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Appendix-19

Appendix

EB530US_E2_202B1237458F.indb 19

2013/12/23 11:51:09

Summary of Contents for EB-530US

Page 1: ...s manual carefully before use to avoid unexpected accidents and take full advantage of the product s capabilities Ultrasonic Endoscope EB 530US English OPERATION MANUAL Preparation and Operation EB530...

Page 2: ...ved for safety when performing endoscopy or electrosurgery are identified by WARNING or CAUTION Perform procedures correctly by reading and understanding the warning information carefully WARNING Read...

Page 3: ...ear even after resetting the processor and light source turn them off straighten the bending portion release the angle lever and then withdraw the ultrasonic endoscope slowly from the patient Should t...

Page 4: ...4 1 4 1 How to Operate Bending Mechanism 4 2 4 2 Suction Valve Forceps Inlet and Water Feed Inlet 4 3 4 3 Remote Operating Switches 4 4 4 4 Forceps Valve 4 5 4 5 Suction Button 4 6 Chapter 5 Preparati...

Page 5: ...in Specification Appendix 2 Troubleshooting Combination with EPX 4400 system Appendix 8 Troubleshooting Combination with EPX 2500 system Appendix 12 After Sales Service Appendix 16 Disposal of Electri...

Page 6: ...ions that may cause death or serious accident if not avoided CAUTION Explains situations that may cause slight or moderate levels of injury if not avoided CAUTION Explains situations that may cause da...

Page 7: ...Chapter 1 Safety This chapter summarizes the information necessary for safe use of Ultrasonic Endoscope 1 1 EB530US_E2_202B1237458F indb 1 2013 12 23 11 50 47...

Page 8: ...pected accidents such as equipment failure If a replacement is not available you may not be able to continue endoscopic procedures Make sure to inspect the equipment before use according to the proced...

Page 9: ...ell as damage the instrument If you feel any abnormal resistance do not force the Ultrasonic Endoscope to insert and pull out Please operate the Ultrasonic Endoscope slowly Do not perform the insertio...

Page 10: ...ment due to the effect of electromagnetic waves In this case turn off the device emitting the electromagnetic waves or move the device away from this equipment This equipment complies with the require...

Page 11: ...onnector with hands immediately after use of the Endoscope may cause a burn injury Combination with the VP 4400 and XL 4400 or VP 4450HD and XL 4450 Set a suction pressure at 53kPa or less Ultrasonic...

Page 12: ...rce an endotracheal tube onto the Ultrasonic Endoscope and never apply excessive pressure or force when attempting to pass or withdraw the Ultrasonic Endoscope Do not insert the Ultrasonic Endoscope t...

Page 13: ...ssor Do not touch the LG connector tip until it cools down approximately 5 minutes Touching the LG connector with hands immediately after use of the Endoscope may cause a burn injury Chapter 7 Cleanin...

Page 14: ...te for this Ultrasonic Endoscope There is a risk of infection Chapter 9 Gas Sterilization Clean disinfect and sterilize all the channels after every case regardless of whether used or not Remove the b...

Page 15: ...guration 2 1 Composition of Set 2 2 2 2 System Configuration 2 4 2 2 1 Combination with VP 4450HD or VP 4400 and SU 8000 2 4 2 2 2 Combination with VP 4400 and SU 7000 2 6 2 2 3 Combination with EPX 2...

Page 16: ...ying case The set consists of the following items Note Figures in parentheses indicate quantities Carrying Case 1 Forceps Valve FOV BU1 10 Ventilation Adapter AD 7 1 Cleaning Brush WB3503FW 1 Cleaning...

Page 17: ...orceps Inlet Cleaning Adapter with a Cap WA 003 1 Cleaning Adapter CA 500BU 1 Ultrasonic Endoscope 1 Suction Button SB 500B D 20 US Waterproof Cap WA 7000 1 Balloon Installation Tool BA BU1 1 Syringe...

Page 18: ...inter output Combination with VP 4450HD or VP 4400 and SU 8000 222222 Ultrasonic Endoscope EB 530US Endoscopic Accessory Balloon Foot Switch FS1 Airtightness Tester LT 7 Cart Light Source XL 4450 XL 4...

Page 19: ...UP 55MD SONY UP 21MD SONY CP900UM 120W MITSUBISHI CP900DW MITSUBISHI Monitor CDL1576A CDL1909A RADIANCE24 NDS Monitor CDL1576A CDL1909A RADIANCE24 NDS Note Note Only when using the VP 4450HD Keyboard...

Page 20: ...Endoscopic Accessory Balloon Foot Switch FS1 Airtightness Tester LT 7 Cart Light Source XL 4400 Ultrasonic Processor SU 7000 Processor VP 4400 Data Keyboard DK 4400E Chapter 2 Composition of Set and S...

Page 21: ...t your local dealer Printer UP 51MD SONY UP 55MD SONY UP 21MD SONY CP900UM 120W MITSUBISHI CP900DW MITSUBISHI Monitor CDL1576A Monitor CDL1576A CDL1909A Keyboard CP 7000 Foot Switch FS1 Chapter 2 Comp...

Page 22: ...Cart Processor EPX 2500 Data Keyboard DK 2500 Ultrasonic Endoscope EB 530US Endoscopic Accessory Balloon Airtightness Tester LT 7 Ultrasonic Processor SU 8000 Chapter 2 Composition of Set and System C...

Page 23: ...tact your local dealer Video Printer UP 21MD SONY UP 55MD SONY CP900UM MITSUBISHI Monitor CDL1576A CDL1909A RADIANCE24 NDS Monitor CDL1576A CDL1909A Keyboard CP 8000 Foot Switch FS1 Chapter 2 Composit...

Page 24: ...art Processor EPX 2500 Data Keyboard DK 2500 Ultrasonic Endoscope EB 530US Endoscopic Accessory Balloon Airtightness Tester LT 7 Ultrasonic Processor SU 7000 Chapter 2 Composition of Set and System Co...

Page 25: ...please contact your local dealer Video Printer UP 21MD SONY UP 55MD SONY CP900UM MITSUBISHI Monitor CDL1576A Monitor CDL1576A CDL1909A Keyboard CP 7000 Foot Switch FS1 Chapter 2 Composition of Set an...

Page 26: ...Chapter 2 Composition of Set and System Configuration 2 12 EB530US_E2_202B1237458F indb 12 2013 12 23 11 50 52...

Page 27: ...nd functions of Ultrasonic Endoscope parts as well as the composition of the main body 3 1 Ultrasonic Endoscope 3 2 3 2 Distal End of Ultrasonic Endoscope 3 5 3 3 Ultrasonic Image 3 6 3 4 Balloon Inst...

Page 28: ...Allows suction through forceps outlet in distal end of Ultrasonic Endoscope Ventilation connector Connects to the airtight tester or ventilation adapter Control portion Provides a grip for holding th...

Page 29: ...portion Distal end Contains US head objective lens light guide forceps outlet etc Suction are controlled by buttons on the control portion Index mark Indication of installing direction Insertion port...

Page 30: ...acture LG connector Serial number LG connector CE marking LG connector WEEE marking US connector Consult accompanying documents US connector Degree of waterproof LG connector Super CCD model LG connec...

Page 31: ...er feed outlet Feeds water from the balloon water feed channel Discharges water from the balloon Balloon installation grooves Attaches a balloon ring Small Transducer This is the element that transmit...

Page 32: ...re needle Note The puncture guiding line is only meant as a guide Check the actual needle position on the ultrasonic image For details refer to the operation manual of the ultrasonic processor Balloon...

Page 33: ...tion value etc This chapter describes the operations and functions of these parts 4 1 How to Operate Bending Mechanism 4 2 4 2 Suction Valve Forceps Inlet and Water Feed Inlet 4 3 4 3 Remote Operating...

Page 34: ...ted toward A side the bending portion is bent upward A direction When the angle lever is slanted toward B side the bending portion is bent downward B direction U D U D B side A side A direction B dire...

Page 35: ...rceps valve is attached 4 Balloon Water Feed Inlet Feeds discharges water to from a balloon when the balloon is attached 5 Balloon Water Feed Inlet Cap Fit this on the balloon water feed channel to pr...

Page 36: ...ed 7 Freeze Switch This is the remote switch for still image and the capture The screen image is frozen while this button is being pushed Image freezing is canceled a few seconds after it is released...

Page 37: ...ak or flowback of air 8 Valve Body The valve body is a part that reduces the leakage or backflow of air when an accessory is used 9 Lid The lid functions as a valve for preventing the leak or backflow...

Page 38: ...n is depressed 11 Suction Connector Portion Suction tube connected with the suction unit is connected to this potion Method of attaching suction button Set the direction of the suction connector porti...

Page 39: ...trasonic Endoscope 5 11 5 5 1 Inspecting Insertion Portion 5 11 5 5 2 Inspecting Bending Mechanism 5 12 5 5 3 Inspecting Suction Water Feed and Forceps Channel 5 13 5 5 4 Inspection of Distal End of U...

Page 40: ...quipment 5555 Move the cart with the processor to the place where the Ultrasonic Endoscope is to be used After turning the main switch on the cart to the OFF position plug the power cord from the cart...

Page 41: ...le on the suction unit Prepare an electrosurgical instrument and the applicable Endoscope for unexpected bleeding Chapter 5 Preparation for Use of Ultrasonic Endoscope 5 3 EB530US_E2_202B1237458F indb...

Page 42: ...sing the ultrasonic cleaning unit Pull the button out from the cleaning fluid and rinse with running water clean water Wipe off the remaining water on the button with dry sterile gauze Seal the button...

Page 43: ...oft toothbrush Clean the forceps valve using the ultrasonic cleaning unit Pull out the forceps valve from the cleaning fluid and rinse off with running water clean water Wipe off the remaining water o...

Page 44: ...Appendix Chemicals and Conditions attached to the cleaning disinfection and storage section Pull out the forceps valve from the disinfectant and rinse it with running water sterile water Wipe off the...

Page 45: ...or VP 4450HD and XL 4450 Insert the LG connector of the Ultrasonic Endoscope into the Endoscope socket on the light source Insert the video connector of the Ultrasonic Endoscope into the video connect...

Page 46: ...it to the index position and pull out the entire equipment Connect the suction tube between the suction unit and suction connector portion of the Ultrasonic Endoscope Note Firmly connect the suction...

Page 47: ...stem connector socket on the processor Attach the suction button Use the level of disinfection of sterilization suitable to the application before using the forceps valve and suction button Set the di...

Page 48: ...in damage to the mucous membrane Set the suction pressure to 40 to 53 kPa Place the US connector on the top surface of the ultrasonic processor connector cover and then press down the connector cover...

Page 49: ...the flexible portion with both hands and allow it to go over its full length in such a way that the apex of the semicircle with a diameter of about 200 mm gradually begins to slide Check that the port...

Page 50: ...ward until it stops Check that the bending portion moves smoothly Check that when the angle lever is released in bent state the bending portion unbends a little Chapter 5 Preparation for Use of Ultras...

Page 51: ...water ready Put a forceps valve in forceps inlet Dip the distal end of the Ultrasonic Endoscope in water and check that depressing the suction button sucks in water and that releasing it stops suction...

Page 52: ...e to feed water from the balloon water feed inlet and then check if water is discharged from the balloon water feed outlet at the distal end of Ultrasonic Endoscope Note The syringe can be attached to...

Page 53: ...rasonic processor or STANDBY key on the left hand side of the keyboard Check to confirm by touching with a finger that the transducer of the distal end of Ultrasonic Endoscope is not hot Visually chec...

Page 54: ...may be degraded Turn OFF the lamp Look at the distal end of the Ultrasonic Endoscope at an angle and check that the objective lens is free of dirt or foreign matter It checks that there are no scratc...

Page 55: ...c Endoscope is not sufficiently airtight Run an airtightness test with an airtightness tester LT 7 7 4 1 Airtightness Test Inspecting Ultrasonic Image 555555 Have a glass of water ready Dip the distal...

Page 56: ...XL 4400 or VP 4450HD and XL 4450 Press the key on the keyboard of the ultrasonic processor to freeze the ultrasonic image Turn OFF the power switch of the processor and the light source Remove the su...

Page 57: ...e lock handle and dismount the US connector from the ultrasonic processor Combination with the EPX 2500 system Press the key on the keyboard of the ultrasonic processor to freeze the ultrasonic image...

Page 58: ...r from the processor Remove the LG connector from the processor Turn off the power supply of the ultrasonic processor Loosen the lock handle and dismount the US connector from the ultrasonic processor...

Page 59: ...lloon manually by using a syringe Do not use any other instrument than syringe Note The syringe can be attached to the balloon water feed channel via an extension tube Note If the syringe is not conne...

Page 60: ...n ring and fit the balloon over the distal end of the Ultrasonic Endoscope Note Saturating the balloon and the distal end of the Ultrasonic Endoscope with sterile water beforehand facilitates the atta...

Page 61: ...n water feed channel to discharge air from the balloon If air is not easily discharged from the balloon press the balloon with your fingers while feeding water to discharge air completely Attach the b...

Page 62: ...lloon is inflated Also check that there is no leakage of sterile water air entering into the balloon or distortion of the balloon Suck out the sterile water and check that the balloon shrinks Chapter...

Page 63: ...e is a risk of bleeding or wrong puncturing Check to confirm the expiry date of the puncture needle Do not use any expired puncture needle Inspect in accordance with the operation manual for the punct...

Page 64: ...ually check the forceps for breakage or significant bends and for sharp edges on protrusions that may injure the patient Form the spring of the forceps into a ring approximately 200 mm in diameter Ope...

Page 65: ...nd Observation 6 3 6 3 How to Use Balloon 6 8 6 4 Biopsy 6 9 6 5 Puncture 6 12 6 6 Pulling Out Ultrasonic Endoscope 6 16 6 7 Pre Cleaning performed at bedside immediately after use of Ultrasonic Endos...

Page 66: ...njury as well as damage to the instrument Do not advance or angulate the Ultrasonic Endoscope without obtaining a clear endoscopic view on the monitor Preparation 6666 Preparing Necessary Equipment 66...

Page 67: ...Do not insert the Ultrasonic Endoscope through the nose There is a risk of bleeding Do not allow the distal end to touch the same part for 5 minutes or more Energy of illumination may burn Do not look...

Page 68: ...angulate the Ultrasonic Endoscope while it is within the endotracheal tube Do not use if either Ultrasonic Endoscope or endotracheal tube is damaged or compromised Note In cases where the amount of bl...

Page 69: ...Note Before using a balloon always apply Xylocaine jelly to the balloon Note Do not apply Xylocaine spray or olive oil directly to the insertion portion Note Do not forcibly twist or bend too sharply...

Page 70: ...he brightness by operating the brightness control button on the light source unit Turn the angle lever to direct the distal end of the Ultrasonic Endoscope to the area to be observed Note In case that...

Page 71: ...not suck in solid or viscous materials with the Ultrasonic Endoscope Such material may clog the suction pipe line or stick to the suction button preventing proper stopping of suction To perform spray...

Page 72: ...e water flow rate to the balloon CAUTION Do not feed more than 1 mL of water into the balloon There is a risk of aspiration Note If more than 1 mL of water is fed into the balloon water may leak from...

Page 73: ...you cannot see the forceps outlet on the endoscopic image It may cause perforation or bleeding CAUTION Do not push the forceps forcefully when having in difficulty in insertion It may damage Ultrason...

Page 74: ...ps inlet by observing the image Note When inserting forceps be sure to slowly insert it straight into the slit of the forceps valve Note Keep the lid of the forceps valve closed When the distal end of...

Page 75: ...ngle lever and letting the forceps in and out Pull out the forceps slowly and take out the biopsy specimen Note When pulling out the forceps be sure to slowly pull it straight out from the slit of the...

Page 76: ...he sheath of the puncture needle not protruding from the forceps outlet at the distal end Do not insert the puncture needle in to the Ultrasonic Endoscope with the needle protruding from the sheath Th...

Page 77: ...l end of Ultrasonic Endoscope near the puncturing point If a balloon is used contract it until it is small but not touching the puncture needle by observing the endoscope image Observe the target lesi...

Page 78: ...confirm that there are no blood vessels nearby Unbend the bending portion until it is almost straight by operating the angle lever Insert the puncture needle into the Ultrasonic Endoscope Attach the...

Page 79: ...s only meant as a guide Check the actual part to be punctured on the ultrasonic image After completing the puncture store the needle in the sheath and pull out the puncture needle Eject the biopsy spe...

Page 80: ...a balloon is used contract it fully Unbend the bending portion until it is almost straight by operating the angle lever Pull the Ultrasonic Endoscope out slowly Chapter 6 Method of Use 6 16 EB530US_E2...

Page 81: ...lean suction channel Put distal end of Ultrasonic Endoscope in cleaning fluid and depress suction button to suck in cleaning fluid for 10 seconds Keeping suction button depressed pull distal end of Ul...

Page 82: ...hands immediately after use of the Endoscope may cause a burn injury Combination with the VP 4400 and XL 4400 or VP 4450HD and XL 4450 Turn OFF the power switch of the processor and the light source...

Page 83: ...system Loosen the lock handle and dismount the US connector from the diagnostic ultrasound system Combination with the EPX 2500 system Turn OFF the power switch of the processor Remove the suction tub...

Page 84: ...balloon ring Big from the balloon installation groove Roll the balloon slowly toward the distal end of the Ultrasonic Endoscope to remove Note Do not pinch the transducer with your fingers Note If the...

Page 85: ...function Before cleaning attach the waterproof cap to the EVE connector so that water do not reach the contacts Waterproofing US Connector 666666 Mount the US waterproof cap to the US connector Lock t...

Page 86: ...Chapter 6 Method of Use 6 22 EB530US_E2_202B1237458F indb 22 2013 12 23 11 51 06...

Page 87: ...0 system Appendix 8 Troubleshooting Combination with EPX 2500 system Appendix 12 After Sales Service Appendix 16 Disposal of Electric and Electronic Equipment Appendix 17 Index Appendix 18 Service Cen...

Page 88: ...500 and ultrasonic processor SU 7000 Applied Part Insertion portion Data about Main Unit Endoscopic functions Viewing direction 10 Observation range 3 to 100 mm Field of view 120 Distal end diameter 6...

Page 89: ...and inspection are performed Based on self certification data of our company Applicable Processor and Light Source Ultrasonic processor SU 8000 SU 7000 Processor VP 4450HD Note VP 4400 Ver1 1993 Late...

Page 90: ...3 mm Note 5 9 mm Note 1 1 mm Note 2 mm Note 1 0 mL Single use Sterilized Note When no force is applied Image Size Direction of Forceps Medical Device Directive This product complies with the requirem...

Page 91: ...romagnetic interference may occur on any equipments In this case it is recommended to use this product according to the page 1 3 Chapter 1 Safety Harmonic emissions EN 61000 3 2 Class A Voltage fluctu...

Page 92: ...quality should be that of a typical commercial or hospital Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 11 5V 218 5V dip For 0 5 cycle 92V 138V dip...

Page 93: ...ith the requirements of EN 60601 1 2 2007 However electromagnetic interference may occur on this product under electromagnetic environment that exceeds its noise level Electromagnetic interference may...

Page 94: ...PEAK VP 4400 5 7 Switching the Iris Modes VP 4450HD 5 12 Switching the Metering Mode An image disappears during examination 1 The connection with the scope processor and light source is incomplete 2...

Page 95: ...en damaged 2 The forceps valve has been degraded 3 The suction tube is not attached properly 4 The forceps valve is not attached properly Replace with a new suction button Replace with a new forceps v...

Page 96: ...on closing it If it cannot be closed for some reason return the end of the treatment equipment to the forceps outlet of the Ultrasonic Endoscope and then slowly pull out the Ultrasonic Endoscope and t...

Page 97: ...mage is not recovered turn the ultrasonic processor off and then pull out the endoscope slowly The ultrasonic image is dark 1 The gain level is close to the minimum value 2 The STC level is close to t...

Page 98: ...brightness level to near the center of the indicator EPX 2500 5 6 Adjusting the Brightness An image disappears during examination 1 The connection with the scope and processor is incomplete 2 The sys...

Page 99: ...raded 3 The suction tube is not attached properly 4 The forceps valve is not attached properly Replace with a new suction button Replace with a new forceps valve Reattach the suction tube Reattach the...

Page 100: ...on closing it If it cannot be closed for some reason return the end of the treatment equipment to the forceps outlet of the Ultrasonic Endoscope and then slowly pull out the Ultrasonic Endoscope and t...

Page 101: ...e is not recovered turn the ultrasonic processor off and then pull out the endoscope slowly The ultrasonic image is dark 1 The gain level is close to the minimum value 2 The STC level is close to the...

Page 102: ...ses a Damage caused by fire or natural disaster such as storms or floods b Troubles caused by careless handling or misuse of the product on the part of the user c Troubles caused by repair or modifica...

Page 103: ...and electronic equipment By ensuring this product is disposed of correctly you will help prevent potential negative consequences to the environment and human health which could otherwise be caused by...

Page 104: ...orceps valve 2 2 4 3 4 5 Freeze switch 4 4 G Gas sterilization 9 2 I Insertion portion 3 3 L LG connector 3 3 LG flexible portion 3 2 M Maintenance 1 3 Monitor 2 5 2 7 Mouthpiece 6 4 O Operating envir...

Page 105: ...ur country USA FUJIFILM Medical Systems U S A Inc http www fujifilmendoscopy com 800 385 4666 Australia FUJIFILM Australia Pty Ltd http www fujifilm com au 1800 060 209 Asia FUJIFILM Singapore Pte Ltd...

Page 106: ...Appendix 20 Appendix EB530US_E2_202B1237458F indb 20 2013 12 23 11 51 09...

Page 107: ...Appendix 21 Appendix EB530US_E2_202B1237458F indb 21 2013 12 23 11 51 09...

Page 108: ...225 7 0 DT E2 Printed in Japan FUJIFILM Europe GmbH Heesenstrasse 31 40549 Duesseldorf Germany FUJIFILM Corporation 26 30 Nishiazabu 2 chome Minato ku Tokyo 106 8620 Japan EB530US_E2_202B1237458F indb...

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