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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
•
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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Medical Devices Regulation (EU) 2017/745
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Subsidiary Legislation 427.44, Malta
– Medical Devices regulation Legal Notice 210 of 2008, as amended by Legal Notice
320 of 2020,
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ISO 13485
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EN 60601
–1
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EN 60601-1-2
•
EN 60601-1-11
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EN 60601-2-25
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EN 60601-2-47
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Radio Equipment Directive (2014/53/EU)
This product user quick guide and this user manual are available in several languages
3. Regulatory Information
Brand:
Umana T1 Heart Monitor
Manufacturer: Umana Building, St. Thomas Street, Luqa, LQA 9033, Malta, EU.
Email: