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-0123672-H – 2022/05
Affinity Compact - Instructions for Use - US
Transport and storage humidity limitations
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When connecting the instrument to the computer, the f ollowing warnings must
be observed:
This equipment is intended to be connected to other equipment thus f orming a
Medical Electrical System. External equipment intended f or connection to
signal input, signal output or other connectors shall comply with the relevant
product standard e.g., IEC 60950-1 f or IT equipment and the IEC 60601-series
f or medical electrical equipment. In addition, all such combinations – Medical
Electrical Systems – shall comply with the saf ety 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 f rom the patient support or
shall be supplied via a separation transf ormer to reduce the leakage currents.
Any person who connects external equipment to signal input, signal output or
other connectors has f ormed a Medical Electrical System and is theref ore
responsible f or the system to comply with the requirements. If in doubt, contact
qualif ied medical technician or your local representative. If the instrument is
connected to a PC (IT equipment f orming 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 f rom the equipment located inside the
patient environment. Such a Separation Device is required when a network
connection is made. The requirement f or the Separation Device is def ined in
IEC 60601-1 clause 16
Do not modif y this equipment without authorization of Interacoustics Do not
disassemble or modif y the product as this may impact on the saf ety and/or
perf ormance of the device. Ref er servicing to qualif ied personnel.
For maximum electrical saf ety, turn of f the power when it is lef t 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.
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