ROCAMED MH01 - Urinary Lithotripsy Clinical Parameters; Ent - General Surgery - Gastroenterology - Arthroscopy

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NOTE-MH01-EN rev05
- Sub-pelvine stenosis
- Loss of kidney
- Open revision
Complications for Urology
Read “General laser complications 6.2.3.” for a list of additional complications.
6.4.5 Urinary Lithotripsy Clinical Parameters
Pre-clinical and clinical testing has demonstrated that urinary calculi can be safely and
effectively fragmented starting from power settings of 0.5 or 0.6 Joules and at a frequency
of 5 or 6 Hertz. The use of high power output settings requires special attention, especially
when the fiber tip is in close proximity to the ureteral walls in order to avoid the perforation
of the ureter.
For effective fragmentation, the tip of the optical fiber should be directly in contact with
the stone. Whenever possible, laser energy should be directed at the side of, or at
weaknesses in the stone. The stone should be progressively reduced in size by slowly
removing small fragments. Continuous irrigation should be used to wash away stone
fragments and to provide cooling of the treatment site. The following table shows
recommended pulse energy, repetition rate and average power for endoscopic
fragmentation of urinary calculi. The use of higher power settings should be avoided,
especially when the fiber tip is in close proximity to the ureteral wall, as perforation of the
ureter may result.
Urinary Lithotripsy – Recommended Treatment Clinical Parameters
2
Application
Pulse Energy
(Joules/Pulse)
Repetition Rate
(Hertz)
Average
Power (Watts)
Recommended
Fiber Size
Bladder Calculi
0.5 – 2
3 – 12
7 – 20
550 – 1000 μm
Ureteral Calculi
0.5 – 1
3 – 20
3 – 15
272 – 550 μm
Renal Calculi
0.5 – 1.2
5 – 12
3 – 15
200 – 272 μm
PCNL
0.8 – 2.5
3 - 12
7 – 25
365 – 1000 μm
Note
Laser settings are guidelines only; always start with low settings and increase to achieve
the desired tissue effect. Energy delivered endoscopically in a fluid medium.
Use the Lithotripsy Dusting Effect Mode in order to minimize the size of fragments.
6.5 ENT – General Surgery – Gastroenterology –
Arthroscopy
MH01 laser system and its fiber optic delivery system are intended for use in surgical
procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation,
vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including:
Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, ENT and General
Surgery.