HealthUp AioCare Instructions For Use Manual
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HealthUp AioCare Instructions For Use Manual

Spirometry system
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Instructions for use
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AioCare spirometry
system
© Copyright HealthUp
Current edition (6th edition 21.01.2021)

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Summary of Contents for HealthUp AioCare

  • Page 1 Instructions for use AioCare spirometry system © Copyright HealthUp Current edition (6th edition 21.01.2021)
  • Page 2 Remote monitoring system with spirometer and peak flow meter module and pulse oximeter. Manufacturer: HealthUp sp. z o.o. Address: Contact: Twarda 18, Sarmacka 7B/2, phone: (+48) 798 545 240 00-375 Warsaw 02-972, Warsaw e-mail: info@aiocare.com...

  • Page 3: Table Of Contents

    Peak Exhaust Flow Test (PEF) 6.4. Contraindications for the spirometry test Pulse (HR) and saturation (SpO ) test 1.1. 6.5. Construction of the AioCare spirometry system Operation of the device Equipment Preparing the AioCare device for operation 2.1. 7.1. Operating conditions and equipment classification Communication between AioCare and the user 7.2.
  • Page 4 Declaration of conformity 8.2.3.3. (domestic use) Questions and problems - FAQ Cleaning procedure Training 8.2.3.4. Power supply Precautions: Operating the AioCare spirometer power supply Warnings for use in electromagnetic fields 9.1. 20.1. Changing the battery Recommended separation distances 9.2. 20.2. Disposal...

  • Page 5: Description Of The Aiocare System

    AioCare - a remote monitoring system with a spirometer module, which is used The AioCare spirometer is intended for use by a doctor or a patient under the to perform a spirometry test. These tests are the basis for functional diagnostics supervision of a doctor or a technician.

  • Page 6: Contraindications For The Spirometry Test

    1.1 Contraindications for the spirometry test hypoxemia, hypercapnia, polyglobulia - increased hematocrit value) 2. Screening of persons with risk factors (smoking, exposure to toxic factors - dusts, gases). 1. Absolute contraindications: 3. Respiratory testing in systemic diseases. • fresh (during hospitalization) myocardial infarction, 4.

  • Page 7: Construction Of The Aiocare Spirometry System

    The signal created in the module is processed by the microcontroller of the spirometer and sent via AioCare is a portable spirometer for functional tests of the respiratory system. Bluetooth® 4.0 to the mobile application, where the data is converted into curves The AioCare spirometry system consists of: and numerical values of the parameters displayed on the mobile device screen.

  • Page 8: Measured Spirometric Parameters

    Protection of the casing against water ingress, Spirometric flow measurement range: 0-16 l/s IP 22 according to IEC 60529 (spirometer elements) Flow accuracy: ±5% or 200 mL/s Communication: Bluetooth® 4.0. Low Energy Resistance: < 0.5 cm H2O/L/s Bluetooth® frequency: 2.4-2.48 GHz Volume range: 0-8 litres Measurement frequency:...

  • Page 9: Construction Diagram Of The Aiocare

    4. Construction diagram of the AioCare [Diagram 1] ⑥ ④ ① Measuring module ⑤ ② Flow tube ③ USB socket ③ ④ ON/OFF button ⑤ LED indicator ⑦ ⑥ Pulse (HR) and saturation (SpO2) meter ① ⑦ Housing latch ⑧ Tube holder ⑧...

  • Page 10: Components Of Aiocare

    6.2. Flow zeroing 6.1. Calibration of the spirometry system It aims to increase the accuracy of the measurement. The AioCare spirometer should be placed horizontally, away from sources generating air movement, and Calibration of the device is carried out at the manufacturer. The sensor and flow the flow zero function should be called up in the mobile application.
  • Page 11 5. Place the AioCare device on a flat surface and wait 5 seconds until the device is fastest and deepest possible inhalation. This should be followed by a deep, violent reset.
  • Page 12 Spirometry test [Diagram 2] 6 - 10...

  • Page 13: Peak Exhaust Flow Test (Pef)

    7. Operating the device ③ Select "Peak Flow Meter" from the menu. ④ Place the AioCare device on a flat surface and wait 5 seconds to reset the flow. 7.1. Preparing the AioCare device for operation ⑤ Click the Start button on the mobile device when you are ready.
  • Page 14 7.1. Preparing the AioCare device for operation [Diagram 3] ② ③ ① Make sure the system contains Check the charging state Connect the flow tube with all elements of the device the measuring module ④ ⑤ ⑥ Attach the antibacterial filter...

  • Page 15: Communication Between Aiocare And The User

    Bluetooth data transmission during All LEDs blink smoothly: measurement AioCare spirometer - Applications is via Bluetooth® 4.0 (BT LE). This version of the module must be equipped with mobile devices on which applications will be installed. 4 of 8 LEDs flash: Low battery - connect to power source The iPhone version is a minimum iPhone 5S.
  • Page 16 Communication between AioCare and the user [Diagram 4] One-time flashing of all the diodes All the LEDs flashing smoothly: ony by one 360° to the moment the Bluetooth® data transmission during light is steady: starting the device. the measurement. Diodes flashing in a sequence in a...

  • Page 17: Application Installation

    Click the App Store or Google Play icon and Click "Install" to download the application and install icon on your smartphone. search for an application called AioCare. Select the it on your phone. When the installation is complete, application version: AioCare Doctor - for the Doctor click the "open"...

  • Page 18: First Start-Up Of The Application

    ② ③ ① A button that opens the main application menu After installing the AioCare application, in order to continue using it, it is necessary to create a doctor's or which consists of: user's account or log in, if such an account is already •...
  • Page 19 Doctor application home screen Carrying out the test [Diagram 8] On the main screen user has access to the following ① ② ③ ① The spirometry test starts by pressing the "Start" functionalities: ① Main menu button of the application, containing: button on the main screen.
  • Page 20 Step ① Step ②: View for the application in the Patient version Step ③: View for the application in the Patient version...
  • Page 21 ③ View for the application in the Measurement results View for the application in the Patient View for the application in the Doctor Doctor version version version The first screen shows the interpretation of the results, and below all measured spirometric parameters are presented.

  • Page 22: Maintenance Of The Aiocare Spirometer

    • Testing and safety AioCare consists of three main parts: • Measuring module, AioCare has been tested by an independent laboratory which confirms the compliance • Tube holder, of the product with the European standard for electrical safety and home use •...

  • Page 23: Daily Maintenance

    In case of problems do not attempt to repair it yourself. (BVF) CE 0086, Art, number: 2820/28501) have been tested in operation with the AioCare spirometer and are recommended for safe usage with the device. The setting of configurable parameters must be done by qualified personnel.

  • Page 24: Cleaning And Inspection Of The Flow Tube

    After disconnecting the tube holder from the measuring module, the measuring ⑤ Checking the correctness of the measurement function: turn on AioCare and module should be cleaned with non-alcoholic cloths for cleaning and disinfection of medical devices. AioCare recommends the use of the Sani-Cloth AF3 disposable proceed as if you wanted to perform a spirometry test.
  • Page 25 Cleaning of the flow tube [Diagram 9]...

  • Page 26: Disinfection Methods For Multiple Patient Use

    Checking if the measuring function is correct: 1. Ecolab OxyCide Daily disinfectant (EPA registration No. 1677-237). Turn on AioCare and proceed as if you wanted to perform a spirometry test. Take 2. PDI Sani-Cloth AF3 disposable bactericidal ready to use wipes (RTU) the device in one hand and slowly move it from right to left and vice versa so that (EPA registration 9480-9).
  • Page 27 Cleaning of the flow tube - method 1 [Diagram 10]...

  • Page 28: Cleaning Procedure For The Device Used By 1 Patient

    If you have additional questions about cleaning, disinfection or reprocessing, please 4. Rinse (2) with deionised water. contact the Healthup team: info@AioCare.com or call + 48 798545240. 5. 90°C thermal disinfection. For 5 minutes, deionised water 8.2.3.3. Cleaning procedure for the device used by 1 patient + neodisher MediKlar 0.5 ml/l.
  • Page 29 Cleaning of the flow tube - method 2 [Diagram 11]...

  • Page 30: Cleaning Procedure

    8.2.3.4. Cleaning procedure The Vyaire MicroGard® II (510 (K): K111408) or Vitalograph ECO Bacterial Viral Filters (BVF) CE 0086, Art, number: 2820/28501) have been tested with the AioCare spiro- meter and are recommended for safe usage with the device. • Cleaner: PDI Sani-Cloth AF3 Germicidal Dispipeable Wipe Ready-to-Use (RTU) (EPA registration 9480-9), •...
  • Page 31 Cleaning procedure [Diagram 12]...

  • Page 32: Power Supply

    Allow the tube to dry for 5 minutes. The AioCare spirometer is powered by a 3.7 V LiPo battery, placed in the measuring ③ Clean the tube holder under running water with mild soap if you notice visible dirt module housing, with a capacity of 300mAh.
  • Page 33 During standard operation, the LEDs indicate the battery charge level charging of the measuring module, the spirometer functions are disconnected, no according to the model below: tests can be performed (the device cannot be switched on with the 'ON/OFF' button). To fully charge the battery, the charging process should take 3.5 hours.

  • Page 34: Changing The Battery

    • damage to the measuring module • explosion or ignition of a battery of AioCare and connect it to a power source (any USB port), the LEDs at the top of AioCare should flash to show the current battery level.

  • Page 35: Disposal

    10. Disposal 12. Working environment Dispose of this equipment in accordance with the national regulations in force in Optimum ambient temperature for the From +15°C to +40°C measurement: your country. Do not place used appliances or batteries in normal waste containers. Contact your recycling company for this purpose.

  • Page 36: Information On Compliance With Fcc Usa

    2019 - production year, 0001- copy number, 14 - hardware number) AioCare has been designed and complies with the safety requirements for mobile Warning symbol for WEEE; waste electrical components; disposal in radio exposure in accordance with FCC §2.1093 and KDB 447498 D01.

  • Page 37: Declaration Of Conformity

    1. How to register for the AioCare application? Read the online manual To register to the application, on the initial screen, click the "Join AioCare" button and then enter the email to which you want to register your account and password...
  • Page 38 Bluetooth® module being turned on. one digit and one special character). 2. I have been logged out of the application. How to log in to the AioCare The problem occurs mainly on mobile devices based on the Android system. The...
  • Page 39 If the application still detects airflow even though the patient has finished blowing into AioCare, finish the test and reset the airflow and start a new test. For measurements to qualify for a correctly performed test in accordance with interna- tional standards, the criterion of correctness of measurements as well as the criterion 9.
  • Page 40 The green dot during the measurement means that the measurement was carried When the AioCare LEDs start flashing even though no test has been carried out, this out correctly without any errors.

  • Page 41: Training

    The AioCare application contains several tips on how to take measurements correctly: ① Pop-up information / hints in the application about errors or warnings, ② The guide available on our website - how to use AioCare application can be easily found in the Support section, ③...
  • Page 42 ② Guide available on our website ③ Explanatory video (vimeo.com/332398775) ④, ⑥ FAQ and digital manual...
  • Page 43 ⑤ Training sections in our application...

  • Page 44: Precautions

    1. The use of a disposable antimicrobial filter is mandatory when testing different • does not work properly (LED is not lit)! patients on the same AioCare device. Failure to comply with this warning may result • has been stored for a long time in unfavourable conditions (-10°C or higher than in cross or secondary infection.

  • Page 45: Warnings For Use In Electromagnetic Fields

    • Do not leave your smartphone unattended • Use your password to access your data • Make sure that AioCare and the smartphone on which the application is installed • Check the correct email address to which the test results are to be sent are within 2 meters from each other.

  • Page 46: Recommended Separation Distances For Rf Communication

    The Bluetooth® word and logo are registered trademarks owned by Bluetooth SIG, Inc. Not applicable 0,550 1100 and their usage by Healthup Sp. z o.o. is under license. Other trademarks and trade names are those of their respective owners. Not applicable 0,750...

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