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
1
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.