OLYMPUS
OLYMPUS Scopes Gastrointestinal System
GIF TYPE x180 Series EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE Reprocessing Manual Dec 2009
Reprocessing Manual
112 Pages
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Page 1
INSTRUCTIONS
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF TYPE N180 OLYMPUS GIF TYPE XP180N OLYMPUS GIF TYPE Q180 OLYMPUS GIF TYPE H180 OLYMPUS GIF TYPE H180J EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE Q180AL/I OLYMPUS CF TYPE H180AL/I OLYMPUS CF TYPE H180DL/I OLYMPUS PCF TYPE Q180AL/I OLYMPUS PCF TYPE H180AL/I Accessories: • Water resistant cap (MH-553, MAJ-942)
• Chain for water-resistant cap (MAJ-1119)
• Biopsy valve (MB-358)
• Suction valve (MH-443)
• Air/water valve (MH-438)
• Mouthpiece (MB-142, MA-474)
• Auxiliary water tube (MAJ-855)
• Auxiliary water inlet cap (MAJ-215)
• Suction cleaning adapter (MH-856)
• Channel plug (MH-944)
• Channel cleaning brush (BW-20T)
• Injection tube (MH-946)
• Channel-opening cleaning brush (MH-507)
• AW channel cleaning adapter (MH-948)
• Single use channel cleaning brush (BW-201T)
• Single use channel-opening cleaning brush (MAJ-1339)
MH-553
MAJ-942
MAJ-1119
MB-358 MH-443
MH-856
MH-944
BW-20T BW-201T
MH-946
MH-507 MAJ-1339
MH-438
MB-142 MA-474
MAJ-855
MAJ-215
MH-948
Refer to the endoscope’s companion manual, the “OPERATION MANUAL” with your endoscope model listed on the cover, for operation information. USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents
Contents Chapter 1
General Policy ...
1
1.1
Instructions...
1
1.2
Importance of cleaning, disinfection, and sterilization...
2
1.3
Signal words ...
2
1.4
Precautions ...
3
1.5
Reprocessing before the first use ...
9
1.6
Reprocessing and storage after use ...
10
1.7
Reprocessing before patient procedure...
10
Function and Inspection of the Accessories for Reprocessing...
11
2.1
Water resistant cap (MH-553)...
11
2.2
Water resistant cap (MAJ-942) ...
13
2.3
Channel plug (MH-944)...
14
2.4
Injection tube (MH-946) ...
15
2.5
Channel cleaning brush (BW-20T)...
18
2.6
Channel-opening cleaning brush (MH-507) ...
20
2.7
Auxiliary water tube (MAJ-855)...
21
2.8
Suction cleaning adapter (MH-856) ...
22
2.9
AW channel cleaning adapter (MH-948)...
24
2.10 Single use channel cleaning brush (BW-201T)...
25
2.11 Single use channel-opening cleaning brush(MAJ-1339) ...
27
2.12 Chain for water-resistant cap (MAJ-1119) ...
29
2.13 Auxiliary water inlet cap (MAJ-215) ...
30
Chapter 2
Chapter 3
Compatible Reprocessing Methods and Chemical Agents ...
31
3.1
Compatibility summary...
31
3.2
Water (for reprocessing) ...
33
3.3
Detergent solution...
34
3.4
Disinfectant solution...
34
3.5
Rinse water ...
34
3.6
Alcohol ...
34
3.7
Ethylene oxide gas sterilization...
35
3.8
Steam sterilization (autoclaving) ...
36
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
i
Contents
Chapter 4
Reprocessing Work Flow for Endoscopes and Accessories...
37
Work flow for manually cleaning and disinfecting endoscopes and accessories ...
38
Work flow for cleaning and disinfecting endoscopes and accessories using an AER ...
40
Work flow for manually cleaning and sterilizing endoscopes and accessories ...
42
Reprocessing the Endoscope (and related reprocessing accessories) ...
44
5.1
Preparing the equipment for reprocessing ...
47
5.2
Precleaning the endoscope and accessories...
48
5.3
Leakage testing of the endoscope ...
58
5.4
Manually cleaning the endoscope and accessories...
62
5.5
Manually disinfecting the endoscope and accessories ...
78
5.6
Rinsing the endoscope and accessories following disinfection...
82
5.7
Sterilizing the endoscope and accessories ...
86
5.8
Presoaking the endoscope ...
89
Reprocessing the Accessories ...
91
6.1
Manually cleaning the accessories ...
93
6.2
Manually disinfecting the accessories...
96
6.3
Rinsing the accessories following disinfection ...
98
6.4
Sterilizing the accessories...
101
4.1 4.2 4.3
Chapter 5
Chapter 6
ii
Chapter 7
Reprocessing Endoscopes and Accessories using an Automated Endoscope Reprocessor... 102
Chapter 8
Storage and Disposal ... 103
8.1
Storing the disinfected endoscope and accessories ...
104
8.2
Storing the sterilized endoscope and accessories ...
106
8.3
Disposal ...
106
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
Chapter 1 General Policy
Chapter 1 General Policy 1.1
Instructions •
This manual contains the cleaning, disinfection, and sterilization methods recommended by Olympus for the endoscopes and accessories listed on the front cover.
•
This instruction manual contains essential information on reprocessing endoscopes and accessories safely and effectively.
•
Before reprocessing, thoroughly review this manual and the manuals 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 occurs while reprocessing that cannot be solved, contact Olympus.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
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Chapter 1 General Policy
1.2
Importance of cleaning, disinfection, and sterilization The medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, or sterilization. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals of all ancillary equipment, and have a thorough understanding of the following items: •
Professional health and safety policies of your hospital
•
Instruction manuals of 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.
2
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
Chapter 1 General Policy
1.4
Precautions •
An insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.
•
All disinfection methods (whether performed manually or by an automated endoscope reprocessor), and all sterilization methods (whether performed by ethylene oxide gas or steam) require thorough prior cleaning of the instrument being reprocessed. If the equipment is not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective. Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope.
•
All channels of the endoscope, including the instrument channel and 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-855), must be cleaned and high-level disinfected or sterilized after each patient procedure, even if the channels or accessories were not used during the patient procedure. Insufficient cleaning and disinfection or sterilization of these components may pose an infection control risk to patients and/or operators.
•
Disinfectant solutions are hazardous. After disinfection, rinse all external surfaces and channels of the endoscope and accessories thoroughly with water to remove residual disinfectant solution.
•
The results of sterilization depend on various factors. These factors include how the equipment was packaged, and the placing and loading of the package in the sterilization device. Verify the sterilization process using biological and/or chemical indicators. Follow the guidelines for sterilization issued by national authorities, professional organizations and infection control professionals, as well as the instruction manual for the sterilization device.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
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Chapter 1 General Policy
•
Establish an internal system of identifying contaminated versus reprocessed endoscopes and accessories to prevent both mix-ups and cross-contamination. Touching a reprocessed endoscope and/or accessories with contaminated gloves or placing them on a contaminated hanger or surface, including letting them touch the floor, will recontaminate them.
•
Prior to each patient procedure, confirm that the endoscope and accessories have been properly reprocessed and stored. If there are any doubts or questions, reprocess them again before the patient procedure, following the instructions given in this manual.
•
Perform a leakage test on the endoscope after each precleaning procedure. Do not use the endoscope if a leak is detected. Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions. Use of a leaking endoscope may also pose an infection control risk. Leakage tester
Figure 1.1 •
4
Store alcohol in an 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 GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
Chapter 1 General Policy
•
Do not use the AW channel cleaning adapter (MH-948) for patient procedures. It will cause continuous insufflation and could result in patient injury.
AW channel cleaning adapter (MH-948)
Figure 1.2 •
The accessories listed on the front cover of this manual are consumable, meaning that these accessories cannot be refurbished or repaired and are intended to be replaced once they show any signs of wear. Should any irregularity be observed, use a replacement accessory instead. Using defective accessories may cause equipment malfunction, reduce the efficacy of reprocessing, present a risk to patients and/or operators, or damage the endoscope and/or accessories.
•
Single-use brushes such as the single-use channel cleaning brush (BW-201T) and the single-use channel-opening cleaning brush (MAJ-1339) 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.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
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Chapter 1 General Policy
6
•
Patient debris and reprocessing chemicals are hazardous. To guard against contact with dangerous chemicals and potentially infectious material, wear appropriate personal protective equipment during cleaning, disinfection and sterilization. Such protective equipment should include appropriate eyewear, face mask, cap, moisture-resistant clothing, shoe covers and chemical-resistant gloves that fit properly and are long enough to prevent skin exposure.
•
The reprocessing room must be adequately ventilated. Adequate ventilation protects against the buildup of toxic chemical fumes.
•
Always remove contaminated personal protective equipment before leaving the reprocessing area to prevent contamination from spreading.
•
Only Olympus-recommended or Olympus-endorsed automated endoscope reprocessors (AERs) have been validated by Olympus. When using an AER that is not recommended by Olympus, the manufacturer of the AER is responsible for validating compatibility of the AER with each Olympus endoscope and accessory.
•
Before using an AER, confirm that it is capable of reprocessing the endoscope including all channels 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, please contact that repair facility for instructions regarding reprocessing.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
Chapter 1 General Policy
•
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, 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 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.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
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Chapter 1 General Policy
•
When reprocessing the endoscope, confirm that the water resistant cap (MH-553) is securely attached to the electrical connector before immersing the endoscope in reprocessing fluids. If the water resistant cap is not securely attached, the reprocessing fluids could enter the endoscope and damage the endoscope. Endoscopes which have an Endoscope position detection (e.g., CF-H180DL/I) require the attachment of an additional water resistant cap (MAJ-942), as illustrated in Figure 1.4.
Electrical connector
Water resistant cap (MH-553)
Figure 1.3
UPD scope connector
Water resistant cap (MAJ-942)
Figure 1.4 •
8
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.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
Chapter 1 General Policy
•
When reprocessing an endoscope that has a flexibility adjustment mechanism, make sure that the insertion tube is set to its most flexible condition (indicated by the “ ” mark on the flexibility adjustment ring). If the endoscope is cleaned, disinfected or sterilized while the insertion tube is in a rigid condition, the endoscope may be damaged.
“
” mark Flexibility adjustment ring
Figure 1.5
1.5
•
Store spare accessories in their original packaging to prevent damage.
•
To prevent damage, do not apply excessive force to the endoscope and accessories during reprocessing.
•
Vapors from disinfectant solutions and alcohol may damage electronic devices such as computers.
Reprocessing before the first use New endoscopes, repaired endoscopes, accessories and the carrying case for endoscopes are not cleaned, disinfected, or sterilized prior to shipping from Olympus, regardless of whether those instruments are for new purchase, demo or loaner purposes. Reprocess all such endoscopes and accessories received from Olympus according to the instructions given in this manual before storage and before using them in a patient procedure.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
9
Chapter 1 General Policy
1.6
1.7
Reprocessing and storage after use •
Do not reuse rinse water.
•
High-level disinfectant solutions are only effective when used according to the disinfectant manufacturer’s instructions. Follow the manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time and use life required to achieve high-level disinfection.
•
If the disinfectant solution is reused, check its efficacy with a test strip according to the disinfectant manufacturer’s recommendations prior to use.
•
Do not reuse alcohol.
•
Alcohol is not a sterilant or high-level disinfectant.
•
To maintain sterility of equipment following sterilization, use sterile packaging and wraps according to national guidelines.
Reprocessing before patient procedure •
Improper storage practices, such as not thoroughly drying external and internal surfaces (lumens) prior to storage, will lead to an infection control risk.
•
Improper handling, such as touching a reprocessed endoscope and/or accessories with contaminated gloves, placing a reprocessed device on a contaminated hanger or surface, allowing devices to touch the floor, etc., will recontaminate the device.
Some national or professional guidelines recommend reprocessing endoscopes prior to their first use of the day. Confirm that the endoscope and accessories have undergone proper reprocessing following their last use and that they have been stored properly. Check the storage period of reprocessed endoscopes, and check for surface contamination (e.g., dust). Check the sterilization expiration date(s) of all items so marked and for tears or breaches in sterile packaging. If there are any doubts or questions concerning whether a device is contaminated, reprocess it again following the instructions given in this manual.
10
EVIS EXERA II GIF/CF/PCF TYPE 180 Series 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
Water resistant cap (MH-553) Groove Seals
Venting connector
Figure 2.1
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
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Chapter 2 Function and Inspection of the Accessories for Reprocessing
Function The water resistant cap is attached to the electrical connector on the endoscope to protect the connector and the endoscope from water penetration during reprocessing. During leakage testing, the leakage tester (MB-155) is attached to the venting connector of the water resistant cap. Water resistant cap (MH-553)
Electrical connector
Chain for water resistant cap (MAJ-1119)
Figure 2.2 Venting Connector
Maintenance unit (MU-1)
Leakage tester (MB-155)
Figure 2.3 The water resistant cap must be attached to the electrical connector of the endoscope whenever the endoscope is immersed in reprocessing fluids. It is detached from the connector whenever the endoscope is used for patient procedures, being sterilized by ethylene oxide gas, or stored in an endoscope storage cabinet.
Always use a dry water resistant cap. Any water remaining inside the cap may cause damage to the endoscope.
12
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
Chapter 2 Function and Inspection of the Accessories for Reprocessing
Use the chain for water-resistant cap (MAJ-1119) to connect the water resistant cap to the endoscope. The water resistant cap can remain connected to the endoscope by the chain at all times (including during patient procedures, reprocessing, and storage of the endoscope).
Inspection
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.
2.2
Water resistant cap (MAJ-942) Function The water resistant cap (MAJ-942) is attached to the UPD scope connector on the endoscope to protect the connector and the endoscope from water penetration during reprocessing. The cap is connected to the endoscope by a chain.
Chain
Seal
Screw
Figure 2.4
Always use a dry water resistant cap. Any water remaining inside the cap may cause damage to the endoscope.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
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Chapter 2 Function and Inspection of the Accessories for Reprocessing
Inspection
1. Confirm that the inside of the cap is dry and free from debris. Wipe with a dry cloth if the inside of the cap is wet or if debris is detected.
2. Confirm that the seal of the cap is free from scratches, flaws, and debris.
2.3
Channel plug (MH-944) Plug frame
Biopsy valve cap
Suction plug
Air/water plug
Figure 2.5
Function The channel plug is used to plug the openings of the instrument channel port and the suction and air/water cylinders of the endoscope whenever the injection tube (MH-946) is used to flush the suction and air/water channels of the endoscope with reprocessing fluids.
Channel plug
Instrument channel port
Figure 2.6
14
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
Chapter 2 Function and Inspection of the Accessories for Reprocessing
When attached to the endoscope, the channel plug is designed to allow a small amount of fluid to exit from the openings of the endoscope. This enables reprocessing fluids to contact the endoscope openings.
Inspection Confirm that the suction plug, air/water plug and the biopsy valve cap of the channel plug are free from cracks, scratches and debris.
The channel plug does not need to be cleaned, disinfected or sterilized prior to its first use.
2.4
Injection tube (MH-946) Information card
Suction channel tube Connector plug
Suction channel port
Air pipe port
Air/water channel port Air/water channel tube
Suction port (including the filter mesh)
Filter tube Filter mesh
Figure 2.7
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
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Chapter 2 Function and Inspection of the Accessories for Reprocessing
Function The injection tube is used to inject reprocessing fluids into the instrument channel, suction channel and air/water channels of the endoscope. It is also used to flush air through these channels to expel fluids. Syringe
Air/water channel tube
Suction channel tube Suction port Air pipe port Basin
Connector plug
Reprocessing fluids
Figure 2.8
Inspection
1. Confirm that all components of the injection tube are free from cracks, scratches, flaws and debris (see Figure 2.7).
2. Confirm that the filter mesh is in the suction port of the injection tube.
16
EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
Chapter 2 Function and Inspection of the Accessories for Reprocessing
3. Attach a clean 30 ml syringe to the suction channel port of the injection tube. With the suction port of the injection tube immersed in the water referred to in Section 3.2, withdraw the syringe plunger and confirm that the water is drawn into the syringe. Depress the plunger and confirm that the water is emitted from the suction channel tube of the injection tube. Confirm that the water is not emitted from the suction port when removing the suction port from the water. Suction channel tube
Suction channel port
Syringe Suction port
Figure 2.9
4. Move the syringe to the air/water channel port of the injection tube. With the suction port of the injection tube immersed in the water, withdraw the syringe plunger and confirm that the water is drawn into the syringe. Depress the plunger and confirm that the water is emitted from the air pipe port of the injection tube. Confirm that the water is not emitted from the suction port when removing the suction port from the water. Suction channel tube
Air/water channel port
Syringe Suction port
Air pipe port
Figure 2.10
The injection tube does not need to be cleaned, disinfected or sterilized prior to its first use. EVIS EXERA II GIF/CF/PCF TYPE 180 Series REPROCESSING MANUAL
17