Performance Characteristics - Freestyle Libre 2 Manuel D'utilisation

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Sensor is used exceeds the applicable RF compliance level above, the Sensor
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orientating or relocating the Sensor.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Immunity Test: Proximity fields from RF wireless communications equipment; IEC 61000-4-3
Test Level: See the table below
Compliance Level: Compliance to the tested levels
Electromagnetic Environment - guidance:
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to the Sensor. Otherwise, degradation of the
performance of the System could result.
The table below lists the immunity test levels at specific test frequencies for testing the effects of some
wireless communications equipment. The frequencies and services listed in the table are representative
examples in healthcare and in various locations where the System may be used.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used, because while it does not represent actual modulation, it
would be worst case.

Performance Characteristics

Performance Characteristics
Overview of Clinical Studies Overview of Clinical Studies
Two studies were conducted in the United States (US) to evaluate the performance, safety,
effectiveness, and precision of the FreeStyle Libre 2 Flash Glucose Monitoring System (System). One
study included adults (Adult study) and the other study included children (Paediatric study). All subjects
in both studies required insulin to manage their diabetes. To measure the precision of the System, each
ART41758-100_rev-A 3:14pm 18-JAN-2021