EVIS EXERA Type 160 Two Instrument Channels Series Videoscope Reprocessing manual

Contents

Contents Symbols...

1

Chapter 1

General Policy ...

2

1.1

Instructions...

2

1.2

Signal words ...

3

1.3

Precautions ...

3

Compatible Reprocessing Methods and Chemical Agents ...

6

2.1

Compatibility summary...

6

2.2

Detergent solution...

8

2.3

Disinfectant solution...

8

2.4

Rinsing water ...

8

2.5

ETO gas sterilization...

9

2.6

Steam sterilization (autoclaving) of accessories ...

11

Chapter 2

Chapter 3

Cleaning, Disinfection and Sterilization Procedures ... 12

3.1

Required reprocessing equipment ...

12

3.2

Cleaning, disinfection and sterilization procedures...

20

3.3

Precleaning ...

21

3.4

Leakage testing...

27

3.5

Manual cleaning...

30

3.6

High-level disinfection ...

43

3.7

Rinsing after high-level disinfection ...

46

3.8

Sterilization ...

49

3.9

Cleaning, disinfection and sterilization procedures for reusable parts and reprocessing equipment... 50

Chapter 4

Cleaning and Disinfection Equipment...

57

Chapter 5

Storage and Disposal...

59

5.1

Storage ...

59

5.2

Disposal ...

59

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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Contents

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EVIS EXERA TYPE 160 Two Instrument Channels 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 TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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Chapter 1 General Policy

Chapter 1 General Policy 1.1

Instructions •

Chapters 1, “General Policy” through 4, “Cleaning and Disinfection Equipment” describe recommended procedures and equipment for cleaning and disinfecting or sterilizing this instrument.

•

Thoroughly review the manuals of all equipment which will be used with this instrument and use the equipment as instructed.

•

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.

•

The medical literature reports incidents of patient cross contamination resulting from improper cleaning, disinfection or sterilization. It is strongly recommended that reprocessing personnel have a thorough understanding of and follow all national and local hospital guidelines and policies.

•

A specific individual or individuals in the endoscopy unit should be responsible for reprocessing endoscopic equipment. It is highly desirable that a trained backup be available should the primary reprocessing individual(s) be absent.

•

All individuals responsible for reprocessing should thoroughly understand:  occupational health and safety regulations  all national and local hospital guidelines and policies  the instructions in this manual  the mechanical aspects of endoscopic equipment  pertinent germicide labeling

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EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

Chapter 1 General Policy

1.2

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.

1.3

Precautions •

Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each examination the endoscope must undergo thorough manual cleaning followed by high-level disinfection or sterilization.

•

ALL channels of the endoscope, including auxiliary water channel where fitted, 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.

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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Chapter 1 General Policy

4

•

Olympus confirms validation of the endoscope reprocessors recommended by Olympus only. If using endoscope reprocessor that are not recommended by Olympus, the endoscope reprocessor manufacturers are responsible for validation of the endoscope reprocessor with the endoscope models listed in its intended use statement. If using an endoscope reprocessor, confirm that it is capable of reprocessing endoscope including all channels. If there are channels and/or other parts which cannot be cleaned and high-level disinfected by the endoscope reprocessor, have to undergo manual cleaning and high-level disinfection or sterilization 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 endoscope including all channels, contact the endoscope reprocessor supplier for specific instructions and/or 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, channels and cleaning equipment thoroughly with clean 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 TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

Chapter 1 General Policy

•

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).

•

When reprocessing EVIS videoscope models, confirm that the water-resistant cap is securely attached to the endoscope connector before immersion in reprocessing fluids.

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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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. 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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EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Steam sterilization (autoclaving) ETO gas sterilization 2 – 3.5% glutaraldehyde 70% ethyl or isopropyl alcohol Detergent solution Ultrasonic cleaning Endoscope Water-resistant cap (MH-553) Channel cleaning brush (BW-20T) Channel-opening cleaning brush (MH-507) Air/water valve (MH-438) Suction valve (MH-443) Channel plug (MH-944) Injection tube (MH-946) Channel connection tube (MAJ-420) AW channel cleaning adapter (MH-948) Mouthpiece (MB-142) Biopsy valve (MAJ-419) Auxiliary water tube (MAJ-855) applicable

not applicable

Table 2.1

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

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

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.

Alcohol is not a sterilant or high-level disinfectant.

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.

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EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

2.5

ETO gas sterilization This instrument 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 sterilization, follow the hospital’s protocol and the sterilization equipment manufacturer’s instructions.

•

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.

•

Exceeding the recommended parameters may cause equipment damage.

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

 ETO gas exposure parameters Process ETO gas sterilization

Parameters Temperature

57C (135F)

Pressure

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

Aeration

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 For the USA 12% ETO/88% CFC For countries other than the USA 20% ETO/80% CO2

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EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

2.6

Steam sterilization (autoclaving) of accessories These 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 hospital’s protocol and the sterilization equipment manufacture’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.

•

Exceeding the recommended parameters may cause equipment damage.

•

Do not steam sterilize the endoscope. Steam sterilization (autoclaving) will severely damage the endoscope.

•

Effective sterilization will not be possible if items are packed tightly together in the autoclave; always pack items loosely.

•

Inspect each instrument package for openings, tears or other damage. If an instrument package is opened or damaged, seal the components in a new package and sterilize again.

•

Allow the packages to dry within the autoclave, using the autoclave’s drying cycle (if available) or by opening the door of the autoclave and allowing the packages to air dry. Handling a wet package can compromise its sterility.

Process Prevacuum

Parameters Temperature

132 – 134C (270 – 274F)

Exposure time

Table 2.3

5 minutes

Steam sterilization (autoclaving) exposure parameters

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Chapter 3 Cleaning, Disinfection and Sterilization Procedures ALL channels of the endoscope, including auxiliary water channel where fitted, 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.

3.1

Required reprocessing equipment Preparation of the equipment Prior to cleaning, disinfection or sterilization, prepare the equipment shown in Figure 3.1.

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•

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.

•

For proper reprocessing results, do not coil the insertion tube or the universal cord with a diameter of less than 40 cm.

•

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.

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Water-resistant cap (MH-553)

Channel plug (MH-944)

Biopsy valve (MAJ-419)

Channel cleaning brush (BW-20T)

Channel-opening cleaning brush (MH-507)

Leakage tester (MB-155)

Channel connection tube (MAJ-420) Injection tube (MH-946)

AW channel cleaning adapter (MH-948)

Suction pump (KV-4, SSU-2)

Auxiliary water tube (MAJ-855)

Maintenance unit (MU-1)

• Detergent solution

• Large, non-metallic basins with tight fitting lids for detergent and disinfectant solution

• Personal protective equipment

• Clean water

• Large basins for rinsing and leakage testing

• Clean, lint-free cloths

• 70% ethyl or isopropyl alcohol

• 30 cm3 (30 ml) syringe

• Sterile, lint-free cloths

• Disinfectant solution

• Soft brush

• Sterile cotton swabs

• Sterile water

• 500 cm3 (500 ml) containers

• Small containers

Figure 3.1

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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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 must be connected to the leakage tester (see Figure 3.2). Venting connector

Figure 3.2

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

Biopsy valve cap

Cylinder plug

Figure 3.3

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EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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).

Notice card

Suction channel tube Connector plug

Suction channel port

Air pipe port

Air/water channel port

Suction port (including the filter mesh)

Air/water channel tube

Figure 3.4

 Channel connection tube (MAJ-420) The channel connection tube is used to connect both instrument channel ports. It is also used to inject and aspirate detergent solution, disinfectant solution, water and alcohol into both instrument channels and to flush air through the channels to expel fluids. Make sure that the biopsy valve (MAJ-419) is detached when using the channel connection tube (see Figure 3.5).

Figure 3.5

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 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 3.6).

Clip

Luer port

Figure 3.6

 Channel cleaning brush (BW-20T) The channel cleaning brush is used to brush the inside of the instrument and suction channels and the holes in the air/water and suction valves and the opening of the suction switchover lever (see Figure 3.7).

Metal tip

Figure 3.7

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EVIS EXERA TYPE 160 Two Instrument Channels 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 external surface of the distal end of the endoscope, the suction cylinder and the instrument channel ports and the opening of the biopsy valve’s main body (see Figure 3.8).

Figure 3.8

 AW channel cleaning adapter (MH-948) During precleaning, the AW channel cleaning adapter is connected to the air/water cylinder. When the adapter is depressed, water is fed through the air/water nozzle. Air is continuously fed when the adapter is not depressed (see Figure 3.9).

Figure 3.9

EVIS EXERA TYPE 160 Two Instrument Channels Series REPROCESSING MANUAL

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