BF-UC180F ULTRASONIC BRONCHOFIBERVIDEOSCOPE Instructions

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

Spare equipment ...

4

Maintenance management ...

4

Prohibition of improper repair and modification ...

4

Signal words...

5

Warnings and cautions ...

5

Examples of inappropriate handling...

9

Chapter 1

Checking the Package Contents...

10

1.1

Standard components...

10

1.2

Ultrasonic cable ...

11

1.3

Optional components ...

12

Instrument Nomenclature and Specifications ...

14

2.1

Nomenclature...

14

2.2

Endoscope functions...

16

2.3

Specifications...

17

2.4

Attaching the cap chain (MAJ-1723)...

21

Preparation and Inspection ...

24

3.1

Preparation of the equipment...

25

3.2

Inspection of the endoscope ...

26

3.3

Preparation and inspection of accessories ...

28

3.4

Attaching accessories to the endoscope ...

34

3.5

Inspection and connection of ancillary equipment ...

38

3.6

Inspection of the endoscopic system ...

44

3.7

Preparation and inspection of the balloon...

49

Chapter 2

Chapter 3

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

i

Contents

Chapter 4

Operation...

55

4.1

Insertion ...

58

4.2

Observation of the ultrasonic image...

62

4.3

Using EndoTherapy accessories ...

63

4.4

Withdrawal of the endoscope...

65

4.5

Removal of the balloon ...

66

4.6

Transportation of the endoscope ...

68

Reprocessing: General Policy...

69

5.1

Instructions...

69

5.2

Importance of cleaning, disinfection, and sterilization...

69

5.3

Precautions ...

70

Compatible Reprocessing Methods and Chemical Agents...

73

6.1

Compatibility summary...

73

6.2

Detergent solution ...

75

6.3

Disinfectant solution ...

76

6.4

Rinse water ...

76

6.5

Ethylene oxide gas sterilization...

77

6.6

Steam sterilization (autoclaving) of accessories ...

79

Cleaning, Disinfection, and Sterilization Procedures...

80

7.1

Required reprocessing equipment ...

81

7.2

Cleaning, disinfection, and sterilization procedures ...

89

7.3

Precleaning ...

90

7.4

Leakage testing...

94

7.5

Manual cleaning ...

100

7.6

High-level disinfection ...

111

7.7

Rinsing after high-level disinfection...

113

7.8

Sterilization ...

117

7.9

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

118

7.10 Care of the ultrasonic cable (MAJ-1597, MAJ-1722) ...

128

Chapter 5

Chapter 6

Chapter 7

Chapter 8

ii

Cleaning and Disinfection Equipment ... 129

8.1

Set up the endoscope to the cleaning tub (OER-A) ...

131

8.2

Set up the endoscope to the cleaning tub (OER-AW)...

133

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

Contents

Chapter 9

Storage and Disposal... 135

9.1

Storage of the endoscope...

135

9.2

Storage of reusable parts and reprocessing equipment ...

136

9.3

Storage of ultrasonic cable ...

136

9.4

Disposal ...

136

Chapter 10 Troubleshooting ... 137 10.1 Troubleshooting guide ...

138

10.2 Withdrawal of the endoscope with an irregulality...

141

10.3 Returning the endoscope for repair ...

142

Appendix A: System Chart ... 143 Appendix B: EMC information... 146 Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” ... 150 Acoustic output table with Olympus compact endoscopic ultrasound center ...

150

Acoustic output table with Aloka diagnostic ultrasound system ...

152

Clinical measurement accuracy with Aloka diagnostic ultrasound system

157

Appendix D: Acoustic Output Information Accordance with IEC 60601-2-37 ... 158 Acoustic output table with Olympus compact endoscopic ultrasound center ...

158

Acoustic output table with Aloka diagnostic ultrasound system ...

158

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

iii

Contents

iv

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

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

Authorized representative in the European Community IPX7

Ingress protection rating (except for connectors)

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

1

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 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 ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus 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.

2

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

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 that 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 or pulmonology, 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 by following guidelines set by academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment.

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.

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

3

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, “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 resterilize a balloon.

Spare equipment Be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.

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 138. 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 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.

4

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

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 section without viewing the endoscopic image. Patient injury 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 injury may result.

•

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

•

This endoscope is not intended for fetal use.

•

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

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

5

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 detach from the distal end of the endoscope when inflating it, and could 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 detach from the distal end of the endoscope. If the balloon cannot be deflated, insert the channel cleaning brush (BW-7B) into the irrigation port. Using slow, short strokes, carefully feed the brush 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.

•

Transnasal insertion is accompanied by the risk of inflammation of the nasal cavity. If this happens, the nasal passage will be constricted, making it more difficult to withdraw the endoscope. In this case, do not use force to withdraw the endoscope because patient injury such as bleeding or perforation may result.

•

Transnasal insertion is accompanied by the risk of bleeding in the nasal cavity. Be sure to be prepared to deal with any bleeding. When withdrawing the endoscope, observe the inside of the nasal cavity to ensure that there is no bleeding. Even when the endoscope has been withdrawn without bleeding, do not allow the patient to blow his or her nose strongly because this could cause it to start bleeding.

•

Before transnasal insertion, apply the appropriate pretreatment and lubrication to the patient to enlarge the nasal cavity. Otherwise, patient injury can result or the endoscope could become lodged and be difficult to withdraw. Otherwise, the treatment will have no effect. The effects of the pretreatment agent and lubricant will decrease the longer the procedure lasts. Apply the pretreatment agent or lubricant as required during the procedure – for example, when withdrawal seems to be difficult.

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

Important Information - Please Read Before Use

•

Transnasal insertion of the endoscope should be performed carefully. If resistance to insertion is felt, or the patient reports pain, stop insertion immediately. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw.

•

If it becomes impossible to withdraw the transnasally inserted endoscope, detach the ultrasonic cable from the ultrasonic cable connector, pull its distal end out of the mouth, cut the flexible tube using wire cutters and, after ensuring that the cut section will not injure the body cavity or nasal cavity of the patient, withdraw the endoscope carefully. Therefore, always prepare wire cutters in advance.

•

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 section, 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 section, 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.

•

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 section with excessive force. Otherwise, the insertion section 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.

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

7

Important Information - Please Read Before Use

8

•

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 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.

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

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. •

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 with higher suction pressure than required or with prolonged suction time may cause bleeding or suction lesions.

•

Inserting, withdrawing 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.

Natural rubber latex medical alert Balloons used with this instrument contain natural rubber latex that may cause allergic reactions in some patients. Do not use this instrument on a latex-sensitive patient.

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

9

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

Water-resistant cap (MH-553, 2 pcs) Channel cleaning brush (BW-7B, 2 pieces)

Cap chain (MAJ-1723)

Single use adapter biopsy valve (MAJ-1414, 10 pcs, sterile)

Channel-opening cleaning brush (MH-507) or single use channel-opening cleaning brush (MAJ-1339, 3 pcs)

Suction cleaning adapter (MAJ-222)

10

Channel cleaning brush (BW-15B) or single-use channel cleaning brush (BW-201B, 3 pcs)

Balloon (MAJ-1351, 20 pieces, sterile)

Balloon applicator (MAJ-1352)

Single-use suction valve (MAJ-209, 20 pcs, sterile) or suction valve (MAJ-207, 10 pcs)

Instruction manual

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

Chapter 1 Checking the Package Contents

1.2

Ultrasonic cable The ultrasonic cable (MAJ-1722, MAJ-1597) is necessary to use this endoscope (BF-UC180F). The ultrasonic cable is optional, and may be purchased from Olympus.

 For the Olympus compact endoscopic ultrasound center

Endoscope-side connector Ultrasonic connector

Ultrasonic cable (MAJ-1722)

 For the diagnostic ultrasound system (ALOKA CO., LTD)

Endoscope-side connector

Ultrasonic connector Ultrasonic cable (MAJ-1597)

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

11

Chapter 1 Checking the Package Contents

1.3

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

Biopsy valve  For the U.S.A.

Single-use biopsy valve (MAJ-210)

 For countries other than the U.S.A.

Cap

Main body Biopsy valve (MD-495)

12

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

Chapter 1 Checking the Package Contents

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

13

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature Universal cord

1. Ultrasonic cable connector

2. Endoscope connector

Water-resistant cap (MH-553) 3. Videoscope cable connector

Product number and serial number Electrical contact points

Light guide

14

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

Chapter 2 Instrument Nomenclature and Specifications

9. Remote switches Suction cylinder

9. Remote switches

4. Suction valve (MAJ-207 for the countries other than the U.S.A.) or single-use suction valve (MAJ-209, for the U.S.A.)

Top view

Suction cylinder

10. UP/DOWN angulation control lever

Slit Control section 5. Single use adapter biopsy valve (MAJ-1414) Instrument channel

6. Instrument channel port Balloon channel

7. Irrigation port Boot

Balloon groove

Light guide

insertion section/working length

Objective lens Instrument channel outlet

Ultrasonic transducer

Detail of distal end

Balloon water feeding and suction port

Distal end

ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

8. Bending section

15