Use Claims And Contraindications; Use Claims; Contraindications And Warnings - BodyCAP e Celsius Performance Connect User Manual

P063GUI001 - User guide eCelsius Performance Connect.1 - EN
2. USE CLAIMS AND
CONTRAINDICATIONS
The eCelsius Performance Connect system is an electronic device for non-medical uses only.
The device is designed for continuous human gastrointestinal temperature measurement.
The level of accuracy of the system, in comparison with the absolute temperature value, is ±0.2°C.
The temperature data resolution is 0.01°C.
eCelsius Performance Connect system is not designed for medical use cases.
It is designed for physiological monitoring in order to optimize sports performances, to improve
knowledge of human physiology or to follow physiological parameter in research study on healthy people.
The eCelsius Performance Connect device must not be used for diagnosis or therapeutic uses in patients.
Contraindications:
The eCelsius Performance Connect system is contraindicated in a number of situations:
- Individuals under the age of 18 years
- For people weighting less than 40Kg.
- For Pregnant women.
- For people with pacemaker or electrico-medical implant
- For people with or presenting risk of intestinal disorders that can lead to obstruction of the digestive tract,
including people suffering gastroparesis.
- For people suffering history of diverticula
- For people who have undergone surgical procedures in the gastrointestinal tract or having such medical
history (esophageus, stomach, instestines).
- For people with known swallowing disorders (gag reflex expecially)
- For people who have to undergo strong electromagnetic field during the period of use of the system (MRI
in particular)
- For people suffering Chron's disease

USE CLAIMS

CONTRAINDICATIONS AND WARNINGS

8