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.