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The sensor is not compatible with X-ray scan, Computed Tomography and Magnetic Resonance Imaging as it integrates non
removable metal parts.
Keep device away from children and pets when not in use to minimize the risk of mechanical damage due to mishandling. The
sensors should not be left in reach of children or animals so as not to be placed in the mouth. The sensor pouch must be
cut open only when the sensor is to be used immediately.
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. The materials chosen to make the sensors
have been selected specifically for their common use in skin applications for normal skin and do not harm the dermal layers.
If you experience any irritation, burning or severe redness, apply baby oil to the sensor and remove immediately. Your
doctor should be consulted as this might be due to an allergy you were not aware of.
The Umana T1 sensors should only be applied to intact undamaged skin which has been thoroughly cleaned with the
provided wipe and dried off.
To remove the sensors, apply a generous amount of baby oil to the sensor, rub gently and pull away the sensor from the
edge of the protective film. If any redness appears after removing the sensor, this is a very normal reaction and should
disappear quickly. Cleaning with alcohol wipes and applying smoothing cream can also help.
Adult supervision is required when using charger near children.
If at any point Bluetooth connection stops between the device and smartphone/tablet, a notification will appear on the screen
asking you to reconnect the T1 device. If the T1 device does not appear in the smartphone/tablet`s list of BT available
devices within range, switch off and on both the monitor device and the application. This can be caused by slight
electromagnetic disturbances.
Patients with known intolerance with acrylic adhesive should not use
SmarterSkin
sensors.
Patients with known intolerance with nickel should not use the UMANA T1Tempo
Dongle.
The Umana TEMPO
Dongle should not be applied on tattooed areas as this could interfere with the infrared light used by the
SpO
2
.
Patients with excessive dry skin should not utilise this device since it may interfere with the readings.
Patients with suspected allergies to medical adhesives should consult their health care professional before using the SmarterSkin
/Smar sensors.
Do not make fundamental changes in your treatment program without talking to your health care team. Serious illness or accidents
may result.
In case of several continuous measurements that are considered to be abnormal, the device will notify you as a suggestion to
consult your healthcare professional.
Do not make therapy treatment decisions based on the Umana T1 heart monitor.
Follow the instructions for the placement and disposal of the Umana SmarterSkin/Smar sensors.
The SmarterSkin/Smar sensors should not be applied on tattooed areas.
Latex is not part of the materials used to create the sensor; however, it is not guaranteed that contamination does not happen
during the manufacturing/packaging process.
Patients with excessive dry skin should not utilise this device since it may interfere with the readings.
Keep away all the contents from children due to the risk of swallowing small parts.
The behaviour of the Umana T1 Tempo Dongle has not been tested under motion and for this reason, when the Umana T1 Heart
Monitor is utilised with the Umana T1 Tempo dongle, movement should be limited entirely, and patient should be at rest.
The Umana T1 Tempo Dongle has not been tested for low perfusion conditions.
Ensure that a minimum of 30 minutes warm up to measure the temperature using the Umana T1 Tempo Dongle
Do not use with patients with tremors or convulsions.
Diseases with peripheral circulatory disturbance may cause incorrect readings of the SpO2 measurement through the Umana T1
Tempo Dongle
The Umana T1 tempo Dongle cannot be utilised in critical conditions.
The device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may
degrade pulse oximeter performance or affect the accuracy of the measurement include the following: Device not applied correctly,
Excessive motion, Methaemoglobin and Intravascular dyes
Do not install applications that may contain malware.
Do not leave smartphone unattended and unlocked.
Use security measures to lock smartphone when not in use.