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Approved Accessories
1.3 FEDERAL LAW MAY GOVERN THE USE OF THIS DEVICE
Federal law restricts the use of certain medical devices. Seiler’s LED Heliolux is intended to be a sub-com-
ponent of a medical device (system). Such device (system) may be regulated by Federal Law. It is the
user’s responsibility to ensure that the device is being used in a manner appropriate with Federal Law.
1.4 QUALIFICATION OF PERSONNEL
At a minimum, personnel working with the device should have the following qualifications:
•
Installation – hospital engineer or similar training plus specific training by the supplier of the larger
medical system (surgical microscope for instance).
•
Operation – medical or dental training in surgical procedures / dental health procedures plus specific
training by the supplier of the larger medical system (surgical microscope for instance).
Mains Cable
Hospital Grade Only - Consult Factory
Light Guide Cable
(For Light Port)
Non-Electrical, Liquid or Fiber Based, Having Appropriate Ferrules for Insertion -
Consult Factory
Camera (For Camera Port)
Use only cameras that operate from 12 VDC at 500 ma or lower consumption and
having certifications suitable for the particular medical application – for use of
HelioLux with a surgical microscope this requires that the camera be certified
to IEC 60601-1 and IEC 60601-1-2 and any additional standards relevant for the
application. Consult Factory with any questions.
Programming Port
FOR FACTORY USE ONLY!
