Endoscope ED530XT Cleaning, Disinfection and Storage Operation Manual

Important Safety Information

Important Safety Information 1. Safety Prior to use carefully review this manual. Use this product following all the provided instructions (“Preparation and Operation”, “Cleaning, Disinfection and Storage” and “Electrosurgical Instruments”). The items important for the safe use of this product are summarized in Chapter 1 “Safety” in the preparations and operations section. Safety precautions associated with individual operations and/or reprocessing procedures are provided separately marked by “ WARNING” or “ CAUTION.”

2. Warning The items that must be observed for safety when performing endoscopy or electrosurgery are identified by “ WARNING” or “ CAUTION” comments in our three operation manuals describing “Preparation and Operation”, “Cleaning, Disinfection and Storage” and “Electrosurgical Instruments.” Follow all caution and warning statements in our operation manuals.

WARNING Read this manual and the Operation Manual (Preparation and Operation) thoroughly and carefully before use. Improper use or operation of this product may injure patients, physicians, or individuals within the immediate procedure environment. Failure to adhere to all reprocessing instructions could compromise patient safety and present infection control risks. Improper operations that will damage the equipment only are identified by “CAUTION.”

3. First Time Use This product has not been cleaned, disinfected or sterilized. It must be reprocessed for the first time prior to use and after any subsequent use as per instructions provided Chapter 7 “Cleaning,” Chapter 8 “High-Level Disinfection,” or Chapter 9 “ETO Gas Sterilization.”

4. Single Patient Use Only DO NOT reuse the forceps valve and cleaning brush WB1318DE as their reuse may pose an infection risk. Each of these products is intended for single use only.

5. Annual Return and Inspection All duodenoscopes must be returned to your local FUJIFILM dealer or authorized service representative for inspection of the forceps elevator seal once a year to maintain safe use of the device. 2

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Contents

Contents Important Safety Information...2 Preface...4 Conventions Used in This Manual...6 Chapter 7

Cleaning... 7-1 7.1 Methods of Cleaning... 7-2 7.2 Preparation for Cleaning... 7-3 7.3 Equipment and Materials... 7-4 7.4 Pre-cleaning... 7-6 7.5 Manual Cleaning (cleaning in basin)... 7-11

Chapter 8

High-Level Disinfection... 8-1 8.1 Methods of High-Level Disinfection... 8-2 8.2 Conditions of High-Level Disinfection... 8-3 8.3 High-Level Disinfection of Endoscope... 8-4 8.4 8.5

Chapter 9

Rinsing Endoscope... 8-7 Cleaning and/or High-Level Disinfection Using an Automated Endoscope Reprocessor (AER)... 8-11

ETO Gas Sterilization... 9-1 9.1 Conditions of Ethylene Oxide (ETO) Gas Sterilization... 9-2 9.2 ETO Gas Sterilization... 9-4

Chapter 10 Cleaning and High-Level Disinfection/Sterilization of Endoscopic Accessories... 10-1 10.1 Cleaning, Disinfecting and Sterilizing Air/Water Button and Suction Button... 10-3 10.2 Cleaning and Disinfecting Cleaning Brushes... 10-7 10.3 Autoclaving Cleaning Adapter Kit CA-503/A... 10-10 10.4 High-Level Disinfecting and Sterilizing Forceps Valve (FOV-DV7)... 10-11 Chapter 11 Storage... 11-1 Appendix...Appendix-1 Autoclaving Conditions...Appendix-2 Index...Appendix-3

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Preface

Preface This manual describes how to clean, disinfect, sterilize and store ED-530XT duodenoscope. [Note] This model is a fully immersible, single-instrument channel flexible endoscope. Carefully follow the instructions in this manual as well as recommendations for ancillary equipment before using other accessories. This endoscope is heat-sensitive and should not be exposed to high temperatures associated with sterilization processes such as steam autoclaving. Handle this product with care since the insertion portion is pliable and acute bending, excessive twisting and/or force can damage the insertion tube as well as underlying internal components. [Note] FUJIFILM cannot assure the successful reprocessing (cleaning, high-level disinfection and sterilization) of the endoscope and/or accessories if reprocessing methods, chemicals, packaging and/or conditions other than those described in this manual are used. Users are responsible to ensure that if any alternative reprocessing methods, chemicals, packaging and/or conditions are used, appropriate efficacy validation studies have been performed.

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Preface

B A

C H F D

E

G D to A to G : Air/Water Supply Channel E to D : Air Supply Channel F to B to G : Suction Channel C to G : Forceps Channel

Legend A : Air/water supply valve B : Suction valve C : Forceps inlet D : Feed water connector E : Air supply channel F : Suction connector G : Distal end H : Ventilation connector

[Note] The ED-530XT duodenoscope features a distal elevator mechanism with a sealed (fully enclosed) elevator control wire channel. While the enclosed elevator channel itself does not require special reprocessing, the elevator, surrounding recessed surfaces and distal tip still should be manually cleaned and then high-level disinfected.

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Conventions Used in This Manual

<Summary chart>

Withdrawal from patient

Pre-cleaning (in examination room)

High-level disinfection Cleaning

Leak testing (in decontamination area/ cleaning room)

Water Rinse

Alcohol/ Air/Dry Use (or storage)

Water Rinse Alcohol/ Air/Dry

ETO gas sterilization

Aeration

Conventions Used in This Manual This manual uses the following conventions for easier understanding.

General Conventions Convention

Description Indicates a potential danger that may cause harm to people.

WARNING

Explains dangerous situations that may cause death or serious injury if not avoided.

CAUTION

Explains situations that may cause injury if not avoided.

CAUTION

Explains situations that may cause damage to equipment if not avoided.

(1), (2), (3), ...

Indicates consecutive numbers in operating procedures for the order in which successive steps in the procedure should be taken.

[Note]

Indicates a comment or supplementary information. Indicates a reference.

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Chapter 7

Cleaning

This chapter describes FUJIFILM recommended manual cleaning procedures. Carry out pre-cleaning at the bedside immediately after completion of endoscopic procedure.

7.1 7.2 7.3 7.4

Methods of Cleaning...7-2 Preparation for Cleaning...7-3 Equipment and Materials...7-4 Pre-cleaning...7-6 7.4.1 Wiping...7-6 7.4.2 Purging the Air/Water (A/W) Supply Channel...7-6 7.4.3 Pre-cleaning Suction Channel...7-7 7.4.4 Cleaning Forceps Elevator...7-8 7.4.5 Disconnecting Endoscope from Processor...7-8 7.4.6 Detaching Endoscope Components (A/W button, suction button, forceps valve, etc.)...7-9 7.4.7 Transporting Endoscope for Reprocessing...7-10 7.5 Manual Cleaning (cleaning in basin)...7-11 7.5.1 Preparation for Cleaning Endoscope...7-12 7.5.2 Endoscope Components...7-12 7.5.3 Leak Testing...7-13 7.5.4 Inspecting Cleaning Brushes...7-16 7.5.5 Cleaning Surface of Endoscope...7-17 7.5.6 Brushing Suction Channel and Channel Ports...7-21 7.5.7 Connecting Cleaning Adapter Kit...7-22 7.5.8 Cleaning of Endoscope...7-24 7.5.9 Rinsing Endoscope...7-26

7-1

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Chapter 7 Cleaning

Chapter 7 Cleaning 7.1 Methods of Cleaning

CAUTION Clean this product before first time use and after subsequent use following the instructions provided in this manual. Improper cleaning can negatively affect the functionality of this product and/or result in incomplete high-level disinfection or sterilization. Cleaning is a crucial first step in reprocessing, which if not properly performed, can result in incomplete or inadequate high-level disinfection or sterilization. Use potable water or filtered water for rinsing after exposure to a detergent solution. Low foaming neutral pH enzymatic detergents are recommended for cleaning flexible endoscopes. For specific names of compatible detergents, contact your local FUJIFILM dealer.

Table 7.1 Compatible methods of cleaning for endoscope and accessories Detergent cleaning

Ultrasonic cleaning

Endoscope

Yes

No

Air/Water button

Yes

Yes [Note 1]

Suction button

Yes

Yes [Note 1]

Cleaning brush [Note 2]

Yes

Yes [Note 1]

Carrying case

No

No

Yes

No

Cleaning adapter kit

[Note 3]

[Note 1] Use an ultrasonic cleaning unit specialized for medical accessories. [Note 2] F U J I N O N / F U J I F I L M c l e a n i n g b r u s h e s o n l y a r e r e c o m m e n d e d . F o r non-FUJINON/FUJIFILM brushes, contact the original manufacturer. [Note 3] Applies to all components of the cleaning adapter kit excluding a 30 mL syringe.

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Chapter 7 Cleaning

7.2 Preparation for Cleaning Low foaming, neutral pH, enzymatic detergents are recommended for cleaning flexible endoscopes. For specific names of compatible detergents, contact your local FUJIFILM dealer. Refer to the detergent manufacturer’s instructions for preparation and use. Personal protective equipment should be worn by end-users during all reprocessing procedures.

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Chapter 7 Cleaning

7.3 Equipment and Materials Prepare the necessary equipment used in Chapters 7 and 8. • Cleaning adapter kit CA-503/A (Standard accessory) Consists of : Tube for air/water supply channel Tube for suction channel 30 mL syringe [Note 1] Valve adapter CA-503S/A Forceps inlet cleaning adapter CA-503B/C (with a cap) Tank receiving cap [Note 1] The supplied 30 mL syringe is intended for cleaning process. Use a sterile syringe for high-level disinfection process. • Cleaning brushes (Standard accessories) Consists of : Cleaning brush WB11002FW2 Cleaning brush WB4321FW2 Cleaning brush WB1318DE • Air leak tester LT-7F (Required accessory) [Note] LT-7F is a required accessory and leak testing procedures must be performed prior to cleaning.

• High-level disinfectant solution and enzymatic detergent solution • Soaking basin for high-level disinfectant solution and detergent solution • Clean lint-free cloth/sterile gauze • Toothbrush (soft type) for cleaning of accessories • Magnifying glass or loupe • Personal protective equipment For example: Rubber gloves Goggle Facemask Protective clothing [Note] Prepare spare consumable items such as cleaning brushes, sterile gauze, toothbrush, 30 mL syringe, etc. since they may be damaged or consumed. [Note] Use potable, filtered and/or sterile water as described in these operation manuals. In addition, note that ventilation adapter AD-7 is necessary for ETO gas sterilization as described in Chapter 9.

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Chapter 7 Cleaning

Tube for Suction Channel 3 Way Valve 30 mL Syringe Tube for Air/Water Supply Channel

Valve Adapter CA-503S/A Tank Receiving Cap

Forceps Inlet Cleaning Adapter (with a Cap) CA-503B/C

Weight Cleaning Adapter Kit CA-503/A

Cleaning Brush WB11002FW2

Clean Lint-free Cloth/Sterile Gauze

High-Level Disinfectant Solution/ Detergent Solution

Cleaning Brush WB4321FW2

Air Leak Tester LT-7F

Cleaning Brush WB1318DE

Ventilation Adapter AD-7

Toothbrush (Soft Type) for Cleaning of Accessories

Magnifying Glass/ Loupe

Soaking Basin for High-Level Disinfectant Solution/ Detergent Solution Personal Protective Equipment

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Chapter 7 Cleaning

7.4 Pre-cleaning (performed at bedside immediately after use of endoscope)

CAUTION Immediately upon completion of the procedure, it is imperative that precleaning is performed to begin removal of patient material and ensure that residual debris does not dry and harden.

7.4.1 Wiping Wipe off the outside of the insertion portion of the endoscope with a clean lint-free cloth soaked with detergent solution. [Note] When wiping the insertion portion, do not wipe/slide gross soil/patient material directly onto the forceps elevator/ elevator recess at the scope distal tip.

7.4.2 Purging the Air/Water (A/W) S ‌ upply Channel Expel potential body fluids from the A/W supply channel of the endoscope in accordance with the following procedure. Depending upon specific model of light source, set the air setting to its maximum (highest) output pressure to more forcefully expel fluids/materials during pre-cleaning. (1) Provide air for 10 seconds by covering the A/W button with one’s finger. (2) Provide sterile water from the water tank for 10 seconds by depressing the A/W button. (3) Turn the connector of water tank connected to endoscope to remove it. Then cover the feed water connector of endoscope with one’s finger.

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Chapter 7 Cleaning

(4) Continue pressing the A/W button until the A/W supply channels are completely drained.

7.4.3 Pre-cleaning Suction Channel (1) Repeat the following steps (2) and (3) at least 3 times to alternately aspirate detergent solution and air. (2) Immerse the distal end of endoscope in detergent solution and depress the suction button for 10 seconds to aspirate detergent. (3) Keeping the suction button depressed, pull the distal end of endoscope out from detergent solution to aspirate air. (4) Pull the distal end of endoscope out from detergent solution and aspirate air until detergent solution in the suction channel is discharged completely.

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Chapter 7 Cleaning

7.4.4 Cleaning Forceps Elevator Clean the forceps elevator mechanism and all scope tip areas surrounding and behind the elevator. Immerse the distal end of the endoscope in the detergent solution and then move the forceps elevator lever back and forth 5 times ensuring that the elevator and all recessed surfaces surrounding the elevator are in contact with the detergent. While the scope tip remains immersed in detergent, aspirate detergent solution for 10 seconds while the forceps elevator is fully raised, aspirate detergent for 10 seconds while the forceps elevator is fully lowered and aspirate detergent for 15 seconds while moving the forceps elevator back and forth.

7.4.5 Disconnecting Endoscope from Processor

CAUTION Do not touch the tip of LG (Light Guide) connector until it has cooled down (approximately 5 minutes after turning off the power of the light source). Touching the LG connector tip with one’s hand immediately after use of this product may cause a burn. After the endoscope has been disconnected from the video processor and/or light source, transport the endoscope in a covered tray to the decontamination area/cleaning room.

(1) Turn OFF the processor and the light source.

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Chapter 7 Cleaning

(2) Detach suction tube and water tank from LG connector of endoscope.

(3) Detach EVE connector from the processor. (4) Detach LG connector from the light source.

7.4.6 Detaching Endoscope Components (‌ A/W button, suction button, f‌ orceps valve, etc.)

WARNING The forceps valve is a single patient use item. DO NOT reuse it as continued reuse presents an infection risk.

(1) Remove the A/W button, suction button and forceps valve from the endoscope. (2) Place buttons in detergent solution. (3) Discard removed forceps valve. Do not reuse it.

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Chapter 7 Cleaning

7.4.7 Transporting Endoscope for Reprocessing

WARNING To protect the endoscope from damage and to prevent spillage, use a covered tray during transportation to the cleaning room. Transport the endoscope in a covered tray to the decontamination area/cleaning room.

(1) Place endoscope in a transport container. (2) Carry it with endoscopic accessories to the decontamination area/cleaning room.

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Chapter 7 Cleaning

7.5 Manual Cleaning (cleaning in basin) Manual cleaning of endoscope is performed after pre-cleaning at the bed-side in the procedure room. If performed correctly immediately after the procedure, pre-cleaning should prevent drying and hardening of debris on instrument surfaces. “7.4 Pre-cleaning (performed at bedside immediately after use of endoscope)”

CAUTION It is imperative that patient material is not allowed to dry and/or harden onto scope surfaces, particularly the elevator and elevator recess at the scope distal tip, as doing so will make cleaning more difficult and possibly impede adequate high-level disinfection and/or sterilization. Delayed reprocessing of endoscopes, especially duodenoscopes is not recommended. Leak testing must be performed prior to immersing the endoscope in any fluid or solution. [Note] Fresh enzymatic detergent should be prepared for each endoscope. Do not reuse detergent.

WARNING Carefully inspect all cleaning brushes prior to use and check the brushes integrity after use to ensure that the accessories are not damaged and no brush or accessory fragment remains inside the channel. Retained brush/accessory fragments could be a potential source of infection and/or cause patient injury. Before using any cleaning brush for a valve cylinder or channel port, remove any debris from the bristles on the brush. This will avoid reintroduction of patient material into the channels/lumens. If the cleaning brush is damaged and possible brush fragments remain inside the channel, use a new cleaning brush to remove the broken fragments and repeat cleaning of the channel. Do not place endoscopes on top of one another to prevent damage caused by scope-to-scope contact.

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Chapter 7 Cleaning

7.5.1 Preparation for Cleaning Endoscope (1) Prepare all items including cleaning brushes WB4321FW2 and WB11002FW2 and cleaning adapter kit. (2) Attach the waterproof cap to the EVE connector.

(3) Prepare fresh detergent solution (following detergent manufacturer’s instructions for use) in the basin.

7.5.2 Endoscope Components If not already detached, remove all detachable components including air/water button and suction button from endoscope.

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Chapter 7 Cleaning

7.5.3 Leak Testing

CAUTION Do not immerse this product in water or any solution if it fails the leak test because it may cause damage to this product. Perform a leak test to confirm the watertightness of this product. If a leak is detected, do not continue the test and contact your local FUJIFILM dealer. For details on how to use the LT-7F and inspection before use, refer to the instructions in this manual or the separate operation manual for the LT-7F.

(1) Confirm the waterproof cap is connected to the end of the EVE connector. Ensure that the cap and connector, especially the electrical contacts are dry. (2) Align the index of connector of air leak tester with the notch of ventilation connector of endoscope. (3) Push in the connector of air leak tester and rotate it clockwise to connect the air leak tester to the ventilation connector.

Index Notch

(4) Depress the trigger of air leak tester to the pressure side as shown in the figure.

Pressure side

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Chapter 7 Cleaning

(5) Pump the hand bulb of the leak tester to pressurize the endoscope until the meter indicates 20 kPa. [Note] During pressurization, remove fingers from the trigger and do not lay trigger onto the hard surface to avoid inadvertent escape of air.

(6) Release gripping the blower and wait for about 30 seconds, and check that the indicator does not fall. If the indicator falls down 5 kPa (10 indications) or more, the endoscope has an air leak. [Note] If the indicator drops slowly, apply more air until the indicator points to 20 kPa. [Note] In case of air leak, do not clean the endoscope, but immediately contact your local FUJIFILM dealer. (7) While applying air pressure of at least 20 kPa into the endoscope, completely immerse the entire scope in water for not less than one minute and ensure that a steady stream of air bubbles (indicative of a leak) is not found. [Note] Be sure to apply air pressure before immersing the endoscope into water. [Note] Do not immerse the meter or blower of air leak tester but only the connector and tube.

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