ROCAMED SIRIUS - 6.3 General Laser Warnings

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DGM001519.01 UM Sirius CE/ROTW
If tissue adheres to the fiber tip, the fiber has to be extracted from the endoscope so that the tissue can be
removed.
The treatments in open surgery and laparoscopy could cause smoke formation, as in the similar surgical
procedure with electro-ablative surgical tools, therefore the surgeon has to evaluate the use of a smoke
evacuator system. As the output power increases, the smoke formation process increases.
General Laser Warnings
The physician or surgeon should become fully acquainted with the unique surgical and therapeutic effects
produced by the 1.9 µm wavelength before using the Quanta System Sirius Laser in a clinical environment. These
effects include coagulation, depth of penetration and cutting intensity.
Caution should be used with power (Watts) and lasing duration until the surgeon is completely familiar with the
biological interactions of laser energy with various types of tissue. Unless otherwise stated in the specific
application section, the surgeon should begin with the lowest power and use short duration exposures. The
surgeon should observe carefully the induced surgical effect and adjust laser settings until the desired surgical
effect is obtained.
The following warnings and precautions are applicable for each surgical specialty contained in this manual. For
specific application warnings and precautions, see the section specific to a given surgical specialty.
Warnings:
x The Sirius Laser System is a surgical device that should be used only by physicians or surgeons who
have been trained in laser surgery through courses, mentorships, and under the guidance of other
physicians or surgeons knowledgeable in laser use. No claim is made about the certainty of treating
successfully any medical condition by laser.
x BEFORE operating the laser system, surgeons and all staff operating this device should read carefully
Chapter 2 of this manual.
x Surgeons using Quanta System Sirius >ĂƐĞƌ^LJƐƚĞŵŵƵƐƚƵŶĚĞƌƐƚĂŶĚƚŚĞůĂƐĞƌƐƵŶŝƋƵĞƉƌŽƉĞƌƚŝĞƐƉƌŝŽƌ
to using the device.
x Before turning the laser system on, operating room personnel and the conscious/sedated patient
should wear protective eyewear suitable for 1.9 µm laser energy.
x Careful assessment of the target and surrounding tissue should be made, and appropriate power and
pulse duration should always be used.
x Use extreme caution until the biological interaction between laser energy and tissue is thoroughly
understood.
x As with conventional endoscopic surgery, the possibility of complications and adverse events (such as
chills, fever, edema, hemorrhage, inflammation, tissue necrosis or infection) may occur following
treatment. In extreme cases, death may occur due to procedural complications or concurrent illness.
The risk of infection and scarring associated with any surgical procedure has to be taken into account
as well. Therefore, appropriate pre- and postsurgical care should always be practiced.
x Tissue perforation may result if excessive laser energy is applied. This could occur through the use of
excessive laser power or the application of a correct power for excessive periods, particularly in
diseased tissue.
x Incorrect treatment settings can cause serious tissue damage; therefore, it is recommended that you
ƵƐĞƚŚĞůŽǁĞƐƚĂĐĐĞƉƚĂďůĞƚƌĞĂƚŵĞŶƚƐĞƚƚŝŶŐƐƵŶƚŝůLJŽƵŐĞƚĨĂŵŝůŝĂƌǁŝƚŚƚŚĞŝŶƐƚƌƵŵĞŶƚƐĐĂƉĂďŝůŝƚŝĞƐ
x Aim and use the laser only on tissues that are fully visible.
x The laser should be used only on tissues that are fully observable. Do not use the laser if the desired
target is not visible.
x Extra caution should be used when lasing tissue close to known arteries, nerves and veins.