OBITURATOR Instructions for Use

Contents 1 General information... 5 1.1 Upon delivery... 6 1.2 Manufacturer... 6 2 Terminology... 7 3 Compatible components... 10 4 Before use... 15 4.1 Inspection and testing... 15 4.2 Assembly of sheath... 16 5 Use... 17 5.1 Preparation... 17 5.2 Procedure... 17 5.3 After use... 17 6 Reprocessing... 18 7 Repair... 20

General information

1 General information Intended use A0402, A0403, A0404, A0405, A0406, A0407, A0408, A0409, A20902A, A20903A, A20904A, A20905A, A20906A, A20907A, A20908A, A20909A, A20910A Obturator for endoscopic diagnosis and treatment in urologic and gynecologic applications. A20922A, A20923A, A20924A, A20925A, A2922, A2923, A2924, A2925 Optical obturator for endoscopic diagnosis and treatment in urologic applications. 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.

5

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 •• Make sure that the shipping case contains all of the items listed below. •• Contact your Olympus representative or an authorized Olympus service center if any items are missing or damaged. Contents •• Obturator •• Instruction manual 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 Obturators A0402, A0403, A0404, A0405, A0406, A0407, A0408, A0409

1) Distal tip 2) Handle 3) Color code white blue pink orange green brown

15.5 17.0 19.8 21.0 22.5 25.0

Fr. Fr. Fr. Fr. Fr. Fr.

Obturators A20902A, A20903A, A20904A, A20905A, A20906A, A20907A, A20908A, A20909A, A20910A

1) Distal tip 2) Handle

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Terminology 3) Color code violet light blue eggplant pink orange turquois dark green brown

15.5 17.0 17.0 19.8 21.0 21.0 22.5 25.0

Fr. Fr. Fr. (A20909A) Fr. Fr. Fr. (A20902A) Fr. Fr.

Optical obturators A2922, A2923, A2924, A2925

1) Distal tip 2) Handle 3) Color code pink orange green brown

19.8 21.0 22.5 25.0

Fr. Fr. Fr. Fr.

Optical obturators A20922A, A20923A, A20924A, A20925A

1) Distal tip 2) Handle

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Terminology 3) Color code pink orange turquois dark green brown

19.8 21.0 21.0 22.5 25.0

Fr. Fr. Fr. Fr. Fr.

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Compatible components

3 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.

A2933

A0402

A2923 A2913

A0405

A2911

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A0403

A2031A A2032A A2033A A22001A A22002A A22003A A1931A A1932A A1933A

Compatible components

A0404 A2912

A2922

A2031A A2032A A2033A A22001A A22002A A22003A A1931A A1932A A1933A

A2914 A0406

A2934 A2924

A2031A A2032A A2033A A22001A A22002A A22003A A1931A A1932A A1933A

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Compatible components

A0407 A2915

A2925

A2930

A0408

A2931

A0409

A20933A

A20902A

A20923A A20913A

A20905A

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A2031A A2032A A2033A A22001A A22002A A22003A A1931A A1932A A1933A

A2031A A2032A A2033A A22001A A22002A A22003A A1931A A1932A A1933A

Compatible components

A20911A

A20903A

A20904A A20912A

A20922A

A20914A

A20934A

A2031A A2032A A2033A A22001A A22002A A22003A A1931A A1932A A1933A

A20924A

A20906A

A2031A A2032A A2033A A22001A A22002A A22003A A1931A A1932A A1933A

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Compatible components

A20907A A20915A

A20925A

A20916A

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A20910A

A20930A

A20908A

A20931A

A20909A

A2031A A2032A A2033A A22001A A22002A A22003A A1931A A1932A A1933A

Before use

4 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.

4.1 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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Before use

4.2 Assembly of sheath Attach the telescope (only optical obturators A20922A, A20923A, A20924A, A20925A, A2922, A2923, A2924, A2925)

•• Insert a compatible telescope through the telescope channel of the optical obturator. •• Make sure that the connector pin clicks securely into position. Insert the obturator

•• Select a compatible cystoscope sheath. •• Insert the obturator into the cystoscope sheath. •• Make sure that the red dots on the cystoscope sheath and on the obturator are aligned. •• Turn the lever on the cystoscope sheath’s locking ring clockwise until it stops. •• Make sure that the obturator locks into position.

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Use

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

5.1 Preparation Insert the sheath •• Apply a sterile medical grade water soluble lubricant to the sheath. •• Insert the sheath into the patient. •• Remove the obturator from the sheath. •• Insert a compatible bridge or working insert. •• Perform any necessary irrigation.

5.2 Procedure Procedure •• Perform the procedure.

5.3 After use Withdrawal •• Close the stopcocks. •• Remove the bridge or working insert. •• Insert a compatible obturator. •• Remove the sheath from the patient. •• Remove the obturator from the sheath. •• In the case of optical obturators: Remove the 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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Reprocessing

6 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. 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 A0402, A0403, A0404, A0405, A0406, A0407, A0408, A0409, A20902A, A20903A, A20904A, A20905A, A20906A, A20907A, A20908A, A20909A, A20910A, A20922A, A20923A, A20924A, A20925A, A2922, A2923, A2924, A2925

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Manual or automatic cleaning

+

Ultrasonic cleaning

+

Disinfection or high-level disinfection

+

Steam sterilization (autoclaving)

+

Heat sterilization (dry)

-

Gas sterilization (ETO)

+

Gas sterilization (formaldehyde)

+

STERRAD 50/100/100S

+

STERIS

+

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

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Repair

7 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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W7513850_2-0 2016-03-09 en

© Copyright 2016 Olympus Winter & Ibe GmbH