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MasterScope - Instructions for Use
Version 03.00 • Date 19FEB2020
The MasterScope is a customized system used to support clinical studies. This
manual will guide you through setting up and operating the
MasterScope.
Training
All individual users of the MasterScope equipment must have had a training
session by a certified trainer.
Safety
Along with the practical information required to use the MasterScope, the
MasterScope Instructions for Use contains important safety information.
Please refer to the chapter “
General Safety Precautions
“ before installing and
using the equipment.
Troubleshooting
If any of the MasterScope components are not functioning properly, please consult
the MasterScope Instruction for Use, chapter “
Troubleshooting
“.
What is MasterScope?
MasterScope is your comprehensive solution for conducting clinical trials. Our
customized software allows for protocol-driven workflows and can be tailored for
use in multi-center studies.
MasterScope provides automated and secure data transmission for global data
collection and analysis, including review of protocol compliance, test
acceptability and overall quality monitoring.
MasterScope is the most advanced system on the market providing biometric
fingerprint identification to comply with the 21 CFR Part 11 requirements.
All actions are logged in an audit trail, which makes quality and compliance
monitoring easy.
With the MasterScope, data can be transmitted via ethernet, wireless LAN, web
upload or analog modem to the ERT Data Center. If a data transfer is not possible,
data can be backed-up on a external media which is then sent to the ERT Data
Center by mail.
Do not put excessive weight on the Equipment Bag.
Introduction
