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OWNER’S MANUAL PENTAX VIDEO GI SCOPES EG-290Kp EC-380LKp...
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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.
1. NOMENCLATURE AND FUNCTION 1-1. VIDEO ENDOSCOPE AIR/WATER FEEDING VALVE (OF-B121) Covering of hole in the top of the valve delivers pressurized air. Covering of the hole and fully depressing the valve delivers pressurized water. SUCTION CONTROL VALVE (OF-B120) Depress to remove fluids or air through the instrument channel.
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DISTAL END (Refer to the inside rear cover of this manual) RUBBER STRAIN RELIEF BENDING SECTION INSERTION TUBE FEED BACK TERMINAL Certain manufacturers’ electrosurgical units, such VENTING CONNECTOR as older Olympus models, require the connection Accepts “RED” ETO GAS Sterilization Venting cap. of a scope feedback cord (S-cord) to this Also accepts Leakage Tester.
PENTAX accesso- ries be used with PENTAX endocopes. If a unique or highly specialized accessory is available from another source, please contact PENTAX to arrange a test of its compatibility before using it through the PENTAX endoscope.
Although the cap may appear to fit onto the bottle, air may escape resulting in insufficient pressure and flow of air and water during the endoscopic procedure. Both the PENTAX water bottle cap and bottle (container) are identified by their appropriate model designation. Ensure that an OS-H4 cap is used only with the OS-H4 water container/bottle.
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) Attach water bottle assembly, 2/3 filled with sterile water to the appropriate location on the left side of the video processor.
Before proceeding with inspection of individual functions, PENTAX endoscopes should be tested for the integrity of their water-tight design (example: tear in the instrument channel). This test is described in another section of this manual entitled: “Leakage Testing.”...
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If not, crisp images can NOT be dis- played. Wipe with a gauze or the like moistened with enzymatic detergent solution. • As indicated elsewhere in PENTAX product labelling, endoscopes particularly the quality of the endo- scopic image should be checked prior to patient use.
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CAUTION: To avoid damaging the endoscopes, do NOT twist, rotate or bend excessively any of the rubber strain relief ( ) during inspection, clinical use, reprocessing or any handling activity. Be particularly cautious for ① ② the insertion tube strain relief ( ).
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3) Inspection of Air/Water Feeding OF-B121 a) Prior to use, the air/water feeding valve (OF-B121) should be inspected. Remove the valve from the control body and make sure that the black rubber check-valve (OE-C14) in good condition is prop- erly attached to the bottom of the metal valve stem. Don’t let the skirt fold under b) If the rubber check-valve is missing or not attached...
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Whenever channel damage is suspected, the endoscope should be leak tested. 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 department. NOTE: Prior to clinical use, it is important that the entire air channel system be dry.
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CAUTION: The instrument, Air/Water channel systems are made of stainless steel, poly phenylene oxide and fluo- rine-contained polymers. When any fluids are used with this scope, please read carefully and follow all instructions in the manual supplied with the fluids for use and pay special attention to any reactions with the materials identified in the intended fluid path.
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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. 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 clin- ical use.
4) Check the endoscopic image and confirm that it is of acceptable quality for clinical use. Refer also to the owner’s manual supplied with the PENTAX video processor for inspection of the image quality. 5) (SCOPES TO BE INTRODUCED TRANSORALLY) Prior to trans-oral insertion of the endoscope, place a bite-block (mouthpiece) into the patient’s mouth to pro-...
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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. - 14 -...
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.
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NOTE: 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 (processor and/or scope type) to another. It is, therefore, important to closely monitor the patient at all times and to aspirate excessive air to prevent overinsufflation and potential pneumatic perforation.
PENTAX accessories be used with PENTAX endoscopes. If a unique or highly specialized accessory is available from another source, please contact PENTAX to arrange a test of its compatibility before using it through the PENTAX endo- scope.
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, non-explosive gas can be delivered.
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5) The operator and assistant(s) should wear surgical gloves to avoid burns during use of Laser equipment. NOTE: One may choose to leave the OF-G11 adapter attached to the endoscope during conventional air insuf- flation using the standard air/water 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.
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.
This owner’s manual contains detailed recommendations on the manual reprocessing of PENTAX endoscopes using PENTAX supplied cleaning/disinfecting adapters. Automated endoscope reproces- sors (AER) may provide a means of reprocessing flexible endoscopes, including PENTAX instruments. Only those Automated Endoscope Reprocessors (AERs) should be used whose manufacturers provide device-specific instructions and have validation data that support each AER claim with respect to PEN- TAX model instruments.
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CAUTION: (Automated Reprocessing) Unless the AER/WD has validated channel monitoring capability for device- specific scope model. • prior to “automated reprocessing” check and confirm the patency of any lumens/channels to ensure that all internal channels are unblocked and/or unclogged • prior to use of any AER/WD confirm the integrity of all channel tubes and recommended channel clean- ing adapters •...
The following internal schematics have been provided as a service to help users better understand the intricate con- struction of PENTAX endoscopes. Knowledge of the various internal channels and tubes within an instrument and their relation to each other allows one to care for and reprocess the endoscope more easily and with greater confi- dence.
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Air/Water Nozzle Air Feeding Tube Water Bottle Water Feeding Tube Suction Tube Suction Source Video Processor The illustration above shows the actual routes taken by air, water, and suction through single biopsy/instrument channel PENTAX videoscopes with forward optics. - 24 -...
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The PVE Soaking cap should be securely ON the electrical contacts. To reprocess a PENTAX single-channel videoscope, first an enzymatic detergent and then a high-level disinfectant or sterilant must be exposed to all internal lumens as well as to all external instrument surfaces and scope components (air/water valve, suction valve, etc.).
4-1-2 PRE-CLEANING WARNING: The importance of meticulous mechanical cleaning of the endoscope and its removable components cannot be overemphasized. Prior to disinfection or sterilization, all instruments and components must be scrupulously cleaned. Failure to do so could result in incomplete or ineffective disinfection and sterilization. During the reprocessing process, always wear protective garments such as gloves, gowns, face masks, etc.
1) Prepare a basin with warm water and a mild enzymatic detergent per detergent manufacturer’s instructions. The solutions must be enzymatic detergents or other cleaning agents specially formulated to clean flexible endoscopes. For specific brands of compatible solutions, please contact your local PENTAX service facility or sales representative.
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4) Manual Cleaning of Suction System by Brush CAUTION: 1) It is highly recommended that only PENTAX cleaning brushes specified in our manuals should be used to clean PENTAX endoscopes. 2) PENTAX cleaning brushes have been specially designed to clean various PENTAX internal channel systems and valves, ports or cylinders.
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A variety of special brushes have been provided to mechan- Cleaning Brush CS6021SN ically brush clean the entire suction/instrument channels and tubes. Whenever possible, the entire endoscope should be immersed in detergent solution during the remainder of the cleaning procedure. Brush clean the entire instrument/suction channel system: a) Using the cleaning brush provided, insert the brush into the opening of the suction nipple and gently pass...
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5) Chemical Cleaning by Detergent Solution CAUTION: Current PENTAX manual cleaning instructions have been validated using enzymatic detergent solutions. For non-enzymatic solutions always adhere to the specific manual cleaning instructions developed by the manufacturer of the detergent product. When using a non-enzymatic detergent during automated reprocessing refer to the validated cleaning instructions developed by the manufacturer of the Auto- mated Endoscope Reprocessor (AER) or Washer Disinfector (WD) unit/system.
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As an alternative, solution can be drawn into the instrument channels by attaching tubing from an aspirator to the suction nipple, as long as the aspirator is turned on, detergent solution can be suctioned through the scope. WARNING: Avoid introduction of air during the flushing process. Confirm that no air bubbles exit from the channel openings at the scope distal tip.
“2% glutaraldehyde” and/or “3.2% glutaraldehyde”. For specific brands of compatible disinfectants/sterilants, please contact your local PENTAX service facility or sales representative. Please also refer to the inside front cover of this manual regarding infec- tion control.
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2) As long as the entire instrument is immersed in disin- fecting solution, the cleaning adapters, the syringes used in previous steps and the rubber inlet seal should remain removed while the instrument remains fully under the disinfecting solution. The removal of com- ponent parts and cleaning adapters from the endoscope will eliminate the risk of mated surfaces not being exposed to the liquid chemical germicide.
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CAUTION: PENTAX recommended rinsing parameters described in this section on high-level disinfection apply to the use of a 2.4% alkaline Glutaraldehyde solution containing no surfactants. Always check with the manufacturer of the liquid chemical germicide (or AER for “automated reprocess- ing”) to confirm that their specific rinsing instructions are based upon validated test data demonstrating...
OEM of the reprocessing agent/sterilization process and then confirm with your local PENTAX dealer prior to use with any PENTAX products. Prior to using other methods, con- firm the specific compatibility and sterilization claims of ANY sterilizing methods/processes with the steriliz- er manufacturer and ensure manufacturer that they have performed microbiological validation studies that support their claims of achieving sterilization of device specific flexible endoscopes and scope components.
AER/WD, then those components must be reprocessed manually as described in PENTAX instructions/labeling. Prior to use, check with each AER/WD manufacturer as to their specific claims with respect to reprocessing individual endoscope components as well as any endoscopic accessory instrument.
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It is imperative that ultrasonic cleaning of the biopsy forceps, other endoscopic accessory instruments and other components be performed PRIOR to steam sterilization. Only those PENTAX accessories identified by their pink colored handle, labeled sa being autoclavable or identified below may be subjected to steam auto- claving.
4-2-2 HIGH-LEVEL DISINFECTION WARNING: Current infection control guidelines require that biopsy forceps and similar endoscopic accessory instru- ments (EAIs) which enter sterile tissue or the vascular system or break the mucosal barrier must be ster- ilized before each patient use. It is recommended that any endoscopic accessory instruments intended for use in the biliary tract be subjected to an appropriate sterilization process.
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• Steam Sterilization (Autoclaving) Recommended NOTE: The PENTAX accessories and scope components listed on page 28 may be subjected to Steam Auto- claving: 1) Prior to steam sterilization, all autoclavable endoscopic accessary instruments and endoscopic components previously identified should be thoroughly cleaned using manual and ultrasonic cleaning methods as described elsewhere in this manual.
4-3. WATER BOTTLE ASSEMBLY Each water bottle assembly should be cleaned and sterilized at least on a daily basis or more frequently depending upon the patient and/or type of endoscopic procedure. As with all endoscopic accessories, prior to sterilization, water bottle assemblies must be scrupulously cleaned. Failure to do so could result in incomplete or ineffective sterilization.
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Steam Sterilization (Autoclaving) PENTAX water bottle assemblies, Model OS-H4 have been designed to withstand high-pressure steam steri- lization procedures providing the following parameters are adhered to: Sterilizer Type : Prevacuum Temperature : 132 ~ 135°C (270 ~ 275°F) Time : 5 - 18 minutes During steam sterilization, ensure that the cap and tubing section have been removed from the water bottle container.
1) Following reprocessing, the endoscope may either be reused or placed in storage. CAUTION: 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. 2) Prior to reuse, ensure that instrument has been properly inspected and fully prepared for the next clinical pro- cedure.
5-1. SERVICING Prior to returning any instrument for repair to PENTAX, the instrument should first undergo appropriate reproc- essing/decontamination procedures for the purpose of infection control. Check with your local PENTAX service facility for more details. 1) All instruments requiring repair should be shipped in the original carrying case with appropriate packing along with comments describing the instrument damage and complaint.
To highlight and simplify, what may appear to some as being complicated maintenance and reprocessing instruc- tions, PENTAX strongly recommends the users review the following suggestions and advice on the care and main- tenance of your PENTAX flexible endoscopes.
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** Do NOT overtighten the cap to the water bottle assembly. The metal pipe at the top of the PENTAX water bottle assembly functions as an inlet port for air from the light source. This inlet pipe should not be used as a leverage tool to tighten the cap to the water container.
SPECIFICATIONS EG-290Kp EC-380LKp Direction of View Forward Field of View 140° Depth of Field 5 ~ 100 mm 3 ~ 100 mm Tip Deflection Up - Down 210° - 120° 180° - 180° Right - Left 120° - 120° 160° - 160°...
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To avoid and resolve adverse electromagnetic effects, do NOT operate these instruments near the RF energy equipment HOYA Corporation 2-7-5 Naka-Ochiai, Shinjuku-ku, Tokyo 161-8525 Japan HOYA Corporation PENTAX Life Care Tokyo Office 3-16-3 Higashi-Ikebukuro, Toshima-ku, Tokyo 170-0013 Japan Tel: 03-5953-2592 Fax: 03-5953-2595...
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