D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN
Page
4
1.6 Warnings
Throughout this manual, the following meanings of warnings, cautions and notices apply:
The
WARNING
label identifies conditions or practices that may present danger
to the patient and/or user.
The
CAUTION
label identifies conditions or practices that could result in
damage to the equipment.
NOTICE
NOTICE
is used to address practices not related to personal injury.
1.7 Malfunction
In the event of a product malfunction, it is important to protect patients, users, and other
persons against harm. Therefore, if the product has caused, or potentially could cause such
harm, it must be quarantined immediately.
Both harmful and harmless malfunctions, related to the product itself or to its use, must
immediately be reported to the distributor where the product was acquired. Please remember to
include as many details as possible e.g., the type of harm, serial number of the product,
software version, connected accessories and any other relevant information.
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Interacoustics and the local national competent authority.
