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Summary of Contents for Pentax EB-1970TK
- Page 1 Only For the Americas INSTRUCTIONS FOR USE （REPROCESSING) PENTAX VIDEO BRONCHOSCOPES EB-1970TK EB-1170K, EB-1570K EB-1970K, EB-1575K EB-1975K, EB-1990i...
- Page 2 For inspection and preparation prior to its use, please refer to the separate Instructions for Use (Operation). The text contained in this IFU is common to various types/models of PENTAX endoscopes, and users must carefully follow only those sections and instructions pertaining to the specific instrument model in question.
- Page 3 Sterility Statement The endoscopes identified in this IFU are reusable semicritical devices. Since they are packaged non-sterile, they must be high- level disinfected or sterilized BEFORE inital use. Prior to each subsequent procedure, they must be subjected to appropriate cleaning and either high-level disinfection or sterilization processes. 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...
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Page 5: Table Of Contents
1-3. Endoscope components and accessories ..................39 1-3-1. Cleaning ........................40 1-3-2. High-Level Disinfection ....................44 Accessory Cleaning 1-3-3. Optional sterilization ....................47 POST REPROCESSING AND STORAGE ....................50 Accessory Disinfection SERVICING ..............................51 APPENDIX ..............................53 Accessory Sterilization 4-1. PENTAX Medical Compatible Reprocessing Systems/Agents ............. 53... -
Page 6: Nomenclature
NOMENCLATURE Video Bronchoscopes EB-1970TK, EB-1170K, EB-1570K, EB-1970K, EB-1575K, EB-1975K, EB-1990i UMBILICAL CABLE SUCTION CONTROL VALVE (OF–B179) INLET SEAL (OF–B190) STRAIN RELIEF BOOT INSTRUMENT CHANNEL INLET SUCTION NIPPLE CONTROL BODY STRAIN RELIEF BOOT ANGULATION LOCK LEVER EB-1170K, EB-1570K, EB-1970TK only ANGULATION CONTROL LEVER... - Page 7 PVE SOAKING CAP OE-C9 ELECTRICAL CONTACTS VENTILATION CAP OF-C5 VENTING CONNECTOR BENDING SECTION INSERTION TUBE Table of Minimum Instrument Channel Width Video Bronchoscopes EB-1170K EB-1570K EB-1970K EB-1970TK EB-1575K EB-1975K EB-1990i Minimum Instrument Channel Width (I.D. φ mm) – 2 –...
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Page 8: Nomenclature
NOMENCLATURE Endoscope Components and Accessories Endoscope Components ・Suction Valve (OF-B179) ・Inlet Seal (OF-B190) Accessories ・Bite Bock (OF-Z5) – 3 –... - Page 9 Accessories for Reprocessing ・Ventilation Cap (OF-C5) ・PVE Soaking Cap (OE-C9) ・Cleaning Adapter (OF-B155) ・Cleaning Brush (CS-C3S) ・Cleaning Brush (CS6002SN/CS6015ST/CS3010S) Model Number Appearance of Bristles Length of Shaft Diameter of Bristles CS6002SN 20cm φ 6mm CS6015ST 150cm φ 6mm CS3010S 100cm φ...
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Page 10: Endoscope Reprocessing Procedure Flow
ENDOSCOPE REPROCESSING PROCEDURE FLOW Pre-Cleaning • Preparation • Wiping of insertion tube • Aspiration of detergent solution through suction channel • Transport to cleaning room Leak Testing Cleaning • Preparation • Cleaning of all external surfaces • Brushing of suction channel •... -
Page 11: Care After Use
Components and Accessories for Video Bronchoscopes MODEL Video Bronchoscopes EB-1570K EB-1970K TYPE EB-1170K Name Number EB-1970TK EB-1990i EB-1575K EB-1975K Suction Control Valve OF-B179 Endoscope Component Inlet Seal OF-B190 Accessory... -
Page 12: Important Instructions
Endoscopes are semicritical devices that require cleaning and at least high- level disinfection. Use only legally marketed solutions and/or automated endoscope reprocessors (AERs) for which validation testing with PENTAX products has been performed by their manufacturers. A list of legally marketed solutions/systems that have been determined to be compatible with PENTAX brand products is contained in this manual. - Page 13 • After every 100 cycles of STERRAD NX™ exposure, the endoscope should be returned to an authorized PENTAX service facility for repair. Replacement of the insertion tube and bending section will be necessary and other components may also require service.
- Page 14 NOTE PENTAX flexible endoscopes should not be exposed to temperatures in excess of 140 F (60 C) during either reprocessing or storage. During reprocessing...
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Page 15: Internal Channels Of Video Bronchoscopes
1-1-3. Internal Channels of Video Bronchoscopes The following internal schematic is designed to help users better understand the intricate construction of PENTAX endoscopes. Please note that all solution entrance ports and flow pathways are illustrated below. (1) Suction Channel (2) Instrument... -
Page 16: Quick Reference Of Injection Volumes For Internal Channel
Water EB-1170K 4 mL EB-1570K 6 mL EB-1970K 8 mL Suction ① :25 mL ① :35 mL ① :35 mL EB-1970TK 9 mL Channel ② :25 mL ② :35 mL ② :35 mL EB-1575K 6 mL EB-1975K 8 mL EB-1990i 4 mL ①... -
Page 17: Inspection Of Reprocessing Accessories
1-1-5. Inspection of Reprocessing Accessories Before use, inspect reprocessing accessories according to the following procedure. WARNING • Replace reprocessing accessory with a new one when inspection of the device indicates that it is damaged or unable to function properly. General 1-1-5-1. - Page 18 1-1-5-3. Inspection of Cleaning Adapter (OF-B155) Check that there are no scratches, cracking, or chipping of the sealing surfaces inside the Cleaning adapter. General Figure 1.5 1-1-5-4. Inspection Cleaning Brushes (CS-C3S/CS6002SN/CS6015ST/CS3010S) Make sure that there are no missing bristles on Cleaning Brushes. Check that there is no kinking or bending of the Cleaning Brush Shaft.
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Page 19: Cleaning
• When using detergent, use only legally marketed brands that have been tested and found to be compatible by PENTAX. A list of detergents that are compatible with PENTAX endoscopes is contained in this manual. - Page 20 In order to avoid damaging the endoscope, never subject it to suction in excess of 66kPa. NOTE If the use of detergent solution is not permitted in the procedure room, remove the endoscope from the procedure room and perform pre-cleaning solution in another location.
- Page 21 1-2-1-4. Aspiration of detergent solution through the suction channel Connect inlet seal (OF-B190) and suction control valve (OF-B179) to the endoscope. Connect a suction tube from an external suction source to the endoscope suction nipple. Turn on the external suction source. Place the distal end of the endoscope into a basin, and aspirate detergent solution through the suction channel by pressing suction control valve (OF-B179) for 10 seconds.
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Page 22: Leak Testing
1-2-2. Leak Testing Before reprocessing and/or immersion in any fluids, PENTAX endoscopes should be tested for the loss of integrity in their watertight construction by using a leakage tester. Various types of manual and automated endoscope leakage testers exist. Some manual and automated are stand-alone units, and others may be integrated into an AER. -
Page 23: Cleaning
• For cleaning, use only legally marketed detergents that have been tested according to the instructions of the manufacturer and found to Endoscope be compatible by PENTAX. A list of detergents that are compatible with Cleaning PENTAX endoscopes is contained in this manual. - Page 24 • Inlet seal (OF-B190) Reprocessing accessory • PVE soaking cap (OE-C9) • Cleaning brush (CS6002SN) • Cleaning brush (CS6015ST) for EB-1570K, EB-1970K, EB-1970TK, EB-1575K and EB-1975K • Cleaning brush (CS3010S) (EB-1170K and EB-1990i only) • Cleaning brush (CS-C3S) • Cleaning adapter (OF-B155) Other Equipment •...
- Page 25 1-2-3-3. Cleaning of all external surfaces • Do not squeeze or severely bend the insertion tube. • Do not use any abrasive materials. • Be careful to avoid damage to the distal lenses. Fully immerse the endoscope with the components attached in detergent solution. Detach the inlet seal (OF-B190) and suction control valve (OF-B179) from the endoscope.
- Page 26 1-2-3-4. Brushing of the suction channel WARNING • Do not use cleaning brushes other than those that are specified in this instructions for use. Failure to do so could result in endoscope damage or incomplete or ineffective cleaning. • Prior to use, ensure that cleaning brushes are not damaged (e.g., kinked shaft or bent or missing bristles).
- Page 27 Repeat steps 4 and 5 three additional times. Insert cleaning brush (CS3010S for EB-1170K and EB-1990i/CS6015ST: for all other scopes) into the instrument channel inlet, and gently advance it until it exits the distal end of the endoscope. (1) CS3010S (for EB- 1170K and EB-1990i) CS6015T (for all other scopes)
- Page 28 In order to avoid damage to the endoscope, never apply excessive force if resistance is encountered while flushing detergent solution into channels. Do not use the endoscope, and contact your local PENTAX service facility or sales representative. Endoscope...
- Page 29 Check to confirm that detergent solution flows out from the suction channel opening on the distal end of the endoscope. Insert a syringe filled with detergent solution to inlet seal (OF-B190), and inject 25 mL of detergent solution into the suction channel. (1) OF-B190 Figure 1.17 Detach the inlet seal cleaning adapter inlet seal (OF-B190), and cleaning adapter...
- Page 30 1-2-3-6. Soaking in detergent solution WARNING • The detergent solution must remain in contact with ALL internal channels and external endoscope surfaces for the time period recommended by the manufacturer of the detergent. • Adhere to the conditions (temperature, concentration, time) specified by the detergent manufacturer to accomplish effective and complete cleaning.
- Page 31 1-2-3-7. Rinsing WARNING It is important that all internal channels, external endoscope surfaces, and components be thoroughly rinsed with clean water to remove residual detergent solution. Failure to do so can result in ineffective or incomplete disinfection and sterilization. First rinse Place the endoscope with the inlet seal (OF-B190), and cleaning adapter (OF-B155) attached in a basin of clean water that is of sufficient volume to completely immerse the endoscope.
- Page 32 Second rinse 12) Fill a basin with clean water and repeat steps 1-11 to perform a second rinse. Third rinse 13) Fill a basin with clean water and repeat steps 1-11 to perform a third rinse. Forth rinse 14) Fill a basin with clean water and repeat steps 1-11 to perform a fourth rinse. 15) Detach inlet seal (OF-B190), and cleaning adapter (OF-B155) from the endoscope.
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Page 33: High-Level Disinfection
• Use only a legally marketed disinfectant that has been tested according to the instructions provided by the manufacturer and found to be compatible by PENTAX. A list of disinfectants that are compatible with PENTAX endoscopes is contained in this manual. - Page 34 If the endoscope is disinfected without the soaking cap attached, do not use the endoscope, and contact your local PENTAX service facility or sales representative. • Prior to disinfection, detach the ventilation cap (OF-C5). Failure to do so can result in damage to the endoscope.
- Page 35 1-2-4-2. Preparation Wear personal protective equipment. Attach the PVE soaking cap (OE-C9) to the endoscope. Ensure that the ventilation cap (OF-C5) is detached from the endoscope. (1) OE-C9 (2) OF-C5 Figure 1.21 Prepare a basin with a sufficient volume of disinfecting solution to completely immerse the endoscope.
- Page 36 Filling the suction channel with disinfecting solution Attach a syringe filled with disinfecting solution to the suction nipple, and inject 25 mL of disinfecting solution into the suction channel. (1) Suction Nipple Figure 1.23 Confirm that disinfecting solution flows out from the suction channel opening on the distal end.
- Page 37 1-2-4-4. Soaking in disinfecting solution WARNING • The disinfecting solution must remain in contact with ALL internal channels and external endoscope surfaces for the time period recommended by the disinfectant manufacturer. • Adhere to the conditions (temperature, concentration, time) specified by the disinfectant manufacturer to accomplish effective and complete disinfection.
- Page 38 1-2-4-5. Rinsing WARNING • Ideally, all final rinses should be performed with sterile water. However, if sterile water is not used, use potable water or the water that meets the requirements of the health care facility. • The basin that is used to perform rinsing of the endoscope and accessories must be thoroughly cleaned prior to filling it with rinse water.
- Page 39 Take the endoscope with inlet seal (OF-B190) and cleaning adapter (OF-B155) attached out of the water. 10) Attach a syringe filled with air to the suction nipple, and flush the suction channel with at least 35 mL of air to expel residual water. (Figure 1.23, p31) 11) Insert a syringe filled with air into the inlet seal, and flush the suction channel with 35 mL of air.
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Page 40: Optional Sterilization
To avoid the potential for instrument damage and/or endoscope failure, confirm the compatibility of such systems/ solutions with your local PENTAX dealer prior to use with any PENTAX products. Also, confirm the specific claim(s) of any sterilization... -
Page 41: Sterilization
• After every 100 cycles of STERRAD NX™ exposure, the endoscopes should be returned to an authorized PENTAX service facility for repair. Replacement of the insertion tube and bending section will be necessary, and other components may also require repair or replacement. - Page 42 1-2-5-1-2. Preparation WARNING Consult the manufacturer of the sterilization tray regarding its directions for use. ® Prior to the sterilization using STERRAD NX™ system, ensure that Ventilation cap (OF-C5) is attached to the scope. Failure to do so can result in bursting of the bending rubber.
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Page 43: Endoscope Sterilization
1-2-5-1-3. Wrapping WARNING • Contact the manufacturer regarding directions for use of instrument wrap and tape. • Scope components may be wrapped and sterilized together with the scope. However, do not attach any components other than the ventilation cap to the scope •... -
Page 44: Endoscope Components And Accessories
1-3. Endoscope components and accessories Endoscope components and accessories can be subjected to the following cleaning, disinfection, and sterilization processes. Model Cleaning Optional Sterilization High-Level ® STERRAD Steam Disinfection Name Number Manual Ultrasonic NX™ Sterilization system Suction OF-B179 Endoscope Control Valve Component Inlet Seal OF-B190... -
Page 45: Cleaning
• For cleaning, use only legally marketed detergents which have been tested and found to be compatible by PENTAX. A list of detergents that are compatible with PENTAX components and accessories is contained in this manual. - Page 46 Open the cap of inlet seal (OF-B190) during cleaning. Figure 1.31 Cleaning of all external surfaces Wash all surfaces of components and accessories three times with a lint-free gauze. Cleaning of brushes Wash the brush heads of cleaning brushes (CS6002SN, CS6015ST, CS3010S, CS- C3S) by rubbing them with gloved fingers for 30 seconds.
- Page 47 1-3-1-3. Ultrasonic Cleaning WARNING All components and accessories must be ultrasonically cleaned prior to high- level disinfection or sterilization. DO NOT use caustic or abrasive solutions in the ultrasonic cleaner. Prepare detergent solution per the manufacturer’s instructions (temperature, concentration). In the case of ENDOZIME, add 30 mL of ENDOZIME concentrate to 3.8 L (1 gallon) of clean potable water at 20°C~30°C (68°F~86°F).
- Page 48 Third rinse Fill a basin with clean water and repeat steps 2-5 to perform a third rinse. Forth rinse Fill a basin with clean water and repeat steps 2-5 to perform a fourth rinse. Remove all components and accessories from the water. Purging of water from lumens 10) Using a syringe filled with air, flush the lumen of the suction valve (OF-B179) to purge residual water.
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Page 49: High-Level Disinfection
(temperature, concentration, time). Use only legally marketed disinfecting solutions that have been tested and found to be compatible by PENTAX. A list of disinfectant solutions that are compatible with PENTAX components and accessories is contained in this manual. - Page 50 1-3-2-2. Disinfection procedure Preparation Wear personal protective equipment. Prepare a basin of disinfecting solution per manufacturer’s instructions (temperature, concentration). Fully immerse the components and accessories, and keep them immersed in disinfecting solution during the following disinfection procedure. Open the cap of inlet seal (OF-B190) and fully immerse it in disinfecting solution. (see Figure 1.31, p41) Manipulating the valve mechanism While fully immersed, manipulate the suction control valve (OF-B179) mechanism...
- Page 51 Purging of water from lumens 10) Using a syringe filled with air, flush the lumen of the suction valve (OF-B179) to purge residual water. (see Figure 1.33, p41) 1-3-2-4. Drying WARNING Regardless of the quality of the rinse water used, it is essential to perform a final alcohol rinse followed by forced air in order to completely dry the lumens of components and accessories, and prevent bacterial colonization and/or infections associated with waterborne microorganisms.
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Page 52: Optional Sterilization
1-3-3. Optional sterilization WARNING • Please note that PENTAX Medical has not validated any sterilization methods for flexible endoscopes other than steam sterilization and the ® STERRAD NX™ system. • During the reprocessing process, always wear protective equipment (e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross contamination. - Page 53 1-3-3-1-2. Wrapping Prior to steam sterilization, wrap the components and accessories individually with two layers of one-ply Kimguard KC200 sterilization wrap (Kimberly-Clark) using sequential wrapping technique. 1-3-3-1-3. Parameters Steam sterilization can be performed under the following conditions: Sterilizer Type Temperature Exposure Drying Time 132°C...
- Page 54 1-3-3-2-2. Preparation WARNING Contact the manufacturer of the tray regarding directions for use of the tray. Lay APTIMAX Instrument Tray Mat on APTIMAX Instrument Tray. Place the suction control valve (OF-B179) and the inlet seal (OF-B190). Cover the tray with the lid. 1-3-3-2-3.
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Page 55: Post Reprocessing And Storage
Contact with sharp objects can puncture, scratch, or otherwise damage the endoscope. • When utilizing heated disinfectants for reprocessing PENTAX endoscopes, the instruments should be allowed to return to room temperature prior to use and/or further handling. -
Page 56: Servicing
Never drop this equipment or subject it to severe impact, as it can 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. - Page 57 Prior to returning any instrument for repair to PENTAX, the instrument should first undergo appropriate reprocessing/decontamination procedures for the purpose of infection control. Check with your local PENTAX service facility for more details. All instruments requiring repair should be shipped in the original carrying case with appropriate packing along with comments describing the instrument damage and complaint.
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Page 58: Appendix
Prior to reprocessing PENTAX Medical brand endoscopes in a specific model AER machine, contact the AER manufacturer to confirm the following: • The AER efficacy claims have been validated for the specific PENTAX Medical model endoscopes in question. • Instructions are available for the specific PENTAX Medical model endoscopes and endoscope components in question. - Page 59 High Level Disinfectants The following liquid chemical germicides have received FDA 510(k) clearance for claims of high level disinfection (HLD). Some HLD products may have multiple label claims and/or may be FDA-cleared only for use in a legally marketed AER machine that can attain specific use parameters (e.g., temperature).
- 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.
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