ndd Easy on-PC Spirometer

Description

ndd Easy on-PC Spirometer

The ndd Easy on-PC spirometer is a versatile device designed for FVC, FVL, SVC, MVV, and provocation tests. It operates on any Windows-based device, utilizing TrueFlow™ technology to deliver highly accurate and reliable results without the need for calibration.

Key features include:

• Real-time curves and pediatric incentives
• An intuitive PC-based solution
• Automated user guidance throughout maneuvers, adhering to current ATS/ERS standards
• Reproducible results for comparability in multicenter studies
• Immediate test quality feedback in line with ATS/ERS criteria
• Integrated provocation test with customizable protocols
• Fast interpretation of results using Z-score, LLN, and %predicted
• Export options for PDF files and raw data
• Flexible interfaces (HL7, XML, GDT, API) for easy EMR/EHR integration
• A wide range of selectable predicted values, including the new GU predicted set
• An absolute hygienic solution with Spirette consumables to eliminate cross-contamination risks
• Customizable reports
• Powerful data management, supporting both local storage and SQL Server databases

Real-time graphs and animated incentive screens enhance the user experience, motivating both children and adults to achieve optimal results

ndd Easy on-PC Spirometer – Technical

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 °F
Rel. Humidity: 5 – 95%
Atmospheric Pressure: 500 – 1060 hPa

PC/Laptop Requirements
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

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

Flow & Volume Sensor
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:

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