Medical device class | IIA EU Classification |
---|---|
Flow range | 0-16 l/s |
Flow accuracy | ±5% or 200 mL/s |
Volume range | 0-8 litres |
Volume accuracy | ±2.5% or 50 ml, whichever is greater |
Linearity | 2.5% |
Tests | FVC, pre and post (bronchodilator) |
Accuracy standards | ATS/ERS 2019 |
Quality standards | ISO 13485, ISO 26782, ISO 10993-1, ISO 14971, ISO 15223-1, ISO 23747, EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 60601-1-11, MDD 93/42/EEC, FCC §2.1093, KDB 447498 D01, ISED RSS-102 Iss. 5 |
Parameters | FVC, FEV1 , FEV1/FVC, PEF FEF25, FEF50, FEF75, TPTEF/TE, VPTEF/VE, BEV, TE, TEPEF |
Predicted values | GLI |
BTPS correction | Automatic |
Measurement frequency | 100 Hz |
Calibration | No calibration required |
---|---|
Water resistance | IP22 |
Expiratory impedance | <0,15 kPa/(l/s) at 14l/s |
Communication | Bluetooth 4.0 |
Bluetooth frequency | 2.4-2.48 GHz |
Power supply | Battery (LiPo 3.7 V) |
Charging | Micro USB or wireless (NFC) |
Algorithms | Plateau, Cough, BEV |
Dimensions & weight | 118 mm 38 mm 48 mm 0,3 kg |
Interface device | Android, iOS smartphones
on-line panel (Chrome, Safari, Firefox, Opera, Explorer) |
Data storage | Microsoft Azure cloud system |
Apple Health Kit | Yes |
API integration | Yes, on request |
To maintain the functionality of the device, ensure accuracy of measurements and prevent cross-contamination, always keep the device clean. Always use a disposable antibacterial filter when taking measurements. If the device is used by several patients, the filter must be used to avoid cross-contamination.
The device can be used with different types of filters, certified 30 mm diameter. The filters are a simple way to ensure protection against cross-contamination, both for patient and operator safety.
The Vyaire MicroGard® II (510 (K): K111408) or Vitalograph ECO Bacterial Viral Filters (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 application is intended for the patient
See what you get in the Patient Plus version:
Application designed for the Doctor
See what you get in the Doctor Plus version: