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CONTENTS

1 General Information............................................................. 5

1.1 User Instructions.......................................................... 5

1.2 Signal Words............................................................... 5

1.3 Conventions................................................................. 6

1.4 Trademarks.................................................................. 6

1.5 Manufacturer................................................................ 6

2 Safety Information................................................................ 7

2.1 Intended Use............................................................... 7

2.2 Contraindications......................................................... 7

2.3 User Qualification........................................................ 8

2.4 Environment of Use..................................................... 8

2.5 General Warnings and Cautions.................................. 9

3 Upon Delivery.................................................................... 12

4 Product Description............................................................ 14

4.1 Ureteroscope............................................................. 14

4.2 Attachment................................................................. 22

4.3 Symbols..................................................................... 25

4.4 Warranty.................................................................... 27

5 Preparation........................................................................ 28

5.1 Safety Information for Preparation............................. 28

5.2 Inspection.................................................................. 28

5.3 Assembly and Connection......................................... 30

6 Use.................................................................................... 35

6.1 Safety Information for Use......................................... 35

6.2 Inserting the Surgical Instrument .............................. 37

7 After Use............................................................................ 40

8 Reprocessing..................................................................... 41

8.1 Safety Information for Reprocessing.......................... 41

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8.2

8.3

8.4

8.5

8.6

General Information for Reprocessing....................... 42

Manual Cleaning........................................................ 45

Automated Cleaning and Disinfection........................ 47

Maintenance.............................................................. 49

Sterilization................................................................ 49

9 Repair and Disposal........................................................... 51

9.1 Repair........................................................................ 51

9.2 Disposal..................................................................... 52

10 Compatible Equipment...................................................... 53

11 Technical Data................................................................... 55

11.1 General Dimensions.................................................. 55

11.2 Dimensions for Reprocessing.................................... 61

11.3 Specifications............................................................. 65

11.4 Classification of ME Equipment and ME Systems..... 65

11.5 Ambient Conditions.................................................... 65

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1 General Information

1.1 User Instructions

The complete set of instructions for use for this product

consists of the product-specific instructions for use (this

document) and the system-related instructions for use

“System Guide Endoscopy”.

• Before use, thoroughly read these instructions for use, the

“System Guide Endoscopy”, and the instructions for use of

all other products that will be used during the procedure.

• Use the instructions in this document if the instructions differ

from the “System Guide Endoscopy”.

• If the required instructions for use are missing, immediately

contact an Olympus representative.

• Keep the instructions for use in a safe, accessible location.

1.2 Signal Words

The following signal words are used throughout this

document.

WARNING

Indicates a potentially hazardous situation which, if not

avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not

avoided, may result in minor or moderate injury.

NOTICE

Indicates a property damage message.

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1.3 Conventions

This is the safety alert symbol. It is used to alert the user to

potential physical injury hazards. Observe all safety messages

that follow this symbol to avoid possible injury.

1. A numeration indicates a sequence of actions.

2.

• Bullet points indicate individual actions or different options

for action.

-- Dashes indicate the listing of data, options or objects.

1) Numbers with right parenthesis name elements in

illustrations.

1.4 Trademarks

-- STERRAD®

-- NXTM

are trademarks of their respective owner.

1.5 Manufacturer

Olympus Winter & Ibe GmbH

Kuehnstr. 61

22045 Hamburg

Germany

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2 Safety Information

2.1 Intended Use

Ureteroscope

WA02943A, WA02944A, WA02946A, WA29040A,

WA29040B, WA29041A, WA29041B, WA29042A,

WA29042B, WA29048A, WA29048B, WA29049A,

WA29049B

Semi-rigid optical instrument for the visualization of the

following diagnostic and therapeutic procedures:

-- Transurethral inspection of the ureters and the kidneys for

diagnosis

-- Transurethral insertion of catheters, guide wires, cannulas,

forceps and electrodes into the urethra, the urinary bladder

and the ureters

-- Transurethral treatment and removal of tissue, catheters,

guide wires, debris and stones from the urethra, the urinary

bladder and the ureters

-- Transurethral treatment and removal of tissue and stones

from the ureters and the kidneys

• Do not use for any other purposes.

Attachment

A0395, A0396, WA00395A, WA00396A

Attachment for use in combination with a compatible

ureteroscope for the following applications:

-- Connection of the irrigation tubing

-- Insertion of compatible instruments

• Do not use for any other purposes.

2.2 Contraindications

There are no known contraindications.

The intended use and contraindications of the equipment

used in combination with the ureteroscope must be observed.

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2.3 User Qualification

Medical use

This product is only intended to be used by a trained physician

or trained qualified medical personnel under the supervision

of a physician.

These instructions for use do not explain or discuss clinical

procedures.

Reprocessing

Reprocessing of the product may only be performed by

qualified hygiene personnel.

Repair

Repair of the product may only be performed by trained

qualified servicing personnel that has been authorized by

Olympus.

Otherwise, Olympus cannot be held responsible for the safety

and performance of the product.

2.4 Environment of Use

Medical use

This product is only intended to be used in hospitals and

medical rooms with appropriate endoscopic equipment.

Reprocessing

This product must be reprocessed according to the applicable

national and local standards and regulations.

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2.5 General Warnings and Cautions

The following warnings and cautions apply to the

general handling of the product. This information is to be

supplemented by the dangers, warnings and cautions given

in each chapter in this document, in the “System Guide

Endoscopy” or in the instructions for use of any product being

used with this product.

WARNING

Risk of injury to the patient and/or the user

An insufficient understanding of the dangers, warnings,

cautions, and instructions can result in serious injury and/or

damage to the product.

• Make sure to have the complete set of instructions for use.

• Follow the dangers, warnings, cautions, and instructions in

the “System Guide Endoscopy”.

• In case of conflicting information, follow the dangers,

warnings, cautions, and instructions in this document.

WARNING

Risk of injury to the patient and/or the user

The use of a damaged product or of a product with improper

functioning may cause an electric shock, mechanical injury,

infection, and/or thermal injury.

• Before each use, observe the instructions in the section

“Inspection” in this document.

• Do not use a damaged product or a product with improper

functioning.

• Replace a damaged product or a product with improper

functioning.

WARNING

Risk of injury to the patient

There is a risk of an electric shock when using endoscopic

equipment or when using endoscopic equipment in

combination with energized endotherapy devices. The patient

leakage currents may be additive.

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• Before each use, check the applied part classification of

the endoscopic equipment and especially the energized

endotherapy devices used during the procedure.

• Only use endoscopic equipment or endoscopic equipment

in combination with energized endotherapy devices that

meet at least the same requirements of applied part

classification.

This is particularly important if a type CF applied part

endoscope is used. In this case a type CF applied part

energized endotherapy device should be used to minimize

total leakage current.

• For the applied part classification, refer to the respective

instructions for use.

WARNING

Risk of injury to the patient

There is a risk of electric shock when using light sources with

noninsulated light-guide connectors.

• Only use light sources or light-guide cables that meet at

least the same requirements of applied part classification.

• For the applied part classification, refer to the respective

instructions for use.

WARNING

Risk of injury to the patient

There is a risk of injury to the patient due to malfunction of the

equipment.

• Always have spare equipment available.

WARNING

Risk of injury to the patient and/or the user

There is a risk of injury to the patient and/or the user caused

by unauthorized repairs and product modification. Possible

injuries include mechanical injuries, electric shock, burns, and

toxication.

• Repairs may only be performed by qualified servicing

personnel that has been authorized by Olympus.

• Contact your Olympus representative or an authorized

service center for repair information.

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CAUTION

Risk of injury to the patient and/or the user

Using incompatible equipment may lead to injury of the

patient and/or the user as well as damage to the product.

• Only use compatible equipment as listed in the chapter

“Compatible Equipment” in this document.

NOTICE

Risk of damage to the product

The endoscope is a precise optical device. Careless handling

may damage the endoscope.

• Always handle the endoscope with care.

• Do not hold the endoscope by the distal end only.

• Do not bend the insertion tube.

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3 Upon Delivery

• Make sure that the shipping case contains all of the items

listed below.

• Contact an Olympus representative or an authorized service

center if any items are missing or damaged.

Contents

WA02943A, WA02944A, WA02946A

-- Ureteroscope (with light-guide adapter O0332 and A0460)

-- Instrument tray A5961

-- Instructions for use

-- System Guide Endoscopy

Contents

WA29040A, WA29041A, WA29048A, WA29049A

-- Ureteroscope

-- Instrument tray A5961

-- Attachment WA00395A

-- Sealing caps WA00387A

-- Instructions for use

-- System Guide Endoscopy

Contents

WA29040B, WA29041B, WA29048B, WA29049B

-- Ureteroscope

-- Instrument tray A5961

-- Attachment A0395

-- Sealing caps A0387

-- Instructions for use

-- System Guide Endoscopy

Contents

WA29042A

-- Ureteroscope

-- Instrument tray A5961

-- Attachment WA00396A

-- Sealing caps WA00387A

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-- Instructions for use

-- System Guide Endoscopy

Contents

WA29042B

-- Ureteroscope

-- Instrument tray A5961

-- Attachment A0396

-- Sealing caps A0387

-- Instructions for use

-- System Guide Endoscopy

Contents

A0395, A0396

-- Attachment

-- Sealing caps A0387

-- Access information sheet

Contents

WA00395A, WA00396A

-- Attachment

-- Access information sheet

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4 Product Description

4.1 Ureteroscope

A semi-rigid endoscope designed for the visualization of

diagnostic and therapeutic procedures.

There are single-channel ureteroscopes and dual-channel

ureteroscopes.

An image relay system of fiber bundles transmits the

endoscopic image.

A bundle of optical fibers transmits light from an external light

source to illuminate the endoscopic image.

Ureteroscopes are precise optical devices which are very

sensitive to mechanical impacts.

Entire ureteroscope

WA02943A

WA02944A

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WA02946A

WA29040A, WA29040B

WA29041A, WA29041B

WA29042A, WA29042B

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WA29048A, WA29048B

WA29049A, WA29049B

4.1.1 Ureteroscope WA02943A

1)

2)

3)

4)

Insertion tube

Light-guide adapter A0460

Light-guide adapter O0332

Light-guide connector

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5) Eyepiece cup

6) Finger rest

7) Instrument/irrigation port

8) Instrument/irrigation port

9) Finger rest

10) Blue ring

4.1.2 Ureteroscope WA02944A, WA02946A

1) Insertion tube

2) Light-guide adapter A0460

3) Light-guide adapter O0332

4) Light-guide connector

5) Finger rest

6) Eyepiece cup

7) Instrument/irrigation port

8) Instrument/irrigation port

9) Finger rest

10) Blue ring

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4.1.3 Ureteroscope WA29040A, WA29040B, WA29041A,

WA29041B, WA29042A, WA29042B

1)

2)

3)

4)

5)

6)

7)

Insertion tube

Light-guide connector

Eyepiece cup

Finger rest

Locking ring

Finger rest

Blue ring

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4.1.4 Ureteroscope WA29048A, WA29048B, WA29049A,

WA29049B

1)

2)

3)

4)

5)

6)

7)

Insertion tube

Light-guide connector

Finger rest

Eyepiece cup

Locking ring

Finger rest

Blue ring

4.1.5 Distal End

1) Instrument channel

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2) Objective cover glass

3) Light emission surface

4.1.6 Eyepiece Cup

1) Eyepiece cover glass

4.1.7 Light-Guide Connector

1) Light admission surface

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4.1.8 Direction of View and Minimum Instrument

Channel Width

WA02943A, WA02944A, WA02946A

-- The direction of view is indicated in degree under the

eyepiece cup.

-- The minimum instrument channel width is indicated in

French on the instrument/irrigation port.

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54

WA29040A, WA29040B, WA29041A, WA29041B,

WA29042A, WA29042B, WA29048A, WA29048B,

WA29049A, WA29049B

-- The direction of view is indicated in degree under the

eyepiece cup.

-- The minimum instrument channel width is indicated in

French on the locking ring.

4.2 Attachment

The attachment features Luer-Lock connectors (male) for the

connection of the irrigation tubing and the attachment of the

sealing cap(s). The instrument channel of the attachment

allows the insertion of surgical instruments. Stopcocks are

designed to control the flow of the irrigation fluid.

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4.2.1 Attachment A0395

1)

2)

3)

4)

5)

Locking cone

Stopcock

Sealing cap

Instrument channel

Irrigation port

4.2.2 Attachment A0396

1) Locking cone

2) Stopcock

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3) Sealing cap

4) Instrument channel

5) Irrigation port

4.2.3 Attachment WA00395A

1)

2)

3)

4)

5)

Locking cone

Stopcock

Sealing cap

Instrument channel

Irrigation port

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4.2.4 Attachment WA00396A

1)

2)

3)

4)

5)

Locking cone

Stopcock

Sealing cap

Instrument channel

Irrigation port

4.3 Symbols

This section gives an explanation for each symbol used on the

product and on the packing of the product.

Catalog number

Serial number

Batch code

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Quantity of content

Manufacturer

Date of manufacture

Consult instructions for use

Indicates the range of humidity to which the medical device

can be safely exposed

Indicates the temperature limits to which the medical device

can be safely exposed

Autoclavable

Green Dot symbol for dual recycling system

CE certification mark – symbol for the compliance with the

Medical Device Directive 93/42/EEC

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