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DGM001519.01 UM Sirius CE/ROTW
o Water-surgery in small cavities/channels: Conversely, when using the laser in water (as the surgical irrigation
solution) within small cavities or narrow channels (as in ureter), it is recommended to start ablation or
vaporization at 5-10W 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.
o Other endoscopic procedures: When using the laser endoscopically, without any fluid in between of fiber tip
and targeted tissue, 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. It is recommendable to use the fiber in non-contact with the tissue (distance from 1mm). If tissue
adheres to the fiber tip, the fiber has to be extracted from the endoscope so that the tissue can be removed.
For information and warnings regarding smoke formation, hemostasis and interaction with tissue, the same
indications reported for laparoscopic procedures apply.
Warning for BPH treatment: Use caution when treating tissue at the bladder neck to avoid incidental injury to
the bladder wall and/or ureteral orifices. Similarly to any endoscopic prostate procedure involving tissue
removal (including TURP, HoLEP, HoLAP or PVP), possibility of capsular perforation does exist. To minimize the
risk of capsule perforation, it is important to recognize the end point of the procedure. The fiber has to be kept
moving, without directing laser energy towards a fixed site for a prolonged time
When the treatment area is not filled with water, as the output power increases the smoke formation process
increases. The treatments in endoscopic surgery could cause smoke formation and hinder dramatically field
visibility (similarly to electro-ablative surgical tools), therefore the surgeon shall evaluate the use of a smoke
evacuator system (if possible) or the use of water injection in the area of treatment to dissipate the smoke.
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 prostate surgery
and lung resection) and its use is under the responsibility of the operator based on his best medical
knowledge.
Damage to Endoscope:
The Sirius can cause significant damage to the endoscope. Damage will occur if the laser is activated while the
laser fiber is aimed towards the endoscope or while the aiming beam is directed towards the inside of the
endoscope.
ĂŵĂŐĞƚŽĞŶĚŽƐĐŽƉĞƐŽƵƚĞƌƐŚĞĂƚŚŵĂLJĐĂƵƐĞƌŽƵŐŚŽƌƐŚĂƌƉƐƉŽƚƐŽŶƚŚĞƐŚĞĂƚŚǁŚŝĐŚŵĂLJďĞƚƌĂumatic to
ƚŝƐƐƵĞƐĂŵĂŐĞƚŽƐĐŽƉĞƐŝŶŶĞƌƐŚĞĂƚŚĐŽƵůĚĐƌĞĂƚĞƐŚĂƌƉƉŽŝŶƚƐŽƌƌŝĚŐĞƐƚŚĂƚŵĂLJĚĂŵĂŐĞƚŚĞĨŝďĞƌĂŶĚ
result in premature fiber degradation or failure.
To avoid damage to the endoscope, please be sure that the blue shell of the fiber is visible at all times.
Clinical Parameters for Soft Tissue in Urology
The thulium wavelength provides effective haemostasis without damaging surrounding or non-targeted tissues.
Coagulation can be achieved by reducing the energy or power density over the vascularized tissue or by
increasing the distance between fiber tip and point of bleeding.
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