LithoClast Select System Reprocessing Instructions May 2015

PLEASE READ THIS BEFORE BEGINNING WORK! 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, please note the corresponding directives.

About this manual The instructions in this manual are only applicable to the equipment with which it was delivered. Note that the English version in this manual is the master from which translations derive. In case of any discrepancy, the binding version is the English text.

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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INTRODUCTION These reprocessing instructions provide instructions for cleaning, disinfection, packaging and sterilization of the Swiss LithoClast ® Select System components intended to be reprocessed in medical facilities. The goal of reprocessing reusable products is to reduce bio burden and to achieve sterility of those products in order to eliminate the risk of product reuse related infection. Decisions regarding cleaning, disinfecting or sterilizing medical instruments are based on the potential risk of infection associated with their use. It is recommended to use steam sterilization. Remember that sterilization or disinfection cannot be achieved unless the components are cleaned first. If there is anything in the following instructions that is not clear, do not hesitate to contact your Boston Scientific Representative.

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CONTENTS Reprocessing instructions applicable to reusable products...2 Application...2 Important...2 Basic principles...2 Post-operative treatment...4 Steps...4 Cleaning and disinfection...4 Manual or mechanical cleaning and disinfection...4 Mechanical cleaning and disinfection...6 Manual cleaning and disinfection...8 Inspection...8 Packaging and sterilization...10 Service life...12 Warranty ...12

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REPROCESSING INSTRUCTIONS APPLICABLE TO REUSABLE PRODUCTS The instructions are binding for the reprocessing of all reusable products* of Swiss LithoClast® Select System. When necessary, additional product specific instructions are included with the product to provide additional information. *(Here after called "products") The use of any other procedure not expressly recommended in this manual may adversely affect or damage devices and may void product warranty.

APPLICATION

Basic principles It is only possible to carry out effective sterilization after the completion of cleaning and disinfection. Please ensure that, as part of your responsibility for the sterility of products during use, only sufficiently validated equipment and product specific procedures are used for cleaning/disinfection and sterilization, and that the validated parameters are adhered to during every cycle. Please also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic. This applies to the additional requirements for the inactivation of prions.

Important 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. Reusable products must be cleaned and sterilized prior to first use. They must be replaced after the number of operations specified by manufacturer. Disposable products may not be reused.

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POST-OPERATIVE TREATMENT

CLEANING AND DISINFECTION

The post-operative treatment must be carried out immediately within a maximum of 30 minutes after the completion of the operation. Disassembly instructions and any other additional information are provided in the respective product specific Directions for Use.

Manual or mechanical cleaning and disinfection

Steps

Cleaning and disinfection must be performed within a maximum of 2 hours following the post operative cleaning preparation.

Do not submerge the end of cords and hoses.

Mechanical cleaning and disinfection should always be used if available to improve cleaning effectiveness.

1. Rinse away any surface soiling on the product with distilled or deionized water or with a cleaning agent. 2. Rinse through all lumina (e.g. irrigation and suction connection) at least 3 times in the normal direction of flow (no back rinsing) using a disposable syringe (min. volume 50 ml) filled with distilled or deionized water applied to the back nozzle. 3. An aldehyde-free cleaning and disinfection solution that is compatible with the products may also be used as an alternative rinsing solution. In such cases it is necessary to rinse through afterwards at least 3 times with distilled or deionized water.

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Mechanical cleaning and disinfection Thermal disinfection should be used if available. To reach an A0 value of 3000, thermal disinfection over 5 minutes at 90°C or 10 minutes at 80°C is required (e.g. by use of TD Vario program). Note that there is risk of disinfectant residue on product with the use of chemical disinfectant.

Concentrations and contact times specified by the manufacturer of the cleaning and disinfection agent must be followed. Only freshly prepared solutions may be used.

Ensure the following criteria are met when selecting disinfector system:

1. Carefully place products in the disinfection basket. Fasten products only if they can move freely within the fixture. Ensure products do not come in contact with one another.

Steps for mechanical cleaning and disinfection

•

Disinfector is proven effective through testing (e.g. FDA approved or CE marked / EN 15883 compliant).

•

Disinfector has suitable baskets to hold small fragile products and has rinsing connections for the attachment to product lumina.

•

Program is suitable for products and has sufficient rinsing cycles.

4. Remove products from disinfector and inspect it per criteria in the Inspection After Cleaning section.

•

Only sterilized or low microbe count (<10 cfu/ml) distilled or deionized water is used for all rinsing steps. (e.g. Aqua purificata, as per the specifications of Pharm. Eur. or USP). • Requirements for purity of water used with washer / disinfectors are according to the EN 15883.

5. Wrap products directly following disinfection and drying (see Packaging and Sterilization section).

•

Air used for drying is HEPA filtered.

•

Disinfector is serviced and checked on a regular basis.

Ensure the following criteria are met when selecting cleaning and disinfection agent: •

Chemicals are compatible with products (see Service section for compatibility details).

•

With non-thermal disinfection, a suitable disinfectant with tested effectiveness (e.g. FDA approved or CE marked), that is compatible with the cleaning agent, must be used.

2. Using a suitable rinsing adapter, connect the product lumina to the rinsing connectors of the disinfector. 3. Run the program.

If necessary, repeat drying of product in a clean place. Verification of fundamental suitability of products for effective mechanical cleaning and disinfection by machine was provided by an independent accredited testing laboratory, when used with G 7736 CD thermal disinfector (Miele & Cie. GmbH & Co., Gutersloh), and the cleaning agent Neodisher® Medizym (Dr. Weigert GmbH & Co. KG, Hamburg). The procedure described above was adhered to as part of this.

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Manual cleaning and disinfection Ensure the following criteria are met when selecting cleaning and disinfection agent: •

Chemicals are compatible with products (see Service section for compatibility details).

•

Disinfectant has tested effectiveness (e.g. FDA approved or CE marked) and is compatible with the cleaning agent.

•

Disinfection solution is not allowed to foam.

•

Cleaning and disinfection solution should be aldehyde-free.

The use of combined cleaning / disinfection agents is not recommended. Concentrations and contact times specified by the manufacturer of the cleaning and disinfection agent must be followed. Only freshly prepared solutions may be used. •

Only sterilized or low microbe count (<10 cfu/ml) distilled or deionized water is used for all rinsing steps (e.g. Aqua purificata, as per the specifications of Pharm. Eur. Or USP)

Steps for manual cleaning 1. Place the products in the cleaning solution for the minimum time and concentration specified by the manufacturer of the cleaning agent. 2. Remove any external soil with a soft brush or cloth. 3. Rinse the products vigorously at least five times, each time with fresh distilled or deionized water. Product lumina must be rinsed with at least 50ml water. Repeat the cleaning process if the last rinse does not run clear or if soil is visible on the product.

Steps for manual disinfection 1. Place the products in the disinfection solution for the minimum time specified by the disinfection agent manufacturer. Use an aldehyde-free disinfection solution. 2. Dry the products with filtered compressed air (max 40 psi) and inspect per criteria in the Inspection and Maintenance section. 3. Wrap the products directly following disinfection and drying (see Packaging and Sterilization section). If necessary, repeat drying process in a clean place. Verification of the fundamental suitability of the products for effective manual cleaning and disinfection was provided by an independent accredited testing laboratory using the following cleaning and disinfection agents: Cidezyme LF (enzymatic cleaner) and Cidex OPA (disinfectant). The procedure described above was adhered to as part of this.

INSPECTION If stains are still visible on the product after cleaning and disinfection, the entire cleaning and disinfection procedure must be repeated. Product with visible damage, chip/flake loss, corrosion or bent must be disposed of (no further use is allowed).

PACKAGING AND STERILIZATION Do not exceed the maximum number of sterilization cycles of products according to their directions for use.

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Only cleaned and disinfected products are permitted to be sterilized. Prior to sterilization, the products need to be placed in a suitable sterilization container: •

in accordance with EN 868 and ISO 11607

•

resistant to 138°C, with adequate steam permeability

• maintained on a regular basis If double, single-use sterilization packaging (double bag) is to be used, this must also comply with EN 868 and ISO 11607 and be suitable for steam sterilization (temperature resistant to 138°C, with adequate steam permeability). Use only the following listed steam sterilization procedures for sterilization; other sterilization procedures are not permissible:

•

Cycle

Temperature °C

Exposure time (min)

Pre-vacuum

132

10

GravityDisplacement

132

15

Steam sterilizer must be in accordance with EN 13060 or EN 285 validated in accordance with AAMI TIR No. 12, DIN EN ISO 14161 or DIN EN 556 (with EN IS0 17665).

•

Validation must include valid commissioning and product specific performance assessment (DQ, IQ, OQ, and PQ).

•

Maximum sterilization temperature 134°C (+4°C tolerance as per EN 554, IS0 11134 (as per: EN IS0 17665).

•

Sterilization at 134°C for a maximum of 20 minutes is permissible.

Verification of the fundamental suitability of the products for effective steam sterilization was provided by an independent, accredited testing laboratory for use of the pre-vacuum and gravity displacement procedures (EuroSelectomat from MMM Münchener Medizin Mechanik GmbH, Planegg, validated according to DIN EN 285). The procedure described above was adhered to as part of this. The hot-air sterilization and radio-sterilization procedure must not be used or product will be damaged. BSC and the manufacturer assume no responsibility for the use of other sterilization procedures (e.g. ethylene oxide, formaldehyde and low temperature plasma sterilization). In such cases, please observe the respective valid standards (EN IS0 14937/ANSI AAMl IS0 14937 or the procedure-specific standard) and verify the suitability and effectiveness in principle of the procedure (if necessary investigations on sterilizing agent residue), taking into account the specific product geometry as part of the validation.

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SERVICE LIFE

WARRANTY

The products have been designed for a large number of sterilization cycles. The materials used in their manufacture were selected accordingly. However with every renewed preparation for use, thermal and chemical stresses will result in aging of the products.

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 factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond the control of the manufacturer 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.

The number of permissible sterilization cycles is defined in the Technical Data section in the corresponding product Directions for Use. Cleaning and disinfection solutions must be aldehyde-free. The use of ultrasound baths and strong cleaning and disinfection fluids (5 > pH > 9) can reduce the lifespan of products. The manufacturer accepts no liability in such cases. The products may not be exposed to temperatures above 138°C.

Swiss LithoClast® is a registered trademark. Neodisher® is a registered trademark of Chemische Fabrik Dr. Weigert (GmbH & Co.). Cidezyme ® and Cidex® are registered trademarks of Johnson & Johnson Corporation.

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