Vitalograph logo
Spirotrac®

Model 7000

User Training Manual

Device illustration

CE


 

Vitalograph Ltd. UK
Maids Moreton, Buckingham,
MK18 1SW, England
Tel: 01280 827110
Fax: 01280 823302
E-mail: sales@vitalograph.co.uk
www.vitalograph.co.uk

Vitalograph Ltd. International
Maids Moreton, Buckingham,
MK18 1SW, England
Tel: +44 1280 827120
Fax: +44 1280 823302
E-mail: sales@vitalograph.co.uk
www.vitalograph.eu

Vitalograph GmbH
Rellinger Straße 64a,
D-20257 Hamburg,
Germany
Tel: +49 40 547391-0
Fax: +49 40 547391-40
E-mail: info@vitalograph.de
www.vitalograph.de

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: contact@vitalograph.com
www.vitalograph.com

Manufacturer symbol Vitalograph (Ireland) Ltd.
Gort Road Business Park,
Ennis, Co. Clare,V95 HFT4
Ireland
Tel: +353 65 6864100
Fax: : +353 65 6829289
E-mail: sales@vitalograph.ie
www.vitalograph.ie

Vitalograph Ltd. Hong Kong/China
Unit 2001, Floor 20, Block A
New Trade Plaza,
6 On Ping Street, Shatin,
Hong Kong
Tel: +852 2117 2678
Fax: : +852 2117 2679
E-mail: sales@vitalograph.cn
www.vitalograph.cn

© Copyright Vitalograph 2018
Current Edition (Issue 20)
Cat. No. 07402

Vitalograph logo is a registered trademark

 

 


 

Table of Contents


1.    Description of the Vitalograph Spirotrac

1.1    Indications for Use

2.    BUTTONS AND ICONS USED IN SPIROTRAC

3.    Features of the Vitalograph Spirotrac

4.    Getting the Vitalograph Spirotrac Ready For Use

4.1    Loading the Spirotrac Software on a PC

4.1.1      Spirotrac Database Connection Details setup on a PC or Vitalograph COMPACT

4.2    Spirotrac Setup on a Compact Device

4.2.1      First Use

4.2.2      How to create a user database

4.2.3      Subsequent logon

4.3    Network Database Installation

4.3.1      Network Database Installation on a PC during first setup

4.3.2      Network Database Setup on a PC after initial setup or on a Vitalograph COMPACT

4.4    Installing the Vitalograph Pneumotrac/intrac USB drivers on a PC

4.5    Installing the Vitalograph In2itive and Alpha USB drivers on a PC

4.6    Installing the drivers for the Nonin Pulse Oximeter on a PC

4.7    Connecting the USB Vitalograph Pneumotrac to your PC

4.8    Connecting the Serial Vitalograph Pneumotrac to your PC

4.9  Connecting the Serial Vitalograph 2120 to your PC or Vitalograph COMPACT

4.10  Connecting the Vitalograph In2itive and Alpha to your PC or Vitalograph COMPACT

4.11  Connecting the Nonin Pulse Oximeter to your PC or Vitalograph

4.12  Preparing the ECG Software

4.13  Preparing the Wifi adaptor for use with the Vitalograph COMPACT

4.14  Installing drivers supplied by Vitalograph technical support on a COMPACT

4.15  Configuration Mode on the Vitalograph COMPACT device

4.16  Connecting the Gold standard to your PC or Vitalograph COMPACT

5.    OPERATING VITALOGRAPH SPIROTRAC

5.1    Starting Spirotrac for the first time

5.2    Start-up / Logon

5.2.1      Logging into Spirotrac

5.2.2      Application Lock (Autolock) / Unlock

5.2.3      Forgotten Logon Details

5.3    Subject Management

5.3.1      Autogeneration of Subject ID’s

5.3.2      Creating a Subject

5.3.3      Editing a Subject

5.3.4      Selecting/Viewing a Subject

5.3.5      Finding a Subject

5.3.6      Deleting a Subject

5.3.7      Subject Data Setup

5.4    Predicted Values

5.4.1      Population Group Setup

5.5    Device Downloads/Uploads

5.6    Exporting Data

5.7    Accuracy Checking

5.7.1      Accuracy Checking in Spirotrac

5.7.2      Checking Accuracy

5.7.3      Calibration update

5.7.4      Viewing/Printing accuracy log

5.8    Institute and Department

5.8.1      Viewing Institution or Department Details

5.8.2      Editing Institution or Department Details

5.8.3      Department Management

5.9    Audit Trail

5.9.1      Audit Trail Codes

5.9.2      Viewing/Printing the Audit Trail

5.10  Reporting and Printing

5.10.1   Printer Setup

5.10.2   Report configuration

5.10.3   Printing a Test Report

5.10.4   Printing a Trend Report

5.11  Users

5.11.1   User Management

5.11.2   User Access within Spirotrac

5.12  User Preferences

5.13  Licence Management

5.13.1   Manage Licence Keys and Features within Spirotrac

5.14  Language Variants

5.15  Fault Finding Guide

                  5.15.1  Technical Support Menu 

5.16  Database Management

5.16.1   Select a new database 

5.16.2   Backup or Restore a Database 

5.16.3   Database merge

5.16.4   Automated Database Backup

5.17  Vitalograph Spirotrac Fusion

5.17.1   Fusion

5.17.2   Sending sessions to Over-Read

5.17.3   Viewing Sent Session

5.17.4   Setup mail settings

5.18  Reference Curve and Data

5.19  Health LEVEL 7 Interface

5.19.1   Changing Health Level 7 (HL7) Settings within Spirotrac

5.19.2   Identifying Subjects with Pending Requests from an EMR System

5.19.3   Editing Subject Demographics before EMR Requested Testing

5.19.4   Transmitting Sessions for EMR Subjects

5.19.5   Transmitting Sessions for Non-EMR Subjects

5.19.6   Transmitting Sessions automatically

5.19.7   Viewing the HL7 Logfile

5.20  Interpretation Display           

5.21  Custom Report Template Selection

6.    TESTING USING SPIROTRAC

6.1    Spirometry Testing

6.1.1      Checks to Make before Performing VC, FVC and Post Tests

6.1.2      VC Testing

6.1.3      Performing FVC Testing

6.1.4      Post Testing

6.1.5      PCF Testing

6.1.6      ATS Waveforms

6.1.7      Parameter Definition

6.1.8      Test Quality Information

6.1.9      System Acceptability

6.1.10   Best Test Criteria

6.1.11   Session Grades

6.1.12   Incentive Device Setup

6.2    Pulse Oximetry Testing

6.3    Challenge Testing

6.3.1      Challenge Test Procedure

6.4    six minute walk test

6.5    Blood Pressure Management

6.6    12-Lead ECG Measurements

6.6.1      Description

6.6.2      Main Components of the Vitalograph ECG Software

6.6.3      Features of the Vitalograph ECG Software

6.6.4      Configuring the Connected BT12 Device

6.6.5      Operating the Vitalograph ECG Software

6.6.6      Configure Spirotrac prior to performing an ECG recording

6.6.7      Glasgow Interpretation Algorithm

6.6.8      Common Standards for Quantitative Electrocardiography Database

6.6.9      ECG Fault Finding Guide

6.7    Maximum Voluntary Ventilation Testing

                   6.7.1      Performing an MVV Test

6.8    vITALOGRAPH iNTRAC tESTING

                   6.8.1      Configuring the Vitalograph Inctrac Test

                   6.8.2      Performing a Vitalograph Inctrac Test

6.9    Audiometry tESTING

        6.9.1      Audiometry Description

        6.9.2      Performing an Audiometry test

        6.9.3      Audiometry Test Types

                        6.9.3.1 Pure Tone Audiometry

                        6.9.3.2 Masking

                        6.9.3.3 Automatic Tests

                        6.9.3.4 Weber Tests

        6.9.4      Device Configuration and Settings

        6.9.5      Audiogram and results table options

        6.9.6      Printing an Audiometry report

                        6.9.6.1 Change audiometry report template

        6.9.7      Shadow measurements

        

7.    CUSTOMER SERVICE

8.    TECHNICAL SPECIFICATIONS

8.1    System Requirements

9.    CE NOTICE

10.  FDA NOTICE

11.  DECLARATION OF CONFORMITY

12.  GUARANTEE






1. Description of the Vitalograph SPIROTRAC

Vitalograph Spirotrac is a Microsoft Windows based computerized Spirometry system that is intended for use by medical professionals who are trained in respiratory and lung function testing. The Spirotrac application interfaces with the Vitalograph Pneumotrac, Vitalograph In2itive, Vitalograph Alpha, Vitalograph Alpha Touch, Vitalograph 2120, Vitalograph 2160, Gold Standard, Intrac and asma-1 Spirometry devices. In addition to spirometry testing, Spirotrac also includes Pulse Oximetry, Challenge Testing, Blood Pressure, Six Minute Walk Test, 12-lead ECG and Audiometry modules.

Spirotrac is intended for use in occupational health centres, hospitals, pharmaceutical research centres, physicians' and GPs' offices, and wherever else advanced PC-based spirometry or cardio respiratory monitoring is required. Spirotrac is not intended for use for vital signs monitoring in a critical-care setting.

Spirotrac provides a system for adding and recalling subjects, performing relevant tests, saving the results to its own database and printing reports.

To launch the Help file:

 1.    Select User Training Manual  from the Help menu

 
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. Select About from the Help menu

 

1.1. Indications for Use

The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients. The device is a PC based software application which is intended to be used as a spirometer or connect to compatible devices to acquire, view, store and print the device output.



2. BUTTONS AND ICONS USED IN SPIROTRAC

The following buttons are visible on the main toolbar:


Create a new subject
Create a New Subject
Perform VC Test
VC Testing
Perform FVC Test
FVC Testing
Perform Post Test
Post Mode Testing
Perform PCF Test
PCF Test
Perform MVV Test
MVV Test
Perform Inhaler Test
Inhaler Test
Perform Challenge Test
Challenge Test
Perform ECG Test
12-Lead ECG
Recall ECG Session
Recall/View 12-Lead ECG

Audiometry

Recall/View Audiometry
Perform SP02 Test
Pulse Oximetry Testing
Perform Walk Test
Six Minute Walk Test
Perform BP Test
Measure Blood Pressure Test
Print Report
Print current session report
Print PDF
Print current session report to PDF
Export
Send sessions to over-read
Calibration
Perform an Accuracy Check on the Vitalograph Pneumotrac



3. Features of the Vitalograph SPIROTRAC

Vitalograph Spirotrac offers a number of sophisticated features, summarised as follows:

These features include:



4. Getting the Vitalograph SPIROTRAC Ready For Use

Note: Vitalograph commits to providing software that is virus-free. Vitalograph assumes no liability for the security of customer computer systems.  Any computer connected to the local area network {LAN} or internet is at risk of the system being compromised. Vitalograph recommends that customers take appropriate measures to mitigate such risk including installation and maintenance of anti-virus software and firewall(s) on IT systems to prevent intrusion and protect those systems, in line with customer’s internal IT policies.


4.1 Loading the Spirotrac Software on a PC

Note: Spirotrac must be installed by a User with Administrative privileges on a PC.The Vitalograph COMPACT is supplied with a full installation of Spirotrac including all device drivers and a test station licence.

To install Spirotrac, do the following:
  1. Place the Spirotrac DVD in the DVD/CD-ROM disk drive. After a moment, the installer application will automatically run.
  2. When the installer starts click Install Spirotrac to start the installation of Spirotrac.
  3. Click the Next button to begin the installation.
  4. Read the Licence Agreement and if you are satisfied with the terms agree to it. If you do not, the installation will not continue.
  5. Click the Next button.
  6. If necessary, make changes to the install location by selecting the Browse button. Click the Next button when finished.
  7. The files are copied to the selected drive and directory. An error message is displayed if there is insufficient space on the drive. If this occurs, you should click on the OK button. Create space by deleting or backing up files and then start installing again from step 1.
  8. A virtual PDF printer driver is installed onto the system. This allows the user to select this printer when printing, which allows the user to print to an Adobe Acrobat compatible PDF file.
  9. When the installation has completed, a message is displayed on the screen informing the user of same. Click on the Close button.
  10. The program name appears in the START menu under Start-> All Programs -> Vitalograph ->Spirotrac along with a Shortcut icon which is placed on the desktop.
  11. Setup Spirotrac by starting the Spirotrac application. The Spirotrac Setup is displayed.
  12. The user is prompted to enter the Device Serial Number of a Vitalograph device to be used with Spirotrac, and their email address. Entering a valid Device Serial Number will allow Spirotrac to be used as a local test station. Alternatively click Skip to use Spirotrac only as a local review station.
  13. To activate Spirotrac for use on a network as a multi-user review station, enter the Network Licence Key exactly as provided in the ‘If you have purchased an additional Network Licence Key, enter this below’ field.
  14. Click Activate to move to the next step of the setup, or Cancel to cancel setup.
  15. After clicking Continue the user is brought to the Database Connection Details screen.


4.1.1 Spirotrac Database Connection Details setup on a PC or Vitalograph COMPACT

  1. For installations on a PC, a Database Connection Details form is displayed. Ensure details are correct. If the current pc is a client pc, enter the server name/instance of the database. Select Continue and the database is created.
  1. For new installations Spirotrac shall default to the Default database. See Select a new database for details on how to create/change the default database. Note: For additional information see Network Database Installation
  2. Next:
Note: The user may select to cancel out of the set-up at any time. However, as the above details are required prior to launching Spirotrac, the application will not be launched until all the details are provided. Only then will Spirotrac actually launch. Once, Spirotrac is launched, checking the configuration settings is recommended, to ensure that user preferences are set-up as required.

Additional documentation is available on the CD as support. These can be found under the following headings on the installer: ‘Release Notes’, ‘Spirometry Guidelines’ and ‘Other Manuals’.


4.2  Spirotrac setup on a COMPACT device

4.2.1 First Use

  1.  When switched on, the COMPACT should load Vitalograph Spirotrac.  
  2. The default database is prepopulated with sample data.  It is recommended to create a subject database specific to your institution or select a network database (see Network Database setup on a Vitalograph COMPACT). 
  3. The COMPACT may be used for testing straight away using default settings. 
  4. To enter text, touch the keyboard icon on the screen.  To close the keyboard, touch X at the right top hand corner of the onscreen keyboard.
  5. It is recommended to familiarise yourself with the operation of the COMPACT prior to testing subjects.

4.2.2 How to create a user database 

  1. To create a user database:

a.    Select  the Tools -> Database Management -> Create tab , enter the details of the new database and click Create.

b.    Click the Select tab, select the new database and click Apply. Note: You shall be prompted to restart Spirotrac. 

c.    Enter Administrator User details.

d.    Enter Username and Password and select Continue.

Note: Selecting the disable user logon option here will allow the device to be used with reduced security, so is not recommended.

e.    Enter institution details and select Continue.

f.     Enter department details and select Continue.

g.    Spirotrac software will open to show the newly created user database (no data).


4.2.3 Subsequent Logon

  1. User ID will be pre-populated with the user ID of the last person who logged into the COMPACT.  If required, replace this with your (current user) ID. 
  2. The COMPACT will open Spirotrac when login is successful.


4.3 Network Database Installation

4.3.1 Network Database Installation on a PC during first setup

Note: At any point during the Spirotrac Setup Wizard the User may click the Setup Later button. The Wizard will pick up from where it left off during next run.


4.3.2 Network Database Setup on a PC after initial setup or on a Vitalograph COMPACT.

In order to use a network database with Spirotrac, a network licence key is required. This may be obtained from technical support +44 1280 827177 or email tech.support@vitalograph.co.uk. In order to activate your network licence, follow the instructions in the Licence Management section.

To configure Spirotrac to use a network database, once the network db has been setup (Consult with your SQL Server Database Administrator), do the following:

4.3.2.1  Connecting to a network database with Vitalograph Spirotrac on a Compact device

The Vitalograph COMPACT is supplied with a full installation of Spirotrac, including all device drivers and a test station licence. As with a PC a network licence key is required (see above)

To gain access to a network database from the compact device you need to ensure the sql server:
Consult with your SQL Server Database Administrator

To use this network database from the compact device you need to
  1. Select Tools -> Database Management
  2. Select/Enter the name or I.P. address of the SQL Server host
  3. Select/Enter the SQL Server instance name
  4. Select SQL Server Authentication from the Authentication drop down list
  5. Enter the sql server user login and password
  6. Select the required database from the list and select Apply


4.4 Installing the Vitalograph Pneumotrac/Intrac USB drivers on a PC

Note: These drivers are installed automatically as part of the Spirotrac Installation.

To install Vitalograph Pneumotrac USB drivers manually, do the following:

  1. Place the Spirotrac CD in the DVD/CD-ROM disk drive. After a moment, the installer application will automatically run.
  2. When the installer starts click Install USB Pneumotrac
  3. A WinZip self-extracting file will automatically execute and display the Vitalograph USB Pneumotrac Installer dialog – click the Next button.
  4. The USB Pneumotrac drivers will be installed at this point. Click the Finish button.


4.5. Installing the Vitalograph In2itive and Alpha USB drivers on a PC

Note: These drivers are installed automatically as part of the Spirotrac Installation.

To install Vitalograph In2itive and Alpha USB drivers manually, do the following:

  1. Make sure the Spirotrac CD is inserted in the CD/DVD drive of the PC. If not, insert it now. (Note: When the CD is inserted, the installation wizard will start.)
  2. Click on the Install USB Device Driver option. The USB drivers will be installed at this point. Click the Finish button.
  3. Connect one end of the USB cable into an available USB port on the PC.
  4. Power Up the Vitalograph In2itive/Alpha device.
  5. Connect to the other end of the USB cable into the Vitalograph In2itive/Alpha device.
  6. The PC will detect that new hardware has been connected and the ‘Found New Hardware’ installation wizard shall be displayed. This dialog will ask, Can Windows connect to Windows Update to search for Software?” Select No, not this time and click the Next button.
  7. Follow the default options on the screen until you are asked where to install your hardware from and choose Install the software automatically – click the Next button.
  8. You may be presented with an information dialog in relation to Windows Logo checks. Choose Continue Anyway on this screen.
  9. The In2itive/Alpha drivers will be installed at this point and you will be presented with a Finish button. Click this button.

4.7. Installing the drivers for the Nonin Pulse Oximeter on a PC

Note: These drivers are installed automatically as part of the Spirotrac Installation.

To install the drivers manually, do the following:

  1. Make sure the Spirotrac CD is inserted in the CD/DVD drive of the PC. If not, insert it now. (Note: When the CD is inserted, the installation wizard will start. You can close this)
  2. Connect one end of the USB cable into an available USB port on the PC.
  3. When windows auto-detects new hardware has been connected
    1. The ‘Found New Hardware’ installation wizard shall be displayed. This dialog will ask, “Can Windows connect to Windows Update to search for Software?” Select “No, not this time” and click the Next button.
    2. Follow the default options on the screen until you are asked where to install your hardware from and choose “Browse my computer for driver software”.When prompted for “Search for driver software in this location:”, navigate to the PulseOximetryDriver folder on the CD and click the Next button.
  4. When Windows does not auto-detect new hardware,
    1. Open Control Panel and double-click the Add hardware icon to run the hardware detection wizard.
    2. When prompted by the 'Update Driver Software' wizard, point to the PulseOximetryDriver folder containing the drivers for the device and click the Next button.
  5. The drivers will be installed at this point and you will be presented with a Finish button. Click this button.

4.8. Connecting the USB Vitalograph Pneumotrac to your PC

The following simple steps need to be carried out to prepare the Vitalograph Pneumotrac for use.

Attention

For safety, it is recommended that the PC is fully powered off before you start this procedure.

  1. Plug one end of the USB cable into an available USB port at the back of the PC (usually marked with the usbsymbol).
  2. Plug the other end of the USB cable into the USB port at the side of the Vitalograph Pneumotrac (marked with the usbsymbol).

Attention

If you connect additional equipment (not produced by Vitalograph) to the USB interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g. EN60950 for data equipment, EN60601 for medical equipment. Non-medical equipment must be kept outside the patient environment i.e. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons touching parts of the system can occur. (Contact your distributor if you have any queries.)

  1. Unwrap the flowhead connection tubing from its packaging and connect one end to the Vitalograph Pneumotrac device. If the tubing is ribbed ensure that the ribbed side of the tubing is connected to the ribbed half of the connector. If the tubing is smooth it is shaped so that it will only connect one way. 
  2. Unwrap the flowhead from its packaging and connect the other end of the flowhead connection tubing to it. If the tubing is ribbed ensure that the ribbed side of the tubing is connected to the ribbed half on the flowhead connector. If the tubing is smooth it is shaped so that it will only connect one way. Note: If flowhead connection tubing is connected the wrong way round flows will be displayed as inverted on Spirotrac.  
  3. The Vitalograph Pneumotrac device is now ready for use.
  4. The USB driver must be installed on the PC to begin testing. Refer to the USB driver instructions for details.

Attention

Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph Pneumotrac comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.

 

4.9. Connecting the Serial Vitalograph Pneumotrac to your PC

The following simple steps need to be carried out to get the Vitalograph Pneumotrac ready for use.

Attention

For safety, it is recommended that the PC is fully powered off before you start this procedure.

  1. Plug one end of the serial cable into an available serial port at the back of the PC (usually marked with the Serialsymbol). If the PC has a 25 pin serial port connector use a 9 pin to 25 pin port adapter.
  2. Plug the other end of the serial cable into the serial port at the side of the Vitalograph Pneumotrac (marked with the Serialsymbol).

Attention

If you connect additional equipment (not produced by Vitalograph) to the serial interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g. EN60950 for data equipment, EN60601 for medical equipment. Non-medical equipment must be kept outside the patient environment i.e. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons touching parts of the system can occur. (Contact your distributor if you have any queries.)

  1. Unwrap the flowhead connection tubing from its packaging and connect one end to the Vitalograph Pneumotrac device. If the tubing is ribbed ensure that the ribbed side of the tubing is connected to the ribbed half of the connector. If the tubing is smooth it is shaped so that it will only connect one way.
  2. Unwrap the flowhead from its packaging and connect the other end of the flowhead connection tubing to it. If the tubing is ribbed ensure that the ribbed side of the tubing is connected to the ribbed half of the flowhead connector. If the tubing is smooth it is shaped so that it will only connect one way. Note: If flowhead connection tubing is connected the wrong way round flows will be displayed as inverted on Spirotrac. 
  3. The Vitalograph Pneumotrac device is now ready for use.

 

4.10. Connecting the Serial Vitalograph 2120 to your PC or Vitalograph COMPACT

The following simple steps need to be carried out to get the Vitalograph 2120 ready for use.

  1. Make sure that the PC is turned off.
  2. Connect the serial cable supplied with the Vitalograph 2120 and following the instructions supplied with it, ensure that the power supply is connected to it unless the battery is already charged.
  3. Connect the 9 pin ‘D’ serial connector on the other end of the 2120 cable to the appropriate serial ‘COM’ port on the back of the PC.

 

4.11. Connecting the Vitalograph In2itive and Alpha to your PC or Vitalograph COMPACT

The following simple steps need to be carried out to get the Vitalograph In2itive and Vitalograph Alpha devices ready for use.

Attention

For safety, it is recommended that the PC is fully powered off before you start this procedure.

  1. Plug one end of the USB cable into an available USB port on the PC/COMPACT (usually marked with the usbsymbol).
  2. Plug the other end of the USB cable into the USB port at the side of the Vitalograph In2itive/Alpha (marked with the usbsymbol).

Attention

If you connect additional equipment (not produced by Vitalograph) to the USB interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g. EN60950 for data equipment, EN60601 for medical equipment. Non-medical equipment must be kept outside the patient environment i.e. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons touching parts of the system can occur. (Contact your distributor if you have any queries.)

  1. The Vitalograph In2itive/Alpha device is now ready for use.
  2. The In2itive/Alpha driver must be installed on the PC to begin testing. Refer to the USB driver instructions for details.

Attention

Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph Pneumotrac comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.

Note: This equipment may be affected by electromagnetic interference. Also the Pneumotrac/In2itive/Alpha/2120 may affect other electrical equipment in the close vicinity. If such effects are suspected either switch off the offending equipment or increase the distance between the affected equipment and that suspected of causing the interference, or shorten connecting leads.

4.13 Connecting the Nonin Pulse Oximeter to your PC or Vitalograph COMPACT

The following simple steps need to be carried out to get the Nonin Pulse Oximeter ready for use:

1.      Plug one end of the USB cable into an available USB port on the PC/COMPACT (usually marked with the Image of USB Symbolsymbol).

2.    The Nonin Pulse Oximeter is now ready for use, see Pulse Oximetry Testing for how to perform pulse oximetry testing.

3.    When entering the test screen, if issues occur with communicating with the device, select Tools -> Options -> Pulse Oximetry and select the Detect button.


4.14 Preparing the ECG Software

The following steps need to be carried out in order to prepare the ECG software for use on a PC/COMPACT:

Note: When using a COMPACT device, the device must be running in configuration mode prior to this setup. See Configuration Mode on the Vitalograph COMPACT device.

1.    Prior to obtaining an ECG recording using the BT12 device and the Vitalograph ECG software, the PC/COMPACT running the ECG software and the BT12 device must be paired using a Bluetooth connection.

2.    A Bluetooth dongle must be plugged into the PC/COMPACT before starting the ECG software. Plug the Bluetooth dongle into an available USB slot on the PC. Note: Where the PC has integrated Bluetooth capability with the Microsoft Bluetooth stack, a Bluetooth dongle will not be required here.

3.    Turn on the ECG device. Select the ECG test button and the device should automatically pair.

4.    If problems occur go to Tools-Options-ECG-Device Configuration and select the Add/Pair button. Spirotrac shall auto-detect available devices. After the device BT12 has been found by Spirotrac, the serial number of the device is shown. Note: The serial number shall be preceded with 'BT12v_SN:' identifier.

5.    Select the serial number of the BT12 device you wish to pair with and then click on OK. If the serial number of the BT12 device is not displayed, this may be because it already paired with another PC/COMPACT. To clear prior BT12 device pairings, make sure the device is off and then press the device On/Off button and hold for 20 seconds until a double-beep is heard.

6.    The Bluetooth driver should ask for a PIN during the pairing. Enter the PIN "1111" in the provided text field and confirm by pressing the OK button.

7.    The device is now connected and ready for operation.

 

4.15 Preparing the Wifi adaptor for use with the Vitalograph COMPACT

Note: Please see the manufacturer’s user instructions for more details.

The following steps needs to be carried out in order to setup the COMPACT device for wireless networking:

1.    Plug the Wifi adapter into an available USB port on the COMPACT.

2.    The Wifi adaptor client manager will display in the bottom corner on screen.

3.    Select the Create Profile option

4.    Next select the setup method:

4.1.  Select Automatic Secure Setup to setup automatically

4.2.  Select Advanced Setup for manual selection

5.    Next select the connection method:

5.1.  Select Connect manually to be presented with a list of wireless access points available.

5.2.   Select Connect with WPS-PIN to configure wireless connection settings manually.

6.    Once connection has been successful, save and close the Wifi manager. The COMPACT is now ready for use with network.

 

4.16 Installing drivers supplied by Vitalograph technical support on a COMPACT

Note: Any drivers to be installed must be obtained from Vitalograph.

The following steps need to be carried out in order to install drivers on a COMPACT device:

1.    Put the device in configuration mode, see Configuration Mode on the Vitalograph COMPACT device

2.    Connect the USB device containing the driver files to an available USB port on the COMPACT.

3.    Select Tools -> Administration -> Install Software. 

4.    Select the required installer/self-extractor, then select Run and follow the on-screen instructions/wizard as displayed.

 

4.17 Configuration Mode on the Vitalograph COMPACT Device

In order for some settings to be available upon a restart of the COMPACT, they require the COMPACT to be in configuration mode when configured. Examples of these settings are: Adding a printer, Installing Software, Wifi settings, Timezone/Date/Time changes and pairing with ECG device.

To place the COMPACT device into configuration mode, do the following:

1.    Logon as an Administrator user.

2.    Select Tools -> Administration -> Configuration Mode.

3.    The COMPACT will now re-start in configuration mode. 

Note: When in configuration mode, testing is disabled. In order to return to normal mode, select File -> Exit and restart your COMPACT.

 


4.18. Connecting the Gold Standard to your PC 

First check that the contents of the packaging correlate with what is outlined on the contents label on the inside of the packaging carton.

The following simple steps need to be carried out to prepare the Vitalograph Gold Standard for use.

Attention

For safety, it is recommended that the PC is fully powered off before you start this procedure.

  1. Plug one end of the USB cable into an available USB port at the back of the PC (usually marked with the usbsymbol).
  2. Plug the other end of the USB cable into the USB port at the rear of the Vitalograph Gold Standard  (marked with the usbsymbol).

Attention

If you connect additional equipment (not produced by Vitalograph) to the USB interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g. EN60950 for data equipment, EN60601 for medical equipment. Non-medical equipment must be kept outside the patient environment i.e. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons touching parts of the system can occur. (Contact your distributor if you have any queries.)

  1. Unwrap the breathing tube from its packaging and connect the flexible end of the breathing tube to the Vitalograph Gold Standard device. 
  2. Insert a disposable bacterial viral filter (BVF) into the plastic adaptor at the other end of the tubing.
  3. Set the desired starting position using the Volume Adjustment Handle.
  4. The Vitalograph Gold Standard device is now ready for use. 
  5. The USB driver must be installed on the PC to begin testing. Refer to the USB driver instructions for details.
Note: Bacterial viral filters must be used to provide maximum protection against the possibility of contamination and inter-subject cross infection during testing.


5. OPERATING VITALOGRAPH SPIROTRAC

5.1 Starting Spirotrac for the first time

On starting Spirotrac for the first time a Logon dialog is displayed prompting the user for their ID and password (These will have been set-up during installation). See Logging into Spirotrac.


5.2. Start-up / Logon

Note: In order to use the application, Spirotrac requires that the PC user adhere to one of the following:


5.2.1. Logging into Spirotrac

  1. Users who have been successfully added to the Spirotrac software (reference the Users section) will have their own User ID and Password.
  2. The logon screen will be presented on start-up, prompting for User ID and Password to be entered. For Network installations the Database field will be enabled allowing the user to select the server database.
  3. The User ID will be pre-populated with the User ID of the last person who logged into the Spirotrac software application. If appropriate, enter your own User ID.
  4. Enter your password and click the OK button, or press Enter on your keyboard.
  5. If the login is successful (your user criteria is accepted by the system), you will be presented with the Spirotrac software application desktop.
  6. If the login is not successful (your user criteria is rejected by the system), you will be presented with the Login screen again. Note: Spirotrac can be configured to lock a user out for a configurable time period on failure to logon after a configurable number of attempts.
  7. If you wish to abort the login process at this stage, click on the Cancel button.


5.2.2. Application Lock (Autolock) / Unlock

Spirotrac will automatically lock after defined periods of inactivity (The default is 45 minutes). Only the currently logged on user, or the Administrator user can unlock Spirotrac.

1.    Automatic application locking can be configured to different time intervals (Go to Tools -> Options -> General-Security to configure application lock timeout)

2.    While Spirotrac is locked all active windows & dialogs will be hidden, they will be restored to their current state upon unlock.

3.    To unlock Spirotrac enter User ID and Password in the Unlock screen and click OK.


5.2.3. Forgotten Logon Details

Spirotrac provides a facility whereby, in the event of the user logon details/password being forgotten, the user can setup new logon details.

In order to do this, do the following:

1.    A reset passcode may be obtained from technical support +44 1280 827177 or email tech.support@vitalograph.co.uk.

2.    Launch Spirotrac.

3.    When prompted to logon, click the ‘Forgot my password’ link on the user logon form.

4.    Enter the reset passcode as provided by Vitalograph which shall be validated by Spirotrac prior to continuing.

5.    To reset a user’s password:

a.    Select the option to reset password

b.    Enter the user’s name (this must match an existing user)

c.    Enter and confirm the new password (these must match)

6.    To setup new user details:

a.    Select the option to setup a new user name and password

b.    Enter the user’s name (this must be a new user name)

c.    Enter and confirm the password (these must match)

7.    Once the new user logon details have been validated, Spirotrac will login using these user details.

 

5.3. Subject Management

5.3.1 Autogeneration of Subject ID’s

Each subject created within Spirotrac must be allocated a subject ID. Spirotrac can automatically generate the subject ID if required, at the time of subject creation. Autogeneration of subject ID’s is enabled by default.
  1. To enable/disable autogeneration of subject ID’s, select Tools -> Options -> Subject Entry. Tick Subject ID Auto Generate to enable autogeneration of subject ID’s. Untick to disable.

 

5.3.2. Creating a Subject

1.    Select New -> Subject in the File menu or click the new subject button on the main toolbar.

2.    Enter details for each field as follows: -

a.    Subject ID - a unique number for each subject, this will be generated automatically if autogeneration of subject ID’s is enabled, but the user may change this ID if required. This field is mandatory. Note 1: To create a new subject, the Subject ID is mandatory. All other details are optional. Note 2: On Swedish and Norwegian variants, Swedish and Norwegian ID formats are supported here.

b.    Alternative Subject ID - an alternative identifier for the subject. It is configurable as to whether this field is displayed or not (see Subject Data Setup). 

c.    First Name - the Subject's first name, can be up to 20 characters in length

d.    Middle Name - the Subject's middle name

e.    Last Name - the Subject’s last name, can be up to 20 characters in length

f.     Subject date of birth (DD-MMM-YYYY)

g.    Gender – the gender of the subject, can be male or female (drop down list)

h.    Height – the height of the subject in either cm or inches. Can be 3 numeric characters. Unit of measurement is user configurable (see Subject Data Setup)

i.      Weight - the weight of the subject in either kg or lbs. Unit of measurement is user configurable and also whether this field can be entered for Subject or not (see Subject Data Setup)

j.      Population group – drop down list with predicted values associated with each group. It is user configurable whether this field is entered for Subject's or not (see Subject Data Setup)

k.    Smoking Information - the Smoking status of the subject. This can be Smoker, Non-smoker or Ex-smoker via a drop down list

l.      Notes – notes/comments can be entered for the subject

m.   Attachments - External documents can be linked to subject information as attachments. Select Tools ->Options -> Subject Entry to enable/disable.

n.    User Field1 – Field added for extra information, The Label is configurable (see Subject Data Setup). The label can be up to 20 characters in length, the data associated with the label can also be up to 20 characters in length.

o.    User Field2 - Field added for extra information, The Label is configurable (see Subject Data Setup). The label can be up to 20 characters in length, the data associated with the label can also be up to 20 characters in length.

p.    Attachments may also be saved with the subject information

q.    Pacemaker Detection – checkbox to indicate whether or not the subject has a pacemaker.

3.    Click on the OK button to save this subject to the database.

4.    Click on the Cancel button to discard new subject and return to the Spirotrac desktop.


5.3.3 Editing a Subject

  1.    In order to edit a subject a user may: 

a.    Right click on the subject in the subject list on the left panel and select edit subject

b.    Select the subject from the subject list on the left panel and select the edit button in the subject demographics panel

c.    Select the subject in the subject list on the left panel and select the Subject Details from the Edit menu

  1. The subject information is displayed. See Creating a Subject for details on fields.
  2. Click on the OK button to save the changes.
  3. Click on the Cancel button to undo the changes and return to the Spirotrac desktop.

Note: If the date of birth, gender, height or population group of the subject is changed, the predicted values for the subject shall be recalculated.

 

5.3.4. Selecting/Viewing a Subject

Select the subject in the subject list on the left panel. The subject becomes the current subject. You may perform a Spirometry test on this subject, view his/her sessions, select a session for print and/or view his/her trend data.

  1. The corresponding subject demographics appear for that subject, with any previously modified data appearing in green, and with all his/her sessions appearing in the lower left panel.

Note: Click on Expandto expand tree and view sessions.

  1.  A trend of previous subject’s sessions is displayed on the lower main panel.

Note: This trend information is configurable.

 

5.3.5. Finding a Subject

A search facility is available on the main desktop for finding subjects.

  1. Using the radio buttons, select to search for a subject by either ID or Last name
  2. Enter the relevant search information in the space provided and the select the Search button
  3. The search arrow will automatically move to the first subject found beginning with the information entered in the search field.

Note: When searching by ID if subject with matching Subject ID is not found Spirotrac will search for a subject with a matching Alternative ID

 

5.3.6. Deleting a Subject

  1. Select the Subject to be deleted from subject list.
  2. Right-click this Subject and select Delete Subject.
  3. Select Yes to delete the subject or No to cancel.

 

5.3.7. Subject Data Setup

  1. Select Tools -> Options from Main Menu and then select Subject Entry.
  1. The user can configure the following: -

a.    Name fields: The user can select whether or not to enter any/all of last name, first name and/or middle name as part of the subject demographics

b.    Unit of Height: the user can select to enter height in cm or inches

c.    Enter subject's weight: the user can select to enter weight as part of subject demographics or not. When checkbox is ticked, weight can be entered/displayed/printed for subjects.

d.    Unit of Weight: the user can select to enter weight in kg or lbs

e.    Alternative Subject ID: the user can select to enter an alternative subject number as part of subject demographics. When 'Display/Report On', this alternative number will be displayed/printed for the subject. 

f.     Population Group: the user can select to enter Population Group as part of subject demographics. When Select Population Group for Subject’ is ticked, then a Population Group can be selected for a subject, and therefore, displayed and printed. When it is not ticked, it will not be possible to select a population group for a subject.

g.    Extra Subject Information: The user can select to enter extra subject information as part of the subject demographics dialog. When ‘Display Subject Attachments’ is ticked the New Subject dialog will contain a section allowing the user to associate attachments with the subject. The Extra Subject Information section also provides the user with the ability to add two additional fields to the New Subject dialog by ticking the enabled checkboxes for User Field 1 and User Field 2. Names can be specified for each of these fields in the spaces provided.

h.    Smoking Information: The user can select whether or not to enter smoking information as part of the subject demographics.

i.      Notes: The user can select whether or not to enter comments/notes as part of the subject demographics

j.      Validate Subject Id: The user can select whether or not subjects id’s are to be validated for Sweden and Norway

k.    Subject ID Auto Generate: The user can select whether Spirotrac will automatically create a subject ID for new subjects.

l.    Alternative ID's: When enabled, the Subject ID Configurable label and the ALT ID Configurable label values defined here will replace the standard Subject ID and ALT ID throughout the application and in reports.

  1. Click on the OK button to save the settings or Cancel to ignore.
  2. The user can choose to reset the Subject Data entry settings by selecting the Reset Subject Settings button.

5.4 Predicted Values

5.4.1. Population Group Setup

  1. Select Tools -> Options from Main Menu and select General.
  2. In the Population Groups & Regression Sets section, select the Manage button.
  3. To add a new population group, do the following: 
  1. To rename a population group, do the following:
  1. To Edit a population group, do the following:
  1. To Delete a population group, do the following:


5.5. Device Downloads/Uploads

  1. This provides the user with the following functionality
  2. Ability to download subjects from Vitalograph In2itive/Alpha Touch/2120/2160 devices.
  3. Ability to upload subjects to Vitalograph In2itive/Alpha Touch/2120/2160 devices.
  4. Ability to download tests (parameters and curves) from Vitalograph In2itive/Alpha Touch/2120/2160 devices.
  5. Ability to download calibration/accuracy check data from Vitalograph In2itive/ Alpha Touch /2120 devices.
  6. Ability to upload subject history to Vitalograph In2itive/ Alpha Touch devices.
  7. Ability to delete tests and subjects from Vitalograph In2itive/Alpha Touch /2120/2160 devices.
  8. Ability to set the date/time on the In2itive/ Alpha Touch device.
  9. Ability to connect to a USB, serial or Bluetooth asma-1 device.
  10. Ability to copy data from an asma-1 device.
  11. Ability to delete tests from an asma-1 device.

Device Downloads/Uploads Options are configurable. Select Tools -> Options and click the Communications Icon. The user is provided with the following options:

In2itive/Alpha Touch

2120/2160

asma-1

Click the OK button to save changes or the Cancel button to discard them.

 On selecting Download Tests Spirotrac connects to the appropriate device, downloads subject and test session data and presents a dialog containing a list of Subjects and tests downloaded. On selecting the save option the Subject(s) selected and associated test sessions are saved to the Spirotrac database.

Selecting Upload Subjects presents the user with a list of all subjects in the Spirotrac database. The user can then select the subject(s) that they wish to send to the Vitalograph device. On selecting the upload button these subjects are saved to the Vitalograph device. Test sessions are not saved.

 If Synchronisation mode is not selected in Options the user can manually perform a sync by selecting Tools -> Device Downloads/Uploads -> In2itive.

Selecting Multiple Sync allows the user to synchronise with multiple In2itive devices in sequential order. Each In2itive device is switched off on synchronisation completion.

 

5.6. Exporting Data

Spirotrac provides a facility whereby the user can select session(s) for subject(s) and export that data to CSV files.

  1. To export session(s) for a subject:
    1. Select the subject whose session(s) are to be exported
    2. Select Export from the File Menu
    3. Select the session(s) to be exported from the list
    4. Select/Enter the location for the exported files
    5. Select Export to export the files
  2. To export session(s) for multiple subject(s):
    1. Select Export from the File Menu
    2. Select a Subject from the drop-down list
    3. Select the session(s) to be exported from the list
    4. Repeat point b & c for each subject whose session(s) are to be exported
    5. Select/Enter the location for the exported files
    6. Select Export to export the files
  3. To export all sessions:
    1. Select Export All from the file menu
  4. To export session(s) in the NIOSH export format:
    1. Select Niosh Export from the file menu
    2. Select the required Subject from the drop-down list
    3. Select the session(s) to be exported from the list
    4. Select/Enter the location for the exported files
    5. Select Export to export the files for the required subject
  5. To print a session report to pdf in the NIOSH report format:
    1. Select the required Subject and Session from the visit tree
    2. Then, Select Niosh Reports->Print Spirometry Report from the file menu
Note: The software will require the user to confirm whether or not sensitive personal identifying information should be exported. The following warning message shall be presented:


Spirotrac provides a technical support menu function for the purpose of provision of information to Vitalograph support to aid on customer support queries.


To export Log Files:
  1. Select the 'Help' menu item on the top of the screen.
  2. On the drop down menu select 'Technical Support'.
  3. Select the 'Export Logs' sub menu item.


5.7 Accuracy Checking

5.7.1 Accuracy Checking in Spirotrac

     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 system should never be outside accuracy limits unless the measuring device is damaged or in a fault condition. In this event, see the corresponding faultfinding 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%.

Routine user accuracy checking on the measuring equipment should be performed

  • before the instrument has been dismantled
  • after the instrument has been dismantled
  • after cleaning
  • if damage is suspected
  • after annual maintenance checks
  • after adjusting calibration
  • if the flow-head has been dropped
  •  

    The equipment used to perform the accuracy check should itself be certified and traceable to national or international standards. All measuring equipment should be checked for accuracy on an annual basis. Although it is not a specified requirement, a routine annual service on this equipment is strongly recommended.

     

    Mandatory daily accuracy checking can be switched on and off as follows:

    Note:

     

    5.7.2 Checking Accuracy

    Follow these steps to perform an accuracy check.

    1. Attach the Vitalograph device flow head to the precision syringe.
    2. Select the Accuracy Check from the Tools menu. Alternatively select the Accuracy Check button on the main toolbar.
    3. Enter the syringe reference and the syringe volume in L (1-9) in the dialog displayed.
    4. Click on the Check button and follow the instructions on the screen. (For the Vitalograph Intrac device, see Note below for differences)
    5. A message shall appear prompting you to pump air through the flow head in order to ensure that the flowhead is at ambient temperature before an accuracy check is performed. Once you have pumped air through the flow head click OK
    6. Make sure the plunger is out fully and inject the syringe when prompted.
    7. Press in the syringe with a smooth, firm stroke (not too slowly).
    8. Follow the instructions on the screen and repeat step 6 and 7. Three repeatable syringe strokes are required.
    9. If the accuracy is outside the limits it is suggested that you perform another check before updating the device.
    10. If three consecutive strokes are not reproducible within 3%, an error message is displayed.
    11. It is possible for the user to enter comments for an accuracy check on the results pop-up dialog.
    12. It is possible to view and print the Accuracy Check results at the end of the procedure. To re-check the accuracy select the Re-Check button.
    Note: When performing an accuracy check using the Vitalograph Intrac device:

     

    5.7.3 Calibration update

    Follow these steps to perform a Calibration Update.

    1. Attach the flowhead to the precision syringe.
    2. Select the Calibration Adjustment from the Tools menu.
    3. Perform steps 3-9 as per Checking Accuracy.
    4. If the accuracy is outside the limits the user shall be presented with the option to Adjust the calibration or not, only after a re-check has been performed. Select Yes to adjust the calibration, Select No to go back to result screen where a re-check can be performed if desired.
    5. If user selects to perform a Re-Check, step 3 (3-10 as per Checking Accuracy) will be performed again but this time the user will not be prompted to re-check if a calibration adjustment is recommended.
    6. If three consecutive strokes are reproducible within 3%, but the overall % difference is greater than 25% the user shall not be allowed adjust the calibration. This may be as a result of the following:
    1. It is possible for the user to enter comments on the results popup dialog.
    2. The user may view and print the results at the end of the procedure.

     

    5.7.4 Viewing/Printing accuracy log

    1. Spirotrac maintains an accuracy check log.
    2. The accuracy check Log is updated each time that an accuracy check is performed with the Pneumotrac in Spirotrac.
    3. Select the Accuracy Check Log from the View menu.
    4. You will be prompted to select the device ID from a drop down list, or alternatively, select All Devices to view the entire accuracy log.
    5. A screen is displayed with the following information:
    1. The following extra information is shown when the individual accuracy check is selected.
    1. The log may be filtered by User, device serial number, the date/time of the accuracy check. To remove all filters and show all entries click the Show All entries button.
    2. Select the Report icon to print the accuracy log.
    3. You may view an individual accuracy check and flow volume curves by double clicking on an individual check or selecting one in the list and clicking on the View button. The following window shall be displayed. The accuracy check results may be printed by selecting the Report button.

     

    5.8. Institute and Department

    5.8.1 Viewing Institution or Department Details

    1. Select Institution Details or Current Department in the View menu.
    2. The institution or department information will be displayed.
    3. Modifications will not be allowed here.
    4. Click on the OK button when finished.

     

    5.8.2 Editing Institution or Department Details

    1.    In order to edit institution or department details, select Institution Details or Department Details in the Edit menu.

    2.    The institution or department information will be displayed.

    3.    Make the changes required. (any non-editable fields will be greyed out)

    4.    Select OK to save changes or Cancel to ignore changes.

     

    5.8.3 Department Management

    The Institute can have multiple Departments, which are managed through the 'Department Management' screen.

    1. Select Tools -> Department Management.
    2. To add a new department, select New, enter department details and press the OK button
    3. To switch to another department, select the department name from list and then press Select button. When prompted for confirmation, select Yes to switch departments or No to keep the current department active.
    4. Click on the Close button to return to the main screen.



    5.9 Audit Trail

    5.9.1. Audit Trail Codes

    Note: The user will only be prompted to enter a reason for a change on versions of the software which include audit trail activities and where 'User Annotation' below is indicated with a 'Yes'

    Activity Grade

    Activity Description

    System Annotation

    User
    Annotation

    AC01

    User Logon

     

    No

    AC02

    User Logoff
    /Application exit

    Switch User
    only when user is logged off due to a switch in user

    No

    AC03

    Institute Create

    Institute ID

    No

    AC04

    Institute Edit

    Institute Name, Field modified: From<previous value> To <updated
    value>

    No

    AC05

    Department Create

    Department Name

    No

    AC06

    Department Edit

    Department Name, Field name modified: From<previous value> To <updated value>

    Yes

    AC07

    Subject Create

    Subject Create: Subject ID

    No

    AC08

    Subject Edit

    Subject ID, Field name modified: From<previous value> To <updated value>

    Yes

    AC09

    Subject Delete

    Subject Number: Subject ID

    Yes

    AC10

    User Create

    User ID = ID of new user

    No

    AC11

    User Edit

    User ID, <Password Change>

    Yes

    AC12

    User Delete

    User ID = ID of deleted user

    Yes

    AC14

    Session Create

    Subject ID = Subject ID, Session Type

    No

    AC15

    Session Edit

    Subject ID=Subject ID, Session=Session Date/Time Field modified
    From<previous value> To <updated value>

    Yes

    AC16

    Calibration Update

    Device Name Device
    ID=device serial number

    Yes

    AC17

    Add Population Group

    <Regression Set Map, Population Group Name: New Population Groups Name, Regression Set: Regression Set Name, Correction Factor: Correction Factor>

    No

    AC18

    Edit Population
    Group

    Field modified From <previous value> To <updated value>

    Yes

    AC19

    Delete Population Group

    <Regression Set Map, Population Group Name: name of the deleted population group, Regression Set: name of the regression set the deleted population group was mapped to, Correction Factor: the correction factor of the deleted population group>

    Yes

    AC21

    Date/Time Change

     

    No

    AC20

    Software Update

     

    No

    AC22

    Test Performed
    Outside Temp

    Subject ID=Subject ID,
    Session=Session Date/Time

    No

    AC23

    Calibration
    Update Outside
    Temp

    Pneumotrac Device
    ID=device serial number

    Yes

    AC24

    Manual Test
    Temperature
    Update

    Temperature modified
    From <previous value> To <updated value>

    No

    AC25

    Manual Cal/Acc
    Temperature Update

    Manually changed temperature from
    <previous value> to <updated value>

    No

    AC26

    In2itive Upload

    # Subject(s) uploaded successfully to In2itive

    No

    AC27

    In2itive Download

    # Subject(s) downloaded

    No

    AC28

    In2itive
    Synchronisation

    # Subject(s) successfully synchronised

    No

    AC29

    2120 Upload

    # Subject(s) uploaded successfully to 2120

    No

    AC30

    2120 Download

    # Subject(s) downloaded.
    Source = 2120

    No

    AC31

    Subject Move

    From department<old dept> To department<new department>: Subject
    Number(s)<list of subject numbers moved>

    Yes

    AC32

    Model 4000 Download

    # Test(s) Downloaded

    No

    AC33

    MDE Subject Create

    Subject ID=subject id

    No

    AC34

    MDE Subject Edit

    Subject ID=subject id

    No

    AC35

    MDE Test Addition

    Subject ID=subject id

    No

    AC36

    Alpha Accuracy Log Download

    ALPHA accuracy log downloaded

    No

    AC37

    Alpha Touch Upload

    # Subject(s) uploaded successfully

    No

    AC38

    Alpha Touch
    Download

    # Subject(s) downloaded. Source = Alpha Touch

    No

    AC39

    Alpha Touch
    Synchronisation

    # Subject(s) successfully synchronised

    No

    AC40

    Migrate SpIV Data

     

    No

    AC41

    Pin Code Read

    PIN Code Save Cancelled for Subject: SubjectNumber by User: UserName.

    Yes

    AC42

    Delete All Diary Data

    All Data Deleted for Diary: DeviceSerialNumber by User: UserName.

    No

    AC43

    Pin Code Reveal

    PIN Code revealed for Subject: SubjectNumber

    Yes

    AC43

    Pin Code Reveal

    PIN Code revealed for User: UserName

    Yes

    AC44

    Failed Logon Attempt

    Attempted User Name=User Id, Attempted Password=Password length represented in ‘*’

    No

    AC45

    User Lockout

    User Name=User Id

    No

    AC46

    Challenge Target not met

    Subject ID=SubjectNumber, Visit=VisitLabel

    No

    AC47

    No Reversibility performed

    Subject ID=SubjectNumber, Visit=VisitLabel

    No

    AC48

    Visit Edit

    Subject[subject number],Visit[Visit DateTime] Edit Visit Label: From<previous value> To <updated value>

    Yes

    AC49

    DB Merge - Start

    Source [source db information], [destination db information]

    No

    AC50

    DB Merge - Stop

    Source [source db information], [destination db information]

    No

    AC51

    DB Merge - Duplicate Subject

    Subject Number [subject number]
    Source [source db information], [destination db information]

    No

    AC52

    DB Merge - Undo Subject Delete

    Subject Number [subject number]
    Source [source db information], [destination db information]

    No

    AC53

    DB Merge Summary

    No

    AC54

    Re-Opening FVC Session

    Subject=[subject ID], Session Date/Time=[Date and time of the session which was re-opened]

    No

    AC55

    Re-Opening VC Session

    Subject=[subject ID], Session Date/Time=[Date and time of the session which was re-opened]

    No

    AC56

    Re-Opening POST Session

    Subject=[subject ID], Session Date/Time=[Date and time of the session which was re-opened]

    No

    AC57

    Re-Opening AUDIOMETRY Session

    Subject=[subject ID], Session Date/Time=[Date and time of the session which was re-opened]

    No

    AC58

    Export Subject PII:

    Subject ID’s: [list of subject ID’s exported]

    No

     

    5.9.2. Viewing/Printing the Audit Trail

    Spirotrac records an entry in an audit trail each time certain events occur within the application. For a list of these events see Audit Trail Codes. All Users can view and print reports of the Audit Trail.

    Note: This only applies to versions of the software that include this functionality.

    1. Select Audit Trail from the View menu.
    2. All entries are sorted by date/time initially. The User can change the sort order by clicking any of the column headers.
    3. The following information is shown:
      1. User ID – the user who performed this action.
      2. Date/Time - when the action was performed.
      3. Annotation Code – the type of action performed. (AC code)
      4. System Annotation – details of the change will be recorded by Spirotrac e.g. previous and new values etc.
      5. User Annotation – the comment the user entered at the time of the change if required. (Configurable)
    4. The following extra information is shown for individually selected audit entries:
      1. Annotation Type – a description of this type of annotation record, e.g. User Logon etc
      2. System Annotation – as above.
      3. User Annotation – as above.
    5. The Entries can be filtered by User User, Date Dateand/or Annotation TypeNote. Click any of the corresponding filter buttons and enter your criteria. The matching records will automatically be shown. To remove all filters and show all entries click the Show All entries button Show.
    6. The current entries can be printed by clicking the Report button Report.
      Note: Only the entries displayed on screen will be printed i.e. if data is filtered by a user ID, then only the entries belonging to that user id will be printed on the report.
       


    5.10 Reporting and Printing

    5.10.1. Printer Setup

    Spirotrac offers a facility for printing various reports such as audit trail reports, accuracy log reports, trend reports and test session reports. Spirotrac shall save the current selected printer and it shall be possible to change printer setup from within the application.

    1. Select Printer Setup from the File menu.
    2. Select the desired printer and click OK.

     Note: When the COMPACT is not connected to the network, a USB flash drive shall be required to save report to PDF.

     

    5.10.2. Report configuration

    Spirotrac provides the user with the option to configure reports as follows:

    1. Select Tools -> Options and then Reports.
    2. The user can enter/change the headings to appear on VC/FVC reports (Report Header) and Post Test Reports (Post Report Header)
    3. The user can select whether the application will print spirometry reports in full, Full Report format, or limit them to one page, One Page Report format.
    4. When the Full Report is selected, the user can configure which tests will be printed on the report. The following print options are available:
      1. Best Summary - Print the ATS/ERS Best Test only
      2. All Tests - Prints all tests from the session, up to a max of 8, in order of test
    5. An Economode option is available for selection. When selected, all test session reports printed will have any shaded areas removed.
    6. The user can select whether the report shall contain the following information: LLN, Graphs, Session Comments, Session Interpretation and reference graphs and data
    7. The user can select whether or not to print rejected tests on the report
    8. The user can choose to reset the Report configuration settings by selecting the Reset Report Settings button.
    9. Select OK to save change or Cancel to discard.

    Note: When the One Page Report is printed, only the first 7 enabled parameters are printed on the report.

    When Custom Reports (Custom Report Template Selection) are enabled, the options above shall be disabled.

     

    5.10.3. Printing a Test Report.

    To print a test report for any test session do the following:

    1. Select the Subject to which the test session belongs.
    2. Select the session to be printed
    3. Select File -> Report -> Test Report OR alternatively select the Print button

     

    5.10.4. Printing a Trend Report.

    To print a Trend Report for a subject do the following:

    1. Select the Subject to view the Trend Graph.
    2. Select File -> Report -> Trend Report

     

    5.11. Users

    5.11.1. User Management

    Spirotrac can have multiple Users that are managed through the 'User Management' screen.

    1. Select Tools -> User Management.
    2. A dialog is displayed, listing all the users available on the system, with the current user highlighted in Bold
    3. The following actions are available:
      1. Add a new user
      2. Edit user password
      3. Delete an existing user
    4. Click on the Close button to return to the main screen.


    5.11.2 User Access within Spirotrac

    5.11.2.1 User Classes and Characteristics

    The following user types are available in Spirotrac:

     

    5.11.2.2 User Access Matrix

    Function System Administrator Site Administrator Operator
    Institution
    View YES YES YES
    Edit YES YES NO
    Department
    View YES YES YES
    Edit YES NO NO
    New YES NO NO
    Manage YES NO YES
    Subject
    New YES NO YES
    Select YES YES YES
    Edit YES NO YES
    Manage YES NO NO
    Search YES YES YES
    Testing
    VC YES NO YES
    FVC YES NO YES
    Post YES NO YES
    PCF YES NO YES
    MVVYESNOYES
    Challenge YES NO YES
    InhalerYESNOYES
    ECG YES NO YES
    ECG-View YES NO YES
    AudiometryYESNOYES
    Audiometry-ViewYESNOYES
    SpO2 YES NO YES
    6MWT YES NO YES
    6MWT-Post YES NO YES
    BP YES NO YES
    View YES YES YES
    Delete YES YES YES
    Reports
    Print report YES YES YES
    Report Setup YES YES NO
    Accuracy Check YES YES YES
    Perform check YES YES YES
    Perform update YES YES YES
    View/Print Log YES YES YES
    Security
    User Management YES YES YES
    User Logon Configuration YES NO NO
    New User YES YES YES

    Other operator users only 
    Edit User YES YES NO
    Delete User YES YES NO
    Change Password YES YES YES
    Edit other users password YES NO NO
    Display/Print Audit Trail YES YES YES
    Licence Management YES YES YES
    Database Management YES YES YES
    Select YES YES YES
    Create YES NO NO
    Backup YES YES YES
    Restore YES YES YES
    Configuration
    Device Selection YES YES YES
    Customize Toolbar YES YES YES
    Subject Demographics YES YES YES
    Daily Accuracy Check YES YES YES
    Security Settings YES YES YES
    General (Posture, Session Comments, Environmental data, Test Acceptability, SDS v's %Pred, Nose clip) YES YES YES
    Manage Population
    Groups
    YES YES YES
    Parameter Selection YES NO NO
    Communications YES YES NO
    Language YES YES YES
    Curve compression YES YES YES
    Labels YES YES YES
    6MWT Predicteds YES YES YES
    ECG YES YES YES
    Challenge YES YES YES
    Reports YES YES YES
    Incentives YES YES YES
    Trending YES YES YES
    Pulse Oximetry YES YES YES
    GDT YES YES YES
    System Configuration NO NO NO
    Biometrics YES YES NO
    Automatic Backup (Mirror db) YES YES NO
    Configuration Mode YES
    Compact device only
    NO NO
    Export/Email
    Export data YES YES YES
    Send Email YES YES YES
    Setup Email YES YES NO



    5.12. User Preferences

    The following information is available to the user for configuration by selecting Options from the Tools menu:

    1. Subject data information settings
      1. Data to be entered for a subject (see Subject Data Setup)
      2. Population Group configuration (see Population Group Setup)
    2. Spirometry Testing settings (see Checks to Make before Performing VC, FVC and Post Tests)
      1. Parameter Selection
      2. Subject posture during testing
      3. Session comment settings
      4. Incentive Device settings (see Incentive Device Setup)
      5. Device Selection
    3. Accuracy Check settings. (Check the Perform Accuracy Check Daily checkbox to enforce a passed accuracy check each day before testing can be performed)
    4. Security settings
      1. Automatic Application Lock settings (For ‘Lock application after’, select the number of minutes from the
        drop down list)
      2. Password expiration settings (For ‘Expire passwords after’, select the number of minutes from the drop down list)
    5. Advanced Settings
      1. Audit trail (Configure ‘Prompt for user annotation’ on, when user is to be required to enter a reason for editing data, see Audit Trail)
      2. Visit Labels (these labels shall be displayed in the visit tree for each visit performed for a subject)
        1. Define the list of visit labels for association with test visits.
        2. Select the default visit label to be used.
        3. Configure whether or not the visit label shall be selected prior to testing.
      3. Trending
        1. Configure the date range
        2. Configure the parameters used for Spirometry trending
        3. Configure the frequencies used for Audiometry trending 
      4. Six Minute Walk Test Predicted Values (Configure the predicted set to be used during the Six Minute Walk Test assessment)

     

    5.13. Licence Management

    5.13.1. Manage Licence Keys and Features within Spirotrac

    Spirotrac can have multiple features enabled via licence keys that are managed through the ‘Licence Management’ screen.

    1. Select Help -> Licencing Information.
    2. A dialog is displayed, listing all the features available on the system, indicating which are currently enabled through the presence of a licence key.
    3. The user can update an existing licence key or add a new licence key to enable a new feature as follows:
      1. Select the Update button
      2. The Licence Activation wizard is displayed. The user may enter the Device Serial Number of a Vitalograph device to be used with Spirotrac to activate Spirotrac as a local test station.
      3. If the user wishes to use a network database, enter the Network Licence Key exactly as provided in the ‘If you have purchased an additional Network Licence Key, enter this below’ field.
      4. Click Activate to complete the Licence Activation, or Cancel to cancel the activation.

     

    5.14. Language Variants

    Language variants are available in Spirotrac.

    To switch to another language do the following:

    1. Select Tools->Options->Advanced
    2. In the Language Configuration section select the required language from the list provided.
    3. Select the Ok button.
    4. The system will prompt the user to restart Spirotrac.


    5.15 Fault Finding Guide

    Problem Fault Symptoms:

    • Not measuring flow

    Possible Causes:
    (In probable order)

    • Ensure tubing is connected correctly. Ribbed side of the tubing should be connected to the ribbed half of the connector on the Vitalograph device

     

    Problem Fault Symptoms:

    • Incorrect or no volume measurements

    Possible Causes:
    (In probable order)

    • Ensure tubing is connected correctly. Ribbed side of the tubing should be connected to the ribbed half of the connector on the Vitalograph
      device
    • Ensure that the connectors are clear of obstruction or dirt and that they are inserted fully
    • Ensure the tubing is not kinked or squeezed

     

    Problem Fault Symptoms:

    • Excessive calibration drift

    Possible Causes:
    (In probable order)

    • Clean the flow head thoroughly
    • Contact the nearest dealer for replacement

     

    Problem Fault Symptoms:

    • Test performed but does not show on screen

    Possible Causes:
    (In probable order)

    • Ensure correct device is selected from Tools- >Device
    • Ensure device is connected to PC correctly
    • Ensure tubing is connected between flow-head and device correctly (same colour connector at both ends).

     

    Problem Fault Symptoms:

    • Report does not print all tests
    • Report does not print some parameters

    Possible Causes:
    (In probable order)

    • Ensure the correct report settings are set-up in Tools-Options-Reports
    • Ensure the parameters you require are selected from Tools-Options-Parameters

    Note: If a particular parameter is selected but has no measurement for any test then it will not appear on the printout

     

    Problem Fault Symptoms:

    • Communication error message appears when entering the Test screen, the Accuracy Check screen or the Calibration Update screen

    Possible Causes:
    (In probable order)

    • Ensure that the Vitalograph device is attached correctly

     

    Problem Fault Symptoms:

    • Accuracy check variations > +/- 3%

    Possible Causes:
    (In probable order)

    • Recheck Calibration with reference to section Checking Accuracy
    • Was the correct syringe volume entered?
    • Ensure that the tubing connectors are clear of obstruction or dirt and that they are inserted fully
    • Ensure the tubing is not kinked or squeezed
    • Ensure flow-head is clean

     

    Problem Fault Symptoms:

    • Test begins automatically
    • Volume accumulates automatically without the subject blowing
    • Very small VC or FVC test displayed

    Possible Causes:
    (In probable order)

    • Flowhead and/or tubing not stationary at the start of test. Hold them steady until the ‘Blow Now’ prompt appears.
    • Return to Main Menu and re-enter the test routine



    5.15.1 Technical Support Menu Item

    Spirotrac provides a technical support menu function for the purpose of provision of information to Vitalograph support to aid on customer support queries. The log files will be saved as a single zip file.


    To export Log Files:
    1. Select the 'Help' menu item on the top of the screen.
    2. On the drop down menu select 'Technical Support'.
    3. Select the 'Export Logs' sub menu item.
    4. A save as dialog will be shown, chose the destination for the log files, select the save button.
    Note: When running Spirotrac on the Compact device, the user will only be allowed to save the log files on a removable storage device.


    5.16 Database Management

    5.16.1 Select a new database 

    Spirotrac provides the ability to create a new database and select it for use through the ‘Database Management’ screen.
    1. Select Tools -> Database Management.
    2. To select a new database go to the 'Select' tab and do the following:

    a.    Select/Enter the name or I.P. address of the SQL Server host

    b.    Select/Enter the SQL Server instance name

    c.    Select the desired authentication mode from the drop down list and enter the user login and password if SQL authentication and then select the refresh button

    d.    Select the name of the database from the drop down list and select Apply

    e.    You shall be prompted to restart Spirotrac.

    Note: Upon re-start,for new databases only, Spirotrac shall prompt for database details setup. See Spirotrac Database Setup for more information.

    To create a new database:
    1. Select the Create tab within the Database Management screen.
    2. Select/Enter the database connection details as above.
    3. Enter a name for the new database and select Create.


    5.16.2 Backup or Restore a Database 

    Spirotrac provides the ability to backup and restore databases through the Database Management screen.
    1. Select Tools -> Database Management.

    5.16.2.1 Backup 

    1.    Click the Backup tab within the Database Management screen.

    2.    Select the database to backup and enter a location to store the backup to.

    3.    Click the Backup button.

    4.    The user will be notified when the database backup is complete.

     

    5.16.2.2 Restore 

    1.    Click the Restore tab within the Database Management screen.

    2.    Enter the new database name for the backup to be restored under.

    3.    Select the file which will be restored.

    4.    Click the Restore button.

    5.    The user will be notified when the database is restored.

     

    5.16.3 Database merge

    Spirotrac provides the ability to merge a source database with a destination database through the ‘Database Management’ screen. Data from the source database shall be copied into the destination database. The source database shall remain unchanged.

    Note: Performing a database merge is not recommended for larger databases. The merge should be restricted to databases with no more than 1000 subjects/8000 blows.

    The merge is designed to be performed in one of the following ways
    Note: You cannot merge from a network database to a local database.

    Before performing a merge, you should note the following


    In order to perform the merge, you can proceed as follows
    1. Select Tools -> Database Management
    2. Click the Merge tab within the Database Management screen.
    3. Enter the source database details. Click the Next button.
    4. Enter the destination database details. Click the Next button.
    5. Click on the Merge button to proceed. Note: See Database Merge Troubleshooting in the event of any pre-requisite failures.
    6. The merge status will be displayed on screen as it is being performed. The user will be notified once the merge is complete.


    5.16.3.1 Database Merge to a COMPACT device 

    In order to perform a merge to a COMPACT device, you must first set a remote access password for the COMPACT's sql user "SpvRemote" as follows:
    1. Log in to the COMPACT device as the Administrator user. 
    2. Select Tools -> Database Management.
    3. Select the 'Settings' tab within the Database Management screen.
    4. Enter the remote access password and click Set to apply the new password. 
    5. From another PC, select to perform the merge as per the Database Merge section above using sql server authentication details for this "SpvRemote" user.


    5.16.3.2 Database Merge Troubleshooting 

    Symptoms:

    • The pre-requisite Spirotrac Database Version check has failed.

    Possible Cause:

    • Ensure that both the source and destination databases are configured for Spirotrac version 1.13 or greater.

     

    Symptoms:

    • The Department Count check has failed.

    Possible Cause:

    • In order to perform the merge, there must be at least one department set up in both the source and destination databases.

     

    Symptoms:

    • The Institution Count check has failed.

    Possible Cause:

    • Possible Cause: In order to perform the merge, there must be at least one institution set up in both the source and destination databases.

     

    Symptoms:

    • The Database Size and Availability check has failed.

    Possible Cause:

    • Possible Cause: Ensure there is enough space on the hard drive of the destination machine to store the source records.

     

    Symptoms:

    • After a database merge spirotrac restarted in safe mode

    Possible Cause:

    • This can appear where larger databases are merged due to timing constraints. If this is noticed, restart Spirortac.


    5.16.4 Automated Database Backup

    Spirotrac provides the ability to perform automatic backups of the current local database on close of the Spirotrac application.
    1. Select Tools -> Database Management to display the Database Management Screen.
    2. Click the Settings tab within the Database Management screen of Spirotrac.
    3. To enable automated database backups, check the tickbox Perform automatic backup of current local database on close of Spirotrac. To disable automated database backups, uncheck this tickbox.


    5.17. Vitalograph Spirotrac Fusion

    On selecting the Send Sessions, Send All Unsent options from the File menu or by selecting the Send sessions to over-read button the user will be presented with a dialog informing them that the Vitalograph Fusion Quality Assured Spirometry System is not currently enabled. On selecting Yes they will be presented with a dialog informing them about the system. This dialog contains a link that allows the user to contact Vitalograph regarding more information about Fusion.

     

    5.17.1. Fusion

    Vitalograph Spirotrac Fusion is an integrated, easy to use Quality Assured Spirometry System providing expert over-reading of spirometry in primary care, occupational health, or post-training environments. The expert over-readers can be your own experts or provided as an optional service by Vitalograph.

    Spirotrac Fusion supports you in the delivery of good and cost effective clinical governance by providing assurance, backed up by hard data, that the quality of your entire group’s spirometry meets acceptable standards. Where an individual operator’s spirometry quality is less than optimum, this automated feedback data enables identification of specific training needs by the project manager.

    Requiring only Internet access or a mail client, Spirotrac Fusion is very easy to use:

    On receiving access to the Vitalograph Fusion Quality Assured Spirometry System the user will be provided with the following Over- Read functionality:

     

    5.17.2. Sending sessions to Over-Read

    Spirotrac provides the ability to send FVC session data to an Over-Reader through two options:-

    a.    Send Sessions – which allows the user to select which sessions are to be sent

    b.    Send All Unsent – which sends all session data which have never been sent to any over-reader

    To select sessions to send to over-read do the following:-

    1.    Select the subject whose session(s) are to be sent to overread.

    2.    Select Send -> Send Session(s) from the File Menu or click the Send Sessions to Over-Read button on the main toolbar

    3.    All FVC session(s) for the currently selected subject are listed, however, a different subject may be selected from the drop down list if required.

    4.    Select the session(s) to be sent from the list and then select the Add selected session(s) to send list button Send List.

    5.    To remove any session(s) from the send list, select the relevant session and then select the Remove selected pending session(s) from send list button Send List.

    6.    Once all session(s) for the subject(s) have been added to the send list, select the Send button to send the sessions or select the Cancel button to cancel.

    To send all unsent sessions to over-read do the following:-

    1.    Select Send –> Send All Unsent from the File menu or click the Send All Unsent Sessions option from the send button on the main toolbar.

    2.    All unsent session(s) will be sent to over-read.

    5.17.3 Viewing Sent Session

    1.    Select the subject whose sent session(s) are to be viewed.

    2.    Select View –> Sent Session(s) from the Main Menu.

    3.    All sent FVC sessions for that subject will be displayed.

    4.    To view sent sessions for another subject, select that subject from the drop down list.

    5.    Select the Close button to return.


    5.17.4. Setup mail settings

    In addition to access to the Vitalograph Fusion Quality Assured Spirometry System in order to send data to an Over-Reader, Spirotrac needs to be setup with a suitable mail server.

    1.    Select Tools -> Options from the Main Menu and then select Mail Setup.

    2.    Enter the details required as follows:-

    a.    SMTP Server – this is the mail server name with your Internet Service Provider (ISP).b.

    b.    SMTP Port – this is the mail server port number with your Internet Service Provider (ISP), typically port 25, however this can be different.

    c.    Connection – this is the dialup connection to establish during transmission, if required.

    d.    SMTP Username – this is the user ID of your account with the ISP, if a login is required.

    e.    SMTP Password – this is the user password of your account with the ISP, if a login is required.

    f.     Over-Read E-Mail Address – this is the email address of the over-reader to which any session data is to be sent

    3.    A connections button is provided which will take the user to the System Dial-up connection manager.

    4.    A test button is provided to check your settings.


    5.18 Reference Curve and Data

    Spirotrac allows the user to compare the best test (curve and data) from a user defined reference session. When set, the reference test will appear in both the data and graph results.

    1.    To enable Reference Curve functionality within Spirotrac, select Tools -> Options -> General and click Yes for the Reference Curve and Data option. To disable the functionality, click No.

    2.    When enabled, to set a session as a reference session select Reference -> Set as reference when in the main testing screen.

    3.    Alternatively, when in the Visits list for a subject, right click on the test that is to be set as the reference.


    5.19 Health Level 7 Interface

    Health Level 7 (HL7) is an internationally recognised standard for the exchange and management of electronic healthcare information.

     HL7 provides an interface between Electronic Medical Record (EMR) systems and Spirotrac and automates the transfer of order messages and associated subject demographic data to Spirotrac, while also providing an interface for the transfer of test results from Spirotrac to the EMR system.

     More information about using the HL7 interface can be obtained from technical support at +353 65 6864082 or email spirotrac@vitalograph.ie


    5.19.1 Changing Health Level 7 (HL7) Settings within Spirotrac

    1. Select Tools -> Options -> Advanced, and check HL7 Enabled, to enable HL7. Uncheck to disable.
    2. Click on Options beside the HL7 Enabled checkbox to edit settings for PDF report generation. This will display the HL7 Options window.
    3. From within the HL7 Options window generation of the PDF report can be enabled by ticking the Output PDF Report with Export checkbox.
    4. The location of the PDF file can be changed by editing the PDF File Location field within the HL7 Options window.
    5. The label that will display in the Return EMR Data window for EMR Request Messages can be modified using the Message Checkbox Display Text control. The fields appearing in the right window define the information that will be included in the label. By default Message Date/Time is used. Fields can be moved between the left and right window by clicking the arrow buttons.

     

    5.19.2 Identifying Subjects with Pending Requests from an EMR System

    Upon receiving a test request for a subject from an EMR system over HL7, Spirotrac will flag this subject in the Subject List with an ‘e’
    1. Select View -> Subject View -> EMR Subjects in the File Menu to display only those subjects with a pending test request from an EMR system.
    2. Select View -> Subject View -> Non EMR Subjects in the File Menu to display only those subjects who do not have a pending test request from an EMR system.
    3. To view all subjects, select View -> Subject View -> All Subjects in the File Menu.

     

    5.19.3 Editing Subject Demographics before EMR Requested Testing

    The subject’s demographics can be updated before performing the EMR requested testing.
    1. Select the subject from within the Subject List and click Edit from within the Subject Demographics window.
    2. Update the form information as required and click OK to save the changes. Click Cancel to exit the form without saving.

     

    5.19.4 Transmitting Sessions for EMR Subjects

    When testing is complete, the test session can be returned to the EMR system.
    1. Select the EMR subject.
    2. From within the Subject Demographics window, click Return EMR
    3. Tick the EMR Request message(s) for which the session is being sent. To send an unsolicited message, i.e. a message not corresponding to any EMR Request, tick Send Unsolicited Message and select the appropriate test type.
    4. Tick the session data which is to be sent.
    5. Click Return Items to transmit the session data for the selected EMR request(s) or click Close to exit the Return EMR Data window without transmitting the session data.

     

    5.19.5 Transmitting Sessions for Non-EMR Subjects

    Test session data can also be returned for subjects that do not have a pending EMR test request. In this case, only an unsolicited message can be returned to the EMR.
    1. Select the non-EMR subject.
    2. From within the Subject Demographics window, click Return EMR
    3. To send an unsolicited message, i.e. a message not corresponding to any EMR Request, tick Send Unsolicited Message and select the appropriate test type
    4. Tick the session data which is to be sent.
    5. Click Return Items to transmit the session data for the selected EMR request(s) or click Close to exit the Return EMR Data window without transmitting the session data.

     

    5.19.6 Transmitting Sessions automatically

    Test session data can also be returned automatically without a pending EMR test request. To configure Spirotrac to automatically return unsolicited messages:
    1. Select Tools -> Options -> Advanced, click on Options beside the HL7 Enabled checkbox to edit settings and enable the Auto Return HL7 Data option.
    2. Perform an FVC session and when the session is closed (e.g. on selecting another subject), the session data shall be transmitted.

    5.19.7 Viewing the HL7 Logfile

    To view or print the log of all HL7 messages sent and received:
    1. Select View -> View and Print HL7 Logs from the Main Menu. This will display the HL7 View and Print dialog window. Note that this option only appears when HL7 is enabled.
    2. Select the logfile from the dialog and click Open. This will open the selected file in a new window.
    3. To print the log, select Print Log from the menu. To close the log, click the X in the top right corner of the window.

    5.20 Interpretation Display

    Spirotrac can provide algorithm based interpretations of test results. The interpretations are provided for consideration by trained physicians in conjunction with other relevant medical data and are not intended to be used as the sole indication for subject diagnosis.
    1. Select Tools -> Options -> Advanced -> Interpretation Display and click Manage.
    2. Tick Display on screen Text Interpretation to enable text interpretation. Untick to disable.
    It is possible to override the algorithm based interpretation with a user interpretation. To do this, click the Edit button below the 'User Interpretation' textbox on the Interpretation tab and enter the new interpretation.

    5.21 Custom Report Template Selection

    Spirotrac provides the option for the user to select different FVC Test Spirometry report templates, other than the standard Spirotrac reports.

    To activate this feature and choose templates:

    1.     Select Tools -> Options -> Reports -> Custom Report Settings 
    2.     When the Custom Report Options window is shown, tick the relevant Pre and Post check boxes to           activate the required report. 
    3.     To select the available report templates for the Pre or Post FVC test click the "..." button, to the right         hand side of the relevant check box.


    6. Testing Using Spirotrac

    6.1. Spirometry Testing

    Testing may be done either in the sitting or standing position. The standing position may not be appropriate in some circumstances, such as in hospitals where many subjects may not be able to tolerate the standing position, especially when making forced manoeuvres. If the standing position is used, an appropriately shaped chair should be placed behind the subject so he/she can quickly and easily be eased into a sitting position if he/she becomes light-headed during the manoeuvres. The posture type must be selected prior to testing (see Checks to Make before Performing VC, FVC and Post Tests) For recommended methods of spirometry testing refer to the Vitalograph website (see contacts section at the top of this manual).


    During testing:

    1. If the Pneumotrac/In2itive is connected correctly, the correct COM port is selected, and the device is within temperature operating limits, the FVC test screen shall be displayed.
    2. If the device is not within temperature, testing may still continue but results may not be valid. This will be indicated by displaying a warning message to the user.
    3. If the test screen is left idle for two minutes or more, Spirotrac will suspend the test.
    4. The maximum number of blows that a subject should perform in any one session is eight.
    5. You may leave the test screen at any time by selecting Return. This brings you back to the main screen, but the test session remains open. Selecting the test button again returns you to the test screen, and testing can continue.
    6. A test session will remain open until one of the following occurs, and at that point you will be prompted whether or not you wish to close the session:


    6.1.1. Checks to Make before Performing VC, FVC and Post Tests

    Before commencing a test routine, check that the options for testing are set up correctly as follows: 
    1. Check that the Vitalograph spirometer device is connected correctly. (See the appropriate Connecting the Vitalograph device to your PC)
    2. Check that the correct device is selected:
    1. Check that the accuracy of the device was checked recently
    2. Check that the parameters to be measured are selected as required: 

    Note: All the results of tests are calculated and stored automatically so that the user can later recall a test and display any additional parameters that have been selected from this window.

    Note: The user can reset the parameter selection at any time by selecting the ‘Reset Parameter List’ button.

    1. Check that the correct subject is selected.
    2. Check that the correct posture is selected:

    Note: When performing Spirometry testing, it is recommended by the joint International ATS/ERS standard on Spirometry that the subject is in a seated position for the duration of the test(s).

    1. Check that the required end of test option is selected:

    ·         Select Tools -> Options from Main Menu and then select General

    ·         Select the appropriate End Test option and click OK

    o   Automated for the test to automatically end once the ATS/ERS end of test criteria has been achieved

    o   Manual for the test to continue until the user intervenes via the Spacebar or Stop Test (if using COMPACT Expert) to end the test


    6.1.2. VC Testing

    1. Select a subject by clicking on the Subject in the subject list on left hand side of main screen.
    2. Once the required subject has been selected from the list, select VC from the Test menu or click on the VC test button
    3. Wait for the ‘BLOW NOW’ message to appear on screen
    4. Alternatively, select the Volume/Time Graph tab where multi-breath testing is required.
    5. Again, wait for the ‘BLOW NOW’ message to appear on screen, before performing the next blow.
    6. After each blow, the user shall be prompted to Accept or Reject the test.
    7. It shall be possible for the user to Accept or Reject the test at any time using the User Acceptability drop down list. Changing the acceptability of a test will automatically update the best test information.
    8. When all blows are complete, click on the Return button to return to the previous screen.

     

    6.1.3. Performing FVC Testing

    1. Select a subject by clicking on the Subject in the subject list on left hand side of main screen.
    2. Once the required subject has been selected from the list, select FVC from the Test menu or click on the FVC Test button
    3. Wait for the ‘BLOW NOW’ message to appear on screen before beginning the test.
    4. After each blow a quality summary window is displayed. The test acceptability and session quality for the test performed is displayed to the user (see Test Quality Information).
    5. It is possible for the user to Accept, Reject or keep the automatic interpretation for the test at any time using the User Acceptability drop down list. Changing the acceptability of a test will automatically update the best test, reproducibility and quality information.
    6. Session information, Quality information, Acceptability and Usability information can be viewed at any time during testing by selecting the relevant tab on the test screen. The Parameters tab contains the parameter values and also includes System Acceptability information and User Acceptability information. The Test QA tab contains information on the status of all test acceptability criteria for each test. The Info tab contains information about the overall session such as Session Grade information, Repeatability information, Session Comments and Interpretations.
    7. The next test can be performed once the ‘BLOW NOW’ message re-appears on screen.

    6.1.3.1. Re-open a closed spirometry session and continue testing

    1. Select a subject by clicking on the Subject in the subject list on left hand side of main screen.
    2. Once the required subject has been selected from the list, select the required VC, FVC, or Post FVC session to be re-opened. Note: This session must have been performed on the same calendar day and cannot be an FVC session which already has a Post session associated with it.
    3. Select the appropriate test button , VC for a VC session or FVC for an FVC session (pre or post)