Introduction
Other documents relating to this product
1
LUCEA 50-100
IFU 01741 EN 11
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1.2.3.3 Groups of people
Users
• Users are persons who are authorised to use the device, either by virtue of their qualifications
or as a result of receiving training from a qualified person.
• Users are responsible for the safe use of the device and for ensuring that it is used as inten-
ded.
Qualified personnel:
• Qualified personnel are persons who have acquired knowledge through specialised training
in medical technology or due to their professional experience and knowledge of the safety
rules relating to the tasks performed.
• In countries where certification is required to exercise a medico-technical profession, person-
nel must hold the necessary authorisation in order to be considered as qualified.
1.2.3.4 Light types
Minor surgical light
Single light located in the patient’s environment in an operating room and designed to facilitate
treatment and diagnosis procedures which can be interrupted without compromising patient
safety in the event of a light failure.
Surgical lighting system
Combination of several surgical lights designed to facilitate treatment and diagnosis operations
and to be used in operating rooms. A surgical lighting system must be failsafe and must provide
adequate central illumination to light the body of the patient locally even if an initial fault condition
occurs.
Example: A combination of at least two minor surgical lights constitutes a surgical lighting sys-
tem.
1.3 Other documents relating to this product
• Maintenance manual (Ref. ARD01740)
• Repair manual (Ref. ARD01742)
• Installation manual (Ref. ARD01744)
• Decommissioning instructions (Ref. ARD01745)
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