GPI Umana T1 User Manual Download Page 4

 

 

 

umanamedical.com 

 

Page 4 of 27 

 

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 

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: