OBTURATORS Instructions for Use

Contents 1 General information... 5 1.1 Upon delivery... 6 1.2 Manufacturer... 6 2 Terminology... 7 3 Compatible components... 11 4 Before use... 14 4.1 Inspection and testing... 14 4.2 Assembly of sheath... 14 5 Use... 17 5.1 Preparation... 17 5.2 Using obturator A2634... 17 5.3 Resection... 18 5.4 After use... 19 6 Reprocessing... 21 6.1 Maintenance... 22 7 Repair... 23

General information

1 General information Intended use A0410, A0411, A0412, A22081A, A22082A, A22083A, A22085A, A22086A, A22087A, A2631, A2632, A2633, A2634, A2636, A2637, A2638 Obturator for endoscopic diagnosis and treatment in urologic and gynecologic applications. A22071A, A22072A, A22073A Optical obturator for endoscopic diagnosis and treatment in urologic applications. A42071A Optical obturator for endoscopic diagnosis and treatment in gynecologic 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.

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General information 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.

1.1 Upon delivery Inspect immediately •• Make sure that the shipping case contains all of the 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 Standard obturators A0410, A0411, A0412

1) Distal end 2) Handle 3) Color code: yellow 24 Fr., red 26 Fr., black 28 Fr. Standard obturators A22081A, A22082A, A22083A

1) 2) 3) 4)

Distal end Direction arrow Color code: yellow 24 Fr., red 26 Fr., violet 28 Fr. Handle

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Terminology Optical obturators A22071A, A22072A, A22073A

1) 2) 3) 4) 5)

Distal end Handle Telescope release buttons Color code: yellow 24 Fr., red 26 Fr., violet 28 Fr. Thumb rest

Optical obturator A42071A

1) Distal end 2) Telescope release buttons 3) Color code: yellow 24 Fr.

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Terminology Optical obturators A2631, A2632, A2633

1) Distal end 2) Handle 3) Color code: yellow 24 Fr., red 26 Fr., black 28 Fr. Optical obturator A2634, with 6 Fr. channel

1) 2) 3) 4) 5)

Distal end Handle Color code: yellow 24 Fr. Stopcock Channel port

Obturator with deflectable tip A2636, A2637, A2638

1) Distal end 9

Terminology 2) Handle 3) Color code: yellow 24 Fr., red 26 Fr., black 28 Fr. Obturator with deflectable tip A22085A, A22086A, A22087A

1) 2) 3) 4)

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Distal end Direction arrow Color code: yellow 24 Fr., red 26 Fr., violet 28 Fr. Handle

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.

A22081A

A22014A A22014T A22040A A22040T

A22041A A22041T A42011A

A22085A

A22071A

A2031A A2032A A2033A

A22001A A22002A A22003A

A2031A A2032A A2033A

A22001A A22002A A22003A

A22082A

A22042A A22042T

A22086A

A22072A

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Compatible components

A0411

A2642 A2642T

A2637

A2632

A2031A A2032A A2033A

A22001A A22002A A22003A

A2031A A2032A A2033A

A22001A A22002A A22003A

A2031A A2032A A2033A

A22001A A22002A A22003A

A22083A

A22043A A22043T

A22087A

A22073A

A0412

A2643 A2643T

A2638

A2633

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Compatible components

A42021A

A42071A

A2031A A2032A

A22001A A22002A

A0410

A2641 A2641T A4725

A2636

A2631

A2634

A2031A A2032A A2033A

A22001A A22002A A22003A

A2031A A2032A

A22001A A22002A

≤ 6 Fr. A0298 O0131

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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.

4.2 Assembly of sheath Attach the telescope (only optical obturators A22071A, A22072A, A22073A, A2631, A2632, A2633, A2634, A42071A)

•• Insert a compatible telescope into the telescope channel of the optical obturator. 14

Before use •• Make sure that the connector pin clicks securely into position. Attach a sealing cap (only for optical obturator A2634) •• Attach a compatible sealing cap to the obturator’s channel port. Insert the obturator (only when using A2641, A2642, A2643, A4725)

•• Select a compatible inner sheath. •• Insert the obturator into the inner sheath. •• Make sure that the red dots on the inner sheath and on the obturator are aligned. •• Press the obturator into the sheath’s automatic locking ring until it is securely attached. Insert the obturator (only when using A22040A, A22040T, A22041A, A22041T, A22042A, A22042T, A22043A, A22043T, A42011A)

•• Insert a compatible obturator into the resection sheath. •• Make sure that the arrow on the obturator is aligned with the resection sheath’s release knob. •• Press the obturator into the resection sheath’s automatic locking ring.

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Before use Insert the obturator A42071A

•• Insert the obturator into the outer sheath. •• Press the obturator into the outer sheath’s automatic locking ring. Complete the resectoscope Attach an irrigation port or an outer sheath to the inner sheath. Refer to the sheath’s instruction manual.

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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 sterile, conductive medical-grade lubricant to the sheath. •• Open the stopcocks. •• Insert the sheath into the patient. •• Perform necessary irrigation or distension. WARNING (A2636, A2637, A2638, A22085A, A22086A, A22087A) A damaged sheath can cause injury to the urethra. If the obturator’s distal end does not move when inserted into the patient, do not try to remove the obturator from the sheath. Remove the entire sheath/obturator assembly from the patient. Otherwise the sheath’s distal end may be damaged.

5.2 Using obturator A2634 Insertion of surgical instruments

≤ 6 Fr.

•• Select a compatible surgical instrument. •• Close its jaws. •• Insert the surgical instrument’s distal end into the sealing cap’s proximal opening. •• Open the obturator’s stopcock.

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Use •• Advance the surgical instrument under visual control until its distal end is visible through the telescope. •• Perform the intervention. Withdrawal of surgical instruments •• Close the surgical instrument’s jaws. •• Withdraw the surgical instrument. •• Close the obturator’s stopcock. CAUTION Risk of damage Always insert and withdraw surgical instruments with their jaws closed. Do not withdraw surgical instruments forcibly. Do not close the obturator’s stopcock when a surgical instrument is inserted.

5.3 Resection Insert the working element (not for A22060A, A22061A, A22063A, A22065A)

•• Press down the sheath’s locking ring. •• Remove the obturator from the sheath. •• Insert the working element and tele­scope into the sheath. •• Make sure that the red dots on the sheath’s locking ring and on the working element are aligned. •• Press the working element into the sheath’s automatic locking ring until it is securely attached.

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Use Insert the working element (only for A22060A, A22061A, A22063A, A22065A)

•• Press the resection sheath’s release knob, and remove the obturator from the resection sheath. •• Insert the working element and telescope into the resection sheath. •• Make sure that the arrow on the working element’s locking cone is aligned with the resection sheath’s release knob. •• Press the working element’s locking cone into the resection sheath’s automatic locking ring. Procedure •• Perform the procedure.

5.4 After use Withdrawal •• Close all stopcocks. •• Remove working element with resec­tion electrode and telescope. •• Remove the sheath from the patient. Remove the telescope from the obturator •• Press the obturator’s telescope release buttons (only for A22071A, A22072A, A22073A, A42071A). •• Withdraw the telescope from the obturator. Reprocessing •• Immediately bring the product to the reprocessing area.

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Use •• 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. 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 A2631, A2632, A2633, A2634 A2636, A2637, A2638, A0410, A0411, A0412, A22071A, A22072A, A22073A, A22081A, A22082A, A22083A, A22085A, A22086A, A22087A, A42071A

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

+

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

6.1 Maintenance Lubrication (A22085A, A22086A, A22087A, A2636, A2637, A2638)

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

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