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DGM001519.01 UM Sirius CE/ROTW
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This section could help physicians in the use of the Sirius laser system. It adds or reinforces information
presented in this User Manual about instructions for use, precautions and warnings necessary to reduce the risk
of injury.
The following information must be considered as guidelines only, that do not replace the clinical knowledge
of the surgeons. All operators must read the entire User Manual before reviewing this section and before
operating the system.
Intended Use
Sirius laser is intended solely for use by surgeons and staff who have been appropriately trained and who are
thoroughly familiar with the instructions and safety precautions provided in this manual. A review of the
published literature is strongly encouraged and recommended.
The Sirius laser device and its accessories are intended for use in surgical procedures using open, laparoscopic
and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue
and lithotripsy of stones in use in medical specialties including: Urology, Thoracic and Pulmonary, ENT,
Neurosurgery, Gastroenterology, Gynecology and General Surgery.
Note
dŚĞƵƐĞŽĨĂůĂƐĞƌŝŶƐƚƌƵŵĞŶƚĨŽƌĂŶĂƉƉůŝĐĂƚŝŽŶŝƐĂƚƚŚĞƉŚLJƐŝĐŝĂŶƐĚŝƐĐƌĞƚŝŽŶĞdžĐĞƉƚŝŶĐĂƐĞƐǁŚĞƌĞƚŚĞŝŶĚŝĐĂƚŝŽŶ
has been contraindicated.
Physicians should frequently consult current literature and information provided in advanced workshops to keep
abreast of the most effective and up-to-date practices.
Urology:
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)
including:
x Urethral Strictures
x Bladder Neck Incisions (BNI)
x Ablation and Resection of Bladder Tumors, Urethral and Ureteral Tumors
x Transurethral Incision of the Prostate (TUIP)
x Laser Resection of the Prostate
x Laser Enucleation of the Prostate
x Condylomas
x Lesions of external genitalia
x Urinary Lithotripsy
Thoracic and Pulmonary:
Open, laparoscopic and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation,
vaporization, coagulation and hemostasis) of soft tissue, including:
x Laryngeal lesions
x Airway obstructions including carcinoma
x Palliation of obstructing carcinoma of the tracheobronchial tree
x Lung Resection
ENT:
Endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft
tissue) including:
x Sialolitiasis
x Endonasal/sinus Surgery
x Partial turbinectomy
x Polyps
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