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The device and its software accessories, collectively referred to as ‘Umana T1 Heart Monitor’ are identified with
Product/ Accessory
1. Technical Name
2. Brand Name
Product ID
Code
Design
Variant
code
Intended Use
Classification
1. Umana T1 Heart
Monitor
2. T1 Heart Monitor
UMT-T1
(UMT-T1)02
The Umana T1 Heart Monitor is an active medical
device for diagnostic ECG data collection and
analysis. It consists of the T1 Heart Monitor which
uses Umana Medical’s T1 SmarterSkin and
SmarterSkin Plus Sensors for gathering heart
activity data. Data is transmitted via Bluetooth to its
accessory T1 Monitor App installed on a third-party
smartphone or tablet. The T1 Heart Monitor and App
can be used at home or in a clinical setting. The App
enables either Holter session recording or real-time
Monitoring with an optional extension device for
longer sessions. The App transfers the ECG data to
the dashboards which can then be downloaded and
analyzed in the accessory software T1 Biosignals
Studio by medical professionals. The device also
presents non-diagnostic data to the medical
professional as supporting information. This
includes Long-term Heart Rate, ECG-derived
Respiratory Rate, Systolic Blood Pressure and
Physical Activity with Fall Detection recorded by an
onboard accelerometer. This data is synchronized
with the diagnostic ECG data. The T1 system can be
used to either monitor cardiac patients or healthy
individuals, both males and females, from the age of
10 upwards.
Class IIa, Rule
10
1. Umana T1 Heart
Monitor Application
2. T1 Monitor App
UMT-
T1App
(UMT-
T1App)
The T1 Monitor Application is an accessory
standalone software for third-party devices which
receives and displays data transmitted via Bluetooth
from the Umana T1 Heart Monitor. The application
can operate in either ‘Monitoring Mode,’ where it
processes ECG data in real-time and presents it to
the user on screen together with ECG-derived long-
term heart rate and respiratory rate, and physical
activity data for viewing purposes only, or in ‘Holter
Mode,’ which is accessed by a qualified technician
to connect and activate the monitor as a Holter
device and retrieve the raw ECG data from the
monitor after the prescribed monitoring session. The
application uploads the ECG data file to the web
application automatically when the smartphone or
tablet is connected to the internet. This data can be
opened and studied by medical professionals in the
T1 Biosignals Studio software.
Class IIa, Rule
10
1. Umana T1 Tempo
Dongle
2. T1 Tempo Dongle
UMT-
T1Tempo
(UMT-
T1Tempo)
The Umana Tempo dongle is a medical device
accessory that connects to the Umana T1 Heart
Monitor port. Its function is to measure the oxygen
saturation of a user’s blood and body temperature,
and transmits it via Bluetooth to the T1 Umana
Biosignals Web Application.
Class IIa, Rule
10
1. Biosignals Studio
2. T1 Biosignals Studio
UMT-
T1Biosig
(UMT-
T1Biosig)
The Biosignals Studio is an accessory standalone
PC software intended for use by medical
professionals for viewing the . uma diagnostic ECG
file collected through the T1 Heart Monitor. In the
Biosignals Studio, all the diagnostic ECG data is
filtered and automatically analyzed for detecting
abnormalities. The non-diagnostic ECG-derived
Respiration Rate and Systolic Blood Pressure data
as well as the Physical Activity data gathered are
time stamped and synchronized with the ECG
Class IIa, Rule
10