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BodyCAP e Celsius Performance Connect - Risk and Complications

BodyCAP e Celsius Performance Connect
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9
P063GUI001 - User guide eCelsius Performance Connect.1 - EN
Risks:
• The eCelsius Performance capsule has to be swallowed by the subject with a drink
of water, special attention must be paid to the risk of taking a ‘‘wrong way’’, especially in
people who have or have had swallowing disorders. This phenomenon of taking the
wrong route can cause a blockage in the airways requiring extraction.
• Electrocution.
• Burns.
• Intoxication.
• Gastrointestinal disorders.
• Infections.
• Waste of time for the user / Extension of support time.
• Loss of traceability (subject / capsule).
• The loss of communication between the eCelsius Performance capsule and the
ePerf Connect device, causing a stop of the subject’s temperature monitoring
• The collection of temperature data affected by the ingestion of cold or hot drinks,
which could lead to an erroneous interpretation of the data.
• Exposure to a strong electromagnetic eld (MRI), which may lead to a risk of
mobilization with possible trauma to the digestive tract, or a disturbance of capsule
electronics and risk of erroneous data.
Potential complications:
• A ‘‘wrong way’’ when ingesting the eCelsius Performance capsule, which may induce
partial or total airway obstruction.
• Blockage of the capsule within the digestive tract, which may require recovery by
endoscopy or surgery.
• Lesions or injury to the gastrointestinal system requiring surgery.

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