Hysteroresectoscope Instructions for Use

Contents 1 General information... 5 1.1 Upon delivery... 5 1.2 Manufacturer... 6 2 Terminology... 7 3 Compatible components... 9 4 Before use... 11 4.1 Inspection and testing... 11 4.2 Sheath assembly with optical obturator... 12 4.3 Sheath assembly with standard obturator... 13 5 Use... 15 5.1 Insertion... 15 5.2 Hysteroresection... 17 5.3 After use... 18 6 Reprocessing... 19 6.1 Maintenance... 20 7 Repair... 21

General information

1 General information Intended use This product has been designed for endoscopic diagnosis and treatment in gynecological 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. 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. 5

General information •• Contact your Olympus representative or an authorized service center if any items are missing or damaged. Outer sheath A4740 •• Outer sheath •• Instruction manual Inner sheath A4741 •• Inner sheath •• Obturator •• Instruction manual Optical obturator A4742 •• Optical 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 Outer sheath

1) 2) 3) 4) 5) 6) 7) 8)

Distal end Sheath Irrigation stopcock Luer-lock connector Inflow port Outflow port Locking ring Color code: green 24 Fr.

Inner sheath

1) Distal end 2) Insulation 7

Terminology 3) 4) 5) 6)

Bypass holes Sheath Color code: green 22.5 Fr. Automatic locking ring

Optical obturator

1) 2) 3) 4)

Distal end Bypass holes Color code: green 22.5 Fr. Telescope channel

Obturator

1) Distal end 2) Handle 3) Color code: green

8

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.

A4742

A4673A

A4740

A4743

*

*7 Fr. instruments

9

Compatible components

A4744 A4745

A4741

A4740

A0418

A2663

A0480

A4741 A4742

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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 Ceramic insulation at distal end (of A4741)

Visually inspect the sheath’s ceramic insulation at the distal end before each use. Do not use the instrument in case of damage (e.g. cracks, fractures). WARNING Risk of injury Impact, fall, shock, or similar stress can result in damage of the ceramic insulation at the sheath’s distal end. Damaged instruments can cause injuries of the patient and/or user. Do not use the instrument if damaged. Damaged product If the product is damaged or does not function properly, contact an Olympus representative or an authorized service center. 11

Before use

4.2 Sheath assembly with optical obturator Assembly of the optical obturator

•• Insert a compatible telescope into the telescope channel of the obturator. •• Align the telescope’s connector pin and advance the telescope. •• Make sure that the connector pin clicks securely into position. Assembly of the sheath

•• Open the outer sheath’s locking ring by turning it counterclockwise.

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Before use •• Insert the optical obturator and the telescope into the locking ring until it stops. •• Turn the lever on the outer sheath’s locking ring clockwise until it stops and make sure that the optical obturator locks into position.

4.3 Sheath assembly with standard obturator Insert the obturator

•• Insert a compatible obturator into the inner sheath. •• Make sure that the red dots on the inner sheath’s automatic locking ring and on the obturator are aligned. •• Press the obturator into the inner sheath’s automatic locking ring until it is securely attached.

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Before use Assembly of the sheath

•• Open the outer sheath’s locking ring by turning it counterclockwise. •• Insert the inner sheath and obturator into the locking ring until it stops. •• Turn the lever on the outer sheath’s locking ring clockwise until it stops and make sure that the inner sheath locks into position.

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Use

5 Use Before use Make sure that the product has been properly reprocessed, inspected, and tested. DANGER Water intoxication During prolonged procedures, the combination of open blood vessels and certain pressure conditions can cause irrigation fluid to be absorbed into the circulation system (creating a water intoxication condition called TUR-syndrome or fluid overloadsyndrome). Water intoxication presents a lethal condition to the patient. DANGER Air embolism Prevent any air flow into the uterus.There is a risk of air embolism, which is a lethal condition for the patient.

5.1 Insertion Tubing connections

O0103

Use the O0103 adapter to connect the tubing to the Luer-lock connectors. The tubing can also be connected directly.

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Use Connect the irrigation tubing

•• Close the irrigation stopcocks. •• Connect the inflow tube to the inflow port. •• Connect the outflow tube to the outflow port. Insert the outer sheath •• Dilate the patient, if necessary. •• Fill the instrument’s inflow channel with irrigation fluid. •• Insert the outer sheath into the patient. •• When using the optical obturator, open the irrigation stopcocks and perform the necessary distension. WARNING Risk of injury To prevent burns caused by HF current: use non-conductive distension fluid only. Withdraw the optical obturator •• Close the inflow stopcock. •• Open the outer sheath’s locking ring by turning it counterclockwise. •• Remove the optical obturator and the telescope from the outer sheath. •• Insert a compatible inner sheath into the outer sheath until it stops. •• Turn the lever on the outer sheath’s locking ring clockwise until it stops and make sure that the inner sheath locks into position.

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Use Withdraw the standard obturator •• Press the red dot on the inner sheath’s automatic locking ring to unlock the mechanism. •• Remove the standard obturator from the inner sheath.

5.2 Hysteroresection Insert the working element

•• Close the inflow stopcock. •• Insert a compatible working element, with a telescope, and HF electrode into the inner sheath. •• Make sure that the red dots on the inner sheath’s automatic locking ring and on the working element are aligned. •• Press the working element into the automatic locking ring until it is securely attached. •• Open the inflow stopcock. DANGER Risk of death or serious injury Improper use of HF current can cause endogenous or exogenous burns, and explosions. Thoroughly review the HF current safety information included in the System Guide Endoscopy. Rotation The outer sheath remains stationary inside the patient. The inner sheath together with working element, HF electrode, and telescope can be rotated inside the outer sheath.

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Use Procedure •• Perform the procedure.

5.3 After use Withdrawal •• Close the irrigation stopcocks. •• Withdraw the instrument from the patient. •• Disassemble the instrument. 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. 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 A4740 A4741 A4742

Manual or automatic cleaning

+

Ultrasonic cleaning

+

Disinfection or high-level disinfection

+

Steam sterilization (autoclaving)

+

Heat sterilization (dry)

–

Gas sterilization (ETO)

+

Gas sterilization (formaldehyde)

+

STERRAD

+

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

•• Lubricate the areas indicated by arrows. •• Use only Olympus A0273. Apply lubricant sparingly. Sealing rings (only for A4741, A4742)

•• If damaged, replace the sealing rings with compatible sealing rings. •• Refer to the sealing rings’ instruction manual.

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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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© Copyright 2017 Olympus Winter & Ibe GmbH