Vitalograph 4000 User manual
asma-1 BT
Instructions for Use
MODEL 4000
© Copyright Vitalograph 2020 Current Edition (Issue 2, 03-Nov-2020) Cat. No. 09740
Vitalograph Ltd, UK
Maids Moreton, Buckingham
MK18 1SW
England
Tel: 01280 827110
Fax: 01280 823302
E-mail: [email protected]
www.vitalograph.co.uk
Technical Support
Tel: 01280 827177
Email: [email protected]
Vitalograph Ltd, International
Maids Moreton, Buckingham
MK18 1SW
England
Tel: +44 1280 827120
Fax: +44 1280 823302
E-mail: [email protected]
www.vitalograph.eu
Technical Support
Tel: +353 65 6864111
Email: [email protected]
Vitalograph GmbH
Rellinger Straße 64a
D-20257 Hamburg
Germany
Tel: +49 40 547391-40
Fax: +49 40 547391-40
www.vitalograph.de
Technical Support
Telefon: +49 40 547391-14
E-mail: [email protected]
Vitalograph Inc.
13310 West 99th Street
Lenexa, Kansas, 66215
USA
Toll Free: 800 255 6626
Tel: (913) 730 3200
Fax: (913) 730 3232
E-mail: [email protected]
www.vitalograph.com
Technical Support
Tel: (913) 730-3205
Email: [email protected]
Vitalograph (Ireland) Ltd
Gort Road Business Park
Ennis, Co Clare, V95 HFT4
Ireland
Tel: +353 65 6864100
Fax: +353 65 6829289
E-mail: [email protected]
www.vitalograph.ie
Technical Support
Tel: +353 65 6864111
Email: [email protected]
Vitalograph Ltd, Hong Kong/China
P.O. Box 812
Shatin Central Post Oce
Hong Kong
E-mail: [email protected]
www.vitalograph.cn
Technical Support
Tel: +353 65 6864111
Email: [email protected]
© Copyright Vitalograph 2020
Current Edition (Issue 2, 03-Nov-2020)
Cat. No. 09740
Vitalograph is a registered trademark.
Vitalograph Branch Addresses
DT_0006 Issue 15
1. Main Components of the Vitalograph asma-1 BT
Figure 1 Vitalograph asma-1 BT Components
1 User Buttons
2 Display
3 Flowhead
Down Button
Up Button
Enter Button
1.1. Features of the Vitalograph asma-1 BT
• Electronic records
• Stores 600 test sessions
• Download test results via Bluetooth and export to PDF
report using Vitalograph Reports software.
• Automatically assesses test quality
• Measures PEF and FEV1 and % of personal best
• PEF and FEV1 zones can be personalized
• Automatically stores best values
2. Setting Up the Vitalograph asma-1 BT
To get the asma-1 BT ready for use:
1. Remove the detachable battery door at rear of unit. Fit two
AAA 1.5V batteries. Replace battery door.
2. Attach a mouthpiece to the owhead.
Figure 2. Mouthpiece inserted into owhead
3. If used for multiple subjects, Vitalograph intends that a
new Eco Bacterial Viral Filter (Eco BVF) be used for every
test subject to prevent cross contamination. Using a new
Eco BVF provides a signicant level of protection of the
subject, the device and the user against the risk of cross
contamination during spirometry manoeuvres. Eco BVF
and SafeTway mouthpieces are single use items and must
be disposed of after use.
4. Turn on via the On/Off Button. (The same button is used
to power down.)
3. Operating Instructions
If the device has just been unpacked or transported, ensure that it is
left sitting, fully powered and is at room temperature prior to testing.
3.1. Setting Personal Best (Reference) Values
Personal Best (reference) values can be set for peak ow (PEF)
and/or forced expiratory volume after 1 second (FEV1).
To set the Personal Best (reference) PEFs:
1. Turn the device on, .
2. When the device is ready for a test ( ), press the and
buttons together for 3 seconds.
3. Set the reference PEF value by pressing the button and
releasing when the value is reached. Press the to roll
back. The values will increase/decrease in values of 10. If
the button is kept depressed, the values will scroll faster.
4. Press ENTER to save the reference PEF value.
5. Press again to exit, OR to set the Best Test (reference)
FEV1:
6. Set the reference FEV1 value by pressing the button and
releasing when the value is reached. Press the to roll
back. The values will increase/decrease in values of 0.10.
If the button is kept depressed, the values will scroll faster.
7. Press ENTER to save the reference FEV1 value. The
device will return to the test screen.
Note: to de-activate zones, set both the PEF and FEV1 reference
values to 000/0.00.
3.2. Setting Management Zones
The asma-1 BT can be set for use with 3 or 4 zone management
plans. The zones are factory set to 2 boundaries (80% & 50%)
resulting in 3 Zones (0-50%, 50-80%, 80-100%). For 4 zones the
middle boundary is set last. The colour systems for each zone are:
Green Green
Top Boundary Yellow Yellow Top Boundary
Orange Middle Boundary
Bottom Boundary Red Red Bottom Boundary
3 Zone 4 Zone
To set boundary percentage values for 3 zones:
1. Turn the device on, .
2. When the device is ready for a test ( ), press the and
buttons together for approximately 3 seconds.
3. Set the top (Green/Yellow) boundary by pressing the
or button and releasing when the value is reached. The
values will increase/decrease in values of 1%. If the button
is kept depressed, the values will scroll faster.
4. Press ENTER to save the boundary value.
5. Set the bottom (Yellow/Red) boundary by pressing the
or button and releasing when the value is reached.
6. Press to save the boundary value.
7. Select the next value as 0% (default). Only 2 boundaries are
required for the 3 zone system.
8. Press . The device will return to the test screen.
To set boundary percentage values for 4 zones:
1. Set the top and bottom boundaries – see steps 1 – 6
above.
2. Set the middle (Yellow/Orange) boundary by pressing the
button and releasing when the middle boundary value
is reached. The values will increase/decrease in values of
1% after an initial jump to the lower boundary value. If the
button is kept depressed, the values will scroll faster. This
boundary value cannot be set at a value that is greater than
the top boundary value or less than the bottom boundary
value.
3. Press to save the middle boundary value. The device
will return to the test screen.
3.3. Performing a Test
1. Fit a mouthpiece, SafeTway or Eco BVF lter to the device.
2. Turn the device on.
3. Sit down to blow into the device (unless the physician
advises otherwise).
4. When the device is ready for a test ( ), holding the head
high, breathe in as deeply as possible, hold the Vitalograph
asma-1 BT ready in front of the mouth, see Figure 3.
Figure 3. Holding device during test.
5. Holding the breath, place mouthpiece into the mouth, biting the
mouthpiece lightly, and with the lips rmly sealed around it.
6. Blow out as HARD and as FAST as possible for a second or
more. Be careful not to block the mouthpiece with the tongue
or teeth. A ‘spitting’ action will give false readings.
7. The PEF result for this blow displays on screen, followed by the
FEV1 result after approximately 3 seconds. If the Personal Best
has been set, an arrow indicates which colour management
zone the blow relates to.
8. When the blow icon shows, blow again ( ). Usually 3 blows
are required.
9. To view the best test in the session (best PEF and best FEV1),
press the button. This value is recorded as the result for
the session in the device history.
Note: An exclamation mark ! indicates a poor quality blow and the
blow should be repeated.
The ! warning appears when the time to Peak Flow > 120ms or a
cough is detected in the rst second.
If dizziness or fatigue is experienced during the test session, wait
until this passes before blowing again, or terminate the session.
3.4. Reviewing Previous Results
The asma-1 BT can store up to 600 test sessions. To view
previously performed test sessions:
1. When the device is ready for a test ( ), press the
button for approximately 3 seconds.
2. The most recent test session displays. The best PEF result
will be displayed for approximately 3 seconds, followed
by the best FEV1 result. The session number ‘1’ is also
displayed, this is the latest session.
3. View earlier test sessions by pressing the button.
4. Press . The device will return to the test screen.
3.5. Deleting All Results History
Caution: Results history cannot be recovered once it has been
deleted.
To delete entire history, i.e. all previously stored session results:
1. When the device is ready for a test ( ), press the and
buttons simultaneously for approximately 10 seconds.
2. A long beep indicates success. The device returns to the test
screen.
3.6. Downloading saved results
The test session may be transmitted to Vitalograph Reports
software on your PC where it can be stored as a PDF le and viewed
or printed.
Vitalograph Reports must be installed and running on the PC before
data is transmitted. The software is running if the Vitalograph ’V’
icon shows in the PC System Tray. If not, refer to help button of the
software for more information. The Bluetooth Adaptor should be
plugged in to the host PC to allow communication. Drivers should
automatically install.
1. Run Vitalograph Reports.
2. If the ‘No devices have been detected’ message appears,
click ‘Continue’.
a. Turn device on, .
b. In Vitalograph Reports ensure ‘Vitalograph asma-1’ is
selected as the device via the Device Selection Button
3. To print the test results from the asma-1 BT:
When the device is ready for a test ( ), press the
button for 3 seconds. The device will show the Report
icon ( ). OR
After completing the test session, press the or
button until the Report icon ( ) is displayed. Press .
4. Once the print icon is displayed on the device, start the
service as shown by selecting ‘Start Report Service’ from
the ‘File’ Menu
5. Vitalograph Reports will download the report and the report
will be generated.
6. In Vitalograph Reports enter the Subject Demographic
details and Comments. When the information is entered
select ‘Continue’.
7. The PDF report saves in the default location: C:\
Vitalograph\VitalPrint2.0\Reports
4. Power Management
The asma-1 BT operates with 2 AAA 1.5V disposable batteries.
If the battery symbol ashes the batteries should be replaced.
Replace the batteries by removing the battery door on the underside
of the device.
Note: Dispose of used batteries safely.
5. Cleaning & Hygiene
The Vitalograph asma-1 BT is not designed or supplied as a ‘sterile’
device. Keep the device clean and dust free. If you suspect the
device is damaged or is measuring incorrectly, contact your medical
professional immediately.
The Vitalograph asma-1 BT should continue to give reliable
measurements for up to three years in home use. It should then be
replaced with a new device.
5.1. Cleaning in Single Patient Environment
For single patient use, the plastic mouthpiece may be used.
Weekly cleaning of the mouthpiece, outside surfaces and owhead
of the device is recommended. A cloth impregnated with 70%
isopropyl alcohol may be used. The reusable plastic mouthpiece
may be washed in warm soapy water and then rinsed in clean water.
The device should be cleaned before and after an extended period
of storage.
5.2. Preventing Cross-Contamination of Subjects in Clinic use
For multi-patient use in a clinic or telemedicine environment
Vitalograph recommends the use of ECO BVF lters or, if these
aren’t available then SafeTway mouthpieces may be used based on
the customer own risk assessment and hygiene controls.
Before use by the next subject, the mouthpiece, outside surfaces
and owhead of the device should be cleaned with a cloth
impregnated with 70% isopropyl alcohol. The device should be
cleaned before and after an extended period of storage. If you
suspect that a device intended for multi-patient use has become
contaminated, it should be replaced.
When used in the clinic environment, it is recommended that
the device be replaced annually. There is no planned preventive
maintenance for this medical device.
6. Fault Finding Guide
Problem Fault Symptoms: No ow measurements
Possible Solutions: (In
probable order)
The batteries may be low. Replace
the batteries.The owhead may be
damaged. Check that the rotating
vane is spinning freely.
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