Olympus EVIS LUCERA TJF 260V, EVIS LUCERA JF 260V Reprocessing Manual

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INSTRUCTIONS

EVIS LUCERA DUODENOVIDEOSCOPE

OLYMPUS JF TYPE 260V OLYMPUS TJF TYPE 260V

Refer to the endoscope’s companion manual, the “OPERATION MANUAL” whose cover lists the model of your endoscope, for operation information.

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Contents

Symbols......................................................................................... 1

Chapter 1 General Policy ......................................................... 2

1.1 Instructions...................................................................................... 2

1.2 Importance of cleaning, disinfection and sterilization...................... 2

1.3 Signal words ................................................................................... 3

1.4 Precautions ..................................................................................... 3

1.5 Reprocessing before the first use and reprocessing and

storage after use ............................................................................. 6

Chapter 2 Compatible Reprocessing Methods and Chemical

Agents ...................................................................... 7

2.1 Compatibility summary.................................................................... 7

2.2 Detergent solution........................................................................... 9

2.3 Disinfectant solution........................................................................ 9

2.4 Rinsing water .................................................................................. 10

2.5 ETO gas sterilization....................................................................... 10

2.6 Steam sterilization (autoclaving) of accessories ............................. 11

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

.................................................................................. 13

3.1 Required reprocessing equipment .................................................. 14

3.2 Cleaning, disinfection and sterilization procedures......................... 21

3.3 Precleaning ..................................................................................... 22

3.4 Leakage testing............................................................................... 29

3.5 Manual cleaning.............................................................................. 33

3.6 High-level disinfection ..................................................................... 48

3.7 Rinsing after high-level disinfection ................................................ 51

3.8 Sterilization ..................................................................................... 54

3.9 Cleaning, disinfection and sterilization procedures for reusable parts

and reprocessing equipment........................................................... 56

3.10 Cleaning, disinfection and sterilization procedures for distal cover 63

Chapter 4 Cleaning and Disinfection Equipment................... 68

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

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Contents

Chapter 5 Storage and Disposal .............................................. 71

5.1 Storage of the endoscope............................................................... 71

5.2 Storage of reusable parts and reprocessing equipment ................. 72

5.3 Disposal .......................................................................................... 72

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

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Symbols

The meaning(s) of the symbol(s) shown on the back cover of this instruction

manual are as follows:

Manufacturer

Authorized representative in the European Community

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

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Chapter 1 General Policy

1.1 Instructions

• This manual contains the cleaning, disinfection and sterilization methods recommended by Olympus for the endoscopes listed on the

front cover.

• This instruction manual contains essential information on reprocessing

these instruments safely and effectively.

• Before reprocessing, thoroughly review the manuals of the reprocessing chemicals and all equipment which will be used and reprocess the

equipment as instructed.

• Note that the complete instruction manual set for this endoscope

consists of this manual and the “OPERATION MANUAL” whose cover

lists the model of your endoscope, both of which accompanied the endoscope at shipment.

• Keep this manual and all related manuals in a safe accessible location.

• If you have any questions or comments about any information in this

manual, or if a problem that cannot be solved occurs while reprocessing,

contact Olympus.

1.2 Importance of cleaning, disinfection and sterilization

The medical literature reports incidents of cross contamination resulting from

improper cleaning, disinfection or sterilization. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in

this manual and the manuals of all ancillary equipment, and have a thorough

understanding of the following items:

 Professional health and safety criteria of your hospital.

 Individual cleaning, disinfection and sterilization protocols.

 Structure and handling of endoscopic equipment.

 Handling of pertinent chemicals.

For the types and conditions of the means of cleaning, disinfection and

sterilization to be adopted, please make judgments from your professional

viewpoints.

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1.3 Signal words

The following signal words are used throughout this manual:

Chapter 1 General Policy

Indicates a potentially hazardous situation which, if not

avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not

avoided, may result in minor or moderate injury. It may also

be used to alert against unsafe practices or potential equipment damage.

Indicates additional helpful information.

1.4 Precautions

• Some endoscope reprocessors are not designed to

reprocess an elevator channel. When using one of these endoscope reprocessors, the elevator channel must be

reprocessed manually as described in Chapter 3.

• Failure to properly clean and high-level disinfect or sterilize

endoscopic equipment after each procedure can compromise patient safety. To minimize the risk of

transmitting diseases from one patient to another, after each

procedure the endoscope and its ancillary equipment must undergo thorough manual cleaning followed by high-level

disinfection or sterilization as described in Chapter 3,

“Cleaning, Disinfection and Sterilization Procedures”.

Reprocess not only the external surface of the endoscope but also all channels.

• ALL channels of the endoscope, including the elevator wire

channel where existing, MUST be cleaned and high-level

disinfected or sterilized during EVERY reprocessing cycle, even if the channels were not used during the previous

examination. Otherwise, insufficient cleaning and disinfection

or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the

next examination with the endoscope.

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Chapter 1 General Policy

• If the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible. Clean the

endoscope and accessories thoroughly before disinfection or

sterilization to remove microorganisms or organic material that could reduce the efficacy of disinfection or sterilization.

• Olympus confirms validation of the endoscope reprocessors

recommended by Olympus only. If using endoscope

reprocessor that are not recommended by Olympus, the endoscope reprocessor manufacturers are responsible for

validation of the endoscope reprocessor with the endoscope

models listed in its intended use statement. If using an endoscope reprocessor, confirm that it is capable of

reprocessing endoscope including all channels. If there are

channels and/or other parts which cannot be cleaned and high-level disinfected by the endoscope reprocessor, have to

undergo manual cleaning and high-level disinfection or

sterilization as described in Chapter 3, “Cleaning,

Disinfection and Sterilization Procedures” after using the endoscope reprocessor. Otherwise, insufficient cleaning and

disinfection or sterilization of the endoscope may pose an

infection control risk to the patient and/or operators performing the next procedure with the endoscope. If you are

uncertain as to the ability of your endoscope reprocessor to

clean and high-level disinfect endoscope including all channels, contact the endoscope reprocessor supplier for

specific instructions and/or connectors.

• Patient debris and reprocessing chemicals are hazardous.

Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material.

During cleaning and disinfection or sterilization, wear

appropriate personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and

chemical-resistant gloves that fit properly and are long

enough so that your skin is not exposed. Always remove contaminated personal protective equipment before leaving

the reprocessing area.

• Thoroughly rinse off the disinfectant solution. Rinse the

external surface of the endoscope, all channels and the cleaning equipment thoroughly with sterile water to remove

any disinfectant solution residue.

• The disinfection/sterilization room must be adequately

ventilated. Adequate ventilation protects against the buildup of toxic chemical fumes.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

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Chapter 1 General Policy

• Store alcohol in an air-tight container. Alcohol stored in an

open container is a fire hazard and will lose its efficacy due to

evaporation.

• Be sure to perform a leakage test on the endoscope prior to

manual cleaning, and do not use the endoscope if a leak is detected. Use of an endoscope with a leak may cause a

sudden loss of the endoscopic image, damage to the

bending mechanism or other malfunctions.

• Prior to each procedure, confirm that the endoscope has

undergone proper cleaning, disinfection and sterilization. If it

is determined that the endoscope has not been properly

reprocessed, reprocess it again following the instructions given in this manual.

• With the cleaning, disinfection and sterilization methods

stated in this instruction manual, prions, which are

considered to be the pathogenic substance of the

Creutzfeldt-Jakob disease (CJD) cannot be destroyed or inactivated. When using this instrument on a patient with CJD

or variant Creutzfeldt-Jakob disease (vCJD), be sure to use

this product for such patient only and/or immediately dispose of this product after use in an appropriate manner. For

methods to handle CJD, please follow the respective

guidelines in your country.

• This instrument is not durable, or does not have sufficient

durability against the respective methods stated in the

guidelines of each country for destroying or inactivating

prions. For information on the durability against each method, please contact Olympus. If cleaning, disinfection

and sterilization methods not stated in this instruction manual

are performed, Olympus cannot guarantee the effectiveness, safety and durability of this instrument. Make sure to confirm

that there is no abnormality before use, and use under

responsibility of a physician. Do not use if any abnormality is found.

• When aerating or irrigating the endoscope channels, the air

or water pressure must not exceed 0.5 MPa (5 kgf/cm

71 psia). Higher pressures may cause damage to the

endoscope.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

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Chapter 1 General Policy

• When reprocessing an endoscope, confirm that the

water-resistant cap is securely attached to the endoscope connector before immersion in reprocessing fluids. If the

water-resistant cap is not securely attached, water, detergent

and/or disinfectant solution could enter the endoscope and damage the equipment.

1.5 Reprocessing before the first use and reprocessing and storage after use

This instrument was not cleaned, disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the

instructions given in this manual.

After using this instrument, reprocess and store it according to the instructions

given in this manual. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce

performance.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Chapter 2 Compatible Reprocessing

Methods and Chemical Agents

2.1 Compatibility summary

Olympus endoscopic equipment is compatible with several methods of

reprocessing. Certain components and accessories, however, are not compatible with some methods, which can cause equipment damage. For

appropriate reprocessing methods, refer to Table 2.1 below, the

recommendations of your infection control committee and all national and local

hospital guidelines and policies.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Applicable

Not applicable

Steam sterilization (autoclaving)

ETO gas sterilization

ACECIDE 6% disinfectant solution *3

(use OER-A)

2 – 3.5% glutaraldehyde

70% ethyl or isopropyl alcohol

Detergent solution

Ultrasonic

cleaning

Endoscope

Water-resistant cap

(MH-553)

Chain for water-resistant

cap (MAJ-1119)

Channel cleaning brush

(BW-20T)

Channel-opening

cleaning brush (MH-507)

Air/water valve (MH-438)

Suction valve (MH-443)

Biopsy valve (MB-358)

Channel plug (MH-944)

Injection tube (MH-946)

AW channel cleaning

adapter (MH-948)

Suction cleaning

adapter (MH-856)

Mouthpiece (MB-142)

Washing tube (MH-974)

Distal cover

(MAJ-311/411)

Table 2.1

*1 The endoscope is compatible with ultrasonic cleaning by endoscope reprocessor

(OER, OER-A) only. OER, OER-A are not available in some areas.

*2 The water-resistant cap and the chain for water-resistant cap can only be

ultrasonically cleaned if connected to endoscope that is being cleaned in an endoscope reprocessor with an ultrasonic cleaning phase.

*3 ACECIDE 6% disinfectant solution is exclusively for OER-A.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Alcohol is not a sterilant or high-level disinfectant.

Endo-therapy accessories which are marked by the words

“AUTOCLAVE” or “AUTOCLAVABLE”, or accessories with a

green model reference label are compatible with autoclaving.

2.2 Detergent solution

Use a medical-grade, low-foaming, neutral pH detergent or enzymatic detergent

and follow the manufacturer’s dilution and temperature recommendations. Contact Olympus for the names of specific brands that have been tested for

compatibility with the endoscope. Do not reuse detergent solutions.

Excessive detergent foaming can prevent fluid from adequately contacting internal lumens (e.g. channels).

2.3 Disinfectant solution

In the U.S., agents used to achieve high-level disinfection are defined as liquid

chemical germicides registered with the U.S. Food and Drug Administration as

“sterilant/disinfectants” which are used according to the time, temperature and dilution recommended by the disinfectant manufacturer for achieving high-level

disinfection. These conditions usually coincide with those recommended by the

disinfectant manufacturer for 100% kill of mycobacterium tuberculosis.

In general, 2.0 – 3.5% glutaraldehyde solutions, when used according to the

manufacturer’s instructions for achieving high-level disinfection, are compatible with Olympus endoscopes. Contact Olympus for the names of specific brands

that have been tested for compatibility with the endoscope.

If the disinfectant solution is reused, routinely check its efficacy with a test strip recommended by the manufacturer. Do not use solutions beyond their expiration

date.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

2.4 Rinsing water

Once removed from disinfectant solution, the instrument must be thoroughly

rinsed with sterile water to remove any disinfectant residue. If sterile water is not

available, clean potable tap water or water which has been processed (e.g. filtered) to improve its microbiological quality may be used.

When non-sterile water is used after disinfection, wipe the endoscope and flush the channels with 70% ethyl or isopropyl alcohol, then air-dry all internal

channels to inhibit the growth of residual bacteria. Do not reuse rinsing water.

2.5 ETO gas sterilization

This instrument and accessories listed as compatible with ethylene oxide (ETO)

gas sterilization in Table 2.1 can be sterilized by ETO gas and aerated within the

parameters given in Table 2.2. When performing ETO gas sterilization, follow the cleaning, disinfection and sterilization protocols of your hospital and the

instruction manuals of the sterilization equipment.

• Before sterilization, the instrument must be thoroughly cleaned and dried. Residual moisture inhibits sterilization.

• The results of sterilization depend on various factors such as

how the sterilized instrument was packed or the positioning,

method of placing and loading of the instrument in the sterilization device. Please verify the sterilization effects by

using biological or chemical indicators. Also follow the

guidelines for sterilization issued by medical administrative authorities, public organizations or the infection management

sections at each medical facility, as well as the instruction

manual of the sterilization device.

• All instruments must be properly aerated following ETO gas sterilization to remove toxic ethylene oxide residuals.

• Disconnect the water-resistant cap from the endoscope

connector before ETO gas sterilization. If the water-resistant cap is attached during ETO gas sterilization, the air inside the

endoscope will expand and rupture the covering of the

bending section and/or damage the angulation mechanism.

• Exceeding the recommended parameters may cause

equipment damage (see Table 2.2).

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

 ETO gas exposure parameters

Process Parameters

Tem per atur e 57°C (135°F)

ETO gas sterilization

Aeration

Pressure

Humidity 55%

Exposure time 1.75 hours

ETO gas

concentration

Minimum aeration

parameters

0.1 – 0.17 MPa (1 – 1.7 kgf/cm

(16 – 24 psig)

0.6 – 0.7 mg/cm

(600 – 700 mg/l)

12 hours in an aeration chamber

at 50 – 57°C (122 – 135°F) or

7 days at room temperature

Table 2.2

 Gas mixture

20% ETO/80% CO

2.6 Steam sterilization (autoclaving) of accessories

)

The accessories listed as compatible with steam sterilization (autoclaving) in

Table 2.1 can be sterilized by steam within the parameters given in Table 2.3.

When steam sterilizing, follow the cleaning, disinfection and sterilization

protocols of your hospital and the sterilization equipment manufacturer’s instructions.

The results of sterilization depend on various factors such as

how the sterilized instrument was packed or the positioning, method of placing and loading of the instrument in the

sterilization device. Please verify the sterilization effects by

using biological or chemical indicators. Also follow the guidelines for sterilization issued by medical administrative

authorities, public organizations or the infection management

sections at each medical facility, as well as the instruction manual of the sterilization device.

• Do not steam sterilize the endoscope. Steam sterilization

(autoclaving) will severely damage the endoscope.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

• Exceeding the recommended parameters may cause equipment damage (see Table 2.3).

Process Parameters

Prevacuum

Tem per atur e

Exposure time 5 minutes

132 – 134°C

(270 – 274°F)

Table 2.3 Steam sterilization (autoclaving) exposure parameters

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Chapter 3 Cleaning, Disinfection and

Sterilization Procedures

ALL channels of the endoscope, including the elevator wire channel where existing, MUST be cleaned and high-level

disinfected or sterilized during EVERY reprocessing cycle,

even if the channels were not used during the previous

patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an

infection control risk to the patient and/or operators

performing the next procedure with the endoscope.

• Do not coil the endoscope’s insertion tube or universal cord

with a diameter of less than 12 cm. The endoscope can be

damaged if coiled too tightly.

• For proper reprocessing results, do not coil the insertion tube

or the universal cord with a diameter of less than 40 cm. If

the diameter is less than 40 cm, it will be difficult to insert the

channel cleaning brush (BW-20T).

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Channel-opening cleaning brush (MH-507)

Leakage tester (MB-155)

Water-resistant cap (MH-553)

Channel cleaning brush (BW-20T)

AW channel cleaning adapter (MH-948)

Suction cleaning adapter (MH-856)

Channel plug (MH-944)

Light source (CLV-260/U40/U20)

Injection tube (MH-946)

Maintenance unit (MU-1)

Washing tube (MH-974)

Suction pump (KV-4/5)

3.1 Required reprocessing equipment

Preparation of the equipment

Prior to cleaning, disinfection or sterilization, prepare the equipment shown in Figure 3.1.

Use basins which are at least 40 cm by 40 cm (16” by 16”) in size and deep enough to allow the endoscope to be

completely immersed.

• Detergent solution • Large basins with tight fitting lids for

• Clean water • Large basins for rinsing and leakage

• Sterile water

• 70% ethyl or isopropyl alcohol

• Disinfectant solution • Soft brush • Small basins

•5cm

(5 ml) syringe

Figure 3.1

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

detergent and disinfectant solution

testing

•30cm

• 500 cm

(30 ml) syringe

(500 ml) containers

• Personal protective

equipment

• Clean lint-free cloths

• Sterile lint-free cloths

• Sterile cotton swabs

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Groove

Venting connector

Seal

Biopsy valve cap

Cylinder plug

Reprocessing equipment parts and functions

For inspection of other equipment than that mentioned below, refer to the

instruction manual for the equipment being used.

 Water-resistant cap (MH-553)

The water-resistant cap is attached to the electrical connector on the endoscope

to protect the connector from water penetration during reprocessing. For leakage

testing, the venting connector on the water-resistant cap must be connected to the leakage tester (see Figure 3.2).

Figure 3.2

 Channel plug (MH-944)

The channel plug is used to plug the openings of the instrument channel port,

air/water and suction cylinders during cleaning (see Figure 3.3).

Figure 3.3

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Suction channel tube

Notice card

Connector plug

Suction channel port

Air pipe port

Air/water channel port

Suction port

Air/water channel tube

(including the filter mesh)

Filter tube

Metal tip

Shaft

Brush head

 Injection tube (MH-946)

The injection tube is used to inject detergent solution, disinfectant solution, water and alcohol into the air/water and suction channels and to flush air through the

channels to expel fluids (see Figure 3.4).

Figure 3.4

 Channel cleaning brush (BW-20T)

The channel cleaning brush is used to brush the inside of the instrument and suction channels and the interior and/or openings of the suction valve, air/water

valves, AW channel cleaning adapter and biopsy valve (see Figure 3.5).

Figure 3.5

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Brush handle

Shaft

Brush

Connecting end

Luer port

 Channel-opening cleaning brush (MH-507)

The channel-opening cleaning brush is used to brush the external surfaces of the distal end of the endoscope, the suction cylinder and the instrument channel

port (see Figure 3.6).

Figure 3.6

 Washing tube (MH-974)

The washing tube is used to inject detergent solution, disinfectant solution, water

and alcohol into the elevator wire channel and to flush air through the channel to expel fluids (see Figure 3.7).

Figure 3.7

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Weighted end

Connecting end

Notice card

Slider

Non-return valve

Piston

Packing

 Suction cleaning adapter (MH-856)

The suction cleaning adapter is used to aspirate reprocessing fluids from the distal end of the endoscope through the instrument channel (see Figure 3.8).

Figure 3.8

 AW channel cleaning adapter (MH-948)

During precleaning, the AW channel cleaning adapter is connected to the

air/water cylinder. When the adapter is depressed, water is fed through the

air/water nozzle. Air is continuously fed when the adapter is not depressed (see Figure 3.9).

Figure 3.9

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Inspection of equipment

For inspection of other equipment than that mentioned below, refer to the

instruction manual for the equipment being used.

All equipment mentioned below are consumable items.

Should the slightest irregularity be suspected, use a spare

instead. Using defective equipment may make it difficult to effectively reprocess the endoscope, and could cause

endoscope and/or equipment damage.

Do not immerse the water-resistant cap alone into water. Moisture remaining inside the cap may penetrate the

electrical connector and cause equipment damage.

 Inspection of the water-resistant cap (MH-553)

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

1. Confirm that the inside of the water-resistant cap is dry and free from debris

(see Figure 3.2 on page 15). Wipe with a dry cloth if the inside of the

water-resistant cap is wet or there is debris.

2. Confirm that the seal inside the water-resistant cap is free from scratches,

flaws and debris.

3. Check the venting connector for looseness.

 Inspection of the channel plug (MH-944)

Confirm that the cylinder plug and biopsy valve cap are free from cracks,

scratches, flaws and debris (see Figure 3.3 on page 15).

 Inspection of the injection tube (MH-946)

1. Confirm that all components of the injection tube are free from cracks,

scratches, flaws and debris (see Figure 3.4 on page 16).

2. Confirm that the filter mesh is in the suction port.

3. Attach the 30 cm

filter mesh immersed in rinsing water, withdraw the syringe’s plunger and

confirm that rinsing water is drawn into the syringe. Depress the plunger and

confirm that rinsing water is emitted from the air pipe port. Confirm that water is not emitted from the suction port.

(30 ml) syringe to the air/water channel port. With the

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

4. Attach the 30 cm

mesh immersed in rinsing water, withdraw the syringe plunger and confirm

that rinsing water is drawn into the syringe. Depress the plunger and confirm that rinsing water is emitted from the distal end of the suction channel tube.

Confirm that water is not emitted from the suction port.

(30 ml) syringe to the suction channel port. With the filter

 Inspection of the channel cleaning brush (BW-20T)

1. Confirm that the brush head and the metal tip of the distal end are securely

in place. Check for loose or missing bristles (see Figure 3.5 on page 16).

2. Check for bends, scratches and other damage to the shaft.

3. Check for debris on the shaft and/or in the bristles of the brush.

 Inspection of the channel-opening cleaning brush

(MH-507)

1. Check for loose or missing bristles (see Figure 3.6 on page 17).

2. Check for bends, scratches and other damage to the shaft.

3. Check for debris on the shaft and/or in the bristles of the brush.

 Inspection of the washing tube (MH-974)

Check for cracks, scratches, flaws, debris and other damage (see Figure 3.7 on

page 17).

 Inspection of the suction cleaning adapter (MH-856)

Check for cracks, scratches, flaws, debris and other damage (see Figure 3.8 on

page 18).

 Inspection of the AW channel cleaning adapter (MH-948)

Check for cracks, scratches, flaws, debris and other damage (see Figure 3.9 on page 18).

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Withdrawal of the endoscope

Precleaning (Section 3.3)

Leakage testing (Section 3.4)

Manual cleaning (Section 3.5)

High-level disinfection (Section 3.6)

Sterilization (Section 3.8)

Rinsing after high-level disinfection (Section 3.7)

Storage and Disposal (Chapter 5)

3.2 Cleaning, disinfection and sterilization procedures

After each procedure, clean, disinfect and sterilize the endoscope according to the procedure described below.

Endoscope reprocessing summary chart

ALL channels of the endoscope, including the elevator wire

channel where existing, MUST be cleaned and high-level disinfected or sterilized during EVERY reprocessing cycle,

even if the channels were not used during the previous

patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an

infection control risk to the patient and/or operators

performing the next procedure with the endoscope.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.3 Precleaning

If the endoscope is not immediately cleaned after each

procedure, residual organic debris will begin to solidify and it

may be difficult to effectively reprocess the endoscope.

Preclean the endoscope at the bedside in the procedure room immediately after

each procedure. During precleaning, wear appropriate personal protective equipment.

Equipment needed

Prepare the following equipment.

• Personal protective equipment

• Clean lint-free cloths

•500cm

• Detergent solution

• AW channel cleaning adapter (MH-948)

• Clean water

• Suction pump

• Washing tube (MH-974)

•5cm

(500 ml) containers

(5 ml) syringe

Preparation

Turn the video system center and light source OFF.

2. Prepare a 500 cm

temperature and concentration recommended by the detergent

manufacturer.

(500 ml) container of detergent solution at the

3. Prepare clean water in a 500 cm

Wipe down the insertion tube

Handle the insertion tube carefully. Tightly gripping or sharply bending the insertion tube or bending section can stretch or

severely damage the insertion tube and/or the covering of the

bending section.

Wipe the entire insertion tube with a clean, lint-free cloth soaked in detergent

solution. Wipe from the boot at the control section toward the distal end.

(500 ml) container.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Suction valve

Detergent solution

Aspirate detergent solution

Monitor the suction bottle on the suction pump carefully to

ensure that it does not overflow. Otherwise, suction pump damage could result.

1. Turn the suction pump ON.

2. Attach the biopsy valve cap.

3. Immerse the distal end of the insertion tube in detergent solution. Depress

the suction valve and aspirate detergent solution into the instrument channel for 30 seconds (see Figure 3.10).

4. Remove the distal end of the insertion tube from the detergent solution and

immerse it in clean water. Depress the suction valve and aspirate clean water into the instrument channel for 10 seconds.

5. Remove the distal end of the insertion tube from the clean water. Depress

the suction valve and aspirate air for 10 seconds.

6. Turn the suction pump OFF.

Figure 3.10

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

AW channel cleaning adapter

Flush water and air into the air/water channel

Do not use the AW channel cleaning adapter for patient

examinations. It will cause continuous insufflation and could result in patient injury.

• To prevent clogging of the air/water nozzle, always use the

AW channel cleaning adapter to clean the air/water channel

after each use.

• Do not apply lubricants to the AW channel cleaning adapter. Lubricants may cause malfunction of the AW channel

cleaning adapter.

1. Turn the light source ON.

2. Switch “OFF” the airflow regulator on the light source.

3. Remove the air/water valve from the endoscope and place it in a container

of detergent solution (see Figure 3.11).

Water may drip from the air/water cylinder when the air/water valve is detached. The water dripping from the air/water

cylinder is clean (i.e., sterile water in the water container). If

water is dripping from the air/water cylinder, hold the control section higher than the water container.

4. Attach the AW channel cleaning adapter to the air/water cylinder of the

endoscope (see Figure 3.11).

Figure 3.11

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

AW c hannel cleaning adapter

Clean water

Elevator channel plug

Washing tube

5. Immerse the distal end of the insertion tube in the clean water (see Figure

3.12).

6. Switch the airflow regulator to maximum output (“HIGH” or “3”).

7. Depress the AW channel cleaning adapter to feed water through the

channels for 30 seconds. Release the adapter to feed air through the

channels for 10 seconds or more (see Figure 3.12).

Figure 3.12

8. Turn the light source OFF.

Flush detergent solution and air into the elevator wire channel

Connect the washing tube to the elevator channel plug (see Figure 3.13).

Figure 3.13

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

2. Immerse the distal end of the insertion tube in the water.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

5 cm3 (5 ml) syringe

Elevator wire channel

Endoscope connector

Washing tube

Elevator channel plug

3. Using the 5 cm

elevator wire channel via the washing tube several times until no air bubbles

exit the distal end (see Figure 3.14).

4. Using the 5 cm

channel via the washing tube several times.

5. Using the 5 cm

channel via the washing tube several times until a steady stream of air

bubbles exits the distal end (see Figure 3.14).

(5 ml) syringe, slowly flush detergent solution through the

(5 ml) syringe, slowly flush water through the elevator wire

(5 ml) syringe, slowly flush air through the elevator wire

Figure 3.14

Disconnect the endoscope, reusable parts and cleaning equipment

Do not touch the light guide of the endoscope connector immediately after removing it from the light source because it

is extremely hot. Operator or patient injury may result.

1. Disconnect the videoscope cable from the endoscope’s electrical connector.

2. Disconnect the suction tube from the suction connector of the endoscope

connector.

3. Disconnect the metal tip of the water container from the air/water supply

connector of the endoscope connector and attach the metal tip to the tip receptacle on the lid of the water container as described in the water

container’s instruction manual.

4. Disconnect the endoscope connector from the light source.

5. Transport the endoscope to the reprocessing area.

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6. Detach the AW channel cleaning adapter, washing tube, suction valve and

Distal part

biopsy valve from the endoscope and place them in a container of detergent

solution.

Detach the distal cover

• When detaching the distal cover, forcefully grasping other

parts of the bending section can result in damage to the

bending mechanism of the bending section or deform its

covering.

• After the distal cover has been removed, make sure not to

subject the forceps elevator to impact or bend the elevator wire during cleaning, disinfection, sterilization, storage or

preparation of the endoscope. This could adversely affect the

function of the forceps elevator.

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

1. Move the elevator control lever all the way in the opposite direction of the

“ U” direction until it stops.

2. Gently hold the distal part in the covering of the bending section (see Figure

3.15). Hold the top end of the distal cover with the other hand.

Figure 3.15

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

4. Turn

3. Push

5. Pull

3. Push the distal cover as far as possible toward the endoscope (see Figure

3.16).

4. Turn it counterclockwise until it stops (see Figure 3.16).

5. Pull the distal cover off the endoscope slowly and straightly (see Figure

3.16).

Figure 3.16

6. Reprocess the distal cover as described in Section 3.10, “Cleaning,

disinfection and sterilization procedures for distal cover”.

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3.4 Leakage testing

After precleaning, perform leakage testing on the endoscope to ensure that it is

waterproof. Also be sure to wear appropriate personal protective equipment.

Equipment needed

Prepare the following equipment:

• Personal protective equipment

• Large basin

• Clean water

• Maintenance unit or light source (MU-1 or CLV-260, U40, U20)

• Leakage tester (MB-155)

• Water-resistant cap (MH-553)

Attaching the water-resistant cap (MH-553)

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

• The electrical connector of the endoscope is not waterproof.

Before immersing or leakage testing the endoscope, always attach the water-resistant cap. Otherwise, equipment

damage may result.

• If the exterior of the electrical connector is scratched, the

connector may no longer be waterproof and the seal inside the water-resistant cap may be scratched. If the electrical

connector is scratched, send it immediately to Olympus for

repairs.

• Always use a dry water-resistant cap. Any water remaining

on the water-resistant cap may cause damage to the

endoscope, maintenance unit or light source.

1. Confirm that the inside of the water-resistant cap is dry and free from debris.

Wipe with a dry clean cloth if the inside of the water-resistant cap is wet or there is debris.

2. Align the OER/ETD/EW character (see Figure 3.17 (a)) or the EW character

on the water-resistant cap with mark 2 on the electrical connector housing. When using a manual disinfector, align the KC/TD character (see Figure

3.17 (b)) on the water-resistant cap with mark 2 on the electrical connector

housing.

3. Align the pin on the electrical connector with the groove on the

water-resistant cap.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Water-resistant cap

(b) When using a manual disinfector

Rotate

Mark 2 (gray)

(a) When leakage testing, cleaning,

disinfection or using an endoscope reprocessor

4. Push the water-resistant cap into position and rotate it clockwise until it

stops (approximately 45°).

Figure 3.17

Performing the leakage test

• During leakage testing, a continuous series of air bubbles

• Never connect or disconnect the water-resistant cap or the

• Rotate the leakage tester’s connector cap until it stops. If it is

emerging from a location on the endoscope indicates a leak

at that location. This means that water will be able to

penetrate the inside of the endoscope. If you locate a leak, remove the endoscope from the water and contact Olympus.

leakage tester’s connector cap while immersed. Doing so

could allow water to enter the endoscope and equipment damage can result.

not fully and properly attached, the endoscope’s interior will

not be pressurized and accurate leakage testing will be impossible.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Maintenance unit or light source

Leakage tester connector

Leakage tester’s connector cap

Venting connector

• When connecting the leakage tester’s connector cap to the

water-resistant cap’s venting connector, make sure that the inside of the leakage tester’s connector cap and the outside

of the water-resistant cap’s venting connector are thoroughly

dry. Water remaining on either component may penetrate the inside of the water-resistant cap and could cause endoscope

malfunction.

When the leakage tester connector is in place, the covering of the bending section will expand as the air pressure inside

the endoscope increases. This is normal.

1. Fill a basin with clean water. Use a basin which is at least 40 cm by 40 cm

(16” by 16”) in size and deep enough to allow the endoscope to be

completely immersed.

2. Insert the leakage tester connector into the output socket of the

maintenance unit or the light source (see Figure 3.18) and turn it ON. Set

the light source’s airflow regulator switch to its maximum level.

3. Confirm that the leakage tester is emitting air by gently depressing the pin

located inside the leakage tester’s connector cap. Confirm that no water is

inside the leakage tester’s connector cap.

4. Confirm that no water is outside of the water-resistant cap’s venting

connector. Connect the leakage tester’s connector cap to the venting

connector of the water-resistant cap (see Figure 3.18).

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Figure 3.18

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

5. With the leakage tester connected, immerse the endoscope in the water and

observe for approximately 30 seconds while angulating the bending section.

Confirm that there is no location on the endoscope from which a continuous series of air bubbles emerges.

6. Remove the endoscope from the basin with the leakage tester attached.

7. Turn the maintenance unit or the light source OFF.

8. Disconnect the leakage tester from the maintenance unit or the light source.

Always disconnect the leakage tester connector from the

light source or maintenance unit before disconnecting the leakage tester’s connector cap from the venting connector.

Failure to do this will not allow the endoscope to

depressurize properly. This may damage the endoscope.

9. Wait 30 seconds, or until the covering of the bending section contracts to its

pre-expansion size. Disconnect the leakage tester’s connector cap from the

venting connector.

10. Thoroughly dry the leakage tester.

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3.5 Manual cleaning

After completing the leakage test, perform manual cleaning according to the

procedures described below.

In case of excessive bleeding and/or delayed reprocessing, first follow the

procedure described in “Presoak for excessive bleeding and/or delayed

reprocessing after each procedure” on page 47, then follow the procedure

described below.

Reusable parts which are normally reprocessed with the endoscope

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

To prevent a water leak, do not apply excessive force when

washing the endoscope.

• Channel plug (MH-944)

• Injection tube (MH-946)

• Water-resistant cap (MH-553)

• Chain for water-resistant cap (MAJ-1119)

• Washing tube (MH-974)

Equipment needed

Prepare the following equipment, and wear appropriate personal protective

equipment.

• Personal protective equipment

• Soft brush

• Clean lint-free cloths

• Large basin

• Detergent solution

• Clean water

• Suction cleaning adapter (MH-856)

• Channel plug (MH-944)

• Injection tube (MH-946)

• Channel cleaning brush (BW-20T)

• Channel-opening cleaning brush (MH-507)

• Suction pump

•30cm

• Washing tube (MH-974)

•5cm

(30 ml) syringe

(5 ml) syringe

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Lint-free cloth

Air/water nozzle opening

Objective lens

To prevent damage to the endoscope, never immerse it together with objects other than the equipment listed above.

Preparation

Fill a basin with detergent solution at the temperature and concentration

recommended by the detergent manufacturer. Use a basin which is at least 40 cm by 40 cm (16” by 16”) in size and deep enough to allow the

endoscope to be completely immersed.

2. Fill a basin with clean water. Use a basin which is at least 40 cm by 40 cm

(16” by 16”) in size and deep enough to allow the endoscope to be completely immersed.

Cleaning the external surface

Immerse the endoscope in the detergent solution.

2. With the endoscope immersed, use a soft brush or lint-free cloth to

thoroughly brush or wipe all external surfaces of the endoscope. Pay

particular attention to the air/water nozzle opening and the objective lens,

and ensure that all surfaces of the distal end are cleaned thoroughly (see Figure 3.19).

Figure 3.19

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Brushing around the forceps elevator and instrument channel outlet

Using a stiff brush or excessive force when brushing may

scratch the distal end and result in water leakage; cause the

elevator wire to come off the distal end, bend or kink the elevator wire so that the forceps elevator will no longer work.

1. Turn the elevator control lever all the way in the opposite direction of the

“ U” direction. Perform the following brushing in the detergent solution.

2. While the bending section is kept straight, insert the channel-opening

cleaning brush into the instrument channel opening at the distal end of the

endoscope, then pull it out (see Figure 3.20).

3. Repeat until all debris is removed.

4. Brush along the forceps wire, and the groove of the instrument channel

outlet (for TJF-260V only) using a commercially available soft brush or the channel-opening cleaning brush (see Figure 3.21).

5. While holding the distal end with one hand and keeping the forceps elevator

lowered with the fingers, brush both sides of the forceps elevator, the groove of the interior of the forceps elevator, around the axis of the forceps elevator,

and guidewire-locking groove of the forceps elevator using the soft brush or

the channel-opening cleaning brush (see Figures 3.22 and 3.23).

6. Remove fingers from the forceps elevator.

7. Brush the distal end of the endoscope, using the soft brush or the

channel-opening cleaning brush.

Figure 3.20

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Groove

Channel-opening cleaning brush

Guidewire-locking groove

Figure 3.21

Figure 3.22

Figure 3.23

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Brushing the channels

• Be sure to brush the inside of the suction channel.

Otherwise, insufficient cleaning and/or disinfection of the endoscope may pose an infection control risk to the patient

and/or operators performing the next procedure with the

endoscope.

• To avoid splattering detergent solution when the channel

cleaning brush is pulled out, keep the endoscope

submerged.

• The channel cleaning brush is a consumable item. Repeated

use may cause the brush head to become bent or kinked,

which could cause it to come off during use. Confirm that the brush is free from any damage or other irregularities before

and after each use. Should a part of the brush come off

inside the endoscope, immediately retrieve it and carefully confirm that no parts remain inside the channel of the

endoscope by passing a new cleaning brush or other

endo-therapy accessory through the channel. Any parts left in the channel can drop into the patient during the procedure.

Depending on the location, the missing part may not be

recoverable by passing a new brush or other endo-therapy accessory through the channel. In this case, contact

Olympus.

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

• Withdraw the channel cleaning brush from the suction

channel gently, ensuring that its shaft does not rub against

the external opening of the suction cylinder. This could

damage the brush and/or may wear a groove in the opening, leading to impaired suction and liquid leakage.

• Do not attempt to pass the channel cleaning brush from the

distal end of the insertion tube and/or suction connector. It

may get caught, making retrieval impossible.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Suction cylinder

Instrument channel port

Suction connector

While the endoscope is submerged, brush the instrument and suction channels,

suction cylinder and instrument channel port according to the following

procedures (see Figure 3.24).

Figure 3.24

 Brushing the instrument channel in the insertion tube and

suction channel in the control section (location A)

1. Immerse the endoscope in the detergent solution to avoid splattering.

2. Straighten the endoscope’s bending section. Grip the channel cleaning

brush at a point 3 cm from the bristles.

3. Insert the channel cleaning brush at a 45° angle into the opening located in

the side wall of the suction cylinder as illustrated by A in Figure 3.24. Using

short strokes, feed the brush through the insertion tube until it emerges from

the distal end of the endoscope.

4. Clean the bristles with your fingertips in the detergent solution. Carefully pull

the brush out through the channel.

5. Clean the bristles in the detergent solution again.

6. Repeat until all debris is removed.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Brushing the suction channel in the universal cord

(location B)

1. Grip the channel cleaning brush at a point 3 cm from the bristles.

2. Insert the channel cleaning brush straight into the opening of the suction

cylinder as illustrated by B in Figure 3.24. Using short strokes, feed the brush through the universal cord until it emerges from the suction connector

on the endoscope connector.

3. Clean the bristles with your fingertips in the detergent solution. Carefully pull

the brush out through the channel.

4. Clean the bristles in the detergent solution again.

5. Repeat until all debris is removed.

 Brushing the suction cylinder (location C)

When inserting the channel-opening cleaning brush into the suction cylinder, do not forcibly insert the brush beyond the

middle of the brush section. Otherwise, the brush may

become stuck in the suction cylinder.

1. Insert the channel-opening cleaning brush into the suction cylinder as

illustrated by C in Figure 3.24, until half of the brush section is inserted.

2. Turn the inserted brush once.

3. Pull the brush out and clean the bristles with your fingertips in the detergent

solution.

4. Repeat until all debris is removed.

 Brushing the instrument channel port (location D)

1. Insert the channel-opening cleaning brush into the instrument channel port

until the brush handle touches the channel opening as illustrated by D in

Figure 3.24.

2. Turn the inserted brush once.

3. Pull the brush out and clean the bristles with your fingertips in the detergent

solution.

4. Repeat until all debris is removed.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Suction cleaning adapter

Weighted end

5. Reprocess the cleaning brushes as described in Section 3.9, “Cleaning,

disinfection and sterilization procedures for reusable parts and reprocessing

equipment”.

6. Remove the endoscope from the detergent solution.

Aspirating detergent solution into the instrument channel and the suction channels

Attach the suction cleaning adapter to the instrument channel port (see

Figures 3.25 and 3.26).

2. Connect the suction tube from the suction pump to the suction connector on

the endoscope connector. Turn the suction pump ON.

3. Immerse both the endoscope’s distal end and the weighted end of the

suction cleaning adapter in the detergent solution.

4. Cover the suction cylinder with your finger and aspirate detergent solution

for approximately 30 seconds.

5. Release your finger from the suction cylinder.

6. Turn the suction pump OFF.

7. Disconnect the suction tube and the suction cleaning adapter.

8. Reprocess the suction cleaning adapter as described in Section 3.9,

“Cleaning, disinfection and sterilization procedures for reusable parts and reprocessing equipment”.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

Figure 3.25

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Weighted end

Instrument channel port

Suction channel

Suction cleaning adapter

Insertion tube

Instrument channel

Suction cylinder

Universal cord

Endoscope connector

Suction connector

Suction tube

Suction pump

Suction bottle

Forceps elevator

Detergent solution

Figure 3.26

Flushing the interior of the forceps elevator

Immerse the distal end in detergent solution, and operate the elevator

control lever to raise and lower the forceps elevator 3 times.

2. With the forceps elevator raised, flush the interior of the forceps elevator

with detergent solution using the 30 cm

Figure 3.27

(30 ml) syringe (see Figure 3.27).

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Cylinder plug

Air/water cylinder

Suction cylinder

Biopsy valve cap

Instrument channel port

Push

Slide

Flushing detergent solution into the air/water channels

Attach the channel plug’s biopsy valve cap to the instrument channel port

(see Figure 3.28).

2. Lower the channel plug’s cylinder plug onto the air/water and suction

cylinders (see Figure 3.28).

3. Push the plug down on the endoscope’s control section and slide the plug

until it stops (see Figure 3.28).

Figure 3.28

4. Attach the injection tube’s connector plug to the air and water supply

connectors on the endoscope connector (see Figures 3.29 and 3.30).

5. Attach the injection tube’s air pipe port to the air pipe on the endoscope

connector (see Figures 3.29 and 3.30).

6. Attach the injection tube’s suction channel tube to the suction connector on

the endoscope connector (see Figures 3.29 and 3.30).

7. Immerse the suction port of the injection tube in the detergent solution.

8. Attach the 30 cm

port (see Figure 3.30).

9. Inject 90 cm

(30 ml) syringe to the injection tube’s air/water channel

(90 ml) of detergent solution into the air/water channel.

10. Detach the channel plug and injection tube from the endoscope, and leave

all items immersed.

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Figure 3.29

Syringe

Air/water channel tube

Suction channel tube

Air pipe port

Suction port

Basin

Detergent solution

Connector plug

Biopsy valve cap

Channel plug

Air channel

Water channel

Air/water cylinder

Air/water nozzle

Connector plug

Suction cylinder

Water supply connector

Air supply connector

Suction connector

Suction port

Injection tube

Suction channel port

Air/water channel port

Syringe

Air pipe port

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Figure 3.30

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Elevator channel plug

Washing tube

5 cm3 (5 ml) syringe

Elevator wire channel

Endoscope connector

Washing tube

Elevator channel plug

Flushing detergent solution into the elevator wire channel

Connect the washing tube to the elevator channel plug (see Figure 3.31).

Figure 3.31

2. Using the 5 cm

into the elevator wire channel via the washing tube (see Figure 3.32).

Figure 3.32

(5 ml) syringe, inject 15 cm3 (15 ml) of detergent solution

3. Disconnect the washing tube from the endoscope and immerse it in

detergent solution.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Soaking the endoscope and all reprocessing equipment in detergent solution

Using a lint-free cloth, wipe all debris from the endoscope’s external

surfaces while the endoscope is immersed in the detergent solution.

2. Cover the basin with a tight fitting lid to minimize the diffusion of detergent

vapors.

3. Soak the endoscope and all reprocessing equipment for the amount of time

and at the temperature and concentration recommended by the detergent

manufacturer.

4. Remove the endoscope and all reprocessing equipment from the detergent

solution.

5. Inspect all reprocessing equipment. If debris remains on any of the

equipment, ultrasonically clean it at 33 – 48 kHz for 5 minutes.

6. Place the endoscope and all reprocessing equipment in clean water and

gently agitate them to thoroughly rinse.

Removing detergent solution from all channels

Attach the channel plug and the injection tube to the endoscope. Place the

suction port of the injection tube in clean water. Attach the channel plug’s biopsy valve cap to the instrument channel port (see Figure 3.33).

2. Attach the 30 cm

tube and inject 90 cm

Figure 3.33).

3. Attach the 30 cm

injection tube and inject 90 cm channel (see Figure 3.30).

(30 ml) syringe to the suction channel port of the injection

(90 ml) of clean water into the suction channel (see

(30 ml) syringe to the air/water channel port of the

(90 ml) of clean water into the air/water

4. Connect the washing tube to the elevator channel plug (see Figure 3.31).

5. Attach the 5 cm

wire channel with 5 cm

(5 ml) syringe to the washing tube and flush the elevator

(5 ml) of clean water (see Figure 3.32).

6. Remove the endoscope, together with all equipment, from the water.

7. Cover the distal end and control section of the endoscope with a clean

lint-free cloth.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Suction channel

Biopsy valve cap

Channel plug

Suction cylinder

Suction connector

Suction port

Injection tube

Suction channel port

Air/water channel port

Syringe

Suction channel

8. Using the 30 cm

with 90 cm

3.30 and 3.33).

9. Using the 5 cm

(10 ml) of air via the washing tube (see Figures 3.31 and 3.32).

(30 ml) syringe, flush the air/water and suction channels

(90 ml) of air, respectively, via the injection tube (see Figures

(5 ml) syringe, flush the elevator wire channel with 10 cm3

10. Remove the clean, lint-free cloth from the distal end and the control section

of the endoscope.

11. Detach the channel plug and injection tube from the endoscope.

12. Disconnect the washing tube from the endoscope.

Dry external surfaces

Figure 3.33

Using a clean lint-free cloth, wipe and dry the external surfaces of the

endoscope and all equipment thoroughly.

2. Inspect the endoscope and all equipment for residual debris. Should debris

remain, repeat the procedures given in this section.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Presoak for excessive bleeding and/or delayed reprocessing after each procedure

Follow the steps below only in cases of excessive bleeding

and/or delayed reprocessing; unnecessary immersions

should be avoided. Consecutive extended immersions may damage the endoscope.

1. Fill a basin with detergent solution at the temperature and concentration

recommended by the detergent manufacturer. Use a basin which is at least

40 cm by 40 cm (16” by 16”) in size and deep enough to allow the

endoscope to be completely immersed.

2. Carefully coil the endoscope’s insertion tube and universal cord, and

completely immerse the endoscope in the detergent solution.

3. Fill all channels with the detergent solution following the procedures

described in this section.

4. Remove only the reprocessing equipment from the detergent solution.

5. Cover the basin with a tight fitting lid to minimize the diffusion of detergent

vapors.

6. Soak the endoscope for 10 hours at the temperature and concentration

recommended by the detergent manufacturer.

7. Remove the endoscope from the detergent solution.

8. After soaking the endoscope, manually clean it following the procedures

described in this section.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.6 High-level disinfection

All disinfection steps should be performed with the

endoscope and all equipment completely immersed in

disinfectant solution. If the equipment is connected to the endoscope while they are immersed, or any part of them is

not immersed completely, disinfectant solution may not

adequately contact all surfaces of the equipment.

After manual cleaning, disinfect the endoscope according to the procedures

described below.

Equipment needed

Prepare the following equipment, and wear appropriate personal protective

equipment.

• Personal protective equipment

• Clean lint-free cloths

• Large basin

• Disinfectant solution

•30cm

• Channel plug (MH-944)

• Injection tube (MH-946)

• Washing tube (MH-974)

•5cm

Preparation

2. Attach the channel plug and the injection tube to the endoscope. Attach the

(30 ml) syringe

(5 ml) syringe

Fill a basin with disinfectant solution at the temperature and concentration

recommended by the disinfectant manufacturer. Use a basin which is at least 40 cm by 40 cm (16” by 16”) in size and deep enough to allow the

endoscope to be completely immersed.

channel plug’s biopsy valve cap to the instrument channel port (see Figures

3.28 and 3.29).

3. Connect the washing tube to the elevator channel plug (see Figure 3.31).

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Flushing disinfectant solution into all channels

Completely remove all air bubbles from all channels.

Disinfection effects cannot be obtained if air bubbles remain in the channels.

Air bubbles removal can be facilitated by injecting

disinfectant solution into the channels with strong force.

1. Immerse the endoscope and all equipment in the disinfectant solution.

2. Confirm that the suction port of the injection tube is immersed in disinfectant

solution.

3. Using the 30 cm

disinfectant solution through the air/water and suction channels respectively via the injection tube. Confirm that no air bubbles exit the distal end of the

endoscope (see Figure 3.30 and 3.33).

4. Using the 5 cm

through the elevator wire channel via the washing tube. Confirm that no air

bubbles exit the distal end of the endoscope (see Figure 3.31 and 3.32).

(30 ml) syringe, flush at least 90 cm3 (90 ml) of

(5 ml) syringe, flush 10 cm3 (10 ml) of disinfectant solution

5. While immersed in disinfectant solution, raise the forceps elevator and flush

the vicinity of the forceps elevator with disinfectant solution using the 5 cm (5 ml) syringe.

Soaking the endoscope and all equipment in disinfectant solution

All disinfection steps should be performed with the

endoscope and all equipment completely immersed. If the equipment is disconnected while not immersed, disinfectant

solution may not adequately contact all surfaces. As a result,

the effectiveness of disinfection may be reduced.

1. With the endoscope and all equipment completely immersed in the

disinfectant solution, disconnect all equipment from the endoscope. Leave

the endoscope and all equipment immersed in the disinfectant solution.

2. If air bubbles adhere to the surfaces of the endoscope and/or equipment,

remove them using a clean lint-free cloth.

3. Cover the basin with a tight fitting lid to minimize the diffusion of disinfectant

vapors.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

4. Soak the endoscope and all equipment in disinfectant solution for the

amount of time and at the temperature and concentration recommended by

the disinfectant manufacturer.

Removing the endoscope and all equipment from disinfectant solution

Before removing the endoscope from the disinfectant solution, connect the

channel plug and injection tube to the endoscope. Attach the channel plug’s

biopsy valve cap to the instrument channel port.

2. Before removing the endoscope from the disinfectant solution, connect the

washing tube to the elevator channel plug.

3. Remove the injection tube’s suction port from the disinfectant solution.

4. Using the 30 cm

air/water and suction channels respectively via the injection tube.

5. Using the 5 cm

(10 ml) of air via the washing tube.

(30 ml) syringe, flush 90 cm3 (90 ml) of air through the

(5 ml) syringe, flush the elevator wire channel with 10 cm3

6. Remove the endoscope and all equipment from the disinfectant solution.

7. Disconnect all equipment from the endoscope.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.7 Rinsing after high-level disinfection

After reprocessing, purge the channels of the endoscope to

thoroughly dry them. Otherwise, bacteria may proliferate in

the channels and pose an infection-control risk to the patient and/or operators performing the next procedure with the

endoscope.

After high-level disinfection, rinse the endoscope and all equipment according to

the procedures described below.

Use water of appropriate microbiological quality. Once removed from disinfectant

solution, the instrument must be thoroughly rinsed with sterile water to remove any disinfectant residue. If sterile water is not available, fresh potable tap water

or water which has been processed (e.g. filtered) to improve its microbiological

quality may be used with 70% ethyl or isopropyl alcohol rinse (see “Non-sterile water rinse and alcohol flush” on page 53). Consult with your hospital’s infection

control committee.

Equipment needed

Prepare the following equipment, and wear appropriate personal protective

equipment.

• Personal protective equipment

• Sterile lint-free cloths

• Sterile large basin

• Large basin

• Sterile water for sterile water rinse

•30cm

• Channel plug (MH-944)

• Injection tube (MH-946)

• Suction pump (with sterile suction tube)

• Washing tube (MH-974)

•5cm

If sterile water is not available, prepare the following equipment.

• Clean water for non-sterile water rinse

• 70% ethyl or isopropyl alcohol

• Sterile cotton swabs

• Small basin

(30 ml) syringe

(5 ml) syringe

Alcohol is flammable. Handle it with care.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Sterile water rinse

1. Fill a basin with sterile water. Use a basin which is at least 40 cm by 40 cm

(16” by 16”) in size and deep enough to allow the endoscope to be

completely immersed.

2. Immerse the endoscope, channel plug and injection tube in the sterile water.

Using a sterile lint-free cloth, thoroughly rinse and wipe all external surfaces.

3. Immerse the washing tube in the sterile water. Using a sterile, lint-free cloth,

thoroughly rinse and wipe all external surfaces.

4. Attach the channel plug and the injection tube to the endoscope. Place the

suction port in the sterile water. Attach the channel plug’s biopsy valve cap to the instrument channel port.

5. Using the 30 cm

with 90 cm

(30 ml) syringe, flush the air/water and suction channels

(90 ml) of sterile water respectively via the injection tube.

6. Connect the washing tube to the elevator channel plug.

7. Using the 5 cm

(15 ml) of sterile water via the washing tube.

(5 ml) syringe, flush the elevator wire channel with 15 cm3

8. Remove the endoscope, together with all equipment, from the sterile water

and place them in the sterile large basin.

9. Using the 30 cm

air/water and suction channels respectively via the injection tube.

10. Using the 5 cm

(15 ml) of air via the washing tube.

(30 ml) syringe, flush 90 cm3 (90 ml) of air through the

(5 ml) syringe, flush the elevator wire channel with 15 cm3

11. Detach the injection tube only. Connect a sterile suction tube from the

suction pump to the suction connector on the endoscope. Turn the suction pump ON and aspirate air for at least 15 seconds.

12. Turn the suction pump OFF and disconnect all equipment from the

endoscope.

13. Using a sterile lint-free cloth, thoroughly wipe and dry the external surfaces

of the endoscope and all equipment.

14. Dry the endoscope and all equipment.

15. Store the components following the instructions given in Chapter 5, “Storage

and Disposal”.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Flushing the channels with 70% ethyl or isopropyl alcohol after rinsing them with sterile water facilitates drying inside

the channels.

 Non-sterile water rinse and alcohol flush

1. Inject non-sterile water and air following the procedures given in “Sterile

water rinse” on page 52.

2. Fill a small basin with 70% ethyl or isopropyl alcohol.

3. Attach the channel plug and the injection tube to the endoscope. Attach the

channel plug’s biopsy valve cap to the instrument channel port.

4. Cover the distal end and control section of the endoscope with a sterile,

lint-free cloth.

5. Immerse the suction port of the injection tube in the alcohol. Using the

30 cm

air/water and suction channels respectively via the injection tube.

(30 ml) syringe, flush 90 cm3 (90 ml) of the alcohol through the

6. Remove the suction port of the injection tube from the alcohol. Using the

30 cm the suction channels respectively via the injection tube.

(30 ml) syringe, flush 90 cm3 (90 ml) of air through the air/water and

7. Connect the washing tube to the elevator channel plug.

8. Using 5 cm

(10 ml) of the alcohol via the washing tube.

9. Using 5 cm

(15 ml) of the air via the washing tube.

(5 ml) syringe, flush the elevator wire channel with 10 cm3

(5 ml) syringe, flush the elevator wire channel with 15 cm3

10. Remove the sterile lint-free cloth from the distal end and the control section

of the endoscope.

11. Disconnect all equipment from the endoscope.

12. Using a sterile, lint-free cloth moistened with alcohol, thoroughly wipe the

external surfaces of the endoscope and all equipment.

13. Using sterile cotton swabs, dry the inside of the air/water cylinder, suction

cylinder and instrument channel port.

14. Dry the endoscope and all equipment.

15. Store the components following the instructions given in Chapter 5, “Storage

and Disposal”.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.8 Sterilization

ETO gas sterilization

As an alternative to high-level disinfection, the endoscope can be sterilized by ethylene oxide (ETO) gas. After performing manual cleaning and drying as

described in Section 3.3, “Precleaning” and Section 3.5, “Manual cleaning”,

follow the procedures given below.

• Exceeding the recommended parameters may cause

equipment damage.

• If ETO gas sterilization is performed while the water-resistant

cap is attached, the covering of the bending section can be

damaged.

• The chain for water-resistant cap (MAJ-1119) and the water-resistant cap itself (MH-553) cannot be sterilized by

ETO gas and may be damaged if they are subjected to ETO

gas sterilization.

1. Dry the endoscope and all equipment before ETO gas sterilization.

2. Remove the water-resistant cap before ETO gas sterilization (see Figure

3.34). If the water-resistant cap is connected to the endoscope using the

chain, be sure to remove the chain for water-resistant cap and water-resistant cap from the endoscope before proceeding to ETO gas

sterilization.

Figure 3.34

3. Seal the instrument in a package appropriate for ETO gas sterilization

according to your hospital’s protocol.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

4. Sterilize the package according to the recommended ETO gas exposure

parameters described in Section 2.5, “ETO gas sterilization” and the

sterilizer manufacturer’s instructions.

5. Aerate the components following the minimum aeration parameters

specified in Section 2.5, “ETO gas sterilization”.

6. Store the components following the instructions given in Chapter 5, “Storage

and Disposal”.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.9 Cleaning, disinfection and sterilization procedures for reusable parts and reprocessing equipment

This section includes the cleaning, disinfection and sterilization procedures for

the reusable parts and reprocessing equipment listed below.

• Air/water valve (MH-438)

• Suction valve (MH-443)

• AW channel cleaning adapter (MH-948)

• Mouthpiece (MB-142)

• Biopsy valve (MB-358)

• Channel-opening cleaning brush (MH-507)

• Channel cleaning brush (BW-20T)

• Suction cleaning adapter (MH-856)

Equipment needed

Prepare the following equipment, and wear appropriate personal protective

equipment.

• Sterile lint-free cloths

• Sterile water for sterile water rinse

• Clean water (non-sterile water)

• 70% ethyl or isopropyl alcohol

• Clean lint-free cloths

• Personal protective equipment

• Detergent solution

• Soft brush

• Disinfectant solution

• Small basins

•30cm

• Channel cleaning brush (BW-20T)

• Channel-opening cleaning brush (MH-507)

(30 ml) syringe

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Manual cleaning

Main body

Cap

1. Fill a small basin with clean water. Use a basin which is deep enough to

allow all equipment to be completely immersed.

2. Fill a small basin with the detergent solution at the temperature and

concentration recommended by the detergent solution. Use a basin which is deep enough to allow all equipment to be completely immersed.

3. Detach the biopsy valve’s cap from the main body, before immersing in the

detergent solution (see Figure 3.35).

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

• Make sure that the items immersed in detergent solution do

not contact one another.

• Make sure not to scratch the seals on the air/water valve and AW channel cleaning adapter with brushes, etc.

Figure 3.35

4. Immerse all other equipment in the detergent solution.

5. Using a soft brush or clean lint-free cloth, clean the external surfaces of all

equipment in detergent solution.

6. Using a soft brush or clean lint-free cloth, clean the inside of the mouthpiece

in detergent solution.

7. Using the channel cleaning brush, thoroughly brush the openings of the

suction valve, air/water valve and AW channel cleaning adapter until no debris can been seen.

8. Using the channel cleaning brush and channel-opening cleaning brush,

thoroughly brush the interior and openings of the biopsy valve.

9. Clean the bristle of the cleaning brushes thoroughly while the brushes are

immersed.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

10. Using the 30 cm

equipment until no air bubbles can be seen.

(30 ml) syringe, flush the interior and openings of all

11. While immersed, depress and release the pistons of the air/water valves,

suction valves and AW channel cleaning adapter. Ensure that all air bubbles

are expelled.

12. Rub the bristles of the channel cleaning brush and channel-opening

cleaning brush to remove all air bubbles.

13. Using the 30 cm

adapter with the detergent solution while the adapter is immersed. Ensure that all air bubbles are expelled.

(30 ml) syringe, flush the inside of the suction cleaning

14. Cover the basin with a tight fitting lid to minimize the diffusion of detergent

vapors. Soak all equipment at the temperature and concentration recommended by the detergent manufacturer.

15. Remove all equipment from the detergent solution and inspect it. If debris

remains on any of the equipment, ultrasonically clean it at 33 – 48 kHz for

5minutes.

16. Immerse all equipment in the clean water.

17. Gently agitate the equipment to thoroughly rinse.

18. While immersed, depress and release the pistons of the air/water valve,

suction valve and AW channel cleaning adapter. Ensure that all air bubbles

are expelled.

19. Rub the bristles of the channel cleaning brush and channel-opening

cleaning brush to remove all air bubbles.

20. Using the 30 cm

adapter thoroughly with clean water while it is immersed. Ensure that all air bubbles are expelled.

(30 ml) syringe, flush the inside of the suction cleaning

21. Remove the suction cleaning adapter from the clean water. Hold the adapter

and tilt it to expel the clean water remaining in the adapter.

22. Remove all equipment from the clean water.

23. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces.

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High-level disinfection

• Completely remove air bubbles from all equipment.

• All disinfection steps should be performed with all equipment

1. Fill a basin with disinfectant solution at the temperature and concentration

recommended by the disinfectant manufacturer. Use a basin which is deep

enough to allow all equipment to be completely immersed.

2. Immerse all equipment in the disinfectant solution.

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Disinfection effects cannot be obtained if air bubbles remain on the equipment.

completely immersed. If any part of the equipment is not

immersed completely, disinfectant solution may not adequately contact all surfaces.

3. Using a lint-free cloth and/or 30 cm

surfaces with the disinfectant solution to remove all air bubbles.

4. Using the 30 cm

them while they are immersed. Ensure that all air bubbles are expelled.

(30 ml) syringe, flush the interiors and recessed parts of

(30 ml) syringe, wipe and/or flush all

5. While immersed, depress and release the pistons of the valves and AW

channel cleaning adapter. Ensure that all air bubbles are expelled.

6. Using the 30 cm

valve with disinfectant solution while the valve is immersed. Ensure that all

air bubbles are expelled.

(30 ml) syringe, flush the recessed parts of the biopsy

7. Rub the bristles of the channel cleaning brush and channel-opening

cleaning brush to remove all air bubbles.

8. Using the 30 cm

adapter thoroughly with disinfectant solution while it is immersed in the

disinfectant solution. Ensure that all air bubbles are expelled.

(30 ml) syringe, flush the inside of the suction cleaning

9. Cover the basin with a tight fitting lid to minimize the diffusion of disinfectant

vapor. Soak all equipment at the temperature and concentration

recommended by the disinfectant manufacturer.

10. Remove the suction cleaning adapter from the disinfectant solution. Hold

the adapter and tilt it to expel the disinfectant solution remaining in the

adapter.

11. Remove all equipment from the disinfectant solution.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Rinsing after high-level disinfection

After high-level disinfection, rinse all equipment according to the procedures

described below. Use water of appropriate microbiological quality. Once removed from disinfectant

solution, the instrument must be thoroughly rinsed with sterile water to remove

any disinfectant residue. If sterile water is not available, fresh potable tap water or water which has been processed (e.g. filtered) to improve its microbiological

quality may be used with 70% ethyl or isopropyl alcohol rinse (see “Non-sterile

water rinse and alcohol flush” on page 61). Consult with your hospital’s infection control committee.

Alcohol is flammable. Handle it with care.

 Sterile water rinse

1. Fill a small basin with sterile water. Use a basin which is deep enough to

allow all equipment to be completely immersed.

2. Immerse all equipment in the sterile water.

3. Gently agitate the equipment to thoroughly rinse them.

4. Using the 30 cm

equipment with sterile water while they are immersed. Ensure that all air bubbles are expelled.

(30 ml) syringe, flush the interior and recessed parts of all

5. While immersed, depress and release the pistons of the air/water valve,

suction valve and AW channel cleaning adapter. Ensure that all air bubbles are expelled.

6. Rub the bristles of the channel cleaning brush and channel-opening

cleaning brush to remove all air bubbles.

7. Attach the 30 cm

the adapter with 30 cm

that all air bubbles are expelled.

(30 ml) syringe to the suction cleaning adapter and flush

(30 ml) of sterile water while it is immersed. Ensure

8. Remove the suction cleaning adapter from the sterile water. Hold the

adapter and tilt it to expel the sterile water remaining in the adapter.

9. Using the 30 cm

cleaning adapter.

(30 ml) syringe, flush air to dry the inside of the suction

10. Remove all equipment from the sterile water.

11. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

12. Dry all equipment thoroughly.

13. Store the components following the instructions given in Chapter 5, “Storage

and Disposal”.

Flushing the channels with 70% ethyl or isopropyl alcohol

after rinsing them with sterile water facilitates drying inside

the channels.

 Non-sterile water rinse and alcohol flush

1. Fill a small basin with clean water.

2. Immerse all equipment in clean water and follow all procedures described in

“Sterile water rinse” on page 60.

3. Fill a small basin with 70% ethyl or isopropyl alcohol.

4. Immerse all equipment in the alcohol.

5. Gently agitate all equipment in the alcohol.

6. Using the 30 cm

equipment with alcohol to remove all air bubbles.

(30 ml) syringe, flush the interior and recessed parts of all

7. While immersed, depress and release the pistons of the air/water valve,

suction valve and AW channel cleaning adapter. Ensure that all air bubbles

are expelled.

8. Rub the bristles of the channel cleaning brush and channel-opening

cleaning brush to remove all air bubbles.

9. Attach the 30 cm

the adapter with 30 cm

(30 ml) syringe to the suction cleaning adapter and flush

(30 ml) of alcohol to remove all air bubbles.

10. Remove the suction cleaning adapter from the alcohol. Hold the adapter

and tilt it to expel the alcohol remaining in the adapter.

11. Using the 30 cm

cleaning adapter.

(30 ml) syringe, flush air to dry the inside of the suction

12. Remove all equipment from the alcohol.

13. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces.

14. Dry all equipment thoroughly.

15. Store the components following the instructions given in Chapter 5, “Storage

and Disposal”.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Sterilization

Some components are compatible with several sterilization

methods. Certain components, however, are not compatible with some methods, which can cause equipment damage.

In this section, the sterilization methods for equipment compatible with ETO gas sterilization or steam sterilization (autoclaving), listed in Table 2.1, are described

below.

The channel plug (MH-944), the injection tube (MH-946) and the washing tube

(MH-974), which were cleaned and disinfected together with the endoscope, can

also be sterilized by the procedures described below.

 ETO gas sterilization

Follow the procedures described in Section 3.8, “Sterilization”.

 Steam sterilization (autoclaving)

After cleaning as described in “Manual cleaning” on page 57, steam sterilize

(autoclave) the equipment according to the procedures given below.

• Before taking the equipment package out of the autoclave, let it cool down to room temperature. Otherwise, it may cause

burns.

• Effective sterilization will not be possible if items are packed

tightly together in the autoclave; always pack items loosely.

• Inspect each equipment package for openings, tears or other damage. If the equipment package is open or damaged, seal

the equipment in new package and re-sterilize as described

below.

• Allow the packages to dry within the autoclave, using the autoclave’s drying cycle (if available) or by opening the door

of the autoclave and allowing the packages to air-dry.

Handling a wet package can compromise its sterility.

Sudden changes in temperature may damage the

instruments.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

1. Seal the individual parts or equipment separately in packages appropriate

for steam sterilization (autoclaving) according to your hospital’s protocol.

2. Steam sterilize the packages according to the recommended steam

sterilization (autoclaving) exposure parameters given in Section 2.6, “Steam

sterilization (autoclaving) of accessories” and the sterilizer manufacturer’s instructions.

3. Following steam sterilization (autoclaving), let all components gradually cool

down to room temperature.

4. Store the components following the instructions given in chapter 5, “Storage

and Disposal”.

3.10 Cleaning, disinfection and sterilization procedures for distal cover

Equipment needed

Prepare the following equipment, and wear appropriate personal protective

equipment.

• Personal protective equipment

• Small basin

• Clean water (non-sterile water)

• Detergent solution

• Soft brush

• Clean lint-free cloths

•30cm

• Disinfectant solution

• Sterile water for sterile water rinse

• Sterile lint-free cloths

• 70% ethyl or isopropyl alcohol

(30 ml) syringe

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Manual cleaning

To prevent damage, make sure that the items immersed in

detergent solution do not contact one another.

1. Fill a small basin with clean water. Use a basin which is deep enough to

allow the distal cover to be completely immersed.

2. Fill a small basin with detergent solution at the temperature and

concentration recommended by the detergent manufacturer. Use a basin which is deep enough to allow the distal cover to be completely immersed.

3. Immerse the distal cover in the basin filled with detergent solution.

4. Using the 30 cm

distal cover with detergent solution while the distal cover is immersed.

(30 ml) syringe, flush the interior and recessed parts of the

5. Using a clean, soft brush or lint-free cloth, meticulously clean the external

surfaces in detergent solution.

6. Cover the basin with a tight fitting lid to minimize the diffusion of detergent

vapors. Soak the distal cover at the temperature and concentration

recommended by the detergent manufacturer.

7. Remove the distal cover from the detergent solution. If debris remains,

ultrasonically clean it at 33 – 48 kHz for 5 minutes.

8. Immerse the distal cover in the clean water.

9. Gently agitate the distal cover to thoroughly rinse them.

10. Remove the distal cover from the water.

11. Use a sterile lint-free cloth to thoroughly wipe and dry all external surface.

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High-level disinfection

Fill a small basin with disinfectant solution at the temperature and

concentration recommended by the disinfectant manufacturer. Use a basin

which is deep enough to allow the distal cover to be completely immersed.

2. Immerse the distal cover in the disinfectant solution.

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3. Using the 30 cm

distal cover with disinfectant solution while the distal cover is immersed.

(30 ml) syringe, flush the interior and recessed parts of the

4. Using a clean lint-free cloth, wipe off any air bubbles adhering to surfaces.

5. Cover the disinfectant basin with a tight fitting lid to minimize the diffusion of

disinfectant vapors. Soak the distal cover for the amount of time at the

temperature and concentration recommended by the disinfectant manufacturer.

6. Remove the distal cover from the disinfectant solution.

Rinse after high-level disinfection

After high-level disinfection, rinse the distal cover according to the procedures

described below.

Alcohol is flammable. Handle with care.

 Sterile water rinse

1. Fill a small basin with sterile water. Use a basin which is deep enough to

allow the distal cover to be completely immersed.

2. Immerse the distal cover in the sterile water.

3. Gently agitate the distal cover to thoroughly rinse.

4. Remove the distal cover from the sterile water.

5. Wipe and dry the distal cover with a sterile lint-free cloth.

6. Dry the distal cover.

7. Store the distal cover to following the instructions given in Chapter 5,

“Storage and Disposal”.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Non-sterile water rinse and alcohol flush

1. Prepare a small basin with clean water.

2. Immerse the distal cover in clean water and follow the procedures given in

“Sterile water rinse” on page 65.

3. Fill a small basin with 70% ethyl or isopropyl alcohol.

4. Immerse the distal cover in the alcohol.

5. Gently agitate the distal cover in the alcohol.

6. Remove the distal cover from the alcohol.

7. Wipe and dry the distal cover with a sterile lint-free cloth.

8. Dry the distal cover.

9. Store the distal cover to following the instructions given in Chapter 5,

“Storage and Disposal”.

Sterilization

 Steam sterilization (autoclaving)

After cleaning as described in “Manual cleaning” on page 64, steam sterilize

(autoclave) according to the procedures given below.

• Before taking the distal cover package out of the autoclave, let it cool down to room temperature. Otherwise, it may cause

burns.

• Effective sterilization will not be possible if the distal cover is

packed tightly together in autoclave; always pack items loosely.

• Inspect each distal cover package for openings, tears or

other damage. If the distal cover package is open or

damaged, seal the distal cover in new package and re-sterilize it as described below.

• Allow the packages to dry within the autoclave, using the

autoclave’s drying cycle (if available) or by opening the door

of the autoclave and allowing the packages to air-dry. Handling a wet package can compromise its sterility.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

1. Seal the distal cover separately in packages appropriate for steam

sterilization (autoclaving) according to your hospital’s protocol.

2. Steam sterilize the packages according to the recommended steam

sterilization (autoclaving) exposure parameters as described in Section 2.6,

“Steam sterilization (autoclaving) of accessories” and the sterilizer manufacturer’s instructions.

• When placing the distal cover in the sterile packing, do not

place it together with other cleaning equipment, accessories,

etc. The distal cover could be deformed and may become difficult to attach, or the risk of the distal cover falling off

during the examination will increase.

• When steam sterilizing the distal cover, do not place other

objects on top of the distal cover. The distal cover could be deformed and may become difficult to attach, or the risk of

the distal cover falling off during the examination will

increase.

• Sudden changes in temperature may damage the distal

cover.

3. Following steam sterilization (autoclaving), let the distal cover gradually cool

down to room temperature.

4. Store the distal cover to following the instructions given in Chapter 5,

“Storage and Disposal”.

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Chapter 4 Cleaning and Disinfection Equipment

Chapter 4 Cleaning and Disinfection

Equipment

The endoscope is compatible with some endoscope reprocessors recommended by Olympus. Refer to the instruction manual of the endoscope

reprocessor for details on operation.

• Thoroughly clean the endoscope as described in Chapter 3,

“Cleaning, Disinfection and Sterilization Procedures” before reprocessing the endoscope in an endoscope reprocessor. If

an endoscope that has not been thoroughly manually

cleaned is placed into the endoscope reprocessor, debris attached to the endoscope may impair the cleaning and

disinfection capabilities of the reprocessor, and the

endoscope can pose an infection-control risk to the patient and/or operators who perform the next procedure with it.

Note that if the instrument is not precleaned immediately

after the procedure, patient debris may solidify, which could impair proper cleaning and disinfection of the endoscope.

Refer to the endoscope reprocessor’s instruction manual for

details on proper connection of the endoscope to the reprocessor and operation of the reprocessor.

• Olympus only confirms validation of endoscope reprocessors

it recommends. When using an endoscope reprocessor that

is not recommended by Olympus, the endoscope reprocessor’s manufacturer is responsible for validation of

the reprocessor with the endoscope models listed in its

instruction manual.

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Chapter 4 Cleaning and Disinfection Equipment

• Before using an endoscope reprocessor, confirm that it is

capable of reprocessing the endoscope including all channels. If there are channels and/or other parts of the

endoscope that cannot be cleaned and/or high-level

disinfected by the endoscope reprocessor, manual cleaning and high-level disinfection or sterilization must be performed

as described in Chapter 3, “Cleaning, Disinfection and

Sterilization Procedures” after using the endoscope reprocessor. Otherwise, insufficient cleaning and disinfection

or sterilization of the endoscope may pose an

infection-control risk to the patient and/or operators performing the next procedure with the endoscope. If you are

uncertain as to the ability of your endoscope reprocessor to

clean and high-level disinfect the endoscope including all channels, contact the endoscope reprocessor’s

manufacturer for specific instructions and/or information on

connectors.

• When cleaning and disinfecting an endoscope in an

endoscope reprocessor, use connectors that are compatible with the endoscope model. Otherwise, insufficient cleaning

and disinfection or sterilization of the endoscope may occur,

which could pose an infection-control risk to the patient and/or operators performing the next procedure with the

endoscope. The applicable connectors for each endoscope

model should be listed in the instruction manual of the endoscope reprocessor. If your endoscope model is not

listed in that instruction manual, please contact the

manufacturer of the endoscope reprocessor.

• Use connectors special to each model when cleaning and

disinfecting the endoscope with the endoscope reprocessor.

Otherwise, insufficient cleaning and disinfection or

sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next

procedure with the endoscope. The applicable connectors for

each endoscope model should be listed in the automated endoscope reprocessor instruction manual. If your

endoscope model is not listed in this table, please contact the

manufacturer of the endoscope reprocessor.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

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Chapter 4 Cleaning and Disinfection Equipment

• The elevator wire channel may not be properly high-level

disinfected by all reprocessors. If using a reprocessor, please contact the manufacturer of the reprocessor for certification

that the elevator wire channel can be efficaciously high-level

disinfected in their unit. If the elevator wire channel cannot be high-level disinfected by a reprocessor, clean and disinfect

the elevator wire channel according to procedures described

in Chapter 3, “Cleaning, Disinfection and Sterilization Procedures”.

• If using the endoscope reprocessor, be sure to attach the

appropriate connectors (see Table 4.1). Otherwise,

insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient

and/or operators performing the next procedure with the

endoscope.

For air/water

channel

OER

EW-30

OER-A MAJ-818 MAJ-819 MAJ-825

MH-861 MAJ-33 MAJ-41

For instrument

channel, suction

channel

For elevator water

channel

Table 4.1

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Chapter 5 Storage and Disposal

• Keep the reprocessed endoscope and accessories away

from the contaminated equipment after cleaning and disinfection or sterilization. If the clean endoscope and

accessories become contaminated between procedures,

they could present an infection control risk to the patient and/or operators in the subsequent procedure.

• To prevent contamination of the reprocessed endoscope and

accessories, be sure to keep the storage cabinet clean.

• The storage cabinet must be clean, dry, well ventilated and

maintained at ambient temperature. Do not store the

endoscope in direct sunlight, at high temperature, in high humidity or exposed to X-rays and/or ultraviolet-rays. These

could damage the endoscope or present an infection control

risk.

• Do not store the endoscope in the carrying case. Use the

carrying case only for shipping the endoscope. Routinely

storing the endoscope in a humid, non-ventilated

environment such as the carrying case may present an infection control risk.

5.1 Storage of the endoscope

When storing the endoscope, make sure that the forceps

elevator is not protruded from the distal end so that it cannot

strike any objects, as this could damage the forceps elevator.

1. Detach all equipment (the air/water valve, suction valve, biopsy valve,

water-resistant cap and distal cover) from the endoscope.

2. Confirm that all surfaces of the endoscope (especially all internal lumens,

the distal end, lens and electrical contacts) are completely dry.

3. Place the endoscope’s angulation locks in the “F ” position.

4. Hang the endoscope in the storage cabinet with the distal end hanging

freely. Make sure that the insertion tube hangs vertically and as straight as

possible.

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Chapter 5 Storage and Disposal

5.2 Storage of reusable parts and reprocessing equipment

1. Confirm that all reusable parts and reprocessing equipment are dry.

2. Store all reusable parts in the storage cabinet. Make sure that the parts do

not touch each other during storage.

3. Store all reprocessing equipment in a container, then place the container in

the storage cabinet.

5.3 Disposal

When disposing of the endoscope, or any of its components (such as valves),

follow all applicable national and local laws and guidelines.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL

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Page 78

Page 79

OLYMPUS is a registered trademark of OLYMPUS CORPORATION.

Trademarks, product names, logos, or trade names used in this document are generally registered trademarks or trademarks of each company.

Page 80

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