Olympus EVIS LUCERA TJF 260V User manual

Refer to the endoscope’s companion manual, the “OPERATION MANUAL” whose cover lists the model of
your endoscope, for operation information.
INSTRUCTIONS
EVIS LUCERA DUODENOVIDEOSCOPE
OLYMPUS JF TYPE 260V
OLYMPUS TJF TYPE 260V

Contents
i
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Contents
Symbols......................................................................................... 1
Chapter 1 General Policy ......................................................... 2
1.1 Instructions...................................................................................... 2
1.2 Importance of cleaning, disinfection and sterilization...................... 2
1.3 Signal words ................................................................................... 3
1.4 Precautions ..................................................................................... 3
1.5 Reprocessing before the first use and reprocessing and
storage after use ............................................................................. 6
Chapter 2 Compatible Reprocessing Methods and Chemical
Agents ...................................................................... 7
2.1 Compatibility summary.................................................................... 7
2.2 Detergent solution........................................................................... 9
2.3 Disinfectant solution........................................................................ 9
2.4 Rinsing water .................................................................................. 10
2.5 ETO gas sterilization....................................................................... 10
2.6 Steam sterilization (autoclaving) of accessories ............................. 11
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
.................................................................................. 13
3.1 Required reprocessing equipment .................................................. 14
3.2 Cleaning, disinfection and sterilization procedures......................... 21
3.3 Precleaning ..................................................................................... 22
3.4 Leakage testing............................................................................... 29
3.5 Manual cleaning.............................................................................. 33
3.6 High-level disinfection ..................................................................... 48
3.7 Rinsing after high-level disinfection ................................................ 51
3.8 Sterilization ..................................................................................... 54
3.9 Cleaning, disinfection and sterilization procedures for reusable parts
and reprocessing equipment........................................................... 56
3.10 Cleaning, disinfection and sterilization procedures for distal cover 63
Chapter 4 Cleaning and Disinfection Equipment................... 68

Contents
ii EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Chapter 5 Storage and Disposal .............................................. 71
5.1 Storage of the endoscope............................................................... 71
5.2 Storage of reusable parts and reprocessing equipment ................. 72
5.3 Disposal .......................................................................................... 72

Symbols
1
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Symbols
The meaning(s) of the symbol(s) shown on the back cover of this instruction
manual are as follows:
Manufacturer
Authorized representative in the European Community

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Chapter 1 General Policy
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Chapter 1 General Policy
1.1 Instructions
• This manual contains the cleaning, disinfection and sterilization
methods recommended by Olympus for the endoscopes listed on the
front cover.
• This instruction manual contains essential information on reprocessing
these instruments safely and effectively.
• Before reprocessing, thoroughly review the manuals of the reprocessing
chemicals and all equipment which will be used and reprocess the
equipment as instructed.
• Note that the complete instruction manual set for this endoscope
consists of this manual and the “OPERATION MANUAL” whose cover
lists the model of your endoscope, both of which accompanied the
endoscope at shipment.
• Keep this manual and all related manuals in a safe accessible location.
• If you have any questions or comments about any information in this
manual, or if a problem that cannot be solved occurs while reprocessing,
contact Olympus.
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 of all ancillary equipment, and have a thorough
understanding of the following items:
Professional health and safety criteria of your hospital.
Individual cleaning, disinfection and sterilization protocols.
Structure and handling of endoscopic equipment.
Handling of pertinent chemicals.
For the types and conditions of the means of cleaning, disinfection and
sterilization to be adopted, please make judgments from your professional
viewpoints.

Chapter 1 General Policy
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EVIS LUCERA JF/TJF TYPE 260V REPROCESSING 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.
1.4 Precautions
• Some endoscope reprocessors are not designed to
reprocess an elevator channel. When using one of these
endoscope reprocessors, the elevator channel must be
reprocessed manually as described in Chapter 3.
• Failure to properly clean and high-level disinfect or sterilize
endoscopic equipment after each procedure can
compromise patient safety. To minimize the risk of
transmitting diseases from one patient to another, after each
procedure the endoscope and its ancillary equipment must
undergo thorough manual cleaning followed by high-level
disinfection or sterilization as described in Chapter 3,
“Cleaning, Disinfection and Sterilization Procedures”.
Reprocess not only the external surface of the endoscope
but also all channels.
• ALL channels of the endoscope, including the elevator wire
channel where existing, MUST be cleaned and high-level
disinfected or sterilized during EVERY reprocessing cycle,
even if the channels were not used during the previous
examination. Otherwise, insufficient cleaning and disinfection
or sterilization of the endoscope may pose an infection
control risk to the patient and/or operators performing the
next examination with the endoscope.

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Chapter 1 General Policy
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
• If the endoscope is not cleaned meticulously, effective
disinfection or sterilization may not be possible. Clean the
endoscope and accessories thoroughly before disinfection or
sterilization to remove microorganisms or organic material
that could reduce the efficacy of disinfection or sterilization.
• Olympus confirms validation of the endoscope reprocessors
recommended by Olympus only. If using endoscope
reprocessor that are not recommended by Olympus, the
endoscope reprocessor manufacturers are responsible for
validation of the endoscope reprocessor with the endoscope
models listed in its intended use statement. If using an
endoscope reprocessor, confirm that it is capable of
reprocessing endoscope including all channels. If there are
channels and/or other parts which cannot be cleaned and
high-level disinfected by the endoscope reprocessor, have to
undergo manual cleaning and high-level disinfection or
sterilization as described in Chapter 3, “Cleaning,
Disinfection and Sterilization Procedures” after using the
endoscope reprocessor. Otherwise, insufficient cleaning and
disinfection or sterilization of the endoscope may pose an
infection control risk to the patient and/or operators
performing the next procedure with the endoscope. If you are
uncertain as to the ability of your endoscope reprocessor to
clean and high-level disinfect endoscope including all
channels, contact the endoscope reprocessor supplier for
specific instructions and/or connectors.
• Patient debris and reprocessing chemicals are hazardous.
Wear personal protective equipment to guard against
dangerous chemicals and potentially infectious material.
During cleaning and disinfection or sterilization, wear
appropriate personal protective equipment, such as eye
wear, face mask, moisture-resistant clothing and
chemical-resistant gloves that fit properly and are long
enough so that your skin is not exposed. Always remove
contaminated personal protective equipment before leaving
the reprocessing area.
• Thoroughly rinse off the disinfectant solution. Rinse the
external surface of the endoscope, all channels and the
cleaning equipment thoroughly with sterile water to remove
any disinfectant solution residue.
• The disinfection/sterilization room must be adequately
ventilated. Adequate ventilation protects against the buildup
of toxic chemical fumes.

Chapter 1 General Policy
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EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
• Store alcohol in an air-tight container. Alcohol stored in an
open container is a fire hazard and will lose its efficacy due to
evaporation.
• Be sure to perform a leakage test on the endoscope prior to
manual cleaning, and 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.
• Prior to each procedure, confirm that the endoscope has
undergone proper cleaning, disinfection and sterilization. If it
is determined that the endoscope has not been properly
reprocessed, reprocess it again following the instructions
given in this manual.
• With the cleaning, disinfection and sterilization methods
stated in this instruction manual, prions, which are
considered to be the pathogenic substance of the
Creutzfeldt-Jakob disease (CJD) cannot be destroyed or
inactivated. When using this instrument on a patient with CJD
or variant Creutzfeldt-Jakob disease (vCJD), be sure to use
this product for such patient only and/or immediately dispose
of this product after use in an appropriate manner. For
methods to handle CJD, please follow the respective
guidelines in your country.
• This instrument is not durable, or does not have sufficient
durability against the respective methods stated in the
guidelines of each country for destroying or inactivating
prions. For information on the durability against each
method, please contact Olympus. If cleaning, disinfection
and sterilization methods not stated in this instruction manual
are performed, Olympus cannot guarantee the effectiveness,
safety and durability of this instrument. Make sure to confirm
that there is no abnormality before use, and use under
responsibility of a physician. Do not use if any abnormality is
found.
• When aerating or irrigating the endoscope channels, the air
or water pressure must not exceed 0.5 MPa (5 kgf/cm2,
71 psia). Higher pressures may cause damage to the
endoscope.

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Chapter 1 General Policy
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
• When reprocessing an endoscope, confirm that the
water-resistant cap is securely attached to the endoscope
connector before immersion in reprocessing fluids. If the
water-resistant cap is not securely attached, water, detergent
and/or disinfectant solution could enter the endoscope and
damage the equipment.
1.5 Reprocessing before the first use and
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 this manual.
After using this instrument, reprocess and store it according to the instructions
given in this manual. Improper and/or incomplete reprocessing or storage can
present an infection control risk, cause equipment damage or reduce
performance.