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GPI Umana T1 User Manual

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User Manual – Version 7
umanamedical.com

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Summary of Contents for GPI Umana T1

  • Page 1 User Manual – Version 7 umanamedical.com...

  • Page 2: Table Of Contents

    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 8.6. Holter Mode ............................. 12 8.7.

  • Page 3: Intended Use

    2. Safety Information • The Umana T1 Heart Monitor is a Class IIA device according to the classification in the Council Directive 93/42/EEC for medical devices. the device is intended for continuous use. It conforms to the following Standards and Directives: •...
  • Page 4 The device and its software accessories, collectively referred to as ‘Umana T1 Heart Monitor’ are identified with Product/ Accessory Product ID Design Intended Use Classification 1. Technical Name Code Variant code 2. Brand Name 1. Umana T1 Heart UMT-T1 (UMT-T1)02...

  • Page 5: Advice & Safety Warnings

    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.
  • Page 6 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.

  • Page 7: Contents Of The Box

    • Enclosures of the Umana T1 Heart Monitor are protected against the ingress of solid foreign objects of 1mm diameter and greater and are protected against water projected by a nozzle (diameter 6.3mm) at a distance of 2.5-3m. classification of Ingress Protection is IP45.

  • Page 8: Labels

    Monitor Mode Flashing Green Holter Mode Flashes Green every 10s BLE not connected Flashing Blue BLE connected Solid Blue Lead off detect Solid Red Charging Solid Red Low Battery Flashing Red 7. Labels Starter Pack: Sensor Packs: Software Accessories: • Smartphone/Tablet application operable in Monitoring Mode and Holter Mode •...

  • Page 9: Operations Instructions

    Class IIa Umana T1 Heart Monitor.

  • Page 10: Preparing The T1 Heart Monitor

    8.1. Preparing the T1 Heart Monitor • Charge the T1 Heart Monitor for 4 hours using the provided charger and charging adapter only. Connect the charger to the adapter, then connect the adapter to the middle magnetic connector of the T1 Heart Monitor. Ensure corrected orientation accordingly to the plastic notch in the adapter.

  • Page 11: Application Of The Umana T1 Heart Monitor

    • Take the Umana T1 Heart monitor out of the packaging. • Clip the Umana T1 Heart monitor with the stud connector sockets on the corresponding studs 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.

  • Page 12: Holter Mode

    8.6. Holter Mode For the first time use, contact your local distributer for an Account or send an email to Info@umanamedical.com 3. In the ‘File Manager’ 1. Log (Internet 2. Enter the patient 4. Choose your sensor, code/ID and tap “Next” tap ‘Find the Bluetooth connection is required for SmarterSkin...

  • Page 13: Monitoring Mode

    1. Open the Data Transfer Interface software 2. Log in using the same T1 app credentials (internet connection is required) 3. Switch on T1 Heart Monitor and plug into the offload dock. 4. With the USB cable provided, connect the offload dock to a PC. 5.

  • Page 14: Extension

    9. Extension The Extension T1 Heart Monitor is to be utilized when the other Umana T1 Heart monitor is being charged. The Extension T1 is identified with the same UMT-T102, however it is identified with an S after each serial number. The extension can only work if you already purchased an Umana T1 monitor.

  • Page 15: Maintenance And Servicing

    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.

  • Page 16: Continuous Support

    Firmware updates might be needed more frequently but will be restricted as much as possible to quarterly scheduled releases. Disposal: If you need to dispose of the Umana T1 Heart Monitor for any reason or if it has reached its end of service life, please return the device with all original contents to the respective distributor or contact Umana Medical for proper disposal of the device.

  • Page 17: Technical Specifications

    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.
  • Page 18 Isoelectric segments of ECG All the signal is one continuous flow, so all isoelectric segments between the global QRS onset and the global QRS offset should be captured, recorded, and displayed. This also includes the duration measurements of the respective adjacent waveform. Heart Rate calculation method Heart rate is calculated by converting the time between consecutive beats (obtained from the measuring the R-R interval) and converting this value to beats per minute.
  • Page 19 -25°C - 70°C (With No UV Exposure) Operating/Storage Humidity 15% - 93% 70 – 106kPa Operating/Storage Pressure Power Supplier 4.20±0.05V Coin Type Lithium Ion within the Umana T1 Heart Monitor Features Specifications Measurement Principles 2-Wavelength Relative Optical Absorption Signal Detection Method...

  • Page 20: Symbols Used

    In terms of monitoring, an Internet connection is required to start up the Umana T1 Heart Monitor, to perform initial data transfer, and to upload data to the server, ideally in real-time so as not to take up the smartphone’s memory.
  • Page 21 CE marked device certified by the Notified Body n. 0426 of the European Community. ISO 7000-2606 ‘do not use device if product or packaging have been damaged’ symbol The 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 within the Atmospheric Pressure Limits of 70kPa and 106kPa...
  • Page 22 Unique Device Identifier Country of Manufacture according to ISO15223-1:2021(EN) Fragile, 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 name and address of the entity that is responsible for the translation activity adjacent to the symbol Catalogue number Page 22 of 27...

  • Page 23: Emc Information

    Harmonic Emissions IEC 61000-3-2 Class A for domestic purposes. The Umana T1 is suitable for use in a specified electromagnetic environment. Users should ensure that it is used in an electromagnetic environment as described below: Page 23 of 27 umanamedical.com...
  • Page 24 NOTE: U is the A/c main’s voltage prior to application of the test level. The Umana T1 is suitable for use in a specified electromagnetic environment. Users should ensure that it is used in an electromagnetic environment as described below:...
  • Page 25 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength outside the shielded location in which the Umana T1 is used exceeds the applicable RF compliance level above, the Umana T1 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Umana T1.

  • Page 26: Change Record

    Separation Distance – Meters Rated Maximum Output Power of Transmitted - Watts 800 MHz to 2,5 GHz d=2,3 P 150KHz to 80KHz 150 kHz to 800 MHz d=1,2 P d=1,2 P 0.01 0,12 0,12 0,23 0,38 0,38 0,73 For transmitters rated at a maximum output power not listed above, the separation distance can be estimated using the equation in the corresponding column, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 27 Updated User Manual instructions as per CC 27/01/2021 20-009. Updates following the First Evaluation by the 28-04-2021 notified body Ns. rif. DM527-21026 of the RND- TCH-001-E Updates of new labelling and IFUs as per CC 15-03-2022 22-002 and updates of holter mode and monitoring mode user interface Page 27 of 27 umanamedical.com...

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