Warnings and Precautions
Lumenis Pulse 120H UM-10012510 Rev. F
Page 28
NOTE:
Lumenis has no clinical information concerning the safety of laser
treatment on pregnant or nursing women.
Warnings and Precautions
This section contains warnings and precautions that are applicable to
surgical procedures specifically related to the use of this system.
• Holmium lasers are intended solely for use by physicians trained in the
use of the Ho:YAG (2.1 µm) wavelength.
• Incorrect treatment settings can cause serious tissue damage. Therefore,
it is recommended that you use the lowest acceptable treatment settings
until familiar with the instrument’s capabilities. Use extreme caution
until the biological interaction between the laser energy and tissue is
thoroughly understood.
• Due to interaction between flammable gases in the operating field and
the laser energy a flash fire may occur. Therefore, during laser
procedures, measures to minimize this potential hazard should be
practiced (e.g. avoid administration of inhaled general anesthetics;
reduce oxygen levels during mechanical ventilation, use of laser-
resistant endotracheal tubes). The flammability of methane gas must
also be considered when treating in or near the perianal area.
• The laser should be used only on tissues that are fully observable. Do
not use the laser if the desired target is not visible. All available
measures to visualize the target tissue (e.g. copious irrigation,
hemostasis) should be taken.
• When using endoscopic equipment confirm that the tip of the fiber
optic delivery device extends at least 6 mm beyond the end of the scope
during laser treatment. Activating the laser when the tip of the delivery
device is within the scope can result in penetration of holmium laser
energy through the scope and destruction of the scope.
• Use of the laser on anatomical structures in proximity to known critical
structures, such as large arteries, veins, bowel, ureter, bladder, nerves,
etc., should be performed carefully to avoid inadvertent or unintended
damage of such structures. If applicable, maintain irrigation in the
treatment area to reduce heat accumulation.