BodyCAP e Celsius - Declaration of Conformity

5
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN
To our customers,
Thank you for purchasing the e-Celsius® Medical Connect System. This medical device
is manufactured by BodyCAP. This manual is designed to introduce you to the features and
operation of your system and to assist you in the setup and using this product. The use of
this device does not require any special training or specic skills; however, please read these
instructions carefully and keep it handy in order to refer it whenever you need.
Failure to follow these instructions may results in measurement failure, personal injuries and
property damage. The responsibility of the manufacturer and of his distributors cannot be
engaged in case of bad use of the material having caused alterations of measures or any other
physical injury and material damage. Inspection and repair operations must be carried out by
approved persons who have undergone appropriate training.
Purpose and use cases:
e-Celsius® Medical Connect System is intended for continuous, reliable and accurate
measurement of core temperature via the gastrointestinal tract in humans for diagnostic or
therapeutic monitoring purposes.
Declaration of conformity:
BodyCAP declares that the e-Celsius® Medical Connect System complies with the following
current guidelines and regulations:
- 2017/745, relating to medical devices,
- 2011/65/EU, on the restriction of the use of certain hazardous substances in electrical and
electronic equipment
- 2014/53/EU on the placing of radio equipment on the market
- 1907/2006 concerning the registration, evaluation and authorization of chemicals,
and the restrictions applicable to these substances (REACH)
- 207/2012 on electronic instructions for use of medical devices.
This system (Ref: P073-M) is composed of:
- An activator (Ref P030-M) and its power cable: allows to activate the capsules and
to put them in operation before ingestion
- A Gateway e-Med Connect watch (Ref P110-M) and its charging cable: allows the
collection of temperature data from 1 to 3 capsules simultaneously.
- An Android application e-Celsius Mobile (Ref P111-M) for Android Smartphone or
Tablet (available on the Play Store): allows you to set up the watch and view the data recorded
by the watch.
- A USB key (including the user manual)
- One (or more) e-Celsius Medical capsule(s) (Ref P022-M) delivered sterile for single
use for central temperature measurement.
- An identication bracelet provided for each delivered capsule.