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  MasterScope® CT Concept
 

Centralized Spirometry, ECG & Tremor - Unique As Your Fingerprint
MasterScope® CT is the most comprehensive platform solution for centralized Spirometry, ECG and Tremor in the clinical trial industry. Our customized software allows for protocol-driven workflows and can be tailored for use in multi-center studies. MasterScope® CT supports automatic and secure data transmission allowing for global data collection and analysis including review of protocol compliance, test acceptability and overall quality monitoring.

MasterScope® CT is the most advanced and complete system on the market and the only one providing biometric fingerprint identification to comply with the 21 CFR 11 requirements. Only trained site staff are able to perform the tests and everything is logged in an audit trail. This makes quality and compliance monitoring easy.

 
MasterScope® CT Spirometry
The MasterScope® CT Spirometry system measures all required lung function parameters according to the most current ATS recommendations. The integrated animation program supports caregivers to perform cooperation-dependent flow-volume measurements especially with children and elderly people in order to provide the highest possible reproducibility and quality.

The ultimate solution for centralized spirometry in clinical trials
• Highest precision and accuracy
• 50 years of experience in spirometry testing

Protocol-driven workflows
• On-screen quality assurance
• Automated visit & procedure controls
• Inclusion/randomization checks

Electronic data collection
• Expert quality assurance review
• Electronic data export

Ready for 21CFR Part 11 and HIPAA
• Strong authentification
• Single sign-on
• Role-based access
• Secure database
• Audit trails

MasterScope® CT is not only your first choice for centralized Spirometry but also a powerful platform to integrate with APS, the dosimeter for automated Methacholine challenge tests and the Jaeger AM2+, the most advanced electronic patient diary and spirometer.
Online Guidance for all steps Spirometry according to ATS/ERS standards
Protocol driven workflow User identification by fingerprint
Online Guidance for all steps Spirometry according to ATS/ERS standards Final results with study parameters highlighted
 
Technical Specifications

System Description
MasterScope® CT is a unique device platform customized to perform centralized Spirometry, ECG and Tremor measurements in clinical trials.
It consists of a portable computer with fingerprint sensor and built-in modem, a fast color DeskJet printer and the proven high-quality Jaeger pneumotach sensor.

MasterScope® CT Spirometry exceeds the current ATS recommendations and is prepared for the measurement, evaluation, storage and documentation of:
- Slow Spirometry (VT, VCin, VCex, ERV,...).
- Flow-Volume (FVC, FEV1 , FEF50 ,...)


Technical Data
Flow measurement High-quality JAEGER pneumotach
Flow range 0 to ±20 L/s
Flow accuracy ±2% / 0.2 to 12 L/s
Resistance <0.05 kPa/(L/s) at 10 L/s
Volume measurement Digital integration
Volume range 0 to ±20 L
Volume resolution < 1 ml


Options
• Centralized Spirometry
• Centralized ECG
• Centralized Tremor
• Impulse Oscillometry (IOS)
• Aerosol Provocation System (APS) for automated methacholine tests
• Airway Resistance R occ
• Respir. Drive (P 0.1 ), Respiratory Muscle Strength (Pi max , Pe max )
• Ambulatory Spirometry and eDiary (AM2+)
• 24h - ABPM
• 24/48h - Holter



Quality and Safety
- VIASYS Healthcare operates a quality system according to ISO 9001/IEC 13485
- MasterScope/MasterScreen complies with the regulations of European (Medical Device Directive) and United States (FDA) law.


Literature
- Please ask us for a detailed literature list.

     
     
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