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1.3
Safety Related Labels & Symbols (continued)
Indicates the temperature limits to which
the medical device can be safely exposed
(Operational)
This product is provided non-sterile. Do not
attempt to re-sterilize the device.
This product uses wireless Bluetooth
communication
To identify a type BF applied part complying
with IEC 60601-1
Contents (Quantity)
Protection against dust and water jets when
IP55
earpieces are attached.
The earpieces are not IP protected.
Keep away from magnetic resonance
imaging (MRI) equipment
Rx Only
Requires prescription in the United States.
Signifies European technical conformity
(number is identification of notified body).
0537
Indicates the medical device manufacturer.
Indicates the Authorized representative in the
EC REP
European Community
Indicates the medical device manufacturing
date.
P.
3

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