Important Safety Instructions; Electrical System Safety; Electrical Safety - Interacoustics AD528 Instructions D'utilisation

2.3 Important safety instructions

Read these instructions carefully and completely before using the product

Electrical system safety

WARNING

Electrical safety

WARNING
D-0121151-B – 2018/11
AD528 - Instructions for Use - EN
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 any additional multiple socket-outlet or extension cord. For safe
setup please refer to section 2.4.1.
Do not use the equipment if it is showing visible signs of damage.
This instrument contains a coin-type lithium battery. The cell can only be
changed by service personnel. Batteries may explode or cause burns, if
disassembled, crushed or exposed to fire or high temperatures. Do not short-
circuit.
The instrument is not protected against ingress of water or other liquids. If any
spillage occurs, check the instrument carefully before use or return for service.
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