Empatica E4 - Device Care and Environmental Considerations

13
empaca
©
2015
Water resistance
Very Low risk level – no harm – the device is splash proof and will operate normally aer contact
with sweat, rain or splashes. The device is not fully waterproof so the user should not submerge
it in liquid or wear it in the shower. In the event that there is water ingress into the case the User
will not be harmed, but the device may stop working.
Biocompability
Very Low risk level – no harm - the E4 is made of a well known biocompable material and the
manufacturer is qualied, ensuring that no contaminaon occurs during the manufacturing
process. Materials are outlined in Technical Specicaons secon.
Electromagnec compability
Very Low risk level – no harm – design validaon and vericaon has been conducted and has
demonstrated that the E4 is safe for use with other electronic devices. It is compliant with the
following standards:
• IEC 60601-1-2:2007 (third edion)
• FCCC FR47Part15bedIC (Industry Canada)
• ETSIEN301489-1e3V
There should be no precauons to be taken for any interference with the magnec elds, or to
the environmental condions of use.
Use Condion
Ambient - E4 can be used in domiciliary sengs, indoor or outdoor; it’s resistant to water but
cannot be immerged in water, can be lost by subject during use, should be worn ght to the
wrist.
Light condion - 100-500lx, Visual distance: 20-40 cm, Visual angle +-90°
Environmental condion - Temperature -10°C +40°C, Relave humidity 20% - 95%, Air pressure –
500hPa to 1200hPa, Acousc level - not relevant
Use frequency - It is extremely variable depending on subject/praconer prescripon:
Repeve use (once per day) or prolonged use (few minutes to 40hrs)