LithoClast Select System Pneumatic Handpiece pn 3 Directions for Use June 2015

COMPONENTS

COMPOSANTS

1

Disposable probe

1

Broche jetable

2

Adjustment interface / handpiece cap

2

Interface de réglage / capuchon de pièce à main

3

Pneumatic Handpiece pn3

3

Pièce à main pneumatique pn3

4

Connector for the Pneumatic Handpiece pn3

4

Raccord pour la pièce à main pneumatique pn3

5

Protective sterilization cap for the connector

5

Capuchon de stérilisation pour le raccord

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,

PLEASE READ THIS BEFORE BEGINNING WORK!

Pneumatic Handpiece The Pneumatic Handpiece is used with the Swiss LithoClast® Select System for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder. Contraindications: Use of these products 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 Instructions concerning the specific components are provided separately in the relative instruction for use. 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.

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 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 Pneumatic Handpiece...4 Combined ultrasound and pneumatic lithotripsy...6 Probes selection...8 Endoscopy...8 Treatment...10 Cleaning and sterilization...10 Preliminary recommendations...10 Preparation for cleaning...12 Safety precautions...14 Maintenance...14 Storing the product...16 Accessories...16 Product warranty...16 Warranty ...16 Symbols...18 Customer service...20 Troubleshooting...20 Technical data...20

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PREPARING FOR TREATMENT Clean, disinfect and sterilize all the components before first use and after as described in the "Reprocessing Instructions" manual. Assemble the application parts under sterile conditions. Before first cleaning, disinfection and sterilization, connect the supplied silicone tubing for the air supply to the connector of the Pneumatic Handpiece. Handpiece damage will occur if moisture enters the handpiece interior. Before treatment, perform a function test according to the instructions given in the respective paragraph. Sterilized backup probes should be available in case of a probe failure during treatment. Should a probe break distally, sterile grasping forceps should be used to remove probe pieces from the urinary tract. A wide range of Pneumatic Probes are available to cover lithotripsy applications. Please contact your BSC representative.

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Assembly of the Pneumatic Handpiece

STERILE

The Pneumatic Handpiece is provided non sterile in two pieces, the handpiece and the air supply tubing that connects it to the control unit. They must be connected as shown before the handpiece is sterilized per the recommendations. The Pneumatic Probes are single use and are packaged sterile. Once the handpiece has been sterilized and the air supply tubing connected, attach the Pneumatic Probe in a sterile manner to the front end of the handpiece with slight axial pressure and a ¼ clockwise turn until it ‘clicks’ into place. Once the handpiece is assembled, remove the protective sterilization cap and connect the plug of the Pneumatic Handpiece into the control unit. There are no dots to align so just push the connector into the control unit. The plug must be completely dry before attachment.

Function testing A function test should be performed prior to using the handpiece. Verify that probe impacts are generated in the Pneumatic Handpiece and transmitted to the probe. Hand feel the shock waves by holding the Pneumatic Probe, however never touch the probe tip for function testing as this may hurt. Pneumatic impulses are released by pressing the pneumatic foot pedal and are controlled by the control unit.

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Combined ultrasound and pneumatic lithotripsy

Please refer to the instruction manuals of the ultrasound handpiece and of the control unit for details on the combined application. The use of the Stone Catcher device is optional when using the combined ultrasound and pneumatic lithotripsy in order to collect stone fragments.

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PROBES SELECTION

ENDOSCOPY

The tables below show which type of probe is recommended for various stone types.

The following endoscope working channel sizes are recommended.

1.6 mm, 2.0 mm or 3.2 mm

Ureteric stones

0.8 mm, 1.0 mm or 1.6 mm

Ureteric or renal stones via flexible ureteroscope

0.89 mm Flexprobe

Bladder stones

1.6 mm, 2.0 mm or 3.2 mm

Kidney

Endoscope type

Working channel

Ø 2 mm probe

Nephroscope

> 12 (Fr.)

Ø 1.6 mm probe

Nephroscope, cystoscope with straight channel

> 10.5 (Fr.)

Ø 3.2 mm probe

Nephroscope, cystoscope with straight channel

> 10 (Fr.)

Ø 2 mm probe

Nephroscope, cystoscope with straight channel

> 7 (Fr.)

Ø 1.6 mm or Ø 0.8 mm probe

Ureteroscope with straight channel

> 5 (Fr.)

Ø 1 mm probe

Ureteroscope with straight channel

> 3.5 (Fr.)

Ø 0.8 mm probe

Ureteroscope with straight channel or slightly curved channel

> 3 (Fr.)

Ø 0.89 mm Flexprobe

Flexible ureterorenoscope. Flexible nephroscope / cystoscope

> 3 (Fr.)

Ureter

Kidney stones through percutaneous access

Pneumatic probe diameter

Kidney and bladder

Stone types:

Pneumatic probe diameter:

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TREATMENT

CLEANING AND STERILIZATION

In order to ensure contact between the stone and the pneumatic probe, the probe extension must be carefully adjusted so that the end of the pneumatic probe is flush with the end of the endoscope. There is a risk of mucosal perforation if the pneumatic probe extends beyond the endoscope.

Preliminary recommendations

Adjusting the position of the probe tip Also make sure that the tip of the Pneumatic Probes does not extend beyond the tip of the endoscope by more than 10 to 20 mm when the probe is fully inserted into the working channel of the endoscope.

Please conform to the recommendations of the "Reprocessing Instructions" manual delivered with the product regarding procedure of cleaning, disinfecting, packaging and sterilizing of the components. Please follow the applicable present day sterilization regulations in your country. Do not disconnect the silicone air supply tube from the Pneumatic Handpiece for cleaning, disinfection and sterilization. Handpiece damage will occur if moisture enters the handpiece interior.

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Preparation for cleaning

Dispose of probe per hospital protocol. Do not disconnect the air supply tubing from the handpiece. Secure the protective sterilization cap onto the end of the hose.

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SAFETY PRECAUTIONS Boston Scientific (distributor) or EMS (manufacturer) assume 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 product. 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. Use for the intended purpose only. 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. This product must be used only by trained and qualified personnel.

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 the product. Non-sterile pieces and accessories may cause bacterial or viral infections.

MAINTENANCE Should legal provisions in your country demand shorter intervals, these must be observed. For the safety of patients, users and third parties, it is essential to observe certain intervals for maintenance to ensure that safety features and functions are updated. The recommended maintenance intervals for the unit are:

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.

Component Handpiece pn3

1)

Interval Each year

Action Handpiece overhaul1

Must be executed through BSC.

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. 14

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STORING THE PRODUCT Keep the original packaging until the product is to be disposed of permanently. You can use it for shipping or storing at any time. Should you wish to store the product for an extended period of time: • Proceed as described in the chapter "Cleaning, disinfecting and sterilizing", • Pack the product and all accessories in the original packaging. Please refer to the storage and transport conditions in the "Technical data".

ACCESSORIES Accessories are available from Boston Scientific Customer Service. For safety reasons this product may only be used with genuine Swiss LithoClast® Select System accessories. The user assumes all risks of using this product with non-genuine accessories or otherwise in non-compliance with the instructions manual.

Warranty The manufacturer warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond the manufacturer’s and/or BSC’s control directly affect the instrument and the results obtained from its use. The manufacturer’s obligation under this warranty is limited to the repair or replacement of this instrument if deemed by the manufacturer to be defective in material or workmanship, and neither the manufacturer nor BSC shall be liable for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this instrument. The user assumes responsibility for any consequences which may arise pertaining to the use of the products. BSC and the manufacturer neither assume, nor authorize any other person to assume for it, any other or additional liability or responsibility in connection with this instrument.

PRODUCT WARRANTY The warranty is valid for one year from the date of purchase. Damages due to non-adherence to the operating instructions or wear out of parts are excluded from warranty.

Swiss LithoClast® is a registered trademark.

The warranty of the product will be cancelled if you try to open or disassemble it.

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SYMBOLS

Manufacturer’s logo

Caution! Read the operating instructions

CE symbol refers to directive 93/42/EEC, including EN 60601-1 and EN 60601-1-2

135°C

Sterilizable at up to 135°C in the autoclave

For single use only. Do not reuse.

pn3

Abbreviated model name of the Swiss LithoClast ® Pneumatic Handpiece

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CUSTOMER SERVICE

TECHNICAL DATA

Please contact your BSC representative for any servicing or repairs.

DESCRIPTION

Boston Scientific and EMS decline responsibility for the safety of the device and declare the warranty null and void if service or repair is carried out by an unauthorized third party or if non-genuine spare parts are used.

Distributor

Boston Scientific Corporation Marlborough, MA USA 01752

Manufacturer

EMS SA, CH-1260 Nyon, Switzerland

Models

Swiss LithoClast® Pneumatic Handpiece pn3

Classification EN-60601-1

Class I Applied part BF IP67 Mode: Continuous operation

Classification MDD 93/42 EEC

Class IIb

Weight

150 g (5.3 oz)

Dimensions

Length: 169 mm (6.7 in) Width: 36 mm (1.4 in)

Operating conditions

+10°C to +40°C (50°F to 104°F) 30% to 75% relative humidity

Validated life time

> 500 sterilization cycles > 1.000.000 pulses

Storage and transport conditions

–10°C to +40°C (14°F to 104°F) 10% to 95% relative humidity 500 hPa to 1060 hPa air pressure (7.2 psi to 15.3 psi)

It is best to ship your product in the original packaging. It protects your product against damage during shipment. Before dispatching your product including all accessories, please clean, disinfect and sterilize as described in the operating instructions. Risk of transmitting micro-organisms! To protect the personnel of the repair center and for safety reasons during transport and shipment, all products and accessories returned to the factory for repair or revision must be cleaned, disinfected and sterilized in accordance with the instructions manual. Repair can be refused for product or accessories received in a contaminated condition.

TROUBLESHOOTING For all error codes displayed on the unit, please read the instruction manual of the unit.

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