Related Manuals for Vitalograph Lung Monitor BT Smart
Summary of Contents for Vitalograph Lung Monitor BT Smart
- Page 1 Lung Monitor BT Smart MODEL 4000 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 1, 05-Feb-2020) Cat. No. 09881...
- 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 User Buttons Display Flowhead Down Button Up Button Enter Button 1.1. Features of the Vitalograph Lung Monitor BT Smart • Measures PEF, FEF25-75, FEV1, FEV and the ratio • Displays % of personal best PEF and FEV1 • PEF and FEV1 zones can be personalized •...
- Page 4 2. Setting Up the Vitalograph Lung Monitor BT Smart To get the Lung Monitor BT Smart ready for use: 1. Remove the detachable battery door at rear of unit. Fit two AAA 1.5V batteries. Replace battery door. 2. Turn on via the On/Off Button.
- Page 5 000/0.00. 3.2. Setting Management Zones The Lung Monitor BT Smart can be set for use with 3 or 4 zone management plans. The zones are factory set to 2 boundaries (90% & 95%) resulting in 3 Zones (0-90%, 90-95%, 95-100%). For 4 zones the...
- 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 device on, 2. When device is ready for a test ( ), press the buttons together for approximately 10 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 Lung Monitor BT Smart ready in front of the mouth, see Figure 3. Figure 3. Holding device during test.
- Page 8 3.4. Reviewing Previous Results The Vitalograph Lung Monitor BT Smart can store up to 600 test sessions. To view previously performed test sessions: 1. When the device is ready for a test ( ), press approximately 3 seconds.
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Page 9: Power Management
Note: Dispose of used batteries safely. 5. Cleaning & Hygiene The Lung Monitor BT Smart 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 10: 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 11: Consumables And Accessories
8. Consumables and Accessories Cat. No Description 28501 Eco BVF (100) 28572 Eco BVF + Disposable Noseclips (80) 40168 Plastic Mouthpiece 4000 series (20) 20303 Disposable Noseclips (200) 40167 Pouch Spare (x10) 20242 SafeTway Mouthpieces (200) 67201 Bluetooth Adaptor 9. Disposal The device and Bluetooth Adapter must be taken to separate collection at the product end-of-life. - Page 12 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.
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Page 13: Technical Specification
Transmit Report Symbol 11. Description of the Vitalograph Lung Monitor BT Smart The Vitalograph Lung Monitor BT Smart is an easy to use home monitoring device designed to record key lung function parameters for those with respiratory conditions, including cystic fibrosis and transplant patients. - Page 14 PEF: 25 – 840 L/min BTPS Measurement Range: FEF25-75: 25 – 840 L/min BTPS FEV1, FEV: 0 – 9.99 L BTPS Maximum test duration 6 seconds Slow start of test (Vext>5%) or a ! Bad Test Criteria cough detected in the first second Power Supply 3V (2 x 1.5V AAA batteries) 3 months of use, 3 tests per day...
- Page 15 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...
- Page 16 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 17 ME system for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high. The customer or the user of the Lung Monitor BT Smart should assure that it is not used in such an environment.
- Page 18 EN 60601-1-2 - Emissions tests Electromagnetic Emissions test Compliance environment - guidance The Model 4000 Lung Monitor BT Smart uses RF energy only for its internal RF emissions function. Therefore, its RF Group 1 CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment.
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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, Lung Monitor BT Smart 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: •... - 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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