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202B1262871D

1.5.2 Symbols

Symbol

Description

Do not re-use /
Single patient use only

Use by date / Expiration date of use

Lot number

Serial number

Date of manufacture

Manufacturer

Authorised representative in the European Community

Consult instructions for use

Temperature limitation

Keep dry

Non-sterile

CE marking

Degree of waterproof

Type BF applied part

WEEE marking

[Note 1]

Phthalates marking

[Note 2]

Humidity limitation

Chapter 1 Precautions

EG580UR_E2-50_202B1262871D.indb 24

2016/07/04 16:06:48

Содержание EG-580UR

Страница 1: ...doscope and cautions to be observed when operating it Please read this manual thoroughly before actually operating the ultrasonic endoscope After reading this manual store it nearby the ultrasonic end...

Страница 2: ...202B1262871D 2 EG580UR_E2 50_202B1262871D indb 2 2016 07 04 16 06 45...

Страница 3: ...precautions and the cleaning disinfection and storage methods for the ultrasonic endoscope If you are a first time user of this product be sure to read this manual before actual operation Also after...

Страница 4: ...nctions and damages resulting from negligence of the precautions and operating methods contained in this manual 7 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from u...

Страница 5: ...doscopes EG 580UT and EG 580UR Reprocessing Manual as Reprocessing Manual How to Read This Manual Conventions Used in This Manual This manual uses the following conventions for easier understanding Ge...

Страница 6: ...tem configuration Chapter 3 Preparation and Inspection Before Use This chapter describes the inspection and preparation methods to be performed for using the ultrasonic endoscope Chapter 4 Method of U...

Страница 7: ...ossible Combinations for Use 26 1 6 1 Accessories 26 1 6 2 Compatible Processor Light Source and Ultrasonic Processor 26 1 6 3 Peripheral Devices 26 1 7 Cautions Warnings 27 1 7 1 Abnormalities during...

Страница 8: ...e Ultrasonic Endoscope Processor Light Source Water Tank and Suction Unit 54 3 6 Inspecting Ultrasonic Endoscope 56 3 6 1 Inspecting the Insertion Portion 56 3 6 2 Inspecting the Bending Mechanism 57...

Страница 9: ...Troubleshooting 85 5 1 Troubleshooting 85 Main Specification 93 Service 100 Disposal of Electric and Electronic Equipment 101 Index 102 Service Centers 103 9 Contents EG580UR_E2 50_202B1262871D indb...

Страница 10: ...performing observation diagnosis and endoscopic treatment of small intestine refer to general contraindications to upper gastrointestinal tract endoscopy and colonoscopy In addition if the general co...

Страница 11: ...against electric shock Type BF applied part 3 Degree of explosion protection Use is prohibited in an oxygen rich environment or in a flammable gas atmosphere 4 Degree of waterproof IEC 60529 IPX7 with...

Страница 12: ...zation to protect your eye and skin and to prevent infection When using this product for a patient with Creutzfeldt Jakob disease especially variant Creutzfeldt Jakob disease use it exclusively for a...

Страница 13: ...is a risk of infection During ultrasonic procedures in which a balloon is not used do not fully depress the suction valve and do not attempt to aspirate patient material into through the balloon evacu...

Страница 14: ...infection Use a cleaned and disinfected or sterilized air water valve and suction valve An inadequately cleaned and disinfected or sterilized valve may pose an infection risk Use a cleaned and disinf...

Страница 15: ...how to operate the electrosurgical instrument Connect the electrosurgical instruments and electrosurgical generators in accordance with each operation manual Incorrect connection may cause electric sh...

Страница 16: ...oves when using an electrosurgical instrument or accessory If not worn there is a risk of thermal injury or electric shock Always keep pacemaker users away from electrosurgical instruments The operati...

Страница 17: ...osurgical instruments Doing so may cause thermal injury Operate the instruments within specified output range as per the device s operating instructions Leakage current may cause thermal injury Perfor...

Страница 18: ...lation of the balloon Do not use a balloon on patients allergic to latex There is a risk of an anaphylactic reaction Do not supply an excessive amount of air or gas during the procedure as doing so co...

Страница 19: ...ended period of time Use the ultrasonic endoscope with a minimum necessary amount of brightness and time while maintaining an appropriate distance When the shutter speed is set to HIGH take care not t...

Страница 20: ...ion pressure between 40 and 53 kPa If the suction pressure is too high the ultrasonic endoscope may adhere to mucous membrane resulting in damage to the mucous membrane Do not look directly into the l...

Страница 21: ...vices that can be determined by turning the processor off and on we recommend that you may try to correct the interference by one or more of the following measures Change the orientation or position o...

Страница 22: ...elow The relevant safety signs are also described 1 5 1 Location of Labels Control Portion Model Label Instrument Channel Diameter Label LG Connector LG Connector Label Label for the Serial Number Lab...

Страница 23: ...202B1262871D US Connector Caution Label 23 Chapter 1 Precautions EG580UR_E2 50_202B1262871D indb 23 2016 07 04 16 06 46...

Страница 24: ...f manufacture Manufacturer Authorised representative in the European Community Consult instructions for use Temperature limitation Keep dry Non sterile CE marking Degree of waterproof Type BF applied...

Страница 25: ...e for autoclave Note 1 This product shall not be treated as household waste Note 2 This symbol indicates that this specific type of medical device contains dibutyl phthalate DBP But the device has lit...

Страница 26: ...cessories refer to each operation manual of accessories 1 6 2 Compatible Processor Light Source and Ultrasonic Processor This product is used in combination with the VP 4450HD processor XL 4450 light...

Страница 27: ...e monitor Not doing so may cause damage to both the ultrasonic endoscope and body cavities of the patient Wear personal protective equipment when handling an ultrasonic endoscope to prevent infection...

Страница 28: ...re reusable devices subject to routine wear and tear Many factors can contribute to the reuse life of any instrument Besides clinical use routine handling as well as repeated cleaning and disinfection...

Страница 29: ...he light source Using the ALC Automatic Light Control mode is recommended Refer to the manual of the light source for the ALC mode When this product projects light at the maximum brightness for 2 3 mi...

Страница 30: ...ote Figures in parentheses indicate the number of articles Forceps Valve FOV DV7 10 Manuals Operation Manual 1 Reprocessing Manual 1 Carrying Case 1 Waterproof Cap 1 Air Water Valve AW 602 1 Suction V...

Страница 31: ...003FW 1 Ventilation Adapter AD 7 1 Cleaning Adapter CA 608 1 Injection Tube WA 007 Channel Plug WA 008 Air Water Channel Cleaning Adapter CA 609 1 US Waterproof Cap WA 7000 1 Chapter 2 Product Overvie...

Страница 32: ...treatment Recording video images Printing still images Ultrasonic Endoscope EG 580UR Data Keyboard DK 4450E Processor VP 4450HD Cart Water Tank WT 4 WT 2 Light Source XL 4450 Ultrasonic Processor SU 1...

Страница 33: ...DIANCE24 NDS Electrosurgical Unit Note 1 ICC 200 ERBE Note 1 For details refer to the manual of the electrosurgical instrument Keyboard CP 1 Foot Switch FS1 Monitor CDL1909A CDL1576A RADIANCE24 NDS Pr...

Страница 34: ...to the ultrasonic processor LG Flexible Portion Contains the light guide air water tube suction tube and cables LG Connector Connects to the light source Air Supply Tube Supplies air from the pump of...

Страница 35: ...lid It performs the function of preventing leak or backflow of air Instrument Channel Inlet Inlet for passing forceps or endotherapy device through the instrument channel The forceps valve is attache...

Страница 36: ...with the air water valve operation Transducer This portion transmits and receives ultrasonic waves Balloon Attachment Grooves This portion is used to attach the balloon ring Imaging Section Inside Li...

Страница 37: ...prevents leak or backflow of air when an endoscopic accessory such as an endotherapy device is used Lid This portion functions as a valve for preventing the leak or backflow of air How to Use the For...

Страница 38: ...d to this connector to feed air or fluid to the air water channel of the ultrasonic endoscope Tube for Instrument Suction Channel Connects to the suction channel Air Supply Tube Port Connects to the a...

Страница 39: ...the ultrasonic endoscope or to the instrument channel inlet cleaning adapter Instrument Channel Inlet Cleaning Adapter Connects to the instrument channel inlet of the ultrasonic endoscope with the ins...

Страница 40: ...failure The bending section is operated by using up down left right angulation knobs Up down Angulation Knob Turn the up down angulation knob in the direction of U to angulate the bending section upw...

Страница 41: ...ion knob in the direction of L to angulate the bending section to the left Turn it in the direction of R to angulate the bending section to the right R L R L Chapter 2 Product Overview 41 202B1262871D...

Страница 42: ...operated either before or after operating the bending section Note When operating the bending section while the angle is locked angulation knob rotation becomes heavy Up down Angulation Lock Move the...

Страница 43: ...Free unlock Allows external force to angulate the bending section freely Rotate the knob in the direction opposite to F to lock the bending section Note Lock Maintains the angle of the bending sectio...

Страница 44: ...is pressed halfway the water is supplied When the air water valve is fully pressed water is supplied to the balloon Stopping the hole with a finger Half press Full press Suction valve Suctions water...

Страница 45: ...ch For details see the operation manual of the processor Scope Switch 4 Scope Switch 5 Scope Switch 3 Scope Switch 2 Scope Switch 1 For details see the operation manual of the processor Chapter 2 Prod...

Страница 46: ...e of the ultrasonic image Note The ultrasonic image is a radial image extending from the point approximately 10 mm ahead of the distal end of the ultrasonic endoscope For details refer to the operatio...

Страница 47: ...an create a risk of infection to patients and or end users Be sure to inspect the forceps valve before attachment If any abnormality is found during inspection do not use the product It could be a sou...

Страница 48: ...he cap a and hole in the main body b of the forceps valve are free from abnormalities such as tears cracks discoloration etc 2 Attach the lid to the main body of the forceps valve 3 1 3 Attaching the...

Страница 49: ...infected or sterilized air water valve and suction valve 3 2 1 Inspecting the Air Water Valve and Suction Valve Visually check that the valves are free from abnormalities such as foreign substances ad...

Страница 50: ...s air water valve cylinder and push in the valve firmly Note The air water valve and the air water valve cylinder have a blue mark 2 Attach the suction valve to the ultrasonic endoscope s suction valv...

Страница 51: ...eparing Peripheral Devices For details on preparation and inspection of peripheral devices refer to their manuals Chapter 3 Preparation and Inspection Before Use 51 EG580UR_E2 50_202B1262871D indb 51...

Страница 52: ...a risk of infection 3 4 1 Preparing the System 1 Move the cart with the processor light source ultrasonic processor and peripherals to the place where ultrasonic endoscope is to be used Note Refer to...

Страница 53: ...t daily using sterile water Note When using the balloon the sterile water in the water tank must be deaerated Note Use a cleaned and disinfected or sterilized water tank 5 As a precaution in case of u...

Страница 54: ...is no dirt on the light incident distal face and no cracks on the glass of the light incident distal face 2 Insert the LG connector of the ultrasonic endoscope into the ultrasonic endoscope socket on...

Страница 55: ...between the suction unit and suction connector of the ultrasonic endoscope 7 Turn on the suction unit and then set the suction pressure of suction source between 40 and 53 kPa 8 Check that the US conn...

Страница 56: ...ith both hands to make a semicircle with a diameter of approximately 200 mm referring to the figure at right Then move the apex of semicircle sliding insertion tube for full length Check that the tube...

Страница 57: ...turns smoothly When the angulation knob is released the bending section should move toward its neutral position 3 Turn the up down and left right angulation locks in the direction opposite to F and t...

Страница 58: ...t may splash 4 With the distal end of the ultrasonic endoscope held in the air press the air water valve completely Check that water is discharged from the balloon water port Note Mind the direction i...

Страница 59: ...nd check that the water is sucked in from the balloon water port and suction stops when the finger is released from the valve Note If little or no sterile water is aspirated refer to Chapter 5 Trouble...

Страница 60: ...into the light coming from the light guide at the distal end of the ultrasonic endoscope Turn off the lamp before inspecting the objective lens Viewing the light from the light guide directly may dama...

Страница 61: ...and check that it is not heated 4 Visually check the transducer the US connector and the cables for abnormalities such as cracks or dents etc Chapter 3 Preparation and Inspection Before Use 61 EG580U...

Страница 62: ...ee from cracks and crushes and is securely fixed The side surface of the distal end is free from scratches peeling and abnormal bulging Note If the distal adhesives are missing peeling deteriorated or...

Страница 63: ...wiping does not remove cloudiness from objective lens it is possible that ultrasonic endoscope is not sufficiently watertight Perform air tightness test Reprocessing Manual 4 6 Air Tightness Test 8 W...

Страница 64: ...ndoscope into water 2 Press the FREEZE key on the keyboard of the ultrasonic processor to cancel the freeze mode 3 Check that an ultrasonic image appears 4 Check that the ultrasonic image is displayed...

Страница 65: ...e is a risk of an anaphylactic reaction CAUTION Do not feed more than 5 ml of water into the balloon There is a risk of rupturing the balloon Note It takes approximately 3 seconds to feed in 5 ml of w...

Страница 66: ...le water 4 Hold the balloon ring with your fingers and put it around the balloon attachment tool 5 Insert the distal end of the ultrasonic endoscope into the balloon attachment tool until the balloon...

Страница 67: ...the amount of water to be fed before use Note Check that there is no water leak from the balloon 8 Press the suction valve fully to suck out all sterile water inside of the balloon Note If water cann...

Страница 68: ...Press the suction valve fully and check that all of the sterile water is sucked out and the balloon shrinks Chapter 3 Preparation and Inspection Before Use 68 EG580UR_E2 50_202B1262871D indb 68 2016...

Страница 69: ...o could cause an embolism Do not overinsufflate during any clinical procedure to minimize the potential for pneumatic perforation Note Always observe the patient closely If the patient has symptoms su...

Страница 70: ...dotherapy devices etc to be used and a spare forceps valve as well Note Use a cleaned and disinfected or sterilized mouthpiece only 4 1 2 Pretreatment of Patient Prepare the patient in the normal endo...

Страница 71: ...nic endoscope into the oral cavity Otherwise it may cause pain to the patient Do not forcibly advance or withdraw the ultrasonic endoscope into from the patient It may cause damage to the body lumen b...

Страница 72: ...asonic endoscope may be coagulated by the energy of illumination For details on how to use the light save function refer to the operation manual of light source Note If any steam like smoke appears in...

Страница 73: ...a patient to lie on examining table in a proper position according to endoscopy procedures 2 Unlock the bending section by turning the up down and left right angulation locks in the direction of F unt...

Страница 74: ...he like directly to the insertion portion 5 Press the Lamp button on the light source to turn on the lamp Note If the light source is off press the power button to turn it on 6 Insert the distal end o...

Страница 75: ...w the ultrasonic endoscope forcibly Note In case that the bending section does not return or cannot be pulled out easily because it is inverted inside the narrow lumen do not pull it out forcibly 9 In...

Страница 76: ...r complete clog of the narrow balloon evacuation channel especially if the ultrasonic endoscope is not cleaned immediately after each procedure and if not reprocessed as per FUJIFILM recommendations 4...

Страница 77: ...Note It takes approximately 3 seconds to feed in 5 ml of water Check the amount of water to be fed before use Note Check the endoscopic and ultrasonic images while injecting discharging water into fro...

Страница 78: ...nd Note If the balloon does not deflate while depressing the suction valve fully remove clogs in the balloon channel using the cleaning brush WB2221FW2 Reprocessing Manual 4 9 4 Brushing the Balloon C...

Страница 79: ...ully when encountering difficulty during insertion There is a risk of damaging the ultrasonic endoscope Note The forceps may not pass through the bending section smoothly In such a case slightly unben...

Страница 80: ...field of view 4 Slowly move the forceps to the biopsy site 5 Perform a biopsy by controlling the forceps and the angulation knobs 6 Pull out the forceps slowly and take out the biopsy speci men Chapt...

Страница 81: ...ched deflate it completely Note If the balloon does not deflate while depressing the suction valve fully remove clogs in the balloon channel using the cleaning brush WB2221FW2 Reprocessing Manual 4 9...

Страница 82: ...02B1262871D 5 Slowly pull out the ultrasonic endoscope 6 Press the Lamp button on the light source to turn off the lamp Chapter 4 Method of Use 82 EG580UR_E2 50_202B1262871D indb 82 2016 07 04 16 07 0...

Страница 83: ...2 Roll the balloon slowly toward the distal end of the ultra sonic endoscope to remove Note Do not pinch the transducer with your fingers Note If the balloon is too slippery to be held cover the ballo...

Страница 84: ...after use of the ultrasonic endoscope The ultrasonic endoscope is removed after pre cleaning Note For details on pre cleaning and removal of the ultrasonic endoscope refer to the Reprocessing Manual...

Страница 85: ...e bending section to unlock release the angulation knobs and then withdraw the ultrasonic endoscope slowly from the patient 2 Reconnect the ultrasonic endoscope 3 5 Connecting Ultrasonic Endoscope 3 S...

Страница 86: ...aighten the bending section to unlock release the angulation knobs and then withdraw the ultrasonic endoscope slowly from the patient 2 Reconnect the ultrasonic endoscope 3 5 Connecting Ultrasonic End...

Страница 87: ...charge 3 The video signal cable has shorted out or broken 1 2 3 If the problem occurred during treatment stop treatment and remove the endotherapy device from the ultrasonic endoscope Then reset Note...

Страница 88: ...the angulation knobs and then withdraw the ultrasonic endoscope slowly from the patient No air and or water delivery 1 Pump is switched off 2 Abnormality in the air water button 3 The air water butto...

Страница 89: ...on valve cannot be removed The suction valve or the control portion of the ultrasonic endoscope has been damaged Contact your local FUJIFILM dealer The volume of water supplied to or discharged from t...

Страница 90: ...he grip and pull out the endotherapy device from the ultrasonic endoscope 3 Reduce the angle of the bending section slightly and then pull out the endotherapy device from the ultrasonic endoscope 4 Wi...

Страница 91: ...ices 2 Turn the power switches ON 3 Increase the amount of water fed to the balloon or adjust the angle of the transducer by operating it so that it comes in close contact with the wall of gastrointes...

Страница 92: ...he US connector is poorly connected 1 Stop power supply to the diathermic treatment equipment to restore image output The ultrasonic endoscope is working properly 2 Redo the scope connection 3 5 Conne...

Страница 93: ...t Main Unit Endoscopic functions Model EG 580UR Viewing direction 0 Observation range 3 to 100 mm Field of view 140 Distal end diameter 11 4 mm Maximum diameter of insertion portion 12 7 mm Insertion...

Страница 94: ...mode Spatial peak temporal average intensity Ispta 720 mW cm 2 assuming the attenuation coefficient of 0 3 dB cm 1 MHz 1 Mechanical Index MI 1 0 or less Frequency 5 MHz 7 5 MHz 10 MHz 12 MHz Operatin...

Страница 95: ...any deterioration or abnormality is found in accessories they need to be replaced Accessories cannot be repaired or refurbished Thus if any abnormality is found replace with a new one Consumable Supp...

Страница 96: ...tube BF2418SF BF2418FN BF3018FN BF2418LN BF2218A GF2318T GF2418V GF2318B DS2323M DS2323H DC1818R DC2318S WT1720ST Note For combination with accessories other than those above contact your local FUJIFI...

Страница 97: ...very low and are not likely to cause any interference in nearby electric equipment Radiated emissions EN 55011 Class A This product is intended for use in medical facilities and commercial facilities...

Страница 98: ...wer 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...

Страница 99: ...with 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 ma...

Страница 100: ...s product will be repaired free of charge within warranty guidelines The warranty period for the ultrasonic endoscope excluding accessories is one year after date of purchase Note that the warranty is...

Страница 101: ...ectronic 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 inappr...

Страница 102: ...ht angulation knob 35 Left right angulation lock 35 LG connector 34 LG connector label 22 Light guide rod 34 M Monitor 33 P Precautions 10 Preparation 47 Printer 33 S S connector 34 Storage environmen...

Страница 103: ...in your 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 Pt...

Страница 104: ...5 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 EG580UR_E2 50_202B1262871D indb...

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