Precautions For Use; Synthesis Of Cautions; Functional Hazards; Eye Exposition To Led Light - Empatica E4 User Manual

F. PRECAUTIONS FOR USE
The E4 is in the process of undergoing certification 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 profile
device.

Synthesis of cautions

The list below represents all aspects that should be considered as cautions resulting from Risk analysis of the E4.
The user is required to carefully read this manual before using the device.

Functional hazards

that affects the output of one or more sensor (i.e., Heart rate, EDA, Temperature, Accelerometers).
Very Low risk level – no harm
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
current through the skin to operate: Max 100 µA as required by IEC 60601-1:2005
Very Low risk level – no harm
after design validation and verification, which means that the amount of current produced is safe
for the user.

Eye exposition to LED light

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
may be exposed in their daily environment. The User is advised to not look at the PPG LEDs for a
prolonged time.
Heat produced by PPG LEDs
Very Low risk level – no harm
produces sufficient insulation to protect the skin from the levels of heat that may be produced by
the LEDs.
Battery
Very Low risk level – no harm
event. Batteries are qualified before use and are also certified by the Supplier.
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– including any error that might result from errant read and /or transfer of data
– safe transfer protocols and fault detection algorithms monitor the
– the E4 has been validated to be compliant with ISO 60601-1:2005
- PPG LEDs are extremely bright; typically they are totally obscured
– the quantity of light is comparable with other light sources that Users
– PPG LEDs might produce heat
– the LEDs are not in direct contact with the skin and the PPG window
– batteries have a low energy density and an explosion is a rare
– The EDA circuit drives a small amount of ionic
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