BF/ENF/LF Endoscopes Without Channel Instructions

Contents

Contents Symbols...

1

Chapter 1

General Policy ...

2

1.1

Instructions...

2

1.2

Signal Words...

3

1.3

Precautions ...

3

Chapter 2

Compatible Reprocessing Methods and Chemical Agents ...6

2.1

Compatibility Summary ...

6

2.2

Detergent Solution ...

7

2.3

Disinfectant Solution ...

7

2.4

Rinsing Water ...

8

2.5

ETO Gas Sterilization ...

8

2.6

Steam Sterilization (Autoclaving) of Accessories...

10

Chapter 3

Cleaning, Disinfection and Sterilization Procedures 11

3.1

Required Reprocessing Equipment ...

11

3.2

Cleaning, Disinfection and Sterilization Procedures ...

14

3.3

Precleaning ...

15

3.4

Leakage Testing ...

16

3.5

Manual Cleaning ...

20

3.6

High Level Disinfection ...

23

3.7

Rinsing After High Level Disinfection...

25

3.8

Sterilization ...

26

3.9

Cleaning, Disinfection and Sterilization Procedures for Reusable Parts and Cleaning Equipment... 27

Chapter 4

Cleaning and Disinfection Equipment...

31

Chapter 5

Storage and Disposal...

33

5.1

Storage ...

33

5.2

Disposal ...

33

BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Contents

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BF/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

BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 1 General Policy

Chapter 1 General Policy 1.1

2

Instructions •

This instruction manual is for the Broncho, Rhino-laryngo and Tracheal Intubation videoscope/fiberscope models without 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

BF/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. During use, the instrument normally comes in contact with intact mucous membranes. 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.

•

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.

BF/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.

•

Use 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 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.

BF/ENF/LF ENDOSCOPE 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 reprocessing fiberscope models, before immersing the endoscope in detergent or disinfectant solution, confirm that the ETO Cap is not attached to the Endoscope Connector.

•

When reprocessing videoscope models, before immersing the endoscope in detergent or disinfectant solution, confirm that the Water-resistant Cap is attached to the Endoscope Connector.

BF/ENF/LF ENDOSCOPE 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, the recommendations of your infection control committee and national and local hospital guidelines and policies. 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) ETO Cap (MB-156) Protection Tube (MD-515) Mouthpiece (MA-651) Protection Tube (For ENF-XP only) applicable

Table 2.1

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BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

not applicable

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

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.

2.2

•

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

•

When performing Ultrasonic Cleaning of the endoscope, use the Endoscope Reprocessor (OER).

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 – 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. 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. BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

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 with 70% ethyl or isopropyl alcohol 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 Table 2.3. When performing sterilization, follow the hospital’s protocol and the sterilization equipment manufacturer’s instructions.

8

•

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.

•

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

•

When reprocessing fiberscope models, 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.

BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

•

When reprocessing videoscope models, remove the Water-resistant Cap from the Endoscope Connector before ETO gas sterilization. If the Water-resistant Cap is attached on the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the Bending Section.

•

Repeated ETO gas sterilization procedures will gradually deteriorate the instrument. Do not ETO gas sterilize the instrument unnecessarily.

•

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.

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

Parameters

ETO Gas Sterilization Temperature Pressure

57C (135F) 0.1 – 0.17 MPa (1.0 – 1.7 kgf/cm2, 16 – 24 psia)

Humidity

55%

Exposure Time

1.75 hours

ETO Gas Concentration Aeration (Minimum)

600 – 700 mg/l

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

Table 2.2

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

Parameters

ETO Gas Sterilization Temperature Pressure

57C (135F) 0.10 – 0.17 MPa (1.0 – 1.7 kgf/cm2, 16 – 24 psia)

Aeration (Minimum)

Humidity

55%

Exposure Time

1.75 hours

ETO Gas Concentration

600 – 700 mg/l

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

Table 2.3 BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

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 – 47 kHz is required.

•

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.

•

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

Prevacuum

Temperature

Exposure Time

132 – 134C (270 – 274F)

5 minutes

Table 2.4

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BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

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

ETO Cap (MB-156 for fiberscopes)

Leakage Tester (MB-155)

Water-resistant Cap (MH-553 for videoscopes)

Maintenance Unit (MU-1)

• Detergent Solution

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

• Soft Sponge

• Disinfectant Solution

• Large Basin for Rinsing

• Personal Protective Equipment

• Rinsing Water

• Large Basin for Leakage Testing

• Soft-Bristled Toothbrush

• 70% ethyl or isopropyl Alcohol

• 30 cm3 (30 ml) Syringe

• Lint-free Cloth

Figure 3.1 BF/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.

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

Connector

Figure 3.2

 Water-resistant Cap (MH-553) The Water-resistant Cap is attached to the Endoscope Connector on the videoscope to protect the connector from water penetration during immersion. For leakage testing, the Venting Connector on the Water-resistant Cap must be connected to the Leakage Tester (MB-155) (see Figure 3.3).

Venting Connector

Figure 3.3

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BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Inspection of the Equipment For inspection of other equipment than that mentioned below, refer to the instruction manual for the equipment being used.

 Inspection of the ETO Cap (Fiberscope Models) Check that the ETO Cap is free from scratches, flaws and debris (see Figure 3.2).

 Inspection of the Water-resistant Cap (Videoscope Models)

1. Check that the inside of Water-resistant Cap is free from scratches, flaws and debris (see Figure 3.3).

2. Check the Venting Connector for looseness.

BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.2

Cleaning, Disinfection and Sterilization Procedures Reprocessing Summary Chart

Withdrawal of the Endoscope

Precleaning (Section 3.3)

Leakage Testing (Section 3.4)

Manual Cleaning (Section 3.5)

High Level Disinfection (Section 3.6)

Sterilization (Section 3.8)

Rinsing After High Level Disinfection (Section 3.7)

Storage and Disposal (Chapter 5)

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BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.3

Precleaning Preclean the endoscope at the bedside in the procedure room immediately following the procedure. These steps are to be performed when the Light Source is turned OFF.

Equipment Needed Prepare the following equipment: • Personal Protective Equipment • Clean, Lint-free Cloth • Detergent Solution

Wipe Down the Insertion Tube Handle the Insertion Tube carefully. Tightly gripping or sharply bending the Insertion Tube or Bending Section can stretch or severely damage the Insertion Tube and the covering of the Bending Section. Wipe the entire Insertion Tube with a clean, lint-free cloth soaked in detergent solution. Begin wiping from the Boot toward the Distal End.

Disconnect the endoscope Disconnect the endoscope connector from the light source.

The endoscope connector is very hot immediately after it is disconnected. Avoid touching it.

BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.4

Leakage Testing After precleaning, leakage test the endoscope to ensure that the endoscope is waterproof.

Equipment Needed Prepare the following equipment: • Personal Protective Equipment • Large Basin • Maintenance Unit or Light Source

(MU-1, CLK-4 or CLV-U40)

• Leakage Tester

(MB-155)

• Water-resistant Cap

(MH-553 for videoscope models)

Attach the Water-resistant Cap (Videoscope models Only)

16

•

The Electrical Connector of the videoscope is not waterproof. Before immersing the videoscope, always attach the Water-resistant Cap (MH-553).

•

If the outer perimeter of the Electrical connector is scratched, the connector may no longer be watertight and the seal inside the Water-resistant Cap may become scratched. If the Electrical Connector becomes scratched, send it out for repairs immediately.

•

Never immerse the cap unless its attached to the videoscope. Water remaining inside the cap can be transferred to and damage the Electrical Connector.

BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

1. Attach the Water-resistant Cap (MH-553): Position the OER/ETD/EW, EW or KC/TD character on the Water-resistant Cap at Mark 2 on the electrical connector housing (see Figure 3.4).

2. Align the groove on the connector with the pin on the Water-resistant Cap and lower the cap into position. Rotate the cap clockwise until it stops in place (see Figure 3.4).

Mark 2

Mark 2

Rotate

1.

Rotate

2.

Figure 3.4

BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL

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