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Contents

Contents

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

1.1

Instructions ............................................................................................................... 1

1.2

Importance of reprocessing .................................................................................... 2

1.3

Signal words ............................................................................................................. 2

1.4

Warnings and cautions ............................................................................................ 3

1.5

Reprocessing before the first use .......................................................................... 7

1.6

Reprocessing and storage after use ...................................................................... 7

1.7

Reprocessing before patient procedure ................................................................ 8

Chapter 2 Function and Inspection of the Accessories for

Reprocessing ..........................................................................9

2.1

Sterilization cap (MAJ-1538) .................................................................................... 9

2.2

Single use single-ended cleaning brush (BW-400B) ........................................... 10

2.3

Suction connector cleaning brush (BW-15SH) .................................................... 12

2.4

Channel cleaning brush (BW-15B) ........................................................................ 14

2.5

Channel-opening cleaning brush (MH-507) ......................................................... 16

2.6

Single use combination cleaning brush (BW-411B) ............................................ 18

2.7

Suction cleaning adapter (MAJ-222) .................................................................... 21

Chapter 3 Compatible Reprocessing Methods and

Chemical Agents ...................................................................23

3.1

Compatibility summary .......................................................................................... 23

Microbiological efficacy ........................................................................................................

Material durability ................................................................................................................

List of compatible methods validated in terms of microbiological efficacy and

material durability ................................................................................................................

List of compatible methods validated in terms of material durability ....................................

24

24

25

27

3.2

Water (for reprocessing) ........................................................................................ 29

3.3

Detergent solution .................................................................................................. 29

3.4

Disinfectant solution .............................................................................................. 30

3.5

Rinse water ............................................................................................................. 30

3.6

Alcohol .................................................................................................................... 30

3.7

Ethylene oxide gas sterilization ............................................................................ 31

3.8

Steam sterilization (autoclaving) .......................................................................... 33

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Chapter 4 Reprocessing Workflow for Endoscopes and

Accessories...........................................................................35

4.1

Summary of reprocessing workflow ..................................................................... 35

4.2

Workflow for manually cleaning and disinfecting endoscopes and

accessories ...............................................................................................................36

4.3

Workflow for cleaning and disinfecting endoscopes and accessories

using an AER/WD .....................................................................................................38

4.4

Workflow for manually cleaning and sterilizing endoscopes and

accessories ...............................................................................................................40

Chapter 5 Reprocessing the Endoscope

(and Related Reprocessing Accessories) ..........................43

5.1

Summary of reprocessing the endoscope ........................................................... 43

5.2

Preparing the equipment for reprocessing .......................................................... 45

Equipment needed .............................................................................................................. 45

5.3

Precleaning the endoscope ................................................................................... 47

Equipment needed ..............................................................................................................

Preparation ..........................................................................................................................

Wipe the insertion section ...................................................................................................

Aspirate water ......................................................................................................................

Detach the suction tube from the endoscope ......................................................................

Detach the endoscope from the light source .......................................................................

5.4

47

48

48

49

50

50

Leakage testing of the endoscope ........................................................................ 50

Equipment needed .............................................................................................................. 50

Detach the accessories from the endoscope ...................................................................... 51

Perform the leakage test ..................................................................................................... 52

5.5

Manually cleaning the endoscope and accessories ........................................... 54

Equipment needed ..............................................................................................................

Clean the external surface ...................................................................................................

Brush the channels ..............................................................................................................

Aspirate detergent solution through the instrument channel and the suction channel ........

Immerse the endoscope and the suction cleaning adapter in detergent solution ................

Remove detergent solution from all channels .....................................................................

Dry external surfaces ...........................................................................................................

5.6

Manually disinfecting the endoscope and accessories ...................................... 66

Equipment needed ..............................................................................................................

Preparation ..........................................................................................................................

Immerse the endoscope and the suction cleaning adapter in disinfectant solution .............

Remove the endoscope and the suction cleaning adapter from disinfectant solution .........

5.7

54

55

55

62

64

65

65

66

66

67

69

Rinsing the endoscope and accessories following disinfection ....................... 70

Equipment needed .............................................................................................................. 71

Rinse the endoscope and accessories ................................................................................ 71

Alcohol flush ........................................................................................................................ 73

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5.8

Sterilizing the endoscope and accessories ......................................................... 74

Ethylene oxide gas sterilization of the endoscope and accessories .................................... 74

Steam sterilization (autoclaving) of the accessories ............................................................ 76

STERRAD® 50/100S/200/NX sterilization of the endoscope and accessories ................. 76

5.9

Presoaking the endoscope .................................................................................... 78

Equipment needed .............................................................................................................. 78

Chapter 6 Reprocessing the Accessories .......................................... 79

6.1

Summary of reprocessing the accessories ......................................................... 79

Equipment needed .............................................................................................................. 80

6.2

Manually cleaning the accessories ...................................................................... 81

Disassembling the suction valve (MAJ-207) ........................................................................ 81

Manually cleaning the accessories ...................................................................................... 82

6.3

Manually disinfecting the accessories ................................................................. 86

6.4

Rinsing the accessories following disinfection .................................................. 87

Rinse the accessories ......................................................................................................... 87

Alcohol flush ........................................................................................................................ 88

6.5

Sterilizing the accessories .................................................................................... 89

Ethylene oxide gas sterilization ........................................................................................... 89

Steam sterilization (autoclaving) .......................................................................................... 90

Chapter 7 Reprocessing Endoscopes and Accessories

Using an Automated Endoscope

Reprocessor/Washer-Disinfector ........................................91

7.1

Reprocessing endoscopes and accessories using an automated endoscope

reprocessor/washer-disinfector.............................................................................. 91

Chapter 8 Storage and Disposal ......................................................... 93

8.1

Warnings and cautions: storage and disposal .................................................... 93

8.2

Storing the disinfected endoscope and accessories .......................................... 94

8.3

Storing the sterilized endoscope and accessories ............................................. 95

8.4

Disposal .................................................................................................................. 95

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1.1 Instructions

Chapter 1

1.1

General Policy

Ch.1

Instructions

• This manual contains the reprocessing methods recommended by Olympus for the

endoscopes and accessories listed on the front cover.

• This instruction manual contains essential information on reprocessing endoscopes and

accessories safely and effectively.

• Before reprocessing, thoroughly review this manual and the manuals of the reprocessing

equipment and chemicals that will be used for reprocessing. Reprocess all the devices as

instructed.

• Note that the complete instruction manual set for the endoscope and accessories consists of

this manual and the “OPERATION MANUAL” with your endoscope model listed on the cover.

Both manuals accompanied the endoscope at shipment.

• Keep this manual and all related manuals in a safe and accessible location (e.g., in the

reprocessing area).

• 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.

 Terms used in this manual

AER/WD:

AER and WD are abbreviations for Automated Endoscope Reprocessor and

Washer-Disinfector, which are used for reprocessing the endoscopes and accessories.

Disinfection:

Some countries classify the disinfection level and define “high-level disinfection”, and other

countries do not. The term “disinfection” is used, including the meaning “high-level

disinfection”, in this manual. For disinfectant solution, follow the instructions as described

in Section 3.4, “Disinfectant solution”.

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1.2 Importance of reprocessing

Ch.1

1.2

Importance of reprocessing

The medical literature reports incidents of cross-contamination resulting from improper reprocessing. 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 policies of your hospital

• Instruction manuals for the endoscope, accessories, and all the other reprocessing

equipment

• Structure and handling of the endoscope and accessories

• Handling of pertinent chemicals

When selecting appropriate methods and conditions for cleaning and disinfection and sterilization,

follow the policies at your institution, applicable national laws and standards, and professional society

guidelines and recommended practices, in addition to the instructions given in this manual.

1.3

Signal words

The following signal words are used throughout this manual:

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in

death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor

or moderate injury. It may also be used to alert against unsafe practices or potential

equipment damage.

NOTE

2

Indicates additional helpful information.

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1.4 Warnings and cautions

1.4

Ch.1

Warnings and cautions

WARNING

• An insufficiently reprocessed endoscope and/or accessory may pose an infection

control risk to the patients and/or operators who touch them.

• The endoscope reprocessor, video system center, light source, front panels of

equipment, and/or mouthpiece may cause an infection control risk. Perform proper

cleaning and disinfection as described in their respective instruction manuals. A

tap, basin, and/or nozzle of pharyngeal anesthetic spray that medical personnel

come in contact with may cause an infection control risk as well. Perform proper

replacement, cleaning, and disinfection.

• All disinfection methods (whether performed manually or by an AER/WD) and all

sterilization methods (whether performed by ethylene oxide gas or steam) require

thorough prior cleaning of the instruments being reprocessed. If the instruments

are not adequately cleaned prior to disinfection/sterilization, these processes will

be ineffective. Immediately after each patient procedure and before

disinfection/sterilization, thoroughly clean the endoscope and the accessories used

with the endoscope.

• All channels of the endoscope and all accessories used with the endoscope during

the patient procedure must be reprocessed after each patient procedure, even if

the channels or accessories were not used during the patient procedure.

Insufficient reprocessing of these components may pose an infection control risk to

patients and/or operators.

• Residual disinfectant solution may cause adverse reactions in patients. Therefore,

rinse all external surfaces and channels of the endoscope and accessories

thoroughly with water to remove residual disinfectant solution following disinfection.

• The results of sterilization depend on various factors. These factors include how

the equipment was packaged and the placing and loading of the package in the

sterilization device. Verify the sterilization process using biological and/or chemical

indicators. Follow the guidelines for sterilization issued by national authorities,

professional organizations and infection control professionals, including the

frequency of the above verification, as well as the instruction manual for the

sterilization device.

• Establish an internal system of identifying contaminated versus reprocessed

endoscopes and accessories to prevent both mix-ups and cross-contamination.

Some national or professional guidelines recommend separating dirty

(contaminated) area, clean area, and storage area. Touching a reprocessed

endoscope and/or accessories with contaminated gloves or placing them on a

contaminated hanger or surface, including letting them touch the floor, will

recontaminate them.

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1.4 Warnings and cautions

Ch.1

WARNING

• Prior to each patient procedure, confirm that the endoscope and accessories have

been properly reprocessed and stored. If there are any doubts or questions,

reprocess them again before the patient procedure, following the instructions given

in this manual.

• Perform a leakage test on the endoscope after each precleaning procedure. 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. Use of a leaking endoscope may also pose an infection

control risk.

Leakage tester

Figure 1.1

• Store alcohol in an airtight container. Alcohol stored in an open container may

cause a fire hazard and may result in a loss of efficacy due to evaporation.

• The accessories listed on the front cover of this manual cannot be refurbished or

repaired and are intended to be replaced once they show any signs of wear and

tear. Should any irregularity be observed, use a replacement accessory instead.

Using defective accessories may cause equipment malfunction, reduce the efficacy

of reprocessing, present a risk to patients and/or operators, or damage the

endoscope and/or accessories.

• Single-use brushes, such as the single use single-ended cleaning brush

(BW-400B) and the single use combination cleaning brush (BW-411B), are

designed for cleaning only one endoscope and its related accessories. Dispose of

the single-use brush immediately after use. Using a single-use brush to clean

multiple endoscopes and/or accessories may reduce its cleaning efficacy and may

damage the brush leading to brush breakage or the endoscope and/or accessory

damage.

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1.4 Warnings and cautions

Ch.1

WARNING

• Patient debris and used reprocessing chemicals pose infection control risks. To

guard against contact with dangerous chemicals and potentially infectious material,

wear appropriate personal protective equipment during reprocessing. Such

protective equipment should include appropriate eyewear, face mask, cap,

moisture-resistant clothing, shoe covers, and chemical-resistant gloves that fit

properly and are long enough to prevent skin exposure.

• The reprocessing room must be adequately ventilated to minimize the risks from

chemical vapors.

• Always remove contaminated personal protective equipment before leaving the

reprocessing area to prevent contamination from spreading.

• Only Olympus-recommended or Olympus-endorsed AERs/WDs have been

validated by Olympus. When using an AER/WD that is not recommended by

Olympus, the manufacturer of the AER/WD is responsible for validating

compatibility of the AER/WD with each Olympus endoscope and accessory.

• Before using an AER/WD, confirm that it is capable of reprocessing the endoscope

including all channels and accessories. Be sure to attach all required

connectors/adapters. Otherwise, insufficient reprocessing may pose an infection

control risk. If you are uncertain as to the ability of your AER/WD to reprocess the

endoscope including all channels and accessories, contact the manufacturer of the

AER/WD for specific instructions and information on compatibility and the required

connectors/adapters.

• Instructions provided in this manual are not valid for Olympus devices repaired by a

non-Olympus facility. The Olympus recommended reprocessing procedures have

not been validated for reprocessing devices repaired by a non-Olympus facility. In

the event that your device has been repaired by a non-Olympus facility, contact the

repair facility for instructions regarding reprocessing.

• Prions, which are the pathogenic agents of the Creutzfeldt-Jakob disease (CJD)

cannot be destroyed or inactivated by the reprocessing methods stated in this

instruction manual. When using the endoscope and accessories on patients with

CJD or variant Creutzfeldt-Jakob disease (vCJD), be sure to use them for such

patients only, or immediately dispose of them after use in an appropriate manner to

prevent the usage of exposed devices on other patients. For methods to handle

CJD, follow the respective guidelines in your country.

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1.4 Warnings and cautions

Ch.1

WARNING

• The endoscope and accessories may be damaged by published methods for

destroying or inactivating prions. For information on the durability of Olympus

equipment against a particular reprocessing method, contact Olympus. In general,

Olympus cannot guarantee the effectiveness, safety, and durability of reprocessing

methods not described in this reprocessing manual. If you choose to use a

reprocessing method not recommended in this manual, the local institution and/or

physicians must assume responsibility for its safety and efficacy. Make sure to

carefully inspect each piece of endoscopic equipment for irregularities (damage)

prior to each patient procedure. Do not use the equipment if any irregularity is

found.

• Good quality control practices typically require appropriate documentation. Items

such as local SOPs (Standard Operating Procedures), confirmation of operator

training, routine testing of the disinfectant’s MEC (Minimal Effective Concentration),

confirmation of the disinfectant’s use-life, etc. should be documented as performed.

CAUTION

• Before immersing the endoscope in reprocessing fluids, confirm that the

sterilization cap (MAJ-1538) is not attached to the endoscope. If the sterilization

cap is attached, the reprocessing fluids will be able to penetrate the inside of the

endoscope, and it can be damaged.

• Do not turn the insertion tube rotation ring in reprocessing fluids. The reprocessing

fluids will be able to penetrate the inside of the endoscope, and it can be damaged.

• When aerating or irrigating the endoscope channels, the air or water pressure must

not exceed 0.2 MPa (2 kgf/cm2, 29 psig). Higher pressures may cause damage to

the endoscope.

• Store spare accessories in their original packaging to prevent damage.

• To prevent damage, do not apply excessive force to the endoscope and

accessories during reprocessing.

• Vapors from disinfectant solution and alcohol may damage electronic devices such

as computers. Properly manage the quality and durability of the devices used in

reprocessing rooms and the ventilation performance of the rooms.

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1.5 Reprocessing before the first use

1.5

Ch.1

Reprocessing before the first use

New endoscopes, repaired endoscopes, accessories, and the carrying case for endoscopes are not

reprocessed prior to shipping from Olympus, regardless of whether those instruments are for new

purchase, demo, or loaner purposes. Reprocess all such endoscopes and accessories received from

Olympus according to the instructions given in this manual before storage and before using them in a

patient procedure.

1.6

Reprocessing and storage after use

WARNING

• Do not reuse rinse water.

• Disinfectant solution is only effective when used according to the disinfectant

manufacturer’s instructions. Follow the manufacturer’s instructions regarding

activation (if required), concentration, temperature, contact time and use life

required to achieve disinfection.

• If the disinfectant solution is reused, check its efficacy by proper methods, such as

using a test strip, according to the disinfectant manufacturer’s recommendations

prior to use.

• Do not reuse alcohol.

• Alcohol is not a sterilant or high-level disinfectant.

• To maintain sterility of equipment following sterilization, use sterile packaging and

wraps according to national guidelines.

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1.7 Reprocessing before patient procedure

Ch.1

1.7

Reprocessing before patient procedure

WARNING

• Improper storage practices, such as not thoroughly drying external and internal

surfaces (lumens) prior to storage, will lead to an infection control risk.

• Improper handling, such as touching a reprocessed endoscope and/or accessories

with contaminated gloves, placing a reprocessed device on a contaminated hanger

or surface, allowing devices to touch the floor, etc. will recontaminate the device.

NOTE

Some national or professional guidelines recommend reprocessing endoscopes

prior to their first use of the day.

Confirm that the endoscope and accessories have undergone proper reprocessing following their last

use and that they have been stored properly. Check the storage period of reprocessed endoscopes,

and check for surface contamination (e.g., dust). Check the expiration date marked on all items and

check for tears or breaches in the sterile packaging. If there are any doubts or questions concerning

whether a device is contaminated, reprocess it again following the instructions given in this manual.

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2.1 Sterilization cap (MAJ-1538)

Chapter 2

Function and Inspection of

the Accessories for

Reprocessing

Ch.2

Certain accessories are required for reprocessing the endoscope. This chapter describes the function

of these accessories. It also describes how to inspect these accessories before using them to

reprocess the endoscope.

2.1

Sterilization cap (MAJ-1538)

Connector

Figure 2.1

 Function

When performing gas sterilization (e.g., ethylene

oxide gas sterilization, hydrogen peroxide low

temperature plasma), the sterilization cap must be

attached to the venting connector on the endoscope

connector.

Venting connector

Sterilization cap

Figure 2.2

 Inspection

Confirm that the sterilization cap is free from scratches, flaws, and debris.

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2.2 Single use single-ended cleaning brush (BW-400B)

2.2

Single use single-ended cleaning brush

(BW-400B)

Ch.2

Endoscope model: BF-XP190

Metal tip

Bristles

Brush head

Shaft

Figure 2.3

 Function

The single use single-ended cleaning brush is used to brush the inside of the instrument

channel of the endoscope.

Suction cylinder

Instrument channel port

Suction channel

Figure 2.4

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Instrument channel

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2.2 Single use single-ended cleaning brush (BW-400B)

 Inspection

CAUTION

Do not reprocess single use single-ended cleaning brush prior to use. The brush

may be damaged.

1

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

Check the brush head for loose or missing bristles.

2

Check the bristles for damage. If the bristles are crushed, gently straighten them with

your gloved fingertips.

3

4

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

Visually check for debris on the shaft and/or the bristles of the brush head. If there is

debris on the brush, immerse the brush in the water as described in Section 3.2,

“Water (for reprocessing)” and clean the brush until no debris is observed on the

brush.

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2.3 Suction connector cleaning brush (BW-15SH)

2.3

Ch.2

Suction connector cleaning brush (BW-15SH)

Endoscope model: BF-XP190

Bristles

Shaft

Metal tip

Brush head

Figure 2.5

 Function

The suction connector cleaning brush is used to brush the inside of the suction channel of the

endoscope, and the inside of the suction valve (MAJ-207) and the biopsy valve (MD-495).

Suction cylinder

Instrument channel port

Suction channel

Instrument channel

Figure 2.6

Suction valve (MAJ-207)

Figure 2.7

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Biopsy valve (MD-495)

Page 19

2.3 Suction connector cleaning brush (BW-15SH)

 Inspection

1

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

Check the brush head for loose or missing bristles.

2

Check the bristles for damage. If the bristles are crushed, gently straighten them with

your gloved fingertips.

3

4

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

Visually check for debris on the shaft and/or the bristles of the brush head. If there is

debris on the brush, immerse the brush in the water as described in Section 3.2,

“Water (for reprocessing)” and clean the brush until no debris is observed on the

brush.

NOTE

The suction connector cleaning brush does not need to be reprocessed prior to its

first use.

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2.4 Channel cleaning brush (BW-15B)

2.4

Ch.2

Channel cleaning brush (BW-15B)

Endoscope model: except BF-XP190

Metal tip

Bristles

Brush head

Shaft

Figure 2.8

 Function

The channel cleaning brush is used to brush the inside of the instrument channel and suction

channel of the endoscope and the inside of the suction valve (MAJ-207) and the biopsy valve

(MD-495).

Suction cylinder

Instrument channel port

Suction channel

Instrument channel

Figure 2.9

Suction valve (MAJ-207)

Figure 2.10

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Biopsy valve (MD-495)

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2.4 Channel cleaning brush (BW-15B)

 Inspection

1

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

Check the brush head for loose or missing bristles.

2

Check the bristles for damage. If the bristles are crushed, gently straighten them with

your gloved fingertips.

3

4

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

Visually check for debris on the shaft and/or the bristles of the brush head. If there is

debris on the brush, immerse the brush in the water as described in Section 3.2,

“Water (for reprocessing)” and clean the brush until no debris is observed on the

brush.

NOTE

The channel cleaning brush does not need to be reprocessed prior to its first use.

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Ch.2

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2.5 Channel-opening cleaning brush (MH-507)

2.5

Channel-opening cleaning brush (MH-507)

Ch.2

Shaft

Bristles

Brush handle

Brush head

Figure 2.11

 Function

The channel-opening cleaning brush is used to brush the endoscope’s suction cylinder,

instrument channel port, and both the inside and outside of the suction valve (MAJ-207).

Suction cylinder

Instrument channel port

Figure 2.12

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2.5 Channel-opening cleaning brush (MH-507)

Piston

Ch.2

Spring

Main body

Valve

Suction valve (MAJ-207)

Figure 2.13

 Inspection

1

2

Check the brush head for loose or missing bristles.

3

4

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

Check the bristles for any damage. If the bristles are crushed, gently straighten them

with your gloved fingertips.

Visually check for debris on the shaft and/or the bristles of the brush head. If there is

debris on the brush, immerse the brush in the water as described in Section 3.2,

“Water (for reprocessing)” and clean the brush until no debris is observed on the

brush.

NOTE

The channel-opening cleaning brush does not need to be reprocessed prior to its

first use.

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2.6 Single use combination cleaning brush (BW-411B)

2.6

Single use combination cleaning brush

(BW-411B)

Ch.2

Bristles

Tip

Channel cleaning

brush part

Handle

Shaft

Bristles

Channel-opening

cleaning brush part

Figure 2.14

 Function

The channel cleaning brush part of the single use combination cleaning brush is used to brush

the inside of the instrument channel (except BF-XP190) and suction channel of the endoscope,

and the inside of the suction valve (MAJ-207) and the biopsy valve (MD-495). The

channel-opening cleaning brush part of the single use combination cleaning brush is used to

brush the endoscope’s suction cylinder, instrument channel port, and both the inside and

outside of the suction valve.

Suction cylinder

Instrument channel port

Suction channel

Figure 2.15

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Instrument channel

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2.6 Single use combination cleaning brush (BW-411B)

Ch.2

Suction valve (MAJ-207)

Biopsy valve (MD-495)

Figure 2.16

Piston

Spring

Main body

Valve

Suction valve (MAJ-207)

Figure 2.17

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2.6 Single use combination cleaning brush (BW-411B)

 Inspection

CAUTION

Ch.2

Do not reprocess single use combination cleaning brush prior to use. The brush

may be damaged.

20

1

2

Remove the brush from its packaging just prior to use.

3

Check the channel cleaning brush and channel-opening cleaning brush parts for

loose or missing bristles.

4

Check the bristles of the channel cleaning brush and the channel-opening cleaning

brush parts for any damage. If the bristles are crushed, gently straighten them with

your gloved fingertips.

5

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

Confirm that the channel cleaning brush part and tip at the distal end are securely

attached.

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