Related Manuals for Vitalograph asma-1 BT
Summary of Contents for Vitalograph asma-1 BT
- Page 1 BT MODEL 4000 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 2, 03-Nov-2020) Cat. No. 09740...
- 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 BT Figure 1 Vitalograph asma-1 BT Components User Buttons Display Flowhead Down Button Up Button Enter Button 1.1. Features of the Vitalograph asma-1 BT • Electronic records • Stores 600 test sessions •...
- Page 4 2. Attach a mouthpiece to the flowhead. Figure 2. Mouthpiece inserted into flowhead 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...
- Page 5 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. 3.1. Setting Personal Best (Reference) Values Personal Best (reference) values can be set for peak flow (PEF) and/or forced expiratory volume after 1 second (FEV1).
- Page 6 Green Green Top Boundary Yellow Top Boundary Yellow Orange Middle Boundary Bottom Boundary Red Bottom Boundary 3 Zone 4 Zone To set boundary percentage values for 3 zones: 1. Turn the device on, 2. When the device is ready for a test ( ), press the buttons together for approximately 3 seconds.
- Page 7 4. When the device is ready for a test ( ), holding the head high, breathe in as deeply as possible, hold the Vitalograph asma-1 BT ready in front of the mouth, see Figure 3. Figure 3. Holding device during test.
- Page 8 PC where it can 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’ icon shows in the PC System Tray. If not, refer to help button of the software for more information.
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Page 9: Power Management
Note: Dispose of used batteries safely. 5. Cleaning & Hygiene The Vitalograph asma-1 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... -
Page 10: 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 11: Customer Service
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: Explanation Of Symbols
products as unsorted municipal waste. The pouch can be disposed of in unsorted municipal waste. Used Eco BVFs and SafeTways, constitute minimally soiled waste from human healthcare and should be disposed of in line with local requirements. Eco BVFs are made from 100% polypropylene. 10. - Page 13 Transmit Report Symbol 11. Description of the Vitalograph asma-1 BT The Vitalograph asma-1 BT 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 14: Technical Specification
• What triggers the asthma attack (such as exercise-induced asthma) 11.1. Indications for Use The Vitalograph asma-1 BT 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 15 1. No modification of this equipment is allowed. Any unauthorised changes to the device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported. 2. The device should only be used under the supervision of a healthcare professional.
- Page 16 4. If used for multiple subjects, 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 Vitalograph 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 18 The customer or 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...
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Page 19: 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 20: 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 21 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 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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