EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE 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

Suction cleaning adapter (MAJ-222) ... 12

2.3

Single use combination cleaning brush (BW-411B) ... 13

2.4

Single use single-ended cleaning brush (BW-400B) ... 15

Chapter 3 Compatible Reprocessing Methods ... 17 3.1

Compatibility summary ... 17

3.2

List of the compatible methods ... 18

3.3

Detergent solution for manual cleaning ... 21

3.4

Disinfectant solution for manual disinfection ... 22

3.5

Water ... 23

3.6

Rinse water ... 23 Rinsing after disinfection ... 23

3.7

Alcohol ... 23

3.8

ETD (Endo Thermo Disinfectors) ... 24

3.9

OER-AW (Olympus Endoscope Reprocessor) ... 25

3.10 Washer-Disinfector ... 26 3.11 Hydrogen peroxide sterilization ... 29 3.12 Steam sterilization (autoclaving) ... 32 3.13 Signs of degradation from reprocessing and its number of times ... 33

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Chapter 4 Reprocessing Workflow for Endoscopes and Accessories ... 37 4.1

Summary of reprocessing workflow ... 37

4.2

Workflow for reprocessing endoscopes and accessories ... 38

Chapter 5 Reprocessing the Endoscope (and Related Reprocessing Accessories) ... 41 5.1

Summary of reprocessing the endoscope ... 41

5.2

Preparing the equipment for reprocessing ... 43 Equipment needed ... 43

5.3

Precleaning the endoscope ... 45 Equipment needed ... 45 Preparation ... 46 Wipe the insertion section ... 46 Aspirate water ... 47 Detach the suction tube from the endoscope ... 49 Detach the endoscope from the light source ... 49

5.4

Leakage testing of the endoscope ... 50 Equipment needed ... 50 Detach the accessories from the endoscope ... 51 Attach the US connector cap (MAJ-2295) ... 53 Perform the leakage test ... 55

5.5

Manually cleaning the endoscope and accessories ... 60 Equipment needed ... 60 Clean the external surface ... 61 Brush the channels ... 66 Aspirate detergent solution through the instrument channel and the suction channel ... 81 Immerse the endoscope and the suction cleaning adapter in detergent solution ... 83 Remove detergent solution from all channels ... 85 Dry the external surfaces ... 89

5.6

Manually disinfecting the endoscope and accessories ... 90 Equipment needed ... 90 Preparation ... 90 Immerse the endoscope and the suction cleaning adapter in disinfectant solution ... 91 Remove the endoscope and the suction cleaning adapter from disinfectant solution ... 95

5.7

Rinsing the endoscope and accessories following disinfection ... 97 Equipment needed ... 98 Rinse the endoscope and accessories ... 98 (Optional) Alcohol flush ... 104 Dry the endoscope ... 109

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5.8

Sterilizing the endoscope and accessories ... 111 Equipment needed ... 111 Steam sterilization (autoclaving) of the accessories ... 111 STERRAD® 100S/100NX sterilization of the endoscope and accessories ... 112 V-PRO® maX sterilization of the endoscope and accessories ... 114

5.9

Presoaking the endoscope ... 116 Equipment needed ... 116 Presoak the endoscope ... 117

Chapter 6 Reprocessing the Accessories ... 121 6.1

Summary of reprocessing the accessories ... 121 Equipment needed ... 123

6.2

Manually cleaning the accessories ... 124 Equipment needed ... 124 Manually cleaning the accessories ... 124 Clean the external surfaces ... 124 Flush the suction cleaning adapter (MAJ-222) with detergent solution ... 125 Immerse the accessories in detergent solution ... 125 Remove detergent solution from all accessories ... 126 Dry the external surfaces ... 126

6.3

Manually disinfecting the accessories ... 127 Equipment needed ... 127 Preparation ... 127 Flush the suction cleaning adapter (MAJ-222) with disinfectant solution ... 128 Immerse the accessories in disinfectant solution ... 129 Remove the accessories from disinfectant solution ... 130

6.4

Rinsing the accessories following disinfection ... 131 Equipment needed ... 131 Rinse the accessories ... 132 Remove the accessories from rinse water ... 133 (Optional) Alcohol flush ... 134

6.5

Sterilizing the accessories ... 135 Steam sterilization (autoclaving) of the accessories ... 135 STERRAD® 100S sterilization ... 136 V-PRO® maX sterilization ... 137

Chapter 7 Reprocessing Endoscopes and Accessories Using an AER/WD ... 139 7.1

Reprocessing endoscopes and accessories using an AER ... 139

7.2

Reprocessing endoscope and accessories using an ETD ... 140 (Optional) Alcohol flush ... 140 Dry the endoscope and accessories ... 140 ETD ... 140

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7.3

Reprocessing endoscopes and accessories using an OER-AW ... 141 OER-AW ... 141 (Optional) Alcohol flush ... 141 Dry the endoscope and accessories ... 141

7.4

Reprocessing accessories using a WD ... 142 Washer disinfector ... 142 (Optional) Alcohol flush ... 142 Dry the accessories ... 142

Chapter 8 Storage and Disposal ... 143

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8.1

Precaution of storage and disposal ... 143

8.2

Storing the disinfected endoscope and accessories ... 144

8.3

Storing the sterilized endoscope and accessories ... 145

8.4

Disposal ... 145

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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. • 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 for 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.

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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, 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, 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/or disinfection. • All disinfection methods (whether performed manually or by an AER) 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 and 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 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. • 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.

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1.4 Precautions

Ch.1

WARNING • Single-use brushes, such as 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. • 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 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, 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 to reprocess the endoscope including all channels, accessories, and medical instruments, contact the manufacturer of the AER 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, 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/vCJD, follow the respective guidelines in your country. BF-UC290F REPROCESSING MANUAL

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1.4 Precautions

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 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 cleaning and reprocessing process has to be performed again according to the “REPROCESSING MANUAL” before patient procedure.

CAUTION • When aerating or irrigating the endoscope channels, the air or water pressure must not exceed 0.3 MPa (3 kgf/cm2, 43 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. • When reprocessing the endoscope, confirm that the US connector cap (MAJ-2295) is securely attached to the electrical connector before immersing the endoscope in reprocessing fluids. If the US connector cap (MAJ-2295) is not securely attached, the reprocessing fluids could enter the endoscope and damage the endoscope.

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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. • 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 expiration date, and use life required to successful cleaning and 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. • Store the endoscope and accessories in a proper storage cabinet, following the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices. • 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 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 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)

Seals

Groove

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

During leakage testing, the leakage tester (MB-155) is attached to the venting connector of the US connector cap (MAJ-2295). Maintenance unit (MU-1)

Venting connector Leakage tester (MB-155)

Figure 2.3

The US connector cap (MAJ-2295) must be attached to the ultrasound cable connector of the endoscope whenever the endoscope is reprocessed. It is detached from the ultrasound cable connector whenever the endoscope is used for patient procedures, being stored in an endoscope storage cabinet. CAUTION Always use a dry US connector cap (MAJ-2295). Any water remaining inside the cap may cause damage to the endoscope.

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2.1 US connector cap (MAJ-2295)

 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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Ch.2

2.2 Suction cleaning adapter (MAJ-222)

2.2

Suction cleaning adapter (MAJ-222)

Ch.2

Suction opening

Suction cylinder cap

Port cap

Figure 2.4

 Function The suction cleaning adapter is used to flush reprocessing fluids through the instrument channel and suction channel of the endoscope and to expel the fluids from the channels. Suction cylinder cap

Port cap

Figure 2.5

 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.

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

2.3

Single use combination cleaning brush (BW-411B)

Bristles

Tip

Shaft

Channel cleaning brush part

Ch.2

Bristles

Handle

Channel-opening cleaning brush part

Figure 2.6

 Function • The channel cleaning brush part of the single use combination cleaning brush is used to brush the inside of the instrument channel, suction channel, and irrigation port of the endoscope. • The channel-opening cleaning brush part of single use combination cleaning brush is used to brush the endoscope’s suction cylinder, instrument channel port, irrigation port, and balloon grooves.

Balloon channel

Suction channel

Instrument channel

Irrigation port Suction cylinder

Instrument channel port

Figure 2.7

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

Balloon grooves

Ch.2

Figure 2.8

 Inspection CAUTION Do not reprocess single use combination cleaning brush prior to use. The brush may be damaged.

1 Remove the brush from its packaging just prior to use. 2 Confirm that the channel cleaning brush part and tip at the distal end are securely attached.

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 fingertips.

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

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

2.4

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

Ch.2

Metal tip Bristles Brush head

Shaft

Figure 2.9

 Function The single use single-ended cleaning brush is used to brush the inside of the instrument channel of the endoscope.

Irrigation port

Balloon channel

Figure 2.10

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