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6. Ensure that the calibration screen on the smartphone Monitor Mode app confirms that the sensor is fully connected and
therefore a good signal is being received, the Bluetooth is connected to the phone and connected to the online cloud server
using Wi-Fi or 3G/4G/5G before starting a monitoring session. If any or all these performances are not met, even after changing
sensor, charging battery, reconnecting Bluetooth or reconnecting to internet, therefore preventing the full and correct use of
the device, then contact your local distributor for a device replacement if it is still under warranty. The manufacturer will inspect
the device for any faults.
7. A distorted signal may be due to the degradation of the electrodes. The app will advise you if a good signal is not being
received. Check the label on the silver pouch containing the sensor and if it indicates a production date over than two years
prior contact distributor for replacement sensors. If sensors are still within the two-year period after production and the
electrodes are visibly degraded and signal is distorted, try another sensor. If same issue is experienced contact distributor or
manufacturer who will provide you with replacement sensors and inspect the problem.
The Umana T1 Heart Monitor should only be serviced by trained personnel appointed by the manufacturer. Contact your local
distributor for more information. Service personnel are provided with all technical data needed for proper servicing and
maintenance, upon request. Terms of payment for repair and replacement depend on the warranty.
Life Expectancy:
The lifetime of the Umana T1 Monitors is determined by the lifetime of the battery which amounts to 500
complete cycles of charging and discharging. Depending on whether the device is used by one person or more such as in a clinic,
occasionally or daily, for short periods or long periods such as 24hr Holter Mode, and depending on the correct usage, storage
and maintenance of the product as per user instructions the number of years of how long the monitor will be functional will vary.
If the device is used correctly and regularly it should last around 2 years. T1 Heart Monitors that have not been used for a while
should ideally be charged every 6 months. When using the device for the first time it is recommended to charge it fully before use.
The smartphone/tablet software monitoring application and the Biosignals Studio software lifetime is to depend on the number of
versions that are released. Typically, a new version of the software is released every year, denoted by the version number change
in the first digit: V.n.0.0. New and improved features denoted by the second digit: 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 users cannot make proper use of the application and therefore the device, which in such a case would
need an urgent release within not longer than a month. On Google Play, it is possible to automatically update your application
with new uploaded releases without involving the user’s intervention. The PCB firmware lifetime can be considered to coincide
with the need for implementing improvements and new features, also version controlled in the format of Vn.n.n. These are typically
restrained to an update every 6 months if needed. At the early stages of market entry, as feedback from device usage is gathered,
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.
Before returning the device, it should be cleaned and disinfected and placed in its original packaging or in a similar cardboard box
that is properly sealed and labelled. The courier used to transport the devices should be licensed to carry such devices, i.e., waste
electrical and electronic equipment. The distributor will return the received device to Umana Medical which in turn will deliver it to
the appropriate disposal site which processes electrical and electronic waste according to the DIRECTIVE 2012/19/EU OF THE
EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 on waste electrical and electronic equipment (WEEE).
The single-use sensors and protective films can be disposed of with normal waste as they do not contain any active or electrical
parts.
12. Continuous Support
Data access option:
The Umana T1 Heart Monitor system ensures that users and operators receive continuous regular support
from our Support team. Our Software department issues regular updates which will either automatically update your software
version or notify and instruct you how to do so. These software updates are issued in response to the regular feedback and
suggestions provided by users, as well as new features and performance optimization of the application.
During Registration, the
user is required to enter personal details. Following this, the user is asked to read and accept the terms and conditions of use.
This allows Umana Medical to store the users’ anonymized data from recording sessions on a secure database for research
purposes and continuous improvement.
In-app support;
The application itself also gives the option to view progress throughout a session. This is available in the
Monitoring screen.
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