USER MANUAL SAGA
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PRODUCT OVERVIEW
Product
The product consists of the following components:
•
SAGA 32+/64+: (Electro-)physiological amplifier consisting of:
o
Data Recorder.
o
Docking Station.
•
Accompanying documentation: User Manual and certificates.
•
TMSi Device Driver.
The product is delivered with the following items to increase the ease of use: a
suitcase, battery charger, SAGA bracket and TMSi Polybench including the Quick
Recording Application for SAGA.
The product is intended to be used with approved electrodes and sensors which can
be found on the TMSi website
. Please refer to the instructions for use
of those electrodes and sensors.
Intended use
Subject population
The product is designed for acquisition of (electro)-physiological signals (e.g. EEG,
EMG or ECG). The product is intended to be used by research professionals in a
laboratory setup, or to be set-up in such an environment after which the subject must
be instructed how to handle/operate the device. After that instruction the subject can
be sent out for an ambulatory measurement. Upon return, the data is retrieved from
the on-board memory of the device.
There are no restrictions on the subject population where the product can be used
on. The product can be used on subjects regardless of age, gender or other criteria.
Subject interface and operating principle
The product amplifies and stores signal data picked up via electrode leads or sensors
that are connected to a single subject; no data interpretation is performed. Intended
use of this product does not require expected positions of the user or subject. No
essential consumables are required for the intended use of this product, however
commercially available disposable electrode patches and/or contact gel can be used
for contact between electrode and subject skin.
The Data Recorder can be worn on the body during portable and ambulatory
measurement setups in which case its enclosure outside is an accessible part. The
Data Recorder’s main function is to capture and digitize the (electro-) physiological
data. The Docking Station’s main function is to receive the data from the Data
Recorder and transfer it to the PC and to (re)charge the battery. The Docking Station
is not intended to contact the subject or carried by the subject.
Applied parts
The product has a single Type CF applied part with multiple functions. It consists of
the front-side receptacles (pins and shield) on the SAGA Data Recorder enclosure
