GPI Umana T1 User Manual Download Page 3

 

 

 

umanamedical.com 

 

Page 3 of 27 

 

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:  

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

 Medical Devices Regulation (EU) 2017/745 

 Subsidiary Legislation 427.44, Malta 

– Medical Devices regulation Legal Notice 210 of 2008, as amended by Legal Notice 

320 of 2020,  

 ISO 13485 

 EN 60601

–1 

 EN 60601-1-2 

 EN 60601-1-11 

 EN 60601-2-25 

 EN 60601-2-47 

 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

[email protected] 

Summary of Contents for Umana T1

Page 1: ...umanamedical com User Manual Version 7...

Page 2: ...Preparing Patient for the SmarterSkin or SmarterSkin Sensor Placement 10 8 3 Application of SmarterSkin or SmarterSkin Sensor 10 8 4 Application of the Umana T1 Heart Monitor 11 8 5 System Set up 11 8...

Page 3: ...he 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 studie...

Page 4: ...itor 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 e...

Page 5: ...ection is also necessary Clean the area where the sensor and the T1 Heart Monitor will be applied by shaving and cleaning the area from dust sweat and dead skin cells using alcohol wipes It is a known...

Page 6: ...Dongle The Umana TEMPO Dongle should not be applied on tattooed areas as this could interfere with the infrared light used by the SpO2 Patients with excessive dry skin should not utilise this device s...

Page 7: ...physiological readings from the user to the device Three stud connectors Protective film supplied with each sensor Each sensor and protective film are supplied in a sealed pouch B Battery in Monitor...

Page 8: ...Packs Software Accessories Smartphone Tablet application operable in Monitoring Mode and Holter Mode Biosignals Studio software The real time Monitoring Mode of the application and the offline Biosig...

Page 9: ...n This is marketed as an Extension Pack as it is essentially a clone or a slave of the master Umana T1 Heart monitor that is provided within the Starter Pack The clinicians may make use of this device...

Page 10: ...skin to increase sensor adherence and remove unwanted dead skin cells Such pastes help reduce skin impedance for improved quality of recordings Ensure product compatibility with patient prior to use...

Page 11: ...of the sensor Switch on the UmanaT1 Heart Monitor by pressing the push button Refer to LED section in this manual Fully charge T1 Heart Monitor using the Battery Charger and Charger adapter provided 8...

Page 12: ...marterSkin or SmarterSkin refer to sensor packaging 5 Tap Test Monitor and confirm signal on ECG plot 6 Check that all statuses are Connected and battery of device is full before you start a session 7...

Page 13: ...D and click Next 8 The offload process starts and wait until the process is completed successfully 9 Switch off the T1 Heart Monitor and disconnect the offload dock from the PC 10 Close the offload up...

Page 14: ...f you already purchased an Umana T1 monitor When monitor connected to the app is switched off without battery the app will notify you Switch on the Extension and press Ok on the popup notification in...

Page 15: ...ings synchronize the data so that it is uploaded to the web application A 3G or Wi Fi connection is required Note If you require assistance need to report an issue or experience unforeseen events plea...

Page 16: ...it V 0 n 0 and minor bug fixes denoted by the third digit V 0 0 n are ideally grouped per quarter or four times a year This is unless improving features and bug fixes are urgent such as in cases where...

Page 17: ...y using the Contact form on the Umana Medical website 13 Technical Specifications Battery 1 The Umana T1 Heart Monitor requires one charged internal coin battery to function 2 A charger for the intern...

Page 18: ...one Lead A slope qualifier is implemented if the value is less than 90 degrees The ST Analysis has a minimum duration of 60 seconds designed with the option of increasing it or decreasing it to a maxi...

Page 19: ...hours BLE Applicable Frequency band Rx Tx 2 4 GHz 2 5 GHz Biosignals Studio Software required platform of PC laptop Windows 10 Biosignals Studio Software required specifications of PC laptop 1920 x 10...

Page 20: ...to the cloud system and to run pre session checks every time before use In terms of monitoring an Internet connection is required to start up the Umana T1 Heart Monitor to perform initial data transfe...

Page 21: ...e device should be operated within the Temperature limits of 0 C and 45 C The device should only be stored and used within the Humidity limits of 15 and 93 The device should only be stored and used wi...

Page 22: ...le handle with care Medical Device On Off button Single use Medical Device information has undergone translation which supplements or replaces the original information Symbol is accompanied by the nam...

Page 23: ...d below Emissions test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The Umana T1 only uses RF energy for its internal function Therefore its RF emissions are very low...

Page 24: ...5 cycle 70 U For 25 30 cycles Main power quality should be that of a typical commercial and or hospital environment If the user of the Umana T1 requires continued operation during power main interrupt...

Page 25: ...m fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with...

Page 26: ...netic propagation is affected by absorption and reflection from structures objects and people 16 Change Record Version Date Changes Made 1 12 02 2018 First draft 2 14 07 2018 Following notified body f...

Page 27: ...tructions as per CC 20 009 6 0 28 04 2021 Updates following the First Evaluation by the notified body Ns rif DM527 21026 of the RND TCH 001 E 7 0 15 03 2022 Updates of new labelling and IFUs as per CC...

Reviews: