PENTAX EG-3870UTK, EG-3670URK Instruction Manual

INSTRUCTIONS FOR USE

Z845 R22EEG 3670URK,

3870UTK.book

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ULTRASOUND UPPER GI VIDEO SCOPES

CURVED LINEAR ARRAY TYPE

EG-3870UTK

RADIAL ARRAY TYPE

EG-3670URK

Intended Use

WARNING

CAUTION

NOTE

Manufacturer
Fabricant

Date of manufacture
Date de fabrication

Authorized representative in the European Community
Représentant autorisé dans l'Union européenne

Serial number
Numéro de série

This is a UDI (Unique Device Identification) code required by Unique Device Identification System designed to adequately identify devices through distribution
and use. The following information is coded in 2D bar code (GS1 Data Matrix).

- (01) GS1 Commodity code (Global Trade Item Number)

- (11) Production date

- (21) Serial number
Ce code d’UDI (Unique Device Identification, ou identification unique des dispositifs médicaux) est requis par Unique Device Identification System pour identifier
correctement les dispositifs lors de leur distribution et leur utilisation. Les informations suivantes sont contenues dans le code-barres 2D (GS1 Data Matrix) :

- (01) Code de marchandise GS1 (code article international)

- (11) Date de production

- (21) Numéro de série

Attention, consult instructions for use
Attention, consulter le manuel d’utilisation

Type BF applied part
Partie appliquée de type BF

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PENTAX ultrasound endoscopes are intended to provide optical and ultrasonic visualization of (via a video monitor), and
therapeutic access to, the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and
subsystems: Esophagus, Stomach and Duodenum.
These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in
adult and pediatric patient populations.
NEVER use these endoscopes for any purpose other than that for which they have been designed.
These video endoscopes contained in this Instructions for Use can be used with PENTAX video processors EPK-i5000, EPK-i,
EPK-100p, EPK-1000, or EPK-i7000/i7000(A). See the addendum sheet No.370.

Notes

Read this Instructions for Use (IFU) before operating and save this IFU for future reference. Failure to read and thoroughly
understand the information presented in this IFU, as well as those developed for ancillary endoscopic equipment and
accessories, may result in serious injury including infection by cross contamination to the patient and/or user. Furthermore, failure
to follow the instructions in this IFU may result in damage to, and/or malfunction of, the equipment.
This IFU describes the recommended procedures for inspecting and preparing the equipment prior to its use and for the
reprocessing and maintenance of the equipment after its use. It does not describe how an actual procedure is to be performed,
nor does it attempt to teach the beginner the proper technique or any medical aspects regarding the use of the equipment.
It is the responsibility of each medical facility to ensure that only well educated and appropriately trained personnel, who are competent
and knowledgeable about the endoscopic equipment, antimicrobial agents/processes and hospital infection control protocol be
involved in the use and the reprocessing of these medical devices. Known risks and/or potential injuries associated with flexible
endoscopic procedures include, but are not limited to, the following: perforation, infection, hemorrhage, burns and electric shock.
Current infection control guidelines require that gastroscopes and other semi-critical medical devices, that normally come into
contact with intact mucous membranes, such as in the gastrointestinal tract, must at least be high-level disinfected before clinical
use. Only the users can determine if an instrument has undergone appropriate infection control procedures prior to each clinical
use. It must be recognized that infection control practices involve many complex and often controversial issues which are
constantly evolving. PENTAX strongly recommends that users remain informed of the latest federal and local regulations, and
encourages users to follow infection control guidelines developed by various organizations for health care professionals.
If you have any questions regarding any of the information in this IFU or concerns pertaining to the safety and/or use of this
equipment, please contact your local PENTAX service facility.

Sterility Statement

The instruments identified in this IFU are reusable medical devices. Since they are packaged non-sterile, they must be high-level disinfected
or sterilized BEFORE initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high­level disinfection or sterilization process. After servicing, these endoscopes and those components must be reprocessed prior to clinical use.

Contraindication

Please consult regional and national health authority recommendations and requirements regarding protocols to follow in order to
reprocess and/or destroy endoscopes that will be used or have been determined to have been used (post procedure) on patients
afflicted with Creutzfeldt-Jacob Disease (CJD or vCJD).

Conventions

Throughout this IFU, the following conventions will be used to indicate a potentially hazardous situation which, if not avoided;

: could result in death or serious injury.

: may result in minor or moderate injury or property-damage.

: may result in property-damage. Also, advises owner/operator about important information on the use of this

equipment.

Prescription Statement

Federal (U.S.A) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional

Symbols on Marking
Symbols distinctifs

TABLE OF CONTENTS

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1. NOMENCLATURE AND FUNCTION ................................................................................................ 1

1-1. Video Endoscope .......................................................................................................... 1

1-2. Accessories ................................................................................................................3

1-3. Video Processor ........................................................................................................... 4

2. PREPARATION AND INSPECTION FOR USE ..................................................................................... 7

2-1. Inspection of the Video Processor ..................................................................................... 7

2-2. Inspection of Endoscope ................................................................................................. 9

2-3. Preparation of Ultrasound Scanning Unit ............................................................................21

2-4. Preparation before the Examination ..................................................................................21

2-5. Preparation just before Insertion of Endoscope ....................................................................24

3. DIRECTIONS FOR USE ............................................................................................................26

3-1. Pretreatment ..............................................................................................................27

3-2. Insertion and Withdrawal ...............................................................................................27

3-3. Precise Accessory Control (For EG-3870UTK only) .................................................................31

3-4. Biopsy ......................................................................................................................32

4. CARE AFTER USE .................................................................................................................37

4-1. Internal Channels of PENTAX endoscopes ...........................................................................38

4-2. Reprocessing System ....................................................................................................42

4-3. Endoscopes ...............................................................................................................44

4-3-1. Pre-Cleaning .....................................................................................................44

4-3-2. Leakage Testing ................................................................................................46

4-3-3. Cleaning ..........................................................................................................46

4-3-4. High-Level Disinfection ........................................................................................65

4-3-5. Sterilization ......................................................................................................76

4-4. Endscopic Accessory Instruments (EAIs) and Endoscope Components .........................................78

4-4-1. Cleaning ..........................................................................................................78

4-4-2. High-Level Disinfection ........................................................................................79

4-4-3. Sterilization ......................................................................................................81

4-5. Water Bottle Assembly ..................................................................................................82

5. POST REPROCESSING ............................................................................................................83

5-1. Servicing ...................................................................................................................84

5-2. Care and Maintenance Tips ............................................................................................86

SPECIFICATION....................................................................................................................

89

1. NOMENCLATURE AND FUNCTION

RIGHT/LEFT
ANGULATION LOCK KNOB:

Functions similar to Up/Down
Angulation Lock.

UP/DOWN ANGULATION
CONTROL KNOB

SUCTION/BALLOON SUCTION VALVE (OF-B171)

Depress to remove fluids or air through
the instrument channel or
aspirate air or water from the balloon.
For details, refer to “6) Inspection of Suction
Mechanism (on page 17)”.

Push to freeze an image.

REMOTE BUTTON 1

REMOTE BUTTON 2

Push to activate the hardcopy
system that was selected between
“File” and “HARD COPY”.

When this lever is in the “F” position,
turned clockwise, the bending section
moves freely. When turned
counterclockwise, the bending
section becomes progressively
more stabilized.

Push to change the intensity of
enhancement that was previously
assigned.

REMOTE BUTTON 4

REMOTE BUTTON 3

Push to activate the VCR
for recording live
procedures.

STRAIN RELIEF BOOT

AIR/WATER/BALLOON FEEDING VALVE (OF-B172):

To control air/water delivery.
For details, refer to 4) Inspection of Air/Water/Balloon
Feeding Mechanism (on page 14)”.

CONTROL BODY

INLET SEAL

INSTRUMENT CHANNEL INLET

For introduction of biopsy forceps
and other accessories.

STRAIN RELIEF BOOT

CONTROL BODY

(EG-3870UTK)

INLET CAP (OE-B3)

(EG-3870UTK)

ELEVATOR WIRE CHANNEL
CLEANING INLET

The elevator wire and the
elevator wire channel can
easily be reprocessed with
an appropriate solution
administered through
this inlet.

STRAIN RELIEF BOOT

SCANNING UNIT CONNECTOR CABLE

(EG-3870UTK) ELEVATOR CONTROL LEVER

To guide and direct forceps and other accessories.

UMBILICAL CORD

UP/DOWN ANGULATION
LOCK LEVER:

RIGHT/LEFT ANGULATION CONTROL KNOB

NOTE:

Function of each button depends upon the processor. The
function can be changed. For more details, refer to the
Instructions for Use supplied with the processor. The table
below shows the factory setting.

EPK-i5000

EPK-1000 EPK-100p

Remote
Button

1 Freeze Freeze Freeze Freeze

Remote

Button

2 P

eripheral Hard Copy

Remote

Button

3 AV

E/PEAK VCR

VCR (for NTSC)

Enhance

Enhance (for PAL)

Remote

Button

4 Enhance Enhance

Enhance (for NTSC)

AVE/PEAK

AVE/PEAK (for PAL)

EPK-i,
EPK-i7000,

Hard Copy

Hard Copy

EPK-i7000(A)

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

1-1. Video Endoscope

– 1 –

STRAIN RELIEF BOOT

DISTAL END

BENDING SECTION

INSERTION TUBE

SCANNING UNIT CONNECTOR
LOCK LEVER

Securely locks the scanning
unit connector of the PENTAX
endoscope into the
scanning unit (FUJIFILM
Healthcare Corporation) to
ensure proper contact with
and functioning of
the electronic circuitry.

SCANNING UNIT CONNECTOR

SCANNING UNIT CONNECTOR SOAKING CAP
(Model OE-U1)

VENTILATION CAP RED
(Model OF-C5)

AIR/WATER PORT
To connect feeding tube from water

bottle assembly.

PVE CONNECTOR

Can be rotated within
a 180° range.

Provides venting of endoscope interior to equalize
internal and external pressures. This cap must be
removed before immersion.

PVE SOAKING CAP
(Model OE-C9)

VENTING CONNECTOR

Accepts “RED” VENTILATION Cap
and Leakage Tester.

STRAIN RELIEF
BOOT

ELECTRICAL
CONTACTS

FEEDBACK TERMINAL
NOT USED TO
THESE SCOPES

LIGHT GUIDE PLUG
Transmits light from
light source to distal
end of endoscope.

SUCTION NIPPLE
For attachment to
external suction
source.

NOTE:

To avoid damaging the endoscope, do NOT
twist, rotate or bend excessively any of the
strain relief boots.
The strain relief boots of endoscopes with
split (bifurcated) umbilical cord should
never be grasped together or pressed
firmly against each other to avoid the
potential for scope damage in these
areas.

NOTE:

Function of each button can be changed by the
processor. For more details, refer to the
Instructions for Use provided with the processor.

Immediately after use, the metal light guide plug and the electrical contacts/pins of the
endoscope may be HOT. To avoid burns, do NOT touch these areas immediately after use.
For safer handling after a procedure, grasp the PVE connector housing.

NOTE:

Ensure that the soaking caps have been securely attached (by properly rotating them) to
prevent the caps from coming off during reprocessing. Failure to securely attach the soaking
caps can result in endoscope damage.

WARNING:

CAUTION:

Do NOT immerse it without the soaking cap.

CAUTION:

Prior to immersion this cap must be attached
to the scanning unit connector.

NOTE:

See important separate section regarding
the use of this cap! (p.42, 43, 46, 65, 77)

NEVER perform electrosurgery with these
endoscopes.

WARNING:

This cap must be securely atached to the
electrical contact before immersion.

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– 2 –

1-2. Accessories

CAUTION:

(4)

(5)

(3)

(2)

(1)

(2)

(1)

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

1) Biopsy Forceps

Figure 1.1

2) Aspiration Needle (For EG-3870UTK)

Figure 1.2

3) Channel Cleaning Brush

(1) Enhanced Flexible

Portion
(2) Flexible Shaft
(3) Grip
(4) Handle
(5) Cups/Jaws

(1) Needle
(2) Flexible Shaft
(3) Handle
(4) Proximal End
(5) Luer Lock(Female)

(1) Back End (Blue)
(2) (CS6021T)

Figure 1.3

This brush is provided non-sterile for one time use. NEVER reuse this

disposable brush on more than one instrument.

4) Cylinder Cleaning Brush for Air/Water/Balloon feeding Cylinder and

Suction/Balloon Suction Cylinder

(1) (2)

(3)

Figure 1.4

• Because of the effect that accessories used through the
instrument channel of the endoscope can have on the
performance of the endoscope itself, it is strongly
recommended that PENTAX accessories be used with PENTAX
endocopes. If a unique or highly specialized accessory is
available from another source, the accessory manufacturer
should be consulted to confirm compatibility with PENTAX
endoscopes before use.

• Maximum outer diameter of an endoscopic accessory
instrument must be at least 0.2 mm less than the specified
instrument channel diameter in PENTAX endoscopes. Working
length of an endoscopic accessory instrument should be
approximately 30 cm longer than the endoscope working
length.

(1) Large Bristle
(2) Small Bristle
(3) (CS-C9S)

– 3 –

NOTE:

• Depending upon country and/or local PENTAX service facility,

NOTE:

WARNING:

NOTE:

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each PENTAX endoscopic accessory may be an optional
accessory.

• For patient contact endoscopic accessories, follow the specific
and detailed instructions on use, care and maintenance
supplied with each product.

• To confirm the exact condition of any new accessory device,
check the labeling/packaging accompanying the product.
Each label/package should clearly identify the contents as
either sterile or non-sterile.

1-3. Video Processor

Please read the Instructions for Use supplied with the processor.

Do not install, operate or store electro-medical equipment in a
dusty environment. Accumulation of dust within these units may
cause malfunction, smoke, or ignition.

Do NOT use the new PENTAX OS-H4 water bottle cap with the
older OS-H2 water container/bottle. Although the cap may
appear to fit onto the bottle, air may escape resulting in
insufficient pressure and flow of air and water during the
endoscopic procedure. Both the PENTAX water bottle cap and
bottle (container) are identified by their appropriate molded-in
model designation. Ensure that an OS-H4 cap is used only with
the OS-H4 water container/bottle. Do NOT overtighten the bottle
cap. Overtightening can cause the bottle cap to break.

– 4 –

(1) EPK-i5000/EPK-i

WARNING:

NOTE:

WARNING:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

(1) Endoscope

Electrical

(1)

(2)

Connector
(2) Lamp Switch
(3) Light Guide

Receptacle
(4) Power Switch
(5) Water Bottle

Assembly

(5)

Figure 1.5

The lamp life for EPK-i5000 is 500 hours. Check the lamp life
indicator on the touch panel before you use the processor.
Replace the lamp cartridge if one of the bars on the LIFE
indicator lights red and the [Please replace the lamp] message
appears on the monitor. The lamp life could be affected by
frequency of use. In which case, the lamp life might become
shorter than 500 hours.

Software update may be required depending on the software
version of the EPK-i5000 processor. If the software is not
updated, the image will not be displayed. If the images are not
displayed correctly, please contact your local PENTAX service
facility.

(2) EPK-i7000/EPK-i7000(A)

(4)

(3)

（5）

Figure 1.6

The lamp life for EPK-i7000/EPK-i7000(A) is 500 hours. Check
the LIFE indicator (lamp life indicator) on the touch panel before
you use the processor. Replace the lamp cartridge if a red circle
is displayed on the LIFE indicator. The lamp life may not be as
long as 500 hours depending on the method of use and
operating environment.

（1）

（4）

（2）

（3）

(1) Endoscope

Electrical

Connector
(2) Touch Panel
(3) Power Switch
(4) Light Guide

Receptacle
(5) Water Bottle

Assembly

– 5 –

(3) EPK-1000/EPK-100p

WARNING:

NOTE:

(1)

(2)

(3)

(4)

(5)

(6)

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Figure 1.7

The lamp life when used in this equipment is 400 hours. Prior to
use, check the lamp life indicator on the front panel to ensure
the indicator is lit green or yellow. After 400 hours of use, the
indicator turns red and the image quality will deteriorate.
Excessive use of the lamp beyond its rated 400 hours
(approaching a thousand hours of use or more) could cause the
lamp to explode resulting in damage to the video processor.

(1) Endoscope

Electrical

Connector
(2) Air Pump Switch
(3) Power Switch

I : ON

O: OFF
(4) Lamp Switch
(5) Light Guide

Receptacle
(6) Water Bottle

Assembly

The lamp life could be affected by frequency of use. In which
case, the lamp life might become shorter than 400 hours.

– 6 –

2. PREPARATION AND INSPECTION FOR USE

NOTE:

WARNING:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

Prior to use, the endoscope, video processor and endoscopic accessory
instruments must be carefully inspected for cleanliness and proper function to
determine that they are appropriate for patient use:

PENTAX video endoscopes contained in this Instructions for Use
are compatible with PENTAX video processors, EPK-i, EPK-i5000,
EPK-i7000, EPK-i7000(A), EPK-100p, and EPK-1000.

2-1. Inspection of the Video Processor

Please refer to the Instructions for Use of the specific model of PENTAX video
processor for complete instructions.

1) Attach water bottle assembly, 2/3 filled with de-aerated sterile water to the

appropriate location on the left side of the video processor.

The addition of defoaming agents to the water supply is NOT
recommended. Due to their nature, these silicone based agents
cling tenaciously to surfaces. Unless they are rinsed very
thoroughly, a “barrier” could be created which could reduce the
effectiveness of the disinfection/sterilization process.
Additionally, repeated use of such defoamers could eventually
lead to residual silicone build up resulting in equipment
malfunction such as clogged air and/or water channels.

2) Set the drain lever on the water bottle cap to the upright position labelled A/
W (air/water).

3) Plug the processor into a properly grounded receptacle with the power
switch in the OFF position.

4) Make sure that the PENTAX PVE connector is aligned with the endoscope
electrical connector on the front panel of the processor.

5) Connect the endoscope to the endoscope electrical connector on the
processor as illustrated.

(1) Air/

Water
Feeding
Tube

Figure 2.1

– 7 –

6) Rotate the lever of the endoscope electrical connector clockwise after

CAUTION:

CAUTION:

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insertion.

After connecting the video endoscope to the video processor,
always make sure that the endoscope is firmly secured to the
endoscope receptacle by turning the locking lever to the “lock”
position.

7) Connect the air/water feeding tube from the water bottle assembly to the air/

water port on the side of the PVE connector.

8) Turn the processor and air pump to the “ON” position and check for proper

functioning.

9) Prior to each procedure, check the endoscope image quality displayed on

the monitor. Confirm that the image quality, color, automatic brightness

(iris) functions are acceptable as per the instructions provided with the

PENTAX video processor.

2-2. Inspection of Endoscope

If the endoscope is intended to be clinically used after testing of
individual endoscope functions (suction, air/water delivery, etc.)
without further reprocessing, the following precaution should be
exercised. Use sterile water during individual endoscope function
tests to avoid recontamination of the previously reprocessed
instrument by waterborne microorganisms. Tap water,
especially that which may be left idle and uncovered for a
prolonged period of time, should not be used during any
inspection/testing of the endoscope.

Before reprocessing and/or immersion in any fluids, PENTAX endoscopes

should be tested for the loss of integrity in their watertight construction by using

PENTAX brand leakage testers. For specific details on PENTAX recommended

leakage detection procedures, please refer to the instructions supplied with

PENTAX leakage testers.

– 8 –

CAUTION:

Various types of endoscope leakage testers exist including

NOTE:

CAUTION:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

manual, electro-mechanical and “automated” versions, some of
which are stand alone units and others which may be integrated
into Automated Endoscope Reprocessors (AERs)/Washers­Disinfectors (WDs). It must be recognized that PENTAX does not
evaluate non-PENTAX leakage tester systems to satisfy their
specific product claims, for their effectiveness to accurately
detect leaks and/or for their compatibility with PENTAX
endoscopes. Insufficient pressures may reduce the likelihood for
accurate leak detection, especially if the endoscope’s distal
bending section is not flexed during testing. Excessive pressures
may adversely affect the endoscope, especially if pressurization
occurs during automated reprocessing at elevated temperatures.
PENTAX accepts no responsibility for use of non-PENTAX leakage
testers.
Users should check with the leakage tester manufacturer and
confirm their specific product claims, including compatibility with
PENTAX endoscopes at various temperatures and their ability to
detect leaks with/without fluid immersion and with/without
flexing of the endoscope’s distal bending section.

Do not use a water supply device that can exert 30kPa or
greater of water pressure to the suction channel (suction valve)
during endoscopic examination.

1) Inspection of the Insertion Tube

a) Check the entire surface of the insertion tube for abnormal conditions

such as dents, crush marks, wrinkles, bumps, buckles, excessive

bending, protrusions, bite marks, peeling of outer sheath, cuts/holes or

other irregularities. Any crush or indentation of the flexible shaft of the

endoscopes can cause damage to the internal mechanisms of the

endoscopes.

b) Similarly, check the condition of the umbilical cord for outward signs

of damage such as buckling, crush marks, etc.

c) Also check the condition of the scanning unit cord for any outward

signs of damage.

To avoid further damage to the endoscope or the possibility of
malfunction during a procedure, do NOT use any endoscope with
outward signs of damage.

– 9 –

d) These areas [A], [B] should be checked for ANY abnormalities or

WARNING:

NOTE:

CAUTION:

(1)

(2)

(3) (4)

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irregularities. If anything unusual is found including but not limited to

rough textured surfaces, cracks, brittleness, sharp-edges, holes,

peeling, tackiness, etc., the endoscope should NOT BE USED. During

this inspection process check the surface/condition of the adhesive by

applying slight pressure with one's gloved fingers and by slightly

wiping this area with dry gauze. Make sure the glue is not peeling, nor

does it have roughened texture or any sharp-edges.

(1) Bending Section
(2) Close-Up View
(3) Black adhesive band

[A]

(4) Black adhesive band

[B]

Figure 2.2

e) Make sure that the entire endoscope is cleaned and has been subjected

to either a high-level disinfection or sterilization process before each

patient use.

All instruments must be reprocessed prior to first time use, after
any repairs/service and before any patient use. When utilizing
chemo-thermal processes for reprocessing PENTAX endoscopes,
the instruments should be allowed to return to room
temperature prior to use and/or further handling.

2) Inspection of Insertion Tube flexibility

Perform this process as part of the pre-use inspection of the
endoscope.

When performing this inspection, ensure that other components
of the endoscope (Distal End, Control Body, etc.) are not
damaged by impact to surfaces or objects in the area. Do NOT
adjust the Bending Section of the endoscope as part of this
inspection. Maintain the distal end in a straight orientation.

• Hold the Insertion Tube at the junction of the Insertion Tube
and Bending Section,

• Do NOT close your hand around the Bending Section.

– 10 –

Inspection Process

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

a) Starting at the Bending Section junction, create a 50cm loop of the

Insertion Tube as shown in the figure below.

Figure 2.3

b) Gently raise/lower the left/right hands alternately and confirm equal

flexibility for the length of the loop. Do NOT use the endoscope if

there are any:

• extraordinarily rigid portion which do not bend as easily as the rest

of the loop or

• extraordinarily flexible portions which bend much more than the rest

of the loop.

Figure 2.4

Figure 2.5

– 11 –

c) Repeat steps a and b above until the inspection of the entire insertion

NOTE:

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tube is complete. If the endoscope fails the inspection above: Do NOT

use the endoscope and Contact your PENTAX service facility.

• The distal end as well as the electrical contacts/pins on the
PVE connector and scanning unit connector of the endoscope
must be protected against damage from impact. NEVER apply
excess force such as twisting, or severe bending to the
flexible portion of the endoscope.

• As indicated elsewhere in PENTAX product labelling,
endoscopes particularly the quality of the endoscopic image
should be checked prior to patient use. Similarly the quality
of the ultrasound image should be checked.

• During pre-use inspection, ensure that the distal objective
lens and the illumination (LCB) cover glass are clean and no
residues are present on these distal surfaces. If not, crisp
images can NOT be displayed. Wipe them with a gauze or the
like moistend with 70-90% medical grade ethyl or isopropyl
alcohol.

• Ideally all patients should be prepped well to maximize
visualization of the intended areas of interest. Patient
material and secretions should be removed from the area of
observation to eliminate the potential to blur the endoscopic
image and/or obscure the illumination system.

• Prior to a procedure, remove debris or secreta from
observation area as much as possible.

• Continued use of the endoscope’s light guide lens system
covered with adhering patient material might cause a visible
steam-like vaporization associated with moisture loss from
heated organic material clinging to the distal LCB lens
surface. If this vapor is observed during a procedure, stop it
immediately, withdraw the endoscope from patient and clean
off any foreign material clinging to the endoscope lens/end.

– 12 –

CAUTION:

Flexible endoscopes and other sophisticated medical instruments

(1)

(4)

(5)

(3)

(2)

Figure 2.6

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

are constructed of special materials, unique parts and intricate
components with strict dimensional tolerances. Specialized
assembly techniques and application of specific sealants and/or
adhesives are required to ensure the watertight integrity and
maintain the functionality of these devices. It is therefore
imperative that endoscopes be routinely checked to ensure that
parts used in their construction are not loose, missing or
compromised that could otherwise negatively affect the
functionality of these devices. Compromised or loose
components could result in device failure, endoscope damage
(via fluid invasion) and/or in incomplete decontamination of
used instruments. PENTAX recommends that prior to use
endoscopes should be carefully inspected for their integrity and
checked for any “looseness” in the mating or joining of
components including the following parts/areas:

• the channel inlet assembly (Instrument Channel Inlet) (1)

• the suction nipple (2)

• the air/water port (3)

• any valve cylinder (4)

• the elevator wire channel cleaning inlet (5) (For EG-3870UTK)

• basically, any inlet or outlet port associated with an internal channel, an

indirect patient contact portion of the endoscope

One method to check for looseness is to lightly grip the exposed
part, and while grasping the component carefully attempt to
move it in various directions. Use of lint-free gauze while
grasping metal parts is recommended as a protection for one's
fingers.

If any part/component remains loose (after attempting to
tighten) and/or if there is any indication or suspicion of
an abnormality or outward signs of damage, do NOT use
the endoscope. Contact your local PENTAX service facility.

– 13 –

CAUTION:

To avoid damaging the endoscopes, do NOT twist, rotate or bend

NOTE:

Do NOT Twist or Rotate

Do NOT Bend

(1)

(2)

(2)

Figure 2.7

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excessively any of the strain relief boot (1), (2) during
inspection, clinical use, reprocessing or any handling activity. Be
particularly cautious for the insertion tube strain relief boot(1).
When wiping the insertion tube and the umbilical cord, use a
slow back and forth motion to wipe them along the tube/cord.
Never apply excessive force or torque on these strain relief
boots or slim tubes/cords.

3) Inspection of Angulation Controls and Locks

a) Slowly manipulate the Up/Down and the Right/Left control knobs to

see that they function smoothly. Be certain that a full and appropriate

range of angulation is possible.

b) Engage the angulation lock knob/lever to be certain that the position of

the angulated distal end can be stabilized.

The angulation lock knob/lever are of the friction type and the
degree of friction is adjustable. The degree of locking friction
depends on the rotational position of the lock knob/lever.

– 14 –

CAUTION:

ANY lack of smooth operation of the angulation controls may be

WARNING:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

an early indication of internal damage to and/or part(s) failure
within the endoscope’s angulation system. To avoid the
possibility of further endoscope damage or the potential for
malfunction of the angulation system, do NOT use the
endoscope if the angulation mechanism does not operate
properly. Prior to use, ensure that the angulation controls can
rotate smoothly, that there is no grinding or excess friction
within the angulation system and that the distal bending section
bends freely and smoothly. NEVER APPLY EXCESSIVE FORCE TO
THE ANGULATION CONTROLS! When an endoscope exhibits
excessive “knob play” or if angulation is lost in any direction, do
NOT use the instrument. Excessive “knob play” can be defined
as rotating of the angulation control knob(s) in any one direction
for more than 30 degrees without any corresponding distal end
angulation. The examples above are indications that service is
required to avoid more serious problems with the angulation
control system, including angle or pulley wire breakage and/or
the possibility of a “frozen” distal bending section.
A “frozen” bending section can make instrument extraction from
a patient more difficult.

(1)

(2)

Figure 2.8

(1) OF-B172
(2) O-ring Set

(OF-B191)

4) Inspection of Air/Water/Balloon Feeding Mechanism

a) Prior to use, the air/water/balloon feeding valve, OF-B172, should be

inspected. Remove the valve from control body. Make sure that O-

rings are in good condition and are properly attached and lubricated

with a small amount of OF-Z11 silicone oil.

A worn or damaged valve and/or O-rings should be replaced
with a new one. The entire valve mechanism should be
subjected to a high-level disinfection or sterilization procedure
prior to use (O-ring set, model OF-B191, is optionally available).
For repeated use, always ensure that the valve and/or O-rings
have already been reprocessed. A damaged or worn valve and/
or O-rings could create continuous air flow or excessive air
insufflation and result in potential patient injury such as
pneumatic perforation or could create a risk of cross
contamination to the end user due to the potential for reflux
(spit-back) of patient fluids out of the valve.

– 15 –

b) To inspect air delivery, cover the hole at the top of the OF-B172 and

NOTE:

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confirm that air flows freely from the endoscope distal end.

c) By depressing the top button of OF-B172, the water delivery system is

activated. Water should flow in a steady stream from the distal end of

the endoscope. (This may take several seconds on the initial attempt.)

USE STERILE WATER ONLY.

d) By fully depressing both buttons of OF-B172, the delivery system to

fill the balloon with water is activated. Water should flow in a steady

stream from the balloon injection nozzle at the distal end of the

endoscope (this may take several seconds on the initial attempt).

e) Release the air/water/balloon feeding valve to determine if the valve

freely returns to its OFF (neutral) position and delivery of water (and

air) ceases.

f) If the air/water/balloon feeding valve does not move smoothly, remove

the valve and apply a small amount of silicone oil lubricant onto all the

O-rings. Remove/wipe off excessive lubricant with a soft gauze. Do

NOT use excessive silicone oil.

Excessive silicone oil (lubricant) should be avoided to prevent
occlusion of the internal Air/Water/Suction channel and potential
impairment of the normally clear endoscopic image.

g) If air and/or water do not flow properly, NEVER attempt to clear any

of the distal channel openings with a needle or any other sharp object.

Instead, the following steps should be followed.

[1] EG-3670URK

[a] Disconnect the endoscope from the video processor.

[b] Remove the air/water/balloon feeding valve (OF-B172).

[c] Using a cotton tipped applicator and alcohol, clean the valve

recess (receptacle) in the control body thoroughly to remove any

debris. Do NOT attempt to insert the applicator into the small

openings within the cylinder as the cotton or applicator could

become lodged within these openings and cause channel

blockage.

[d] Clean the air/water/balloon feeding valve (OF-B172) assembly

thoroughly and rinse well.

– 16 –

NOTE:

CAUTION:

Figure 2.9

(1)

(2)

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Thoroughly dry the air and water channels of the endoscope. 70­90% medical grade ethyl or isopropyl alcohol followed by
compressed air, not greater than 165 kPa (1.69 kg/cm
PSI), may be used to facilitate drying via the adapter.

(2)

(1)

(1) Cleaning Adapter

(OE-C5)

(EG-3670URK only)

(2) Cleaning Adapter

(OF-B153)

(EG-3670URK only)

[e] Remove the suction/balloon suction valve, and install the

adapters as illustrated.

[f] After attaching the adapters as illustrated, follow the section of

this Instructions for Use for cleaning the Air/Water/Suction

channel.

2

, 24

[g] Remove the adapters used in step [f] and install the air/water/

balloon feeding valve. Test for normal delivery of air and water.

It may be necessary to repeat the procedure outlined in steps [e]

& [f] if normal air and water delivery is still not available.

[2] EG-3870UTK

Follow the reproc

essing instructions as described in section 4.

CARE AFTER USE.

If repeated attempts to flush the air/water system are
unsuccessful, do NOT attempt to use the endoscope on a
patient. Contact the PENTAX service facility.

5) Inspection of elevator (EG-3870UTK only)

This is the control that will guide and direct either the biopsy forceps or

other accessory during a procedure. To inspect, push the elevator control

knob forward with thumb of the left hand. The elevator in the distal end

should elevate in proportion to the distance the control knob is moved. The

motion of the elevator and the knob should be smooth and easy without any

“play” involved.

Figure 2.10

(1) Elevator
(2) Elevator Control knob

– 17 –

WARNING:

As with all other internal channels of the endoscope, the elevator

WARNING:

(2)

(1)

(3)

(3)

(2)

(4)

(1)

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wire channel must have been properly cleaned and subjected to
an appropriate high-level disinfection or sterilization process
before each use.

6) Inspection of Suction Mechanism

(1) Depress
(2) Suction Tube
(3) Suction Nipple

Figure 2.11

a) Prior to use, the suction/balloon suction valve, OF-B171 should be

inspected. Remove the valve from the control body and ensure that O-

rings are in good condition and properly attached and are lubricated

with a small amount of OF-Z11 Silicone Oil.

Figure 2.12

A worn or damaged valve and/or O-rings should be replaced
with a new one. The entire valve mechanism should be
subjected to a high-level disinfection or sterilization procedure
prior to use (O-ring set, model OF-B187, is optionally available).
Failure to do so could result in continuous aspiration which in
certain clinical situation can suction tissue into the distal channel
opening at the distal end and/or create a loss of insufflated air
via the suction system. A compromised valve could also result in
the potential for reflux or spit-back of patient fluids that may
present infection control risks.

(1) OF-B171
(2) O-Ring (Large)
(3) O-Ring (Small)
(4) O-Ring Set

(OF-B187)

b) Connect suction tubing from an external suction source to the suction

nipple located on the PVE Connector at the end of the umbilical cord.

Place the distal end of the endoscope in a basin of sterile water.

– 18 –

c) Fully depress and then release the suction/balloon suction valve to

CAUTION:

NOTE:

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determine if the valve freely returns to its OFF position and the

aspiration of water ceases.

d) Pressing the suction/balloon suction valve halfway down to its 1st

stage will start suctioning through the biopsy/instrument channel

system.

e) Fully depressing the suction/balloon suction valve down to its 2nd

stage will initiate suctioning of and empty the contents of the balloon

through the balloon suction channel.

If the instrument is to be used immediately after the inspection,
use only sterile water. To avoid recontamination of a previously
reprocessed endoscope, avoid use of idle/uncovered tap water.

Inlet seals in good condition must be on the instrument channel
inlet to prevent the loss of suction and a risk of cross
contamination to the end user due to the potential for reflux
(spit-back) of patient fluids. Worn seals will result in leakage and
should be replaced. To ensure maximum performance of these
sealing mechanisms, consider replacing the inlet seal with a new
fully reprocessed one for each procedure.

f) If the suction/balloon suction valve does not move smoothly or feels

“sticky”, remove the valve from the suction/balloon suction cylinder

on the control body of the endoscope.

Apply a small amount of silicone oil lubricant, OF-Z11, onto rubber

part and rubber O-rings. Remove/wipe off excess lubricant with a soft

gauze. Do NOT use excessive silicone oil.

– 19 –

7) Inspection of Biopsy Forceps/Accessory and Instrument Channel

WARNING:

WARNING:

CAUTION:

(1)
(2)

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a) Make sure there are no kinks in the flexible shaft of the biopsy forceps.

(1) Close
(2) Open

Figure 2.13

b) The cups/jaws of the forceps must be free of any residual debris. Any

debris must be cleaned from the forceps before they are used. Use only

sterile forceps.

c) The handle mechanism on the forceps should be operated to open and

close the cups/jaws. This mechanism should operate freely.

d) Close and inspect the cups/jaws of the forceps to make sure the cups/

jaws are in proper alignment. If the forceps has a spike, the spike must

be completely straight and fully within the cups/jaws.

The use of any forceps or accessory that shows any sign of
damage or difficulty of operation must be avoided. Any
malfunction of a forceps or accessory during a patient procedure
could result in serious injury to the patient. Also, the use of
damaged forceps or accessories may result in serious and costly
damage to the endoscope.

e) Any accessory should be slowly inserted through the instrument

channel inlet with the endoscope in a straight position. There should be

no resistance encountered. If resistance is encountered, do NOT

attempt to introduce the accessory further. The instrument channel

may be damaged and the endoscope should not be used. Contact your

local PENTAX service facility.

All patient contact accessories must be thoroughly cleaned and
subjected to an appropriate high-level disinfection or
sterilization process before being used for the first time and
subsequently after each clinical use.

The instrument channel system is made of stainless steel, Noryl
and fluorine-contained polymers. When any fluids are used with
this endoscope, please read carefully and follow all instructions
in the Instructions for Use provided with the fluids and pay
special attention to any reactions with the materials identified in
the intended fluid path. Only the user can determine if the fluids
are appropriate for patient use.

– 20 –

NOTE:

Accessories should always be inspected and checked with the

WARNING:

NOTE:

WARNING:

NOTE:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

particular endoscope prior to each procedure.

Do NOT clinically use the endoscope if any irregularity or
abnormality is suspected. If there is any doubt as to the
suitability of use for any endoscope component, replace it with a
new fully reprocessed one. An instrument irregularity may cause
endoscope damage and/or compromise patient or user safety.

2-3. Preparation of Ultrasound Scanning Unit

1) The ultrasound scanning unit made by FUJIFILM Healthcare Corporation

listed on the addendum sheet F370 is currently compatible with these

PENTAX ultrasound endoscopes.

2) For complete details on the handling, operation, care and maintenance, etc.

of the ultrasound scanning units, refer to the Instructions for Use provided

with each unit.

2-4. Preparation before the Examination

The latex balloons and their O-Rings are disposable. They are
provided sterile for single patient use.

Please be advised that PENTAX balloons, Model OF-A67 for EG­3870UTK and Model OE-A51 for EG-3670URK supplied for
endoscopic ultrasound applications are made of latex material.
Appropriate precautions are therefore recommended. Due to the
potential severe allergic reactions to medical devices containing
latex (natural rubber), healthcare professionals are encouraged
to identify latex sensitive patients and be prepared to treat
allergic reactions promptly.

A. Procedures using Balloon Method

When attaching or removing the latex balloon, be careful not to
damage the endoscope, especially the sensitive transducer,
optical lenses or bending section at the distal portion.

1) Ensure that the endoscope is connected properly to the video processor.

2) Connect the scanning unit connector of the endoscope to the ultrasound

scanning unit.

– 21 –

3) Fully depress the air/water/balloon feeding valve (OF-B172) until the water

NOTE:

(2)

(1)

(3)

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exits the distal end of the endoscope.

4) Prior to attempting to secure the latex balloon to the endoscope, moisten

both balloon and distal end with sterile water. This will create a more

slippery surface to allow easier sliding of the balloon over the transducer at

the distal end of the endoscope.

5) Carefully attach the balloon provided onto the distal end. Gently slide the

balloon over the distal end of the endoscope.

(1)

(5)

Figure 2.14

(2)

(2)

(3)

(4)

(6)

(1) EG-3670URK
(2) Balloon Attachment

Groove
(3) Balloon (OE-A51)
(4) Balloon Band
(5) EG-3870UTK
(6) Balloon (OF-A67)

6) (EG-3670URK) see Figure 2.15

lace the balloon band into the balloon attachment groove at the endoscope

P

distal end.

7) (EG-3870UTK) see Figure 2.16

S

lide the larger Balloon Band onto the balloon installation device (OF-A37)

.

(1) EG-3870UTK
(2) Balloon Installation

Device (OF-A37)
(3) Large Balloon Band

Figure 2.15

(Optional method) Instead of using the provided rubber bands to secure the
distal balloon, the user may opt to use suture thread to secure attachment.

Balloon O-Ring Kit, OF-A67, is available. The kit consists of:

• Balloon

• 2 pieces of Large Balloon Bands (O-Rings)

• Small Balloon Band* (O-Ring)
*The small Balloon Band is not used for this endoscope.

– 22 –

8) To check the integrity of the balloon, inflate it with water in the following

NOTE:

NOTE:

(2)

(3)

(4)

(1)

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manner.

Automated Balloon Filling with air/water/balloon feeding valve (OF-

B172) and water bottle

a) Ensure that the water bottle assembly for the video processor has been

filled (2/3 full) with de-aerated sterile water. Connect the bottle tube to

the endoscope.

b) Fully depressing the air/water/balloon feeding valve all the way down

should activate water delivery to the balloon.

Do NOT overfill the balloon with water. Since an excessive
volume of water may literally burst the balloon, the amount of
sterile water injected should be kept down to a minimum.

(1) EG-3870UTK
(2) Balloon Injection/

Evacuation Nozzle
(3) Air
(4) Sterile Water

Figure 2.16

Figure 2.17

If any air remains trapped within the balloon, it may be removed
as follows:

1) Position the endoscope distal end so that the entrapped air

2) Proceed to evacuate the excess air as described in the next

(1)

(2)

(3)

(4)

(1) EG-3670URK
(2) Balloon Injection

Nozzle
(3) Balloon Evacuation

Nozzle
(4) Air
(5) Sterile Water

(5)

rises above the water surface and is in contact with the
balloon evacuation nozzle. (Figure 2.19, 2.20)

section.

9) Emptying the balloon

a) To evacuate the contents of the balloon, connect tubing from a

regulated source of suction to the suction nipple located on the PVE

connector at the end of the umbilical cord.

b) When the suction/balloon suction valve (OF-B171) is depressed fully,

the contents of the balloon will be removed.

– 23 –

10) Volume of water for distension of balloon

NOTE:

WARNING:

WARNING:

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Since an excessive volume of water may literally burst the balloon, the amount

of de-aerated sterile water injected should be kept down to a minimum.

NEVER reuse the LATEX balloons and their O-rings. They are
provided sterile for single patient use.

B. Procedures Using Water Immersion Method

1) Connect the scanning unit connector of the endoscopes to the ultrasound

scanning unit.

2) Via the instrument channel inlet located just below the control body, sterile

water can be injected to completely fill the stomach.

2-5. Preparation just before Insertion of Endoscope

Every endoscope should be properly disinfected or sterilized
before being used for the first time. The endoscope should have
been properly cleaned and disinfected or sterilized after any
previous use and after being returned for any repairs/service.

Current infection control guidelines require that endoscopes and
their patient contact accessories either be sterilized or at the
least be subjected to high-level disinfection.
Accessories which ENTER STERILE TISSUE or THE VASCULAR
SYSTEM must be sterilized before patient use. It is
recommended that any accessory intended for use in the biliary
tract be subjected to an appropriate sterilization process.
Only the user can determine if an instrument has undergone
appropriate infection control procedures prior to each clinical
use.

1) If the endoscope has just recently been reprocessed, has been prepared or

stored properly and passed all pre-procedure inspections, the instrument

should be ready for use. If necessary, the endoscope’s insertion tube may be

wiped down with a gauze dampened with 70-90% medical grade ethyl or

isopropyl alcohol.

2) Gently clean the objective lens with a cotton-tip applicator moistened with

70-90% medical grade ethyl or isopropyl alcohol. A lens cleaner (anti-

fogging agent) may also be applied via gauze or other applicator.

3) Check the endoscopic image and confirm that it is of acceptable quality for

clinical use. Refer also to the Instructions for Use provided with the

PENTAX video processor for inspection of the image quality.

4) Prior to trans-oral insertion of the endoscope, place a bite-block

(mouthpiece) into the patient’s mouth to protect the endoscope from

– 24 –

damage during the procedure. Failure to do so can result in scratches, tears

NOTE:

WARNING:

WARNING:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

and/or crushing of the insertion portion of the endoscope.

5) Apply a medical grade water soluble lubricant to the insertion tube. Do

NOT use petroleum based lubricants.

The objective lens must be kept free of the lubricant and excess
lens cleaner.

Ensure that only sterile water is used for water delivery (lens
washing) and balloon filling. Do NOT use tap water.

NEVER drop this equipment or subject it to severe impact as it
could compromise the functionality and/or safety of the unit.
Should this equipment to be mishandled or dropped, do NOT use
it. Return it to an authorized PENTAX service facility for
inspection or repair.

– 25 –

3. DIRECTIONS FOR USE

WARNING:

CAUTION:

CAUTION:

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This instrument should only be used by physicians who have
thoroughly studied all the characteristics of this instrument and
who are familiar with the proper techniques of endoscopic
ultrasonography. During the procedure, always wear protective
garments such as gloves, gowns and face masks, etc. to
minimize the risk of cross contamination.

(Curved Linear Array Type : EG-3870UTK)

The PENTAX ultrasound endoscopes identified above are special
instruments that house a distal, precision transducer for
ultrasonic imaging. It must be recognized that compared to
conventional endoscopes, the distal end of these ultrasound
endoscopes contain a longer distal rigid section. This design
combined with its forward oblique optics in the distal end results
in the image not being in full endoscopic view. Only medical
professionals appropriately trained in EUS technique should
operate these devices and special care should be exercised when
using these instruments. Use caution during any movement or
angulation of the endoscope distal end and/or elevator (where
applicable) to avoid patient trauma, tissue damage and/or
perforation. NEVER apply excessive pressure of the endoscope
distal end against patient tissue.

(Radial Array Type : EG-3670URK)

The PENTAX ultrasound endoscopes identified above are special
instruments that house a distal, precision transducer for
ultrasonic imaging. It must be recognized that compared to
conventional endoscopes, the distal end of these ultrasound
endoscopes contain a longer distal rigid section. Only medical
professionals appropriately trained in EUS technique should
operate these devices and special care should be exercised when
using these instruments. Use caution during any movement or
angulation of the endoscope distal end to avoid patient trauma,
tissue damage and/or perforation. NEVER apply excessive
pressure of the endoscope distal end against patient tissue.

– 26 –

3-1. Pretreatment

WARNING:

WARNING:

F

U
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The patient should be prepared in your normal endoscopy regimen.

Please be advised that PENTAX balloons, supplied for endoscopic ultrasound

applications are made of latex material and thiuram and appropriate precautions,

are therefore, recommended.

Due to the potential severe allergic reactions to medical devices
containing latex (natural rubber), healthcare professionals are
encouraged to identify latex sensitive patients and be prepared
to treat allergic reactions promptly.

3-2. Insertion and Withdrawal

1) Slowly insert the endoscope under direct vision.

(1) Bite Block

(1)

Figure 3.1

2) When the distal end of the endoscope is passed through the pharynx, the

patient should be gently biting down on the bite block to maintain the bite

block’s position during the procedure.

3) Adjust the intensity of the video processor to obtain a brightness level

suitable for observation.

The light emission from the endoscope could cause thermal
injury. To minimize the risk, use only the minimum amount of
brightness and avoid close stationary viewing and unnecessary
prolonged use.

4) The angulation controls should be used as needed to position the endoscope.

Angulation of the distal end should be performed under direct vision in a

gentle and deliberate manner.

– 27 –

CAUTION:

ANY lack of smooth operation of the angulation controls may be

NOTE:

WARNING:

WARNING:

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an early indication of internal damage to and/or part(s) failure
within the endoscope’s angulation system. To avoid the potential
for malfunction of the angulation system, do NOT use the
endoscope if the angulation mechanism does not operate
properly. Ensure that the angulation controls can rotate
smoothly, that there is no grinding or excess friction within the
angulation system and that the distal bending section bends
freely and smoothly.
NEVER APPLY EXCESSIVE FORCE TO THE ANGULATION
CONTROLS!
If during a procedure angulation is lost in any direction such as
when “cords snap” (broken pulley wire, broken angle wire, etc.),
do NOT continue to use the instrument and do NOT rotate the
angulation controls. Should the angulation system fail for any
reason, stop the procedure, release the lock lever/knob and
carefully withdraw the endoscope under direct visualization. The
examples above are indications that service is required to avoid
more serious problems with the angulation control system,
including the possibility of a “frozen” distal bending section. A
“frozen” bending section can make instrument extraction from a
patient more difficult.

5) Insufflation should be controlled by the combined use of the air/water/

balloon feeding valve (OF-B172) to increase the amount of insufflation and

the suction/balloon suction valve (OF-B171) to decrease the level of

insufflation.

Be careful not to deliver too much air.

It must be recognized that variations in air flow (pressure and
volume) for patient insufflation may exist from one
manufacturer’s equipment (light source, video processor and/or
endoscope type) to another. It is, therefore, important to closely
monitor the patient at all times and to aspirate excessive air to
prevent over insufflation and potential pneumatic perforation.

6) Mucous, fluids and/or other patient material should be aspirated via the

instrument/suction channel and suction/balloon suction valve (OF-B171) to

improve visualization. Maintain a clear view during aspiration, avoid

prolonged suction time and use the minimum level of negative pressure

required to perform the clinical procedure.

Do not push button down all the way (to second stage). This
would activate the Balloon Suction Channel and pull patient
fluids into it. The Instrument Channel must be used to perform
such aspiration.

– 28 –

WARNING:

Do not apply excessively negative pressures (high suction

NOTE:

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settings) and/or prolonged contact of the distal instrument
channel opening (distal end) against mucosal surfaces to avoid
“suction polyps”, bleeding and/or other trauma to the patient.
During aspiration keep as clear as possible an endoscopic view
of patient anatomy and maintain some distance from endoscope
distal end to tissue to avoid suctioning of mucosa onto/into the
distal channel opening.

The endoscope has a single, common channel for air/water
delivery and suction. Since all three functions occur within a
single channel, the following may be experienced when
alternating between these functions:

• A slight delay in air delivery with subsequent residual water
(fluid) flow may occur immediately after switching from water
(or from suction) to air activation. This flow of fluid is due to
the purging (emptying) of residual fluid from the common
internal channel.

• A slight delay in water delivery may occur if activated
immediately after air delivery (or after suction) due to filling
of the empty common internal channel occupied by air.

7) Image capture, hard copy documentation, video recording, etc. may be

carried out as necessary.

8) Guide the endoscope distal end to the area to be observed sonographically.

a) Balloon Method

In this method of sonographic imaging, sterile water-filled balloon is

placed in contact with the target area to be observed. Inflate the

balloon with de-aerated sterile water as previously explained in section

2-4 of this Instructions for Use entitled “PREPARATION BEFORE

THE EXAMINATION”.

b) Water Immersion Method

In this method of sonographic imaging, the distal end is placed in de-

aerated sterile water which acts as the transmission medium for the

ultrasonic signals. Via the instrument channel inlet, de-aerated sterile

water can be injected through the endoscope to completely fill the

stomach.

9) Following the Instructions for Use provided with the ultrasound scanning

unit, observe the sonographic image on the monitor, and obtain desired

photographic and/or video documentation as necessary.

– 29 –

10) Relationship between direction of the ultrasound endoscope and the

(1)

EG-3670URK

(3)

(2)

(1)

(2)

(5)

(4)

(3)

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orientation mark on the image is shown below:

Figure 3.2

Figure 3.3

EG-3870UTK

(1)

(2)

(1) Orientation Mark Side
(2) Right-Left Orientation

Mark

(1) UP
(2) Orientation Mark Side
(3) Up-Down Orientation

Mark

(1) Up/Down Angulation

Lock Lever
Free Position (Lock
Released)

(2) Right/Left Angulation

Lock Knob
Free Position (Lock

Released)
(3) Lock Position
(4) Lock Position
(5) Top spoke of

Figure 3.4

angulation knobs in

this position

corresponds to neutral

distal end orientation

11) Before withdrawing the endoscope shrink the balloon by fully depressng

OF-B171 and then trapped air should be suctioned to reduce patient

discomfort by allowing OF-B171 to rise back up to its 1st stage position

(halfway up), thereby suctioning through the Instrument Channel.

– 30 –

12) When attempting to withdraw the endoscope, return the angulation lock

WARNING:

NOTE:

CAUTION:

WARNING:

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lever/knob to their free position. Always withdraw the endoscope under

direct visualization.

If for any reason, the image is lost due to power shortage, lamp
or processor failure, etc. the right/left angulation lock knob and
the up/down angulation lock lever should be released, the
endoscope distal end should be straightened to its neutral
position, and the insertion tube should be carefully and slowly
withdrawn from the patient.

3-3. Precise Accessory Control (For EG-3870UTK only)

The combination of endoscopic forward oblique optics, linear array ultrasound

imaging and a distal elevator gives users the ultimate control for precise

accessory applications. This unique capability allows users to maintain a view

(both endoscopic and sonographic) for pinpoint guidance of accessories such as

the aspiration needle. Once the accessory exits the distal instrument channel

opening, the accessory can be guided by the elevator, located on the proximal

control section of the endoscope.

Should resistance in passing the accessory be encountered at
the distal portion of the scope, gently pull back the accessory,
reduce the angle of the elevator, then re-advance the accessory.

If the elevator is not deflected at all, the accessory may not be
seen in the field of view since this instrument has 45° forward
oblique optic. It is recommended that the elevator be slightly
deflected so that the accessory exits the distal scope end and
advanced only under full view.

For ALL types of endoscopic accessory instruments, always
maintain a endoscopic view and sonographic view of the
accessory during advancement, use and withdrawal of the
device Otherwise it could result in patient injury such as
perforation.

– 31 –

3-4. Biopsy

NOTE:

NOTE:

(1)

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Since these PENTAX video endoscopes in this Instructions for
Use contain a single channel (within the insertion tube) serving
as a common channel for delivery of air or water as well as
suction capability, it is recommended that water delivery should
NOT

be attempted WHILE an endoscopic accessory instrument is
inserted into the instrument/working channel. Under the
conditions described above, it is possible for fluid or water to
leak from the inlet seal/instrument channel inlet area. This is
due to the fact that the accessory device occupies the vast
majority of channel volume leaving very little open space
between accessory and channel for flow of water. If one insists
on activating water delivery while an accessory device is in the
channel, caution must be exercised as this expelled fluid may
contain patient material. As always for endoscopic procedures,
personal protective equipment should be worn and additional
protection such as covering the channel inlet with gauze or
similar means should be used to prevent potential exposure to
expelled fluids.

1) (For EG-3870UTK) Raise the elevator.

(1)

Figure 3.5

2) Insert the accessory through the slit in the inlet seal.

Figure 3.6

(1) Elevator

(1) 50 mm

When the tip of the accessory is first passed through the inlet
seal, a temporary resistance will be encountered. Hold the shaft
tightly at about 50mm from the tip of the accessory and push it
through.

– 32 –

NOTE:

During insertion, if the accessory is found hard to advance

NOTE:

CAUTION:

(1)

(2)

(3)

(1)

(2)

(3)

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further due to resistance, decrease the angulation of the
bending section to a level suitable for smooth insertion and
insert the accessory again.

Be certain to hold the forceps handle in such a way to ensure
that the cups/jaws of the forceps are in a fully closed position
during insertion.

NEVER apply excessive pressure when introducing any accessory
since the instrument channel may be damaged. Malfunction of
the endoscope as well as costly repairs may result.

3) (For EG-3870UTK) Insert accessory until reaching the elevator.

(1) Elevator
(2) Tip of the Accessory
(3) Cross section view of
the distal end

Figure 3.7

4) (For EG-3870UTK) The elevator should be lowered to allow accessory

advancement.

(1) Elevator
(2) Tip of the Accessory
(3) Cross section view of
the distal end

Figure 3.8

– 33 –

5) When the tip of accessory extends about 10mm from the distal of the

WARNING:

WARNING:

(2)

(1)

(7)

(3)

(6)

(4)

(5)

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endoscope, the accessory appears in a endoscopic view and sonographic

view (See Figure 3.9, 3.10).

(1) about 10 mm
(2) Cross-section view of

the distal end

(1)

(1)

(2)

Figure 3.9

()

Figure 3.10

(1) Accessory appearence

area
(2) Tip of Accessory
(3) Endoscopic view
(4) Orientation mark side
(5) Tip of Accessory
(6) Sonographic view
(7) Accessory appearence

area

For ALL types of endoscopic accessory instruments, always
maintain endoscopic view and sonographic view of the accessory
during advancement, use and withdrawal of the device.
Otherwise it could result in patient injury such as perforation.

If the accessory doesn’t appear in endoscopic view and
sonographic view when the accessory is advanced over 15mm, it
may be necessary to repeat the procedure from step 1).
Otherwise it could result in patient injury such as perforation.

– 34 –

WARNING:

Some kinds of accessories could be derailed from the elevator

CAUTION:

NOTE:

(1)

(2)

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while moving the bending section and/or the elevator (see
Figure 3.11).

If the accessory has derailed from the elevator, there is a
possibility that the accessory does not appear in the endoscopic
view and sonographic view.
Therefore, for ALL types of endoscopic accessory instruments,
always maintain the endoscopic view and sonographic view of
the accessory during advancement, use, and withdrawal.
Otherwise it could result in patient injury such as perforation.

(1) Derailed position of
accesory
(2) The distal end

Figure 3.11

6) The elevator may now be maneuvered as needed to bring the accessory into

a view and to aid in the application of the accessory (See Figure 3.10).

If the accessory does not move in the endoscopic view when
operating the elevator, it may be necessary to repeat from step 1).
If the accessory in the endoscopic view is not moved in spite of
repeating the procedure from step 1), please contact your local
PENTAX service facility.

7) When a portion of the tip of the accessory becomes visible in the viewing

field, carefully advance the accessory onto the target area.

8) (When the forceps are used) Open the forceps cups/jaws and advance the

forceps against the target area. Carefully squeeze the forceps handle close

the cups/jaws and obtain a specimen within the cups/jaws. Always maintain

an endoscopic view of accessory during advancement.

9) Withdraw the accessory slowly.

Because of the effect accessories used in the instrument channel
of the endoscope can have on the performance of the endoscope
itself, it is strongly recommended that only PENTAX accessories
be used with PENTAX endoscopes. If a unique or highly
specialized accessory is available from another source, the
accessory manufacturer should be consulted to confirm
compatibility with PENTAX endoscope before use.

– 35 –

CAUTION:

When withdraw/insert the forceps from the endoscope, you

WARNING:

WARNING:

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must close the cups/jaws of the forceps.
Otherwise the endoscope could be broken.

Accessories which ENTER STERILE TISSUE or THE VASCULAR
SYSTEM must be sterile. Accessories intended for use in the
biliary tract should be sterilized before patient use.

After using operational/cleaning accessories (e.g., forceps,
needles, snares, brushes etc.) with the endoscope, carefully
check that all accessories are intact and that no parts have fallen
off and become lodged within the endoscope's instrument/
suction channel. Furthermore, ensure that any therapeutic
devices (e.g., clips, stents, etc.) passed through the channel are
accounted for after use.
If the channel becomes blocked or clogged due to the
accumulation of debris, an accessory that cannot be removed, or
other cause, do NOT attempt to correct the blockage or continue
to use the endoscope. In such a case, contact your local PENTAX
Medical service facility to have the endoscope repaired.
The use of an endoscope with a blocked internal channel may
result in ineffective reprocessing and/or the introduction of
debris and/or device components into a patient during a
subsequent procedure, posing a risk of cross-contamination.

– 36 –

4. CARE AFTER USE

NOTE:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

IMPORTANT INSTRUCTIONS

Cleaning / High-Level Disinfection / Sterilization

To maintain maximum performance and a long service life of the endoscope,

proper care after each procedure is extremely important. Immediately after the

completion of a procedure, the endoscope and its removable components should

be thoroughly and carefully cleaned. If the endoscope or its components are left

uncleaned for some time after use, dried blood, mucous, or other debris may

cause damage to the instrument/component or may interfere with the ability of

the user to properly reprocess the endoscope/component.

This Instructions for Use contains detailed recommendations on
the manual reprocessing of PENTAX endoscopes using PENTAX
supplied cleaning/disinfecting adapters. Automated Endoscope
Reprocessors (AERs)/Washer-Disinfectors (WDs) may provide a
means of reprocessing flexible endoscopes, including PENTAX
instruments. However, only those Automated Endoscope
Reprocessors (AERs)/Washer-Disinfectors (WDs) should be used
whose manufacturers provide device-specific instructions and
have validation data that support each AER/WD claim with
respect to PENTAX model instruments. AER/WD manufacturers
should be consulted for their specific claims including but not
necessarily limited to
a) the ability of the AER/WD to provide a cleaned and high-level

disinfected (or sterilized) endoscope and endoscope
components (e.g., valves),

b) the identification of any special feature area (internal

channel) or endoscope component that can not be

reprocessed and therefore requires manual reprocessing,
c) the microbial quality of the rinse water,
d) the inclusion of an “automated” alcohol rinse cycle,
e) the inclusion of a terminal drying cycle that removes the

majority of water/fluid within endoscope channels,
f) maintenance procedures for water filter replacement and/or

decontamination of the filtration system to ensure the

microbial claim of water, etc.
g) compliance with local regulations and/or guidelines.

Summary of PENTAX Reprocessing Instructions

PENTAX reprocessing instructions can be broken down into 6 basic steps:
1 PRE-CLEANING (in the Examination Room) Section 4-3-1
2 LEAKAGE TESTING (in a designated Decontamination Area)
Section 4-3-2
3 CLEANING (in a designated Decontamination Area) Section 4-3-3
4 HIGH-LEVEL DISINFECTION OR STERILIZATION

(in a designated Decontamination Area) Section 4-3-4, 4-3-5

5 ENDOSCOPIC ACCESSORY INSTRUMENTS (EAIs) AND ENDOSCOPE

COMPONENTS Section 4-4

6 POST REPROCESSING Section 5

– 37 –

NOTE:

The instructions for manual reprocessing of PENTAX endoscope

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contained in this Instructions for Use are consistent with
reprocessing guidelines, developed by medical professional
organizations (e.g., ESGE, SGNA, ASGE, APIC) and/or national
consensus groups (including ASTM).

Items required for reprocessing:

• 10 mL Syringe (For EG-3870UTK)

• 60 mL Syringe

• Tray/Reprocessing basin (at least 40 cm by 40 cm/16 in × 16 in)

• Soft Sponge

• Personal Protective Equipment (PPE) including gloves, face mask, etc.

• Soft Sterile Gauze

•PVE Soaking Cap OE-C9

• Scanning Unit Connector Soaking Cap OE-U1

• Cleaning Adapter OF-B153(For EG-3670URK)

• Inlet Seal OF-B190

• Cleaning Brush CS-6021T

• Cleaning Brush CS-C9S

• Cleaning Adapter OE-C5(For EG-3670URK)

• Injection Tube OE-B5 (For EG-3870UTK)

• Cleaning adapter OF-G17 (For EG-3870UTK)

• Suction/Balloon Suction Valve OF-B171

• Air/Water/Balloon Feeding Valve OF-B172

•Detergent

• Disinfectant

• Alcohol (if applicable, according to local/national regulation)

• Source of compressed/forced air

4-1. Internal Channels of PENTAX endoscopes

The following internal schematics have been provided as a service to help users

better understand the intricate construction of PENTAX endoscopes. Knowledge

of the various internal channels and tubes within an instrument and their relation

to each other allows one to care for and reprocess the endoscope more easily and

with greater confidence.

Much time and effort has been expended into designing endoscopes and their

cleaning/disinfecting components so that reprocessing of the instruments before

each patient use can be effectively and efficiently performed by either manual

methods or automated processes.

Connectors on all PENTAX cleaning/disinfecting adapters and endoscope inlet

ports incorporate standard size luer-lock and/or luer-slip fittings to easily

accommodate reprocessing devices or systems available from other

manufacturers. As can be seen from the internal schematics, the PENTAX

cleaning system promotes efficient unidirectional flow of solution beginning

from connections at the PVE connector, travelling up tubings in the umbilical

cord to the valve cylinders in the control body, passing through the channels in

the insertion tube and finally exiting nozzles or channel openings at the distal

end of the endoscope.

– 38 –

WARNING:

(In the U.S.A. or other countries adhering to FDA

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regulations)

It is imperative that flexible endoscopes and other semi-critical
devices be reprocessed using at least high-level disinfection with
a legally marketed sterilant/disinfectant. Only legally marketed
endoscope automated reprocessing devices/systems whose
device specific claims have been validated by the AER/WD
manufacturer and anti-microbial agents which have been tested
and found to be compatible by PENTAX should be used with
PENTAX products.
Endoscopes are semi-critical devices that require at least high­level disinfection. Only use legally marketed solutions and/or
automatic endoscope reprocessing machines or washing
disinfection machines whose manufacturers have made
validation testing with PENTAX products (specific to PENTAX
endoscope model number). A listing of legally marketed
solutions/systems which have been determined to be compatible
with PENTAX brand products is available from your local PENTAX
dealer/authorized service facility. Be aware of the important
note regarding infection control on the inside cover of this
Instructions for Use.

– 39 –

(1) EG-3870UTK

Balloon Suction Channel

Balloon Injection Channel

Elevator Wire
Channel Cleaning Inlet

Scanning Unit

Suction/Balloon Suction Valve (OF-B171)

Instrument Channel
Inlet

Water Bottle
Assembly

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– 40 –

(2) EG-3670URK

Scanning Unit
Connector

Balloon Injection Channel

Balloon Suction Channel

Suction/Balloon Suction Valve (OF-B171)

Instrument Channel Inlet

Water Bottle
Assembly

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– 41 –

4-2. Reprocessing System

CAUTION:

NOTE:

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(1) EG-3870UTK

Balloon Injection Channel

Scanning Unit
Connector
Soaking Cap
(OE-U1)

Air/Water/Suction Channel

Balloon Suction Channel

Injection Tube (OE-B5)

Suction/Balloon Suction Valve (OF-B171)

Air/Water/Balloon Feeding Valve (OF-B172)

Instrument Channel
Inlet

Elevator Wire Channel

Scanning Unit
Connector

Cleaning Adapter
(OF-G17)

PVE Soaking
Cap (OE-C9)

Ventilation Cap (OF-C5)

Air Feeding Tube

Water Feeding Tube

Suction Tube

BEFORE IMMERSING:
a) The ‘Red’ Ventilation Cap (OF-C5) must be taken OFF.
b) The PVE Soaking Cap (OE-C9) should be securely ON the

electrical contacts.
The Scanning Unit Connector Soaking Cap (OE-U1) should be
securely on the electrical contacts of the scanning unit
connector.

To reprocess a PENTAX endoscope, first cleaning detergent and then a high-

level disinfectant or sterilant must be exposed to all internal lumens as well as to

all external instrument surfaces and endoscope components (air/water/balloon

feeding valve, suction/balloon suction valve, etc.). Exposure times of detergent

and disinfectant/sterilant must be strictly adhered to as recommended by each

respective manufacuturer.

Please note that all solution entrance ports and flow pathways are illustrated

above.

While the endoscope is immersed in cleaning detergent, all
brushable channels should be manually cleaned with cleaning
brushes.

– 42 –

(2) EG-3670URK

CAUTION:

NOTE:

Instrument Channel Inlet

Balloon Suction Channel

Balloon Injection Channel

Ventilation Cap (OF-C5)

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BEFORE IMMERSING:
a) The ‘Red’ Ventilation Cap (OF-C5) must be taken OFF.
b) The PVE Soaking Cap (OE-C9) should be securely ON the

electrical contacts.
c) The Scanning Unit Connector Soaking Cap (OE-U1) should be

securely on the electrical contacts of the scanning unit

connector.

To reprocess a PENTAX endoscope, first cleaning detergent and then a high-

level disinfectant or sterilant must be exposed to all internal lumens as well as to

all external instrument surfaces and endoscope components (air/water/balloon

feeding valve, suction/balloon suction valve, etc.). Exposure times of detergent

and disinfectant/sterilant must be strictly adhered to as recommended by each

respective manufacuturer.

Please note that all solution entrance ports and flow pathways are illustrated

above.

While the endoscope is immersed in cleaning detergent, all
brushable channels should be manually cleaned with cleaning
brushes.

– 43 –

4-3. Endoscopes

WARNING:

WARNING:

NOTE:

F

U
L

R

D

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4-3-1. Pre-Cleaning

The importance of meticulous mechanical cleaning of the
endoscope and its removable components cannot be
overemphasized. Prior to disinfection or sterilization all
instruments and components must be scrupulously cleaned.
Failure to do so could result in incomplete or ineffective
disinfection and sterilization. During the reprocessing process,
always wear protective garments such as gloves, gowns and
face masks to minimize the risk of cross contamination.

During pre-clenaing, never wipe the insertion portion with
alcohol or disinfecting solution. These solutions may fix organic
contaminants and proteinaceous debris to the instrument and
have an adverse effect on endoscope functionality and proper
reprocessing.

1) Immediately after removing the endoscope from the patient, gently wipe all

debris from the insertion tube with gauze or the like moistened with

cleaning detergent solution.

Figure 4.1

2) Carefully remove the balloon attached to the distal end of the endoscope.

When removing the balloon, be careful not to damage the
endoscope, especially the sensitive transducer, optical lenses or
bending section at the distal portion. The balloons and O-Rings
are disposable and provided sterile for single patient use.

– 44 –

3) Place the distal end of the endoscope into detergent solution and aspirate

WARNING:

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3870UTK.book

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

through the instrument channel for 5~10 seconds by depressing OF-B171

halfway down (first stage) and confirm that solution is being aspirated by

moving the distal end above and below the liquid level, suctioning some air

and hearing the difference. Place the distal end of the endoscope into

detergent solution and aspirate through the balloon channel for 5~10

seconds by fully depressing suction/balloon suction valve (OF-B171)

(second stage) and confirm that solution is being aspirated by moving the

distal end above and below the liquid level, suctioning some air and hearing

the difference. Alternate aspiration of solution and air several times for each

channel by raising and lowering the distal end above and below the liquid

level to create agitation for better precleaning.

Figure 4.2

4) Set the lever on the water bottle cap to the drain position. With the air pump

of the processor turned ON and set to the HIGHEST pressure setting, partly

depress the air/water/balloon feeding valve (OF-B172) (first stage) of the

endoscope until all water has been discharged from the endoscope.

Alternate covering of the hole in the valve and depressing the valve to

forcefully expel mucous, debris, etc., which may have entered the air and

water channel. Then fully depress the valve (second stage) all the way down

until all water has been discharged.

5) (For EG-3870UTK) Attach the injection tube, OE-B5, to the elevator wire

channel cleaning inlet located below the control body. Using a 10 mL

syringe filled with detergent solution, flush the solution through the

injection tube down the entire length of the elevator wire channel until

detergent is seen exiting the distal channel opening (of the elevator wire

channel).

Check that there is no any damage on the luer connector prior to
use the injection tube (OE-B5). When the injection tube (OE-B5)
is connected with locking type of luer connector, ensure that the
luer connectors are properly locked. Do NOT use the the
injection tube (OE-B5), if there is damage of the luer connector
of the injection tube (OE-B5) and/or luer connection is not
properly locked.
The use of damaged luer connector may result in ineffectiveness
endoscope reprocessing due to water leakage from the
connected part or tube disconnection, posing a risk of cross­contamination.

– 45 –

4-3-2. Leakage Testing

CAUTION:

CAUTION:

(3)

(2)

(1)

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Before reprocessing and/or immersion in any fluids, PENTAX endoscopes

should be tested for the loss of integrity in their watertight construction by using

PENTAX brand leakage testers. For specific details on PENTAX recommended

leak detection procedures, please refer to the instructions devided with PENTAX

leakage testers.

Various types of endoscope leakage testers exist including the
Instructions for Use, electro-mechanical and “automated”
versions, some of which are stand alone units and others which
may be integrated into Automated Endoscope Reprocessor
(AER)/Washers-Disinfector (WD). It must be recognized that
PENTAX does not evaluate non-PENTAX leakage tester systems
to satisfy their specific product claims, for their effectiveness to
accurately detect leaks and/or for their compatibility with
PENTAX endoscopes. Insufficient pressures may reduce the
likelihood for accurate leak detection, especially if the
endoscope’s distal bending section is not flexed during testing.
Excessive pressures may adversely affect the endoscope,
especially if pressurization occurs during automated
reprocessing at elevated temperatures. PENTAX accepts no
responsibility for use of non-PENTAX leakage testers.
Users should check with the leakage tester manufacturer and
confirm their specific product claims, including compatibility with
PENTAX endoscopes at various temperatures and their ability to
detect leaks with/without fluid immersion and with/without
flexing of the endoscope’s distal bending section.

4-3-3. Cleaning

1) Prepare a tray/reprocessing basin with water and cleaning detergent per

Figure 4.3

NEVER subject the endoscope to ultrasonic cleaning methods.

detergent manufacturer's instructions. The solutions must be cleaning

detergents or other cleaning agents specially formulated to clean flexible

endoscopes. For specific brands of compatible solutions, please contact

your local PENTAX service facility.

(1) PVE Soaking Cap

(OE-C9)

(2) Ventilation Cap (OF-

C5)

(3) Scanning Unit

Connector Soaking
Cap (OE-U1)

– 46 –

CAUTION:

BEFORE IMMERSING:

CAUTION:

CAUTION:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

a) The 'Red' Ventilation Cap (OF-C5) must be taken OFF.
b) The PVE Soaking Cap (OE-C9) should be securely ON the

electrical contact.
c) The Scanning Unit Connector Soaking Cap (OE-U1) should be

securely ON the electrical contacts of the scanning unit

connector.

The use of cleaning detergent immediately after each procedure
to dissolve and remove organic contaminants and proteinaceous
debris is essential to the care and maintenance of the endoscope
from the standpoints of infection control and functionality.

2) a.Immerse the endoscope and its components in detergent solution. After

removing the removable components (numbered 1 through 4 in Figure

4.4), thoroughly (but gently) wash the entire surface of the endoscope and

its components.

Make sure that the recessed areas such as the channel openings, valve

cylinders, elevator (if present), distal endoscope end, etc. are brushed

clean using the provided brushes.

b. (For EG-3870UTK) The distal end of this endoscope has several

recessed areas including the groove for the balloon stabilization peg,

groove for balloon band, and elevator. Ensure that all recessed areas are

thoroughly cleaned with an appropriately sized cleaning brush (ex. CS-

C9S) or other means to remove any adherent organic soil/patient material.

(1)

Figure 4.4

• Do NOT squeeze or severely bend the insertion tube.

• Do NOT use any abrasive materials.

• Be careful to avoid damage to the distal lenses.

(2)

(3)

(4)

(1) Suction/Balloon

Suction Valve (OF­B171)

(2) Air/Water/Balloon

Feeding Valve
(OF-B172)

(3) Inlet Seal

(OF-B190)

(4) Inlet Cap (OE-B3)

(EG-3870UTK only)

(5) Scanning Unit

Connector Soaking
Cap (OE-U1)

(5)

– 47 –

3) Manual Cleaning of Channels and/or Ports/Cylinders by Brush

WARNING:

CAUTION:

CAUTION:

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A variety of special brushes have been provided to clean internal channels and tubes.
Whenever possible, the entire endoscope and its components should be immersed in
detergent solution during the remainder of the cleaning procedure.

After using operational/cleaning accessories (e.g., forceps, needles,
snares, brushes etc.) with the endoscope, carefully check that all
accessories are intact and that no parts have fallen off and become
lodged within the endoscope's instrument/suction channel.
Furthermore, ensure that any therapeutic devices (e.g., clips, stents,
etc.) passed through the channel are accounted for after use.
If the channel becomes blocked or clogged due to the
accumulation of debris, an accessory that cannot be removed, or
other cause, do NOT attempt to correct the blockage or continue
to use the endoscope. In such a case, contact your local PENTAX
Medical service facility to have the endoscope repaired.
The use of an endoscope with a blocked internal channel may
result in ineffective reprocessing and/or the introduction of debris
and/or device components into a patient during a subsequent
procedure, posing a risk of cross-contamination.

The cleaning brush (CS6021T) is for one time use. NEVER reuse
the brush on more than one instrument.

1) It is highly recommended that ONLY PENTAX cleaning brushes

specified in our Instructions for Use should be used to clean PENTAX

endoscopes.

2) PENTAX cleaning brushes have been specially designed to clean

various PENTAX internal channel systems and valves/ports/

cylinders. Validation studies have been performed supporting the

use of PENTAX supplied brushes and cleaning adapters for cleaning

PENTAX endoscopes following PENTAX manual reprocessing

instructions.

3) Over the years some other manufacturers’ cleaning brushes/devices

have been found to damage PENTAX endoscopes and/or create the

need for servicing as some cleaning devices can became lodged

(“stuck”) inside various lumens of PENTAX endoscopes. The

likelihood for endoscope damage or servicing increases if a cleaning

device does not have a protective tip (or contains any sharp-edged

surface), if its flexible shaft uses a flimsy plastic material that is not

firm enough to allow for easy accessory advancement and/or if the

proper sequence and/or direction of channel cleaning is not followed

as described in PENTAX Instructions for Use.

4) The cleaning brushes should be always inserted as described in this

Instructions for Use.

5) It is recommended that cleaning brushes should be grasped about 5

cm (2 inches) from any channel ports/openings while advancing/

withdrawing a brush. To avoid endoscope and brush damage, do not

use excessive force.

6) To prevent excess friction between brush and channel, do NOT

tightly coil the endoscope while brushing. Keep the insertion tube

and umbilical cord as straight as possible and never attempt to pass

the cleaning brush through a fully angulated endoscope. Failure to

follow these instructions could result in endoscope or brush damage.

7) PENTAX cleaning brush (CS6021T) should NOT be inserted from the

suction/balloon suction cylinder into suction tube within the

umbilical cord.

Bristles from the cleaning brush (CS6021T) could become stuck

within the suction/balloon suction cylinder when pulling it out from

the suction nipple at the PVE Connector.

– 48 –

(1) EG-3870UTK

Endoscope Distal End

(5)Suction/Balloon Suction Valve(OF-B171)

(3)Instrument Channel Inlet

(OF-B172)

(4)Suction

/Balloon Suction
Cylinder

Elevator Wire
Channel
Cleaning Inlet

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

Fig Place Brush Entrance Exit Section

(1)

Suction Tube CS6021T Suction Nipple

(2)

(3)

(4)

(5)

(6)

(7)

(8)

Air/Water/Suction Channel CS6021T Suction/Balloon Suction Cylinder

Instrument Channel Inlet CS-C9S Instrument Channel Inlet — 4-(c)

Suction/Balloon Suction Cylinder CS-C9S Suction/Balloon Suction Cylinder — 4-(d)

Suction/Balloon Suction Valve CS-C9S Suction/Balloon Suction Valve — 4-(e)

Endoscope Distal End CS-C9S Endoscope Distal End — 4-(f)-[1]

Air/Water/Balloon Feeding Valve CS-C9S Air/Water/Balloon Feeding Valve — 5-(a)

Air/Water/Balloon Feeding Cylinder CS-C9S Air/Water/Balloon Feeding Cylinder — 5-(b)

Suction

/Balloon Suction

Cylinder

Endoscope Distal

End

4-(a)

4-(b)

– 49 –

(2) EG-3670URK

(4) Suction

/Balloon Suction
Cylinder

Endoscope
Distal End

(5) Suction/Balloon Suction Valve (OF-B171)

(3) Instrument Channel Inlet

(OF-B172)

Balloon Injection Channel

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Fig Place Brush Entrance Exit Section

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

Suction

Suction Tube CS6021T Suction Nipple

Air/Water/Suction Channel CS6021T Suction/Balloon Suction Cylinder

Instrument Channel Inlet CS-C9S Instrument Channel Inlet — 4-(c)

Suction/Balloon Suction Cylinder CS-C9S Suction/Balloon Suction Cylinder — 4-(d)

Suction/Balloon Suction Valve CS-C9S Suction/Balloon Suction Valve — 4-(e)

Endoscope Distal End CS-C9S Endoscope Distal End — 4-(f)-[2]

Air/Water/Balloon Feeding Valve CS-C9S Air/Water/Balloon Feeding Valve — 5-(a)

Air/Water/Balloon Feeding Cylinder CS-C9S Air/Water/Balloon Feeding Cylinder — 5-(b)

/Balloon Suction

Cylinder

Endoscope

Distal End

4-(a)

4-(b)

– 50 –

4) Brush clean the entire instrument/suction channel system:

CAUTION:

WARNING:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

a) Using the cleaning brush (CS6021T), insert the blue tip end of the

brush into the opening of the suction nipple and gently pass the brush

until it appears in the suction/balloon suction cylinder. Grasp the back

end (blue tip) of the brush shaft and gently pull the brush from the

valve cylinder. This will clean the suction tube within the light guide/

umbilical cord.

Brush this

The cleaning brush (CS6021T) is for one time use.
NEVER reuse the brush on more than one instrument.

channel at least 2 times or until it is visibly clean.

(1) CS6021T
(2) CS6021T

Figure 4.5

• The cleaning brush (CS6021T) is provided non-sterile for one

•

(1)

(2)

time use. Never reuse the brush on more than one instrume
When using the cleaning brush (CS6021T), slowly remove it
from the endoscope being careful not to fling patient debris/
contaminants into air as the bristles exit the endoscope.

b) Insert the back end (blue) of the shaft of the cleaning brush (CS6021T)

into the opening at the bottom of the suction/balloon suction cylinder

on the control head and gently advance until it exists the endoscope

distal end. Grasp the back end of the brush shaft and then gently pull

nt.

the brush from the endoscope distal end. DO NOT USE EXCESS

FORCE.

Brush this channel at least 2 times or until it is visibly clean.

c) Insert the large bristle of the cleaning brush (CS-C9S) into the

instrument channel inlet until the grip is stopped at the inlet and scrub

clean the surface inside the instrument channel inlet and then gently

withdraw the brush. Repeat several times ensuring that only a clean

brush is introduced into the channel each time.

– 51 –

WARNING:

(1) CS-C9S

(1)

(2)

(1)

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(2) Instrument Channel

Inlet

Figure 4.6

d) Using the large bristle of the cleaning brush (CS-C9S), scrub clean the

surfaces inside the suction/balloon suction cylinder on the control

head. Do NOT insert the brush too far.

(1) CS-C9S

Figure 4.7

Be sure to inspect the bottom of the suction/balloon suction
cylinder on the control head for any debris.

e) Scrub all internal and external surface of the Suction/Balloon Suction

Valve OF-B171 using the smaller side of the cleaning brush (CS-C9S).

(1)

(2)

(3)

(1) OF-B171
(2) Press the button all the

way in to brush clean
the hole in the valve

stem.
(3) CS-C9S_Smaller end
(4) CS-C9S_Smaller end

(4)

Figure 4.8

– 52 –

CAUTION:

While fully immersed, manipulate valve mechanisms and inject

CAUTION:

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3870UTK.book

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

detergent via syringe into/through removable endoscope
components. This will remove entrapped air bubbles that could
inhibit contact of solution with component surfaces and provide
for better exposure of surfaces to detergent.

A worn or damaged valve and/or O-Ring should be replaced with
a new one. The entire valve mechanism should be subjected to a
high-level disinfection or sterilization procedure prior to use (O­Ring set, Model OF-B187, is optionally available). Failure to do
so could result in continuous aspiration which in certain clinical
situations can suction tissue into the distal channel opening at
the endoscope distal end and/or create a loss of insufflated air
via the suction system. A compromised valve could also result in
the potential for reflux or spit-back of patient fluids that may
present infection control risks.

f) [1] (For EG-3870UTK) If not already done, using the cleaning brush

(CS-C9S) the distal end of the endoscope including the elevator,

area in back of and surrounding the elevator and the grooves for

the balloon stabilization peg and balloon band.

[2] (For EG-3670URK) If not already done, using the cleaning brush

(CS-C9S) the distal end of the endoscope including the grooves

for the balloon band.

5) Brush clean the Air/Water/Balloon Feeding Valve (OF-B172) and Cylinder

The entire air/water system must be cleaned by exposure to an appropriate

cleaning solution prior to high-level disinfection or sterilization.

a) Remove the Air/Water/Balloon Feeding Valve (OF-B172). Scrub all

internal and external surface of the valve using the smaller side of the

cleaning brush (CS-C9S). Repeat several times until the bristle of the

brush is visibly clean.

(1) OF-B172

(2)

(2) CS-C9S

Figure 4.9

(1)

– 53 –

CAUTION:

While fully immersed, manipulate valve mechanisms and inject

CAUTION:

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detergent via syringe into/through removable endoscope
components. This will remove entrapped air bubbles that could
inhibit contact of solution with component surfaces and provide
for better exposure of surfaces to detergent.

A damaged or worn Air/Water/Balloon Feeding valve(OF-B172)
(and/O-Rings) could create continuous air flow or excessive air
insufflation and result in potential patient injury such as
pneumatic perforation. If there is any doubt, replace valves and/
or O-Rings with a new, fully reprocessed ones. Also, any
damaged or worn O-Ring should be replaced with a new one (O­Ring set, Model OF-B191, is optionally available).

b) Using the larger end of the cleaning brush (CS-C9S), scrub clean the

surfaces inside the air/water cylinder. Repeat brushing at least 2 times

or until the bristles of the brush are visibly clean.

(1) CS-C9S

(1)

Figure 4.10

– 54 –

6) Chemical Cleaning by Detergent Solution

WARNING:

CAUTION:

NOTE:

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3870UTK.book

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

• The cleaning detergent solution must remain in contact with
ALL internal channels and external surfaces for the time period
recommended by the detergent manufacturer.

• It is important that ALL internal channels (e.g., air,water,

instrument, elevator wire channel), external endoscope
surfaces, and components be thoroughly rinsed with clean
water to remove residual detergent solution.

• Prior to disinfection or sterilization, it is imperative that any
solutions previously used in the cleaning process be thoroughly
rinsed and dried. Failure to do so could result in effective or
incomplete disinfection or sterilization.

• During all flushing steps, always make sure that there are no

obstructions or blockages within ANY internal channel system
by confirming that solution always exits the appropriate distal
channel opening(s) at the scope distal end.

• To ensure smooth operation and maximum performance and

to avoid potential cross-contamination, the elevator wire
channel as well as all other channels must be reprocessed
after each procedure.

• Do NOT put tension on the insertion tube of the endoscope

while drying, as the outer cover of the bending section may
be excessively stretched.

It is imperative that the air/water/balloon feeding valve (OF­B172) and the suction/balloon suction valve (OF-B171) be
securely attached to their respective valve cylinders. Failure to
properly match and secure these valves can result in ineffective
and incomplete reprocessing.

a) EG-3870UTK

OUTLINE:The following shows the overview of steps in the

chemical cleaning process

a)-1 Injecting detergent solution into the channels

[1] Preparation
[2] Air/W
[3]
[4]

ater, Balloon injection channel
Suction, Balloon suction channel
Elevator wire channel

a)-2 Immersion in detergent solution
a)-3 Removal of detergent solution from the channels
a)-4 External surface rinse
a)-5 Rinsing of channels
a)-6 Removal of water from the channels
a)-7 Dry

– 55 –

Channel

(1)

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Air channel

Water channel

Balloon injection

channel

Suction channel

Balloon suction

channel

Elevator wire

channel

Table 1 The table above shows the amount of solution/water and air to be injected into the

channels.
Follow the precise instruction in each section for proper cleaning process.

Adapters/Components

to be attached

OF-B172:

Air/Water/Balloon

feeding valve

OF-G17:

Cleaning adapter

OF-B171:

Suction/Balloon suction

valve

OF-B190:

Inlet seal

OE-B5:

Injection tube

Syringe

50ml 40ml or more 70ml or more

50ml 40ml or more 70ml or more

50ml 10ml or more 15ml or more

50ml 60ml or more 100ml or more

50ml

10ml

Detergent

Solution

10ml

or more

5ml

or more

Rinse

water/Air

15ml

or more

10ml

or more

a)-1 Inject detergent solution into the channels

Always immerse the endoscope during cleaning

[1] Preparation

[a] Install the air/water/balloon feeding valve (OF-B172) into the air/

water cylinder, and install the suction/balloon suction valve (OF-

B171) into the suction cylinder.

[b] Install the cleaning adapter (OF-G17) on the air/water port.

[c] Attach the inlet seal (OF-B190) to the instrument channel inlet.

[2] Air/Water, Balloon injection channel

[a] While covering the hole at the top of the air/water/balloon feeding

valve (OF-B172), attach a 50ml syringe to the cleaning adapter

(OF-G17) and inject a minimum of 40ml of detergent solution into

the air channel.

(1) OF-G17

Figure 4.11

– 56 –

[b] While depressing the button of the air/water/balloon feeding valve

(1)

(1)

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

(OF-B172) to the first stop, attach a 50ml syringe to the cleaning

adapter (OF-G17) and inject a minimum of 40ml of detergent

solution into the water channel.

Figure 4.12

(1) OF-G17

[c] While fully depressing the button of the air/water/balloon feeding

valve (OF-B172), attach a 50ml syringe to the cleaning adapter

(OF-G17) and inject a minimum of 10ml of detergent solution into

the balloon injection channel.

Figure 4.13

(1) OF-G17

– 57 –

[3] Suction, Balloon suction channel

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[a] While depressing the button of the suction/balloon suction valve

(OF-B171) to the first stop, attach a 50ml syringe to the suction

nipple and inject a minimum of 60ml of detergent solution into the

suction channel.

Figure 4.14

[b] While fully depressing the button of the suction/balloon suction

valve (OF-B171), attach a 50ml syringe to the suction nipple and

inject a minimum of 10ml of detergent solution into the balloon

suction channel.

Figure 4.15

– 58 –

[c] Detach the cleaning adapter (OF-G17), inlet seal (OF-B190),

CAUTION:

WARNING:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

suction/balloon suction valve (OF-B171), and air/water/balloon

feeding valve (OF-B172) from the endoscope, while the instrument

and components remain completely immersed in detergent

solution. Open the cap of inlet seal (OF-B190) during immersion.

[4] Elevator wire channel

To ensure smooth operation and maximum performance and to
avoid potential cross-contamination for patients, the elevator
wire channel must be cleaned after each procedure.

[a] Attach the injection tube (OE-B5) to the elevator wire channel cleaning inlet.

[b] Attach 10ml syringe to the injection tube (OE-B5) and inject a

minimum of 5ml of detergent solution into the elevator wire channel.

Check that there is no any damage on the luer connector prior to
use the injection tube (OE-B5). When the injection tube (OE-B5) is
connected with locking type of luer connector, ensure that the luer
connectors are properly locked. Do NOT use the the injection tube
(OE-B5), if there is damage of the luer connector of the injection
tube (OE-B5) and/or luer connection is not properly locked. The
use of damaged luer connector may result in ineffectiveness
endoscope reprocessing due to water leakage from the connected
part or tube disconnection, posing a risk of cross-contamination.

[c] Detach the injection tube (OE-B5) and 10ml syringe. Leave the

injection tube (OE-B5) immersed in the detergent solution.

a)-2 Immersion in detergent solution

[a] While fully immersed, ensure there are no air bubbles on the scope

surfaces, distal end, all around the elevator (including onto and behind

it) and components. If air bubbles are observed, inject detergent

solution using a 50 mL syringe until no air bubbles are observed.

[b] Immerse the endoscope, cleaning adapter (OF-G17), inlet seal (OF-B190),

injection tube (OE-B5), suction/balloon suction valve (OF-B171), and air/

water/balloon feeding valve (OF-B172) under conditions (temperature,

concentration, time) specified by the manufacturer of the detergent.

a)-3 Removal of detergent solution from the channels

[a] Inject air using the same procedure as described in section 6)-a)-1,

“Inject detergent solution into the channels”.

Consult

Tab le 1

for details concerning the volumes of air to be used.

[b] Remove the endoscope and its components from the detergent solution.

a)-4 External surface rinse

[a] Prepare a basin with clean water and immerse the endoscope and

its components.

[b] Rinse the external surface of the endoscope.

[c] Discard the water.

[d] Fill the basin with clean water and repeat steps [b] and [c].

[e] Fill the basin with clean water.

– 59 –

a)-5 Rinsing of channels

WARNING:

WARNING:

(1)

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Inject clean water using the same procedure as described in section

6)-a)-1, “Inject detergent solution into the channels”.

Leave cleaning adapter (OF-G17), inlet seal (OF-B190), injection

tube (OE-B5), suction/balloon suction valve (OF-B171), and air/

water/balloon feeding valve (OF-B172) connected to the

endoscope.

Consult Ta bl e 1 for details concerning the volumes of rinse water

to be used.

a)-6 Removal of water from the channels

After removing the endoscope and its components from the water,

Inject air using the same procedure as described in section 6)-a)-1,

“Inject detergent solution into the channels”.

Consult Tabl e 1 for details concerning the volumes of air to be

used.

a)-7 Dry

Gently dry all external surfaces of the endoscope with soft gauze or a

similar material. Remove the soaking caps and dry the electrical contacts

and the objective lens with a cotton tip applicator.

Figure 4.16

It is important that ALL internal channels such as air, water,
instrument, elevator wire channel etc., external endoscope
surfaces and components be thoroughly rinsed with clean water
to remove residual detergent solution.

(1) Objective Lens

Prior to disinfection or sterilization, it is imperative that any
solutions previously used in the cleaning process be thoroughly
rinsed and dried. Failure to do so could result in ineffective or
incomplete disinfection and sterilization.

– 60 –

b) EG-3670URK

(1)

(2)

(3)

[1]

(2)

(1)

(3)

[2]

[3]

(1)

(2)

[4]

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Channel

Air/Water/

Suction/Balloon

channel

Adapters/Components

to be attached

OF-B153

OE-C5

Inlet Seal

Syringe Detergent Rinse water

50mL

110 mL

or more

200mL

or more

The Cleaning Adapter (OF-B153) should be attached to the air/water and

suction cylinders. This adapter caps (seals) off the air/water/balloon

cylinder and suction/balloon cylinder to allow unidirectional flow of

solution through these delivery/aspiration systems.

b)-1 For Air/Water/Suction/Balloon channel cleaning when using the Cleaning

Adapter (OF-B153) adapter

[1] Raise the locking cap and slide the side covers (marked with )

downward.

[2] Align the cylinder guide over the air/water/balloon feeding

cylinder port and the suction/balloon suction cylinder ports after

removing parts OF-B172 and OF-B171 from these two ports.

[3] Slide the Cleaning Adapter (OF-B153) forward.

[4] Holding the side covers (marked with ), push down and slide

the locking cap under the locking tab to secure.

[5] Lock the locking cap with the locking tab of the base.

(1) Locking Cap
(2) Rubber Seal
(3) Base

(1) Cylinder Guide
(2) Cylinder Ports
(3) Cylinder Receptacle

(1) End of Locking Cap
(2) Locking Tab

– 61 –

NOTE:

(1) Locking Tab

(1)

(1)

[5]

(1)

(2)

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Figure 4.17

It is imperative that the Cleaning Adapter (OF-B153) be securely
attached to valve cylinders. Failure to properly secure the
cleaning adapter could result in ineffective and incomplete
reprocessing.

[6] Unlike most other PENTAX gastroscopes, the EG-3670URK has a

common channel for air, water and suction functions. Therefore, the

cleaning adapters and actual connections for reprocessing of the

internal channels are different for the endoscope compared to other

PENTAX endoscopes. For simultaneous flushing of the entire air,

water, suction/biopsy and balloon channel systems, the unique

PENTAX Cleaning Adapter (OE-C5) must be used. After connecting

the metal portion of Cleaning Adapter (OE-C5) to the air/water port

on the PVE connector, attach the open end of the tube to the suction

nipple. Install the inlet seal on the instrument channel inlet prior to

injecting cleaning solution into the channel. Please refer to the internal

schematics.

Figure 4.18

[7]

(1) Cleaning Adapter

(OE-C5)

(2) Cleaning Adapter

(OF-B153)

Attach a 60 mL syringe filled with cleaning detergent directly to the

top (luer fitting) of the Cleaning Adapter (OE-C5). While the

endoscope remains completely submerged, flush the cleaning solution

through the Cleaning Adapter (OE-C5) into all the internal channels.

Applying steady, forceful pressure to the syringe will create a fast

moving, turbulent flow of solution to better aid in the removal of

adherent debris.

– 62 –

[8] Repeat this process a second time for a total of at least two full

CAUTION:

WARNING:

WARNING:

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syringes to ensure complete filling of all internal channels with

detergent. Avoid introduction of air into the channels during flushing.

During all flushing steps always make sure that there are no
obstructions or blockages within ANY internal channel system by
confirming that solution always comes out all distal channel
openings at the endoscope distal end.

The cleaning detergent solution should remain in contact with
ALL internal channels and external endoscope surfaces for the
time period recommended by the manufacturer of the detergent.

b)-2 After the endoscope and its component parts have been in contact with the

detergent solution for the time period recommended by the manufacturer of

the solution, attach the previously removed adapters, inlet seal and injection

tube and purge all internal channels with air (using a syringe) to expel

residual detergent solution out from each channel, then remove the

endoscope and its components from the solution.

b)-3 Using clean water, immerse the entire endoscope as well as all removed

components and thoroughly rinse all items. While fully immersed,

manipulate valve mechanism and inject clean water via syringe into/through

removable endoscope components.

b)-4 With all cleaning adapters, including inlet seal, still attached to the

endoscope, flush all previously air purged channels with clean water (at

least 180 mL for Air/Water/Suction/Balloon channels). All internal

channels must be thoroughly rinsed to remove residual detergent and debris.

It is important that ALL internal channels such as air, water,
instrument, etc., external endoscope surfaces and components
be thoroughly rinsed with water to remove residual detergent
solution.

b)-5 Remove the endoscope and its components from the solution.

b)-6 Rinse water remaining within the channels should be purged by using air to

prevent dilution and/or adulteration of antimicrobial agents to be used in the

subsequent disinfection or sterilization process. Remove the cleaning

adapter, inlet seal and the syringe.

– 63 –

b)-7 Gently dry all external surfaces of the endoscope with soft gauze or a

CAUTION:

WARNING:

EG-3670URK

(1)

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similar material. Remove the soaking caps and dry the electrical contacts

and the objective lens with a cotton tip applicator.

(1) Objective Lens

Figure 4.19

Do NOT put tension on the insertion tube on the endoscope
while drying since the outer cover of the bending section may be
excessively stretched.

Prior to disinfection or sterilization, it is imperative that any
solutions previously used in the cleaning process be thoroughly
rinsed and dried. Failure to do so could result in ineffective or
incomplete disinfection and sterilization.

– 64 –

4-3-4. High-Level Disinfection

WARNING:

WARNING:

CAUTION:

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Before any attempt is made to disinfect the endoscope, the complete cleaning

procedure described elsewhere in this Instructions for Use must have been

completed.

Prior to high-level disinfection, the end user should confirm the minimum

effective concentration (MEC) of reused disinfectant, as per the manufacturer’s

instructions. Before complete immersion in any disinfecting solution, the

endoscope should have been “Leakage Tested” as described elsewhere in this

Instructions for Use.

It is imperative that flexible endoscopes and other semi-critical
devices be reprocessed using at least high-level disinfection with
a legally marketed sterilant/disinfectant. Only legally marketed
endoscope automated reprocessing devices/systems whose
device specific claims have been validated by the AER/WD
manufacturer and anti-microbial agents which have been tested
and found to be compatible by PENTAX should be used with
PENTAX products.
Endoscopes are semi-critical devices that require at least high­level disinfection. Only use legally marketed solutions and/or
automatic endoscope reprocessing machines or washing
disinfection machines whose manufacturers have made
validation testing with PENTAX products (specific to PENTAX
endoscope model number). A listing of legally marketed
solutions/systems which have been determined to be compatible
with PENTAX brand products is available from your local PENTAX
dealer/authorized service facility. Be aware of the important
note regarding infection control on the inside cover of this
Instructions for Use.

The disinfecting solution must remain in contact with ALL
internal channels and external surfaces for the time period
recommended by the disinfectant manufacturer.

BEFORE IMMERSING:
a) The ‘Red’ Ventilation Cap (OF-C5) must be taken OFF.
b) The PVE Soaking Cap (OE-C9) should be securely ON the

electrical contacts.

c) The Scanning Unit Connector Soaking Cap (OE-U1) should be

securely attached to the electrical contacts of the scanning
unit connector.

– 65 –

CAUTION:

• During all flushing steps, always make sure that there are no

NOTE:

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obstructions or blockages within ANY internal channel system
by confirming that solution always exits the appropriate distal
channel opening(s) at the endoscope distal end.

• To ensure smooth operation and maximum performance and
to avoid potential cross-contamination, the elevator wire
channel (EG-3870UTK) as well as all other channels must be
reprocessed after each procedure.

• Do NOT put tension on the insertion tube of the endoscope
while drying, as the outer cover of the bending section may
be excessively stretched.

1) EG-3870UTK

It is imperative that the air/water/balloon feeding valve (OF­B172) and the suction/balloon suction valve (OF-B171) be
securely attached to their respective valve cylinders. Failure to
properly match and secure these valves can result in ineffective
and incomplete reprocessing.

OUTLINE: The following shows the overview of steps in the high level

disinfection process

a) In

ject disinfecting solution into the channels

a)-1 Preparation
a)-2 Air/Water, Balloon injection channel
a)-3 Suction, Balloon suction channel

a)-4 Elevator wire channel
b) Immersion in disinfecting solution
c) Removal o
d) External surface
e) Rin

sing of channels

f) Removal of water from the

f disinfecting solution from the channels

rinse

channels

g) Dry

Channel

Air channel

Balloon channel

Balloon injection

channel

Suction channel

Balloon suction

channel

Elevator wire

channel

Table 2 The table above shows the amount of solution/water and air to be injected

into the channels.
Follow the precise instruction in each section for proper disinfection
process.

Adapters/Components

to be attached

OF-B172:

Air/Water/Balloon

feeding valve

OF-G17:

Cleaning adapter

OF-B171:

Suction/Balloon suction

valve

OF-B190:

Inlet seal

OE-B5:

Injection tube

Syringe

50ml 40ml or more 70ml or more

50ml 40ml or more 70ml or more

50ml 10ml or more 15 ml or more

50ml 60ml or more 100ml or more

50ml

10ml

Disinfecting

Solution

10ml

or more

5 ml

or more

Rinse

water/Air

15ml

or more

10ml

or more

– 66 –

a) Inject disinfecting solution into the channels

(1)

(1)

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Always immerse the endoscope during disinfection

a)-1 Preparation

[1] Install the air/water/balloon feeding valve (OF-B172) into the air/

water cylinder, and install the suction/balloon suction valve (OF-

B171) into the suction cylinder.

[2] Install the cleaning adapter (OF-G17) on the air/water port.

[3] Attach the inlet seal (OF-B190) to the instrument channel inlet.

a)-2 Air/Water, Balloon injection channel

[1] While covering the hole at the top of the air/water/balloon feeding

valve (OF-B172), attach a 50ml syringe to the cleaning adapter

(OF-G17) and inject a minimum of 40ml of disinfecting solution

into the air channel.

(1) OF-G17

Figure 4.20

[2] While depressing the button of the air/water/balloon feeding valve

(OF-B172) to the first stop, attach a 50ml syringe to the cleaning

adapter (OF-G17) and inject a minimum of 40ml of disinfecting

solution into the water channel.

(1) OF-G17

Figure 4.21

– 67 –

[3] While fully depressing the button of the air/water/balloon feeding

(1)

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valve (OF-B172), attach a 50ml syringe to the cleaning adapter

(OF-G17) and inject a minimum of 10ml of disinfecting solution

into the balloon injection channel.

Figure 4.22

a)-3 Suction, Balloon suction channel

[1] While depressing the button of the suction/balloon suction valve

(OF-B171) to the first stop, attach a 50ml syringe to the suction

nipple and inject a minimum of 60ml of disinfecting solution into

the suction channel.

(1) OF-G17

Figure 4.23

– 68 –

[2] While fully depressing the button of the suction/balloon suction valve (OF-

CAUTION:

WARNING:

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

B171), attach a 50ml syringe to the suction nipple and inject a minimum of

10ml of disinfecting solution into the balloon suction channel.

Figure 4.24

[3] Detach the cleaning adapter (OF-G17), inlet seal (OF-B190),

suction/balloon suction valve (OF-B171), and air/water/balloon

feeding valve (OF-B172) from the endoscope, while the instrument

and components remain completely immersed in disinfecting

solution. Open the cap of inlet seal (OF-B190) during immersion.

a)-4 Elevator wire channel

To ensure smooth operation and maximum performance and to
avoid potential cross-contamination for patients, the elevator
wire channel must be cleaned after each procedure.

[1] Attach the injection tube (OE-B5) to the elevator wire channel

cleaning inlet.

[2] Attach 10 mL syringe to the injection tube (OE-B5) and inject a

minimum of 5ml of disinfecting solution into the elevator wire

channel.

Check that there is no any damage on the luer connector prior to
use the injection tube (OE-B5). When the injection tube (OE-B5) is
connected with locking type of luer connector, ensure that the luer
connectors are properly locked. Do NOT use the the injection tube
(OE-B5), if there is damage of the luer connector of the injection
tube (OE-B5) and/or luer connection is not properly locked. The
use of damaged luer connector may result in ineffectiveness
endoscope reprocessing due to water leakage from the connected
part or tube disconnection, posing a risk of cross-contamination.

– 69 –

[3] Detach the injection tube (OE-B5) and 10ml syringe. Leave the

WARNING:

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injection tube (OE-B5) immersed in the disinfecting solution.

b) Immersion in disinfecting solution

[1] While fully immersed, ensure there are no air bubbles on the scope

surfaces, distal end, all around the elevator (including onto and behind

it) and components. If air bubbles are observed, inject disinfecting

solution using a 50 mL syringe until no air bubbles are observed.

[2] Immerse the endoscope, cleaning adapter (OF-G17), inlet seal

(OF-B190), injection tube (OE-B5), suction/balloon suction valve

(OF-B171), and air/water/balloon feeding valve (OF-B172) under

conditions (temperature, concentration, time) specified by the

manufacturer of the disinfectant.

The disinfecting solution must remain in contact with the ALL
internal channels and external endoscope surfaces for the time
period recommended by the manufacturer of the disinfectant.

c) Removal of disinfecting solution from the channels

[1] Inject air using the same procedure as described in section 1)-a,

“Inject disinfecting solution into the channels”.

Consult

Tab l e 2

for details concerning the volumes of air to be used.

[2] Remove the endoscope and its components from the disinfecting solution.

d) External surface rinse

[1] Prepare a basin with sterile water and immerse the endoscope and

its components.

[2] Rinse the external surface of the endoscope.

[3] Discard the water.

[4] Fill the basin with sterile water and repeat steps [2] and [3].

[5] Fill the basin with sterile water.

e) Rinsing of Channels

[1] Inject sterile water using the same procedure as described in

section 1)-a, “Inject disinfecting solution into the channels”.

Leave the cleaning adapter (OF-G17), inlet seal (OF-B190), injection

tube (OE-B5), suction/balloon suction valve (OF-B171), and air/

water/balloon feeding valve (OF-B172) connected to the endoscope.

Consult Ta bl e 2 for details concerning the volumes of rinse water

to be used.

f) Removal of water from the channels

[1] After removing the endoscope and its components from the water,

Inject air using the same procedure as described in section 1)-a,

“Inject disinfecting solution into the channels”.

Consult

Tab l e 2

for details concerning the volumes of air to be used.

– 70 –

g) Dry

WARNING:

WARNING:

CAUTION:

(1)

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Gently dry all external surfaces of the endoscope with soft gauze or the

like. Dry the electrical contacts and the objective lens with a cotton-tip

applicator.

Figure 4.25

• Ideally, all final rinses should be performed with sterile water.

(1) Objective Lens

However, if sterile water is not used, use portable water or
water that meets the requirements of the health care facility or
national/local regulations.

• It is important to completely dry the endoscope channels in
order to prevent bacterial colonization and/or infections
associated with waterborne microorganisms. In some
countries a final alcohol rinse followed by forced air, not
greater than 165kPa (24 PSI) is recommended. However, in
case this not in accordance with your national/regional
regulations or guidances, sterile water must be used as the
rinse water and completely dry the endoscope channels.

If the endoscope is to be stored after reprocessing, detach
removable valves, components, etc. All channels, valves and
valve cylinders should be completely dry before storage.

PENTAX recommended rinsing parameters described in this
section on high-level disinfection apply to the use of a 2.4%
alkaline Glutaraldehyde solution containing no surfactants.
Always check with the manufacturer of the liquid chemical
germicide (or AER for “automated reprocessing”) to confirm that
their specific rinsing instructions are based upon validated test
data demonstrating that no harmful levels of residues remain on
any device or lumen surfaces that may pose a risk to patient
and/or user.

– 71 –

2) EG-3670URK

CAUTION:

WARNING:

WARNING:

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Channel

Air/Water/

Suction/Balloon

channel

Adapters/

Components to be

attached

OF-B153

OE-C5

Inlet seal

Syringe

50mL

Disinfecting

solution

110 mL

or more

Rinse
water

200mL

or more

(if applicable)

a) The cleaning adapter (OF-B153) and cleaning adapter (OE-C5) should

be installed on the endoscope. Confirm that an inlet seal is attached to

the channel inlet during the next step. All subsequent reprocessing

steps should be performed while the entire instrument remains fully

immersed in the disinfecting solution.

b) [1] Cleaning adapter (OE-C5) incorporates a standard ISO luer lock

connector to which a syringe or other device should be attached.

Fresh disinfecting solution (or used disinfectant whose MEC has

been confirmed) should be flushed into this connector and

disinfectant will simultaneously flow through the channels of the

endoscope. (Please refer to the internal schematics)

Attach a 60 mL syringe filled with a high-level disinfecting

[2]

solution directly to the top of the cleaning adapter (OE-C5) . While

the endoscope remains completely submerged, flush the

disinfectant through the cleaning adapter (OE-C5) into all the

internal channels (air, water, suction and balloon). Applying steady,

forceful pressure to the syringe will allow penetration of solution to

these internal channels.

[3] R

epeat this process a second time with another 60 mL syringe to

ensure complete filling of all internal channels with disinfectant.

Alcohol

flash

60mL

During all flushing steps always make sure that there are no
obstructions or blockages within ANY internal channel system by
confirming that solution always comes out all distal channel
openings at the endoscope distal end.

Avoid introduction of air during the flushing process. Confirm
that no air bubbles exit from the channel openings at the
endoscope distal end. The presence of the air bubbles could
prevent contact of the disinfectant with channel surfaces.

It is imperative that ALL internal surfaces of the channels are in
contact with the disinfecting solution for the time period
recommended by the manufacturer of the solution.

– 72 –

c) To provide the endoscope being completely submerged in the

(1)

DC

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disinfecting solution, all cleaning/disinfecting adapters, the injection

tube, the inlet seal and syringes should be detached to allow contact of

disinfectant with all previously mated surfaces.

(1) Follow exposure times

as per product label

Figure 4.26

d) While fully immersed, manipulate the valve mechanisms and inject

disinfecting solution via syringe into/through removable endoscope

components. Also inject disinfecting solution into/through inlet seal. This

will remove entrapped air bubbles that could inhibit contact of solution

with component surfaces and provide for better exposure of surfaces to

disinfecting solution. The endoscope’s component parts, including all

valves, should remain in contact with the disinfecting solution for the

time period recommended by the manufacturer of the solution.

e) After the endoscope and its component parts have been in contact with

the disinfecting solution for an appropriate time, attach the previously

removed adapters, inlet seal and flush all channels with air to purge

remaining disinfecting solution using the syringes, then remove the

endoscope and its components from the solution. Thoroughly rinse the

entire endoscope and all its components with sterile water. Typical

rinsing recommendations following exposure to a generic 2.4%

alkaline Glutaraldehyde disinfectant solution containing no surfactants

call for three separate complete immersions in fresh sterile water.

f) With the channel cleaning adapter (OF-B153 and OE-C5) and inlet

seal attached, a 60 mL syringe filled with sterile water should be

attached to the cleaning adapter (OE-C5) to flush the Air/Water/

Suction/Balloon channels with at least 180 mL sterile water. Fill a

syringe with air and flush through the channels several times to force

any residual water out of the tubing.

If alcohol is not allowed to use, skip step g).

g) A final alcohol rinse of external instrument surfaces and ALL internal

channels, including the elevator wire followed by forced air to thoroughly

dry all areas should be performed. As before syringes and channel

adapters should be used to flush 70-90% medical grade ethyl or isopropyl

alcohol through all channels – at least two 60 mL syringes of alcohol

should be flushed through the air/water/suction/balloon channels. All

channels must then be thoroughly dried using forced air up to 24 PSI.

– 73 –

h) The following steps may be performed to aid in the drying process, if

(1)

(2)

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filtered compressed or forced air is not available.

[1] Remove the cleaning adapters (OE-B153), reinstall the previously

reprocessed suction/balloon suction valve (OF-B171) and air/

water/balloon feeding valve (OF-B172) and the inlet seal.

[2] Attach the endoscope to an external suction source, and aspirate air

through the channel to remove any residual moisture and to air dry

channel surfaces.

(1) A/W
(2) DRAIN

Figure 4.27

[3] Attach the endoscope to the processor with the air pump turned ON

to its HIGHEST pressure setting, and the drain lever of the water

bottle set in the DRAIN position, depress the air/water/balloon

feeding valve (OF-B172) of the endoscope down to the first stage

and then down to the second stage until all moisture has been

discharged from the water and water injection channels, exiting the

endoscope distal end. Thoroughly drain all moisture from the air

channel as well by covering the hole in the air/water/balloon

feeding valve (OF-B172).

[4]Thoroughly air purge the exposed elevator wire channel several

times using a 10 mL syringe.

i) Gently dry all external surfaces of the endoscope with soft gauze or

the like. Dry the electrical contacts and the objective lens with a

cotton-tip applicator.

EG-3670URK

(1)

Figure 4.28

– 74 –

(1) Objective Lens

CAUTION:

Do NOT put tension on the insertion tube while drying since the

WARNING:

CAUTION:

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outer cover of the bending section may be excessively stretched.

If the endoscope is to be stored after reprocessing, detach
removable valves, components, etc. All channels, valves and
valve cylinders should be completely dry before storage.

PENTAX recommended rinsing parameters described in this
section on high-level disinfection apply to the use of a 2.4%
alkaline Glutaraldehyde solution containing no surfactants.
Always check with the manufacturer of the liquid chemical
germicide (or AER for “automated reprocessing”) to confirm that
their specific rinsing instructions are based upon validated test
data demonstrating that no harmful levels of residues remain on
any device or lumen surfaces that may pose a risk to patient
and/or user.

– 75 –

4-3-5. Sterilization

CAUTION:

WARNING:

CAUTION:

(1)

(2)

(3)

(4)

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Before any attempt is made to sterilize the endoscope, the complete cleaning

procedure as described elsewhere in this Instructions for Use must have been

completed.

A) Ethylene Oxide Gas Sterilization

Ethylene Oxide (ETO) Gas Sterilization can be performed on these endoscopes,

provided the following special instructions, which may differ from other

endoscopes, are followed to ensure the proper performance of the instrument.

Adhere to the ETO sterilizer manufacturer’s instructions and always use a

biological indicator.

1) The endoscope must first have been properly cleaned and thoroughly dried

according to the instructions in this Instructions for Use and each of the

component parts such as air/water/balloon feeding valve, suction/balloon

suction valve, inlet seals and inlet cap OE-B3 (For EG-3870UTK), etc.

should be removed.

NEVER place the endoscope in a steam autoclave nor subject it
to high-frequency ultrasonic cleaning methods!! Follow provided
ETO gas sterilization parameters.

(1) Suction/Balloon

Suction Valve (OF­B171)

(2) Air/Water/Balloon

Feeding Valve
(OF-B172)

(3) Inlet Seal

(OF-B190)

(4) Inlet Cap (OE-B3)

(EG-3870UTK only)

Figure 4.29

Failure to thoroughly dry all surface areas could result in
incomplete or ineffective sterilization. Moisture could prevent
contact of the ETO gas with the actual contaminated surfaces.

Prior to placing these endoscopes in a Gas Sterilizer or Aeration
Chamber:
a) The ‘Red’ Ventilation cap MUST be “ON” securely.
b) The PVE soaking cap OE-C9 should be “OFF” the electrical

contacts.

c) The scanning unit connector soaking cap OE-U1 should be

“OFF” the electrical contacts of the scanning unit connector.

This is opposite of the immersion instructions.

– 76 –

CAUTION:

WARNING:

(1) PVE Soaking Cap

(2)

(3)

(1)

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(OE-C9)

(2) Ventilation Cap (OF-

C5)

(3) Soaking Unit

Connector Soaking
Cap (OE-U1)

Figure 4.30

2) The following parameters for Ethylene Oxide Gas Sterilization are

proposed:

Temperature: 55°C (131°F)

Relative Humidity: 50%RH

EO Concentration : 600-650 mg/L

Gas Exposure Time: 5 Hours

Aeration: 12 Hours at 55°C (131°F)

B) Other Methods of Sterilization

Other types of sterilization systems/processes are available for the reprocessing

of medical devices. However, due to the heat sensitive nature and/or the specific

biocompatible materials used in the construction of flexible endoscopes, some of

these marketed systems/processes/ solutions could have detrimental effects on

flexible endoscopes. To avoid the potential for instrument damage and/or

endoscope failure, confirm the compatibility of such sterilization systems/

solutions with your local PENTAX service facility prior to use with any

PENTAX products.

Prior to using other methods, confirm the specific claims of any sterilization

methods/processes with the sterilizer manufacturer and ensure that they have

performed microbiological validation studies that support their claims of

achieving sterilization of device specific flexible endoscopes and endoscope

components.

Use appropriate heat process indicators and/or biological
monitors as recommended by the manufacturer of the sterilizer.

In addition to efficacy claims always check with the
manufacturer of the sterilizer/disinfector to confirm that they
have test data demonstrating that no harmful levels of any
residues (active/inert ingredients, their byproducts or
derivatives of the processed devices) remain on any instrument
or lumened surfaces that may pose a risk to patients and users.

– 77 –

4-4. Endscopic Accessory Instruments (EAIs) and Endoscope

CAUTION:

CAUTION:

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Components

4-4-1. Cleaning

NEVER use ultrasonic cleaning methods with high-frequency
ultrasound on the endoscope itself.

Not all manufacturers of Automated Endoscope Reprocessors
(AERs) and Washer-Disinfectors (WDs) make specific claims nor
provide special instructions for reprocessing all of the removable
endoscope components that are integral to the safe and
effective operation of flexible endoscopes. Therefore, should the
AER/WD manufacturer’s instructions not specifically address
reprocessing of any particular endoscope component (air/water/
balloon feeding valve, suction/balloon suction valve, inlet seal,
injection tube, check-valve, selector mechanism, etc.) in the
AER/WD, then those components must be reprocessed manually
as described in PENTAX instructions/labeling. Prior to use, check
with each AER/WD manufacturer as to their specific claims with
respect to reprocessing individual endoscope components as
well as any endoscopic accessory instrument.

1) Reusable endoscopic accessory instruments (such as biopsy forceps, needle,

etc.) and removable endoscope components (such as suction/balloon

suction valve) should be cleaned immediately after each use since dried

blood, mucous, or other debris may cause damage to the instrument and

render the mechanism inoperable, or may interfere with the ability of the

user to reprocess the device or component.

2) Place the EAIs and/or components in a basin with fresh cleaning detergent

solution for the time period recommended by the manufacturer of the

detergent being careful not to tightly coil or kink the flexible shaft.

3) Clean the handle and flexible shaft by gently wiping with a soft gauze or the

like. Removable components such as suction/balloon suction valve should

be manipulated and detergent injected directly into/onto component

surfaces and then brushed clean.

4) Rinse all residual detergent from the EAIs by immersing the entire EAIs

under clean water and manipulating the handle mechanism. Similarly rinse

component surfaces.

5) Ultrasonic cleaning of forceps and similar accessories is then

recommended, provided the manufacturer’s instructions and the parameters

below are followed: Heavily soiled and/or difficult-to-manually clean

components such as valve mechanisms, inlet seals, etc. should be

ultrasonically cleaned prior to subsequent high-level disinfection or

sterilization.

Frequency Range 44 kHz ± 6% Time 5 minutes

– 78 –

DO NOT use caustic or abrasive solutions in the ultrasonic cleaner.

NOTE:

NOTE:

NOTE:

NOTE:

WARNING:

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All detergent must be removed from the inner mechanism of the
forceps and individual endoscope components.
Detergent that remains after the water evaporates may cause
increased friction that may render the mechanism inoperable.
Residual detergent may also interfere in the subsequent biocidal
process.

It is imperative that ultrasonic cleaning of the EAIs and other
components be performed PRIOR to steam sterilization. To
identify PENTAX accessories applicable to ultrasonic cleaning,
refer to the above list or the Instructions for Use supplied with
each accessory.

6) After cleaning and thorough rinsing, the EAls and components should be

gently dried using soft gauze or the like. Avoid tight coiling or kinking and

do NOT put tension on the flexible shaft of the forceps and similar

endoscopic accessory instruments.

Other PENTAX reusable accessories (channel cleaning adapters,
cleaning brushes, bite block, etc.) not specifically identified
previously should be cleaned in a similar manner as above.
Ultrasonic cleaning methods are recommended for accessories
whose entire surfaces are not easily accessible by manual
cleaning.

The endoscopic accessory instruments and endoscope
components on the following page may be subjected to
ultrasonic cleaning methods and/or steam sterilization.

4-4-2. High-Level Disinfection

Current infection control guidelines require that needle and
similar endoscopic accessory instruments (EAIs) which enter
sterile tissue or the vascular system or break the mucosal
barrier must be sterilized before each patient use.
For patient contact endoscopic accessories, follow the specific
and detailed reprocessing instructions supplied with each
product.

Before any attempt is made to disinfect EAIs and/or components such as bite

block, suction/balloon suction valve, brushes, etc. the complete cleaning

procedure, as described elsewhere in this Instructions for Use, must have been

completed. Heavily soiled components such as valve mechanisms, inlet seals,

etc. should be ultrasonically cleaned prior to subsequent high-level disinfection.

– 79 –

WARNING:

Accessory Ultrasonic-Cleanable Autoclavable

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Suction/Balloon Suction Valve OF-B171

Air/Water/Balloon Feeding Valve OF-B172

Inlet Seal OF-B190

Inlet Cap OE-B3

(For EG-3870UTK)

Bite Block OF-Z5

Balloon Installation Device OF-A37

(For EG-3870UTK)

Cleaning Adapter OF-B153

(For EG-3670URK)

Cleaning Adapter OE-C5

(For EG-3670URK)

Injection Tube OE-B5 (For EG-3870UTK)

Cleaning adapter

OF-G17 (For EG-3870UTK)

Biopsy Forceps

Aspiration Needle (For EG-3870UTK)

All Cleaning Brushes

Water Bottle Assembly OS-H4

1) The entire accessory or components should be immersed in disinfecting

solution.

2) Accessory and components surfaces should remain in contact with the

disinfecting solution for the time period recommended by the manufacturer

of the solution. To ensure better contact, manipulate components such as

valve mechanisms while injecting disinfectant into/onto surfaces.

3) After the item has been in contact with the disinfecting solution for the

appropriate amount of time, remove it from the solution.

4) Rinse all residual disinfecting solution from the accessory/components by

immersing it under sterile water.

5) After thoroughly rinsing, the items should be gently dried using soft gauze

or a similar material. Compressed air may also be used to facilitate drying.

• Ideally, all final rinses should be performed with sterile water.
However, if sterile water is not used, use portable water or
water that meets the requirements of the health care facility or
national/local regulations.

• It is important to completely dry lumen of the endoscopic
instruments as well as any removable endoscope components
including valve mechanisms in order to prevent bacterial
colonization and/or infections associated with waterborne
microorganisms. In some countries a final alcohol rinse
followed by forced air, not greater than 165kPa (24 PSI) is
recommended. However, in case this not in accordance with
your national/regional regulations or guidances, sterile water
must be used as the rinse water and completely dry the lumen.

– 80 –

WARNING:

4-4-3. Sterilization

WARNING:

CAUTION:

NOTE:

NOTE:

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The addition of defoaming agents to the water supply and/or
automated reprocessing system is NOT recommended. Due to
their nature, these silicone based agents cling tenaciously to
surfaces. Unless they are rinsed very thoroughly, a “barrier”
which could reduce the effectiveness of the disinfection/
sterilization process could be created. Additionally, repeated use
of such defoamers could eventually lead to residual silicone build
up resulting in equipment malfunction such as clogged air and
water channels. Similarly, silicone residues can deposit a “film”
onto the distal objective lens causing “blurry” endoscopic
images.

Current infection control guidelines require that needle and
similar accessories which enter sterile tissue or vascular system
or break the mucosal barrier must be sterilized before each
patient use.
It is recommended that any endoscopic accessory instruments
intended for use in the biliary tract be subjected to an
appropriate sterilization process. For patient contact endoscopic
accessories, follow the specific and detailed reprocessing
instructions supplied with each product.

Before any attempt is made to sterilize the accessories, the complete cleaning

procedure as described elsewhere in this Instructions for Use must have been

completed. Heavily soiled components such as valve mechanisms, inlet seals,

etc. should be ultrasonically cleaned prior to subsequent sterilization.

Use only the type of packaging material and package
configuration as recommended by the manufacturer of the
sterilizer. Use appropriate heat process indicators and/or
biological monitors as recommended by the manufacturer of the
sterilizer.

The following sterilization parameters are only valid with
sterilization equipment that is properly maintained and
calibrated.

• Steam Sterilization (Autoclaving) Recommended

The PENTAX EAls and endoscope components may be subjected
to steam sterilization.
To identify PENTAX accessories applicable to steam sterilization,
refer to the list on Page 81 or the Instructions for Use devided
with each accessory.

– 81 –

1) Prior to steam sterilization, all autoclavable accessories and endoscopic

CAUTION:

NOTE:

NOTE:

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components identified above should be thoroughly cleaned using manual

and ultrasonic cleaning methods as described elsewhere in this Instructions

for Use.

2) Autoclaving can then be performed under the following conditions:

Sterilizer Type Temperature Exposure time

Pre-vacuum 132 to 135 °C (270 to 275 °F) 5 minutes

Also, the steam sterilization with the conditions below can be used.

Sterilizer Type Temperature Exposure time

Pre-vacuum 134 °C (273 °F) 18 minutes

NEVER place the endoscope in a steam autoclave nor subject it
to ultrasonic cleaning methods!

• ETO GAS Sterilization

1) ETO Gas Sterilization can be performed on these accessories, provided they

have first been properly cleaned and thoroughly dried.

2) Following ETO GAS Sterilization, aeration is required.

For ethylene oxide sterilization of PENTAX accessories, follow the
same ETO parameters as for PENTAX endoscopes.

4-5. Water Bottle Assembly

Please read the Instructions for Use provided with the water
bottle assembly.

– 82 –

5. POST REPROCESSING

NOTE:

CAUTION:

NOTE:

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1) Following reprocessing, the endoscope may either be reused or placed in

storage.

When utilizing chemo-thermal processes for reprocessing
PENTAX endoscopes, the instruments should be allowed to
return to room temperature prior to use and/or further handling.

2) Prior to reuse, ensure that instrument has been properly inspected and fully

prepared for the next clinical procedure.

3) Prior to storage, ensure that all internal channels, endoscope components,

instrument surfaces and accessories are thoroughly dry.

4) A cotton tipped applicator moistened with 70-90% medical grade ethyl or

isopropyl alcohol may be used to carefully remove any films or residues left

upon the lens surfaces, such as the distal objective lens.

5) The endoscope should be hung in a clean, dry, well-ventilated storage

cabinet at room temperature. The insertion tube, umbilical cord and

scanning unit connector cable should be hung and kept as straight as

possible during storage.

• Make sure that all removable components such as the air/

water/balloon feeding valve, suction/balloon suction valve,
inlet seal(s), inlet cap, injection tube, etc. are detached from
the endoscope. This will allow for better air circulation
throughout the internal channels to ensure thorough drying.

• NEVER store the endoscope, its components and accessories

in the carrying case, as this type of dark, humid and
unventilated environment is conducive to bacteria
colonization, which increases the risk of cross contamination.
These cases are intended for transportation of the
instrument, not storage.

• NEVER store the endoscope in areas of high humidity, high

temperatures or in direct exposure to sunlight or X-rays.

• Avoid storage of the endoscope in cabinets, which have any

sharp edges, exposed nails/screws, etc. Contact with sharp
objects can puncture, scratch or otherwise damage the
endoscope.

Store the reprocessed endoscope in a clean, dry, and well­ventilated place with the insertion tube and umbilical cord
hanging vertically or it can be stored horizontally if it is
completely dried. The method of storage should include
adequate measures to reduce the possibility of recontamination.

– 83 –

5-1. Servicing

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Prior to returning any instrument for repair to PENTAX, the instrument should

first undergo appropriate reprocessing/decontamination procedures for the

purpose of infection control. Check with your local PENTAX service facility for

more details.

1) All instruments requiring repair should be shipped in the original carrying

2) A repair purchase order number, contact name and phone number of the

3) The “Red” Ventilation cap should be attached to the instrument if it will be

4) Any accessories and/or endoscope components potentially related to the

5) Soaking caps should also be returned with the endoscope to check/confirm

6) After servicing, all endoscopes and components must be reprocessed prior

7) For disposal of instruments, follow local or country regulations.

case with appropriate packing along with comments describing the

instrument damage and complaint.

individual responsible for authorizing repairs, as well as shipping address

should be included.

shipped by air freight.

endoscope damage or complaint should also be returned with the

endoscope.

the integrity of their watertight seal.

to patient use.

– 84 –

WARNING:

Instrument repairs should only be performed by an authorized

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PENTAX service facility. PENTAX assumes no liability for any
patient/user injury, instrument damage or malfunctions, or
REPROCESSING FAILURE due to repairs made by
unauthorized personnel.

Your local PENTAX service facility can provide a list of
“compatible” reprocessing agents with PENTAX endoscopes
based upon material compatibility and functionality studies
performed by PENTAX, Japan. These tests of course apply only
to genuine PENTAX parts, components and materials including
proprietary adhesives, sealants, lubricants, etc. specifically
selected for use in PENTAX endoscopes to satisfy their original
design criteria. PENTAX manual reprocessing instructions
supplied with each product have been validated for PENTAX
endoscopes utilizing exclusive PENTAX parts/materials and
assembled based upon proprietary PENTAX manufacturing
technologies and/or servicing techniques.

It must be recognized that PENTAX does not evaluate non­PENTAX parts, components, materials and/or servicing methods
and therefore questions regarding material compatibility and/or
functionality of PENTAX instruments built with these
unauthorized, untested and unapproved items, materials,
repair/assembly methods must be referred to the third party
service organization and/or device remanufacturer. It is
unknown to PENTAX if serviced or remanufactured instruments
(performed by unauthorized PENTAX entities) which still bear a
PENTAX label are within PENTAX device specifications and/or if
unauthorized activities have significantly changed the
instrument’s performance, intended use, safety and/or
effectiveness.

These companies should confirm the ability for these serviced/
remanufactured devices to be reprocessed safely and effectively
with reprocessing agents/systems recognized as compatible by
PENTAX for standard PENTAX products. These third party
companies and/or remanufacturers should be consulted to
confirm if they have performed reprocessing validation studies
on instrument models which they have serviced (or
remanufactured) that support the cleaning, high-level
disinfection and/or sterilization of these endoscopes via the
normal endoscope OEM reprocessing recommendations,
standard AER device-specific instructions and/or their own
unique reprocessing recommendations.
Ultimately, owners of these medical devices are responsible for
selecting an appropriate service facility or vendor whose
activities render an instrument to the same expectations and
quality of a finished device supplied by the endoscope OEM.

– 85 –

5-2. Care and Maintenance Tips

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Flexible endoscopes have been an invaluable tool in the medical community’s

armamentarium to successfully diagnose and treat a wide variety of illnesses in

patients for several decades. Perhaps due to their longevity and progressive

design changes over the years which have simplified their use, flexible

endoscopes have been somewhat taken for granted and have erroneously not

been considered highly technological medical devices.

In fact, current generation flexible endoscopes although easier to clinically use,

are much more sophisticated than ever. Special reprocessing instructions must be

followed to ensure the instruments are patient ready and patient safe. Special

care and handling must be exercised and practiced to prevent instrument

malfunction and prolong the reliability of the endoscope.

The burden of responsibility to ensure safe and reliably functioning instruments

is left in the hands of the healthcare professionals who actually care for and

reprocess flexible endoscopes.

Naturally, equipment manufacturers share in this responsibility and tremendous

efforts have been spent in designing instruments which could be reprocessed and

maintained as easy as possible. However, due to the nature of their use and

application, flexible endoscopes must be subjected to special cleaning

procedures, followed by a disinfection or sterilization process after each and

every patient use.

To highlight and simplify, what may appear to some as being complicated

maintenance and reprocessing instructions, PENTAX strongly recommends the

users review the following suggestions and advice on the care and maintenance

of your PENTAX flexible endoscopes.

These tips, particularly those involving endoscope reprocessing should not be

construed as “shortcuts” and are not intended as substitute directions for

complete instructions found elsewhere in the Instructions for Use.

 NEVER immerse the ultrasound scanning unit connector in fluids. When

utilizing chemo-thermal processes for reprocessing PENTAX endoscopes,

the instruments should be allowed to return to room temperature prior to

use and/or further handling.

 Avoid soaking of the endoscope with accessories (forceps, injection or

aspiration needles, etc.) or any sharp edged objects which could

inadvertently scratch or cut the distal bending section sheath. (Subsequent

flexing back and forth of the rubber sheath could eventually stretch the

scratched rubber until a pinhole and leak develops.)

 Exposure to a compatible cleaning detergent is essential to thorough

cleaning of all surfaces of the endoscope. Rinsing and drying after cleaning

is imperative to prevent dilution and/or adulteration of the disinfectant/

sterilant.

– 86 –

 Not all manufacturers of Automated Endoscope Reprocessors (AERs)/

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Washer-Disinfectors (WDs) make specific claims nor provide special

instructions for reprocessing all of the removable endoscope components

that are integral to the safe and effective operation of flexible endoscopes.

Therefore, should the AER/WD manufacturer’s instructions not specifcally

address reprocessing of any particular endoscope component (air/water/

balloon feeding valve, suction/balloon suction valve, inlet seal, injection

tube, check-valve, selector mechanism, etc.) in the AER/WD, then those

components must be reprocessed manually as described in PENTAX

instructions/labeling. Prior to use, check with each AER/WD manufacturer

as to their specific claims with respect to reprocessing individual endoscope

components.

 Do NOT reuse disposable accessories intended for single patient or one

time use.

 Do NOT expose the endoscope or endoscopic accessory instruments to

harsh chemical solutions. Strictly adhere to exposure times recommended

by the manufacturers of compatible solutions.

 Avoid contact of any flexible portion of the endoscope with any sharp edge

objects (bed frames, table top corners, sink drains, accessories hanging in

storage cabinets, etc.) at any time during the handling, reprocessing or

storage of the endoscope.

 Avoid stretching of the bending section rubber sheath at the distal portion of

the endoscope. During mechanical cleaning with a dampened gauze, do

NOT use excessive force. A gentle back and forth wiping motion should be

sufficient to remove gross debris. Subsequent soaking in an cleaning

detergent will clean the remainder of debris.

 Disinfectants and sterilants are toxic substances by nature. All residual

solution must be thoroughly rinsed off. The endoscope has to be dried prior

to each patient use.

 The key to preventing clogged air or water channels/nozzles is to

immediately flush the channels with either air pressure or fluid/detergent

right after removal from the patient. This should be followed by brushing of

each accessible channel and then soaking with an cleaning detergent.

 Avoid attempting to remove or unscrew endoscope components which

should not be removed. Parts such as the distal portion of the light guide

plug, any inlet ports and any strain relief boots on either the insertion tube

or umbilical cord are essential to the watertight integrity of the instrument.

Removal or loosening of these components and subsequent immersion

could lead to fluid invasion into the endoscope and/or compromise effective

reprocessing.

 Check for any sharp edges on all surfaces of an automated cleaning/

reprocessing unit which may come in contact with an endoscope. Some

units may have sharp edged wire mesh filters and baskets or inlet/outlet

ports which could damage your endoscope.

– 87 –

 Do NOT overtighten the cap to the water bottle assembly. The metal pipe at

WARNING:

CONTRAINDICATION:

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the top of the PENTAX water bottle assembly functions as an inlet port for

air from the light source. This inlet pipe should not be used as a leverage

tool to tighten the cap to the water container. Overtightening could cause

the plastic cap to crack.

 Do NOT introduce air bubbles into the endoscope’s internal channels

during flushing of cleaning and/or disinfecting/sterilizing solutions as these

bubbles could interfere in the effectiveness of the disinfection/sterilization

process.

 Do NOT store the endoscope, its components or and accessories in the

carrying case as this type of dark, humid and unventilated environment is

conducive to bacteria colonization which increases the risk of cross-

contamination.

 Prior to each use, check the condition of all endoscopic accessory

instruments.

Do NOT use any accessories with kinked or bent flexible shafts.

Do NOT use forceps with misaligned cups/jaws and/or bent needles/spikes.

Do NOT use aspiration or injection needles which are not retractable or

whose sharp tips can not be protected.

Do NOT use cleaning brushes without smooth or rounded distal ends.

Do NOT use accessory instruments with exceptionally long distal rigid

sections or whose outer diameter restricts passage through the instrument

channel/channel inlet.

Use of any of the above accessories could result in channel damage and

costly repairs.

 Verification of the Minimum Effective Concentration (MEC) of active

ingredients (via test strips or similar methods) is recommended to ensure

potency of the liquid chemical germicide to achieve high-level disinfection/

sterilization.

Instrument repairs should only be performed by an authorized
PENTAX service facility. PENTAX assumes no liability for any
patient/user injury, instrument damage or malfunctions, or
REPROCESSING FAILURE due to repairs made by unauthorized
personnel.

Please consult regional and national health authority
recommendations and requirements regarding protocols to
follow in order to reprocess and/or destroy endoscopes that will
be used or have been determined to have been used (post
procedure) on patients afflicted with Creutzfeldt-Jacob Disease
(CJD or vCJD)

– 88 –

SPECIFICATIONS

(1) (2)

(3)

(4)

(5)

(7)

(5)

(6)

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(2)

(7)

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

EG-3870UTK EG-3670URK

Field of View 120° (45° forward oblique) 140° (forward)

Depth of Field 5–100 mm 4–100 mm

Tip Angulation

Rigid Distal Width

Up-Down 130
Right-Left 120°–120° 60°–60°

Probe 12.5 × 12.3 mm ø 12.6 mm

Optic ø 14.3 mm ø 12.0 mm

Distal End Width ø 14.3 mm ø 10.3 mm

Insertion Tube Width ø 12.8 mm ø 12.1 mm

Maximum Insertion Portion Width ø 14.65 mm ø 13.45 mm

*Minimum Instrument Channel Width ø 3.8 mm ø 2.4 mm

Insertion Portion Working Length 1250 mm

Total Length 1560 mm

Acoustic Frequency 5–10 MHz switchable

Scan Direction Longitudinal Latitudinal

Scan System Convex Radial

Scan Angle 120° 360°

Balloon Removable

Ambient Temperature 10–40

Operation Environment

Relative Humidity 30–85% RH

Air Pressure 700–1060 hPa

Ambient Temperature –20– +60

Storage
Environment

Relative Humidity 0–85% RH

Air Pressure 700–1060 hPa

Degree of protection against electric shock typeBF

°–130° 130°–60°

°C

°C

*There is no guarantee that instruments selected solely using this minimum instrument channel width will be compatible in combination.

Note: Specifications are subject to change without prior notice and without any obligation on the part of the

manufacturer.

(1) Elevator
(2) Objective Lens
(3) Light Guide
(4) Balloon Attachment Groove
(5) Balloon Injection/Evacuation Nozzle
(6) Groove
(7) Convex Array Transducer

(1) Balloon Attachment Groove
(2) Balloon Evacuation Nozzle
(3) Radial Array Transducer
(4) Balloon Attachment Groove
(5) Light Guide
(6) Objective Lens
(7) Balloon Injection Nozzle
(8) Air/Water/Instrument Channel

– 89 –

MEMO

Z845 R22EEG 3670URK,

3870UTK.book

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2022. 06 6217001 Z845 R22

– 90 –

MEMO

Z845 R22EEG 3670URK,

3870UTK.book

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Ultrasound Upper GI Video Scopes EG-3870UTK/EG-3670URK

– 91 –

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2022. 06 6217001 Z845 R22

– 92 –

Manufacturer

Distributors

Contacts

In the interest of technical progress, specifications may change without notice.

88138

2022. 06 6217001 Z845 R22

HOYA Corporation

6-10-1 Nishi-shinjuku,
Shinjuku-ku, Tokyo
160-0023 Japan

PENTAX Europe GmbH

Julius-Vosseler-Straße 104
22527 Hamburg, Germany
Tel: [phone]
Fax: [phone]

PENTAX Medical
A Division of PENTAX of America, Inc.

3 Paragon Drive
Montvale, NJ 07645-1782
USA
Tel: [phone]
Toll Free: [phone]
Fax: [phone]

PENTAX Medical Shanghai Co., Ltd.

Room 701, 291 Fumin Road, Shanghai
200031 P. R. China
Tel: [phone]
Fax: [phone]

PENTAX Medical Singapore Pte. Ltd.

438A Alexandra Road, #08-06
Alexandra Technopark, 119967 Singapore
Tel: [phone]
Fax: [phone]
Customer Service Toll Free:
400 102 0968 (within China)
1800 2005 968 (within India)
1300 PENTAX (within Australia)

NOTICE
These instruments are used with Class B Medical Equipment (specified CISPR11) and are intended
for hospital, ambulatory surgery centers, and medical clinics .

Together, these endoscopes and the compatible scanning unit comply with EN 60601-1-2 for
Europe, IEC 60601-1-2 for other countries.

NOTE: The SYSTEM is suitable for use in all establishments other than domestic and those
directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purpose.

When used in clinical or residential areas near radio and TV receiver units, these instruments may
cause radio interference.

To avoid and resolve adverse electromagnetic effects, do NOT operate these instruments near the
RF energy equipment.

Z845 R22EEG 3670URK,

3870UTK.book

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