Hysteroscope Sheaths Instructions for Use

Contents 1 General Information... 5 1.1 Upon delivery... 5 1.2 Manufacturer... 6 2 Terminology... 7 3 Technical data... 9 4 Compatible components... 10 5 Before use... 13 5.1 Inspection and testing... 13 6 Use... 14 6.1 Insertion... 15 6.2 After use... 18 7 Reprocessing... 19 7.1 Cleaning... 20 7.2 Maintenance... 20 8 Repair... 21

General Information

1 General Information Intended use 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.

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. 5

General Information 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

6

Terminology

2 Terminology Sheath A4771, A4772, A4773, A4776

1) 2) 3) 4)

Distal end Inflow stopcock Outflow stopcock Instrument stopcock

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

7

Terminology Sheath A4770, A4775

1) Distal end 2) Telescope channel 3) Irrigation stopcock

8

Technical data

3 Technical data Single flow system A4770, A4775 Continuous flow system A4771, A4772, A4773, A4776 Working channel A4771... 3 Fr. A4772, A4776... 5 Fr. A4773�������������������������������������������������������������������������������������� 7 Fr. Sheath diameter A4770... 4.0 mm A4771, A4776... 4.5 mm A4772... 5.5 mm A4773... 6.5 mm A4775... 3 mm Working length A4770, A4775... 255 mm A4771, A4772, A4773, A4776... 187 mm

9

Compatible components

4 Compatible components

A4775

A4676A A4677A A4776

A4770 A4771 A4772 A4773*

10

A4673A A4674A

Compatible components

A4771

Ø 3 Fr. **

A4772

Ø 5 Fr. **

A4776

A4773*

Ø 7 Fr. **

* Not available in the US ** semiflexible

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Compatible components Sheath

Sealing cap

Instrument size [Fr.]

A4771

A0310

3

gray

A4772, A4776

A0313

5

black

A4773*

A0282

7

transparent

*Not available in the U.S. A0310

A0313

A0282

12

Color code

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, especially the instrument’s distal part, is free of corrosion, dents, scratches, and cracks. •• Make sure that the sealing cap (only for A4771, A4772, A4773, A4776) is not damaged. Test the instrument •• Make sure that the stopcocks open and close smoothly. 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 highviscosity 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 overload‑syndrome). 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 (not for A4775, A4776)

•• Insert a compatible telescope into the telescope channel of the hysteroscope sheath until it stops. •• Make sure that the connector pin clicks securely into position. Insert the telescope (only for A4775, A4776)

•• Make sure that the two red dots/black arrows on the sheath are aligned. •• Insert the telescope’s locking cone into the sheath’s telescope channel. Make sure that the red dot/black arrow on the telescope’s locking cone and on the sheath’s locking ring are aligned. •• Turn the locking lever to lock the telescope inside the sheath.

15

Use Tubing connections

O0103

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

•• Close the irrigation stopcocks. •• Connect the inflow tubing to the inflow stopcock. •• Connect the outflow tubing to the outflow stopcock (not for A4770, A4775). 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.

16

Use Insert a surgical instrument (not in the case of A4770, A4775)

•• Select a compatible semiflexible surgical instrument. •• 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. •• 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. 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.

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Use Intervention •• Perform the intervention.

6.2 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. Withdrawing the surgical instrument (not in the case of A4770, A4775) •• When using surgical instruments with jaws, close the jaws. •• Withdraw the surgical instrument from the working channel of the hysteroscope sheath 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 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

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 has been microbiologically validated and/or tested for its material compatibility with the reprocessing methods listed in the table. For details of the procedures, refer to the System Guide Endoscopy. + –

compatible incompatible A4770, A4771, A4772, A4773, A4775, A4776

Manual or automatic cleaning

+

Ultrasonic cleaning

+

Disinfection or high-level disinfection

+

Steam sterilization (autoclaving)

+

Heat sterilization (dry)

–

Gas sterilization (ETO)

+

Gas sterilization (H-CHO)

+

STERRAD 100S

+

STERIS

+

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

7.1 Cleaning Cleaning brushes We recommend to use cleaning brushes A0444 (4 x 500 mm) and A0446 (4 x 400 mm) for the telescope channel and A0452 (1 x 700 mm) for the working channel/outflow channel. NOTE Continuous flow sheaths (A4771, A4772, A4773, A4776) Special care must be taken to clean the continuous flow sheaths’ working channel/outflow channel.

7.2 Maintenance Reusable sealing cap A0310

If damaged, replace the sealing cap on the working channel of the hysteroscope sheath with a compatible sealing cap.

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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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W9214265_00 2016-12-28 en

© Copyright 2016 Olympus Winter & Ibe GmbH