Important Safety Instructions; Electrical System Safety; Electrical Safety - Interacoustics Affinity Compact Instructions For Use Manual

2.3 Important safety instructions

Read these instructions carefully and completely before using the product

2.3.1 Electrical system safety

WARNING

2.3.2 Electrical safety

WARNING
D-0123234-D – 2020/05
Affinity Compact - 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.
Do not use the equipment if it is showing visible signs of damage.
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
No part of the equipment can be serviced or maintained while in use with the
patient.
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Page 7