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
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
1
Chapter 1 General Policy
Chapter 1General Policy
1.1Instructions
•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.
1.2Importance 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.
2
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
1.3Signal words
The following signal words are used throughout this manual:
Chapter 1 General Policy
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.
1.4Precautions
•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.
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
3
Chapter 1 General Policy
•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.
4
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Chapter 1 General Policy
•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
2
or water pressure must not exceed 0.5 MPa (5 kgf/cm
,
71 psia). Higher pressures may cause damage to the
endoscope.
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
5
Chapter 1 General Policy
•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.
1.5Reprocessing 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.
6
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
Chapter 2Compatible Reprocessing
Methods and Chemical
Agents
2.1Compatibility summary
Olympus endoscopic equipment is compatible with several methods of
reprocessing. Certain components and accessories, however, are not
compatible with some methods, which can cause equipment damage. For
appropriate reprocessing methods, refer to Table 2.1 below, the
recommendations of your infection control committee and all national and local
hospital guidelines and policies.
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
7
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
Applicable
Not
applicable
Steam sterilization (autoclaving)
ETO gas sterilization
ACECIDE 6% disinfectant solution *3
(use OER-A)
2 – 3.5% glutaraldehyde
70% ethyl or isopropyl alcohol
Detergent solution
Ultrasonic
cleaning
Endoscope
Water-resistant cap
(MH-553)
Chain for water-resistant
cap (MAJ-1119)
Channel cleaning brush
(BW-20T)
Channel-opening
cleaning brush (MH-507)
Air/water valve (MH-438)
Suction valve (MH-443)
Biopsy valve (MB-358)
Channel plug (MH-944)
Injection tube (MH-946)
AW channel cleaning
adapter (MH-948)
Suction cleaning
adapter (MH-856)
Mouthpiece (MB-142)
Washing tube (MH-974)
Distal cover
(MAJ-311/411)
*
1
*
2
Table 2.1
*1The endoscope is compatible with ultrasonic cleaning by endoscope reprocessor
(OER, OER-A) only. OER, OER-A are not available in some areas.
*2The water-resistant cap and the chain for water-resistant cap can only be
ultrasonically cleaned if connected to endoscope that is being cleaned in an
endoscope reprocessor with an ultrasonic cleaning phase.
*3ACECIDE 6% disinfectant solution is exclusively for OER-A.
8
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
Alcohol is not a sterilant or high-level disinfectant.
Endo-therapy accessories which are marked by the words
“AUTOCLAVE” or “AUTOCLAVABLE”, or accessories with a
green model reference label are compatible with autoclaving.
2.2Detergent solution
Use a medical-grade, low-foaming, neutral pH detergent or enzymatic detergent
and follow the manufacturer’s dilution and temperature recommendations.
Contact Olympus for the names of specific brands that have been tested for
compatibility with the endoscope. Do not reuse detergent solutions.
Excessive detergent foaming can prevent fluid from
adequately contacting internal lumens (e.g. channels).
2.3Disinfectant solution
In the U.S., agents used to achieve high-level disinfection are defined as liquid
chemical germicides registered with the U.S. Food and Drug Administration as
“sterilant/disinfectants” which are used according to the time, temperature and
dilution recommended by the disinfectant manufacturer for achieving high-level
disinfection. These conditions usually coincide with those recommended by the
disinfectant manufacturer for 100% kill of mycobacterium tuberculosis.
In general, 2.0 – 3.5% glutaraldehyde solutions, when used according to the
manufacturer’s instructions for achieving high-level disinfection, are compatible
with Olympus endoscopes. Contact Olympus for the names of specific brands
that have been tested for compatibility with the endoscope.
If the disinfectant solution is reused, routinely check its efficacy with a test strip
recommended by the manufacturer. Do not use solutions beyond their expiration
date.
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
9
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
2.4Rinsing water
Once removed from disinfectant solution, the instrument must be thoroughly
rinsed with sterile water to remove any disinfectant residue. If sterile water is not
available, clean potable tap water or water which has been processed (e.g.
filtered) to improve its microbiological quality may be used.
When non-sterile water is used after disinfection, wipe the endoscope and flush
the channels with 70% ethyl or isopropyl alcohol, then air-dry all internal
channels to inhibit the growth of residual bacteria. Do not reuse rinsing water.
2.5ETO gas sterilization
This instrument and accessories listed as compatible with ethylene oxide (ETO)
gas sterilization in Table 2.1 can be sterilized by ETO gas and aerated within the
parameters given in Table 2.2. When performing ETO gas sterilization, follow the
cleaning, disinfection and sterilization protocols of your hospital and the
instruction manuals of the sterilization equipment.
•Before sterilization, the instrument must be thoroughly
cleaned and dried. Residual moisture inhibits sterilization.
•The results of sterilization depend on various factors such as
how the sterilized instrument was packed or the positioning,
method of placing and loading of the instrument in the
sterilization device. Please verify the sterilization effects by
using biological or chemical indicators. Also follow the
guidelines for sterilization issued by medical administrative
authorities, public organizations or the infection management
sections at each medical facility, as well as the instruction
manual of the sterilization device.
•All instruments must be properly aerated following ETO gas
sterilization to remove toxic ethylene oxide residuals.
•Disconnect the water-resistant cap from the endoscope
connector before ETO gas sterilization. If the water-resistant
cap is attached during ETO gas sterilization, the air inside the
endoscope will expand and rupture the covering of the
bending section and/or damage the angulation mechanism.
10
•Exceeding the recommended parameters may cause
equipment damage (see Table 2.2).
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
ETO gas exposure parameters
ProcessParameters
Tem per atur e57°C (135°F)
ETO gas sterilization
Aeration
Pressure
Humidity55%
Exposure time1.75 hours
ETO gas
concentration
Minimum aeration
parameters
0.1 – 0.17 MPa (1 – 1.7 kgf/cm
(16 – 24 psig)
0.6 – 0.7 mg/cm
(600 – 700 mg/l)
12 hours in an aeration chamber
at 50 – 57°C (122 – 135°F) or
7 days at room temperature
3
Table 2.2
Gas mixture
20% ETO/80% CO
2
2.6Steam sterilization (autoclaving) of accessories
2
)
The accessories listed as compatible with steam sterilization (autoclaving) in
Table 2.1 can be sterilized by steam within the parameters given in Table 2.3.
When steam sterilizing, follow the cleaning, disinfection and sterilization
protocols of your hospital and the sterilization equipment manufacturer’s
instructions.
The results of sterilization depend on various factors such as
how the sterilized instrument was packed or the positioning,
method of placing and loading of the instrument in the
sterilization device. Please verify the sterilization effects by
using biological or chemical indicators. Also follow the
guidelines for sterilization issued by medical administrative
authorities, public organizations or the infection management
sections at each medical facility, as well as the instruction
manual of the sterilization device.
•Do not steam sterilize the endoscope. Steam sterilization
(autoclaving) will severely damage the endoscope.
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
11
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
•Exceeding the recommended parameters may cause
equipment damage (see Table 2.3).
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Chapter 3Cleaning, Disinfection and
Sterilization Procedures
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
patient procedure. 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.
•Do not coil the endoscope’s insertion tube or universal cord
with a diameter of less than 12 cm. The endoscope can be
damaged if coiled too tightly.
•For proper reprocessing results, do not coil the insertion tube
or the universal cord with a diameter of less than 40 cm. If
the diameter is less than 40 cm, it will be difficult to insert the
channel cleaning brush (BW-20T).
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
13
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Channel-opening
cleaning brush
(MH-507)
Leakage tester
(MB-155)
Water-resistant cap
(MH-553)
Channel cleaning brush
(BW-20T)
AW channel cleaning
adapter (MH-948)
Suction cleaning
adapter (MH-856)
Channel plug
(MH-944)
Light source
(CLV-260/U40/U20)
Injection tube
(MH-946)
Maintenance unit
(MU-1)
Washing tube (MH-974)
Suction pump (KV-4/5)
3.1Required reprocessing equipment
Preparation of the equipment
Prior to cleaning, disinfection or sterilization, prepare the equipment shown in
Figure 3.1.
Use basins which are at least 40 cm by 40 cm (16” by 16”) in
size and deep enough to allow the endoscope to be
completely immersed.
• Detergent solution• Large basins with tight fitting lids for
• Clean water• Large basins for rinsing and leakage
• Sterile water
• 70% ethyl or isopropyl alcohol
• Disinfectant solution• Soft brush• Small basins
3
•5cm
(5 ml) syringe
14
Figure 3.1
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
detergent and disinfectant solution
testing
3
•30cm
• 500 cm
(30 ml) syringe
3
(500 ml) containers
• Personal protective
equipment
• Clean lint-free cloths
• Sterile lint-free cloths
• Sterile cotton swabs
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Groove
Venting connector
Seal
Biopsy valve cap
Cylinder plug
Reprocessing equipment parts and functions
For inspection of other equipment than that mentioned below, refer to the
instruction manual for the equipment being used.
Water-resistant cap (MH-553)
The water-resistant cap is attached to the electrical connector on the endoscope
to protect the connector from water penetration during reprocessing. For leakage
testing, the venting connector on the water-resistant cap must be connected to
the leakage tester (see Figure 3.2).
Figure 3.2
Channel plug (MH-944)
The channel plug is used to plug the openings of the instrument channel port,
air/water and suction cylinders during cleaning (see Figure 3.3).
Figure 3.3
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
15
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Suction
channel tube
Notice 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
Metal tip
Shaft
Brush head
Injection tube (MH-946)
The injection tube is used to inject detergent solution, disinfectant solution, water
and alcohol into the air/water and suction channels and to flush air through the
channels to expel fluids (see Figure 3.4).
Figure 3.4
Channel cleaning brush (BW-20T)
The channel cleaning brush is used to brush the inside of the instrument and
suction channels and the interior and/or openings of the suction valve, air/water
valves, AW channel cleaning adapter and biopsy valve (see Figure 3.5).
Figure 3.5
16
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Brush handle
Shaft
Brush
Connecting end
Luer port
Channel-opening cleaning brush (MH-507)
The channel-opening cleaning brush is used to brush the external surfaces of
the distal end of the endoscope, the suction cylinder and the instrument channel
port (see Figure 3.6).
Figure 3.6
Washing tube (MH-974)
The washing tube is used to inject detergent solution, disinfectant solution, water
and alcohol into the elevator wire channel and to flush air through the channel to
expel fluids (see Figure 3.7).
Figure 3.7
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
17
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Weighted end
Connecting end
Notice card
Slider
Non-return valve
Piston
Packing
Suction cleaning adapter (MH-856)
The suction cleaning adapter is used to aspirate reprocessing fluids from the
distal end of the endoscope through the instrument channel (see Figure 3.8).
Figure 3.8
AW channel cleaning adapter (MH-948)
During precleaning, the AW channel cleaning adapter is connected to the
air/water cylinder. When the adapter is depressed, water is fed through the
air/water nozzle. Air is continuously fed when the adapter is not depressed (see
Figure 3.9).
Figure 3.9
18
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
Inspection of equipment
For inspection of other equipment than that mentioned below, refer to the
instruction manual for the equipment being used.
All equipment mentioned below are consumable items.
Should the slightest irregularity be suspected, use a spare
instead. Using defective equipment may make it difficult to
effectively reprocess the endoscope, and could cause
endoscope and/or equipment damage.
Do not immerse the water-resistant cap alone into water.
Moisture remaining inside the cap may penetrate the
electrical connector and cause equipment damage.
Inspection of the water-resistant cap (MH-553)
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
1. Confirm that the inside of the water-resistant cap is dry and free from debris
(see Figure 3.2 on page 15). Wipe with a dry cloth if the inside of the
water-resistant cap is wet or there is debris.
2. Confirm that the seal inside the water-resistant cap is free from scratches,
flaws and debris.
3. Check the venting connector for looseness.
Inspection of the channel plug (MH-944)
Confirm that the cylinder plug and biopsy valve cap are free from cracks,
scratches, flaws and debris (see Figure 3.3 on page 15).
Inspection of the injection tube (MH-946)
1. Confirm that all components of the injection tube are free from cracks,
scratches, flaws and debris (see Figure 3.4 on page 16).
2. Confirm that the filter mesh is in the suction port.
3. Attach the 30 cm
filter mesh immersed in rinsing water, withdraw the syringe’s plunger and
confirm that rinsing water is drawn into the syringe. Depress the plunger and
confirm that rinsing water is emitted from the air pipe port. Confirm that
water is not emitted from the suction port.
3
(30 ml) syringe to the air/water channel port. With the
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
19
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
4. Attach the 30 cm
mesh immersed in rinsing water, withdraw the syringe plunger and confirm
that rinsing water is drawn into the syringe. Depress the plunger and confirm
that rinsing water is emitted from the distal end of the suction channel tube.
Confirm that water is not emitted from the suction port.
3
(30 ml) syringe to the suction channel port. With the filter
Inspection of the channel cleaning brush (BW-20T)
1. Confirm that the brush head and the metal tip of the distal end are securely
in place. Check for loose or missing bristles (see Figure 3.5 on page 16).
2. Check for bends, scratches and other damage to the shaft.
3. Check for debris on the shaft and/or in the bristles of the brush.
Inspection of the channel-opening cleaning brush
(MH-507)
1. Check for loose or missing bristles (see Figure 3.6 on page 17).
2. Check for bends, scratches and other damage to the shaft.
3. Check for debris on the shaft and/or in the bristles of the brush.
Inspection of the washing tube (MH-974)
Check for cracks, scratches, flaws, debris and other damage (see Figure 3.7 on
page 17).
Inspection of the suction cleaning adapter (MH-856)
Check for cracks, scratches, flaws, debris and other damage (see Figure 3.8 on
page 18).
Inspection of the AW channel cleaning adapter (MH-948)
Check for cracks, scratches, flaws, debris and other damage (see Figure 3.9 on
page 18).
20
EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL
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