EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE Instructions

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

3

Intended use ...

3

Instruction manual ...

3

User qualifications ...

3

Instrument compatibility ...

4

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

4

Prohibition of improper repair and modification ...

4

Signal words...

5

Warnings and cautions ...

5

Examples of inappropriate handling...

8

Chapter 1

Checking the Package Contents...

9

1.1

Standard components...

9

1.2

Optional components ...

10

Instrument Nomenclature and Specifications ...

12

2.1

Nomenclature...

12

2.2

Endoscope functions...

14

2.3

Specifications...

16

Preparation and Inspection ...

19

3.1

Preparation of the equipment...

20

3.2

Inspection of the endoscope ...

21

3.3

Preparation and inspection of accessories ...

23

3.4

Attaching accessories to the endoscope ...

28

3.5

Inspection and connection of ancillary equipment ...

30

3.6

Inspection of the endoscopic system ...

34

3.7

Preparation and inspection of the balloon...

38

Operation ...

45

4.1

Insertion ...

47

4.2

Observation of the ultrasonic image ...

51

4.3

Using EndoTherapy accessories ...

52

4.4

Withdrawal of the endoscope...

56

4.5

Transportation of the endoscope ...

57

Chapter 2

Chapter 3

Chapter 4

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Contents

Chapter 5

Reprocessing: General Policy...

58

5.1

Instructions...

58

5.2

Notes for Cleaning, Disinfection and Sterilization ...

58

5.3

Precautions ...

59

Chapter 6

Compatible Reprocessing Methods and Chemical Agents... 62

6.1

Compatibility summary...

62

6.2

Detergent solution ...

64

6.3

Disinfectant solution ...

64

6.4

Rinsing water ...

64

6.5

ETO gas sterilization ...

65

6.6

Steam sterilization (autoclaving) of accessories ...

66

Chapter 7

Cleaning, Disinfection and Sterilization Procedures 68

7.1

Required reprocessing equipment ...

68

7.2

Cleaning, disinfection and sterilization procedures ...

74

7.3

Precleaning ...

76

7.4

Leakage testing...

79

7.5

Manual cleaning ...

83

7.6

High-level disinfection ...

92

7.7

Rinsing after high-level disinfection...

95

7.8

Sterilization ...

99

7.9

Cleaning, disinfection and sterilization procedures for reusable parts and cleaning equipment ... 100

Chapter 8

Cleaning and Disinfection Equipment ... 109

Chapter 9

Storage and Disposal ... 111

9.1

Storage of the endoscope ...

111

9.2

Storage of reusable parts and reprocessing equipment ...

112

9.3

Disposal ...

112

Chapter 10 Troubleshooting ... 113

ii

10.1 Troubleshooting guide ...

114

10.2 Withdrawal of the endoscope with an abnormality...

117

10.3 Returning the endoscope for repair...

118

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

Contents

Appendix ... 119 System chart ...

119

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

123

About the acoustic output table...

125

EMC information ...

127

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Contents

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ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

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

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

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Symbols

Keep away from sunlight

Keep dry

Do not use if package is damaged

Contains or Presence of Natural Rubber Latex

Manufacturer

Authorized representative in the European Community

2

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

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 compact endoscopic ultrasound center, video system center, light source, documentation equipment, video monitor, EndoTherapy accessories and other ancillary equipment. This instrument is designed for endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways and trancheobronchial tree. Do not use this instrument for any purpose other than its intended 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 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.

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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 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.

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, “Reprocessing: General Policy” through 9, “Storage and Disposal”. 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.

Prohibition of improper repair and modification Never repair by persons other than Olympus-qualified technicians or modify the instrument, as this may result in injury of the patient or operator as well as equipment damage to the equipment. 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.

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ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

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.

•

This endoscope has a “forward oblique” view. There is a difference between the direction of view and the insertion direction of the endoscope. The insertion direction appears in the lower portion of the endoscopic view, and the visible area in that direction is limited. Always view the endoscopic image carefully, and insert the endoscope prudently. Otherwise, patient injury may occur.

•

Never perform angulation control, perform suction, insert or withdraw 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.

•

Regardless of the flexibility of the endoscope’s insertion tube, do not attempt to bend it with excessive force. Otherwise, patient injury could result.

•

This endoscope is not intended for fetal use.

•

Clean and disinfect or sterilize the endoscope as described in Chapter 5 through 8 of this manual, before use.

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Important Information - Please Read Before Use

6

•

Never perform high-suction continuously. Patient injury can result.

•

Never tie the elastic opening of both sides of the balloon with a thread. This may cause the balloon to rupture or come off the distal end of the endoscope when inflating it excessively. This can result in patient injury.

•

Never inflate the balloon to a diameter of more than 20 mm when using the endoscope in the trachea. This could result in suffocation of the patient.

•

Never withdraw the endoscope while the balloon is still inflated. Otherwise, the balloon may burst or come off the distal end of the endoscope. If the balloon cannot be deflated, insert the channel cleaning wire into the irrigation port. Using slow, short strokes, carefully feed the wire to remove debris.

•

When withdrawing the endoscope, make sure that the balloon is completely deflated, using the ultrasonic image and endoscopic field of view. Withdrawing the endoscope while the balloon is inflated could result in patient injury.

•

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.

•

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 and/or the ultrasonic image will be abnormal.

•

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.

•

The cover of the irrigation port part cannot be removed. Equipment damage can result.

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

Important Information - Please Read Before Use

•

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.

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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 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.

•

Inserting and using EndoTherapy accessories without a clear endoscopic image may cause patient injury.

•

Patient injury may be caused by: − inserting or withdrawing the endoscope or applying suction without a clear endoscopic image − forcefully pulling or rotating the angulated bending section

The system limits the surface temperature of the transducer to 40°C. The surface temperature is limited by means of a power monitor protection circuit that protects against the electrical current exceeding established specifications. If the power monitor protection circuit detects a current overload, the transducer shits off immediately, preventing over-heating of the surface.

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 this instrument on a latex-sensitive patient.

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ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

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”.

Endoscope

Cap chain (MAJ-1193) Water-resistant cap (MH-553) Channel cleaning wire (BW-16C, 2 pieces) Single-use suction valve (MAJ-209, 20 pcs) or Suction valve (MAJ-207, 10 pcs)

Single-use biopsy valve (MAJ-210, 20 pcs) or Biopsy valve (MD-495, 10 pcs) Channel cleaning brush (BW-15B) Channel-opening cleaning brush (MH-507)

Instruction manual

Suction cleaning adapter (MAJ-222)

Balloon (MAJ-1351, 20 pieces, sterile)

Water-resistant cap (MAJ-1057)

Balloon applicator (MAJ-1352)

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Chapter 1 Checking the Package Contents

1.2

Optional components The items listed below are optional, and may be possible to purchased from Olympus.

Suction valve  For the U.S.A. only

Single-use suction valve (MAJ-209)

 For countries other than the U.S.A.

Suction valve (MAJ-207)

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ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

Chapter 1 Checking the Package Contents

Biopsy valve  For the U.S.A. and Europe

Single-use biopsy valve (MAJ-210)

 For countries other than the U.S.A. and Europe

Cap

Main body Biopsy valve (MD-495)

Balloon

Front band

Rear band Balloon (MAJ-1351)

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature Universal cord

Ultrasonic cable

Water-resistant cap (MAJ-1057)

1. Ultrasonic connector

2. Endoscope connector

Product number and serial number Electrical contact points 3. Electrical connector Water-resistant cap (MH-553)

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Light guide

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

Chapter 2 Instrument Nomenclature and Specifications

9. Remote switches

Suction cylinder

9. Remote switches

4. Suction valve (MAJ-207) or Single-use suction valve (MAJ-209, for U.S.A.)

Top view

10. UP/DOWN angulation control lever Slit Control section

5. Single-use biopsy valve (MAJ-210, for U.S.A. and Europe) or Biopsy valve (MD-495)

6. Instrument channel port

7. Irrigation port Boot

Balloon groove

Light guide

Insertion tube/working length

Objective lens Instrument channel outlet

Ultrasonic transducer

Detail of distal end

Balloon water feeding and suction port

Distal end 8. Bending section

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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 endoscopic ultrasound center. 2. 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. 3. Electrical connector The electrical connector connects the EVIS video system center via the videoscope cable. 4. Suction valve (MAJ-207) or Single-use suction valve (MAJ-209, for U.S.A.) The suction valve is depressed to activate suction. The valve is also used to remove any fluid or debris adhering to the objective lens.

•

Use of the suction valve (MAJ-207) is not recommended for more than 6 procedures.

•

The single-use suction valve (MAJ-209) is designed for a single use only. Do not reuse or attempt to resterilize it.

5. Single-use biopsy valve (MAJ-210, for U.S.A. and Europe) or Biopsy valve (MD-495) Accessories may be inserted through the slit in this valve. When using the single-use biopsy valve (MAJ-210), a syringe may be inserted for the introduction of fluids.

The single-use biopsy valve (MAJ-210) is designed for a single use only. Do not attempt to reuse or resterilize it. 6. Instrument channel port The instrument channel port functions as: •

channel for insertion of EndoTherapy accessories.

•

suction channel

•

fluid feed channel (from a syringe via the biopsy valve)

7. Irrigation port Connects an extension tube, a three-way stopcock or a syringe to feed water in the balloon or suck water from the balloon through the balloon channel.

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ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC160F-OL8

Chapter 2 Instrument Nomenclature and Specifications

8. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated. 9. Remote switches 1 to 4 The functions of 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. 10. UP/DOWN angulation control lever When the lever is moved in the “U” direction, the bending section moves UP; when the lever is moved in the “D” direction, the bending section moves DOWN.

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