Device Studio

Instructions for Use

© Copyright Vitalograph 2022. Current Edition (Issue 3, 21-Apr-2022) Cat. No. 09550
 A Global Leader in Respiratory Diagnostics

Vitalograph Branch Addresses

Vitalograph Ltd, UK Vitalograph GmbH Vitalograph (Ireland) Ltd

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Maids Moreton, Buckingham Rellinger Straße 64a Gort Road Business Park
MK18 1SW D-20257 Hamburg Ennis, Co Clare, V95 HFT4
England Germany Ireland
Tel: 01280 827110 Tel: +49 40 547391-40 Tel: +353 65 6864100
Fax: 01280 823302 Fax: +49 40 547391-40 Fax: +353 65 6829289
E-mail: sales@[Link] E-mail: info@[Link] E-mail: sales@[Link]
[Link] [Link] [Link]
Technical Support Technical Support Technical Support
Tel: 01280 827177 Telefon: +49 40 547391-14 Tel: +353 65 6864111
Email: [Link]@[Link] E-mail: support@[Link] Email: [Link]@[Link]

Vitalograph Ltd, International Vitalograph Inc.

Maids Moreton, Buckingham 13310 West 99th Street
MK18 1SW Lenexa, Kansas, 66215
England USA
Tel: +44 1280 827120 Toll Free: 800 255 6626
Fax: +44 1280 823302 Tel: (913) 730 3200
E-mail: sales@[Link] Fax: (913) 730 3232
[Link] E-mail: contact@[Link]
Technical Support [Link]
Tel: +353 65 6864111 Technical Support
Email: [Link]@[Link] Tel: (913) 730-3205
Email: technical@[Link]

© Copyright Vitalograph 2022

Current Edition (Issue 3, 21-Apr-2022)
Cat. No. 09550 is a registered trademark.

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Device Studio - Instructions for Use 09550 Issue 3

Contents
1. Indications for Use....................................................................................................................................... 4
2. Contraindications, Warnings, Precautions and Adverse Reactions.......................................................... 4

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3. Main Components of Vitalograph Device Studio....................................................................................... 4
3.1. Features of Vitalograph Device Studio...............................................................................................4
4. Setting Up Vitalograph Device Studio ........................................................................................................ 5
4.1. Installation...........................................................................................................................................5
5. Operating Instructions................................................................................................................................. 5
5.1. Starting Device Studio.........................................................................................................................5
5.2. Assessment Reports...........................................................................................................................5
5.3. Printing Assessment / Calibration Verification Reports...................................................................6
5.4. Software Settings................................................................................................................................6
5.5. Device Update......................................................................................................................................6
5.6. Shutting Down the Application...........................................................................................................7
6. Devices.......................................................................................................................................................... 7
6.1. Vitalograph Alpha................................................................................................................................7
6.2. Vitalograph Micro................................................................................................................................7
7. Power Management..................................................................................................................................... 7
8. Cleaning & Hygiene...................................................................................................................................... 7
9. Fault Finding Guide...................................................................................................................................... 8
9.1. Software Check....................................................................................................................................8
10. Customer Service......................................................................................................................................... 8
11. Consumables and Accessories................................................................................................................... 8
12. Disposal........................................................................................................................................................ 8
13. Explanation of Symbols............................................................................................................................... 8
14. Description of Vitalograph Device Studio................................................................................................... 9
15. Technical Specification................................................................................................................................ 9
16. CE Notice...................................................................................................................................................... 9
17. FDA Notice.................................................................................................................................................... 9
18. EU Declaration of Conformity...................................................................................................................... 9
19. Guarantee..................................................................................................................................................... 10

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 A Global Leader in Respiratory Diagnostics

1. Indications for Use

Device Studio is a PC based software application intended to generate PDF or printed reports to a user’s PC from a
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standalone desktop or handheld spirometer, respiratory monitor or screener manufactured by Vitalograph.

Device Studio is intended for use by adult professionals or non-professionals (e.g. administrative staff) in a variety of
healthcare environments, e.g. primary care, hospitals and occupational health centres.

2. Contraindications, Warnings, Precautions and Adverse Reactions

N/A

3. Main Components of Vitalograph Device Studio

Device Studio is a software application, supplied on USB flash drive for installation on a computer and intended to
generate reports from Vitalograph spirometers and respiratory monitors.

Figure 1 Main components of Vitalograph Device Studio

Note: Computer not supplied

3.1. Features of Vitalograph Device Studio

The features include:
• Automatic detection and connection to supported Vitalograph devices
• Report generation including:
• Archive to PDF
• Print to External Printer
• Configurable report location and naming
• Customisation of report logo and report header text
• Backup and restore data on connected devices
• Update firmware on connected devices

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4. Setting Up Vitalograph Device Studio

Recommended PC Requirements

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Refer to Section 15 Technical Specification

4.1. Installation

1. Insert USB flash drive into USB port on the PC. Browse media contents and run Setup.
2. Follow onscreen instructions. Click “Install Device Studio” to start the installer.
3. If prompted “Do you want to allow this app to make changes to your device?”, click Yes.
4. A message confirms when installation is complete. Click Close.

5. Operating Instructions
5.1. Starting Device Studio

1. Open Device Studio from the start menu or Vitalograph icon on the desktop.
2. The “No Current Device” icon displays until a successful connection has been established.
3. To connect a device, the device must be switched on and connected to the PC by USB cable. For instructions
for compatible devices, refer to Section 6 Devices
4. The flashing green icon indicates a successful connection to the device.
5. The application shows on screen and the Vitalograph icon shows in the Windows® taskbar when the
application is open.
6. Minimising removes the application from view on the screen and shows it in the task bar. It can be shown on
screen again by double clicking the icon.
5.2. Assessment Reports
5.2.1. Searching Assessment Reports on Alpha
There are 4 quick search options and a custom search tool.
The default search option shows sessions performed that day.
Searches can be filtered to include sessions performed over the last 7 days, last 30 days or all days.
Filter options in the custom search tool:
1. From date – search for sessions from this date
2. To date – search for sessions to this date
3. Session Type – e.g. FVC, VC
4. First name of subject
5. Last name of subject
6. Subject ID
5.2.2. Assessment Reports on Micro
Select the next available session on Device by clicking “Next Session” button
The latest session performed on the Micro will be next session available

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User can add the following to the Session for Printing

• First Name
• Last Name
• Additional Subject Information
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• Additional Session Information

• Additional Interpretation Information
• Session ID can be edited

Entered data can be cleared using the “Clear Text” option

Select to print or save the session report (see section 5.3)
Move to the Next Session on the Device by clicking the “Next Session” button
5.3. Printing Assessment / Calibration Verification Reports
There are two options for printing session and accuracy reports:
1. Print selected reports to an external printer.
2. Save selected reports as PDF files to a chosen folder for archiving.

By default, Assessment Reports are saved as a PDF to the following location:

“C:\Vitalograph\DeviceStudio” folder.
To change default options, refer to Section 5.4 Software Settings.
5.4. Software Settings
To change software settings, click on Settings menu on the main screen.
1. Automatic Start
• Automatically start Device Studio on Windows start-up
2. Saved Reports
• Save to Folder: Select a location for saving reports. The default location is C:\Vitalograph\DeviceStudio
• Use File Name format:
• Report Type, Assessment Date, Patient Name
• Report Type, Assessment Date, Patient Number
• Report Type, Assessment Date, Patient Number, Patient Name
3. Report Header
• Customize Logo:
• Select a new logo by clicking Custom
• Select the default Vitalograph Logo by clicking Default or
• Select no logo on the report by clicking None.
• Header Text: Add a custom header to the report (up to a maximum of 34 characters).
4. Report Templates:
• Additional report templates are available from Vitalograph. Select the Request New Template option to
generate an email request.
• Save the new report template to the required folder under:
• C:\ProgramData\Vitalograph\DeviceStudio\ReportTemplates (Note – “Show hidden files/folders” must be
enabled in File explorer options)
• FVC - For custom FVC and Post FVC reports
• VC - For custom VC and Post VC reports
• ACC - For custom Calibration Verification reports
5.5. Device Update
Note – A backup should be performed prior to an update or formatting.
Note – No Backup is available for Micro Device
The following options are available:
• Update Firmware on Connected Device
• Manually from a File (file can be located on USB key or PC location)
1. Select the ‘From File…’ Button
2. Perform a backup as prompted
3. Browse and select the firmware update package (.ipk file)
4. Select Update, the device will restart and disconnect from device studio
• Online (Internet access is required)
1. Select the ‘Check Online…’ Button
2. Perform a backup as prompted
3. If an update is available a notification will appear
4. Select Update, the device will restart and disconnect from device studio
• Backup Connected Device

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• Backup the connected device contents to a user defined folder location.

• Restore previously backed up contents of a device from a folder location.
• Format Connected Device
• Clear Memory: This option allows the user to format a device.

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5.6. Shutting Down the Application
Shut down the application by clicking the X on the top right or via the Exit option. To continue to use Device Studio,
restart the application from either the short-cut in the Start menu or on the Windows® Desktop.

6. Devices
6.1. Vitalograph Alpha
6.1.1. Connecting to the Vitalograph Alpha
• Open Device Studio on the computer.
• Power on the Alpha.
• Ensure device is on the main screen where Subject, Quick Test and Configuration are displayed.
• Connect the Alpha to the computer by USB cable, using the USB port at the back of the device.
• When the Alpha is detected click on the Connect Device button.
• The Alpha will display a USB connection symbol to confirm that connection has been made.

6.1.2. Disconnecting from the Vitalograph Alpha

• Click on the Disconnect button
• The Alpha shall return to its main menu.
• Note: Removing the USB cable without first disconnecting shall result in the Alpha restarting.
6.2. Vitalograph Micro
6.2.1. Connecting to the Vitalograph Micro
• Open Device Studio on the computer.
• If device does not have battery power
• Connect device by USB cable, using the USB port at the side of the device.
• Power On
• The Micro will display a USB connection symbol to confirm that connection has been made.
• If device does have battery power
• Power On
• Ensure device is on the main screen where Subject, Quick Test and Configuration are displayed.
• Connect device by USB cable, using the USB port at the side of the device
• The Micro will display a USB connection symbol to confirm that connection has been made.

6.2.2. Disconnecting from the Vitalograph Micro

• Remove the USB Cable from Device

7. Power Management
N/A

8. Cleaning & Hygiene

N/A

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 A Global Leader in Respiratory Diagnostics

9. Fault Finding Guide

Problem Fault
Cannot connect to the attached device
Symptoms:
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Possible Solution: For the Vitalograph Alpha or Micro check the device is connected to the PC, powered on
(In probable order) and on the main screen before starting the application.

Problem Fault The application indicates that a report was created but it does not appear to have been
Symptoms: created/saved to the PC.
Check that the PC user has full read/write access rights to the folder and sub-folders of
Possible Solution both the location where the Device Studio application is installed, and also the location
(In probable order): chosen to save the PDF report files. The System Administrator on the PC will have to set
these security settings.
Problem Fault An error message appears saying that an application instance is already running even
Symptoms: though no Vitalograph icon is visible in the processes section of the taskbar.
Check there are no other users logged onto the system with the application running.
Possible Solution
It may be that another user is also logged onto the system using the “Switch User”
(In probable order):
Windows® function and that user may have an application instance running.
Problem Fault
The application disappears on minimising.
Symptoms:
Possible Solution
The application is running in the system tray. Double click its icon in the tray to view.
(In probable order):

9.1. Software Check

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, click on Help > About Device
Studio on the toolbar of the application main screen.

10. Customer Service

Service and support should be carried out only by the manufacturer, or by Service Agents approved by Vitalograph.
Contact information for approved Vitalograph Service Agents may be found at the start of this manual.

Any serious incident that has occurred in relation to this software should be reported to Vitalograph or its Authorised
Representative and the Regulatory Authorities of the country. Refer to the Vitalograph contact information at the start
of this manual.

11. Consumables and Accessories

N/A

12. Disposal
N/A.

13. Explanation of Symbols

Main Screen

Assessment reports or Calibration reports menu icon

Settings menu icon

Updates menu icon

Connect/Disconnect device menu icon

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System information menu icon

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Help menu icon

Exit application menu icon

14. Description of Vitalograph Device Studio

Device Studio is an application that provides functionality for generating PDF reports for Vitalograph Alpha and In2itive
devices. The application also facilitates database backup/restore and firmware updates on these devices.

15. Technical Specification

Product Vitalograph Device Studio
Minimum PC System Requirements
Processor Speed 2GHz or greater
RAM 2GB (Min), 4GB (Recommended)
Disk Space 1GB or greater
Operating System Windows 7 or above
Display A display supporting a resolution of 1280 x 800 pixels, higher recommended
Input Device Microsoft® mouse or compatible pointing device
Installation of .NET Framework 4.6.1
USB Port to connect to Vitalograph devices, e.g., Alpha

Other Install the application as System Administrator and provide full read/write access rights
to the folder and sub-folders where the application has been installed, for all applicable
users.
PDF Viewer

16. CE Notice
N/A

17. FDA Notice

N/A

18. EU Declaration of Conformity

N/A

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 A Global Leader in Respiratory Diagnostics

19. Guarantee

Terms of Guarantee
Subject to the conditions listed below, Vitalograph Ltd. and its associated companies,
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(hereinafter called the Company) guarantee to repair or at its option replace any
component thereof, which, in the opinion of the Company is faulty or below standard
as a result of inferior workmanship or materials.

The conditions of this guarantee are:-

1. This Guarantee shall only apply to hardware defects which are notified to the
Company or to its accredited distributor within 1 year of the date of purchase of the
equipment, unless otherwise agreed in writing by the Company.
2. Software (meaning computer software, or user installable modules) is guaranteed
for 90 days from the date of purchase.
3. The Company warrants that the software when correctly used in conjunction with
the hardware will perform in the manner described in the Company’s literature and
user manuals. The Company undertakes to rectify at no expense to the customer
any software failure notified within the period stated above, provided that the
failure can be recreated and the software has been installed and used in accordance
with the user manual. Notwithstanding this clause, the software is not warranted to
be free of errors.
4. This Guarantee does not cover any faults caused by accident, misuse, neglect,
tampering with the equipment, use of consumable items or parts not approved by
the Company, or any attempt at adjustment or repair other than by personnel
accredited by the Company, nor does it cover reinstatement of any configuration
changes caused by the installation of any software.
5. If a defect occurs please contact the supplier from it was purchased for advice. The
Company does not authorise any person to create for it any other obligation or
liability in connection with Vitalograph® equipment.
6. This Guarantee is not transferable and no person, firm or company has any
authority to vary the terms or conditions of this guarantee.
7. To the maximum extent permitted by law, the Company does not accept liability
for any consequential damages arising out of the use of, or inability to use any
Vitalograph® equipment.
8. This Guarantee is offered as an additional benefit to the Consumer’s statutory rights
and does not affect these rights in any way.

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