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OLYMPUS

OLYMPUS Light Guide Cable WA033xxx Instructions for Use

Revision Rev W7094650

OLYMPUS Light Guide Cable Systems

34 Pages

Instructions For Use LIGHT GUIDE CABLE  WA03300A WA03310A   Contents 1 General information... 5 1... User instructions...  5 1... Signal words...  1... Conventions throughout this document... 6 1... Trademarks... 6 1... Manufacturer...  6 2 Safety information... 7 2... Intended use...  7 2... Contraindications... 7 2... User qualification... 7 2... Environment of use... 8 2... General warnings and cautions... 8 3 Product description...  11 3... Scope of delivery...  11 3... Light-guide cable... 1 3... Symbols... 13 3... Warranty... 13 4 Preparation... 14 4... Safety information for preparation... 14 4... Inspection...  14 4... Assembly and connection... 15 5 Use...  17 5... Safety information for use... 17 6 After use...  19 6... Disassembly... 19 6... Preparation for reprocessing at the point of use... 9 7 Reprocessing... 1 7... Safety information for reprocessing...  21 7... General information for reprocessing...  21
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olympus_light_guide_cable_instructions_for_use__rev.pdf

Page 1

Instructions For Use

LIGHT GUIDE CABLE

WA03300A

WA03310A

Page 3

Contents

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

1.1 User instructions..................................................................... 5

1.2 Signal words............................................................................ 5

1.3 Conventions throughout this document................................... 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.................................................................... 7

2.4 Environment of use................................................................. 8

2.5 General warnings and cautions............................................... 8

3 Product description............................................................... 11

3.1 Scope of delivery.................................................................. 11

3.2 Light-guide cable................................................................... 11

3.3 Symbols................................................................................ 13

3.4 Warranty................................................................................ 13

4 Preparation............................................................................. 14

4.1 Safety information for preparation......................................... 14

4.2 Inspection.............................................................................. 14

4.3 Assembly and connection..................................................... 15

5 Use.......................................................................................... 17

5.1 Safety information for use..................................................... 17

6 After use................................................................................. 19

6.1 Disassembly.......................................................................... 19

6.2 Preparation for reprocessing at the point of use................... 19

7 Reprocessing......................................................................... 21

7.1 Safety information for reprocessing....................................... 21

7.2 General information for reprocessing.................................... 21

Page 4

7.3 Manual cleaning.................................................................... 24

7.4 Manual disinfection............................................................... 24

7.5 Automated cleaning and disinfection.................................... 25

7.6 Maintenance.......................................................................... 26

7.7 Sterilization............................................................................ 26

8 Repair, shipment and disposal............................................. 28

8.1 Repair.................................................................................... 28

8.2 Shipment............................................................................... 28

8.3 Disposal................................................................................ 29

9 Ordering information............................................................. 30

10 Compatible equipment........................................................ 31

11 Technical data...................................................................... 33

11.1 General dimensions............................................................ 33

11.2 Dimensions for reprocessing............................................... 33

11.3 Classification of ME equipment and ME systems............... 34

11.4 Ambient conditions.............................................................. 34

Page 5

General information

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.

5

Page 6

General information

1.3 Conventions throughout this document

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.

This symbol indicates additional helpful information.

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

6

Page 7

Safety information

2 Safety information

2.1 Intended use

2.1.1 General intended use

Transmission of light energy from the light source to an

endoscope.

•• Do not use for any other purposes.

2.1.2 Specific intended use

The light-guide cable is used to transmit light during endoscopic

diagnosis and therapy. The light-guide cable is designed for

use with halogen, xenon or LED based light sources of cold light

which are utilized in medical applications. High-intensity visible

light is transmitted to the instrument through a bundle of optical

fibers.

•• 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 light-guide cable must be observed.

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.

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Page 8

Safety information

Reprocessing

Reprocessing of reusable products may only be performed by

qualified hygiene personnel.

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

Reusable products must be reprocessed according to the

applicable national and local standards and regulations.

2.5 General warnings and cautions

The following dangers, 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.

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Page 9

Safety information

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” on page 14.

•• 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.

•• Only use type F applied part endoscopic equipment.

•• 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 injury to the patient due to malfunction of the

equipment.

•• Always have spare equipment available.

9

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Safety information

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.

•• Do not attempt to repair or modify the product.

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.

•• For information on compatible equipment, refer to the chapter

“Compatible equipment” on page 31.

NOTICE

Risk of damage to the product

Bending and coiling the light-guide cable may damage the

product and may result in loss of transmission.

•• Do not coil the light-guide cable into a diameter less than 15 cm

(6 inches).

•• Do not hang the light-guide cable on a hook.

10

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Product description

3 Product description

3.1 Scope of delivery

•• Before use, check that all items listed below are available.

•• Contact an Olympus representative or an authorized service

center if any items are missing or damaged.

WA03300A, WA03310A

-- Light-guide cable (with light-guide adapter)

-- Instructions for use

3.2 Light-guide cable

The light-guide cable includes a bundle of optical fibers as

transmission medium to transmit light from a light source to an

optical instrument. A bundle of optical fibers does not transmit

UV radiation.

The light-guide cable is equipped with a light-guide adapter for

Olympus light sources with plug connection.

Entire light-guide cable

1) Endoscope connector

2) Kink protection

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Product description

3) Connector casing

4) Light source connector with light-guide adapter

Endoscope connector

1) Light emission surface

Light source connector with light-guide adapter

1) Cover glass (light admission surface)

12

Page 13

Product description

3.3 Symbols

This section gives an explanation for each symbol used on the

product and on the packaging of the product.

Symbol

Explanation

Symbol

Explanation

Catalog number ​

Indicates the temperature limits

to which the medical device can

be safely exposed

Batch code

Type CF applied part

Quantity of content

Storage conditions

Manufacturer

Transport conditions

Date of manufacture

Autoclavable

Consult instructions for use

Federal (USA) law restricts this

device to sale by or on the order

of a physician

Indicates the range of humidity

to which the medical device can

be safely exposed

CE certification mark – symbol

for the compliance with the

Medical Device Directive 93/42/

EEC

Protection class according to

IEC 60529: Protected against

the effects of temporary

immersion in water

3.4 Warranty

Any warranty claims towards Olympus are forfeited if the user

or unauthorized persons attempt repair or modification of the

product. No warranty is provided for any damage due to misuse

of the product.

13

Page 14

Preparation

4 Preparation

4.1 Safety information for preparation

WARNING

Risk of injury to the patient and/or the medical personnel

Improper and/or incomplete reprocessing can cause infection of

the patient and/or medical personnel as well as damage to the

product.

•• Reprocess the product before first and each subsequent use.

•• For reprocessing the product, observe the instructions in the

chapter “Reprocessing” on page 21.

•• Do not use a product that has not been reprocessed.

•• Before each use, inspect the product as described in the

section “Inspection” on page 14.

•• Do not use a damaged product.

WARNING

Risk of injury to the patient

If the light-guide cable is not properly connected to the

endoscope or the light source, the endoscopic image may

suddenly disappear during the procedure. This may lead to

mechanical injury to the patient.

•• Properly connect the adapters to the light-guide cable and the

endoscope.

•• Properly connect the light-guide cable to the endoscope and

the light source.

4.2 Inspection

Inspection regarding reprocessing

•• Make sure that the product has been properly reprocessed.

•• Visually inspect the product thoroughly. The product must be

visually clean.

General inspection

•• Check that the product has:

14

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Preparation

-- no dents, cracks, kinks, or deformations

-- no cuts and other defects on the insulation of the cable

-- no deep scratches

-- no corrosion

-- no lens damages or cover glass damages

-- no missing or loose parts

•• Check all markings on the product for clear visibility.

Checking the light transmission

•• Hold the endoscope connector of the light-guide cable against

a lamp.

•• Look into the endoscope connector of the light-guide cable.

Black dots indicate defective light-guide fibers.

•• Do not use a light-guide cable with more than 25 to 30%

defective light-guide fibers.

•• Replace the light-guide cable if the image appears too dark.

4.3 Assembly and connection

If force is required to assemble the product, dispose of the

product and use another one.

The light-guide cable is equipped with a light-guide adapter for

Olympus light sources with plug connection. To use other lightguide adapters, proceed as follows:

1. Remove the light-guide adapter.

2. Select a light-guide adapter.

Refer to the chapter “Compatible equipment” on page 31.

3. Attach the light-guide adapter to the light source connector of

the light-guide cable.

Refer to the respective instructions for use of the light-guide

adapter.

15

Page 16

Preparation

4.3.1 Connecting the light-guide cable to the light source

•• Connect the light-guide cable to the light-guide connector.

4.3.2 Connecting the light-guide cable to the endoscope

•• Connect the light-guide cable to the light-guide connector.

16

Page 17

Use

5 Use

5.1 Safety information for use

WARNING

Risk of injury to the patient

There is a risk of an electric shock when the endoscopic

equipment is inserted into the patient and the remote end of the

light-guide cable comes in contact with the mains power.

•• Always connect the endoscopic equipment before inserting the

endoscope into the patient.

CAUTION

Risk of injury to the patient

Light sources emit large amounts of energy. As a result the

connectors of the endoscopic equipment and the distal end of the

endoscope become hot. There is a risk of:

-- thermal injury to the patient’s tissue (e.g., from prolonged

exposure to the intense illumination in cavities with small

lumens, or if the distal end of the endoscope is placed into

close proximity to the tissue).

-- burns to the patient’s or user’s skin.

-- burns or thermal damage to surgical equipment (e.g., surgical

drapes, plastic materials).

•• Do not place the endoscopic equipment on the patient’s skin,

on flammable materials, or on heat-sensitive materials.

•• Set the output power of the light source to the minimum level

that is necessary for a sufficient illumination of the target area.

Avoid prolonged exposure to intense illumination.

•• Switch off the light source or set the light source to standby

mode whenever the light source is not in use.

17

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Use

CAUTION

Risk of injury to the user

There is a risk of damaging the eye when looking into the

endoscope connector of the light-guide cable and the light source

is switched on.

•• Do not look into the endoscope connector of the light-guide

cable when the light source is switched on.

18

Page 19

After use

6 After use

6.1 Disassembly

CAUTION

Risk of injury to the user

The connectors on the light-guide cable become hot. There is a

risk of burns when touching the connectors.

•• Let the light-guide cable cool down after use.

NOTICE

Risk of damage to the product

A severe change in temperature of the hot light-guide cable may

damage the product.

•• Let the light-guide cable cool down after use.

•• Do not use fluids to cool down the light-guide cable.

NOTICE

Risk of damage to the product

Pulling on the cable may damage the product.

•• Pull on the connector casing when disconnecting the lightguide cable from the light source.

If force is required to disassemble the product, dispose of the

product.

1. Switch off the light source.

2. Disconnect the light-guide cable from the light source.

3. If applicable, disconnect the light-guide cable from the

endoscope.

4. If applicable, remove the light-guide adapters.

6.2 Preparation for reprocessing at the point of use

•• Immediately after use, bring the product to the reprocessing

area.

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After use

•• Reprocess the product according to the instructions in this

document and the “System Guide Endoscopy”.

20

Page 21

Reprocessing

7 Reprocessing

7.1 Safety information for reprocessing

WARNING

Risk of injury to the patient and/or the medical personnel

Improper and/or incomplete reprocessing can cause infection of

the patient and/or medical personnel as well as damage to the

product.

•• Reprocess the product before first and each subsequent use.

•• Reprocess the product according to the instructions in this

chapter and the instructions in the “System Guide Endoscopy”.

•• Use the reprocessing information in this document if the

reprocessing information differs from the “System Guide

Endoscopy”.

7.2 General information for reprocessing

Compatible reprocessing methods (according to ISO 17664)

The microbiological efficacy and/or material compatibility of the

reprocessing methods listed in the table have been validated or

verified with this product. For detailed information on validated

reprocessing methods, refer to the instructions following the

table. For detailed information on reprocessing methods, refer to

the “System Guide Endoscopy”.

++

+

–

o

Method validated for microbiological efficacy and verified

for material compatibility

Method verified for material compatibility

Incompatible

Contact an Olympus representative for additional

information

21

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Reprocessing

Process

WA03300A

WA03310A

Preparation at the

point of use

Deposition

Wet

+

Dry

Decontamination

Preparation

Selection according to the

cleaning and disinfection

procedures

+

Cleaning

Manual

Machine

Disinfection

Ultrasonic

–

Alkaline

detergent

+

Acidic

detergent

–

Neutral

detergent

++

Alkaline

detergent

++

Acidic

detergent

o

Neutral

detergent

+

Manual

Machine

++

Chemical

+

Thermal

++

Rinsing

+

Drying (dry heat)

Tmax

Moist heat

(preferred method)

Autoclave (prevacuum)

95 °C (203 °F)

(max. 10 min)

Maintenance

Sterilization

++

Low temperature:

steam and

formaldehyde

+

Ethylene oxide

Gas Plasma

+

STERRAD® 100S

++

STERRAD® NX™/100NX™

++

STERRAD® 50/200

++

Preparing the product for reprocessing

The equipment must be disassembled. For information on

disassembly, refer to the chapter “After use” on page 19.

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Reprocessing

Cleaning brush

In the following reprocessing instructions, Olympus uses the

terms “appropriate brush” and “appropriate surface brush”. Select

an appropriate brush/surface brush according to the following

information:

-- The brush diameter must be greater than or equal to the

diameter of the inner lumen being brushed.

-- The brush bristles must fully extend and contact the surface of

the inner lumen.

-- The brush must move easily in and out of the instrument.

-- The brush must be at least 50 mm longer than the lumen of the

instrument.

-- Tapered or irregular lumens may require the use of different

brushes with different brush diameter.

-- A surface brush is for outer surfaces only. Do not use a lumen

brush for surfaces.

•• Do not use a brush with metal bristles or any other types of

bristle which can scratch and damage the instrument.

•• Only use brushes which the manufacturer has designated for

reprocessing of medical devices.

•• Refer to the “System Guide Endoscopy” for further information

on Olympus brushes.

For the dimensions of the product, refer to the section

“Dimensions for reprocessing” on page 33.

Instructions for using detergents

•• Use the maximum concentration and the corresponding

maximum immersion time as recommended by the

manufacturer of the solution.

•• Do not exceed the maximum concentration and the

corresponding maximum immersion time given by the

manufacturer of the solution.

-- All components of the product must be completely immersed in

the detergent.

-- All lumens of the product must be completely filled with

detergent.

•• Make sure that there are no air bubbles.

23

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Reprocessing

7.3 Manual cleaning

This section describes the manual cleaning of the product.

Alternatively, automatically clean and disinfect the product as

described in the section “Automated cleaning and disinfection” on

page 25.

Manual cleaning of the light-guide cable and light-guide adapter

has been validated with the following detergent:

-- Neodisher MediZym 2% manufactured by Dr. Weigert

1. Immerse the product in enzyme-based detergent for at least

15 min.

2. Thoroughly flush all gaps with enzyme-based detergent using

a syringe of at least 10 ml.

3. Thoroughly brush all gaps with an appropriate surface brush.

4. Only for light-guide adapter: Thoroughly brush the lumen with

an appropriate brush.

5. Wipe the light admission surface and the light emission

surface with a cotton swab that has been moistened with

70% ethanol solution.

Do not wipe with a metal cotton applicator.

6. Thoroughly flush all gaps again with fresh enzyme-based

detergent using a syringe of at least 10 ml.

7. Thoroughly rinse the product with deionized water using a

cleaning pistol or other rinse device.

The cleaning pistol or other rinse device must be suitable for

cleaning medical devices and deliver a minimum pressure of

1 bar (14.5 psi).

8. Dry the product.

7.4 Manual disinfection

1. Completely immerse the light-guide cable and light-guide

adapter in Cidex OPA® Solution by Johnson & Johnson.

Ensure that all parts are covered.

24

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Reprocessing

2. Soak the light-guide cable and light-guide adapter in

Cidex OPA® Solution for as long as recommended by the

manufacturer of the solution, but for at least 12 minutes.

3. Remove the products from the solution.

4. Rinse the light-guide cable and the adapter by completely

immersing them in 8 liters of sterile water for at least 1

minute.

5. Repeat the rinsing process twice. Always use fresh portions

of water for each rinse.

6. Dry the products.

7.5 Automated cleaning and disinfection

This section describes the automated cleaning and disinfection of

the product.

7.5.1 Preparation for automated cleaning

Preparation for automated cleaning of the light-guide cable

and light-guide adapter has been validated with the following

detergent:

-- 2% Neodisher MediClean forte manufactured by Dr. Weigert

1. Immerse the product in enzyme-based detergent for at least

5 min.

2. Thoroughly rinse the product with deionized water for at least

30 s using a cleaning pistol or other rinse device.

The cleaning pistol or other rinse device must be suitable for

cleaning medical devices and deliver a minimum pressure of

1 bar (14.5 psi).

7.5.2 Automated cleaning and disinfection

Automated cleaning of the light-guide cable and light-guide

adapter has been validated with the following detergents:

-- Neodisher MediClean forte manufactured by Dr. Weigert

25

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Reprocessing

-- Neodisher Z manufactured by Dr. Weigert

•• Refer to the “System Guide Endoscopy” for detailed information

on automated cleaning and thermal disinfection.

•• For automated cleaning, use alkaline detergent.

7.6 Maintenance

Inspection

This product does not require any dedicated maintenance or

calibration actions.

•• Visually inspect the product thoroughly after cleaning. The

product must be visually clean. If there are any signs of debris,

repeat the cleaning process.

•• Observe the instructions in the section “Inspection” on page

14.

Even products designed to be reused have a limited service

life. A number of factors connected with handling and some

reprocessing methods may lead to increased wear of the product.

The service life can be markedly shortened. The product must be

replaced if signs of wear become visible.

7.7 Sterilization

This section gives two alternative sterilization methods to sterilize

the product:

-- Steam sterilization

-- Sterilization with STERRAD®

•• Choose one sterilization method.

7.7.1 Steam sterilization

•• Refer to the “System Guide Endoscopy” for detailed information

on steam sterilization.

26

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