Olympus EVIS EXERA II User manual

Single use soft brush (MAJ-1888)
Refer to the endoscope’s companion manual, the “OPERATION MANUAL” with your endoscope model
listed on the cover, for operation 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
Accessories:
• Water resistant cap (MH-553) • Chain for water-resistant cap (MAJ-1119)
• Biopsy valve (MB-358) • Suction valve (MH-443)
• Air/water valve (MH-438) • Mouthpiece (MB-142)
• Suction cleaning adapter (MH-856) • Channel plug (MH-944)
• Channel cleaning brush (BW-20T) • Injection tube (MH-946)
• Single use channel cleaning brush (BW-201T) • Single use channel-opening cleaning brush (MAJ-1339)
• AW channel cleaning adapter (MH-948) • Single use combination cleaning brush (BW-412T)
• Single use soft brush (MAJ-1888)
MH-553 MH-438MH-443MB-358 MB-142MAJ-1119 MH-856
MH-944 MH-946 MAJ-1339
BW-20T
BW-201T MH-948 BW-412T MAJ-1888

Revision History
Note: The Revision History shows the latest changes.
Version Date Description of Changes
RC2409 01 March, 2015 Cover
Section 1.4
Sections 2.10, 3.1, and 4.1
Section 4.2
Sections 4.3 and 5.1
Section 5.2
Section 5.3
Section 5.4
Section 5.5
Section 5.6
Chapter 7
Single use soft brush (MAJ-1888) information.
Updated WARNING statements for MAJ-1888 and
using an AER.
Updated MAJ-1888 information.
Updated MAJ-1888 and AER information.
Updated MAJ-1888 information.
Updated “Aspirate water” section.
Updated “Detach the endoscope from the light
source” section.
Updated “Equipment needed” chart and CAUTION for
MAJ-1888, Step 5 on page 69, and added “Brush and
flush the forceps elevator recess” section.
Updated “Flush all channels and around the forceps
elevator with disinfectant solution” section.
Updated “Rinse the endoscope and accessories”
section; the “Alcohol flush” section.
Updated WARNING statements for AER.
GE8415 09 February,
2015

Contents
i
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
Contents
Chapter 1 General Policy ......................................................... 1
1.1 Instructions...................................................................................... 1
1.2 Importance of cleaning, disinfection, and sterilization..................... 2
1.3 Signal words ................................................................................... 2
1.4 Precautions ..................................................................................... 3
1.5 Reprocessing before the first use ................................................... 8
1.6 Reprocessing and storage after use ............................................... 9
1.7 Reprocessing before patient procedure.......................................... 9
Chapter 2 Function and Inspection of the Accessories for
Reprocessing........................................................... 10
2.1 Water resistant cap (MH-553)......................................................... 10
2.2 Channel plug (MH-944)................................................................... 12
2.3 Injection tube (MH-946) .................................................................. 14
2.4 Channel cleaning brush (BW-20T).................................................. 16
2.5 Suction cleaning adapter (MH-856) ................................................ 18
2.6 AW channel cleaning adapter (MH-948)......................................... 19
2.7 Single use channel cleaning brush (BW-201T)............................... 20
2.8 Single use channel-opening cleaning brush (MAJ-1339) ............... 22
2.9 Single use combination cleaning brush (BW-412T)........................ 24
2.10 Single use soft brush (MAJ-1888)................................................... 25
2.11 Chain for water-resistant cap (MAJ-1119) ...................................... 27
Chapter 3 Compatible Reprocessing Methods and
Chemical Agents .................................................... 28
3.1 Compatibility summary.................................................................... 28
3.2 Water (for reprocessing) ................................................................. 30
3.3 Detergent solution........................................................................... 31
3.4 Disinfectant solution........................................................................ 31
3.5 Rinse water ..................................................................................... 31
3.6 Alcohol ............................................................................................ 31
3.7 Ethylene oxide gas sterilization....................................................... 32
3.8 Steam sterilization (autoclaving) ..................................................... 33

Contents
ii EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
Chapter 4 Reprocessing Workflow for the Endoscope
and Accessories ...................................................... 35
4.1 Workflow for manually cleaning and disinfecting the endoscope
and accessories .............................................................................. 36
4.2 Workflow for cleaning and disinfecting the endoscope and
accessories using an AER .............................................................. 38
4.3 Workflow for manually cleaning and sterilizing the endoscope
and accessories .............................................................................. 40
Chapter 5 Reprocessing the Endoscope
(and related reprocessing accessories) ................ 42
5.1 Preparing the equipment for reprocessing ...................................... 44
5.2 Precleaning the endoscope and accessories.................................. 45
5.3 Leakage testing of the endoscope .................................................. 51
5.4 Manually cleaning the endoscope and accessories........................ 56
5.5 Manually disinfecting the endoscope and accessories ................... 80
5.6 Rinsing the endoscope and accessories following disinfection....... 86
5.7 Sterilizing the endoscope and accessories ..................................... 94
Chapter 6 Reprocessing the Accessories .............................. 96
6.1 Manually cleaning the accessories ................................................. 98
6.2 Manually disinfecting the accessories............................................. 101
6.3 Rinsing the accessories following disinfection ................................ 102
6.4 Sterilizing the accessories............................................................... 105
Chapter 7 Reprocessing Endoscopes and Accessories
using an Automated Endoscope Reprocessor..... 106
Chapter 8 Storage and Disposal .............................................. 108
8.1 Storing the disinfected endoscope and accessories ....................... 109
8.2 Storing the sterilized endoscope and accessories .......................... 111
8.3 Disposal .......................................................................................... 111

Chapter 1 General Policy
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EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
Chapter 1 General Policy
1.1 Instructions
• This manual contains the cleaning, disinfection, and sterilization
methods recommended by Olympus for the endoscopes and
accessories listed on the front cover.
• This instruction manual contains essential information on reprocessing
endoscopes and accessories safely and effectively.
• Before reprocessing, thoroughly review this manual and the manuals for
the reprocessing equipment and chemicals that will be used for
reprocessing. Reprocess all the devices as instructed.
• Note that the complete instruction manual set for the endoscope and
accessories consists of this manual and the “OPERATION MANUAL”
with your endoscope model listed on the cover. Both manuals
accompanied the endoscope at shipment.
• Keep this manual and all related manuals in a safe and accessible
location (e.g., in the reprocessing area).
• If you have any questions or comments about any information in this
manual, or if a problem occurs while reprocessing that cannot be solved,
contact Olympus.

2
Chapter 1 General Policy
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
1.2 Importance of cleaning, disinfection, and
sterilization
The medical literature reports incidents of cross-contamination resulting from
improper cleaning, disinfection, or sterilization. It is strongly recommended that
all individuals engaged in reprocessing closely observe all instructions given in
this manual and the manuals for all ancillary equipment, and have a thorough
understanding of the following items:
• Professional health and safety policies of your hospital
• Instruction manuals for the endoscope, accessories, and all the other
reprocessing equipment
• Structure and handling of endoscope and accessories
• Handling of pertinent chemicals
When selecting appropriate methods and conditions for cleaning and disinfection
and sterilization, follow the policies at your institution, applicable national laws
and standards, and professional society guidelines and recommended practices,
in addition to the instructions given in this manual.
1.3 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.

Chapter 1 General Policy
3
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
1.4 Precautions
• An insufficiently cleaned, disinfected, or sterilized endoscope
and/or accessories may pose an infection control risk to the
patients and/or operators who contact them.
• All disinfection methods (whether performed manually or by
an automated endoscope reprocessor), and all sterilization
methods (whether performed by ethylene oxide gas or
steam) require thorough prior cleaning of the instrument
being reprocessed. If the equipment is not adequately
cleaned prior to disinfection/sterilization, these processes will
be ineffective. Immediately after each patient procedure and
before disinfection/sterilization, thoroughly clean the
endoscope and the accessories used with the endoscope.
• All channels of the endoscope, including the instrument
channel and all accessories used with the endoscope during
the patient procedure, such as all valves, must be cleaned
and high-level disinfected or sterilized after each patient
procedure, even if the channels or accessories were not
used during the patient procedure. Insufficient cleaning and
disinfection or sterilization of these components may pose an
infection control risk to patients and/or operators.
• Disinfectant solutions are hazardous. After disinfection, rinse
all external surfaces and channels of the endoscope and
accessories thoroughly with water to remove residual
disinfectant solution.
• The results of sterilization depend on various factors. These
factors include how the equipment was packaged, and the
placing and loading of the package in the sterilization device.
Verify the sterilization process using biological and/or
chemical indicators. Follow the guidelines for sterilization
issued by national authorities, professional organizations and
infection control professionals, as well as the instruction
manual for the sterilization device.

4
Chapter 1 General Policy
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
• Establish an internal system of identifying contaminated
versus reprocessed endoscopes and accessories to prevent
both mix-ups and cross-contamination. Touching a
reprocessed endoscope and/or accessories with
contaminated gloves or placing them on a contaminated
hanger or surface, including letting them touch the floor, will
recontaminate them.
• Prior to each patient procedure, confirm that the endoscope
and accessories have been properly reprocessed and stored.
If there are any doubts or questions, reprocess them again
before the patient procedure, following the instructions given
in this manual.
• Perform a leakage test on the endoscope after each
precleaning procedure. Do not use the endoscope if a leak is
detected. Use of an endoscope with a leak may cause a
sudden loss of the endoscopic image, damage to the
bending mechanism, or other malfunctions. Use of a leaking
endoscope may also pose an infection control risk.
Figure 1.1
• Store alcohol in an airtight container. Alcohol stored in an
open container may cause a fire hazard and may result in a
loss of efficacy due to evaporation.
Leakage tester

Chapter 1 General Policy
5
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
• Do not use the AW channel cleaning adapter (MH-948) for
patient procedures. It will cause continuous insufflation and
could result in patient injury.
Figure 1.2
• The accessories listed on the front cover of this manual are
consumables, meaning that these accessories cannot be
refurbished or repaired and are intended to be replaced once
they show any signs of wear. Should any irregularity be
observed, use a replacement accessory instead. Using
defective accessories may cause equipment malfunction,
reduce the efficacy of reprocessing, present a risk to patients
and/or operators, or damage the endoscope and/or
accessories.
• Single-use brushes, such as the single use channel cleaning
brush (BW-201T), the single use combination cleaning brush
(BW-412T), the single use channel-opening cleaning brush
(MAJ-1339), and the single use soft brush (MAJ-1888), are
designed for cleaning only one endoscope and its related
accessories. Dispose of the single-use brush immediately
after use. Using a single-use brush to clean multiple
endoscopes and/or accessories may reduce its cleaning
efficacy and may damage the brush leading to brush
breakage or endoscope and/or accessory damage.
AW channel cleaning
adapter (MH-948)

6
Chapter 1 General Policy
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
• Patient debris and reprocessing chemicals are hazardous.
To guard against contact with dangerous chemicals and
potentially infectious material, wear appropriate personal
protective equipment during cleaning, disinfection, and
sterilization. Such protective equipment should include
appropriate eyewear, face mask, cap, moisture-resistant
clothing, shoe covers, and chemical-resistant gloves that fit
properly and are long enough to prevent skin exposure.
• The reprocessing room must be adequately ventilated.
Adequate ventilation protects against the buildup of toxic
chemical fumes.
• Always remove contaminated personal protective equipment
before leaving the reprocessing area to prevent
contamination from spreading.
• Only Olympus-recommended or Olympus-endorsed
automated endoscope reprocessors (AERs) have been
validated by Olympus. When using an AER that is not
recommended by Olympus, the manufacturer of the AER is
responsible for validating compatibility of the AER with each
Olympus endoscope and accessory.
• Before using an AER, confirm that it is capable of
reprocessing the endoscope including all channels, the
forceps elevator recess, and accessories. Be sure to attach
all required connectors. Otherwise, insufficient reprocessing
may pose an infection control risk. If you are uncertain as to
the ability of your AER to reprocess the endoscope including
all channels, the forceps elevator recess, and accessories,
contact the manufacturer of the AER for specific instructions
and information on compatibility and required connectors.
When you use an AER which allows you skip some steps in
precleaning and manual cleaning of endoscopes, confirm
with the AER manufacturer that such skip is applicable to this
endoscope and establish detailed precleaning and manual
cleaning procedures of this endoscope according to both
instructions of this manual and the AER manufacturer.
• Put the forceps elevator in intermediate position of the range
of movement by turning the elevator control lever and set it in
your AER.

Chapter 1 General Policy
7
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
• Instructions provided in this manual are not valid for Olympus
devices repaired by a non-Olympus facility. The Olympus
recommended reprocessing procedures have not been
validated for reprocessing devices repaired by a
non-Olympus facility. In the event that your device has been
repaired by a non-Olympus facility, contact that repair facility
for instructions regarding reprocessing.
• Prions, which are the pathogenic agent of the
Creutzfeldt-Jakob disease (CJD), cannot be destroyed or
inactivated by the cleaning, disinfection, and sterilization
methods stated in this instruction manual. When using the
endoscope and accessories on patients with CJD or variant
Creutzfeldt-Jakob disease (vCJD), be sure to use them for
such patients only, or immediately dispose of them after use
in an appropriate manner to prevent the usage of exposed
devices on other patients. For methods to handle CJD, follow
the respective guidelines in your country.
• The endoscope and accessories may be damaged by
published methods for destroying or inactivating prions. For
information on the durability of Olympus equipment against a
particular reprocessing method, contact Olympus. In general,
Olympus cannot guarantee the effectiveness, safety, and
durability of cleaning, disinfection, or sterilization methods
not described in this reprocessing manual. If you chose to
use a reprocessing method not recommended in this manual,
the local institution and/or physicians must assume
responsibility for its safety and efficacy. Make sure to
carefully inspect each piece of endoscopic equipment for
irregularities (damage) prior to each patient procedure. Do
not use the equipment if any irregularity is found.
• Good quality control practices typically require appropriate
documentation. Items such as local SOPs (standard
operating procedures), confirmation of operator training,
routine testing of the disinfectant’s MEC (minimal effective
concentration), confirmation of the disinfectant’s use-life,
etc., should be documented as performed.

8
Chapter 1 General Policy
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
• When reprocessing the endoscope, confirm that the water
resistant cap (MH-553) is securely attached to the electrical
connector before immersing the endoscope in reprocessing
fluids. If the water resistant cap is not securely attached, the
reprocessing fluids could enter the endoscope and damage
the endoscope.
Figure 1.3
• When aerating or irrigating the endoscope channels, the air
or water pressure must not exceed 0.5 MPa (5 kgf/cm2,
71 psig). Higher pressures may cause damage to the
endoscope.
• Store spare accessories in their original packaging to prevent
damage.
• To prevent damage, do not apply excessive force to the
endoscope and accessories during reprocessing.
• Vapors from disinfectant solutions and alcohol may damage
electronic devices such as computers.
1.5 Reprocessing before the first use
New endoscopes, repaired endoscopes, accessories, and the carrying case for
endoscopes are not cleaned, disinfected, or sterilized prior to shipping from
Olympus, regardless of whether those instruments are for new purchase, demo
or loaner purposes. Reprocess all such endoscopes and accessories received
from Olympus according to the instructions given in this manual before storage
and before using them in a patient procedure.
Water resistant
cap (MH-553)
Electrical connector

Chapter 1 General Policy
9
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
1.6 Reprocessing and storage after use
• Do not reuse rinse water.
• High-level disinfectant solutions are only effective when used
according to the disinfectant manufacturer’s instructions.
Follow the manufacturer’s instructions regarding activation (if
required), concentration, temperature, contact time and use
life required to achieve high-level disinfection.
• If the disinfectant solution is reused, check its efficacy with a
test strip according to the disinfectant manufacturer’s
recommendations prior to use.
• Do not reuse alcohol.
• Alcohol is not a sterilant or high-level disinfectant.
• To maintain sterility of equipment following sterilization, use
sterile packaging and wraps according to national guidelines.
1.7 Reprocessing before patient procedure
• Improper storage practices, such as not thoroughly drying
external and internal surfaces (lumens) including the forceps
elevator recess prior to storage, will lead to an infection
control risk.
• Improper handling, such as touching a reprocessed
endoscope and/or accessories with contaminated gloves,
placing a reprocessed device on a contaminated hanger or
surface, allowing devices to touch the floor, etc., will
recontaminate the device.
Some national or professional guidelines recommend
reprocessing endoscopes prior to their first use of the day.
Confirm that the endoscope and accessories have undergone proper
reprocessing following their last use and that they have been stored properly.
Check the storage period of reprocessed endoscopes, and check for surface
contamination (e.g., dust). Check the sterilization expiration date(s) of all items
so marked and for tears or breaches in sterile packaging. If there are any doubts
or questions concerning whether a device is contaminated, reprocess it again
following the instructions given in this manual.

10
Chapter 2 Function and Inspection of the Accessories for Reprocessing
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
Chapter 2 Function and Inspection of
the Accessories for
Reprocessing
Certain accessories are required for reprocessing the endoscope. This chapter
describes the function of these accessories. It also describes how to inspect
these accessories before using them to reprocess the endoscope.
2.1 Water resistant cap (MH-553)
Figure 2.1
Groove
Venting connector
Seals

Chapter 2 Function and Inspection of the Accessories for Reprocessing
11
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
Function
The water resistant cap is attached to the electrical connector on the endoscope
to protect the connector and the endoscope from water penetration during
reprocessing. During leakage testing, the leakage tester (MB-155) is attached to
the venting connector of the water resistant cap.
Figure 2.2
Figure 2.3
The water resistant cap must be attached to the electrical connector of the
endoscope whenever the endoscope is immersed in reprocessing fluids. It is
detached from the connector whenever the endoscope is used for patient
procedures, being sterilized by ethylene oxide gas, or stored in an endoscope
storage cabinet.
Always use a dry water resistant cap. Any water remaining
inside the cap may cause damage to the endoscope.
Water resistant
cap (MH-553)
Chain for water-resistant
cap (MAJ-1119)
Electrical connector
Maintenance
unit (MU-1)
Venting
connector
Leakage tester (MB-155)

12
Chapter 2 Function and Inspection of the Accessories for Reprocessing
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
Use the chain for water-resistant cap (MAJ-1119) to connect
the water resistant cap to the endoscope. The water resistant
cap can remain connected to the endoscope by the chain at
all times (including during patient procedures, reprocessing,
and storage of the endoscope).
Inspection
1. Confirm that the inside of the cap is dry and free from debris. Wipe with a
dry, lint-free cloth if the inside of the cap is wet or if debris is detected.
2. Confirm that the seals inside the cap are free from scratches, cuts, and
debris.
3. Check to ensure that the venting connector on the cap is not loose.
2.2 Channel plug (MH-944)
Figure 2.4
Biopsy valve cap Plug frame
Suction plug
Air/water plug

Chapter 2 Function and Inspection of the Accessories for Reprocessing
13
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
Function
The channel plug is used to plug the openings of the instrument channel port
and the suction and air/water cylinders of the endoscope whenever the injection
tube (MH-946) is used to flush the suction and air/water channels of the
endoscope with reprocessing fluids.
Figure 2.5
When attached to the endoscope, the channel plug is
designed to allow a small amount of fluid to exit from the
openings of the endoscope. This enables reprocessing fluids
to contact the endoscope openings.
Inspection
Confirm that the suction plug, air/water plug, and the biopsy valve cap of the
channel plug are free from cracks, scratches, and debris.
The channel plug does not need to be cleaned, disinfected,
or sterilized prior to its first use.
Instrument
channel port
Channel plug

14
Chapter 2 Function and Inspection of the Accessories for Reprocessing
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
2.3 Injection tube (MH-946)
Figure 2.6
Function
The injection tube is used to inject reprocessing fluids into the instrument
channel, suction channel, and air/water channels of the endoscope. It is also
used to flush air through these channels to expel fluids.
Figure 2.7
Inspection
1. Confirm that all components of the injection tube are free from cracks,
scratches, flaws, and debris (see Figure 2.6).
2. Confirm that the filter mesh is in the suction port of the injection tube.
Suction channel tube
Information
card
Connector plug
Suction
channel port Air pipe port
Air/water
channel port
Suction port
Air/water channel tube
(including the filter mesh)
Filter tube
Filter mesh
Syringe Air/water channel tube
Suction channel tube
Air pipe port
Suction port
Basin
Reprocessing
fluids
Connector plug

Chapter 2 Function and Inspection of the Accessories for Reprocessing
15
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
3. Attach a clean 30 ml syringe to the suction channel port of the injection tube.
With the suction port of the injection tube immersed in the water referred to
in Section 3.2, withdraw the syringe plunger and confirm that the water is
drawn into the syringe. Depress the plunger and confirm that the water is
emitted from the suction channel tube of the injection tube. Confirm that the
water is not emitted from the suction port when removing the suction port
from the water.
Figure 2.8
4. Move the syringe to the air/water channel port of the injection tube. With the
suction port of the injection tube immersed in the water, withdraw the
syringe plunger and confirm that the water is drawn into the syringe.
Depress the plunger and confirm that the water is emitted from the air pipe
port of the injection tube. Confirm that the water is not emitted from the
suction port when removing the suction port from the water.
Figure 2.9
The injection tube does not need to be cleaned, disinfected,
or sterilized prior to its first use.
Suction port
Suction channel
port
Suction channel
tube
Syringe
Suction port
Air/water channel port
Air pipe
port
Suction
channel tube
Syringe

16
Chapter 2 Function and Inspection of the Accessories for Reprocessing
EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
2.4 Channel cleaning brush (BW-20T)
Figure 2.10
Function
The channel cleaning brush is used to brush the inside of the instrument channel
and suction channel of the endoscope, and the interior and openings of the
suction valve (MH-443), the air/water valve (MH-438) and the biopsy valve
(MB-358).
Figure 2.11
Metal tip Shaft
Brush head
Bristles
Suction cylinder
Instrument channel
Suction channel