EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE Reprocessing Manual

Contents

Contents Symbols...

1

Chapter 1

General Policy ...

2

1.1

Instructions...

2

1.2

Importance of cleaning, disinfection, and sterilization...

3

1.3

Signal words ...

3

1.4

Precautions ...

4

1.5

Reprocessing before the first use ...

9

1.6

Reprocessing and storage after use ...

9

1.7

Reprocessing before patient procedure...

10

Function and Inspection of the Accessories for Reprocessing ...

11

2.1

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

11

2.2

Auxiliary water tube (MAJ-2021)...

13

2.3

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

14

2.4

Chain for water-resistant cap (MAJ-1739) ...

16

2.5

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

16

2.6

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

18

2.7

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

20

2.8

Cleaning adapter for instrument channel port (MAJ-350) ...

22

2.9

Suction cleaning adapter (MH-856) ...

23

2.10 Channel plug (MH-944)...

24

2.11 Injection tube (MH-946) ...

26

2.12 Auxiliary water inlet cap (MAJ-215) ...

28

Chapter 2

Chapter 3

Compatible Reprocessing Methods and Chemical Agents ...

29

3.1

Compatibility summary...

29

3.2

Water (for reprocessing) ...

32

3.3

Detergent solution...

32

3.4

Disinfectant solution...

32

3.5

Rinse water ...

33

3.6

Alcohol ...

33

3.7

Ethylene oxide gas sterilization...

34

3.8

Steam sterilization (autoclaving) ...

35

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

i

Contents

Chapter 4

Reprocessing Workflow for the Endoscope and Accessories ...

37

Workflow for manually cleaning and disinfecting the endoscope and accessories ...

38

Workflow for cleaning and disinfecting the endoscope and accessories using an AER ...

40

Workflow for manually cleaning and sterilizing the endoscope and accessories ...

42

Reprocessing the Endoscope (and related reprocessing accessories) ...

44

5.1

Preparing the equipment for reprocessing ...

46

5.2

Precleaning the endoscope and accessories...

47

5.3

Leakage testing of the endoscope ...

57

5.4

Manually cleaning the endoscope and accessories...

61

5.5

Manually disinfecting the endoscope and accessories ...

79

5.6

Rinsing the endoscope and accessories following disinfection...

83

5.7

Sterilizing the endoscope and accessories ...

88

5.8

Presoaking the endoscope ...

91

Reprocessing the Accessories ...

93

6.1

Manually cleaning the accessories ...

95

6.2

Manually disinfecting the accessories...

98

6.3

Rinsing the accessories following disinfection ...

100

6.4

Sterilizing the accessories...

102

6.5

Care of the Ultrasound Cable (MAJ-1597, MAJ-2056) ...

104

4.1 4.2 4.3

Chapter 5

Chapter 6

ii

Chapter 7

Reprocessing Endoscopes and Accessories using an Automated Endoscope Reprocessor ... 105

Chapter 8

Storage and Disposal ... 109

8.1

Storing the disinfected endoscope and accessories ...

110

8.2

Storing the sterilized endoscope and accessories ...

112

8.3

Storing the ultrasound cable ...

112

8.4

Disposal ...

112

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

Symbols

Symbols The meaning(s) of the symbol(s) shown on the back cover of the instruction manual are as follows:

Manufacturer

Authorized representative in the European Community

For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

1

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 endoscope and accessories listed on the front cover.

•

This instruction manual contains essential information on reprocessing endoscopes and accessories safely and effectively.

•

Before reprocessing, thoroughly review this manual and the manuals of the reprocessing equipment and chemicals that will be used for reprocessing. Reprocess all the devices as instructed.

•

Note that the complete instruction manual set for the endoscope and accessories consists of this manual and the “OPERATION MANUAL” with your endoscope model listed on the cover. Both manuals accompanied the endoscope at shipment.

•

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

•

If you have any questions or comments about any information in this manual, or if a problem that cannot be solved occurs while reprocessing, contact Olympus.

 Terms used in this manual AER/WD: AER and WD are abbreviated names 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 meaning “high-level disinfection”, in this manual. For disinfectant solution, follow the instructions as described in 3.4, “Disinfectant solution” on page 32.

2

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

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 of all ancillary equipment, and have a thorough understanding of the following items: •

Professional health and safety policies of your hospital

•

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

•

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.

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

3

Chapter 1 General Policy

1.4

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.

•

The endoscope reprocessor, video system center, light source, front panels of equipment, and/or mouthpiece may cause an infection control risk. Perform proper cleaning and disinfection as described in their respective instruction manuals. A tap, basin, and/or nozzle of pharyngeal anesthetic spray that medical personnel come in contact with may cause an infection control risk as well. Perform proper replacement, cleaning, and disinfection.

•

All disinfection methods (whether performed manually or by an 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, the auxiliary water channel, and all accessories used with the endoscope during the patient procedure, such as all valves, and the auxiliary water tube (MAJ-2021), 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.

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

Chapter 1 General Policy

•

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.

•

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 •

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.

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

5

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

6

•

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 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 endoscope and/or accessory damage.

•

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.

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

Chapter 1 General Policy

•

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 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 and accessories, contact the manufacturer of the AER for specific instructions and information on compatibility and required connectors.

•

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.

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

7

Chapter 1 General Policy

•

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.

•

When reprocessing the endoscope, confirm that the two water-resistant caps (MH-553) are securely attached to the videoscope cable connector and the ultrasound cable connector respectively before immersing the endoscope in reprocessing fluids. If the two water-resistant caps are not securely attached, the reprocessing fluids could enter the endoscope and damage the endoscope. Videoscope cable connector Water-resistant cap (MH-553)

Ultrasound cable connector

Chain for water-resistant cap (MAJ-1739)

Figure 1.3

8

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

Chapter 1 General Policy

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. Properly manage the quality and durability of the devices used in reprocessing rooms and the ventilation performance of the rooms.

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.

1.6

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 sterilant or high-level disinfectant.

•

To maintain sterility of equipment following sterilization, use sterile packaging and wraps according to national guidelines.

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

9

Chapter 1 General Policy

1.7

Reprocessing before patient procedure •

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.

Some national or professional guidelines recommend reprocessing endoscopes prior to its 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.

10

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

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

AW channel cleaning adapter (MH-948)

Slider

Button

Information card

One-way valve Piston Seals

Figure 2.1

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

11

Chapter 2 Function and Inspection of the Accessories for Reprocessing

 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 these channels when the button is not depressed. AW channel cleaning adapter Air/water nozzle

Depress

Air channel

Water channel Water container

Air/water cylinder

Figure 2.2

 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.

12

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

Chapter 2 Function and Inspection of the Accessories for Reprocessing

2.2

Auxiliary water tube (MAJ-2021) Clip

One-way valve

Luer port

Figure 2.3

The auxiliary water tube needs to be cleaned, disinfected or sterilized prior to its use in any patient procedure.

MAJ-855 is not compatible with TGF-UC180J. The clip of MAJ-855 may cause damage to the universal cord of TGF-UC180J.

 Function when reprocessing the endoscope The auxiliary water tube is used to inject reprocessing fluids into the auxiliary water channel of the endoscope, and to flush air through this channel to expel fluids.

Auxiliary water channel

Auxiliary water tube

Figure 2.4 EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

13

Chapter 2 Function and Inspection of the Accessories for Reprocessing

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

2.3

Water-resistant cap (MH-553) Groove Seals

Venting connector

Figure 2.5

 Function The two water-resistant caps are respectively attached to the videoscope cable connector and the ultrasound cable connector on the endoscope to protect the connectors 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. Videoscope cable connector Water-resistant cap (MH-553)

Ultrasound cable connector

Chain for water-resistant cap (MAJ-1739)

Figure 2.6

14

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

Chapter 2 Function and Inspection of the Accessories for Reprocessing

Venting connector

Maintenance unit (MU-1)

Leakage tester (MB-155)

Figure 2.7 The two water-resistant caps must be respectively attached to the videoscope cable connector and the ultrasound cable connector of the endoscope whenever the endoscope is immersed in reprocessing fluids. They are 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.

Use the chain for water-resistant cap (MAJ-1739) to connect the two water-resistant caps to the endoscope. The two water-resistant caps can remain connected to the endoscope by the chain at all times (including during patient procedures, reprocessing, and storage of the endoscope).

 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.

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

15

Chapter 2 Function and Inspection of the Accessories for Reprocessing

2.4

Chain for water-resistant cap (MAJ-1739)

Figure 2.8

 Function The chain for water-resistant cap is used to keep the two water resistant caps (MH-553) with the endoscope at all times.

 Inspection It is not necessary to inspect the chain before reprocessing.

2.5

Channel-opening cleaning brush (MH-507)

Shaft Bristles

Brush handle

Brush head

Figure 2.9

16

EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

Chapter 2 Function and Inspection of the Accessories for Reprocessing

 Function The channel-opening cleaning brush is used to brush the suction cylinder, the instrument channel port, and the groove of the distal end of the endoscope. Suction cylinder Instrument channel port

Figure 2.10

Groove

Figure 2.11

 Inspection

1. Check the brush head for loose or missing bristles. 2. Check the bristles for any 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-opening cleaning brush does not need to be cleaned, disinfected or sterilized prior to its first use. EVIS EXERA II TGF-UC180J REPROCESSING MANUAL

17