GPI Umana T1 Скачать руководство пользователя страница 17

 

 

 

umanamedical.com 

 

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Note: It is advisable that data represented by the Raw ECG is always interpreted by a medical professional. Users should 
never make any assumptions or diagnosis based on the data collected without consulting a medical professional. The 
data needs to be opened in a dedicated ECG viewer. This data can assist the medical professional in determining the 
course of treatment and make his or her own diagnosis of the patient. 

 

Feedback: 

The Umana Medical team is trained to help you maximize usage of the Umana T1 Heart Monitor system and obtain 

the best possible results. We design any product iterations with our users in mind. We therefore greatly appreciate your comments 
and feedback. By completing the simple questionnaire sent from time to time through the app or by email, you can help guide us 
on what could be done to improve our products. Your feedback will help us design and develop future versions of the product.

 

Frequently Asked Questions: 

A comprehensive list of FAQs is available on the website, www.umanamedical.com. This list is 

regularly updated. 

Contacting Support at Umana Medical; 

Customers with support requests should contact the distributor or reseller from whom 

they purchased the Umana T1 Heart Monitor with their query or can contact Umana Medical directly on [email protected] 
or by 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 internal battery is provided with the Starter Pack.  
3.  The battery is not removeable or replaceable. 
4.  It should be noted that the battery will be over-discharged if the device is not used for a long time. To prevent over-discharging, 

the battery should be charged periodically. 

5.  Over-discharging may cause loss of cell performance, or damage battery function. 
6.  Expected life cycle> 500 cycles > 70 % of initial capacity. 
7.  Charging with a higher voltage than specified may cause damage to cell. 
8.  The usual time to charge a battery from the cut-off voltage to the maximum capacity is typically around 4 hours, but it depends 

on every specific battery (battery life and memory is a function of time). 

 

 

Umana T1 Heart Monitor Specifications 

 

 

Battery Nominal Capacity 

300mAh 

 

Battery Type 

Coin Type Lithium-ion 
Rechargeable Battery 
 

Battery Voltage 

4.20±0.05V 

 

Battery Charger Description 

With Micro USB cable, IEC 60601-1 
certified 
 

Operating Temperature 

0°C to +45°C 

 

Storage Temperature (Power 
Off for less than 90 days) 
 

0°C to +35°C 

Operating / Storage Humidity 

15% to 93% 

 

Operating / Storage Pressure 
 

700-1060 hPa 

ECG 

 

 

Digital Resolution 

24 bit 

Sampling Rate 

533Hz 

 

Input Voltage Range 

 

±400mV 

Input Dynamic range 

±400mV 

 

Input Offset Range 

16µV 

Sampling Rates 

 

 

Mono or Pluri Derived 

Single Lead or 2 Lead + 4 
Derivations 

ECG 

533Hz 

 

 

 

Accelerometer 

64Hz 

 

T1 Monitor Size 

~𝑅17𝑚𝑚 𝑥 𝐻13𝑚𝑚

 

Содержание Umana T1

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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