Indications For Use; Contraindications; Side Effects - SDC MLD-810 Manuel D'utilisation

Power Controller: The laser power controller provides electric power to the diode
in either Continuous Wave Mode or Pulse Mode. It supplies approximately 2 VDC and
current up to 4 A to the diodes. The controller contains a high-efficiency DC-to-DC
converter that converts the battery voltage to the precise voltage needed for laser
operation. This ensures that the majority of the energy is used for light and not
converted into heat.
Lithium-ion Battery: Rechargeable lithium-ion battery with overcharge and
undercharge protection.
Foot Pedal: The foot pedal contains a UL-approved commercial foot switch that
controls initiation/termination of laser power wirelessly, using 2.4 GHz frequency.
Disposable Fiber Tip Delivery System: The delivery system is composed of a
single-use plastic tip with a built-in 400 micron core multi-mode, optical quartz fiber.
The fiber attaches to a custom-made steel connector, which attaches via a magnet
onto the laser aperture component. The magnet acts as a guide and functions as an
alignment mechanism, enabling a precise fit of the disposable tip onto the laser unit.
This design offers a simplified approach to fiber management:
• The fiber is factory-installed into the tip and requires no installation by the end user
• The tip is provided pre-scored which decreases setup time and reduces the likelihood
of user error
• The complete component is fully disposable, which increases clean-up efficiency
in the operatory

Indications for Use

The MLD-810 Laser is intended to be used for removal of soft tissue when removal
of tissue is indicated by the doctor. The device may be used in the following areas:
general and cosmetic dentistry.

Contraindications

All clinical procedures performed with the MLD-810 Laser must be subjected to the
same clinical judgment and care as with traditional techniques. Patient risk must
always be considered and fully understood before clinical treatment. The clinician
must completely understand the patient's medical history prior to treatment. Exercise
caution for general medical conditions that might contraindicate a local procedure.
Such conditions may include allergy to local or topical anesthetics, heart disease, lung
disease, bleeding disorders, and immune deficiency, or any medical conditions or
medications that may contraindicate use of certain light/laser type sources associated
with this device. Medical clearance from the patient's physician is advisable when
doubt exists regarding treatment.
• Not suitable for use in or around an MRI
• Do not use in an oxygen tent

Side Effects

•
Temporary transient discoloration as with the thermal energy at the tissue surface
• Possible discomfort during healing and tissue recession
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