Related Manuals for Vitalograph asma-1 USB
Summary of Contents for Vitalograph asma-1 USB
- Page 1 USB MODEL 4000 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 1, 28-Jan-2020) Cat. No. 09720...
- 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 asma-1 USB Figure 1 Vitalograph asma-1 USB Components User Buttons Display Flowhead On / Off button Down Button Up Button Enter Button...
- Page 4 • Automatically stores best values 2. Setting Up the Vitalograph asma-1 USB To get the Vitalograph asma-1 USB ready for use: 1. Remove the detachable battery door at rear of unit. Fit two AAA 1.5V batteries. Replace battery door. 2. Attach a mouthpiece to the flowhead.
- Page 5 3. 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 provides a significant level of protection of the subject, the device and the user against the risk of cross contamination during spirometry manoeuvres.
- Page 6 3.2. Setting Management Zones The asma-1 USB can be set for use with 3 or 4 zone management plans. The zones are factory set to 2 boundaries (80% & 50%) resulting in 3 Zones (0-50%, 50-80%, 80-100%). For 4 zones the middle boundary is set last.
- Page 7 ), holding the head high, breathe in as deeply as possible, hold the Vitalograph asma-1 USB ready in front of the mouth, see Figure 3. Figure 3. Holding device during test. 5. Holding the breath, place the mouthpiece into the mouth, biting the mouthpiece lightly, and with the lips firmly sealed around it.
- Page 8 3.4. Reviewing Previous Results The asma-1 USB can store up to 600 test sessions. To view previously performed test sessions: 1. When the device is ready for a test ( ), press the button for approximately 3 seconds.
- Page 9 2. In Vitalograph Reports ensure ‘Vitalograph asma-1’ is selected as the device via the Device Selection Button 3. To print the test results from the asma-1 USB: 1. When the device is ready for a test ( ), press the button for 3 seconds.
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Page 10: Power Management
Note: Dispose of used batteries safely. 5. Cleaning & Hygiene The Vitalograph asma-1 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
5.2. Preventing Cross-Contamination of Subjects in Clinic use For multi-patient use in a clinic or telemedicine 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 12: Consumables And Accessories
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: Explanation Of Symbols
10. Explanation of Symbols Symbol Description Type BF equipment Power rating Direct current Instructions for Use; operating instructions Manufacturer Date of Manufacture (include date in format yyyy-mm-dd) The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste ... - Page 14 Transmit Report Symbol 11. Description of the Vitalograph asma-1 USB The Vitalograph asma-1 USB is a medical device intended to give objective measures of lung function for help in managing asthma. It is intended to be used in a variety of professional healthcare environments, e.g.
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Page 15: Technical Specification
• What triggers the asthma attack (such as exercise-induced asthma) 11.1. Indications for Use The Vitalograph asma-1 USB is a hand held respiratory monitor which measures subject respiratory parameters FEV1 and PEF. It is designed for lung function testing of adults and children, 5 years and older, in home and professional healthcare environments, e.g. - Page 16 3. The device is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals. 4. If used for multiple subjects, Vitalograph intends that a new Eco Bacterial Viral Filter (Eco BVF) be used for every subject to...
- 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 Model 4000 asma-1 to the Medical Devices Directive of the European Community. The Vitalograph Model 4000 asma-1 is intended for use in a variety of Home and professional healthcare environments, e.g. primary care, hospital wards and occupational health centres, except for...
- Page 19 the user of the asma-1 should assure that it is not used in such an environment. The Model 4000 asma-1 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.
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Page 20: 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 21: Eu Declaration Of Conformity
16. EU Declaration of Conformity Product: Respiratory Monitor 4000, asma-1 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 7. 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. 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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