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Warnings and precautions
Throughout this manual the following meaning of warnings, cautions and notices are used:
NOTICE
WARNING indicates a hazardous situation which, if not avoided, could result in death or serious
injury.
1. Federal law restricts this device to sale by, or on the order of a physician.
2. Do not disassemble or modify the product as this may impact on the safety and/or performance of the
device. Always refer to qualified/authorized personnel for product service. No modification (if necessary)
should be done to this equipment/its component without authorization from Interacoustics.
3. 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
must 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 –
must comply with the safety 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 from the patient support or must 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 these requirements. If in doubt, contact a qualified 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.
4. 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, edition 3, clause 16.
5. The system must not be used in presence of explosive or flammable gases.
6. The system must be switched off before cleaning.
7. Do not use any additional multiple socket-outlet or extension cord.
8. The manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel to repair those parts of this
system that are designated by the manufacturer as repairable by authorized service personnel.
D-0126472-A – 2020/08
VisualEyes™ 505 Instructions for Use -US
WARNING identifies conditions or practices that may present danger to the patient
and/or user.
CAUTION label identifies 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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