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DGM001519.01 UM Sirius CE/ROTW
General Laser Precautions
x Use caution with patients who have had difficulty with previous endoscopic procedures.
x Electrocautery and/or suture (ligature) should be easily accessible in the event that a bleeding artery or
vein is too large to be coagulated by laser.
x Use caution when treating patients who have recently undergone radiotherapy. Such patients may be
at greater risk of tissue perforation or erosion.
x Discontinue laser treatment immediately if the patient develops any cardiopulmonary problem.
x Quanta System has no clinical information concerning the safety of laser treatment on pregnant or
nursing women.
x Refer to the delivery system instruction guide for use instructions.
Urology precautions and warnings
x Care should be exercised so as not to over distend the bladder when using the laser endoscopically.
Excessive bladder distension could result in coagulative necrosis of the superficial and inner muscular
region of the bladder wall.
x Extra precautions should be taken when radiation therapy and laser therapy have to be carried out
concurrently, including more stringent post-operative monitoring. Clinical studies have shown that
patients who have undergone radiation therapy present a greater risk of perforation or tissue erosion.
x To avoid the potential risk of endoscope ignition or damage from the treatment beam or treatment
beam backscatter, it is recommended that the fiber protrudes 4 to 6 mm beyond the distal port of the
endoscope so it is fully in the visual field.
x Use of lower power levels and shorter exposure times are required in order to prevent thermal damage
to underlying structures (e.g. to thin-walled structures such as the bladder).
x WůĞĂƐĞĨƵƌƚŚĞƌƌĞĨĞƌƚŽƚŚĞƐĞĐƚŝŽŶTreatment parameters and instructions for Endoscopic Procedure
for additional information regarding endoscopic surgery in urology field.
Precautions and warnings in other medical specialties
Thoracic and Pulmonary Surgery
It is suggested not to overcome a 40W output emission during lung resection (or at least to be extremely
careful when doing so).
Lithotripsy
x The laser should be used with an optical fiber delivery system in direct view and in direct contact with
the targeted ureteral stone. To minimize the potential migration up to the ureter, laser energy should
be directed to the side of the stone, if possible, rather than the leading edge. Maintaining low energy
levels and repetition rates will reduce the potential for possible stone migration.
x Be aware of edematous folds of epithelium that may lie between the optical fiber and the stone.
x Basketing may be used with larger stone fragments that are relatively hard or tend to escape to the
ureter in a retrograde fashion.
x Baskets, guide wires, and other endoscopic accessories may be damaged by direct contact with the
laser beam.
x The use of irrigation is recommended throughout the lithotripsy procedure to absorb any produced
heat, to carry stone fragments out of the urinary system, and to enhance direct visualization. The rate
of irrigation should be carefully adjusted to avoid flux of calculi into the kidney.
Other medical specialties:
Please refer to General Laser Warning and General Lasr Precautions for additional information
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