USER MANUAL SAGA
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marked with an applied part symbol, because these connect galvanically to proximal
and distal ends of subject accessories (simple leads as well as transducers).
User population
The product is intended to be used by, or under supervision of, a physician or
research professional. The user must have knowledge of current good practice in
physiological measurement applications. In ambulatory measurement setups the
subject can be a user as well, after being instructed how to use the system. Refer to
for the instructions for lays.
User interface
The different user interfaces of the product are:
•
The user interface of the Data Recorder.
•
The user interface of the Docking Station.
•
The user interface of the control software running on the computer or
remote interface.
The user interface of the Data Recorder consists of an Event marker button,
Recording button, an On/Off button and status indicators. The user interface of the
Docking Station consists of status indicators. All status indicators are explained in
The product can be controlled via the user interface of the application software
running on a computer, or via the remote interface. The application software on the
PC is used for storage and visualization of the acquired signal data.
Use environment and conditions of use
The product is intended for use on humans in a research laboratory or home
environment (only the Data Recorder), within environmental limits as specified in
, excluding environments with restricted access due to ionizing radiation
and/or strong magnetic fields. The product is not intended for use in a life supporting
system. The product is designed for continuous operation and is reusable without
requiring any level of sterility or reprocessing. No special handling or pre-treatment
is required other than connecting subject accessories between subject and SAGA.
Only use the product with the supplied parts and accessories. In case other parts or
accessories are required, contact TMSi Support (
) for information.
Expected service life
The expected service life of the device is 7 years. If the product is intended to be
used after its expected service life, contact TMSi to have the product inspected
before continued use. For the expected service life and shelf life of the batteries,
refer to the instructions for use of the batteries. For the expected service life of the
other accessories delivered with the system, refer to the instructions for use of the
accessories.
The product requires no regular servicing or maintenance and may not be modified,
but it may be cleaned as described in
. Repairs and modifications can only
be performed by the manufacturer.
