2.3.1 Electrical System Safety; 2.3.2 Electrical Safety - Interacoustics OtoRead Instructions For Use Manual

2.3 General warnings and precautions
Read these instructions carefully and completely before using the product

2.3.1 Electrical system safety

WARNING

2.3.2 Electrical safety

WARNING
D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US
DC- Direct current.
China RoHS label. Indicates that the product does not contain toxic and
hazardous substances or elements above the maximum concentration
values, and that it is an environmentally-friendly product which can be
recycled and reused.
Keep Dry.
When connecting the instrument to the computer, the following
warnings must be observed:
This equipment is intended to be connected to other equipment thus
forming a Medical Electrical System. External equipment intended for
connection to signal input, signal output or other connectors shall
comply with the relevant product standard e.g. IEC 60950-1 for IT
equipment and the IEC 60601-series for medical electrical equipment.
In addition, all such combinations – Medical Electrical Systems – shall
comply with the safety requirements stated the general standard IEC
60601-1, edition 3, clause 16. Any equipment not complying with the
leakage current requirements in IEC 60601-1 shall be kept outside the
patient environment i.e. at least 1.5 m from the patient support or shall
be supplied via a separation transformer to reduce the leakage
currents. Any person who connects external equipment to signal input,
signal output or other connectors has formed a Medical Electrical
System and is therefore responsible for the system to comply with the
requirements. If in doubt, contact qualified medical technician or your
local representative. If the instrument is connected to a PC (IT
equipment forming a system) ensure not to touch the patient while
operating the PC.
A Separation Device (isolation device) is needed to isolate the
equipment located outside the patient environment from the equipment
located inside the patient environment. In particular such a Separation
Device is required when a network connection is made. The
requirement for the Separation Device is defined in IEC 60601-1 clause
16
Do not modify this equipment without authorization of Interacoustics Do
not disassemble or modify the product as this may impact on the safety
and/or performance of the device. Refer servicing to qualified
personnel.
For maximum electrical safety, turn off the power when it is left unused
The power plug shall be placed so it is easy to pull out the plug
Do not use the equipment if it is showing visible signs of damage.
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