PAJUNK Handle and Suctions / Irrigation Tubes Instructions for Use

3 Instructions for use - Suction-/Irrigation System Manufacturer PAJUNK GmbH Medizintechnologie Karl-Hall-Strasse 1 78187 Geisingen Germany Initial distributor Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany Article number reference table Olympus

A5797

A5798

A5799

A5796

Pajunk

1298-00-10OL 1298-00-05OL 1298-00-03OL 1298-62-00OL

1298-00-03OL 1298-00-05OL 1298-00-10OL

1298-62-00OL

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Handle and Suction/Irrigation Tubes

4 Special Observance Please read the following information and application notes carefully. The product may only be used by experienced medical staff in accordance with these Instructions for Use. PAJUNK® does not give any recommendation regarding a method of treatment. The treating medical specialist staff is responsible for the manner of application and for the selection of the patient. If these instructions are not observed or if they are violated, this will lead to the expiry of the guarantee, and the safety of the patient will be endangered. If used in combination with further products, please always observe the indications for usage and the compatibility statements for such products. Please check the product and the packaging for completeness, intactness and the status of sterility before application. Do not use product if you have reason to doubt the completeness, the intactness and the non hazardous status of sterility. Product specification/compatibility Components of the respective serie for the suction-/ irrigation system are a suction-/irrigation handle with pistol handle and suction-/irrigation tubes. Indications Minimally invasive surgery (“keyhole surgery”) Contraindications The contraindications will depend on the minimally invasive intervention to be carried out. Warning indications Please be absolutely sure that you initially also clean and sterilise medical devices which have been delivered in nonsterile condition before the first application! Sort out and replace damaged or faulty instrument. Use consumable parts only once. Check consumable parts for damage before every use and replace if necessary.

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5 The serviceable life is influenced in a considerable degree by careful treatment and the application of adequate maintenance and cleaning measures. The valve tappets must be coated with a medically approved lubricant to ensure free movement and tightness. Special warning indications for use with other compatible products: Exclusively the products of the respective serie may be connected with each other and used together. Exclusively the products of the respective serie are compatible among each other. Application (Sequence of use) The assembled instrument is used in accordance with the selected indication (usually by way of a port/a trocar sleeve). Dismantle after use. Reusable components are to be re-processed. Cleaning/Sterilisation The instruments must be dismantled and cleaned after use. After cleaning and drying, reassemble the dry components again, check the instruments for intactness and perform maintenance and care if necessary. Now the cleaned and completely reassembled instruments can be sterilised. Preparation The methods, facilities and equipment validated by the user are always to be observed and checked for compatibility with the details given here in every case. Reusable instruments and equipment must be checked regarding functionality and intactness immediately before and after use, as well as after cleaning operations. Contaminated instruments are to be processed as soon as possible after every use. Dismantle the dismountable instrument into its components according to the dismantling instructions.

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Handle and Suction/Irrigation Tubes

6 Rinse the instrument with clear, flowing water before machine-cleaning and disinfection. Remove coarse contaminations carefully by means of a soft cloth or soft brush. Clean manually or mechanically. Strictly avoid unwashed areas/product residue patterns. Always observe the manufacturer’s instructions. Cleaning process Remove adhering contaminations using a soft brush with plastic bristles. Do not use scouring/abrasive cleaning agents or metal brushes. Clean lumen and passage ducts using soft, rounded brushes with plastic bristles. The lumen diameter and the diameter of the brush must correspond matchingly. Finally, rinse with distilled or demineralised, flowing water. Dry instrument with absorbent, soft and lint-free cloth. Dry lumen and passage ducts using grease- and dust-free compressed air. Perform disinfection only in a suitable cleaning- and disinfection machine, applying a correspondingly appropriate cleaning/disinfection method. Connect components with lumen and passage ducts directly to the special cleaning element of the machine. To clean the instruments which have been provided with a cleaning duct and which cannot be dismantled, connect the instruments to the special cleaning element of the machine by means of Luer-Lock connector, if available. When selecting the washing program, take the material of the instrument to be cleaned into account (e.g. stainless instrument steel, chrome-plated surfaces, aluminium). Follow the instructions of the appliance manufacturer. Finally, rinse with demineralised water. Allow for a sufficient drying phase. Remove the instrument from the machine immediately after completion of the cleaning program.

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7 Clean thermo-resistant instruments using Vario-TD- or BGA-program. The following cleaning agents may be used: deconex, Borer Chemie (cleaner), mucapur-AF, Merz Consumer (cleaner), neodisher Z dental, Dr. Weigert (cleaner, neutraliser). Assembly and Maintenance Allow instruments to cool down to room temperature. Slightly lubricate movable parts with sterilisable, steam permeable servicing oil. The valve tappets must be coated with a medically approved lubricant to ensure free movement and tightness. Assemble dismountable instrument. Check instrument after every cleaning and disinfection with regard to: cleanness, function and intactness e.g. bent, broken, cracked, worn and broken off parts. Sort out and replace damaged or faulty instrument. Use consumable parts only once. Check consumable parts for damage before every use and replace if necessary. PAJUNK® recommends to handle the instruments prudently and carefully, as well as the unconditional observance of these directions for use in order to achieve greatest possible serviceable life. The serviceable life is influenced in a considerable degree by careful treatment and the application of adequate maintenance and cleaning measures. Sterilising with steam Steam sterilisation must be performed according to a validated steam sterilisation process (e.g. steriliser in accordance with DIN EN 285 and validated in accordance with DIN EN 17665-1). If sterilisation is to be performed using the fractionated vacuum method, then the 134 °C/3 bar - program is to be used, employing a minimum - hold time of 4 minutes. Drying time: 20 min. Allow equipment/instruments to cool down to room temperature before renewed use. After steam sterilisation, store exclusively in suitable containers designated for such purpose. W7091500

Handle and Suction/Irrigation Tubes

8

1) Valve tap 2) Retaining plate 3) Handle Dismantling:

1) Complete instrument.

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9

2) Unscrew the spring-loaded retaining plate completely from the valve tap.

3) Press the valve tap until it is released from the body of the valve.

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10 Assembly:

1) Disassembled instrument, consisting of handle, valve tap and retaining plate.

2) Insert the valve tap completely from the rear in its centred position.

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3) Screw the spring-loaded retaining plate onto the threaded pin of the valve tap and tighten it.

12 Limitation of Warranty/Disclaimer PAJUNK® GmbH Medizintechnologie guarantees to manufacture its products with greatest possible care. THIS IS THE ONLY VALID GUARANTEE, AND IT SHALL REPLACE ALL OTHER WARRANTIES GIVEN AND REPRESENTATIONS MADE. It shall be observed, that due to the biological differences of the persons to be treated, no product is always absolutely effective under all environmental conditions and circumstances. Components of the sets manufactured by PAJUNK® GmbH Medizintechnologie, as well as their individual components are compatible with each other. Before the use of individual products/sets of PAJUNK® GmbH Medizintechnologie in connection with products from other companies, the user must ensure the application-specifical compatibility of the individual products. PAJUNK® GmbH Medizintechnologie has no influence on the application of the product, on the diagnosis of the patient and on the handling of the product outside of the company. PAJUNK® GmbH Medizintechnologie can neither guarantee a beneficial nor a complication-free application of the product. PAJUNK® GmbH Medizintechnologie therefore assumes no liability for damages and costs. PAJUNK® GmbH Medizintechnologie will replace products showing a deficiency, which is to be represented by PAJUNK® GmbH Medizintechnologie. Employees of PAJUNK® GmbH Medizintechnologie shall not be authorised to amend the aforementioned conditions, to extend liability, or to accept or consent to additional product-related obligations. General Notes In accordance with U.S. law, this product may only be sold by a physician or upon his prescription. All rights to change or modification of the product shall remain reserved. Products are free of latex. Made in Germany – manufactured by PAJUNK® GmbH Medizintechnologie Handle and Suction/Irrigation Tubes

W7091500

13 Storage conditions 40°C 10°C 85

30

Symbol for: Keep away from sunlight

Keep away from rain

Temperature limitation

Humidity limitation

Consult instructions for use

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Handle and Suction/Irrigation Tubes

14 Consult instructions for use

Do not use if package is damaged

Do not resterilize

Sterilized using ethylene oxide Do not re-use

Manufactured and monitored acc. to European Legislation for Medical Devices

Manufactured acc. to European Legislation for Medical Devices Does not contain Phthalates (acc. to sec. 7.5 of Annex I 93/42/EWG)

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15 Does contain Phthalates as identified

Does not contain latex

Contains latex

Non-pyrogenic

Pieces

Catalog number, Unique identifier

Batch-Identification

”Use-by”-date

W7091500

Handle and Suction/Irrigation Tubes

16 Date of manufacture

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W7091500_02 2016-07-05 en

© Copyright 2016 Olympus Winter & Ibe GmbH