Evis Lucera TJF 260v

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INSTRUCTIONS

EVIS LUCERA DUODENOVIDEOSCOPE

OLYMPUS JF TYPE 260V


OLYMPUS TJF TYPE 260V

Refer to the endoscope’s companion manual, the “OPERATION MANUAL” whose cover lists the model of
your endoscope, for operation information.
Contents

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

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL i


Contents

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

ii EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Symbols

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

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 1


Chapter 1 General Policy

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.

2 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 1 General Policy

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.

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


or water pressure must not exceed 0.5 MPa (5 kgf/cm2,
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.

1.5 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.

6 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Chapter 2 Compatible Reprocessing


Methods and Chemical
Agents

2.1 Compatibility 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

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 *1

Water-resistant cap
(MH-553) *2
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)

Not
Applicable
applicable

Table 2.1
*1 The endoscope is compatible with ultrasonic cleaning by endoscope reprocessor
(OER, OER-A) only. OER, OER-A are not available in some areas.
*2 The 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.
*3 ACECIDE 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.

2.2 Detergent 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).

2.3 Disinfectant 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

2.4 Rinsing 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.

2.5 ETO 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.
• Exceeding the recommended parameters may cause
equipment damage (see Table 2.2).

10 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 2 Compatible Reprocessing Methods and Chemical Agents

 ETO gas exposure parameters

Process Parameters

Temperature 57°C (135°F)

Pressure 0.1 – 0.17 MPa (1 – 1.7 kgf/cm2)


(16 – 24 psig)

ETO gas sterilization Humidity 55%

Exposure time 1.75 hours

ETO gas 0.6 – 0.7 mg/cm3


concentration (600 – 700 mg/l)

Minimum aeration 12 hours in an aeration chamber


Aeration parameters at 50 – 57°C (122 – 135°F) or
7 days at room temperature

Table 2.2

 Gas mixture

20% ETO/80% CO2

2.6 Steam sterilization (autoclaving) of accessories


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).

Process Parameters

132 – 134°C
Temperature
Prevacuum (270 – 274°F)

Exposure time 5 minutes

Table 2.3 Steam sterilization (autoclaving) exposure parameters

12 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Chapter 3 Cleaning, 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

3.1 Required 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.

Water-resistant cap Channel cleaning brush Washing tube (MH-974)


(MH-553) (BW-20T)
Injection tube
(MH-946)

Channel-opening
cleaning brush AW channel cleaning Suction pump (KV-4/5)
(MH-507) adapter (MH-948)

Channel plug
(MH-944)

Leakage tester Suction cleaning


Light source Maintenance unit
(MB-155) adapter (MH-856) (CLV-260/U40/U20) (MU-1)

• Detergent solution • Large basins with tight fitting lids for • Personal protective
detergent and disinfectant solution equipment
• Clean water • Large basins for rinsing and leakage • Clean lint-free cloths
testing
• Sterile water • 30 cm3 (30 ml) syringe • Sterile lint-free cloths
• 70% ethyl or isopropyl alcohol • 500 cm3 (500 ml) containers • Sterile cotton swabs
• Disinfectant solution • Soft brush • Small basins
• 5 cm3 (5 ml) syringe

Figure 3.1

14 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

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).

Groove

Seal Venting connector

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).

Biopsy valve cap

Cylinder plug

Figure 3.3

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 15


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 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).

Suction
channel tube
Notice card
Connector plug
Suction
channel port Air pipe port

Air/water
channel port
Air/water channel tube

Filter tube
Suction port
(including the filter mesh)

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).

Metal tip Shaft

Brush head

Figure 3.5

16 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 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).

Brush
Brush handle

Shaft

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).

Luer port

Connecting end

Figure 3.7

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 17


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 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).

Connecting end

Weighted end

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).

Slider Notice card

Non-return valve
Piston
Packing

Figure 3.9

18 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

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)

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 cm3 (30 ml) syringe to the air/water channel port. With the
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.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 19


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

4. Attach the 30 cm3 (30 ml) syringe to the suction channel port. With the filter
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.

 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


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.2 Cleaning, disinfection and sterilization


procedures
After each procedure, clean, disinfect and sterilize the endoscope according to
the procedure described below.

Endoscope reprocessing summary chart

Withdrawal of the endoscope

Precleaning (Section 3.3)

Leakage testing (Section 3.4)

Manual cleaning (Section 3.5)

High-level disinfection
(Section 3.6)
Sterilization (Section 3.8)

Rinsing after high-level


disinfection (Section 3.7)

Storage and Disposal (Chapter 5)

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.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 21


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.3 Precleaning

If the endoscope is not immediately cleaned after each


procedure, residual organic debris will begin to solidify and it
may be difficult to effectively reprocess the endoscope.

Preclean the endoscope at the bedside in the procedure room immediately after
each procedure. During precleaning, wear appropriate personal protective
equipment.

Equipment needed
Prepare the following equipment.

• Personal protective equipment


• Clean lint-free cloths
• 500 cm3 (500 ml) containers
• Detergent solution
• AW channel cleaning adapter (MH-948)
• Clean water
• Suction pump
• Washing tube (MH-974)
3
• 5 cm (5 ml) syringe

Preparation

1. Turn the video system center and light source OFF.

2. Prepare a 500 cm3 (500 ml) container of detergent solution at the


temperature and concentration recommended by the detergent
manufacturer.

3. Prepare clean water in a 500 cm3 (500 ml) container.

Wipe down the insertion tube

Handle the insertion tube carefully. Tightly gripping or sharply


bending the insertion tube or bending section can stretch or
severely damage the insertion tube and/or the covering of the
bending section.

Wipe the entire insertion tube with a clean, lint-free cloth soaked in detergent
solution. Wipe from the boot at the control section toward the distal end.

22 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Aspirate detergent solution

Monitor the suction bottle on the suction pump carefully to


ensure that it does not overflow. Otherwise, suction pump
damage could result.

1. Turn the suction pump ON.

2. Attach the biopsy valve cap.

3. Immerse the distal end of the insertion tube in detergent solution. Depress
the suction valve and aspirate detergent solution into the instrument channel
for 30 seconds (see Figure 3.10).

4. Remove the distal end of the insertion tube from the detergent solution and
immerse it in clean water. Depress the suction valve and aspirate clean
water into the instrument channel for 10 seconds.

5. Remove the distal end of the insertion tube from the clean water. Depress
the suction valve and aspirate air for 10 seconds.

6. Turn the suction pump OFF.

Suction valve

Detergent solution

Figure 3.10

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Flush water and air into the air/water channel

Do not use the AW channel cleaning adapter for patient


examinations. It will cause continuous insufflation and could
result in patient injury.

• To prevent clogging of the air/water nozzle, always use the


AW channel cleaning adapter to clean the air/water channel
after each use.
• Do not apply lubricants to the AW channel cleaning adapter.
Lubricants may cause malfunction of the AW channel
cleaning adapter.

1. Turn the light source ON.

2. Switch “OFF” the airflow regulator on the light source.

3. Remove the air/water valve from the endoscope and place it in a container
of detergent solution (see Figure 3.11).

Water may drip from the air/water cylinder when the air/water
valve is detached. The water dripping from the air/water
cylinder is clean (i.e., sterile water in the water container). If
water is dripping from the air/water cylinder, hold the control
section higher than the water container.

4. Attach the AW channel cleaning adapter to the air/water cylinder of the


endoscope (see Figure 3.11).

AW channel cleaning adapter

Figure 3.11

24 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

5. Immerse the distal end of the insertion tube in the clean water (see Figure
3.12).

6. Switch the airflow regulator to maximum output (“HIGH” or “3”).

7. Depress the AW channel cleaning adapter to feed water through the


channels for 30 seconds. Release the adapter to feed air through the
channels for 10 seconds or more (see Figure 3.12).

AW channel
cleaning adapter

Clean water

Figure 3.12

8. Turn the light source OFF.

Flush detergent solution and air into the elevator wire channel

1. Connect the washing tube to the elevator channel plug (see Figure 3.13).

Elevator channel plug

Washing tube

Figure 3.13

2. Immerse the distal end of the insertion tube in the water.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 25


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3. Using the 5 cm3 (5 ml) syringe, slowly flush detergent solution through the
elevator wire channel via the washing tube several times until no air bubbles
exit the distal end (see Figure 3.14).

4. Using the 5 cm3 (5 ml) syringe, slowly flush water through the elevator wire
channel via the washing tube several times.

5. Using the 5 cm3 (5 ml) syringe, slowly flush air through the elevator wire
channel via the washing tube several times until a steady stream of air
bubbles exits the distal end (see Figure 3.14).

Washing tube
5 cm3 (5 ml)
syringe Elevator channel
Elevator wire plug
channel

Endoscope
connector

Figure 3.14

Disconnect the endoscope, reusable parts and cleaning


equipment

Do not touch the light guide of the endoscope connector


immediately after removing it from the light source because it
is extremely hot. Operator or patient injury may result.

1. Disconnect the videoscope cable from the endoscope’s electrical connector.

2. Disconnect the suction tube from the suction connector of the endoscope
connector.

3. Disconnect the metal tip of the water container from the air/water supply
connector of the endoscope connector and attach the metal tip to the tip
receptacle on the lid of the water container as described in the water
container’s instruction manual.

4. Disconnect the endoscope connector from the light source.

5. Transport the endoscope to the reprocessing area.

26 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

6. Detach the AW channel cleaning adapter, washing tube, suction valve and
biopsy valve from the endoscope and place them in a container of detergent
solution.

Detach the distal cover

• When detaching the distal cover, forcefully grasping other


parts of the bending section can result in damage to the
bending mechanism of the bending section or deform its
covering.
• After the distal cover has been removed, make sure not to
subject the forceps elevator to impact or bend the elevator
wire during cleaning, disinfection, sterilization, storage or
preparation of the endoscope. This could adversely affect the
function of the forceps elevator.

1. Move the elevator control lever all the way in the opposite direction of the
“ U” direction until it stops.

2. Gently hold the distal part in the covering of the bending section (see Figure
3.15). Hold the top end of the distal cover with the other hand.

Distal part

Figure 3.15

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3. Push the distal cover as far as possible toward the endoscope (see Figure
3.16).

4. Turn it counterclockwise until it stops (see Figure 3.16).

5. Pull the distal cover off the endoscope slowly and straightly (see Figure
3.16).

4. Turn

3. Push

5. Pull

Figure 3.16

6. Reprocess the distal cover as described in Section 3.10, “Cleaning,


disinfection and sterilization procedures for distal cover”.

28 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.4 Leakage testing


After precleaning, perform leakage testing on the endoscope to ensure that it is
waterproof. Also be sure to wear appropriate personal protective equipment.

Equipment needed
Prepare the following equipment:

• Personal protective equipment


• Large basin
• Clean water
• Maintenance unit or light source (MU-1 or CLV-260, U40, U20)
• Leakage tester (MB-155)
• Water-resistant cap (MH-553)

Attaching the water-resistant cap (MH-553)

• The electrical connector of the endoscope is not waterproof.


Before immersing or leakage testing the endoscope, always
attach the water-resistant cap. Otherwise, equipment
damage may result.
• If the exterior of the electrical connector is scratched, the
connector may no longer be waterproof and the seal inside
the water-resistant cap may be scratched. If the electrical
connector is scratched, send it immediately to Olympus for
repairs.
• Always use a dry water-resistant cap. Any water remaining
on the water-resistant cap may cause damage to the
endoscope, maintenance unit or light source.

1. Confirm that the inside of the water-resistant cap is dry and free from debris.
Wipe with a dry clean cloth if the inside of the water-resistant cap is wet or
there is debris.

2. Align the OER/ETD/EW character (see Figure 3.17 (a)) or the EW character
on the water-resistant cap with mark 2 on the electrical connector housing.
When using a manual disinfector, align the KC/TD character (see Figure
3.17 (b)) on the water-resistant cap with mark 2 on the electrical connector
housing.

3. Align the pin on the electrical connector with the groove on the
water-resistant cap.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 29


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

4. Push the water-resistant cap into position and rotate it clockwise until it
stops (approximately 45°).

Mark 2 (gray) Mark 2 (gray)

Water-resistant
cap
2. 2.

Rotate Rotate
3. 3.

4. 4.

(a) When leakage testing, cleaning, (b) When using a manual disinfector
disinfection or using an
endoscope reprocessor

Figure 3.17

Performing the leakage test

• During leakage testing, a continuous series of air bubbles


emerging from a location on the endoscope indicates a leak
at that location. This means that water will be able to
penetrate the inside of the endoscope. If you locate a leak,
remove the endoscope from the water and contact Olympus.
• Never connect or disconnect the water-resistant cap or the
leakage tester’s connector cap while immersed. Doing so
could allow water to enter the endoscope and equipment
damage can result.
• Rotate the leakage tester’s connector cap until it stops. If it is
not fully and properly attached, the endoscope’s interior will
not be pressurized and accurate leakage testing will be
impossible.

30 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

• When connecting the leakage tester’s connector cap to the


water-resistant cap’s venting connector, make sure that the
inside of the leakage tester’s connector cap and the outside
of the water-resistant cap’s venting connector are thoroughly
dry. Water remaining on either component may penetrate the
inside of the water-resistant cap and could cause endoscope
malfunction.

When the leakage tester connector is in place, the covering


of the bending section will expand as the air pressure inside
the endoscope increases. This is normal.

1. Fill a basin with clean water. Use a basin which is at least 40 cm by 40 cm


(16” by 16”) in size and deep enough to allow the endoscope to be
completely immersed.

2. Insert the leakage tester connector into the output socket of the
maintenance unit or the light source (see Figure 3.18) and turn it ON. Set
the light source’s airflow regulator switch to its maximum level.

3. Confirm that the leakage tester is emitting air by gently depressing the pin
located inside the leakage tester’s connector cap. Confirm that no water is
inside the leakage tester’s connector cap.

4. Confirm that no water is outside of the water-resistant cap’s venting


connector. Connect the leakage tester’s connector cap to the venting
connector of the water-resistant cap (see Figure 3.18).

Maintenance unit
or light source Leakage tester connector

Leakage tester’s connector cap

Venting connector

Figure 3.18

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

5. With the leakage tester connected, immerse the endoscope in the water and
observe for approximately 30 seconds while angulating the bending section.
Confirm that there is no location on the endoscope from which a continuous
series of air bubbles emerges.

6. Remove the endoscope from the basin with the leakage tester attached.

7. Turn the maintenance unit or the light source OFF.

8. Disconnect the leakage tester from the maintenance unit or the light source.

Always disconnect the leakage tester connector from the


light source or maintenance unit before disconnecting the
leakage tester’s connector cap from the venting connector.
Failure to do this will not allow the endoscope to
depressurize properly. This may damage the endoscope.

9. Wait 30 seconds, or until the covering of the bending section contracts to its
pre-expansion size. Disconnect the leakage tester’s connector cap from the
venting connector.

10. Thoroughly dry the leakage tester.

32 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.5 Manual cleaning

To prevent a water leak, do not apply excessive force when


washing the endoscope.

After completing the leakage test, perform manual cleaning according to the
procedures described below.

In case of excessive bleeding and/or delayed reprocessing, first follow the


procedure described in “Presoak for excessive bleeding and/or delayed
reprocessing after each procedure” on page 47, then follow the procedure
described below.

Reusable parts which are normally reprocessed with the


endoscope

• Channel plug (MH-944)


• Injection tube (MH-946)
• Water-resistant cap (MH-553)
• Chain for water-resistant cap (MAJ-1119)
• Washing tube (MH-974)

Equipment needed
Prepare the following equipment, and wear appropriate personal protective
equipment.

• Personal protective equipment


• Soft brush
• Clean lint-free cloths
• Large basin
• Detergent solution
• Clean water
• Suction cleaning adapter (MH-856)
• Channel plug (MH-944)
• Injection tube (MH-946)
• Channel cleaning brush (BW-20T)
• Channel-opening cleaning brush (MH-507)
• Suction pump
• 30 cm3 (30 ml) syringe
• Washing tube (MH-974)
3
• 5 cm (5 ml) syringe

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

To prevent damage to the endoscope, never immerse it


together with objects other than the equipment listed above.

Preparation

1. Fill a basin with detergent solution at the temperature and concentration


recommended by the detergent manufacturer. Use a basin which is at least
40 cm by 40 cm (16” by 16”) in size and deep enough to allow the
endoscope to be completely immersed.

2. Fill a basin with clean water. Use a basin which is at least 40 cm by 40 cm


(16” by 16”) in size and deep enough to allow the endoscope to be
completely immersed.

Cleaning the external surface

1. Immerse the endoscope in the detergent solution.

2. With the endoscope immersed, use a soft brush or lint-free cloth to


thoroughly brush or wipe all external surfaces of the endoscope. Pay
particular attention to the air/water nozzle opening and the objective lens,
and ensure that all surfaces of the distal end are cleaned thoroughly (see
Figure 3.19).

Lint-free cloth

Air/water nozzle
opening

Objective lens

Figure 3.19

34 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Brushing around the forceps elevator and instrument channel


outlet

Using a stiff brush or excessive force when brushing may


scratch the distal end and result in water leakage; cause the
elevator wire to come off the distal end, bend or kink the
elevator wire so that the forceps elevator will no longer work.

1. Turn the elevator control lever all the way in the opposite direction of the
“ U” direction. Perform the following brushing in the detergent solution.

2. While the bending section is kept straight, insert the channel-opening


cleaning brush into the instrument channel opening at the distal end of the
endoscope, then pull it out (see Figure 3.20).

3. Repeat until all debris is removed.

4. Brush along the forceps wire, and the groove of the instrument channel
outlet (for TJF-260V only) using a commercially available soft brush or the
channel-opening cleaning brush (see Figure 3.21).

5. While holding the distal end with one hand and keeping the forceps elevator
lowered with the fingers, brush both sides of the forceps elevator, the groove
of the interior of the forceps elevator, around the axis of the forceps elevator,
and guidewire-locking groove of the forceps elevator using the soft brush or
the channel-opening cleaning brush (see Figures 3.22 and 3.23).

6. Remove fingers from the forceps elevator.

7. Brush the distal end of the endoscope, using the soft brush or the
channel-opening cleaning brush.

Figure 3.20

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 35


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Groove

Figure 3.21

Channel-opening
cleaning brush

Figure 3.22

Guidewire-locking groove

Figure 3.23

36 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Brushing the channels

• Be sure to brush the inside of the suction channel.


Otherwise, insufficient cleaning and/or disinfection of the
endoscope may pose an infection control risk to the patient
and/or operators performing the next procedure with the
endoscope.
• To avoid splattering detergent solution when the channel
cleaning brush is pulled out, keep the endoscope
submerged.
• The channel cleaning brush is a consumable item. Repeated
use may cause the brush head to become bent or kinked,
which could cause it to come off during use. Confirm that the
brush is free from any damage or other irregularities before
and after each use. Should a part of the brush come off
inside the endoscope, immediately retrieve it and carefully
confirm that no parts remain inside the channel of the
endoscope by passing a new cleaning brush or other
endo-therapy accessory through the channel. Any parts left
in the channel can drop into the patient during the procedure.
Depending on the location, the missing part may not be
recoverable by passing a new brush or other endo-therapy
accessory through the channel. In this case, contact
Olympus.

• Withdraw the channel cleaning brush from the suction


channel gently, ensuring that its shaft does not rub against
the external opening of the suction cylinder. This could
damage the brush and/or may wear a groove in the opening,
leading to impaired suction and liquid leakage.
• Do not attempt to pass the channel cleaning brush from the
distal end of the insertion tube and/or suction connector. It
may get caught, making retrieval impossible.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 37


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

While the endoscope is submerged, brush the instrument and suction channels,
suction cylinder and instrument channel port according to the following
procedures (see Figure 3.24).

B C

Suction cylinder

Instrument channel port

B
A

Suction connector

Figure 3.24

 Brushing the instrument channel in the insertion tube and


suction channel in the control section (location A)

1. Immerse the endoscope in the detergent solution to avoid splattering.

2. Straighten the endoscope’s bending section. Grip the channel cleaning


brush at a point 3 cm from the bristles.

3. Insert the channel cleaning brush at a 45° angle into the opening located in
the side wall of the suction cylinder as illustrated by A in Figure 3.24. Using
short strokes, feed the brush through the insertion tube until it emerges from
the distal end of the endoscope.

4. Clean the bristles with your fingertips in the detergent solution. Carefully pull
the brush out through the channel.

5. Clean the bristles in the detergent solution again.

6. Repeat until all debris is removed.

38 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Brushing the suction channel in the universal cord


(location B)

1. Grip the channel cleaning brush at a point 3 cm from the bristles.

2. Insert the channel cleaning brush straight into the opening of the suction
cylinder as illustrated by B in Figure 3.24. Using short strokes, feed the
brush through the universal cord until it emerges from the suction connector
on the endoscope connector.

3. Clean the bristles with your fingertips in the detergent solution. Carefully pull
the brush out through the channel.

4. Clean the bristles in the detergent solution again.

5. Repeat until all debris is removed.

 Brushing the suction cylinder (location C)

When inserting the channel-opening cleaning brush into the


suction cylinder, do not forcibly insert the brush beyond the
middle of the brush section. Otherwise, the brush may
become stuck in the suction cylinder.

1. Insert the channel-opening cleaning brush into the suction cylinder as


illustrated by C in Figure 3.24, until half of the brush section is inserted.

2. Turn the inserted brush once.

3. Pull the brush out and clean the bristles with your fingertips in the detergent
solution.

4. Repeat until all debris is removed.

 Brushing the instrument channel port (location D)

1. Insert the channel-opening cleaning brush into the instrument channel port
until the brush handle touches the channel opening as illustrated by D in
Figure 3.24.

2. Turn the inserted brush once.

3. Pull the brush out and clean the bristles with your fingertips in the detergent
solution.

4. Repeat until all debris is removed.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 39


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

5. Reprocess the cleaning brushes as described in Section 3.9, “Cleaning,


disinfection and sterilization procedures for reusable parts and reprocessing
equipment”.

6. Remove the endoscope from the detergent solution.

Aspirating detergent solution into the instrument channel and


the suction channels

1. Attach the suction cleaning adapter to the instrument channel port (see
Figures 3.25 and 3.26).

2. Connect the suction tube from the suction pump to the suction connector on
the endoscope connector. Turn the suction pump ON.

3. Immerse both the endoscope’s distal end and the weighted end of the
suction cleaning adapter in the detergent solution.

4. Cover the suction cylinder with your finger and aspirate detergent solution
for approximately 30 seconds.

5. Release your finger from the suction cylinder.

6. Turn the suction pump OFF.

7. Disconnect the suction tube and the suction cleaning adapter.

8. Reprocess the suction cleaning adapter as described in Section 3.9,


“Cleaning, disinfection and sterilization procedures for reusable parts and
reprocessing equipment”.

Suction cleaning
adapter

Weighted end

Figure 3.25

40 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Weighted end Instrument


channel port

Suction channel
Suction cleaning adapter

Insertion tube Instrument


channel Suction
cylinder

Universal cord
Endoscope connector Suction connector

Suction tube

Suction bottle Suction pump

Figure 3.26

Flushing the interior of the forceps elevator

1. Immerse the distal end in detergent solution, and operate the elevator
control lever to raise and lower the forceps elevator 3 times.

2. With the forceps elevator raised, flush the interior of the forceps elevator
with detergent solution using the 30 cm3 (30 ml) syringe (see Figure 3.27).

Forceps elevator Detergent solution

Figure 3.27

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 41


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Flushing detergent solution into the air/water channels

1. Attach the channel plug’s biopsy valve cap to the instrument channel port
(see Figure 3.28).

2. Lower the channel plug’s cylinder plug onto the air/water and suction
cylinders (see Figure 3.28).

3. Push the plug down on the endoscope’s control section and slide the plug
until it stops (see Figure 3.28).

Cylinder plug
Air/water cylinder

Suction cylinder

Biopsy valve cap Push


Slide

Instrument
channel port

Figure 3.28

4. Attach the injection tube’s connector plug to the air and water supply
connectors on the endoscope connector (see Figures 3.29 and 3.30).

5. Attach the injection tube’s air pipe port to the air pipe on the endoscope
connector (see Figures 3.29 and 3.30).

6. Attach the injection tube’s suction channel tube to the suction connector on
the endoscope connector (see Figures 3.29 and 3.30).

7. Immerse the suction port of the injection tube in the detergent solution.

8. Attach the 30 cm3 (30 ml) syringe to the injection tube’s air/water channel
port (see Figure 3.30).

9. Inject 90 cm3 (90 ml) of detergent solution into the air/water channel.

10. Detach the channel plug and injection tube from the endoscope, and leave
all items immersed.

42 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Syringe Air/water channel tube


Suction channel tube

Suction port

Air pipe port

Basin

Detergent
Connector plug solution

Figure 3.29

Air channel Biopsy valve cap Channel plug

Water channel Air/water cylinder

Air/water nozzle
Connector plug Suction cylinder

Water supply connector

Air supply connector


Suction connector

Air pipe port


Suction port

Injection tube
Suction channel port

Syringe
Air/water channel port

Figure 3.30

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 43


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Flushing detergent solution into the elevator wire channel

1. Connect the washing tube to the elevator channel plug (see Figure 3.31).

Elevator channel plug

Washing tube

Figure 3.31

2. Using the 5 cm3 (5 ml) syringe, inject 15 cm3 (15 ml) of detergent solution
into the elevator wire channel via the washing tube (see Figure 3.32).

5 cm3 (5 ml) syringe Washing tube

Elevator channel
plug
Elevator wire channel

Endoscope connector

Figure 3.32

3. Disconnect the washing tube from the endoscope and immerse it in


detergent solution.

44 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Soaking the endoscope and all reprocessing equipment in


detergent solution

1. Using a lint-free cloth, wipe all debris from the endoscope’s external
surfaces while the endoscope is immersed in the detergent solution.

2. Cover the basin with a tight fitting lid to minimize the diffusion of detergent
vapors.

3. Soak the endoscope and all reprocessing equipment for the amount of time
and at the temperature and concentration recommended by the detergent
manufacturer.

4. Remove the endoscope and all reprocessing equipment from the detergent
solution.

5. Inspect all reprocessing equipment. If debris remains on any of the


equipment, ultrasonically clean it at 33 – 48 kHz for 5 minutes.

6. Place the endoscope and all reprocessing equipment in clean water and
gently agitate them to thoroughly rinse.

Removing detergent solution from all channels

1. Attach the channel plug and the injection tube to the endoscope. Place the
suction port of the injection tube in clean water. Attach the channel plug’s
biopsy valve cap to the instrument channel port (see Figure 3.33).

2. Attach the 30 cm3 (30 ml) syringe to the suction channel port of the injection
tube and inject 90 cm3 (90 ml) of clean water into the suction channel (see
Figure 3.33).

3. Attach the 30 cm3 (30 ml) syringe to the air/water channel port of the
injection tube and inject 90 cm3 (90 ml) of clean water into the air/water
channel (see Figure 3.30).

4. Connect the washing tube to the elevator channel plug (see Figure 3.31).

5. Attach the 5 cm3 (5 ml) syringe to the washing tube and flush the elevator
wire channel with 5 cm3 (5 ml) of clean water (see Figure 3.32).

6. Remove the endoscope, together with all equipment, from the water.

7. Cover the distal end and control section of the endoscope with a clean
lint-free cloth.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 45


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

8. Using the 30 cm3 (30 ml) syringe, flush the air/water and suction channels
with 90 cm3 (90 ml) of air, respectively, via the injection tube (see Figures
3.30 and 3.33).

9. Using the 5 cm3 (5 ml) syringe, flush the elevator wire channel with 10 cm3
(10 ml) of air via the washing tube (see Figures 3.31 and 3.32).

10. Remove the clean, lint-free cloth from the distal end and the control section
of the endoscope.

11. Detach the channel plug and injection tube from the endoscope.

12. Disconnect the washing tube from the endoscope.

Biopsy valve cap Channel plug

Suction channel Suction cylinder

Suction channel

Injection tube
Suction connector

Suction port

Air/water channel port

Syringe
Suction channel port

Figure 3.33

Dry external surfaces

1. Using a clean lint-free cloth, wipe and dry the external surfaces of the
endoscope and all equipment thoroughly.

2. Inspect the endoscope and all equipment for residual debris. Should debris
remain, repeat the procedures given in this section.

46 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Presoak for excessive bleeding and/or delayed reprocessing


after each procedure

Follow the steps below only in cases of excessive bleeding


and/or delayed reprocessing; unnecessary immersions
should be avoided. Consecutive extended immersions may
damage the endoscope.

1. Fill a basin with detergent solution at the temperature and concentration


recommended by the detergent manufacturer. Use a basin which is at least
40 cm by 40 cm (16” by 16”) in size and deep enough to allow the
endoscope to be completely immersed.

2. Carefully coil the endoscope’s insertion tube and universal cord, and
completely immerse the endoscope in the detergent solution.

3. Fill all channels with the detergent solution following the procedures
described in this section.

4. Remove only the reprocessing equipment from the detergent solution.

5. Cover the basin with a tight fitting lid to minimize the diffusion of detergent
vapors.

6. Soak the endoscope for 10 hours at the temperature and concentration


recommended by the detergent manufacturer.

7. Remove the endoscope from the detergent solution.

8. After soaking the endoscope, manually clean it following the procedures


described in this section.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 47


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.6 High-level disinfection

All disinfection steps should be performed with the


endoscope and all equipment completely immersed in
disinfectant solution. If the equipment is connected to the
endoscope while they are immersed, or any part of them is
not immersed completely, disinfectant solution may not
adequately contact all surfaces of the equipment.

After manual cleaning, disinfect the endoscope according to the procedures


described below.

Equipment needed
Prepare the following equipment, and wear appropriate personal protective
equipment.

• Personal protective equipment


• Clean lint-free cloths
• Large basin
• Disinfectant solution
• 30 cm3 (30 ml) syringe
• Channel plug (MH-944)
• Injection tube (MH-946)
• Washing tube (MH-974)
• 5 cm3 (5 ml) syringe

Preparation

1. Fill a basin with disinfectant solution at the temperature and concentration


recommended by the disinfectant manufacturer. Use a basin which is at
least 40 cm by 40 cm (16” by 16”) in size and deep enough to allow the
endoscope to be completely immersed.

2. Attach the channel plug and the injection tube to the endoscope. Attach the
channel plug’s biopsy valve cap to the instrument channel port (see Figures
3.28 and 3.29).

3. Connect the washing tube to the elevator channel plug (see Figure 3.31).

48 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Flushing disinfectant solution into all channels

Completely remove all air bubbles from all channels.


Disinfection effects cannot be obtained if air bubbles remain
in the channels.

Air bubbles removal can be facilitated by injecting


disinfectant solution into the channels with strong force.

1. Immerse the endoscope and all equipment in the disinfectant solution.

2. Confirm that the suction port of the injection tube is immersed in disinfectant
solution.

3. Using the 30 cm3 (30 ml) syringe, flush at least 90 cm3 (90 ml) of
disinfectant solution through the air/water and suction channels respectively
via the injection tube. Confirm that no air bubbles exit the distal end of the
endoscope (see Figure 3.30 and 3.33).

4. Using the 5 cm3 (5 ml) syringe, flush 10 cm3 (10 ml) of disinfectant solution
through the elevator wire channel via the washing tube. Confirm that no air
bubbles exit the distal end of the endoscope (see Figure 3.31 and 3.32).

5. While immersed in disinfectant solution, raise the forceps elevator and flush
the vicinity of the forceps elevator with disinfectant solution using the 5 cm3
(5 ml) syringe.

Soaking the endoscope and all equipment in disinfectant


solution

All disinfection steps should be performed with the


endoscope and all equipment completely immersed. If the
equipment is disconnected while not immersed, disinfectant
solution may not adequately contact all surfaces. As a result,
the effectiveness of disinfection may be reduced.

1. With the endoscope and all equipment completely immersed in the


disinfectant solution, disconnect all equipment from the endoscope. Leave
the endoscope and all equipment immersed in the disinfectant solution.

2. If air bubbles adhere to the surfaces of the endoscope and/or equipment,


remove them using a clean lint-free cloth.

3. Cover the basin with a tight fitting lid to minimize the diffusion of disinfectant
vapors.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

4. Soak the endoscope and all equipment in disinfectant solution for the
amount of time and at the temperature and concentration recommended by
the disinfectant manufacturer.

Removing the endoscope and all equipment from disinfectant


solution

1. Before removing the endoscope from the disinfectant solution, connect the
channel plug and injection tube to the endoscope. Attach the channel plug’s
biopsy valve cap to the instrument channel port.

2. Before removing the endoscope from the disinfectant solution, connect the
washing tube to the elevator channel plug.

3. Remove the injection tube’s suction port from the disinfectant solution.

4. Using the 30 cm3 (30 ml) syringe, flush 90 cm3 (90 ml) of air through the
air/water and suction channels respectively via the injection tube.

5. Using the 5 cm3 (5 ml) syringe, flush the elevator wire channel with 10 cm3
(10 ml) of air via the washing tube.

6. Remove the endoscope and all equipment from the disinfectant solution.

7. Disconnect all equipment from the endoscope.

50 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.7 Rinsing after high-level disinfection

After reprocessing, purge the channels of the endoscope to


thoroughly dry them. Otherwise, bacteria may proliferate in
the channels and pose an infection-control risk to the patient
and/or operators performing the next procedure with the
endoscope.

After high-level disinfection, rinse the endoscope and all equipment according to
the procedures described below.
Use water of appropriate microbiological quality. 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, fresh potable tap water
or water which has been processed (e.g. filtered) to improve its microbiological
quality may be used with 70% ethyl or isopropyl alcohol rinse (see “Non-sterile
water rinse and alcohol flush” on page 53). Consult with your hospital’s infection
control committee.

Equipment needed
Prepare the following equipment, and wear appropriate personal protective
equipment.

• Personal protective equipment


• Sterile lint-free cloths
• Sterile large basin
• Large basin
• Sterile water for sterile water rinse
• 30 cm3 (30 ml) syringe
• Channel plug (MH-944)
• Injection tube (MH-946)
• Suction pump (with sterile suction tube)
• Washing tube (MH-974)
3
• 5 cm (5 ml) syringe

If sterile water is not available, prepare the following equipment.

• Clean water for non-sterile water rinse


• 70% ethyl or isopropyl alcohol
• Sterile cotton swabs
• Small basin

Alcohol is flammable. Handle it with care.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 51


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Sterile water rinse

1. Fill a basin with sterile water. Use a basin which is at least 40 cm by 40 cm


(16” by 16”) in size and deep enough to allow the endoscope to be
completely immersed.

2. Immerse the endoscope, channel plug and injection tube in the sterile water.
Using a sterile lint-free cloth, thoroughly rinse and wipe all external surfaces.

3. Immerse the washing tube in the sterile water. Using a sterile, lint-free cloth,
thoroughly rinse and wipe all external surfaces.

4. Attach the channel plug and the injection tube to the endoscope. Place the
suction port in the sterile water. Attach the channel plug’s biopsy valve cap
to the instrument channel port.

5. Using the 30 cm3 (30 ml) syringe, flush the air/water and suction channels
with 90 cm3 (90 ml) of sterile water respectively via the injection tube.

6. Connect the washing tube to the elevator channel plug.

7. Using the 5 cm3 (5 ml) syringe, flush the elevator wire channel with 15 cm3
(15 ml) of sterile water via the washing tube.

8. Remove the endoscope, together with all equipment, from the sterile water
and place them in the sterile large basin.

9. Using the 30 cm3 (30 ml) syringe, flush 90 cm3 (90 ml) of air through the
air/water and suction channels respectively via the injection tube.

10. Using the 5 cm3 (5 ml) syringe, flush the elevator wire channel with 15 cm3
(15 ml) of air via the washing tube.

11. Detach the injection tube only. Connect a sterile suction tube from the
suction pump to the suction connector on the endoscope. Turn the suction
pump ON and aspirate air for at least 15 seconds.

12. Turn the suction pump OFF and disconnect all equipment from the
endoscope.

13. Using a sterile lint-free cloth, thoroughly wipe and dry the external surfaces
of the endoscope and all equipment.

14. Dry the endoscope and all equipment.

15. Store the components following the instructions given in Chapter 5, “Storage
and Disposal”.

52 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Flushing the channels with 70% ethyl or isopropyl alcohol


after rinsing them with sterile water facilitates drying inside
the channels.

 Non-sterile water rinse and alcohol flush

1. Inject non-sterile water and air following the procedures given in “Sterile
water rinse” on page 52.

2. Fill a small basin with 70% ethyl or isopropyl alcohol.

3. Attach the channel plug and the injection tube to the endoscope. Attach the
channel plug’s biopsy valve cap to the instrument channel port.

4. Cover the distal end and control section of the endoscope with a sterile,
lint-free cloth.

5. Immerse the suction port of the injection tube in the alcohol. Using the
30 cm3 (30 ml) syringe, flush 90 cm3 (90 ml) of the alcohol through the
air/water and suction channels respectively via the injection tube.

6. Remove the suction port of the injection tube from the alcohol. Using the
30 cm3 (30 ml) syringe, flush 90 cm3 (90 ml) of air through the air/water and
the suction channels respectively via the injection tube.

7. Connect the washing tube to the elevator channel plug.

8. Using 5 cm3 (5 ml) syringe, flush the elevator wire channel with 10 cm3
(10 ml) of the alcohol via the washing tube.

9. Using 5 cm3 (5 ml) syringe, flush the elevator wire channel with 15 cm3
(15 ml) of the air via the washing tube.

10. Remove the sterile lint-free cloth from the distal end and the control section
of the endoscope.

11. Disconnect all equipment from the endoscope.

12. Using a sterile, lint-free cloth moistened with alcohol, thoroughly wipe the
external surfaces of the endoscope and all equipment.

13. Using sterile cotton swabs, dry the inside of the air/water cylinder, suction
cylinder and instrument channel port.

14. Dry the endoscope and all equipment.

15. Store the components following the instructions given in Chapter 5, “Storage
and Disposal”.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 53


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.8 Sterilization

ETO gas sterilization


As an alternative to high-level disinfection, the endoscope can be sterilized by
ethylene oxide (ETO) gas. After performing manual cleaning and drying as
described in Section 3.3, “Precleaning” and Section 3.5, “Manual cleaning”,
follow the procedures given below.

• Exceeding the recommended parameters may cause


equipment damage.
• If ETO gas sterilization is performed while the water-resistant
cap is attached, the covering of the bending section can be
damaged.
• The chain for water-resistant cap (MAJ-1119) and the
water-resistant cap itself (MH-553) cannot be sterilized by
ETO gas and may be damaged if they are subjected to ETO
gas sterilization.

1. Dry the endoscope and all equipment before ETO gas sterilization.

2. Remove the water-resistant cap before ETO gas sterilization (see Figure
3.34). If the water-resistant cap is connected to the endoscope using the
chain, be sure to remove the chain for water-resistant cap and
water-resistant cap from the endoscope before proceeding to ETO gas
sterilization.

Figure 3.34

3. Seal the instrument in a package appropriate for ETO gas sterilization


according to your hospital’s protocol.

54 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

4. Sterilize the package according to the recommended ETO gas exposure


parameters described in Section 2.5, “ETO gas sterilization” and the
sterilizer manufacturer’s instructions.

5. Aerate the components following the minimum aeration parameters


specified in Section 2.5, “ETO gas sterilization”.

6. Store the components following the instructions given in Chapter 5, “Storage


and Disposal”.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 55


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.9 Cleaning, disinfection and sterilization


procedures for reusable parts and reprocessing
equipment
This section includes the cleaning, disinfection and sterilization procedures for
the reusable parts and reprocessing equipment listed below.

• Air/water valve (MH-438)


• Suction valve (MH-443)
• AW channel cleaning adapter (MH-948)
• Mouthpiece (MB-142)
• Biopsy valve (MB-358)
• Channel-opening cleaning brush (MH-507)
• Channel cleaning brush (BW-20T)
• Suction cleaning adapter (MH-856)

Equipment needed
Prepare the following equipment, and wear appropriate personal protective
equipment.

• Sterile lint-free cloths


• Sterile water for sterile water rinse
• Clean water (non-sterile water)
• 70% ethyl or isopropyl alcohol
• Clean lint-free cloths
• Personal protective equipment
• Detergent solution
• Soft brush
• Disinfectant solution
• Small basins
• 30 cm3 (30 ml) syringe
• Channel cleaning brush (BW-20T)
• Channel-opening cleaning brush (MH-507)

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Manual cleaning

• Make sure that the items immersed in detergent solution do


not contact one another.
• Make sure not to scratch the seals on the air/water valve and
AW channel cleaning adapter with brushes, etc.

1. Fill a small basin with clean water. Use a basin which is deep enough to
allow all equipment to be completely immersed.

2. Fill a small basin with the detergent solution at the temperature and
concentration recommended by the detergent solution. Use a basin which is
deep enough to allow all equipment to be completely immersed.

3. Detach the biopsy valve’s cap from the main body, before immersing in the
detergent solution (see Figure 3.35).

Cap Main body

Figure 3.35

4. Immerse all other equipment in the detergent solution.

5. Using a soft brush or clean lint-free cloth, clean the external surfaces of all
equipment in detergent solution.

6. Using a soft brush or clean lint-free cloth, clean the inside of the mouthpiece
in detergent solution.

7. Using the channel cleaning brush, thoroughly brush the openings of the
suction valve, air/water valve and AW channel cleaning adapter until no
debris can been seen.

8. Using the channel cleaning brush and channel-opening cleaning brush,


thoroughly brush the interior and openings of the biopsy valve.

9. Clean the bristle of the cleaning brushes thoroughly while the brushes are
immersed.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

10. Using the 30 cm3 (30 ml) syringe, flush the interior and openings of all
equipment until no air bubbles can be seen.

11. While immersed, depress and release the pistons of the air/water valves,
suction valves and AW channel cleaning adapter. Ensure that all air bubbles
are expelled.

12. Rub the bristles of the channel cleaning brush and channel-opening
cleaning brush to remove all air bubbles.

13. Using the 30 cm3 (30 ml) syringe, flush the inside of the suction cleaning
adapter with the detergent solution while the adapter is immersed. Ensure
that all air bubbles are expelled.

14. Cover the basin with a tight fitting lid to minimize the diffusion of detergent
vapors. Soak all equipment at the temperature and concentration
recommended by the detergent manufacturer.

15. Remove all equipment from the detergent solution and inspect it. If debris
remains on any of the equipment, ultrasonically clean it at 33 – 48 kHz for
5 minutes.

16. Immerse all equipment in the clean water.

17. Gently agitate the equipment to thoroughly rinse.

18. While immersed, depress and release the pistons of the air/water valve,
suction valve and AW channel cleaning adapter. Ensure that all air bubbles
are expelled.

19. Rub the bristles of the channel cleaning brush and channel-opening
cleaning brush to remove all air bubbles.

20. Using the 30 cm3 (30 ml) syringe, flush the inside of the suction cleaning
adapter thoroughly with clean water while it is immersed. Ensure that all air
bubbles are expelled.

21. Remove the suction cleaning adapter from the clean water. Hold the adapter
and tilt it to expel the clean water remaining in the adapter.

22. Remove all equipment from the clean water.

23. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces.

58 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

High-level disinfection

• Completely remove air bubbles from all equipment.


Disinfection effects cannot be obtained if air bubbles remain
on the equipment.
• All disinfection steps should be performed with all equipment
completely immersed. If any part of the equipment is not
immersed completely, disinfectant solution may not
adequately contact all surfaces.

1. Fill a basin with disinfectant solution at the temperature and concentration


recommended by the disinfectant manufacturer. Use a basin which is deep
enough to allow all equipment to be completely immersed.

2. Immerse all equipment in the disinfectant solution.

3. Using a lint-free cloth and/or 30 cm3 (30 ml) syringe, wipe and/or flush all
surfaces with the disinfectant solution to remove all air bubbles.

4. Using the 30 cm3 (30 ml) syringe, flush the interiors and recessed parts of
them while they are immersed. Ensure that all air bubbles are expelled.

5. While immersed, depress and release the pistons of the valves and AW
channel cleaning adapter. Ensure that all air bubbles are expelled.

6. Using the 30 cm3 (30 ml) syringe, flush the recessed parts of the biopsy
valve with disinfectant solution while the valve is immersed. Ensure that all
air bubbles are expelled.

7. Rub the bristles of the channel cleaning brush and channel-opening


cleaning brush to remove all air bubbles.

8. Using the 30 cm3 (30 ml) syringe, flush the inside of the suction cleaning
adapter thoroughly with disinfectant solution while it is immersed in the
disinfectant solution. Ensure that all air bubbles are expelled.

9. Cover the basin with a tight fitting lid to minimize the diffusion of disinfectant
vapor. Soak all equipment at the temperature and concentration
recommended by the disinfectant manufacturer.

10. Remove the suction cleaning adapter from the disinfectant solution. Hold
the adapter and tilt it to expel the disinfectant solution remaining in the
adapter.

11. Remove all equipment from the disinfectant solution.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Rinsing after high-level disinfection


After high-level disinfection, rinse all equipment according to the procedures
described below.
Use water of appropriate microbiological quality. 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, fresh potable tap water
or water which has been processed (e.g. filtered) to improve its microbiological
quality may be used with 70% ethyl or isopropyl alcohol rinse (see “Non-sterile
water rinse and alcohol flush” on page 61). Consult with your hospital’s infection
control committee.

Alcohol is flammable. Handle it with care.

 Sterile water rinse

1. Fill a small basin with sterile water. Use a basin which is deep enough to
allow all equipment to be completely immersed.

2. Immerse all equipment in the sterile water.

3. Gently agitate the equipment to thoroughly rinse them.

4. Using the 30 cm3 (30 ml) syringe, flush the interior and recessed parts of all
equipment with sterile water while they are immersed. Ensure that all air
bubbles are expelled.

5. While immersed, depress and release the pistons of the air/water valve,
suction valve and AW channel cleaning adapter. Ensure that all air bubbles
are expelled.

6. Rub the bristles of the channel cleaning brush and channel-opening


cleaning brush to remove all air bubbles.

7. Attach the 30 cm3 (30 ml) syringe to the suction cleaning adapter and flush
the adapter with 30 cm3 (30 ml) of sterile water while it is immersed. Ensure
that all air bubbles are expelled.

8. Remove the suction cleaning adapter from the sterile water. Hold the
adapter and tilt it to expel the sterile water remaining in the adapter.

9. Using the 30 cm3 (30 ml) syringe, flush air to dry the inside of the suction
cleaning adapter.

10. Remove all equipment from the sterile water.

11. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces.

60 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

12. Dry all equipment thoroughly.

13. Store the components following the instructions given in Chapter 5, “Storage
and Disposal”.

Flushing the channels with 70% ethyl or isopropyl alcohol


after rinsing them with sterile water facilitates drying inside
the channels.

 Non-sterile water rinse and alcohol flush

1. Fill a small basin with clean water.

2. Immerse all equipment in clean water and follow all procedures described in
“Sterile water rinse” on page 60.

3. Fill a small basin with 70% ethyl or isopropyl alcohol.

4. Immerse all equipment in the alcohol.

5. Gently agitate all equipment in the alcohol.

6. Using the 30 cm3 (30 ml) syringe, flush the interior and recessed parts of all
equipment with alcohol to remove all air bubbles.

7. While immersed, depress and release the pistons of the air/water valve,
suction valve and AW channel cleaning adapter. Ensure that all air bubbles
are expelled.

8. Rub the bristles of the channel cleaning brush and channel-opening


cleaning brush to remove all air bubbles.

9. Attach the 30 cm3 (30 ml) syringe to the suction cleaning adapter and flush
the adapter with 30 cm3 (30 ml) of alcohol to remove all air bubbles.

10. Remove the suction cleaning adapter from the alcohol. Hold the adapter
and tilt it to expel the alcohol remaining in the adapter.

11. Using the 30 cm3 (30 ml) syringe, flush air to dry the inside of the suction
cleaning adapter.

12. Remove all equipment from the alcohol.

13. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces.

14. Dry all equipment thoroughly.

15. Store the components following the instructions given in Chapter 5, “Storage
and Disposal”.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Sterilization

Some components are compatible with several sterilization


methods. Certain components, however, are not compatible
with some methods, which can cause equipment damage.

In this section, the sterilization methods for equipment compatible with ETO gas
sterilization or steam sterilization (autoclaving), listed in Table 2.1, are described
below.

The channel plug (MH-944), the injection tube (MH-946) and the washing tube
(MH-974), which were cleaned and disinfected together with the endoscope, can
also be sterilized by the procedures described below.

 ETO gas sterilization

Follow the procedures described in Section 3.8, “Sterilization”.

 Steam sterilization (autoclaving)

After cleaning as described in “Manual cleaning” on page 57, steam sterilize


(autoclave) the equipment according to the procedures given below.

• Before taking the equipment package out of the autoclave, let


it cool down to room temperature. Otherwise, it may cause
burns.
• Effective sterilization will not be possible if items are packed
tightly together in the autoclave; always pack items loosely.
• Inspect each equipment package for openings, tears or other
damage. If the equipment package is open or damaged, seal
the equipment in new package and re-sterilize as described
below.
• Allow the packages to dry within the autoclave, using the
autoclave’s drying cycle (if available) or by opening the door
of the autoclave and allowing the packages to air-dry.
Handling a wet package can compromise its sterility.

Sudden changes in temperature may damage the


instruments.

62 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

1. Seal the individual parts or equipment separately in packages appropriate


for steam sterilization (autoclaving) according to your hospital’s protocol.

2. Steam sterilize the packages according to the recommended steam


sterilization (autoclaving) exposure parameters given in Section 2.6, “Steam
sterilization (autoclaving) of accessories” and the sterilizer manufacturer’s
instructions.

3. Following steam sterilization (autoclaving), let all components gradually cool


down to room temperature.

4. Store the components following the instructions given in chapter 5, “Storage


and Disposal”.

3.10 Cleaning, disinfection and sterilization


procedures for distal cover

Equipment needed
Prepare the following equipment, and wear appropriate personal protective
equipment.

• Personal protective equipment


• Small basin
• Clean water (non-sterile water)
• Detergent solution
• Soft brush
• Clean lint-free cloths
• 30 cm3 (30 ml) syringe
• Disinfectant solution
• Sterile water for sterile water rinse
• Sterile lint-free cloths
• 70% ethyl or isopropyl alcohol

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Manual cleaning

To prevent damage, make sure that the items immersed in


detergent solution do not contact one another.

1. Fill a small basin with clean water. Use a basin which is deep enough to
allow the distal cover to be completely immersed.

2. Fill a small basin with detergent solution at the temperature and


concentration recommended by the detergent manufacturer. Use a basin
which is deep enough to allow the distal cover to be completely immersed.

3. Immerse the distal cover in the basin filled with detergent solution.

4. Using the 30 cm3 (30 ml) syringe, flush the interior and recessed parts of the
distal cover with detergent solution while the distal cover is immersed.

5. Using a clean, soft brush or lint-free cloth, meticulously clean the external
surfaces in detergent solution.

6. Cover the basin with a tight fitting lid to minimize the diffusion of detergent
vapors. Soak the distal cover at the temperature and concentration
recommended by the detergent manufacturer.

7. Remove the distal cover from the detergent solution. If debris remains,
ultrasonically clean it at 33 – 48 kHz for 5 minutes.

8. Immerse the distal cover in the clean water.

9. Gently agitate the distal cover to thoroughly rinse them.

10. Remove the distal cover from the water.

11. Use a sterile lint-free cloth to thoroughly wipe and dry all external surface.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

High-level disinfection

1. Fill a small basin with disinfectant solution at the temperature and


concentration recommended by the disinfectant manufacturer. Use a basin
which is deep enough to allow the distal cover to be completely immersed.

2. Immerse the distal cover in the disinfectant solution.

3. Using the 30 cm3 (30 ml) syringe, flush the interior and recessed parts of the
distal cover with disinfectant solution while the distal cover is immersed.

4. Using a clean lint-free cloth, wipe off any air bubbles adhering to surfaces.

5. Cover the disinfectant basin with a tight fitting lid to minimize the diffusion of
disinfectant vapors. Soak the distal cover for the amount of time at the
temperature and concentration recommended by the disinfectant
manufacturer.

6. Remove the distal cover from the disinfectant solution.

Rinse after high-level disinfection


After high-level disinfection, rinse the distal cover according to the procedures
described below.

Alcohol is flammable. Handle with care.

 Sterile water rinse

1. Fill a small basin with sterile water. Use a basin which is deep enough to
allow the distal cover to be completely immersed.

2. Immerse the distal cover in the sterile water.

3. Gently agitate the distal cover to thoroughly rinse.

4. Remove the distal cover from the sterile water.

5. Wipe and dry the distal cover with a sterile lint-free cloth.

6. Dry the distal cover.

7. Store the distal cover to following the instructions given in Chapter 5,


“Storage and Disposal”.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 65


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Non-sterile water rinse and alcohol flush

1. Prepare a small basin with clean water.

2. Immerse the distal cover in clean water and follow the procedures given in
“Sterile water rinse” on page 65.

3. Fill a small basin with 70% ethyl or isopropyl alcohol.

4. Immerse the distal cover in the alcohol.

5. Gently agitate the distal cover in the alcohol.

6. Remove the distal cover from the alcohol.

7. Wipe and dry the distal cover with a sterile lint-free cloth.

8. Dry the distal cover.

9. Store the distal cover to following the instructions given in Chapter 5,


“Storage and Disposal”.

Sterilization

 Steam sterilization (autoclaving)

After cleaning as described in “Manual cleaning” on page 64, steam sterilize


(autoclave) according to the procedures given below.

• Before taking the distal cover package out of the autoclave,


let it cool down to room temperature. Otherwise, it may cause
burns.
• Effective sterilization will not be possible if the distal cover is
packed tightly together in autoclave; always pack items
loosely.
• Inspect each distal cover package for openings, tears or
other damage. If the distal cover package is open or
damaged, seal the distal cover in new package and
re-sterilize it as described below.
• Allow the packages to dry within the autoclave, using the
autoclave’s drying cycle (if available) or by opening the door
of the autoclave and allowing the packages to air-dry.
Handling a wet package can compromise its sterility.

66 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 3 Cleaning, Disinfection and Sterilization Procedures

1. Seal the distal cover separately in packages appropriate for steam


sterilization (autoclaving) according to your hospital’s protocol.

2. Steam sterilize the packages according to the recommended steam


sterilization (autoclaving) exposure parameters as described in Section 2.6,
“Steam sterilization (autoclaving) of accessories” and the sterilizer
manufacturer’s instructions.

• When placing the distal cover in the sterile packing, do not


place it together with other cleaning equipment, accessories,
etc. The distal cover could be deformed and may become
difficult to attach, or the risk of the distal cover falling off
during the examination will increase.
• When steam sterilizing the distal cover, do not place other
objects on top of the distal cover. The distal cover could be
deformed and may become difficult to attach, or the risk of
the distal cover falling off during the examination will
increase.
• Sudden changes in temperature may damage the distal
cover.

3. Following steam sterilization (autoclaving), let the distal cover gradually cool
down to room temperature.

4. Store the distal cover to following the instructions given in Chapter 5,


“Storage and Disposal”.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 67


Chapter 4 Cleaning and Disinfection Equipment

Chapter 4 Cleaning and Disinfection


Equipment

The endoscope is compatible with some endoscope reprocessors


recommended by Olympus. Refer to the instruction manual of the endoscope
reprocessor for details on operation.

• Thoroughly clean the endoscope as described in Chapter 3,


“Cleaning, Disinfection and Sterilization Procedures” before
reprocessing the endoscope in an endoscope reprocessor. If
an endoscope that has not been thoroughly manually
cleaned is placed into the endoscope reprocessor, debris
attached to the endoscope may impair the cleaning and
disinfection capabilities of the reprocessor, and the
endoscope can pose an infection-control risk to the patient
and/or operators who perform the next procedure with it.
Note that if the instrument is not precleaned immediately
after the procedure, patient debris may solidify, which could
impair proper cleaning and disinfection of the endoscope.
Refer to the endoscope reprocessor’s instruction manual for
details on proper connection of the endoscope to the
reprocessor and operation of the reprocessor.
• Olympus only confirms validation of endoscope reprocessors
it recommends. When using an endoscope reprocessor that
is not recommended by Olympus, the endoscope
reprocessor’s manufacturer is responsible for validation of
the reprocessor with the endoscope models listed in its
instruction manual.

68 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 4 Cleaning and Disinfection Equipment

• Before using an endoscope reprocessor, confirm that it is


capable of reprocessing the endoscope including all
channels. If there are channels and/or other parts of the
endoscope that cannot be cleaned and/or high-level
disinfected by the endoscope reprocessor, manual cleaning
and high-level disinfection or sterilization must be performed
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 the endoscope including all
channels, contact the endoscope reprocessor’s
manufacturer for specific instructions and/or information on
connectors.
• When cleaning and disinfecting an endoscope in an
endoscope reprocessor, use connectors that are compatible
with the endoscope model. Otherwise, insufficient cleaning
and disinfection or sterilization of the endoscope may occur,
which could pose an infection-control risk to the patient
and/or operators performing the next procedure with the
endoscope. The applicable connectors for each endoscope
model should be listed in the instruction manual of the
endoscope reprocessor. If your endoscope model is not
listed in that instruction manual, please contact the
manufacturer of the endoscope reprocessor.
• Use connectors special to each model when cleaning and
disinfecting the endoscope with 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. The applicable connectors for
each endoscope model should be listed in the automated
endoscope reprocessor instruction manual. If your
endoscope model is not listed in this table, please contact the
manufacturer of the endoscope reprocessor.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 69


Chapter 4 Cleaning and Disinfection Equipment

• The elevator wire channel may not be properly high-level


disinfected by all reprocessors. If using a reprocessor, please
contact the manufacturer of the reprocessor for certification
that the elevator wire channel can be efficaciously high-level
disinfected in their unit. If the elevator wire channel cannot be
high-level disinfected by a reprocessor, clean and disinfect
the elevator wire channel according to procedures described
in Chapter 3, “Cleaning, Disinfection and Sterilization
Procedures”.
• If using the endoscope reprocessor, be sure to attach the
appropriate connectors (see Table 4.1). 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.

For instrument
For air/water For elevator water
channel, suction
channel channel
channel

OER MH-861 MAJ-33 MAJ-41


EW-30

OER-A MAJ-818 MAJ-819 MAJ-825

Table 4.1

70 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


Chapter 5 Storage and Disposal

Chapter 5 Storage and Disposal

• Keep the reprocessed endoscope and accessories away


from the contaminated equipment after cleaning and
disinfection or sterilization. If the clean endoscope and
accessories become contaminated between procedures,
they could present an infection control risk to the patient
and/or operators in the subsequent procedure.
• To prevent contamination of the reprocessed endoscope and
accessories, be sure to keep the storage cabinet clean.
• The storage cabinet must be clean, dry, well ventilated and
maintained at ambient temperature. Do not store the
endoscope in direct sunlight, at high temperature, in high
humidity or exposed to X-rays and/or ultraviolet-rays. These
could damage the endoscope or present an infection control
risk.
• Do not store the endoscope in the carrying case. Use the
carrying case only for shipping the endoscope. Routinely
storing the endoscope in a humid, non-ventilated
environment such as the carrying case may present an
infection control risk.

5.1 Storage of the endoscope

When storing the endoscope, make sure that the forceps


elevator is not protruded from the distal end so that it cannot
strike any objects, as this could damage the forceps elevator.

1. Detach all equipment (the air/water valve, suction valve, biopsy valve,
water-resistant cap and distal cover) from the endoscope.

2. Confirm that all surfaces of the endoscope (especially all internal lumens,
the distal end, lens and electrical contacts) are completely dry.

3. Place the endoscope’s angulation locks in the “F ” position.

4. Hang the endoscope in the storage cabinet with the distal end hanging
freely. Make sure that the insertion tube hangs vertically and as straight as
possible.

EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL 71


Chapter 5 Storage and Disposal

5.2 Storage of reusable parts and reprocessing


equipment

1. Confirm that all reusable parts and reprocessing equipment are dry.

2. Store all reusable parts in the storage cabinet. Make sure that the parts do
not touch each other during storage.

3. Store all reprocessing equipment in a container, then place the container in


the storage cabinet.

5.3 Disposal
When disposing of the endoscope, or any of its components (such as valves),
follow all applicable national and local laws and guidelines.

72 EVIS LUCERA JF/TJF TYPE 260V REPROCESSING MANUAL


©2005 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved.
No part of this publication may be reproduced or distributed without the
express written permission of OLYMPUS MEDICAL SYSTEMS CORP.

OLYMPUS is a registered trademark of OLYMPUS CORPORATION.

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document are generally registered trademarks or trademarks of each
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