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DGM001519.01 UM Sirius CE/ROTW
Warning: The user must understand that the greater the increase of settings, the greater the additional
energy released (along with fluid heating risk of injury risk).
Use small pulse energy in order to minimize the size of fragments.
Consider using a shorter pulse duration in case of harder stones.
Use short pulse duration and high pulse energy in order to maximize the speed of fragmentation
Warning: In general, when performing endoscopic stone lithotripsy, it is recommended to start with a minimum
power setup. High power setting (<20-30W) should be used with caution.
&ƵƌƚŚĞƌ ƌĞĨĞƌ ƚŽ dƌĞĂƚŵĞŶƚ ƉĂƌĂŵĞƚĞƌƐ ĂŶĚ ŝŶƐƚƌƵĐƚŝŽŶƐ ĨŽƌ ŶĚŽƐĐŽƉŝĐ WƌŽĐĞĚƵƌĞƐ ƐĞĐƚŝŽŶ ĨŽƌ ĂĚĚŝƚŝŽŶĂů
information.
Treatment parameters and instructions for open surgery & laparoscopic procedures
Before firing the laser, the aiming beam and fiber tip must be clearly visible and directed towards the targeted
tissue. Direct the aiming beam towards the tissue you intend to treat. Never fire the laser unless you can see
the aiming beam on the targeted tissue. Use of a surgical handpiece is recommendable when manipulating the
fiber.
Caution: when firing, fiber tip must protrude from equipment operative channel (e.g. handpiece
cannula). Damage to fiber or device operative channel could result when operators do not comply with
this provision.
DO NOT START LASERING AT MAXIMUM POWER. In open surgery or in laparoscopic procedures (with the
fiber tip non-submerged in water solution) begin the procedure at a lower power (5-10W) and
increase the power until desired tissue effect is achieved. Do not adjust the power of the laser until the
effect of the laser on the tissue has been evaluated.
When using the laser in open surgery or in laparoscopic procedures with the fiber tip submerged in water
solution, it may be reasonable to increase the output power (with respect to a similar endoscopic situation
without irrigant presence) and adjust the power according to the observed effect. Indeed, part of the emitted
energy will be absorbed by the liquid in between of fiber tip and targeted tissue.
In open surgery a maximum output power equal to 40W is recommendable.
It is recommendable to use the fiber in non-contact with the tissue (distance from 1mm).
N.B.: Maximum device power (60W) must be used with extreme caution and exclusively when the user is fully
acquainted with the Sirius device and laser surgery within that specific field. Use of high power settings should
be limited to treatment of large organs / tissue portions only (e.g. in lung resection) and its use is under the
responsibility of the operator based on his best medical knowledge.
Warning: When the fiber is firing in contact with the tissue 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.
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 keeping
the same distance from the tissue.
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