D-0126440-A – 2020/08
VisualEyes™ 515/525 Instructions for Use - US Page 5
1.5 Warnings and precautions
The general warnings, precautions and points to be noticed for the VisualEyes™ system are discussed in this
section with appropriate symbols. Some of the specific warnings are discussed under respective sections
to get the maximum attention from the user.
Throughout this manual the following meaning of warnings, cautions and notices are used:
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
NOTICE is used to address practices not related to personal injury.
General warnings and precautions
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
shall comply with the relevant product standard e.g. IEC 62368-1 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 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 shall
be kept outside the patient environment, i.e. at least 1.5 m from the patient or shall be supplied via a
separation transformer to reduce the leakage currents. Any person who connects external equipment to
a 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 a qualified medical
technician or your local representative.
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 requirements for separation devices are
defined in IEC 60601-1, edition 3, clause 16.
5. The system must not be used in the 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. For irrigators, to avoid the risk of electric shock, this equipment must only be connected to a supply main
with protective earth.
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