D-0134090-A – 2022/11
VisualEyes™ - Instructions for Use - EN
Page
10
Included major
p
arts:
•
Datalink
•
7x electrode cables (3
channels)
•
Snap electrodes
•
Electrode skin preparation
accessory
•
ENG built into the back of the
Orion C/AT rotary chairs
•
7x electrode cables (3
channels)
•
Snap electrodes
•
Electrode skin preparation
accessory
•
Pediatric front mount goggle
(USBM2.1P)
•
Child seat
•
Pediatric observation camera
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.
