Pentax EG-2990i, EG-2790K, EG-2990K, EG-1690K, EG-2790i Instructions For Use Manual

PENTAX VIDEO UPPER G.I. SCOPES

INSTRUCTIONS FOR USE

(

OPERATION

)

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).

EG-2990i, EG-2790i

EG-1690K, EG-2490K

EG-2790K, EG-2990K

EG-3490K, EG-3890TK

EG27-i10, EG29-i10

Only For the Americas

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 upper digestive tract including the esophagus, stomach, and duodenum.

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: Upper gastrointestinal tract (the esophagus, stomach, and duodenum)

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 EG-3890TK 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 service facility.

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.

Partie appliquée de type BF (niveau de sécurité spécifié par la norme CEI 60601-1)

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

CAUTION

NOTE

: could result in death or serious injury.

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

:

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

Prescription Statement

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

Symbols on Marking
Symboles distinctifs

Symbol for “MANUFACTURER”

Symbol for “DATE OF MANUFACTURE”

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.

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

Type BF applied part (Safety degree specified by IEC 60601-1)

TABLE OF CONTENTS

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

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

1-2. Accessories ............................................................................................................... 5

1-3. Video Processor.......................................................................................................... 6

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

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

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

2-3. Preparation just before Insertion of Endoscope .................................................................... 28

3. DIRECTIONS FOR USE ........................................................................................................... 30

3-1. Operation .................................................................................................................. 31

3-2. Pretreatment ............................................................................................................. 33

3-3. Insertion and Withdrawal ............................................................................................... 33

3-4. Biopsy ..................................................................................................................... 37

3-5. Laser ...................................................................................................................... 39

3-6. Electrosurgery (Except EG-1690K) ................................................................................... 43

4. CARE AFTER USE ................................................................................................................ 46

SPECIFICATIONS ..................................................................................................................... 48

Push to freeze an image.

Push to activate the hardcopy system.

MODEL DESIGNATION

SUCTION CONTROL VALVE (OF-B120)
Depress to remove fluids or air through
the instrument channel.

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.

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.

Push to activate the Video for recording live procedures.

STRAIN RELIEF BOOT

INLET SEAL
Allows passage of accessories while
preventing escape of fluids and air.

CONTROL BODY

INSTRUMENT
CHANNEL INLET
For introduction of
biopsy forceps
and other accessories.

RIGHT/LEFT ANGULATION
CONTROL KNOB

UP/DOWN ANGULATION
CONTROL KNOB

RIGHT/LEFT ANGULATION LOCK KNOB
Functions similar to Up/Down lock

UMBILICAL CORD

PVE CONNECTOR
Can be rotated
within a 180˚
range.

AIR/WATER PORT
To connect feeding tube from water
bottle assembly.

REMOTE BUTTON 1

REMOTE BUTTON 4

MAGNIFICATION CONTROL LEVER (

EG-2990i

)

See detail Information on section 2-2.7) on page 22.

Allows connection of special irrigation tube
(OF-B113) for pressurized source of a spray
directed at the endoscopically visualized surface.

WATER JET PORT (Endoscopes with water jet system)

STRAIN RELIEF BOOT

To connect the OL-Z3 cable
From the a compatible
PENTAX video processor.
(Not available in EG-1690K)

FEEDBACK TERMINAL

REMOTE BUTTON 2

REMOTE BUTTON 3

REMOTE BUTTON 3

REMOTE BUTTON 1

REMOTE BUTTON 2

REMOTE BUTTON 4
MAGNIFICATION CONTROL LEVER (EG-2990i)

Model Name

Minimum Instrument
Channel Width

1. NOMENCLATURE AND FUNCTION

1-1. Video Endoscope

•EG-2990i, EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG-2990K, EG-3490K, EG-3890TK

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

*Remote Button 1 Freeze Freeze

*Remote Button 2 Copy Copy

*Remote Button 3 Video Video

*Remote Button 4 - Enhance

**Magnication Control

Lever

*Setting at factory
**Not applicable to PENTAX Video Processor, model EPK-i5020

EG-2990i

EG-2790i/1690K/2490K/2790K

EG-2990K/3490K/EG-3890TK

Magnication(electronic) -

– 1 –

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

SUCTION NIPPLE
For attachment to
external suction
source.

PVE CONNECTOR
Can be rotated
within a 180˚
range.

AIR/WATER PORT
To connect feeding tube from water
bottle assembly.

BENDING SECTION

VENTILATION CAP OF-C5

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

VENTING CONNECTOR
Accepts “RED” Ventilation cap.
Also accepts Leakage Tester.

PVE SOAKING CAP
OE-C9

ELECTRICAL CONTACTS

INSERTION PORTION

(APPLIED PART)

RED

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.

Allows connection of special irrigation tube
(OF-B113) for pressurized source of a spray
directed at the endoscopically visualized surface.

WATER JET PORT (Endoscopes with water jet system)

STRAIN RELIEF BOOT

To connect the OL-Z3 cable
From the a compatible
PENTAX video processor.
(Not available in EG-1690K)

FEEDBACK TERMINAL

INSERTION TUBE

DISTAL END

CAUTION:

To avoid damaging the
endoscope, do NOT
twist, rotate or bend
excessively any of the
strain relief boot.

CAUTION:

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

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.

EG-3890TK ONLY

INLET SEAL

Allows passage of accessories while
preventing escape of fluids and air.

“B” identifies a small channel

“A” identifies a large channel

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

– 2 –

UP/DOWN ANGULATION

CONTROL KNOB

RIGHT/LEFT ANGULATION

CONTROL KNOB

INSTRUMENT
CHANNEL INLET
For introduction of
biopsy forceps
and other accessories.

AIR/WATER FEEDING VALVE (OF-B188)

•EG27-i10/EG29-i10

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)

REMOTE BUTTON 1
Push to freeze an image.

REMOTE BUTTON 2

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

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.

Depress to remove fluids or air through
the instrument channel

CONTROL BODY

REMOTE BUTTON 4

Enhance

REMOTE BUTTON 3
Push to activate the VCR for recording live procedures.

RIGHT/LEFT ANGULATION LOCK KNOB

Functions similar to Up/Down lock

STRAIN RELIEF BOOT

UMBILICAL CORD

Minimum Instrument
Channel Width

Model Name

MODEL DESIGNATION

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

*Remote Button 1 Freeze

*Remote Button 2 Copy

*Remote Button 3 Video

*Remote Button 4 Enhance

*Setting at factory

– 3 –

EG27-i10
EG29-i10

INSTRUMENT
CHANNEL INLET
For introduction of
biopsy forceps
and other accessories.

STRAIN RELIEF BOOT

INLET SEAL
Allows passage of accessories while
preventing escape of fluids and air.

DISTAL END

CAUTION:

To avoid damaging the
endoscope, do NOT twist, rotate
or bend excessively any of the
strain relief boot.

UP/DOWN ANGULATION

CONTROL KNOB

RIGHT/LEFT ANGULATION

CONTROL KNOB

PVE CONNECTOR
Can be rotated
within a 180˚
range.

INSERTION TUBE

INSERTION PORTION (APPLIED PA RT)

WATER JET PORT

(Endoscopes with water jet system)
Allows connection of special irrigation tube
(OF-B113) for pressurized source of a spray
directed at the endoscopically visualized surface.

AIR/WATER PORT
To connect feeding tube from water
bottle assembly.

BENDING SECTION

VENTING CONNECTOR
Accepts “RED” Ventilation Cap.
Also accepts Leakage Tester.

VENTILATION CAP OF-C5

RED

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

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

SUCTION NIPPLE
For attachment to
external suction
source.

LIGHT GUIDE PLUG

Transmits light from
light source to distal
end of endoscope.

CAUTION:

Ensure that the PVE soaking cap has been securely
attached (by properly rotating it) to prevent the
cap from coming off during reprocessing. Failure to
securely attach the cap can result in endoscope
damage.

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.

– 4 –

1-2. Accessories

(2)

(3)

1) Biopsy Forceps

Figure 1.1

Biopsy Forceps/Endoscope compatibility

(1)

(4)

Biopsy Forceps Endoscope

EG-2990i/ EG-2790i/ EG-2790K

KW2415R

EG-2990K/ EG-3490K/ EG-3890TK/

EG27-i10/ EG29-i10

KW1815S EG-1690K/ EG-2490K

(1) Flexible Shaft
(2) Grip
(3) Handle (pink handle

denes autoclavable
forceps)

(4) Cups/Jaws

CAUTION:

• Because of the effect that accessories used through the instrument

• Maximum outer diameter of an endoscopic accessory instrument

NOTE:

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

• For patient contact endoscopic accessories, follow the specific and

• To confirm the exact condition of any new accessory device, check

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.

must be at least 0.2 mm less than the specied instrument channel

diameter in PENTAX endoscopes. Working length of an endoscopic
accessory instrument may be approximately 30 cm longer than the
endoscope working length.

PENTAX endoscopic accessory may be an optional accessory.

detailed instructions on use, care and maintenance supplied with each
product.

the labeling/packaging accompanying the product. Each label/package
should clearly identify the contents as either sterile or non-sterile.

– 5 –

1-3. Video Processor

(6)

(1)

(5)

(4)

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 insufcient pressure and ow of air and water during

the endoscopic procedure.

1) PENTAX Video Processor

(1) Lamp Switch
(2) Pump Switch
(3) Endoscope Electrical

Connector

(4) Light Guide

Receptacle

(5) Power Switch
(6) Water Bottle Assembly

(2)

(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.

– 6 –

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 specied 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.

– 7 –

4) Make sure that the PENTAX PVE connector is aligned with the Endoscope

(1)

Electrical Connector and Light Guide Receptacle 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

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.

– 8 –

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 water­tight 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 leakage tester systems to

satisfy their specic 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.

– 9 –

1) Inspection of the Insertion Portion

(3) (4)

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 nd 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 ngers

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
(2) Close-Up View
(3) [A] Black Adhesive

(2)

(1)

Figure 2.2

Band

(4) [B] Black Adhesive

Band

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.

– 10 –

2) Inspection of insertion tube exibility

a) Form an arch with the Insertion Tube as shown in the gure below.

Approx.
30cm

Approx. 20cm

Figure 2.3

b) Gently raise/lower the left/right hands alternately and conrm equal exibility

for the length of the loop. Do NOT use the endoscope if there are any:

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

• extraordinarily exible 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 local PENTAX service facility.

– 11 –

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.

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

– 12 –

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 connector (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 ngers.

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.

Figure 2.7

(5)

U

L

F

F

R

D

(4)

(1)

(3)

(2)

– 13 –