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INSTRUCTIONS
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
OLYMPUS SIF TYPE Q180
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 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/reprocessing and storage after use
7
Compatible Reprocessing Methods and Chemical Agents ...
8
2.1
Compatibility summary...
8
2.2
Detergent solution...
10
2.3
Disinfectant solution...
11
2.4
Rinsing water ...
11
2.5
Ethylene oxide gas sterilization...
12
2.6
Steam sterilization (autoclaving) of accessories ...
14
Chapter 2
Chapter 3
Cleaning, Disinfection, and Sterilization Procedures ... 15
3.1
Required reprocessing equipment ...
16
3.2
Cleaning, disinfection, and sterilization procedures for the endoscope 26
3.3
Precleaning ...
27
3.4
Leakage testing...
32
3.5
Manual cleaning...
36
3.6
High-level disinfection ...
51
3.7
Rinsing after high-level disinfection ...
54
3.8
Sterilization ...
57
3.9
Cleaning, disinfection, and sterilization procedures for reusable parts and reprocessing equipment... 59
Chapter 4
Cleaning and Disinfection Equipment...
67
Chapter 5
Storage and Disposal...
69
5.1
Storage of the endoscope...
70
5.2
Storage of reusable parts and reprocessing equipment ...
70
5.3
Disposal ...
70
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
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Contents
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EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
Symbols
Symbols The meaning of the symbol(s) shown on the back cover of this instruction manual are as follows:
Manufacturer
Authorized representative in the European Community
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
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Chapter 1 General Policy
Chapter 1 General Policy 1.1
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Instructions •
This manual contains the cleaning, disinfection, and sterilization methods recommended by Olympus for the endoscopes listed on the front cover.
•
This instruction manual contains essential information on reprocessing this instrument safely and effectively.
•
Before reprocessing, thoroughly review the manuals of the reprocessing chemicals and all equipment that will be used and reprocess the equipment as instructed.
•
Note that the complete instruction manual set for this endoscope consists of this manual and the “OPERATION MANUAL” with your endoscope model listed on the cover. Both manuals accompany the endoscope at shipping.
•
Keep this manual and all related manuals in a safe and accessible location.
•
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.
EVIS EXERA II SIF TYPE Q180 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 criteria of your hospital
•
Individual cleaning, disinfection, and sterilization protocols
•
Structure and handling of endoscopic equipment
•
Handling of pertinent chemicals
For the types and conditions of the means of cleaning, disinfection, and sterilization to be adopted, please make judgments from your professional viewpoints.
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 SIF TYPE Q180 REPROCESSING MANUAL
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Chapter 1 General Policy
1.4
4
Precautions •
Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each procedure the endoscope and its ancillary equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization as described in Chapter 3, “Cleaning, Disinfection, and Sterilization Procedures”. Reprocess not only the external surface of the endoscope but also all channels.
•
ALL channels of the endoscope MUST be cleaned and high-level disinfected or sterilized during EVERY reprocessing cycle, even if the channels were not used during the previous patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.
•
If the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible. Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms or organic material that could reduce the efficacy of disinfection or sterilization.
•
Olympus only confirms validation of endoscope reprocessors it recommends. When using an endoscope reprocessor that is not recommended by Olympus, the manufacturer of the endoscope reprocessor is responsible for validating compatibility of the reprocessor with the endoscope models listed in its instruction manual.
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
Chapter 1 General Policy
•
Before using an endoscope reprocessor, confirm that it is capable of reprocessing the endoscope including all channels. If there are channels and/or other parts of the endoscope that cannot be cleaned and/or high-level disinfected by the endoscope reprocessor, manual cleaning and high-level disinfection or sterilization must be performed immediately after using the reprocessor as described in Chapter 3, “Cleaning, Disinfection, and Sterilization Procedures”. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope. If you are uncertain as to the ability of your endoscope reprocessor to clean and high-level disinfect the endoscope including all channels, contact the endoscope reprocessor’s manufacturer for specific instructions and/or information on connectors.
•
Patient debris and reprocessing chemicals are hazardous. Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During cleaning and disinfection or sterilization, wear appropriate personal protective equipment, such as eye wear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. Always remove contaminated personal protective equipment before leaving the reprocessing area.
•
Thoroughly rinse off the disinfectant solution. Rinse the external surface of the endoscope, all channels, and the reprocessing equipment thoroughly with water to remove any disinfectant solution residue.
•
The disinfection/sterilization room must be adequately ventilated. Adequate ventilation protects against the buildup of toxic chemical fumes.
•
Store alcohol in an air-tight container. Alcohol stored in an open container is a fire hazard and will result in a loss of efficacy due to evaporation.
•
Be sure to perform a leakage test on the endoscope prior to manual cleaning. 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.
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Chapter 1 General Policy
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•
Prior to each procedure, confirm that the endoscope has undergone proper cleaning, disinfection, and sterilization. If it is determined that the endoscope has not been properly reprocessed, reprocess it again following the instructions given in this manual.
•
With the cleaning, disinfection, and sterilization methods stated in this instruction manual, prions, which are considered to be the pathogenic substance of the Creutzfeldt-Jakob disease (CJD) cannot be destroyed or inactivated. When using this instrument on a patient with CJD or variant Creutzfeldt-Jakob disease (vCJD), be sure to use this product for such patient only and/or immediately dispose of this product after use in an appropriate manner. For methods to handle CJD, please follow the respective guidelines in your country.
•
This instrument is not durable, or does not have sufficient durability against the respective methods stated in the guidelines of each country for destroying or inactivating prions. For information on the durability against each method, please contact Olympus. If cleaning, disinfection, and sterilization methods not stated in this instruction manual are performed, Olympus cannot guarantee the effectiveness, safety and durability of this instrument. Make sure to confirm that there is no abnormality before use, and use under responsibility of a physician. Do not use if any abnormality is found.
•
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.
•
When reprocessing an endoscope, confirm that the water-resistant cap is securely attached to the endoscope connector before immersing the endoscope in reprocessing fluids. If the water-resistant cap is not securely attached, water, detergent solution, and/or disinfectant solution could enter the endoscope and damage the equipment.
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
Chapter 1 General Policy
1.5
Reprocessing before the first use/reprocessing and storage after use This instrument was not cleaned, disinfected, or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in this manual. After using this instrument, reprocess and store it according to the instructions given in this manual. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage, or reduce performance.
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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
Chapter 2 Compatible Reprocessing Methods and Chemical Agents 2.1
Compatibility summary Olympus endoscopic equipment is compatible with several methods of reprocessing. However, certain components and accessories are not compatible with some methods, that can cause equipment damage. For appropriate reprocessing methods, refer to Table 2.1 below, the recommendations of your infection control committee and all national and local hospital guidelines and policies.
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EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
.
Steam sterilization (autoclaving) Ethylene oxide gas sterilization (gas mixture 20% ethylene oxide gas/80% CO2, for countries other than the USA) Ethylene oxide gas sterilization (100% ethylene oxide gas) ACECIDE disinfectant solution∗3 (use OER-A) 2 – 3.5% glutaraldehyde 70% ethyl or isopropyl alcohol Detergent solution Ultrasonic cleaning Endoscope
∗1
Water-resistant cap (MH-553) Chain for water-resistant cap (MAJ-1119)
∗2
Channel-opening cleaning brush (MH-507) Channel cleaning brush (BW-9Y) Air/water valve (MH-438) Suction valve (MH-443) Biopsy valve (MB-358) Channel plug (MH-944) Injection tube (MH-946) AW channel cleaning adapter (MH-948) Suction cleaning adapter (MH-856) Mouthpiece (MB-142, MA-474) Single use channel cleaning brush (BW-201T)∗4 Single use channel-opening cleaning brush (MAJ-1339)∗4 Compatible
Not compatible
Table 2.1 EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
∗1 The endoscope is only compatible with ultrasonic cleaning as performed in an endoscope reprocessor such as OER and OER-A (OER and OER-A are not available in some areas). ∗2 The water-resistant cap and the chain for water-resistant cap can only be ultrasonically cleaned if connected to the endoscope that is being cleaned in an endoscope reprocessor with an ultrasonic cleaning phase. ∗3 ACECIDE disinfectant solution is exclusively for OER-A. ∗4 Single use channel cleaning brush (BW-201T) and single use channel-opening cleaning brush (MAJ-1339) are intended for a single-use only. Do not attempt to reuse them.
Alcohol is not a sterilant or high-level disinfectant.
2.2
•
EndoTherapy accessories which are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, or accessories with a green model reference label are compatible with steam sterilization (autoclaving).
•
The endoscope is compatible with some endoscope reprocessors such as the ETD system distributed by Olympus. Refer to the respective instruction manual for details on operation. For any other details, please contact Olympus.
Detergent solution Use a medical-grade, low-foaming, neutral pH detergent or enzymatic detergent and follow the manufacturer’s dilution and temperature recommendations. Contact Olympus for the names of specific brands that have been tested for compatibility with the endoscope. Do not reuse detergent solutions.
Excessive detergent foaming can prevent fluid from adequately contacting the interior of the channels.
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EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
2.3
Disinfectant solution In the U.S., agents used to achieve high-level disinfection are defined as liquid chemical germicides registered with the U.S. Food and Drug Administration as “sterilant/disinfectants” that are used according to the time, temperature, and dilution recommended by the disinfectant manufacturer for achieving high-level disinfection. These conditions usually coincide with those recommended by the disinfectant manufacturer for 100% kill of mycobacterium tuberculosis. In general, 2 – 3.5% glutaraldehyde solutions, when used according to the manufacturer’s instructions for achieving high-level disinfection, are compatible with Olympus endoscopes. Contact Olympus for the names of specific brands that have been tested for compatibility with the endoscope. If the disinfectant solution is reused, routinely check its efficacy with a test strip according to the manufacturer’s recommendations. Do not use solutions beyond their expiration date.
2.4
Rinsing water Once removed from disinfectant solution, the instrument must be thoroughly rinsed with sterile water to remove any disinfectant residue. If sterile water is not available, clean, potable tap water or water that has been processed (e.g., filtered) to improve its microbiological quality may be used. When nonsterile water is used after disinfection, wipe the endoscope and flush the channels with 70% ethyl or isopropyl alcohol, then air-dry all internal channels to inhibit the growth of residual bacteria. Do not reuse rinsing water.
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
2.5
Ethylene oxide gas sterilization The instruments and other accessories listed as compatible with ethylene oxide gas sterilization in Table 2.1 on page 9 can be sterilized by ethylene oxide gas and aerated within the parameters given in Table 2.3. When performing ethylene oxide gas sterilization, follow the cleaning, disinfection, and sterilization protocols of your hospital and the instruction manuals of the sterilization equipment.
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•
Before sterilization, the instrument must be thoroughly cleaned and dried. Residual moisture inhibits sterilization.
•
The results of sterilization depend on various factors such as how the sterilized instrument was packed or the positioning, method of placing and loading of the instrument in the sterilization device. Please verify the sterilization effects by using biological or chemical indicators. Also follow the guidelines for sterilization issued by medical administrative authorities, public organizations or the infection management sections at each medical facility, as well as the instruction manual of the sterilization device.
•
All instruments must be properly aerated following ethylene oxide gas sterilization to remove toxic ethylene oxide residuals.
•
Disconnect the water-resistant cap from the endoscope connector before ethylene oxide gas sterilization. If the water-resistant cap is attached during ethylene oxide gas sterilization, the air inside the endoscope will expand and rupture the covering of the bending section and/or damage the angulation mechanism.
•
Exceeding the recommended parameters may cause equipment damage (see Tables 2.2 and 2.3).
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
Parameters for 100% ethylene oxide gas sterilization cycles Process phase Sterilization
Parameter Temperature
value 55°C (130°F)
Vacuum 0.05 – 0.07 Mpa (Absolute pressure) (7.25 – 10.15 psia)
Aeration
Relative humidity
50 – 80%
Ethylene oxide gas concentration
0.735 – 0.740 mg/cm3 (735 – 740 mg/L)
Exposure time
60 minutes
Minimum aeration parameters
12 hours in an aeration chamber at 50 – 57° (122 – 135°F) or 7 days at room temperature
Table 2.2
Parameters for 20% ethylene oxide gas/80% CO2 gas sterilization cycles, for countries other than the USA Process phase Sterilization
Aeration
Parameter
value
Temperature
57°C (135°F)
Relative pressure
0.1 – 0.17 MPa
Relative humidity
55%
Exposure time
105 minutes
Ethylene oxide gas concentration
0.6 – 0.7 mg/cm3 (600 – 700 mg/L)
Minimum aeration parameters
12 hours in an aeration chamber at 50 – 57°C (122 – 135°F) or 7 days at room temperature
Table 2.3
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
2.6
Steam sterilization (autoclaving) of accessories The accessories listed as compatible with steam sterilization (autoclaving) in Table 2.1 on page 9 can be sterilized by steam within the parameters given in Table 2.4. When steam sterilizing, follow the cleaning, disinfection, and sterilization protocols of your hospital as well as the instructions provided by the manufacturer of your sterilization equipment.
The results of sterilization depend on various factors such as how the sterilized instrument was packed or the positioning, method of placing and loading of the instrument in the sterilization device. Please verify the sterilization effects by using biological or chemical indicators. Also follow the guidelines for sterilization issued by medical administrative authorities, public organizations or the infection management sections at each medical facility, as well as the instruction manual of the sterilization device.
•
Do not steam sterilize the endoscope. Steam sterilization (autoclaving) will severely damage the endoscope.
•
Exceeding the recommended parameters may cause equipment damage (see Table 2.4).
Process Prevacuum
Parameters Temperature
132 – 134°C (270 – 274°F)
Exposure time
Table 2.4
14
5 minutes
Steam sterilization (autoclaving) exposure parameters
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
Chapter 3 Cleaning, Disinfection, and Sterilization Procedures
Chapter 3 Cleaning, Disinfection, and Sterilization Procedures ALL channels of the endoscope MUST be cleaned and high-level disinfected or sterilized during EVERY reprocessing cycle, even if the channels were not used during the previous patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.
•
Do not coil the endoscope’s insertion tube or universal cord with a diameter of less than 12 cm. Doing so may damage the endoscope.
•
For proper reprocessing results, do not coil the insertion section or the universal cord with a diameter of less than 40 cm. If the diameter is less than 40 cm, it will be difficult to insert the channel cleaning brush (BW-9Y) and/or the single use channel cleaning brush (BW-201T).
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
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Chapter 3 Cleaning, Disinfection, and Sterilization Procedures
3.1
Required reprocessing equipment Preparation of the equipment Prior to cleaning, disinfection, or sterilization, prepare the equipment shown in Figure 3.1.
Use basins that are at least 40 cm by 40 cm (16” by 16”) in size and deep enough to completely immerse the endoscope.
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EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
Chapter 3 Cleaning, Disinfection, and Sterilization Procedures
Water-resistant cap (MH-553)
Channel-opening cleaning brush (MH-507) or single use channel-opening cleaning brush (MAJ-1339)
Channel cleaning brush (BW-9Y) or single use channel cleaning brush (BW-201T)
AW channel cleaning adapter (MH-948)
Channel plug (MH-944)
Light source (CLV-180, CLV-160, CLV-U40) (sold separately)
Suction cleaning adapter (MH-856)
Injection tube (MH-946)
• Personal protective equipment
• Soft brush
• 500 cm3 (500 ml) containers
• Clean lint-free cloths
• Large basins with tight fitting lids∗1
• Sterile lint-free cloths
• Small basins with tight fitting lids (size: 25 (W) × 10 (H) × 25 (D) cm or more)
• Sterile cotton swabs
• Clean water
• 30 cm3 (30 ml) syringe
Leakage tester (MB-155) (sold separately)
Maintenance unit (MU-1) (sold separately)
Suction pump (KV-4, KV-5, SSU-2) (sold separately)
• Detergent solution • Disinfectant solution • Sterile water • 70% ethyl or isopropyl alcohol
∗1 Use basins that are at least 40 cm by 40 cm (16” by 16”) in size and deep enough to completely immerse the endoscope. Figure 3.1
EVIS EXERA II SIF TYPE Q180 REPROCESSING MANUAL
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