Technical
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Printing options | Direct to printer or over network |
Data management | EasyWare Pro (SQLite, MS SQL Server) |
Interface | HL7, XML, GDT |
Number of tests | > 10,000 tests |
Age range | Spirometry > 4 years |
Device classification | Type BF applied part |
Operating conditions | Temp 0 - 40 °C/ 32 - 104 °FRel. Humidity 5 - 95%Athmosph. Pressure 500 - 1060 hPa |
PC/Laptop Requirements
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Hard disk capacity | Installation/system 1GB Data: up to 4GB |
RAM | 2 GB |
Operating system | Windows 7, Windows 8 and 8.1 (32 and 64 bit), Windows 10 (32 and 64 Bit) |
Parameters
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FVC | ATI, BEV, EOTV, FEF10, FEF25, FEF2575, FEF2575_6, FEF40, FEF50, FEF50/FVC, FEF50/VCmax, FEF60, FEF75, FEF75-85, FEF80, FET, FET25-75, FEV.25, FEV.5, FEV.5/FVC, FEV.75, FEV.75/FEV6, FEV.75/FVC, FEV.75/VCmax, FEV1, FEV1/FEV6, FEV1/FVC, FEV1/FVC6, FEV1/VCmax, FEV1/VCext, FEV3/FVC, FEV3/VCmax, FEV3, FEV6, FVC, FVC6, MEF20,MEF25, MEF40, MEF50, MEF60, MEF75, MEF90, MMEF, MTC1, MTC2, MTC3, MTCR, PEF, PEFT, t0, VCext, VCmax |
FVL | ATI, BEV, CVI, E50/150, EOTV, FEF10. FEF25, FEF2575, FEF2575_6, FEF40, FEF50, FEF50/FVC, FEF50/VCmax, FEF60,FEF75, FEF75-85, FEF80, FET, FET25-75, FEV.25, FEV.5, FEV.5/FVC, FEV.75, FEV.75/FEV6, FEV.75/FVC, FEV.75/VCmax,FEV1, FEV1/FEV6, FEV1/FIV1, FEV1/FVC, FEV1/VCmax, FEV1/VCext, FEV3/FVC, FEV3/VCmax, FEV3, FEV6, FIF25,FIF50, FIF50/FEF50, FIF75, FIV.25, FIV.5, FIV1, FIVC, FVC, MEF20, MEF25, MEF40, MEF50, MEF60, MEF75, MEF90,MIF25, MIF50, MIF75, MMEF, MTC1, MTC2, MTC3, MTCR, PEF, PEFT, PIF, t0, VCext, VCmax |
SVC | ERV, IC, IRV, Rf, VC, VCex, VCext, VCin, VCmax, VT |
MVV | MVV, MVV6, MVVtime, VT |
Predicted Normal Values
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GLI | Stanojevic 2009, Quanjer 2012 |
North America | NHANES III (Hankinson) 1999, Knudson 1983, Knudson 1976, Crapo 1981, Morris 1971 & 1976, Hsu 1979, Dockery (Harvard) 1993, Polgar 1971, Gutierrez (Canada) 2004, Eigen 2001 |
Latin America | Pereira 1992, Perreira 2006 & 2008, Pérez-Padilla (PLATINO) 2006, Pérez-Padilla (Mexico) 2001, Pérez-Padilla (Mexico, Pediatrics) 2003, Chile 2010, Chile (Pediatrics) 1997 |
Europe | ERS (ECCS, EGKS, Quanjer) 1993, Zapletal 1977, Zapletal 2003, Rosenthal 1993, Austria 1988, Austria 1994, Sapaldia (Switzerland) 1996, Roca (Spain, SEPAR) 1982, Garcia-Rio (SEPAR) 2013, Vilozni 2005, Falaschetti 2004, Klement (Russia) 1986 |
Europe Scandinavia | Hedenström 1985 & 1986, Gulsvik (Norway) 1985, Berglund Birath (Sweden) 1963, Langhammer (Norway) 2001, Finnish 1982 (1998), Nystad 2002 |
Australia | Hibbert 1989, Gore Crockett 1995 |
Asia | Chhabra (India) 2014, Dejsomritrutai (Thailand) 2000, Indonesia 1992, IP (China, HongKong) 2000 & 2006, JRS 2001 & 2014 |
Africa | Ethiopia 1985 |
Flow & Volume Sensor
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Type | Ultrasonic transit time |
Flow Range | ± 16 L/s |
Flow Resolution | 4 mL/s |
Flow Accuracy (except PEF) | ± 2% or 0.02 L/s |
PEF Accuracy | ± 5% or 0.200 L/s |
MVV Accuracy | ± 5% or 5 L/min |
Volume Resolution | 1 mL |
Volume Accuracy | ± 2% or 0.050 L |
Resistance | ~0.3 cm H20/L/s at 16 L/s |
Sample rate | 400 Hz |
Standards & Recommendations
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Quality, Medical Devices & Electrical | EN ISO 9001 , EN ISO 13485 , EN ISO 14971 , EN 62366 , EN 62304 , EN ISO 26782 , EN ISO 23747 , IEC 60601-1, IEC 60601-1-2 |
FDA | 510(k) clearance |
MDD 93/42/EEC | CE marked |
Associations & Institutes | ATS/ ERS 2005, NIOSH, OSHA, SSA Disability |
Languages
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English, French, German, Spanish, Italian, Brazilian-portuguese, Dutch, Russian, Vietnamese, Turkish, Chinese |