Recordings from a specific Patient or User


Define the search parameters and click the Search icon (1) to display only the
recordings from the defined settings.

Reviewing and Printing the Search result


To review or print the search results click the preview or print icon (2)
Art. no.: 2.510368 Rev.: d

Page 69
10 Other Program Functions
10.13 Technical Data PC Spirometry

10.13 Technical Data


Method of Measurement Pneumotachometer

Measurement Ranges Flow: 0 to ±14 l/s


Volume: 0 to ±11 litres

Measurement Accuracy ± 2%

Flow Impedance Less than 0.2 mbar * s/l at 12 l/s

Measured Values FVC, ERV, IRV, TV, FVC, FEV0.5, FEV1.0, FEV3.0, FEV0.5/SVC, FEV1.0/FVC,
FEV3.0/VC, FEF 0.2 - 1.2 (litres), FEF25-75%, FEF75-85%,PEF, MEF75%, MEF50%,
MEF25%, MV, MVV, FIVC, FIV1.0, FIV1.0/FIVC, FIV1.0/FVC, PIF, MIF50%.

Comparison pre/post medication possible.

Extrapolated predicted values.

Prediction Equation Adults: ECCS / Austria / Berglund / Finnish / Indian / Morris / Crapo / Knudson
/ Knudson 76 / Polgar / Composite
Children: Quanjer & Tammeling / Austria / Indian / Knudson / Knudson 76 / Pol-
gar

Standards Compliance: ATS, OSHA, NIOSH

Art. no.: 2.510368 Rev.: d

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Index 11
PC Spirometry User Guide

11 Index
A M Resting ECG Defaults ........................ 58
Adding a Program Icon .......................... 67 Maintenance .......................................... 66 Spiro ................................................... 51
System Configuration ......................... 49
Address Headquarters ............................ 2 Maximum Voluntary Ventilation (MVV) . 28
Text Editing ........................................ 57
Air Obstruction Categories .................... 36 Measured Values ........................ 34, 70
Archive Conditions ................................ 62 Measured Volume ................................. 25 Time Format ....................................... 49
Transfer .............................................. 55
Archive Destination Path ....................... 61 Measurement Procedure ....................... 26
Units ................................................... 49
Archiving ................................................ 61 Miscellaneous Functions and Settings .. 32
Assigning a Recording to a Patient ....... 60 Morris .................................................... 43 Users, Departments and Institutions -
Defining .............................................. 48
ATS criteria ............................................ 27 Morris and Crapo Norm Values for Children .
Slow Vital Capacity (SVC) ..................... 28
Audit ...................................................... 68 44
Audit Trail .............................................. 68 Mouthpiece Changing ........................... 17 SP-150 Sensor ....................................... 15
SP-260 Sensor ....................................... 16
Austrian Standard .................................. 40
Spirometry
N References ......................................... 60
B Norm Values ......................................... 38 Solymar Standard .............................. 42
Berglund ................................................ 40 Norm Values USA and Canada ............ 42 Swedish Standards (Berglund) .............. 40
BTPS ..................................................... 25

P T
C Password .............................................. 18 Technical Data ....................................... 70
Calibration ............................................. 24 Patient Data - entering .......................... 22 Temperature .......................................... 25
Calibration Factor .................................. 25 Phone Book ................................. 64, 65 Tra .......................................................... 68
Chest Restriction Categories ................. 37 Polgar .................................................... 47 Trend ...................................................... 31
Composite Norm Values ....................... 46 Post-Medication Tests ........................... 28
Crapo ..................................................... 43 Predicted Values ................................... 32
Preparation ............................................ 17
U
Program Icon ......................................... 67 User ID ................................................... 18
D Program Overview ................................ 17
Deleting a Patient Entry ......................... 60
Deleting a Patient/Recording ................. 60
Pulmonary Test Overview ..................... 28 V
Viewing and Editing a Recording ........... 29
Diagnosis ............................................... 35
Q
Quad Graphic ........................................ 30
E Quanjer and Tammeling ........................ 39
ECCS .................................................... 39
e-mail ..................................................... 60
Ethnic Influences on Norm Value .......... 38 R
Ethnic Influences on Predicted Values .. 33 Rebuild Archive ..................................... 62
Result Table .......................................... 31
Results Screen ...................................... 30
F Retreiving Archived Recordings ............ 62
Finnish Standard ................................... 41
Forced Vital Capacity (FVC) .................. 28
S
Screen Information ................................ 27
G Select test ............................................. 26
Generating a PDF File ........................... 66 Settings
Address Book .................................... 54
Art. no.: 2.510368 Rev.: d

Break reasons ................................... 57


I Data Input and Output Settings ......... 53
Importing a Recording ........................... 63
Date Format ...................................... 49
Indian Standard ..................................... 41 Directories ......................................... 56
International ................................. 35, 36
Display Average ................................ 51
International Norm Standards ............... 39
ECG Defaults .................................... 51
Interpretation ......................................... 30 Formats ............................................. 49
Interpretation Acronyms .................... 57
K Modem .............................................. 54
Myogram filter .................................... 56
Knudson ................................................ 45
Options and Unit Software ................ 58
Knudson 76 ........................................... 46
Patient ID Format .............................. 49
PDF Defaults ..................................... 53
Printer Defaults .................................. 52

Page 71
11 Index
PC Spirometry

Art. no.: 2.510368 Rev.: d

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