GPI Umana T1 User Manual Download Page 3

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1. Intended Use

Umana T1 Heart Monitor UMT-T1;

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.

Umana T1 Heart Monitor Application 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  dashboards
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.

Umana T1 Biosignals Studio 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 reading so that they can provide further information to the medical professional. The ECG data and
report can be used by medical professionals to make diagnosis and make informed decisions about patient treatment.

Umana Tempo UMT-T1Tempo;

The Umana T1 Tempo dongle is a medical device accessory that connects to the Umana T1

Heart Monitor por

t. Its function is to measure the oxygen saturation of a user’s blood and body temperature, and transmits it via

Bluetooth to the Umana T1 App.

2. Safety Information

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The Umana T1 Heart Monitor is a Class IIA device according to the classification in the Council Directive 93/42/EEC for medical

devices. the device is intended for continuous use. It conforms to the following Standards and Directives:

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Directive 93/42/EEC for medical devices, with amendments by 2007/47/EC

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