Marking; General Warnings And Precautions - Interacoustics PA5 Gebrauchsanweisung

2.2

Marking

The following marking can be found on the instrument:
Symbol
0123
2.3

General warnings and precautions

NOTICE
Be sure to use only stimulation intensities, which will be acceptable for the patient.
NOTICE
The transducers (headphones, bone conductor, etc.) supplied with the instrument are calibrated to this
instrument - exchange of transducers require a recalibration.
NOTICE
It is recommended that parts which are in direct contact with the patient (e.g., earphone cushions) are
subjected to standard disinfecting procedure between patients. This includes physically cleaning and
use of a recognised disinfectant. Individual manufacturer's instruction should be followed for use of
this disinfecting agent to provide an appropriated level of cleanliness.
NOTICE
Always remove the batteries when the instrument is left unused for more than a month.
PA5 Instructions for Use - EN
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.
The CE-mark in combination with MD symbol indicates that Interacoustics
A/S meets the requirements of the Medical Device Regulation (EU)
2017/745. Approval of the quality system is made by TÜV – identification no.
0123.
Medical Device
Year of manufacture
Manufacturer
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