EY-470S/B Endoscope Operation Manual

Important Safety Information

Important Safety Information 1. Safety Read and understand this manual carefully before use. Use the Endoscope following the provided instructions. The items important for the safe use of the Endoscope are summarized in Chapter 1 “Safety” in the preparations and operations section. Safety precautions associated with individual operations or procedures are provided separately marked “ WARNING” or “ CAUTION.”

2. Warning The items that must be observed for safety when performing endoscopy or electrosurgery are identified by “ WARNING” or “ CAUTION.” Read and understand the warning information carefully, and perform the procedures correctly.

WARNING Improper use or operation of the equipment may injure patients, physicians, or people in the vicinity. Read and understand this manual carefully before operating the equipment. Conditions that may give damage to the equipment are identified by “CAUTION”. For details about differences between conventions, “ WARNING”, “ CAUTION” and “CAUTION”, refer to “Conventions Used in This Manual” on page 4.

3. When Using the Endoscope for the First Time Endoscopes have not been sterilized. When using this product for the first time, use the level of disinfection or sterilization suitable to the application according to Chapter 8 “Cleaning,” Chapter 9 “Chemical Disinfection,” or Chapter 10 “Gas Sterilization.”

4. Handling of Endoscope When holding Endoscope, hold it by the control portion. Handling it up at the insertion portion or LG flexible portion generates unnatural force, and causes the instrument failure.

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Contents

Contents Important Safety Information...2 Preface...4 Conventions Used in This Manual ...4 Chapter 8

Cleaning... 8-1 8.1 Methods of Cleaning... 8-2 8.2 Conditions of Cleaning... 8-3 8.3 Necessary Equipment and Materials... 8-4 8.4 Manual Cleaning (cleaning in sink)... 8-6 8.5 Cleaning and Sterilizing Biopsy Forceps... 8-15 8.6 Cleaning and Disinfecting Cleaning Brush... 8-17

Chapter 9

Chemical Disinfection... 9-1 9.1 Methods of Chemical Disinfection... 9-2 9.2 Conditions of Disinfection... 9-3 9.3 Chemical Disinfection of Endoscope... 9-4 9.4 Rinsing of Endoscope... 9-6 9.5 Cleaning and Disinfection Using Cleaning and Disinfecting Devices... 9-9

Chapter 10 Gas Sterilization... 10-1 10.1 Conditions of Gas Sterilization... 10-3 10.2 EOG (Ethylene Oxide Gas) Sterilization... 10-4 Chapter 11 Storage... 11-1 Appendix...Appendix-1 Chemicals and Conditions...Appendix-2 Index...Appendix-5

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Preface

Preface This manual describes how to clean, disinfect, sterilize and store EY-470S/B.

Conventions Used in This Manual This manual uses the following conventions to make it easy to understand the operations described in it. General conventions Convention

Meaning Indicates a potential danger that may harm to people.

WARNING

Indicates the dangerous conditions that may cause to death or serious accident unless it is avoided.

CAUTION

Indicates the conditions that may cause to light or medium injury unless it is avoided.

CAUTION

Indicates the conditions that may damage to equipment unless it is avoided.

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

Consecutive numbers in operating procedures indicate the sequence of successive operations.

[Note]

Indicates a comment or supplementary information. Indicates a reference.

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Chapter 8

Cleaning

This chapter describes methods of cleaning. Cleaning of the Endoscope consists of pre cleaning to be performed at bedside immediately after pulling it out and subsequent manual cleaning to be performed thoroughly in a sink or the like.

8.1 Methods of Cleaning...8-2 8.2 Conditions of Cleaning...8-3 8.3 Necessary Equipment and Materials...8-4 8.4 Manual Cleaning (cleaning in sink)...8-6 8.4.1 Removing Endoscope from the Processor...8-6 8.4.2 Water Proofing the EVE Connector...8-7 8.4.3 Air Tightness Test...8-8 8.4.4 Brushing the Channel...8-12 8.4.5 Brushing the Distal End...8-12 8.4.6 Cleaning the Channel...8-13 8.4.7 Cleaning the Entire Endoscope...8-14 8.5 Cleaning and Sterilizing Biopsy Forceps...8-15 8.6 Cleaning and Disinfecting Cleaning Brush...8-17 8-1

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Chapter 8 Cleaning

Chapter 8 Cleaning 8.1 Methods of Cleaning

CAUTION Improper cleaning may cause damage to Endoscope. Proceed the cleaning of Endoscope by the specified method. Perform pre cleaning at bedside immediately after pulling the Endoscope out. After pre cleaning, perform thorough manual cleaning in a sink or the like. The pre cleaning method is described in Chapter 6 “Method of Use” in the Operation manual (Preparation and Operation). Use tap water or cleaning fluids for cleaning. For cleaning, we recommend you to use the cleaning fluid listed in the Appendix-2, “Chemicals and conditions.”

Table 8.1 Applicable methods of cleaning for Endoscope and accessories Chemical cleaning

Ultrasonic cleaning

Endoscope

Yes

Yes Note

Biopsy forceps

Yes

Yes

Carrying case

No

No

Cleaning adapter

Yes

No

Note: Use an ultrasonic cleaning unit specialized for Endoscope.

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Chapter 8 Cleaning

8.2 Conditions of Cleaning For cleaning, we recommend you to use the cleaning fluids listed in the Appendix-2, “Chemicals and conditions.” We have confirmed that the Endoscope has resistance to the cleaning fluids listed in the Appendix-2. If you want to use cleaning fluids other than those listed in the Appendix-2, “Chemicals and conditions,” inquire of us about the resistance of the Endoscope to them beforehand. For the resistance of equipment, follow the cleaning conditions specified in the Appendix-2, “Chemicals and conditions.” For effects, dilution, and preparation of a cleaning fluid under use conditions indicated in the Appendix-2, refer to the manufacturer of the respective cleaning fluid. Some cleaning fluids require “precautions in use” or “handling precautions,” such as wearing of a protective gear. Refer also to the instruction manual of the respective cleaning fluid.

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Chapter 8 Cleaning

8.3 Necessary Equipment and Materials Prepare the necessary equipments used in chapter 8 and 9. • Cleaning Adapter (Standard accessory) CA-500H : Components Syringe Forceps inlet cleaning adapter CA-503B/C (with a cap) Note 1 • Cleaning brush (Standard accessory) Note 2 WB3212FW2 WB11002FW2 (for valve) • Air leak tester LT-7F (optional item) Note 1: Not used. Note 2: Prepare spare consumable items such as cleaning brushes since they may be damaged. • Chemical solution/cleaning fluid • Container for chemical solution/cleaning fluid • Sterile gauze • Toothbrush (soft type) • Protective gear Rubber gloves Goggle Facemask Protection clothes • Suction Unit • Luer Lock Adapter

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Chapter 8 Cleaning

Syringe

Forceps Inlet Cleaning Adapter CA-503B/C

Luer Lock Adapter

Suction Unit

Cleaning Adapter CA-500H

Sterile Gauze

Chemical solution/cleaning fluid

Air Leak Tester LT-7F

Toothbrush (soft type)

Container for chemical solution/ cleaning fluid

Cleaning Brush (for Valve) WB11002FW2

Protective Gear

Cleaning Brush WB3212FW2

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Chapter 8 Cleaning

8.4 Manual Cleaning (cleaning in sink) After pre cleaning at bedside, perform thorough manual cleaning in a sink. Run an air tightness test on the Endoscope before cleaning.

WARNING The Endoscope could be a source of infection. In case the cleaning brush is damaged during a cleaning process, remove any residue from inside the tube. In case the cleaning brush is damaged, insert a spare brush to remove the residue by pushing it out of the tube. If a damaged brush is left in the tube, the residue might fall out during use and injure the patient’s body cavity.

CAUTION Touching the LG connector with hands immediately after use of the Endoscope may cause to burn. Do not touch the LG connector tip until it will be cooled down (5 minutes) 8.4.1 Removing Endoscope from the Processor (1) Turn OFF the power switch of the processor and the light source.

(2) Remove the EVE connector from the processor. (3) Remove the LG connector from the light source.

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Chapter 8 Cleaning

8.4.2 Water Proofing the EVE Connector If the EVE connector with water on the electrical contacts is used, it will cause a malfunction. Before cleaning, attach the water proof cap to the EVE connector so that water do not reach the contacts.

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Chapter 8 Cleaning

8.4.3 Air Tightness Test

WARNING Do not store the air leak tester together with the medical equipment that has been cleaned and disinfected. Store the air leak tester in a place out of reach of persons except for physicians and healthcare professionals. If the air leak tester is touched carelessly, it may cause infection.

CAUTION Do not perform air tightness test with a damaged air leak tester. Do not attach or remove the air leak tester while the endoscope is immersed in clean water. Do not attach the air leak tester while the endoscope is wet. Do not attach the air leak tester to the endoscope while moisture remains in the connector of the air leak tester. If moisture enters the air leak tester, do not attach it to the endoscope. When supplying air, apply pressure until the air leak tester reaches the working pressure (20±1.5 kPa). Do not clean the endoscope with the air leak tester attached. The endoscope may be damaged. If the air tightness of the endoscope is insufficient, do not immerse it in clean water or chemical solution. Clean water may enter inside and damage the endoscope. [Note] For other precautions, refer to the manual of the air leak tester. [Note] If the result of air tightness test shows that the air tightness is insufficient, contact your local FUJIFILM dealer immediately. [Note] If water droplets enter the air leak tester or tube, dry it out before use. Make sure that no moisture remains in the tube. Squeeze the blower to make sure that no moisture flows inside the tube.

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Chapter 8 Cleaning

<Inspection before Use> If any abnormality is found during inspection, do not use the product. (1) Visually check the tube leading to the connector for abnormalities such as folds, bends or flaws. (2) Press the trigger of the air leak tester to the pressure side. Squeeze the blower to make sure that enough amount of air is supplied from the connector, and that the indicator moves. (3) Make sure that the endoscope to be tested is compatible with the air leak tester.

<Test Procedure> (1) Connect an air leak tester LT-7F (optional item) to the ventilation connector of the endoscope. [Note] Align the notch “a” of the ventilation connector of the endoscope with the index “b” of the connector of the air leak tester and then push in the connector of the air leak tester and rotate it clockwise to attach the air leak tester to the ventilation connector.

a b

[Note] For details on how to use the air leak tester, refer to the operation manual of the air leak tester. (2) Securely press the trigger of the air leak tester to the pressure side.

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Chapter 8 Cleaning

(3) Squeeze the blower of the air leak tester to supply air until the air leak tester indicates 20 kPa.

Working pressure: 20±1.5 kPa

[Note] Release your finger from the trigger so as not to pull the trigger.

(4) Allow tester to stand for 30 seconds and check that the indication does not fall down. If the change in the indication is 5 kPa or more (10 gradations or more), the air tightness of the endoscope is insufficient. [Note] If the air tightness is insufficient, do not clean the endoscope and contact your local FUJIFILM dealer immediately. (5) Apply pressure until the indication reaches 20 kPa and then immerse the endoscope in clean water. [Note] The temperature of clean water must be between +10 to +40°C. [Note] Completely immerse the endoscope. [Note] Do not immerse the meter and blower of the air leak tester. Immerse the endoscope to the extent that the connector and tube of the air leak tester is immersed. [Note] When the indicator falls down slowly, squeeze the blower to supply air until the indicator reaches 20 kPa. [Note] Keep the endoscope immersed for not less than one minute.

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Chapter 8 Cleaning

(6) Operate the endoscope to move the insertion portion and bending section in various directions and ensure that a steady stream of air bubbles (indicative of a leak) is not found. [Note] If a stream of air bubbles comes out from the endoscope while it is immersed in clean water for at least one minute, the endoscope has a leak. Do not clean the endoscope and contact your local FUJIFILM dealer immediately. (7) Remove the endoscope from clean water, wipe the ventilation connector, air leak tester connector and their surroundings with dry gauze, and then dry them out. (8) Pull the trigger of the air leak tester to the release side to release air pressure from the endoscope. [Note] Release air until the indicator falls and returns to its starting position (0 kPa). (9) Remove the connector of the air leak tester by pressing and then rotating it counterclockwise.

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Chapter 8 Cleaning

8.4.4 Brushing the Channel (1) Brush following areas with attached cleaning brush WB3212FW2. • From forceps inlet to distal end of Endoscope

(2) Using a cleaning brush WB11002FW2, brush the inside of the forceps inlet.

8.4.5 Brushing the Distal End Using a cleaning brush WB11002FW2 or a soft toothbrush, brush the distal end.

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Chapter 8 Cleaning

8.4.6 Cleaning the Channel (1) Attach a syringe to the fluid supply inlet. (2) Inject cleaning fluid into the channel of the Endoscope with a syringe. Inject the cleaning fluid until it is discharged from the channel outlet. (3) Using a syringe, feed air into the channel of the Endoscope to remove cleaning fluid in the channel. Inject air until the cleaning fluid is discharged completely from the channel. (4) Repeat steps (2) and (3) a couple of times to feed cleaning fluid and air alternately. (5) Using a syringe, feed clean water into the channel of the Endoscope to rinse cleaning fluid in the channel. Inject clean water until the cleaning fluid is discharged completely from the channel outlet. (6) Finally, feed air into the channel until moisture is discharged completely.

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Chapter 8 Cleaning

8.4.7 Cleaning the Entire Endoscope

CAUTION Cleaning liquid might flow into a patient’s body. After cleaning, rinse off any remaining chemical with water.

(1) Using a clean soft sponge, wash the Endoscope with the cleaning fluid. (2) Rinse the Endoscope with running water (clean water).

(3) Wipe off any water remaining on the Endoscope with sterilized gauze

(4) Using the syringe, inject air to discharge moisture from the channel. Inject air until the cleaning fluid is discharged completely from the channel.

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Chapter 8 Cleaning

8.5 Cleaning and Sterilizing Biopsy Forceps

WARNING Sterilization might not be maintained by the sterile pack’s rupture. Close the forceps before putting the forceps in a sterile pack. For operational methods of the ultrasonic cleaning unit/autoclaving unit, please follow the instructions described in each operation manual for the respective units.

(1) Wipe the surface of the forceps with gauze soaked in cleaning fluid.

(2) Brush entire forceps in cleaning fluid using a soft toothbrush. (3) Clean entire biopsy forceps using the ultrasonic cleaning unit.

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Chapter 8 Cleaning

(4) Take out the forceps from the cleaning fluid and rinse off with running water (clean water). (5) Wipe off the remaining water on the forceps with dry sterile gauze. (6) Coil the insertion portion and seal it in a sterile pack.

(7) Carry out an autoclaving operation in accordance with the operation manual of the autoclaving unit.

Recommended steam sterilization (autoclaving) conditions Sterilization temperature (ºC) 121 126 134

Operation time Max 20 minutes Min 15 minutes Max 15 minutes Min 10 minutes Max 8 minutes Min 5 minutes

For France and Switzerland only: Sterilization temperature 134ºC with minimum exposure time (while sterilization temperature) of 18 minutes. Steam Sterilizer Class B according EN 13060

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