Technical Information - Osstell Beacon Manual Del Usuario

16) Technical information

Technical description
Osstell Beacon is CE-marked according to MDD in Europe (Class IIa,
internally powered, type BF applied parts. Not AP or APG equipment,
not protected against ingress of water).
Osstell Beacon is in accordance with applicable parts of
IEC 60601-1/ANSI/AAMI ES 60601-1.
The symbols used, follow the European standard EN 60601-1 and
ISO 15223 as far as possible.
Notes on electromagnetic compatibility (EMC)
Medical electrical equipment is subjected to particular precautions with
regards to EMC and must be put into operation in accordance with the
EMC notes included below:
Osstell guarantees the compliance of the device with the EMC require-
ments only when used with original accessories and spare parts. The use
of other accessories / other spare parts can lead to an increased emis-
sion of electromagnetic interference or to a reduced resistance against
electromagnetic interference.
You can find the current EMC manufacturer's declaration on our website
at osstell.com/products/Osstell-Beacon.
Alternatively, you can obtain it directly from your local sales
representative or distributor.
The Osstell Beacon contains a Bluetooth module.
FCC ID: QOQBLE113, IC: 5123A-BGTBLE113
Battery
The instrument contains a rechargeable lithium-ion battery.
The instrument should be charged using the Osstell USB cable, type
A-C, directly connected to a standard USB 2.0 or 3.0, 5 Volt USB type A
port. Battery status and charging is indicated in the lower display with
a battery symbol having 4 levels: 100% (fully charged), 75%, 50% and
less than 25%. When the level is less than 10%, the Osstell Beacon will
change the battery symbol to alert that it is time to charge the instru-
ment.
Note! It is not possible to perform an ISQ measurement during
charging.
Transport mode
Transport mode can be used when, e.g. travel to different places outside
the clinic and thereby frequently move the Osstell Beacon, which will
wake up the instrument more frequent than regular use and thereby
draining the battery faster.
The transport mode is activated by connecting the Osstell USB cable,
type A-C, (when connected to an USB port) and removing it within 5
seconds as illustrated by a count-down sequence in the lower display.
The two displays will turn dark and the instrument will no longer wake
up by motion.
If the Osstell USB cable, type A-C, is not removed within these 5 seconds,
the instrument will enter charging mode.
To deactivate transport mode, connect the cable again, as is described
section 7.
Accuracy
The Osstell Beacon instrument has an ISQ accuracy/resolution of
+/- 1 ISQ. When the SmartPeg is attached to an implant, the ISQ value
can vary up to 2 ISQ depending on SmartPeg attachment torque.
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