GPI Umana T1 User Manual Download Page 6

 

 

 

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  The sensor is not compatible with  X-ray  scan,  Computed  Tomography  and Magnetic  Resonance  Imaging  as  it integrates  non 

removable metal parts.  

  Keep device away from children and pets when not in use to minimize the risk of    mechanical damage due  to  mishandling. The 

sensors should not be left in reach of children or animals so as not to be placed in the mouth. The sensor pouch must be 
cut open only when the sensor is to be used immediately. 

  Ensure that the device is only switched on when the Umana T1 Heart Monitor is already placed on the chest of the user. 
  If the person who will be wearing the sensor has sensitive skin or is aware of any causes of allergy or irritation to his or  her 

skin, they should consult their doctor before purchasing the Umana T1 system. The materials chosen to make the sensors 
have been selected specifically for their common use in skin applications for normal skin and do not harm the dermal layers. 
If  you  experience  any  irritation,  burning  or  severe  redness,  apply  baby  oil  to  the  sensor  and  remove  immediately.  Your 
doctor should be consulted as this might be due to an allergy you were not aware of.  

  The  Umana  T1  sensors  should  only  be  applied  to  intact  undamaged  skin  which  has  been  thoroughly  cleaned  with  the 

provided wipe and dried off. 

  To remove the sensors, apply a generous amount of baby oil to the sensor, rub gently and pull away the sensor from the 

edge  of  the  protective  film.  If  any  redness  appears  after  removing  the  sensor,  this  is  a  very  normal  reaction  and  should 
disappear quickly. Cleaning with alcohol wipes and applying smoothing cream can also help. 

  Adult supervision is required when using charger near children. 
  If at any point Bluetooth connection stops between the device and smartphone/tablet, a notification will appear on the screen 

asking  you  to  reconnect  the  T1  device.  If  the  T1  device  does  not  appear  in  the  smartphone/tablet`s  list  of  BT  available 
devices  within  range,  switch  off  and  on  both  the  monitor  device  and  the  application.  This  can  be  caused  by  slight 
electromagnetic disturbances. 

  Patients with known intolerance with acrylic adhesive should not use 

SmarterSkin

 sensors. 

  Patients with known intolerance with nickel should not use the UMANA T1Tempo

 

Dongle.  

  The Umana TEMPO

 

Dongle should not be applied on tattooed areas as this could interfere with the infrared light used by the 

SpO

2

.  

  Patients with excessive dry skin should not utilise this device since it may interfere with the readings.   
  Patients with suspected allergies to medical adhesives should consult their health care professional before using the SmarterSkin 

/Smar sensors. 

  Do not make fundamental changes in your treatment program without talking to your health care team. Serious illness or accidents 

may result. 

  In case of several continuous measurements that are considered to be abnormal, the device will notify you as a suggestion to 

consult your healthcare professional.  

  Do not make therapy treatment decisions based on the Umana T1 heart monitor.   
  Follow the instructions for the placement and disposal of the Umana SmarterSkin/Smar sensors.  
  The SmarterSkin/Smar sensors should not be applied on tattooed areas.  
  Latex is not part of the materials used to create the sensor; however,  it is not guaranteed that contamination does not happen 

during the manufacturing/packaging process. 

  Patients with excessive dry skin should not utilise this device since it may interfere with the readings.   
  Keep away all the contents from children due to the risk of swallowing small parts. 
  The behaviour of the Umana T1 Tempo Dongle has not been tested under motion and for this reason, when the Umana T1 Heart 

Monitor is utilised with the Umana T1 Tempo dongle, movement should be limited entirely, and patient should be at rest.  

  The Umana T1 Tempo Dongle has not been tested for low perfusion conditions.    
  Ensure that a minimum of 30 minutes warm up to measure the temperature using the Umana T1 Tempo Dongle 
  Do not use with patients with tremors or convulsions. 
  Diseases with peripheral circulatory disturbance may cause incorrect readings of the SpO2 measurement through the Umana T1 

Tempo Dongle 

  The Umana T1 tempo Dongle cannot be utilised in critical conditions. 
  The  device  is  designed  to  determine  the  percentage  of  arterial  oxygen  saturation  of  functional  hemoglobin.  Factors  that  may 

degrade pulse oximeter performance or affect the accuracy of the measurement include the following: Device not applied correctly, 
Excessive motion, Methaemoglobin and Intravascular dyes 

  Do not install applications that may contain malware. 
  Do not leave smartphone unattended and unlocked. 
  Use security measures to lock smartphone when not in use. 

  

 

 

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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