Pentax EG-2990i Instructions For Use Manual
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Pentax EG-2990i Instructions For Use Manual

Video upper g.i. scopes
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PENTAX VIDEO UPPER G.I. SCOPES
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).
INSTRUCTIONS FOR USE
EG-2990i, EG-2790i
EG-1690K, EG-2490K
EG-2790K, EG-2990K
EG-3490K, EG-3890TK
EG27-i10, EG29-i10
Only For the Americas
( OPERATION )

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Summary of Contents for Pentax EG-2990i

  • Page 1 Only For the Americas INSTRUCTIONS FOR USE ( OPERATION ) PENTAX VIDEO UPPER G.I. SCOPES EG-2990i, EG-2790i EG-1690K, EG-2490K EG-2790K, EG-2990K EG-3490K, EG-3890TK EG27-i10, EG29-i10 This Instructions for Use describes the recommended procedures for inspecting and preparing the equipment prior to its use.
  • Page 3 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.
  • Page 4 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).

  • Page 5: Table Of Contents

    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.

  • Page 6: Nomenclature And Function

    1. NOMENCLATURE AND FUNCTION 1-1. Video Endoscope • EG-2990i, EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG-2990K, EG-3490K, EG-3890TK 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.
  • Page 7 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 8 • EG27-i10/EG29-i10 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. CONTROL BODY SUCTION CONTROL VALVE (OF-B120) Depress to remove fluids or air through the instrument channel REMOTE BUTTON 1 Push to freeze an image.
  • Page 9 Ensure that the PVE soaking cap has been securely To connect the OL-Z3 cable attached (by properly rotating it) to prevent the from the PENTAX video cap from coming off during reprocessing. Failure to processor securely attach the cap can result in endoscope damage.

  • Page 10: Accessories

    PENTAX accessories be used with PENTAX endoscopes. If a unique or highly specialized accessory is available from another source and its manufacturer claims...

  • Page 11: Video Processor

    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.

  • Page 12: Preparation And Inspection For Use

    (PENTAX SAT-1300 or other medical purpose isolation transformers). Also, be sure to use a video processor specified by PENTAX. Attach water bottle assembly, 2/3 filled with sterile water to the appropriate location on the left side of the video processor.
  • Page 13 Make sure that the PENTAX PVE connector is aligned with the Endoscope Electrical Connector and Light Guide Receptacle on the front panel of the video processor. Connect the endoscope to the Endoscope Electrical Connector and Light Guide Receptacle on the video processor as illustrated.

  • Page 14: Inspection Of Endoscope

    CAUTION: PENTAX endoscopes should be tested for the integrity of their water- tight 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.
  • Page 15 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 –...
  • Page 16 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 –...
  • Page 17 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...
  • Page 18 (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 19 CAUTION: To avoid damaging the endoscopes, do NOT twist, rotate or bend excessively any of the strain relief boots (1), (2) during inspection, clinical use, reprocessing or any handling activity. Be particularly cautious for the insertion tube strain relief boot (1). When wiping the insertion tube and the umbilical cord, use a slow back and forth motion to wipe them along the tube/cable.
  • Page 20 c) Engage fully the angulation locks to be certain that the position of the angulated tip can be stabilized. (1) Right-Left (2) Up-Down Figure 2.9 WARNING: Prior to use ensure that the angulation controls can rotate smoothly, that there is no grinding or excess friction within the angulation system and that the bending section bends freely and smoothly.
  • Page 21 WARNING: If air bubbles discharge continuously from the distal end of the endoscope during inspection, it is possible that the O-ring may be damaged, installed incorrectly, or the air/water feeding valve may be damaged or installed incorrectly. If the device is used in this condition, it could cause infection by cross contamination to the patient as result of reflux or spit-back of patient fluids from the valve or damage the patient’s body cavity.
  • Page 22 f) Release the air/water feeding valve to determine if the valve freely returns to its OFF (neutral) position and delivery of water (and air) ceases. CAUTION: Before use, make sure that the air/water feeding valve is not clogged or does not have any other problem that could cause the uninterrupted flow of air/water.
  • Page 23 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. h) If the air/water feeding 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 (OF-Z11) onto all the O-rings.
  • Page 24 WARNING: The check-valve OE-C14 is a reusable component and it as well as the OE- C12 check valve adapter, water jet cylinder, irrigation tube and water jet channel should be reprocessed after each use. Make sure that the check-valve OE-C14 is securely attached to the check valve adapter OE-C12.
  • Page 25 In place of manual flushing via syringe, specially designed irrigator pumps intended for endoscopic irrigation may be used via the PENTAX water jet system. PENTAX check-valve mechanisms should always be connected and positioned within the water jet channel pathway.
  • Page 26 Inspection of Suction Channel Selector (EG-3890TK ONLY) a) Check the condition of the Suction Channel Selector (OF-B161). The selector knob should move smoothly when rotated and click into position at the prescribed indicators. The Suction Channel Selector allows the user the choice of suction capability through either channel, or simultaneous suction through both channels.
  • Page 27 The function can be assigned to remote buttons #1, #2, #3, or #4. For more details, refer to the instructions for use supplied with the video processor. b) Magnification Control NOTE: PENTAX Video Processor, model EPK-i5020 is not compatible. (1) Endoscopes with the Magnification Control Lever (2) Endoscopes without the...
  • Page 28 [1] Endoscopes with the Magnification Control Lever Turn the magnification control lever clockwise to magnify the image up to two times. Turn counterclockwise to return to the original size. [2] Endoscopes without the Magnification Control Lever Press the remote button which the magnification function is assigned to magnify the image.
  • Page 29 (1) Suction Control Valve OF-B120 (orange) Figure 2.18 (1) Depress (2) Suction Source Tube (3) Suction Nipple (4) Inlet Seal Figure 2.19 (1) Correct (2) Incorrect (3) Metal Figure 2.20 WARNING: Make sure suction control valve OF-B120 is correctly attached (see figure 2.21).
  • Page 30 WARNING: An inlet seal in good condition (that is not worn or damaged) must be attached to the instrument channel inlet to prevent the loss of suction and a risk of cross contamination to the end user due to the potential for reflux (spit-back) of patient fluids.
  • Page 31 NOTE: Endoscope instrument, A/W and the water jet channels are composed of stainless steel, Noryl and fluorine contained polymers. PENTAX is not aware of any reports of material incompatibility between these materials and fluids that are commonly used during endoscopic procedures. As relates to reprocessing, PENTAX publishes a list of compatible detergents and disinfectants.
  • Page 32 • Never attempt to force endoscopic accessories, such as biopsy forceps through a fully angulated bending section. • Prior to using accessories from another source (non-PENTAX products), contact the manufacturers of the accessories to confirm if the device has been checked for compatibility.

  • Page 33: Preparation Just Before Insertion Of Endoscope

    Check the endoscopic image and confirm that it is of acceptable quality for clinical use. Refer also to the instructions for use supplied with the PENTAX video processor for inspection of the image quality.
  • Page 34 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 be mishandled or dropped, do not use it. Return it to an authorized PENTAX service facility for inspection or repair. – 29 –...

  • Page 35: 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. There is a possibility of backflow and/ or spit-back of patient fluids, chemicals, etc.

  • Page 36: Operation

    3-1. Operation Angulation function a) Manipulate the Angulation Control Lever in the “U” direction in order to angulate the distal end in the UP direction. b) Manipulate the Angulation Control Lever in the “D” direction in order to angulate the distal end in the DOWN direction. c) Manipulate the Angulation Control Lever in the “R”...
  • Page 37 Remote Button 4 Enhance Electronic Magnification Control function NOTE: PENTAX Video Processor, model EPK-i5020 is not compatible. a) EG-2990i [1] The image is electronically magnified by turning the Magnification Control Lever clockwise. [2] The image returns to normal by turning the Magnification Control Lever counter-clockwise.

  • Page 38: Pretreatment

    NOTE: For details of operations such as starting and stopping, please refer to the PENTAX Video Processor Instructions for Use. (Endoscopes with Magnification Control Lever) Turn the magnification control lever counterclockwise to return to the standard non- magnified viewing.
  • Page 39 CAUTION: The endoscope not necessarily can be used trans-nasally to all patients because there are individual differences in the shape and size of patient’s nasal lumen, as well as the receptivity of trans-nasal insertion. There is a potential for nasal lumen injury if trans-nasal insertion is forced. Whether to insert trans-nasally should be confirmed, and carefully judged by the doctor.
  • Page 40 Suction Control Valve from operating properly. If it is impossible to confirm that all foreign objects and solid particles have been removed from the Suction Channel, do not use the endoscope and contact your local PENTAX service facility. – 35 –...
  • Page 41 The objective lens may be cleaned during the procedure by alternately using the air/water and suction control valves. CAUTION Patient material and secretions should be removed from the area of observation to eliminate the potential to blur the endoscopic image and/or obscure the illumination system.

  • Page 42: Biopsy

    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 endoscope before use.
  • Page 43 CAUTION: Never apply excessive pressure when introducing any accessory since the instrument channel may be damaged. Malfunction of the endoscope as well as costly repairs may result. When a portion of the cups of the forceps becomes visible in the viewing field, carefully advance the forceps onto the target area.

  • Page 44: Laser

    Laser equipment is suitable. WARNING: The PENTAX endoscopes identified in this instructions for use are compatible with Nd: YAG laser (wavelength 1064nm) only. Do not use these endoscopes with other types of laser such as KTP, He-Cd, or Excimer laser Systems.
  • Page 45 As long as the air/water feeding tube from a PENTAX water bottle assembly is connected to the gas adapter and the air pump in the video processor is turned OFF, nonflammable gas can be delivered.
  • Page 46 NOTE: One may choose to leave the OF-G11 adapter attached to the endoscope during conventional air insufflation using the air/water feeding valve. However, the luer sideport of the OF-G11 must be capped. Similarly, for normal water delivery, the air pump must be turned ON and the plastic luer lock cap must be secured to the OF-G11 adapter.
  • Page 47 11) When activating the laser at high power (about 100W for Yag Laser) and/or if the endoscope tip comes to within 10mm of the irradiated tissue, flare may appear at the corners of the image as shown below in Figure 3.13. (1) Flare (2) Probe Figure 3.9...

  • Page 48: Electrosurgery (Except Eg-1690K)

    3-6. Electrosurgery (Except EG-1690K) WARNING: Please refer to the instructions for use provided with the electrosurgical unit. Electrosurgical systems may be of the floating type (Type BF, Type CF) or non-floating (Type B). To avoid patient and user burn, use only the floating type electrosurgical systems.
  • Page 49 CAUTION: It should be noted that as long as the valve of the CO gas cylinder is OPEN and the hole at the top of the Air/Water feeding valve is NOT covered, gas will constantly be vented through the Air/Water feeding valve into the room.
  • Page 50 PENTAX has developed a condenser earth cable, model OL-Z3 intended to reduce potential RF interference and electronic noise that may appear in the endoscope image when using electrosurgical device.

  • Page 51: Care After Use

    REPROCESSING FAILURE due to repairs made by unauthorized personnel. Your local PENTAX service facility can provide a list of “compatible” reprocessing agents with PENTAX endoscopes based upon material compatibility and functionality studies performed by PENTAX, Japan.
  • Page 52 • Follow the instructions in the Instructions for Use for appropriate pre- use inspections, proper usage, care after use, storage, and replacement of consumables. • Have the vendor/specialist specified by PENTAX to perform repairs and annual periodic inspections. WARNING: Follow the national or local laws/guidelines to appropriately dispose of the consumables.

  • Page 53: Specifications

    **PENTAX flexible endoscopes should not be exposed to temperatures in excess of 140°F (60°C) during either reprocessing or storage. In reprocessing, depending on detergents, even if the temperature does not exceed 60°C, the scopes may be damaged. For specific brands of compatible detergents, please contact your local PENTAX service facility or sales representative.
  • Page 54 **PENTAX flexible endoscopes should not be exposed to temperatures in excess of 140°F (60°C) during either reprocessing or storage. In reprocessing, depending on detergents, even if the temperature does not exceed 60°C, the scopes may be damaged. For specific brands of compatible detergents, please contact your local PENTAX service facility or sales representative.
  • Page 55 **PENTAX flexible endoscopes should not be exposed to temperatures in excess of 140°F (60°C) during either reprocessing or storage. In reprocessing, depending on detergents, even if the temperature does not exceed 60°C, the scopes may be damaged. For specific brands of compatible detergents, please contact your local PENTAX service facility or sales representative.
  • Page 56 MEMO – 51 –...
  • Page 57 MEMO – 52 –...
  • Page 58 MEMO – 53 –...
  • Page 60 HOYA Corporation 2-7-5 Naka-Ochiai, Shinjuku-ku, Tokyo, 161-8525 Japan PENTAX Medical Company A Division of PENTAX of America, Inc. 3 Paragon Drive Montvale, New Jersey 07645-1782 USA Tel: +1-201-571-2300 Toll Free: +1-800-431-5880 Fax: +1-201-391-4189 PENTAX Canada, Inc.

This manual is also suitable for:

Eg-2790kEg-2990kEg-1690kEg-2790iEg-3490kEg-3890tk ... Show all

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