ReliOn PLATINUM User Manual page 37

Wireless blood glucose monitoring system
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9
Technical Information
Representation of Accuracy for Home Use
Your ReliOn Platinum meter result may vary slightly from your actual blood glucose value.
This is due to slight differences in technique and the natural variation in the test technology.
See the table below with performance study data that shows the ReliOn Platinum system
achieved 96 % of results within ±15 % of the laboratory. In this study, the meter gave
results within ±15 % of their true blood glucose level 336 out of 350 times.
The data in the following table was collected from a typical user study to demonstrate the
ReliOn Platinum meter accuracy.
ReliOn Platinum Accuracy Results compared to Laboratory Results
(within ±20 % of laboratory)
Accurate Results (within ±15 % of laboratory)
More Accurate Results (within ±10 % of laboratory)
Most Accurate Results (within ±5 % of laboratory)
Bluetooth Wireless Technology – The
meter uses Bluetooth low energy wireless
technology to communicate and transfer
information. Bluetooth wireless technology
is a form of radio frequency (RF)
technology that operates in the unlicensed
industrial, scientific, and medical band at
2.4 to 2.485 GHz. The RF channel utilized
for communication between the meter and
other devices, such as a smartphone, is
not an open channel. The meter can only
communicate with the device that
1. utilizes Bluetooth low energy
technology,
2. it is paired with, and
3. has an application that can accept
the meter's data.
Electromagnetic Compatibility – The
meter meets the electromagnetic emission
requirements as per EN ISO 15197. The
chosen basis for electrostatic discharge
immunity testing was basic standard
IEC 61000-4-2. In addition, the meter
meets the electromagnetic emissions
(99 %) 346 of 350 results
(96 %) 336 of 350 results
(88 %) 307 of 350 results
(63 %) 220 of 350 results
requirements as per EN 61326-2-6 / EN
60601-1-2. Its electromagnetic emission
is thus low. Interference from the meter to
other electrically-driven equipment is not
anticipated.
This device complies with Part 15 of the
FCC Rules. Operation is subject to the
following two conditions:
1. This device may not cause harmful
interference, and
2. this device must accept any
interference received, including
interference that may cause undesired
operation.
In the event there is interference from
another device, it is recommended that
you increase the distance between the
meter and that device. You can also turn
off the interfering device. In addition, you
can turn off Bluetooth low energy wireless
technology on the meter.
This equipment complies with FCC
radiation exposure limits set forth for an
36

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