Vitalograph In2itive 2120 User manual

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Model 2120 Hand Held
Spirometer
Vitalograph
Vitalograph Vitalograph
Vitalograph In2itive™
User Manual
l

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Vitalograph Ltd.
Maids Moreton
Buckingham
MK18 1SW England
Tel: [phone]
Fax: [phone]
e- mail: [e-mail]
Vitalograph GmbH
Rellinger Straße 64a
D-20257 Hamburg
Germany
Tel: [phone]
Fax: [phone]
e-mail: [e-mail]
Vitalograph Inc.
13310 West 99
th
Street
Lenexa
Kansas 66215 USA
Tel: [phone]
Fax: [phone]
e-mail: [e-mail]
Vitalograph (Ireland) Ltd.
Gort Road Business Park
Ennis
Co Clare Ireland
Tel: [phone]
Fax: [phone]
e-mail: [e-mail]
Internet: www.vitalograph.co.uk
© Copyright Vitalograph 2009, 2010 & 2011
Current Edition (Issue 5)
Cat. No. 07514
Vitalograph is a registered trademark

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Table of Contents
DESCRIPTION OF THE VITALOGRAPH DEVICE 5
FEATURES OF THE VITALOGRAPH DEVICE 7
GETTING THE VITALOGRAPH DEVICE READY FOR USE 7
OPERATING THE DEVICE WITH SPIROTRAC V 8
CONNECTING THE REMOTE FLOWHEAD 8
POWER MANAGEMENT IN THE VITALOGRAPH DEVICE 10
B ATTERY P ACK 11
B ATTERY L OW D ETECT 11
OPERATING THE VITALOGRAPH DEVICE 11
E NTERING S UBJECT I NFORMATION 11
P ERFORMING A T EST S ESSION 12
Checks to Make before Performing a Test Session 12
Performing a VC Test 12
Performing an FVC Test 14
S AVING THE T EST S ESSION . 17
P ERFORMING A P OST T EST S ESSION 17
P ERMANENT S TORAGE OF P RE -T EST S ESSIONS 18
P RINTING AND V IEWING THE T EST S ESSION 18
C LEAR R ESULTS 19
C HECKING A CCURACY 20
When to Check Accuracy 21
C ONFIGURATION O PTIONS 21
Test Preferences 21
Database 22
Calibration 22
Settings 23
Subject Options 26
Smart Options 27
Report Options 27
CLEANING INSTRUCTIONS 30
C LEANING AND D ISINFECTING THE V ITALOGRAPH I N 2 ITIVE 30
R EMOVING THE F LEISCH F LOWHEAD 32
R EASSEMBLING THE F LEISCH F LOWHEAD 33

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FAULT FINDING GUIDE 33
CUSTOMER SERVICE 35
CONSUMABLES AND ACCESSORIES 36
EXPLANATION OF SYMBOLS 36
TECHNICAL SPECIFICATIONS 37
CE NOTICE 38
FDA NOTICE 43
DECLARATION OF CONFORMITY 44
GUARANTEE 45

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D ESCRIPTION OF THE V ITALOGRAPH D EVICE
The Vitalograph In2itive is a handheld 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 the Configuration button from the Main Menu.
2. Press the About button.
The main components for the Vitalograph In2itive are shown in Figure
1.

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Figure 1
PC Software
Mini USB ports in
cradle and device
Enter Button
Up Button
Down Button
Cancel
Button
Stylus
Holder
On/Off
Button
LCD/Touch
panel Display
Flowhead
Flowhead
Release Button

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F EATURES OF THE V ITALOGRAPH D EVICE
The Vitalograph In2itive features include:
• Fleisch pneumotachograph
• Integral and removable flowhead
• Touch screen color display or buttons
• Clear sounds for audio feedback
• Choice of child incentive displays
• Fully customizable report format
• Desktop cradle supplied as standard
• Optional cradle for connection to A4 USB printers (PCL
compatible)
• Optional communications cradles
• Automatic download of new subjects
• 10,000 subject test memory
• Automatic upload of all test data
• Pre/post bronchodilator comparison
• Choice of predicted values and languages
• Diagnostic interpretation options
• Lung age for adults and adolescents
• Real-time test quality prompts
• Vitalograph PC software included
• Stylus
• Can enter subject details on device
G ETTING THE V ITALOGRAPH D EVICE R EADY F OR U SE
1. Place the Spirotrac V CD-ROM into the CD drive. The installation
program starts automatically after a short period of time and leads
you through the installation. The following are the most important
points of the installation procedure.
2. If you do not already have Acrobat reader installed then select
‘Install Acrobat Reader’. You will require it to read the User Manual
and any Test Reports that you have chosen to ‘Print’ as a PDF
document.
3. Spirotrac V can import and export to your practice software, if your
practice software supports one of the communications standards in

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Spirotrac V. Administration rights on your PC are required. This
can also be installed later.
4. For security reasons it is necessary during installation to enter an
activation key and licence key. These are available on the CD
cover.
5. When installation is complete remove the CD and keep in a safe
place.
6. Connect one end of the USB cable into an available USB
connection on your computer and the other end into the USB
connection on the side of the cradle. The cable can also be
connected into the left side of the Vitalograph In2itive device. The
device is powered via the USB cable.
7. Place the In2itive device into the cradle.
8. The Vitalograph In2itive device may also be powered using 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 5 volts DC. Connect the mini USB connector
from the power supply into the USB socket on the side of the unit
or into the cradle. Plug the mains plug into a suitable socket.
9. Operate the On/Off switch on the front face of the instrument and
the Vitalograph In2itive is ready for use.
10. For portability the Vitalograph In2itive comes fitted with
rechargeable batteries, which allows the device to be used for a
period of time without the mains connected.
O PERATING THE D EVICE WITH S PIROTRAC V
Refer to the Help Files on Spirotrac V for information on operating the
Vitalograph In2itive with Spirotrac V.
C ONNECTING THE R EMOTE F LOWHEAD
The flowhead on the Vitalograph In2itive can be set up to work
remotely from the device. This can be done as follows (see figure 2):
1. Hold the device body firmly in your left hand.
2. Hold the flowhead with your right hand, at the same time press and
hold the button firmly on the front of the fleisch flowhead.
3. Slide the flowhead away from the device from left to right.
4. Attach the device cap in the same position as the flowhead was
attached. This is done by sliding the flowhead into the grooves in

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the top cover. The Vitalograph font and button on the device cap
should be on the same face as the LCD when assembled. Ensure
this is fully pushed in.
5. Attach the remote flowhead adaptor to the flowhead. This is done
by sliding the flowhead into the grooves in the remote flowhead
adaptor. Ensure this is fully pushed in.
6. Open the rubber cover on the left side of the device cap. This will
expose the two pressure ports on the device cap.
7. Attach the remote flowhead to the Vitalograph In2itive device cap
by the dual silicone tubing (Flowhead Connection Tube).
8. A recess is provided on the cradle to hold the remote flowhead
when not in use.
9. The remote flowhead can be disconnected by removing the device
cap from the Vitalograph In2itive, and removing the remote
flowhead adaptor from the flowhead. Then slide the flowhead back
onto the Vitalograph In2itive.
10.It is recommended that an accuracy check is carried out after the
remote flowhead is fitted or removed to verify correct operation and
accuracy.

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Figure 2
P OWER M ANAGEMENT IN THE V ITALOGRAPH D EVICE
The Vitalograph In2itive can be powered using the purpose-built low
voltage Power Supply unit with which it is supplied or from the PC via
the USB cable or from the internal Battery Pack. When powered from
the low voltage Power Supply or the PC the LED on the front face on
the device will be orange. The LED will be green when the device is
powered from the Battery Pack.
Device Cap
Release Button
Device Cap
Flowhead
Flowhead
Release Button
Remote Flowhead
Adaptor
Flowhead
Connection Tube
Rubber
Cover

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Battery Pack
The Vitalograph In2itive is fitted with a rechargeable Battery Pack. This
allows the device to be used without the 5V Power Supply connected.
The battery pack can be re-charged by plugging in the 5 V Power
Supply. To fully re-charge switch off the Vitalograph In2itive and leave
it plugged in over-night.
The battery pack can also be re-charged by connecting the device or
cradle to a PC via the USB cable. The USB connector is located on the
left side of the device.
Battery Low Detect
The Vitalograph In2itive 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 5V Power Supply or attach
the device to a PC 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.
Plug in the 5V Power Supply or attach to a PC to re-
charge the batteries and continue testing.
O PERATING THE V ITALOGRAPH D EVICE
Entering Subject Information
After turning on the device, you are presented with the Main Menu
screen.
Note: In Smart mode you can configure the device to go directly into
the Subject Select screen. See Smart Options.

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1. Select the Subject button, to bring you into the Select Subject
screen.
2. You can list the subjects saved on the device by selecting
either the Name or ID tab.
3. To select a subject from the database, hi-light the subject. This
will allow you the view the subject details. Select Enter to make
the subject current.
4. To create a new subject, select the New tab. Enter the subject
details by hi-lighting the required field and typing in the
information using the touch panel keypad. Additional subject
information may also be entered by selecting the Optional tab.
Press the Enter button to save the subject to the database and
return to the Home Menu.
Note: The current subject surname and forename will be
displayed on the bottom left hand corner of the screen. If the
subject name is not entered then the subject ID will be
displayed. If the subject has test session results associated
with it then the subject name and ID will appear in black. If
there are no test session results then the subject name and
ID will appear in grey.
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 In2itive unit was
checked recently. (Refer to the section on Checking Accuracy)
2. Ensure a subject is selected (subject ID or name will appear on the
status bar at the bottom of the Main Menu) and the required
demographic information is entered for the subject.
3. Fit a disposable BVF or SafeTway mouthpiece. The use of a
disposable noseclip is also recommended.
Performing a VC Test
Perform the VC test as follows:
1. Select the ‘VC Test’ option from the Main Menu.
2. Wait for the ‘Exhale to Begin’ icon to appear.

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This indicates that the Vitalograph In2itive unit is ready to accept a
blow.
Note: You can view the results as either a Volume/time graph or a
Volume bar graph by selecting the relevant tab.
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. Sit upright, fit the nose clip and relax.
b. Hold the unit, keeping it away from your mouth.
c. Inhale as deeply as possible, hold your breath, then insert
the mouthpiece carefully into your mouth, not like a trumpet,
but clamping it gently between your teeth.
d. Seal your lips around the mouthpiece and keep your tongue
down.
e. Blow out as long as possible. Keep blowing until all air is
expelled. It is vital that the operator encourages to subject
to keep blowing to ensure all air is squeezed out.
f. Listen for two beeps. This indicates that Vitalograph In2itive
is ready for the next blow.
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. Sit upright, fit the noseclip and relax.
b. Insert the mouthpiece carefully into your mouth, not like a
trumpet, but clamping it gently between your teeth.
c. Seal your lips around the mouthpiece and keep your
tongue down.
d. Breathe in and out normally. This is tidal breathing.

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When you are happy that the subject has achieved steady
tidal breathing, continue with:
e. Blow out as long as possible. Keep blowing until all air is
expelled. It is vital that the operator encourages to subject
to keep blowing to ensure all air is squeezed out.
f. Inhale as deeply 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.
4. Repeat the blow three times or more to obtain good test quality.
5. After performing the VC tests press the Cancel button 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.
2. Wait for the ‘Exhale to Begin’ icon to appear.
This indicates that the Vitalograph In2itive 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 by selecting the relevant tab.
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. Sit upright, fit the noseclip and relax.
b. Hold the unit, keeping it away from your mouth.

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c. Inhale as deeply as possible, hold your breath, then insert the
mouthpiece carefully into your mouth, not like a trumpet, but
clamping it gently between your teeth.
d. Seal your lips around the mouthpiece and keep your tongue
down.
e. Blow out as long as possible. Keep blowing for at least 6
seconds. (From the very beginning of the blow the operator
should encourage the subject to keep going in a lively
fashion. Keep eye contact with the subject)
f. If inspiratory indices are selected, then inhale as quickly as
possible.
g. Listen for two beeps. This indicates that Vitalograph In2itive
is ready for the next blow.
Method 2:
a. Sit upright, fit the noseclip and relax.
b. Insert the mouthpiece carefully into your mouth, not like a
trumpet, but clamping it gently between your teeth.
c. Seal your lips around the mouthpiece and keep your tongue
down.
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. Blow out as long as possible. Keep blowing for at least 6
seconds. (From the very beginning of the blow the operator
should encourage the subject to keep going in a lively
fashion. Keep eye contact with the subject)
g. Inhale fully as quickly as possible
h. Return to tidal breathing, i.e. breathe in and out normally
again.
4. The FVC, FEV1 and PEF values recorded for the blow are
tabulated. The best FVC, FEV1 and PEF for the current session
are displayed.
The test quality (QA) is shown at the bottom of the test screen.

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The best 3 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
Information 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 the blow three times or more to obtain good test quality.
6. To view results select the results tab.
- You can view the results for each blow by selecting the up/down
arrows on the top right of the screen. If any of the parameters
are below the Lower Limit of Normality (LLN), then they will be
displayed in red, provided the subject age, height and gender
are entered.
- To view the graph of the blow select the graph button on the
bottom of the screen.
- You can choose to manually accept or reject a blow using the
drop down list for User Acceptability.
- You can view the trend graph by selecting the trend button on
the bottom left of the screen.
7. After performing the FVC tests press the Cancel button to exit the
FVC Test screen. This brings you back to the Main Menu.
Note: The measurements obtained from a lung function test form part
of the various findings of a physician in the detection, diagnosis and
control of chest diseases. Spirometry may support or exclude
diagnosis, but it cannot make one.

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Saving the Test Session.
The test session is saved to the database by following the on-screen
messages. These messages appear when a new subject, an accuracy
check or POST mode is selected.
Note: If a micro SD card is inserted into the micro SD connector at the
right side of the device, then all test blows and not just the best three
will be saved to the micro SD 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.
2. If you want to perform a Post Test on the Pre-test Session just
performed select ‘Perform Post test on Current Subject’. This will
return you to the test screen. The text Post Mode will appear on the
graph.
3. If you wish to perform a Post Test on a different subject or Pre-test:
a. Select ‘Select Subject from List’.
b. A message ‘Warning! Current test session will end. Do you
want to save the test session?’ will appear. Select Yes and
the Select Subject screen will appear.
c. Select the subject you wish to perform the Post test on, and
the Select Test Session screen will appear. Select the test
session.
Note: The letters P, V or F or a combination of these will
appear after the session ID.
If the letter P appears then a POST test session has
already been performed on this pre session.
If V appears then a VC test has been done as part of the
pre-session.
If F appears then and FVC test has been performed as
part of the pre-session.

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d. Press ‘Enter’ to bring you to the test screen. The text Post
Mode will appear on the graph.
4. Perform the Post FVC test as outlined in section Performing a Test
Session.
Permanent Storage of Pre-Test Sessions
The Post Mode screen also gives you the option to save and recall
test sessions to and from a permanent storage location on the device.
This permanent storage does not get deleted when test sessions are
sent to Spirotrac V or printed. To access this option select ‘Permanent
Storage’.
The Permanent Storage screen gives you four options:
1) Save Test to Permanent Storage: When this option is selected a
message will appear informing you of the memory location where
the test session will be saved. There are nine permanent memory
locations on the Vitalograph In2itive.
2) Load Test from Permanent Storage: When this option is selected
the list of permanent pre-test sessions will appear. Select the
required pre-test session from the list and select enter to bring you
into the Post Mode screen.
3) Delete Test from Permanent Storage: When this option is selected
the list of permanent pre-test sessions will appear. Select the Test
session you wish to delete and press enter. This location will then
be marked as ‘Empty’.
4) Delete all Tests from Permanent Storage. When this option is
selected a warning message will appear:- ‘Do you want to delete all
tests stored in permanent storage?’. Press enter to delete all tests.
Printing and Viewing the Test Session
You can print the current test session for the subject by selecting ‘Print’
from the FVC Test screen.
The Vitalograph In2itive can be connected through the USB port at the
side of the unit or from the cradle to the Vitalograph Reports Utility, so
that the report can be written to a PC. By using the optional Print
Cradle the Vitalograph In2itive can also be connected to an external
PCL compatible printer.

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The information printed on the session report and also the reports
method (Vitalograph Reports or External Printer) can be configured to
suit individual requirements. Refer to section on Report Options.
You can also select the Report option from the Main Menu. If you
already have a Current Subject selected the following options are
available:
a)Current Test Session: You can select to print the current
test session. To print the current session, select the print
icon at the top of the session results screen.
b)Select Test Session: You can select a test session for the
current subject. To print the session, select the print icon at
the top of the session results screen.
c) All Test Sessions: You can print all test sessions for the
current subject.
You can also print Test Session(s) from a different subject in the
database. This is done by selecting the ‘Select’ tab in the View and
Report screen. The following options are available:
a)Select Test Session: You must first select a subject from
the database, and then select a test session for that
subject. To print the selected session, select the print icon
at the top of the session results screen.
b)All Test Sessions: This will print all test sessions performed
on a subject. When you select this option you must first
select a subject from the database.
c) All Test Sessions Between…: This will print all sessions
stored on the device between specified dates. You must
first select the dates.
The default test parameters on the report will vary according to
regional requirements. Test parameters can be configured to suit
individual requirements. Refer to section on Parameters.
Clear Results
If you wish to delete the current session you can do this as follows:
1. Select the ‘Clear’ option from the Main Menu.
2. A message will appear ‘Warning! Current Test Session Will End. Do
you want to save the test session?’ Select ‘Yes’ to save the current
test session and return to the Main Menu. Select ‘No’ to not save

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the current test session and return to the Main Menu. Select ‘C’ to
cancel the operation and continue with the current test session.
Checking Accuracy
All spirometry standards (e.g. ATS/ERS/BTS/ANZRS) recommend
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 In2itive 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. Enter the Syringe volume and reference using the touch panel
keypad.
3. Depending on how the device is configured you may be
prompted to enter the ambient temperature, humidity (0-99%),
pressure (25-31 inHg or 850-1060 hPa-mbar) and altitude (1-
8500m). Enter these values using the touch panel keypad.
4. 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.
5. Press the ‘Enter’ key to bring you into the Accuracy Check
screen and follow the on-screen instructions.
Note: Note: Press the ‘C’ key to exit the Accuracy Check screen
and return to the Main Menu. The accuracy check will not be
logged to the Vitalograph In2itive memory in this case.
6. If an Accuracy Check report is required select the Report option.