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Calculating Physical Activity from accelerometric data
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Detecting Falls
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Measuring Function: Calculating Sp0
₂
(optional using T1 Tempo Dongle)
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Measuring Function: Body Temperature (optional using T1 Tempo Dongle)
The data viewed in the app or on the dashboards are 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 analyze to decide if further actions or tests need to be taken. Only the
ECG data is diagnostic. The other vital signs are not since they are extracted from ECG through algorithmic calculations and are
presented only as additional information, synchronized in time to the ECG. The smartphone app and the Biosignals Studio are
accessories and stand-alone software because they drive a device or influence the use of a device and as such, they fall
automatically in the same class of the medical device they influence, which is the Class IIa Umana T1 Heart Monitor.
Hardware Accessories:
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Offload Dock
Transfer data from Device storage to Device (to be used in Holter mode only).
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T1 Tempo Dongle
: Measures the oxygen saturation of a patient’s blood (to be used in Monitor mode only) and Body
Temperature and is considered as a medical device accessory for the Umana T1 Heart Monitor with a measuring function.
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T1 Heart Monitor Extension:
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 to increase the monitoring
durations.
8. Operations Instructions
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Turn off and inspect T1 Heart Monitor to ensure that it is free from any damage, including cracks.
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Clean T1 Heart Monitor by wiping the surface thoroughly with disposable, clean, lint-free cloth impregnated with cleaning agent.
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Repeat step 2 using disinfecting agent.
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Ensure moisture does not enter critical areas of device (i.e., ports).
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Air-dry or hand-dry using a disposable, clean, lint-free cloth.
For single-patient use, it is recommended to clean and disinfect T1 Heart Monitor on a regular basis. For multiple-patient
use, it is mandatory to clean and disinfect T1 Heart Monitor prior to every session.
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Disinfectants containing Mercury, Phenols, Bromine, Iodine, Zinc, Tin and organo-metallic compounds should be avoided.
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Do not use steam sterilization as the cable insulation might not withstand the heat.
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It is very important that no water/cleaning agent/alcohol enters the device case. Ensure that the cloth being used is only
slightly wet to minimize the risk of the cleaning agent flowing into the device.
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The use of the incorrect solution concentrations or the immersion of a transducer to a greater depth or for a longer period
than indicated in the instructions could damage the device.
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Always use any protective goggles and gloves as indicated on the product when cleaning and disinfecting of any device or
equipment.
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If using a premixed solution, always respect the “
USE BY
” date of the disinfectant.