Use Instructions

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MasterScope - Instructions for Use
Version 03.00 • Date 19FEB2020
4. Subject, Proficiency and Training Mode
Choose whether you would like to work in Subject Mode, Proficiency Mode or
Training Mode.
4.1 Subject Mode
The data from subjects entered in Subject Mode will be used for the study and
transferred to the study database. In Subject Mode you will have to follow the time
periods and study phases as outlined in the study protocol when testing a subject.
All tests performed in Subject Mode pass through the corresponding QA
processes.
The Subject Mode is blocked for all users until successfully passed proficiency. See
chapter “Subject Mode Activation” how to enable the Subject Mode per user.
4.2 Proficiency Mode
In Proficiency Mode, measurements are performed for the purpose of user
certification. The goal of the Proficiency Test is for the user to show that he/
she is capable of performing a designated number of acceptable spirometry
measurements (tests). In Proficiency Mode, only Proficiency Test Subjects can be
created or selected. All data entered or measured in Proficiency Mode will not be
included in the study data.
Proficiency tests should be performed on healthy, preferably PFT naïve volunteers.
Please perform the requested number of proficiency tests and transfer the data.
The quality of the tests will be reviewed and the results will be sent back to the
site. Once you have passed the sufficient number of tests, you will receive a
Proficiency Certificate.
4.3 Training Mode
The Training Mode is for practice purposes only to get a major understanding of
the look and feel of the MasterScope system with protocol specific customized
visit workflows. Mainly the ideal workflow path can be worked through without
considering criteria are met or not. However, if there are complex side workflow
paths within the study specific visit configuration then these workflow paths are
ONLY available if the criteria are fulfilled even in the Training Mode.