Pentax ED-3490TK Operation 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 / Indications for use (Duodenoscopes)
WARNING
CAUTION
NOTE
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 highlevel 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 confor me 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 ..................................................................................................................... 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
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 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 DEFLECTION LOCK
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.
BUTTON 3
Push to activate the VCR for recording live procedures.
RUBBER STRAIN RELIEF
RUBBER INLET SEAL (OF-B190)
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 DEFLECTION
CONTROL KNOB
UP/DOWN DEFLECTION
CONTROL KNOB
RIGHT/LEFT DEFLECTION LOCK
Functions similar to Up/Down lock
CANNULA/FORCEPS ELEVATOR
CONTROL KNOB
To g uide and direct cannula or
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
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
Magnification
Control Lever
Enhance (NTSC)
AVE/PEAK (PAL)
–
*Setting at factory
– 1 –
LIGHT GUIDE
Tr ansmits 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.
DISTAL END
(Refer to the inside rear cover of this manual)
BENDING SECTION
ETO GAS STERILIZATION VENTING CAP OF-C5
Provides venting of endoscope interior to equalize
internal and external pressures. This cap must be
removed before immersion.
NOTE: See important separate section regarding the use
of this cap!
VENTING CONNECTOR
Accepts “RED” ETO GAS Sterilization Venting cap.
Also accepts Leakage Tester.
SOAKING CAP
OE-C9
ELECTRICAL CONTACTS
INSERTION TUBE
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.
FEED BACK TERMINAL
RUBBER STRAIN RELIEF
To connect the OL-Z3 cable
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/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.
– 2 –
1-2. ACCESSORIES
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-C
9S )
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 accessories used through the instrument channel of the endoscope can have on the
performance of the endoscope itself, it is strongly recommended that PENTAX accessories be used with
PENTAX endocopes. If a unique or highly specialized accessory is available from another source, the
accessory manufacturer sho
•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.
uld be consulted to confirm compatibility with PENTAX endoscopes before use.
NOTE:
• Depending upon country and/or local PENTAX distributor, each PENTAX endoscopic access
ory 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.
– 3 –
1-3. VIDEO PROCESSOR
EPK-1000
POWER SWITCH
I : ON
O: OFF
LAMP SWITCH
INTERFACE
SOCKET
BRIGHTNESS
CONTROLS
AIR PUMP SWITCH
WATER BOTTLE
EPK-i
WATER BOTTLE
EPK-1000
POWER SWITCH
INTERFACE SOCKET
LCD
LAMP SWITCH
AIR PUMP SWITCH
WARNING:
The lifetime of the lamp in EPK-i processor
is 500 hours. Prior to use, check the lamp life
meter on the rear panel to ensure the lamp
life is less than 500 hours. After 500 hours of
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 is 400 hours. Prior to use, check
the lamp life meter on the front panel to
ensure
the lamp life is less than 400 hours.
After 400 hours of use, the image quality will
deteriorate. Excessive use of the lamp
beyond 400 hours could 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 instruct
ion supplied with the processor.
NOTE:
Use an air/water delivery system that is compatible with PENTAX endoscopes and video processors, and ensure
that the cap assembly is securely fitted to the corresponding water bottle with matched model. Failure to properly
secure the cap assembly to the water bottle may result in insufficient flows of air and water during the endoscopic
procedure.
NOTE:
Software update
updated, the image will not be displayed. If the images are not displayed correctly, please contact your local
may be required depending on the software version of the EPK-i processor. If the software is not
PENTAX service facility.
– 4 –
2. PREPARATION AND INSPECTION FOR USE
air/water feeding tube
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 90K series video endoscopes contained in this manual are only compatible with PENTAX video
processor model EPK-i or EPK-1000.
CAUTION:
To a void discontinuation of the endoscopic procedure, have an extra (spare) instrument available as a standby
device. Should any unforseen event or circumstance render the original instr
patient.
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.
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 cou
air and/or water channels.
ld eventually lead to residual silicone build up resulting in equipment malfunction such as clogged
ument inoperable and/or unsafe for
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, always make sure that the endoscope is
firmly secured to the scope receptacle by turning the
locking lever to the “lock” position.
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.
– 5 –
2-2. INSPECTION OF ENDOSCOPE
CAUTION:
If the endoscope is intended 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 tests to avoid recontamination of the previously reprocessed
instrument by waterborne microorganisms. Tap water, especially that which m
prolonged period of time, should not be used during any inspection/testing of the endoscope.
Before reprocessing and/or immersion in any fluids, PENTAX endoscopes should be tested for the loss of integrity in their
watertight construction by using PENTAX brand leak testers. For specific details on PENTAX recommended leak detection
procedures, please refer to the instructions supplied with PENTAX leak testers.
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)/Was
her-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 eleva
ted temperatures. PENTAX accepts no responsibility for use of non-PENTAX leakage testers.
Users should check with the leakage testermanufacturer 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 scope’s
distal bending section.
ay be left idle and uncovered for a
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.
CAUTION:
To avoid further damage to the endoscope or the possibility of malfunction during a procedure, do not use any
endoscope with any abnormalities or outward signs of damage.
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.
WARNING:
All instruments must be reprocessed prior to first time use, after any repairs/service and before every patient
use. When utilizing chemo-thermal processes for reprocessing PENTAX endos
copes, the instruments should be
allowed to return to room temperature prior to use and/or further handling.
– 6 –
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