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reading so that they can provide further information
to the medical professional. The ECG data and
report can be used by medical professionals to make
diagnosis and make informed decisions about
patient treatment.
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.
People with pacemakers or other heart implants (ICD/CRT devices) should not use the Umana T1 Heart Monitor.
General operation of the device may be affected by the use of an electrosurgical unit (ESU). This device should not be used
adjacent to other equipment. If adjacent use is necessary, the device should be observed carefully to verify normal operation.
We suggest not to use device on children under 10 years old. Children and elderly people should be assisted when applying the
sensors and the device and connecting to the application due to mobility difficulties.
WARNING
: The device is not intended to be used in emergency situations and is not an alarm device intended to prevent
immediate danger to the patient.
The Umana T1 cannot be used to call emergency numbers including 112.
In emergency or critical situations where, immediate real-time diagnosis is necessary, such as in an ambulance, when using a
defibrillator, or during electrosurgery, the Umana T1 Monitor should be removed.
The data viewed in the app or on the dashboards is for viewing purposes only. The abnormalities detected in the ECG are
suggestions for the medical professional. The Biosignals Studio does not give diagnosis automatically but indicates potential
suggested abnormalities which the doctor can view and analyse to decide if further actions or tests need to be taken. Only th e
ECG data is diagnostic.
Other vital signs presented including Average Heart Rate, Respiration Rate and Systolic Blood Pressure are not diagnostic since
they are extracted from ECG through algorithmic calculations. This applies also to the Physical Activity and Fall detection data.
These vital signs are presented only as additional information for the medical professional, synchronized in time to the ECG.
Home use patients and their careers using the Monitoring Mode application should keep in mind that the indicated abnormalities
are suggestions which must be shared with a medical professional to take any treatment or diagnostic actions.
Clean the T1 Heart Monitor regularly as described in this document. If it is used by more than one person, disinfection 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 fact that shaving, or waxing can cause irritation if damaged or low-quality blades
or material are used. If the area that has been shaved, or waxed, appears to be irritated or sore, allow some time before cleaning
with alcohol wipes and applying the sensors.
Do not let water fall on the T1 Heart Monitor, including sweat if possible. Remove the monitor before showering, bathing, or
swimming.
Use only the charger provided to charge the device. Other commercially available adapters may not meet the safety requirements
for the use with medical devices.
The port on the monitor is only to be used for charging the device using the provided charger.
WARNING: Do not use the T1 Heart Monitor while charging. As a safety feature, this device does not work while charging
as an internal system prevents this.
While charging the power outlet where the charger is inserted must be easily accessible
Charging should not be carried out by children, especially if unsupervised, to avoid the possibility of strangulation due to
the adaptor’s cable.
The duration of a monitoring session should be discussed with your medical professional to make sure that enough data is
recorded for analysis. Duration is however limited to 24 continuous hours due to battery life and the sensor must be replaced
after 3 to 5 days.
It is imperative that the Umana T1 Heart Monitor is used with the Umana T1 SmarterSkin sensors.
When a pop-up appears requesting that you connect the T1 Heart Monitor properly, check that all the connection ports are
making good contact with the corresponding ports on the sensors.
Ensure that your software is up to date. Umana Medical may issue software updates to improve the performance of the
system and to introduce new features.
WARNING: No modification of this equipment is allowed. Warranty is forfeited if device is tampered with.
The battery cannot be changed or replaced except by the manufacturer.
Do not point sprays or nebulizers at the device; keep the device clear of these substances.
Keep device away from sources of heat or open flames. This includes outdoor activities that can lead to excessive sweating
or heat.
Electromagnetic interference while the device is in use might affect other electrical equipment, such as radios, Bluetooth
–
connected devices, etc.
Electromagnetic interference from other electrical equipment might interfere with the functioning of the monitor. While no
RF equipment disturbances have been notified whilst using devices up till a frequency of 5GHz near the device, it is advised
that any Radio Frequency (RF) equipment of this frequency or higher should be kept at 2 meters.