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*2.510368*
Art. no.: 2.510368 Rev.: d
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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
6 Calibration ............................................... 24
6.1 Procedure............................................................................ 24
6.2 Calibration Information ...................................................... 25
Page 3
PC Spirometry
Page 4
PC Spirometry User Guide
11 Index ........................................................ 71
Art. no.: 2.510368 Rev.: d
Page 5
Page 6
PC Spirometry
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.
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
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.
Page 8
Safety Notes 1
PC Spirometry User Guide Safety Symbols and Pictograms 1.5
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.
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
Page 9
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:
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).
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:
Page 11
3 Installation
3.2 Mechanical Installation PC Spirometry
Keyboard
Connector
RS-232 connector
Art. no.: 2.510368 Rev.: d
To Keyboard
Page 12
Installation 3
PC Spirometry User Guide Mechanical Installation 3.2
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)
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3 Installation
3.3 Software Installation PC Spirometry
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.
Notes:
Page 14
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
1. Remove mouthpiece by gently but firmly pulling it away from the handle
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
Page 16
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.
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5 Program Overview
5.1 Login PC Spirometry
5 Program Overview
5.1 Login
Click the desktop icon to open the program.
For the first time only (or if ID or password has been forgotten), the following can be
typed to open the program:
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).
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Program Overview 5
PC Spirometry User Guide The Patient Screen 5.2
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
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5 Program Overview
5.2 The Patient Screen PC Spirometry
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
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.).
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
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5 Program Overview
5.3 Entering / Editing Patient and Recording Data PC Spirometry
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:
• 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).
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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).
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).
3 4
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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.
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.
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.
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
Calibration Factor Calculated value between measured and effective calibration air volume.
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
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).
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.
When the difference is greater than 200ml, the following message is given:
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).
quent tests are made, the result with the highest value will always be saved and giv-
en in the measurement columns.
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
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).
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.
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 8 9
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.
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Taking a Spiro Measurement 7
PC Spirometry User Guide Viewing Stored Recordings 7.4
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.
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:
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).
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.
Page 32
Spiro References 8
PC Spirometry User Guide Predicted Values 8.2
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
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:
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.
The following diagnosis criteria are applicable when the spiro standard (see page 58)
is set to American.
Page 36
Spiro References 8
PC Spirometry User Guide Diagnosis 8.4
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
• 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
Page 38
Spiro References 8
PC Spirometry User Guide Norm Values 8.5
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
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)
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)
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]
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]
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
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
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
Page 42
Spiro References 8
PC Spirometry User Guide Norm Values 8.5
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
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
Page 43
8 Spiro References
8.5 Norm Values PC Spirometry
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%
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
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
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
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
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
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.
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
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
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:
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.
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
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:
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
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:
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
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.
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 ‘-‘.
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.
Device The options given here are only applicable when Line or Modem is selected in `Type`
above. The device options available are as follows:
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.
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
9.8 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.
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
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.
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9 Program Settings
9.10 Options and Unit Software PC Spirometry
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
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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.
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
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10 Other Program Functions
10.1 Deleting a Recording / Deleting a Patient PC Spirometry
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.
Patient and Recording editing and defining a new patient is detailed earlier in this
book (see page 22).
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.
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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.
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).
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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).
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.
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Other Program Functions 10
PC Spirometry User Guide Importing a Recording 10.5
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
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.
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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.
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.
export icon.
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Other Program Functions 10
PC Spirometry User Guide Sending Patient Data 10.8
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
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10 Other Program Functions
10.9 Refreshing the Database PC Spirometry
Details of the SemaComm program, installation and settings are provided in the
SemaComm installation guide available from the SCHILLER service department.
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.
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Other Program Functions 10
PC Spirometry User Guide Adding a Program Icon 10.11
1. In the root directory of the program (usually SDS104 on your local harddisk),
open the file ExternalApp.ini. The following is displayed:
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.
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10 Other Program Functions
10.12 Audit Trail PC Spirometry
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).
The audit trail is viewed and printed from the function menu in the patient
screen Function menu > Show Audit Trail. The following is displayed:
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Other Program Functions 10
PC Spirometry User Guide Audit Trail 10.12
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10 Other Program Functions
10.13 Technical Data PC Spirometry
Measurement Accuracy ± 2%
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%.
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
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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
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11 Index
PC Spirometry
Page 72