Vitalograph Spirotrac 6 Instructions For Use Manual
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Vitalograph Spirotrac 6 Instructions For Use Manual

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Spirotrac 6
MODEL 7000
Instructions for Use
© Copyright Vitalograph 2023 Current Edition (Issue 15, 18-Dec-2023) Cat. No. 07790

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Summary of Contents for Vitalograph Spirotrac 6

  • Page 1 Spirotrac 6 MODEL 7000 Instructions for Use © Copyright Vitalograph 2023 Current Edition (Issue 15, 18-Dec-2023) Cat. No. 07790...
  • Page 2 E-mail: contact@vitalograph.com Technical Support www.vitalograph.com Tel: +353 65 6864111 Technical Support Email: technical.support@vitalograph.ie Tel: (913) 730-3205 Email: technical.support@vitalograph.com © Copyright Vitalograph 2023 Current Edition (Issue 15, 18-Dec-2023) is a registered trademark. Cat. No. 07790 2 of 44 Page DT_0006 Issue 17...

  • Page 3: Table Of Contents

    6.1.6. Filtering Tests ..........................20 6.1.7. Using a reference session for comparison.................. 21 6.2. 12-Lead ECG Measurements ......................21 6.2.1. Performing an ECG Test with the Vitalograph BT12 ECG device ..........21 6.2.2. Test Parameters ..........................21 6.2.3. Glasgow Interpretation Algorithm ....................22 6.3.
  • Page 4 10.3.2. Migrate Spirotrac V Subjects and data to Spirotrac 6 ............... 35 10.3.3. Upgrading a Spirotrac 6 Database ....................35 10.3.4. Performing a backup or restore of a Spirotrac 6 Database ............35 10.3.5. Setting/changing the database used by Spirotrac..............36 10.4.

  • Page 5: Indications For Use

    Vitalograph cannot be held responsible and the device will no longer be supported. 2. The Vitalograph device is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.

  • Page 6: Security Recommendations

    Figure 1 Main components of Vitalograph Spirotrac System Note: Computer not supplied Note: Both the Vitalograph Compact and Pneumotrac utilize Spirotrac software. All instructions in this IFU for the Pneumotrac device apply also to the Compact device USB Flash Drive containing Spirotrac, Utilities and manuals...

  • Page 7: Compatible Devices

    • Audit Trail • Configurable Subject Demographics • Configurable report templates • Animated Incentives • EMR systems integration via HL7 and GDT using Vitalograph Connect • In-App software updates • Integration with ArtiQ services • Integration with Active Directory • Download results from Vitalograph In2itive device •...

  • Page 8: Setup

    4. Enter Site information and setup your Administrator user. This account will later be used to setup other Spirotrac users, refer to Section 8.5 5. After Login, the main dashboard displays. 5. Operating Instructions 5.1. Buttons and Icons used in Vitalograph Spirotrac Spirotrac buttons/icons Icon Description Home Settings Report Templates e.g., configure the content reported on the FVC Base Report, or configure the batch of...

  • Page 9: Main Dashboard

    Spirotrac 6 - Instructions for Use 07790 Issue 15 Filter e.g., filter the tests displayed on the graph Enlarge Record ECG trace Stop ECG trace Vital Capacity Forced Vital Capacity Challenge Testing Peak Cough Flow Electrocardiogram Maximal Inspiratory Pressure Maximal Expiratory Pressure Sniff Nasal Inspiratory Pressure MVV Testing...

  • Page 10: Subject Management

    A Global Leader in Respiratory Diagnostics About View software information and contact details Lock Lock the application via Exit/Lock Log Off Log off from the application via Exit/Lock Exit Shut down the application via Exit/Lock License Allows registration of software to unlock all features 5.3.

  • Page 11: Deleting Subjects

    • FVC Test (base and post) • PCF Test test session: Before starting a 1. Connect the Vitalograph spirometer device correctly, see relevant device IFU. 2. Ensure that device calibration was checked recently, refer to Section 7.1.1 3. Wash hands (operator and subject).

  • Page 12: Performing An Fvc Test

    A Global Leader in Respiratory Diagnostics 5. Inhale completely with a brief pause when lungs are completely full (≤ 2 secs)*. 6. Exhale in a relaxed manner with no hesitation until no more air can be expelled while maintaining an upright posture. It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled (when a plateau has been reached or expiration time reaches 15 seconds*).

  • Page 13: Fvc Parameters

    Spirotrac 6 - Instructions for Use 07790 Issue 15 6.1.2.2. FVC Parameters Parameter Unit Description Forced vital capacity. The maximum/highest volume achieved over the expiratory cycle. Expiratory volume achieved after one second taking the Time Zero parameter (TExt) into consideration. It is the volume achieved after Time Zero plus one second.
  • Page 14 A Global Leader in Respiratory Diagnostics /FVC ratio divided by FVC and expressed as a ratio. /FVC ratio divided by FVC and expressed as a ratio. The mean forced expiratory flow in the volume interval between 0.2 L and 1.2 L 0.2-1.2 of the test. /FVC ratio divided by FVC and expressed as a ratio. 25-75 25-75 The average forced expiratory flow in the time interval between 75% and 85% of...

  • Page 15: Best Parameters

    Spirotrac 6 - Instructions for Use 07790 Issue 15 The maximal volume of air inhaled from the point of maximal exhalation. The maximum flow detected. FEV1/HT2 divided by the subjects’ height in metres squared. kPa/L/s is derived indirectly, based on the FEV1% of predicted.

  • Page 16: Test Quality

    A Global Leader in Respiratory Diagnostics 6.1.3. Test Quality After every test manoeuvre, quality feedback with ATS/ERS acceptability is displayed for that test. 6.1.3.1. FVC Quality Feedback Artifact Description The extrapolated volume must be less than 5% of the FVC or less than 0.100L, whichever is greater.

  • Page 17: Fvc Analysis Details

    Spirotrac 6 - Instructions for Use 07790 Issue 15 Reference Previous Visit VC Contains the best VC value from a VC test performed in the previous visit. Information 6.1.4.2. FVC Analysis Details 3 acceptable FVC values of which two are repeatable, and...

  • Page 18: Session Grades

    A Global Leader in Respiratory Diagnostics 6.1.4.3. Session Grades guidelines From ATS/ERS 2019 Standardization of Spirometry , session grades for FVC and FEV1 are calculated as follows: 1. For 0-6 year olds: a. If there are three or more acceptable tests the following shall apply: i.
  • Page 19 Spirotrac 6 - Instructions for Use 07790 Issue 15 Base FVC interpretation algorithm. 19 of 44 Page...

  • Page 20: Artiq Analysis

    A Global Leader in Respiratory Diagnostics Post FVC interpretation algorithm. 6.1.5. ArtiQ analysis As an optional feature, Spirotrac can integrate with ArtiQ services to provide interpretation of pulmonary function tests and automated quality control of Spirometry curves and sessions. This feature is accessed via the ArtiQ dashboard in the FVC test screen.

  • Page 21: Using A Reference Session For Comparison

    3. Choose the required session for the subject from the list. 4. Once reference curve/data are enabled, best curve along with best and % change values will display. 6.2. 12-Lead ECG Measurements 6.2.1. Performing an ECG Test with the Vitalograph BT12 ECG device 1. Select a subject, refer to Section 5.3.1.

  • Page 22: Glasgow Interpretation Algorithm

    Note: The push connector on the connection port should be pushed firmly and squarely against the face of the connector when connecting/disconnecting the tubing. 6.3.1. Before performing MIP and MEP tests 1. Connect the Vitalograph Pneumotrac with the RMS device, see relevant device IFU. 2. Wash hands (operator and subject). 3. For optimal protection fit a new Bacterial Viral Filter (BVF) to the flowhead for each test subject. The use of noseclip a disposable is preferred.

  • Page 23: Mip And Mep Parameters

    This test type requires the Pneumotrac with RMS (Respiratory Muscle Strength) device with the relevant SNIP nasal probe consumables. 6.4.1. Before performing a SNIP test 1. Connect the Vitalograph Pneumotrac with RMS (Respiratory Muscle Strength) device, see relevant device IFU. 2. Wash hands (operator and subject). 23 of 44...

  • Page 24: Performing Snip Testing

    • For Europe: techsupporteu@thorasys.com When installing, ensure that Tremoflo software is installed in the default folder location. The Tremoflo software must be configured before use with Spirotrac. 6.5.1. Setup Tremoflo for use with Spirotrac 6 1. Run Tremoflo outside of Spirotrac. Follow the Tremoflo setup wizard. 2. Create a user when running setup. Note: The user credentials will have to be re-entered in Spirotrac.

  • Page 25: Performing Oscillometry

    To connect the Vitalograph Alpha or Vitalograph In2itive: 1. Plug one end of USB cable into USB port on PC/COMPACT (usually marked with  symbol). 2. Plug other end of USB cable into USB port at side of the Vitalograph Alpha/In2itive device (marked with  symbol).

  • Page 26: Downloading Sessions(S) From Vitalograph Alpha Or In2Itive Device To Spirotrac

    Create new Subject – this will add a new subject to the device c. Skip – no subject demographics is transferred to the device 6.9.3. Downloading sessions(s) from Vitalograph Alpha or In2itive device to Spirotrac Note: Ensure your device is on the main screen.

  • Page 27: Mannitol Challenge Testing

    Spirotrac includes a Maximum Voluntary Ventilation (MVV) test to determine the maximum volume of air a subject can breathe over a specified period of time. 6.11.1. Before performing MVV tests 1. Connect the Vitalograph Pneumotrac device, see relevant device IFU. 2. Wash hands (operator and subject). 3. For optimal protection fit a new Bacterial Viral Filter (BVF) to the flowhead for each test subject. The use of a disposable noseclip is preferred.

  • Page 28: Performing Mvv Testing

    Thoracic Society and European Respiratory Society. See device manual for device instructions for use and storage. 6.12.1. Setup NIOX VERO device for use with Spirotrac 6. If the Biological QC setting is enabled a QC check of the NIOX VERO is enforced. See Section 8.2.11...

  • Page 29: Performing Feno Testing

    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. M andatory daily calibration verification can be switched on and off in the Application Settings refer to Section 8.2.4. Note: It is recommended that the Vitalograph Precision 3 Litre Syringe is used to perform accuracy checks. This has an accuracy of +/-0.5%. 29 of 44 Page...

  • Page 30: Performing A Calibration Verification

    9. A faulty equipment or technique message shall be displayed if three consecutive strokes are outside the reproducibility limit of 3% or the percentage difference from the syringe volume is more than 25%. Contact Vitalograph if failure is persistent. 7.1.2. View/Export/Print Calibration Verification History...

  • Page 31: Test Settings

    Note: Predicted sets are named after author/paper and contain a subset of parameters. All other predicted parameters are taken from Vitalograph’s background set. For more information on this contact Vitalograph (Refer to contact information at the start of this manual) 8.2.

  • Page 32: Mip, Mep And Snip Settings

    A Global Leader in Respiratory Diagnostics 3. Recording Duration Analysis Settings: a. Analysis QTc Parameter for Glasgow algorithm 4. Filter Settings: a. Select appropriate filter required. 8.2.6. MIP, MEP and SNIP Settings The following settings are available: 1. Parameters: Turn On/Off parameters required for testing. 2.

  • Page 33: Security Settings

    1. Enable/disable the Connect functionality. 2. The Connect URL must be provided. Note: For all other configuration, see Vitalograph Connect IFU. 3. Enable/disable Auto Process Orders (for more information ref 10.6.2.1) and select the required default population group to be used.

  • Page 34: Other Functions

    Note: When using Spirotrac on a SQL instance not provided by Spirotrac, consult with your SQL Server Database Administrator to ensure Filestream is enabled. • Ensure the version of Database Studio being used is compatible with Spirotrac 6 by checking the software version number is the same.

  • Page 35: Migrate Spirotrac V Subjects And Data To Spirotrac 6

    07790 Issue 15 10.3.2. Migrate Spirotrac V Subjects and data to Spirotrac 6 Database Studio can be used to migrate Subject data from Spirotrac V version 1.19 or later to Spirotrac 6: • Check Spirotrac V is version 1.19. Upgrade if required.

  • Page 36: Setting/Changing The Database Used By Spirotrac

    10.6.1. Setup Spirotrac 6 for use with Vitalograph Connect Note: For Vitalograph Connect setup and configuration see Vitalograph Connect specific IFU. The exchange of data with EMR systems must be setup and enabled from within Spirotrac 6 also, refer to Section 8.8 10.6.2.

  • Page 37: Allowing Auto Processing Of Orders

    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. Note: This is only applicable when enabled in Connect, for details refer to Vitalograph Connect IFU. Ensure Vitalograph Connect is setup and configured, and enabled for Spirotrac, refer to Section 10.6.1 2. If not already selected, select the subject whose test results you intend to transmit back to the EMR...

  • Page 38: Cleaning & Hygiene

    • Not measuring flow Possible Causes/Solutions: • Ensure tubing is connected correctly. Ribbed side of tubing should be connected to ribbed half of connector on the Vitalograph device. (In probable order) Problem Fault Symptoms: • Incorrect or no volume measurements •...

  • Page 39: Ecg

    Spirotrac 6 - Instructions for Use 07790 Issue 15 • Device is not connected to your PC correctly, see relevant device IFU Possible Causes/Solutions: • Drivers did not successfully install. To install drivers manually, Run Setup from (In probable order) USB Flash Drive and Select “Install USB Pneumotrac”...

  • Page 40: Oscillometry

    A Global Leader in Respiratory Diagnostics Problem Fault Symptoms: • After the recording, red lines are occasionally displayed in the ECG signal. • There were transmission errors during recording. Possible Causes/Solutions: • ECG device was out of range temporarily during recording. (In probable order) •...

  • Page 41: Customer Service

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

  • Page 42: Ce Notice

    Vitalograph Spirotrac Model 7000 to the Medical Devices Directive of the European Community. The Vitalograph Spirotrac Model 7000 is intended for use in a variety of professional healthcare environments, e.g., primary care, hospital wards and occupational health centres, except for near active high frequency surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high.

  • Page 43: Guarantee

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

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