Related Manuals for Vitalograph copd-6 4000
Summary of Contents for Vitalograph copd-6 4000
- Page 1 Vitalograph copd-6 Vitalograph Vitalograph Vitalograph User Manual Model No. 4000 Medical Devices Directive 93/42/EEC L169, Vol. 36. EN ISO 13485 FDA QSR 21 CFR 820/803 Manufacturer: Vitalograph (Ireland) Ltd, Ennis, Ireland...
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Page 2: Table Of Contents
Explanation of Symbols......................11 Technical Specifications......................12 Warranty ............................ 12 Quick Start Guide ........................13 Regulatory Notices for the Vitalograph copd-6 ............... 14 CE Notice..........................14 FDA Notice ......................... 14 Declaration of Conformity ....................16 © Copyright Vitalograph 2007 & 2008 Print Ref. -
Page 3: Warnings And Advisory Notices
Warnings and Advisory Notices: Note: Please read all the information in this manual before using the Vitalograph copd-6. A full set of instructions, including cleaning instructions, is available at www.vitalograph.co.uk. • This Vitalograph device is intended to measure lung function for use in clinic with disposable mouthpieces or filters or for patient use at home under medical supervision. -
Page 4: Main Components Of The Vitalograph Copd-6
Main Components of the Vitalograph copd-6 Flowhead On / off button Display User buttons... -
Page 5: What Is The Vitalograph Copd-6 Tm Used For
What Is The Vitalograph copd-6 Used For? The Vitalograph copd-6 is a device intended for measuring lung function. It can be used by a healthcare professional or assistant as a rapid pre-spirometry test to screen-out at-risk individuals that do not have COPD and indicate those that may be at risk of COPD at the pre- symptomatic stage of the disease. -
Page 6: Performing The Test
5. (This step may be omitted, depending on the variant) The Population Group (On some variants this is Weight instead) can now be set ( ). This is done by pressing the B or C button and releasing when the desired setting is reached. Press the E button to set. -
Page 7: Setting The Obstructive Index And Copd Classification Zones
Setting the Obstructive Index and COPD Classification Zones The Vitalograph copd-6 Obstructive Index and COPD Classification zones are set by the manufacturer to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) standard and it is unlikely that a user will wish to change this – however if this is required please follow the following instructions;... -
Page 8: Reviewing The Last Session Test Results
9. Press E. The device will return to the age entry screen. Reviewing the Last Session Test Results The Vitalograph copd-6 will always store the last test session, even after the device has powered itself down or has been switched OFF. In order to view the last test session, follow these steps;... -
Page 9: Care And Cleaning Of The Vitalograph Copd-6
Care and Cleaning Of The Vitalograph copd-6 Daily Procedures A new mouthpiece (either SafeTway or BVF) should be used for each subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device. -
Page 10: Removing The Flowhead For Cleaning And Disinfecting
All external parts of the Vitalograph asma-1 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. This device is not designated as a ‘sterile’... -
Page 11: Explanation Of Symbols
® 28350 Bacterial/Viral Filters (50) Explanation of Symbols Device symbols; Type BF equipment Class II The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste. Attention (reference relevant section in manual) User Interface Symbols;... -
Page 12: Technical Specifications
Auto power down time Set to 2 minutes as standard Warranty Your Vitalograph copd-6 is guaranteed for one year*. Replace if it is faulty, otherwise replace the unit every three years. * Excepting accidental / transit damage or inappropriate use of the device. -
Page 13: Quick Start Guide
Appendices Quick Start Guide... -
Page 14: Regulatory Notices For The Vitalograph Copd-6
Devices Directive of the European Community. Such marking is indicative that the Vitalograph copd-6 meets or exceeds the referenced technical standards. The Vitalograph copd-6 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. - Page 15 Recommended separation distances between portable and mobile RF communication equipment and the system The Vitalograph copd-6 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent...
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Page 16: Declaration Of Conformity
Vitalograph copd-6 Vitalograph Vitalograph Product: 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. This device, classified as 2a as per Annex IX of MDD 93/42/EEC, meets the following provisions of Annex II of the Medical Devices Directive as per Article 11, section 3a, excluding point 4 of Annex II.
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