GRASPING FORCEPS Instructions for Use

Contents 1 General information... 4 1.1 Upon delivery... 5 1.2 Manufacturer... 5 2 Terminology... 6 3 Technical data... 9 4 Compatible components... 10 5 Before use... 11 5.1 Assembly (only for WA63817A, WA63819A)... 12 5.2 Inspection and testing... 14 6 Use... 15 6.1 Procedure... 15 6.2 After use... 16 6.3 Disassembly (only for WA63817A, WA63819A)... 17 7 Reprocessing... 19 7.1 Cleaning... 20 7.2 Maintenance... 21 8 Repair... 24

General information

1 General information Intended use Grasping forceps for cystoscopy and percutaneous nephroscopy. Do not use it for any other purpose. Medical use This product is to be used only in a medical facility by trained medical personnel. NOTE Instruction manual set The complete instruction manual set for this product consists of this product-specific instruction manual (delivered together with this product) and the system-related instruction manual, entitled “System Guide Endoscopy” (supplied separately). Immediately contact an Olympus representative if either manual is missing or lost. Keep the instruction manual set in a safe, accessible location. WARNING! Read all instruction manuals thoroughly Before use, read this manual, the System Guide Endoscopy, and the manuals for all other equipment which will be used during the procedure. An insufficient understanding of the dangers, warnings, cautions, and information in these manuals can result in death, serious injury, or equipment damage. Medical Device Directive (Europe) This product complies with the requirements of Directive 93/42/EEC concerning medical devices.

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General information

1.1 Upon delivery Inspect immediately •• Make sure that the shipping case contains all items. •• Contact your Olympus representative or an authorized service center if any items are missing or damaged. Unpacking •• Remove the product from the packaging. Do not use the packaging for routine storage.

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

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Terminology

2 Terminology Grasping forceps WA63810A, WA63813A, WA63815A

1) Distal end 2) Handle 3) Luer-Lock connector

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Terminology Grasping forceps WA63817A

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

Distal end Sealing cap Small sealing cap on laser/probe port Handle Grasping insert Shaft

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Terminology Grasping forceps WA63819A

1) 2) 3) 4) 5)

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Distal end Sealing cap Handle Grasping insert Shaft

Technical data

3 Technical data Dimensions Diameter... 12 Fr. Working length... 400 mm

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Compatible components

4 Compatible components WARNING! Risk of injury to the patient and/or user Use only compatible equipment as listed in this section. If other combinations are used, the full responsibility is assumed by the user. Future products may also be compatible. For further details contact an Olympus representative.

WA33039A WA63810A WA63813A WA63815A

A3342

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WA63817A WA63819A

Before use

5 Before use WARNING! Infection control risk Properly reprocess the product 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.

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Before use

5.1 Assembly (only for WA63817A, WA63819A) Assemble the WA63817A grasping forceps before use

1. Attach the large sealing cap (1). 2. Insert the grasping insert into the shaft’s distal end and advance it through the sealing cap (2).

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Before use 3. Hook the grasping insert’s proximal end into the handle’s groove so that it clicks into position within the upper part of the groove (3). Make sure that the more distally located groove clicks into position within the handle so that the grasping insert’s proximal end protrudes about 5 mm from the handle. 4. Attach the small sealing cap to the grasping insert’s proximal end (4). Assemble the WA63819A grasping forceps before use

1. Attach the sealing cap (1). 2. Insert the grasping insert into the shaft’s distal end and advance it through the sealing cap (2). 3. Hook the grasping insert’s proximal end into the handle’s groove so that it clicks into position within the upper part of the groove (3).

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Before use

5.2 Inspection and testing Inspecting the product Visually inspect the product. Make sure that it has: -- no corrosion -- no dents -- no scratches •• Make sure that the sealing caps are not damaged. Test the instrument •• Operate the handle. Make sure that the jaws open and close smoothly. Damaged product If the product is damaged or does not function properly, contact an Olympus representative or an authorized service center. CAUTION! Wear 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

6 Use Before use Make sure that the product has been properly reprocessed, inspected, and tested.

6.1 Procedure CAUTION! Risk of damaging the instrument Do not close the instrument stopcock when a surgical instrument is inserted. CAUTION! Risk of damaging the instrument Hand instruments may be damaged if excess force is applied or if the instrument is used in a manner for which it is not intended. In order to avoid damage, make sure that the force applied to the handle is adequate and reasonable for the intended application. Insert the hand instrument into the OP telescope

•• Refer to the OP telescope’s instruction manual. 15

Use •• Close the jaws (only for WA63810A, WA63813A, WA63815A). •• Insert the hand instrument’s distal end into the attachment’s sealing cap. •• Open the instrument stopcock (only for WA33039A). •• Advance the hand instrument into the working channel until the distal end appears in the endoscopic image. Procedure •• Perform the procedure.

6.2 After use CAUTION! Risk of damaging the instrument Make sure that the instrument stopcock is open and the jaws are closed when withdrawing the instrument. Never withdraw the instrument with excessive force. Withdrawal •• Operate the handle to close the jaws (only for WA63810A, WA63813A, WA63815A). •• Remove the hand instrument from the OP telescope. Reprocessing •• Immediately bring the product to the reprocessing area. •• Reprocess the product following the instructions in this manual and in the System Guide Endoscopy.

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Use

6.3 Disassembly (only for WA63817A, WA63819A) Disassemble the instrument before reprocessing

1. Only for WA63817A: Remove the small sealing cap from the grasping insert’s proximal end (1). 17

Use 2. Unhook the grasping insert’s proximal end from the handle (2). 3. Remove the grasping insert from the shaft (3). 4. Remove the sealing cap (4).

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Reprocessing

7 Reprocessing WARNING! Infection control risk Properly reprocess the product 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. Information in this section The following reprocessing information supplements that in the System Guide Endoscopy. However, if the information given in this section differs from that in the System Guide Endoscopy, use the information given here. 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

Manual or automatic cleaning

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Ultrasonic cleaning

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Disinfection or high-level disinfection

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Steam sterilization (autoclaving)

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Heat sterilization (dry)

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Gas sterilization (ETO)

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Gas sterilization (formaldehyde)

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STERRAD 50/100/100S

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STERIS

+

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Reprocessing CAUTION! Risk of damaging the product Do not use incompatible reprocessing methods. Product damage may occur.

7.1 Cleaning CAUTION! Risk of instrument damage caused by cleaning and disinfectant solutions Do not exceed maximum recommended levels of concentration and immersion time given by the solution’s manufacturer. These solutions can affect the instrument’s usability. There is a risk that the instrument’s jaws break apart. Rinsing (only for WA63810A, WA63813A, WA63815A)

1. Use the O0103 adapter to connect a tube to the Luer-Lock connector (washing port). 2. Use the adapter and tube for flushing the instrument until all blood and tissue residues are removed. 3. Blow air through the Luer-Lock connector and dry the instrument thoroughly.

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Reprocessing Rinsing (only for WA63817A, WA63819A) 1. Attach the O0190 cleaning pistol to the shaft’s distal or proximal end (refer to the cleaning pistol’s instruction manual). 2. Flush the instrument until all blood and tissue residues are removed. 3. Blow air through the shaft and dry the instrument thoroughly.

7.2 Maintenance Lubrication

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

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