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5.0

27/01/2021

Updated User Manual instructions 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
22-002 and updates of holter mode and
monitoring mode user interface

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...