EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE Reprocessing Manual

Contents

Contents Chapter 1 General Policy ... 1 1.1

Instructions ... 1

1.2

Importance of reprocessing ... 2

1.3

Signal words ... 2

1.4

Precautions ... 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

US connector cap (MAJ-2295) ... 9

2.2

Channel plug (MAJ-621) ... 11

2.3

Injection tube (MH-946) ... 13

2.4

Channel cleaning brush (BW-20T) ... 16

2.5

Channel-opening cleaning brush (MH-507) ... 18

2.6

Cleaning brush (MAJ-1534) ... 20

2.7

Single use single-ended cleaning brush (BW-400L) ... 21

2.8

Suction cleaning adapter (MH-856) ... 22

2.9

Air/water channel cleaning adapter (MAJ-629) ... 23

2.10 Single use combination cleaning brush (BW-412T) ... 24

Chapter 3 Compatible Reprocessing Methods and Chemical Agents ... 27 3.1

Compatibility summary ... 27

3.2

Water (for reprocessing) ... 30

3.3

Detergent solution ... 30

3.4

Disinfectant solution ... 31

3.5

Rinse water ... 31

3.6

Alcohol ... 32

3.7

Ethylene oxide gas sterilization ... 32

3.8

Steam sterilization (autoclaving) ... 34

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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 ... 47 Preparation ... 48 Wipe the insertion section ... 48 Aspirate water through the suction and balloon channels ... 49 Flush the air/water and balloon water channels with water and air ... 50 Detach the suction tube and the water container’s metal tip from the endoscope ... 53 Detach the endoscope from the light source ... 54

5.4

Leakage testing of the endoscope ... 55 Equipment needed ... 55 Detach the accessories from the endoscope ... 56 Attach the US connector cap ... 57 Perform the leakage test ... 59

5.5

Manually cleaning the endoscope and accessories ... 63 Equipment needed ... 63 Clean the external surfaces ... 64 Brush the channels ... 73 Aspirate detergent solution through the instrument channel, the suction channel, and the balloon suction channel ... 85 Flush the air/water channel and balloon water channel with detergent solution ... 88 Immerse the endoscope and accessories in detergent solution ... 92 Remove detergent solution from all channels ... 92 Dry the external surfaces ... 96

5.6

Manually disinfecting the endoscope and accessories ... 96 Equipment needed ... 96 Preparation ... 96 Flush all channels with disinfectant solution ... 99 Immerse the endoscope and accessories in disinfectant solution ... 102 Remove the endoscope and accessories from disinfectant solution ... 104

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5.7

Rinsing the endoscope and accessories following disinfection ... 106 Equipment needed ... 107 Rinse the endoscope and accessories ... 107 Alcohol flush ... 111 Dry the endoscope ... 113

5.8

Sterilizing the endoscope ... 116 Equipment needed ... 116 Ethylene oxide gas sterilization of the endoscope ... 116 Steam sterilization (autoclaving) of the accessories ... 117

5.9

Presoaking the endoscope ... 118 Equipment needed ... 119 Presoak the endoscope ... 119

Chapter 6 Reprocessing the Accessories ... 121 6.1

Summary of reprocessing the accessories ... 121 Equipment needed ... 122

6.2

Manually cleaning the accessories ... 124 Equipment needed ... 124 Clean the external surfaces ... 124 Brush the biopsy valve (MB-358) ... 125 Flush the accessories with detergent solution ... 126 Clean the brushes ... 132 Immerse the accessories in detergent solution ... 132 Remove detergent solution from all accessories ... 133 Dry the external surfaces ... 134

6.3

Manually disinfecting the accessories ... 135 Equipment needed ... 135 Preparation ... 135 Flush the accessories with disinfectant solution ... 136 Rub the brushes ... 142 Immerse the accessories in disinfectant solution ... 142 Remove the accessories from disinfectant solution ... 143

6.4

Rinsing the accessories following disinfection ... 144 Equipment needed ... 144 Rinse the accessories ... 145 Remove the accessories from rinse water ... 147 Alcohol flush ... 148

6.5

Sterilizing the accessories ... 151 Ethylene oxide gas sterilization of the accessories ... 151 Steam sterilization (autoclaving) of the accessories ... 151

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Contents

Chapter 7 Reprocessing Endoscopes and Accessories Using an Automated Endoscope Reprocessor/ Washer-Disinfector ... 153 7.1

Reprocessing endoscopes and accessories using an automated endoscope reprocessor/washer-disinfector ... 153

Chapter 8 Storage and Disposal ... 155

iv

8.1

Precautions of storage and disposal ... 155

8.2

Storing the disinfected endoscope and accessories ... 156

8.3

Storing the sterilized endoscope and accessories ... 157

8.4

Disposal ... 157

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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 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 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 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 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 the endoscope and accessories • Handling of pertinent chemicals When selecting appropriate methods and conditions for cleaning, 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 Precautions

1.4

Ch.1

Precautions 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, ultrasound center, ultrasound cable, video system center, light source, front panels of equipment, and/or mouthpiece may cause an infection control risk. Perform proper cleaning and/or disinfection as described in their respective instruction manuals. A tap and/or basin that medical personnel come in contact with may cause an infection control risk as well. Perform proper replacement, cleaning, and/or 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, including the instrument channel, and all accessories used with the endoscope during the patient procedure, such as all valves, 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 and residual detergent 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 and residual detergent solution following cleaning. • 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.

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1.4 Precautions

Ch.1

WARNING • 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. • 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. • Do not use the Air/water channel cleaning adapter (MAJ-629) for patient procedures. It will cause continuous insufflation and could result in patient injury.

Air/water channel cleaning adapter (MAJ-629)

Figure 1.2

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1.4 Precautions

Ch.1

WARNING • 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-400L), 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. A damaged brush may break, which can damage the endoscope or accessories. • 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. 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. • The 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.

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1.4 Precautions

Ch.1

WARNING • 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. • 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 observed. • 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. • In case of performing any microbial test or other test using extraction fluid on the reprocessed endoscope, the reprocessing process has to be performed again according to the “REPROCESSING MANUAL” before patient procedure.

CAUTION • Before immersing the endoscope in reprocessing fluids, confirm that the US connector cap (MAJ-2295) is attached to the ultrasound cable connector on the endoscope. If the US connector cap is not attached, 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 0.5 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 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 detergent solution. • 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, use life, and expiration date 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 sterilization pouches 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 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 US connector cap (MAJ-2295)

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

US connector cap (MAJ-2295) Groove Seals

Venting connector

Figure 2.1

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2.1 US connector cap (MAJ-2295)

 Function • The US connector cap (MAJ-2295) is attached to the ultrasound cable connector on the endoscope to protect the ultrasound cable connector and the endoscope from water penetration during reprocessing.

Ch.2

US connector cap (MAJ-2295)

Ultrasound cable connector

Figure 2.2 • For leakage testing, the venting connector on the US connector cap must be connected to the leakage tester.

Venting connector

Maintenance unit (MU-1)

Leakage tester (MB-155)

Figure 2.3

 Inspection 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.

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2.2 Channel plug (MAJ-621)

2.2

Channel plug (MAJ-621) Ch.2 Suction plug Plug frame

Air/water plug

Biopsy valve cap

Figure 2.4

 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, air/water, and balloon channels of the endoscope with reprocessing fluids.

Plug frame

Biopsy valve cap

Instrument channel port

Figure 2.5

NOTE 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.

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2.2 Channel plug (MAJ-621)

 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.

Ch.2

NOTE The channel plug does not need to be reprocessed prior to its first use.

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2.3 Injection tube (MH-946)

2.3

Injection tube (MH-946) Ch.2 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

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. Suction channel tube

Syringe

Air/water channel tube

Suction port

Reprocessing fluids Basin

Connector plug

Air pipe port

Figure 2.7

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2.3 Injection tube (MH-946)

 Inspection 1 Confirm that all components of the injection tube are free from cracks, scratches,

Ch.2

flaws, and debris.

2 Confirm that the filter mesh is in the suction port of the injection tube. 3 Attach a clean 30 ml syringe to the suction channel port of the injection tube. 4 While immersing the suction port of the injection tube completely in the water as described in Section 3.2, “Water (for reprocessing)”, pull the syringe plunger and confirm that the water is drawn into the syringe.

5 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 port Suction channel tube Syringe Suction port

Figure 2.8

6 Move the syringe to the air/water channel port of the injection tube. 7 While immersing the suction port of the injection tube completely in the water, pull the syringe plunger and confirm that the water is drawn into the syringe.

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2.3 Injection tube (MH-946)

8 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.

Ch.2 Air/water channel port

Syringe Suction port

Air pipe port

Figure 2.9

NOTE The injection tube does not need to be reprocessed prior to its first use.

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