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DGM001519.01 UM Sirius CE/ROTW
x Use of the laser on anatomical structures in proximity to known critical structures, such as large arteries,
veins, nerves, bowel, ureter, bladder, etc., should be performed carefully to avoid inadvertent or
unintended treatment of such structures.
x Begin laser treatment at the lowest power, with short duration exposures until fully familiar with effects
of the applied wavelength on the tissues.
x Flash fire may occur. Refer to Chapter 2 for more information. A bowl of water should be available in
case a fire occurs. Inhalation general anaesthetics must not be used if flammable. Oxygen levels in the
direct surgical area must not exceed 50%. The risks of combustion, perforation, and laser-induced
haemorrhage, any of which could cause death, must be fully explained to the patient.
x The flammability of methane gas must be considered when treating in or near the perianal area.
x Quanta System S.p.A. has no clinical information or experience concerning the use of the Sirius Laser
System on pregnant women or nursing mothers.
x Patients who experience discomfort during laser treatment may require analgesics.
x As with conventional non-laser surgical procedures, there is no guarantee that treatment with the
Sirius Laser System will entirely eliminate the disease. Repeated treatment or alternative therapies
may subsequently be required.
x The laser may not be effective for coagulation in massive hemorrhage situations. The surgeon must be
prepared to control hemorrhages with alternative non-laser techniques, such as ligature or cautery.
x Alterations in surgical approach or technique may be required to accommodate laser use.
x The surgeon should schedule follow-up visits in the same manner as for any patient undergoing such
surgery with other modalities.
x Surgeons should be thoroughly trained and proficient in all aspects of endoscopic surgery prior to using
the laser through an endoscope. Depth perception through an endoscope is distorted. The surgeon
must rely on both the visual and tactile feedback of the delivery system.
x Care must be taken to protect endotracheal tubes from laser radiation. Ignition or perforation of
endotracheal tubes by the laser beam could result in serious or fatal patient complications.
x A smoke evacuator and in-line filter should be used to capture the smoke plume resulting from laser
procedures. The plume should be regarded as a source of active biological material and a possible
carcinogen.
x The recommended power settings are less important than the visual tissue effect. Changes in tissue
texture and color are the best indicators of laser impact upon the targeted area. Specific pulse duration
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x The lowest possible power settings required to achieve the desired tissue effect should be used for
treatment.
x Higher wattages of power may be necessary to achieve the desired tissue effects if fluid cooling is
employed. Excessive power settings may cause damage to the Disposable Optical Fiber Delivery
Devices.
x The use of mechanical pressure on the Disposable Optical Fiber Delivery Devices does not increase its
cutting or vaporization effects but may induce bleeding, thermal damage and fiber destruction.
x For equal powers emitted from laser source, fibers with smaller diameter generate greater power
densities (on the contrary fibers with bigger diameter generate lower power densities). Thus, the
operator must regulate the output power (on laser device display) taking into account the fiber
diameter.
x There is an increased risk of back-scatter (reflection) and forward scatter (penetration) when using the
laser in non-contact mode.
x Different energy densities induce different effects upon tissues, therefore using fibers with different
diameters with the same output power could have different outcomes on irradiated tissues. Employed
laser power has to be tuned also according to fiber diameter.
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