Pentax ED-3490TK Operation Manual
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Pentax ED-3490TK Operation Manual

Pentax ED-3490TK Operation Manual

Video duodeno scope
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OPERATION MANUAL
PENTAX VIDEO DUODENO SCOPE
ED-3490TK
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.

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  • Page 1 Only for the US OPERATION MANUAL PENTAX VIDEO DUODENO SCOPE ED-3490TK 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...
  • Page 2 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.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS NOMENCLATURE AND FUNCTION ..................1-1. VIDEO ENDOSCOPE ........................1-2. ACCESSORIES..........................1-3. VIDEO PROCESSOR ........................PREPARATION AND INSPECTION FOR USE ............... 2-1. INSPECTION OF THE VIDEO PROCESSOR ................2-2. INSPECTION OF ENDOSCOPE ....................2-3. PREPARATION JUST BEFORE INSERTION OF ENDOSCOPE..........15 DIRECTIONS FOR USE......................

  • Page 4: Nomenclature And Function

    Push to activate the VCR for recording live procedures. RUBBER STRAIN RELIEF 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 UMBILICAL CABLE Processor EPK-i EPK-1000 *Button 1...
  • Page 5 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.

  • Page 6: Accessories

    • 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 should be consulted to confirm compatibility with PENTAX endoscopes before use.

  • Page 7: Video Processor

    Please refer to the instruction 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.

  • Page 8: Preparation And Inspection For 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.

  • Page 9: 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.
  • Page 10 (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: •...
  • Page 11 CAUTION: To avoid damaging the endoscopes, do NOT twist, rotate or bend excessively any of the rubber strain relief (①,②) during inspection, clinical use, reprocessing or any handling activity. Be particularly cautious for the insertion tube strain relief ( ① ). When wiping the insertion tube and the umbilical cable, use a slow back and forth motion to wipe them along the tube/cable.
  • Page 12 3) Prior to use, the air/water feeding valve (OF-B188) should be  OF-B188 inspected. Remove the air/water valve from the control body and ensure that rubber O-rings (OF-B192) in good condition are properly attached. CAUTION: Since the rubber check-valve can NOT be replaced by O-Ring the end user, replace the entire A/W valve with a new one if the check valve is damaged/ missing.
  • Page 13 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. g) If the air/water 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 onto all the O-rings.
  • Page 14 4) Inspection of Elevator  a) Make sure that the entire surfaces of the elevator (mechanism and surrounding area) are clean and have been properly reprocessed. b) This is the control that will guide and direct either the biopsy forceps or other accessory during a procedure. To inspect, push elevator control knob forward with thumb of the left hand.
  • Page 15  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.
  • Page 16 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 Department. CAUTION: Endoscopic accessory instruments (EAIs) may be used with PENTAX flexible endoscopes.
  • Page 17 WARNING: 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, poly phenylene oxide and fluorine- contained polymers.

  • Page 18: Preparation Just Before Insertion Of Endoscope

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

  • Page 19: Directions For Use

    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. During the procedure, always wear protective garments such as gloves, gowns, face masks, etc. to minimize the risk of cross contamination. NOTE: 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.
  • Page 20 5) Insufflation shoud be controlled by the combined use of the air/water valve to increase the amount of insufflation and the suction control to decrease the level of insufflation. CAUTION: Be careful not to deliver too much air. WARNING: 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 scope type) to another.

  • Page 21: Biopsy

    NOT attempt to correct the blockage or continue to use the endoscope. In such a case, contact your local PENTAX Medical service facility to have the endoscope repaired. The use of an endoscope with a blocked internal channel may result in ineffective reprocessing and/or the introduction of debris and/or device components into a patient during a subsequent procedure, posing a risk of cross-contamination.

  • Page 22: Cholangiopancreatography (Ercp)

    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 endoscopes before use.

  • Page 23: Electro-Surgery

    NOTE: There are several types of prosthetic devices available, be sure to review the specific instructions supplied with each prosthesis. 3-6. ELECTRO-SURGERY WARNING: Please refer to the operating manual provided with the electrosurgical unit. Electrosurgical systems may be of the floating type (BF type, CF-type) or non-floating (B type).
  • Page 24 PENTAX has developed an earth cable, model OL-Z3 intended to reduce potential RF interference and electronic noise that may appear in the endoscope image when using electro-surgical devices.

  • Page 25: Care After Use

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

  • Page 26: Specifications

    SPECIFICATIONS ED-3490TK Direction of View Side Field of View 100°(retro 10°) Depth of Field 4 ~ 60mm Up-Down 120° –90° Tip Deflection Right-Left 105° –90° Rigid Distal Width ø13.2mm Distal End Width ø13.2mm Insertion Tube Width ø11.6mm Maximum Insertion Portion Width ø13.4mm...
  • Page 28 Julius Vosseler Strasse 104, 22527 Hamburg, Germany Tel : +49-040-56-1920 Fax: +49-040-560-4213 PENTAX U.K. Ltd. PENTAX House, Heron Drive, Langley SLOUGH SL3 8PN, Great Britain Tel : +44-1753-792792 Fax: +44-1753-792794  Specifications are subject to change without notice and without 83734 any obligation on the part of the manufacturer.

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