Olympus EVIS EXERA II User manual

Refer to the endoscope’s companion manual, the “OLYMPUS TJF TYPE Q180V
REPROCESSING MANUAL”, for reprocessing information.
USA: CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
INSTRUCTIONS
EVIS EXERA II DUODENOVIDEOSCOPE
OLYMPUS TJF TYPE Q180V

Contents
i
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
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 ............................................................................ 4
Reprocessing before the first use/reprocessing and storage after use .... 4
Spare equipment ...................................................................................... 4
Maintenance management........................................................................ 5
Prohibition of improper repair and modification ........................................ 5
Signal words ............................................................................................. 5
Warnings and cautions.............................................................................. 6
Examples of inappropriate handling ......................................................... 9
Chapter 1 Checking the Package Contents............................ 10
Chapter 2 Instrument Nomenclature and Specifications ...... 12
2.1 Nomenclature.................................................................................. 12
2.2 Endoscope functions....................................................................... 14
2.3 Specifications.................................................................................. 16
2.4 Attaching the chain for water-resistant cap (MAJ-1119) ................. 19
Chapter 3 Preparation and Inspection .................................... 22
3.1 Preparation of the equipment.......................................................... 23
3.2 Inspection of the endoscope ........................................................... 24
3.3 Preparation and inspection of accessories ..................................... 28
3.4 Attaching accessories to the endoscope ........................................ 32
3.5 Inspection and connection of ancillary equipment .......................... 34
3.6 Inspection of the endoscopic system .............................................. 37
Chapter 4 Operation ................................................................. 41
4.1 Insertion .......................................................................................... 44
4.2 Using EndoTherapy accessories .................................................... 49
4.3 Withdrawal of the endoscope.......................................................... 62
4.4 Transportation of the endoscope .................................................... 63

Contents
ii EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Chapter 5 Troubleshooting ...................................................... 64
5.1 Troubleshooting guide .................................................................... 64
5.2 Withdrawal of the endoscope with an irregularity............................ 68
5.3 Returning the endoscope for repair................................................. 70
Chapter 6 Inspection Schedule Related to Forceps Elevator 71
6.1 Inspection after each patient procedure.......................................... 71
6.2 Inspection before each patient procedure....................................... 72
6.3 Annual inspection............................................................................ 72
Appendix........................................................................................ 73
System chart ............................................................................................ 73
EMC information........................................................................................ 84

Symbols
1
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Symbols
The meaning(s) of the symbol(s) shown on the component packaging, the back
cover of the instruction manual, and/or the instrument are as follows:
Refer to instructions.
Caution
Endoscope
TYPE BF applied part
Single use only
Lot number
Manufacturer
Authorized representative in the European Community
Serial number

2
Important Information — Please Read Before Use
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Important Information — Please Read
Before Use
Intended use
This instrument has been designed to be used with an Olympus video system
center, light source, documentation equipment, monitor, EndoTherapy
accessories (such as a biopsy forceps), and other ancillary equipment for
endoscopy and endoscopic surgery within the duodenum.
Do not use this instrument for any purpose other than its intended use. Select
the endoscope to be used according to the objective of the intended procedure
based on the full understanding of the endoscope’s specifications and
functionality as described in this instruction manual.
Applicability of endoscopy and endoscopic treatment
If there are official standards on the applicability of endoscopy and endoscopic
treatment that are defined by the hospital’s administrations or other official
institutions, such as academic societies on endoscopy, follow those standards.
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.

Important Information — Please Read Before Use
3
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Instruction manual
This instruction manual contains essential information on using this instrument
safely and effectively. Before use, thoroughly review this manual and the
manuals for all equipment that will be used during the procedure and use the
equipment as instructed.
Note that the complete instruction manual set for this endoscope consists of this
manual and the “REPROCESSING MANUAL” with your endoscope model listed
on the cover. It also accompanied the endoscope at shipment.
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,
contact Olympus.
Terms used in this manual
User qualifications
If there are official standards for user qualifications to perform endoscopy and
endoscopic treatment that are defined by the hospital’s medical administrators or
other official institutions, such as academic societies on endoscopy, follow those
standards. If there are no official qualification standards, 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.
NBI (Narrow Band Imaging) observation mode:
This is an observation mode using narrowband light.
Normal light observation mode (or WLI (White Light Imaging) observation
mode):
This is an observation mode using standard white light illumination.

4
Important Information — Please Read Before Use
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
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 2 (IEC 60601-1-2: 2001). However, when connected with an
instrument that complies with the 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 the endoscope’s companion “REPROCESSING MANUAL”
with your endoscope model listed on the cover.
After using this instrument, reprocess and store it according to the instructions
given in the endoscope’s companion reprocessing manual. Improper and/or
incomplete reprocessing or storage can pose an infection control risk, cause
equipment damage, or reduce performance.
Spare equipment
Be sure to prepare another endoscope to avoid interruption of the examination
due to equipment failure or malfunction.

Important Information — Please Read Before Use
5
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
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 5.1,
“Troubleshooting guide” on page 64. If the irregularity is still observed after
inspection, contact Olympus.
Maintenance of the forceps elevator has to be performed according to Chapter 6,
“Inspection Schedule Related to Forceps Elevator” in the manual.
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 may 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.
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.

6
Important Information — Please Read Before Use
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
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.
• For more information on combining the endoscope with a
particular electrosurgical generator, refer to “System chart”
on page 73. Do not use an electrosurgical generator that
does not comply with medical electrical equipment (EN
60601-1:2013). It could cause patient burns.
• After using this instrument, reprocess and store it according
to the instructions given in the endoscope’s companion
“REPROCESSING MANUAL” with your endoscope model
listed on the cover. Using improperly or incompletely
reprocessed or stored instruments may cause patient
cross-contamination and/or infection.
• Before endoscopy, remove any metallic objects (watch,
glasses, necklace, etc.) from the patient. Performing
high-frequency cauterization treatment while the patient is
wearing metallic objects may cause burns on the patient in
areas around the metallic objects.
• Do not strike, hit, or drop the endoscope’s distal end,
insertion tube, bending section, control section, universal
cord, or endoscope connector. Also, do not bend, pull, or
twist the endoscope’s distal end, insertion tube, bending
section, control section, universal cord, or endoscope
connector with excessive force. The endoscope may be
damaged and could cause patient injury, burns, bleeding,
and/or perforations. It could also cause parts of the
endoscope to fall off inside the patient.
• Never perform angulation control forcibly or abruptly. Never
forcefully pull, twist, or rotate the angulated bending section.
Patient injury, bleeding, and/or perforation may result. It may
also become impossible to straighten the bending section
during an examination.
• Never insert or withdraw the endoscope’s insertion section
while the bending section is locked in position. Patient injury,
bleeding, and/or perforation may result.

Important Information — Please Read Before Use
7
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
• Never operate the bending section, feed air or perform
suction, insert or withdraw the endoscope’s insertion section,
or use EndoTherapy accessories without viewing the
endoscopic image. Patient injury, bleeding, and/or perforation
may result.
• Never operate the bending section, feed air or perform
suction, insert or withdraw the endoscope’s insertion section,
or use EndoTherapy accessories while the image is frozen.
Patient injury, bleeding, and/or perforation may result.
• Never insert or withdraw the insertion section abruptly or with
excessive force. Patient injury, bleeding, and/or perforation
may result.
• 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.
• Never insert or withdraw the endoscope’s insertion section or
use EndoTherapy accessories while the image is magnified.
Patient injury, bleeding, and/or perforation can result (when
using the image magnification function of the video system
center).
• Do not touch the light guide on the endoscope connector
immediately after removing it from the light source because it
is extremely hot. Operator or patient burns can 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.
• Do not rely on the NBI observation mode alone for primary
detection of lesions or to make a decision regarding any
potential diagnostic or therapeutic intervention.
• 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 with a
diameter of less than 12 cm. Equipment damage can result.
• Do not attempt to bend the endoscope’s insertion section
with excessive force. Otherwise, the insertion section may be
damaged.

8
Important Information — Please Read Before Use
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
• Do not touch the electrical contacts inside the electrical
connector. CCD damage may result.
• Do not apply shock to the distal end of the insertion section,
particularly the objective lens surface at the distal end. Visual
irregularities 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.
• Turn the video system center ON only when the videoscope
cable is connected to both the video system center and the
electrical connector on the endoscope. In particular, confirm
that the video system center is OFF before connecting or
disconnecting the videoscope cable from 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 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.
• 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.
• To check the electromagnetic interference from other
equipment (any equipment other than this instrument or the
components that constitute this system), the system should
be observed to verify its normal operation in the configuration
in which it will be used.

Important Information — Please Read Before Use
9
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
This endoscope contains a memory chip that stores
information about the endoscope and communicates this
information to the video system center CV-180, CV-160.
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 described 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 the angle of the bending section and/or withdraw the
endoscope from the patient. 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 EndoTherapy 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.
• For reasons described below, do not rely on the NBI1 observation mode
alone for primary detection of lesions or to make a decision regarding
any potential diagnostic or therapeutic intervention.
NBI has not been demonstrated to increase the yield or
sensitivity of finding any specific mucosal lesion, including
colonic polyps or Barrett’s esophagus.
NBI has not been demonstrated to aid in differentiating or
establishing the presence or absence of dysplasia or
neoplastic changes within mucosa or mucosal lesions.
1 Narrow Band Imaging. For more details, refer to the
instruction manual for the video system center CV-180.

10
Chapter 1 Checking the Package Contents
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Chapter 1 Checking the Package
Contents
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 described in the endoscope’s companion “REPROCESSING
MANUAL” with your endoscope model listed on the cover.

Chapter 1 Checking the Package Contents
11
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Endoscope
Channel cleaning brush
(BW-20T)
Water-resistant cap
(MH-553)
Injection tube (MH-946)
AW channel cleaning
adapter (MH-948)
Channel-opening cleaning
brush (MH-507)
Channel plug
(MH-944)
Air/water valve
(MH-438, 2 pcs)
Suction valve
(MH-443, 2 pcs)
Reprocessing manual
Biopsy valve
(MB-358, 10 pcs)
Suction cleaning adapter
(MH-856)
Operation manual
Mouthpiece
(MB-142, 2 pcs)
Instructions (caution for
locking the guidewire)
Single use soft brush
(MAJ-1888, 5pcs)

12
Chapter 2 Instrument Nomenclature and Specifications
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Chapter 2 Instrument Nomenclature
and Specifications
2.1 Nomenclature
2. S-cord connector mount
Universal cord
Air pipe
Light guide
Product name (model) and serial number
3. Water supply connector
3. Air supply connector
1. Suction connector
5. Electrical connector
4. Endoscope connector
Contact pins

Chapter 2 Instrument Nomenclature and Specifications
13
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
Control
section
Top view Insertion tube
Distal end
13. Bending section
14. Remote switches
1 to 4
Boot
Insertion section
12. Forceps
elevator
11. Insertion section
limit mark
Guidewire locking
function mark
15. Color code
(orange)
Biopsy valve (MB-358)
Instrument channel port
10. Instrument channel
17. RIGHT/LEFT
angulation
control knob
16. RIGHT/LEFT
angulation lock
Grip section
Guidewire locking
function color (blue)
Suction cylinder
8. Suction valve (MH-443)
9. Air/water valve (MH-438)
6. UP/DOWN angulation control knob
7. UP/DOWN angulation lock
18. Elevator control lever
Air/water cylinder

14
Chapter 2 Instrument Nomenclature and Specifications
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
2.2 Endoscope functions
1. Suction connector
Connects the endoscope to the suction tube of the suction pump.
2. S-cord connector mount
Connects the endoscope with the Olympus electrosurgical unit via the
S-cord. The S-cord conducts leakage current from the endoscope to the
electrosurgical unit. To connect the S-cord, refer to the instruction manual
for the electrosurgical unit. When the endoscope is used with the
electrosurgical unit ESG-100, it is not necessary to use the S-cord. Connect
the fitting part of the chain for water-resistant cap to this mount, as required
(refer to Section 2.4 on page 19).
3. Water supply connector and air supply connector
Connects the endoscope to the water container via the water container tube
to supply water to the distal end of the endoscope.
4. Endoscope connector
Connects the endoscope to the output socket of the light source and
transmits light from the light source to the endoscope.
5. Electrical connector
Connects the endoscope to the video system center via the videoscope
cable. The endoscope contains a memory chip that stores information about
the endoscope and communicates this information to the video system
center CV-180, CV-160. For more details, refer to the instruction manual for
the CV-180, CV-160.
6. UP/DOWN angulation control knob
When this knob is turned in the “ U” direction, the bending section moves
UP; when the knob is turned in the “D ” direction, the bending section
moves DOWN.
7. UP/DOWN angulation lock
Moving this lock in the “F ” direction frees angulation. Moving the lock in
the opposite direction locks the bending section at any desired position.
8. Suction valve (MH-443)
This valve is depressed to activate suction. The valve is used to remove any
fluids, debris, flatus, or air from the patient.
9. Air/water valve (MH-438)
The hole in this valve is covered to insufflate air and the valve is depressed
to feed water for lens washing. It also can be used to feed air for removing
any fluids or debris adhering to the objective lens.

Chapter 2 Instrument Nomenclature and Specifications
15
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
10. Instrument channel
The instrument channel functions as:
Channel for the insertion of EndoTherapy accessories
Suction channel
Fluid feed channel (from a syringe via the biopsy valve)
11. Insertion section limit mark
This mark shows the maximum point to which the endoscope may be
inserted into the patient’s body.
12. Forceps elevator
The elevator moves EndoTherapy accessories when the elevator control
lever is operated.
In addition, the elevator is used to assist the locking function of the
guidewire while inserting/withdrawing the wire-guided type EndoTherapy
accessory.
13. Bending section
This section moves the distal end of the endoscope when the UP/DOWN
and RIGHT/LEFT angulation control knobs are operated.
14. Remote switches 1 to 4
The functions of remote switches 1 to 4 can be selected on the video system
center. Refer to the instruction manual for the video system center when
setting these functions.
15. Color code (orange)
The endoscope can be used with EndoTherapy accessories that have the
same color code. For more information on combining the endoscope with
particular EndoTherapy accessories, refer to the “System chart” in the
Appendix and the instruction manuals for the compatible accessories.
16. RIGHT/LEFT angulation lock
Turning this lock in the “F ” direction frees angulation. Turning the lock in
the opposite direction locks the bending section at any desired position.
17. RIGHT/LEFT angulation control knob
When this knob is turned in the “R ” direction, the bending section moves
RIGHT; when the knob is turned in the “ L” direction, the bending section
moves LEFT.
18. Elevator control lever
When this lever is moved in the “ U” direction, the forceps elevator is
raised. When the lever is turned in the opposite direction, the forceps
elevator is lowered.

16
Chapter 2 Instrument Nomenclature and Specifications
EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL
2.3 Specifications
Environment
Operating
environment
Ambient temperature 10 – 40C (50 – 104F)
Relative humidity 30 – 85%
Atmospheric
pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Standard storage
environment
(e.g. within the
hospital)
Ambient temperature 5 – 40C (41 – 104F)
Relative humidity 10 – 95%
Atmospheric
pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Transportation
environment
(conditions during
transportation and
short-term storage)
Ambient temperature –47 to 70C (–52.6 to 158F)
Relative humidity 10 – 95%
Atmospheric
pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)