Prescriptive Information
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Please refer to the Directions for Use provided with the product for complete instructions for use, contraindications, warnings and precautions.
DEVICE DESCRIPTION
The Swiss LithoClast Select System is a combination ultrasonic and pneumatic urological lithotripter. Use for the intended purpose only.
INTENDED USE / INDICATION FOR USE
The Swiss LithoClast Select System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
CONTRAINDICATIONS
Use of the product is contraindicated in patients with the following:
- Active bleeding disorders
- Solitary functioning kidney
- Creatinine greater than or equal to 3 μg %
- During pregnancy
- Stricture and obstruction problems
- With an electrical stimulator implanted e.g. pacemaker.
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.
PRECAUTION
Boston Scientific (distributor) or EMS (manufacturer) assumes no liability for direct or consequential injury or damage resulting from improper use, arising in particular through non-observance of the operating instructions, or improper preparation and maintenance.
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Read this instruction manual before using this device. This
product may only be applied for its intended use by qualified personnel and for the applications described in this manual. If the unit is used in combination with other instruments, please refer to their instruction.
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Before using the product, make sure the operating instructions have been carefully studied. This also applies to any equipment used with this product. Failure to observe the operating instructions may result in the patient or user suffering serious injury or the product being damaged.
Risk of explosion: Do not use this product in the presence of
inflammable anaesthetics or gases.
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This product must be used only by trained and qualified
personnel.
- Always examine the product for damage before commencing treatment. Damaged accessories or a damaged unit must not be used and must be replaced. Use original Swiss LithoClast Select System spare parts and accessories only.
- Proper care and maintenance are required to ensure safe
operation of medical devices. Therefore it is recommended that devices and instruments be checked regularly for proper functioning and completeness, upon receipt and prior to each application, to prevent injury to patients and users.
- Product repairs are to be executed exclusively through Boston Scientific. After any repair or modification, the technical safety of the device and accessories must meet the corresponding standard applicable for such equipment. Each repair, modification or test must be recorded in a report.
- Before each use, always clean, disinfect and sterilize the different pieces and accessories of this product. Please refer to the information provided in the "Reprocessing Instructions" manual delivered with your product. Non-sterile pieces and accessories may cause bacterial or viral infections.
