WARNINGS
Danger of urothelial and mucosal perforation! Due to the
tendency of the ultrasound probe to perforate the stone rather than
fragment it, there is a risk of injuring the mucosa of the kidney and
bladder behind the stone. During the entire treatment, the user must
keep the probe tips under endoscopic view (the probe tip is extended
10-20 mm beyond the endoscope tip).
Do not apply pressure with the distal part of the probes against
tissues as damage to tissue or perforation could occur. Use particular
caution with thin probes.
Do not touch the ultrasound probe when ultrasound is activated.
The ultrasound vibrations of the probes may cause heat and instant
burns.
The user's hand may have a tendency to push forward under
the influence of the repeated pneumatic pulses. This tendency must
be corrected by the user who will continuously control the relative
position of the probe to reduce risks of perforations.
When using the unit in multiple pulse mode, be sure to check the
progress of fragmentation and the probe position on a frequent basis
(every 1 to 2 seconds).
Sterile backup ultrasound and pneumatic lithotripsy probes must be
available in the event of a probe failure during treatment.
If a probe breaks distally, use sterile grasping forceps to remove probe
pieces from the urinary tract.
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POST-TREATMENT PROCEDURE
Emptying of suction tubes and Stone Catcher device
•
Remove the silicone tubing of the Stone Catcher device from
the pinch valve,
•
Suck air in to empty the suction tubes,
•
Tilt the Stone Catcher device in order to empty the receptacle
by suction.
Elimination or conservation of Stone Catcher device content
•
If fragments are not to be kept for analysis, dispose of the stone
fragments per hospital protocol.
•
If the fragments are to be kept, close the receptacle with the
yellow transport closing cap.
6/3/2015 2:33:54 PM