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AioCare Spirometry System User Manual
- system for remote monitoring, with a spirometer, peak flow meter and pulse meter module
Manufacturer:
HealthUp sp. z o.o.
ul. Smolna 4,
00-375 Warsaw, Poland
Telephone: (+48) 736 836 869, e-mail: support@healthup.pl
© Copyright HealthUp
Current edition (revision 2.1 of 03/10/2017)
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Table of Contents
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Summary of Contents for HealthUp AioCare
- Page 1 - system for remote monitoring, with a spirometer, peak flow meter and pulse meter module Manufacturer: HealthUp sp. z o.o. ul. Smolna 4, 00-375 Warsaw, Poland Telephone: (+48) 736 836 869, e-mail: support@healthup.pl © Copyright HealthUp Current edition (revision 2.1 of 03/10/2017)
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Page 2: Table Of Contents
3.4. Flow reset.............................. 7 4. Conducting testing ..........................7 4.1 Preparing AioCare for operation ......................7 4.2 Communication between AioCare device and user ................ 8 4.3 Hardware and software requirements for the mobile device ............9 4.4. First launch of application ........................9 4.5 Log in .............................. -
Page 3: Description Of Aiocare System
1. Description of AioCare system AioCare has been developed at Healthup by a team of experts with practical experience in design and manufacture of medical devices and software development. The main innovation of our system is a unique combination of measurement sensors, our proprietary measurement channel, and a functional application working on iOS and Android operating systems. -
Page 4: Contraindications For Spirometry Testing
1.2. Contraindications for peak flow measurement No contraindications for peak flow measurement. 2. Structure of AioCare spirometry system AioCare is a portable spirometer for the testing of the respiratory function. AioCare spirometry system comprises: • measuring module with a flow tube •... -
Page 5: Measuring Module Combined With Mobile Device
2.1 Measuring module combined with mobile device The purpose of the measurement module is to transform the patient’s inhalation and exhalation parameters into electric signal. The signal generated in the module is processed by the spirometer’s microcontroller and sent through Bluetooth 4.0 to the mobile application where the data are processed into graphs and numeric values of parameters displayed on the screen of a mobile device. -
Page 6: Schematic Structure Of Aiocare
All spirometry standards (including ATS/ERS) recommend that the reliability of pulmonary measurement devices should be checked at least once daily with a 3L calibration syringe when AioCare is used in clinical and hospital environment. With normal use, calibration or calibration check is recommended as part of the annual routine maintenance service. -
Page 7: Flow-Volume Loop
Prior to measurement, attach the bacterial filter (IMPORTANT: in the case of infection accompanied by coughing when the device is used individually, and always when AioCare is used in clinical or hospital environment) and the nose clip to the flow tube, make several quiet breathing cycles, and make a slow, deepest possible exhalation, followed by quickest and deepest possible inhalation. -
Page 8: Communication Between Aiocare Device And User
5S. We don't recommend operating the application on tablets or iPads. 4.4. First launch of application Upon installing the AioCare application, to continue using it, you need to create a doctor’s or user’s account, or log in if such account is already in the system. -
Page 9: Main Screen
Main screen On the main screen, you have access to the following functionalities: Button opening the application main menu containing: • Button to start a spirometry test • • Statistics • My device • My profile • Help • Shop •... -
Page 10: Conducting A Test
4.6. Conducting a test A spirometry test begins by pressing “Start” on the main screen. It redirects to the test screen. Make sure the device has been connected and paired with the application, then reset the flow. The next step displays the measurement preparation screen. Prepare the spirometer, filter and nose clip. When the patient is ready, press “Start”. -
Page 11: Measurement Results
Next displayed is the “live” measurement screen with visualisation and graph of the flow rate in real time. Measurement is stopped by pressing the “Stop” button. 4.7 Measurement results Spirometry The first screen shows the interpretation of results, and all measured spirometry parameters are shown at the bottom. -
Page 12: Aiocare Spirometer Maintenance
5.1 Operation guidance Tests and safety AioCare has been tested by an independent laboratory which has certified the conformity of the device with the European standard for electric safety and for home use (EN 60601-1 and EN 60601-11) and warrants its conformance with electromagnetic compatibility requirements set out in the EN 60601-1-2 European standard. -
Page 13: Meaning Of Symbols Used By The Manufacturer
CAUTION: Bacterial filter must be used. Don’t use the same filter if you test different patients on the same AioCare device. Failure to comply with this caution may lead to cross- or secondary contamination. PRECAUTIONS: Don’t use this device while charging! Disposable filter must be used if you test different patients on the same AioCare device. - Page 14 Plate on AioCare device example: MS- CE - this symbol 16110001 (where means that the product 16 is the year of has the certificate of manufacture/11 – compliance with Class month of IIa according to manufacture/ Directive 93/42/EEC 0001-consecutive on medical devices.
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Page 15: Maintenance
7.1. Operation of AioCare power supply AioCare is powered by a 300mAh 3.7 V LiPo battery installed inside the measurement module. Fully charged battery is capable of working continuously for 5.5-6 hours. The user is notified on the battery status in the mobile application or through LED signals on the device casing. -
Page 16: Battery Replacement
Battery life is estimated by the manufacturer at 2 years and is a precondition for the device to be used. After 2 years of starting using the device, AioCare is used by the user only on their own responsibility.
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