The DATOSPIR touch spirometer has been designed by the RDI department of SIBEL, S.A.U. with the collaboration of the Pneumology Department of the “Hospital de la Santa Creu i Sant Pau de Barcelona” and the Biophysics and Bioengineering Unit of the University of Barcelona, fulfilling the standardization criteria of the ATS/ERS TASK FORCE 2005 & SEPAR.
The W20s Spirometry Software allows the interoperability with
- High resolution color touchscreen.
- Internal printer.
- Rechargeable battery.
- 3 operating modes: Primary Care, Occupational Health or Diagnostic.
- Spirometry quality control program: quality grades for tests, accuracy verification, and calibration program.
- Modules: SpO2, MIP-MEP, Sniff and electronic weather station
- Database with more than 3000 tests with graphs
- Tests: FVC, VC, MVV, Bronchodilation,
- Simultaneous F/V and V/T graphs.
- Adult and pediatric incentive graphs.
- On-screen help.
- Integrated temperature sensor.
- Connectivity via USB, BLUETOOTH, or ETHERNET*.
- Interoperability compatible with HL7 (spirometry CDA)**.
- Suitable for telemedicine.
- PIN available (In compliance with the European standards for data protection, 95/46/EC).
*Ethernet: Connectivity to the Internet for sending tests by e-mail and for remote data monitoring. **HL7: Health Level Seven is an international standard for the interoperability of health information systems. (With W20s software) CDA: Clinical Document Architecture.
- Flow transducer: Fleisch, turbine or disposable (Lilly)
- Measurement range (BTPS): Flow 0 ± 16 l/s; Volume 0 to 10 l
- Accuracy (BTPS): Flow 5% or 200 ml/s; Volume: 3% or 50ml (ATS/ERS)
- Dynamic resistance:
- Display: 640 x 480 px and 5.7 inch high resolution color VGA touchscreen
- Printer: 112 mm thermal graphic printer
- Rechargeable battery: Ni-Mh 10.8V 2500mAh. Duration 1.5h approx.
- No. of maneuvers per patient: 8 FVC, 8 VC, 8 MVV
- Operating Temperature-Humidity: 5 to 40ºC. < 85% (without condensation)
- Power supply: 100 to 240V, 50 to 60Hz
- Power: 30W
- Dimensions: 195 x 270 x 100 mm
- Weight: 1.7 kg
- Storage temperature: -20ºC to 70ºC
- Directive: 93/42/CEE on Medical Devices, Class IIa Product
- Standards: EN ISO 13485:2016+AC:2016, EN ISO 9001:2015, EN ISO 14971:2012, EU 2016/679, EN 60601-1:2006 +AC:2010+A11:2012+A1:2013+AC:2014, EN 60601-1-2:2015, EN ISO 10993-1: 2009+AC: 2010, EN 60601-1-6:2010+A1:2015, EN 62366:2008+A1:2015, EN ISO 26782:2009+AC:2009, EN ISO 23747:2015, EN 62304:2006+AC:2008+A1:2015, EN ISO 80601-2-61:2011, EN 60721:1995, EN 60068:1999, EN 1041:2008, EN ISO15223-1:2016, EN 980:2008.
Quality control program
Spirometry quality control program:
- DATOSPIR touch includes an automatic function for spirometry quality control, based on the recommendations of the National Lung & Health Education Program (NLHEP).
- QC Prompts: Helps the technician to provide good instructions to the patient in order to obtain high quality spirometry tests. At the end of a maneuver, an on-screen notification will inform of its acceptability.
- QC Grades: At the end of the test, a quality grade from A to F will be shown to indicate the reliability of the results, according to the NLHEP criteria.
Accuracy verification program:
ATS/ERS 2005 recommends to check periodically volume spirometers.
In order to check that the transducer is measuring correctly, the spirometer includes a simple verification procedure, to be performed in a few seconds if required.