Vitalograph micro 6300 Instructions For Use Manual
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Vitalograph micro 6300 Instructions For Use Manual

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MODEL 6300
Instructions for Use
© Copyright Vitalograph 2020 Current Edition (Issue 2, 22-May-2020) Cat. No. 09200

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Summary of Contents for Vitalograph micro 6300

  • Page 1 MODEL 6300 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 2, 22-May-2020) Cat. No. 09200...
  • Page 2 Technical Support Technical Support Tel: +353 65 6864111 Telefon: +49 40 547391-14 Email: technical.support@vitalograph.ie E-mail: support@vitalograph.de © Copyright Vitalograph 2020 Current Edition (Issue 2, 22-May-2020) Cat. No. 09200 Vitalograph is a registered trademark. Page of 40 DT_0006 Issue 15...

  • Page 3: Table Of Contents

    Calibration Verification ........13 3.5. Setting up a New Flowhead ........ 15 3.6. Configuration Options ......... 16 4. Power Management in the Vitalograph micro ..... 21 4.1. Batteries ............... 21 4.2. Power Save Mode ..........22 5. Cleaning & Hygiene ............... 22 5.1.

  • Page 4: Main Components

    A Global Leader in Respiratory Solutions 1. Main Components Figure 1 The main components of the Vitalograph micro. PC Software Flowhead Flowhead Release Button LCD/Touch Panel Display Mini USB Port On/Off Button Battery compartment (4 x 1.5V AAA Batteries) Note: Computer not supplied.

  • Page 5: Features

    3. The Vitalograph® micro is now ready for use. 4. To use with the Vitalograph Reports Application, install the software provided with the micro following the instructions supplied with the software.

  • Page 6: Operating The Vitalograph Micro

    A Global Leader in Respiratory Solutions 3. Operating the Vitalograph micro The Main Menu screen includes the following options - New Subject, VC Test, FVC Test and Post Test (for bronchodilator responsiveness testing). When turning the device on for the first time the test screen icons will appear greyed out and can’t be selected until a subject is...
  • Page 7 Vitalograph micro - Instructions for Use 09200 Issue 2 3. Age, Height and Gender are on the first screen and are enabled by default. Weight and Ethnicity are on the second screen and are not enabled by default. Enable options by selecting:...

  • Page 8: Conducting A Test

    A Global Leader in Respiratory Solutions 3.2. Conducting a Test Before starting a test session: 1. Ensure that the accuracy of the device was checked recently. (Refer to the section on Calibration Verification). 2. Select a subject and ensure the required demographic information is entered.
  • Page 9 Vitalograph micro - Instructions for Use 09200 Issue 2 It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled (when a plateau has been reached or forced expiratory time (FET) reaches 15 seconds). The operator should repeat instructions as necessary, coaching vigorously.
  • Page 10 The Vitalograph micro is intended to be used to store test data temporarily. When the device is connected to Vitalograph Reports to produce pdf reports of the session data, all subject/sessions are moved to Vitalograph Reports and cleared from the device with the exception of the last FVC Pre-test done.
  • Page 11 Vitalograph micro - Instructions for Use 09200 Issue 2 Volume/time (V/t) Volume bar graph 1. The graph may be changed to a full screen graph by using the zoom button on the side of the test screen. To return to normal mode select the zoom in button.

  • Page 12: Reporting

    A session ends and is saved when one of the following occur: • The device is turned off • A new subject is created • The device is connected to Vitalograph Reports 3.3. Reporting Generating PDF reports from the micro requires a computer running Vitalograph Reports.

  • Page 13: Calibration Verification

    2. Run Vitalograph Reports on the computer.  3. Ensure the micro is switched on and in the home screen.  4. Guidance on using Vitalograph Reports can be found in the Vitalograph Reports instruction for Use and in the software help menu.
  • Page 14 A Global Leader in Respiratory Solutions Figure 2. Calibration verification 6. Pump air through the flowhead to bring it to ambient temperature. If the flowhead has very recently been used for testing or has come from a cold environment, its temperature should be equilibrated by pumping air through it from the syringe several times.

  • Page 15: Setting Up A New Flowhead

    • If a new flowhead has been fitted 3.5. Setting up a New Flowhead After fitting a New Flowhead to the Vitalograph micro it is necessary set up the flowhead with the device. Follow these steps when setting up a new flowhead.

  • Page 16: Configuration Options

    Note: To exit the New Flowhead screen, press the Enter key again to return to the Configuration Menu screen. The result will not be logged to the Vitalograph micro memory in this case. 3.6. Configuration Options To access the Configuration menu select the configuration icon on the top right corner of the main screen.
  • Page 17 Vitalograph micro - Instructions for Use 09200 Issue 2 1. Subject Options • Posture - sets Posture to be recorded as sitting or standing. • Weight - turn on to enable the option to enter Weight in the subject screen.
  • Page 18 A Global Leader in Respiratory Solutions Parameters (See Parameters section) • Select the parameters to be displayed in results. • Use the left/right arrows to navigate between the screens. • A maximum of 8 parameters can be selected. Date/Time • Select this option to set or change the Date and/or Time. •...
  • Page 19 Vitalograph micro - Instructions for Use 09200 Issue 2 4. About Box • Information about the software can be obtained from the About box. This information is required for queries to Vitalograph or a service agent. • Information includes the Model...
  • Page 20 A Global Leader in Respiratory Solutions FIVC Forced inspiratory vital capacity (L) FIVC/FVC Ratio FIVC of FVC FEV.5 Forced expiratory volume after 0.5 seconds (L) PIF L/s Peak inspiratory flow (L/sec) FMFT Forced mid-expiratory flow time (sec) Forced expiratory time (sec) FEV.5/FVC Ratio FEV 0.5 of FVC FEV.75...

  • Page 21: Power Management In The Vitalograph Micro

    Ratio FEV1 to EVC 4. Power Management in the Vitalograph micro The Vitalograph micro can be powered from a computer via the USB cable or from its internal batteries. The LED on the front face of the device and the battery power icon show the power status of the device.

  • Page 22: Power Save Mode

    USB cable connected to the device. 4.2. Power Save Mode During battery only use the screen on the Vitalograph micro device will dim after 30 seconds, go blank after 60 seconds and the device will automatically power down after 2 minutes if left unused.

  • Page 23: Inspection Of The Vitalograph Micro

    Vitalograph micro - Instructions for Use 09200 Issue 2 decontamination, then it should be cleaned as per the instructions on ‘Cleaning and Hygiene’ on the Vitalograph website. 5.2. Inspection of the Vitalograph micro Figure 3. Flowhead Assembly Flowhead Body containing Fleisch...

  • Page 24: Fault Finding Guide

    A Global Leader in Respiratory Solutions 1. Press and hold the Flowhead release button and slide the flowhead away from the device from left to right. 2. From the remote flowhead adaptor kit, attached the device cap in the space that was occupied by the flowhead. 3.
  • Page 25 Possible • Ensure that the grommets on flowhead are Solutions: (In not pinched or trapped. probable order) • Cannot print to PC (Vitalograph Reports Problem Fault Application). Symptoms: • Corrupt or missing data on printout. • Check USB cable is connected between Vitalograph micro and the PC.

  • Page 26: Customer Service

    Any serious incident that has occurred 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 27: Disposal

    Vitalograph micro - Instructions for Use 09200 Issue 2 79192 Flowhead Connection Tube 79163 Remote Flowhead Adaptor Kit 41421 USB Cable 65030SPR Vitalograph Reports Application 10. Disposal The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste.

  • Page 28: Icons Used In The Vitalograph Micro

    Use by Date (Date format yyyy-mm-dd) Device Order Number Lot/Batch Number Serial Number On/Off Button Battery Positive 11.1. Icons used in the Vitalograph micro Subject  VC Test FVC Test Post Test Page of 40 DT_0006 Issue 15...
  • Page 29 Vitalograph micro - Instructions for Use 09200 Issue 2 Settings Enter Subject Options Device Settings Device and software Accuracy / Calibration information Height Gender- Male Gender- Female Posture - Sitting  Posture - Standing Weight On Weight Off Population Group Population Group - On...
  • Page 30 A Global Leader in Respiratory Solutions Zoom Out Zoom In Test Results Blow Now FVC Volume-Time FVC Flow - Volume Graph Graph Error or Invalid Entry Delete (re-enter field) Serial Number Software Number Syringe Volume micro Device USB Power Battery Full Battery Low Battery Empty Z Score...

  • Page 31: Description Of The Vitalograph Micro

    The Vitalograph micro is a handheld spirometer which measures subject respiratory parameters including but not limited to VC, FVC, FEV1, PEF and MVV. The Vitalograph micro is designed for portable spirometry. The Fleisch flowhead is used for testing and is integral to the device, although it may be removed to use with an adaptor for remote testing.

  • Page 32: Technical Specification

    A Global Leader in Respiratory Solutions 13. Technical Specification Product Vitalograph micro, Model 6300 Flow Detection Principal Fleisch type pneumotachograph Volume detection Flow integration sampling at 100Hz Maximum test duration 90 seconds Maximum displayed volume 10 L Better than ±3% or ±0.05L of the Volume Accuracy reading.
  • Page 33 Vitalograph micro - Instructions for Use 09200 Issue 2 USB & Bluetooth option available (Note: Vitalograph reports Communications is not enabled for Bluetooth communications with this device) 4 x 1.5V AAA batteries (6V)5V Power Supply DC via USB 2.0/3.0 Processor: Pentium, Celeron CPU, 1.73 GHz or better...

  • Page 34: Contraindications, Warnings, Precautions And Adverse Reactions

    Vitalograph cannot be held responsible and the device will no longer be supported. 2. The Vitalograph micro is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.
  • Page 35 10. Time zero is determined using the back-extrapolated method, from the steepest part of the curve. 11. After fitting a New Flowhead to the Vitalograph micro it is necessary to set-up the flowhead with the device. The procedure is outlined in section 3.6.

  • Page 36: Ce Notice

    Model 6300 micro to the Medical Devices Directive of the European Community. The Vitalograph Model 6300 micro 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...
  • Page 37 Vitalograph micro - Instructions for Use 09200 Issue 2 requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. EN 60601-1-2:2015- Emissions tests Emissions Electromagnetic environment - Compliance test guidance The Model 6300 micro uses RF energy only for its internal function.

  • Page 38: Fda Notice

    17. EU Declaration of Conformity Product: Vitalograph micro™, model 6300 Vitalograph hereby ensures and declares that the above product associated with these instructions for use, is designed and manufactured in accordance with the following QMS regulations and standards: •...

  • Page 39: Guarantee

    7. To the maximum extent permitted by law, the Company does not accept liability for any consequential damages arising out of the use of, or inability to use any Vitalograph® equipment. 8. This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not affect these rights in...

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