Only For the Americas

INSTRUCTIONS FOR USE

(OPERATION)

PENTAX VIDEO COLONOSCOPES

EC-3890TLK,
EC-2990Li, EC-3490Li
EC-3890Li, EC-3490TLi
EC-3490LK, EC-3890LK
EC-3890LZi, EC34-i10L
EC38-i10L

This instructions for use describes the recommended procedures for inspecting and
preparing the equipment prior to its use.
For the cleaning and maintenance of the equipment after its use, please refer to the
separate Instructions for Use (reprocessing).
Product Overview
These instruments photograph the subject of observation using a solid-state image sensor located at the endoscope tip under the
light transmitted from the processor/light source. The target of the observation is monitored by the physician using the endoscopic
image displayed on the video monitor. The endoscopic procedure is performed by inserting biopsy forceps and other endoscopic
accessories into the instrument channel inlet on the control body.
The bending section angulates in the intended direction and angle by operating the Angulation Control Knobs, air and water is fed
from the distal end of the endoscope by operating the Air/Water Feeding Valve, and air or fluids can be suctioned from the distal
end of the endoscope by operating the Suction Control Valve.

Indication for Use

These instruments are intended to be used with a PENTAX video processor (including light source), documentation equipment,
Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery
within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

Application
Medical purpose: Provide images for optical visualization, recording, and/or diagnostic aid.
Patient populations: Adults and pediatrics who have been determined by the physician to be appropriate candidates for the use of
these instruments.
Intended anatomical area: Lower gastrointestinal tract (rectum, sigmoid colon, colon and ileocecal valve)
User: Medical doctors (experts approved by the medical safety officer to perform endoscopic examinations at each medical facility)
Place of use: Medical facility

Functions Used Frequently

The frequently used functions in this model are as follows:
•• Angulation capability using control knob
•• Remote control operation using remote buttons
•• Air/Water feeding function
•• Suctioning function

Removable Components
OF-B118 Water jet connector cap
OF-B120 Suction control valve
OF-B161 Suction channel selector(for EC-3890TLK only)
OF-B188 Air/Water feeding valve
OF-B190 Inlet seal
OE-C12 Water jet check valve adapter

Notes
Read this Instructions for Use (IFU) before operating, and save this book 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 or the companion Instructions for Use (reprocessing) may result in damage to, and/or
malfunction 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.
This IFU describes the recommended procedures for inspecting and preparing the equipment prior to 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. For the cleaning and maintenance after its use, please refer to the
separate Instructions for Use (reprocessing).
The text contained in this IFU is common for various types/models of PENTAX endoscopes and users must carefully follow only
those sections and instructions pertaining to the specific instrument models appearing on the front cover.
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 representative.
Sterility Statement
These endoscopes identified in this IFU are reusable semi-critical 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 high-level disinfection or sterilization processes.
Refer to the companion PENTAX Instruction for Use (reprocessing) describing in detail the recommended instructions on the
care, cleaning, disinfection, and sterilization of these endoscopes.

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

WARNING : could result in death or serious injury.

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

NOTE : 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
Symboles distinctifs
Symbol for “MANUFACTURER” Attention, consult instructions for use
Attention, consulter le manuel d’utilisation
Type BF applied part (Safety degree specified by IEC 60601-1)
Symbol for “DATE OF MANUFACTURE” Partie appliquée de type BF (niveau de sécurité spécifié par la norme CEI 60601-1)

Symbol for “Authorised Representative in the European Union”

このCEマーキングはEC指令への適合宣言マークです。
The CE marking assures that this product complies with the requirements of the EC directive for safety.
Das CE Zeichen garantiert, daß dieses Produkt die in der EU erforderlichen Sicherheitsbestimmungen erfüllt.
Le logo CE certifie que ce produit est conforme aux normes de sécurité prévues par la Communauté Européenne.
II marchio CE assicura che questo prodotto è conforme alle direttive CE relative alla sicurezza.
La marca CE asegura que este producto cumple todas las directivas de seguridad de la CE.
 TABLE OF CONTENTS

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

1-1. Video Endoscope......................................................................................................... 1
1-2. Accessories................................................................................................................ 7
1-3. Video Processor.......................................................................................................... 8

2. PREPARATION AND INSPECTION FOR USE.................................................................................... 9

2-1. Inspection of the Video Processor..................................................................................... 9
2-2. Inspection of Endoscope................................................................................................ 11
2-3. Preparation just before Insertion of Endoscope..................................................................... 32

3. DIRECTIONS FOR USE............................................................................................................ 34

3-1. Operation................................................................................................................... 35
3-2. Pretreatment.............................................................................................................. 37
3-3. Insertion and Withdrawal................................................................................................ 37
3-4. Magnification Control (EC-3890LZi)................................................................................... 41
3-5. Biopsy...................................................................................................................... 43
3-6. Laser ....................................................................................................................... 45
3-7. Electrosurgery............................................................................................................. 49

4. CARE AFTER USE................................................................................................................. 53

SPECIFICATIONS................................................................................................................. 55
1. NOMENCLATURE AND FUNCTION
1-1. Video Endoscope
•• EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK

AIR/WATER FEEDING VALVE (OF-B188)

Covering of hole in the top of the valve delivers
pressurized air. Covering of the hole and fully
depressing the valve delivers pressurized water. INLET SEAL
SUCTION CONTROL VALVE (OF-B120) Allows passage of accessories while
Depress to remove fluids or air through preventing escape of fluids and air.
the instrument channel.
REMOTE BUTTON 1 INSTRUMENT
Push to freeze an image. CHANNEL INLET
For introduction of
REMOTE BUTTON 2 biopsy forceps
Push to activate the hardcopy system. and other accessories.

REMOTE BUTTON 1 CONTROL BODY

REMOTE BUTTON 2
REMOTE BUTTON 4
MAGNIFICATION CONTROL LEVER
(EC-3490Li, EC-3890Li)
MODEL DESIGNATION

REMOTE BUTTON 3
Model Name
UP/DOWN ANGULATION LOCK LEVER
When this lever is in the “F position, turned clockwise, Minimum Instrument
the bending section moves freely. When turned fully counterclockwise, Channel Width
the bending section becomes progressively more stabilized.
RIGHT/LEFT ANGULATION
CONTROL KNOB
REMOTE BUTTON 4
MAGNIFICATION CONTROL LEVER (EC-3490Li, EC-3890Li) UP/DOWN ANGULATION
CONTROL KNOB
See detail Information on section 2-2. 7-1) on page 25.
RIGHT/LEFT ANGULATION LOCK
REMOTE BUTTON 3
Functions similar to Up/Down lock
Push to activate the VCR for recording live procedures.

UMBILICAL CORD
STRAIN RELIEF BOOT

NOTE:
Function of each remote button depends upon the video processor. The
function can be changed. For more details, refer to the instructions for use
supplied with the video processor.
EC-3890TLK
EC-3490Li
Endoscope Model EC-2990Li, EC-3490TLi
EC-3890Li
EC-3490LK, EC-3890LK
*Remote Button 1 Freeze Freeze
*Remote Button 2 Copy Copy
*Remote Button 3 Video Video
*Remote Button 4 Enhance -
**Magnification Control Lever - Magnification(electronic)
*Setting at factory
**Not applicable to PENTAX Video Processor, model EPK-i5020

–1–
 EC-3890TLK ONLY
INLET SEAL
Allows passage of accessories while “B” identifies a small channel
preventing escape of fluids and air.

SUCTION CHANNEL SELECTOR OF-B161

Alignment of the indicator to the prescribed positions
allows the user the choice of suction capability through
either channel (2.8mm or 3.8mm) or simultaneous
suction through both channels

“A” identifies a large channel

CAUTION:
DISTAL END To avoid damaging the
endoscope, do NOT
INSERTION TUBE
STRAIN RELIEF BOOT twist, rotate or bend
BENDING SECTION
excessively any of the
strain relief boot.

INSERTION PORTION
(APPLIED PART) VENTING CONNECTOR
WATER JET CONNECTOR Accepts “RED” Ventilation cap.
Also accepts Leakage Tester.
Allows connection of special irrigation tube
(OF-B113) for pressurized source of a spray RED VENTILATION CAP OF-C5
directed at the endoscopically visualized surface. Provides venting of endoscope interior to equalize
internal and external pressures. This cap must be
AIR/WATER PORT removed before immersion.
To connect feeding tube from water
bottle assembly.
PVE CONNECTOR ELECTRICAL CONTACTS
Can be rotated
within a 180˚
range. PVE SOAKING CAP
OE-C9
This cap must be securely attached before
immersion. Align the black arrow on the
soaking cap with the green dot at the base
of the silver collar surrounding the
electrical contacts on the PENTAX PVE
connector. Press the cap down onto the
metal collar and turn clockwise to secure.

LIGHT GUIDE PLUG

Transmits light from
light source to distal CAUTION:
FEEDBACK TERMINAL end of endoscope. Ensure that the soaking cap has been securely attached
To connect the OL-Z3 cable (by properly rotating it) to prevent the cap from coming
From the a compatible off during reprocessing. Failure to securely attach the
PENTAX video processor. soaking cap can result in endoscope damage.

SUCTION NIPPLE CAUTION:

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

–2–
・EC-3890LZi

AIR/WATER FEEDING VALVE (OF-B188)

Covering of hole in the top of the valve delivers
pressurized air. Covering of the hole and fully
depressing the valve delivers pressurized water.
INLET SEAL
SUCTION CONTROL VALVE (OF-B120) Allows passage of accessories while
Depress to remove fluids or air through preventing escape of fluids and air.
the instrument channel.

REMOTE BUTTON 1 INSTRUMENT

CHANNEL INLET
Push to freeze an image.
For introduction of
biopsy forceps
REMOTE BUTTON 2 and other accessories.
Push to activate the hardcopy system.

CONTROL BODY

L U
REMOTE BUTTON 1

F
REMOTE BUTTON 2

F
REMOTE BUTTON 3

F
D
MAGNIFICATION CONTROL LEVER MODEL DESIGNATION

UP/DOWN ANGULATION LOCK LEVER

When this lever is in the “F position, turned clockwise, Model Name
the bending section moves freely.
When turned fully counterclockwise, Minimum Instrument
the bending section becomes progressively more stabilized. Channel Width

REMOTE BUTTON 3 RIGHT/LEFT ANGULATION

Push to activate the video for recording live procedures. CONTROL KNOB

UP/DOWN ANGULATION
CONTROL KNOB
MAGNIFICATION CONTROL LEVER
See detail information on section 2-2. 7-2) on page 26. RIGHT/LEFT ANGULATION LOCK
KNOB
Functions similar to Up/Down lock
STRAIN RELIEF BOOT
lever.

UMBILICAL CORD

NOTE:
Function of each remote button depends upon the video processor. The function can
be changed. For more details, refer to the instructions for use supplied with the video
processor.
Endoscope Model EC-3890LZi
*Remote Button 1 Freeze
*Remote Button 2 Copy
*Remote Button 3 Video
Magnification Control Lever Magnification(optical)
*Setting at factory

–3–
 CAUTION:
DISTAL RUBBER HOOD To avoid damaging the
OE-A59 for EC-3890LZi endoscope, do NOT
twist, rotate or bend
excessively any of the
strain relief boots.

STRAIN RELIEF BOOT

DISTAL END

INSERTION TUBE
BENDING SECTION

INSERTION PORTION
(APPLIED PART)
VENTING CONNECTOR
WATER JET PORT Accepts “RED” Ventilation Cap.
Allows connection of special irrigation tube Also accepts Leakage Tester.
(OF-B113) for pressurized source of a spray RED VENTILATION CAP OF-C5
directed at the endoscopically visualized surface. Provides venting of endoscope interior to equalize
AIR/WATER PORT internal and external pressures. This cap must be
To connect feeding tube from water removed before immersion.
bottle assembly.
PVE CONNECTOR
Can be rotated ELECTRICAL CONTACTS
within a 180°
range.
STRAIN RELIEF PVE SOAKING CAP OE-C9
BOOT This cap must be securely attached before
immersion. Align the black arrow on the
soaking cap with the green dot at the base
of the silver collar surrounding the
electrical contacts on the PENTAX PVE
connector. Press the cap down onto the
metal collar and turn clockwise to secure.

LIGHT GUIDE PLUG

Transmits light from CAUTION:
light source to distal Ensure that the PVE soaking cap has been securely
end of endoscope. attached (by properly rotating it) to prevent the
FEEDBACK TERMINAL cap from coming off during reprocessing. Failure to
securely attach the cap can result in endoscope
To connect the OL-Z3 cable damage.
From a compatible PENTAX
video processor.
CAUTION:
Immediately after use, the metal light guide plug
and the electrical contacts/pins of the endoscope
SUCTION NIPPLE may be HOT. To avoid burns, do not touch these
For attachment to areas immediately after use. For safer handling after
external suction a procedure, grasp the PVE connector housing.
source.

–4–
・EC34-i10L/EC38-i10L

INLET SEAL
Allows passage of accessories while
AIR/WATER FEEDING VALVE (OF-B188) preventing escape of fluids and air.
Covering of hole in the top of the valve delivers
pressurized air. Covering of the hole and fully
depressing the valve delivers pressurized water.

SUCTION CONTROL VALVE (OF-B120) INSTRUMENT

Depress to remove fluids or air through CHANNEL INLET
the instrument channel For introduction of
REMOTE BUTTON 1
biopsy forceps
Push to freeze an image. and other accessories.
REMOTE BUTTON 2
Push to activate the hardcopy system
CONTROL BODY

UP/DOWN ANGULATION LOCK LEVER

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

REMOTE BUTTON 4 Model Name

Enhance
Minimum Instrument
REMOTE BUTTON 3 Channel Width
Push to activate the video for recording live procedures.

UP/DOWN ANGULATION
CONTROL KNOB

RIGHT/LEFT ANGULATION
CONTROL KNOB

RIGHT/LEFT ANGULATION LOCK KNOB

Functions similar to Up/Down lock

STRAIN RELIEF BOOT

UMBILICAL CORD

NOTE:
Function of each remote button depends upon the video
processor. The function can be changed. For more details, refer
to the instructions for use supplied with the video processor.
EC34-i10L
Endoscope Model
EC38-i10L
*Remote Button 1 Freeze
*Remote Button 2 Copy
*Remote Button 3 Video
*Remote Button 4 Enhance
*Setting at factory

–5–
 CAUTION:
To avoid damaging the
endoscope, do NOT
twist, rotate or bend
excessively any of the
DISTAL END strain relief boots.

STRAIN RELIEF BOOT

INSERTION TUBE
BENDING SECTION

INSERTION PORTION
(APPLIED PART)
WATER JET PORT
Allows connection of special irrigation tube
(OF-B113) for pressurized source of a spray VENTING CONNECTOR
directed at the endoscopically visualized surface. Accepts “RED” Ventilation Cap.
Also accepts Leakage Tester.
AIR/WATER PORT
To connect feeding tube from water VENTILATION CAP RED OF-C5
bottle assembly. Provides venting of endoscope interior to equalize
internal and external pressures. This cap must be
removed before immersion.
PVE CONNECTOR
Can be rotated
within a 180˚
range. ELECTRICAL CONTACTS

PVE SOAKING CAP

OE-C9
This cap must be securely attached before
immersion. Align the black arrow on the
soaking cap with the base of the silver collar
surrounding the electrical contacts on the
PENAX PVE connector. Press the cap
down onto the metal collar and turn
clockwise to secure.

FEEDBACK TERMINAL
To connect the OL-Z3 cable
from the PENTAX video
processor. CAUTION:
Ensure that the PVE soaking cap has been securely
LIGHT GUIDE PLUG attached (by properly rotating it) to prevent the cap from
Transmits light from coming off during reprocessing. Failure to securely attach
light source to distal
the cap can result in endoscope damage.
SUCTION NIPPLE end of endoscope.
For attachment to
external suction
source. CAUTION:
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.

–6–
1-2. Accessories
Biopsy Forceps (KW2422R)

(1) Flexible Shaft

(2)
(2) Grip
(1)
(3) Handle (pink handle
defines autoclavable
forceps)
(4) (4) Cups/Jaws
(3)

Figure 1.1

CAUTION:
••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 endoscopes. If a unique or highly specialized
accessory is available from another source and its manufacturer claims
compatibility with PENTAX instruments, the accessory manufacturer
should be consulted to confirm compatibility with PENTAX endoscope
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 may be approximately 30 cm longer than the
endoscope working length.

NOTE:
••Depending upon country and/or local PENTAX distributor, 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.

–7–
1-3. Video Processor

NOTE:
Read the instructions for use supplied with the video processor.

WARNING:
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.

NOTE:
Be sure to use compatible bottle and water bottle cap. If incompatible
bottle and a water bottle cap are used together, it could cause the air to
escape resulting in insufficient pressure and flow of air and water during
the endoscopic procedure.

1) PENTAX Video Processor

(1) Lamp Switch
(1)
(2) Pump Switch
(3) Endoscope Electrical
Connector
(4) Light Guide
Receptacle
(5) Power Switch
(6) Water Bottle Assembly

(2)
(6) (5) (4) (3)

Figure 1.2

CAUTION:
Replace the lamp before the lamp life expires. Prior to use, check the lamp
life indicator. Excessive use of the lamp beyond the lamp life could cause
the lamp to explode resulting in damage to the video processor. Refer to
the video processor's instructions for use regarding the lamp life.

NOTE:
Software update may be required depending on the software version of
the PENTAX video 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.

–8–
2. PREPARATION AND INSPECTION FOR USE
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.

NOTE:
PENTAX video endoscope contained in this instructions for use is only
compatible with PENTAX video processors.

CAUTION:
To avoid discontinuation of endoscopic procedure, have an extra (spare)
instrument available as a standby device. Should any unforeseen event or
circumstance render the original instrument inoperable and/or unsafe for
patient.

2-1. Inspection of the Video Processor

NOTE:
For details of operations such as starting and stopping, please refer to the
PENTAX video Processor Instructions for Use.

WARNING:
To avoid the risk of an electric shock, check that the video processor is
properly grounded, or that it is connected to an appropriate isolation
transformer (PENTAX SAT-1300 or other medical purpose isolation
transformers). Also, be sure to use a video processor specified by PENTAX.

1) Attach water bottle assembly, 2/3 filled with sterile water to the appropriate
location on the left side of the video processor.

WARNING:
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 assembly to the upright position labeled
A/W (air/water).

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

–9–
4) Make sure that the PENTAX PVE connector is aligned with the interface socket
on the front panel of the video processor.
5) Connect the endoscope to the Endoscope Electrical Connector and Light Guide
Receptacle on the video processor as illustrated.
(1) Air/Water Feeding
Tube

(1)

Figure 2.1

6) Rotate the locking lever clockwise after insertion.

CAUTION:
After connecting the endoscope to the PENTAX 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 video processor and air pump to the “ON” position and check for proper
functioning.
9) Press the lamp switch of the video processor to turn ON the lamp.

CAUTION:
Do not look directly at the light emitted from the endoscope distal tip or
the video processor unit. The intense light might hurt your eyes. Turn off
the lamp when looking directly at the endoscope distal tip.

10) 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.

– 10 –
2-2. Inspection of Endoscope

WARNING:
Disassembling or modifying a PENTAX endoscope may impair its original
functionality and possibly result in a serious injury. Never disassemble or
modify the endoscope.

WARNING:
If the endoscope is intended to be clinically used after testing of individual
endoscope functions (suction, air/water delivery, water jet, 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. Sterile water should be used during endoscopic
examination also. 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 proceeding with inspection of individual functions, PENTAX endoscopes should be

tested for the integrity of their water-tight design (example: tear in the instrument channel).

CAUTION:
PENTAX endoscopes should be tested for the integrity of their water-
tight design using PENTAX leakage tester. If the endoscope is used in a
condition where the integrity of its water-tight design is compromised, it
could result in endoscope damage due to permeated water.

CAUTION:
Various types of endoscope leakage testers exist including manual,
electro-mechanical and “automated” versions, some of which are stand
alone units and others which may be integrated into Automated Endoscope
Reprocessors (AERs)/Washer-Disinfectors (WDs). It must be recognized
that PENTAX does not evaluate non-PENTAX leak tester systems to satisfy
their specific products claims, for their effectiveness to accurately detect
leaks and/or for their compatibility with PENTAX endoscopes. Insufficient
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.

– 11 –
1) Inspection of the Insertion Portion
a) Check the entire surface of the insertion tube for abnormal conditions such as
sharp edges, 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.

WARNING:
To avoid serious damage to the patient or possibility of malfunction during
a procedure, do not use any endoscope if you find any abnormalities or
outward signs of damage.

c) These areas [A], [B] should be checked for ANY abnormalities or 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 adhesive band is not peeling, nor does it have roughened texture
or any sharp-edges.
(1) Bending Section
(3) (4)
(2) Close-Up View
(3) [A] Black Adhesive
(2)
Band
(1) (4) [B] Black Adhesive
Band

Figure 2.2

d) Make sure that the entire endoscope is clean and has been subjected to either a
high-level disinfection or sterilization process before each patient use.

WARNING:
From the standpoint of infection control, all instruments must be
reprocessed prior to first time use, after any repairs/service and before
every patient use.

CAUTION:
In order to obtain crisp endoscopic images, 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.

– 12 –
2) Inspection of insertion tube flexibility
a) Form an arch with the Insertion Tube as shown in the figure below.

Approx.
30cm

Approx. 20cm

Figure 2.3

b) Gently raise/lower the left/right hands alternately and confirm equal flexibility
for the length of the arch. Do NOT use the endoscope if there are any:
•• extraordinarily rigid portion which do not bend as easily as the rest of the arch
or
•• extraordinarily flexible portions which bend much more than the rest of the
arch.

Figure 2.4

Figure 2.5

c) Repeat steps a) and b) above until the inspection of the entire insertion tube is
complete. If the endoscope fails the inspection above;
•• Do NOT use the endoscope and
•• Contact your PENTAX representative.

– 13 –
 CAUTION:
When performing this inspection, ensure that other components of the
endoscope (distal end, control body, etc.) are not damaged by impact to
surface or objects in the area.
Do NOT exercise 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. It could cause the
bending section to be damaged.

CAUTION:
The distal end of the endoscope as well as the electrical contacts/pins on
the PVE connector must be protected against damage from impact. Never
apply excess force such as twisting, or severe bending to the flexible
portion of the endoscope. These actions could result in endoscope damage
or membrane/tissue damage to the patient. Therefore, do not use the
endoscope if there is any sign of abnormalities in the distal end of the
endoscope.

CAUTION:
During pre-use inspection, ensure that the distal objective lens and the
illumination (LCB) cover glass are clean. If not, crisp images can NOT be
displayed.

NOTE:
As indicated elsewhere in PENTAX product labeling, endoscopes particularly
the quality of the endoscope image should be checked prior to patient use.

– 14 –
CAUTION:
When transporting the endoscope, do NOT grasp or carry it only by its
umbilical cord or insertion tube, and take care to protect the distal tip of
the insertion portion from damage. Loosely coil both the umbilical cord
and insertion tube so that the endoscope can be carried by grasping both
the control body and distal portion of the insertion portion in one hand and
the PVE connector in the other hand. Failure to do so could result in severe
impact damage that will require repair by PENTAX service personnel.

Figure 2.6

– 15 –
CAUTION:
Flexible endoscopes and other sophisticated medical devices 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 instrument channel inlet (biopsy inlet port) (1)

••the suction nipple (2)
••the air/water port (3)
••the water jet port (4)
••any valve cylinder (5)
••basically, any inlet or outlet port associated with an internal channel, an
indirect patient contact portion of the endoscope
••strain relief boot along insertion tube and umbilical cord (rotate
clockwise only to tighten)
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 a 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.

(5) (1)
L U
F

F
D R

(3)
(4)

(2)

Figure 2.7

– 16 –
 CAUTION:
To avoid damaging the endoscopes, do NOT twist, rotate or bend
excessively any of the strain relief boots (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/cable. Never apply excessive force or torque on these strain relief
boots or slim tubes/cables. During ANY handling of the instrument avoid
excess force, twisting, rotation and/or bending of the actual insertion tubes
and umbilical cord to prevent inadvertent damage (crush, compression,
deformity, etc.) to these parts as well as to internal components contained
within the endoscope.

F
F

L U
L U

F
F

R
R D
D

Do NOT Twist or Rotate Do NOT Bending

L U
F

F
D R

(1)

(2)

Figure 2.8

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) Check that the observed image turns in the intended direction when the control
knob is operated to move the angulation up/down and left/right.

– 17 –
 c) Engage fully the angulation locks to be certain that the position of the angulated
tip can be stabilized.
(1) Right-Left
F

(2) Up-Down

L U
F

R (1)

D
(2)

Figure 2.9

WARNING:
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 bending section bends freely and smoothly. NEVER APPLY
EXCESSIVE FORCE TO THE ANGULATION CONTROLS!
ANY lack of smooth operation of the angulation controls may be 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. Use of endoscope with suspect angulation mechanism
could lead to angulated distal tip to not being able to be released and end
up damaging patient tissue/membrane or perforation.

CAUTION:
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 tip angulation. The examples above are indications
that service is required to avoid more serious problems with the angulation
control system.

4) Inspection of Air/Water Feeding System

a) Prior to use, the air/water feeding valve (OF-B188) should be inspected. Remove
the air/water valve from the control body and ensure that O-rings in good
condition are properly attached.

(1)
(1) OF-B188
(2)
(2) Cap
(3) O-Ring
(4) Check Valve

(3)

(4)

Figure 2.10

– 18 –
WARNING:
If air bubbles discharge continuously from the distal end of the endoscope
during inspection, it is possible that the O-ring may be damaged, installed
incorrectly, or the air/water feeding valve may be damaged or installed
incorrectly.

If the instrument is used in this condition, it could cause infection by cross

contamination to the patient as result of reflux or spit-back of patient
fluids from the valve or damage the patient’s body cavity. Also, the air
could be delivered to the patient's body excessively as well as continuously
and expose the patient to pain and suffering and/or cause damage as
result of gas embolism, etc.

Therefore, if the aforementioned characteristic was observed, make sure

to replace the O-ring or the air/water feeding valve with fully reprocessed
new ones which have already been subjected to a high-level disinfection
or sterilization procedure (O-ring set, model OF-B192, and the air/water
feeding valve, model OF-B188 can be used) and perform the inspection
again.
Since the check-valve can NOT be replaced by the end user, replace the
entire A/W valve with a new one if the check valve is damaged/missing.

b) Install the valve into the A/W cylinder by gently pushing the valve into the
cylinder. Never apply excessive force to push the valve into the A/W cylinder.
c) Connect the endoscope to the video processor. Turn air pump “ON” to desired
pressure setting. Place the endoscope distal tip into sterile water and confirm that
no air bubbles exit the distal air nozzle.
d) To inspect air delivery, cover the hole at the top of the air/water valve and
confirm that air flows freely from the air/water nozzle at the endoscope distal tip.
e) By depressing the air/water feeding valve, the water delivery system is activated.
Water should flow in a steady stream from the air/water nozzle at the distal tip
of the endoscope. (This may take several seconds on the initial attempt.) USE
STERILE WATER ONLY.

Action

Air Water
Result –
Feeding Feeding

– 19 –
f) Release the air/water feeding valve to determine if the valve freely returns to its
OFF (neutral) position and delivery of water (and air) ceases.

CAUTION:
Before use, make sure that the air/water feeding valve is not clogged or
does not have any other problem that could cause the uninterrupted flow
of air/water. If the endoscope is used in such condition, it will hinder its
capability to clear the debris off the objective lens and the endoscopic
examination might be interrupted.

g) If air and/or water do not flow properly, the following steps should be followed.
[1] Disconnect the endoscope from the video processor.
[2] Remove the suction control valve and the air/water feeding valve.
[3] 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 valve
receptacle as the cotton or applicator could become lodged within these
openings and cause channel blockage.
[4] • Following the companion Instructions for Use (reprocessing) for chemical
cleaning of the air and water channel with detergent, flush detergent
through both the air and water channels.
Rinse the air and water channel(s) with sterile water.
Then flush the air several times to force any residual solution out of the
channel.
• If the cleaning adapter is being attached, remove the adapters and install
the air/water feeding valve.
(Alternate) By leaving the air/water feeding valve in the cylinder instead of
the OF-B153 adapter, one may direct pressured fluid (or air) independently
to either channel to expel debris from and/or more forcefully flush solution
into either the air or water channel. This should not be attempted on a
completely clogged/blocked air or water channel/nozzle.
[5] Test for normal delivery of air and water. It may be necessary to repeat the
above procedure if normal air and water delivery is still not available.

CAUTION:
Do NOT apply excessive force or use a sharp object in an attempt to
unblock a clogged channel as the endoscope channel could become
damaged. Whenever channel damage is suspected, the endoscope should
be leak tested.

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.

– 20 –
 h) If the air/water feeding valve does not function properly, does not move smoothly
or feels “sticky”, remove the valve and apply a very small amount of silicone oil
lubricant (OF-Z11) onto all the O-rings. Do NOT use excess oil, avoid “blobs”,
large drops and/or squirts of oil directly onto the metal valve stems - instead,
simply place a small droplet of oil on one’s sterile gloved forefinger and gently
swirl between thumb and forefinger. Next place the valve with O-ring in-between
thumb and finger and gently rotate the valve so that the oil is evenly applied to
the outer edges of each O-ring. Make sure the oil is applied to all O-rings and
wipe off all excess.
Do NOT apply excess oil. Doing so can allow for inadvertent migration of the
oil inside channels or other areas not intended to be lubricated.

NOTE:
Prior to clinical use, it is important that the entire air channel system be
dry. Failure to thoroughly dry the air system could result in an unclear or
blurry image caused by very fine droplets of moisture being swept over
and/or onto the objective lens at the distal end of the endoscope.

5) Inspection of Water Jet

a) Prior to use, the water jet check valve adapter (OE-C12) should be inspected.
Open the water jet connector cap (OF-B118). Turn the water jet adapter
counterclockwise and remove it from its cylinder. Make sure that the black
check-valve (OE-C14) is properly attached to the bottom of the water jet check
valve adapter.
If the check-valve is missing or not attached properly, correctly reposition the
check-valve by turning it several times on the water jet adapter unit.
For proper positioning, there should be no clearance (gap) between the check-
valve and the water jet check valve adapter stem.
(1) OE-C12
(1)
(2) OE-C14

(2)

Figure 2.11

– 21 –
WARNING:
The check-valve OE-C14 is a reusable component and it as well as the OE-
C12 check-valve adapter, water jet cylinder, irrigation tube and water jet
channel should be reprocessed after each use.

Make sure that the check-valve OE-C14 is securely attached to the check-
valve adapter OE-C12.

A worn or damaged check-valve should be replaced with a new one which

has already been subjected to a high level disinfection or sterilization
procedure (Check valve set, model OE-C15 which contains 10 pieces of
OE-C14 is optionally available).
For repeated use, always ensure that the valve has already been
reprocessed. A damaged, worn or missing check-valve could create a risk
of cross-contamination to the end user due to the potential for reflux (spit-
back) of patient fluids through an unsealed path if the check-valve is not
attached properly.

b) Attach the water jet check-valve adapter (OE-C12) and water jet connector cap
(OF-B118) opened and then irrigation tube (OF-B113) to the water jet port on
the (PVE) connector.
c) Attach a syringe filled with sterile water to this tube and flush water through the
tube. Water should flow in a steady and forceful stream from the water jet nozzle
at the distal end of the endoscope (this may take several seconds on the initial
attempt).
(1) Water Jet Connector
(1)
Cap (OF-B118)
(2) Irrigation Tube
(OF-B113)
(2) (3) Water Jet Check Valve
Adapter
(OE-C12)
(3)

Figure 2.12

d) Use only sterile water in the water jet system.

e) If water does not flow properly, the following steps should be followed:
[1] Attach a syringe filled with a compatible cleaning detergent solution to the
irrigation tube.
[2] Flush solution through the tube and nozzle. Soaking of the water jet channel
with detergent solution should help dissolve and dislodge whatever is
restricting the normal forceful stream from the water jet nozzle.
[3] Remove the syringe containing detergent solution and attach a syringe with
air. Purge the channels with air and then rinse the air and water channel(s)
with sterile water. Then, flush air through the irrigation tube and nozzle
several times to remove any residual solution from the tubing and nozzle.

– 22 –
 CAUTION:
It may be necessary to repeat the steps above several times to obtain
proper water jet function.

If water still does not flow properly after several attempts, contact your
local PENTAX service facility.
Do NOT apply excessive force or use a sharp object in an attempt to
unblock a clogged channel as it could result in endoscope damage.

f) In place of manual flushing via syringe, specially designed irrigator pumps

intended for endoscopic irrigation may be used via the PENTAX water jet
system. PENTAX check-valve mechanisms should always be connected and
positioned within the water jet channel pathway. Always use the lowest irrigator
pump setting as the procedure requires and increase water flow rates as patient
conditions allow.

WARNING:
Although the water jet system may not be clinically used during each
procedure, because the water jet channel of the endoscope enters the
body cavity, it can be contaminated the same way as the insertion
portion of the endoscope. Therefore, it still MUST be properly cleaned and
subjected to the same disinfection/sterilization processes as other internal
channels of the endoscope.

NOTE:
The water jet system featured in PENTAX endoscopes should not be
confused with “auxiliary” or manual water feed systems whose function is
simply to clean the distal objective lens. A true forward water jet allows
the endoscopist to direct a forceful stream of water to clear blood, debris,
etc. from a particular area of interest to improve visualization.

(1) Water Jet water shoots

straight out to area of
interest
(1)
(2) Auxiliary Water System
water is directed
across endoscope tip
(2)
to clean lens
Figure 2.13

6) Inspection of Instrument Channel Selector (EC-3890TLK ONLY)

a) Check the condition of the instrument channel selector (OF-B161). The
selector knob should move smoothly when rotated and click into position at the
prescribed indicators. The instrument channel selector allows the user the choice
of suction capability through either channel, or simultaneous suction through
both channels.

NOTE:
The suction channel selector knob can be rotated either clockwise or
counterclockwise.

– 23 –
warning
NEVER use the OF-B161 with any outward signs of damage or any
abnormal conditions. Using a compromised selector or failure to attach
the selector appropriately to the suction selector cylinder could result in
decreased suction capability, air/fluid leakage and/or the potential for
cross contamination due to the possible reflux or spit-back of patient
fluids.

HANDLING OPERATION
Simultaneous suction through “B” Align the instrument channel
both channels. selector knob to the combined
“A B” indicator and depress
(1) Suction Channel Selector the suction valve to start/stop
(1) activation of suction.
“A”

Suction through the small “B”

Align the instrument channel
channel only. selector knob to the single
“B” indicator and depress the
suction valve to start/stop
activation of suction.

Suction through the large Align the instrument channel

channel only. selector knob to the single
“A” indicator and depress the
suction valve to start/stop
“A” activation of suction.

b) Should the instrument channel selector not rotate smoothly, it might require
further cleaning.
(1) Suction Channel Selector
(1)
(2) Suction Cylinder

(2)

Figure 2.14

[1] Remove the entire instrument channel selector mechanism from the
endoscope.
[2] Scrub all internal and external surfaces of the selector using the smaller side
of the cleaning brush (CS-C9S).
(1) Suction Channel
(1) Selector
(2) CS-C9S

(2)

Figure 2.15

– 24 –
 [3] Using the large bristle of the specially designed cleaning brush, CS-C9S,
insert the brush into the opening of the instrument channel selector cylinder.
Thoroughly clean the surface areas.
[4] Next, thoroughly clean the instrument channel selector and rinse well.

7-1) Inspection of Remote Buttons and Magnification Control (except EC-3890LZi)

a) Remote Buttons
Check to ensure that the function that you assigned to each remote button works
properly.

NOTE
The function can be assigned to remote buttons #1, #2, #3, or #4. For
more details, refer to the instructions for use supplied with the video
processor.

b) Magnification control

NOTE
PENTAX Video Processor, model EPK-i5020 is not compatible.

(1) Endoscopes with the

Magnification Control
(1) (2)
Lever
(2) Endoscopes without
the Magnification
Control Lever
(3) Magnification Control
(3) Lever
(4) Standard Image
(5) Magnified Image

(4) (5)

Figure 2.16

[1] Endoscopes with the Magnification Control Lever

Turn the magnification control lever clockwise to magnify the image up to
two times. Turn counterclockwise to return to the original size.
[2] Endoscopes without the Magnification Control Lever
Press the remote button which the magnification function is assigned to
magnify the image. Pressing the same remote button again will make the
image return to the original size.

NOTE:
As this magnification function is performed electronically, focus and depth
of field do not change. Clarity is slightly reduced.

– 25 –
7-2) Inspection of Remote Buttons and Magnification Control (EC-3890LZi)

a) Remote Buttons
Check to ensure that the function that you assigned to each remote button works
properly.

NOTE:
The function can be assigned to remote buttons #1, #2, or #3.
For more details, refer to the instructions for use supplied with the video
processor.

b) Electronic Magnifying System

NOTE
PENTAX Video Processor, model EPK-i5020 is not compatible.

Press the remote button which the magnification function is assigned to magnify
the image. Pressing the same remote button again will make the image return to
the original size.

NOTE:
As this magnification function is performed electronically, focus and depth
of field do not change. Clarity is slightly reduced.

c) Optical Magnifyng System

(1) Magnification Control

(2) Lever
(2) Remote Button 3
(1)

Figure 2.17

To inspect the optical magnification, check that the observed image on the
monitor changes when the magnification control lever is operated to turn to
clockwise/counterclockwise.
Turn the lever clockwise to magnify the image, counterclockwise to return to
the standard size image.

NOTE:
PENTAX 90Zi endoscope can use Optical Magnification System and
Electrical Magnification System at the same time.
However, the magnification control lever is designed to control ONLY the
Optical Magnification System. It cannot control the electrical magnification
system.

– 26 –
8) Inspection of Suction Mechanism

a) Prior to use, the suction control valve (OF-B120) should be inspected. For easier
identification, an orange colored indicator is placed on top of the OF-B120 valve
mechanism. Remove the valve from the control body and make sure that rubber
portions of the valve are not damaged or worn.
(1) OF-B120
(1)

Figure 2.18

WARNING:
Make sure that the correct suction control valve (OF-B120) is being used.
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 (O-ring set, model OF-
B127, 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 tip 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 risks.

b) Position the valve OF-B120 so that the small metal tab near the base on the valve
stem aligns with the notched suction valve cylinder, also color coded in orange.
Install the valve into the suction cylinder by gently pushing the valve into the
cylinder. Never apply excessive force to push the valve into the suction cylinder.
(1) Suction Control Valve
OF-B120 (orange)
1

(1)

Figure 2.19

– 27 –
 (1) Depress
(1)
(4) (2) Suction Source Tube
F
(3) Suction Nipple

L U
F
F

(4) Inlet Seal

R
D
(2)

(3)

Figure 2.20

(1) (2)
(1) Correct
(2) Incorrect
(3) Metal
OF-B120
OF-B120

(3)

Figure 2.21

WARNING:
Make sure suction control valve OF-B120 is correctly attached (see figure
2.21).

Improperly installed valves may not function as originally intended. Such

valves may not return to their neutral (released) positions and/or they
may provide continuous suction.
Continuous aspiration can cause loss of air/fluid, difficulty in maintaining
proper insufflation and/or inadvertent suctioning of tissue into the distal
instrument channel opening. Also it could possibly result in the potential
for reflux or spitback of patient fluids.

c) Connect suction tubing from an external suction source to the suction nipple
located on the PVE Connector at the end of the umbilical cord. Make sure that
the inlet seal is attached to the instrument channel inlet. Place the distal tip of the
endoscope in a basin of sterile water and depress the suction control valve. Water
should be rapidly aspirated into the suction system collection container.

WARNING:
An inlet seal in good condition (that is not worn or damaged) must be
attached to 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 fully reprocessed new one for each
procedure.

d) Release the suction control valve to determine if the valve freely returns to its
OFF position and the aspiration of water ceases.

– 28 –
 e) If the suction control valve does not move smoothly or feels “sticky”, remove the
valve from the suction cylinder on the control body of the endoscope. Apply a
small amount of silicone oil lubricant (OF-Z11) onto rubber part and the O-ring.
Place a small droplet of oil (OF-Z11) on one’s sterile gloved forefinger and
gently swirl between thumb and forefinger. Next place the valve with O-ring in-
between thumb and finger and gently rotate the valve so that the oil is evenly
applied to the outer edges of the O-ring.
Remove/wipe off excess lubricant with a soft gauze. Do not use excessive
silicone oil.
(1) OF-B120
(1)
(2) Rubber Part
(3) O-Ring

(2)

(3)

Figure 2.22

9) Inspection of Biopsy Forceps and Instrument Channel

a) Make sure there are no kinks in the flexible shaft of the biopsy forceps.
b) The 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
jaws. This mechanism should operate freely.
(1) Close
(1)
(2)
(2) Open

Figure 2.23

d) Close and inspect the 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.

– 29 –
WARNING:
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 the PENTAX service facility.

– 30 –
CAUTION:
Endoscopic accessory instruments (EAIs) may be used with PENTAX
flexible endoscopes. It should be understood that special care and caution
must be exercised when using accessories, particularly non-PENTAX
products through the instrument/suction channel of an endoscope. This
is especially true when attempting to pass accessories through narrow
channels when curved in a tight bending radius.
Please note that damage to the endoscope and/or accessory instrument
is possible if excessive force is applied during insertion (or withdrawal) of
the EAI. Also, using excessive force during insertion causes the withdrawal
of the EAI to be more difficult. Subsequently it contributes to the cause of
injury to patient tissue/membrane. To prevent instrument damage, device
failure, or patient injury, please adhere to the following precautions:
••Never apply too much pressure or excessive force during insertion
through the instrument channel.
••Never attempt to force endoscopic accessories, such as biopsy forceps
through a fully angulated bending section.
••Prior to using accessories from another source (non-PENTAX products),
contact the manufacturers of the accessories to confirm if the device
has been checked for compatibility.
Failure to follow these recommendations can result in endoscope and/or
accessory damage/failure, including but not limited to:

••Channel puncture/leakage
••Fluid invasion
••Fiber breakage
••Other internal component failure
Should resistance be encountered when inserting an accessory, STOP! If
resistance is at the endoscope tip, slightly withdraw the accessory, reduce
the angulation (within the bending section), then slowly and carefully
advance the accessory under direct vision.
Several factors can affect the ease/difficulty of accessory passage through
the endoscope channel:
••Outside diameter of accessory compared to inside channel diameter
••Non-flexible (rigid) portions of an accessory
••The curve or bend (bending radius) within a channel through which the
accessory will pass
••Damaged accessory
Due to the variables above, prior to each procedure, it is important to
check the particular accessory intended to be used to satisfy the clinical
procedure to be performed. Such pre-use inspections will allow for
uninterrupted and more expeditious examinations.
To confirm the absence of severe channel damage affecting the watertight
integrity of the endoscope, perform appropriate leak testing of the
endoscope per PENTAX instructions.

– 31 –
 WARNING:
From the standpoint of infection control, 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.

CAUTION:
The instrument, A/W and the water jet channel systems are 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 supplied with the fluids for use and pay special
attention to any reactions with the materials identified in the intended fluid
path.

NOTE:
Endoscope instrument, A/W and the water jet channels are composed
of stainless steel, Noryl and fluorine contained polymers. PENTAX is not
aware of any reports of material incompatibility between these materials
and fluids that are commonly used during endoscopic procedures. As
relates to reprocessing, PENTAX publishes a list of compatible detergents
and disinfectants. In the event that the healthcare team intends to infuse
a less commonly or rarely used fluid through the instrument channel in
conjunction with a procedure, it is strongly advised that the manufacturer
of the fluid be consulted for material compatibility information with
stainless steel and polymers containing fluorine. Also, please consult the
PENTAX list of compatible reprocessing agents for guidance regarding
compatible detergents and disinfectants.

NOTE:
Accessories should always be inspected and checked with the particular
endoscope prior to each procedure.

CAUTION:
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 just before Insertion of Endoscope

WARNING:
From the standpoint of infection control, 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.
Refer to the companion instructions for use describing in detail PENTAX
reprocessing instructions.

– 32 –
 WARNING:
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. Only the
user can determine if any instruments and accessories have 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
to use. If necessary, the endoscope’s insertion tube may be wiped down with a
gauze moistened with 70-90% medical grade ethyl or isopropyl alcohol.

WARNING:
Contact the manufacturer and follow local regulations regarding safe use,
appropriate handling and disposal of cleaning and disinfection solution
including alcohol. Material Safety Data Sheets (Health and Safety Data
Sheets or similar documents depending upon country) available from the
cleaning and disinfection solution (including alcohol) manufacturer should
provide guidance to end users about composition, hazards, chemical and
physical properties, first aid, handling and storage, stability, precautions,
disposal, etc., associated with cleaning and disinfection solution including
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 supplied with the PENTAX
video processor for inspection of the image quality.
4) Apply a medical grade water soluble lubricant to the insertion portion. Do not use
petroleum based lubricants.

NOTE:
The objective lens must be kept free of the lubricant. Try avoid using
excess lens cleaner.

CAUTION:
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 be mishandled or dropped, do not use it. Return it to an
authorized PENTAX service facility for inspection or repair.

– 33 –
3. DIRECTIONS FOR USE

WARNING:
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 endoscopy. There is a possibility of backflow and/
or spit-back of patient fluids, chemicals, etc. from the Instrument Channel
Inlet or the Suction Control Valve. During the procedure, always wear
protective garments such as gloves, gowns, face masks, etc. to minimize
the risk of cross contamination.

WARNING:
When using this instrument on a patient with invasive medical device such
as pacemaker, consult a physician specialized in the field to determine
whether the use of this instrument is safe by taking all factors into
consideration.

WARNING:
Because of the leakage current from the endoscope, there is a possibility
of electric shock if any part of the skin comes in contact with exposed
metallic surfaces of an endoscope while using an electrosurgical device. Be
sure to wear protective rubber gloves during endoscopic examinations to
prevent the skin from contacting the metallic surfaces of an endoscope.

WARNING:
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. Failure to do so could result in the potential for reflux (spit-
back) of patient fluids through an unsealed path due to any looseness/
missing in the installed valve.

– 34 –
3-1. Operation
1) Angulation function
a) Manipulate the Angulation Control Lever in the “U” direction in order to
angulate the distal end in the UP direction.
b) Manipulate the Angulation Control Lever in the “D” direction in order to
angulate the distal end in the DOWN direction.
c) Manipulate the Angulation Control Lever in the “R” direction in order to
angulate the distal end in the Right direction.
d) Manipulate the Angulation Control Lever in the “L” direction in order to
angulate the distal end in the Left direction.

(1) Right-Left
F
(2) Up-Down
L U

R (1)
D

(2)

Figure 3.1

2) Angulation Lock function

a) Turn the Up/Down Angulation Lock Lever counterclockwise to lock the Up/
Down angulation position.
b) Turn the Up/Down Angulation Lock Lever clockwise to unlock the Up/Down
angulation position.
c) Turn the Right/Left Angulation Lock Knob counterclockwise to lock the Right/
Left angulation position.
d) Turn the Right/Left Angulation Lock Lever clockwise to lock the Right/Left
angulation position.

(1) Up-Down Angulation

(1)
(2) Lock Lever
Free Position
(Lock Released)
(2) Right-Left Angulation
F

Lock Knob
Free Position
(3)
(3) (Lock Released)
(3) Lock Position

Figure 3.2

– 35 –
3) Air/ Water Feeding function
a) Connect the air/water feeding tube from the water bottle assembly to the air/
water port located on the PVE connector.
b) Cover the hole on top of the Air/Water Feeding Valve to feed air.
c) Depress the Air/Water Feeding Valve to feed water.
d) Release the Air/Water Feeding Valve to stop feeding air/water.

Action

Air Water
Result –
Feeding Feeding

4) Suction function
a) Connect the suction source tube from an external suction source to the suction
nipple located on the control body.
b) Depress the Suction Control Valve to suction fluid and/or gas, debris.
c) Release the Suction Control Valve to stop suctioning.

5) Remote Button function

Function assigned to each Remote Button is activated by pressing the corresponding
Remote Button. Refer to the Instructions for Use supplied with the processor for
assignment of function to each Remote Button.

The following table shows the factory setting.

EC-3890TLK
EC-3490Li/3890Li EC34-i10L
Endoscope 2990Li/3490TLi
EC-3890LZi EC38-i10L
3490LK/3890LK
Remote Button 1 Freeze Freeze Freeze
Remote Button 2 Copy Copy Copy
Remote Button 3 Video Video Video
Remote Button 4 Enhance - Enhance

6-1) Electronic Magnification Control function

NOTE
PENTAX Video Processor, model EPK-i5020 is not compatible.

a) EC-3490Li EC-3890Li
[1] The image is electronically magnified by turning the Magnification Control
Lever clockwise.
[2] The image returns to normal by turning the Magnification Control Lever
counter-clockwise.

– 36 –
 b) Except EC-3490Li, EC-3890Li
[1] The image is electronically magnified by pressing the Remote Button to
which the magnification function is assigned.
[2] The image returns to normal by pressing the Remote Button again.

6-2) Optical Magnification Control function (EC-3890LZi)

a) The image is optically magnified by turning the Magnification Control Lever

clockwise.
b) The image returns to normal by turning the Magnification Control Lever counter-
clockwise.

3-2. Pretreatment
The patient should be prepared appropriately based on your expertise as an endoscopic
specialist.

3-3. Insertion and Withdrawal

WARNING:
Never operate the endoscope with excessive force. Insertion or bending
with excessive force may cause a mucosal injury or perforation to the
patients.

NOTE:
For details of operations such as starting and stopping, please refer to the
PENTAX video Processor Instructions for Use.

1) (Endoscopes with Magnification Control Lever)

Turn the magnification control lever counterclockwise to return to the standard
non-magnified viewing.

CAUTION:
For safety reasons, always insert and advance the endoscope in the
standard, non-magnified mode. Magnified vision reduces the area of the
viewing field. Do not advance the endoscope in the magnified mode.

2) Slowly insert the endoscope under direct vision.

3) Adjust the intensity of the video processor to obtain a brightness level suitable for
observation.

CAUTION:
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.

– 37 –
4) The angulation controls should be used as needed to position the endoscope.
Angulation of the tip should be performed under direct vision in a gentle and
deliberate manner. Should resistance be encountered, never apply excessive force.

WARNING:
Ensure that the angulation controls can rotate smoothly, that there is
no grinding or excess friction within the angulation system and that the
bending section bends freely and smoothly.

NEVER APPLY EXCESSIVE FORCE TO THE ANGULATION CONTROLS!

ANY lack of smooth operation of the angulation controls may be 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. Use of endoscope with suspect
angulation mechanism could lead to angulated distal tip to not being able
to be released and could cause possibly perforation.

If during a procedure angulation is lost in any direction such as when “cables

snap” (broken pulley wire, broken angle wire, etc.), do NOT continue to
use the instrument and do NOT rotate the angulation control knob. Should
the angulation system fail for any reason, stop the procedure, release the
lock lever and carefully withdraw the endoscope under direct visualization.
If the endoscope is withdrawn without releasing the angulation lock lever,
it may cause an injury such as perforation to the patient.

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 feeding

valve to increase the amount of insufflation and the suction control to decrease
the level of insufflation.

WARNING:
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 to prevent
the pain and/or gas embolism that is caused by excessive air aspiration.

6) Procedures involving poorly prepped patients should be avoided as excessive

patient material can negatively affect certain endoscope channel functions as well
as the ability to maintain a clear endoscopic view.

7) Mucous, fluids and/or other patient material should be aspirated via the
instrument/suction channel and suction control valve 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.

– 38 –
 CAUTION:
Do not apply excessively negative pressures (high suction settings) and/
or prolonged contact of the distal instrument channel opening (endoscope
tip) against mucosal surfaces to avoid “suction polyps”, bleeding and/or
other trauma to the patient. During aspiration keep an endoscopic view
of patient anatomy as clear as possible and maintain some distance from
endoscope tip to tissue to avoid suctioning of mucosa onto/into the distal
channel opening.

CAUTION:
Avoid suctioning foreign objects and solid particles that are large enough
to potentially clog the Suction Channel and Suction Control Valve. If such
objects and/or particles have been suctioned into the endoscope, insure
that they have been completely removed from the endoscope before
continuing to use it. If the Suction Control Valve has been clogged to the
extent that it is not possible to stop the suctioning operation, detach the
Suction Source Tube that is attached to the endoscope from the suction
source, detach the Suction Control Valve from the endoscope, and remove
any trapped debris that might be preventing the Suction Control Valve
from operating properly.
If it is impossible to confirm that all foreign objects and solid particles have
been removed from the Suction Channel, do not use the endoscope and
contact your local PENTAX service facility.

8) The objective lens may be cleaned during the procedure by alternately using the
air/water and suction control valves.

CAUTION
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. Continuing use of the light guide with
sticky debris might cause steam because debris is deprived of moisture
by heat. As a result, endoscopic images become blurry. If steam is found
on the light guide during a procedure, stop it immediately and withdraw
the endoscope carefully from a patient.

CAUTION:
Use of the distal rubber hood might result in decreased visibility during a
procedure due to the accumulation of debris on the distal objective lens.
When using the distal rubber hood, please pay particular attention to
maintaining adequate visibility by suctioning and then delivering water and
air to remove debris from the distal objective lens. Depending upon the
particular procedure being performed, consideration should be given to
removing the distal rubber hood completely if it is found excessively hinder
adequate visibility.

NOTE:
Should debris on the objective lens be difficult to clean, one can
temporarily use the HIGH air pressure setting on the video processor and
simultaneously press the air/water and suction control valves. Return air
pressure setting to original selection before proceeding.

– 39 –
9) A Water Jet may be directed at the target area during the procedure as necessary.
USE STERILE WATER ONLY.

10) Image capture, hard copy, video recording, etc. may be carried out as necessary.

NOTE:
Leaving the finger on the button could cause the function (hard copy or
recording, etc.) to be activated inadvertently.

11) Before withdrawing the endoscope, trapped air should be suctioned to reduce
patient discomfort.
12) When attempting to withdraw the endoscope, return the angulation lock levers to
their free position. Always withdraw the endoscope under direct visualization.

WARNING:
If for any reason, the image is lost due to power shortage, lamp or video
processor failure, etc. the angulation lock levers should be released, the
endoscope tip should be straightened to its neutral position, and the
insertion tube should be carefully and slowly withdrawn from the patient.
If the endoscope is withdrawn without releasing the angulation lock lever,
it may cause an injury such as perforation to the patient.

(1) (1) Up/Down Angulation

(2) Lock Lever
Free Position (Lock
Released)
(2) Right/Left Angulation
F

Lock Knob
Free Position (Lock
(3)
(3) Released)
(3) Lock Position
Top spoke of angulation knobs in this position
corresponds to neutral distal tip orientation
Figure 3.3

– 40 –
3-4. Magnification Control (EC-3890LZi)

1) Optical Magnifying System

•• Optical magnification System is controlled with lever on the control body.

•• Turn the control lever clockwise to activate Optical Magnification System,

counterclockwise to return to the standard image size. While turning the
control lever, image size changes continuously. Release the lever to stop
Optical Magnification System.

NOTE:
While optical magnification is activated, focus and depth of field are
changed. To achieve optimum view, please adjust the distance from
objective lens to observation object. When the magnification is maximum,
optimum working distance is about 2~3 mm. Magnified image can be
achieved without losing clarity.

•• Optical magnified image is shown as below.

As the image is magnified, Magnification Indicator changes. Magnification
Indicator is displayed in the lower right portion of the screen.
(1) Standard Image
(2) Magnified Image
(3)
(3) Mask

Indicator Indicator

(1) (2)

Figure 3.4

2) Electrical Magnifying System

NOTE
PENTAX Video Processor, model EPK-i5020 is not compatible.

•• Electrical Magnification System can be activated with video processor,

keyboard, foot switch, or remote button.

•• Electrical magnified image is shown as below.

As the image is magnified, magnification indicator changes, and mask is
swept away to outside of the screen.
(1) Standard Image
(3)
(2) Magnified Image
(3) Mask

Indicator Indicator

(1) (2)

Figure 3.5

– 41 –
3) Magnification Indicator
•• Magnification indicator is shown as below. Optical magnification and
Electrical magnification are indicated separately.
(1) Electrical magnification indicator
When the electrical magnification is activated, this
E. Zoom: ™1.5 W㸫㸩㸫㸫㸫T
(1) (2)
item is displayed.
(2) Optical magnification indicator
“+” indicates the magnification. When the
Figure 3.6 magnification is not activated (standard image),
position of “+” is far left (next to W). As the
image is magnified, “+” moves to right. When the
magnification is maximum, position of “+” is far
right (next to T).

NOTE:
Magnification indicator area acts as both message area and magnification
indicator. Magnification indicator is cleared briefly when the message
is displayed (Ex: “Capture OK”). After the message is displayed,
magnification indicator will be redisplayed.

4) Distal Rubber Hood

•• The Distal Rubber Hood can be attached (OE-A59 for EC-3890LZi) to
maintain the optimum distance from the distal objective lens to the observed
area (mucosal surface). It makes observing the target easier especially under
the magnified image.

•• To attach or detach a Distal Rubber Hood, gently press the Distal Rubber
Hood onto the endoscope tip until the Distal Rubber Hood completely
covers the endoscope tip. Make sure that there is no space between the Distal
Rubber Hood end and the plastic endoscope tip.
(1) OE-A59 for EC-3890LZi

Figure 3.7

CAUTION:
In standard image mode, the tip of the Distal Rubber Hood may appear on
the screen depending on how it is attached.
Do not hold the endoscope or grab the bending section too firmly when
attaching or detaching the Distal Rubber Hood. Applying excessive force to
the bending section causes damages to the endoscope.

– 42 –
3-5. Biopsy

WARNING:
From the standpoints of infection control, accessories which ENTER
STERILE TISSUE, THE VASCULAR SYSTEM, BLOOD VESSELS, or MUCOUS
MEMBRANE must be sterile.

WARNING:
For ALL types of endoscopic accessory instruments, always maintain a
view of the accessory during advancement, use, and withdrawal of the
device.
Incautious use of EAI devices could end up damaging patient tissue/
membrane or perforation.

CAUTION:
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.

CAUTION:
For safety reasons, always insert and advance the accessory in the
standard, non-magnified mode.

Magnified vision reduces the depth of the viewing field making it difficult to
maintain a clear view of the accessory.
(Not applicable to PENTAX Video Processor, model EPK-i5020)

1) Insert the forceps through the slit in the inlet seal. 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.

NOTE:
When the cups/jaws are first passed through the inlet seal, a temporary
resistance will be encountered.
Hold the shaft tightly at about 5cm from the cups/jaws and push it
through. During insertion, if the forceps are found hard to advance further
due to resistance, decrease the angulation of the bending section to a level
suitable for smooth insertion and insert the forceps again.

(1) 5 cm

)
(1

Figure 3.8

– 43 –
 CAUTION:
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.

2) When a portion of the cups/jaws of the forceps becomes visible in the viewing
field, carefully advance the forceps onto the target area.

Figure 3.9

3) Open the forceps cups/jaws and advance the forceps against the target area.
Carefully squeeze the forceps handle to close the cups/jaws and obtain a specimen
within the cups/jaws. Always maintain a view of accessory during advancement.
4) Withdraw the forceps slowly with the cups/jaws closed.

WARNING:
Withdraw the forceps carefully and gently. Never withdraw the forceps
rapidly.
It could cause reflux of patient debris left in the endoscope channel.

– 44 –
3-6. Laser
Laser equipment should only be used by physicians who have thoroughly studied all
the characteristics of the equipment and who are familiar with the proper techniques of
endoscopic laser therapy. The user must carefully read and follow all instructions in the
instructions for use supplied with the Laser equipment. The Laser equipment should be
carefully and thoroughly inspected and calibrated. Only the user can determine if the
condition of the Laser equipment is suitable.

WARNING:
The PENTAX endoscopes identified in this instructions for use are
compatible with Nd: YAG laser (wavelength 1064nm) only. Do not use
these endoscopes with other types of laser such as KTP, He-Cd, or Excimer
laser Systems. It could result in serious injury to the patient.

WARNING:
••Using laser devices in a flammable surroundings, such as an
environment with a high oxygen concentration, may cause explosion.
If there is a possibility of flammable gas being present within a body
cavity, use nonflammable gas (such as CO2 or air) instead.
••When using nonflammable gas, there is a possibility of gas embolism
if excessive gas is flushed. When using nonflammable gas, be careful
not to flush excessive gas. Use suction capability of an endoscope to
remove gas if necessary.

WARNING:
••When using a laser equipment, the physicians as well as the assisting
personnel should wear goggles.
••Do not look directly at the light emitted from the laser equipment.
The intense light may cause damage to your retinas.

1) The user has the option of using a nonflammable gas for insufflation.
Nonflammable gas from a pressure-regulated and flow-rate controlled source can
be connected to the provided or optionally available gas adapter, model OF-G11,
as illustrated.
(1) CO2 Gas Feeding
(1) (2)
Adapter OF-G11
(2) CO2 Gas Cylinder
(3) PVE Connector
(4) Video Processor

(4) (3)

Figure 3.10

NOTE:
When connecting to the PENTAX endoscope, connect only the medical
grade regulated source of gas which pressure can be controlled.

– 45 –
2) The gas adapter, which can be secured to the air/water port on the PVE connector,
has a luer receptacle to accept tubing from an external source of nonflammable
gas. As long as the air/water feeding tube from a PENTAX water bottle assembly
is connected to the gas adapter and the air pump in the video processor is turned
OFF, nonflammable gas can be delivered.

NOTE:
Set the pressure below 49kPa (7.1psi) and the flow rate at about 4 liters/
min.

CAUTION:
Open the valve of the CO2 gas cylinder only AFTER turning off the pump
switch of the video processor. Failure to do so will apply excessive pressure
to the video processor and can cause damage to the air pump.

3) Flow of gas from the nozzle at the distal end of the endoscope can be checked
by placing the tip of the endoscope under water and covering the hole on the top
of the air/water feeding valve. The flow rate of gas should be no greater than the
rate of air delivery when the air/water feeding valve on the control head of the
endoscope is covered.

4) The water delivery system is activated by pressing the air/water feeding valve.

5) The operator and assistant(s) should wear surgical gloves to avoid burns during use
of laser equipment.

CAUTION:
It should be noted that as long as the valve of the CO2 gas cylinder is
OPEN and the hole at the top of the A/W feeding valve is NOT covered,
CO2 gas will constantly be vented through the A/W valve into the room.
To reduce excessive CO2 concentrations, it is, therefore, recommended to
close the CO2 gas cylinder valve, work in a well ventilated room, and use
air delivery whenever possible during examinations which are lengthy or in
very confined quarters.
As an alternative, the optionally available gas/water feeding valve, model
OF-B194, may be used in place of the standard air/water feeding valve.
OF-B194 is a closed two-stage valve mechanism. Pressing the first stage
delivers CO2 gas and depressing the second stage activates water delivery.

NOTE:
When using the OF-B194 valve, there will be no venting of CO2 gas into
the room. Place OF-B194 with the air/water feeding valve OF-B188 after
using the CO2 gas.

NOTE:
One may choose to leave the OF-G11 adapter attached to the endoscope
during conventional air insufflation using the air/water feeding valve.
However, the luer sideport of the OF-G11 must be capped.
Similarly, for normal water delivery, the air pump must be turned ON and
the plastic luer lock cap must be secured to the OF-G11 adapter.

– 46 –
6) The laser probe should be introduced through the endoscope in the same manner
as described for biopsy forceps in section 3-5.

7) The position of the active portion of the laser probe should always be clearly
visualized before laser equipment is activated.

8) It should be recognized that a variety of factors can affect the quality of the video
endoscope image during laser use. Intensity of the aiming beam, high power
setting of the laser, close distance of laser fiber to endoscope tip, excessive tissue
burning, can each adversely influence image quality. To obtain optimum results, it
is recommended that the power settings of the aiming beam and laser be adjusted
to minimal levels capable of achieving the desired clinical effect.

9) Follow standard hospital protocol regarding safe-use of lasers, including the

wearing of safety eyewear.

CAUTION:
Prior to activation of the laser, make sure that the laser fiber exits the
distal channel opening of the endoscope. Failure to confirm activation and
deactivation of the laser could result in endoscope damage.

10) Should the distal tip of the endoscope be moved closer than 20mm from the
irradiated tissue surface, the aiming beam may create a “smear” in the image
as shown in figure 3.11. If this smear affect becomes too severe and distorts the
visual field, the intensity of the aiming light should be decreased.
(1) Smear
(1)
(2) Irradiated Area
(3) Probe
(2)

(3)

Figure 3.11

– 47 –
11) When activating the laser at high power (about 100W for Yag Laser) and/or if the
endoscope tip comes to within 10mm of the irradiated tissue, flare may appear at
the corners of the image as shown below in Figure 3.12.
(1) Flare
(1)
(2) Probe

(2)

Figure 3.12

WARNING:
Activation of the laser at high power settings may cause patient injury or
thermal damage of the endoscopes tip.
Do not use the laser at high power setting.

– 48 –
3-7. Electrosurgery

WARNING:
Please refer to the instructions for use provided with the electrosurgical
unit. Electrosurgical systems may be of the floating type (Type BF, Type
CF) or non-floating (Type B). To avoid patient and user burn, use only
the floating type electrosurgical systems. Do not use the non-floating
(Type B) electrosurgical systems. The electrosurgical generator and any
electrosurgical accessory should be carefully and thoroughly inspected.
Only the user can determine if the condition of the electrosurgical
generator and the electrosurgical accessory are suitable.

WARNING:
••Using electrosurgical devices in a flammable atmosphere, such as an
environment with a high oxygen concentration, may cause explosion.
If there is a possibility of flammable gas being present within a body
cavity, use nonflammable gas (such as CO2 or air) instead.
••When using nonflammable gas, there is a possibility of gas embolism
if excessive gas is flushed. When using nonflammable gas, be careful
not to flush excessive gas. Use suction capability of an endoscope to
remove gas if necessary.

1) The user has the option of using a nonflammable gas for insufflation.
Nonflammable gas from a pressure-regulated and flow-rate controlled source can
be connected to the provided or optionally available gas adapter, model OF-G11,
as described for Laser in section 3-6.
(1) CO2 Gas Feeding
(1) (2)
Adapter OF-G11
(2) CO2 Gas Cylinder
(3) PVE Connector
(4) Video Processor

(4) (3)

Figure 3.13

– 49 –
CAUTION:
It should be noted that as long as the valve of the CO2 gas cylinder is OPEN
and the hole at the top of the Air/Water feeding valve is NOT covered,
CO2 gas will constantly be vented through the Air/Water feeding valve
into the room. To reduce excessive CO2 concentrations, it is, therefore,
recommended to close the CO2 gas cylinder valve, work in a well ventilated
room, and use air delivery whenever possible during examinations which
are lengthy or in very confined quarters.

As an alternative, the optionally available gas/water feeding valve, model

OF-B194, may be used in place of the standard air/water feeding valve.
OF-B194 is a closed two-stage valve mechanism.
Pressing the first stage delivers CO2 gas and depressing the second stage
activates water delivery.

CAUTION:
Prior to performing electrosurgery, make sure that the electrosurgical
device exits the distal channel opening of the endoscope. Failure to confirm
activation and deactivation of the electrosurgical device could result in
endoscope damage.

– 50 –
2) The electrosurgical devices should be introduced through the endoscope in the
same manner as described for biopsy forceps in section 3-5.

WARNING:
To avoid user burn and/or severe damage to the patient, follow the
instructions below before high frequency energy is delivered.

1) Use only the electrosurgical systems with the floating grounding

type (Type BF or Type CF). Do not use the non-floating (Type B)
electrosurgical systems.
2) There are two types of Floating Ground Electrosurgical Generators. The
operator should confirm if the Floating Ground Electrosurgical Generator
requires an endoscope feedback cord (s-cord).
For Floating Ground Electrosurgical Generators which require an s-cord,
connect the s-cord between;

••the endoscopes feedback terminal and

••the Electrosurgical Generator patient ground connecting socket.
For Floating Ground Electrosurgical Generators which do not require an
s-cord;

••DO NOT use the s-cord, to avoid potential patient injury.

••use the Condenser Earth Cable, OL-Z3 to reduce interferences or noise
that may appear in the video image.
If the video processor does not have an equipotential terminal, do not
connect any functional ground cord.

3) High frequency energy should be delivered for as short a time period as

necessary to accomplish the desired clinical effect.
4) Select a high frequency output power setting suitable for the particular
intended procedure in order to avoid thermal invasion of the tissue or
insufficient coagulation. Otherwise, it will result in excessive bleeding.

– 51 –
CAUTION:
To avoid user burn and/or unexpected burn to the patient, follow the
instructions below before high frequency energy is delivered.

1) Do not touch the exposed metal parts of the endoscope with unprotected
skin to avoid burns while using an electrosurgical device. Be sure to wear
protective gear such as rubber gloves and goggles.
2) The position of the target area, the insulated distal portion of the
electrosurgical device and the active portion of the electrosurgical device,
should be visible.
3) The active portion of the electrosurgical device should not touch the
metallic distal portion of the endoscope directly or via fluids.
4) The metallic portion of the endoscope should not touch the surrounding
tissue directly or via fluids.
5) The active portion of the electrosurgical device should not touch the
surrounding tissue directly or via fluids.
6) The head of any lesion such as polyp should not touch the surrounding
tissue directly or via fluids.
7) Physicians and assisting personnel should avoid contact with the patient
while high frequency energy is delivered.
8) To avoid the risk of thermal injury, use only insulated devices.
Never use non-insulated devices while performing endoscopic
electrosurgical procedures.

CAUTION:
Before start using electrosurgical device, the noise level should be checked
to make sure that problems that interfere with endoscopic examination
such as loss of image will not be caused by the existing noise.

It should be recognized that the use of electro-surgical devices employing

high frequency current may interfere with the normal endoscopic image
and this interference is not indicative of a malfunction of the video
endoscope system. PENTAX has developed a condenser earth cable,
model OL-Z3 intended to reduce potential RF interference and electronic
noise that may appear in the endoscope image when using electrosurgical
device. Ensure that cable OL-Z3 is correctly connected between the
endoscope and video processor as described in the instructions provided
with the OL-Z3. If electronic noise appears in the endoscope image when
using the OL-Z3, select a high frequency setting to minimum levels
capable of achieving the desired clinical effect.

(1) To Video Processor

(2) To Endoscope

(1)

(2)

Figure 3.14

– 52 –
4. CARE AFTER USE
For the cleaning and maintenance of the equipment after its use, please refer to the

separate Instructions for Use (reprocessing).

WARNING:
Instrument repairs should only be performed by an authorized PENTAX
service facility. PENTAX assumes no liability for any patient/user injury,
instrument damage or malfunction, or REPROCESSING FAILURE due to
repairs made by unauthorized personnel.

Your local PENTAX distributor 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 non-PENTAX

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.

– 53 –
CAUTION:
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 be mishandled or dropped, do not use it. Return it to an
authorized PENTAX service facility for inspection or repair.

CAUTION:
••The service life of this product is 6 years from the date of manufacture.
••Follow the instructions in the Instructions for Use for appropriate pre-
use inspections, proper usage, care after use, storage, and replacement
of consumables.
••Have the vendor/specialist specified by PENTAX to perform repairs
and annual periodic inspections.

WARNING:
Follow the national or local laws/guidelines to appropriately dispose of
the consumables.

Ask the manufacturer or PENTAX representative about the disposal of

the instrument.

– 54 –
SPECIFICATIONS
Endoscope Model EC-3890TLK EC-2990Li EC-3490Li EC-3490TLi EC-3890Li
Direction of View Forward
Field of View 140°
Depth of Field (mm) 3 - 100 4 - 100 3 - 100 4-100
Tip Up-Down 180° - 180° 210° - 180° 180° - 180°
Angulation Right-Left 160° - 160°
Rigid Distal Width (O. D. φmm) ø13.2 ø10.2 ø11.5 ø10.5 ø13.2
Distal End Width (O. D. φmm) ø13.2 ø10.2 ø11.5 ø10.5 ø13.2
Insertion Tube Width (O. D. φmm) ø13.2 ø9.8 ø11.6 ø11.6 ø13.2
Maximum Insertion Portion Width
ø14.65 ø11.35 ø12.85 ø12.85 ø14.65
(O. D. φmm)
*Minimum Instrument Channel Width
ø2.8, ø3.8 ø2.8 ø3.2 ø3.2 ø3.8
(I. D. φmm)
Insertion Tube Working Length(mm) 1,700
Total Length(mm) 2,023
Ambient temperature 10 - 40°C
Operating
Relative humidity 30 - 85%RH
environment
Air pressure 700 - 1060 hPa
Ambient temperature –20 - 60°C
Storage
Relative humidity 0 - 85%RH
environment
Air pressure 700 - 1060 hPa
**Maximum reprocessing temperature 60°C
Degree of protection against electric shock Type BF (Use on heart is prohibited)
Mode of Operation Continuous Operation

Function Magnification (Optical) N N N N N

Y: Yes Selection of Suction
N: No Y N N N N
Channel

* There is no guarantee that instruments selected solely using this minimum instrument channel width will be
compatible in combination.
**PENTAX flexible endoscopes should not be exposed to temperatures in excess of 140°F (60°C) during either
reprocessing or storage. In reprocessing, depending on detergents, even if the temperature does not exceed 60°C,
the scopes may be damaged. For specific brands of compatible detergents, please contact your local PENTAX service
facility or sales representative.
Note: Specifications are subjected to change without prior notice and without any obligation on the part of the
manufacturer.

DISTAL END
EC-3890TLK (1) Objective Lens EC-2990Li (1) Objective Lens
(2) Light Guide (2) Light Guide
(1) (2) (1) (2)
(2) (2) (3) Water Nozzle (3) Water Nozzle
(3) (4) Water Jet Nozzle (4) Water Jet Nozzle
(5) Air Nozzle (5) Air Nozzle
(3)
(4)
(6) Instrument Channel (4)
(6) Instrument Channel
(6)
(5)
(6) (5) (6)

EC-3490Li (1) Objective Lens EC-3490TLi, EC-3890Li (1) Objective Lens

(2) Light Guide (2) Light Guide
(1) (1)
(2) (2) (3) Water Nozzle (2)
(2) (3) Water Nozzle
(4) Water Jet Nozzle (3) (4) Water Jet Nozzle
(5) Air Nozzle (5) Air Nozzle
(3)
(6) Instrument Channel (5) (6) Instrument Channel
(6) (4) (6) (4)
(5)

– 55 –
 Endoscope Model EC-3490LK EC-3890LK EC-3890LZi
Direction of View Forward
Field of View 140° 140° (Wide) / 50° (Tele)
Depth of Field (Magnifying) (mm) 3 - 100 4 - 100 (Wide) / ***2-3 (Tele)
Tip Up-Down 180° - 180°
Angulation Right-Left 160° - 160°
Rigid Distal Width (O. D. φmm) ø11.5 ø13.2 ø13.0
Distal End Width (O. D. φmm) ø11.5 ø13.2 ø12.0
Insertion Tube Width (O. D. φmm) ø11.6 ø13.2 ø13.2
Maximum Insertion Portion Width (O. D. φmm) ø12.85 ø14.65 ø14.65
*Minimum Instrument Channel Width (I. D. φmm) ø3.8 ø4.2 ø3.8
Insertion Tube Working Length (mm) 1,700
Total Length (mm) 2,023 2,025
Ambient temperature 10 - 40°C
Operating
Relative humidity 30 - 85%RH
environment
Air pressure 700 - 1060 hPa
Ambient temperature –20 - 60°C
Storage
Relative humidity 0 - 85%RH
environment
Air pressure 700 - 1060 hPa
**Maximum reprocessing temperature 60°C
Degree of protection against electric shock Type BF (Use on heart is prohibited)
Mode of Operation Continuous Operation
Function Magnification (Optical) N N Y
Y: Yes
N: No Selection of Suction Channel N N N

* There is no guarantee that instruments selected solely using this minimum instrument channel width will be
compatible in combination.
**PENTAX flexible endoscopes should not be exposed to temperatures in excess of 140°F (60°C) during either
reprocessing or storage. In reprocessing, depending on detergents, even if the temperature does not exceed 60°C,
the scopes may be damaged. For specific brands of compatible detergents, please contact your local PENTAX service
facility or sales representative.
***Reference value.
Note: Specifications are subjected to change without prior notice and without any obligation on the part of the
manufacturer.

DISTAL END
EC-3490LK (1) Objective Lens EC-3890LK (1) Objective Lens
(2) Light Guide (2) Light Guide
(1) (3) Water Nozzle (1) (3) Water Nozzle
(2) (2)
(2) (2)
(3) (4) Water Jet Nozzle (4) Water Jet Nozzle
(5) Air Nozzle (5) Air Nozzle
(5) (6) Instrument Channel (3) (6) Instrument Channel
(6) (4) (6) (4)
(5)

EC-3890LZi (1) Objective Lens

(2) Light Guide
(1)
(2) (3) Water Nozzle
(2)
(4) Water Jet Nozzle
(6) (5) Air Nozzle
(6) Instrument Channel
(3)
(5) (4)

– 56 –
 Endoscope Model EC34-i10L EC38-i10L
Direction of View Forward
Field of View 140°
Depth of Field (mm) 2 - 100 4 - 100
Tip Up-Down 180° - 180°
Angulation Right-Left 160° - 160°
Rigid Distal Width (O. D. φmm) ø11.5 ø13.2
Distal End Width (O. D. φmm) ø11.5 ø13.2
Insertion Tube Width (O. D. φmm) ø11.6 ø13.2
Maximum Insertion Portion Width
ø12.85 ø14.8
(O. D. φmm)
*Minimum Instrument Channel Width
ø3.8 ø3.8
(I. D. φmm)
Insertion Tube Working Length (mm) 1,700
Total Length (mm) 2,016
Ambient temperature 10 - 40°C
Operating
Relative humidity 30 - 85%RH
environment
Air pressure 700 - 1060 hPa
Ambient temperature –20 - 60°C
Storage
Relative humidity 0 - 85%RH
environment
Air pressure 700 - 1060 hPa
**Maximum reprocessing temperature 60°C
Degree of protection against electric shock Type BF (Use on heart is prohibited)
Mode of Operation Continuous Operation
Function Magnification (Optical) N N
Y: Yes Selection of Suction
N: No N N
Channel
* There is no guarantee that instruments selected solely using this minimum instrument channel width will be
compatible in combination.
**PENTAX flexible endoscopes should not be exposed to temperatures in excess of 140°F (60°C) during either
reprocessing or storage. In reprocessing, depending on detergents, even if the temperature does not exceed 60°C,
the scopes may be damaged. For specific brands of compatible detergents, please contact your local PENTAX service
facility or sales representative.
Note: Specifications are subjected to change without prior notice and without any obligation on the part of the
manufacturer.

DISTAL END
EC34-i10L (1) Objective Lens EC38-i10L (1) Objective Lens
(2) Light Guide (1)
(2) Light Guide
(1)
(3) Air Nozzle (2) (2) (3) Water Nozzle
(2) (2)
(4) Water Jet Nozzle (4) Water Jet Nozzle
(5) Water Nozzle (5) Air Nozzle
(3)
(3) (6) Instrument Channel (6) (6) Instrument Channel
(6) (4)
(4)
(5)
(5)

– 57 –
 NOTICE
These instruments are used with Class B Medical Equipment (specified CISPR11) and are intended
for Hospitals, Ambulatory Surgery Centers, and Medical Clinics.
Together, these endoscopes and the compatible processor comply with EN 60601-1-2 for EU, IEC
60601-1-2 for other countries.
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
radio frequency energy equipment.

HOYA Corporation
2-7-5 Naka-Ochiai, Shinjuku-ku, Tokyo, 161-8525 Japan
PENTAX Medical Company
A Division of PENTAX of America, Inc.
3 Paragon Drive Montvale, New Jersey 07645-1782 USA
Tel: +1-201-571-2300 Toll Free: +1-800-431-5880
Fax: +1-201-391-4189
PENTAX Canada, Inc.
6715 Millcreek Drive, Unit 1 Mississauga, Ontario L5N 5V2 Canada
Tel: +1-905-286-5585
Fax: +1-905-286-5571
PENTAX Europe GmbH
EC REP
Julius Vosseler Strasse 104, 22527 Hamburg, Germany
Tel: +49-40-561-920
Fax: +49-40-560-4213
Manufacturing Site
HOYA Corporation, PENTAX Miyagi Factory
30-2 Okada, Aza-Shimomiyano, Tsukidate, Kurihara-shi, Miyagi 987-2203 Japan

• Specifications are subject to change without notice and without any obligation
on the part of the manufacturer.
88897
2014. 09 6217001 S017 R01 printed in JAPAN