GF-UC240 and GF240P-AL5 ULTRASONIC GASTROVIDEOSCOPE Instructions July 2014

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 ...

4

Reprocessing and storage ...

5

Maintenance management ...

5

Prohibition of improper repair and modification ...

5

Repair and modification ...

6

Signal words ...

6

Warnings and cautions ...

6

Chapter 1

Checking the Package Contents...

10

1.1

Standard components...

10

1.2

Optional components ...

12

Instrument Nomenclature and Specifications ...

14

2.1

Nomenclature...

14

2.2

Endoscope functions...

16

2.3

Specifications...

18

Preparation and Inspection ...

21

3.1

Preparation of the equipment...

21

3.2

Preparation and inspection of the endoscope...

23

3.3

Preparation and inspection of accessories ...

25

3.4

Attaching accessories to the endoscope ...

28

3.5

Preparation, inspection and connection of ancillary equipment...

30

3.6

Inspection of the endoscopic system ...

34

3.7

Preparation and inspection of the balloon...

37

Operation ...

41

4.1

Insertion ...

42

4.2

Observation of the ultrasound image ...

46

4.3

Using endo-therapy accessories...

48

4.4

Withdrawal of the endoscope...

52

4.5

Transportation of the endoscope ...

53

Chapter 2

Chapter 3

Chapter 4

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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Contents

Chapter 5

Reprocessing: General Policy...

54

5.1

Instructions...

54

5.2

Precautions ...

55

Chapter 6

Compatible Reprocessing Methods and Chemical Agents ... 58

6.1

Compatibility summary...

58

6.2

Detergent solution ...

60

6.3

Disinfectant solution ...

60

6.4

Rinsing water ...

61

6.5

ETO gas sterilization ...

61

6.6

Steam sterilization (autoclaving) of accessories ...

63

Cleaning, Disinfection and Sterilization Procedures ...

65

7.1

Required reprocessing equipment ...

65

7.2

Cleaning, disinfection and sterilization procedures ...

75

7.3

Precleaning ...

77

7.4

Leakage testing...

82

7.5

Manual cleaning ...

86

7.6

High-level disinfection ...

99

7.7

Rinsing after high-level disinfection...

101

7.8

Sterilization ...

104

7.9

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

105

Chapter 7

Chapter 8

Cleaning and Disinfection Equipment ... 111

Chapter 9

Storage and Disposal ... 113

9.1

Storage ...

113

9.2

Disposal ...

113

Chapter 10 Troubleshooting ... 114 10.1 Troubleshooting guide ...

114

10.2 Returning the endoscope for repair...

119

Appendix... 121

ii

System chart ...

121

Inspection of the endoscope after cleaning, disinfection or sterilization in accordance with IEC 60601-2-37 ...

128

Acoustic output tables ...

130

EMC information...

132

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-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. Caution TYPE BF applied part Serial number IPX7

Ingress protection rating (except for connectors) Lock the ultrasonic connector Release the ultrasonic connector Ultrasonic endoscope Single use only Do not resterilize Use by (expiration date) Sterilized using ethylene oxide Sterilization lot number Lot number Non-sterile Keep away from sunlight Keep dry

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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Symbols

Do not use if package is damaged Contains or Presence of Natural Rubber Latex Date of manufacture

Manufacturer

Authorized representative in the European Community

2

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This instrument has been designed to be used with the diagnostic ultrasound system ProSound SSD-5500/SSD-5000/SSD-4000/SSD-5/SDD-10/F75 (ALOKA CO., LTD.), EVIS video system center, Olympus light source, documentation equipment, video monitor, endo-therapy accessories (such as aspiration biopsy needles) and electrosurgical unit. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. 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.

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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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.

 Terms used in this manual 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 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. This manual, therefore, does not explain or discuss clinical endoscopic procedures.

Instrument compatibility Refer to “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 injury or equipment damage. This instrument complies with EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001) and 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.

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ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

Important Information - Please Read Before Use

Reprocessing and storage 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”. After using this instrument, reprocess and store it according to the instructions given in Chapters 5 through 8. 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 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 114. 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.

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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Important Information - Please Read Before Use

Repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 10, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 10, contact Olympus.

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.

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•

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

•

Never perform angulation control, feed air, perform suction or insert/withdrawal the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can 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 injury can result.

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

Important Information - Please Read Before Use

•

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. Otherwise, patient injury, bleeding, and/or perforation could result.

•

Never operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube while the image is frozen. Patient injury can result.

•

This endoscope is not intended for fetal use.

•

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.

•

Do not pull the universal cord. 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, universal cord or 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 may 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. Visual abnormalities may result.

•

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.

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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Important Information - Please Read Before Use

•

Turn the EVIS video system center OFF before connecting or disconnecting the videoscope cable from electrical connector on the endoscope. Turn the EVIS video system center ON or OFF only when the videoscope cable is connected to both the video system center and 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 or pulling them with excessive force can break the switches.

•

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 connector.

•

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

•

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.

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.

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•

Over-insufflating the lumen may cause patient pain and/or perforation.

•

Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and infection.

•

Applying prolonged suction with the distal end in contact with the mucosal surface may cause bleeding or suction lesions.

•

Retroflexing the endoscope within the esophagus or duodenal bulb may cause mucosal trauma or impaction of the endoscope.

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

Important Information - Please Read Before Use

•

Inserting and using endo-therapy accessories without a clear endoscopic view may cause burns or perforation.

•

Patient injury may be caused by:  inserting or withdrawing the endoscope, feeding air or applying suction without a clear endoscopic image  withdrawing the endoscope with the angulation controls locked  forcefully pulling, twisting or rotating the angulated bending section

To prevent unnecessary patient exposure to ultrasonic radiation, follow the “as-low-as-reasonably achievable” (ALARA) principal when using Acoustic Imaging 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 into the patient.

Natural rubber latex medical alert Balloons used with this instrument contain natural rubber latex which may cause allergic reactions. 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 ultrasound image”, in Chapter 4, “Operation”.

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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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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ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

Chapter 1 Checking the Package Contents

Endoscope

Mouthpiece (MB-142, 2 pcs)

Balloon (MAJ-213) Injection tube (MH-946) Channel plug (MAJ-621)

Balloon applicator (MAJ-675)

Cleaning adapter for instrument channel port (MAJ-350) Channel cleaning brush (BW-20T)

Suction cleaning adapter (MH-856) Channel cleaning brush (BW-7L, 2 pcs1) Single use single-ended cleaning brush (BW-400L, 3 pcs1)

Biopsy valve (MAJ-853, non-sterile, 10 pcs)

Channel-opening cleaning brush (MH-507) Air/water channel cleaning adapter (MAJ-629)

Water-resistant cap (MH-553)

Washing tube (MH-974)

Water-resistant cap (MAJ-896)

Instruction manual

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

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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Chapter 1 Checking the Package Contents

1.2

Optional components The items listed below is optional, 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-UC240P-AL5, GF-UCT240-AL5

MAJ-249

Table 1.1

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ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

Chapter 1 Checking the Package Contents

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature Universal cord Ultrasonic cable

2. Suction connector

1. Ultrasonic connector

3. Air supply connector 3. Water supply connector 4. Endoscope connector 5. S-cord connector mount Product number and serial number

6. Electrical connector

Electrical contact points Air pipe

Water-resistant cap

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Light guide

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

Chapter 2 Instrument Nomenclature and Specifications

9. UP/DOWN angulation lock 10. Elevator channel plug

8. UP/DOWN angulation control knob 7. Elevator control lever

Suction cylinder 12. Suction valve (MAJ-1443) 13. Air/water valve (MAJ-1444)

Air/water cylinder 14. RIGHT/LEFT angulation control knob

Control section

15. RIGHT/LEFT angulation lock 18. Color code Biopsy valve (MAJ-853) <non-sterile> 16. Instrument channel port Boot

Ultrasonic transducer

Insertion tube limit mark

Balloon water supply port is in the groove

Distal end

Balloon attachment groove

17. Bending section

Light guide lens

Nozzle Objective lens Forceps elevator Instrument channel outlet

Insertion tube

Working length Detail of distal end 11. Remote switches Top view

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Ultrasonic connector The ultrasonic connector connects the endoscope to the diagnostic ultrasound system. 2. Suction connector The suction connector connects the endoscope to the suction tube of the suction pump. 3. 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 at the distal end of the endoscope. 4. 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. 5. S-cord connector mount The 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. 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. 6. Electrical connector The electrical connector connects the endoscope to the EVIS video system center via the videoscope cable. 7. Elevator control lever When this lever is turned in the “ U” direction, the forceps elevator is raised. When turned in the opposite direction, the forceps elevator is lowered. 8. UP/DOWN angulation control knob When turned in the “ U” direction, the bending section moves UP; when turned in the “D ” direction, the bending section moves DOWN. 9. UP/DOWN angulation lock Pushing this lever in the “F ” direction frees angulation. Pushing the lever in the opposite direction locks the bending section at any desired position. 10. Elevator channel plug The elevator channel plug is used for connection of the washing tube to clean and disinfect the elevator wire channel.

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ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

Chapter 2 Instrument Nomenclature and Specifications

11. Remote switches 1 to 4 The functions of the remote switches 1 to 4 can be selected on the EVIS video system center. When selecting the functions, refer to the instruction manual for the EVIS video system center. 12. 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. 13. 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. 14. RIGHT/LEFT angulation control knob When turned in the “R ” direction, the bending section moves RIGHT; when turned in the “ L” direction, the bending section moves LEFT. 15. 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. 16. Instrument channel port The instrument channel port functions as:  channel for the insertion of endo-therapy accessories  suction channel  de-aerated water feed channel (from the water supply unit via the biopsy valve) 17. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN and RIGHT/LEFT angulation control knobs are operated. 18. Color code 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. • Yellow:

GF-UC240P-AL5

• Orange:

GF-UCT240-AL5

ULTRASONIC GASTROVIDEOSCOPE GF-UC240P-AL5/GF-UCT240-AL5

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