EVIS EXERA II Gastrointestinal and Colonovideoscope Reprocessing Manual

Contents

Contents Symbols...

1

Chapter 1

General Policy ...

2

1.1

Instructions...

2

1.2

Importance of cleaning, disinfection and sterilization...

2

1.3

Signal words ...

3

1.4

Precautions ...

3

1.5

Reprocessing before the first use/reprocessing and storage after use ...

6

Compatible Reprocessing Methods and Chemical Agents ...

7

2.1

Compatibility summary...

7

2.2

Detergent solution...

9

2.3

Disinfectant solution...

9

2.4

Rinsing water ...

10

2.5

ETO gas sterilization...

10

2.6

Steam sterilization (autoclaving) of accessories ...

12

Chapter 2

Chapter 3

Cleaning, Disinfection and Sterilization Procedures ... 13

3.1

Required reprocessing equipment ...

14

3.2

Cleaning, disinfection and sterilization procedures...

21

3.3

Precleaning ...

22

3.4

Leakage testing...

27

3.5

Manual cleaning...

31

3.6

High-level disinfection ...

45

3.7

Rinsing after high-level disinfection ...

48

3.8

Sterilization ...

51

3.9

Cleaning, disinfection and sterilization procedures for reusable parts and reprocessing equipment... 53

Chapter 4

Cleaning and Disinfection Equipment...

61

Chapter 5

Storage and Disposal...

63

5.1

Storage of the endoscope...

63

5.2

Storage of reusable parts and reprocessing equipment ...

64

5.3

Disposal ...

64

EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

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Contents

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EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

Symbols

Symbols The meaning(s) 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 GIF/CF TYPE 165 Series REPROCESSING MANUAL

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Chapter 1 General Policy

Chapter 1 General Policy 1.1

1.2

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 these instruments safely and effectively.

•

Before reprocessing, thoroughly review the manuals of the reprocessing chemicals and all equipment which 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” whose cover lists the model of your endoscope, both of which accompanied the endoscope at shipment.

•

Keep this manual and all related manuals in a safe, 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.

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.

2

EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

Chapter 1 General Policy

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.

1.4

Precautions •

Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure can 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, including the auxiliary water channel where existing, 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.

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Chapter 1 General Policy

4

•

Olympus only confirms validation of endoscope reprocessors it recommends. When using an endoscope reprocessor that is not recommended by Olympus, the endoscope reprocessor’s manufacturer is responsible for validation of the reprocessor with the endoscope models listed in its instruction manual.

•

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 as described in Chapter 3, “Cleaning, Disinfection and Sterilization Procedures” after using the endoscope reprocessor. 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 cleaning 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 lose its efficacy due to evaporation.

EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

Chapter 1 General Policy

•

Be sure to perform a leakage test on the endoscope prior to manual cleaning, and 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.

•

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 immersion 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.

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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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EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

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. Certain components and accessories, however, are not compatible with some methods, which 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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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

.

Steam sterilization (autoclaving) ETO gas sterilization ACECIDE disinfectant solution *3 2 – 3.5% glutaraldehyde 70% ethyl or isopropyl alcohol Detergent solution Ultrasonic cleaning Endoscope

*1

Water-resistant cap (MH-553)

*2

Channel cleaning brush (BW-20T) Channel-opening cleaning brush (MH-507) 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) Auxiliary water tube (MAJ-855)

*4 Applicable

Not applicable

Table 2.1

*1

The endoscope is only compatible with ultrasonic cleaning as performed in an Olympus-recommended reprocessor, such as OER, OER-A, and OER-AW (OER, OER-A, and OER-AW may not be available in some areas). When using an AER/ WD that is recommended by Olympus other than listed above, please contact Olympus.

*2

8

The 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.

EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

*3

ACECIDE disinfectant solution is exclusively for an Olympus-recommended endoscope reprocessor, such as OER-A and OER-AW (ACECIDE may not be available in some areas.)

*4

The auxiliary water tube (MAJ-855) is compatible with only the OER-AW (OER-AW may not be available in some areas).

Alcohol is not a sterilant or high-level disinfectant.

Endo-therapy accessories which are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, or accessories with a green model reference label are compatible with autoclaving.

2.2

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 internal lumens (e.g. channels).

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” which 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, 2.0 – 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 recommended by the manufacturer. Do not use solutions beyond their expiration date.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

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 which has been processed (e.g. filtered) to improve its microbiological quality may be used. When non-sterile 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.

2.5

ETO gas sterilization The instruments and other accessories listed as compatible with ethylene oxide (ETO) gas sterilization in Table 2.1 can be sterilized by ETO gas and aerated within the parameters given in Table 2.2. When performing ETO 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 ETO gas sterilization to remove toxic ethylene oxide residuals.

•

Disconnect the water-resistant cap from the endoscope connector before ETO gas sterilization. If the water-resistant cap is attached during ETO 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 Table 2.2).

EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

 ETO gas exposure parameters Process

ETO gas sterilization

Aeration

Parameters Temperature

57°C (135°F)

Pressure

0.1 – 0.17 MPa (1 – 1.7 kgf/cm2) (16 – 24 psig)

Humidity

55%

Exposure time

1.75 hours

ETO 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 2.2

 Gas mixture 20% ETO/80% CO2

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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 can be sterilized by steam within the parameters given in Table 2.3. When steam sterilizing, follow the cleaning, disinfection and sterilization protocols of your hospital and the sterilization equipment manufacturer's instructions.

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 2.3).

Process Prevacuum

Table 2.3

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Parameters Temperature

132 – 134°C (270 – 274°F)

Exposure time

5 minutes

Steam sterilization (autoclaving) exposure parameters

EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Chapter 3 Cleaning, Disinfection and Sterilization Procedures ALL channels of the endoscope, including the auxiliary water channel where existing, 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. The endoscope can be damaged if coiled too tightly.

•

For proper reprocessing results, do not coil the insertion tube 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-20T).

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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 which are at least 40 cm by 40 cm (16” by 16”) in size and deep enough to allow the endoscope to be completely immersed.

Water-resistant cap (MH-553)

Channel cleaning brush (BW-20T)

AW channel cleaning adapter (MH-948)

Channel-opening cleaning brush (MH-507)

Suction cleaning adapter (MH-856)

Leakage tester (MB-155)

Auxiliary water tube (MAJ-855 for endoscopes with auxiliary water feeding only)

Channel plug (MH-944)

Injection tube (MH-946)

Suction pump (KV-4/5, SSU-2)

• Large basins with tight fitting lids for detergent and disinfectant solution • Large basins for rinsing and leakage testing

• Personal protective equipment • Clean lint-free cloths

• Sterile water

• 30 cm3 (30 ml) syringe

• Sterile lint-free cloths

• 70% ethyl or isopropyl alcohol

• 500 cm3 (500 ml) containers • Soft brush

• Sterile cotton swabs

Light source (CLE-145, CLV-160/U40)

Maintenance unit (MU-1)

• Detergent solution • Clean water

• Disinfectant solution

• Small basins

Figure 3.1

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EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Reprocessing equipment parts and functions For inspection of other equipment than that mentioned below, refer to the instruction manual for the equipment being used.

 Water-resistant cap (MH-553) The water-resistant cap is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing. For leakage testing, the venting connector on the water-resistant cap has to be connected to the leakage tester (see Figure 3.2).

Groove Seal

Venting connector

Figure 3.2

 Channel plug (MH-944) The channel plug is used to plug the openings of the instrument channel port, air/water and suction cylinders during cleaning (see Figure 3.3).

Biopsy valve cap

Cylinder plug

Figure 3.3

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Injection tube (MH-946) The injection tube is used to inject detergent solution, disinfectant solution, water and alcohol into the air/water and suction channels and to flush air through the channels to expel fluids (see Figure 3.4). Suction channel tube Notice card Connector plug Suction channel port

Air pipe port

Air/water channel port Air/water channel tube

Suction port (including the filter mesh)

Filter tube

Figure 3.4

 Channel cleaning brush (BW-20T) The channel cleaning brush is used to brush the inside of the instrument and suction channels and the interior and/or openings of the suction valve, air/water valve, AW channel cleaning adapter and biopsy valve (see Figure 3.5).

Metal tip

Shaft

Brush head

Figure 3.5

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EVIS EXERA II GIF/CF TYPE 165 Series REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Channel-opening cleaning brush (MH-507) The channel-opening cleaning brush is used to brush the suction cylinder and the instrument channel port (see Figure 3.6).

Brush handle

Brush

Figure 3.6

 Auxiliary water tube (MAJ-855 for endoscopes with auxiliary water feeding only) The auxiliary water tube is used to inject detergent solution, disinfectant solution, water and alcohol into the auxiliary water channel and to flush air through the channel to expel fluids (see Figure 3.7). Clip

Luer port

Figure 3.7

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