Model note · Spirometer
MIR Spirolab
The Spirolab is a desktop diagnostic spirometer from the Italian maker MIR, with an optional pulse oximetry channel for spot checks. It is used in hospital clinics, GP surgeries, occupational health and pharmacies for adult and paediatric lung function testing. It works stand alone with a 7 inch colour touchscreen and a built in thermal printer, and measures flow with a bidirectional turbine that can be a disposable FlowMIR or a reusable type.
The model
Maker, model and type.
- Maker
- MIR Medical International Research S.r.l.
- Model
- Spirolab
- Device type
- Spirometer
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Flow and volume sensor | Bidirectional turbine read by infrared interruption; disposable FlowMIR or reusable turbine | Source |
| Maximum volume and flow range | 10 L maximum volume; flow range plus or minus 16 L/s | Source |
| Accuracy (ATS 2019) | Volume 2.5% or 50 mL; flow 5% or 200 mL/s | Source |
| Dynamic resistance | Below 0.5 cmH2O/L/s at 12 L/s | Source |
| Display | 7 inch colour touchscreen LCD, 800 x 480 | Source |
| Battery and autonomy | NiMH 7.2 V, 4000 mAh pack (six 1.2 V cells), about 10 hours; charged by a Friwo FW8000M/12 12 W medical supply | Source |
| Size and weight | Main body 220 x 210 x 51 mm; about 1450 g with battery | Source |
| Memory | Over 10,000 spirometry tests (exact figure depends on configuration) | Source |
| Interfaces | USB and Bluetooth; EMR links via HL7, GDT and FHIR through MIR software | Source |
| Electrical class | Internally powered, Class II while charging, type BF applied part, IPX1 | Source |
| Standards | ATS/ERS 2005 with 2019 update, ISO 23747:2015, ISO 26782:2009; ISO 80601-2-61:2017 for oximetry | Source |
| FDA clearance (earlier Spirolab family) | K052140, Spirolab and Spirolab II, product code BZG, 21 CFR 868.1840, decided 16 March 2006 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Use a new single use mouthpiece for every patient, and a new disposable turbine per patient if that type is used, to avoid cross contamination. Source
- Never autoclave or sterilise the turbine, and avoid alcohol or oil based cleaners, hot liquids, running water or sprays, as these can ruin it. Source
- Only original MIR turbines, oximetry sensors and cables are permitted; others may give wrong readings or raise emissions. Source
- Not suitable for operating theatres or near flammable anaesthetic mixtures, and must not be used while the battery is charging. Source
- Dyes such as methylene blue, poor perfusion, nail varnish and dyshaemoglobins can make SpO2 readings inaccurate. Source
- Repairs, adjustments and modifications must be done only by MIR or personnel it authorises. Source
Sources
Where this note comes from.
- MIR Spirolab product page
- Spirolab User Manual Rev. 2.2 (16 Feb 2023), hosted on the Moldovan public procurement portal
- FDA 510(k) K052140, Spirolab and Spirolab II
- openFDA MAUDE problem counts, brand Spirolab
- openFDA recall search, Spirolab (no results)
Not covered: No FDA recalls were found and MAUDE holds only three single reports, so failure data is thin. The only FDA clearance found (K052140, 2006) covers the earlier Spirolab and Spirolab II, and it is unclear which clearance covers the current touchscreen Spirolab. The Spirolab Service Guide was not publicly reachable, so the error list comes from the user manual troubleshooting table only.
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.