GF-UE160-AL5 ULTRASONIC GASTROVIDEOSCOPE Instructions Nov 2018

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

Maintenance management ...

5

Prohibition of improper repair and modification...

6

Signal words ...

6

Warnings and cautions ...

6

Examples of inappropriate handling...

10

Natural rubber latex medical alert ...

10

Chapter 1

Checking the Package Contents...

11

1.1

Standard components...

11

1.2

Optional components ...

13

Instrument Nomenclature and Specifications ...

14

2.1

Nomenclature...

14

2.2

Endoscope functions...

16

2.3

Specifications...

18

2.4

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

20

Preparation and Inspection ...

23

3.1

Preparation of the equipment...

23

3.2

Inspection of the endoscope ...

25

3.3

Preparation and inspection of accessories ...

28

3.4

Attaching accessories to the endoscope ...

31

3.5

Inspection and connection of ancillary equipment ...

33

3.6

Inspection of the endoscopic system ...

37

3.7

Preparation and inspection of the balloon...

42

Chapter 2

Chapter 3

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Contents

Chapter 4

Operation...

47

4.1

Insertion ...

49

4.2

Observation of the ultrasonic image...

53

4.3

Using endo-therapy accessories...

55

4.4

Withdrawal of the endoscope...

58

4.5

Removal of the balloon ...

59

4.6

Transportation of the endoscope ...

60

Reprocessing: General Policy...

62

5.1

Instructions...

62

5.2

Importance of cleaning, disinfection and sterilization...

62

5.3

Precautions ...

63

5.4

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

66

Compatible Reprocessing Methods and Chemical Agents...

67

6.1

Compatibility summary...

67

6.2

Detergent solution ...

69

6.3

Disinfectant solution ...

70

6.4

Rinsing water ...

70

6.5

ETO gas sterilization ...

71

6.6

Steam sterilization (autoclaving) of accessories ...

73

Cleaning, Disinfection and Sterilization Procedures ...

74

7.1

Required reprocessing equipment ...

75

7.2

Cleaning, disinfection and sterilization procedures ...

83

7.3

Precleaning ...

84

7.4

Leakage testing...

88

7.5

Manual cleaning ...

93

7.6

High-level disinfection ...

106

7.7

Rinsing after high-level disinfection...

109

7.8

Sterilization ...

112

7.9

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

114

Chapter 5

Chapter 6

Chapter 7

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ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Contents

Chapter 8

Cleaning and Disinfection Equipment... 122

Chapter 9

Storage and Disposal... 124

9.1

Storage of the endoscope...

124

9.2

Storage of reusable parts and reprocessing equipment ...

125

9.3

Disposal ...

125

Chapter 10 Troubleshooting ... 126 10.1 Troubleshooting guide ...

126

10.2 Withdrawal of the endoscope with an abnormality...

131

10.3 Returning the endoscope for repair ...

132

Appendix ... 133 System chart ...

133

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

137

Acoustic output table...

139

EMC information ...

141

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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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. 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-UE160-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

For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf

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ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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 an diagnostic ultrasound system (Hitachi, 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.

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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 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.

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ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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 the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable.

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.

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

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Important Information - Please Read Before Use

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.

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 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.

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Important Information - Please Read Before Use

•

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.

•

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.

•

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.

•

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.

•

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.

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Important Information - Please Read Before Use

•

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, Ltd.) in Canada.

8

•

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.

•

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.

ULTRASONIC GASTROVIDEOSCOPE GF-UE160-AL5

Important Information - Please Read Before Use

•

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 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.

•

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”.

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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) Balloon applicator (MAJ-864)

Mouthpiece (MB-142, 2 pcs.)

Channel plug (MAJ-621) Channel-opening cleaning brush (MH-507)

Suction cleaning adapter (MH-856)

Channel cleaning brush (BW-20T) Biopsy valve (MB-358, 10 pcs.)

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

Chain for water-resistant cap (MAJ-1119)

Water-resistant cap (MH-553)

Water-resistant cap (MAJ-896)

Air/water channel cleaning adapter (MAJ-629)

Instruction manual

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

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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

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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)

14

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

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