Pentax ED-3490TK User manual

PENTAX VIDEO DUODENO SCOPE
ED-3490TK
OPERATION MANUAL
This manual describes the recommended procedures for inspecting and preparing
the equipment prior to its use. For cleaning, high-level disinfection, and sterilization,
refer to the separate Instructions for Use (Reprocessing) with the model name of the
instrument.
Only for the US

Intended Use / Indicationsfor use (Duodenoscopes)
The Video Duodenoscopes are intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via
the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Esophagus, Stomach,
Duodenum, Common Bile, Hepatic and Cystic Ducts.
These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and
pediatric patient populations.
Never use these endoscopes for any purpose other than that for which they have been designed.
The ED-3490TK can only be used with PENTAX Video Processors, Model EPK-i or EPK-1000.
Notes
Read this manual before operating, and save this book for future reference. Failure to read and thoroughly understand the information
presented in this manual, 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 manual 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 manual 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 manual 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 manual or concerns pertaining to the safety and/or use of this equipment,
please contact your local PENTAX representative.
Sterility Statement
The instruments identified in this manual are reusable semi-critical medical devices. Since they are packaged non-sterile, they must be high-
level disinfected or sterilized BEFORE initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning
and either high-level disinfection or sterilization process.
Refer to the companion PENTAX Instructions for Use (Reprocessing) describing in detail the recommended instructions on the care,
cleaning, disinfection and sterilization of these endoscopes.
Conventions
Throughout this manual, the following conventions will be used to indicate a potentially hazardous situation which, if not avoided;
: could result in death or serious injury.
: may result in minor or moderate injury or property-damage.
: may result in property-damage. Also, advises owner/operator about important information on the use of this equipment.
Prescription Statement
Federal (U.S.A) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional
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.
WARNING
CAUTION
NOTE

TABLE OF CONTENTS
1. NOMENCLATURE AND FUNCTION ....................................................................................... 1
1-1. VIDEO ENDOSCOPE ..................................................................................................................... 2
1-2. ACCESSORIES................................................................................................................................ 3
1-3. VIDEO PROCESSOR ...................................................................................................................... 4
2. PREPARATION AND INSPECTION FOR USE ....................................................................... 5
2-1. INSPECTION OF THE VIDEO PROCESSOR............................................................................... 5
2-2. INSPECTION OF ENDOSCOPE .................................................................................................... 6
2-3. PREPARATION JUST BEFORE INSERTION OF ENDOSCOPE................................................ 15
3. DIRECTIONS FOR USE........................................................................................................... 16
3-1. PRETREATMENT........................................................................................................................... 16
3-2. INSERTION AND WITHDRAWAL............................................................................................... 16
3-3. BIOPSY ............................................................................................................................................ 18
3-4. CHOLANGIOPANCREATOGRAPHY (ERCP)............................................................................ 19
3-5. BILIARY DRAINAGE (ERBD)..................................................................................................... 19
3-6. ELECTRO-SURGERY .................................................................................................................... 20
4. CARE AFTER USE................................................................................................................... 22
SPECIFICATIONS

– 1 –
BUTTON 1
Push to freeze an image.
BUTTON 2
Push to activate the hardcopy system that
was selected between “FILE”and “HARD COPY”.
MODEL DESIGNATION
SUCTION CONTROL VALVE (OF-B120)
Depress to remove fluidsor 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 deliverspressurized water.
UP/DOWN DEFLECTION LOCK
When thislever isin the “F”position, turned clockwise,
the bending section movesfreely. When turned fully counterclockwise,
the bending section becomesprogressively more stabilized.
BUTTON 3
Push to activate the VCR for recording live procedures.
RUBBER STRAIN RELIEF
RUBBER INLET SEAL (OF-B190)
Allowspassage of accessorieswhile
preventing escape of fluidsand air.
CONTROL BODY
INSTRUMENT
CHANNEL INLET
For introduction of
biopsy forceps
and other accessories.
RIGHT/LEFT DEFLECTION
CONTROL KNOB
UP/DOWN DEFLECTION
CONTROL KNOB
RIGHT/LEFT DEFLECTION LOCK
Functionssimilar to Up/Down lock
CANNULA/FORCEPSELEVATOR
CONTROL KNOB
To g uide and direct cannulaor
forceps.
UMBILICAL CABLE
BUTTON 1
BUTTON 2
BUTTON 4
BUTTON 3
BUTTON 4
Push to select light measurement method, AVE/PEAK.
1. NOMENCLATURE AND FUNCTION
1.1 VIDEO ENDOSCOPE
*Setting at factory
NOTE:
The function of each button can be changed. For more details, refer to the
manual supplied with the EPK-i or the EPK-1000.
Scope ED-3490TK
Processor EPK-i EPK-1000
*Button 1 Freeze
*Button 2 Hard Copy
*Button 3 VCR (NTSC)/Enhance (PAL)
*Button 4 Enhance Enhance (NTSC)
AVE/PEAK (PAL)
Magnification
Control Lever
–

– 2 –
LIGHT GUIDE
Transmitslight from
light source to distal
end of endoscope.
SUCTION NIPPLE
For attachment to
external suction
source.
PVE CONNECTOR
Can be rotated
within a180
range.
AIR/WATER PORT
To connect feeding tube from water
bottle assembly.
DISTAL END
(Refer to the inside rear cover of thismanual)
BENDING SECTION
ETO GASSTERILIZATION VENTING CAP OF-C5
Providesventing of endoscope interior to equalize
internal and external pressures. Thiscap must be
removed before immersion.
NOTE: See important separate section regarding the use
of this cap!
VENTING CONNECTOR
Accepts“RED”ETO GASSterilization Venting cap.
Also acceptsLeakage Tester.
SOAKING CAP
OE-C9
ELECTRICAL CONTACTS
INSERTION TUBE
RED
Thiscap 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 contactson the PENTAX PVE
connector. Press the cap down onto the
metal collar and turn clockwise to secure.
FEED BACK TERMINAL
RUBBER STRAIN RELIEF
To connect the OL-Z3cable
From the PENTAX video
processor, model EPK-i/1000.
See detail information on
page 21.
NOTE:
To avoid damaging the endoscope, do NOT twist, rotate or bend excessively any of the rubber strain reliefs.
NOTE:
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 scope damage.
WARNING:
Immediately after use, the metal light guide prong and the
electrical contacts/pinsof the endoscope may be HOT. To
avoid burns, do not touch these areas immediately after use.
For safer handling after aprocedure, grasp the PVE
connector housing.

– 3 –
1-2. ACCESSORIES
1) Cleaning Brush for Suction System (Instrument Channel, Suction Tube)
2) Cleaning brush for recessed areas, scope tip, valve/selector cylinders and channel ports
(including A/W, Suction, Forward Water Jet, surrounding the elevator mechanism, etc.)
CAUTION:
•Because of the effect that accessoriesused through the instrument channel of the endoscope can have on the
performance of the endoscope itself, it isstrongly recommended that PENTAX accessoriesbe used with
PENTAX endocopes. If aunique or highly specialized accessory isavailable from another source, the
accessory manufacturer should be consulted to confirm compatibility with PENTAX endoscopesbefore 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.
•Forpatient contact endoscopic accessories, follow the specific and detailed instructionson 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 contentsas either sterile or non-sterile.
BACK END (BLUE)
Proximal End (White)
This brush is provided non-sterile for one time use. Never reuse this disposable brush on more than one instrument.
(CS6021T)
( CS-C9S )

– 4 –
1-3. VIDEO PROCESSOR
EPK-i
EPK-1000
WARNING:
The lifetime of the lamp in EPK-i processor
is500 hours. Prior to use, check the lamp life
meter on the rear panel to ensure the lamp
life isless than 500 hours. After 500 hoursof
use, the image quality will deteriorate.
Excessive use of the lamp beyond 500 hours
could break the lamp inside the equipment
resulting in damage to the equipment.
WARNING:
The lifetime of the lamp in EPK-1000
processor is400 hours. Prior to use, check
the lamp life meter on the front panel to
ensure the lamp life isless than 400 hours.
After 400 hoursof use, the image quality will
deteriorate. Excessive use of the lamp
beyond 400 hourscould break the lamp
inside the equipment resulting in damage to
the equipment.
NOTE:
The lamp life could be affected by frequency of use. In which case, the lamp life might become shorter than its
respective rated hours(EPK-i: 500 hours, EPK-1000: 400 hours)
CAUTION:
Please refer to the instruction supplied with the processor.
NOTE:
Use an air/water delivery system that iscompatible with PENTAX endoscopesand video processors, and ensure
that the cap assembly issecurely fitted to the corresponding water bottle with matched model. Failure to properly
secure the cap assembly to the water bottle may result in insufficient flowsof air and water during the endoscopic
procedure.
NOTE:
Software update may be required depending on the software version of the EPK-i processor. If the software isnot
updated, the image will not be displayed. If the imagesare not displayed correctly, please contact your local
PENTAX service facility.
WATER BOTTLE
LAMP SWITCH
AIR PUMP SWITCH
LCD
POWER SWITCH INTERFACE SOCKET
EPK-1000
POWER SWITCH
I : ON
O: OFF
LAMP SWITCH
INTERFACE
SOCKET
BRIGHTNESS
CONTROLSAIR PUMP SWITCH
WATER BOTTLE

– 5 –
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:
2-1. INSPECTION OF THE VIDEO PROCESSOR
Please refer to the Owner’s Manual of the specific model of PENTAX video processor for complete instructions.
1) Mount the water bottle assembly within reach of the air pump fitting on the video processor and the air/water port on the PVE
connector of the endoscope.
6) Connect the air/water feeding tube from the water bottle assembly to the air/water port on the side of the PVE connector.
7) Turn the processor and air pump to the “ON” position and check for proper functioning.
8) Press the lamp switch of the processor to turn ON the lamp.
9) Prior to each procedure, check the endoscope image quality displayed on the monitor. Confirm that the image quality, color,
automatic brightness (iris) functions are acceptable as per the instructions provided with the PENTAX video processor.
NOTE:
PENTAX 90K seriesvideo endoscopescontained in thismanual are only compatible with PENTAX video
processor model EPK-i or EPK-1000.
CAUTION:
To avoid discontinuation of the endoscopic procedure, have an extra(spare) instrument available as astandby
device. Should any unforseen event or circumstance render the original instrument inoperable and/or unsafe for
patient.
WARNING:
The addition of defoaming agentsto the water supply isNOT recommended. Due to their nature, these silicone
based agentscling 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
defoamerscould eventually lead to residual silicone build up resulting in equipment malfunction such as clogged
air and/or water channels.

2) Plug the processor into a properly grounded receptacle with
the power switch in the OFF position.
3) Make sure that the PENTAX PVE connector is aligned with
the interface socket on the front panel of the processor.
4) Connect the endoscope to the interface socket on the
processor as illustrated.
5) Rotate the lever of the interface socket clockwise after
insertion.
CAUTION:
After connecting the endoscope to the EPK-i video
processor, alwaysmake sure that the endoscope is
firmly secured to the scope receptacle by turning the
locking lever to the “lock” position.
air/water feeding tube

– 6 –
2-2. INSPECTION OF ENDOSCOPE
Before reprocessing and/or immersion in any fluids, PENTAX endoscopes should be tested for the loss of integrity in their
watertight construction by using PENTAX brand leak testers. For specific details on PENTAX recommended leak detection
procedures, please refer to the instructions supplied with PENTAX leak testers.
1) Inspection of the Insertion Tube
a) Check the entire surface of the insertion tube for abnormal conditions such as dents, crush marks, wrinkles, bumps, buckles,
excessive bending, protrusions, bite marks, peeling of outer sheath, cuts/holes or other irregularities. Any crush or indentation
of the flexible shaft of the endoscopes can cause damage to the internal mechanisms of the endoscopes.
b) Similarly, check the condition of the umbilical cable for outward signs of damage such as buckling, crush marks, etc.
c) 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.
CAUTION:
If the endoscope isintended to be clinically used after testing of individual scope functions(suction, air/water
delivery, water jet, etc.) without further reprocessing, the following precaution should be exercised.
Use sterile water during individual scope function teststo avoid recontamination of the previously reprocessed
instrument by waterborne microorganisms. Tap water, especially that which may be left idle and uncovered for a
prolonged period of time, should not be used during any inspection/testing of the endoscope.
CAUTION:
Various typesof endoscope leakage testersexist including manual, electro-mechanical and “automated”
versions, some of which are stand alone unitsand otherswhich may be integrated into Automated Endoscope
Reprocessors(AERs)/Washer-Disinfectors(WDs). It must be recognized that PENTAX doesnot
evaluate non-PENTAX leak tester systemsto satisfy their specific productsclaims, for their effectiveness
to accurately detect leaksand/or for their compatibility with PENTAX endoscopes. Insufficient pressures
may adversely affect the endoscope, especially if pressurization occursduring automated reprocessing
at elevated temperatures. PENTAX acceptsno responsibility for use of non-PENTAX leakage testers.
Usersshould check with the leakage testermanufacturer and confirm their specific product claims, including
compatibility with PENTAX endoscopesat various temperaturesand their ability to detect leakswith/
without fluid immersion and with/without flexing of the scope’sdistal bending section.
CAUTION:
To avoid further damage to the endoscope or the possibility of malfunction during aprocedure, do not use any
endoscope with any abnormalitiesor outward signsof damage.
WARNING:
All instrumentsmust be reprocessed prior to first time use, after any repairs/service and before every patient
use. When utilizing chemo-thermal processesfor reprocessing PENTAX endoscopes, the instrumentsshould be
allowed to return to room temperature prior to use and/or further handling.

– 7 –
NOTE:
• The distal end of the endoscope as well as the electrical contacts/pinson 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.
•Asindicated elsewhere in PENTAX product labeling, endoscopesparticularly the quality of the endoscopic
image should be checked prior to patient use.
•During pre-use inspection, ensure that the distal objective lensand the illumination (LCB) cover glass are clean
and no residuesare present on these distal surfaces. If not, crisp imagescan NOT be displayed. Wipe them
with agauze or the like moistened with amild detergent solution (e.g. enzymatic detergent or cleaning solution
specially formulated to clean endoscopes).
•Ideally all patientsshould be prepped well to maximize visualization of the intended areas of interest. Patient
material and secretionsshould be removed from the areaof observation to eliminate the potential to blur the
endoscopic image and/or obscure the illumination system.
• Prior to aprocedure, remove debrisor secretafrom observation areaas much as possible.
•Continuing use of the light guide with sticky debrismight cause steam because debrisisdeprived of moisture
by heat. If steam isfound on the light guide during aprocedure, stop it immediately and withdraw the scope
carefully from apatient.
NOTE:
Flexible endoscopesand other sophisticated medical instrumentsare constructed of special materials, unique
partsand intricate componentswith strict dimensional tolerances. Specialized assembly techniquesand
application of specific sealantsand/or adhesivesare required to ensure the watertight integrity and maintain the
functionality of these devices. It istherefore imperative that endoscopesbe 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 componentscould result in device failure, scope damage
(viafluid invasion) and/or in incomplete decontamination of used instruments.
PENTAX recommendsthat prior to use endoscopesshould be carefully inspected for their integrity and checked
for any “looseness” in the mating or joining of componentsincluding the following parts/areas:
•thechannel inlet assembly (biopsy inlet port) (①)
•thesuction nipple/connector (②)
•theair/water inlet port (③)
•any valve cylinder (④)
•basically, any inlet or outlet port associated with an internal channel, an indirect patient contact portion of the
endoscope
•rubber strain relief along insertion tube and umbilical cable (rotate clockwise only to tighten)
One method to check for looseness isto lightly grip the
exposed part, and while grasping the component carefully
attempt to move it in various directions. Use of alintfree
gauze while grasping metal partsisrecommended as a
protection for one’sfingers.
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.
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