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15 Glossary
A
accessory
includes micromotors, cords, hand-
pieces, nozzles, LED rings, optical
guides, tips, sterilisation boxes, and sili-
cone supports used in conjunction with
the control units
B
bag
container filled with physiological
saline solution or sterile water. Can
designate either a flexible container
or rigid container like a bottle.
F
fixed installed medical
devices
devices and their accessories which
are intended to be installed, fastened
or otherwise secured at a special loca-
tion in a healthcare facility so that
they cannot be moved from this loca-
tion or detached without using tools or
apparatus, and which are not spe-
cifically intended to be used within a
mobile healthcare facility [European
regulation No.207/2012]
I
Instructions for use
information provided by the manu-
facturer to inform the user of the
device of its safe and proper use, of its
intended performances and of any pre-
cautions to be taken [European regu-
lation No.207/2012]
instructions for use in elec-
tronic form
instructions for use displayed in elec-
tronic form by the device, contained in
portable electronic storage media sup-
plied by the manufacturer together
with the device, or instructions for use
available through a website [European
regulation No.207/2012]
P
professional users
persons using the medical device in
the course of their work and in the fra-
mework of a professional healthcare
activity [European regulation
No.207/2012]
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Summary of Contents for ImplantCenter M+
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