Vitalograph Model 4000 User Training Manual
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Vitalograph Model 4000 User Training Manual

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11/16/2018
07560
lung monitor BT
Model 4000
User Training Manual
Medical Devices Directive
93/42/EEC L169, Vol. 36.
EN ISO 13485
FDA QSR 21 CFR 820/803
Manufacturer: Vitalograph (Ireland) Ltd, Ennis, Ireland
file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html
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  • Page 1 11/16/2018 07560 lung monitor BT Model 4000 User Training Manual Medical Devices Directive 93/42/EEC L169, Vol. 36. EN ISO 13485 FDA QSR 21 CFR 820/803 Manufacturer: Vitalograph (Ireland) Ltd, Ennis, Ireland file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html 1/19...
  • Page 2 Vitalograph (Irl.) Ltd. Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: sales@vitalograph.ie www.vitalograph.ie © Copyright Vitalograph 2013 Current Edition (Issue 4) Cat. No. 07560 is a registered trademark file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html 2/19...

  • Page 3: Table Of Contents

    Table of Contents 1. WARNINGS AND ADVISORY NOTICES 2. MAIN COMPONENTS OF THE VITALOGRAPH LUNG MONITOR BT 3. WHAT IS THE VITALOGRAPH LUNG MONITOR BT USED FOR? 4. HOW TO USE THE VITALOGRAPH LUNG MONITOR BT 1. SETTING PERSONAL BEST (REFERENCE) VALUES 2.

  • Page 4: Warnings And Advisory Notices

    Keypad - Up, Down & Enter Button 3. WHAT IS THE VITALOGRAPH LUNG MONITOR BT USED FOR? The Vitalograph lung monitor BT is an easy to use home monitoring device designed to record key lung function parameters for those with respiratory conditions, including cystic fibrosis and transplant patients.

  • Page 5: Setting Personal Best (Reference) Values

    Note: to de-activate zones, set the FEV1 reference value to 0.00. 4.2. Setting Management Zones The Vitalograph lung monitor can be set for use with 3 or 4 zone management plans. The zone percentages are factory set to 2 boundaries, 95% & 90%, i.e. 3 Zones (95-100%, 90-95%, 0-90%).

  • Page 6: Performing The Test

    3. When the device is ready for a test ( ), holding the head high, breathe in as deeply as possible, hold the Vitalograph lung monitor ready in front of the mouth. 4. Holding the breath, place the mouthpiece into the mouth, biting the mouthpiece lightly, and with the lips firmly sealed around it.

  • Page 7: Reviewing Previous Results

    3. A long beep will indicate success and the device will return to the test screen. 4.6. Sending Test Results to Vitalograph Reports The test session may be transmitted to the Vitalograph Reports Utility on your PC where it can be stored as a PDF file and viewed or printed.

  • Page 8: Care And Cleaning Of The Vitalograph Lung Monitor Bt

    ‘Continue’ on Vitalograph Reports when you are finished entering the information. 6. Select a location for the test report on your PC as requested by Vitalograph Reports. A PDF of the test results will appear and will also be stored to the PC.

  • Page 9: Table Of Materials Used & Cleaning/Disinfection Methods

    Maximum of 50 cleaning cycles allowed. All external parts of the Vitalograph lung monitor require cleaning, i.e. the removal of visible particulate contamination. The parts of the device that make up the flowhead, which comes into contact with the breath of the subjects being tested, also require disinfecting.

  • Page 10: Removing The Flowhead For Cleaning And Disinfecting

    Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals or equipment. Reassemble the flowhead by pushing back on until it ‘clicks’ into position. Ensure that the flowhead is pushed fully home. 6. CONSUMABLES, ACCESSORIES AND SPARE PARTS file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html 10/19...

  • Page 11: Explanation Of Symbols

    Battery status Full Battery status Half Battery status Quarter Battery status Empty (flashing) Blow Now Symbol Bad Test Symbol (Slow start or Cough) Transmit Report Symbol Memory 90% - 100% Full Icon Flashes when memory reaches 100% 8. TECHNICAL SPECIFICATIONS file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html 11/19...

  • Page 12: Ce Notice

    Vitalograph 4000 Respiratory Monitor lung monitor device to the Medical Devices Directive of the European Community. Such marking is indicative that the Vitalograph 4000 Respiratory Monitor lung monitor device meets or exceeds the following technical standards: file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html...
  • Page 13 Harmonic Class A emissions IEC 61000-3-2 Voltage Class A fluctuations/ flicker emissions IEC 61000-3-3 file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html 13/19...
  • Page 14 <5% 100V (>95% dip in 100V) for 5 sec Power frequency 3 A/m Performance A Power frequency (50/60 Hz) magnetic magnetic fields should field be at levels characteristic of a IEC 61000-4-8 typical location in a typical commercial or hospital environment. file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html 14/19...
  • Page 15 (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html 15/19...
  • Page 16 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 product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible.

  • Page 17: Fda Notice

    11/16/2018 07560 10. FDA NOTICE Caution: Federal Law restricts this device to sale by, or on the order of a physician. file:///C:/Users/lcapamagian/Downloads/Vitalograph%20lung%20monitor%20bt%20-%20User%20Training%20Manual.html 17/19...

  • Page 18: Declaration Of Conformity

    11. DECLARATION OF CONFORMITY Product: Vitalograph 4000 Respiratory Monitor lung monitor Vitalograph hereby ensures and declares that the above product associated with this user manual, is designed and manufactured in accordance with the following QMS regulations and standards: European Medical Devices Directive {MDD} 93/42/EEC.

  • Page 19: Guarantee

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

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