Warning - EMS DOLORCLAST FT-245 Instructions For Use Manual

1. WARNING

EMS and the distributor of this product accept no liability for direct or consequential injury or damage resulting from
improper use, arising in particular through the failure to follow the operating instructions, or improper maintenance.
Before using this product, please carefully read,
understand and follow the recommendations
contained in the instruction manual. Failure to
follow the instructions for use may result in serious
injury or harm to the patient or user. This product
can only be used by qualified personnel and for the
intended use and the applications described in this
manual. If the product is used in combination with
other instruments, please refer to their instruction
manuals.
D o not use this product in the presence of flammable
anesthetics or oxidizing gases (such as nitrous
oxide (N2O) and oxygen) or in close proximity
to volatile solvents (such as ether or alcohol), as
explosion may occur. Keep the operating area
free from flammable objects such as paper, cotton
pads, plastics, wood or similar. Use of the laser
causes the release of endogenous gases.
Caution: fumes and/or vapors caused by the laser
may contain particles of living tissue.
Before using the product, inspect for any damage.
Do not use if the product is damaged. Only use
original EMS replacement parts and accessories.
Do not modify or repair the product yourself.
Please contact an EMS-approved service center.
The electrical system that powers the medical
device must comply with all applicable legislation.
Check that the power outlet for the premises has
an effective ground connection.
When the mains power switch is in the "0" position,
the product is disconnected from the electric power
source.
Remove the ignition key when the system is not
in use.
The environment in which the machine operates
must be indoors and appropriately set up, with no
reflective surfaces in order to avoid reflections that
may damage the eyes.
The room temperature must be between +15°C
and +35°C and the relative humidity must be
between 45% and 60% with no condensation.
The laser safety label must be applied to all access
doors to the operational area.
When the equipment is in operation, access to
the operating area must be limited to authorized
personnel only, and use of the safety goggles
provided is compulsory for both the user and the
patient. Avoiding looking directly at the aperture of
the handpiece during delivery.
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Bending with too tight a bending radius and/or
pulling on the optical fiber containment jacket can
damage the internal fibers and/or cause injury to
the patient or laser operator.
Do not use the machine if the upper panel is open
or not closed correctly.
Use of extension cables, multi-socket extension
leads, adaptors and/or resistors is not permitted.
When the machine is turned on for the first time,
particularly after having been transported in
temperatures below 10°C/50°F, the device must
be left in STAND-BY mode for at least 15 minutes
before activating the laser emission.
The FT-245 laser is equipped with a forced-air
cooling system with internal fans located near to
the laser diodes. Never obstruct the slots on the
back of the machine, as this may result in internal
overheating with subsequent damage to the
device.
Eye and skin exposure: The laser beam emitted
by the FT-245 can cause sight loss. The device
functions at a visible (red guide light) and invisible
(IR light) wavelength. Any energy transmitted by
laser devices that enters the eyes will be focused
directly onto the retina. Direct absorption of laser
energy by the retina may cause temporary blurred
vision, retina injury, long-term scotoma and long-
term photophobia.
In any event, there is a risk of:
- Direct laser radiation
- Reflected laser radiation
- Diffuse laser radiation
Anyone in the area in which the FT-245 is
operating or undergoing maintenance must wear
safety glasses with DIR LB6 protection, in line with
directive EN207.
All individuals present in the laser's operating area
must wear all protective equipment.
Always check the integrity and condition of safety
glasses. Before putting on the safety glasses,
check that the safety lenses are in good condition.
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