GPI Umana T1 User Manual Download Page 15

 

 

 

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1.  Connect  tempo  dongle  to  the  Umana 

T1 Heart Monitor 
 

 

 

2.  Switch ON the monitor 

 
 

 

 
3.  Place 

the 

monitor 

on 

the 

SmarterSkin 

or 

Smar 

Sensor.  Switch  on  the  application 
and  follow  the  instructions  in  the 
Normal use section of this manual 

 

11.  Maintenance and Servicing 

 

 

General maintenance and Troubleshooting 

 

For  the  Umana  T1  Heart  Monitor  to  remain  in  good  operable  condition,  it  is  necessary  to  take  the  following  precautionary 
measures: 
 
1.  Clean the Umana T1 Heart Monitor daily and disinfect as instructed. 
2.  Avoid mishandling of the enclosure. For this reason, it should be kept away from children and pets when not in use and stored 

securely. 

3.  Avoid charging the batteries excessively 

– batteries are to be charged only when required, as indicated on software or by the 

red LED light on the monitor. Batteries in the device can only be charged using the charger provided.  

4.  Synchronize the data regularly. This should happen automatically when an Internet connection is active, and the device is 

switched on. Synchronization is important so that all your data is saved on the online server. 

5.  If the software application is experiencing problems such as loading and synchronization, check whether you have the latest 

version of the T1 Heart Monitor application on the Google Play Store and update if it is necessary. 

6.  If the smartphone memory is full of data and cannot store any more recordings, 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 please contact your local 

distributor or send an email to info@umanamedical.com 

 

Servicing: 

When you encounter the following problems, contact your local distributor for servicing. If needed, you will be provided 

with a temporary replacement device until yours is repaired. If the damage is not repairable, review the product warranty with your 
local distributor to define next steps. Some servicing examples include: 

 

1.  If  the  On/Off  button  becomes  jammed,  or  the  LED  light  does  not  light  up  when  the  device  is  switched  on,  service  repair 

personnel will replace the T1 Heart Monitor with a new one. 

2.  If the sensors in your starter pack or sensors pack, despite being stored as instructed, do not adhere properly when applied 

or their connection to T1 Heart Monitor is not constant, contact distributor for replacement or to purchase new sensors. 

3.  If device enclosure breaks or monitor is not performing its functions properly, service repair personnel will replace the T1 Heart 

Monitor with a new one. 

4.  If the battery stops charging or the device needs too frequent charging, the device should be returned to the manufacturer 

through the distributor. The battery cannot be changed or replaced by anyone except than the manufacturer. If the device is 
still within the warranty period it will be replaced with a new one from your distributor. 

5.  Before using the device, make sure the LED is not red and the battery is fully charged.  

 

 

 

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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