Model note · Spirometer
ndd EasyOne Air Spirometer
The EasyOne Air is a hand held diagnostic spirometer with a colour touchscreen, used in clinics, pharmacies, occupational health and hospitals for patients over 4 years old. Its ultrasonic transit time sensor measures flow and molar mass through a single use EasyOne Flow Tube, so there is no flow head to clean or calibrate. It runs on a rechargeable lithium ion battery and links by USB or Bluetooth to EasyOne Connect software.
The model
Maker, model and type.
- Maker
- ndd Medizintechnik AG
- Model
- EasyOne Air Spirometer
- Device type
- Spirometer
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Measurement principle | Ultrasonic pulse transit time; measures flow velocity, volume and gas molar mass | Source |
| Accuracy | Volume plus or minus 2% or 0.050 L; flow (except PEF) plus or minus 2% or 0.020 L/s; PEF plus or minus 5% or 0.200 L/s; MVV plus or minus 5% or 5 L/min | Source |
| Range and resolution | Volume plus or minus 12 L at 1 mL; flow plus or minus 16 L/s at 4 mL/s | Source |
| Flow resistance | 0.3 cmH2O/L/s at 16 L/s | Source |
| Size and weight | 87 x 155 x 36 mm; 302 g without battery, 356 g with battery | Source |
| Display and storage | 320 x 240 touchscreen LCD; up to 10,000 tests | Source |
| Connectivity | USB and Bluetooth; HL7, XML and GDT export via EasyOne Connect | Source |
| Power | Rechargeable lithium ion battery, USB power supply 4.5 to 5.5 V, up to 7.5 W | Source |
| FDA clearance | K161536, product code BZG, 21 CFR 868.1840, decided 5 January 2017; predicate EasyOne (K993921) | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Do not open the case or attempt repair; ndd says third party service must not repair it either. Source
- Non original flow tubes can cause measurement errors and false results. Source
- Use only the original battery, charge only with ndd's supply, and keep it away from heat to avoid fire or explosion. Source
- Operating outside the specified environment can cause measurement errors and false diagnosis. Source
Sources
Where this note comes from.
- EasyOne Air Operator's Manual V1.1 (distributor copy, henrotech.be)
- FDA 510(k) K161536 summary, EasyOne Air Spirometer
- openFDA 510(k) search, ndd
Not covered: The manual is version 1.1 from a Belgian distributor; a later V03 (2020) exists and figures may differ by firmware. openFDA has no recall or MAUDE records for ndd or the EasyOne brand. The specification table extracted from the PDF was column shifted and was matched by hand, so a reviewer should check the accuracy figures against the current manual.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.