Ossur i-Digits Quantum - Compliance; Medical Device Standards

11
ENVIRONMENTAL CONDITIONS
Do not use, transport or store the i-Digits outside of the boundaries in the table below:
Use Shipping Extended Storage
Temperature - °C to + °C - °C +  °C - °C +  °C
Relative Humidity  % to  %  % to  %  % to  %
Atmospheric pressure  hPa tp  hPa  hPa to  hPa  hPa to  hPa
COMPLIANCE
The device complies with:
EN -:/AC:
– Protection against electrical shock – Class II ME Equipment
– Degree of protection against electrical shock – Type BF provides additional protection against electric shock
– Degree of protection against ingress of water - IP (IEC. :)
EMI/EMC
Complies with standard EN --:/IEC --:
Radio Spectrum Matters (ERM)/Bluetooth
Complies with standard EN  - V..
BLUETOOTH MODULES REGULATED INFORMATION
This device contains the following radio frequency transmitters:
Model Re
Type and Frequency
Characteristics
Effective Radiated Power
Bluetooth Low Energy
Dual Mode Module
Model BR-LE.-DA
FCC
Contains FCC ID:
XDULE-D
Canada
Contains IC: A-LED
Japan
Contains transmitter with
certificate number
(Dual Mode)
Version V. +ED (GFSK +
π/ DQPSK + DPSK) 
- MHz
Version V. (GFSK)
 - MHz
Adjustable Power (- dBm
to . dBm) short to
long range
205-160268