Olympus BF UC180F User manual

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TECH READY document
Product
OLYMPUS®
Evis Exera II Ultrasonic Bronchofibervideoscope
Model OLYMPUS BF TYPE UC180F
Extended Tech Ready
The detail required incleaning, maintaining and sterilizing this product is
much more extensive than most other products. To ensure no important
information is left out, we have set up aninteractive Table of Contents page in
place ofthe normal tech ready document.
Important Information
1. On the contents page, each HEADING has been LINKED to that section of
the document.
2. Click on the HEADINGS inthe Table of Contents to move directly to the
selected section.
3. Click on the TOP RIGHT CORNER of any page to go back to this Cover Letter.
4. Click on TOP LEFT CORNER to return to the TABLE OF CONTENTS.
5. Compatible Reprocessing Methods Table CLICK HERE
6. There are no STERRAD references in this document.
Source Document: Olympus_BF_UC180F_Evis_Exera_II_Ultrasonic_Bronchofibervideoscope_GE5938_r22_201612.pdf
MF201707

USA: CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
CAUTION : Balloons Used with This Product Contain Natural Rubber Latex, Which May Cause Allergic Reactions.
INSTRUCTIONS
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
OLYMPUS BF TYPE UC180F

Contents
i
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
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 before the first use/reprocessing and storage after use..... 5
Spare equipment ...................................................................................... 5
Maintenance management ....................................................................... 5
Prohibition of improper repair and modification ........................................ 5
Signal words.............................................................................................. 6
Warnings and cautions ............................................................................. 6
Examples of inappropriate handling.......................................................... 10
Chapter 1 Checking the Package Contents............................ 11
1.1 Standard components..................................................................... 11
1.2 Ultrasonic cable .............................................................................. 12
1.3 Optional components...................................................................... 13
Chapter 2 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
Chapter 3 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.............................................. 45
3.7 Preparation and inspection of the balloon....................................... 50

Contents
ii ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Chapter 4 Operation.................................................................. 56
4.1 Insertion .......................................................................................... 59
4.2 Observation of the ultrasonic image................................................ 63
4.3 Using EndoTherapy accessories .................................................... 64
4.4 Withdrawal of the endoscope.......................................................... 67
4.5 Removal of the balloon ................................................................... 68
4.6 Transportation of the endoscope .................................................... 70
Chapter 5 Reprocessing: General Policy................................ 71
5.1 Instructions...................................................................................... 71
5.2 Importance of cleaning, disinfection, and sterilization..................... 71
5.3 Precautions..................................................................................... 72
Chapter 6 Compatible Reprocessing Methods and Chemical
Agents ...................................................................... 75
6.1 Compatibility summary.................................................................... 75
6.2 Water (for reprocessing) ................................................................. 77
6.3 Detergent solution........................................................................... 77
6.4 Disinfectant solution........................................................................ 78
6.5 Rinse water..................................................................................... 78
6.6 Ethylene oxide gas sterilization....................................................... 79
6.7 Steam sterilization (autoclaving) of accessories............................. 81
Chapter 7 Cleaning, Disinfection, and Sterilization
Procedures .............................................................. 82
7.1 Required reprocessing equipment.................................................. 83
7.2 Cleaning, disinfection, and sterilization procedures........................ 92
7.3 Precleaning..................................................................................... 93
7.4 Leakage testing............................................................................... 97
7.5 Manual cleaning.............................................................................. 102
7.6 High-level disinfection..................................................................... 114
7.7 Rinsing after high-level disinfection................................................. 116
7.8 Sterilization ..................................................................................... 120
7.9 Cleaning, disinfection, and sterilization
procedures for reusable parts and cleaning equipment.................. 121
7.10 Care of the ultrasonic cable (MAJ-1597, MAJ-1722)...................... 131
Chapter 8 Cleaning and Disinfection Equipment................... 132
8.1 Set up the endoscope to the cleaning tub (OER-A)........................ 134
8.2 Set up the endoscope to the cleaning tub (OER-AW)..................... 136

Contents
iii
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Chapter 9 Storage and Disposal.............................................. 138
9.1 Storage of the endoscope............................................................... 138
9.2 Storage of reusable parts and reprocessing equipment................. 139
9.3 Storage of ultrasonic cable ............................................................. 139
9.4 Disposal.......................................................................................... 139
Chapter 10 Troubleshooting...................................................... 140
10.1 Troubleshooting guide .................................................................... 141
10.2 Withdrawal of the endoscope with an irregulality............................ 144
10.3 Returning the endoscope for repair ................................................ 145
Appendix A: System Chart .......................................................... 146
Appendix B: EMC information..................................................... 150
Appendix C: Acoustic Output Information in Accordance
with the FDA Guidance:
“Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and
Transducers”........................................................... 155
Acoustic output table with Olympus compact endoscopic ultrasound
center ....................................................................................................... 155
Acoustic output table with Hitachi diagnostic ultrasound system.............. 157
Clinical measurement accuracy with Hitachi diagnostic ultrasound
system ...................................................................................................... 162
Appendix D: Acoustic Output Information Accordance with
IEC 60601-2-37......................................................... 163
Acoustic output table with Olympus compact endoscopic ultrasound
center ....................................................................................................... 163
Acoustic output table with Hitachi diagnostic ultrasound system ............. 163

Contents
iv ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

Symbols
1
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
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)
Ultrasonic endoscope
Single use only
Do not resterilize
Use by (expiration date)
Sterilized using ethylene oxide
Sterilization lot number
Lot number
Keep away from sunlight
Keep dry
Do not use if package is damaged

2
Symbols
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Contains or Presence of Natural Rubber Latex
Lock the ultrasonic connector
Release the ultrasonic connector
Manufacturer
Authorized representative in the European Community

Important Information — Please Read Before Use
3
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Important Information — Please Read
Before Use
Intended use
This instrument has been designed to be used with an Olympus compact
endoscopic ultrasound center or an Olympus universal endoscopic ultrasound
center or a diagnostic ultrasound system (Hitachi, 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.

4
Important Information — Please Read Before Use
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
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.
Terms used in this manual
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.
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.

Important Information — Please Read Before Use
5
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
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 141. 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.

6
Important Information — Please Read Before Use
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
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.

Important Information — Please Read Before Use
7
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
• 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.

8
Important Information — Please Read Before Use
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
• 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.
• 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.
• 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.
1 Elastography is not available with the diagnostic
ultrasound system (Hitachi, Ltd.) in Canada.

Important Information — Please Read Before Use
9
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
• 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.
• 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.

10
Important Information — Please Read Before Use
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
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.
• The endoscope has not been designed for use in retroflexed
observation. Performing retroflexed observation in a narrow lumen may
make it impossible to straighten the angle of the bending section and/or
withdraw the endoscope from the patient. In case the patient moves due
to coughing and other reasons while the endoscope is angulated in the
narrow lumen, the bending section of the endoscope may be pushed
into the lumen and be retroflexed. Pretreatment to control patient’s
coughing reflex and other possible unexpected moves is the
responsibility of trained specialists. Retroflexed observation 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 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.

Chapter 1 Checking the Package Contents
11
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
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-1723)
Single-use suction valve
(MAJ-209, 20 pcs, sterile) or
suction valve
(MAJ-207, 10 pcs)
Balloon applicator
(MAJ-1352)
Balloon (MAJ-1351,
20 pieces, sterile)
Suction cleaning adapter
(MAJ-222)
Channel-opening
cleaning brush (MH-507) or
single use channel-opening
cleaning brush
(MAJ-1339, 3 pcs1)
Single use adapter
biopsy valve
(MAJ-1414, 10 pcs, sterile)
Water-resistant cap
(MH-553, 2 pcs)
Channel cleaning brush
(BW-7B, 2 pieces1) or
single use single-ended
cleaning brush
(BW-400B, 3 pcs1)
Channel cleaning brush
(BW-15B) or
single-use channel cleaning
brush (BW-201B, 3 pcs1)
Instruction manual
1 These products may not be available in some areas.
Single use combination
cleaning brush
(BW-411B, 3 pcs1)

12
Chapter 1 Checking the Package Contents
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
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
For the diagnostic ultrasound system (Hitachi, Ltd.)
and the Olympus universal endoscopic ultrasound center
Ultrasonic cable (MAJ-1722)
Endoscope-side
connector
Ultrasonic connector
Ultrasonic cable
(MAJ-1597)
Endoscope-side
connector
Ultrasonic
connector

Chapter 1 Checking the Package Contents
13
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
1.3 Optional components
The items listed below are optional, and may be purchased from Olympus.
Biopsy valve
For the U.S.A.
For countries other than the U.S.A.
Single-use biopsy valve (MAJ-210)
Cap Main body
Biopsy valve (MD-495)