Product Name | Spiromagic® |
Handheld Portable Spirometer | Yes |
Spirometry Testing | Yes |
Intended Use | Professional Screening and Home Monitoring |
Parameters Displayed by Application | FEV1, FEV6, FEV1/FEV6, PEF, FEV1/RefFEV1, ELA |
Additional Information Displayed by Application | Estimated Lung Age (ELA), Location, Temperature, Humidity, Wind Speed/Direction, Air Pressure |
Environment of Care | Hospitals, Healthcare Centres and Homes |
Target Population | Adults & Paediatrics (6 years or older) |
Telemedicine Competent | Yes. API Ready to Integrate with Telemedicine Platforms |
Volume Accuracy | < +/- 3% |
Size (mm) | 120 x 63 x 20 |
Net Weight (g) | 59,3 g ± 2 g |
Power | 2 x 1.5v AAA |
CE Mark | Yes |
FCC Declaration of Conformity | Yes |
Data Transmission | Bluetooth® (4.0 or higher) |
Performance Standards | ISO 26782:2009 ATS/ERS 2005 |
Safety Standards | IEC 60601-1:2005 |
Medical Safety Standard | Medical Devices 93/42/EEC |
Designed and Manufactured to Following QA/GMP Standards | ISO 13485:2003 |
Reusable Mouthpiece | Yes |
Measurements Stored in a Secure Database | Yes |