Interacoustics OtoRead - Page 12

D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US Page 6
2.2 Markings
The following markings can be found on the instrument:
Symbol
Explanation
Type B applied parts.
Patient applied parts that are not conductive and can be immediately
released from the patient.
WEEE (EU-directive).
This symbol indicates that when the end-user wishes to discard this
product, it must be sent to separate collection facilities for recovery and
recycling. Failing to do so may endanger the environment.
0123
The CE-mark indicates that Interacoustics A/S meets the requirements
of Annex II of the Medical Device Directive 93/42/EEC.
TÜV Product Service, Identification No. 0123, has approved the quality
system.
Date of manufacture.
Manufacturer.
Do not re-use.
Parts like ear tips and similar are for single use only.
Underwriters Laboratories, Inc. label
MEDICAL-GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS
ONLY
IN ACCORDANCE WITH ANSI/AAMI ES 60601-1 (2005) + AMD (2012)
CAN/CSA-C22.2 No. 60601-1 (2008) + (2014)
Serial Number.
Reference Number.
Global Trade Item Number.
Logo.
FCC marking with ID.
The instrument includes a RF transmitter.