Vitalograph alpha 6000 User manual

ALPHA
Instructions for Use
MODEL 6000
© Copyright Vitalograph 2021 Current Edition (Issue 1, 27-Jan-2021) Cat. No. 09060

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Vitalograph Ltd, UK
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.co.uk
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph Ltd, International
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.eu
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph GmbH
Rellinger Straße 64a
D-20257 Hamburg
Germany
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.de
Technical Support
Telefon: [phone]
E-mail: [email protected]
Vitalograph Inc.
13310 West 99th Street
Lenexa, Kansas, 66215
USA
Toll Free: 800 255 6626
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.com
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph (Ireland) Ltd
Gort Road Business Park
Ennis, Co Clare, V95 HFT4
Ireland
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.ie
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph Ltd, Hong Kong/China
P.O. Box 812
Shatin Central Post Oce
Hong Kong
E-mail: [email protected]
www.vitalograph.cn
Technical Support
Tel: [phone]
Email: [email protected]
© Copyright Vitalograph 2021
Current Edition (Issue 1, 27-Jan-2021)
Cat. No. 09060
Vitalograph is a registered trademark.
Vitalograph Branch Addresses

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Contents
1. Main Components.................................................................................4
1.1. Features .....................................................................................5
2. Setting up the device ............................................................................5
3. Operating Instructions...........................................................................5
3.1. Entering Subject Data................................................................7
3.2. Conducting a Test......................................................................8
3.3. Reporting.................................................................................11
3.4. Calibration Verication............................................................14
3.5. Connection to Electronic Medical Records (EMR)
via Vitalograph Connect .........................................................15
4. Cybersecurity Considerations.............................................................19
4.1. Specication ............................................................................19
4.2. Security Recommendations....................................................19
4.3. Interfaces .................................................................................20
5. Power Management............................................................................20
5.1. Battery Pack.............................................................................20
5.2. Battery Power Indications......................................................20
5.3. Power Save Mode....................................................................21
6. Cleaning & Hygiene .............................................................................21
6.1. Preventing Cross-Contamination of Subjects........................21
6.2. Inspection of the Vitalograph Model 6000 Alpha..................22
7. Fault Finding Guide..............................................................................23
7.1. Software Check........................................................................24
7.2. Product Useful Life Checks.....................................................24
8. Customer Service ................................................................................25
9. Consumables and Accessories..........................................................25
10.Disposal ...............................................................................................26
11.Explanation of Symbols ......................................................................26
12.Description of the Vitalograph Model 6000 Alpha ............................27
12.1.Indications for Use ..................................................................28
13. Technical Specication.......................................................................28
14.Contraindications, Warnings, Precautions and
Adverse Reactions...............................................................................30
15.CE Notice .............................................................................................32
16.FDA Notice...........................................................................................35
17.EU Declaration of Conformity .............................................................35
18.Guarantee & Free Five Year Warranty.................................................36

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1. Main Components
The main components are:
Figure 1.a
Figure 1.b
A Flowhead
B Touchscreen display
C Micro SD card connector
D On/Off button
E Printer door release button
F Printer
G USB connector
H Ethernet connector
I Power supply input
J Flowhead tubing connector (device)
KFlowhead tubing connector (owhead)

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1.1. Features
The features include:
• Fleisch type pneumotachograph
• Ambient temperature sensor
• Colour touchscreen display
• Sounds for audio feedback
• Integral 4” thermal printer
2. Setting up the device
Check that the contents of the packaging match the contents label inside the
carton.
Preparing for use:
1. Unwrap owhead connection tubing and connect one end to the device
base. The tubing is keyed, so will only connect one way.
2. Connect the other end of owhead tubing to the owhead.
3. Open the printer door and check that a roll of thermal paper is present.
4. Only use the device 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.
5. Connect the power supply into the socket on the rear of the device. Plug the
mains plug into a suitable socket, press the On/Off switch on the side of the
instrument. The device is ready for use.
6. The device is tted with rechargeable batteries, which allows the device to
be used without the power supply connected.
7. On rst use the internal battery pack will require a full charge, this may be
completed overnight and will take a minimum of 12 hours.
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.
Ensure a calibration verication is completed at least once daily, prior to using
the device (see Section 3.4 Calibration Verication).
3. Operating Instructions
On all screens:
the (blue) arrow at the top left goes back one step,
the (green) arrow at the top right moves forward one step.
1. After turning on the device for the rst time, the Start-up Wizard opens
giving 2 options:
 DeviceCong allows the user to change audio level, haptic feedback,
screen brightness, units and language.
Date/Time allows the user to update the Date/Time.

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2. If defaults are acceptable, press the green arrow to move to the main
menu.
3. The Main Menu offers three standard options - Subject, Quick Test and
Conguration - and a fourth option Connect, if Connect is congured.
Figure 2.a
Figure 2.b
The Calibration Verication prompt displays in the centre of the screen
when the device has just been powered on if a calibration verication has not
been completed that day. To complete a calibration verication, press the green
button (see Section 3.4 Calibration Verication).
If a calibration verication is not required press .
4. Subject allows the user to select a current subject by ID, forename or
surname (see section 3.2 Conducting a Test) or to add/create a new subject
(see Section 3.1 Entering Subject Data).

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All subject demographics may be added in the add subject screen.
5. Quick Test allows the user to select Spirometry or Reports .
Reports will always be blank for the Quick Test.
Figure 3
Spirometry option includes VC, FVC and Post (see Sections 3.2
Conducting a Test).
Report option allows printing of a subject’s report to the internal
printer (see section 3.3 Reporting).
6. Conguration - allows the user to:
• carry out a calibration verication (Section 3.4),
• congure reports (Section 3.3),
• congure parameters for test (Section 3.2),
• congure the device including audio level, hepatic feedback and
screen brightness level, setting the date and time , population groups
(Section 3.1) and has the About box containing details of the
device, including software revision number (Section 6.1).
3.1. Entering Subject Data
1. Select ‘Subject’ from the Main Menu.
2. Select ‘Add Subject’ .
Subject information elds are divided into primary and secondary, on 2

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separate pages. Enter details in subject information elds:
Primary: ID , Date of Birth , Height , Birth Sex ,
Population .
Secondary: Alternative ID , Forename , Surname
Weight , Smoker and Pack years .
On the comments page, comments may be freeform or selected from a
pre-dened list.
3. Press the green forward arrow to save subject details and return to
main menu. A warning will appear on screen that no predicted values
will be generated if a required eld is missed.
3.2. Conducting a Test
1. Before starting a test session ensure that a calibration verication of
the device was completed recently (refer to section 3.4 Calibration
Verication).
2. Select a subject and ensure subject details are entered.
3. Wash hands (operator and subject).
4. Fit a disposable BVF to the owhead. The use of a disposable nose clip
is recommended.
5. Instruct and demonstrate the test.
3.2.1. Testing
1. Select ‘VC Test’ or ‘FVC Test’ from ‘Spirometry’ in the Main
Menu.
2. Select how the results should be presented by scrolling across the
screens or pressing the circles at the top of the
screen:
• VC Test - Volume/Time (V/T) graph or Volume (Bar Chart).
• FVC Test - Volume/Time (V/T) graph or Flow/Volume (F/V) graph.
3. When the ‘Exhale to Begin’ icon appears the device is ready to
accept a blow.
• Sit upright, t the nose clip and relax.
• Place BVF in mouth and close lips around the mouthpiece.
• Seal lips around the mouthpiece and keep the tongue down.
• Breathe normally.

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VC test session
a. Breathe normally until the end-expiratory lung volume is stable.
Stability is dened as having at least three tidal breaths with end
expiratory lung volume within 15% of the tidal volume (the device
will alert a user when this has been achieved).
b. Inhale completely, with a brief pause when lungs are completely
full (≤ 2 secs).
c. While maintaining an upright posture, exhale in a relaxed manner
with no hesitation until no more air can be expelled.
d. It is vital that the operator encourages the subject to keep exhaling
to ensure all air is expelled (when a plateau has been reached or
expiration time reaches 15 seconds).
e. The operator should repeat instructions as necessary, with
enthusiasm.
f. When prompted by the device that a satisfactory expiratory ow
plateau has been achieved or expiration time >15 seconds, inhale
maximally and then return to normal breathing.
g. The manoeuvre is now complete. Remove the BVF from the mouth.
h. Listen for two beeps. The device is now ready for the next blow.
i. Repeat for a minimum of three manoeuvres, up to a maximum of
eight.
j. Check VC repeatability and perform more manoeuvres as
necessary.
k. Click on for quality information and test acceptability.
Note: A single-breath VC technique may also be performed on the
device.
FVC test session:
a. Inhale completely and rapidly, with a brief pause when lungs are
completely full (≤ 2 secs).
b. While maintaining an upright posture, exhale with maximal effort
until no more air can be expelled.
c. It is vital that the operator encourages the subject to keep exhaling
to ensure all air is expelled (when a plateau has been reached or
forced expiratory time (FET) reaches 15 seconds).
d. The operator should repeat instructions as necessary, with
enthusiasm.
e. Breathe in with maximal effort until completely full. The
manoeuvre is now complete, remove the BVF from the mouth.
f. Listen for two beeps. The device is now ready for the next blow.
g. Repeat for a minimum of three manoeuvres, up to a maximum of

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eight.
h. Check FEV1 and FVC repeatability and perform more manoeuvres
as necessary.
i. Click on for quality information and test acceptability.
Note: A single-breath FVC technique may also be performed on the
device.
Results grading for FEV1 and FVC is shown below in Table 1.
Grade Number of measurements Repeatability:
Age >6yr
Repeatability:
Age ≤ 6yr
A≥ 3 acceptable Within 0.150L Within 0.100 L*
B 2 acceptable Within 0.150 L Within 0.100 L*
C≥ 2 acceptable Within 0.200 L Within 0.150 L*
D≥ 2 acceptable Within 0.250 L Within 0.200 L*
E≥ 2 acceptable
OR 1 acceptable
> 0.250 L
N/A
> 0.200 L*
N/A
U0 acceptable AND ≥ 1
usable N/A N/A
F 0 acceptable and 0 usable N/A N/A
*Or 10% of the highest value, whichever is greater; applies for age 6 years or
younger only.
Table 1: Grades
3.2.2. Bronchodilator Responsiveness Testing
Bronchodilator responsiveness testing can be performed on any pre-
test session performed.
1. Select ‘Spirometry’ from the Menu, then select ‘Post’ .
2. Select the relevant pre-test from the list and perform the post-test as
outlined in section 3.2.1 Testing.
Note: A Post-test may only be completed if an existing Pre-test is
available.
3.2.3. Viewing FVC Test Results
Results may be viewed as either a Volume/time (V/t)or Flow/
Volume (F/V)graph by scrolling across the screens or pressing the
circles at the top of the screen. Screens viewed in
order: F/V graph, V/t graph, Results screen.
The Results screen displays Best, %Pred, Pred values, z-score, LLN by

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pressing the tabs .
There are additional options to add comments and information
on session quality and session interpretation.
The user may add comments of up to 250 characters to the results by
clicking in the top right corner. Select again to save and close.
The icons and in the bottom right corner allow the user
to select from pre-dened comments as per ATS/ERS 2019. Select
again to save and close.
The icon in the top right corner displays the session information,
quality, and interpretation. Select again to close.
3.2.4. Viewing VC Test results
VC test results may be viewed as either a Volume/time (V/t) or Volume
Bar graph by scrolling across the screens. First screen is the bar graph,
second is the V/t graph, third is the Results screen. All other viewing is
as per section 3.2.3
3.2.5. Saving and ending the Test Session
The device has capacity to store at least 20,000 tests, with a maximum
of 8 blows allowed for each test session. Stored session
information includes subject details and best pre-test if it is a
bronchodilator responsiveness test session.
A session ends and is saved when the user exits the test screen by
pressing the green arrow on the top right.
A session also ends and is saved if any of the following occur:
• The device is turned off.
• A new subject is created.
• The device is connected to Device Studio.
3.3. Reporting
To print the current subject test session:
1. Select the green forward arrow to go to the print screen.
2. Select the ‘Print’ icon on screen.
3. Alternatively returning to the main menu and selecting the ‘Reports’

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option will display a list of the sessions available for print. Clicking on a
session will allow it to be reviewed, a long press will print.
Report Conguration: Select in ‘Conguration’ of the Main
Menu to congure reports. Options include enable/disable predicted
shading, predicted I-bars, test graphs, report % predicted, session
comments, subject comments, environmental data, auto acceptability
and posture.
3.3.1. Internal Printer
The device has an internal 4” thermal printer.
To load paper to the internal printer: with the device facing forward
press the printer button to open the door. Remove the tape from the
new paper roll, unroll a small amount of paper and load it into the paper
holder with the blue writing facing out on the right-hand side. Close the
printer door.
Figure 4
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 Device Studio Utility.
3.3.2. External Printer via Vitalograph Device Studio
The device can print to an external printer using the Device Studio
application.
To generate PDF reports from the device:
1. Use the USB cable supplied to connect the device to a computer
running Device Studio.
2. Ensure that Device Studio application is open, the device is switched

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on and in the main screen. If the device is not already connected,
click on the ‘Connect Device’ option in the menu.
Figure 5.a
3. Device Studio will search for assessments on the device (see Fig
5.a). Available assessments are shown on screen and may be
selected and printed and/or saved (see Fig 5.b).
Figure 5.b
4. Device Studio may also be used to print/save calibration verication
reports and to update device rmware.
5. When nished with Device Studio click on the ‘Disconnect Device’
option in the application menu before disconnecting the USB cable/
device.
Note: If the USB cable/device is disconnected prior to clicking the
‘Disconnect Device’ option the device will restart.

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Additional guidance on using Device Studio can be found in the
Instruction for Use PN 09550 supplied on the USB ash drive PN 93002
and in the software help menu of the application.
The settings option allows the user to congure information displayed
on the session report.
3.4. CalibrationVerication
ISO 26782 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% (2.5% for the device with
an additional 0.5% allowed for the syringe).
1. Attach the owhead to the syringe as per gure 6.
Figure 6
2. Select ‘Conguration’ on the main menu, select ‘Calibration Verication’
option.
3. Enter syringe details: serial number, syringe volume (will default to 3L),
pressure, altitude and humidity %. At a minimum the serial number,
syringe volume and temperature must be entered. The temperature
auto lls from the internal temperature sensor but may be changed if
required. If a calibration verication was performed previously this will
pre-populate with the details of last syringe used.
Press Continue.
4. Complete 3 full strokes as per onscreen instructions.
5. If the reproducibility between the 3 consecutive syringe strokes is less
than 3% of 3L, the calibration verication has passed, and a green
tick displays on the syringe icon and <3% is displayed in the top right
corner.
In the unlikely event the result is outside 3% or non-reproducible, an
error icon will display.
Successful verication check with tick in syringe
indicating a pass.

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Non-reproducible syringe strokes (red syringe, after
the 5th Stroke). Repeat calibration verication.
Outside 3%, 6% or 25% (purple syringe, and shows
>3%, >6% or >25% in top right corner of screen).
The % it is out by indicates the severity of the issue.
Over 3%, repeat calibration verication.
Over 6% may indicate the device requires cleaning or
maintenance.
Over 25%, the user should contact technical support.
The following displays after the calibration update:
Calibration update (purple syringe with purple tick
in a circle, % shown in top right corner of screen).
A report may be printed or saved for the calibration verication if required, see
section 3.3. Reporting.
If the procedure was followed correctly and the error icon is showing, the
calibration verication may be repeated. If the error continues to show, contact
the manufacturer using contact information at the start of this document.
3.5. Connection to Electronic Medical Records (EMR) via Vitalograph
Connect
Connection to an EMR system may be achieved using the Connect
service. This is available on the Flash Drive PN 93002 supplied with the
device. Refer to the Connect IFU PN 09570 for information on installing
and running Connect.
3.5.1. ConnectConguration
On the main menu select ‘Connect Cong’ .
The following information is required:
- Address: URL for the Connect service - http://{host}[:{port}]/
connect
- Network information: Three options - disabled, wired or wireless.

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Figure 7 – Example set up for Connect
Once the information is entered, select the appropriate tab: wireless or
wired.
a. Wireless Network
1. When the wireless tab is selected the device searches all
available networks.
2. Select the required network and enter passkey. The ‘Advanced’
option allows the user to add/edit the advanced network details
if required.
3. Press the green forward button to save.
4. To test the connection, re-select the ‘Connect Cong’ option and
press the ‘Test Connection’ button at the bottom of the screen
(see Figure 7).
5. This message conrms if there is a good connection

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.
6. When connected, a WiFi symbol displays in the status
bar, top left.
b. Wired Network
1. For a wired connection complete the required information in the
‘Wired Network’ tab, including:
• MAC address
• Connection method (DHCP or Static)
• IP address
• Netmask
Figure 8 - Example set up for Connect (wired)
2. When connected, a wired Ethernet symbol displays in the
status bar, top left.
Once Connect is congured, the Main menu offers Subject,Quick Test,
Conguration and Connect options. (See section 3, Figures 2.a and 2.b
above).
Scroll right to access the Connect option.
The Connect screen has three tabs (see Figure 9).
• New Orders
• Open Orders

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• Return Orders
Figure 9
3.5.2. New Orders
To process a new order, go to the ‘New Orders’ tab, select the order
required and press the ‘Start Testing’ button (see Figure 9). The subject
information displays. Review and press the green forward button to
proceed with a test. The main test menu displays. Select ‘Spirometry’
and complete a test (see section 3.2.1 Testing). When complete, select
the green forward button to exit and close the session.
3.5.3. Open Orders
The ‘Open Orders’ tab shows a list of orders allocated to the device
which have not yet had a test completed. These remain on the list until
they are processed. To process an open order, select it from the list and
follow the same instructions as for new orders in section 3.5.2 New
Orders above.
3.5.4. Return an Order
To return an order to the EMR go to the ‘Return Orders’ tab, select the
order required. All available sessions for that order will be shown.
If the order is complete, ensure the required sessions are selected
and press the ‘Return’ button (see Figure 10). If additional testing is
required select the ‘Start Testing’ button rst (see Figure 10 below)
and press the green forward button to proceed with a test (see section
3.5.2 New Orders). When complete, select the green forward button to
return and complete the order.

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Figure 10
3.5.5. Return Unsolicited
Unsolicited Orders are tests that were not allocated by the EMR.
If the EMR is congured for unsolicited orders the user may select the
‘Return Unsolicited’ button , complete a test, and return it
to the EMR.
The ‘Return Unsolicited’ button does not show if the EMR is not
congured for unsolicited orders.
4. Cybersecurity Considerations
4.1. Specication
The device employs an Operating System (OS) that is not accessible
under normal use. The application runs on top of the OS and is the only
user interface to the device. The OS has a congured rewall
to protect against any unauthorised access over the
communications ports, only Vitalograph PC based applications
can access the device over a secure connection. No further controls are
required to be applied by users to secure the device. The
device will timeout and auto power down after 5 minutes of inactivity.
4.2. Security Recommendations
When connecting to a PC it is recommended that the PC has the
following cybersecurity in place:
• Up to date Operating System: the Operating System should be
congured for automatic update for security patches and have all of
the latest patches applied.
• Antivirus/antimalware: the PC should have a reputable antivirus or
antimalware application installed and all updated virus denitions in
place.
• Secure Login: the PC should be password protected via industry
standard user access controls, via active directory or other methods.
• Firewall: if the PC is connected to the internet ensure a reputable
rewall or equivalent protection is in place to protect against
unauthorised external access.

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4.3. Interfaces
Communications interfaces – USB, WiFi, Ethernet: The device will
communicate with Vitalograph PC based applications for:
• Back-ups and restore
• Software updates
• Printing to external printer
• Transfer of test data
SD Card: Only used for encrypted backup of stored data.
5. Power Management
The device can be powered using the 12V low voltage Power Supply with which
it is supplied, or from the internal Battery Pack.
5.1. Battery Pack
The device is tted with a rechargeable Battery Pack which allows it to
be used without the 12V power supply connected. To fully recharge,
switch off the device and leave the power supply plugged in overnight.
A full charge will allow 5 hours testing with 5 reports from the internal
printer.
Note: With the power supply plugged in the device will continue to
charge even if it auto powers down after 5 minutes of inactivity.
The recommended battery pack replacement interval is 3 years. Battery
replacement should be carried out only by the manufacturer, the
approved importer or by Service Agents approved by Vitalograph.
Note: Powering the device or recharging the battery pack from the
USB is not possible.
5.2. Battery Power Indications
The device has several battery power indications:
When the battery is fully charged, a white ‘Battery Full’
icon displayson the status bar at the top of the screen.
Disconnect the device from external power source when
it is fully charged.
When the battery is at less than 20% capacity, an orange
‘Battery Low’ icon displays on the status bar at the top of
the screen.
You may continue to use the device, but it is advisable to
connect to an external power source.