KNIFE Instructions for Use

Contents 1 General information... 5 1.1 Upon delivery... 6 1.2 Manufacturer... 7 2 Terminology... 8 3 Compatible components... 9 4 Before use... 10 4.1 Inspection and testing... 10 5 Use... 12 5.1 Preparation... 12 5.2 Procedure... 14 5.3 After use... 14 6 Reprocessing... 15 6.1 Maintenance... 16 7 Repair... 17

General information

1 General information Intended use A3328 Guided knife for establishing a percutaneous access to the kidney. A3329 Spare knife for A3328. Do not use it for any other purpose. For more information regarding the application and safe use of this product, refer to the System Guide Endoscopy. Medical use This product is to be used only in a medical facility by trained medical personnel. Safety advisory Follow all warnings and cautions contained in this manual and in the System Guide Endoscopy. Review all instruction manuals thoroughly Before use, review this manual, the System Guide Endoscopy, and the manuals for all other equipment which will be used during the procedure. WARNING An insufficient understanding of the information in these manuals can result in serious injury or equipment damage. Use of this manual This manual contains valuable specification, care, and problem solving information which will help you use the product safely and effectively. This manual can be a useful training aid for new users of endoscopic equipment and is a good reference for experienced users. Keep it in a safe, accessible location.

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General information Medical Device Directive (Europe) This product complies with the requirements of Directive 93/42/ EEC concerning medical devices.

1.1 Upon delivery Inspect immediately •• Contact your Olympus representative or an authorized service center if any items are missing or damaged. WARNING Risk of injury

The knife is delivered with a protection sleeve around the blade. Remove this sleeve carefully. The blade is extremely sharp. Unpacking Remove the instrument from the packaging. Do not use the packaging for routine storage.

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General information

1.2 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

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Terminology

2 Terminology

1) 2) 3) 4) 5) 6)

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Guide wire channel Blade guide, graduated Stop plate Fastening screw Handle Blade (double-sided)

Compatible components

3 Compatible components

A2380

A3328

A3329

A3328

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Before use

4 Before use WARNING Infection control risk Properly reprocess all equipment before first and each subsequent use following the instructions in this manual and in the System Guide Endoscopy. Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.

4.1 Inspection and testing WARNING Risk of injury There is a risk of injury at the knife’s blade. Inspect the instrument Visually inspect the instrument: •• Make sure that the instrument is free of corrosion, dents, cracks, and scratches. •• Make sure that the blade is not damaged. Damaged instrument If the instrument is damaged or does not function properly, contact your Olympus representative or an authorized service center. Replace if necessary (knife) If the knife’s blade is damaged or blunt, replace the knife with a spare knife A3329.

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Before use CAUTION Wear (blade)

When used as intended this product is more or less subject to wear depending on the intensity of use. In case a product has externally visible defects contact the responsible Olympus representative at once. Later guarantee claims are forfeited. Any guarantee claims are void by previous use.

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Use

5 Use Before use •• Make sure that the instrument has been properly reprocessed, inspected, and tested.

5.1 Preparation Placing the guide wire

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1

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1) Assisted by X-ray and ultrasound, insert a hollow needle and advance it into the renal pelvis. 2) Insert a compatible guide wire into the hollow needle and advance it into the renal pelvis. 3) Remove the hollow needle. Adjust the distance

•• Determine the distance between renal surface and skin by means of an ultrasonic probe. •• Loosen the fastening screw.

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Use •• Adjust the desired distance by moving the blade guide. The scale on the blade guide indicates the distance in cm. •• Tighten the fastening screw. WARNING Risk of injury •• Make sure that the adjusted distance does not exceed the distance between renal surface and skin. •• Make sure that the blade does not reach the renal capsule. Otherwise this can cause injuries of the kidney and massive bleeding. Insert the guide wire into the knife

•• Introduce the guide wire’s end into the knife’s distal channel opening. •• Advance the guide wire through the channel until it protrudes from the opening at the knife’s proximal end.

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Use

5.2 Procedure Insert the knife

•• Insert the knife over the guide wire. •• Advance the knife until there is a soft contact between the stop plate and the skin. Do not compress the tissue!

5.3 After use Withdrawal •• Withdraw the knife. Reprocessing •• Bring the instrument to the reprocessing area. •• Reprocess all equipment following the instructions in this manual and in the System Guide Endoscopy.

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Reprocessing

6 Reprocessing WARNING Infection control risk Properly reprocess all equipment before first and each subsequent use following the instructions in this manual and in the System Guide Endoscopy. Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel. Observe the following instrument-specific instructions. Before reprocessing

•• Remove the knife from the handle. •• Remove the fastening screw from the handle. Compatible reprocessing methods This product is compatible with the reprocessing methods listed in the table. For details of the procedures, refer to the System Guide Endoscopy. + –

compatible incompatible A3328, A3329

Ultrasonic cleaning

+

Steam sterilization (autoclaving)

+

Heat sterilization (dry)

–

Gas sterilization (ETO)

+

Low temperature plasma sterilization

+

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Reprocessing CAUTION Risk of damaging the instrument Do not use incompatible reprocesssing methods for this instrument. Instrument damage may occur.

6.1 Maintenance Spare parts

• If damaged, replace the knife. Spare part: A3329. Lubrication

•• Lubricate the areas indicated by arrows. •• Use only Olympus oil A0273. Apply lubricant sparingly.

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Repair

7 Repair Policy Contact your Olympus representative or an authorized Olympus Service Center for repair and warranty information. Repair guidelines Follow the general repair guidelines in the System Guide Endoscopy.

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W9214508_00 2017-01-19 en

© Copyright 2017 Olympus Winter & Ibe GmbH