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BodyCAP e Celsius - Possible Complications; E-Celsius Medical System Features

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12
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
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 persons 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.

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