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DGM001519.01 UM Sirius CE/ROTW
Treatment Parameters and Instructions
The Sirius and its accessories are surgical devices 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 about laser use. No claim is made about the certainty of treating successfully any
medical condition by laser.
All users and support staff must have thorough knowledge of its operation and its effects. Users should get
acquainted with this manual and with the device in a non-clinical setting before using it for patient treatment in
a clinical situation.
BEFORE operating the laser system, surgeons and all staff operating the laser should carefully read this User
Manual. Please use major attention to the General Warning of Section 2 (Laser Safety) and Section 6 (Clinical
Applications).
The Sirius is a Laser System emitting an invisible infrared beam at 1.9 µm wavelength. This laser beam is strongly
absorbed by water (chromophore) which is ubiquitous in all tissues. Thus, the speed of cutting and vaporization
action will remain relatively constant regardless of tissue vascularization.
Treatment parameters and instructions for endoscopic procedures
Before firing the laser, both aiming beam and fiber tip must be clearly visible through the endoscope. The aiming
beam must be directed towards the targeted tissue.
Illuminate the tissue you wish to treat with the aiming beam. Never fire the laser unless you can see the aiming
beam on the targeted tissue.
Caution: Fiber tip must protrude from endoscope when firing. Fiber or endoscope damage could
result when operators do not comply with this provision.
DO NOT START LASING AT MAXIMUM POWER. Begin the procedure with a low power and regulate the output
power until the desired tissue vaporization/ablation/coagulation effect is achieved. Do not adjust laser power
until the effect of the radiation on the tissue has been evaluated.
In endoscopic surgery within water-filled large environments (as in BPH procedure), it is possible to use the
maximum output power (60W). It is possible to use the fiber in contact with the tissue.
If the fiber tip is submerged in water (e.g. endoscopic incision/ablation of soft tissues in urology treatments), it
is possible to use the fiber in contact with the tissue. Conversely, if this condition does not apply, some tissue
may remain attached to fiber tip upon ablation/cutting when in contact with the tissue. Thus, where/when
possible, a near-contact (small distance) approach should be preferable in this case.
Warning: When the fiber is firing in contact with no liquid in between of fiber tip and target
tissues or is deepened into that, the user should fire with extreme caution as the interaction between
laser and tissue is not (or only partially) visible. Wrong evaluation of ongoing process may result in
unwanted tissue damage or perforation.
Ablation/Vaporization effect decreases when the distance between fiber tip and the tissue increases. On the
contrary, Coagulation effect increases when the distance between fiber tip and tissue increases.
Depending on the environment where the surgical procedures is being carried out, different treatment
recommendations apply:
o Water-surgery in large cavities: When using the laser in water (as the surgical irrigation solution) within large
cavities (as in bladder during BPH treatment) it is recommended to start ablation or cutting at 30W and adjust
the power according to the observed effect. If bleedings are found, coagulate the tissue surrounding the
bleeders; the surgeon may choose to defocus the laser energy by increasing the distance between tissue and
fiber tip or by decreasing the laser power.
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