Hysteroscope Sheaths Instructions for Use

Contents 1 General information... 5 1.1 Upon delivery... 6 1.2 Manufacturer... 6 2 Terminology... 7 3 Technical data... 12 4 Compatible components... 13 5 Before use... 16 5.1 Inspection and testing... 16 6 Use... 17 6.1 Insertion... 18 6.2 Procedure... 21 6.3 After use... 21 7 Reprocessing... 23 7.1 Cleaning... 24 7.2 Maintenance... 24 8 Repair... 26

General information

1 General information Intended use A4760, A4761, A4763, A4764, A4765, A4766, A47610A Hysteroscope sheaths 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. 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 of the items listed below. •• Contact your Olympus representative or an authorized service center if any items are missing or damaged. Unpacking •• Remove the instrument 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 Sheath A4761

1) 2) 3) 4)

Distal end Inflow stopcock Outflow stopcock Instrument stopcock

5) Working channel 6) Telescope channel 7) Sealing cap

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Terminology Sheath A47610A

1) 2) 3) 4)

Distal end Inflow stopcock Outflow stopcock Instrument stopcock

5) Working channel 6) Telescope channel 7) Sealing cap Sheath A4760

1) Distal end 8

Terminology 2) Telescope channel 3) Irrigation stopcock Sheath A4763

1) Distal end 2) Outflow stopcock 3) Locking ring Working insert A4764

1) 2) 3) 4)

Ramp Working channel Instrument stopcock Sealing cap

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Terminology 5) Telescope channel

6) Locking cone 7) Inflow stopcock Working insert A4765

1) 2) 3) 4) 5)

Albarran lever Working channel Instrument stopcock Sealing cap Telescope channel

6) Locking cone 7) Inflow stopcock 10

Terminology 8) Operating levers of Albarran Optical obturator A4766

1) 2) 3) 4)

Distal end Locking cone Inflow stopcock Telescope channel

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Technical data

3 Technical data Single flow system A4760 Continuous flow system A4761, A47610A Working channel A4761... 3 Fr. A47610A... 5 Fr. A4764... 7 Fr. A4765... 7 Fr. Sheath diameter A4760... 5.0 mm A4761... 5.5 mm A47610A... 6.5 mm A4763... 8.0 mm Working length A4760... 255.0 mm A4761... 187.0 mm A47610A... 187.0 mm A4763... 187.5 mm A4764... 198.0 mm A4765... 198.0 mm A4766... 202.0 mm A4767... 285.0 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.

A4760 A4761 A47610A

A4767

A4764 A4765

A1931A A1935A A2031A A4629A

A4763

A4766

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Compatible components Sheath

Sealing cap

Instrument size [Fr.]

A4761

A0310

3

gray

A47610A

A0313

5

black

A4764 A4765

A0282

7

transparent

A0310

A0313

A0282

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Color code

Compatible components

A4761

*

A47610A

**

A4764

***

A4765

****

*Ø 3 Fr. semiflexible ** Ø 5 Fr. semiflexible *** Ø 7 Fr. semiflexible **** Ø 7 Fr. flexible 15

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 Inspect the instrument Visually inspect the instrument: •• Make sure that the instrument is free of corrosion, dents, and scratches. •• Make sure that the sealing cap (only for A4761, A47610A, A4764, A4765) is not damaged. Test the instrument •• Make sure that the stopcocks open and close smoothly (not for A4767). •• Using the operating levers, make sure that the Albarran lever (only for A4765) moves easily. 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. Distension medium This instrument has been designed for the use of gaseous as well as high-viscosity or low-viscosity fluid distension media. The distension medium used must comply with national pharmaceutical regulations. 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 Gas embolism Uncontrolled inflow of the gaseous distension medium can create a lethal embolism. For distension of the uterine cavity with carbon dioxide gas, use only insufflators with a maximum flow rate of 100 ml/min. The use of a laparoscopic insufflator can result in a lethal injury to the patient. Never use other systems with active delivery of gases during endoscopy. Such systems may include: lasers with probe tips cooled using CO2 or other gases, and Argon-Enhanced Coagulation Systems (AEC). DANGER Anaphylactic shock When a dextran solution is used as distension medium, there is a risk of an anaphylactic shock.

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Use

6.1 Insertion Insert the telescope

•• Insert a compatible telescope into the telescope channel of the inner sheath, working insert, or optical obturator until it stops. •• Make sure that the connector pin clicks securely into position. Outer sheath (for A4764, A4765, A4766) •• Use the operating lever to bring the Albarran lever (for A4765) into a horizontal position. •• Insert the working insert or optical obturator with the telescope into the compatible outer sheath. •• Make sure that the red dots on the outer sheath’s locking ring and on the locking cone of working insert or obturator are aligned. •• Turn the lever on the outer sheath’s locking ring clockwise until it stops and make sure that the working insert or obturator locks into the sheath. 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 tubing to the inflow stopcock (not for A4763). •• Connect the outflow tubing to the outflow stocpcock (not for A4760, A4764, A4765, A4766). Insert the hysteroscope sheath •• Dilate the patient, if necessary. •• Open the inflow stopcock. •• Insert the hysteroscope sheath into the patient. •• Perform the necessary distension. •• When using continuous flow sheaths with fluid distension media, open the outflow stopcock. CAUTION Risk of damaging the instrument Do not insert semiflexible surgical instruments into the working insert with Albarran (A4765).

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Use Insert a surgical instrument (only for A4761, A47610A, A4764, A4765)

•• Select a compatible semiflexible (not for A4765) or flexible surgical instrument. •• Use the operating lever to bring the Albarran lever (only for A4765) into a horizontal position. •• When using surgical instruments with jaws, close the jaws. •• Insert the distal end of the surgical instrument into the sealing cap on the working channel of the hysteroscope sheath or working insert. •• Open the instrument stopcock. •• Advance the surgical instrument further into the working channel until the distal end appears in the endoscopic image. CAUTION Risk of damaging the instrument Do not close the instrument stopcock when a surgical instrument is inserted.

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Use

6.2 Procedure Working insert with Albarran lever (A4765)

Use the operating lever of the Albarran, under visual control, to deflect the surgical instrument. 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. DANGER Risk of death or serious injury Improper use of lasers can cause burns, eye damage, and explosions. Thoroughly review the laser safety information included in the System Guide Endoscopy. Intervention •• Perform the intervention.

6.3 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.

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Use CAUTION Risk of damaging the instrument Make sure that the Albarran lever is in a horizontal position before withdrawing the working insert from the sheath. Withdrawing the surgical instrument (only for A4761, A47610A, A4764, A4765) •• Use the operating lever to bring the Albarran lever (only for A4765) into a horizontal position. •• When using surgical instruments with jaws, close the jaws. •• Withdraw the surgical instrument from the working channel of the hysteroscope sheath or working insert until its distal end is located in the sealing cap. •• Close the instrument stopcock. •• Withdraw the surgical instrument. Withdrawing the endoscope •• Close the irrigation stopcocks. •• Withdraw the complete assembly from the patient. •• Disassemble the instrument. Reprocessing •• Bring the instrument to the reprocessing area. •• Reprocess all equipment following the instructions in this manual and in the System Guide Endoscopy.

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