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OLYMPUS

OLYMPUS Bougie and Guiding Tubes Instruction for Use

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OLYMPUS Bougie and Guiding Tubes

16 Pages

INSTRUCTIONS FOR USE BOUGIE TUBES, GUIDING TUBES  WA33027A WA33028A WA37031A   Contents 1 General information... 5 1... Upon delivery... 6 1... Manufacturer...  6 2 Terminology...  7 3 Technical data... 9 4 Compatible components... 0 5 Before use...  11 5... Inspection and testing... 11 6 Use...  12 6... Procedure...  12 6... After use... 14 7 Reprocessing... 5 7... Cleaning... 16 8 Repair... 17
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File Name: OLYMPUS Bougie and Guiding Tubes Instruction for Use WA37031A March 2016.pdf
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OLYMPUS Bougie and Guiding Tubes Instruction for Use WA37031A March 2016.pdf

Page 1

INSTRUCTIONS FOR USE

BOUGIE TUBES, GUIDING TUBES

WA33027A

WA33028A

WA37031A

Page 3

Contents

1 General information................................................................. 5

1.1 Upon delivery.......................................................................... 6

1.2 Manufacturer........................................................................... 6

2 Terminology.............................................................................. 7

3 Technical data.......................................................................... 9

4 Compatible components....................................................... 10

5 Before use.............................................................................. 11

5.1 Inspection and testing........................................................... 11

6 Use.......................................................................................... 12

6.1 Procedure.............................................................................. 12

6.2 After use................................................................................ 14

7 Reprocessing......................................................................... 15

7.1 Cleaning................................................................................ 16

8 Repair...................................................................................... 17

Page 5

General information

1 General information

Intended use

WA33027A

Set of bougie tubes for use in percutaneous nephroscopy.

WA33028A

Guiding tube for use in conjunction with the WA33027A set of

bougie tubes.

WA37031A

Guiding tube for use in conjunction with the WA33027A set of

bougie tubes in pediatric 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 with Olympus telescopes).

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.

5

Page 6

General information

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

Page 7

Terminology

2 Terminology

WA33027A

1)

2)

3)

4)

5)

Distal opening of guiding tube

Guiding tube

Bougie tubes 1-8

Indication of French size

Number of bougie tube

WA33028A

1) Distal end

7

Page 8

Terminology

2) Proximal end

3) Channel for guide wire

WA37031A

1) Distal end

2) Indication of French size

3) Proximal end

8

Page 9

Technical data

3 Technical data

Diameter

WA33027A......................................................................... 9–28 Fr.

WA33028A............................................................................. 21 Fr.

WA37031A.......................................................................... 13.5 Fr.

9

Page 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

WA33027A

≤ 23 Fr./Ch. (no./Nr. 6)

WA33028A

WA33027A

≤ 15 Fr./Ch. (no./Nr. 3)

WA33027A

≤ 25 Fr./Ch. (no./Nr. 7)

WA33027A

≤ 12 Fr./Ch. (no./Nr. 2)

WA33038A

WA37031A

A37022A

WA33028A

∅ ≤ 3 Fr./ Ch.

10

Page 11

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

Damaged product

If the product is damaged or does not function properly, contact

an Olympus representative or an authorized service center.

11

Page 12

Use

6 Use

Before use

Make sure that the product has been properly reprocessed,

inspected, and tested.

6.1 Procedure

Placing the guide wire

1) Assisted by X-ray and ultrasound, insert a hollow needle and

advance it into the renal pelvis.

2) Insert a compatible guide wire into the hollow needle and

advance it into the renal pelvis.

3) Remove the hollow needle.

12

Page 13

Use

Inserting the bougie tubes

1) Remove the bougie tubes from the guiding tube (only for

WA33027A).

2) Insert the guide wire’s end into the distal opening of the

guiding tube.

3) Advance the guiding tube into the renal pelvis.

4) Successively insert the required amount of bougie tubes over

the guiding tube to dilate the puncture to the required width.

Placing a second guide wire (not for WA37031A)

•• Insert the WA33028A guiding tube after bougie tube no. 3.

•• Insert a compatible guide wire into the guiding tube’s channel

and advance it into the renal pelvis.

•• Remove the WA33028A guiding tube.

Use of WA37031A (pediatric percutaneous nephroscopy)

•• Insert the WA37031A guiding tube after bougie tube no. 2.

13

Page 14

Use

Insert the sheath

•• Insert a compatible sheath over the bougie tubes into the

patient (refer to the sheath’s instruction manual).

•• Remove the bougie tubes from the sheath.

6.2 After use

Withdrawal

•• Withdraw the complete instrument from the patient.

Reprocessing

•• Immediately bring the product to the reprocessing area.

•• Reprocess the product following the instructions in this manual

and in the System Guide Endoscopy.

14

Page 15

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 Olympus

Endoscopy System Guide.

+

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

+

15

Page 16

Reprocessing

CAUTION!

Risk of damaging the product

Do not use incompatible reprocessing methods. Product damage

may occur.

7.1 Cleaning

Cleaning the bougie tubes and guiding tubes

•• Clean the inside of each bougie tube and of the WA33028A

and WA37031A guiding tubes with suitable cleaning brushes.

•• Use the A0452 cleaning brush to clean the guiding tube of

WA33027A.

16

Page 17

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.

17

Page 20

W7514750_1-0

2016-03-18

en

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