LithoClast Select System Directions for Use June 2015

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DEAR CUSTOMERS, The Swiss LithoClast® Select System is a combination ultrasonic and pneumatic urological lithotripter used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder. These operational instructions are applicable only for control units equipped with software version "rel. 3.x", which includes the Swiss LithoClast® Select System and the Swiss LithoClast® Ultra Upgraded System. The software version is displayed when the control unit is turned on. Prior to use, please verify that "rel. 3.x" is shown briefly on the display panel. Please note that units with software "rel. 3.x" are hereafter referred to as the "Swiss LithoClast Select System". 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 • Under the age of 18 • Stricture and obstruction problems • With an electrical stimulator implanted e.g. pacemaker. Potential Complications: Potential complications associated with fragmentation of urinary tract calculi by pneumatic and/or ultrasound energy are: • Perforation • Hemorrhage • Lesion • Stone migration • Pain/colic • Macroscopic hematuria • Infection • Ureteral obstruction Instructions concerning the specific components (handpieces, probes) are provided separately. Read the instruction manual delivered with each of the components before using the Swiss LithoClast® Select System. Do not hesitate to contact your BSC representative for further information.

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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. Always keep this instruction close at hand. Please read these operating instructions carefully as they explain all the most important details and procedures. Please pay special attention to the safety precautions. This instruction manual describes combined ultrasonic and pneumatic lithotripsy, as well as ultrasonic or pneumatic lithotripsy application modes.

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 Installation...3 Connections...3 Electrical Safety precautions...3 Disposable Stone Catcher device...4 Operating the unit...6 Suction control...6 Ultrasound lithotripsy...8 Preparation...8 Ultrasound power...10 Duty cycle...10 Activation...10 Pneumatic lithotripsy...12 Preparation...12 Pulse modes...14 Pulse frequencies ...14 Pneumatic power...14 Activation...14 Ultrasound and pneumatic combined lithotripsy mode...16 Preparation...16 Endoscopy...18 Treatment recommendations...20 General...20 Recommended settings...20 Selection between individual and combined modes... 22 Warnings...24 Post-treatment procedure...24 Cleaning, disinfecting and sterilizing...26 Preparation and cleaning...26 Handpieces and accessories...26

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Maintenance...28 Fuses replacement ... 30 Safety precautions...32 Storing of the product... 34 Accessories... 34 Product warranty... 34 Warranty ... 34 Customer Service... 36 Electromagnetic compatibility... 36 Symbols... 38 Technical data... 44 Troubleshooting... 46

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INSTALLATION

INSTALLATION

Clean, disinfect and sterilize all the components before first use and after all subsequent uses as described in the "Reprocessing Instructions" manual. Assemble the application parts under sterile conditions.

Nettoyez, désinfectez et stérilisez tous les composants avant la première mise en service et après toutes les utilisations suivantes comme décrit dans le manuel "Reprocessing Instructions". Assemblez les pièces de service dans des conditions stériles.

Perform function testing according to the directions for use supplied with the respective accessory. Do not cover the unit. Leave a free space of at least 5 cm around the device for cooling.

CONNECTIONS

Connect the power supply cord to the unit. To prevent damage to the unit, check that its rated voltage meets the local line voltage. Connect only to a FI protected main supply (FI = Residual current protection).

Exécutez le test de bon fonctionnement selon les instructions du mode d’emploi fourni avec les accessoires. Ne pas recouvrir l’appareil. Prévoir un espace de 5 cm autour de l’appareil pour assurer le refroidissement.

BRANCHEMENTS

Be sure that the connectors are perfectly dry before making the connection. To disconnect, pull only the connector sleeve; never pull on the cord itself.

Connectez le cordon d’alimentation électrique à l’appareil. Pour éviter d’endommager l’appareil, vérifiez que sa tension nominale correspond bien à la tension secteur disponible. Connectez l’appareil uniquement à une prise protégée par un interrupteur différentiel (protection FI). Connectez le raccord rapide du tube à air comprimé à l’appareil, en poussant le raccord jusqu’au clic. Utiliser uniquement de l’air comprimé sec, pur, et filtré à 5 µm au moins. Cet air comprimé peut être délivré par: • le réseau central de distribution d’air comprimé (prise murale), • un compresseur séparé, • une bouteille d’air comprimé (ISO 7396). Connectez le cordon de la pédale de commande à l’appareil. Prendre garde à l’orientation du raccord et visser l’écrou de blocage. Veuillez vous assurer que les connecteurs soient parfaitement secs avant de faire les connexions. Pour la déconnexion, tirer uniquement la bague du raccord mais en aucun cas sur le cordon lui-même.

When applicable connect the equipotential plug to other medical devices used.

Si applicable, brancher la prise équipotentielle aux autres appareils médicaux utilisés.

Connect the quick connector of the compressed air tube to the unit, by pushing the connector until it clicks on. Use only medical-quality, dry compressed air, filtered at a minimum of 5 µm. This supply of compressed air can be either: • the central compressed air supply system (wall socket) • a separate compressor • a cylinder (ISO 7396) Connect the foot pedal cord to the unit. Pay attention to the connector orientation and fasten the securing nut.

Electrical Safety precautions To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. No modification shall be made on this product.

Remarques concernant la sécurité electrique Pour éviter le risque de choc électrique, cet équipement doit seulement être connecté au réseau électrique muni d’une liaison terre. N’apportez aucune modification sur cet appareil.

The main switch of the unit must be accessible at any time.

L’interrupteur principal de l’appareil doit être accessible à tout moment.

When the main switch is on the "0" position, the unit is disconnected from the supply network.

Lorsque l’interrupteur principal est sur position "0", l’appareil est 3 déconnecté du réseau électrique.

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Disposable Stone Catcher device

The disposable Stone Catcher device is provided sterile. Read the instruction manual delivered with it before performing installation. Connect the short silicone tubing end with the conical connector to the external suction source. The pinch valve default state is closed and opens when the ultrasound (left) foot pedal is depressed halfway. Install a roller clamp on the suction tubing to enable control of the suction flow independently of the lower pressure.

Stone Catcher device tubing The use of other tubing than the one supplied with the Stone Catcher device can either create an incomplete occlusion of the tubing in the pinch valve, or the tubing can collapse during use. Use only the Stone Catcher device tubing provided by BSC. The suction tube (standard suction tubing with 3 m length and 5 mm internal diameter) must be sterile and single use. Use of a transparent tubing allows for observation of fragment transport to visualize a possible obstruction.

The sterile disposable Stone Catcher device cannot be reprocessed. 4

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OPERATING THE UNIT Suction control Recommendations on suction settings for lithotripsy using BSC handpieces and probes are provided separately. Suction flow can be adjusted by using the roller clamp on the suction tubing. Excessive suction can impair the endoscopic view, collapse the organ, or damage the mucosa. Always check that the suction tubing is inserted into the pinch valve and that the pinch valve is functioning properly. Make sure that suction is always operational. Continuous suction during ultrasound lithotripsy is required to evacuate fragments and liquids as well as to ensure the cooling of the probe and the handpiece. Interruption of the suction must be avoided. It is operator’s responsibility to continuously monitor the suction flow to check that it is operational and that the level of lower pressure is correctly set. Fragments blocked in the lumen of the probe and the handpiece may lead to loss of suction and heating of the probe. If blockage occurs, stop lithotripsy to remove fragments from the probe and from the handpiece lumen before continuing.

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ULTRASOUND LITHOTRIPSY Preparation

CLICK!

Please refer to the Ultrasound Handpiece Directions for use for handpiece preparation and assembly details. Never connect a partially assembled handpiece to the control unit.

The cumulative ultrasound usage time (seconds/hours) is displayed briefly on the left display when the unit is turned on.

Be sure that the control unit is off while connecting the handpiece. The Standby/On button light will turn orange 5 seconds after turning on the unit. Press the Standby/On button to start the corresponding mode.

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Ultrasound power The left rotary knob is used to adjust the ultrasound power from 10 % to 100 % (in 10 % increments).

Duty cycle The duty cycle is the ratio between ultrasound ON and ultrasound OFF over an interval of time of 80 milliseconds. Set the duty cycle using the arrow keys. The last setting of the duty cycle is kept in memory at power off. The handpiece and probe error detection is possible only with a duty cycle set at 100 % (see Troubleshooting chapter).

Activation • •

Press the ultrasound (left) foot pedal halfway to activate the suction (pinch valve opens). Press the ultrasound (left) foot pedal completely to activate the ultrasound handpiece and probe with suction.

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PNEUMATIC LITHOTRIPSY Preparation

Refer to the Pneumatic Handpiece Directions for use for handpiece preparation and assembly details. Never connect a partially assembled handpiece to the control unit.

The cumulative number of pulses is displayed briefly on the right display when the unit is turned on.

Be sure that the control unit is off while connecting the handpiece. The Standby/On button light will turn orange 5 seconds after turning on the unit. Press the Standby/On button to start the corresponding mode.

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Pulse modes Select either single or multiple pulse mode with the "Litho mode" button.

Pulse frequencies When the pulse mode is set to multiple, the frequency can be selected with the arrow keys. Frequency is adjustable on a 1Hz to 12Hz range. The last setting of the pulse mode and frequency is kept in memory at power off.

Pneumatic power The right rotary knob is used to adjust the pneumatic power in percent from 0 % to 100 % (in 10 % increments).

Activation Press the pneumatic (right) foot pedal to activate the pneumatic pulses.

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ULTRASOUND AND PNEUMATIC COMBINED LITHOTRIPSY MODE Preparation

CLICK!

Refer to the handpieces manuals for handpiece preparation and assembly details. Never connect a partially assembled handpiece to the control unit. Be sure that the control unit is off while connecting the handpieces. The Standby/On button light will turn orange 5 seconds after turning on the unit. Press the Standby/On button to start the corresponding mode. 16

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ENDOSCOPY For preparation and settings, refer to the chapters on ultrasound and pneumatic lithotripsy. Activate the ultrasound mode as well as the pneumatic mode on the control unit. The "Select" button toggles between the adjustment of the duty cycle and the setting of the pneumatic pulse frequency. The function in use is indicated by a dot either in the duty cycle display or in the frequency display. The arrow keys are used to adjust the values. Press both foot pedals to activate pneumatic and ultrasound lithotripsy mode with suction simultaneously (place the foot over both pedals). The individual lithotripsy modes can be selectively controlled by pressing only the related foot pedal (left for ultrasound / right for pneumatic).

It may happen that the probe tip is hidden in folds of the edematous tissue. Endoscopes with a 5° to 15° viewing angle offer a better visualization of the probe tip in the near range of the endoscope. Ensure that the tip of the pneumatic or ultrasound probe does not extend beyond the tip of the endoscope by more than 10 to 20 mm when it is fully inserted in the endoscope working channel. Risk of mucosal perforation: When using a 0.8 mm or 1.0 mm pneumatic probe with an ureteroscope, it is recommended to adjust (if needed) the length of the probe to the endoscope length. Adjusting the length of the probe will help limit the risk of perforation and reduce the energy loss, particularly with thin probes. To avoid damage to the endoscope, the probes should not be activated with their tip still inside the working channel of the endoscope.

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TREATMENT RECOMMENDATIONS General

Recommended settings

Intracorporeal lithotripsy by use of ultrasound and pneumatic energies, used simultaneously or individually, requires experience and skill in endoscopic technique. A good balance of irrigation through the endoscope versus suction is important for a proper endoscopic view. Excessive and badly timed flushing should be avoided in order not to flush away the stone.

For each lithotripsy method, whether used individually or in combination, it is recommended to start fragmentation at medium power settings of 50 % to 60 %.

The stone can only be fragmented if the ultrasound probe and/or the pneumatic probe is/are in direct contact with it. Before releasing a pulse or activating the ultrasound, touch the stone with the probe tip and move it slightly to verify contact. Due to the push back effect, mobile ureteric stones should not to be treated from below with the probe positioned in the center of the stone. Best practice is to position the probe tangentially at the stone so that the lithotripsy pulses will not push it back.

The frequency of the pulses should not be higher than 7Hz in individual mode with a duty cycle set at 100 % at the beginning whether used alone or in combination with pneumatic lithotripsy, and can be increased or decreased gradually. For combined application, it is recommended to set the pneumatic pulses frequency at 2~3Hz to help controlling the fragmentation. Working with a duty cycle of less than 100 % can be helpful to reduce warm-up of the ultrasound instrument if e.g. the endoscopic procedure requires to reduce suction through the ultrasound instrument.

The stone should be hit at the corner or at the edges depending on its structure. It is useful to treat the stone by pushing it slightly against the ureter wall and working with a low pulse rate. Use of a stone migration prevention device may be indicated. It is possible to treat impacted stones directly "in situ" using only pneumatic lithotripsy, because pneumatic lithotripsy does not generate heat, therefore no risk of thermal damage to surrounding tissues.

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Selection between individual and combined modes The Swiss LithoClast® Select System offers two modes of lithotripsy; ultrasound lithotripsy and pneumatic direct impact lithotripsy, known as the Swiss LithoClast® principle. These two lithotripsy modes can operate in combination or individually. The selection of the treatment mode depends on the stone location and on the stone properties. Stone fragmentation testing has been conducted to verify that simultaneous use of ultrasound and shock wave pneumatic lithotripsy can reduce the time needed for stone fragmentation and evacuation. In situations where it is time consuming and hard to fragment the stones by using ultrasound energy alone, the simultaneous application of the pneumatic probe guided through the ultrasound probe can considerably improve the process. This is particularly true when treating hard stones, such as mono hydrate stones. The combined use is not indicated when the fragmentation process works fine with the ultrasound probe alone. The flow characteristic of the ultrasound probe is limited when the pneumatic probe is inside. Fragment evacuation is more efficient when the suction channel is kept free.

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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.

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.

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

Preparation and cleaning Unit

Handpieces and accessories Clean the foot pedal only with an alcohol-based, commercially available (ethanol, isopropanol), colorless disinfectant. The use of scouring powder or an abrasive sponge will damage its surface. Dispose of the disposable Stone Catcher device. For the other components, please refer to related instruction manual.

The housing of the unit is not watertight. Please proceed as follows: • Turn off the device • Disconnect the power supply connector • Disconnect the air supply connector • Disconnect the foot pedal connector • Disconnect the handpiece(s) and attach the caps onto the connectors Clean the unit only with an alcohol-based, commercially available (ethanol, isopropanol), colorless disinfectant. The use of scouring powder or an abrasive sponge will damage its surface.

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