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P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN
The mode of action of the device is summarized below:
FUNCTIONS OF THE e-Celsius Medical System
Table 2 : Mode of action
N° Mode of action
1 Setting up e-Med Connect using the Android application e-Celsius Mobile
2
Pairing the e-Celsius® Medical capsule with an e-Med Connect watch via an activator and using the
e-Celsius Mobile application
3 The installation of the bracelet on the person’s wrist
4 The ingestion of the e-Celsius® Medical capsule
5 Data transmission from the e-Celsius® Medical capsule to the e-Med Connect watch
6 Transfer and display of data collected from the watch to the e-Celsius Mobile application
• Loss of traceability (patient/capsule)
• Loss of sterility of the device induces an infectious risk.
• Loss of communication between the e-Celsius® Medical capsule and the e-Med Connect receiver
watch, resulting in the interruption of the patient’s temperature monitoring.
• The collection of temperature data affected by the ingestion of cold or hot beverages, which can lead
to misinterpretation of the data.
• Exposure to a strong electromagnetic eld (MRI), which may induce a risk of mobilization with possible
trauma to the digestive tract, or a disturbance of the capsule electronics and risk of erroneous data
Possible complications
• A false route at the moment of ingestion of the e-Celsius® Medical capsule, which can lead to
partial or total obstruction of the airways.
• Blockage of the capsule within the digestive tract, which may require endoscopic or surgical
recovery.
• Injury or damage to the gastrointestinal tract requiring surgery.