Vitalograph 4000 Instructions For Use Manual
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Vitalograph 4000 Instructions For Use Manual

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Lung Monitor
USB
MODEL 4000
Instructions for Use
© Copyright Vitalograph 2020 Current Edition (Issue 1, 24-Jan-2020) Cat. No. 09860

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Summary of Contents for Vitalograph 4000

  • Page 1 Lung Monitor MODEL 4000 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 1, 24-Jan-2020) Cat. No. 09860...
  • Page 2 Tel: +353 65 6864111 Technical Support Email: technical.support@vitalograph.ie Tel: +353 65 6864111 Email: technical.support@vitalograph.ie Vitalograph GmbH Rellinger Straße 64a Vitalograph Ltd, Hong Kong/China D-20257 Hamburg P.O. Box 812 Germany Shatin Central Post Office Tel: +49 40 547391-40 Hong Kong Fax: +49 40 547391-40 E-mail: sales@vitalograph.cn...
  • Page 3 Flowhead On / Off Button USB Connector Down Button Up Button Enter Button 1.1. Features of the Vitalograph Lung Monitor USB • Measures FEV1, FEV6 and the ratio • Displays % of personal best FEV1 • FEV1 zones can be personalized...
  • Page 4 3. Attach a mouthpiece to the flowhead, see Figure 2. Figure 2. Mouthpiece inserted into flowhead 4. If used for multiple subjects, Vitalograph intends that a new Eco Bacterial Viral Filter (Eco BVF) be used for every test subject to prevent cross contamination. Using a new Eco BVF...
  • Page 5 Note: to de-activate zones, set the FEV1 reference value to 0.00. 3.2. Setting Management Zones The Vitalograph Lung Monitor USB can be set for use with 3 or 4 zone management plans. The zones are factory set to 2 boundaries (90% &...
  • Page 6 3. Sit down to blow into the device (unless a physician advises otherwise). 4. 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, see Figure 3.
  • Page 7 Figure 3. Holding device during test. 5. Holding the breath, place mouthpiece into the mouth, biting the mouthpiece lightly, with the lips firmly sealed around it. 6. Blow out as HARD and as FAST and as LONG as possible (the device will stop taking readings after 6 seconds). Be careful not to block the mouthpiece with tongue or teeth.
  • Page 8 3.4. Reviewing Previous Results The Vitalograph Lung Monitor USB can store up to 200 test sessions. To view previously performed test sessions: 1. When the device is ready for a test ( ), press approximately 3 seconds. 2. The most recent test session displays. The best FEV1 result will be displayed for approximately 3 seconds, followed by the best FEV6 result.
  • Page 9 2. If ‘No devices have been detected’ message appears, click ‘Continue’. a. Turn device on,  . b. In Vitalograph Reports ensure ‘Vitalograph Lung Monitor’ is selected via the Device Selection Button 3. To print the test results from the Lung Monitor USB:...

  • Page 10: Power Management

    Note: Dispose of used batteries safely. 5. Cleaning & Hygiene The Vitalograph Lung Monitor USB is not designed or supplied as a ‘sterile’ device. Keep the device clean and dust free. If you suspect the device is damaged or is measuring incorrectly, contact your medical professional immediately.

  • Page 11: Fault Finding Guide

    Service and repairs should be carried out only by the manufacturer, or by Service Agents approved by Vitalograph. Contact information for approved Vitalograph Service Agents may be found at the start of this manual. Any serious incident that has occurred in relation to the device should be reported to Vitalograph or its Authorized Representative and the Regulatory Authorities of the country.

  • Page 12: Consumables And Accessories

    8. Consumables and Accessories Cat. No Description 28501 Eco BVF (100) 28572 Eco BVF + Disposable Noseclips (80) 40168 Mouthpiece (20) 20303 Disposable Noseclips (200) 40167 Pouch Spare (x10) 20242 SafeTway Mouthpieces (200) 40079 USB Cable - 1M MINI-B to USB A 9.
  • Page 13 Symbol Description The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste   Serial Number Device Order Number Use by Date (Date format yyyy-mm-dd) Keep Dry Do not re-use Non sterile Recycle QR code - matrix bar code.

  • Page 14: Technical Specification

    Transmit Report Symbol 11. Description of the Vitalograph Lung Monitor USB The Vitalograph Lung Monitor USB 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 15: Contraindications, Warnings, Precautions And Adverse Reactions

    13. Contraindications, Warnings, Precautions and Adverse Reactions 1. No modification of this equipment is allowed. Any unauthorised changes to the device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported.
  • Page 16 4. If used for multiple subjects, Vitalograph intends that a new Eco Bacterial Viral Filter (Eco BVF) be used for every subject to prevent cross contamination. Using a new Eco BVF provides a...
  • Page 17 14. CE Notice Marking by the symbol indicates compliance of the Vitalograph Model 4000 Lung Monitor to the Medical Devices Directive of the European Community. The Vitalograph Model 4000 Lung Monitor is intended for use in a variety of Home and professional healthcare environments, e.g.
  • Page 18 Lung Monitor should assure that it is not used in such an environment. The Model 4000 Lung Monitor has been tested in accordance with: EN60601-1:2006 + A1:2013 Medical electrical equipment. General requirements for basic safety...
  • Page 19 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 20: Fda Notice

    16. EU Declaration of Conformity Product: Respiratory Monitor 4000, Lung Monitor 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 21 17. 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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