Olympus UCT180 User manual

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INSTRUCTIONS

EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

OLYMPUS GF TYPE UCT180

CAUTION : Balloons Used with This Product Contain Natural Rubber Latex, Which May Cause

Allergic Reactions.

USA: CAUTION: Federal law restricts this device to sale by or on the order of a

physician.

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Contents

Symbols......................................................................................... 1

Important Information — Please Read Before Use.................... 3

Intended use ............................................................................................ 3

Applicability of endoscopy and endoscopic treatment ............................. 3

Instruction manual..................................................................................... 4

User qualifications .................................................................................... 4

Instrument compatibility ............................................................................ 5

Reprocessing before the first use/reprocessing and storage after use .... 5

Spare equipment ...................................................................................... 5

Maintenance management........................................................................ 6

Prohibition of improper repair and modification ........................................ 6

Signal words ............................................................................................. 6

Warnings and cautions.............................................................................. 7

Examples of inappropriate handling ......................................................... 11

Chapter 1 Checking the Package Contents............................ 13

1.1 Standard components..................................................................... 13

1.2 Ultrasonic cable .............................................................................. 15

1.3 Optional components ...................................................................... 15

Chapter 2 Instrument Nomenclature and Specifications ...... 16

2.1 Nomenclature.................................................................................. 16

2.2 Endoscope functions....................................................................... 18

2.3 Specifications.................................................................................. 21

2.4 Attaching the chain for water-resistant cap (MAJ-1739) ................. 25

Chapter 3 Preparation and Inspection .................................... 28

3.1 Preparation of the equipment.......................................................... 29

3.2 Inspection of the endoscope ........................................................... 30

3.3 Preparation and inspection of accessories ..................................... 34

3.4 Attaching accessories to the endoscope ........................................ 38

3.5 Inspection and connection of ancillary equipment .......................... 40

3.6 Inspection of the endoscopic system .............................................. 46

3.7 Preparation and inspection of the balloon....................................... 52

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Contents

Chapter 4 Operation.................................................................. 57

4.1 Insertion .......................................................................................... 59

4.2 Observation of the ultrasound image .............................................. 64

4.3 Using EndoTherapy accessories .................................................... 66

4.4 Withdrawal of the endoscope.......................................................... 73

4.5 Removal of the balloon ................................................................... 74

4.6 Transportation of the endoscope .................................................... 75

Chapter 5 Reprocessing: General Policy................................ 76

5.1 Instructions...................................................................................... 76

5.2 Importance of cleaning, disinfection, and sterilization..................... 76

5.3 Precautions ..................................................................................... 77

5.4 Reprocessing before the first use/reprocessing

and storage after use ...................................................................... 80

Chapter 6 Compatible Reprocessing Methods and

Chemical Agents ..................................................... 81

6.1 Compatibility summary.................................................................... 81

6.2 Detergent solution........................................................................... 83

6.3 Disinfectant solution ........................................................................ 84

6.4 Rinse water ..................................................................................... 84

6.5 Ethylene oxide gas sterilization....................................................... 85

6.6 Steam sterilization (autoclaving) of accessories ............................. 87

Chapter 7 Cleaning, Disinfection, and Sterilization

Procedures .............................................................. 88

7.1 Required reprocessing equipment .................................................. 88

7.2 Cleaning, disinfection, and sterilization

procedures for the endoscope ........................................................ 102

7.3 Precleaning ..................................................................................... 103

7.4 Leakage testing............................................................................... 108

7.5 Manual cleaning .............................................................................. 113

7.6 High-level disinfection ..................................................................... 132

7.7 Rinsing after high-level disinfection................................................. 135

7.8 Sterilization ..................................................................................... 138

7.9 Cleaning, disinfection, and sterilization procedures for reusable

parts and reprocessing equipment.................................................. 139

7.10 Care of the ultrasonic cable (MAJ-1597)......................................... 147

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Contents

Chapter 8 Cleaning and Disinfection Equipment................... 148

Chapter 9 Storage and Disposal.............................................. 151

9.1 Storage of the endoscope............................................................... 152

9.2 Storage of the balloon..................................................................... 152

9.3 Storage of reusable parts and reprocessing equipment ................. 152

9.4 Storage of the ultrasonic cable ....................................................... 153

9.5 Disposal .......................................................................................... 153

Chapter 10 Troubleshooting ...................................................... 154

10.1 Troubleshooting guide .................................................................... 154

10.2 Withdrawal of the endoscope with an irregularity ........................... 159

10.3 Returning the endoscope for repair ................................................ 161

Appendix A: System Chart .......................................................... 163

Appendix B: Inspection of the endoscope after cleaning,

disinfection or sterilization in accordance with

IEC 60601-2-37 ......................................................... 170

Appendix C: EMC Information..................................................... 172

Appendix D: Acoustic Output Information in Accordance

with the FDA Guidance: “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound

Systems and Transducers” .................................... 177

Symbol key ............................................................................................... 177

Acoustic output table with ALOKA diagnostic ultrasound system ............. 179

Acoustic output table when combined with Olympus universal

endoscopic ultrasound center EU-ME1 .................................................... 182

Clinical measurement accuracy with ALOKA diagnostic

ultrasound system ..................................................................................... 183

Clinical measurement accuracy when combined with Olympus

universal endoscopic ultrasound center EU-ME1 .................................... 183

Appendix E: Acoustic Output Information Accordance with

IEC 60601-2-37 ......................................................... 184

Acoustic output table with ALOKA diagnostic ultrasound system ............ 184

Acoustic output table with Olympus universal endoscopic ultrasound

center EU-ME1 ......................................................................................... 195

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Contents

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Symbols

The meaning(s) of the symbol(s) shown on the package, the back cover of this

instruction manual and/or this instrument are as follows:

Refer to instructions.

Caution

TYPE BF applied part

Serial number

IPX7 Ingress protection rating (except for connectors)

Lock the ultrasound connector

Release the ultrasound connector

Ultrasonic endoscope

Single use only

Do not resterilize

Use by (expiration date)

Sterilized using ethylene oxide

Sterilization lot number

Lot number

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Symbols

Nonsterile

Keep away from sunlight

Keep dry

Do not use if package is damaged

Contains or Presence of Natural Rubber Latex

Date of manufacture

Manufacturer

Authorized representative in the European Community

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Important Information — Please Read Before Use

Intended use

This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO., LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.

This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs. Do not use this instrument for any purpose other than its intended use.

Applicability of endoscopy and endoscopic treatment

If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their nature, extent, and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.

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Important Information — Please Read Before Use

Instruction manual

This instruction manual contains essential information for using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment that will be used during the procedure. Then use the equipment as instructed. Keep this and all related instruction manuals in a safe and accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

 Terms used in this manual

NBI (Narrow Band Imaging) observation mode:

This is an observation mode using narrow band observation light.

Normal light observation (or WLI (White Light Imaging) observation

mode):

This is an observation mode using the standard white light illumination.

Elastography:

Mode for displaying the relative elasticity information of a tissue using color images. For more details, refer to the instruction manual for the ultrasound instrument for which elastography is available.

User qualifications

If there are official standards for user qualifications for performing endoscopy and endoscopic treatment that are defined by the hospital’s medical administrators or other official institutions, such as academic societies on endoscopy, follow those standards. If there are no official qualification standards, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.

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Important Information — Please Read Before Use

Instrument compatibility

Refer to the “System chart” in the Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient or operator injury and/or equipment damage.

This instrument complies with EMC standard for medical electrical equipment, edition 3 (IEC 60601-1-2: 2007). However, when connected with an instrument that complies with EMC standard for medical electrical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Reprocessing before the first use/reprocessing and storage after use

After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage, or reduce performance. The balloons are disposable, and are intended for a single use only; a new one must be used for each patient. Do not attempt to reuse or resterilize a balloon.

Spare equipment

Be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction.

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Important Information — Please Read Before Use

Maintenance management

The probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically. An endoscope with an observed irregularity should not be used, but should be inspected by following Section 10.1, “Troubleshooting guide” on page 154. If the irregularity is still observed after inspection, contact Olympus.

Prohibition of improper repair and modification

This instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage can result. Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not warranted by Olympus in any manner.

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.

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Warnings and cautions

Follow the warnings and cautions given below when handling this instrument. This information is to be supplemented by the warnings and cautions given in each chapter.

• After using this instrument, reprocess and store it according

• Before endoscopy, remove any metallic objects (watch,

Important Information — Please Read Before Use

to the instructions given in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

glasses, necklace, etc.) from the patient. Performing high-frequency cauterization treatment while the patient is wearing metallic objects may cause burns on the patient in areas around the metallic objects.

• Move the elevator control lever slowly in the opposite direction of the “ U” direction until it stops and visually confirm that the portion of the elevator wire extending from the distal end of the insertion section is not broken or bent. If the elevator wire is broken or bent, patient injury, bleeding, and/or perforation could result.

• Do not strike, hit, or drop the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector. Also, do not bend, pull, or twist the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient.

• Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or rotate the angulated bending section. Patient injury, bleeding, and/or perforation may result. It may also become impossible to straighten the bending section during an examination.

• Never insert or withdraw the endoscope’s insertion section while the bending section is locked in position. Patient injury, bleeding, and/or perforation may result.

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Important Information — Please Read Before Use

• Never operate the bending section, feed air, perform suction,

• Never insert or withdraw the insertion section abruptly or with

• Do not touch the light guide of the endoscope connector

• That before each use or after a change of viewing

insert or withdraw the endoscope’s insertion section, or use EndoTherapy accessories without viewing the endoscopic image. Patient injury, bleeding, and/or perforation may result.

insert or withdraw the endoscope’s insertion section, or use EndoTherapy accessories while the image is frozen. Patient injury, bleeding, and/or perforation may result.

excessive force. Patient injury, bleeding, and/or perforation may result.

immediately after removing it from the light source because it is extremely hot. Operator or patient burns can result.

modes/settings, check to ensure the view observed through the endoscope provides a live image (rather than a stored one) and has the correct image orientation. Patient injury, bleeding, and/or perforation could result.

• When the endoscopic image does not appear on the monitor, the CCD may have been damaged. Turn the video system center OFF immediately. Continued power supply in such a case will cause the distal end to become hot and could cause operator and/or patient burns.

• Turn ON the diagnostic ultrasound system only when the ultrasonic cable is connected to both the diagnostic ultrasound system and the ultrasonic cable connector on the endoscope. In particular, confirm that the diagnostic ultrasound system is OFF before connecting or disconnecting the ultrasonic cable from the ultrasonic cable connector on the endoscope. Operator injury may result and/or equipment damage may result.

• Do not rely on the NBI observation mode alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.

• Never withdraw the endoscope while the balloon is still inflated. Otherwise, the balloon may burst or detach from the distal end of the endoscope. If the balloon cannot be deflated, insert the channel cleaning brush (BW-7L) into the balloon channel. Using slow, short strokes, carefully feed the brush to remove debris.

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Important Information — Please Read Before Use

• When withdrawing the endoscope, make sure that the

balloon is completely deflated, using the ultrasound image and endoscopic field of view. Withdrawing the endoscope while the balloon is inflated could result in patient injury.

• If it is difficult to insert the endoscope, do not forcibly insert

the endoscope; stop the endoscopy. Forcible insertion can result in patient injury, bleeding, and/or perforation.

• If any irregularity in the ultrasound image is observed, turn

the ultrasound center OFF immediately. Continued ultrasound radiation will cause the distal end to become hot and could cause operator and/or patient burns.

• Elastography

uses the pulsation of a living body. Intentional pressurization is not necessary. Compression onto the tissue by operating the bending section, inserting or withdrawing the endoscope may cause tissue damage, bleeding or perforation.

1 Elastography is not available with the diagnostic

ultrasound system (Hitachi Aloka Medical, Ltd.) in Canada.

• After using the endoscope reprocess it according to the instructions given in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”. Using improperly or incompletely reprocessed, the endoscope’s distal end damage may result.

• Do not pull the universal cord during an examination. The endoscope connector will be pulled out from the output socket of the light source and the endoscopic image will not be visible.

• Do not coil the insertion tube or universal cord with a diameter of less than 12 cm. Equipment damage can result.

• Do not attempt to bend the endoscope’s insertion section with excessive force. Otherwise, the insertion section may be damaged.

• Do not touch the electrical contacts inside the videoscope cable connector. CCD damage may result.

• Do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end. Visual abnormalities may result.

• Do not hold the ultrasonic transducer when holding the insertion tube. The ultrasonic transducer damage can result and/or the ultrasonic image will be abnormal.

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Important Information — Please Read Before Use

• Do not twist or bend the bending section with your hands.

• Do not squeeze the bending section forcefully. The covering

• Turn the video system center ON only when the videoscope

• The endoscope’s remote switches cannot be removed from

Equipment damage may result.

of the bending section may stretch or break and cause water leaks.

cable is connected to both the video system center and the videoscope cable connector on the endoscope. In particular, confirm that the video system center is OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Failure to do so can result in equipment damage, including destruction of the CCD.

the control section. Pressing, pulling, or twisting them with excessive force can break the switches and/or cause water leaks.

• If remote switch 1 does not return to the OFF position after being pressed strongly from the side, gently pull the switch upwards to return it to the OFF position.

• Do not hit or bend the electrical contacts on the endoscope connector. The connection to the light source may be impaired and faulty contact can result.

• Do not touch the electrical contacts in the ultrasonic cable connector. Equipment damage can result.

• Do not pull, twist or tightly coil the ultrasonic cable. Noise can develop in the ultrasound image.

• Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (radio frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

• To check the electromagnetic interference from other equipment (any equipment other than this instrument or the components that constitute this system), the system should be observed to verify its normal operation in the configuration in which it will be used.

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Important Information — Please Read Before Use

• To prevent unnecessary patient exposure to ultrasound

radiation, follow the ‘as-low-as-reasonably achievable’ (ALARA) principle when using ultrasound equipment. Freeze the image whenever you are not actively viewing the “live” ultrasound image. When the equipment is in the FREEZE mode, no ultrasound energy is emitted.

• It is highly recommended that a backup ultrasonic cable be

available to continue clinical procedures in case of a malfunction.

• This endoscope contains a memory chip that stores

information about the endoscope and communicates this information to the video system center CV-160 and CV-180.

Examples of inappropriate handling

Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility. Examples of inappropriate handling are described below.

• Over-insufflating the lumen may cause patient pain, injury, bleeding, and/or perforation.

• Applying suction with the distal end in prolonged contact with the mucosal surface, with higher suction pressure than required, or with prolonged suction time may cause bleeding and/or lesions.

• The endoscope has not been designed for use in retroflexed observation in parts of the body other than the stomach. Performing retroflexed observation in a narrow lumen may make it impossible to straighten the angle of the bending section and/or withdraw the endoscope from the patient. Retroflexed observation in parts of the body other than the stomach should be performed only when the usefulness of doing so is determined to be greater than the risk that is posed to the patient.

• Inserting, withdrawing, and using EndoTherapy accessories without a clear endoscopic image may cause patient injury, burns, bleeding, and/or perforation.

• Inserting or withdrawing the endoscope, feeding air, applying suction, or operating the bending section without a clear endoscopic image may cause patient injury, bleeding, and/or perforation.

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Important Information — Please Read Before Use

• For reasons described below, do not rely on the NBI alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.

 NBI has not been demonstrated to increase the yield or

sensitivity of finding any specific mucosal lesion including colonic polyps or Barrett’s esophagus.

 NBI has not been demonstrated to aid in differentiating

establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions.

1 NBI stands for Narrow Band Imaging. For more details,

refer to the instruction manual for the video system center CV-180.

Natural rubber latex medical alert

Balloons used with this instrument contain natural rubber latex that may cause allergic reactions. Do not use the balloon on a latex-sensitive patient. Instead, perform the procedure using “The sterile deaerated water immersion method” described in Section 4.2, “Observation of the ultrasound image” on page 64, in Chapter 4, “Operation”.

1

observation mode

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Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package

Contents

1.1 Standard components

Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing, or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”.

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Chapter 1 Checking the Package Contents

Ultrasound endoscope

Balloon 3 for the USA (MAJ-249 sterile, 20 pcs.) Balloon for countries other than the USA (MAJ-213, nonsterile, 20 pcs.)

Mouthpiece (MB-142, 2 pcs.)

Single use channel cleaning brush for the USA (BW-201T, 3 pcs.



) Channel cleaning brush for countries other than the USA (BW-20T, 1 pcs.)

Channel cleaning brush (BW-7L, 2 pcs.



) Single use single-ended cleaning brush (BW-400L, 3 pcs.



)

Water-resistant cap (MH-553, 2 pcs.)

Washing tube (MH-974)

Chain for water-resistant cap (MAJ-1739)

Air/water channel cleaning adapter (MAJ-629)

Instruction manual

Suction cleaning adapter (MH-856)

Single use channel-opening cleaning brush for the USA (MAJ-1339, 3 pcs.



) Channel-opening cleaning brush for countries other than the USA (MH-507, 1 pcs.)

Balloon applicator (MAJ-675)

Biopsy valve (MAJ-853, nonsterile, 10 pcs.)

Cleaning adapter for instrument channel port (MAJ-350)

Injection tube (MH-946)

Channel plug (MAJ-621)

Cleaning brush (MAJ-1534)

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

Single use combination cleaning brush (BW-412T, 3 pcs.



)

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1.2 Ultrasonic cable

Ultrasonic cable (MAJ-1597)

Endoscope-side connector

Ultrasound connector

The ultrasonic cable (MAJ-1597) is necessary to use this endoscope (GF-UCT180), but it must be purchased separately (optional) from Olympus.

 For Olympus universal endoscopic ultrasound center

EU-ME1 and the diagnostic ultrasound system (ALOKA CO., LTD)

Chapter 1 Checking the Package Contents

1.3 Optional components

The item listed below is optional for countries other than the USA, and may be purchased from Olympus.

Balloon 3

Balloon 3 is shipped sterile in sets of 20 pieces, enclosed in a resealable package. The correct model to be used with this endoscope is listed in Table 1.1 below.

Endoscope Balloon 3

GF-UCT180 MAJ-249

Table 1.1

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Chapter 2 Instrument Nomenclature and Specifications

Universal cord

Product number and serial number

Electrical contact points

4. Endoscope connector

Light guide

1. Ultrasonic cable connector

6. Videoscope cable connector

Water-resistant cap (MH-553)

2. Suction connector

3. S-cord connector mount

5. Air supply connector

5. Water supply connector

Chapter 2 Instrument Nomenclature

and Specifications

2.1 Nomenclature

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Control section

Top view

Suction cylinder

11. Air/water valve (MAJ-1444)

9. UP/DOWN angulation lock

7. Elevator control lever

8. UP/DOWN angulation control knob

18. Color code

17. Elevator channel plug

20. RIGHT/LEFT angulation control knob

19. RIGHT/LEFT angulation lock

Grip section

Boot

Insertion section

Insertion tube

Distal end

14. Bending section

Instrument channel port

12. Instrument channel

Air/water cylinder

Biopsy valve (MAJ-853)

Insertion section limit mark

16. Remote switches 1 to 4

10. Suction valve (MAJ-1443)

Air/water nozzle

Detail of distal end

Objective lens

Forceps elevator

Instrument channel outlet

Light guide lens

Balloon attachment groove

Balloon water supply port is in this groove

Ultrasound transducer

Balloon water suction port is in this groove

Chapter 2 Instrument Nomenclature and Specifications

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Chapter 2 Instrument Nomenclature and Specifications

2.2 Endoscope functions

1. Ultrasonic cable connector

Connects the ultrasonic cable of the ultrasound diagnostic equipment to the endoscope.

2. Suction connector

Connects the endoscope to the suction tube of the suction pump.

3. S-cord connector mount

Connects the endoscope with the Olympus electrosurgical unit via the S-cord. The S-cord conducts leakage current from the endoscope to the electrosurgical unit. To connect the S-cord, refer to the instruction manual for the electrosurgical unit. Connect the fitting part of the chain for water-resistant cap to this mount, as required (see Section 2.4, “Attaching the chain for water-resistant cap (MAJ-1739)” on page 25).

4. Endoscope connector

Connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope.

5. Water supply connector and air supply connector

Connects the endoscope to the water container via the water container tube to supply water to the distal end of the endoscope.

6. Videoscope cable connector

Connects the endoscope to the video system center via the videoscope cable. The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-160, CV-180. For more details, refer to the instruction manual for the CV-160, CV-180.

7. Elevator control lever

When this lever is moved in the “ U” direction, the forceps elevator is raised; when the lever is moved in the opposite direction, the forceps elevator is lowered.

8. UP/DOWN angulation control knob

When this knob is turned in the “ U” direction, the bending section moves UP; when the knob is turned in the “D ” direction, the bending section moves DOWN.

9. UP/DOWN angulation lock

Moving this lock in the “F ” direction frees angulation. Moving the lock in the opposite direction locks the bending section at any desired position.

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Chapter 2 Instrument Nomenclature and Specifications

10. Suction valve (MAJ-1443)

The suction valve is depressed to the first stage to activate suction. The valve is also used to remove any fluid or debris adhering to the objective lens. The suction valve is depressed completely to activate suction of sterile water from the balloon through the balloon channel.

11. Air/water valve (MAJ-1444)

The hole in the air/water valve is covered to insufflate air and the valve is depressed to the first stage to feed water for lens washing. It also can be used to feed air to remove any fluid or debris adhering to the objective lens. The valve is depressed completely to fill the balloon with sterile water through the balloon channel.

12. Instrument channel

The instrument channel functions as:

 channel for the insertion of EndoTherapy accessories

 suction channel

 Fluid feed channel (from a syringe via the biopsy valve)

13. Insertion section limit mark

This mark shows the maximum point to which the endoscope may be inserted into the patient’s body.

14. Bending section

This section moves the distal end of the endoscope when the UP/DOWN and RIGHT/LEFT angulation control knobs are operated.

15. Forceps elevator

The elevator moves EndoTherapy accessories when the elevator control lever is operated.

16. Remote switches 1 to 4

The functions of remote switches 1 to 4 can be selected on the video system center. Refer to the instruction manual for the video system center when setting these functions.

17. Elevator channel plug

This plug is used for connection of the washing tube to clean and disinfect the elevator channel.

18. Color code (orange)

This code is used to quickly determine the compatibility of EndoTherapy accessories. The endoscope can be used with EndoTherapy accessories that have the same color code. For more information on combining the endoscope with particular EndoTherapy accessories, refer to the “System chart” in the Appendix and the instruction manuals for the compatible accessories.

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Chapter 2 Instrument Nomenclature and Specifications

19. RIGHT/LEFT angulation lock

Turning this lock in the “F ” direction frees angulation. Turning the lock in the opposite direction locks the bending section at any desired position.

20. RIGHT/LEFT angulation control knob

When this knob is turned in the “R ” direction, the bending section moves RIGHT; when the knob is turned in the “ L” direction, the bending section moves LEFT.

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2.3 Specifications

Environment

Chapter 2 Instrument Nomenclature and Specifications

Operating

environment

Transportation

and storage

environment

Ambient temperature 10 – 40C (50 – 104F)

Relative humidity 30 – 85%

Atmospheric

pressure

Ambient temperature –47 to 70C (–52.6 to 158F)

Relative humidity 10 – 95%

Atmospheric

pressure

700 – 1060 hPa

(0.7 – 1.1 kgf/cm

(10.2 – 15.4 psia)

700 – 1060 hPa

(0.7 – 1.1 kgf/cm

(10.2 – 15.4 psia)

)

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 2 Instrument Nomenclature and Specifications

Specifications

 Endoscope functions

Model GF-UCT180

Optical system Field of view

100

Direction of view

Depth of field 3 – 100 mm

Insertion tube Distal end outer

diameter

Distal end enlarged 1. Air/water nozzle

 forward oblique

ø 14.6 mm

2. Objective lens

3. Light guide lens

4. Forceps elevator

5. Instrument channel outlet

6. Ultrasonic transducer

7. Balloon water supply port

8. Balloon suction port

9. Balloon attachment groove

Insertion tube outer

diameter

Working length 1250 mm

Instrument

channel

Airflow rate

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Channel inner

diameter

Minimum visible

distance

Direction from which

EndoTherapy

accessories enter

and exit the

endoscopic image

6 mm from the objective lens

Note: Standard when CLV-180 (high air

pressure) is used.

ø 12.6 mm

ø3.7mm

20 cm

Page 29

Chapter 2 Instrument Nomenclature and Specifications

Bending

section

Total l e ngth 1555 mm

NBI observation mode

Angulation range

1

UP 130

, DOWN 90,

RIGHT 90

Available

, LEFT 90

1 For more details, refer to the instruction manual for the CV-180.

 Ultrasound function with ALOKA diagnostic ultrasound

system SSD-10/ProSound 71/ProSound F75

Operation mode B-mode, M-mode, D-mode, Bflow mode, Powerflow mode

Scanning method Electronic curved linear array

Scanning direction Parallel to the insertion direction

Receiving frequency

Scanning range 180

Contacting method Balloon method, Direct contact method

Transducer surface

max. temperature

5, 6, 7.5, 10 MHz (SSD-10/ProSound F75

4, 6.67, 10, 13.3 MHz (ProSound 7)

43C >

1

)

1

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

 Ultrasound function with Olympus universal endoscopic

ultrasound center EU-ME1

Operation mode B mode, color flow mode, power flow mode

Scanning method Electronic curved linear array

Scanning direction Parallel to the insertion direction

Receiving frequency 5, 6, 7.5, 10, 12 MHz

Scanning range 180

Contacting method Balloon method, Direct contact method

Transducer surface

max. temperature

43C >

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 2 Instrument Nomenclature and Specifications

1912345

General safety

standard for medical

electrical equipment

Medical Devices

Directive

EMC Applied standards;

Year of manufacture

IEC 60601-1: 2005 Whole of this instrument is possible

IEC 60601-1-2: 2007

IEC 60601-2-37: 2007

to contact live bodies of operators or

patients.

This device complies with the

requirements of Directive 93/42/EEC

concerning medical devices.

Classification: Class II a

This instrument complies with the

standards listed in the left column.

CISPR 11 of emission:

Group 1, Class B

This instrument complies with the

EMC standard for medical electrical

equipment, edition 3 (IEC 60601-1-2:

2007). However, when connecting to

an instrument that complies with the

EMC standard for medical electrical

equipment, edition 1 (IEC 60601-1-2:

1993), the whole system complies

with edition 1.

The last digit of the year of

manufacture is given in the second

digit of the serial number.

Degree of protection

against electric

shock

Ingress protection

rating

IPX7 This instrument complies with the

TYPE BF applied part

standards for medical electrical

equipment: IEC 60601-1: 2005

IEC 60601-2-37: 2007.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 2 Instrument Nomenclature and Specifications

2.4 Attaching the chain for water-resistant cap (MAJ-1739)

• Do not lift the endoscope by the chain for water-resistant cap. Doing so may result in the fitting part of the chain detaching from the S-cord connector mount, causing the endoscope to fall. This could cause operator or patient injury and/or equipment damage.

• Connect the fitting part only to the S-cord connector mount. Connecting the fitting part to the suction connector may impair the connection of the suction tube to the suction connector. It may also cause the suction tube to become disconnected from the endoscope and allow patient debris to spray.

• The chain for water-resistant cap and water-resistant cap itself cannot be ultrasonically cleaned; doing so could damage them. The water-resistant cap with the chain can only be ultrasonically cleaned if connected to endoscopes that are being cleaned in an endoscope reprocessor (such as

1

OER

• Connecting the fitting part to the suction connector may impair the connection of the suction tube to the suction connector. It may also cause the suction tube to become disconnected from the endoscope and allow patient debris to spray.

• When attaching the water-resistant cap to the connector of the endoscope, do not pinch the chain for water-resistant cap between the connector of the endoscope and the water-resistant cap. Otherwise, equipment damage may result.

• The chain for water-resistant cap and water-resistant cap cannot be steam sterilized (autoclaved); doing so can damage them severely.

, OER-A1) with an ultrasonic cleaning phase.

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

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Chapter 2 Instrument Nomenclature and Specifications

Notch

Chain part

Fitting part

Connecting plate

Hole

Connecting plate

Notch

Venting connector

Water-resistant cap

Figure 2.1

To ensure that you do not forget to attach the water-resistant cap, it is recommended that you connect the chain for water-resistant cap to the endoscope’s S-cord connector mount.

1. Confirm that the chain for water-resistant cap is free from cracks, flaws,

wear, deformation, or other damages (see Figure 2.1).

2. Align the notch on the connecting plate with the pin on the venting connector

of the water-resistant cap (MH-553, see Figure 2.2).

3. Place the connecting plate over the venting connector (see Figure 2.2).

4. Confirm that the connecting plate is securely attached to the foot of the

venting connector and can be smoothly rotated.

5. Place the hole on the fitting part over the endoscope’s S-cord connector

mount.

Figure 2.2

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Chapter 2 Instrument Nomenclature and Specifications

The instructions on the remaining pages of this manual are given under the assumption that the chain for water-resistant cap is detached from the endoscope.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Page 34

Chapter 3 Preparation and Inspection

Before each procedure, prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as described in their respective instruction manuals. If this instrument malfunctions, do not use it. Return it to Olympus for repair as described in Section 10.3, “Returning the endoscope for repair” on page 161. If any irregularities are suspected after inspection, follow the instructions given in Chapter 10, “Troubleshooting”.

• This instrument was not cleaned, disinfected, or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”.

• Using an instrument that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.

Do not pull the universal cord or the ultrasonic cable with excessive force when the endoscope is connected to the other equipment. Doing so could cause equipment damage.

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3.1 Preparation of the equipment

mouthpiece

Monitor

Video system center

Light source

Water container

Suction pump

Ultrasound endoscope

Olympus universal endoscopic ultrasound center EU-ME1 or ALOKA diagnostic ultrasound system

Ultrasonic cable

EndoTherapy accessories

Prepare the equipment shown in Figure 3.1 (for compatibility, see the “System chart” in the Appendix) and personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. Refer to the respective instruction manuals for each piece of equipment.

Chapter 3 Preparation and Inspection

• Paper towels • Trays • Lint-free cloths • Personal protective equipment

• 3-way stopcock • Syringe • Extension tube • Sterile deaerated water

• Medical-grade, water-soluble lubricant

Figure 3.1

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Chapter 3 Preparation and Inspection

3.2 Inspection of the endoscope

Clean and disinfect or sterilize the endoscope as described in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures” and Chapter 8, “Cleaning and Disinfection Equipment” of this manual. Then remove the water-resistant cap from the endoscope connector.

Inspection of the endoscope

Inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts, or other irregularities.

2. Inspect the boot and the insertion section near the boot for bends, twists, or

other irregularities.

3. Inspect the external surface of the entire insertion section including the

bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.

4. Gently holding the insertion section with one hand, carefully run your other

hand back and forth over the entire length of the insertion section (see Figure 3.2). Confirm that no objects or metallic wire protrude from the insertion section. Also, confirm that the insertion tube is not abnormally rigid.

Figure 3.2

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 3 Preparation and Inspection

5. Using both hands, bend the insertion tube of the endoscope into a

semicircle. Then, moving your hands as shown by the arrows in Figure 3.3, confirm that the entire insertion tube can be smoothly bent to form a semicircle and that the insertion tube is pliable.

Figure 3.3

6. Gently hold the midpoint of the bending section and a point 20 cm from the

distal end. Push and pull gently to confirm that the junction between the bending section and the insertion tube is not loose.

7. Inspect the objective lens and light guide lens at the distal end of the

endoscope’s insertion section for scratches, cracks, stains, or other irregularities.

8. Inspect the air/water nozzle at the distal end of the endoscope’s insertion

section for abnormal swelling, bulges, dents, or other irregularities.

9. Inspect the ultrasound transducer surface at the distal end of the

endoscope’s insertion tube for scratching, cracks, bulges, dents or other irregularities.

Inspection of the bending mechanisms

Perform the following inspections while the bending section is straight.

If the movement of the UP/DOWN angulation lock, RIGHT/LEFT angulation lock, and the angulation control knobs are loose and/or not smooth, or the bending section does not angulate smoothly, the bending mechanism may be abnormal. In this case, do not use the endoscope because it may be impossible to straighten the bending section during an examination.

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Chapter 3 Preparation and Inspection

 Inspection for smooth operation

1. Confirm that both the UP/DOWN and RIGHT/LEFT angulation locks move

all the way in the “F ” direction.

2. Turn the UP/DOWN and RIGHT/LEFT angulation control knobs slowly in

each direction until they stop, and return them to their respective neutral positions. Confirm that the bending section angulates smoothly and correctly, that maximum angulation can be achieved, and that the bending section returns to its neutral position.

3. When the UP/DOWN and RIGHT/LEFT angulation control knobs are turned

to their respective neutral positions as shown in Figure 3.4, confirm that the bending section returns smoothly to an approximately straight condition.

Figure 3.4

 Inspection of the UP/DOWN angulation mechanism

1. Move the UP/DOWN angulation lock all the way in the opposite direction of

the “F ” mark. Then turn the UP/DOWN angulation control knob in the “ U” or the “D ” direction until it stops.

2. Confirm that the angle of the bending section is roughly stabilized when the

UP/DOWN angulation control knob is released.

3. Confirm that the bending section straightens out when the UP/DOWN

angulation lock is moved all the way in the “F ” direction and the UP/DOWN angulation control knob is released.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 3 Preparation and Inspection

 Inspection of the RIGHT/LEFT angulation mechanism

1. Turn the RIGHT/LEFT angulation lock all the way in the opposite direction of

the “F ” mark. Then turn the RIGHT/LEFT angulation control knob in the “R ” or the “ L” direction until it stops.

2. Confirm that the angle of the bending section is roughly stabilized when the

RIGHT/LEFT angulation control knob is released.

3. Confirm that the bending section straightens out when the RIGHT/LEFT

angulation lock is turned in the “F ” direction and the RIGHT/LEFT angulation control knob is released.

Inspection of the forceps elevator mechanism

Perform the following inspections while the bending section is straight.

Move the elevator control lever slowly in the opposite direction of the “ U” direction until it stops and visually confirm that the portion of the elevator wire extending from the distal end of the insertion section is not broken or bent. If the elevator wire is broken or bent, patient injury, bleeding, and/or perforation could result.

 Inspection for smooth operation

1. Move the elevator control lever slowly all the way in the opposite direction of

the “ U” direction. Visually confirm that the portion of the elevator wire extending from the distal end of the insertion section is not broken or bent (see Figure 3.5).

2. While observing the forceps elevator at the distal end of the insertion

section, slowly move the elevator control lever all the way in the “ U” direction. Confirm that the lever can be operated smoothly and that the forceps elevator is raised smoothly. Also confirm that the forceps elevator remains stationary when pushed from behind while holding the elevator control lever stationary (see Figure 3.5).

3. Move the elevator control lever slowly all the way in the opposite direction of

the “ U” direction. Confirm that the lever can be operated smoothly and that the forceps elevator is lowered smoothly (see Figure 3.5).

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Page 40

Chapter 3 Preparation and Inspection

Forceps elevator

Elevator control lever

Figure 3.5

3.3 Preparation and inspection of accessories

Clean and disinfect or sterilize the air/water valve, suction valve, biopsy valve as described in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”.

Inspection of the air/water and suction valves

Confirm that the top hole of the air/water valve is not blocked (see Figure 3.6). If the hole is blocked, air is fed continuously and patient pain, bleeding, and/or perforation can result.

1. Confirm that the holes of the valves are not blocked (see Figures 3.6 and

3.7).

2. Confirm that the valves are not deformed or cracked (see Figures 3.6 and

3.7).

3. Check for excessive scratching or tears in the air/water valve’s seals (see

Figure 3.6).

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Page 41

Figure 3.6

Air/water valve (MAJ-1444)

Skirt

Seal

Packings

Spring

Cap

Top view

Hole

Suction valve (MAJ-1443)

Skirt

Packing

Hole

Spring

Cap

Chapter 3 Preparation and Inspection

Figure 3.7

The air/water and suction valves are consumables. If the inspection of the air/water or suction valve reveals any irregularity, use new valves.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 3 Preparation and Inspection

Normal Abnormal

Slit

Hole

Main body

Cap

Splits, cracks

Discoloration

Slit

Main body

Cap

Inspection of the biopsy valve

1. Confirm that the slit and hole on the biopsy valve have no splits, cracks,

deformations, discoloration, or other damage (see Figure 3.8).

The biopsy valve is a consumable that should be inspected as follows before each use. Replace it with a new one if any irregularity is observed during the inspection. An irregular, abnormal, or damaged valve can reduce the efficacy of the endoscope’s suction system, and may leak or spray patient debris or fluids, posing an infection control risk.

Figure 3.8

2. Attach the cap to the main body (see Figure 3.9).

Figure 3.9

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Page 43

Inspection of the mouthpiece

Opening

Outer flange

Main body

Do not use a mouthpiece that is damaged, deformed, or reveals other irregularities. Doing so may cause patient injury and/or equipment damage.

Placing the mouthpiece in the patient’s mouth before the procedure prevents the patient from biting and/or damaging the endoscope’s insertion section.

1. Confirm that the mouthpiece is free from cracks, deformations, or

discoloration (see Figure 3.10).

2. Using your fingers, check all surfaces of the mouthpiece for scratches,

cracks, or other irregularities (see Figure 3.10).

Chapter 3 Preparation and Inspection

Figure 3.10

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Page 44

Chapter 3 Preparation and Inspection

Suction valve

Suction cylinder

Skirt

Moving surface

3.4 Attaching accessories to the endoscope

The air/water valve and the suction valve do not require lubrication. Lubricants can cause swelling of the valves’ seals, which will impair valve function.

Attaching the suction valve

Attach the suction valve (MAJ-1443) to the suction cylinder of the endoscope (see Figure 3.11). Confirm that valve is fitted properly without any bulging of the skirt.

Figure 3.11

The suction valve will make a whistling noise when it is dry; this does not indicate a malfunction.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Page 45

Attaching the air/water valve

Skirt

Air/water cylinder

Air/water valve

Biopsy valve

Instrument channel port

Attach the air/water valve (MAJ-1444) to the air/water cylinder of the endoscope (see Figure 3.12). Confirm that valve is fitted properly without any bulging of the skirt.

Chapter 3 Preparation and Inspection

Figure 3.12

The air/water valve may stick at first, but it should operate smoothly after it is depressed a few times.

Attaching the biopsy valve

If a biopsy valve is not properly connected to the instrument channel port, it can reduce the efficacy of the endoscope’s suction system, and leak or spray patient debris, posing an infection control risk.

Attach the biopsy valve to the instrument channel port of the endoscope (see Figure 3.13). Confirm that the biopsy valve fits properly.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Figure 3.13

Page 46

Chapter 3 Preparation and Inspection

3.5 Inspection and connection of ancillary equipment

Inspection of ancillary equipment

• Attach the water container to the specified receptacle on the trolley (cart) or the light source. If the water container is attached anywhere else, water may drip from the water container’s water supply tube, and equipment malfunction can result.

• Take care not to spill water from the water container’s connection adapter when detaching the connection adapter from the endoscope. Spilled water could splash on the equipment, and may cause equipment malfunction.

1. Prepare and inspect the light source, video system center, ultrasound

diagnostic equipment, monitor, water container, suction pump, and EndoTherapy accessories as described in their respective instruction manuals.

2. Confirm that there are no scratches, cracks, excessive wear, or deformation

of the ultrasonic cable.

Connection of the ultrasonic cable (MAJ-1597) and Olympus universal endoscopic ultrasound center

Insert the ultrasonic connector properly into the transducer port of the Olympus universal endoscopic ultrasound center. Rotate the connector’s lock handle 1/4 turn clockwise (see Figure 3.14).

Figure 3.14

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 3 Preparation and Inspection

Connection of the ultrasonic cable (MAJ-1597) and ALOKA diagnostic ultrasound system

Insert the ultrasound connector properly into the transducer port of the diagnostic ultrasound system. Rotate the connector’s lock handle 1/4 turn clockwise (see Figure 3.15).

Connect the Ultrasound connector to one of the probe connectors on the lower side (PROBE 3 or 4) of the ProSound F75 (see Figure 3.15). If the Ultrasound connector is connected to one of the probe connectors on the upper side (PROBE 1 or 2) , the operation panel of the ProSound F75 may hit the Ultrasound connector, which may result in the equipment damage. When adjusting the height, a horizontal and / or vertical position of the operation panel of the ProSound F75 with the Ultrasound connector connected to the PROBE 1 or 2, move slowly the operation panel with visually confirming the position of the bottom of the operation panel.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Page 48

Lock handle

Ultrasound connector

Transducer port

SSD-10

ProSound 7

1

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

Lock handle

Ultrasonic connector

ProSound F75

1

PROBE 1

PROBE 2

PROBE 4

Lock handle

Ultrasound connector

PROBE 3

Chapter 3 Preparation and Inspection

Figure 3.15

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 3 Preparation and Inspection

Connection of the endoscope and ancillary equipment

Firmly connect the suction tube from the suction pump to the suction connector on the endoscope connector. If the suction tube is not attached properly, debris may drip from the tube and can pose an infection control risk, cause equipment damage, and/or reduce suction capability.

The electrical contacts inside the ultrasound connector may be damaged by handling. Do not touch the electrical contacts. If electrical contacts are dirty, wipe the contacts with a soft and lint-free cloth.

1. If any ancillary equipment is ON, turn it OFF.

2. Insert the endoscope connector completely into the output socket of the light

source.

3. Make sure that the inside of the videoscope cable connector is dry and free

of debris.

4. Place the water container’s water supply channel onto the water supply

connector on the endoscope connector at an angle of 90 and push it in until it stops (see Figure 3.16 (1)).

5. Turn the water container’s connection adapter 90 clockwise to align the air

supply channel with the air supply connector of the endoscope connector (see Figure 3.16 (2)).

6. Push the water container’s connection adapter again until it stops (see

Figure 3.16 (3)).

7. Confirm that the water container’s connection adapter fits properly and that

it cannot be rotated (see Figure 3.16 (4)).

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 3 Preparation and Inspection

(1) (2) (3) (4)

Water supply connector

Air supply connector

Water container’s connection adapter

Endoscope connector

Air supply channel

Water supply channel

Metal tip

Mark (gray)

Mark 1 (gray)

Mark 2 (gray)

Figure 3.16

8. Align the mark on the videoscope cable with mark 1 on the endoscope

connector and push it in until it stops (see Figure 3.17).

Figure 3.17

9. Turn the connector of the videoscope cable towards mark 2 until it stops

(see Figure 3.17).

10. Confirm that the mark on the videoscope cable is aligned with mark 2 on the

endoscope connector.

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Chapter 3 Preparation and Inspection

Suction pump

Suction connector

Suction tube

11. Connect the suction tube from the suction pump to the suction connector on

the endoscope connector (see Figure 3.18).

Figure 3.18

Connection of the endoscope and ultrasonic cable

The electrical contacts inside the ultrasound connector have sharp tips and may be damaged by handling. Do not touch the electrical contacts.

For more information on combining the endoscope with the ultrasonic cable, refer to the “System chart” in the Appendix. When connect the endoscope-side connector of the ultrasonic cable to the ultrasonic cable connector, do not entwine the universal cord with the ultrasonic cable. Equipment damage can result.

1. Make sure that the inside of the ultrasonic cable connector is dry and free of

debris.

2. Align the mark on the ultrasonic cable with mark A on the ultrasound

connector and push it until it stops (see Figure 3.19).

3. Turn the endoscope-side connector of the ultrasonic cable clockwise until it

stops (see Figure 3.19).

4. Confirm that the mark on the ultrasonic cable is aligned with mark B on the

endoscope connector (see Figure 3.19).

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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Chapter 3 Preparation and Inspection

Mark A (red)

Mark B (red)

Mark (red)

Mark A (red)

Mark B (red)

Mark (red)

Endoscope-side connector of the ultrasonic cable

Figure 3.19

3.6 Inspection of the endoscopic system

Inspection of the endoscopic image

Do not stare directly into the distal end of the endoscope while the examination light is ON. Otherwise, eye injury may result.

1. Turn the video system center, light source, and monitor ON and inspect the

WLI and NBI endoscopic image as described in their respective instruction manuals.

2. Confirm that light is output from the endoscope’s distal end.

3. While observing the palm of your hand, confirm that the WLI and NBI

endoscopic image is free from noise, blur, fog, or other irregularities.

4. Angulate the endoscope and confirm that the WLI and NBI endoscopic

image does not momentarily disappear or display any other irregularities.

If the object cannot be seen clearly, wipe the objective lens using a clean, lint-free cloth moistened with 70% ethyl or isopropyl alcohol.

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Inspection of the remote switches

All remote switches should be checked prior to the examination, even when they are not expected to be used. The endoscopic image may freeze, or other irregularities may occur during examination and may cause patient injury, bleeding, and/or perforation.

Depress every remote switch and confirm that the specified functions work normally.

Inspection of the air-feeding function

Set the airflow regulator on the light source to “High”, as described in the light source’s instruction manual.

2. Immerse the distal end of the insertion section in sterile water to a depth of

10 cm and confirm that no air bubbles are emitted when the air/water valve is not operated.

Chapter 3 Preparation and Inspection

3. Cover the hole in the air/water valve with your finger and confirm that air

bubbles are continuously emitted from the air/water nozzle.

4. Uncover the hole in the air/water valve and confirm that no air bubbles are

emitted from the air/water nozzle.

If a stream of air bubbles is emitted from the air/water nozzle even though the air/water valve is not being operated and the distal end of the insertion section is 10 cm or more below the surface of the sterile water, there may be an irregularity in the air-feeding function. If the endoscope is used while air is continuously fed, over-insufflation and patient injury may result. If air bubbles are emitted from the air/water nozzle, remove and reattach the air/water valve correctly, or replace it with a new one. If this fails to stop air bubbles from being emitted, do not use the endoscope because there may be a malfunction. Contact Olympus.

When the distal end of the insertion section is immersed less than 10 cm below the surface of the sterile water, a small amount of air bubbles may be emitted from the air/water nozzle even when the air/water valve is not operated. This does not indicate a malfunction.

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Chapter 3 Preparation and Inspection

Inspection of the objective lens cleaning function

1. Keep the air/water valve’s hole covered with your finger and depress the

valve to the first stage. Observe the endoscopic image and confirm that water flows on the entire objective lens.

Use sterile water only. Nonsterile water may cause patient cross-contamination and/or infection.

• When the air/water valve is depressed for the first time, it may take a few seconds before water is emitted.

• If the air/water valve returns to its original position slowly after water feeding, remove the air/water valve and moisten the seals with sterile water.

• During the inspection, place the distal end of the endoscope in a beaker or other container so that the floor does not get wet.

2. Release the air/water valve. While observing the endoscopic image, confirm

that the emission of water stops and that the valve returns smoothly to its original position.

3. While observing the endoscopic image, feed air after feeding water by

covering the hole in the air/water valve with your finger. Confirm that the emitted air removes the remaining water from the objective lens and clears the endoscopic image.

Inspection of the water feeding function into the balloon

Cover the air/water valve’s hole and completely depress the valve. Confirm that water is emitted through the balloon water supply port. It may take a few seconds until water is emitted when the air/water valve is depressed for the first time.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Page 55

Inspection of the suction function

• If the suction valve does not operate smoothly, detach it and

reattach it, or replace it with a new one. If the endoscope is used while the suction valve is not working properly, it may be impossible to stop suction, which could cause patient injury. If the reattached or replaced suction valve fails to operate smoothly, the endoscope may be malfunctioning; stop using it and contact Olympus.

• If the biopsy valve leaks, replace it with a new one. A leaking

biopsy valve can reduce the efficacy of the endoscope’s suction system and may leak or spray patient debris or fluids, posing an infection control risk.

1. Place the container of sterile water and the endoscope at the same height.

For the inspection, adjust the suction pressure to the same level as it will be during the procedure.

Chapter 3 Preparation and Inspection

2. Immerse the distal end of the insertion section in sterile water with the

endoscope’s instrument channel port at the same height as the water level in the water container. Press the suction valve and confirm that water is continuously aspirated into the suction bottle of the suction pump.

3. Release the suction valve. Confirm that suction stops and the valve returns

to its original position.

4. Depress the suction valve to the first stage and aspirate water for one

second. Then, release the suction valve for one second. Repeat this several times and confirm that no water leaks from the biopsy valve.

5. Remove the distal end of the endoscope from the water. Depress the

suction valve and aspirate air for a few seconds to remove any water from the instrument and suction channels.

Inspection of aspiration from the balloon water suction port

Immerse the distal end of the insertion tube in sterile water and completely depress the suction valve. Confirm that water is continuously aspirated.

2. Release the suction valve. Confirm that suction stops and the suction valve

returns to its original position.

3. Remove the distal end from the water.

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Chapter 3 Preparation and Inspection

Inspection of the instrument channel and forceps elevator

1. Confirm that the forceps elevator is lowered, then insert the EndoTherapy

accessory through the biopsy valve. Confirm that the EndoTherapy accessory extends smoothly from the distal end, and that a foreign object does not come out.

2. Extend the EndoTherapy accessory approximately 3 cm from the distal end.

Move the elevator control lever in the “ U” direction and confirm that the forceps elevator is raised smoothly.

3. Move the elevator control lever in the opposite direction of the “ U”

direction and confirm that the forceps elevator is lowered.

Keep your eyes away from the distal end when inserting EndoTherapy accessories. Extending the EndoTherapy accessory from the distal end could cause eye injury.

4. Confirm that the EndoTherapy accessory can be withdrawn smoothly from

the biopsy valve.

Inspection of the ultrasound image with the Olympus universal endoscopic ultrasound center EU-ME1

Turn on Olympus universal endoscopic ultrasound center EU-ME1.

A progress bar is displayed after connecting the ultrasound endoscope (see Figure 3.20). During displaying the progress bar, the information on the connected ultrasonic endoscope has been updated to the ultrasound center. Do not turn OFF the ultrasound center while the progress bar is displayed.

Figure 3.20

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Chapter 3 Preparation and Inspection

Ultrasound image (B-mode)

2. Inspect the endoscopic ultrasound center as described in its instruction

manual.

3. When setting the frequency, choose the setting value CLA2, and then the

frequencies available with the keyboard (see Figure 3.21). Refer to EU-ME1’s instruction manual for instructions on how to set the frequency.

Figure 3.21

4. Press the “FREEZE” switch on the diagnostic ultrasound system to change

the ultrasound image to the REAL-TIME mode.

5. Confirm that the ultrasound image is visible on the endoscopic ultrasound

center (see Figure 3.22).

Figure 3.22

6. Press the “FREEZE” switch to change the ultrasound image to the FREEZE

mode.

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Chapter 3 Preparation and Inspection

Ultrasound image (B-mode)

Inspection of the ultrasound image with the ALOKA diagnostic ultrasound system

Inspect the diagnostic ultrasound system as described in its instruction manual.

2. Turn the diagnostic ultrasound system ON.

3. Confirm that the ultrasound image is visible on the diagnostic ultrasound

system (see Figure 3.23).

Figure 3.23

4. Press the “FREEZE” switch to change the ultrasound image to the FREEZE

mode.

3.7 Preparation and inspection of the balloon

• Balloons used with this instrument contain natural rubber latex that may cause allergic reactions in some individuals. Do not use the balloon on a latex-sensitive patient. Instead, perform the procedure using “The sterile deaerated water immersion method” described in Section 4.2, “Observation of the ultrasound image” on page 64.

• When using the sterile balloon (MAJ-249), do not use an instrument after the expiration date displayed on the sterile package. Doing so may pose an infection control risk.

• The balloons are disposable, and are intended for a single-use only. A new one must be used for each patient. Do not attempt to reuse the balloon. This could pose an infection-control risk or cause equipment damage.

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Chapter 3 Preparation and Inspection

• Confirm that the balloon applicator (MAJ-675) and cotton

thread that is used to tie the balloon have been properly reprocessed as described in Chapters 5, “Reprocessing: General Policy” through 7, “Cleaning, Disinfection, and Sterilization Procedures”.

• If you find that a sterile balloon’s peel pack is open,

damaged, or soiled, do not use that balloon.

• When using the sterile balloon (MAJ-249), inspect the sterile

package for tears, inadequate sealing, or water damage. If the sterile package shows any irregularity, the sterile condition of the instrument may have been compromised.

• The balloons and the balloon applicator to be used with this

endoscope are listed below. Balloon

1

is provided clean and should be ETO gas sterilized before use. Balloon 3 is shipped sterile.

Balloon (nonsterile) MAJ-213

Balloon 3 (sterile) MAJ-249

Balloon applicator MAJ-675

1 This item is not available in the USA.

• The balloon can easily tear, so beware of sharp objects.

• Store the balloon in a cool environment with low humidity.

• The resealable package containing the balloons also contains a deoxidizer to maintain a deoxygenated condition until the sterile peel pack is opened. After the resealable package is opened, the balloons will gradually deteriorate. To minimize deterioration, always keep the package sealed.

• The balloon applicator is reusable and supplied nonsterile.

Prepare the balloon and the balloon applicator.

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Chapter 3 Preparation and Inspection

Balloon

Rear band

Rear end

Balloon applicator

Groove

Installation side

Front end

Balloon attachment groove

Distal end of the endoscope

Attaching the balloon

Inspect the balloon and confirm that there are no holes, swelling, color changes or any other irregularities. If an irregularity is detected, do not use the balloon; use a spare instead, inspecting it thoroughly before use.

2. Insert the front end of the balloon into the installation side of the balloon

applicator. Slide the rear band of the balloon into the groove of the balloon applicator (see Figure 3.24).

Figure 3.24

3. Insert the distal end of the endoscope into the balloon applicator until it

contacts the front end of the balloon.

4. Remove the rear band from the balloon applicator and attach it to the

endoscope’s balloon attachment groove (see Figure 3.25).

Figure 3.25

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5. Remove the balloon applicator from the endoscope.

Do not apply excessive force to the distal end of the endoscope or bend it. Instrument damage may occur.

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Chapter 3 Preparation and Inspection

Inspection of the balloon and expelling air

• Do not feed water into the balloon when the water level in the water container is too low. The balloon may not be inflated properly. If this occurs, refer to Section 10.1, “Troubleshooting guide” on page 154.

• Disconnecting the water container from the endoscope just after removing the air bubbles from the balloon may cause them to reenter the balloon when inflating the balloon again. Therefore, confirm that there are no air bubbles in the balloon according to the following procedure.

1. Check the water level in the water container. If the water level is low, fill the

water container with sterile deaerated water. After adding water to the water container or removing the water container from the endoscope, cover the hole in the air/water valve and depress it to the first stage for about 15 seconds. Turn the light source and suction pump ON.

2. Cover the hole in the air/water valve and completely depress the valve to fill

the balloon with deaerated water.

3. Fill the balloon with deaerated water to a diameter of approximately 3 cm.

Remove your finger from the air/water valve. If the balloon is eccentrically shaped after inflation, gently hold the balloon and turn it around. Confirm that there are no holes or other irregularities in the balloon.

4. Confirm that there are no air bubbles in the balloon.

5. If the balloon has no air bubbles in it, completely depress the suction valve

until all the water has been aspirated from the balloon.

6. If air bubbles are observed in the balloon, lower the distal end of the

endoscope and repeat Steps 2 through 5 until they are completely removed from the balloon. After confirming that all air bubbles have been removed, repeat Steps 2 through 5 two times to make sure they are completely removed.

7. Completely depress the suction valve until all the water has been aspirated

from the balloon.

8. Tie the rear end of the balloon tightly with a sterile cotton thread.

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Chapter 3 Preparation and Inspection

Balloon water supply port

Balloon attachment groove

Do not obstruct the balloon water supply port with the cotton thread. If the balloon water supply port is obstructed, the balloon cannot be inflated or deflated (see Figure 3.26).

Figure 3.26

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Chapter 4 Operation

This manual does not explain or discuss clinical endoscopic procedures. It only describes basic operation and precautions related to the operation of this instrument. Therefore, the operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.

• To guard against dangerous chemicals and potentially infectious material during the procedure, wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.

Chapter 4 Operation

• The temperature of the distal end of the endoscope may exceed 41C (106F) and reach 50C (122F) due to intense endoscopic illumination. Surface temperatures over 41C (106F) may cause mucosal burns. Always maintain a suitable distance necessary for adequate viewing while using the minimum level of illumination for the minimum amount of time. Do not use close stationary viewing or leave the distal end of the endoscope close to the mucous membrane for a long time without necessity.

• Whenever possible, do not leave the endoscope illuminated before and/or after an examination. Continued illumination will cause the distal end of the endoscope to become hot and could cause operator and/or patient burns.

• Turn the video system center ON to operate the light source’s automatic brightness function. When the video system center is OFF, it cannot operate the light source’s automatic brightness function, and the light intensity is set to the maximum level. In this case, the distal end of the endoscope can become hot and could cause operator and/or patient burns, when using the light source CLV-160, CLV-U40.

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Chapter 4 Operation

• Never insert or withdraw the endoscope under any of the following conditions. Otherwise, patient injury, bleeding, and/or perforation can result.

 While the EndoTherapy accessory extends from the distal

end of the endoscope.

 While the bending section is locked in position.

 Insertion or withdrawal with excessive force.

 Insertion or withdrawal while the forceps elevator is

raised.

• If any of the following phenomena occur during an examination, immediately stop the examination and withdraw the endoscope from the patient as described in Section 10.2, “Withdrawal of the endoscope with an irregularity” on page 159.

 Should any irregularity be observed with the functionality

of the endoscope.

 If the endoscopic image on the monitor disappears or

freezes unexpectedly.

 If the angulation control knob is locked.

 If the angulation control mechanism is not functioning

properly.

Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation.

• If an abnormal endoscopic image or function occurs, but quickly corrects itself, the endoscope may have malfunctioned. In this case, stop using the endoscope because the irregularity can occur again and the endoscope may not return to its normal condition. Therefore, stop the examination immediately and slowly withdraw the endoscope while viewing the endoscopic image. Otherwise, patient injury, bleeding, and/or perforation can result.

• The endoscopic image may be disturbed while switching between WLI observation mode and NBI observation mode. Therefore, do not perform an endoscopic operation or treatment while switching between WLI observation mode and NBI observation mode. Otherwise, injury in the body cavity may result.

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Chapter 4 Operation

• Set the brightness of the light source to the minimum level

necessary to perform the procedure safely. If the endoscope is used for a prolonged period at or near maximum light intensity, vapor may be observed in the endoscopic image. This is caused by the evaporation of organic material (blood, moisture in stool, etc.) due to heat generated by the light guide near the light guide lens. If this vapor continues to interfere with the examination, remove the endoscope, wipe the distal end with a lint-free cloth moistened with 70% ethyl or isopropyl alcohol, reinsert the endoscope, and continue the examination.

• The color tone and brightness of NBI observation mode is

different from WLI observation mode. Use NBI observation mode only when fully understanding its features.

4.1 Insertion

Holding and manipulating the endoscope

The control section of the endoscope is designed to be held in the left hand. The air/water and suction valves can be operated using the left index finger. The UP/DOWN angulation control knob and the elevator control lever can be operated using the left thumb. The right hand is free to manipulate the insertion section and the RIGHT/LEFT angulation control knob (see Figure 4.1).

Figure 4.1

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Chapter 4 Operation

> 10 cm

Insertion of the endoscope

Keep the elevator control lever moved all the way in the opposite direction of the “ U” direction while inserting or withdrawing the endoscope into or from the patient. If the elevator control lever is moved all the way in the “ U” direction and the forceps elevator is raised while inserting or withdrawing the endoscope into or from the patient, this may cause patient injury.

• To prevent the patient from accidentally biting the insertion section during an examination, it is strongly recommended that a mouthpiece be placed in the patient’s mouth before inserting the endoscope.

• To prevent the patient from accidentally loosing dental prosthesis, make sure that the patient removes it before the examination.

Figure 4.2

• Do not apply olive oil or products containing petroleum-based lubricants (e.g., Vaseline products may cause stretching and deterioration of the bending section’s covering.

• Do not allow the insertion section to be bent within a distance of 10 cm or less from the junction of the boot. Insertion section damage can occur (see Figure 4.2).

) to the endoscope. These

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1. Move the elevator control lever in the opposite direction of the “ U” until it

stops.

2. If necessary, apply a medical-grade, water-soluble lubricant to the insertion

section.

3. Place the mouthpiece between the patient’s teeth or gums, with the outer

flange on the outside of the patient’s mouth.

Angulation of the distal end

Avoid forcible or excessive angulation as this imposes load on the wire controlling the bending section. This may cause stretching or tearing of the wire, which could impair the movement of the bending section.

Chapter 4 Operation

1. Operate the angulation control knobs as necessary to guide the distal end

for insertion and observation.

2. The endoscope’s angulation locks are used to hold the angulated distal end

in position.

• When passing an EndoTherapy accessory through the

instrument channel while the angulation is locked, the angle of the distal end may change. When it is necessary to keep the angulation stationary, hold the angulation control knobs in place with your hand.

• When operating the UP/DOWN or RIGHT/LEFT angulation

lock, hold the angulation control knob stationary with your finger. If this is not done, the angulation will change.

Air/water feeding and suction

• If the sterile water level in the water container is too low, then

air, not water, will be supplied. In this case, turn the airflow regulator on the light source OFF and add sterile water to the water container until it reaches the specified water level.

• If air/water feeding does not stop, turn the airflow regulator

on the light source OFF and replace the air/water valve with a new one.

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Chapter 4 Operation

Suction valve

Air/water valve

• Before using a syringe to inject liquid through the biopsy valve, detach the valve’s cap from the main body. Then insert the syringe straight into the valve and inject the liquid. If the cap is not detached and/or the syringe is not inserted straight, the biopsy valve could be damaged, which could reduce the efficacy of the endoscope’s suction system, and may leak or spray patient debris or fluids, posing an infection control risk.

• If the biopsy valve is left uncapped during the procedure, debris or fluids could leak or spray from it, posing an infection control risk. When the valve is uncapped, place a piece of sterile gauze over it to prevent leakage.

If the endoscope is cold, condensation may form on the surface of the objective lens and the endoscopic image may appear cloudy. In this case, increase the temperature of the sterile water in the water container to between 40 – 50C (104 – 122F) and then use the endoscope.

 Air/water feeding

1. Cover the air/water valve’s hole to feed air from the air/water nozzle at the

distal end (see Figure 4.3).

2. Depress the air/water valve to the first stage to feed water onto the objective

lens (see Figure 4.3).

Figure 4.3

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 Suction

Chapter 4 Operation

• Avoid aspirating solid matter or thick fluids; instrument

channel, suction channel, or suction valve clogging can occur. If the suction valve clogs and suction cannot be stopped, disconnect the suction tube from the suction connector on the endoscope connector. Turn the suction pump OFF, detach the suction valve and remove solid matter or thick fluids.

• When aspirating, maintain the suction pressure at the lowest

level necessary to perform the procedure. Excessive suction pressure could cause aspiration of and/or injury to the mucous membrane. In addition, patient fluids could leak or spray from the biopsy valve, posing an infection control risk.

• When aspirating, attach the cap to the main body of the

biopsy valve. An uncapped biopsy valve can reduce the efficacy of the endoscope’s suction system, and may leak or spray patient debris or fluids, posing an infection control risk.

During the procedure, make sure that the suction bottle does not fill completely. Aspirating fluids into a full bottle may cause the suction pump to malfunction.

Depress the suction valve to the first stage to aspirate excess fluid or other debris obscuring the endoscopic image (see Figure 4.3).

Performing both air feeding and suction at the same time sometimes makes it easier to remove water droplets from the objective lens surface.

Observation of the endoscopic image

Do not rely only on the NBI observation mode for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.

Refer to the light source’s instruction manual for instructions on how to adjust the brightness.

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Chapter 4 Operation

4.2 Observation of the ultrasound image

The sterile deaerated water immersion method

• Completely insert the water feeding valve (MD-744) of the water supply unit (UWS-1) into the biopsy valve (MAJ-853). Improper connection may cause water to leak.

• If no balloon is attached, do not depress the suction valve completely. The balloon channel may be clogged.

1. Position the distal end of the endoscope near the target site and push the

“FREEZE” switch on the ultrasound system to change the ultrasound image to the REAL-TIME mode.

2. Connect the water supply unit’s water-feeding valve to the biopsy valve of

the endoscope.

3. Depress the water supply unit’s water feeding valve as described in its

instruction manual and supply the necessary amount of sterile deaerated water.

The balloon method

• Do not inflate the balloon to a diameter of more than 3 cm.

• Do not feed water into the balloon when the water level in the water container is too low. The balloon may not be inflated properly.

If the water container is removed from the endoscope while inflating the balloon, cover the hole in the air/water valve and depress the valve to the first stage for about 15 seconds. By doing so, air bubbles can be prevented from entering the balloon.

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1. Position the distal end of the endoscope near the target site and press the

2. Cover the small hole in the air/water valve of the endoscope and completely

3. While viewing the ultrasound image, inflate the balloon to the desired size.

4. Use the endoscope’s angulation mechanism to bring the balloon into full

Observation

Chapter 4 Operation

“FREEZE” switch on the ultrasound system to change the ultrasound image to the REAL-TIME mode.

depress the valve to inflate the balloon.

Do not inflate the balloon to a diameter greater than 3 cm.

contact with the intestinal wall. Move the distal end to the target site.

Keep the ultrasound system in the FREEZE mode, except during ultrasound observation.

When combined with another electrical instrument, noise may be displayed on the video monitor.

When the ultrasound image of the target appears, adjust the ultrasound system as described in its instruction manual to obtain a suitable image.

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Chapter 4 Operation

4.3 Using EndoTherapy accessories

For more information on combining the endoscope with particular EndoTherapy accessories, refer to the “System chart” in the Appendix and the instruction manuals for the accessories.

• When using EndoTherapy accessories, keep the distance between the distal end of the endoscope and the mucous membrane greater than the endoscope’s minimum visible distance so that the EndoTherapy accessory remains visible in the endoscopic image. If the distal end of the endoscope is placed closer than its own minimum visible distance, the position of the accessory cannot be seen in the endoscopic image, which could cause serious patient injury and/or equipment damage. The minimum visible distance depends on the type of endoscope being used. Refer to Section 2.3, “Specifications” on page 21.

• When inserting or withdrawing an EndoTherapy accessory, confirm that its distal end is closed or completely retracted into the sheath. Slowly insert or withdraw the EndoTherapy accessory straight into/from the slit of the biopsy valve. Otherwise, the biopsy valve may be damaged and pieces of it could fall off.

• If the insertion or withdrawal of EndoTherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image. Inserting or withdrawing EndoTherapy accessories with excessive force may damage the instrument channel or EndoTherapy accessories and could cause some parts to fall off and/or cause patient injury.

• Do not switch between WLI observation mode and NBI observation mode while using an EndoTherapy accessory. The endoscopic image may be disturbed while switching between WLI observation mode and NBI observation mode. This could cause patient injury, bleeding, and/or perforation.

• If the distal end of an EndoTherapy accessory is not visible in the endoscopic image, do not open the distal end or extend the needle of the instrument. This could cause patient injury, bleeding, perforation, and/or equipment damage.

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Chapter 4 Operation

• Do not insert EndoTherapy accessories without the forceps

elevator being raised. If they are inserted without the forceps elevator being raised, the accessory cannot be observed in the endoscopic image and it may cause patient injury.

• While raising the forceps elevator, do not insert or withdraw

the EndoTherapy accessory with excessive force, open or close the distal end of the EndoTherapy accessory, or extend the needle of the instrument. This could damage the instrument channel and/or the EndoTherapy accessory and could cause patient injury, bleeding, and/or perforation. If the EndoTherapy accessory cannot be inserted or withdrawn, the distal end of the EndoTherapy accessory cannot be opened or closed, or the needle of the instrument cannot be extended, move the elevator control lever in the opposite direction of the “ U” direction to lower the forceps elevator.

• If the forceps elevator cannot be lowered while using an

EndoTherapy accessory, stop the procedure immediately and take appropriate measures.

• Do not inflate air or a nonflammable gas excessively into the

patient. This could cause gas embolism.

• EUS guided FNA should only be performed when the needle

is visible in the ultrasound image.

• If the ultrasound image disappears while using the needle,

stop the procedure immediately and withdraw the needle from the tissue.

• When using a biopsy forceps with a needle, confirm that the

needle is not excessively bent. A bent needle could protrude from the closed cups of the biopsy forceps. Using biopsy forceps with a protruding needle could damage the instrument channel and/or cause patient injury.

• When using an injector, be sure not to extend or retract the

needle from the catheter of the injector until the injector is extended from the distal end of the endoscope. The needle could damage the instrument channel if extended inside the channel, or if the injector is inserted or withdrawn while the needle is extended.

• Although the color code is orange as with GF-UCT180, do

not use EndoTherapy accessories designed for ø 4.2 mm channel, otherwise the endoscope and/or the EndoTherapy accessories may be damaged.

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Chapter 4 Operation

Insertion of EndoTherapy accessories into the endoscope

• Do not insert EndoTherapy accessories forcibly or abruptly. Otherwise, the EndoTherapy accessory may extend from the distal end of the endoscope abruptly, which could cause patient injury, bleeding, and/or perforation.

• When the biopsy valve’s cap is detached from the main body, it is easier to insert an EndoTherapy accessory into the instrument channel port (see Figure 3.9 on page 36). However, the open biopsy valve, after withdrawing an EndoTherapy accessory, can reduce the efficacy of the endoscope’s suction system, and it may leak or spray patient debris or fluids, posing an infection control risk. When not using an EndoTherapy accessory, attach the cap to the main body of the biopsy valve.

• When the biopsy valve’s cap is detached from the main body, it may cause patient debris or fluids to leak or spray from the endoscope, posing an infection control risk. When the biopsy valve’s cap has to be detached, place a piece of sterile gauze over it to prevent leakage.

• Do not let the EndoTherapy accessory hang down from the biopsy valve. Doing so can create a space between the accessory and the valve’s slit or hole. This can cause damage to the valve that can reduce the efficacy of the endoscope’s suction system, and may leak or spray patient debris or fluids, posing an infection control risk.

• When inserting an EndoTherapy accessory, hold it close to the biopsy valve and insert it slowly and straight into the biopsy valve. Otherwise, the EndoTherapy accessory and/or biopsy valve could be damaged. This can reduce the efficacy of the endoscope’s suction system, and may leak or spray patient debris or fluids, posing an infection control risk.

When using the aspiration needle (NA series), refer to the instruction manuals for the aspiration needle (NA series). Otherwise, the instrument channel and/or the EndoTherapy accessory may become damaged.

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Chapter 4 Operation

1. Select EndoTherapy accessories compatible with the instrument from the

“System chart” in the Appendix. Refer to the accessories’ instruction manuals for operating instructions.

2. Move the elevator control lever all the way in the “ U” direction.

3. Hold the UP/DOWN and RIGHT/LEFT angulation knobs stationary.

4. Confirm that the tip of the EndoTherapy accessory is closed or retracted into

its sheath and insert the EndoTherapy accessory slowly and straight into the slit of the biopsy valve.

Do not open the tip of the EndoTherapy accessory or extend the tip of the EndoTherapy accessory from its sheath while the accessory is in the instrument channel. The instrument channel and/or the EndoTherapy accessory may become damaged.

5. Hold the EndoTherapy accessory approximately 4 cm from the biopsy valve

and advance it slowly and straight into the biopsy valve using short strokes while observing the endoscopic image.

When the tip of the EndoTherapy accessory extends approximately 6 mm from the distal end of the endoscope, the accessory will appear in the endoscopic image, and/or ultrasound image.

6. Hold the EndoTherapy accessory approximately 4 cm from the biopsy valve

and advance it slowly and straight into the biopsy valve using short strokes while observing the endoscopic image. Confirm that the tip of the EndoTherapy accessory contacts the forceps elevator.

7. Move the elevator control lever in the opposite direction of the “ U”

direction to lower the forceps elevator. Advance the EndoTherapy accessory slightly and move the elevator control lever in the “ U” direction confirm that the accessory appears in the endoscopic image.

8. Manipulate the elevator control lever to adjust the height of the elevator (see

Figures 4.4 and 4.5).

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Chapter 4 Operation

Figure 4.4

Figure 4.5

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Operation of EndoTherapy accessories

Operate the EndoTherapy accessory according to the directions given in its instruction manual.

Withdrawal of EndoTherapy accessories

• Patient debris might spray when EndoTherapy accessories

are withdrawn from the biopsy valve. To prevent this, hold a piece of gauze around the accessory and the biopsy valve during withdrawal.

• Do not withdraw the EndoTherapy accessory if the tip is open

or extended from its sheath; patient injury, bleeding, perforation, and/or instrument damage may occur.

• Withdraw the EndoTherapy accessory slowly and straight out

of the biopsy valve. Otherwise, the valve’s slit and/or hole could be damaged. This can reduce the efficacy of the endoscope’s suction system, and may leak or spray patient debris or fluids, posing an infection control risk.

Chapter 4 Operation

• If the EndoTherapy accessory cannot be withdrawn from the

endoscope, close the EndoTherapy accessory and/or retract it into its sheath, then carefully withdraw both the endoscope and the EndoTherapy accessory together under endoscopic observation. Take care not to cause tissue trauma.

Withdraw the EndoTherapy accessory slowly while the tip of the EndoTherapy accessory is closed and/or retracted into its sheath.

1. Close the tip of the EndoTherapy accessory and/or retract it into its sheath.

2. While lowering the forceps elevator gradually, slowly withdraw the

EndoTherapy accessory.

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Chapter 4 Operation

High-frequency cauterization treatment

• Performing treatment while the intestines are filled with a flammable gas could result in an explosion, fire, and/or serious patient injury. If the intestines contain a flammable gas, replace it with air or a nonflammable gas such as CO before performing high-frequency treatment.

• Not all parts of the endoscope are electrically insulated. When applying high-frequency current, there is a danger of unintentional diathermy burns. Always wear electrically insulating, chemical-resistant gloves.

• Never emit high-frequency current before confirming that the distal end of the high-frequency EndoTherapy accessory is in the endoscope’s field of view. Also, confirm that the electrode section and the mucous membrane in the vicinity of the target area are at an appropriate distance from the distal end of the endoscope. If the high-frequency current is emitted while the distal end of the EndoTherapy accessory is not visible or too close to the distal end of the endoscope, patient injury, bleeding, and/or perforation as well as equipment damage can result.

Prepare, inspect, and connect the electrosurgical unit and electrosurgical accessories as described in their instruction manuals.

The application of high-frequency current may interfere with the endoscopic image. This does not indicate a malfunction.

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4.4 Withdrawal of the endoscope

If blood unexpectedly adheres to the surface of the insertion section of the withdrawn endoscope, carefully check the condition of the patient.

1. When using the balloon method, aspirate water from the balloon by

depressing the suction valve while covering the hole in the valve.

2. Freeze the ultrasound image.

3. Aspirate the accumulated air, blood, mucous or other debris by depressing

the suction valve to the first stage while covering the hole in the valve.

• Observe the ultrasound image on the video monitor and

confirm that the balloon deflates.

Chapter 4 Operation

• If the balloon does not deflate even when the suction valve is

completely depressed, turn OFF the switch of the airflow regulator and remove the air/water valve from the endoscope. In most cases, the balloon will be automatically deflated.

• If the balloon does not deflate even when the air/water valve

is removed from the endoscope, tear and deflect the balloon with the EndoTherapy accessory (for example, biopsy forceps).

4. Turn the UP/DOWN and RIGHT/LEFT angulation locks to the “F ”

direction to release them.

5. Carefully withdraw the endoscope while observing the endoscopic image.

6. Remove the mouthpiece from the patient’s mouth.

7. If using the balloon method, detach the balloon.

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Chapter 4 Operation

4.5 Removal of the balloon

• Do not hold the ultrasound transducer when holding the insertion section. The ultrasonic transducer can be damaged, resulting in an abnormal ultrasonic image.

• Do not squeeze the ultrasound transducer forcefully. The ultrasonic transducer can be damaged, resulting in an abnormal ultrasonic image.

• Do not remove the balloon with equipment such as forceps, needle holder, or hemostat that may scratch the surface of the ultrasound transducer. The ultrasonic transducer can be damaged, resulting in an abnormal ultrasonic image.

• Do not pinch the ultrasound transducer surface and balloon together when removing the balloon. The ultrasonic transducer can be damaged, resulting in an abnormal ultrasonic image.

1. Use a clean, lint-free cloth to gently wipe and dry the balloon surface.

2. Roll up the rear end of the balloon with your fingers (see Figure 4.6).

3. After the removal of the balloon, confirm that the surface of the ultrasound

transducer is free from scratches. In case the ultrasound transducer surface is scratched, stop using the endoscope and contact Olympus.

Figure 4.6

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4.6 Transportation of the endoscope

Transporting within the hospital

When carrying the endoscope by hand, loop the universal cord, hold the endoscope connector with the control section in one hand and hold the distal end of the insertion tube securely, but gently without squeezing, in the other hand (see Figure 4.7).

Chapter 4 Operation

Figure 4.7

Transporting outside the hospital

Transport the endoscope in the carrying case.

Always clean, disinfect, or sterilize the endoscope after removing it from the carrying case. If the endoscope is not cleaned, disinfected, or sterilized, it could pose an infection control risk.

• The carrying case cannot be cleaned, disinfected, or

sterilized. Clean and disinfect or sterilize the endoscope before placing it in the carrying case.

• To avoid damage to the endoscope caused by changes in air

pressure, do not attach the water-resistant cap when transporting the endoscope.

• Before putting the endoscope in the carrying case, always

make sure that the forceps elevator is not raised. Putting the endoscope in the carrying case while the forceps elevator is raised could damage the endoscope.

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Chapter 5 Reprocessing: General Policy

Chapter 5 Reprocessing: General

Policy

5.1 Instructions

• Chapters 5, “Reprocessing: General Policy” through 8, “Cleaning and Disinfection Equipment” describe recommended procedures and equipment for cleaning and disinfecting or sterilizing this instrument.

• This instruction manual contains essential information on reprocessing this instrument safely and effectively.

• Before reprocessing, thoroughly review the manuals of the reprocessing chemicals and all equipment that will be used, and reprocess the equipment as instructed.

• Keep this and all related instruction manuals in a safe, accessible location.

• 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.

5.2 Importance of cleaning, disinfection, and sterilization

The medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, or sterilization. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals of all ancillary equipment, and have a thorough understanding of the following items:

• Professional health and safety criteria of your hospital

• Individual cleaning, disinfection, and sterilization protocols

• Structure and handling of endoscopic equipment

• Handling of pertinent chemicals

For the types and conditions of the means of cleaning, disinfection, and sterilization to be adopted, please make judgments from your professional viewpoints.

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5.3 Precautions

Chapter 5 Reprocessing: General Policy

• Some endoscope reprocessors are not designed to reprocess an elevator wire channel. If the elevator wire channel cannot be reprocessed by the endoscope reprocessor, clean, disinfect, and sterilize the endoscope according to procedures described in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”.

• Failure to properly clean and high-level disinfect or sterilize endoscope equipment after each procedure can compromise patient safety. To minimize the risk of transmitting infectious agents from one patient to another, after each procedure the endoscope and the equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization, as described in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”. Reprocess not only the external surface of the endoscope but also all channels.

• ALL channels of the endoscope, including the elevator wire channel and balloon channel, 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.

• After thoroughly brushing or wiping all external surfaces and the distal end of the endoscope and around the forceps elevator with a soft brush or lint-free cloth, always visually confirm that the elevator wire is not broken. If the elevator wire is broken, patient and/or operator injury could result.

• 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 and organic material that could reduce the efficacy of disinfection or sterilization.

• Olympus only confirms validation of the endoscope reprocessors it recommends. When using an endoscope reprocessor that is not recommended by Olympus, the manufacturer of the endoscope reprocessor is responsible for validating compatibility of the reprocessor with the endoscope models listed in its instruction manual.

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Chapter 5 Reprocessing: General Policy

• Before using an endoscope reprocessor, confirm that it is capable of reprocessing the endoscope including all channels. If you are uncertain as to the ability of your endoscope reprocessor to clean and high-level disinfect the endoscope including all channels, contact the endoscope reprocessor’s manufacturer for specific instructions and/or information on connectors. 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.

• 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 eyewear, 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 surfaces 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 airtight container. Alcohol stored in an open container is a fire hazard and will lose its efficacy due to evaporation.

• Be sure to perform a leakage test on the endoscope prior to manual cleaning, and do not use the endoscope if a leak is detected. Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism or other malfunctions.

• Prior to each procedure, confirm that the endoscope has undergone proper cleaning, disinfection, and sterilization. If it is determined that the endoscope has not been properly reprocessed, reprocess it again following the instructions given in this manual.

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Chapter 5 Reprocessing: 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 irregularity before use, and use under responsibility of a physician. Do not use if any irregularity is found.

• When aerating or irrigating the endoscope channels, the air

or water pressure must not exceed 0.2 MPa (2 kgf/cm

, 29 psig). Higher pressures may cause damage to the endoscope.

• When reprocessing an endoscope, confirm that the two water-resistant caps are securely attached to the endoscope connector before immersion in reprocessing fluids. If two water-resistant caps are not securely attached, water, detergent solution and/or disinfectant solution could enter the endoscope and damage the equipment.

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Chapter 5 Reprocessing: General Policy

5.4 Reprocessing before the first use/reprocessing and storage after use

This instrument was not cleaned, disinfected, or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in this manual. After using this instrument, reprocess and store it according to the instructions given in this manual. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage, or reduce performance.

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Chapter 6 Compatible Reprocessing Methods and Chemical Agents

Chapter 6 Compatible Reprocessing

Methods and Chemical Agents

6.1 Compatibility summary

Olympus endoscopic equipment is compatible with several methods of reprocessing. However, certain components and accessories are not compatible with some methods, which can cause equipment damage. For appropriate reprocessing methods, refer to see Table 6.1, the recommendations of your infection control committee and all national and local hospital guidelines and policies.

Endoscope

Water-resistant cap

(MH-553)

Chain for water-resistant

cap (MAJ-1739)

Channel cleaning brush

(BW-20T, BW-7L)

Channel-opening cleaning

brush (MH-507)

Air/water valve (MAJ-1444)

Suction valve (MAJ-1443)

Channel plug (MAJ-621)

Injection tube (MH-946)

Air/water channel cleaning

adapter (MAJ-629)

Steam sterilization (autoclaving)

Ethylene oxide gas sterilization (gas mixture 20% ethylene oxide

gas/80% CO

Ethylene oxide gas sterilization (100% ethylene oxide gas)

ACECIDE disinfectant solution

(use OER-A, OER-AW, OER-Pro)

2 – 3.5% glutaraldehyde

70% ethyl or isopropyl alcohol

Detergent solution

Ultrasonic

cleaning

1

2

for countries other than the USA)



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Chapter 6 Compatible Reprocessing Methods and Chemical Agents

Steam sterilization (autoclaving)

Ethylene oxide gas sterilization (gas mixture 20% ethylene oxide

gas/80% CO

Ethylene oxide gas sterilization (100% ethylene oxide gas)

ACECIDE disinfectant solution

(use OER-A, OER-AW, OER-Pro)

2 – 3.5% glutaraldehyde

70% ethyl or isopropyl alcohol

Detergent solution

Ultrasonic

cleaning

Suction cleaning adapter

(MH-856)

Mouthpiece (MB-142)

Washing tube (MH-974)

Cleaning adapter for

instrument channel port

(MAJ-350)

Biopsy valve (MAJ-853)

for countries other than the USA)



Balloon applicator

(MAJ-675)

Balloon (MAJ-213)

Cleaning brush (MAJ-1534)

Balloon 3 (MAJ-249)

Single use channel

cleaning brush (BW-201T)

Single use channel-opening

cleaning brush (MAJ-1339)

Ultrasonic cable (MAJ-1597)

4

compatible not compatible

Table 6.1

1 The endoscope is compatible with ultrasonic cleaning only when using an

endoscope reprocessor such as OER, OER-A, OER-AW and OER-Pro (OER, OER-A, OER-AW and OER-Pro may not be available in some areas).

2 The water-resistant caps and the chain for water-resistant caps can only

be ultrasonically cleaned if connected to the endoscope that is being cleaned in an endoscope reprocessor with an ultrasonic cleaning phase.

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Chapter 6 Compatible Reprocessing Methods and Chemical Agents

3 ACECIDE disinfectant solution is exclusively for an

Olympus-recommended endoscope reprocessor such as OER-A, OER-AW and OER-Pro (ACECIDE and Acecide-C may not be available in some areas).

4 This item is not available in the USA.

Alcohol is not a sterilant or high-level disinfectant.

• The endoscope is not compatible with steam sterilization (autoclaving). Reprocessing using steam sterilization will result in severe equipment damage.

• The ultrasonic cable is not waterproof. Never immerse it in disinfectant solution or any other fluids.

• The endoscope is compatible with some endoscope reprocessors such as the ETD Olympus. Refer to the respective instruction manual for details on operation. For any other details, please contact Olympus.

• EndoTherapy accessories that are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, or accessories with a green model reference label are compatible with steam sterilization (autoclaving).

6.2 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.

1

system distributed by

1 This product may not be available in some areas.

Excessive detergent foaming can prevent fluid from adequately contacting internal lumens (e.g., channels).

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Chapter 6 Compatible Reprocessing Methods and Chemical Agents

6.3 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” that 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 disinfectant solution is reused, routinely check its efficacy according to the manufacturer’s recommendations. Do not use solutions beyond their expiration date.

6.4 Rinse 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 that has been processed (e.g., filtered) to improve its microbiological quality may be used.

When nonsterile 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 rinse water.

Alcohol is not a sterilant or high-level disinfectant.

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Chapter 6 Compatible Reprocessing Methods and Chemical Agents

6.5 Ethylene oxide gas sterilization

This instrument and other accessories listed as compatible with ethylene oxide gas sterilization in Table 6.1 on page 82 can be sterilized by ethylene oxide gas and aerated within the parameters given in Tables 6.2 and 6.3. When performing ethylene oxide gas sterilization, follow the cleaning, disinfection, and sterilization protocols of your hospital and the instruction manuals of the sterilization equipment.

• Before sterilization, the instrument must be thoroughly cleaned and dried. Residual moisture may inhibit 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 for the sterilization device.

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

• Exceeding the recommended parameters may cause equipment damage (see Tables 6.2 and 6.3).

• Disconnect the water-resistant caps from the endoscope connector before ethylene oxide gas sterilization. If the water-resistant cap is attached during ethylene oxide gas sterilization, the air inside the endoscope will expand and rupture the covering of the bending section and/or damage the angulation mechanism.

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Chapter 6 Compatible Reprocessing Methods and Chemical Agents

 Parameters for 100% ethylene oxide gas sterilization

cycles

Process phase Parameter Value

Sterilization Temperature

Vac uum

(Absolute pressure)

Relative humidity 50 – 80%

Ethylene oxide gas

concentration

Exposure time 60 minutes

Aeration Minimum aeration

parameters

C (130F)

0.05 – 0.07 MPa

(7.25 – 10.15 psia)

0.735 – 0.740 mg/cm

(735 – 740 mg/L)

12 hours in an aeration chamber at

50 – 57

C (122 – 135F) or 7 days at

room temperature

Table 6.2

 Parameters for 20% ethylene oxide gas/80% CO2 gas

sterilization cycles, for countries other than the USA

Process phase Parameter Value

Sterilization Temperature

Relative pressure 0.1 – 0.17 MPa

Relative humidity 55%

Ethylene oxide gas

concentration

Exposure time 105 minutes

57C (135F)

0.6 – 0.7 mg/cm

(600 – 700 mg/L)

Aeration Minimum aeration

parameters

12 hours in an aeration chamber at

50 – 57

room temperature

Table 6.3

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C (122 – 135F) or 7 days at

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Chapter 6 Compatible Reprocessing Methods and Chemical Agents

6.6 Steam sterilization (autoclaving) of accessories

The accessories listed as compatible with steam sterilization (autoclaving) in Table 6.1 on page 82 can be sterilized by steam within the parameters given in Table 6.4. When steam sterilizing, follow the cleaning, disinfection, and sterilization protocols of your hospital as well as the instructions provided by the manufacturer of your sterilization equipment.

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 for the sterilization device.

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

• Do not exceed a setting temperature of 134C (273F), equivalent to a maximum temperature of 137C (279F), nor an exposure time greater than 20 minutes. Otherwise, the accessories may be damaged.

Process Parameters

Prevacuum Temperature

Exposure time 5 minutes

Table 6.4 Steam sterilization (autoclaving) exposure parameters

132 – 134C

(270 – 274

F)

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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures

Chapter 7 Cleaning, Disinfection, and

Sterilization Procedures

ALL channels of the endoscope, including the elevator wire channel and balloon channel, 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.

• Do not coil the endoscope’s insertion section or universal cord into a diameter of less than 12 cm. The endoscope can be damaged if coiled too tightly.

• For proper reprocessing results, do not coil the insertion section or universal cord with a diameter of less than 40 cm. If the diameter is less than 40 cm, it will be difficult to insert the channel cleaning brushes (BW-20T, BW-7L), single use single-ended cleaning brush (BW-400L), single use combination cleaning brush (BW-412T) and/or the single use channel cleaning brush (BW-201T).

7.1 Required reprocessing equipment

Preparation of the equipment

Prior to cleaning and disinfection or sterilization, prepare the equipment shown in Figure 7.1.

Use basins that are at least 40 cm by 40 cm (16” by 16”) in size and deep enough to allow the endoscope to be completely immersed.

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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures

Cleaning adapter for instrument channel port (MAJ-350)

Channel-opening cleaning brush (MH-507) or single use channel-opening cleaning brush (MAJ-1339



)

Biopsy valve (MAJ-853)

Water-resistant cap (MH-553, 2 pcs)

Leakage tester (MB-155)

Suction cleaning adapter (MH-856)

Washing tube (MH-974)

Channel cleaning brush (BW-7L



) or single use single-ended cleaning brush (BW-400L



)

Channel cleaning brush (BW-20T) or single use channel cleaning brush (BW-201T



)

Injection tube (MH-946)

Channel plug (MAJ-621)

Air/water channel cleaning adapter (MAJ-629)

Cleaning brush (MAJ-1534)

Suction pump (KV-4, KV-5, SSU-2) (sold separately)

Maintenance unit (MU-1) (sold separately)

Light source (sold separately)

Single use combination cleaning brush (BW-412T



)

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

• Detergent solution • Large basin with a

• Clean water • Large basin for rinsing

• 70% ethyl or

isopropyl alcohol

• Small containers • Sterile water • Personal protective

tight-fitting lid for

detergent and

disinfectant solution

and leakage testing

• Disinfectant solution

Figure 7.1

• Large basins for

rinsing

• 500 cm

container

•30cm

equipment

• Clean, lint-free cloths

(500 ml)

(30 ml) syringe • 5 cm3 (5 ml) syringe

• Sterile, cotton swabs

• Soft-bristled brush

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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures

Groove

Seal

Venting connector

Metal tip

Shaft

Brush head

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 two water-resistant caps are attached to the videoscope cable connector and the ultrasonic cable connector on the endoscope to protect the connectors from water penetration during reprocessing. For leakage testing, the venting connector on the water-resistant cap must be connected to the leakage tester (MB-155) (see Figure 7.2).

Figure 7.2

 Channel cleaning brush (BW-20T, reusable)

The channel cleaning brush is used to brush the inside of the instrument channel, suction channel, and the interior and/or openings of the suction valve, air/water valve, AW channel cleaning adapter, and biopsy valve (see Figure 7.3).

Figure 7.3

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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures

Tip

Shaft

Caution sticker (OLYMPUS SINGLE USE ONLY)

Brush head

Metal tip

Shaft

 Single use channel cleaning brush (BW-201T)

The single use channel cleaning brush is used to brush the inside of the instrument channel, suction channel, and the interior and/or openings of the suction valve, AW channel cleaning adapter, and biopsy valve (see Figure 7.4).

Figure 7.4

 Channel cleaning brush (BW-7L/reusable)

/Single use single-ended cleaning brush (BW-400L)

The channel cleaning brush or the single use single-ended cleaning brush is used to clean the balloon channel (see Figure 7.5).

Figure 7.5

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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures

Brush handle

Shaft

Brush head

Handle

Shaft

Brush head

 Channel-opening cleaning brush (MH-507, reusable)

The channel-opening cleaning brush is used to brush the external surface of the distal end of the endoscope, the suction cylinder, the irrigation port, and the instrument channel port (see Figure 7.6).

Figure 7.6

 Single use channel-opening cleaning brush (MAJ-1339)

The single use channel-opening cleaning brush is used to brush the external surface of the distal end of the endoscope, the suction cylinder, the irrigation port, and the instrument channel port (see Figure 7.7).

Figure 7.7

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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures

Long bristle row

Short bristle row

Grip section

Connecting end

Weighted end

 Cleaning brush (MAJ-1534)

The cleaning brush is used to brush the external surface of the distal end of the endoscope (see Figure 7.8).

Figure 7.8

 Suction cleaning adapter (MH-856)

The suction cleaning adapter is used to aspirate reprocessing fluids from the distal end of the endoscope through the instrument channel (see Figure 7.9).

Figure 7.9

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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures

Notice card

Pakings

Piston

Suction channel tube

Air pipe port

Air/water channel tube

Connector plug

Notice card

Suction channel port

Air/water channel port

Suction channel port

(including filter mesh)

 Air/water channel cleaning adapter (MAJ-629)

During precleaning, the air/water channel cleaning adapter is connected to the air/water cylinder. When the adapter is depressed, water is fed through the air/water channel. Air is continuously fed when the adapter is not depressed (see Figure 7.10).

Figure 7.10

Use the air/water channel cleaning adapter only during precleaning.

 Injection tube (MH-946)

The injection tube is used to inject detergent solution, disinfectant solution, water and alcohol into the air/water channel, instrument channel and suction channel and to flush air through the channels to expel fluids (see Figure 7.11).

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Figure 7.11