Empatica E4 - F. Precautions for Use; Synthesis of Cautions

12
empaca
©
2015
F. PRECAUTIONS FOR USE
The E4 is in the process of undergoing cercaon as a CE Medical class 2a device according to
ISO 13485:2012. Risk analysis has demonstrated that the E4 can be considered a low risk prole
device.
Funconal hazards – including any error that might result from errant read and /or transfer of data
that aects the output of one or more sensor (i.e., Heart rate, EDA, Temperature, Accelerometers).
Very Low risk level – no harm – safe transfer protocols and fault detecon algorithms monitor the
validity of data. Moreover the E4 is not intended to diagnose a disease; only trained personnel may
interpret the data.
Current leakage through the EDA electrodes – The EDA circuit drives a small amount of ionic
current through the skin to operate: Max 100 µA as required by IEC 60601-1:2005
Very Low risk level – no harm – the E4 has been validated to be compliant with ISO 60601-1:2005
aer design validaon and vericaon, which means that the amount of current produced is safe
for the user.
Eye exposion to LED light - PPG LEDs are extremely bright; typically they are totally obscured
by contact with the skin. However the User can remove the E4 from the wrist, exposing the light
source.
Very Low risk level – no harm – the quanty of light is comparable with other light sources that Users
may be exposed in their daily environment. The User is advised to not look at the PPG LEDs for a
prolonged me.
Heat produced by PPG LEDs – PPG LEDs might produce heat
Very Low risk level – no harm – the LEDs are not in direct contact with the skin and the PPG window
produces sucient insulaon to protect the skin from the levels of heat that may be produced by
the LEDs.
Baery
Very Low risk level – no harm – baeries have a low energy density and an explosion is a rare
event. Baeries are qualied before use and are also cered by the Supplier.
Synthesis of cauons
The list below represents all aspects that should be considered as cauons resulng from Risk analysis of the E4.
The user is required to carefully read this manual before using the device.