Pentax EB-1170K, Instructions For Use Manual

Page 1: ...PENTAX VIDEO BRONCHOSCOPES INSTRUCTIONS FOR USE REPROCESSING EB 1970TK EB 1170K EB 1570K EB 1970K EB 1575K EB 1975K EB 1990i Only For the Americas ...

Page 2: ...using control lever Remote control operation using remote buttons Suctioning function Removable Components OF B179 Suction Control Valve OF B190 Inlet Seal Notes Read this Instructions for Use IFU before reprocessing the endoscope and save this book for future reference Failure to read and thoroughly understand the information presented in this IFU as well as those developed for ancillary endoscop...

Page 3: ... 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 Symbols on Marking Symboles distinctifs このCEマーキングはEC指令への適合宣言マークです The CE marking assures that this product complies with the requirements of the EC directive for safety Das CE...

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Page 5: ...ries 12 1 2 Endoscope Reprocessing 14 1 2 1 Pre Cleaning 14 1 2 2 Leak Testing 17 1 2 3 Cleaning 18 1 2 4 High Level Disinfection 28 1 2 5 Optional Sterilization 35 1 3 Endoscope components and accessories 39 1 3 1 Cleaning 40 1 3 2 High Level Disinfection 44 1 3 3 Optional sterilization 47 2 POST REPROCESSING AND STORAGE 50 3 SERVICING 51 4 APPENDIX 53 4 1 PENTAX Medical Compatible Reprocessing S...

Page 6: ...ymbol This symbol denotes an endoscope model s material compatibility with the STERRAD NX system EB 1575K EB 1975K EB 1990i Endoscopes that do not have this symbol are incompatible with the STERRAD NX system EB 1170K EB 1570K EB 1970K EB 1970TK SUCTION CONTROL VALVE OF B179 UMBILICAL CABLE INLET SEAL OF B190 Minimum Instrument Channel Width Model Name NOMENCLATURE Video Bronchoscopes EB 1970TK EB ...

Page 7: ...TILATION CAP OF C5 VENTING CONNECTOR PVE SOAKING CAP OE C9 STRAIN RELIEF BOOT Video Bronchoscopes EB 1170K EB 1570K EB 1970K EB 1970TK EB 1575K EB 1975K EB 1990i Minimum Instrument Channel Width I D φ mm 1 2 2 0 2 8 3 2 2 0 2 8 1 2 Table of Minimum Instrument Channel Width ...

Page 8: ... 3 NOMENCLATURE Endoscope Components and Accessories Endoscope Components Suction Valve OF B179 Inlet Seal OF B190 Accessories Bite Bock OF Z5 ...

Page 9: ...OE C9 Ventilation Cap OF C5 Cleaning Brush CS C3S Cleaning Brush CS6002SN CS6015ST CS3010S Cleaning Adapter OF B155 Model Number Appearance of Bristles Length of Shaft Diameter of Bristles CS6002SN 20cm φ 6mm CS6015ST 150cm φ 6mm CS3010S 100cm φ 3mm ...

Page 10: ...n detergent solution Rinsing Drying High Level Disinfection Preparation Filling of disinfecting solution into suction channel Soaking in disinfecting solution Rinsing Drying Optional Sterilization Sterilization using STERRAD NX system EB 1575K EB 1975K EB 1990i only Preparation Wrapping Sterilization Parameter Selection CAUTION STERRAD NX Validation data has not been generated for endoscope models...

Page 11: ...e appropriate for patient use Components and Accessories for Video Bronchoscopes TYPE MODEL Video Bronchoscopes Name Number EB 1570K EB 1970K EB 1970TK EB 1575K EB 1975K EB 1170K EB 1990i Endoscope Component Suction Control Valve OF B179 Y Y Inlet Seal OF B190 Y Y Accessory Bite Block Adult Size OF Z5 Y Y Reprocessing Accessory PVE Soaking Cap OE C9 Y Y Ventilation Cap OF C5 Y Y Cleaning Adapter O...

Page 12: ... and components must be meticulously cleaned Failure to do so can result in incomplete or ineffective disinfection or sterilization Always inspect reprocessed endoscopes and accessories prior to use according to their respective Instructions for Use IFU During the reprocessing process always wear protective equipment e g gloves gowns face masks etc to minimize the risk of cross contamination Conta...

Page 13: ... more detail refer to sections 1 2 5 1 and 1 3 3 2 of this instruction for use Video bronchoscopes other than EB 1575K EB 1975K EB 1990i are incompatible with sterilization using STERRAD NX system 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 ...

Page 14: ...ndoscope channels f maintenance procedures for water filter replacement and or decontamination of the filtration system to ensure water of suitable quality g compliance with local regulations and or guidelines NOTE PENTAX flexible endoscopes should not be exposed to temperatures in excess of 140o F 60o C during either reprocessing or storage During reprocessing depending upon the detergent used th...

Page 15: ...understand the intricate construction of PENTAX endoscopes Please note that all solution entrance ports and flow pathways are illustrated below 1 7 3 4 5 6 2 1 Suction Channel 2 Instrument Channel Inlet 3 Inlet Seal OF B190 4 Suction Cylinder 5 Cleaning Adapter OF B155 6 Ventilation Cap OE C5 7 PVE Soaking Cap OE C9 Figure 1 2 ...

Page 16: ...B 1970K 8 mL EB 1970TK 9 mL EB 1575K 6 mL EB 1975K 8 mL EB 1990i 4 mL Injecting from suction nipple Injecting from inlet seal OF B190 Cleaning Process Video Bronchoscopes Internal Channel Maximum Volume Capacity mL High Level Disinfection Injection Volumes mL Alcohol Rinse Injection Volumes mL Disinfectant Sterile Rinse Water Air Alcohol Air EB 1170K Suction Channel 4 mL 25 mL 25 mL 35 mL 35 mL 35...

Page 17: ...1 Inspection of PVE Soaking Cap OE C9 1 Check that there is no cracking on the outer surface of the PVE Soaking Cap 2 Check that there are no scratches cracking or chipping of the sealing surfaces inside the PVE Soaking Cap Figure 1 3 1 1 5 2 Inspection of Ventilation Cap OF C5 1 Make sure that of the Locking Groove Potion of the Ventilation Cap is not deformed 2 Check that there are no scratches ...

Page 18: ...ng or chipping of the sealing surfaces inside the Cleaning adapter Figure 1 5 1 1 5 4 Inspection Cleaning Brushes CS C3S CS6002SN CS6015ST CS3010S 1 Make sure that there are no missing bristles on Cleaning Brushes 2 Check that there is no kinking or bending of the Cleaning Brush Shaft General 1 ...

Page 19: ...leaning cannot substitute for the mechanical cleaning process Always mechanically clean the endoscope after pre cleaning During pre cleaning never wipe the insertion tube with alcohol or disinfecting solution These solutions may fix organic contaminants and proteinaceous debris to the instrument and have an adverse effect on endoscope functionality and proper reprocessing When using detergent use ...

Page 20: ...asin Lint free gauze 30 mL luer lock syringe Inlet seal OF B190 Suction control valve OF B179 1 2 1 2 Preparation 1 Wear personal protective equipment 2 Prepare a 500 mL basin with detergent solution per 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 1 2 1 3 Wiping of th...

Page 21: ...pressing suction control valve OF B179 for 10 seconds 2 3 1 1 OF B190 2 OF B179 3 External Suction Source Figure 1 7 5 Take the distal end out of detergent solution and aspirate air through the suction channel by pressing suction control valve OF B179 for 10 seconds 6 Turn off the external suction source 7 Disconnect tubing from the endoscope suction nipple 1 2 1 5 Transport to cleaning room 1 Tur...

Page 22: ...compatibility with PENTAX endoscopes Insufficient pressures may reduce the likelihood for accurate leak detection especially if the endoscope s distal bending section is not flexed during testing Also excessive pressures may adversely affect the endoscope especially if pressurization occurs during automated reprocessing at elevated temperatures PENTAX accepts no responsibility for use of non PENTA...

Page 23: ...he manufacturer and found to be compatible by PENTAX A list of detergents that are compatible with PENTAX endoscopes is contained in this manual Fresh detergent solution must be used for each endscope that is reprocessed CAUTION PVE soaking cap OE C9 must be properly secured over the electrical contacts Failure to do so could result in water invasion and damage to the endoscope If an endoscope is ...

Page 24: ... water Basin sufficient in size to immerse the entire endoscope at least 50 cm in width x 40 cm in depth x 15 cm in height Lint free gauze 30 mL luer slip syringe 1 2 3 2 Preparation 1 Wear personal protective equipment 2 Attach PVE soaking cap OE C9 to the endoscope 3 Detach Ventilation Cap OF C5 from the endoscope 1 2 1 OE C9 2 OF C5 Figure 1 8 4 Fill a basin with a sufficient volume of detergen...

Page 25: ...1 OF B190 Figure 1 10 4 Reprocess suction control valve OF B179 separately from the endoscope see Section 1 3 Endoscope components and accessories 5 While still immersed in detergent solution wash the entire surface of the endoscope and OF B190 three times with a lint free gauze 6 Visually inspect the entire surface of the endoscope to insure that no soil is present paying special attention to are...

Page 26: ...ssure to introduce or withdraw the brush This can result in damage to the endoscope and or the brush Always fully immerse the endoscope during brushing 1 Insert cleaning brush CS6002SN into the opening of the suction nipple and gently push it until it appears in the suction cylinder 1 3 2 1 CS6002SN 2 Suction Nipple 3 Suction Cylinder Figure 1 11 2 Gently withdraw the brush and remove from debris ...

Page 27: ...Instrument Channel Inlet Figure 1 13 8 Remove debris from the brush head by rubbing it with gloved fingers and then gently withdraw the brush 9 Repeat steps 7 and 8 three additional times 10 Insert cleaning brush CS C3S into the suction cylinder and rotate it for 30 seconds Do not insert the brush excessively 1 2 1 CS C3S 2 Suction Cylinder Figure 1 14 11 Withdraw the brush Remove debris from the ...

Page 28: ...te reprocessing CAUTION 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 Always immerse the endoscope components and accessories in detergent solution during cleaning Attaching components and accessories to...

Page 29: ...o inlet seal OF B190 and inject 25 mL of detergent solution into the suction channel 1 1 OF B190 Figure 1 17 5 Detach the inlet seal cleaning adapter inlet seal OF B190 and cleaning adapter OF B155 from the endoscope and leave them to soak along with the endoscope in detergent solution Open the cap of inlet seal OF B190 1 2 1 OF B190 2 OF B155 Figure 1 18 Endoscope Cleaning 1 ...

Page 30: ...s distal end and acessories If any air bubbles are detected flush them away with detergent solution using a 30 mL syringe 2 Soak the endoscope inlet seal OF B190 and cleaning adapter OF B155 under conditions temperature concentration time specified by the detergent manufacturer In the case of Endozime the immersion time is 3 minutes Figure 1 19 3 After soaking ultrasonically clean inlet seal OF B1...

Page 31: ...ntrol body of the scope and PVE connector with two hands and agitate them under the water by moving them from side to side repeatedly for one minute Figure 1 20 5 Similarity agitate inlet seal OF B190 and cleaning adapter OF B155 under the water by moving them from side to side repeatedly for at least one minute 6 Attach inlet seal OF B190 and cleaning adapter OF B155 to the endoscope Figure 1 15 ...

Page 32: ...rm 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 Figure 1 18 p24 1 2 3 8 Drying 1 Gently wipe and dry all external surfaces of the endoscope inlet seal OF B190 and cleaning adapter OF B155 with a new lint free gauze Endoscope Cleaning 1 ...

Page 33: ...tions other than those specified by the disinfectant manufacturer 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 It is imperative that ALL internal channel surfaces be in contact with the disinf...

Page 34: ...ube and umbilical cable excessively To prevent damaging the endoscope do not place any objects other than the reprocessing accessories described in section 1 2 4 1 with the endoscope when immersing the endoscope in the disinfection basin 1 2 4 1 Items required Endoscope component Inlet seal OF B190 Reprocessing accessory PVE soaking cap OE C9 Cleaning adapter OF B155 Other equipment Protective equ...

Page 35: ...ntact of the disinfectant with channel surfaces Always immerse the endoscope while filling endoscope channels with disinfectant It is imperative that cleaning adapter OF B155 and Inlet Seal OF B190 be securely attached to the endoscope Failure to properly mount and secure the cleaning adapter and inlet seal can result in ineffective and incomplete reprocessing Always fully immerse the endoscope co...

Page 36: ...hannel opening on the distal end 4 Insert a syringe filled with disinfecting solution into inlet seal OF B190 and inject 25 mL of disinfecting solution into the suction channel 1 1 OF B190 Figure 1 24 5 After injecting disinfecting solution into the suction channel detach inlet seal OF B190 and cleaning adapter OF B155 from the endoscope and leave them with the endoscope in the disinfecting soluti...

Page 37: ...e surfaces distal end and accessories If any air bubbles are detected flush them away with disinfecting solution using a syringe 2 Soak the endoscope inlet seal OF B190 and cleaning adapter OF B155 under the conditions temperature concentration time specified by the disinfectant manufacturer In the case of Cidex Activated Dialdehyde Solution the immersion time is 45 minutes at 25 C Figure 1 26 Pur...

Page 38: ...ly immerse the endoscope 2 Detach inlet seal OF B190 and cleaning adapter OF B155 from the endoscope Open the cap of inlet seal OF B190 3 Wipe all exterior surfaces of the endoscope inlet seal OF B190 and cleaning adapter OF B155 at least two times with a sterile gauze in order to remove residual disinfecting solution 4 While still completely immersed in water grasp the distal end and control body...

Page 39: ... dry the endoscope channels and prevent bacterial colonization and or infections associated with waterborne microorganisms Flushing the channels with alcohol 1 Attach a syringe filled with 70 90 medical grade ethyl or isopropyl alcohol to the suction nipple and flush the suction channel with 15 mL of alcohol Figure 1 23 p31 2 Insert a syringe filled with 70 90 medical grade ethyl or isopropyl alco...

Page 40: ...rt ingredients their by products or derivatives of the processed devices remain on any instrument that may pose a risk to patients and users After sterilization ensure that the package is intact If there are any signs of abnormalities such as stains tears or any other indications that the packaging has been damaged or opened repeat the sterilization process with new packaging CAUTION Due to the he...

Page 41: ... necessary and other components may also require repair or replacement Although STERRAD NX compatible endoscopes are capable of withstanding STERRAD NX sterilization for up to 100 cycles repair replacement of parts might be necessary prior to reaching 100 cycles depending upon the condition of the endoscope 1 2 5 1 1 Items required protective garments such as gloves gowns face masks etc to minimiz...

Page 42: ...lt in bursting of the bending rubber 1 Detach cleaning adapter OF B155 and the inlet seal OF B190 are detached from the scope 2 1 1 OF B155 2 OF B190 Figure 1 28 2 Detach PVE soaking cap OE C9 from the scope 3 Attach ventilation cap OF C5 to the scope 2 1 1 OF C5 2 OE C9 Figure 1 29 4 Lay the APTIMAX Instrument Tray Mat on APTIMAX Instrument Tray 5 Place the scope onto the mat as shown below Figur...

Page 43: ...eling away from package Failure to do so can result in removal of the tape and ineffective sterilization 1 Wrap the tray containing the scope 2 Apply the tape lengthwise across the three sides of the wrapped container 1 2 5 1 4 Sterilization Parameter Selection WARNING Contact Johnson Johnson regarding directions for use of the STERRAD NX system 1 Set the tray containing the scope into the sterili...

Page 44: ... Y Y Y N Y YES N NO The PVE Soaking Cap OE C9 should be attached to the endoscope during cleaning and disinfection procedures The ventilation cap OF C5 should be attached to the endoscope during the STERRAD sterilization NOTE Automated Endoscope Reprocessor AER manufacturers may not make specific claims or provide special instructions for reprocessing all of the removable endoscope components and ...

Page 45: ...essories is contained in this manual Fresh detergent solution must be used for each set of endoscope components and accessories 1 3 1 1 Items required Protective equipment such as gloves gowns face masks etc to minimize the risk of cross contamination Detergent solution Endozime Ruhof Corporation Clean potable water Basin at least 25 cm in width x 20 cm in depth x 15 cm in height Lint free gauze 1...

Page 46: ...ergent solution 8 Using a syringe filled with detergent solution inject 4 mL of the detergent solution directly into the lumen of the suction control valve OF B179 Figure 1 33 Soaking in detergent solution 9 While fully immersed ensure there are no air bubbles on the surfaces of components and accessories If any bubbles are detected flush them away with detergent solution using a syringe 10 Soak c...

Page 47: ...e the components and accessories from the ultrasonic cleaner 1 3 1 4 Rinsing WARNING All residual detergent solution must be removed from the components and accessories Residual detergent solution may interfere with subsequent disinfection and sterilization processes First rinse 1 Prepare a basin with clean water and fully immerse the components and accessories 2 Wipe all exterior surfaces of the ...

Page 48: ...s 2 5 to perform a fourth rinse 9 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 see Figure 1 33 p41 1 3 1 5 Drying 1 Wipe all surfaces of components and accessories gently with a lint free gauze Accessory Cleaning 1 ...

Page 49: ...terile water is not used use clean potable water that meets the requirements of the health care facility 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 bacteria colonization and or infections associated with waterborne microorganisms The basin t...

Page 50: ...ing to the in structions temperature concentration time specified by the disinfectant manufacturer In the case of Cidex Activated Dialdehyde Solution the immersion time is 45 minutes at 25 C 9 Remove the components and accessories from the disinfecting solution 1 3 2 3 Rinsing First rinse 1 Prepare a basin with sterile water and immerse the components and accessories 2 Wipe all exterior surfaces o...

Page 51: ...fections associated with waterborne microorganisms Flushing of lumens with alcohol 1 Using a syringe filled with 70 90 medical grade ethyl or isopropyl alcohol flush the lumen of the suction valve OF B179 with 2 mL of alcohol see Figure 1 33 p41 Purging of alcohol from lumens 2 Using a syringe filled with air flush the lumen of the suction valve OF B179 with air to purge residual alcohol see Figur...

Page 52: ...he devices to be sterilized sterilization cycle parameters Use a chemical indicator CI and or biological indicator BI recommended by the manufacturer of the sterilizer to control the sterilization process and ensure sterilization efficacy After sterilization ensure that the package is intact If there are any signs of abnormalities such as stains wetness tears or any other indications that the pack...

Page 53: ...mberly Clark Sequential wrapping technique was employed Biological and or chemical indicators used must be appropriate for the stated sterilization cycle parameters and cleared by FDA 1 3 3 2 Sterilization using STERRAD NX system The suction control valve OF B179 and the inlet seal OF B190 can be sterilized using the STERRAD NX sterilization 1 3 3 2 1 Items required protective garments such as glo...

Page 54: ...ap OF C5 to the endoscope The ventilation cap OF C5 must be attached to the endoscope when performing sterilization using STERRAD NX system Secure the wrapping with a length of tape that is sufficient to prevent the wrapping from peeling away from package Failure to do so could result in removal of the tape and ineffective sterilization 1 Wrap the tray containing the components 2 Apply the tape le...

Page 55: ...sure to sunlight or X rays Avoid storage of the endoscope in cabinets that have sharp edges exposed nails screws etc 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 1 Following reprocessing the ...

Page 56: ...facturer It is unknown to PENTAX if serviced or remanufactured instruments performed by unauthorized PENTAX entities which still bear a PENTAX label are within PENTAX device specifications and or if unauthorized activities have significantly changed the instrument s performance intended use safety and or effectiveness Independent Service Organizations should confirm the ability of these serviced r...

Page 57: ...number contact name and phone number of the individual responsible for authorizing repairs as well as shipping address should be included 3 The ventilation cap OF C5 should be attached to the instrument if it will be shipped by air freight 4 Any accessories and or endoscope components potentially related to the endoscope damage or complaint should also be returned with the endoscope 5 PVE soaking ...

Page 58: ...scope Reprocessor AER product claims are the responsibility of the AER manufacturer including but not limited to cleaning disinfection sterilization rinsing drying biocompatibility reprocessing instructions required channel adapters efficacy validation studies and compliance with regulatory requirements and or professional guidelines Prior to reprocessing PENTAX Medical brand endoscopes in a speci...

Page 59: ...ed exclusively in EvoTech ECR Cidex Activated Dialdehyde Solution 14 Day Glutaraldehyde Advanced Sterilization Products MetriCide Glutaraldehyde may also be marketed as Omnicide NS or MaxiCide NS Metrex Research Corporation Sporicidin Glutaraldehyde Contec Incorporated Rapicide Glutaraldehyde Medivators Inc Wavicide 01 Glutaraldehyde Medical Chemical Corporation Sterilization Agents Processes The ...

Page 60: ...2014 06 6217001 S020 R04 printed in JAPAN 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 1770 Argentia Road Mississauga Ontario L5N 3S7 Canada Tel 1 905 286 5585 Fax 1 905 286 5571 PENTAX ...