Model note · Spirometer
Vitalograph Pneumotrac Model 6800
The Pneumotrac is a USB powered desktop spirometer that pairs a Fleisch pneumotachograph flowhead with Vitalograph's Spirotrac PC software. It measures VC, FVC, FEV1, FEV6, PEF and MVV in adults and children from 5 years in primary care, hospitals and occupational health. The flowhead connects to the base by pressure tubing and is protected by a single use bacterial viral filter for each subject.
The model
Maker, model and type.
- Maker
- Vitalograph (Ireland) Ltd
- Model
- Pneumotrac Model 6800
- Device type
- Spirometer
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Flow sensing | Fleisch type pneumotachograph; volume by flow integration sampled at 100 Hz; ambient temperature sensor | Source |
| Volume accuracy | Within plus or minus 2.5% (IFU); 510(k) table gives FEV1 and FEV6 plus or minus 3% | Source |
| Flow range | Maximum plus or minus 16 L/s (960 L/min); minimum plus or minus 0.02 L/s | Source |
| PEF accuracy | Within plus or minus 10% (IFU); 510(k) table states plus or minus 5% | Source |
| Back pressure | Less than 0.1 kPa/L/s at 14 L/s | Source |
| Operating environment | 17 to 37 C (ISO 26782 limits; design 10 to 40 C); 30 to 75% RH; 850 to 1060 hPa | Source |
| Size, weight and power | 160 x 95 x 115 mm; 550 g; 5 V DC over USB 2.0/3.0 | Source |
| Standards | ATS/ERS 2019, ISO 23747:2015, ISO 26782:2009; EN 60601-1 and EN 60601-1-2 | Source |
| FDA clearance | K142812, Vitalograph Model 6800 Pneumotrac, product code BZG, decided 29 June 2015; predicate Model 2120 (K100687) | 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 bacterial viral filter for every subject; the device is not sterile. Source
- Test subjects seated in a chair with arms and no wheels, since fatigue or fainting can occur. Source
- Do not expose the unit to liquids, or use it near flammable gases, dust or sand. Source
- Keep the non medical PC outside the patient environment and keep radios at least 30 cm away. Source
Sources
Where this note comes from.
- Vitalograph Pneumotrac Model 6800 Instructions for Use, Cat. No. 09000 Issue 3 (Nov 2020)
- FDA 510(k) K142812 summary, Vitalograph Model 6800 Pneumotrac
- openFDA 510(k) search, Vitalograph
Not covered: The device has no on board error codes; messages appear in Spirotrac software, whose IFU was not reviewed. Accuracy figures differ between the 2020 IFU (volume 2.5%, PEF 10%) and the 2015 510(k) comparison table (FEV1 3%, PEF 5%); both are shown. openFDA holds no recall or MAUDE records for Vitalograph or Pneumotrac. The first design note's pressure sensor location is the drafter's reading of the tubing and pressure port descriptions.
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.