Descrição
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 Sa
nt 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
Main Features
- 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,
- Bronchoconstriction.
- 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.
Connectivities
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Parameters
FVC / Bronchodilation FVC (l) FEV1 (l) FEV1/FVC (%) PEF (l/s) FEF50%(l/s) FEF25-75% (l/s) FEV6 (l) FEV1/FEV0.5 (-) PEFT Vext (l) FIVC (l) FIF50% FEF50/FIF50 QC Grades FEV.5 (l) FEV3 (l) FEV.5/FVC (%) FEV3/FVC (%) FEV1/VC (%) FEV1/FEV6 (%) FEV1/PEF (%) FEV1/FIV1 (-) PEF/PIF (-) FEF25% (l/s) FEF75% (l/s) FEF75-85% (l/s) FET25-75 (s) FET100 (s) FIV1 (l) FIV1/FIVC (%) PIF (l/s) MTT (s) MVVInd (l/min) COPD Index (%) Lung age (years) VC VC (l) TV (l) ERV (l) IRV (l) IC (l) Ti (s) Te (s) Tt (s) Ti/Tt (%) MVV MVV (l/min) Br./min (Br/min) Bronchoconstriction FVC (l) FEV1 (l) PEF (l/s) FEF25-75% (l/s) PDx Sp02 Maximum SpO2 (%) Average SpO2 (%) Minimum SpO2 (%) SpO2 Std Dev (%) Maximum PR (BPM) Average PR (BPM) Minimum PR (BPM) PR Std Dev (BPM) CT90 (%) CT80 (%) CT70 (%) ODI-4 ODI-3 ODI-2 Test time (hh:mm:ss)
Operating Modes
Occupational Health Mode (OC): Intended for occupational health clinics and insurance companies. Performs FVC and bronchodilation tests quick and easy for early detection of work-related lung diseases. Primary Care Mode (PC): Intended for Primary Care centers. Performs the main tests with interactive help in order to obtain spirometries with similar quality to the ones performed at a specialized center (Spirometry quality control). Helps to detect and follow-up most common respiratory diseases such as Asthma or COPD. Diagnostic Mode (DG): Intended for Pulmonary Function Laboratories specialized in lung diseases, providing the highest spirometry test control. It is the most complete mode that includes Bronchoconstriction Test, Occupational Health and Primary Care modes among other options.
Technical Specifications
- Flow transducer: 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.
Transducer
- Fleisch
- Turbine
- Disposable
References
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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.
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