Olympus UCT180 User manual

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.

Contents

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

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

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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

5.4Reprocessing 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

7.2Cleaning, 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

7.9Cleaning, 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

iv	ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

Symbols

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
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180		1

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

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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3

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

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”.

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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Important Information — Please Read Before Use

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 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.

•Before endoscopy, remove any metallic objects (watch, 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, 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.

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

•Never insert or withdraw the insertion section abruptly or with excessive force. Patient injury, bleeding, and/or perforation may result.

•Do not touch the light guide of the endoscope connector immediately after removing it from the light source because it is extremely hot. Operator or patient burns can result.

•That before each use or after a change of viewing 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*1 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.

ULTRASOUND GASTROVIDEOSCOPE GF-UCT180

9

Important Information — Please Read Before Use

•Do not twist or bend the bending section with your hands. Equipment damage may result.

•Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leaks.

•Turn the video system center ON only when the videoscope 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 endoscope’s remote switches cannot be removed from 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 1 observation mode 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”.

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Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package

Contents

1.1Standard 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.)

Cleaning brush (MAJ-1534)

Injection tube Channel plug (MH-946) (MAJ-621)

Single use channel cleaning brush for the USA (BW-201T, 3 pcs. 1)

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

Single use combination cleaning brush (BW-412T, 3 pcs. 1)

Channel cleaning brush (BW-7L, 2 pcs. 1)

Single use single-ended cleaning brush (BW-400L, 3 pcs. 1)

Single use channel-opening cleaning brush for the USA

(MAJ-1339, 3 pcs. 1)

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

Cleaning adapter for instrument channel port (MAJ-350)

Biopsy valve

(MAJ-853, nonsterile, 10 pcs.)

Balloon applicator	Water-resistant cap	Suction cleaning adapter	Air/water channel cleaning adapter
(MAJ-675)	(MH-553, 2 pcs.)	(MH-856)	(MAJ-629)

	Washing tube	Chain for water-resistant cap
		(MAJ-1739)	Instruction manual
	(MH-974)

1 These products may not be available in some areas.

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Chapter 1 Checking the Package Contents

1.2Ultrasonic cable

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)

Endoscope-side

connector

Ultrasound

connector

Ultrasonic cable

(MAJ-1597)

1.3Optional 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

Chapter 2 Instrument Nomenclature

and Specifications

2.1Nomenclature

Universal cord

1. Ultrasonic cable connector

	2. Suction connector
	3. S-cord connector mount
	4. Endoscope connector
	5. Air supply connector
	5. Water supply connector
resistant cap	Product number and serial number
6. Videoscope cable	Electrical contact points
connector
	Light guide

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Chapter 2 Instrument Nomenclature and Specifications

9.UP/DOWN angulation lock

8.UP/DOWN angulation control knob

7.Elevator control lever

20. RIGHT/LEFT angulation control knob

19.RIGHT/LEFT angulation lock

Grip section

18. Color code

17. Elevator channel plug

Suction cylinder

10. Suction valve (MAJ-1443)

11. Air/water valve (MAJ-1444)

Air/water cylinder

Control

section

Biopsy valve (MAJ-853)

12. Instrument channel

Instrument channel port

Boot

		Insertion section limit mark
		Insertion section	Ultrasound
			transducer	Air/water
			Balloon water	nozzle
			supply port is in
	16. Remote		this groove	Objective
		switches 1 to 4	Balloon	lens
			attachment	Forceps
			groove
				elevator
	Top view		Light guide
		Insertion tube	lens	Instrument
		14. Bending section	Balloon water	channel
				outlet
			suction port is
		Distal end	in this groove
			Detail of distal end
		ULTRASOUND GASTROVIDEOSCOPE GF-UCT180		17

Chapter 2 Instrument Nomenclature and Specifications

2.2Endoscope 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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19

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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Chapter 2 Instrument Nomenclature and Specifications

2.3	Specifications
	Environment
		Operating	Ambient temperature	10 – 40 C (50 – 104 F)
		environment
			Relative humidity	30 – 85%
			Atmospheric	700 – 1060 hPa
			pressure	(0.7 – 1.1 kgf/cm2)
				(10.2 – 15.4 psia)
		Transportation	Ambient temperature	–47 to 70 C (–52.6 to 158 F)
		and storage
			Relative humidity	10 – 95%
		environment
			Atmospheric	700 – 1060 hPa
			pressure	(0.7 – 1.1 kgf/cm2)
				(10.2 – 15.4 psia)

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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		55 forward oblique
	Depth of field		3 – 100 mm
Insertion tube	Distal end outer		ø 14.6 mm
	diameter
	Distal end enlarged	1.	Air/water nozzle
		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
			6.	1.
			7.	8.
			9.	2.
			3.
			5.	4.
	Insertion tube outer		ø 12.6 mm
	diameter
	Working length		1250 mm
Instrument	Channel inner		ø 3.7 mm
channel	diameter
	Minimum visible		6 mm from the objective lens
	distance
	Direction from which
	EndoTherapy
	accessories enter
	and exit the
	endoscopic image
Airflow rate			20 cm3/s

Note: Standard when CLV-180 (high air pressure) is used.

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Chapter 2 Instrument Nomenclature and Specifications

Bending	Angulation range	UP 130 , DOWN 90 ,
section		RIGHT 90 , LEFT 90
Total length		1555 mm
NBI observation mode 1		Available

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

Ultrasound function with ALOKA diagnostic ultrasound system SSD10/ProSound 7 1/ProSound F75 1

	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	5, 6, 7.5, 10 MHz (SSD10/ProSound F75 1)
		4, 6.67, 10, 13.3 MHz (ProSound 7) 1
	Scanning range	180
	Contacting method	Balloon method, Direct contact method
	Transducer surface	43 C >
	max. temperature

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	43 C >
	max. temperature

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Chapter 2 Instrument Nomenclature and Specifications

General safety	IEC 60601-1: 2005	Whole of this instrument is possible
standard for medical		to contact live bodies of operators or
electrical equipment		patients.
Medical Devices		This device complies with the
Directive		requirements of Directive 93/42/EEC
		concerning medical devices.
		Classification: Class II a
EMC	Applied standards;	This instrument complies with the
	IEC 60601-1-2: 2007	standards listed in the left column.
	IEC 60601-2-37: 2007
		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.

Year of manufacture

1912345

The last digit of the year of manufacture is given in the second digit of the serial number.

Degree of protection
against electric		TYPE BF applied part
shock
Ingress protection	IPX7	This instrument complies with the
rating		standards for medical electrical
		equipment: IEC 60601-1: 2005
		IEC 60601-2-37: 2007.

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