Environmental Conditions; Electromagnetic Compatibility - Össur i-LIMB WRIST Instrucciones De Uso

ENVIRONMENTAL CONDITIONS

The i-Limb Wrist is not intended for use outside the boundaries of the environments listed below.
The user of the i-Limb Wrist device should assure that it is not used, transported or stored in such
environments.
Hazardous Area Classif ication
Normal use temperature
Temperature range for transportation and storage
Relative air humidity
BLUETOOTH MODULE REGULATED INFORMATION
This device contains the following radio frequency transmitters:
Model
Bluetooth Low Energy
Dual Mode Module
Model BR-LE4.0-D2A
NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may
cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to
cause harmful interference in which case the user will be required to correct the interference at his own expense.

ELECTROMAGNETIC COMPATIBILITY

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe
product situations, the EN 60601-1-2:2015/ IEC 60601-1-2:2014 standard has been implemented. This standard
defines levels of electromagnetic emissions for medical devices.
The Össur Myoelectric Prosthetic Devices are manufactured by Össur hf. conforms to this EN 60601-1-2:2015/ IEC
60601-1-2:2014 standard for both immunity and emissions.
Re
FCC
Contains FCC ID:
XDULE40-D2
Canada
Contains IC: 8456A-LE4D2
Japan
Contains transmitter with
certificate number
205-160268
Nonhazardous
0°C to +40°C
-10°C to +70°C
0% to 100%
Type and Frequency
Characteristics
(Dual Mode)
Version V2.1 +ED (GFSK +
π/4 DQPSK + 8DPSK) 2402
-2480 MHz
Version V4.0 (GFSK) 2402
-2480 MHz
Effective Radiated Power
Adjustable Power (-23 dBm
to 10.5dBm) short to
long range
10