BodyCAP e Celsius - End of Follow-Up; Technical Data; Essential Performance; EMC Tables

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P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN
5. END OF FOLLOW-UP
6. TECHNICAL DATA
When continuous temperature monitoring is no longer necessary, it must be ensured that the patient
ejected the capsule.
There are 3 solutions to achieve this verication:
- The person is able to attest to the evacuation of the capsule
- The temperature data collected by the system shows a non-physiological variation during a passage to
the saddle.
- If none of the rst 2 solutions is valid, it is possible to check if the capsule is still present in the person's
digestive tract. Approach the e-Med Connect watch connected in real time to the e-Celsius Mobile
application, used for close tracking of the person and check the reception of real time data. The real-
time capture of new data informs you that the e-Celsius® Medical capsule is still present and active. This
verication procedure can be repeated.
The duration of the capsule's operation is limited to 20 days, after which time the method described
above can no longer be used. Since the capsule is radiopaque, an X-ray will allow the removal of any
doubt if the capsule is found blocked, it may be removed by endoscopy, surgery or any other means at the
discretion of a gastroenterologist.
KEY PERFORMANCE
For the e-Celsius® Medical Connect System, the key performance is the continuous measurement of core
temperature via the gastrointestinal tract.
There is no need for testing to maintain essential performance or basic safety because even in case of
product failure there is no electrical or EMC hazard to the person.
EMC TABLES
EMC Product Reference Chart
Applicable model
P022 (e-Celsius
®
Medical)
P110 (e-Med Connect)
P030 (Activatorr)
Important: Information about electromagnetic compatibility (EMC)
Medical devices manufactured by BodyCAP comply with the IEC60601-1-2:2014 standard for immunities
and emissions.
All the information given below is based on the normative requirements to which manufacturers of elec-
tro-medical devices are subject, as dened in the IEC60601-1-2 Ed4 standard. The medical device com-
plies with the applicable electromagnetic compatibility standards, however, the user must ensure that any
electromagnetic interference does not create an additional risk, such as from radio frequency transmitters
or other electronic devices.