Vitalograph copd-6 4000 Instructions For Use Manual
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Vitalograph copd-6 4000 Instructions For Use Manual

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copd-6
MODEL 4000
Instructions for Use
© Copyright Vitalograph 2020 Current Edition (Issue 1, 28-Jan-2020) Cat. No. 09780

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Summary of Contents for Vitalograph copd-6 4000

  • Page 1 MODEL 4000 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 1, 28-Jan-2020) Cat. No. 09780...
  • 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 Figure 1 Vitalograph COPD-6 Components User Buttons Display Flowhead Down Button Up Button Enter Button 1.1. Features of the Vitalograph COPD-6 • Early detection of COPD. • Displays FEV1, FEV6, ratio and % predicted, obstructive index, COPD classification (stage I - IV) and lung age.
  • Page 4 3. Attach a mouthpiece to the flowhead, see Figure 2. Figure 2. Mouthpiece inserted into flowhead 4. Vitalograph intends that a new Bacterial Viral Filter (Eco BVF) be used for every subject to prevent cross contamination. Using a new Eco BVF provides a significant...
  • Page 5 3.1. Entering Subject Data The subject’s physical data should be entered into the device in order to calculate predicted data. There are default values on the device for age, height, and gender. If default values are used instead of the subject’s own information, then the predicted data will not be accurate for the subject being tested.
  • 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 ready in front of the mouth, see Figure 3. Figure 3. Holding device during test. 6. Instruct subject to a.
  • Page 7 This subject should be referred for spirometry. 10. The Obstructive Index (OI) shows on the left-hand arrow. • 0 - Green is NORMAL. • 1, 2 or 3 – Yellow, orange or red are not normal. Refer for spirometry, but this is unlikely to be COPD. •...
  • Page 8 3.3. Setting the Obstructive Index and COPD Classification Zones The device’s Obstructive Index and COPD Classification zones are set to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) standard. It is unlikely that a user will need to change this, however if change is required the instructions are outlined below.
  • Page 9 . The device returns to the age entry screen. 3.4. Reviewing Last Session Test Results The Vitalograph COPD-6 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: Power Management

    5.2. Preventing Cross-Contamination of Subjects in Clinic use For multi-patient use in a clinic environment Vitalograph recommends the use of Eco BVF filters or, if these aren’t available then SafeTway mouthpieces may be used based on the customer own risk assessment and hygiene controls.

  • 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) 20242 SafeTway Mouthpieces (200) 20303 Disposable Noseclips (200) 20980 SafeTway Mouthpieces mini (50) 20991 SafeTway Mouthpieces long (130) 40167 Pouch Spare (x10) 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 Height Icon Gender Icon 11. Description of the Vitalograph COPD-6 The Vitalograph COPD-6 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 15: Technical Specification

    12. Technical Specification Product Respiratory Monitor COPD-6 Model 4000 109mm (length) x 63mm (width) Dimensions x 42mm (height) Weight 63g (not including batteries) Flow Detection Principal Stator/rotor Accuracy: Better than ± 3% Better than 0.15kPa/L/s at Flow Impedance: 14L/s Less than 0.15kPa/L/second Back pressure @ 14L/s Measurement Range:...

  • Page 16: Contraindications, Warnings, Precautions And Adverse Reactions

    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 17 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 18 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 19 EN 60601-1-2  -  Emissions tests Electromagnetic Emissions test Compliance environment - guidance The Model 4000 COPD-6 uses RF energy only for its internal function. Therefore, RF emissions Group 1 its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment.

  • Page 20: Fda Notice

    Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.

  • Page 21: 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 22 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.
  • Page 23 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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