BodyCAP e Celsius - Claims for Use of Contraindications; Claims of Use; Contraindications and Warnings

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P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN
Presence of phthalates
Based on the toxicological evaluation, we inform users that there is an acceptable level of recovered
phthalate without toxicological risk to the individual in the e-Celsius® Medical capsule.
• di--(2--ethylhexyl) DEHP with CAS number 117-81-7
• diisobutyl DIBP with CAS number 84-69-5
• dinonyl under the CAS number 84-76-4
Presence of Bisphenol A: Material of the e-Med Connect watch case (ABS-PC)
2. CLAIMS FOR USE AND CONTRAINDICATIONS
CLAIMS OF USE
The e-Celsius® Medical Connect System is an electronic device for the continuous, reliable and accurate
measurement of core temperature via the gastrointestinal tract in humans for diagnostic or therapeutic
monitoring purposes.
The device is designed for people who need continuous, reliable and accurate temperature monitoring.
The system incorporates a sensor with an accuracy of absolute temperature value ±0.1°C over the
physiological range. The resolution of the temperature is given as 0.01°C.
The device is designed to be managed by the nursing staff (nurses or doctors). The patient is not responsible
for the actions to be performed. The e-Celsius Medical capsule is for single use only. The nursing staff is
responsible for the implementation of the device, its installation and its proper functioning.
CONTRAINDICATIONS AND WARNINGS
Contraindications:
The e-Celsius® Medical Connect System is contraindicated in a number of situations:
- Minors under the age of 18
- People weighing less than 40 kg
- Pregnant women
- People with a pacemaker or an electro-medical implant
- People with or at risk of intestinal disorders that may lead to obstruction of the digestive tract, including
people with gastroparesis
- People with a history of diverticulitis
- For individuals with a history of gastrointestinal pathology or surgery, the capsule should only be used
when prescribed by a physician after an assessment of the risk of bowel obstruction
- People with swallowing disorders, including disorders of the gag reex, leading to the risk of a false route
- People who must be subjected to a strong electromagnetic eld during the use of the system (MRI in
particular)
People who need undergoing surgery on the gastrointestinal tract (esophagus, stomach, intestine) during
the intended use of the device
- People with Crohn’s disease
- People who are unconscious before ingesting the capsule