Electromagnetic Emission Declaration
The VitalPatch device is intended for use in the electromagnetic environment specified below. The end user of the
device should assure that it is used in such an environment.
Heart Rate (stationary
and ambulatory)
30 – 200 Beats per Minute (<±5 or 10% Beats per Minute,
whichever is greater)
o
10-30 Breaths per Minute with a mean absolute error of less
than 3 Breaths per Minute, validated by clinical studies
o
4-42 Breaths per Minute with a mean absolute error of less
than 1.5 Breaths per Minute, validated by simulation studies
Fall or No Fall (> 90% Sensitivity and >98% Specificity)
< 5% Absolute Error Compared to Manual Count
Step count is reset to 0 after step count 65535 is reached.
Lying down, Upright, Walking, Running, or Leaning (>70% Accuracy
Compared to Visual)
Max. 10 Meters (30 Feet Line of Sight)
FSK (Frequency Shift Keying)
AES-CCM 128 Bit Encryption (Advanced Encryption Standard-CCM
mode)
Electromagnetic environment
The VitalPatch device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The VitalPatch device is suitable for use in all establishments,
including domestic establishments and those directly connected to
the public low-voltage power supply network that supplies buildings
used for domestic purposes.
IFU-02 Rev. J Page ! of ! 11 17
DCO-M-1556 | Date: 06Mar2018