English
フジノン和文
Endoscopes
530/590 Series
OPERATION MANUAL
(Cleaning, Disinfection and Storage)
Thank you for purchasing our product. Read this manual carefully before use to avoid
unexpected accidents, and take full advantage of the product's capabilities.
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Important Safety Information
Important Safety Information
1. Safety
Read and understand this manual carefully before use. Use the endoscope following
the provided instructions. The items important for the safe use of the endoscope are
summarized in Chapter 1 “Safety” in the preparations and operations section.
Safety precautions associated with individual operations or procedures are provided
separately marked “ WARNING” or “ CAUTION.”
2. Warning
The items that must be observed for safety when performing endoscopy or electrosurgery
are identified by “ WARNING” or “ CAUTION.” Read and understand the warning
information carefully, and perform the procedures correctly.
WARNING
Improper use or operation of the equipment may
injure patients, physicians, or people in the vicinity.
Read and understand this manual carefully before
operating the equipment.
Reprocess the endoscope and reusable accessories
with an understanding of reprocessing guidelines.
Not doing so may increase a risk of infection.
Improper operations that will damage the equipment only are identified by
“CAUTION.”
3. When Using Endoscope for the First Time
Endoscopes have not been sterilized. When using this product for the first time, use the
level of disinfection or sterilization suitable to the application according to Chapter 7
“Cleaning,” Chapter 8 “Chemical Disinfection,” or Chapter 9 “Gas Sterilization.”
2
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Contents
Contents
Important Safety Information.......................................................................................2
Preface..........................................................................................................................4
Disinfection, Sterilization and Storage Procedures......................................................4
Inspection for Signs of Degradation.............................................................................5
Conventions Used in This Manual................................................................................6
Chapter 7
Cleaning................................................................................................ 7-1
7.1 Methods of Cleaning................................................................... 7-2
7.2 Conditions of Cleaning................................................................ 7-3
7.3 Necessary Equipment and Materials........................................... 7-4
7.4 Manual Cleaning (cleaning in sink)............................................ 7-6
7.5 Cleaning and Sterilize Biopsy Forceps..................................... 7-21
7.6 Cleaning and Sterilize Cannulation Tube.................................. 7-22
7.7 Cleaning, Disinfecting and Sterilize Mouthpiece...................... 7-24
7.8 Cleaning, Disinfecting and Sterilize
Air/Water Button and Suction Button....................................... 7-25
7.9 Cleaning, Disinfecting and
Sterilizing Air/Water Supply Channel Cleaning Adapter......... 7-26
7.10 Cleaning, Disinfecting and Sterilize J Check Valve and Hood.... 7-27
7.11 Cleaning and Disinfecting Flexible Adapter............................. 7-28
7.12 Cleaning and Disinfecting Cleaning Brush............................... 7-32
Chapter 8
Chemical Disinfection.......................................................................... 8-1
8.1 Methods of Chemical Disinfection............................................. 8-2
8.2 Conditions of Disinfection.......................................................... 8-3
8.3 Chemical Disinfection of Endoscope.......................................... 8-4
8.4 Rinsing of Endoscope.................................................................. 8-7
8.5 Cleaning and Disinfection Using an
Automated Endoscope Reprocessor (AER).............................. 8-14
Chapter 9
Gas Sterilization................................................................................... 9-1
9.1 Conditions of Gas Sterilization................................................... 9-3
9.2 EOG (Ethylene Oxide Gas) Sterilization.................................... 9-5
Chapter 10 Storage................................................................................................ 10-1
10.1 Drying Endoscope..................................................................... 10-3
10.2 Drying Accessories................................................................... 10-5
10.3 Storage....................................................................................... 10-7
Appendix......................................................................................................Appendix-1
Chemicals and Conditions.......................................................Appendix-2
Index........................................................................................Appendix-5
3
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Preface
Preface
This manual describes how to clean, disinfect, sterilize and store 530/590 series
endoscope according to ISO 17664.
Disinfection, Sterilization and Storage Procedures
Withdrawal
from patient
Disinfection
Pre-cleaning
(performed at bedside)
Water rinse
(Alcohol)
Air tightness test
(in decontamination
area/cleaning room)
Manual cleaning
Water rinse
Alcohol/
Air/Dry
Usage
(or storage)
Disinfection [Note]
Water rinse
(Alcohol)
Alcohol/
Air/Dry
Gas
sterilization
Aeration
[Note]Be sure to disinfect the endoscope and accessories to guarantee their sterility. If
they are not disinfected, their sterility cannot be guaranteed.
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Inspection for Signs of Degradation
Inspection for Signs of Degradation
When reprocessing the endoscope with chemicals and an AER, you will eventually start
to see signs of deterioration.
Inspect the endoscope according to “Section 5.4 Inspection of Endoscope” in the
Operation Manual in order to find the signs of deterioration or abnormality. Have this
product checked by service personnel once every six months or once every 100 cases,
whichever comes first. If you notice any signs of deterioration, contact your local
FUJIFILM dealer.
WARNING
Make sure to inspect the endoscope before use
according to the procedures provided in this manual.
Do not use the equipment that shows any signs
of abnormality or irregularity. Use of abnormal
equipment may lead to misdiagnosis, cause severe
harm or inflammation to the patient and/ or pose an
infection control risk to the patient.
Visually and manually check the points such as the following:
•
•
•
•
•
•
•
•
•
•
The objective lens is free from scratches, cracks or disengagement.
The areas around the objective lens are free from cracks or gaps.
The light guides are free from scratches, cracks or disengagement.
The areas around the light guides are free from abnormalities such as gaps.
The distal cap is free from abnormalities such as cracks or disengagement.
The air/water nozzle is free from abnormalities such as cracks, abnormal protrusion,
disengagement, crushes, dents or deformation.
The side surface of the distal end is free from abnormalities such as scratches, peeling or
abnormal bulging.
The distal adhesives are free from abnormalities such as loss, peeling or deterioration.
All distal end surfaces are free from foreign residues, debris or sharp edges.
The insertion portion (distal end, bending section and insertion tube) for abnormalities
such as indentations, bumps, peeling, sharp edges or protrusions, etc. In addition, confirm
that the insertion tube is not abnormally rigid.
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Conventions Used in This Manual
Conventions Used in This Manual
This manual uses the following conventions to make it easy to understand operations.
General conventions
Convention
Meaning
Indicates a potential danger that may cause harm to people.
WARNING
Explains dangerous situations that may cause a death or a
serious accident if not avoided.
CAUTION
Explains situations that may cause slight or moderate levels of
injury if not avoided.
CAUTION
(1), (2), (3), ...
[Note]
Explains situations that may cause damage to equipment
if not avoided.
Consecutive numbers in operating procedures indicate the order
in which successive steps in the procedure should be taken.
Indicates a comment or supplementary information.
Indicates a reference.
6
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Chapter 7
Cleaning
This chapter describes methods of cleaning. Carry out pre-cleaning at
the bedside immediately after pulling out the endoscope. Then carry out
manual cleaning carefully in a sink.
7.1
7.2
7.3
7.4
Methods of Cleaning.......................................................................................7-2
Conditions of Cleaning....................................................................................7-3
Necessary Equipment and Materials...............................................................7-4
Manual Cleaning (cleaning in sink)................................................................7-6
7.4.1 Air Tightness Test................................................................................7-7
7.4.2 Removing Air/Water Button, Suction Button, Air/Water Supply
Channel Cleaning Adapter.................................................................7-11
7.4.3 Brushing the Inside of the Valve.......................................................7-11
7.4.4 Brushing Suction Channel.................................................................7-12
7.4.5 Brushing Distal End...........................................................................7-12
7.4.6 Removing Debris in Air/Water Nozzle..............................................7-13
7.4.7 Connecting Cleaning Adapter............................................................7-13
7.4.8 Cleaning Air/Water Supply and Suction Channel.............................7-15
7.4.9 Cleaning Water Jet Channel
(for endoscopes that have these mechanisms only)...........................7-17
7.4.10 Cleaning Balloon Air Feed Channel
(for endoscopes that have these mechanisms only)...........................7-19
7.4.11 Cleaning Entire Endoscope................................................................7-20
7.5 Cleaning and Sterilize Biopsy Forceps.........................................................7-21
7.6 Cleaning and Sterilize Cannulation Tube......................................................7-22
7.7 Cleaning, Disinfecting and Sterilize Mouthpiece..........................................7-24
7.8 Cleaning, Disinfecting and Sterilize Air/Water Button
and Suction Button........................................................................................7-25
7.9 Cleaning, Disinfecting and Sterilizing Air/Water Supply Channel Cleaning
Adapter..........................................................................................................7-26
7.10 Cleaning, Disinfecting and Sterilize J Check Valve and Hood.....................7-27
7.11 Cleaning and Disinfecting Flexible Adapter.................................................7-28
7.11.1 Cleaning the Flexible Adapter...........................................................7-28
7.11.2 Disinfecting the Flexible Adapter......................................................7-30
7.12 Cleaning and Disinfecting Cleaning Brush...................................................7-32
7-1
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Chapter 7 Cleaning
Chapter 7 Cleaning
7.1 Methods of Cleaning
CAUTION
Improper cleaning may cause damage to endoscope.
Proceed the cleaning of endoscope by the specified method.
Carry out pre-cleaning at bedside immediately after pulling out endoscope. Then carry out
manual cleaning carefully in sink.
[Note] Do not clean and disinfect/sterilize the accessories that have already been sterilized.
For the cleaning and disinfection/sterilization methods of the accessories, follow the
instructions provided in the operation manual for the respective items.
Use tap water or cleaning fluids. For cleaning, we recommend you to use the cleaning
fluids listed in the Appendix “Chemicals and conditions.”
Table 7.1 Applicable methods of cleaning for endoscope and accessories
Chemical cleaning
Ultrasonic cleaning
Endoscope
Yes
Yes [Note]
Air/Water button
Yes
Yes [Note]
Suction button
Yes
Yes [Note]
Biopsy forceps
Yes
Yes
Water tank
Yes
Yes
Mouthpiece
Yes
Yes
Cleaning brush
Yes
Yes
J check valve
Yes
Yes
Carrying case
No
No
Protective cap
Yes
Yes
Cleaning adapter
Yes
No
Hood
Yes
Yes
Flexible adapter
Yes
No
[Note] Use an ultrasonic cleaning unit specialized for endoscope.
7-2
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Chapter 7 Cleaning
7.2 Conditions of Cleaning
For cleaning, we recommend you to use the cleaning fluids listed in the Appendix “Chemicals
and conditions.”
We have confirmed that the endoscopes, biopsy forceps, snares, and the like have resistance
to the cleaning fluids listed in the Appendix.
If you want to use cleaning fluids other than those listed in the Appendix “Chemicals and
conditions,” inquire of us about the resistance of the endoscopes, biopsy forceps, snares, or
the like to them beforehand.
For the resistance of equipment, follow the cleaning conditions specified in the Appendix
“Chemicals and conditions.”
For effects, dilution, and preparation of a cleaning fluid under use conditions indicated in
the Appendix refer to the manufacturer of the respective cleaning fluid. Some cleaning
fluids require “precautions in use” or “handling precautions,” such as wearing of a
protective gear. Refer also to the instruction manual of the respective cleaning fluid.
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Chapter 7 Cleaning
7.3 Necessary Equipment and Materials
Prepare the necessary equipments used in chapter 7 and 8.
• Cleaning adapter CA-503/A (Standard accessory)
: Components Tube for air/water supply channel
Tube for suction channel
Valve adapter CA-503S/A
Forceps inlet cleaning adapter CA-503B/C (with a cap)
Tank receiving cap
• J cleaning adapter CJ-500
(Standard accessory for endoscopes that have these mechanisms only)
• Cleaning brush [Note 1] (Standard accessory) : Two kinds
• Air leak tester LT-7F (Optional item)
• Clean syringe [Note 2]/Sterile syringe [Note 3]
• Cleaning adapter CA-500N (Optional item) or air/water supply channel cleaning adapter
CA-511N (Optional item)
•
•
•
•
•
•
•
•
Chemical solution/cleaning fluid
Container for chemical solution/cleaning fluid
Clean water [Note 4]
Sterile water for rinsing after disinfection [Note 5]
Alcohol [Note 6]
Sterilize gauze
Toothbrush (soft type)
Protective gear
Rubber gloves
Goggle
Facemask
Protection clothes
[Note 1]Prepare spare consumable items such as cleaning brushes since they may be
damaged.
[Note 2]Prepare a 30 mL luer-lock or luer-slip syringe. This syringe is used to supply
disinfectant solution.
[Note 3]Prepare a 30 mL luer-lock or luer-slip syringe. This syringe is used for high-level
disinfection process.
[Note 4]Water is used for leak testing and rinsing after manual cleaning of the endoscope
and accessories. For these purposes, use water that is at least potable in quality.
[Note 5]For rinsing endoscope after disinfection, use water for injection that complies
with the European Pharmacopoeia and/or the International Pharmacopoeia or with
the standards of the regulatory authority of your country.
[Note 6]When performing final alcohol rinse, use medical-grade ethyl alcohol (ethanol) or
isopropyl alcohol (IPA) that complies with the European Pharmacopoeia and/or
the International Pharmacopoeia or with the standards of the regulatory authority
of your country.
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Chapter 7 Cleaning
Tube for Suction Channel
Tube for Air/Water Supply Channel
Valve Adapter
CA-503S/A
Forceps Inlet
Cleaning Adapter
(with a Cap)
CA-503B/C
Tank Receiving Cap
Cleaning Adapter CA-503/A
J Cleaning Adapter
CJ-500
Clean Syringe
Sterile Syringe
Cleaning Brush (for Valve)
Cleaning Brush
Protective Gear
Chemical solution/Cleaning fluid
Container for Chemical Solution/
Cleaning Fluid
Toothbrush (Soft Type)
Cleaning Adapter
CA-500N
Sterilize Gauze
Air Leak Tester
LT-7F
Air/Water Supply Channel
Cleaning Adapter
CA-511N
7-5
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Chapter 7 Cleaning
7.4 Manual Cleaning (cleaning in sink)
After the pre-cleaning at bedside, carry out a manual cleaning carefully in the sink. Run an
air tightness test on the endoscope before cleaning.
WARNING
Carefully inspect all cleaning brushes for abnormalities and/or damage
prior to use. Check the brushes integrity after every brushing to ensure
that they are not damaged and no brush fragment remains inside the
channel. Retained brush fragments could be a potential source of
infection and/or cause patient injury.
In case the cleaning brush is damaged during cleaning, remove any
residue from inside the channel using a spare brush. If residue is not
completely removed even with the spare brush, have the endoscope
repaired immediately. If residue remains inside the channel, it could be
a source of infection.
CAUTION
In case the cleaning brush is damaged inside the channel, insert a
spare brush to remove the particles of the damaged cleaning brush
by pushing them out of the channel. If the particles are not completely
removed even with the spare brush, have the endoscope repaired
immediately. If a damaged brush is left in the channel, the residue may
fall out during a procedure and injure the patient.
If any abnormal resistance is experienced while inserting the brush into the tube, have the
endoscope repaired immediately.
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Chapter 7 Cleaning
7.4.1 Air Tightness Test
WARNING
Do not store the air leak tester together with the medical equipment
that has been cleaned and disinfected. Store the air leak tester in a
place out of reach of persons except for physicians and healthcare
professionals. If the air leak tester is touched carelessly, it may cause
infection.
CAUTION
Do not perform air tightness test with a damaged air leak tester. Do not
attach or remove the air leak tester while the endoscope is immersed
in clean water. Do not attach the air leak tester while the endoscope is
wet. Do not attach the air leak tester to the endoscope while moisture
remains in the connector of the air leak tester. If moisture enters the
air leak tester, do not attach it to the endoscope. When supplying air,
apply pressure until the air leak tester reaches the working pressure
(20±1.5 kPa). Do not clean the endoscope with the air leak tester
attached. The endoscope may be damaged.
If the air tightness of the endoscope is insufficient, do not immerse it
in clean water or chemical solution. Clean water may enter inside and
damage the endoscope.
[Note] For other precautions, refer to the manual of the air leak tester.
[Note] If the result of air tightness test shows that the air tightness is insufficient, contact
your local FUJIFILM dealer immediately.
[Note] If water droplets enter the air leak tester or tube, dry it out before use. Make sure that
no moisture remains in the tube. Squeeze the blower to make sure that no moisture
flows inside the tube.
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Chapter 7 Cleaning
<Inspection before use>
If any abnormality is found during inspection, do not use
the product.
(1) Visually check the tube leading to the connector for
abnormalities such as folds, bends or flaws.
(2) Press the trigger of the air leak tester to the pressure side.
Squeeze the blower to make sure that enough amount of
air is supplied from the connector, and that the indicator
moves.
(3) Make sure that the endoscope to be tested is compatible
with the air leak tester.
<Test procedure>
(1) Connect an air leak tester LT-7F (optional item) to the
ventilation connector of the endoscope.
[Note]
Align the notch “a” of the ventilation connector of the
endoscope with the index “b” of the connector of the air
leak tester and then push in the connector of the air leak
tester and rotate it clockwise to attach the air leak tester to
the ventilation connector.
b
a
[Note]
For details on how to use the air leak tester, refer to the
operation manual of the air leak tester.
(2) Securely press the trigger of the air leak tester to the
pressure side.
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Chapter 7 Cleaning
(3) Squeeze the blower of the air leak tester to supply air until
the air leak tester indicates 20 kPa.
Working pressure:
20±1.5 kPa
[Note]
Release your finger from the trigger so as not to pull the
trigger.
(4) Allow tester to stand for 30 seconds and check that the
indication does not fall down.
If the change in the indication is 5 kPa or more (10
gradations or more), the air tightness of the endoscope is
insufficient.
[Note]
If the air tightness is insufficient, do not clean the
endoscope and contact your local FUJIFILM dealer
immediately.
(5) Apply pressure until the indication reaches 20 kPa and then
immerse the endoscope in clean water.
[Note]
The temperature of clean water must be between +10 to
+40°C.
[Note]
Completely immerse the endoscope.
[Note]
Do not immerse the meter and blower of the air leak tester.
Immerse the endoscope to the extent that the connector
and tube of the air leak tester is immersed.
[Note]
When the indicator falls down slowly, squeeze the blower
to supply air until the indicator reaches 20 kPa.
[Note]
Keep the endoscope immersed for not less than one
minute.
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Chapter 7 Cleaning
(6) Operate the endoscope to move the insertion portion and
bending section in various directions and ensure that a
steady stream of air bubbles (indicative of a leak) is not
found.
[Note]
If a stream of air bubbles comes out from the endoscope
while it is immersed in clean water for at least one minute,
the endoscope has a leak. Do not clean the endoscope and
contact your local FUJIFILM dealer immediately.
(7) Remove the endoscope from clean water, wipe the
ventilation connector, air leak tester connector and their
surroundings with dry gauze, and then dry them out.
(8) Pull the trigger of the air leak tester to the release side to
release air pressure from the endoscope.
[Note]
Release air until the indicator falls and returns to its
starting position (0 kPa).
(9) Remove the connector of the air leak tester by pressing
and then rotating it counterclockwise.
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Chapter 7 Cleaning
7.4.2 Removing Air/Water Button, Suction Button, Air/Water Supply Channel Cleaning Adapter
Remove the air/water button and suction button from the
endoscope.
When pre-cleaning was performed using the air/water
supply channel cleaning adapter CA-511N (optional item),
remove it.
7.4.3 Brushing the Inside of the Valve
Using a valve brush, brush the inside of the suction valve,
air/water supply valve and forceps inlet.
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Chapter 7 Cleaning
7.4.4 Brushing Suction Channel
Brush following three areas with furnished cleaning brush.
Repeat brushing three times or more into the cleaning
fluid.
• From forceps inlet to the distal end of endoscope
• From suction valve to forceps inlet
• From suction valve to suction connector
7.4.5 Brushing Distal End
Using a valve brush or a soft toothbrush, brush the distal
end.
• Nozzle
• Forceps inlet
• Forceps elevator mechanism
(for endoscope that have these mechanisms only)
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Chapter 7 Cleaning
7.4.6 Removing Debris in Air/Water Nozzle
Removes debris when the air/water nozzle is blocked.
(1) Attach the cleaning adapter CA-500N (Optional item) to
the air/water valve section.
(2) Remove debris by injecting lukewarm water using the
syringe.
(3) After the debris has been removed, inject air until all the
water in the tube is discharged.
7.4.7 Connecting Cleaning Adapter
Before using the cleaning adapter, check that there is no deterioration, breakage, deviation
from the conduit, leakage from the middle of the conduit or injection failure due to
clogging.
(1) Assemble cleaning adapter by connecting the tube for the
air/water supply channel, tube for suction channel and
valve adapter CA-503S/A as shown in the right figure.
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Chapter 7 Cleaning
(2) Attach the valve adapter as shown in the figure.
[Note]
Hold the valve adapter as shown in the figure, push in the
inside plate in the direction “a” and push the whole valve
adapter in the direction “b.” Let go of the valve adapter
from your hand and confirm that the valve adapter is
surely attached to the endoscope.
(3) Slide the pins to the same position as shown in the figure,
before connecting the forceps inlet cleaning adapter
(CA-503B/C).
a
b
b
a
[Note]
The position of pins can be adjusted by pushing the inside
part with pins.
(4) Attach the forceps inlet cleaning adapter as shown in the
figure.
[Note]
Hold the forceps inlet cleaning adapter as shown in the
figure. Keep pushing it in the direction “a” and slide in the
direction “b.” Let go of the forceps inlet cleaning adapter
from your hand and confirm that the forceps inlet cleaning
adapter is surely attached to the endoscope.
(5) Attach the tank receiving cap to the water tank receiver.
[Note]
Align the notch on the adapter with the projection on the
tank receiver, and rotate and push the adapter against the
tank receiver to secure it.
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Chapter 7 Cleaning
7.4.8 Cleaning Air/Water Supply and Suction Channel
(1) Attach a syringe to the air/water channel side of the
cleaning adapter.
(2) Inject cleaning fluid into air/water supply channel with
syringe.
(3) Using a syringe, feed air into the air/water supply channel
of the endoscope to remove cleaning fluid from the
channel.
(4) Using a syringe, feed clean water into the air/water supply
channel of the endoscope to rinse off cleaning fluid in the
channel.
(5) Finally, feed air into the air/water supply channel until
moisture is discharged completely.
(6) Attach a syringe to suction channel side of the cleaning
adapter.
(7) Inject cleaning fluid into suction channel by syringe.
(8) Using a syringe, feed air into the suction channel of the
endoscope to remove cleaning fluid from the channel.
(9) Repeat the steps (7) and (8) a couple of times to feed
cleaning fluid and air alternately.
(10) Using a syringe, feed clean water into the suction channel
of the endoscope to rinse cleaning fluid in the channel.
(11) Finally, feed air into the suction channel until moisture is
discharged completely.
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Chapter 7 Cleaning
(12) Remove the cap of forceps inlet cleaning adapter.
(13) Attach a syringe to the forceps inlet cleaning adapter.
(14) Inject cleaning fluid into suction channel of the endoscope
with syringe.
(15) Using a syringe, feed air into suction channel of the
endoscope to rinse off cleaning fluid in the channel.
(16) Repeat the steps (14) and (15) a couple of times to feed
cleaning fluid and air alternately.
(17) Using a syringe, feed clean water into the suction channel
of the endoscope to rinse off cleaning fluid in the channel.
(18) Finally, feed air into the suction channel until moisture is
discharged completely.
(19) Remove cleaning adapter from endoscope.
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Chapter 7 Cleaning
7.4.9 Cleaning Water Jet Channel (for endoscopes that have these mechanisms only)
[Note] Clean the water jet channel even if it was not used.
(1) Remove the J check valve from the water jet inlet.
[Note]
Clean the J check valve separately.
(2) Remove the J protective cap.
(3) Attach the J cleaning adapter by rotating it clockwise.
(4) Attach a syringe filled with cleaning fluid to the J cleaning
adapter.
(5) Using the syringe, inject cleaning fluid into the water jet
channel.
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Chapter 7 Cleaning
(6) Remove the syringe and fill it with air.
(7) Attach the syringe filled with air to the J cleaning adapter.
(8) Push air into the water jet channel to eject the cleaning
fluid inside the channel.
(9) Repeat steps (4) to (8) 2 or 3 times.
(10) Remove the syringe and fill it with clean water.
(11) Attach the syringe filled with clean water to the J cleaning
adapter.
(12) Push clean water into the water jet channel to eject the
cleaning fluid inside the channel.
(13) Finally, feed air into the water jet channel until moisture is
discharged completely.
(14) Remove J cleaning adapter from endoscope.
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Chapter 7 Cleaning
7.4.10 Cleaning Balloon Air Feed Channel (for endoscopes that have these mechanisms only)
[Note] Clean the balloon air feed channel even if it was not used.
(1) Attach a syringe filled with cleaning fluid to the balloon
air feed inlet.
(2) Using the syringe, inject cleaning fluid into the balloon air
feed channel.
(3) Remove the syringe and fill it with air.
(4) Attach the syringe filled with air to the balloon air feed
inlet.
(5) Push air into the balloon air feed channel to eject the
cleaning fluid inside the channel.
(6) Repeat steps (1) to (5) 2 or 3 times.
(7) Remove the syringe and fill it with clean water.
(8) Attach the syringe filled with clean water to the balloon air
feed inlet.
(9) Push clean water into the balloon air feed channel to eject
the cleaning fluid inside the channel.
(10) Finally, feed air into the balloon air feed channel until
moisture is discharged completely.
.
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Chapter 7 Cleaning
7.4.11 Cleaning Entire Endoscope
CAUTION
Cleaning liquid might flow into a patient’s body.
After cleaning, rinse off any remaining chemical with water.
(1) Clean the entire endoscope and cleaning adapter in
cleaning fluid with clean soft sponge.
(2) Rinse endoscope and cleaning adapter with running water
(clean water).
(3) Wipe off any water remaining on the endoscope and
cleaning adapter with dry sterilize gauze.
(4) Attach each cleaning adapter, feed air using a syringe, and
remove moisture from the channels.
[Note]
Feed air into the air/water supply channel, the suction
channel, the water jet channel (when provided) and the
balloon air feed channel (when provided) until moisture is
discharged completely.
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Chapter 7 Cleaning
7.5 Cleaning and Sterilize Biopsy Forceps
WARNING
Sterility might not be maintained if the sterilized pack is ruptured.
Close the cap before putting the forceps in a sterilized pack.
For operational methods of the ultrasonic cleaning unit/autoclaving unit, please follow the
instructions described in each operation manual for the respective units.
(1) Wipe the surface of the forceps with gauze soaked in
cleaning fluid.
(2) Brush entire forceps in cleaning fluid using a soft
toothbrush.
(3) Clean entire biopsy forceps using the ultrasonic cleaning
unit.
(4) Pull out the forceps from the cleaning fluid and rinse with
running water (clean water).
(5) Wipe off the remaining water on the forceps with dry
sterilized gauze.
(6) Coil the insertion portion and seal it in a sterilized pack.
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Chapter 7 Cleaning
(7) Carry out an autoclaving operation in accordance with the
operation manual of the autoclaving unit.
Recommended steam sterilization (autoclaving) conditions
Sterilization temperature (ºC)
Operation time
121
Max 20 minutes
Min 15 minutes
126
Max 15 minutes
Min 10 minutes
134
Max 8 minutes
Min 5 minutes
For France and Switzerland only:
Sterilization temperature 134ºC with minimum exposure
time (while sterilization temperature) of 18 minutes.
Steam Sterilizer Class B according EN 13060
7.6 Cleaning and Sterilize Cannulation Tube
For operational methods of the ultrasonic cleaning unit/autoclaving unit, please follow the
instructions described in each operation manual for the respective units.
(1) Wipe the surface of the cannulation tube with gauze
soaked in cleaning fluid.
(2) Inject cleaning fluid into the cannulation tube in the
cleaning fluid using a syringe.
(3) Clean the cannulation tube using the ultrasonic cleaning
unit.
(4) Pull out the cannulation tube from the cleaning fluid and
rinse by injecting clean water in the cannulation tube using
a syringe.
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Chapter 7 Cleaning
(5) Pull out the cannulation tube from the cleaning fluid and
rinse with running water (clean water).
(6) Wipe off the remaining water on the tube with dry
sterilized gauze.
(7) Round the insertion portion and seal it in a sterilized pack.
(8) Carry out an autoclaving operation in accordance with the
operation manual of the autoclaving unit.
Recommended steam sterilization (autoclaving) conditions
Sterilization temperature (ºC)
Operation time
121
Max 20 minutes
Min 15 minutes
126
Max 15 minutes
Min 10 minutes
134
Max 8 minutes
Min 5 minutes
For France and Switzerland only:
Sterilization temperature 134ºC with minimum exposure
time (while sterilization temperature) of 18 minutes.
Steam Sterilizer Class B according EN 13060
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Chapter 7 Cleaning
7.7 Cleaning, Disinfecting and Sterilize Mouthpiece
For operational methods of the ultrasonic cleaning unit/autoclaving unit, please follow the
instructions described in each operation manual for the respective units.
(1) Wipe the surface of the mouthpiece with gauze soaked in
cleaning fluid.
(2) Brush the entire mouthpiece in the cleaning fluid using a
soft toothbrush.
(3) Clean the mouthpiece using the ultrasonic cleaning unit.
(4) Pull out the mouthpiece from the cleaning fluid and rinse
with running water (clean water).
(5) Wipe off the remaining water on the mouthpiece with dry
sterilized gauze.
(6) Seal the mouthpiece in a sterilized pack.
(7) Carry out an autoclaving operation in accordance with the
operation manual of the autoclaving unit.
[Note]
When carrying out chemical disinfection, follow the
conditions specified in the Appendix “Chemicals and
conditions.”
[Note]
If the disinfected mouthpiece is intended to be stored for
more than 3 hours without using an endoscope storage
cabinet that conforms to EN 16442, dry the mouthpiece
according to "10.2 Drying Accessories."
Recommended steam sterilization (autoclaving) conditions
Sterilization temperature (ºC)
Operation time
121
Max 20 minutes
Min 15 minutes
126
Max 15 minutes
Min 10 minutes
134
Max 8 minutes
Min 5 minutes
For France and Switzerland only:
Sterilization temperature 134ºC with minimum exposure
time (while sterilization temperature) of 18 minutes.
Steam Sterilizer Class B according EN 13060
“10.2 Drying Accessories”
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Chapter 7 Cleaning
7.8 Cleaning, Disinfecting and Sterilize Air/Water Button and Suction Button
For operational methods of the ultrasonic cleaning unit/autoclaving unit, please follow the
instructions described in each operation manual for the respective units.
(1) Brush the entire button in the cleaning fluid while the
buttons are actuated using a soft toothbrush.
(2) Clean the buttons using the ultrasonic cleaning unit.
(3) Pull the buttons out from the cleaning fluid and rinse with
running water (clean water).
(4) Wipe off the remaining water on the buttons with dry
sterilized gauze.
(5) Seal the buttons in a sterilized pack.
(6) Carry out an autoclaving operation in accordance with the
operation manual of the autoclaving unit.
[Note]
When carrying out chemical disinfection, follow the
conditions specified in the Appendix “Chemicals and
conditions.”
Recommended steam sterilization (autoclaving) conditions
Sterilization temperature (ºC)
Operation time
121
Max 20 minutes
Min 15 minutes
126
Max 15 minutes
Min 10 minutes
134
Max 8 minutes
Min 5 minutes
For France and Switzerland only:
Sterilization temperature 134ºC with minimum exposure
time (while sterilization temperature) of 18 minutes.
Steam Sterilizer Class B according EN 13060
(7) Store each button.
Attach sterile or disinfected buttons and forceps channel
immediately before using the endoscope.
[Note]
If the disinfected air/water button and suction button are
intended to be stored for more than 3 hours without using
an endoscope storage cabinet that conforms to EN 16442,
dry the air/water button and suction button according to
"10.2 Drying Accessories."
“10.2 Drying Accessories”
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Chapter 7 Cleaning
7.9 Cleaning, Disinfecting and Sterilizing Air/Water Supply Channel Cleaning Adapter
When pre-cleaning was performed using the air/water supply channel cleaning adapter
CA-511N, clean and disinfect/sterilize it according to the procedure below.
For operational methods of the autoclaving unit, please follow the instructions described in
each operation manual for the unit.
(1) Brush the entire button in the cleaning fluid while the
button is actuated using a soft toothbrush.
(2) Pull the buttons out from the cleaning fluid and rinse it off
with running water (clean water).
(3) Wipe off the remaining water on the buttons with dry
sterile gauze.
(4) Seal the buttons in a sterile pack.
(5) Carry out an autoclaving operation in accordance with the
operation manual of the autoclaving unit.
[Note]
When carrying out chemical disinfection, follow the
conditions specified in the Appendix “Chemicals and
conditions.”
[Note]
If the disinfected air/water supply channel creaning
adapter is intended to be stored for more than 3 hours
without using an endoscope storage cabinet that conforms
to EN 16442, dry the air/water supply channel cleaning
adapter according to "10.2 Drying Accessories."
Recommended steam sterilization (autoclaving) conditions
Sterilization temperature (ºC)
Operation time
121
Max 20 minutes
Min 15 minutes
126
Max 15 minutes
Min 10 minutes
134
Max 8 minutes
Min 5 minutes
For France and Switzerland only:
Sterilization temperature 134ºC with minimum exposure
time (while sterilization temperature) of 18 minutes.
Steam Sterilizer Class B according EN 13060
“10.2 Drying Accessories”
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Chapter 7 Cleaning
7.10 Cleaning, Disinfecting and Sterilize J Check Valve and Hood
For operational methods of the ultrasonic cleaning unit/autoclaving unit, please follow the
instructions described in each operation manual for the respective units.
(1) Wipe the surface of the parts with gauze soaked in
cleaning fluid.
(2) Brush the entire J check valve and hood in the cleaning
fluid using a soft toothbrush.
(3) Clean the J check valve and hood using the ultrasonic
cleaning unit.
(4) Pull out the J check valve and hood from the cleaning fluid
and rinse with running water (clean water).
(5) Wipe off the remaining water on the parts with dry
sterilized gauze.
(6) Seal the J check valve and hood in a sterilized pack.
(7) Carry out an autoclaving operation in accordance with the
operation manual of the autoclaving unit.
[Note]
When carrying out chemical disinfection, follow the
conditions specified in the Appendix “Chemicals and
conditions.”
[Note]
If the disinfected J check valve is intended to be stored
for more than 3 hours without using an endoscope storage
cabinet that conforms to EN 16442, dry the J check valve
supply channel cleaning adapter according to "10.2 Drying
Accessories."
Recommended steam sterilization (autoclaving) conditions
Sterilization temperature (ºC)
Operation time
121
Max 20 minutes
Min 15 minutes
126
Max 15 minutes
Min 10 minutes
134
Max 8 minutes
Min 5 minutes
For France and Switzerland only:
Sterilization temperature 134ºC with minimum exposure
time (while sterilization temperature) of 18 minutes.
Steam Sterilizer Class B according EN 13060
“10.2 Drying Accessories”
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Chapter 7 Cleaning
7.11 Cleaning and Disinfecting Flexible Adapter
7.11.1 Cleaning the Flexible Adapter
(1) Wipe the flexible adapter in the cleaning fluid using gauze.
(2) Attach a syringe filled with cleaning fluid to one of the
lure connectors of the flexible adapter.
(3) Inject the cleaning fluid using the syringe.
(4) Remove the syringe and fill it with air.
(5) Attach the syringe again to the lure connector.
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Chapter 7 Cleaning
(6) Inject air to discharge the cleaning fluid inside the flexible
adapter.
(7) Repeat procedures (2) through (6) three times.
(8) Take the flexible adapter out from the cleaning fluid and
rinse it with running water (clean water).
(9) Attach a syringe filled with clean water to one of the lure
connectors of the flexible adapter.
(10) Inject the clean water using the syringe.
(11) Remove the syringe and fill it with air.
(12) Attach the syringe again to the lure connector.
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Chapter 7 Cleaning
(13) Inject the air to discharge the water inside the flexible
adapter.
7.11.2 Disinfecting the Flexible Adapter
“7.11.1 Cleaning the Flexible Adapter”
(1) Immerse entire flexible adapter in chemical solution.
“8.2 Conditions of Disinfection”
(2) Attach a syringe filled with chemical solution to one of the
lure connectors of the flexible adapter.
(3) Inject the chemical solution using the syringe. Repeat
injecting it until no air bubbles come out from the flexible
adapter.
(4) Take the flexible adapter out from chemical solution.
(5) Rinse the flexible adapter with running water (sterilized
water).
Thoroughly rinse with running water (sterilized water) so
that no chemical solution remains on the flexible adapter.
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Chapter 7 Cleaning
(6) Attach a syringe filled with sterilized water to one of the
lure connectors of the flexible adapter.
(7) Inject sterilized water a syringe to remove the remaining
chemical solution.
Repeat this step several times so that no chemical solution
remains in the flexible adapter.
(8) Remove the syringe and fill it with air.
(9) Attach the syringe again to the lure connector.
(10) Inject the air using the syringe to discharge all of the water
inside the flexible adapter.
(11) Wipe off any remaining water on the flexible adapter with
sterilized gauze.
[Note]
If the flexible adapter is intended to be stored for more than
3 hours without using an endoscope storage cabinet that
conforms to EN 16442, dry the flexible adapter supply channel
cleaning adapter according to "10.2 Drying Accessories."
“10.2 Drying Accessories”
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Chapter 7 Cleaning
7.12 Cleaning and Disinfecting Cleaning Brush
For operational method of the ultrasonic cleaning unit, please follow the instructions
described in the operation manual for the respective units.
(1) Brush the entire cleaning brushes in the cleaning fluid
using a soft toothbrush.
(2) Clean the cleaning brushes using the ultrasonic cleaning
unit.
(3) Pull out the cleaning brushes from the cleaning fluid and
rinse with running water (clean water).
(4) Wipe off the remaining water on the parts with dry
sterilized gauze.
(5) Immerse the parts in chemical solution for the prescribed
time.
[Note]
When carrying out chemical disinfection, follow the
conditions specified in the Appendix “Chemicals and
conditions.”
(6) After the parts have been thoroughly rinsed with running
water (sterilized water), remove remaining water
completely using dry sterilized gauze to dry the parts.
[Note]
If the cleaning brushes are intended to be stored for more
than 3 hours without using an endoscope storage cabinet
that conforms to EN 16442, dry the cleaning brushes
according to "10.2 Drying Accessories."
“10.2 Drying Accessories”
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Chapter 8
Chemical Disinfection
This chapter describes methods of chemical disinfection.
Carry out chemical disinfection after pre and manual cleaning.
8.1 Methods of Chemical Disinfection.................................................................8-2
8.2 Conditions of Disinfection..............................................................................8-3
8.3 Chemical Disinfection of Endoscope..............................................................8-4
8.3.1 Immersion in Chemical Solution.........................................................8-4
8.3.2 Injecting Chemical Solution into Air/Water Supply Channel.............8-4
8.3.3 Injecting Chemical Solution into Suction Channel..............................8-5
8.3.4 Injecting Chemical Solution into Water Jet Channel
(for endoscopes that have these mechanisms only).............................8-5
8.3.5 Injecting Chemical Solution into Balloon Air Feed Channel
(for endoscopes that have these mechanisms only).............................8-6
8.3.6 Injection of Chemical Solution into the Cleaning Adapter..................8-6
8.4 Rinsing of Endoscope......................................................................................8-7
8.4.1 Injecting Sterilized Water....................................................................8-7
8.4.2 Drying..................................................................................................8-9
8.5 Cleaning and Disinfection Using an Automated
Endoscope Reprocessor (AER).....................................................................8-14
8.5.1 Air Leak tester....................................................................................8-15
8.5.2 Brushing.............................................................................................8-15
8.5.3 Endoscope Channels..........................................................................8-16
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Chapter 8 Chemical Disinfection
Chapter 8 Chemical Disinfection
8.1 Methods of Chemical Disinfection
CAUTION
Endoscope will be damaged by high temperature.
Do not use boiling or autoclaving for endoscope.
To enhance the effect of disinfection, carry out pre and manual cleaning meticulously
before disinfection according to Sections 7.4 and 7.5.
[Note] Do not clean and disinfect/sterilize the accessories that have already been sterilized.
For the cleaning and disinfection/sterilization methods of the accessories, follow the
instructions provided in the operation manual for the respective items.
Use sterilized water and disinfectants for disinfection. For disinfection, we recommend you
to use the disinfectants listed in the Appendix “Chemicals and conditions.”
Table 8.1 Applicable methods of cleaning, disinfectant and sterilization for endoscope and accessories
Cleaning methods
Method of disinfection and sterilization
Chemical
cleaning
Ultrasonic
cleaning
Autoclaving
Chemical
disinfection
Gas
sterilization
Endoscope
Yes
Yes [Note 1]
No
Yes [Note 2]
Yes [Note 3]
Air/Water button
Yes
Yes [Note 1]
Yes
Yes
Yes
Suction button
Yes
[Note 1]
Yes
Yes
Yes
Biopsy forceps
Yes
Yes
Yes
-
Yes
Water tank
Yes
Yes
Yes
Yes
No
Mouthpiece
Yes
Yes
Yes
Yes
Yes
Cleaning brush
Yes
Yes
No
Yes
Yes
J check valve
Yes
Yes
Yes
Yes
Yes
Carrying case
No
No
No
No
No
Protective cap
Yes
Yes
No
Yes
No
Cleaning adapter
Yes
No
Yes
Yes
Yes
Hood
Yes
Yes
Yes
Yes
Yes
Flexible adapter
Yes
No
No
Yes
No
Yes
[Note 1] Use the ultrasonic cleaning unit specialized for endoscope.
[Note 2] Follow conditions of disinfection (Section 8.2).
[Note 3] Follow conditions of gas sterilization (Section 9.1).
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Chapter 8 Chemical Disinfection
8.2 Conditions of Disinfection
For disinfection, we recommend you to use the disinfectants listed in the Appendix
“Chemicals and conditions.”
We have confirmed that the endoscopes, biopsy forceps, snares and the like have resistance
to the disinfectants listed in the Appendix.
If you want to use disinfectants other than those listed in the Appendix “Chemicals and
conditions,” inquire of us about the resistance of the endoscopes, biopsy forceps, snares or
the like to them beforehand.
For the resistance of equipment, follow the disinfection conditions specified in the
Appendix “Chemicals and conditions.”
For effects, dilution, and preparation of a disinfectant under the use conditions indicated
in the Appendix refer to the manufacturer of the respective cleaning fluid. Some cleaning
fluids require “precautions in use” or “handling precautions,” such as wearing of a
protective gear. Refer also to the instruction manual of the respective disinfectant.
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Chapter 8 Chemical Disinfection
8.3 Chemical Disinfection of Endoscope
8.3.1 Immersion in Chemical Solution
“7.4.7 Connecting Cleaning Adapter”
(1) Attach the protective cap to the end of the EVE connector.
(2) Immerse entire endoscope and cleaning adapter in
chemical solution.
“8.2 Conditions of Disinfection”
8.3.2 Injecting Chemical Solution into Air/Water Supply Channel
Inject chemical solution into the air/water supply channel with the endoscope immersed in
the chemical solution.
(1) Attach a syringe to the air/water channel side of the
cleaning adapter.
(2) Inject chemical solution into air/water supply channel with
syringe.
Repeat this step several times until no more bubbles come
from the distal end of endoscope, air/water supply
connector, and air supply tube.
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Chapter 8 Chemical Disinfection
8.3.3 Injecting Chemical Solution into Suction Channel
Inject chemical solution into the suction channel with the endoscope immersed in the
chemical solution.
(1) Attach a syringe to suction channel side of the cleaning
adapter.
(2) Inject chemical solution into suction channel by syringe.
Repeat this step several times until no more bubbles come
from the distal end of endoscope and suction connector.
(3) Remove cleaning adapter (valve adapter, forceps inlet
cleaning adapter and tank receiving cap) from endoscope.
[Note]
Removal must be executed in the chemical solution.
8.3.4 Injecting Chemical Solution into Water Jet Channel (for endoscopes that have these mechanisms only)
Inject chemical solution into the water jet channel with the endoscope immersed in the
chemical solution.
(1) Using a syringe, charge a chemical solution into the water
jet channel of the endoscope.
Repeat this several times until no more bubbles come out
of the distal end of the endoscope.
[Note]
Injection must be executed in the chemical solution.
(2) Remove J cleaning adapter from endoscope.
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Chapter 8 Chemical Disinfection
8.3.5 Injecting Chemical Solution into Balloon Air Feed Channel (for endoscopes that have these mechanisms only)
Inject chemical solution into the balloon air feed channel with the endoscope immersed in
the chemical solution.
“7.4.10 Cleaning the Balloon Air Feed Channel”
Using a syringe, charge a chemical solution into the
balloon air feed channel of the endoscope.
Repeat this step several times until no more bubbles comes
out from the hole of side of the distal end.
[Note]
Injection must be executed in the chemical solution.
8.3.6 Injection of Chemical Solution into the Cleaning Adapter
(1) Immerse the cleaning adapter in the chemical solution.
(2) Inject the chemical solution into the cleaning adapter using
the syringe.
[Note]
Injection must be executed in the chemical solution.
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Chapter 8 Chemical Disinfection
8.4 Rinsing of Endoscope
8.4.1 Injecting Sterilized Water
CAUTION
Disinfecting liquid might flow into a patient’s body.
After immersing in the chemical solution, rinse off remaining chemical
solution with sterilized water.
(1) Pull out endoscope and cleaning adapter from chemical
solution.
(2) Attach cleaning adapter to endoscope.
(3) Attach a syringe to the air/water channel side of the
cleaning adapter.
(4) Inject sterilized water into air/water supply channel
of endoscope with a syringe to remove the remaining
chemical solution in the channel.
Repeat this step several times so that no chemical solution
remains in the channel.
(5) Attach a syringe to suction channel side of the cleaning
adapter.
(6) Inject sterilized water into suction channel of endoscope
with a syringe to remove the remaining chemical solution
in the channel.
Repeat this step several times so that no chemical solution
remains in the channel.
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Chapter 8 Chemical Disinfection
(7) Remove the cap of forceps inlet cleaning adapter.
(8) Inject sterilized water into forceps inlet with a syringe to
remove remaining chemical solution in the forceps inlet.
(9) Attach the cleaning adapter to the water jet channel (when
provided) as well.
(10) Inject sterilized water into the water jet channel with a
syringe to remove remaining chemical solution.
(11) Same way, inject sterilized water into the balloon air feed
channel (for endoscopes that have these mechanisms only)
with a syringe to remove remaining chemical solution.
(12) Remove cleaning adapter from endoscope.
(13) Clean the endoscope and cleaning adapter with running
water (sterilized water).
Thoroughly rinse it with running water (sterilized water)
so that no chemical solution remains on the endoscope.
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Chapter 8 Chemical Disinfection
8.4.2 Drying
<Drying the endoscope>
(1) Wipe water off external surfaces of endoscope with dry
sterilize gauze.
(2) Attach each cleaning adapter to endoscope.
(3) Send air into air/water supply, suction, water Jet channels
and balloon air feed channel of endoscope to drain them.
(4) Send alcohol into air/water supply, suction, water jet
channels and balloon air feed channel of endoscope to
drain them.
(5) Using a syringe, feed air into the air/water supply, suction,
water jet channels and balloon air feed channel of the
endoscope to dry alcohol from the channel.
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Chapter 8 Chemical Disinfection
<Drying the air/water supply channel “Combination with the EPX-4400 system”>
(1) Remove the protective cap from the end of the EVE
connector.
(2) Clean the end of the EVE connector with dry sterilize
gauze.
(3) Connect LG connector to the light source.
(4) Turn on the power supply of the light source equipment
and operate the air supply pump for 10 minutes to dry the
inside of the channel.
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Chapter 8 Chemical Disinfection
<Drying the air/water supply channel “Combination with the EPX-2500 system”>
(1) Remove the protective cap from the end of the EVE
connector.
(2) Clean the end of the EVE connector with dry sterilize
gauze.
(3) Connect the LG connector to the processor.
(4) Turn on the power supply of the processor equipment
and operate the air supply pump for 10 minutes to dry the
inside of the channel.
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Chapter 8 Chemical Disinfection
<Drying the suction channel>
(1) Connect tube from suction unit to suction connector of
endoscope.
(2) Turn on the power supply of the suction unit and dry the
inside of the tube for 10 minutes.
In the case of EPX-4400 System
In the case of EPX-2500 System
(3) Remove cleaning adapter from endoscope.
Wipe water off external surfaces of cleaning adapter.
[Note]
To autoclave the cleaning adapter, put it in a sterilized
pack and seal the pack closely. Autoclave the cleaning
adapter according to the operation manual for the
autoclave.
Recommended steam sterilization (autoclaving) conditions
Sterilization temperature (ºC)
Operation time
121
Max 20 minutes
Min 15 minutes
126
Max 15 minutes
Min 10 minutes
134
Max 8 minutes
Min 5 minutes
For France and Switzerland only:
Sterilization temperature 134ºC with minimum exposure
time (while sterilization temperature) of 18 minutes.
Steam Sterilizer Class B according EN 13060
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Chapter 8 Chemical Disinfection
(4) Store the air/water and suction buttons.
Attach sterile or disinfected buttons and forceps channel
immediately before using the endoscope.
(5) Wipe water off external surfaces of endoscope.
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Chapter 8 Chemical Disinfection
8.5 Cleaning and Disinfection Using an Automated Endoscope Reprocessor (AER)
WARNING
Some legally marketed automated endoscope reprocessors (AERs)
may be able to clean and/or disinfect FUJIFILM endoscopes.
However, end-users must check with each AER manufacturer to
confirm that their AERs use peracetic acid as disinfectant solution
and conform to ISO 15883 and that they also have validation data
to support their reprocessing claims for FUJIFILM endoscopes and
detachable endoscope components, such as valve mechanisms.
Inadequate device-specific instructions and/or non-validated AER
recommendations could result in unsuccessful cleaning and/or highlevel disinfection which may increase risks to patient safety.
Some legally marketed automated endoscope reprocessors (AERs) may be able to clean
and/or disinfect FUJIFILM endoscopes. However, end-users must check with each AER
manufacturer to confirm that their AERs use peracetic acid as disinfectant solution and
conform to ISO 15883 and that they also have validation data to support their reprocessing
claims for FUJIFILM endoscopes and detachable endoscope components, such as valve
mechanisms.
For information regarding the efficacy of cleaning and high-level disinfection, consult with
the manufacturer of your specific automated endoscope reprocessor (AER). Always follow
all AER manufacturer's validated reprocessing recommendations, including for devicespecific endoscope models, features and detachable scope components and/or accessories.
Prepare the equipment and materials according to the instructions of the AER manufacturer.
[Note]Refer to the disinfectant manufacturer's instructions regarding usage, exposure
conditions and expiration date of disinfectant solution as well as the AER
manufacturer's recommendations including use of exclusive or AER specific
reprocessing solutions.
The disinfectant solution's efficacy (Minimum Effective Concentration) must be confirmed
before use according to the manufacturer's recommendation (such as using a test strip). Do
not use a disinfectant solution whose efficacy is not sufficient.
To enhance the effect of disinfection, carry out pre and main cleaning before automatic
disinfection according to Sections 6.7 and 7.4.
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Chapter 8 Chemical Disinfection
8.5.1 Air Leak tester
“7.4.1 Air Tightness Test”
8.5.2 Brushing
Brush the channels of the endoscope in an appropriate way for each channel.
“7.4.4 Brushing Suction Channel”
“7.4.5 Brushing Distal End”
Removes debris when the air/water nozzle is blocked.
“7.4.6 Removing Debris in Air/Water Nozzle”
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Chapter 8 Chemical Disinfection
8.5.3 Endoscope Channels
The endoscope has channels as shown below. Use a washer-disinfector that can be used for
cleaning and disinfection of individual channels.
For the information on connections to the channels, refer to the operating manual of the
washer-disinfector.
As of the method for connecting each channel, please refer to the washer-disinfector manufacturer.
In the following figure, the connection method of Innova E3 of BHT is described as an
example.
Regarding any questions for cleaning and disinfection effect etc, please refer to washerdisinfector manufacturer.
D
Connect a channel Splitter to
A and B.
Connect a tube connector
to C. In case of a double
channel device, please
connect a second tube
connctor.
Connect a tube connector to D.
B
A
C
Connect the air tightness
tube to I.
I
G
E
Connect a tube
connector to G.
Connect a tube connector to E.
Connect a tube connector to F.
E to A to H :
F to E :
G to B to H :
C to H :
Air/Water Supply Channel
Air Supply Channel
Suction Channel
Forceps Channel
H
F
Legend
A : Air/Water valve cylinder.
B : Suction valve cylinder.
C : Forceps channel inlet.
D : Jet channel or air feed channel for balloon.
E : Water tank connector.
F : Air supply connector.
G : Suction pump connector.
H : Distal end.
I : Ventilation connector.
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Chapter 9
Gas Sterilization
This chapter describes methods of gas sterilization.
9.1 Conditions of Gas Sterilization.....................................9-3
9.2 EOG (Ethylene Oxide Gas) Sterilization......................9-5
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Chapter 9 Gas Sterilization
Chapter 9 Gas Sterilization
WARNING
When performing ethylene oxide gas sterilization, use a sterilizer that
is installed and maintained in accordance with ISO 11135. Not doing
so may cause inadequate sterilization and pose a risk of infection.
When performing ethylene oxide gas sterilization of the endoscope and
its accessories, use a sterile pack or packaging material (compliant
with ISO 11607) appropriate for the type of sterilization to maintain
sterility after sterilization. If not used, the endoscope or accessory may
be re-contaminated and it may be a source of infection.
Applying gas sterilization to wet parts presents incomplete sterilization.
Proceed gas sterilization after vaporizing water out of endoscope.
CAUTION
Gas remaining in endoscope after gas sterilization is harmful to human
body.
Proceed aeration after gas sterilization.
CAUTION
Endoscope will be damaged by high temperature.
Do not use boiling or autoclaving for endoscope.
Use gas sterilization for sterilization of 530/590 series endoscopes.
To enhance the effect of sterilization, carry out pre and manual cleaning before gas
sterilization according to Sections 6.7 and 7.4.
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Chapter 9 Gas Sterilization
9.1 Conditions of Gas Sterilization
Use only legally marketed sterilizers and sterilization accessories.
Ethylene oxide gas sterilizers must be compliant with ISO 11135.
Perform ethylene oxide gas sterilization that must be compliant with ISO 11135.
For gas sterilization, we recommend you to use chemicals listed in Tables 9.1. We have
confirmed that Endoscopes, biopsy forceps, snares, and the like have resistance to methods
of sterilization listed in these tables.
[Note] Do not clean and disinfect/sterilize the accessories that have already been sterilized.
For the cleaning and disinfection/sterilization methods of the accessories, follow the
instructions provided in the operation manual for the respective items.
If you wish to use chemicals and/or conditions other than those listed in Table 9.1, please
make inquiries at our company about the resistance of endoscopes, biopsy forceps, snares
and the like in advance.
For the sterilization effect under the conditions indicted in Table 9.1 and handling details,
please make inquiries at the manufacturer of relevant equipment.
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Chapter 9 Gas Sterilization
Table 9.1 Conditions of EOG sterilization (chamber type)
Concentration of
Ethylene Oxide
Temperature
Humidity
Pressure
Time
Aeration
20 v/v%
55ºC
Normal
humidity
167kPa [Note]
4 hours
Atmospheric
Pressure
[Note] 167kPa
1.7kg/cm2
Table 9.2 Applicable methods of cleaning, disinfectant and sterilization for endoscopes and accessories
Cleaning methods
Method of disinfection and sterilization
Chemical
cleaning
Ultrasonic
cleaning
Autoclaving
Chemical
disinfection
Gas
sterilization
Endoscope
Yes
Yes [Note 1]
No
Yes [Note 2]
Yes [Note 3]
Air/Water button
Yes
Yes [Note 1]
Yes
Yes
Yes
Suction button
Yes
[Note 1]
Yes
Yes
Yes
Biopsy forceps
Yes
Yes
Yes
-
Yes
Water tank
Yes
Yes
Yes
Yes
No
Mouthpiece
Yes
Yes
Yes
Yes
Yes
Cleaning brush
Yes
Yes
No
Yes
Yes
J check valve
Yes
Yes
Yes
Yes
Yes
Carrying case
No
No
No
No
No
Protective cap
Yes
Yes
No
Yes
No
Cleaning adapter
Yes
No
Yes
Yes
Yes
Hood
Yes
Yes
Yes
Yes
Yes
Flexible adapter
Yes
No
No
Yes
No
Yes
[Note 1] Use the ultrasonic cleaning unit specialized for endoscope.
[Note 2] Follow conditions of disinfection (Section 8.2).
[Note 3] Follow conditions of gas sterilization (Section 9.1).
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Chapter 9 Gas Sterilization
9.2 EOG (Ethylene Oxide Gas) Sterilization
CAUTION
Temperature and pressure changes may break the bending portion.
Before applying EOG sterilization, install the ventilation adapter.
Liquid may enter the endoscope and cause damage to it.
Remove the ventilation adapter after aeration.
<Preparation>
(1) Attach each cleaning adapter to endoscope.
(2) Send alcohol into air/water supply, suction, water jet
channels and balloon air feed channel of endoscope to
drain them.
(3) Using a syringe, feed air into the air/water supply, suction,
water jet channels and balloon air feed channel of the
endoscope to dry alcohol from the channel.
[Note]
Prepare a 30mL luer-lock or luer-slip syringe.
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Chapter 9 Gas Sterilization
<Drying Air/Water Supply Channel “Combination with EPX-4400 system”>
(1) Remove the protective cap from the end of the EVE
connector.
(2) Clean the end of the EVE connector with dry gauze.
(3) Connect LG connector to the light source.
(4) Turn on the power supply of the light source equipment
and operate the air supply pump for 10 minutes to dry the
inside of the channel.
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Chapter 9 Gas Sterilization
<Drying Air/Water Supply Channel “Combination with EPX-2500 system”>
(1) Remove the protective cap from the end of the EVE
connector.
(2) Clean the end of the EVE connector with dry sterilize
gauze.
(3) Connect the LG connector to the processor.
(4) Turn on the power supply of the processor equipment
and operate the air supply pump for 10 minutes to dry the
inside of the channel.
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Chapter 9 Gas Sterilization
<Drying Suction Channel>
(1) Connect tube from suction unit to suction connector of
endoscope.
(2) Turn on the power supply of the suction unit and dry the
inside of the tube for 10 minutes.
In the case of EPX-4400 System
In the case of EPX-2500 System
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Chapter 9 Gas Sterilization
<Gas Sterilization>
(1) Remove cleaning adapter from endoscope.
(2) Connect ventilation adapter to ventilation connector in LG
connector of endoscope.
Ventilation adapter connects with outside air. This
prevents inside of endoscope from developing high
pressure.
(3) Put endoscope in EOG sterilizer together with air/water
button, suction button and cleaning adapter.
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Chapter 9 Gas Sterilization
(4) Sterilize instruments, following the operating procedure of
EOG sterilizer.
(5) Sterilize instruments for a specified time, and aerate them
according to operating procedure of EOG sterilizer.
Temperature
Time
50ºC
12 hours
Room Temperature
7 days
(6) When aeration is over, remove the ventilation adapter.
(7) Store each button.
Attach sterile or disinfected buttons and forceps channel
immediately before using the endoscope.
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Chapter 10 Storage
This chapter describes the method and conditions of storage.
10.1 Drying Endoscope.......................................................10-3
10.2 Drying Accessories.....................................................10-5
10.2.1 Drying Mouthpiece..........................................10-5
10.2.2 Drying Air/Water Button and Suction Button....10-5
10.2.3 Drying Air/Water Supply Channel Cleaning
Adapter.............................................................10-5
10.2.4 Drying J Check Valve......................................10-6
10.2.5 Drying Flexible Adapter..................................10-6
10.2.6 Drying Cleaning Brush....................................10-6
10.3 Storage.........................................................................10-7
10-1
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Chapter 10 Storage
Chapter 10 Storage
WARNING
Storage of endoscope in a carrying case may cause infection.
Do not store endoscope in a carrying case.
CAUTION
Non-compliance may result in failure.
Do not store endoscope in locations that do not satisfy the storage
conditions.
Store Endoscope after disinfection or gas sterilization. Store it in a clean location that
satisfies the following conditions.
Storage Conditions
Temperature
: -20 to +60°C
Humidity
: 10 to 85%RH (no dew condensation)
Pressure
: 70 to 106 kPa (within range of atmospheric pressure)
State of endoscope : Straight, rather than bent, state
Location not affected by external force.
Remove the buttons, and hung with control portion up.
Keep out of direct sunlight or UV light.
Store the cleaning brushes, the cleaning adapters and the ventilation adapters in a place that
meets the above conditions of temperature, humidity and atmospheric pressure.
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Chapter 10 Storage
10.1 Drying Endoscope
WARNING
Before storing the endoscope and accessories, thoroughly dry external
and internal surfaces (lumens). Leaving the suction valve, air/water
valve, forceps valve and J tube attached to the endoscope may
result in insufficient drying. If an endoscope or accessory that is not
sufficiently dried is stored, microorganisms may proliferate and may
pose a risk of infection.
[Note]Following disinfection and final alcohol rinse, it is recommended that the
endoscope be dried with medical-grade filtered forced/compressed air before
storage and between patient uses.
If the endoscope is intended to be stored for more than 3 hours without using an endoscope
storage cabinet that conforms to EN 16442, dry the endoscope.
(1) Attach all components of the cleaning adapter to the
endoscope.
"7.4.7 Connecting Cleaning Adapter"
(2) Inject filtered forced/compressed air at 200 to 230 kPa into
the suction channel side of the cleaning adapter for at least
15 seconds.
(3) Detach the forceps inlet cleaning adapter from the forceps
inlet of the endoscope.
(4) Inject filtered forced/compressed air at 200 to 230 kPa into
the forceps inlet of the endoscope for at least 15 seconds.
(5) Attach the forceps inlet cleaning adapter to the forceps
inlet of the endoscope.
(6) Inject filtered forced/compressed air at 200 to 230 kPa into
the air/water channel side of the cleaning adapter for at
least 15 seconds.
(7) Inject filtered forced/compressed air at 200 to 230 kPa into
the water jet inlet for at least 15 seconds.
(8) Perform steps (2) to (7) at least six more times (for a total
of at least seven times).
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Chapter 10 Storage
(9) Cover the distal end of the endoscope with dry, sterile
gauze.
(10) Inject filtered forced/compressed air into the suction
channel side of the cleaning adapter at 200 to 230 kPa for
at least 30 seconds.
(11) Inject filtered forced/compressed air at 200 to 230 kPa into
the air/water channel side of the cleaning adapter for at
least 30 seconds.
(12) Inject filtered forced/compressed air into the water jet inlet
of the endoscope at 200 to 230 kPa for at least 30 seconds.
(13) Check for any water droplets on the sterile gauze.
(14) If water droplets are found, repeat steps (2) to (13) until no
droplets come out from the endoscope.
(15) Detach all components of the cleaning adapter from the
endoscope.
(16) Flush filtered forced/compressed air into the gaps/crevices
between the left-right angle knob and left/right angulation
lock of the endoscope at 200 to 230 kPa for at least 30
seconds.
(17) Flush filtered forced/compressed air into the gaps/crevices
between the left-right angle knob and up-down angle knob
of the endoscope at 200 to 230 kPa for at least 30 seconds.
(18) Flush filtered forced/compressed air into the gaps/crevices
between the up-down angle knob and the main body of
control portion of the endoscope at 200 to 230 kPa for at
least 30 seconds.
(19) Wipe off water droplets remaining on the endoscope and
cleaning adapter with sterile gauze.
(20) Wipe off any water droplets remaining on the inner side of
the air/water supply valve, suction valve and forceps inlet
with a sterile cotton swab.
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Chapter 10 Storage
10.2 Drying Accessories
If the accessories are intended to be stored for more than 3 hours without using an
endoscope storage cabinet that conforms to EN 16442, dry the accessories.
10.2.1 Drying Mouthpiece
(1) Wipe off water droplets on the mouthpiece with sterile
gauze.
(2) Ensure that the mouthpiece is dry.
10.2.2 Drying Air/Water Button and Suction Button
(1) Flush filtered forced/compressed air into each portion (the
spring section, back side of skirt and hole in shaft) of the
suction button at 200 to 230 kPa for at least 30 seconds.
Continually manipulate the button when flushing filtered
forced/compressed air into the spring section and the back
side of skirt.
(2) Flush filtered forced/compressed air into each portion (the
spring section, back side of skirt and hole in shaft) of the
air/ water button at 200 to 230 kPa for at least 30 seconds.
Continually manipulate the button when flushing filtered
forced/compressed air into the spring section and the back
side of skirt.
(3) Repeat steps (1) to (2) at least three times.
(4) Ensure that the suction button and air/water button are dry.
10.2.3 Drying Air/Water Supply Channel Cleaning Adapter
(1) Flush filtered forced/compressed air into each portion
(the spring section and back side of skirt) of the air/water
supply channel cleaning adapter at 200 to 230 kPa for
at least 30 seconds while continually manipulating the
button.
(2) Repeat step (1) at least three times.
(3) Ensure that the air/water supply channel cleaning adapter
is dry.
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Chapter 10 Storage
10.2.4 Drying J Check Valve
(1) Wipe off water droplets on the J check valve with sterile
gauze.
(2) Ensure that the J check valve is dry.
10.2.5 Drying Flexible Adapter
(1) Fill a sterile basin with alcohol.
(2) Attach a sterile syringe filled with alcohol to the lure
connectors of the flexible adapter and flush at least 30 mL
of alcohol into the flexible adapter.
(3) Attach a sterile syringe filled with air to the flexible
adapter and inject air repeatedly until alcohol is discharged
completely.
(4) Wipe off the alcohol on the flexible adapter with sterile
gauze.
(5) Inject filtered forced/compressed air into the lure
connectors of the flexible adapter at 200 to 230 kPa for at
least 30 seconds.
(6) Repeat step (5) at least three times.
(7) Visually check that no alcohol remains inside the flexible
adapter.
(8) If alcohol remains, repeat steps (5) to (7) until no alcohol
comes out from the flexible adapter.
(9) Wipe off water droplets on the flexible adapter with sterile
gauze.
(10) Ensure that the flexible adapter is dry.
10.2.6 Drying Cleaning Brush
(1) Wipe off water droplets on the cleaning brushes with
sterile gauze.
(2) Ensure that the cleaning brushes are dry.
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Chapter 10 Storage
10.3 Storage
WARNING
Be sure that the endoscope storage cabinet is clean, dry and wellventilated. In a high humidity environment, microorganisms may
proliferate and pose an infection control risk.
Keep the cabinet doors closed. Limit access to stored equipment by
unauthorized personnel. Accidental contact to contaminated surfaces
may pose an increased risk of infection.
Avoid mixing up a contaminated and reprocessed endoscope and
accessories. It may cause cross-contamination and pose an infection
risk.
CAUTION
Keep the cabinet doors closed. Limit access to stored equipment by
unauthorized personnel. Accidental contacts may cause equipment
failure or re-contamination.
[Note]It is recommended that the endoscope must be hung in a storage cabinet with
the insertion tube and LG flexible portion hanging vertically and with the video
connector facing downward without attachment of the waterproof cap.
(1) Store the disinfected endoscope and accessories in a
dedicated storage cabinet, following local professional
society guidelines.
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Chapter 10 Storage
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Appendix
Chemicals and Conditions.......................................Appendix-2
Index........................................................................Appendix-5
Appendix-1
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Appendix
Chemicals and Conditions
For effects, dilution, and preparation of solution under the use conditions indicated in the
table below, refer to the manufacturer of the respective chemical. Some chemicals require
“precautions in use” or “handling precautions,” such as wearing of protective gear. Refer
also to the instruction manual of the respective chemicals.
Contact your local dealer.
[Note] To avoid incompatibilities on materials and insufficient disinfection results, please
do not mix up the chemicals other than the recommended solution combination.
[Note] The usage of aldehyde based products may be restricted; follow your national
regulations or recommendations for their usage.
Table.1 Chemicals for Cleaning and Manual Disinfection
Manufacturer
Function
Solution
Dilution ratio
[ml, L or g/l]
Temperature
[°C]
Residence time
[minutes]
8ml with 1L
(0.8%)
20 - 30
2
Ruhof Corporation
Cleaning fluid
Endozime AW
(Enzymatic)
Laboratorios Inibsa
Cleaning fluid
Instrunet EZ
(Enzymatic)
1L with 120L
with warm water
30
5
Maruishi
Pharmaceutical
Disinfectant
Steriscope 3 w/v%
(Glutaraldehyde)
Original solution
20 - 25
15 - 25
Johnson & Johnson
Disinfectant
Cidex 2.25 w/v%
(Glutaraldehyde)
Original solution
20 - 25
30 - 40
Johnson & Johnson
Disinfectant
Cidex Plus 28 3.5 w/w%
(Glutaraldehyde)
Original solution
20 - 25
20 - 30
Cleaning fluid
Bodedex forte
(Tenside)
5ml with 1L
(0.5%)
20
5
Disinfectant
Korsolex extra
(Glutaraldehyde)
40ml with 1L
(4.0%)
20
15
Cleaning fluid
Gigazyme
(Enzymatic)
5ml with 1L
(0.5%)
20
5 - 10
Disinfectant
Gigasept FF
(Glutaraldehyde)
60ml with 1L
(6.0%)
20
15
Cleaning fluid
Sekusept-Cleaner
(Tenside)
5ml with 1L
(0.5%)
20 - 25
5
Disinfectant
Sekucid Konz
(Glutaraldehyde)
40ml with 1L
(4.0%)
20 - 25
30
Cleaning fluid
Sekusept-Cleaner
(Tenside)
5ml with 1L
(0.5%)
20 - 25
5
Disinfectant
Sekucid N
(Glutaraldehyde)
Original solution
20 - 25
20
Bode Chemie
Schuelke & Mayr
Ecolab
Ecolab
Appendix-2
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Appendix
Manufacturer
Function
Dilution ratio
[ml, L or g/l]
Temperature
[°C]
Residence time
[minutes]
Cleaning fluid
Sekusept aktiv
(Peracetic Acid)
10g with 1L
(1.0%)
20 - 25
5 - 10
Disinfectant
Sekusept aktiv
(Peracetic Acid)
20g with 1L
(2.0%)
20 - 25
15
Cleaning fluid
Seku Zyme
(Enzymatic)
10ml with 1L
(1.0%)
20 - 25
5
Disinfectant
Sekusept easy
(Peracetic Acid)
45ml with 1L
(4.5%)
20 - 25
10
Cleaning fluid
Instru Zym
(Enzymatic)
10ml with 1L
(1.0%)
20 - 30
5
Disinfectant
Instru Plus
(Glutaraldehyde)
30ml with 1L
(3.0%)
20
15
5ml with 1L
(0.5%)
20
10 - 15
40ml with 1L
(4.0%)
20
30
Ecolab
Ecolab
Dr. Deppe
Dr. Weigert
Solution
Neodisher
Cleaning fluid Mediclean forte
(Alkaline, Tenside)
Disinfectant
Neodisher
Septo 3000
(Glutaraldehyde)
Appendix-3
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Appendix
Table.2 Chemicals for Cleaning and Machine Disinfection
Manufacturer
Dilution ratio
[ml, L or g/l]
Temperature
[°C]
Residence time
[minutes]
5ml with 1L
(0.5%)
20
5
5ml with 1L
(0.5%)
50
5
Disinfectant
Korsolex
Endo-Disinfectant
(Glutaraldehyde)
10ml with 1L
(1%)
55
5
Pre-Cleaner
Gigazyme
(Enzymatic)
5ml with 1L
(0.5%)
20
5 - 10
Cleaning fluid
Thermosept ER
(Enzymatic, Tenside)
5ml with 1L
(0.5%)
50
5
Disinfectant
Thermosept ED
(Glutaraldehyde)
10ml with 1L
(1%)
55
5
Pre-Cleaner
Instru Zym
(Enzymatic)
10ml with 1L
(1.0%)
20 - 30
5
Cleaning fluid
Labomat E
(Enzymatic)
5ml with 1L
(0.5%)
50
5
Disinfectant
Endomat Plus
(Aldehyde)
10ml with 1L
(1%)
55
5
Pre-Cleaner
Neodisher Mediclean forte
(Alkaline, Tenside)
5ml with 1L
(0.5%)
20
10 - 15
Cleaning fluid
Neodisher Mediclean forte
(Alkaline, Tenside)
5ml with 1L
(0.5%)
50
5
Disinfectant
Neodisher Septo DN
(Aldehyde)
10ml with 1L
(1%)
55
5
Pre-Cleaner
Neodisher Mediclean forte
(Alkaline, Tenside)
5ml with 1L
(0.5%)
20
10 - 15
Cleaning fluid
Neodisher Mediclean forte
(Alkaline, Tenside)
5ml with 1L
(0.5%)
50
5
Disinfectant
Neodisher Septo PAC
(Peracetic Acid)
10ml with 1L
(1%)
25
10
Function
Pre-Cleaner
Bode Chemie
Schuelke & Mayr
Dr. Deppe
Dr. Weigert
Dr. Weigert
Solution
Bodedex forte
(Tenside)
Korsolex
Cleaning fluid Endo-Cleaner
(Enzymatic, Tenside)
Appendix-4
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Appendix
Index
<A>
Aeration................................................................ 9-9
Air tightness test................................................... 7-7
Air/Water button................................................ 7-25
Autoclaving.......................................................... 8-2
<B>
Biopsy forceps.................................................... 7-21
<C>
Cannulation tube................................................ 7-22
Caution.................................................................2, 4
Chemical disinfection.......................................... 8-2
Cleaning............................................................... 7-2
Cleaning adapter................................................ 7-13
Cleaning brush................................................... 7-32
<E>
EOG..................................................................... 9-4
Ethylene oxide gas............................................... 9-4
<F>
Flexible adapter.................................................. 7-28
<G>
Gas sterilization.................................................... 9-2
<H>
Hood................................................................... 7-27
<J>
J check valve............................................. 7-17, 7-27
<M>
Mouthpiece......................................................... 7-24
<S>
Storage............................................................... 10-2
Suction button.................................................... 7-25
<U>
Ultrasonic cleaning.............................................. 7-2
<V>
Ventilation adapter............................................... 9-8
Ventilation connector........................................... 7-8
<W>
Warning................................................................2, 4
Appendix-5
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FUJIFILM Corporation
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan
FUJIFILM Europe GmbH
Heesenstrasse 31, 40549 Duesseldorf, Germany
EU Importer:
FUJIFILM Europe B.V.
Oudenstaart 1, 5047 TK Tilburg, The Netherlands
FC664A
530,590_clean_E2-70_202B1262062F.indb 6
202B1262062F
200910-7.0-DT-E2
Printed in Japan
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