Philips HearLink 2 - Technical Information; Symbols and Abbreviations Guide; Compliance and Declarations

31
2023
Technical information
The following are denitions that may appear in the
Instructions for use and on the About the app screen for
Philips HearLink 2:
Description of symbols used in this booklet
Warnings
Text marked with a warning symbol must be read before using the app.
Manufacturer
The device is produced by the manufacturer whose name and
address are stated next to the symbol. Indicates the medical device
manufacturer, as dened in EU Regulation 2017/745.
CE mark
The device complies with all required EU regulations and directives. The
four digit number indicates the identication of the notied body.
Description of symbols and abbreviations used in the app
eIFU Indicator
Consult electronic instructions for use
Indicates the need for the user to consult electronic instructions for use.
Medical Device
The device is a medical device.
GTIN
Global Trade Item Number
A globally unique 14-digit number used to identify medical device
products including medical device software.
This medical device complies with Medical Device Regulation
(EU)2017/745.
Declaration of Conformity is available at the headquarters:
SBO Hearing A/S
Kongebakken 9
DK-2765 Smørum
Denmark
hearingsolutions.philips.com
SBO Hearing A/S
Kongebakken 9
DK-2765 Smørum
Denmark