Warnings - Interacoustics Affinity2.0 Instructions For Use Manual

1.5 Warnings

Throughout this manual, the f ollowing def initions of warning, caution and notice are used:
WARNING
CAUTION
NOTICE
Federal law restricts the sale, distribution, or use of this device to, by, or on the order of a licensed medical
practitioner.
1. 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
must 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 –
must comply with the saf ety requirements stated in the general standard IEC 60601-1, (edition 3.1),
clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 must be
kept outside the patient environment i.e. at least 1.5m f rom the patient support or must 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 these requirements. If in doubt, contact a qualif ied medical
technician or your local representative. When the instrument is connected to a PC, or other similar items,
beware of not touching the PC and patient simultaneously.
2. 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.
3. To avoid the risk of electric shock, this equipment must only be connected to supply mains with a
protective earth.
4. Do not use any additional multiple socket-outlet or extension cord. For saf e setup please ref er to section
2.3
5. No modif ication of this equipment is allowed without the authorization of Interacoustics.
Interacoustics will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other inf ormation. This will assist service personnel to repair, the parts of this
audiometer that are designated by the Interacoustics service personnel as repairable.
6. For maximum electrical saf ety, turn of f the power to a mains- powered instrument when it is lef t unused.
7. The instrument is not protected against ingress of water or other liquids. If any spillage occurs, check the
instrument caref ully bef ore use or return f or service.
8. No part of the equipment can be serviced or maintained while in use with the patient.
9. Do not use the equipment if it is showing visible signs of damage.
D-0004578-R – 2022/05
Affinity2.0/Equinox2.0 - Instructions for Use - US
The WARNING label identif ies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identif ies conditions or practices that could result in
damage to the equipment.
NOTICE is used to address practices not related to personal injury.
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