HomeSpirotrac® Centralized Pulmonary
Function and Diary System
Standardized systems
Customized to Study Protocol
Expert QA review
Centralized Data Management
Calibration check
forced daily
FDA 21CFR Part 11 and
HIPAA compliant
Integrated Methacholine Challenge Testing
Integrated, Centralized, PEF/FEV1 Diary
Technical Data
Measuring Accuracy:
Better than +/-3% or +/-0.05 liter in volume, which ever is greater, and +/-5% flow
Message Protocols:
Internet mail standard POP3 and SMTP protocol used for mail and transfer
Encryption:
256 bit advanced encryption standard utilized in all data transfers
BTPS Correction:
Automatic temperature compensation via integrated sensor
PERFORMANCE STANDARDS
ATS/ERS: 2005 Guidelines
All COPD Guidelines
Safety Standards:
EN60601-1-2
Designed and manufactured to following QA/GMP standards:
GMP Registration
BS EN ISO 9001
CE 0086
ISO 13485:2003
ISO 46001
FDA 510K Registration
FDA 21 CFR Part 11, Electronic Records
HIPAA