LithoClast Select System VARIO Handpiece Directions for Use June 2015

COMPONENTS

COMPOSANTS

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Ultrasound Handpiece kit Ultrasound Handpiece 5 mm wrench 8 mm wrench Angled suction connector for combination use ultrasound / pneumatic Straight suction connector for ultrasound only use Electrical connector

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Protective sterilization cap for the electrical connector Protective cap for the Ultrasound Handpiece Ultrasound Probe

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Ensemble pièce à main à ultrasons Pièce à main à ultrasons Clés de 5 mm Clés de 8 mm Connecteur d’aspiration latéral pour l'utilisation combinée ultrasons / pneumatique Connecteur d’aspiration droit pour l'utilisation seule des ultrasons Raccord électrique

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Capuchon de stérilisation pour le raccord électrique Capot de protection de la pièce à main à ultrasons Broche à ultrasons

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Technical modifications

Modifications techniques

BSC reserves the right to modify the technique, accessories, operating instructions or contents of the set due to technical or scientific improvements.

BSC se réserve le droit d’apporter à la technique, aux accessoires, au mode d’emploi et au contenu de l’emballage d’origine, les modifications que la poursuite des développements techniques et scientifiques peut induire.

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DEAR CUSTOMERS, This Vario Ultrasound Handpiece is used with the Swiss LithoClast® Select System for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder. The Vario Ultrasound Handpiece is compatible with Swiss LithoClast® Select System control units equipped with software version "rel. 3.x". Control units having a previous version of software installed require an upgrade to enable controlling the Vario Ultrasound Handpiece.

Contraindications Use of the product is contra-indicated in patients with the following: • Active bleeding disorders • Solitary functioning kidney • Creatinine greater than or equal to 3 μg % • During pregnancy • Under the age of 18 • Stricture and obstruction problems • With an electrical stimulator implanted e.g. pacemaker Instructions concerning the specific components are provided separately in the relative Direction for use. Read the Directions for use delivered with each of the components before using the Swiss LithoClast® Select System. Do not hesitate to contact your BSC representative for further information.

PLEASE READ THIS BEFORE BEGINNING WORK! About this manual Note that the English version of this manual is the master from which translations derive. In case of any discrepancy, the binding version is the English text. These operating instructions are to ensure the correct installation and use of this product. Please read these operating instructions carefully as they explain all of the most important details and procedures. Please pay special attention to the safety precautions. Always keep this instruction close at hand. To prevent possible patient or user injury or damage to the Swiss LithoClast® Select System, please note the corresponding directives. Danger Risk of patient or user injury Caution Risk of damage to the device or environmental harm Please note Useful additional information and hints Prohibited Authorized

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CONTENTS Preparing for treatment...2 Assembly of the Vario Ultrasound Handpiece...2 Connecting the Vario Ultrasound Handpiece...4 Ultrasound Lithotripsy Mode...6 Combined ultrasound and pneumatic lithotripsy...8 Connecting the combined handpieces to the unit...12 Preparation...14 Application...16 Selection of lithotripsy mode...18 Change from combined ultrasound and pneumatic lithotripsy to ultrasound mode only...20 Operating the handpiece... 22 Cleaning, disinfecting and sterilizing...24 Preparation of the Ultrasound Handpiece for reprocessing...24 Preparation of the combination handpiece for reprocessing...26 Maintenance...32 O-ring...32 Safety precautions... 34 Storing the product... 36 Accessories... 36 Product warranty... 36 Warranty ... 36 Symbols... 38 Customer Service...40 Troubleshooting...40 Technical data...40

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PREPARING FOR TREATMENT Assembly of the Vario Ultrasound Handpiece

The equipment has been provided non-sterile and must be cleaned and sterilized before use, please refer to the "Reprocessing instructions" manual. The Ultrasound Probe must be tightened onto the Ultrasound Handpiece using the supplied wrench. Keep the wrench sterile. If the probe loosens during treatment, retighten the probe with the wrench. Even a slightly loose probe connection will cause a total loss of fragmentation performance. To thread the suction connector in properly, align it carefully with the handpiece and apply a light axial pressure while screwing it in place.

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Connecting the Vario Ultrasound Handpiece

The single use Stone Catcher device is provided sterile. Read the instruction manual delivered with it before performing installation. Connect the long tube of the sterile single use Stone Catcher device to the suction connector of the Ultrasound Handpiece. The electrical connector must be perfectly dry before connecting it to the unit.

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Ultrasound Lithotripsy Mode Preparation All components (including wrenches) are provided non sterile, therefore they must be sterilized and dried per the recommendations prior to assembly. In a sterile manner, attach the Ultrasound Probe to the front end of the handpiece with clockwise turns until finger tight, then securely fasten with the 5mm wrench. In a sterile manner, attach the straight suction connector to the back end of the handpiece with slight axial pressure and a ¼ clockwise turn. Once complete, connect the long end of the tubing from the disposable Stone Catcher device (packaged sterile) to the straight suction connector. Remove the protective sterilization cap and connect the plug of the Vario Ultrasound Handpiece to the control unit by aligning the red dots. The connector must be completely dry before attachment. Hand the Stone Catcher device off the sterile field and place the short portion of tubing from the Stone Catcher device into the pinch valve on the control unit. Also connect the roller clamp to the short tubing to help regulate the flow of suction. Once completed, place the canister in the Stone Catcher device Holder.

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Combined ultrasound and pneumatic lithotripsy Assembly of the Vario Ultrasound Handpiece for combined use with the Pneumatic Handpiece pn3

STERILE

The equipment has been provided non-sterile and must be cleaned and sterilized before use, please refer to the "Reprocessing instructions" manual. To thread the suction connector in properly, align it carefully with the handpiece and apply a light axial pressure while screwing it in place.

The Ultrasound Probe must be tightened onto the Ultrasound Handpiece by using the supplied wrench. Store the wrench sterile. If the probe loosens during treatment, retighten the probe by using the wrench. Even a slightly loose probe connection will cause a total loss of fragmentation performance.

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Adjust the length of the Pneumatic Probe by turning the wheel of the adjustment interface so that the tip of the Pneumatic Probe is flush with the tip of the Ultrasound Probe.

Both lithotripters work only in direct contact with calculi. The length adjustment of the Pneumatic Probe relative to the Ultrasound Probe is important, when using both lithotripters simultaneously.

If the Pneumatic Probe cannot be adjusted flush with the Ultrasound Probe, this indicates the wrong ultrasound / Pneumatic Probe combination is being used. Combination probes are marked by an identical ring pattern on the proximal shaft of both probes.

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Connecting the combined handpieces to the unit

The single use Stone Catcher device is provided sterile. Read the instruction manual delivered with it before performing installation. Connect the long tube of the sterile single use Stone Catcher device to the suction connector of the Ultrasound Handpiece. Both connectors must be perfectly dry before connecting them to the unit.

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PREPARATION The Vario Handpiece, Pneumatic Handpiece, Ultrasound Probe wrenches, the suction connectors, and Ultrasound Probes are provided non sterile, therefore they must be sterilized per the recommendations prior to assembly. The Pneumatic Probes and Stone Catcher devices are single use and provided sterile. In a sterile manner, attach the Ultrasound Probe to the front end of the handpiece with clockwise turns until finger tight, then securely fasten with the 5 mm wrench. Wrenches should be sterilized with handpieces per sterility guidelines. Attach the angled suction connector to the back end of the handpiece with slight axial pressure and a ¼ clockwise turn. Once completed, insert the Pneumatic Probe down the center lumen of the angled suction adapter, through the Vario Ultrasound Handpiece and Ultrasound Probe, then screw the Pneumatic Probe with clockwise turns into the angled suction adapter until finger tight.

Once the probe has been adjusted attach the long end of the tubing from the Stone Catcher device to the Vario Handpiece and then hand the Stone Catcher device off the sterile field. Place the short portion of tubing from the Stone Catcher device into the pinch valve on the control unit. Also connect the roller clamp to the short tubing to regulate the flow of suction. Once completed, place the canister in the Stone Catcher device Holder. Remove the protective sterilization caps. Connect the plug of the Vario Ultrasound Handpiece to the control unit by aligning the red dots and connect the pneumatic handpiece by just pushing the connector into the control unit. Both connectors must be completely dry before attachment.

Attach the pneumatic handpiece to the Pneumatic Probe with slight axial pressure and a ¼ clockwise turn until the probe ‘clicks’ into place. Once attached, adjust the white dial on the Pneumatic Probe to ensure the Pneumatic Probe is flush or even with the Ultrasound Probe. Clockwise turns move the Pneumatic Probe out and counter clockwise turn pull the Pneumatic Probe in.

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APPLICATION Coding system for the ultrasound and pneumatic probe sets

Set 330 mm serie

Set 403 mm serie

Ultrasound Probes

Pneumatic Probes

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Selection of lithotripsy mode The following table shows which Ultrasound Probe size and Pneumatic combination Probe size is used for various stone types and locations:

Lithotripsy Mode Stone Type

Ultrasound only

Pneumatic & Ultrasound combination

Hard kidney stones through percutaneous access (monohydrate, cystine stones)

Ultrasound probe: 3.3 mm or 3.8 mm Use ultrasound lithotripsy only for hard stones after initial fragmentation with the pneumatic / ultrasound combination (see directions for intraoperative change between combination handpiece setup and ultrasound only)

Ultrasound probe: 3.3 mm or 3.8 mm Pneumatic probe: 1.0 mm Pneumatic probe 1.3 mm (optional) for use with 3.8 mm Ultrasound Probe only

Soft kidney stones (struvite, matrix stones)

Ultrasound probe: 3.3 mm or 3.8 mm

Ureteral stones

Ultrasound probe: 1.5 mm

Hard bladder stones (monohydrate stones)

Ultrasound probe: 3.3 mm or 3.8 mm This method can be used for fragment removal following the pneumatic fragmentation

Soft bladder stones

Ultrasound probe: 3.3 mm or 3.8 mm

Small kidney stones

Ultrasound probe 1.9 mm for use with mini nephroscopes with 6 Fr. work channel size

Ultrasound probe: 3.3 mm or 3.8 mm Pneumatic probe: 1.0 mm Pneumatic probe 1.3 mm (optional) for use with 3.8 mm Ultrasound Probe only

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Change from combined ultrasound and pneumatic lithotripsy to ultrasound mode only

Disconnect the Pneumatic Handpiece from the control unit and attach the sterilization cap to the end of the hose.

Attach the straight connector to the Ultrasound Handpiece and attach the Stone Catcher device tubing to the straight connector.

Disconnect the Pneumatic Probe from the Pneumatic Handpiece by applying slight axial pressure and turning the handpiece ¼ turn counter clockwise.

It is necessary to change the angled suction connector with the straight suction connector.

Remove the angled suction connector and Pneumatic Handpiece from the Ultrasound Handpiece.

Always use the straight suction connector when working in ultrasound mode only.

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OPERATING THE HANDPIECE Do not touch the Ultrasound Probe when the ultrasound is activated. The ultrasound vibrations in the probes may cause instant burns by frictional heating. Danger of urothelial and mucosal perforation! There is a risk of injuring the mucosa of the kidney and bladder, which lies behind the stone. Always work under endoscopic visualization and keep the Pneumatic Probe tip flush with the Ultrasound Probe tip when using the combined modes. Fragments can block suction through the Ultrasound Probe. This will lead to a loss of the ultrasound suction capabilities and to heat-up of Ultrasound Probe and handpiece. Check at regular intervals that the suction is functional. The Ultrasound Handpiece and probe error detection is only possible when working with 100% "Duty cycle". Check that the suction connector is tight on the handpiece to maintain a good seal on the suction system.

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CLEANING, DISINFECTING AND STERILIZING Preparation of the Ultrasound Handpiece for reprocessing

Please conform to the recommendations of the Reprocessing Instructions manual delivered with your product regarding procedure of cleaning, disinfecting, packaging and sterilizing of the components. Please follow present day rules about sterilization applicable in your country.

Ensure sterilization cap is connected to each hose before processing. If the Ultrasound Probe is hard to untighten from the handpiece, use the 5 mm wrench and the 8 mm wrench as shown to unlock.

The handpiece must be fully disassembled for each sterilization. 24

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Preparation of the combination handpiece for reprocessing

Please conform to the recommendations of the "Reprocessing Instructions" manual delivered with your product regarding procedure of cleaning, disinfecting, packaging and sterilizing of the components. Please follow present day rules about sterilization applicable in your country.

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The Ultrasound Handpiece must be fully disassembled for each sterilization.

If the probe has become too tight during the course of the procedure then disconnect the distal protective cap by screwing counter clockwise. Then use the 8 mm wrench to provide counter tension to allow the probe to be loosened and removed.

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Please proceed as follows for proper disassembly of the handpieces. Ultrasound Lithotripsy Mode At the end of the procedure disconnect the Vario Ultrasound Handpiece from the control unit and attach the sterilization cap to the end of the hose. Also remove the suction tubing from the pinch valve, disconnect the suction tubing from the Stone Catcher device, and disconnect the Stone Catcher device tubing from the Vario handpiece. Remove the Stone Catcher device cap with the tubing and replace with the Yellow protective cap so stones can be sent for analysis. Dispose of the remaining Stone Catcher device parts per hospital protocol. Disconnect the Ultrasound Probe from the Vario Handpiece using the 5mm wrench. If the probe has become too tight during the course of the procedure then disconnect the distal protective cap by screwing counter clockwise. Then use the 8 mm wrench to provide counter tension to allow the probe to be loosened and removed. Disconnect the straight suction connector from the back end of the Vario Handpiece. Always ensure the protective sterilization cap is on the end of the hose before reprocessing.

Pneumatic Lithotripsy Mode At the end of the procedure disconnect the Pneumatic Handpiece from the control unit and attach the sterilization cap to the end of the hose. Disconnect the Pneumatic Probe from the Pneumatic Handpiece by applying slight axial pressure and turning the handpiece ¼ turn counter clockwise. Dispose of the probes after use.

Combination Ultrasound and Pneumatic Lithotripsy Mode At the end of the procedure disconnect both the Pneumatic Handpiece and the Vario Handpiece from the control unit and attach the sterilization cap to the end of each hose. Disconnect the Stone Catcher device tubing from the Vario handpiece. Remove the Stone Catcher device cap with the tubing and replace with the Yellow protective cap so stones can be sent for analysis. Disconnect the Pneumatic Probe from the handpiece by applying slight axial pressure and turning the handpiece ¼ turn counter clockwise. Dispose of the remaining Stone Catcher device parts per hospital protocol. Unscrew the Pneumatic Probe from the Vario Handpiece and dispose of. Do not disconnect the air supply tubing from the Pneumatic Handpiece for reprocessing. Disconnect the Ultrasound Probe from the Vario Handpiece using the 5mm wrench. If the probe has become too tight during the course of the procedure then disconnect the distal protective cap by screwing counter clockwise. Then use the 8 mm wrench to provide counter tension to allow the probe to be loosened and removed. Disconnect the angled suction connector from the back end of the Vario Handpiece. Never disconnect the air supply tubing from the Pneumatic Handpiece for reprocessing. Always ensure the protective sterilization cap is on the end of the hose before reprocessing. Handpiece damage will occur if moisture enters the handpiece interior.

Never disconnect the air supply tubing from the Pneumatic Handpiece for reprocessing. Always ensure the protective sterilization cap is on the end of the hose before reprocessing.

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MAINTENANCE O-ring

If the O-ring is damaged or worn out, it must be replaced immediately. Change the O-ring or replace the suction connector.

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