A3661 PUNCH Instructions for Use

Contents 1 General information... 4 1.1 Upon delivery... 5 1.2 Manufacturer... 5 2 Terminology... 6 3 Technical data... 8 4 Compatible components... 9 5 Before use... 10 5.1 Inspection and testing... 10 6 Use... 11 6.1 Preparation... 11 6.2 Procedure... 11 6.3 After use... 12 7 Reprocessing... 14 8 Repair... 16

General information

1 General information Intended use A3661 Punch for disintegration of concrements in 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 Handle, outer shaft

1) 2) 3) 4) 5) 6) 7)

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Knurled nut Telescope guide Telescope channel Fastening screw for inner shaft Fastening screw for spring Spring Main body

Terminology Inner shaft

1) Inner shaft 2) Hole for fastening screw

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Technical data

3 Technical data Dimensions Diameter ... 21 Fr. Working length ... 240 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.

A1931A A2031A A22001A

A3661

A2621 A2622 A2623 A2624 A2625

A22021A A22022A A22023A A22024A A22026A A22027A

A2641 A2642 A2643

A22040A A22041A A22042A A22043A

A3661

A3662

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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.

5.1 Inspection and testing Inspecting the product Visually inspect the product. Make sure that it has: -- no corrosion -- no dents -- no scratches Damaged product If the product is damaged or does not function properly, contact an Olympus representative or an authorized service center.

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Use

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

6.1 Preparation Insert the telescope into the punch

•• Insert a compatible telescope into the telescope channel of the punch. •• Make sure that the connecting pin clicks securely into position.

6.2 Procedure 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.

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Use Disintegration of bladder calculi

•• Insert the punch into a compatible irrigation port. •• Turn the irrigation port’s locking lever until the irrigation port is securely fastened. •• Carefully insert the punch into the urethra. Procedure •• Perform the procedure.

6.3 After use 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 Disassemble the instrument before reprocessing

•• Loosen and remove the fastening screw for the spring and the spring (1). •• Loosen and remove the fastening screw for inner shaft (2). •• Turn the knurled nut until the telescope guide can be removed (3). •• Remove the telescope guide (4). •• Remove the inner shaft (5). Reassemble the instrument after reprocessing •• Reassemble the instrument in the reverse order.

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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 A3661

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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.

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Repair

8 Repair Policy Contact your Olympus representative or an authorized service center for repair and warranty information. Repair guidelines Follow the general repair guidelines in the System Guide Endoscopy.

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© Copyright 2017 Olympus Winter & Ibe GmbH