Vitalograph asma-1 4000 User Manual
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- Quick start manual (16 pages) ,
- Instructions for use manual (24 pages)
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Summary of Contents for Vitalograph asma-1 4000
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Page 1: User Manual
Vitalograph asma-1 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... -
Page 2: Table Of Contents
Setting Management Zones ..................... 6 Performing The Test......................... 7 Reviewing Previous Results .....................8 Deleting All Results History ...................... 8 Care and Cleaning Of The Vitalograph asma-1 In Home Use ..........9 Cleaning and Disinfecting the Vitalograph asma-1 In Clinic Use .......... 9 Table of Materials Used &... -
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 Asma-1
Main Components of the Vitalograph asma-1 Flowhead On / off button Display User buttons... -
Page 5: What Is The Vitalograph Asma-1 Tm Used For
The device measures airflow out of the lungs when blown into as hard and fast as possible. The Vitalograph asma-1 can reveal narrowing of the airways well in advance of an asthma attack being felt by the asthmatic. Used mainly by persons with moderate to severe and persistent asthma, the Vitalograph asma-1 can help determine: when to seek emergency medical care. -
Page 6: How To Use The Vitalograph Asma-1 Tm
Note: to de-activate zones, set both the PEF and FEV1 reference values to 000/0.00. Setting Management Zones The Vitalograph asma-1 can be set for use with 3 or 4 zone management plans. The zone percentages are factory set to 2 boundaries, 80% & 50%, i.e. 3 Zones (80-100%, 50-80%, 0- 50%). -
Page 7: 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 asma-1 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 8: Reviewing Previous Results
Reviewing Previous Results The Vitalograph asma-1 can store up to 600 test sessions. In order to view previously performed test sessions, follow these steps; 1. Turn the device on, D. 2. When the device is ready for a test ( ), press the E button for approximately 3 seconds. -
Page 9: Care And Cleaning Of The Vitalograph Asma-1
Care and Cleaning Of The Vitalograph asma-1 In Home Use The Vitalograph asma-1 should continue to give reliable measurements for up to three years in home use. Then replace it with a new device. The device should be kept clean and dust free. If the asthmatic suspects that the device is damaged or measuring incorrectly they should take it to their doctor who will be able to check its operation and accuracy. -
Page 10: Table Of Materials Used & Cleaning/Disinfection Methods
Dispose – single use mouthpiece or All external parts of the Vitalograph asma-1 require cleaning, i.e. the removal of visible particulate contamination. Do not attempt to insert any object or to clean the rotor or stator in the measuring system. -
Page 11: Consumables, Accessories And Spare Parts
Consumables, Accessories and Spare Parts Cat. No Description 40161 Plastic Mouthpiece for asma-1 (Pack of 12) 20303 Disposable Noseclips (200) ® 20242 SafeTway disposable mouthpieces (200) ® 20980 Mini SafeTway mouthpieces (50) ® 28350 Bacterial/Viral Filters (50) Explanation of Symbols Device symbols;... -
Page 12: Technical Specifications
Auto power down time Set to 2 minutes as standard Warranty Your Vitalograph asma-1 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: Appendices
Appendices Quick Start Guide... -
Page 14: Regulatory Notices For The Vitalograph Asma-1 Tm
Devices Directive of the European Community. Such marking is indicative that the Vitalograph asma-1 meets or exceeds the referenced technical standards. The Vitalograph asma-1 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 asma-1 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...
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Page 16: Declaration Of Conformity
Declaration of Conformity Product: Vitalograph asma-1 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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