Vitalograph copd-6 BT Instructions For Use Manual
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Vitalograph copd-6 BT Instructions For Use Manual

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copd-6 BT
MODEL 4000
Instructions for Use
© Copyright Vitalograph 2020 Current Edition (Issue 2, 29-Oct-2020) Cat. No. 09820

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Summary of Contents for Vitalograph copd-6 BT

  • Page 1 BT MODEL 4000 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 2, 29-Oct-2020) Cat. No. 09820...
  • 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 1. Main Components of the Vitalograph COPD-6 BT Figure 1 Vitalograph COPD-6 BT Components User buttons Display Flowhead Down Button Up Button Enter Button 1.1. Features of the Vitalograph COPD-6 BT • Early detection of COPD. • Displays FEV1, FEV6, ratio and % predicted, obstructive...
  • Page 4 3. Attach a mouthpiece to the flowhead, see Figure 2. Figure 2. Mouthpiece inserted into flowhead 4. 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 significant...
  • Page 5 against the risk of cross contamination during spirometry manoeuvres. Eco BVF and SafeTway mouthpieces are single use items and must be disposed of after use. 3. Operating Instructions If the device has just been unpacked or transported, ensure that it is left sitting, fully powered and is at room temperature prior to testing.
  • Page 6 4. The subject should sit down to blow into the device (unless a physician advises otherwise). 5. Instruct subject to hold their head high and hold the Vitalograph COPD-6 BT ready in front of the mouth, see Figure 3. Figure 3. Holding device during test.
  • Page 7 7. Instruct the subject not to block the mouthpiece with tongue or teeth. A ‘spitting’ action will give false readings. 8. To view the result (the best values in the session), press the   button. 9. The COPD Classification shows on the right-hand arrow. •...
  • Page 8 abrupt end (change in volume is > 25ml in the last second of the test), the value FEV will be displayed instead of FEV6. 3. If the subject experiences side effects such as dizziness or fatigue during the test procedure, stop testing until recovered.
  • Page 9 . The device returns to the age entry screen. 3.4. Reviewing Last Session Test Results The Vitalograph COPD-6 BT always stores the last test session, even after the device has powered itself down or has been switched OFF. To view the last test session: 1.
  • Page 10 3.5. Downloading saved results The test session may be transmitted to Vitalograph Reports on your PC to be stored as a PDF file and viewed or printed. Vitalograph Reports must be installed and running on the PC before data is transmitted. The software is running if the Vitalograph ’V’...

  • Page 11: Power Management

    Note: Dispose of used batteries safely. 5. Cleaning & Hygiene The COPD-6 BT 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 12: 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 13: Consumables And Accessories

    8. Consumables and Accessories Cat. No Description 28501 Eco BVF (100) 28572 Eco BVF + Disposable Noseclips (80) 20242 SafeTway Mouthpieces (200) 20303 Disposable Noseclips (200) 20980 SafeTway Mouthpieces mini (50) 20991 SafeTway Mouthpieces long (130) 40167 Pouch Spare (x10) 67201 Bluetooth Adaptor 9.
  • Page 14 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 15 Transmit Report Symbol 11. Description of the Vitalograph COPD-6 BT The Vitalograph COPD-6 BT is a device intended for measuring lung function. It can be used by healthcare professionals or assistants as a rapid pre-spirometry test to screen-out at-risk individuals who do not have COPD and indicate those who may be at risk of COPD at the presymptomatic stage.

  • Page 16: Technical Specification

    The device is intended to be operated by the patient, under the supervision of a healthcare provider. 12. Technical Specification Product Respiratory Monitor COPD-6 BT Model 4000 109mm (length) x 63mm (width) Dimensions...
  • Page 17 4. 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 significant level of protection of the subject, the device and the user against the risk of cross contamination during spirometry manoeuvres.
  • Page 18 12. Keep device dry. If the device gets wet, do not use it, and contact Vitalograph using the contact information at the start of this manual. Do not connect any part of this device to mains power as there is a risk of injury especially if the device is wet.
  • Page 19 Vitalograph Model 4000 COPD-6 to the Medical Devices Directive of the European Community. The Vitalograph Model 4000 COPD-6 is intended for use in a variety of professional healthcare environments, e.g. primary care, hospital wards and occupational health centres, except for near...
  • Page 20 The Model 4000 COPD-6 has been tested in accordance with: EN60601-1:2006 + A1:2013 Medical electrical equipment. General requirements for basic safety and essential performance EN 60601-1-11: 2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

  • Page 21: Fda Notice

    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 22: Eu Declaration Of Conformity

    16. EU Declaration of Conformity Product: Respiratory Monitor 4000, COPD-6 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: • European Medical Devices Directive {MDD} 93/42/EEC, as amended.
  • Page 23 8. 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. 9. 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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