OLYMPUS ENF and LF (Endoscope With Channel) 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 ...

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 ... 14

3.1

Required Reprocessing Equipment ...

14

3.2

Cleaning, Disinfection and Sterilization Procedures ...

19

3.3

Precleaning ...

20

3.4

Leakage Testing ...

22

3.5

Manual Cleaning ...

25

3.6

High Level Disinfection ...

30

3.7

Rinsing After High Level Disinfection...

32

3.8

Sterilization ...

33

3.9

Cleaning, Disinfection and Sterilization Procedures for Reusable Parts and Cleaning Equipment...

33

Chapter 4

Cleaning and Disinfection Equipment...

39

Chapter 5

Storage ...

41

Storage ...

41

5.1

ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Contents

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ENF/LF ENDOSCOPE 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

ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 1 General Policy

Chapter 1 General Policy 1.1

2

Instructions •

This instruction manual covers the reprocessing of Rhino-laryngo and Tracheal Intubation fiberscope models with a suction or instrument channel.

•

This manual describes the recommended procedures 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 you are using the instrument, 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: •

your institution’s reprocessing procedures

•

occupational health and safety regulations

•

national and local hospital guidelines and policies

•

the instructions in this manual

•

the mechanical aspects of endoscopic equipment

•

pertinent germicide labeling

ENF/LF ENDOSCOPE 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 the manual cleaning followed by high-level disinfection or sterilization.

•

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.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 1 General Policy

4

•

This instruction manual specifies medicines and endoscope reprocessor for cleaning, high-level disinfection and sterilization which can be used in combination with endoscope, and those medicines and endoscope reprocessors which cannot be used with endoscope. For those which do not appear in this manual, contact Olympus-designated service centers, Olympus branches or sales representatives. In case that inappropriate medicines or endoscope reprocessor are used, it may accelerate the deterioration of the endoscope and may cause come-off of parts and adverse event on patients’ health. For the usage of these medicines and endoscope reprocessor, follow the instruction manuals of those. Olympus does not assure the effect of cleaning, disinfection and sterilization. Contact the manufacturers of those medicines and endoscope reprocessor.

•

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.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 1 General Policy

•

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, a 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 protective equipment before leaving the cleaning area.

•

Thoroughly rinse off the disinfectant solution. Rinse the outer surface of the endoscope, channels and cleaning equipment thoroughly with water to remove the disinfectant solution residue.

•

The disinfection/sterilization room must be adequately ventilated. Adequate ventilation protects against toxic chemical fumes.

•

Store alcohol in an air-tight container. Alcohol stored in an open container may cause fires and will lose its efficacy due to evaporation.

•

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.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 1 General Policy

6

•

When aerating or irrigating the endoscope channels, the air or water pressure must not exceed 0.2 MPa (2 kgf/cm2, 29 psia).

•

Before immersing the endoscope in detergent or disinfectant solution, confirm that the ETO Cap is not attached to the Endoscope Connector.

ENF/LF ENDOSCOPE 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, the recommendations of your infection control committee and 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 2 to 3.5% Glutaraldehyde 70% Ethyl or Isopropyl Alcohol Detergent Solution Ultrasonic Cleaning Endoscope

Miniature Light Source (MAJ-524) Halogen Lamp (MAJ-525, option) ETO Cap (MB-156) Channel Cleaning Brush (BW-15B or BW-7B) Suction Connector Cleaning Brush (BW-15SH) Channel-opening Cleaning Brush (MH-507) Suction Valve (MD-493) Syringe Valve (MB-884) Biopsy Valve (MD-495) Light Guide Adapter (MAJ-1413) applicable

not applicable

Table 2.1

•

8

Endo-Therapy Accessories and other items which are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, a green band or yellow-green marking are compatible with autoclaving.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

2.2

•

Some items with no markings are compatible with autoclaving. To determine the compatibility of such equipment with steam sterilization, refer to the item’s instruction manual.

•

Do not subject the endoscope or the Miniature Light Source to a general-purpose ultrasonic cleaner or an ultrasonic cleaner intended for accessories, as the high frequencies generated by these devices can cause equipment damage.

•

Do not steam sterilize the Light Guide Adapter (MAJ-1413). Equipment damage may result.

•

The endoscope is not compatible with STERRAD® NX. Instrument damage and patient injury may result. Regarding the compatibility of other plasma sterilization processes, 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 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 Environmental Protection Agency 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% to 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 this endoscope.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

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 the 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 manual or automated 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 This instrument or other accessories compatible with ETO gas sterilization as shown in Table 2.1 can be sterilized by ethylene oxide gas and aerated within the parameters given in Tables 2.2 and 2.3. When performing sterilization, follow the hospital’s protocol and the sterilization equipment manufacturer’s instructions.

10

•

Before sterilization, the instrument must be thoroughly cleaned and dried. Residual moisture inhibits sterilization.

•

Exceeding the recommended parameters may cause equipment damage.

•

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.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

•

All instruments must be properly aerated following ETO gas sterilization to remove toxic ethylene oxide residuals.

•

Attach the ETO Cap to the Endoscope Connector before ETO gas sterilization. If the ETO Cap is not attached on the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the Bending Section.

•

Inspect the instrument packages for openings, tears and other damage. If the packages are open or damaged, seal the components in new packaging and sterilize again.

 For USA ETO Gas Exposure Parameters (Gas mixture 12% ETO/88% CFC) Process ETO Gas Sterilization

Parameters Temperature

57C (135F)

Pressure

0.1 to 0.17 MPa (1.0 to 1.7 kgf/cm2, 16 to 24 psig)

Aeration (Minimum)

Humidity

55%

Exposure Time

1.75 hours

ETO Gas Concentration

600 to 700 mg/l

12 hours in an aeration chamber at 50 to 57C (122 to 135F) or 7 days at room temperature

Table 2.2

ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

 For Countries Other Than the United States ETO Gas Exposure Parameters (Gas mixture 20% ETO/80% CO2) Process

Parameters

ETO Gas Sterilization

Temperature

57C (135F)

Pressure

0.10 to 0.17 MPa (1.0 to 1.7 kgf/cm2, 16 to 24 psig)

Aeration (Minimum)

Humidity

55%

Exposure Time

1.75 hours

ETO Gas Concentration

600 to 700 mg/l

12 hours in an aeration chamber at 50 to 57C (122 to 135F) or 7 days at room temperature

Table 2.3

2.6

Steam Sterilization (Autoclaving) of Accessories Steam sterilize (autoclave) within the parameters given in Table 2.4 below. When steam sterilizing, follow the hospital’s protocol and the sterilization equipment manufacturer’s instructions. Prior to steam sterilization (autoclaving) of accessories, meticulous manual cleaning followed by at least 5 minutes of ultrasonic cleaning at 38 to 47 kHz is required.

12

•

Before sterilization, the instrument must be thoroughly cleaned and dried. Residual moisture inhibits sterilization.

•

Exceeding the recommended parameters may cause equipment damage.

•

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.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

•

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

•

Inspect the instrument packages for openings, tears and other damage. If the package is open or damaged, seal the components in new packaging 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.

•

Endo-Therapy Accessories and other items which are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, a green band or yellow-green marking are compatible with autoclaving.

•

Some items with no markings are compatible with autoclaving. To determine the compatibility of such equipment with steam sterilization, refer to the item’s instruction manual.

Prevacuum

Temperature

Exposure Time

132 to 134C (270 to 274F)

5 minutes

Table 2.4

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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.

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. Do not coil the endoscope’s Insertion Tube and Universal Cord with a diameter smaller than 40 cm. The endoscope can be damaged if coiled too tightly.

14

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Channel Channel Cleaning Brush Cleaning Brush (BW-7B for LF-2/DP/GP)1 (BW-15B)

Single Use Single-ended Cleaning Brush (BW-400B for LF-2/DP/GP)1

Suction Connector Cleaning Brush (BW-15SH for LF-2/DP/GP)

Channel-opening Cleaning Brush (MH-507)

ETO Cap (MB-156)

Leakage Tester (MB-155)

Suction Pump (KV-4)

Maintenance Unit (MU-1)

• Detergent Solution

• Large Basin for Rinsing

• Personal Protective Equipment

• Disinfectant Solution

• Large Basin for Leakage Testing

• Soft-Bristled Toothbrush

• Rinsing Water

• 30 cm3 (30 ml) Syringe

• Lint-free Cloths

• 70% Ethyl or Isopropyl Alcohol

• Cotton Swab

• Large Non-metallic Basin with a Tight Fitting Lid for Detergent and Disinfectant Solution

• Soft Sponge

Figure 3.1 1 These products may not be available in some areas.

ENF/LF ENDOSCOPE 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.

Do not use the Channel Cleaning Brush for cytologic tissue sampling or other diagnostic or therapeutic purposes. Patient injury, cross-contamination or equipment damage may occur.

 ETO Cap (MB-156) When performing ETO gas sterilization, the ETO Cap must be attached to the Venting Connector on the Endoscope Connector (see Figure 3.2).

Connector

Figure 3.2

 Channel Cleaning Brush (BW-15B or BW-7B) The Channel Cleaning Brush is used to brush the inside of the channel (see Figure 3.3).

Metal Tip

Figure 3.3

16

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Single use single-ended cleaning brush (BW-400B) The single use single-ended cleaning brush is used to brush the inside of the instrument channel (see Figure 3.4).

Metal tip Brush head

Shaft

Figure 3.4

 Channel-opening Cleaning Brush (MH-507) The Channel-opening Cleaning Brush is used to brush the Suction Valve Housing (see Figure 3.5).

Figure 3.5

ENF/LF ENDOSCOPE REPROCESSING MANUAL

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