OUTER SHEATHS, WORKING SHEATH, GUIDING TUBE, OBTURATOR, ADAPTER Instructions for Use

Contents 1 General information... 5 1.1 Upon delivery ... 6 1.2 Manufacturer... 6 2 Terminology... 7 3 Technical data... 10 4 Compatible components... 11 5 Before use... 14 5.1 Inspection and testing... 14 6 Use... 15 6.1 Preparation... 15 6.2 Procedure... 17 6.3 After use... 21 7 Reprocessing... 22 7.1 Maintenance... 23 8 Repair... 24

General information

1 General information Intended use WA33035A, WA33037A Outer sheath for use in cystoscopy and percutaneous nephroscopy. WA33038A Working sheath for use in percutaneous nephroscopy. WA33025A Obturator for use in conjunction with the WA33035A and WA33037A outer sheaths. WA33040A Guiding tube for use in conjunction with a flexible cystoscope. WA33026A Adapter for use in cystoscopy, resectoscopy, and percutaneous nephroscopy. 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.

5

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 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

6

Terminology

2 Terminology Outer sheath WA33035A, WA33037A

1) 2) 3) 4)

Distal end Inflow stopcock Telescope release knobs Outflow stopcock

Working sheath WA33038A

1) Distal end 2) Sealing cap 3) Outflow stopcock

7

Terminology Guiding tube WA33040A

1) Distal end 2) Sealing cap 3) Sealing rings Obturator WA33025A

1) 2) 3) 4)

8

Handle Sealing cap Guide wire port Sealing ring

Technical data

3 Technical data Continuous flow system: WA33035A, WA33037A Sheath diameter WA33035A... 25 Fr. WA33037A... 25 Fr. WA33038A... 28 Fr. WA33040A... 21 Fr. Working length WA33035A... 229 mm WA33037A... 229 mm WA33038A... 177 mm WA33040A... 262 mm

10

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.

WA33035A WA33037A

WA33038A

WA33027A

WA33040A

CYF-3, CYF-4, CYF-5

11

Compatible components

WA33040A

WA33027A

WA33035A WA33037A

WA33026A

WA33025A

WA33036A

O3657

WA33026A

A0555

12

Compatible components

A22021A A22022A A22023A

A22024A A22025A A22026A

A22027A A42021A

WA33026A

Sheath

Sealing cap

Instrument size [Fr.]

WA33025A

O0131

4

WA33038A

A5858

25

WA33040A

A0206

17

13

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 Inspecting the product Visually inspect the product. Make sure that it has: -- no corrosion -- no dents -- no scratches •• Make sure that the sealing cap (only for WA33025A, WA33038A, WA33040A) is not damaged. Test the instrument •• Make sure that the stopcocks open and close smoothly (not for WA33025A, WA33026A, WA33040A). Damaged product If the product is damaged or does not function properly, contact an Olympus representative or an authorized service center.

14

Use

6 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.

6.1 Preparation Tubing connections

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

15

Use Connect the irrigation tubing (not for WA33025A, WA33026A, WA33040A)

•• Close the irrigation stopcocks. •• Connect the inflow tubing to the inflow stopcock (not for WA33038A). •• Connect the outflow tubing to the outflow stopcock. Connect an attachment to the OP telescope •• Connect a compatible attachment to the OP telescope (refer to the OP telescope’s instruction manual).

16

Use

6.2 Procedure Cystoscopy

•• Insert the obturator into the outer sheath. •• Insert the outer sheath with obturator into the patient. •• Remove the obturator from the outer sheath. •• Insert the OP telescope into the outer sheath. •• Press the OP telescope into the outer sheath until it clicks into position. Slightly rotate the OP telescope if it does not click into position right away.

17

Use Percutaneous nephroscopy (using the WA33036A OP telescope without working sheath)

•• Create a percutaneous access to the kidney and insert the outer sheath into the patient. •• Insert the OP telescope into the outer sheath. •• Press the OP telescope into the outer sheath until it clicks into position. Slightly rotate the OP telescope if it does not click into position right away. •• If necessary, insert a compatible surgical instrument through the attachment’s sealing cap (refer to the attachment’s instruction manual).

18

Use Percutaneous nephroscopy (using the WA33036A OP telescope with working sheath)

•• Create a percutaneous access to the kidney and insert the working sheath into the patient. •• Insert the OP telescope into the outer sheath or irrigation port. •• Press the OP telescope into the outer sheath or irrigation port until it clicks into position. Slightly rotate the OP telescope if it does not click into position right away. •• Insert the OP telescope with outer sheath or irrigation port into the working sheath. •• If necessary, insert a compatible surgical instrument through the attachment’s sealing cap (refer to the attachment’s instruction manual).

19

Use Percutaneous nephroscopy (using a flexible cystoscope)

•• Create a percutaneous access to the kidney and insert the outer sheath into the patient. •• Insert the guiding tube into the outer sheath. •• Press the guiding tube into the outer sheath until it clicks into position. Slightly rotate the guiding tube if it does not click into position right away. •• Insert a compatible flexible cystoscope through the guiding tube’s sealing cap. Use of an evacuator or a syringe for lavage

•• If applicable, remove the OP telescope from the outer sheath. •• Attach the WA33026A adapter to the outer sheath. •• Attach an A0555 syringe or an O3657 evacuator to the adapter’s connecting tubing. •• Perform lavage.

20

Use

6.3 After use Reprocessing •• Immediately bring the product to the reprocessing area. •• Reprocess the product following the instructions in this manual and in the System Guide Endoscopy.

21

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 is compatible with the reprocessing methods listed in the table. For details of the procedures, refer to the System Guide Endoscopy. + -

22

compatible incompatible

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.

7.1 Maintenance Sealing cap (only for WA33038A, WA33040A)

•• If damaged, replace the sealing cap with a compatible sealing cap (refer to the chapter “Compatible Components”). Sealing rings (only for WA33025A, WA33026A, WA33040A)

•• If damaged, replace the sealing rings with A00482A sealing ring set (refer to the sealing ring set’s instruction manual).

23