TUCKY 21 Notice D'utilisation page 12

Inspection, repair and calibration
At each start, an auto-diagnosis is performed to check Tucky's operation. When Tucky no longer works, an
error message is sent to the app.
This device has been designed and manufactured to last. It is nevertheless recommended to have it inspected
every two years by e-TakesCare, to guarantee its operation and accuracy.
Checking accuracy is not free of charge. If applicable, we encourage you to make contact with e-takescare.
Memory and connection
Before using Tucky, you must ensure that there is enough memory on the smartphone or tablet to store
the data if the Internet disconnects. As Tucky's memory is limited to 8 hours, it is recommended to avoid
Bluetooth disconnection phases as far as possible. If you encounter problems with the Bluetooth connection:
check that Tucky is within reach of the device you wish to sync with, and check that Bluetooth is enabled on
your device.
Regulations
This device is compliant with the following standards:
NF EN ISO 80601-2-56: 2012 Electromedical device - Part 2-56: Specific requirements relating to basic safety and essential performance
of medical thermometers for measuring body temperature.
NF EN ISO 14971: 2013 Medical devices — Application of the management of risks to medical devices.
NF EN 62366: 2015 Medical devices – Application of engineering of aptitude for use with medical devices.
NF EN 60601-1: 2006 + A1 Electromedical devices - Part 1: General requirements for basic safety and essential performance + Appendix 1.
NF EN 60601-1-2: 2015 Electromedical devices - Part 1-2: General requirements for basic safety and essential performance + Collateral
standard: Electromagnetic compatibility.
NF EN 60601-1-11: 2015 Electromedical devices - Part 1-11: General requirements for basic safety and essential performance + Collateral
standard: Requirements for electromedical devices and electromedical systems used in the home care environment.
NF EN 62304: 2006 Medical device software. Software life cycle process.
NF EN ISO 15223-1: 2016 Symbols to use with labels, labelling and the information to provide relating to medical devices - Part 1: General
requirements.
NF EN 1041: 2008 + A1: 2013 Information provided by the manufacturer of medical devices.
ETSI EN 300 328 V2-1.1: 2016 Bluetooth
IEC 62133: 2012 Battery certificate
EN 71-1: Toy safety: «Testing size» part
Portable of mobile RF communication devices may interfere with electro-medical devices. Any serious incidents with Tucky must be
reported to e-TakesCare (vigilance@e-takescare.com) and to the National Drug and Health Products Safety Agency (ANSM)
[1] KELLY, Greg. Body temperature variability (Part 1) : A review of the history of body temperature and its variability due to site selection,
biological rhythms, fitness, and aging. Alternative medicine review, 2006, vol. 11, no 4, p. 278.
MEANING OF SYMBOLS
CE labelling given in 2016
Follow the
instructions
for use
The device, its accessories and its packaging must be recycled
appropriately at the end of their use. Please observe local regulations
and rules
Non-ionising
radiation
Device containing
BF type
applied parts
Direct
current
Manufacturer : e-TakesCare
35, rue des Chantiers
78000 Versailles France
Serial
SN
number
May 2019. Operating instruction Tucky – Version C
1370
Storage
temperature
+10°C to +27°C
Catalogue
REF
reference