US

Endoscope

EB-530P

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.
Please refer to separate operation manual (Preparation and Operation) regarding detailed
instructions for the preparation, operation and use of these endoscopes.

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 Important Safety Information

Important Safety Information

1. Safety

Prior to use carefully review this manual. Use this product following all the provided
instructions (“Preparation and Operation”, “Cleaning, Disinfection and Storage” and
“Electrosurgical Instruments”). The items important for the safe use of this product are
summarized in Chapter 1 “Safety” in the preparations and operations section.
Safety precautions associated with individual operations and/or reprocessing
procedures are provided separately marked by “ WARNING” or “ CAUTION.”

2. Warning

The items that must be observed for safety when performing endoscopy or electrosurgery
are identified by “ WARNING” or “ CAUTION” comments in our three operation
manuals describing “Preparation and Operation”, “Cleaning, Disinfection and Storage”
and “Electrosurgical Instruments.” Follow all caution and warning statements in our
operation manuals.

WARNING
Read this manual and the Operation Manual
(Preparation and Operation) thoroughly and carefully
prior to use.

Improper use or operation of this product may

injure patients, physicians, or individuals within the
immediate procedure environment.

Failure to adhere to all reprocessing instructions

could compromise patient safety and present
infection control risks.

Improper operations that will damage the equipment only are identified by
“CAUTION.”

3. First Time Use

This product was not cleaned, high-level disinfected or sterilized. It must be

reprocessed for the first time prior to use and after any subsequent use as per
instructions provided - section 6.5 “Pre-cleaning,” Chapter 7 “Cleaning,” Chapter 8
“High-Level Disinfection,” or Chapter 9 “ETO Gas Sterilization.”

4. Single Patient Use Only

DO NOT reuse the forceps valves and suction buttons because they are intended for
single patient use only.

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 Contents

Contents

Important Safety Information.......................................................................................2

Preface..........................................................................................................................4

Conventions Used in This Manual................................................................................6

Chapter 7 Cleaning................................................................................................ 7-1

7.1 Methods of Cleaning................................................................... 7-2
7.2 Preparation for Cleaning............................................................. 7-3
7.3 Equipment and Materials............................................................ 7-4
7.4 Manual Cleaning......................................................................... 7-6

Chapter 8 High-Level Disinfection....................................................................... 8-1

8.1 Methods of High-Level Disinfection.......................................... 8-2
8.2 Conditions of High-Level Disinfection....................................... 8-3
8.3 High-Level Disinfection of Endoscope....................................... 8-4
8.4 Rinsing Endoscope...................................................................... 8-6
8.5 Cleaning and/or High-Level Disinfection Using an Automated
Endoscope Reprocessor (AER)................................................... 8-9

Chapter 9 ETO Gas Sterilization.......................................................................... 9-1

9.1 Conditions of Ethylene Oxide (ETO) Gas Sterilization.............. 9-2
9.2 ETO Gas Sterilization................................................................. 9-4

Chapter 10 Cleaning and High-Level Disinfection or Sterilization

of Endoscopic Accessories................................................................. 10-1
10.1 Cleaning, High-Level Disinfecting and Sterilizing
Cleaning Brushes....................................................................... 10-2
10.2 Autoclaving Cleaning Adapter Kit CA-500C........................... 10-4

Chapter 11 Storage................................................................................................ 11-1

Appendix......................................................................................................Appendix-1
Autoclaving Conditions...........................................................Appendix-2
Index........................................................................................Appendix-3

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 Preface

Preface

This manual describes how to clean, high-level disinfect, sterilize and store EB-530P
bronchoscope. [Note]

This model is a fully immersible, single-instrument channel flexible endoscope.

Carefully follow the instructions in this manual as well as recommendations for
ancillary equipment before using other accessories.
This endoscope is heat-sensitive and should not be exposed to high temperatures
associated with sterilization processes such as steam autoclaving.
Handle this product with care since the insertion portion is pliable and acute bending,
excessive twisting and/or force can damage the insertion tube as well as underlying
internal components.

[Note] FUJIFILM cannot assure the successful reprocessing (cleaning, high-level

disinfection and sterilization) of the endoscope and/or accessories if
reprocessing methods, chemicals, packaging and/or conditions other than
those described in this manual are used. Users are responsible to ensure that if
any alternative reprocessing methods, chemicals, packaging and/or conditions
are used, appropriate efficacy validation studies have been performed.

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 Preface

A : Suction valve
B : Forceps inlet
A to C : Suction Channel C : Distal end
B to C : Forceps Channel D : Ventilation connector

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 Conventions Used in This Manual

<Summary chart>

Leak testing
Pre-cleaning (in decontamination area/
Withdrawal from patient
(in examination room) cleaning room)

High-level Water Alcohol/

disinfection Rinse Air/Dry

Water Use
Cleaning
Rinse (or storage)
Alcohol/ ETO gas
Aeration
Air/Dry sterilization

Conventions Used in This Manual

This manual uses the following conventions for easier understanding.

General Conventions
Convention Description

Indicates a potential danger that may cause harm to people.

Explains dangerous situations that may cause death or serious

WARNING
injury if not avoided.

CAUTION Explains situations that may cause injury if not avoided.

Explains situations that may cause damage to equipment

CAUTION
if not avoided.

Indicates consecutive numbers in operating procedures for the

(1), (2), (3), ...
order in which successive steps in the procedure should be taken.

[Note] Indicates a comment or supplementary information.

Indicates a reference.

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 Chapter 7 Cleaning

This chapter describes FUJIFILM recommended manual cleaning

procedures. Carry out pre-cleaning at the bedside immediately after
completion of endoscopic procedure.

All pre-cleaning instructions as described in section 6.5 “Pre-cleaning”

of the Operation Manual (Preparation and Operation) must be performed
before manual cleaning.

7.1 Methods of Cleaning.....................................................7-2

7.2 Preparation for Cleaning...............................................7-3
7.3 Equipment and Materials..............................................7-4
7.4 Manual Cleaning (Cleaning in Basin)...........................7-6
7.4.1 Preparation for Cleaning Endoscope.................7-6
7.4.2 Leak Testing.......................................................7-7
7.4.3 Inspecting Cleaning Brushes............................7-10
7.4.4 Cleaning Surface of Endoscope.......................7-10
7.4.5 Brushing Instrument/Suction Channel
and Channel Ports............................................7-12
7.4.6 Connecting Cleaning Adapter Kit CA-500C...7-14
7.4.7 Cleaning of Endoscope....................................7-15
7.4.8 Rinsing Endoscope...........................................7-17

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 Chapter 7 Cleaning

Chapter 7 Cleaning

7.1 Methods of Cleaning

CAUTION
Clean this product prior to first time use and after subsequent use
following the instructions provided in this manual. Improper cleaning
can negatively affect the functionality of this product and/or result in
incomplete disinfection or sterilization.

Cleaning is a crucial first step in reprocessing, which if not properly performed, can result
in incomplete or inadequate high-level disinfection or sterilization.

Use potable water or filtered water for rinsing after exposure to a detergent solution.
Low foaming, neutral pH, enzymatic detergents are recommended for cleaning flexible
endoscopes.
For specific names of compatible detergents, contact your local FUJIFILM dealer.

Table 7.1 Applicable methods of cleaning for endoscope and accessories

Detergent cleaning Ultrasonic cleaning
Endoscope Yes No [Note 2]
Cleaning brush [Note 1] Yes Yes
Carrying case No No
Cleaning adapter kit Yes No
[Note 1] FUJINON/FUJIFILM cleaning brushes only are recommended. For non-FUJINON/
FUJIFILM brushes, contact the original manufacturer.
[Note 2] Use an ultrasonic cleaning unit specialized for medical accessories.

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 Chapter 7 Cleaning

7.2 Preparation for Cleaning

Low foaming, neutral pH, enzymatic detergents are recommended for cleaning flexible
endoscopes.
For specific names of compatible detergents, contact your local FUJIFILM dealer.

Refer to the detergent manufacturer’s instructions for preparation and use. Personal
protective equipment should be worn by end-users during all reprocessing procedures.

Prepare a 30 mL luer-lock or luer-slip syringe.

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 Chapter 7 Cleaning

7.3 Equipment and Materials

Prepare the necessary equipments used in the chapters 7 and 8.

• Cleaning adapter kit CA-500C (Standard accessory)

Consists of: Tube for suction channel
Valve adapter
Forceps inlet cleaning adapter CA-503B/C (with a cap)
• Cleaning brushes (Standard accessories)
Consists of: Short channel cleaning brush WB3503FW
Long channel cleaning brush [Note 1]
Valve cleaning brush WB11002FW2
[Note 1] T he specific long cleaning brush may vary
from one endoscope model to another
depending upon channel size.
Refer to the Operation Manual (Preparation
and Operation) of each model for detailed
information.
• Air leak tester LT-7F (Required accessory) [Note 2]

[Note 2] L T-7F is a required accessory and leak

testing procedures must be performed prior to
cleaning.

• Ventilation adapter AD-7 [Note 3]

[Note 3] The ventilation adapter is necessary for ETO
gas sterilization as described in Chapter 9.

• High-level disinfectant solution and enzymatic detergent solution

• Soaking basin for high-level disinfectant solution and detergent solution
• Clean lint-free cloth/sterile gauze
• Toothbrush (soft type)
• Personal protective equipment
For example: Rubber gloves
Goggle
Facemask
Protective clothing

[Note] Prepare spare items such as cleaning brushes, sterile gauze, toothbrush, syringe,
etc. since they may be damaged or consumed.
[Note] Use potable, filtered and/or sterile water as described in these operation manuals.

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 Chapter 7 Cleaning

Tube for Suction Channel

Forceps Inlet Cleaning Adapter (with a Cap)

CA-503B/C

Valve Adapter

Weight

Cleaning Adapter Kit CA-500C

Clean Lint-free Cloth/Sterile Gauze Toothbrush (soft type)

High-Level Disinfectant Solution/ Soaking Basin for Personal Protective Equipment

Detergent Solution High-Level Disinfectant Solution/
Detergent Solution

Air Leak Tester Valve Cleaning Brush Long Channel Cleaning Brush Ventilation Adapter
LT-7F WB11002FW2 WB2212FW2 AD-7
Short Channel Cleaning Brush
WB3503FW

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 Chapter 7 Cleaning

7.4 Manual Cleaning (Cleaning in Basin)

Manual cleaning of endoscope is performed after pre-cleaning at the bed-side in the

procedure room. If performed correctly immediately after the procedure, pre-cleaning
should prevent drying and hardening of debris on instrument surfaces.

Refer to Section 6.5 of the Operation Manual (Preparation and Operation).

Leak testing must be performed prior to immersing the endoscope in any fluid or solution.

[Note] Fresh enzymatic detergent should be prepared for each endoscope. Do not reuse
detergent.

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.

Before using any cleaning brush for a valve cylinder, channel or

channel port, remove any debris from the bristles on the brush. This
will avoid reintroduction of patient material into the channels/lumens.

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.

Do not place endoscopes on top of one another to prevent damage caused by scope-to-scope
contact.

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 Chapter 7 Cleaning

7.4.1 Preparation for Cleaning Endoscope

(1) Prepare all items including channel cleaning brush, valve

cleaning brush and cleaning adapter kit.

(2) Prepare fresh detergent solution in the basin.

7.4.2 Leak Testing

CAUTION
Do not immerse this product in water or any solution if it fails the leak
test because it may cause damage to this product.

If not already detached, remove all detachable components including suction valve, forceps
valve, etc. from the endoscope before performing a leak test.

Perform a leak test to confirm the watertightness of this product.

If a leak is detected, do not continue the test and contact your local FUJIFILM dealer.

For details on how to use the LT-7F and inspection before use, refer to the instructions in
this manual or the separate operation manual for the LT-7F.

(1) Confirm that the waterproof cap is attached to the end of

the EVE connector. Ensure that the cap and connector,
especially the electrical contacts are dry.

(2) Align the index of connector of air leak tester with the
notch of ventilation connector of endoscope.

(3) Push in the connector of air leak tester and rotate it Index

clockwise to connect the air leak tester to the ventilation

connector.
Notch

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 Chapter 7 Cleaning

(4) Depress the trigger of air leak tester to the pressure side as
shown in the figure.

(5) Pump the hand bulb of the leak tester to pressurize the
endoscope until the meter indicates 20 kPa.

[Note]
During pressurization, remove fingers from the trigger
and do not lay trigger onto the hard surface to avoid
inadvertent escape of air.

(6) Release gripping the blower and wait for about 30

seconds, and check that the indicator does not fall.
If the indicator falls down 5 kPa (10 indications) or more,
the endoscope has an air leak.

[Note]
If the indicator drops slowly, apply more air until the
indicator points to 20 kPa.

[Note]
In case of air leak, do not clean the endoscope, but
immediately contact your local FUJIFILM dealer.

(7) While applying air pressure of at least 20 kPa into the

endoscope, completely immerse the entire scope in water
for not less than one minute and ensure that a steady
stream of air bubbles (indicative of a leak) is not found.

[Note]
Be sure to apply air pressure before immersing the
endoscope into water.

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 Chapter 7 Cleaning

[Note]
Do not immerse the meter or blower of air leak tester but
only the connector and tube.

[Note]
The water temperature must be between +10 to +40°C (50
to 104°F).

(8) Operate the endoscope and move the inserting portion and
bending portion every direction in order to check that air
bubbles do not come out continuously from endoscope.

[Note]
If the indicator falls down slowly, squeeze the blower to
blow air until the indicator points to 20 kPa.

[Note]
If a stream of air bubbles comes out from the endoscope
while it is completely immersed in water for at least one
minute, the endoscope has a leak.

[Note]
In case of air leak, do not clean the endoscope, but
immediately contact your local FUJIFILM dealer.

(9) Remove the endoscope from water and wipe around the
ventilation connector and air leak tester connector.

(10) Depress the trigger of air leak tester to release air pressure
from endoscope.

[Note]
Discharge air until the indicator falls and stops at the
bottom.

(11) P ush in the connector of air leak tester and rotate it

counterclockwise to remove the air leak tester. Do not
detach the leak tester connector from the endoscope when
fully immersed.

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 Chapter 7 Cleaning

7.4.3 Inspecting Cleaning Brushes

Check that both cleaning brushes are free from deterioration or damage before using them.
If any abnormality is found, replace the brush with a new one.

(1) Confirm the bristles and the metal tip are securely in place
for the channel cleaning brushes and the valve cleaning Shaft
brush.

Bristles
(2) Check for loose or missing bristles.

(3) Check for bends, scratches and other damage to shaft.

(4) Check for debris on shaft and/or in bristles of brush.

Bristles

Shaft

7.4.4 Cleaning Surface of Endoscope

Check that both cleaning brushes are free from deterioration or damage before using them.
If any abnormality is found, replace the brush with a new one.

(1) Immerse endoscope in fresh detergent solution.

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 Chapter 7 Cleaning

(2) W
 ipe the entire surface of endoscope with a clean lint-free
cloth in the detergent solution.

(3) Brush the distal end of endoscope including forceps

channel, the objective lens, and the light guides with
soft toothbrush or valve cleaning brush for 10 seconds,
respectively.
Check if there is patient debris or material on the distal
end of endoscope. If any debris is found, completely
remove by brushing/cleaning.

(4) Brush the metallic ring and the inside of the LG connector
(shown in arrow in the figure at right) with the valve
cleaning brush or soft toothbrush.
Afterwards, flush the detergent solution to remove any air
bubbles on the surfaces.

(5) Brush the main body of the EVE connector, the connecting
part with the cap and the connecting part of the belt
jointing the cap with the valve cleaning brush (shown in
arrow in the figure at right).
Afterwards, flush the detergent solution to remove any air
bubbles on the surfaces.

(6) Brush the surfaces, and inside the crevices of all rotating
components of the angle lever (shown in arrow in the
figure at right) with the valve cleaning brush.
Afterwards, flush the detergent solution to remove any air
bubbles on the surfaces and inside crevices of the rotating
parts.

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 Chapter 7 Cleaning

7.4.5 Brushing Instrument/Suction Channel and Channel Ports

All subsequent brushing steps should be performed when the endoscope is fully immersed
in detergent solution.

[Note] Only FUJINON/FUJIFILM-brand cleaning brushes are recommended because

non-FUJINON/FUJIFILM brushes have not been validated for their effectiveness.

(1) Perform the following steps (2) to (3) at least three times
until all debris has been removed from the valve cylinder
and channel port.

(2) Insert the valve cleaning brush into the suction valve
cylinder until it can advance no further and rotate the
brush once.

(3) Pull it out carefully, and clean bristles with fingertips in

the detergent solution.

(4) Brush the outer side of metal fittings of suction valve with
the valve cleaning brush.

(5) Perform the following steps (6) to (7) three times at least
until no stain or the like is found on the cleaning brush.

(6) Insert the valve cleaning brush into forceps inlet until it
can advance no further and rotate the brush once.

(7) Carefully remove it, and using one's fingertips clean the
bristles of the brush in the detergent solution.

(8) Brush the outer side of metal fittings of forceps inlet with
the valve cleaning brush.

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 Chapter 7 Cleaning

(9) Perform the following steps (10) to (12) at least three

times until no debris is found on the cleaning brush.

(10) Insert a long channel cleaning brush from forceps inlet

into the instrument channel until it reaches the distal end
of endoscope, while the endoscope remains immersed in
detergent solution.

(11) Using one’s fingertip, wipe clean the bristles of the

cleaning brush before withdrawing the brush back into the
channel. And pull it out of forceps inlet carefully.

(12) Clean the bristles of cleaning brush with the detergent

solution again after removing it.

(13) Perform the following steps (14) to (16) at least three

times until no debris is found on the cleaning brush.

(14) Insert a short channel cleaning brush into the inlet of the
suction valve [Note].

(15) Remove the brush from the inlet of suction valve carefully.

(16) Clean the bristles of cleaning brush with one’s fingertips

in the detergent solution.

[Note]
The insertion length of a short channel cleaning brush
varies with the model of endoscope.
Insert about 250 mm (9.84 in.) or more.

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 Chapter 7 Cleaning

7.4.6 Connecting Cleaning Adapter Kit CA-500C

(1) Ensure that the cleaning adapter kit is fully assembled by

Tube for suction channel
connecting the tube for the suction channel, the syringe,
and the valve adapter as shown in the right figure. 3 way valve

The valve adapter and the tube are connected with a Syringe
luer-connector. Luer-connector

[Note]
Before using cleaning adapter kit, ensure that there are Weight Valve adapter
no abnormalities including any deterioration, breakage, Forceps Inlet Cleaning Adapter (with a Cap)
disconnected channel tube, leak from channel tube or
injection failure due to clogging. If any abnormality is
found, replace it with a new one.

[Note]
Prepare a 30 mL luer-lock or luer-slip syringe.

(2) Connect the valve adapter into the suction valve cylinder
of the endoscope. Align the indicator (dimple) of the
valve adapter with the indicator in the operation portion
of endoscope, and rotate the valve adapter clockwise to
secure it.

(3) Attach the forceps inlet cleaning adapter, by grasping

b a
the forceps inlet cleaning adapter as shown in the figure
at right. Place the forceps inlet cleaning adapter on the
forceps inlet of endoscope, and slide the adapter from
“a” to “b” while applying pressure onto the adapter
as illustrated in the figure at right. Confirm that the
attachment is secure after releasing the forceps inlet
cleaning adapter.

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 Chapter 7 Cleaning

[Note]
If the forceps inlet cleaning adapter can not be installed,
confirm the pin on the backside of forceps inlet cleaning
adapter is in the position shown in the figure at the right.
If not, change the position of the pin by sliding it while
pushing the forceps inlet joint.

Forceps inlet joint Pin

7.4.7 Cleaning of Endoscope

[Note] As an alternate to manual flushing via a syringe, portable flushing devices intended
for endoscope channel purging may be available. Follow the manufacturer's
instructions for set-up, channel connections/adaptations and recommended flushing
times to deliver desired flushing volumes of fluid.

(1) The cap of the forceps inlet cleaning adapter must be

closed. Attach the syringe to 3-way valve of cleaning
adapter kit.

(2) Immerse the weight of cleaning adapter kit in the detergent

solution. Inject 100 mL of the detergent solution with a
Weight
syringe as shown in the figure at right until no bubbles
come out of the distal end of instrument channel.
Detergent solution
[Note]
When the plunger on the syringe is pulled back, detergent
is aspirated up through the weighted intake into the
syringe. When the plunger is pushed forward, solution
is expelled from the syringe and injected into the valve
adapter.

(3) Open the cap of the forceps inlet cleaning adapter. Inject
100 mL of the detergent solution with a syringe until no
bubbles come out of the distal end of instrument channel.

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 Chapter 7 Cleaning

(4) Detach the cleaning adapter from the endoscope, referring

to and following “7.4.6 Connecting Cleaning Adapter Kit
CA-500C” in reverse order. Immerse the endoscope in the
detergent solution, and wipe the outside of the endoscope
with clean lint-free cloth in the detergent solution.

(5) Ensure that the endoscope and cleaning adapter kit

are completely immersed in the detergent solution in
accordance with the usage conditions recommended by
the detergent solution's manufacturer. Close the basin
to prevent the vaporization of detergent solution. If
necessary, position the LG connector on top of the flexible
portion of endoscope to ensure that the scope remains
submerged as shown in the figure at right.

(6) Remove endoscope and cleaning adapter kit from the

detergent solution so that the detergent solution flows out
of the channel and adapter.

Attach the cleaning adapter kit again, pull the weight out
of the detergent solution and flush 50 mL of air into the
forceps inlet in order to discharge remaining detergent
solution.
Close the cap of the forceps inlet cleaning adapter. Flush
200 mL of air into the suction channel.

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 Chapter 7 Cleaning

7.4.8 Rinsing Endoscope

CAUTION
After cleaning, thoroughly remove all detergent residue as per the
provided instructions that follow to prevent the potential for inadvertent
dilution or adulteration of the liquid chemical germicide used in
subsequent steps.

Thoroughly rinse any remaining detergent with potable water

completely after the cleaning process.

(1) Using potable water, fill a basin of adequate size to

completely immerse the endoscope.

(2) Immerse endoscope and cleaning adapter kit in the potable

water, then rinse while gently shaking.

(3) Wipe and clean their externals with a clean lint-free cloth
to eliminate air bubbles completely.

[Note]
All subsequent steps should be performed when endoscope
is fully immersed in potable water.

(4) Attach the cleaning adapter kit to endoscope, referring to

“7.4.6 Connecting Cleaning Adapter Kit CA-500C” for
the attaching method. The cap of the forceps inlet cleaning
adapter must be closed.

(5) Immerse the weight of cleaning adapter kit in the potable

water. Flush 200 mL of the potable water with a syringe as
shown in the right figure until no bubbles come out of the
distal end of the instrument channel.

Potable water

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 Chapter 7 Cleaning

(6) Open the cap of forceps inlet cleaning adapter.

(7) Immerse the weight of cleaning adapter kit in the potable

water. Flush 200 mL of the potable water with a syringe
until no bubbles come out of the channel of forceps inlet
cleaning adapter.

(8) Remove endoscope and cleaning adapter kit from the

potable water so that the potable water might drain away
from them.

(9) Close the cap of the forceps inlet cleaning adapter. Flush
air with a syringe until the potable water is completely
exhausted. Next, open the cap of forceps inlet cleaning
adapter and flush air with a syringe until the potable water
is completely drained.

(10) Detach the cleaning adapter kit from the endoscope.

(11) Wipe the potable water that remains on the surface of

endoscope and the cleaning adapter kit with a clean
lint-free cloth.

(12) Inspect the endoscope and visually confirm there is no

remaining debris. If debris remains, repeat these cleaning
procedures.

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 Chapter 8 High-Level Disinfection

This chapter describes FUJIFILM recommendations for achieving

high-level disinfection.
Perform high-level disinfection after endoscope has been thoroughly
pre-cleaned and manually cleaned as per instructions provided.

[Note] F lexible bronchoscope models identified in this manual are

considered semi-critical devices which require at least high-level
disinfection.

8.1 Methods of High-Level Disinfection............................8-2

8.2 Conditions of High-Level Disinfection.........................8-3
8.3 High-Level Disinfection of Endoscope.........................8-4
8.3.1 High-Level Disinfection of Endoscope.............8-4
8.4 Rinsing of Endoscope....................................................8-6
8.5 Cleaning and/or High-Level Disinfection Using an
Automated Endoscope Reprocessor (AER)..................8-9
8.5.1 Leak Testing.......................................................8-9
8.5.2 Brushing.............................................................8-9
8.5.3 Channel Patency.................................................8-9

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 Chapter 8 High-Level Disinfection

Chapter 8 High-Level Disinfection

8.1 Methods of High-Level Disinfection

CAUTION
These endoscopes are heat-sensitive devices which cannot withstand
high temperatures associated with steam sterilization.

Prior to high-level disinfection, these instruments must be pre-cleaned and manually cleaned in
accordance with Sections 6.5 and 7.4.

Table 8.1 Applicable methods of cleaning and high-level disinfection/sterilization for endoscope and accessories
Cleaning methods Method of high-level disinfection/sterilization
Detergent Ultrasonic High-level ETO gas
Autoclave
cleaning cleaning disinfection sterilization
Endoscope Yes No No Yes [Note 1] Yes [Note 2]
Cleaning brush [Note 3] Yes Yes [Note 4] No Yes Yes
Carrying case No No No No No
Cleaning adapter kit Yes No Yes Yes Yes
[Note 1] Follow “8.2 Conditions of High-Level Disinfection.”
[Note 2] Follow “9.1 Conditions of Ethylene Oxide (ETO) Gas Sterilization.”
[Note 3] FUJINON/FUJIFILM cleaning brushes only are recommended. For non-FUJINON/FUJIFILM brushes,
contact the original manufacturer.
[Note 4] Use an ultrasonic cleaning unit specialized for medical accessories.

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 Chapter 8 High-Level Disinfection

8.2 Conditions of High-Level Disinfection

Legally marketed 2.4 to 3.5% [Note] glutaraldehyde solutions can be used with FUJIFILM
endoscopes for high-level disinfection when used in accordance with the manufacturer’s
instructions. Contact your local FUJIFILM dealer for names of compatible high-level
disinfectant glutaraldehyde solutions.

[Note] United States (U.S.A.) only

Refer to the high-level disinfectant solution manufacturer’s instructions regarding

preparation, use and exposure conditions.

Check the expiry date of high-level disinfectant solution before use. Do not use a high-level
disinfectant solution beyond its expiration date.
Do not use a high-level disinfectant solution whose efficacy is not sufficient. Check the
high-level disinfectant solution’s efficacy before use according to the manufacturer’s
recommendation (such as using a test strip), referring to the instructions of high-level
disinfectant solution.

Ensure that the endoscope, adapters and accessories are completely immersed in a
high-level disinfectant solution during the high-level disinfection process. If the endoscope
is connected to the cleaning adapter kit and/or they are not completely immersed, high-level
disinfection of all processed items may not be achieved.

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 Chapter 8 High-Level Disinfection

8.3 High-Level Disinfection of Endoscope

8.3.1 High-Level Disinfection of Endoscope

(1) Confirm the waterproof cap is attached securely to the

EVE connector, and the suction button and forceps valve
are removed.

(2) Fill the high-level disinfectant solution in the basin at

the temperature and concentration recommended by the
high-level disinfectant solution’s manufacturer.

(3) Immerse endoscope in the high-level disinfectant solution.

(4) Attach the cleaning adapter kit to endoscope, referring to

“7.4.6 Connecting Cleaning Adapter Kit CA-500C” for
the attaching method. The cap of the forceps inlet cleaning
adapter must be closed.

[Note]
Prepare a 30 mL luer-lock or luer-slip syringe.

(5) Immerse the weight of cleaning adapter kit into the

high-level disinfectant solution. Flush at least 100 mL
high-level disinfectant solution with a syringe as shown in
the figure at right until no air bubbles come out of the distal
end of the instrument channel.

[Note]
When the plunger on the syringe is pulled back, high-level
High-level disinfectant
disinfectant is aspirated up through the weighted intake solution
into the syringe. When the plunger is pushed forward,
solution is expelled from the syringe and injected into the
valve adapter.

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 Chapter 8 High-Level Disinfection

(6) Open the cap of the forceps inlet cleaning adapter. Flush
at least 100 mL high-level disinfectant solution with a
syringe until no air bubbles come out of the instrument
channel.

(7) Detach the cleaning adapter kit from endoscope, referring

to and following “7.4.6 Connecting Cleaning Adapter
Kit CA-500C” in reverse order. Immerse endoscope in
the high-level disinfectant solution, and wipe the outside
of endoscope off with sterile gauze in the high-level
disinfectant solution to remove air bubbles completely.

(8) Ensure that the endoscope and the cleaning adapter kit
are completely immersed in the high-level disinfectant
solution in accordance with the usage conditions
recommended by the high-level disinfectant solution’s
manufacturer. Close the basin to prevent the vaporization
of high-level disinfectant solution. If necessary, position
the LG connector on top of the flexible portion of
endoscope to ensure that the scope remains submerged as
shown in the figure at right.

(9) Remove endoscope and cleaning adapter kit from the

high-level disinfectant solution so that the high-level
disinfectant solution may flow out from them.

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 Chapter 8 High-Level Disinfection

8.4 Rinsing Endoscope

CAUTION
After high-level disinfection, thoroughly remove all disinfectant solution
residue as per the provided rinsing instructions that follow to prevent
patient injury from contact with the residual disinfectant solution.

(1) Fill a basin with sterile water to completely immerse the

entire endoscope.

(2) Immerse endoscope and cleaning adapter kit in the sterile

water. Wipe outside of endoscope with sterile gauze in
sterile water.

(3) Rinse well by gently shaking all items in water.

(4) Attach the cleaning adapter kit to endoscope, referring to

“7.4.6 Connecting Cleaning Adapter Kit CA-500C” for
the attaching method. The cap of the forceps inlet cleaning
adapter must be closed.

(5) Immerse the weight of cleaning adapter kit in the sterile

water. Flush sterile water, at least 200 mL, with a syringe
as shown in the right figure until no air bubbles come out
of the distal end of endoscope.

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 Chapter 8 High-Level Disinfection

(6) Open the cap of the forceps inlet cleaning adapter.

(7) Immerse the weight of cleaning adapter kit in sterile water.

Flush sterile water, at least 200 mL, with a syringe as
shown in the right figure until no bubbles come out of the
instrument channel.

(8) Pull endoscope and cleaning adapter kit out of the sterile
water so that the sterile water may flow out of them.

(9) Close the cap of forceps inlet cleaning adapter. Flush

air with a syringe until the sterile water is completely
exhausted. Next, open the cap of forceps inlet cleaning
adapter and flush air with a syringe until the sterile water
is completely exhausted.

[Note]
Instead of manually injecting air via syringe through all
internal channels, compressed air 200 to 230 kPa (29 to
33.3 psi or 1500 to 1725 mmHg) may be used to purge all
channels.

(10) Using a syringe flush 30 mL of 70% Ethanol or 70%

Isopropyl Alcohol into the suction valve cylinder of
endoscope to help evaporate residual moisture in the
channels. Confirm that it flows out from the distal end of
endoscope.

[Note]
As with other chemicals, handle Ethanol or Isopropyl
Alcohol with care and use it as per local guidelines.

(11) Open the cap of forceps inlet cleaning adapter.

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 Chapter 8 High-Level Disinfection

(12) Using a syringe flush 30 mL of 70% Ethanol or 70%

Isopropyl Alcohol into the suction valve cylinder of
endoscope. Confirm that it flows out from the distal end of
endoscope.

[Note]
An alcohol rinse followed by forced air is important to
facilitate drying of endoscope surfaces, especially all
internal channels.

(13) Close the cap of forceps inlet cleaning adapter. Flush air
into the suction valve cylinder with a syringe, and confirm
that 70% Ethanol or 70% Isopropyl Alcohol has been
completely removed or evaporated from the endoscope.
Next, open the cap of forceps inlet cleaning adapter.
Flush air to the instrument channel, and confirm that 70%
Ethanol or 70% Isopropyl Alcohol has been completely
removed or evaporated from the endoscope.

(14) Detach the cleaning adapter kit from the endoscope.

(15) Detach the waterproof cap from the end of EVE connector.

[Note]
The EVE connector and waterproof cap should be
completely dry before use and storage. To prevent
residual water from dripping out of the cap onto electrical
contacts, position the connector so the electrical contacts
face downward and away from potential dripping fluid.

No residual water/fluid should remain inside the connector,

near the electrical contacts or within the seam leading to
the internal connection mechanism.

(16) Wipe off the EVE connector with sterile gauze.

(17) Wipe the surface of the endoscope and the cleaning

adapter kit with sterile gauze.

(18) Dry the endoscope and the cleaning adapter kit thoroughly.
[For example] After a final alcohol rinse, apply forced
air for at least 30 seconds using a compressor or medical
grade air supply to remove the remaining moisture on
external surfaces and inside the channels of the endoscope.

(19) Store them according to Chapter 11 “Storage.”

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 Chapter 8 High-Level Disinfection

8.5 Cleaning and/or High-Level 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 should check with each AER manufacturer to confirm
they have data to support their reprocessing claims for FUJIFILM
endoscopes and removable endoscope components, such as valve
mechanisms. Inadequate device-specific instructions and/or non-
validated AER recommendations could result in unsuccessful cleaning
and/or disinfection which may increase risks to patient safety.

For information on efficacy of cleaning and high-level disinfection, consult the Automated
Endoscope Reprocessor (AER) manufacturer.
Prior to high-level disinfection, all endoscopes must be pre-cleaned and manually cleaned
in accordance with Sections 6.5 and 7.4.

8.5.1 Leak Testing

“7.4.2 Leak Testing”

[Note] FUJIFILM does not test non-FUJINON/FUJIFILM leak testing devices including
those installed in AERs or standalone automated systems. Check with each
AER manufacturer to confirm their specific claims including compatibility with
FUJIFILM endoscopes.

8.5.2 Brushing

Applicable channels of FUJIFILM endoscopes should be manually brushed clean as per the
instructions contained in this operation manual, before attempting high-level disinfection.

“7.4.4 Cleaning Surface of Endoscope”

“7.4.5 Brushing Instrument/Suction Channel and Channel Ports”

8.5.3 Channel Patency

Prior to automated reprocessing, ensure that all internal endoscope channels are “open” and
unclogged. Certain AERs with channel monitoring capability may negate this requirement.
Check with each AER manufacturer for their specific claims regarding channel monitoring.

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 Chapter 8 High-Level Disinfection

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 Chapter 9 ETO Gas Sterilization

This chapter describes FUJIFILM recommendations for ethylene oxide gas

sterilization.

9.1 Conditions of
Ethylene Oxide (ETO) Gas Sterilization.......................9-2
9.2 ETO Gas Sterilization...................................................9-4
9.2.1 Preparation for ETO Gas Sterilization...............9-4
9.2.2 Drying................................................................9-6
9.2.3 ETO Gas Sterilization........................................9-7

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 Chapter 9 ETO Gas Sterilization

Chapter 9 ETO Gas Sterilization

WARNING
Ensure that all instrument surfaces are dry before attempting ETO gas
sterilization. Failure to do so can result in inadequate sterilization.

CAUTION
Aeration procedures must be performed immediately after ETO gas
sterilization in order to remove potentially harmful gas residuals from
contacting patients. No or incomplete aeration can potentially harm
patients.

CAUTION
These endoscopes are heat-sensitive devices which cannot withstand
high temperatures associated with steam sterilization.

Endoscope model EB-530P can be sterilized via ethylene oxide gas per the recommendations
that follow.
Prior to sterilization, these instruments must be pre-cleaned and manually cleaned in
accordance with Sections 6.5 and 7.4 and then thoroughly dried.

9.1 Conditions of Ethylene Oxide (ETO) Gas Sterilization

Efficacy of sterilization is influenced by many factors including but not limited to packaging
of non-sterile items, positioning and placement in the sterilizer, and load capacity. Check
efficacy of sterilization using biological and chemical indicators. Use only legally marketed
sterilizers and sterilization accessories.

Also, follow sterilization guideline provided by health service authorities, public institutions
and other facilities, as well as the operation manual of the sterilizer.

In order to successfully sterilize FUJIFILM endoscopes and accessories by ETO gas

sterilization, use the parameters described in Table 9.1.

If chemicals and/or conditions other than those listed in Table 9.1 are to be used, ensure that
appropriate sterilization efficacy validation studies have been performed.

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 Chapter 9 ETO Gas Sterilization

Table 9.1 100% ETO gas

Sterilization Aeration

ETO gas
Parameter Temperature Humidity Exposure time Time
concentration

0.735 mg/cm3
Value 55ºC (131ºF) 60%RH 90 minutes 12 hours 55ºC (131ºF)
(735mg/liter)

Table 9.2 Applicable methods of cleaning, high-level disinfection and sterilization for endoscope and accessories
Cleaning methods Method of high-level disinfection/sterilization
Detergent Ultrasonic High-level ETO gas
Autoclave
cleaning cleaning disinfection sterilization
Endoscope Yes No No Yes [Note 1] Yes [Note 2]
Cleaning brush [Note 3] Yes Yes [Note 4] No Yes Yes
Carrying case No No No No No
Cleaning adapter kit Yes No Yes Yes Yes
[Note 1] Follow “8.2 Conditions of High-Level Disinfection.”
[Note 2] Follow “9.1 Conditions of Ethylene Oxide (ETO) Gas Sterilization.”
[Note 3] FUJINON/FUJIFILM cleaning brushes only are recommended. For non-FUJINON/FUJIFILM brushes,
contact the original manufacturer.
[Note 4] Use an ultrasonic cleaning unit specialized for medical accessories.

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 Chapter 9 ETO Gas Sterilization

9.2 ETO Gas Sterilization

CAUTION
Install ventilation adapter before applying ETO gas sterilization. Failure
to do so can result in endoscope damage.

Remove ventilation adapter after aeration. Never soak the endoscope

with the ventilation adapter attached, or fluid invasion may severely
damage the endoscope.

9.2.1 Preparation for ETO Gas Sterilization

(1) Ensure that the endoscope is dry by following these steps

below:
Prepare the basket or the container which has been
high-level disinfected. Put sterile gauze to the distal end,
the suction valve, and forceps inlet of endoscope so that
the liquid or the like should not fly in all directions.

(2) Attach the cleaning adapter kit to endoscope, referring to

“7.4.6 Connecting Cleaning Adapter Kit CA-500C.” The
cap of forceps inlet cleaning adapter must be closed.

[Note]
Prepare a 30 mL luer-lock or luer-slip syringe.

(3) Using a syringe flush 30 mL of 70% Ethanol or 70%

Isopropyl Alcohol into the suction valve cylinder of the
endoscope to help evaporate the moisture in the instrument
channel. Confirm that it flows out from the distal end of
endoscope.

[Note]
As with other chemicals, handle Ethanol or Isopropyl
Alcohol with care and use it as per local guidelines.

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 Chapter 9 ETO Gas Sterilization

(4) Open the cap of forceps inlet cleaning adapter.

(5) Using a syringe flush 30 mL of 70% Ethanol or 70%

Isopropyl Alcohol into the suction valve cylinder of the
endoscope. Confirm that it flows out from the distal end of
the instrument channel.

(6) Close the cap of forceps inlet cleaning adapter. Flush air
into the suction valve cylinder with a syringe, and confirm
that 70% Ethanol or Isopropyl Alcohol has completely
removed from the endoscope.
Next, open the cap of forceps inlet cleaning adapter. Flush
air into the suction valve cylinder, and confirm that 70%
Ethanol or Isopropyl Alcohol has completely removed
from the instrument channel.

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 Chapter 9 ETO Gas Sterilization

9.2.2 Drying

CAUTION
Forced or compressed air should be used after an alcohol rinse to
facilitate drying of the endoscope including all internal channels.
Ensure that all channels are unclogged (unobstructed), and do not
exceed 230 kPa (33.3 psi or 1725 mmHg) air pressure to avoid scope
damage.

(1) Prepare a source of forced or compressed air with filter to

remove impurities/contaminants.

(2) Detach tubes from the port of the valve adapter.

(3) Feed forced air through the instrument channel from the
ports of the valve adapter first and then the forceps inlet
for at least 5 minutes using a pressure of 200 to 230 kPa (29
to 33.3 psi or 1500 to 1725 mmHg). Repeat as necessary
until no fluid/droplets are expelled from the channel.

(4) After detaching the cap from the forceps inlet cleaning
adapter, purge the instrument channel with forced air for at
least 5 minutes. Repeat as necessary until no fluid/droplets
are expelled from the channel.

(5) After detaching the cleaning adapter kit from the

endoscope, apply forced air to the cleaning adapter and all
external scope surfaces including recessed areas, channel
ports, valve cylinders, etc. to remove moisture.

(6) Wipe surfaces of the endoscope and cleaning adapter kit

as necessary with a sterile gauze until dry.

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 Chapter 9 ETO Gas Sterilization

9.2.3 ETO Gas Sterilization

Regarding recommended gas sterilization conditions, refer to Table 9.1.

(1) Connect the ventilation adapter to the ventilation

connector of endoscope.
The ventilation adapter “opens” the endoscope to allow a
balance of internal and external pressures.

(2) Place and seal each item (endoscope with ventilation

adapter, cleaning adapter kit, etc.) into individual
packaging/pouches according to institution protocol
consistent with instructions of the sterilizer manufacturer.

(3) Sterilize them according to the condition of ETO gas

sterilization.

(4) Aerate them after ETO gas sterilization.

Store them with sterile pack in a clean place after aeration.

(5) Open the sterile pack of endoscope with ventilation adapter

before using. Use it after removing the ventilation adapter.

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 Chapter 9 ETO Gas Sterilization

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 Chapter 10 Cleaning and High-Level
Disinfection or Sterilization of
Endoscopic Accessories

This chapter describes the recommendations for cleaning and high-level

disinfection or sterilization of endoscopic accessories.

10.1 Cleaning, High-Level Disinfecting and Sterilizing

Cleaning Brush............................................................10-2
10.1.1 Cleaning Cleaning Brushes..............................10-2
10.1.2 High-Level Disinfecting Cleaning Brushes.....10-3
10.1.3 Sterilizing Cleaning Brushes............................10-4
10.2 Autoclaving Cleaning Adapter Kit CA-500C.............10-4

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 Chapter 10 Cleaning and High-Level Disinfection or Sterilization of Endoscopic Accessories

Chapter 10 Cleaning and High-Level Disinfection or Sterilization of Endoscopic

Accessories

10.1 Cleaning, High-Level Disinfecting and Sterilizing Cleaning Brushes

For operational methods of the ultrasonic cleaning unit/autoclaving unit, follow the
instructions described in each operation manual for the respective units.

10.1.1 Cleaning Cleaning Brushes

(1) Fill a basin with detergent solution prepared according to

the detergent manufacturer's recommendations.

(2) Immerse both cleaning brushes in the detergent solution.

(3) Brush the entire cleaning brush(es) in the detergent

solution using a soft bristled toothbrush.

(4) Wash the bristles of cleaning brushes with one’s fingertips

in the detergent solution for 10 seconds.

(5) Flush 100 mL of detergent solution into all gaps of

cleaning brushes with a syringe in the detergent solution
to completely remove all air bubbles.

(6) Keep the cleaning brushes completely immersed in the

detergent solution for the contact conditions recommended
by the detergent manufacturer, and cover the basin to
prevent the vaporization of detergent solution.

(7) Shake the cleaning brush immersed in the detergent

solution for 2 minutes.

(8) Remove the cleaning brushes from the detergent solution.

(9) Clean the cleaning brushes with an ultrasonic cleaner set

at 33-48kHz for 10 minutes in the detergent solution. Use
a neutral pH, low-forming, medical grade non-abrasive
solution for ultrasonic cleaning according to time,
temperature, concentration recommended by the detergent
solution’s manufacturer.

(10) Fill basin with potable water to completely immerse the

cleaning brushes.

(11) Immerse the cleaning brushes into the potable water, and
rinse them well while gently shaking.

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 Chapter 10 Cleaning and High-Level Disinfection or Sterilization of Endoscopic Accessories

(12) Flush 100 mL of the potable water into all gaps/crevices

of cleaning brushes with a syringe in the potable water to
completely remove air bubbles.

(13) Remove the cleaning brushes from the potable water.

(14) Wipe off the remaining water on the cleaning brushes with
a clean lint-free cloth.
If you find any debris, repeat these procedures.

10.1.2 High-Level Disinfecting Cleaning Brushes

(1) Fill a basin with high-level disinfectant solution prepared

according to the instructions by the high-level disinfectant
solution’s manufacturer to completely immerse the entire
cleaning brushes.

(2) Immerse the entire cleaning brushes in the high-level

disinfectant solution.

(3) Flush the high-level disinfectant solution into all gaps with
a syringe, and wipe the surface with sterile gauze in the
high-level disinfectant solution to remove all air bubbles.

(4) Keep the cleaning brushes immersed in the high-level

disinfectant solution in accordance with the temperature,
concentration and time recommended by the high-level
disinfectant solution’s manufacturer, and cover the basin
to prevent the vaporization of high-level disinfectant
solution.

(5) Remove the cleaning brushes from the high-level

disinfectant solution.

(6) Fill a basin with sterile water to completely immerse the

cleaning brushes.

(7) Immerse the cleaning brushes into sterile water, and rinse
them well while gently shaking. Wipe the surface with
sterile gauze in sterile water.

(8) Flush sterile water into all gaps with a syringe in sterile
water to completely remove air bubbles.

(9) Remove the cleaning brushes from the sterile water.

(10) Wipe off the remaining water on the cleaning brushes with
sterile gauze.

(11) Dry them thoroughly.

(12) Store them according to Chapter 11 “Storage.”

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 Chapter 10 Cleaning and High-Level Disinfection or Sterilization of Endoscopic Accessories

10.1.3 Sterilizing Cleaning Brushes

(1) Dry the cleaning brushes thoroughly after cleaning.

(2) Carry out the ETO gas sterilization of the cleaning brushes
according to steps (2) to (5) in Section 9.2.3 “ETO Gas
Sterilization.”

(3) Store them according to Chapter 11 “Storage.”

10.2 Autoclaving Cleaning Adapter Kit CA-500C

(1) Thoroughly dry the cleaning adapter kit.

“7.4 Manual Cleaning (cleaning in basin)”

(2) Put it in a sterilized pack and seal the pack tightly.

(3) Autoclave the cleaning adapter kit according to the

instructions provided by the manufacturer of the
pre-vacuum steam sterilizer as well as specific sterilization
parameters described in this manual.

For recommended pre-vacuum steam sterilization

parameters, refer to Appendix “Autoclaving Conditions”
in this operation manual.

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 Chapter 11 Storage

This chapter describes the recommendations for storage.

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 Chapter 11 Storage

Chapter 11 Storage

WARNING
Do not store this product in a carrying case. Storage of this product in a
carrying case and subsequent clinical use may increse infection risks.
• Detach removable parts (suction button, forceps valve, etc.) from the endoscope.
• Confirm that all endoscope and component surfaces are dry before storage.
• Hang endoscope in a storage cabinet with the distal end hanging freely.
• Be sure that the insertion portion hangs freely and as straight as possible.

CAUTION
Do not store this product in locations that do not satisfy the storage
conditions. Improper storage may cause damage to this product.
Store this product in a location that satisfies the following conditions.

Transport and Storage Environment

Temperature : -20 to +60°C (-4 to 140°F)
Humidity : 10 to 85%RH (no dew condensation)
Pressure : 70 to 106 kPa (10.2 to 15.4 psia or 525 to 795mmHg)
(within range of atmospheric pressure)
State of flexible portion : Straight, rather than bent, state.
Condition not subjected to external force.
Hung with the control portion up and the suction button
removed.
Keep out of direct sunlight, UV light or X-ray.

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 Appendix

Autoclaving Conditions...........................................Appendix-2
Index........................................................................Appendix-3

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 Appendix

Autoclaving Conditions

The efficacy of autoclaving sterilization is influenced by many factors including but not
limited to packaging of non-sterile items, positioning and placement within the sterilizer,
and load capacity. Check the efficacy of sterilization using biological and chemical
indicators. Use only legally marketed sterilizers and sterilization accessories.
Also, follow the sterilization guideline provided by health service authorities, public
institutions and other facilities, and the operation manual of sterilizer.
Handling a wet package can compromise sterility of the contents. Ideally, use the
autoclave's drying cycle to allow the packages to dry.
Thoroughly dry the objects sterilized by autoclaving before handling them.

FUJINON/FUJIFILM cleaning adapter kit may be sterilized using pre-vacuum steam

sterilization by following the parameters described below.

Recommended pre-vacuum steam sterilization (autoclaving) conditions

Sterilizer type Pre-vacuum
Temperature 132°C (270°F)
Exposure time 4 minutes
Drying time 20 minutes

[Note] The above pre-vacuum steam sterilization (autoclaving) conditions (132°C for
4 minutes) were used in FUJIFILM's validation studies. However, each health
care facility should follow the relevant industry standards, facility-specific
procedures and sterilizer manufacturer's instructions to ensure the adequacy of its
sterilization processes.

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 Appendix

Index

<C>
Caution.................................................................2, 4
Cleaning............................................................... 7-2
Cleaning adapter kit............................................. 7-4
Cleaning brushes......................................... 7-5, 10-2
<E>
Ethylene oxide gas............................................... 9-4
ETO gas sterilization............................................ 9-4
<G>
Gas sterilization.................................................... 9-2
<H>
High-level disinfection......................................... 8-2
<L>
Leak testing.......................................................... 7-7
<S>
Sterilization.......................................................... 9-2
Storage............................................................... 10-2
<U>
Ultrasonic cleaning.............................................. 7-2
<V>
Ventilation adapter............................................... 9-7
Ventilation connector........................................... 9-7
<W>
Warning................................................................2, 4

Appendix-3

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 FUJIFILM Corporation
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan

897N200754B
201203-3.0-DT-US2
FB85A-5 Printed in Japan

EB530P_RM_897N200754B_03_us.indb 4 2020/12/08 15:22:22