GF-UE160-AL5 ULTRASONIC GASTROVIDEOSCOPE Instructions July 2006

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

2

Intended use ...

2

Applicability of endoscopy and endoscopic treatment ...

2

Instruction manual...

3

User qualifications ...

3

Instrument compatibility ...

3

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

4

Maintenance management ...

4

Prohibition of improper repair and modification ...

4

Signal words...

5

Warnings and cautions ...

5

Examples of inappropriate handling...

8

Natural rubber latex medical alert ...

8

Chapter 1

Checking the Package Contents...

9

1.1

Standard components...

9

1.2

Optional components ...

11

Instrument Nomenclature and Specifications ...

12

2.1

Nomenclature...

12

2.2

Endoscope functions...

14

2.3

Specifications...

16

2.4

Attaching the chain for water-resistant cap (MAJ-1119) ...

18

Preparation and Inspection ...

21

3.1

Preparation of the equipment...

21

3.2

Inspection of the endoscope ...

23

3.3

Preparation and inspection of accessories ...

26

3.4

Attaching accessories to the endoscope ...

29

3.5

Inspection and connection of ancillary equipment ...

31

3.6

Inspection of the endoscopic system ...

34

3.7

Preparation and inspection of the balloon...

39

Chapter 2

Chapter 3

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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Contents

Chapter 4

Operation...

44

4.1

Insertion ...

46

4.2

Observation of the ultrasonic image...

50

4.3

Using endo-therapy accessories...

52

4.4

Withdrawal of the endoscope...

55

4.5

Removal of the balloon ...

56

4.6

Transportation of the endoscope ...

57

Reprocessing: General Policy...

59

5.1

Instructions...

59

5.2

Importance of cleaning, disinfection and sterilization...

59

5.3

Precautions ...

60

5.4

Reprocessing before the first use/reprocessing and storage after use ... 62

Chapter 5

Chapter 6 6.1

Compatibility summary...

63

6.2

Detergent solution ...

65

6.3

Disinfectant solution ...

66

6.4

Rinsing water ...

66

6.5

ETO gas sterilization ...

67

6.6

Steam sterilization (autoclaving) of accessories ...

69

Chapter 7

Cleaning, Disinfection and Sterilization Procedures ... 70

7.1

Required reprocessing equipment ...

71

7.2

Cleaning, disinfection and sterilization procedures ...

79

7.3

Precleaning ...

80

7.4

Leakage testing...

84

7.5

Manual cleaning ...

89

7.6

High-level disinfection ...

102

7.7

Rinsing after high-level disinfection...

105

7.8

Sterilization ...

108

7.9

Cleaning, disinfection and sterilization procedures for reusable parts and reprocessing equipment... 110

Chapter 8

ii

Compatible Reprocessing Methods and Chemical Agents... 63

Cleaning and Disinfection Equipment ... 118

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Contents

Chapter 9

Storage and Disposal... 120

9.1

Storage of the endoscope...

120

9.2

Storage of reusable parts and reprocessing equipment ...

121

9.3

Disposal ...

121

Chapter 10 Troubleshooting ... 122 10.1 Troubleshooting guide ...

122

10.2 Withdrawal of the endoscope with an abnormality...

127

10.3 Returning the endoscope for repair ...

128

Appendix ... 129 System chart ...

129

Acoustic output table...

133

EMC information ...

135

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Contents

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ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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.

Do not reuse.

Use by (expiration) date.

TYPE BF applied part.

Ultrasonic endoscope.

Sterilized using ethylene oxide.

Sterilization lot number.

Lot number

Lock the ultrasonic connector

Release the ultrasonic connector

Manufacturer

Authorised representative in the European community

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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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 diagnostic ultrasound system (ALOKA CO., LTD), video system center, light source, documentation equipment, video monitor, endo-therapy accessories and other ancillary equipment for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts, 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 risk (their natures, 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.

2

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Important Information - Please Read Before Use

Instruction manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use 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, please contact Olympus.

User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, 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.

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 2 (IEC 60601-1-2: 2001). 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.

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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Important Information - Please Read Before Use

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 Chapters 5 through 9. 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 re-sterilize a balloon.

Maintenance management The probability of failure of the endoscope and ancillary equipment increases as the number of procedure 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 which an irregularity is suspected should not be used, but should be inspected by following the Section 10.1, “Troubleshooting guide”. If the irregularity is still suspected 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 which 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.

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ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Important Information - Please Read Before Use

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.

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.

•

Never use high frequency endo-therapy accessories, because the distal end of this instrument is not insulated. Using high-frequency accessories places the patient at the risk of an electric shock.

•

After using this instrument, reprocess and store it according to the instructions given in Chapters 7 through 9. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

•

Never perform angulation control forcibly or suddenly. Never forcefully pull, twist or rotate the angulated bending section. Patient injury, bleeding and/or perforation can result.

•

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

•

Never insert or withdraw the insertion tube abruptly or with excessive force. Patient injury, bleeding and/or perforation can result.

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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Important Information - Please Read Before Use

6

•

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.

•

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.

•

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.

•

This endoscope is not intended for fetal use.

•

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 into a diameter of less than 12 cm. Equipment damage can result and/or the ultrasonic image will be abnormal.

•

Do not coil the ultrasonic cable into a diameter of less than 12 cm. Equipment damage can result.

•

Do not touch the electrical contacts inside the electrical connector. CCD damage can result.

•

Do not apply shock to the distal end of the insertion tube, particularly the ultrasonic transducer and the objective lens surface at the distal end. This could cause abnormalities in the visual and/or ultrasonic images.

•

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.

•

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 OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Turn the video system center ON or OFF only when the videoscope cable is connected to

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Important Information - Please Read Before Use

both the video system center and 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 may 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 attempt to bend the endoscope’s insertion tube with excessive force. Otherwise, the insertion tube may be damaged.

•

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

•

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

•

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

•

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.

•

It is highly desirable that a backup endoscope 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 CV-160.

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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Important Information - Please Read Before Use

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 given 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 and/or withdraw the endoscope. 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 endo-therapy 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.

Natural rubber latex medical alert Balloons used with this instrument contain natural rubber latex which may cause allergic reactions in some patients. Do not use the balloon on a latex-sensitive patient. Instead, perform the procedure using “The sterile de-aerated water immersion method” described in Section 4.2, “Observation of the ultrasonic image”.

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ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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 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”.

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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Chapter 1 Checking the Package Contents

Endoscope

Balloon 2 for countries other than the USA (MH-303, non-sterile, 20 pcs.) Balloon 3 for the USA (MAJ-233, sterile, 20 pcs)

Air/water valve (MAJ-1444)

Suction valve (MAJ-1443)

Injection tube (MH-946) Mouthpiece (MB-142, 2 pcs.)

Channel plug (MAJ-621)

Balloon applicator (MAJ-864)

Channel-opening cleaning brush (MH-507) Suction cleaning adapter (MH-856) Channel cleaning brush (BW-20T)

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

Water-resistant cap (MH-553)

10

Biopsy valve (MB-358, 10 pcs.)

Chain for water-resistant cap (MAJ-1119)

Water-resistant cap (MAJ-896)

Air/water channel cleaning adapter (MAJ-629)

Instruction manual

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Chapter 1 Checking the Package Contents

1.2

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-UE160-AL5

MAJ-233

Table 1.1

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

Ultrasonic cable

Universal cord

13. Ultrasonic connector 14. Suction connector

11. Water supply connector and air supply connector

15. Electrical connector

12. Endoscope connector 16. Chain connector

Electrical contacts Water-resistant cap (MAJ-896)

12

Water-resistant cap (MH-553)

Air pipe Light guide

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Chapter 2 Instrument Nomenclature and Specifications

3. Suction valve (MAJ-1443)

2. UP/DOWN angulation lock

4. Air/water valve (MAJ-1444)

5. UP/DOWN angulation control knob

6. RIGHT/LEFT angulation control knob 7. RIGHT/LEFT angulation lock

Control section

Suction cylinder Air/water cylinder

Grip section 10. Color code (blue)

Biopsy valve (MB-358) Boot Instrument channel 8. Instrument channel port Insertion tube limit mark Working length

Distal end 9. Bending section

1. Remote switches 1 to 4 Insertion tube

Ultrasonic transducer Top view Balloon water feeding and aspiration ports are in this groove

Balloon attachment groove

Light guide lens Nozzle

Instrument channel outlet

Objective lens Detail of distal end

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Remote switches 1 to 4 The functions of the remote switches 1 to 4 can be selected on the video system center. When selecting the functions, refer to the instruction manual for the video system center. 2. UP/DOWN angulation lock Moving the lock in the “F

” direction frees angulation. Moving the lock in

the opposite direction locks the bending section at any desired position. 3. Suction valve 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 the water from the balloon through the balloon channel. 4. Air/water valve 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. 5. UP/DOWN angulation control knob When the 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. 6. RIGHT/LEFT angulation control knob When the 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. 7. RIGHT/LEFT angulation lock Turning the lock in the “F

” direction frees angulation. Turning the lock in

the opposite direction locks the bending section at any desired position. 8. Instrument channel port The instrument channel port functions as: − channel for the insertion of endo-therapy accessories − de-aerated water feed channel (from the water supply unit or a syringe via the biopsy valve) 9. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN and RIGHT/LEFT angulation control knobs are operated.

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ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Chapter 2 Instrument Nomenclature and Specifications

10. Color code (blue) The color code is used to quickly determine the compatibility of endo-therapy accessories. The endoscope can be used with endo-therapy accessories that have the same color code. 11. Water supply connector and air supply connector The water supply connector and the air supply connector connect the endoscope to the water container via the water container tube, to supply water and pressurized air to the distal end of the endoscope. 12. Endoscope connector The endoscope connector connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope. 13. Ultrasonic connector The ultrasonic connector connects the endoscope to the diagnostic ultrasound system. 14. Suction connector The suction connector connects the endoscope to the suction tube of the suction pump. 15. Electrical connector The electrical connector connects the endoscope to the video system center via the videoscope cable. 16. Chain connector This connector connects the fitting part of the chain for water-resistant cap. Do not connect the S-cord of the electrosurgical unit here.

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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