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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 ECG
The MasterScope® CT ECG system measures all of the required ECG parameters for a Cardiac Safety and Thorough QT/QTc evaluation.

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

Digital Interval Measurements
• QT, RR, QTc, QRS, PR, ST, etc.
• Integrated support for digital Holters and Event Monitoring

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

Expert OverRead -
• Cardiologist review, measurements and interpretation

Electronic data collection
• Electronic data export
• CDISC, XML, etc

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 Tutorials ECG Acquisition
Protocol-driven Workflows User Identification by Fingerprint
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 ECG is prepared for the measurement, evaluation, storage and documentation of:
- 12-lead (QT, RR, QTc,...).

Technical Data, Digital EG, 12-lead
Frequency: 0.05 - 100 Hz
Gain: 5, 10, 20 mm/mV
CMRR:120 db
Sampling Rate:500 Hz
Paper Speed:5, 10, 25, 50 mm/s
A/D Resolution:13 bits = 2.44uV/bit

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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