Vitalograph alpha 6000 User manual

Vitalograph ALPHA User Manual
07368
Issue 2
Vitalograph
alpha
MODEL 6000
User Manual
l
Copyright Vitalograph 2007

Vitalograph ALPHA User Manual
07368
Issue 2
Copyright Vitalograph 2007
Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England
Phone: [phone] Fax: [phone]
e-mail: [email protected]
Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany
Phone: [phone] Fax: [phone]
e-mail: [email protected]
Vitalograph Inc., 13310 West 99th Street, Lenexa, Kansas 66215, U.S.A.
Phone: [phone] Fax: [phone]
e-mail: [email protected]
Vitalograph (Irl.) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: [phone] Fax: [phone]
e-mail: [email protected]
Internet: www.vitalograph.com
© Copyright Vitalograph 2007
Current Edition (Issue 2)
Cat. No. 07368
Vitalograph is a registered trademark

Table of Contents
DESCRIPTION OF THE VITALOGRAPH ALPHA 1
MAIN COMPONENTS OF THE VITALOGRAPH ALPHA 1
FEATURES OF THE VITALOGRAPH ALPHA 1
GETTING THE VITALOGRAPH ALPHA READY FOR USE 2
POWER MANAGEMENT IN THE VITALOGRAPH ALPHA 2
BATTERY PACK 2
BATTERY LOW DETECT 3
OPERATING THE VITALOGRAPH ALPHA 3
ENTERING SUBJECT INFORMATION 3
PERFORMING A TEST SESSION 4
Checks to Make before Performing a Test Session 4
Performing a VC Test 4
Performing an FVC Test 6
SAVING THE TEST SESSION. 7
PERFORMING A POST TEST SESSION 8
PRINTING THE TEST SESSION 8
CLEAR RESULTS 9
CHECKING ACCURACY 9
When to Check Accuracy 10
VIEWING CURRENT SUBJECT DETAILS 10
DELETING STORED SUBJECTS/TEST RESULTS 11
CONFIGURATION OPTIONS 11
Preferences 11
Date/Time 12
Report Settings 13
Syringe/Calibration 13
Sound Volume 15
FITTING A NEW PAPER ROLL 15
CLEANING INSTRUCTIONS 16
CLEANING AND DISINFECTING THE VITALOGRAPH ALPHA 16
DISASSEMBLING THE FLEISCH FLOWHEAD 19
REASSEMBLING THE FLEISCH FLOWHEAD 20
FAULT FINDING GUIDE 21
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CUSTOMER SERVICE 23
CONSUMABLES AND ACCESSORIES 23
EXPLANATION OF SYMBOLS 24
OTHER LABELS 24
TECHNICAL SPECIFICATIONS 24
CE NOTICE 25
FDA NOTICE 29
DECLARATION OF CONFORMITY 30
GUARANTEE 31
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Vitalograph ALPHA User Manual
07368
Issue 2
A
D
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Figure 1
Copyright Vitalograph 2007

DESCRIPTION OF THE VITALOGRAPH ALPHA
The Vitalograph ALPHA is a desktop spirometer designed for use by
trained professionals in the doctor’s office, clinic, hospital department,
etc. for measuring and archiving tests on human subjects.
Demographic data are uploaded or entered via a keypad and stored,
together with spirometry test data. Current test data can be viewed on
the LCD and printed and downloaded to a PC. There are a variety of
backup and other configuration options.
Information about the software can be obtained from the About box.
This information can be used if any queries are made to Vitalograph or
a service agent.
To access the About box:
1. Press 8 (Configuration) from the Main Menu.
2. Press 6 (About the ALPHA)
MAIN COMPONENTS OF THE VITALOGRAPH ALPHA
A Vitalograph ALPHA device
B LCD
C Keypad
D Flowhead
E Printer
FEATURES OF THE VITALOGRAPH ALPHA
The Vitalograph ALPHA’s features include:
Very high accuracy, linearity and stability•
•
•
•
•
•
Extremely simple to operate keypad with extra-large buttons
Integral printer for instant results or printing to the Vitalograph
Report Utility
Storage of tests and demographic information
Ability to exchange information with a PC
Robust, proven fleisch-type flowhead. No moving parts or delicate
sensors
• Simple cleaning. The flowhead completely dismantles for washing,
disinfecting or even autoclaving.
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GETTING THE VITALOGRAPH ALPHA READY FOR USE
1. Attach the flowhead to the Vitalograph ALPHA by the dual silicone
tubing (Flowhead Connection Tube). Ensure that the
coloured/ribbed tapping on the flowhead is connected to the ribbed
side of the connection in the housing.
2. Open the printer door and feed the paper through the printer (See
section Fitting a New Paper Roll).
3. Only use the Vitalograph ALPHA with the purpose-built low voltage
power supply unit with which it is supplied. Attempted use with
other power sources may cause irreparable damage and invalidate
the warranty. The output from the power supply is 12 volts DC.
4. Connect the jackplug from the power supply into the socket on the
rear of the Vitalograph ALPHA. Plug the mains plug into a suitable
socket, operate the On/Off switch on the rear of the instrument and
the Vitalograph ALPHA is ready for use.
5. For portability the Vitalograph ALPHA comes fitted with
rechargeable batteries, which allows the device to be used for a
period of time without the mains connected.
POWER MANAGEMENT IN THE VITALOGRAPH ALPHA
The Vitalograph ALPHA can be powered using the purpose-built low
voltage Power Supply unit with which it is supplied or from the internal
Battery Pack. When powered from the low voltage Power Supply the
LED on the front face on the device will be green. The LED will be
orange when the device is powered from the Battery Pack.
Battery Pack
The Vitalograph ALPHA is fitted with a rechargeable Battery Pack. This
allows the device to be used without the 12V Power Supply connected.
The battery pack can be re-charged by plugging in the 12 V Power
Supply. To fully re-charge switch off the Vitalograph ALPHA and leave
it plugged in over-night.
The battery pack can also be re-charged by connecting the device to a
PC via the USB cable. The USB connector is located on the right side
of the device. Switch off the Vitalograph ALPHA when re-charging the
batteries via USB.
Note: Operating the Vitalograph ALPHA device from the USB is not
possible. The USB can be used to re-charge the batteries only.
2

Battery Low Detect
The Vitalograph ALPHA has a number of battery power detect
messages:
When the Battery Pack starts to run low the Battery Low
icon will flash on and off on the Main Menu screen.
You will be allowed to continue to use the device. It is
advised that you plug in the 12V Power Supply to re-
charge the batteries and continue testing.
When the Battery Pack is approaching fully discharged
the Battery Discharged icon will appear continuously on
the Main Menu screen.
If you press any of the keys a warning message will
appear and you will not be allowed to proceed into any
other screen. Plug in the 12V Power Supply to re-
charge the batteries and continue testing.
OPERATING THE VITALOGRAPH ALPHA
Entering Subject Information
After turning on the device, you are presented with the New Subject
screen. A series of dialog boxes appear in which you enter information
using the keypad. Instructions appear at the bottom of the screen to
guide you through the information to be entered. Once you are ready to
move onto the next dialog box, press the ‘Enter’ key on the keypad.
These dialog boxes appear one at a time in the following order:
1. Reference Number
2. Age
3. Height
4. Gender
5. Population Group
When entering subject information, you can specify the
population group of the subject. There are a number of population
groups to select from. These population groups have an
associated predicted normal set and correction factor. These
normal sets are usually based on sex, age and height and are
useful when comparing a subject’s test results with predicted
normal values from a suitable reference population.
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6. Weight
7. Smoking History
If you wish to change the data entered press the ‘Delete’ key and enter
the data again. Pressing the ‘Delete’ key repeatedly will step back
through the dialogue boxes. Once you have finished entering the data
press the ‘Enter’ key to bring you to the Main Menu.
The Population Group, Weight and Smoking History fields may not
appear in the New Subject screen. This is dependent on the variant of
the device.
Note: The Subject Information will now be printed to the internal printer
if it is selected.
If you wish to enter different subject details select the ‘New Subject’
option from the Main Menu using the keypad. You will be asked if you
wish to clear results.
• Press Yes to bring you to the New Subject screen, and enter
the New Subject details as outlined above.
• Press No to bring you back to the Main Menu.
Performing a Test Session
Checks to Make before Performing a Test Session
Before starting a test session, there are a number of checks which
should be made:
1. Ensure that the accuracy of the Vitalograph ALPHA unit was
checked recently. (Refer to the section on Checking Accuracy)
2. Ensure all the required demographic information is entered for the
subject.
Performing a VC Test
Perform the VC test as follows:
1. Select the ‘VC Test’ option from the Main Menu using the keypad.
2. Wait for the ‘Exhale to Begin’ icon to appear.
This indicates that the Vitalograph ALPHA unit is ready to accept a
blow.
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Note: You can view the results as either a Volume/time graph or a
Volume bar graph:
a. Press key 1 for Volume/time (V/t) graph.
b. Press key 2 for Volume bar graph.
3. The VC test can be performed using two methods. Read either of
the following instructions to the subject so that testing is performed
properly:
Method 1:
a. Stand up
b. Keep the flowhead away from your mouth.
c. Inhale as deeply as possible and insert the bacterial viral
filter into your mouth, clamping it between your teeth.
d. Close your lips around the bacterial viral filter.
e. Exhale normally for as long as possible.
Method 2:
Note: Method 2 can only be used when the Volume/Time (V/t) graph
is selected as the display option. This method cannot be used when
the Volume bar graph is selected as the display.
a. Stand up.
b. Insert the bacterial viral filter into your mouth and,
clamping it between your teeth.
c. Close your lips around the bacterial viral filter.
d. Breathe in and out normally. This is tidal breathing.
When you are happy that the subject has achieved steady
tidal breathing, continue with:
e. Exhale as deeply as possible.
f. Inhale as much as possible (speed is not important) and
when fully inhaled.
g. Return to tidal breathing, i.e. breathe in and out normally
again.
The VC values recorded for the blow are tabulated. The best VC
value for the current session and the Lower Limit of Normality
(LLN) are also displayed.
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4. Repeat to perform another VC test if required.
5. After performing the VC tests press the ‘Enter key’ to exit the VC
Test screen. This brings you back to the Main Menu.
Performing an FVC Test
1. Select the ‘FVC Test’ option from the Main Menu using the keypad.
2. Wait for the ‘Exhale to Begin’ icon to appear.
This indicates that the Vitalograph ALPHA unit is ready to accept a
blow.
Note: You can view the results as either a Volume/time (V/t) or a
Flow/Volume (F/V) graph:
a. Press key 1 for Volume/time graph.
b. Press key 2 for Flow/Volume graph.
3. The FVC test can be performed using 2 methods as follows. Read
either of the following instructions to the subject so that testing is
performed properly:
Method 1:
a. Stand up.
b. Keep the flowhead away from your mouth.
c. Inhale as deeply as possible, then inset the bacterial viral
filter into your mouth, clamping it between your teeth.
d. Close your lips around the bacterial viral filter.
e. Exhale as much and as quickly as possible and try to keep
exhaling for at least 6 seconds.
f. If inspiratory indices are selected, then inhale as quickly as
possible.
Method 2:
a. Clip on the nose clip to seal your nose.
b. Put the bacterial viral filter (BVF) into your mouth, biting it
lightly.
c. Seal your lips around the mouthpiece
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d. Breathe in and out normally. This is called tidal breathing.
When you are happy that the subject has achieved steady tidal
breathing, continue with:
e. Inhale as deeply as possible
f. Exhale as much and as quickly as possible, and when fully
exhaled
g. Inhale fully as quickly as possible
h. Return to tidal breathing, i.e. breathe in and out normally
again.
4. The FVC, FEV1, FEV1ratio and PEF values recorded for the blow
are tabulated. The best FVC, FEV1, FEV1ratio and PEF for the
current session are displayed.
The test quality (QA) is shown at the bottom of the test screen.
The number of tests performed and the Test Grade are shown in
the V/t screen. Each test series is graded in relation to its
repeatability between acceptable manoeuvres. The quality Grades
are A, B, C, D and F.
The repeatability (Within) of FVC and FEV1 are shown in the F/V
screen. The repeatability information is displayed if at least two
tests are performed. I Bars on the F/V graph are shown for FEF25,
FEF 50 and FEF75. An I Bar for FVC is also shown on the Volume
axis. The upper mark on the I Bars indicates the predicted value
for the subject. The lower mark on the I Bar indicates the LLN value
for the subject. The I Bars are based on the predicted sets and will
be shown if sufficient subject demographics information is entered.
5. Repeat to perform another FVC Test if required.
6. After performing the FVC tests press the ‘Enter’ key to exit the FVC
Test screen. This brings you back to the Main Menu.
Saving the Test Session.
1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. Select ‘Save Current Subject Pre Test’ from the Post Mode screen
using the keypad. A message will appear informing you of the
memory location where the test session will be saved. There are
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nine memory locations on the Vitalograph ALPHA. The best three
tests will be saved.
Note: If a Compact Flash card is inserted into the Compact Flash
connector at the right side of the device, then all test blows and not just
the best three will be saved to the Compact Flash card. Results are
saved as per the format outlined in the European Respiratory Journal,
2005; 26: Pages 319-338: ATS/ERS Task Force: Standardisation of
Lung Function Testing.
Performing a Post Test Session
A Post test session can be performed on an FVC test session following
the administration of drugs. Post drug delivery performance is
measured versus pre delivery.
To perform a Post test:
1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. If you want to perform a Post Test on the Pre-test Session just
performed select ‘Set Post Mode for Current Subject’. This will
return you to the Main Menu screen. The text Post Mode will
appear on the top right hand corner of the screen.
3. If you wish to perform a Post Test on a different subject or Pre-test:
a. Select ‘Select a Subject from the Pre-Store’.
b. A message ‘Warning! Current Results will be cleared’
will appear. Select Yes and the Select Subject screen
will appear.
c. Select the number of the Pre-test you wish to perform
the Post test on. This will return you to the Post Mode
screen.
d. Press ‘Enter’ to return you to the Main Menu screen.
4. Perform the Post FVC test as outlined in section Performing a Test
Session.
Note: If there is no Pre-Test performed, the message No FVC Tests
Performed will appear.
Printing the Test Session
You can print the current test session for the subject by selecting ‘Print’
from the Main Menu.
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The Vitalograph ALPHA has an internal printer. It can also be
connected through the USB port at the side of the unit to the
Vitalograph Reports Utility, so that the report can be written to a PC.
The information printed on the session report can be configured to suit
individual requirements. Refer to section on Report Settings.
The test parameters on the report will vary according to regional
requirements. The test parameters and their definitions are available
from the Help files, which can be accessed from the Main Menu.
Note: The internal (thermal) printout will fade over time when exposed
to light or heat. If a permanent record is required, photocopy the
thermal printout or send the report to the Vitalograph Reports Utility.
Refer to the section on Configuration for information on selecting the
internal or Vitalograph Reports Option.
Clear Results
If you wish to delete the current session you can do this as follows:
1. Select the ‘Clear Results’ option from the Main Menu using the
Keypad.
2. A message will appear ‘Warning! Current Results will be Cleared.
Do you wish to proceed?’ in the Clear Results screen. Select
‘Yes’ to delete the current results and return to the Main Menu.
Select ‘No’ to cancel the delete and return to the Main Menu.
Checking Accuracy
All spirometry standards (e.g. ATS/ERS/BTS/ANZRS) recommend
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checking the accuracy of lung function measuring devices at least daily
with a 3-L syringe to validate that the instrument is measuring
accurately. The Vitalograph ALPHA should never be outside accuracy
limits unless damaged or in a fault condition. In this event, see the
fault-finding guide. In normal use, calibration traceability certification is
recommended as a part of the routine annual service.

ATS recommendations require that the difference between the volume
measured by the spirometer and the volume pumped into the
spirometer from a syringe is within 3%.
Follow these steps to check the accuracy of the unit.
1. Select Accuracy Check from the Main Menu using the keypad.
2. Pump air through the flowhead to bring it to ambient
temperature.
If the flowhead has very recently been used for testing or has
come from a cold environment, its temperature should be
equilibrated with ambient by pumping air through it from the
syringe several times.
3. Press the ‘Enter’ key to bring you into the Accuracy Check
screen and follow the on-screen instructions.
Note: Note: Press the ‘Del’ key to exit the Accuracy Check
screen and return to the Main Menu. The accuracy check will not
be logged to the Vitalograph ALPHA memory in this case.
4. If an Accuracy Check report is required select the Report option.
Note: If the device is outside calibration you will be given the
option to update the calibration. If you select this option you will
be brought through the accuracy check routine again.
When to Check Accuracy
• In accordance with your own established procedures
• After annual maintenance checks
• After cleaning or disassembling spirometer for any reason
• After adjusting calibration
• If the flowhead has been dropped.
Viewing Current Subject Details
To view the Current Subject details:
1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. Select ‘View Current Subject’ from the Post Mode screen.
3. The Current Subject screen will be displayed.
Note: You will not be able to modify any of the subject details.
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Deleting Stored Subjects/Test Results
To delete individual Stored Subjects/Test results:
1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. Select ‘Delete Stored Tests’ from the Post Mode screen.
You are presented with the list of the Subjects and the associated
test stored on the device. A maximum of nine Subject/Tests can
be stored on the device in locations 1-9 as indicated in the Delete
Subject screen.
3. Select the number of the Subject/Test you wish to delete using
the keypad. This location will then be marked as ‘Empty’.
4. Continue to delete test as required.
5. Press ‘Enter’ to return to the Post Mode screen.
To delete all Stored Subjects/Test results:
1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. Select ‘Clear Pre Store’ from the Post Mode screen.
3. A message ‘Warning! All data in pre store will be cleared. Do you
wish to proceed?’ will appear in the Clear Results screen.
4. Select ‘Yes’ to delete the all data and return to the Post Mode
screen. Select ‘No’ to cancel the delete and return to the Post
Mode screen.
Configuration Options
There are a number of Configuration options available on the
Vitalograph ALPHA device. To access these, press the ‘Configuration’
option on the Main Menu using the keypad. The options available are:
Preferences
This will allow you to configure the device to your own requirements.
Selecting this will give you the following options:
Printer
This allows you to either print the test report to the Internal Printer or
send it to the Vitalograph Reports Utility on a PC. Press key ‘1’ on
the keypad to switch between the two options.
Note: In order to send the report to the Vitalograph Reports Utility it
is necessary to have the Vitalograph Reports Utility installed on your
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PC and the Vitalograph ALPHA connected to your PC via a USB
cable.
Units
This allows you to select the units as Metric or US (Imperial). Press
key ‘2’ on the keypad to switch between the two options.
Graph Type
This allows you to select the graph type to be shown as default in
the FVC test screen, Press key ‘3’ on the keypad to switch between
the Volume/Time (V/T) and Flow/Volume (F/V) graphs.
Test Acceptability
This allows you to manually accept the tests performed, or allow the
device to determine test acceptability (automatic). Press key ‘4’ to
switch between Manual and Automatic.
VC Test Type
This allows you to select the graph type to be shown as default in
the VC test screen, Press key ‘5’ on the keypad to switch between
the Volume/Time (V/T) and Volume Bar graphs.
Date/Time
1. Select ‘Date/Time’ from the Configuration screen using the
keypad.
2. In the Date/Time screen press key ‘1’ to change the year. Enter
the revised year as required using the keypad and press ‘Enter’.
The Month, Day, Hour and minute fields are modified in the same
way.
3. To modify the Date Format press key ‘6’ to switch between the
different date formats:
DD/MM/YYYY
MM/DD/YYYY
YYYY/MM/DD
4. Press ‘Enter’ to save the change.
5. To modify the Time Format press key ‘7’ to switch between 24
hour and 12 hour.
6. Press ‘Enter’ to save the change.
7. Once you have finished modifying the date and time settings
press ‘Enter’ to save the changes and return to the
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Configuration screen. Press ‘Delete’ to cancel the changes
made and return to the Configuration screen.
Report Settings
The information printed on the session reports can be configured to
suit individual requirements. The Vitalograph ALPHA can print to the
internal printer or send the report to the Vitalograph Reports Utility.
1. Select ‘Report Settings’ from the Configuration screen using the
keypad. You are presented with the list of items that can be
configured on the test reports.
2. In the Report Settings screen press key ‘1’ to switch the
Volume/time (V/t) graph on or off.
3. Press key ‘2’ to switch the Flow/Volume (F/V) graph on or off.
4. Press Key ‘3’ to switch the Comments on of off.
5. Press key ‘4’ to switch the Test QA messages on or off.
6. Press key ‘5’ to switch the Interpretation of the test results on or off.
7. Press key ‘6’ to switch between showing SDS (Standard Deviation
Score) or %Predicted in the session table of results. In the session
table of results the % of Predicted value will be printed by default. If
SDS is on, the SDS (Standard Deviation Score) will be printed
instead.
8. Press key ‘7’ to either show the Best Test only on the report or the
Three Tests saved to the database.
9. Press key ‘8’ to switch colour on or off. This option is not available
for the internal printer.
10. When you have finished modifying the Report Settings press
‘Enter’ to save the changes and return to the Configuration
screen. Press ‘Delete’ to cancel the changes made and return to
the Configuration screen.
Syringe/Calibration
The Vitalograph ALPHA should never be outside accuracy limits unless
damaged or in a fault condition. In this event, see the fault-finding
guide. In normal use, calibration traceability certification is
recommended as a part of the routine annual service.
1. Select the Syringe/Calibration menu using the keypad. You are
presented with three options:
a. Set Syringe Volume
b. Linearity Check
c. Calibration
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Set Syringe Volume:
i. Select Precision Syringe from the
Syringe/Calibration screen using the keypad.
ii. Follow on screen instructions to enter the
volume of the calibrated syringe you are using.
iii. Press ‘Enter’ to save the new volume entered
and return to the Syringe/Calibration screen.
Press Delete to cancel the changes made and
return to the Syringe/Calibration screen.
Linearity Check
i. Select Linearity Check from the
Syringe/Calibration screen using the keypad.
ii. Pump air through the flowhead to bring it to
ambient temperature. If the flowhead has very
recently been used for testing or has come from
a cold environment, its temperature should be
equilibrated with ambient by pumping air.
iii. Press the ‘Enter’ key to bring you into the
Linearity Check screen.
iv. Using a 3L Calibrated syringe pump air into the
flowhead at a slow rate of <2L/s. Immediately
withdraw the syringe at a slow rate. This
manoeuvre should show on the graph between
the two red lines. If it is a correct manoeuvre
the table on the screen will show ‘Test 1’, and
the FVC and FIVC values will be updated.
Note: Press the ‘Del’ key to exit the Linearity
Check screen.
v. Repeat for the slow rate three times in total.
vi. Repeat the procedure outlined in iv & v for a
medium rate >2L/s and <6L/s. This manoeuvre
should show on the graph between the red and
green lines. If it is a correct manoeuvre the test
number and the FVC and FIVC values will be
updated in the table.
vii.Repeat for the medium rate three times in total.
viii. Repeat the procedure outlined in iv & v for a
fast rate >6L/s. This manoeuvre should show
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on the graph between outside green lines. If it is
a correct manoeuvre the test number and the
FVC and FIVC values will be updated in the
table.
ix. Repeat for the medium rate three times in total.
x. When all the manoeuvres are complete press
‘Enter’ for the result.
xi. If a Linearity Check report is required select the
Report option.
Calibration
i. Select Calibration from the Syringe/Calibration
screen using the keypad.
ii. Pump air through the flowhead to bring it to
ambient temperature. If the flowhead has very
recently been used for testing or has come from
a cold environment, its temperature should be
equilibrated with ambient by pumping air
through it from the syringe several times.
iii. Press the ‘Enter’ key to bring you into the
Calibration screen and follow the on-screen
instructions.
Note: Press the ‘Del’ key to exit the Calibration
screen.
iv. If a Calibration report is required select the
Report option.
Sound Volume
1. Select the ‘Sound Volume’ option from the Configuration screen
using the keypad.
2. Adjust the sound level up by pressing key ‘2’.
3. Adjust the sound level down by pressing key ‘8’.
4. When you have finished changing the sound level press ‘Enter’ to
save the changes and return to the Configuration screen.
Fitting a New Paper Roll
The Vitalograph ALPHA is supplied with a roll of paper fitted into the
printer. (Note: The outside of the roll will not give a strong print
impression due to loss of sensitivity on exposure to light.).
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