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led light source
1.0 intended Use
Seiler’s LED Heliolux is a source of continuous high intensity illumination for surgical microscopy
applications.
It is intended for use providing illumination to Class I or Class II surgical microscope systems which, as
larger systems are subject to FDA regulations. It is intended to be used as a sub-component of a larger
surgical imaging system and is not intended to be used as a stand-alone medical device.
Seiler’s LED Heliolux is intended to deliver illumination only through non-electrical light cables made with
optical fibers or optical cavities (liquid light guides).
Seiler’s LED Heliolux is intended for use in a professional healthcare facility environment.
Seiler’s LED Heliolux is only to be used with light cables having the exact mating profile necessary to
ensure proper coupling of the light source to the light cable.
Illumination from this device is to be used for observation of body cavities, body surfaces, teeth, and other
surgical sites.
Portable and mobile RF communications equipment can affect medical electrical equipment.
1.1 PRECAUTIONS FOR USE - CONTRADICTIONS
•
Do not operate
Seiler’s LED Heliolux
in an explosive atmosphere.
•
Do not operate
Seiler’s LED Heliolux
in an MRI environment.
•
Do not operate
Seiler’s LED Heliolux
for home health care.
•
Do not modify
Seiler’s LED Heliolux
.
•
Do not use
Seiler’s LED Heliolux
to illuminate eyes.
•
Do not use near (12 inches or closer) equipment sensitive to electro-magnetic interference. This
device complies with International Standards (as set forth in manufacturer’s declaration following) for
electromagnetic compatibility for medical electrical equipment and/or systems. These standards
are designed to provide reasonable protection against harmful interference in a typical medical
installation. However, because of the proliferation of radio-frequency transmitting equipment and
other sources of electrical noise in healthcare and other environments, it is possible that high levels
of such interference due to close proximity or strength of a source might disrupt the performance
of this device. Medical electrical equipment needs special precautions regarding EMC, and all
equipment must be installed and put into service according to the EMC information specified in this
manual.
1.2 ACCESSORIES
Precautions to take regarding accessories:
•
Accessory equipment connected to the analog and digital interfaces must be certified to the
respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1.
Any equipment connected to the signal input part or signal output part configures a medical system.
Therefore this equipment, and new configuration, must comply with the requirements of the system
standard IEC 60601-1-1.
•
Failure to use approved accessories could result in excessive electromagnetic emissions and cause
harm to the essential function of other medical devices.
•
Use only approved HOSPITAL GRADE mains supply cables 12 gage or better.
•
Use only approved non-electrical light cables (consult factory).
•
Use only approved cameras requiring 12VDC / 500 ma or less.
