Swiss LithoClast® Select

The Versatility and Reliability of Standard LithoClast and More

Four sizes of rigid pneumatic probes for use in the kidney, ureter and bladder
The FlexProbe® Flexible Probe is designed for use through flexible endoscopes

Newly Designed Vario Ultrasound Handpiece: Designed to Treat all types of urinary stones.

Designed to switch from combined ultrasound/ pneumatic mode to ultrasound only mode within seconds
Decreased size and 28% lighter weight designed for more comfort and convenient handling

Faster Stone Clearance – Less Blockings

New suction adapter angle designed to improve clearance

Stone Catcher Device: Designed to reduce setup time

Pre-assembled specimen retention system

Latex Information

This product contains no detectable latex.

Ordering Information- Swiss Lithoclast Select System Kit

Order Number	Description	Size	Quantity
M006840300K0	Swiss Lithoclast Select System	N/A	Each
M0068403020	Swiss Lithoclast Select Directions for Use	N/A	Each
M0068403030	Swiss Lithoclast Select Error Message Laminate	N/A	Each
M0068403040	Vario Ultrasound Handpiece Kit	N/A	Each
M0068407030	Foot Pedal	N/A	Each
M0068407060	Stone Catcher Holder	N/A	Each
M0068407070	Compressed Air Tube – 3m	N/A	Each
M0068407080	Power Cord	N/A	Each
M0068407090	Spare Fuses	N/A	Each
M0068407200	Pneumatic Handpiece Kit	N/A	Each

Ordering Information - Stone Catcher

Order Number	Description	Size	Quantity
M0068407501	Stone Catcher with Tubing and Adapter	N/A	Each

^{FlexProbe is a registered trademark of EMS.}

^MVO630

Ordering Information - Pneumatic Probes

Order Number	Description	Size	Quantity
M0068407310	Disposable Pneumatic Probe	0.8 mm x 668 mm	Each
M0068407320	Disposable Pneumatic Probe*	1.0 mm x 497 mm	Each
M0068407330	Disposable Pneumatic Probe*	1.0 mm x 570 mm	Each
M0068407350	Disposable Pneumatic Probe	1.6 mm x 453 mm	Each
M0068407370	Disposable Pneumatic Probe	2.0 mm x 425 mm	Each
M0068407390	Flexible Ureteroscopy Probe	.089 mm x 940 mm	Each
*Designed for use with Ultrasound Probe

Ordering Information - Ultrasound Probes

Order Number	Description	Size	Quantity
M0068407140	Swiss LithoClast Ultrasound Probe	3.3 mm x 330 mm	Each
M0068407150	Swiss LithoClast Ultrasound Probe	3.8 mm x 330 mm	Each
M0068407160	Swiss LithoClast Ultrasound Probe	3.3 mm x 403 mm	Each
M0068407170	Swiss LithoClast Ultrasound Probe	3.8 mm x 403 mm	Each

Ordering Information - Wrenches

Order Number	Description	Size	Quantity
M0068403180	Vario Ultrasound Handpiece 5mm Wrench	N/A	Each
M0068403050	Vario Ultrasound Handpiece 8mm Wrench	N/A	Each

Ordering Information - Pneumatic Handpiece Accessories

Order Number	Description	Size	Quantity
M0068407280	Pneumatic Handpiece Tube with Q-connect (3M)	N/A	Each
M0068407290	Pneumatic Handpiece Shipping Case	N/A	Each

Ordering Information - Vario Handpiece Suction Connectors

Order Number	Description	Size	Quantity
M0068403060	Angled Suction Connector – Stone Catcher	N/A	Each
M0068403070	Straight Suction Connector – Stone Catcher	N/A	Each
M0068403160	Angled Suction Connector – Suction Tubing	N/A	Each
M0068403170	Straight Suction Connector – Suction Tubing	N/A	Each

Ordering Information - Vario Handpiece Accessories

Order Number	Description	Size	Quantity
M0068403220	Vario Ultrasound Handpiece Shipping Case	N/A	Each
M0068403240	Hose Sterilization Cap	N/A	Each
M0068403190	Vario Ultrasound Distal Protective Cap	N/A	Each
M0068403200	Vario Ultrasound Handpiece O-Ring	N/A	Each
M0068403210	Straight Suction Connector O-Ring	N/A	Each
M0068403110	Vario Ultrasound Handpiece Quick Table	N/A	Each

Prescriptive Information

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.

Indications

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

Federal (USA) law and governing law outside the USA restrict these devices to sale by or on the order of a physician.

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.

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.
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.
This product must be used only by trained and qualified personnel.

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.

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.