BodyCAP e Celsius - Risks and Complications

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P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN
Warnings
Since the e-capsule Celsius Medical must be ingested by the patient, special attention should be paid to,
as described below:
- The e-Celsius® Medical capsule (Fig.1) is intended to be ingested with a glass of water to measure the
temperature. It is delivered in deep sleep mode. It must be activated by the activator and associated with
a watch to operate. The installation of the signaling bracelet (Fig.2) is followed by the ingestion of the
capsule.
- Ingestion of the e-Celsius® Medical capsule involves contact of the PVC capsule shell with the mucous
membranes of the gastrointestinal tract, for an average duration of 2 +/-1.5 days, which may be up to 6 days
depending on individual gastrointestinal motility characteristics. After expulsion of the e-Celsius® Medical
capsule, the temperature monitoring can be continued by the consecutive ingestion of new capsules up
to a limit of 6 capsules. If the capsule is not expelled after this period, please refer to paragraph 5. End of
monitoring.
- The use of the capsule in people prone to gastrointestinal disorders, nausea and vomiting implies an
increased monitoring of the persons.
- As the measurement is taken within the digestive system, the measured data are likely to be inuenced
by certain factors, in particular the artefact of food or water intake (hot or cold) during the rst few hours
following ingestion of the capsule. The impact is limited to the rst 3 hours following ingestion of the
e-Celsius® Medical capsule and is characterized by a signicant, non-physiological drop in the temperature
values collected. It is recommended that during the rst 3 hours following ingestion of the capsule, in order
to guarantee the reliability of the data, you limit the intake of water or food at room temperature.
- The capsule is delivered sterile, must be activated through the blister to maintain its sterile condition, and
is not intended to be disinfected or cleaned after use on the person. Dispose of the capsule after use by the
person. Under no circumstances should the capsule be autoclaved as this may cause permanent damage.
- The device is intended for single use only, any reuse of the capsule is likely to induce an infectious risk.
- In the case of the use of the system in obese persons, communication diculties between the capsule
and the watch may be encountered due to the system’s operating mode. As the communication between
the capsule and the watch is carried out in radio frequency at 433 Mhz - 434 MHz, the signal strength is
attenuated by the presence of fatty tissue. Thus, the communication between the capsule and the watch
could be reduced or even impossible.
- After use, precautions should be taken to ensure safe disposal of the capsule. Each practitioner should
ensure that the requirements of local and national regulations for the disposal of contaminated health care
waste are met.
RISKS AND COMPLICATIONS
Risks
• Since the e-Celsius® Medical capsule must be ingested with a glass of water, particular attention must
be paid to the risk of a false route, especially for people who have or have had swallowing problems.
This phenomenon of false route can cause a blockage in the airways requiring an extraction.
• Electrocution
• Burns
• Intoxication
• Gastrointestinal disorders
• Infections
• Loss of time for the user / Increase in the time of care