Revision Ver RC2409 01

Page 2

Revision History

Note: The Revision History shows the latest changes.

Version

RC2409 01

GE8415 09

Date

March, 2015

February,

2015

Description of Changes

Cover

Single use soft brush (MAJ-1888) information.

Section 1.4

Updated WARNING statements for MAJ-1888 and

using an AER.

Sections 2.10, 3.1, and 4.1

Updated MAJ-1888 information.

Section 4.2

Updated MAJ-1888 and AER information.

Sections 4.3 and 5.1

Updated MAJ-1888 information.

Section 5.2

Updated “Aspirate water” section.

Section 5.3

Updated “Detach the endoscope from the light

source” section.

Section 5.4

Updated “Equipment needed” chart and CAUTION for

MAJ-1888, Step 5 on page 69, and added “Brush and

flush the forceps elevator recess” section.

Section 5.5

Updated “Flush all channels and around the forceps

elevator with disinfectant solution” section.

Section 5.6

Updated “Rinse the endoscope and accessories”

section; the “Alcohol flush” section.

Chapter 7

Updated WARNING statements for AER.

Page 3

Contents

Contents

Chapter 1

General Policy .........................................................

1

1.1

Instructions......................................................................................

1

1.2

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

2

1.3

Signal words ...................................................................................

2

1.4

Precautions .....................................................................................

3

1.5

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

8

1.6

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

9

1.7

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

9

Function and Inspection of the Accessories for

Reprocessing...........................................................

10

2.1

Water resistant cap (MH-553).........................................................

10

2.2

Channel plug (MH-944)...................................................................

12

2.3

Injection tube (MH-946) ..................................................................

14

2.4

Channel cleaning brush (BW-20T)..................................................

16

2.5

Suction cleaning adapter (MH-856) ................................................

18

2.6

AW channel cleaning adapter (MH-948).........................................

19

2.7

Single use channel cleaning brush (BW-201T)...............................

20

2.8

Single use channel-opening cleaning brush (MAJ-1339) ...............

22

2.9

Single use combination cleaning brush (BW-412T)........................

24

2.10 Single use soft brush (MAJ-1888)...................................................

25

2.11 Chain for water-resistant cap (MAJ-1119) ......................................

27

Chapter 2

Chapter 3

Compatible Reprocessing Methods and

Chemical Agents ....................................................

28

3.1

Compatibility summary....................................................................

28

3.2

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

30

3.3

Detergent solution...........................................................................

31

3.4

Disinfectant solution........................................................................

31

3.5

Rinse water .....................................................................................

31

3.6

Alcohol ............................................................................................

31

3.7

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

32

3.8

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

33

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Contents

Chapter 4

Reprocessing Workflow for the Endoscope

and Accessories ......................................................

35

Workflow for manually cleaning and disinfecting the endoscope

and accessories ..............................................................................

36

Workflow for cleaning and disinfecting the endoscope and

accessories using an AER ..............................................................

38

Workflow for manually cleaning and sterilizing the endoscope

and accessories ..............................................................................

40

Reprocessing the Endoscope

(and related reprocessing accessories) ................

42

5.1

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

44

5.2

Precleaning the endoscope and accessories..................................

45

5.3

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

51

5.4

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

56

5.5

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

80

5.6

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

86

5.7

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

94

Reprocessing the Accessories ..............................

96

6.1

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

98

6.2

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

101

6.3

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

102

6.4

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

105

4.1

4.2

4.3

Chapter 5

Chapter 6

ii

Chapter 7

Reprocessing Endoscopes and Accessories

using an Automated Endoscope Reprocessor..... 106

Chapter 8

Storage and Disposal .............................................. 108

8.1

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

109

8.2

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

111

8.3

Disposal ..........................................................................................

111

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Chapter 1 General Policy

Chapter 1 General Policy

1.1

Instructions

•

This manual contains the cleaning, disinfection, and sterilization

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 for

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 occurs while reprocessing that cannot be solved,

contact Olympus.

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Chapter 1 General Policy

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 for 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 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:

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.

2

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Chapter 1 General Policy

1.4

Precautions

•

An insufficiently cleaned, disinfected, or sterilized endoscope

and/or accessories may pose an infection control risk to the

patients and/or operators who contact them.

•

All disinfection methods (whether performed manually or by

an automated endoscope reprocessor), and all sterilization

methods (whether performed by ethylene oxide gas or

steam) require thorough prior cleaning of the instrument

being reprocessed. If the equipment is 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, including the instrument

channel and all accessories used with the endoscope during

the patient procedure, such as all valves, must be cleaned

and high-level disinfected or sterilized after each patient

procedure, even if the channels or accessories were not

used during the patient procedure. Insufficient cleaning and

disinfection or sterilization of these components may pose an

infection control risk to patients and/or operators.

•

Disinfectant solutions are hazardous. After disinfection, rinse

all external surfaces and channels of the endoscope and

accessories thoroughly with water to remove residual

disinfectant solution.

•

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, as well as the instruction

manual for the sterilization device.

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Chapter 1 General Policy

•

Establish an internal system of identifying contaminated

versus reprocessed endoscopes and accessories to prevent

both mix-ups and cross-contamination. 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.

•

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

•

4

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.

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Chapter 1 General Policy

•

Do not use the AW channel cleaning adapter (MH-948) for

patient procedures. It will cause continuous insufflation and

could result in patient injury.

AW channel cleaning

adapter (MH-948)

Figure 1.2

•

The accessories listed on the front cover of this manual are

consumables, meaning that these accessories cannot be

refurbished or repaired and are intended to be replaced once

they show any signs of wear. 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 channel cleaning

brush (BW-201T), the single use combination cleaning brush

(BW-412T), the single use channel-opening cleaning brush

(MAJ-1339), and the single use soft brush (MAJ-1888), 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 endoscope and/or accessory damage.

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Chapter 1 General Policy

6

•

Patient debris and reprocessing chemicals are hazardous.

To guard against contact with dangerous chemicals and

potentially infectious material, wear appropriate personal

protective equipment during cleaning, disinfection, and

sterilization. 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.

Adequate ventilation protects against the buildup of toxic

chemical fumes.

•

Always remove contaminated personal protective equipment

before leaving the reprocessing area to prevent

contamination from spreading.

•

Only Olympus-recommended or Olympus-endorsed

automated endoscope reprocessors (AERs) have been

validated by Olympus. When using an AER that is not

recommended by Olympus, the manufacturer of the AER is

responsible for validating compatibility of the AER with each

Olympus endoscope and accessory.

•

Before using an AER, confirm that it is capable of

reprocessing the endoscope including all channels, the

forceps elevator recess, and accessories. Be sure to attach

all required connectors. Otherwise, insufficient reprocessing

may pose an infection control risk. If you are uncertain as to

the ability of your AER to reprocess the endoscope including

all channels, the forceps elevator recess, and accessories,

contact the manufacturer of the AER for specific instructions

and information on compatibility and required connectors.

When you use an AER which allows you skip some steps in

precleaning and manual cleaning of endoscopes, confirm

with the AER manufacturer that such skip is applicable to this

endoscope and establish detailed precleaning and manual

cleaning procedures of this endoscope according to both

instructions of this manual and the AER manufacturer.

•

Put the forceps elevator in intermediate position of the range

of movement by turning the elevator control lever and set it in

your AER.

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Chapter 1 General Policy

•

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 that repair facility

for instructions regarding reprocessing.

•

Prions, which are the pathogenic agent of the

Creutzfeldt-Jakob disease (CJD), cannot be destroyed or

inactivated by the cleaning, disinfection, and sterilization

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.

•

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 cleaning, disinfection, or sterilization methods

not described in this reprocessing manual. If you chose 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.

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Chapter 1 General Policy

•

When reprocessing the endoscope, confirm that the water

resistant cap (MH-553) is securely attached to the electrical

connector before immersing the endoscope in reprocessing

fluids. If the water resistant cap is not securely attached, the

reprocessing fluids could enter the endoscope and damage

the endoscope.

Electrical connector

Water resistant

cap (MH-553)

Figure 1.3

1.5

•

When aerating or irrigating the endoscope channels, the air

or water pressure must not exceed 0.5 MPa (5 kgf/cm2,

71 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 solutions and alcohol may damage

electronic devices such as computers.

Reprocessing before the first use

New endoscopes, repaired endoscopes, accessories, and the carrying case for

endoscopes are not cleaned, disinfected, or sterilized 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.

8

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Chapter 1 General Policy

1.6

1.7

Reprocessing and storage after use

•

Do not reuse rinse water.

•

High-level disinfectant solutions are 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 high-level disinfection.

•

If the disinfectant solution is reused, check its efficacy with 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.

Reprocessing before patient procedure

•

Improper storage practices, such as not thoroughly drying

external and internal surfaces (lumens) including the forceps

elevator recess 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.

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 sterilization expiration date(s) of all items

so marked and for tears or breaches in 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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Chapter 2 Function and Inspection of the Accessories for Reprocessing

Chapter 2 Function and Inspection of

the Accessories for

Reprocessing

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

Water resistant cap (MH-553)

Groove

Seals

Venting connector

Figure 2.1

10

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

 Function

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

to protect the connector and the endoscope from water penetration during

reprocessing. During leakage testing, the leakage tester (MB-155) is attached to

the venting connector of the water resistant cap.

Water resistant

cap (MH-553)

Electrical connector

Chain for water-resistant

cap (MAJ-1119)

Figure 2.2

Venting

connector

Maintenance

unit (MU-1)

Leakage tester (MB-155)

Figure 2.3

The water resistant cap must be attached to the electrical connector of the

endoscope whenever the endoscope is immersed in reprocessing fluids. It is

detached from the connector whenever the endoscope is used for patient

procedures, being sterilized by ethylene oxide gas, or stored in an endoscope

storage cabinet.

Always use a dry water resistant cap. Any water remaining

inside the cap may cause damage to the endoscope.

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

Use the chain for water-resistant cap (MAJ-1119) to connect

the water resistant cap to the endoscope. The water resistant

cap can remain connected to the endoscope by the chain at

all times (including during patient procedures, reprocessing,

and storage of the endoscope).

 Inspection

2.2

1.

Confirm that the inside of the cap is dry and free from debris. Wipe with a

dry, lint-free cloth if the inside of the cap is wet or if debris is detected.

2.

Confirm that the seals inside the cap are free from scratches, cuts, and

debris.

3.

Check to ensure that the venting connector on the cap is not loose.

Channel plug (MH-944)

Biopsy valve cap

Plug frame

Suction plug

Air/water plug

Figure 2.4

12

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

 Function

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

and the suction and air/water cylinders of the endoscope whenever the injection

tube (MH-946) is used to flush the suction and air/water channels of the

endoscope with reprocessing fluids.

Channel plug

Instrument

channel port

Figure 2.5

When attached to the endoscope, the channel plug is

designed to allow a small amount of fluid to exit from the

openings of the endoscope. This enables reprocessing fluids

to contact the endoscope openings.

 Inspection

Confirm that the suction plug, air/water plug, and the biopsy valve cap of the

channel plug are free from cracks, scratches, and debris.

The channel plug does not need to be cleaned, disinfected,

or sterilized prior to its first use.

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

2.3

Injection tube (MH-946)

Information

card

Suction channel tube

Connector plug

Suction

channel port

Air pipe port

Air/water

channel port

Air/water channel tube

Filter tube

Suction port

(including the filter mesh)

Filter mesh

Figure 2.6

 Function

The injection tube is used to inject reprocessing fluids into the instrument

channel, suction channel, and air/water channels of the endoscope. It is also

used to flush air through these channels to expel fluids.

Syringe

Air/water channel tube

Suction channel tube

Suction port

Air pipe port

Basin

Connector plug

Reprocessing

fluids

Figure 2.7

 Inspection

14

1.

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

scratches, flaws, and debris (see Figure 2.6).

2.

Confirm that the filter mesh is in the suction port of the injection tube.

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

3.

Attach a clean 30 ml syringe to the suction channel port of the injection tube.

With the suction port of the injection tube immersed in the water referred to

in Section 3.2, withdraw the syringe plunger and confirm that the water is

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

emitted from the suction channel tube of the injection tube. Confirm that the

water is not emitted from the suction port when removing the suction port

from the water.

Suction channel

tube

Suction channel

port

Syringe

Suction port

Figure 2.8

4.

Move the syringe to the air/water channel port of the injection tube. With the

suction port of the injection tube immersed in the water, withdraw the

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

Depress the plunger and confirm that the water is emitted from the air pipe

port of the injection tube. Confirm that the water is not emitted from the

suction port when removing the suction port from the water.

Suction

channel tube

Air/water channel port

Syringe

Suction port

Air pipe

port

Figure 2.9

The injection tube does not need to be cleaned, disinfected,

or sterilized prior to its first use.

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

2.4

Channel cleaning brush (BW-20T)

Metal tip

Shaft

Bristles

Brush head

Figure 2.10

 Function

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

and suction channel of the endoscope, and the interior and openings of the

suction valve (MH-443), the air/water valve (MH-438) and the biopsy valve

(MB-358).

Suction cylinder

Instrument channel

Suction channel

Figure 2.11

16

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

Depress

Suction valve

(MH-443)

Air/water valve

(MH-438)

Biopsy valve (MB-358)

Figure 2.12

 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.

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

4.

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 referred to in

Section 3.2 and clean the brush until no debris is observed on the brush.

The channel cleaning brush does not need to be cleaned,

disinfected, or sterilized prior to its first use.

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

2.5

Suction cleaning adapter (MH-856)

Connecting end

Weighted end

Figure 2.13

 Function

The suction cleaning adapter is used to aspirate reprocessing fluids through the

instrument channel port of the endoscope.

Suction cylinder

Connecting end

Suction cleaning

adapter

Instrument

channel port

Weighted end

Suction pump

Figure 2.14

 Inspection

Check for debris, cracks, scratches, and other damage.

The suction cleaning adapter does not need to be cleaned,

disinfected, or sterilized prior to its first use.

18

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

2.6

AW channel cleaning adapter (MH-948)

Slider

Button

Information

card

One-way valve

Piston

Seals

Figure 2.15

 Function

During precleaning of the endoscope, the AW channel cleaning adapter is

attached to the air/water cylinder of the endoscope. When the button of the

adapter is depressed, the water in the water container is fed through the air/

water nozzle of the endoscope to clean the nozzle and air/water channels of the

endoscope. Air is continuously fed through the air/water channels when the

button is not depressed.

AW channel

cleaning adapter

Air/water

nozzle

Water

container

Depress

Air channel

Air/water cylinder

Figure 2.16

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

 Inspection

Check for debris, cracks, scratches, and other damage.

The AW channel cleaning adapter does not need to be

cleaned, disinfected, or sterilized prior to its first use.

2.7

Single use channel cleaning brush (BW-201T)

Caution sticker

Bristles

Tip

Brush head

Shaft

Figure 2.17

 Function

The single use channel cleaning brush is used to brush the inside of the

instrument channel and suction channel of the endoscope and the interior and/or

openings of the suction valve (MH-443), the air/water valve (MH-438), and the

biopsy valve (MB-358).

Suction cylinder

Instrument channel

Suction channel

Figure 2.18

20

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Chapter 2 Function and Inspection of the Accessories for Reprocessing

Depress

Suction valve

(MH-443)

Air/water valve

(MH-438)

Biopsy valve (MB-358)

Figure 2.19

 Inspection

1.

Remove the brush from its packaging just prior to use.

2.

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

Check the brush head for loose or missing bristles.

3.

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

straighten them with your fingertips.

4.

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

The single use channel cleaning brush does not need to be

cleaned, disinfected, or sterilized prior to use.

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21