Vitalograph 4000 User manual
copd-6 USB
Instructions for Use
MODEL 4000
© Copyright Vitalograph 2020 Current Edition (Issue 2, 29-Oct-2020) Cat. No. 09800
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, 29-Oct-2020)
Cat. No. 09800
Vitalograph is a registered trademark.
Vitalograph Branch Addresses
DT_0006 Issue 15
1. Main Components of the Vitalograph COPD-6 USB
Figure 1 Vitalograph COPD-6 USB Components
1 User buttons
2 Display
3 Flowhead
4 On / Off button
5 USB Connector
Down Button
Up Button
Enter Button
1.1. Features of the Vitalograph COPD-6 USB
• Early detection of COPD.
• Displays FEV1, FEV6, ratio and % predicted, obstructive
index, COPD classication (stage I - IV) and lung age.
• Identies risk of COPD at pre-symptomatic stage.
• Screens out those with normal FEV1.
• Automatically assesses test quality.
• Large, easy to read display.
• Built-in quality of blow indicator.
• Can be used with SafeTway mouthpiece or Eco BVF.
• Download test results via USB and export to PDF report
using Vitalograph Reports software.
2. Setting Up the Vitalograph COPD-6 USB
To get the COPD-6 USB ready for use:
1. Remove the detachable battery door at rear of unit. Fit two
AAA 1.5V batteries. Replace battery door.
2. Turn on via the On/Off Button. (The same button is used
to power down.)
3. Attach a mouthpiece to the owhead, see Figure 2.
Figure 2. Mouthpiece inserted into owhead
4. Vitalograph intends that a new Eco Bacterial Viral Filter
(Eco BVF) be used for every 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.
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. Entering Subject Data
The subject’s physical data should be entered into the device in
order to calculate predicted data. There are default values on
the device for age, height, and gender. If default values are used
instead of the subject’s own information, then the predicted data
will not be accurate for the subject being tested.
To enter subject data:
1. Turn device on.
2. Set subject’s age ( ) by pressing the or button to
reach the correct age. Age increases/decreases in values
of 1. If the button is kept depressed, the values scroll
faster. Press to save the age.
3. Set subject’s height ( ) by pressing the or button
to reach the correct height. Height increases/decreases
in values of 1. If the button is kept depressed, the values
scroll faster. Press to save the height.
Note:if height values are set below 100, the device
assumes height is in inches and that Weight will be in Ibs
rather than Kg.
4. Set subject’s gender ( ) by pressing the or button
and releasing when appropriate gender shows: Male ( )
or Female ( ). Press to save the gender. The device
will go to Test Mode showing the Blow Icon. On some
variants, an additional data eld comes rst (see below).
5. (This step may be omitted, depending on the variant. On
some variants this is Weight instead.) The Population
Group can be set ( ) by pressing the or button
and releasing when the desired setting is reached. Press
to save.
Set No. Population Group
1 NHANES III Caucasian C
2 NHANES III African-American AA
3 NHANES III Hispanic-American HA
3.2. Performing the Test
1. Turn the device on.
2. The blow icon shows when the device is ready for a test ( ).
3. Put a SafeTway or Eco BVF lter onto the device.
4. The subject should sit down to blow into the device (unless
a physician advises otherwise).
5. Instruct subject to hold their head high and hold the
Vitalograph COPD-6 USB ready in front of the mouth, see
Figure 3.
Figure 3. Holding device during test.
6. Instruct subject to
a. Breathe in as deeply as possible.
b. Hold the breath.
c. Place the mouthpiece into the mouth (biting the
mouthpiece lightly and sealing the lips rmly around it).
d. Blow out as HARD and FAST as possible until told to stop
(the unit will beep at end of test - after 6 seconds).
e. Repeat the blow two more times.
7. Instruct the subject not to block the mouthpiece with
tongue or teeth. A ‘spitting’ action will give false readings.
8. To view the result (the best values in the session), press
the button.
9. The COPD Classication shows on the right-hand arrow.
• Green is NORMAL, negative for COPD. No need to refer
this subject for spirometry.
• Any one of the blue zones, I, II, III or IV are not normal.
This subject should be referred for spirometry.
10. The Obstructive Index (OI) shows on the left-hand arrow.
• 0 - Green is NORMAL.
• 1, 2 or 3 – Yellow, orange or red are not normal. Refer for
spirometry, but this is unlikely to be COPD.
Note:If the right hand (COPD) arrow is not green, the left hand (OI)
arrow will also not be green.
11. This is the end of the test, but if desired some test
parameters may be viewed.
12. Following each blow and at the end of the test session, the
FEV1 value displays. Below that is the FEV1 % Predicted
results for that blow, or for the best in session if the
button has been pressed. Pressing again will
toggle between best and last blow.
13. Pressing the button shows the FEV6 and FEV6 %
Predicted results.
14. Pressing the button again shows the FEV1/FEV6 and
FEV1/FEV6 % Predicted results.
15. Pressing the button for a nal time shows the estimated
Lung Age. ( )
Notes on testing:
1. During testing, an exclamation mark( ! ) indicates a poor-
quality blow and the user should blow again. Reasons for
poor quality are;
• Slow Start of test: Vext (extrapolated volume) is > 5% or
150mL of FEV6
• Cough detected.
2. In the event that a test is < 3 seconds duration and has an
abrupt end (change in volume is > 25ml in the last second
of the test), the value FEV will be displayed instead of
FEV6.
3. If the subject experiences side effects such as dizziness
or fatigue during the test procedure, stop testing until
recovered.
3.3. Setting the Obstructive Index and COPD Classication
Zones
The device’s Obstructive Index and COPD Classication zones
are set to the GOLD (Global Initiative for Chronic Obstructive Lung
Disease) standard. It is unlikely that a user will need to change this,
however if change is required the instructions are outlined below.
The colour systems for each zone type are pre-set as follows:
FEV1%
Pred.
Obstructive
Index COPD
Classication
FEV1/FEV6
Ratio and
FEV% Pred.
≥ 80% 0 (Green)
Not COPD FEV1/FEV6
> 0.7
Top
Boundary Stage I
FEV1/FEV6
< 0.70and
FEV1 ≥ 80%
Pred.
< 80% 1 (Yellow) Middle
Boundary Stage II
FEV1/FEV6
< 0.70and
FEV1 < 80%
Pred.
< 50% 2 (Orange) Bottom
Boundary Stage III
FEV1/FEV6
< 0.70and
FEV1 < 50%
Pred.
< 30% 3 (Red) Stage IV
FEV1/FEV6
< 0.70and
FEV1 < 30%
Pred.
To set the boundary percentage values for both the Obstructive
Index and COPD Classication zones together:
1. Turn device on, .
2. When the icon appears, press and hold and buttons
for approximately 3 seconds.
3. Set the top boundary by pressing the or button and
releasing when the value is reached. The values increase/
decrease in values of 1%. If the button is kept depressed, the
values scroll faster.
4. Press to save the top boundary value.
5. Set the middle boundary by pressing the or button
and releasing when the value is reached. The values increase/
decrease in values of 1%. If the button is kept depressed, the
values scroll faster.
6. Press to save the middle boundary value.
7. Set the bottom boundary by pressing the or button
and releasing when the value is reached. The values increase/
decrease in values of 1%. If the button is kept depressed, the
values scroll faster.
8. Press to save the bottom boundary value.
9. Press . The device returns to the age entry screen.
3.4. Reviewing Last Session Test Results
The Vitalograph COPD-6 USB always stores the last test session,
even after the device has powered itself down or has been switched
OFF. To view the last test session:
1. Turn the device on.
2. When the device is ready for age entry ( ), press
button for approximately 3 seconds. The last test
session (best results) data will show again.
3. When you have reviewed the data, press the OFF button for 3s.
OR
Press . The device returns to the age entry screen.
3.5. Downloading saved results
The test session may be transmitted to Vitalograph Reports on your
PC to 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. Connect the COPD-6 USB device to
the PC using the USB cable to allow communication, see Figure 4.
Drivers should automatically install.
Figure 4. Attached USB cable.
1. Run Vitalograph Reports.
2. If ‘No devices have been detected’ message appears, click
‘Continue’.
a. Turn device on, .
b. In Vitalograph Reports ensure ‘Vitalograph COPD-6’ is
selected via the Device Selection Button
3. To print test results from the COPD-6 USB:
When the device is ready for age entry, press button
for 3 seconds for the last saved session. Use the or
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