Temperature Monitoring - TUCKY 21 Notice D'utilisation

INSTRUCTIONS FOR USE
Tucky-21 is a non-invasive and reusable electronic device for home use and a non-invasive and single patient
use in the hospital. This product is intended for non-urgent ambulatory continuous armpit body temperature
monitoring from ages 29 days and older.
Tucky-21 also allows position monitoring of patient from ages 29 days and older (this is however not part of
its medical intended use). It is positioned under the right armpit, as high as possible, with a dedicated double-
sided adhesive (ADH-21) and transmits data to the "Tucky" smartphone application.

Temperature monitoring

The thermometer is set in direct mode: it takes the actual axillary temperature, without making adjustment
calculations. You should thus wait about 15 minutes after placing Tucky under the armpit for the temperature
to stabilize. The temperature is displayed with a color code, indicating whether it is normal or not.
Green
normal temperature
From 34.7 to 37.3 °C
(93.2 to 98.6 °F)
Note: rectal temperature is usually 0.7 °C (1.3 °F) higher than axillary temperature
*The arm must be closed so that the measurements are less disturbed by the environment. The normal
temperature varies according to the individual (age, sex, type, skin thickness), the time of day and external
factors (ambient temperature, clothing, etc.) [1]. It is therefore normal to notice temperature variations caused
by changes in the environment or arm position. In this case, the trend can be interpreted by following the
highest values of the last few hours.
An alert is issued when the temperature exceeds the "very high temperature" value. This threshold can be
modified by the user in the application.
Position monitoring
The device also allows position monitoring, especially for babies. An icon on the application indicates
whether the baby is in one of the following 4 positions: standing or sitting, lying on his back, lying on his
stomach, lying on his side.
An alert is issued when the child turns over on his or her stomach. This alert can be deactivated in the
application.
Note: to ensure this functionality, the product must be placed under the right armpit.
[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.
Colour / axillary temperature correlation table:
Orange
high temperature
From 37.3 to 38.4 °C
(98.6 to 100.4 °F)
default value
Red (alert)
Very high temperature
Above 38.4 °C
(100.4 °F)
default value
Grey
Temperature not representative
E.g.: opened arm*
3