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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. 

 

 

4. Advice & Safety Warnings  

 

  Each Umana T1 Heart Monitor system should ideally be used by one user to avoid the possibility of skin-related infection. Where 

this is not the case, be sure to follow the cleaning and disinfection instructions in this manual. 

  People with pacemakers or other heart implants (ICD/CRT devices) should not use the Umana T1 Heart Monitor. 
  General  operation of  the  device  may  be  affected  by  the use  of  an electrosurgical  unit  (ESU).  This device  should not be  used 

adjacent to other equipment. If adjacent use is necessary, the device should be observed carefully to verify normal operation. 

  We suggest not to use device on children under 10 years old. Children and elderly people should be assisted when applying the 

sensors and the device and connecting to the application due to mobility difficulties. 

 

WARNING

:  The  device  is  not  intended  to  be  used  in  emergency  situations  and  is  not  an  alarm  device  intended  to  prevent 

immediate danger to the patient. 

  The Umana T1 cannot be used to call emergency numbers including 112. 
  In emergency or critical situations where, immediate real-time diagnosis is necessary, such as in an ambulance, when using a 

defibrillator, or during electrosurgery, the Umana T1 Monitor should be removed. 

  The  data  viewed  in  the  app  or  on  the  dashboards  is  for  viewing  purposes  only.  The  abnormalities  detected  in  the  ECG  are 

suggestions  for  the  medical  professional.  The  Biosignals  Studio  does  not  give  diagnosis  automatically  but  indicates  potential 
suggested abnormalities which the doctor can view and analyse to decide if further actions or tests need to be taken. Only th e 
ECG data is diagnostic. 

  Other vital signs presented including Average Heart Rate, Respiration Rate and Systolic Blood Pressure are not diagnostic since 

they are extracted from ECG through algorithmic calculations. This applies also to the Physical Activity and Fall detection data. 
These vital signs are presented only as additional information for the medical professional, synchronized in time to the ECG. 

  Home use patients and their careers using the Monitoring Mode application should keep in mind that the indicated abnormalities 

are suggestions which must be shared with a medical professional to take any treatment or diagnostic actions. 

  Clean the T1 Heart Monitor regularly as described in this document. If it is used by more than one person, disinfection 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 fact that shaving, or waxing can cause irritation if damaged or low-quality blades 
or material are used. If the area that has been shaved, or waxed, appears to be irritated or sore, allow some time before cleaning 
with alcohol wipes and applying the sensors. 

  Do  not  let  water  fall  on  the  T1  Heart  Monitor,  including  sweat  if  possible.  Remove  the  monitor  before  showering,  bathing,  or 

swimming. 

  Use only the charger provided to charge the device. Other commercially available adapters may not meet the safety requirements 

for the use with medical devices. 

  The port on the monitor is only to be used for charging the device using the provided charger. 
  WARNING: Do not use the T1 Heart Monitor while charging. As a safety feature, this device does not work while charging 

as an internal system prevents this. 

  While charging the power outlet where the charger is inserted must be easily accessible 
  Charging should not be carried out by children, especially if unsupervised, to avoid the possibility of strangulation due to 

the adaptor’s cable. 

  The  duration of a monitoring session should be discussed with your medical professional  to make sure that enough data is 

recorded for analysis. Duration is however limited to 24 continuous hours due to battery life and the sensor must be replaced 
after 3 to 5 days. 

  It is imperative that the Umana T1 Heart Monitor is used with the Umana T1 SmarterSkin sensors. 
  When a pop-up appears requesting that you connect the T1 Heart Monitor properly,  check that all the connection ports are 

making good contact with the corresponding ports on the sensors. 

  Ensure that your software is up to date. Umana  Medical may issue  software updates  to improve the performance of the 

system and to introduce new features. 

  WARNING: No modification of this equipment is allowed. Warranty is forfeited if device is tampered with. 
  The battery cannot be changed or replaced except by the manufacturer. 
  Do not point sprays or nebulizers at the device; keep the device clear of these substances. 
  Keep device away from sources of heat or open flames. This includes outdoor activities that can lead to excessive sweating 

or heat. 

  Electromagnetic interference while the device is in use might affect other electrical equipment, such as radios, Bluetooth 

– 

connected devices, etc. 

  Electromagnetic interference from other electrical  equipment might interfere with the functioning of the monitor. While no 

RF equipment disturbances have been notified whilst using devices up till a frequency of 5GHz near the device, it is advised 
that any Radio Frequency (RF) equipment of this frequency or higher should be kept at 2 meters. 

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...

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