Gastrointestinal and Colonovideoscope 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

ETO cap (MB-156) ... 9

2.2

Channel plug (MH-944) ... 11

2.3

Injection tube (MH-946) ... 12

2.4

Suction cleaning adapter (MH-856) ... 15

2.5

AW channel cleaning adapter (MH-948) ... 16

2.6

Single use combination cleaning brush (BW-412T) ... 17

Chapter 3 Compatible Reprocessing Methods ... 21 3.1

Compatibility summary ... 21

3.2

List of compatible methods ... 22

3.3

Detergent solution for manual cleaning ... 26

3.4

Disinfectant solution for manual disinfection ... 27

3.5

Water ... 28

3.6

Rinse water ... 28

3.7

Alcohol ... 28

3.8

ETD (Endo Thermo Disinfectors) ... 29

3.9

OER-AW (Olympus Endoscope Reprocessor) ... 30

3.10 Washer-Disinfector ... 31 3.11 Ethylene oxide gas sterilization ... 34 3.12 Hydrogen peroxide sterilization ... 35 3.13 Steam sterilization (autoclaving) ... 36 3.14 Signs of degradation from reprocessing and its number of times ... 38

Chapter 4 Reprocessing Workflow for Endoscopes and Accessories . GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

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Contents

43 4.1

Summary of reprocessing workflow ... 43

4.2

Workflow for reprocessing endoscopes and accessories ... 44

Chapter 5 Reprocessing the Endoscope (and related reprocessing accessories) 47

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5.1

Summary of reprocessing the endoscope ... 47

5.2

Preparing the equipment for reprocessing ... 49

5.3

Precleaning the endoscope and accessories ... 51

5.4

Leakage testing of the endoscope ... 56

5.5

Manually cleaning the endoscope and accessories ... 60

5.6

Manually disinfecting the endoscope and accessories ... 78

5.7

Rinsing the endoscope and accessories following disinfection ... 83

5.8

Sterilizing the endoscope and accessories ... 90

5.9

Presoaking the endoscope ... 92

Equipment needed ... 49 Equipment needed ... 51 Preparation ... 52 Wipe the insertion section ... 52 Aspirate water ... 53 Flush the air/water channel with water and air ... 54 Detach accessories from the endoscope ... 55 Equipment needed ... 56 Detach the endoscope from the video system center ... 57 Perform the leakage test ... 58

Equipment needed ... 60 Clean the external surface ... 61 Brush the channels ... 63 Aspirate detergent solution through the instrument channel and the suction channel ... 69 Flush the air/water channel with detergent solution ... 72 Immerse the endoscope and accessories in detergent solution ... 75 Remove detergent solution from all channels ... 75 Dry external surfaces ... 77 Equipment needed ... 78 Preparation ... 78 Flush all channels with disinfectant solution ... 80 Immerse the endoscope and accessories in disinfectant solution ... 81 Remove the endoscope and accessories from disinfectant solution ... 82 Equipment needed ... 83 Rinse the endoscope and accessories ... 84 (Optional) Alcohol flush ... 87 Dry the endoscope ... 89 Equipment needed ... 90 Ethylene oxide gas sterilization of the endoscope and accessories ... 90

GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

Contents

Equipment needed ... 92 Presoak the endoscope ... 92

Chapter 6 Reprocessing the Accessories ... 95 6.1

Summary of reprocessing the accessories ... 95

6.2

Manually cleaning the accessories ... 98

6.3

Manually disinfecting the accessories ... 112

6.4

Rinsing the accessories following disinfection ... 124

6.5

Sterilizing the accessories ... 137

Equipment needed ... 97

Equipment needed ... 98 Clean the external surfaces ... 99 Brush the valves ... 99 Flush the accessories with detergent solution ... 101 Immerse the accessories in detergent solution ... 110 Remove detergent solution from all accessories ... 110 Dry the external surfaces ... 112 Equipment needed ... 112 Preparation ... 112 Flush the accessories with disinfectant solution ... 113 Immerse the accessories in disinfectant solution ... 122 Remove the accessories from disinfectant solution ... 123 Equipment needed ... 124 Rinse the accessories ... 125 Remove the accessories from rinse water ... 128 (Optional) Alcohol flush ... 129 Dry the accessories ... 131 Ethylene oxide gas sterilization of the accessories ... 137 Steam sterilization (autoclaving) of the accessories ... 138 STERRAD® 100S/NX®/100NX® sterilization ... 139 V-PRO® maX sterilization ... 140

Chapter 7 Reprocessing Endoscopes and Accessories Using an AER/WD 141 7.1

Reprocessing endoscopes and accessories using an AER ... 141

7.2

Reprocessing endoscopes and accessories using an ETD ... 142

7.3

Reprocessing endoscopes and accessories using an OER-AW ... 143

7.4

Reprocessing accessories using a WD ... 144

ETD ... 142 (Optional) Alcohol flush ... 142 Dry the endoscope and accessories ... 142 OER-AW ... 143 (Optional) Alcohol flush ... 143 Dry the endoscope and accessories ... 143 Washer-Disinfector ... 144 GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

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(Optional) Alcohol flush ... 144 Dry the accessories ... 144

Chapter 8 Storage and Disposal ... 145

iv

8.1

Precaution of storage and disposal ... 145

8.2

Storing the disinfected endoscope and accessories ... 146

8.3

Storing the sterilized endoscope and accessories ... 148

8.4

Disposal ... 148

GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

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. • This manual is based on the requirement of ISO 17664: 2017.

 Terms used in this manual AER/EWD/WD: AER is the abbreviation for Automated Endoscope Reprocessor, which is used for reprocessing the endoscopes and accessories. EWD is the abbreviation for Endoscope Washer-Disinfector, which is used for reprocessing the endoscopes and accessories. EWD refers to AER and AER is used in this manual. WD is the abbreviation for Washer-Disinfector, which is used for reprocessing the heat-stable endoscopes, accessories and medical instruments employing alkaline cleaning and thermal disinfection.

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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 healthcare facility • 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 reprocessing, 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.

GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

1.4 Precautions

1.4

Ch.1

Precautions WARNING • An insufficiently reprocessed endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them. • The endoscope reprocessor, video system center, and/or front panels of equipment 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, 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 reprocess 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 after 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. GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

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1.4 Precautions

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 air tight 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 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

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GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

1.4 Precautions

Ch.1

WARNING • 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 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 combination cleaning brush (BW-412T), 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. • 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 in order 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 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, accessories and medical instruments. • Only use the AER/WD that meets the requirements of the relevant parts of EN ISO 15883 series in the member states of the EU. • Before using an AER/WD, confirm that it is capable of reprocessing the endoscope including all channels, accessories, and medical instruments. Be sure to attach all required connectors/adaptors. 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, accessories, and medical instruments, contact the manufacturer of the AER/WD for specific instructions and information on compatibility and required connectors/adaptors. • 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, please contact that repair facility for instructions regarding reprocessing. GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

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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/vCJD, please 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, please 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 ETO cap (MB-156) is not attached to the endoscope. If the ETO cap is 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, 72 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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GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

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. • Detergent and disinfectant solutions are only effective when used according to the detergent and 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 successful cleaning and 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. • Improper storage practices, such as not thoroughly drying external and internal surfaces (lumens) prior to storage, will lead to an infection control risk.

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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, when the certain time passes after disinfecting/sterilizing, or in case the storage time recommended by the national authorities is exceeded. 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 sterilized 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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GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

2.1 ETO cap (MB-156)

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

ETO cap (MB-156)

Connector

CAUTION Caution is described that a miss attaching or removing this cap may cause a breakage of the endoscope.

Figure 2.1

CAUTION Failing to attach/remove the ETO cap may cause a damage to the endoscope.

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2.1 ETO cap (MB-156)

 Function • When performing ETO gas sterilization, the ETO cap must be attached to the venting connector on the endoscope connector.

Ch.2

CAUTION If the ETO cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism. • When performing cleaning and disinfection including ETD, the ETO cap must be removed from the venting connector on the endoscope connector.

 Inspection Confirm that the ETO cap is free from scratches, flaws, and debris.

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GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

2.2 Channel plug (MH-944)

2.2

Channel plug (MH-944) Ch.2 Biopsy valve cap

Plug frame

Suction plug Air/water plug

Figure 2.2

 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.

Plug frame

Biopsy valve cap

Instrument channel port

Figure 2.3

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.

 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. NOTE The channel plug does not need to be reprocessed prior to its first use. GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

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2.3 Injection tube (MH-946)

2.3

Injection tube (MH-946)

Ch.2 Suction channel tube

Information card

Connector plug

Suction channel port

Air pipe port

Air/water channel port

Air/water channel tube Filter tube

Suction port

Filter mesh

Figure 2.4

 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

Suction port

Air/water channel tube

Air pipe port

Basin

Connector plug

Figure 2.5

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GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

Reprocessing fluids

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 3.5, “Water”, 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 2.6

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 Suction channel tube Syringe Suction port

Air pipe port

Figure 2.7

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

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2.4 Suction cleaning adapter (MH-856)

2.4

Suction cleaning adapter (MH-856) Ch.2 Connecting end

Weighted end

Figure 2.8

 Function The suction cleaning adapter is used to aspirate detergent solution through the instrument channel port of the endoscope. Suction cylinder Connecting end Suction cleaning adapter

Instrument channel port Suction pump

Weighted end

Figure 2.9

 Inspection Check for debris, cracks, scratches, and other damage. NOTE The suction cleaning adapter does not need to be reprocessed prior to its first use. GIF-LV1, CF-LV1L/I REPROCESSING MANUAL

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