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202B1262575D

1.7 Cautions/Warnings

Observe the following cautions when handling this product. Also, there are same
cautions in each chapter.

CAUTION

Do not use the ultrasonic endoscope if it has failed its pre-inspection
check. Doing so can negatively affect the functionality of the instrument
or increase risks to patient safety.

Ultrasonic endoscope is a precision instrument. Unnatural force or
impact on the insertion portion, bending section, control portion or
connector may injure the inside of the patient as well as damage the
instrument. If you encounter any resistance, insert it slowly. Do not
force it in. Do not insert or bend the ultrasonic endoscope without
securing the view on the monitor. Not doing so may cause damage to
both the ultrasonic endoscope and body cavities of the patient.

As the front field of view of this product is at an angle, the view direction

and the insertion direction are different. Thoroughly understand this

characteristic, and always take it into consideration before and while

using the equipment.
Wear personal protective equipment when handling an ultrasonic
endoscope to prevent infection and static charges. When holding
ultrasonic endoscope, hold it by the control portion. Handling it up by

the insertion portion or LG flexible portion is difficult to hold and may

exert an unnatural force, resulting in instrument failure.

1.7.1 Abnormalities during Use of This Product

WARNING

If any abnormality is noticed during use, carry out safety checks and
discontinue use immediately.

If any abnormality occurs with this product, refer to “Chapter 5
Troubleshooting”. Should any questions arise regarding information
contained in the operation manuals or any safety concerns, contact
your local FUJIFILM dealer.

27

Chapter 1 Precautions

EG580UT_E2-50_202B1262575D.indb 27

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Содержание EG-580UT

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: ...202B1262575D 2 EG580UT_E2 50_202B1262575D indb 2 2016 07 05 9 28 35...

Страница 3: ...s 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: ...unctions 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...

Страница 5: ...ndoscope EG 580UT Reprocessing Manual as Reprocessing Manual How to Read This Manual Conventions Used in This Manual This manual uses the following conventions for easier understanding General Convent...

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: ...em 54 3 5 Connecting Ultrasonic Endoscope Attachment 56 3 5 1 Connecting the Ultrasonic Endoscope Processor Light Source Water Tank and Suction Unit 56 3 6 Inspecting Ultrasonic Endoscope 58 3 6 1 Ins...

Страница 9: ...88 4 7 Removing Balloon 90 4 8 Pre cleaning Primary Cleaning 91 Chapter 5 Troubleshooting 92 5 1 Troubleshooting 92 Main Specification 100 Service 108 Disposal of Electric and Electronic Equipment 109...

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: ...ization 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: ...sed do not fully depress the suction valve and do not attempt to aspirate patient material into through the balloon evacuation channel Doing so can result in partial or complete clog of the narrow bal...

Страница 14: ...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 disinfected or sterilized puncture needle An in...

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 s...

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: ...rosurgical 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 Perfo...

Страница 18: ...the puncture guiding lines puncturing poses a risk of damaging the internal organs due to respiratory displacement or tumors are highly likely to disseminate Doing so may cause bleeding Do not use an...

Страница 19: ...e inserting or moving the ultrasonic endoscope be sure to lower the forceps stand If the force stand remains raised there is a risk of damaging the inside of the body cavity Do not angulate the bendin...

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: ...evices 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...

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: ...202B1262575D US Connector Caution Label 23 Chapter 1 Precautions EG580UT_E2 50_202B1262575D indb 23 2016 07 05 9 28 36...

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: ...le 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 li...

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: ...t field of view of this product is at an angle the view direction and the insertion direction are different Thoroughly understand this characteristic and always take it into consideration before and w...

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: ...the 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 m...

Страница 30: ...ote Figures in parentheses indicate the number of articles Forceps Valve FOV LL2 10 Manuals Operation Manual 1 Reprocessing Manual 1 Carrying Case 1 Waterproof Cap 1 Air Water Valve AW 602 1 Suction V...

Страница 31: ...lation 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 Cleaning Brush WB1318EW 1 Chapter 2 Pr...

Страница 32: ...rding video images Printing still images Ultrasonic Endoscope EG 580UT Data Keyboard DK 4450E Processor VP 4450HD Cart Water Tank WT 4 WT 2 Light Source XL 4450 Ultrasonic Processor SU 1 Foot Switch F...

Страница 33: ...ADIANCE24 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 P...

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: ...r passing forceps puncture needle or endotherapy device through the instrument channel The forceps valve is attached during use Insertion Tube Connects the bending section and control portion Insertio...

Страница 36: ...mits and receives ultrasonic waves Balloon Attachment Grooves This portion is used to attach the balloon ring Imaging Section Inside Light Guide The light from the light source is emitted from these w...

Страница 37: ...and prevents leak or backflow of air when a puncture needle is used Ring This portion is hooked onto the instrument channel inlet on the ultrasonic endoscope How to Use the Forceps Valve The forceps v...

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 in...

Страница 40: ...a 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 up...

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 202B1262575D...

Страница 42: ...e 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 th...

Страница 43: ...e 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 secti...

Страница 44: ...e 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: ...y device in the field of view moves downward on the monitor When the forceps stand lever is slid toward the direction U The forceps stand at the distal end is raised The endotherapy device in the fiel...

Страница 47: ...direction U to raise the forceps stand at the distal end when the forceps stand lever is slid further toward the direction U it clicks indicating that the stand assist mechanism is activated Note Do...

Страница 48: ...needle Note The puncture guiding line is only a rough guide Check the actual needle position on the ultrasonic image For details refer to the operation manual of the ultrasonic processor Note For det...

Страница 49: ...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 50: ...uch as tears cracks discoloration etc 2 Attach the lid to the main body of the forceps valve 3 1 3 Attaching the Forceps Valve 1 Attach the forceps valve to the instrument channel inlet of the ultraso...

Страница 51: ...sinfected 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 a...

Страница 52: ...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 val...

Страница 53: ...eparing Peripheral Devices For details on preparation and inspection of peripheral devices refer to their manuals Chapter 3 Preparation and Inspection Before Use 53 EG580UT_E2 50_202B1262575D indb 53...

Страница 54: ...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 55: ...st 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...

Страница 56: ...e 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 o...

Страница 57: ...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 58: ...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 59: ...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 60: ...cording to the movement of the lever 3 Slide the forceps stand lever toward the direction U until it clicks to check that the stand assist function is activated normally Note If any operational abnorm...

Страница 61: ...it 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...

Страница 62: ...and 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 Troubl...

Страница 63: ...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 64: ...r 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 64 EG580...

Страница 65: ...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 66: ...f 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...

Страница 67: ...endoscope 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 displaye...

Страница 68: ...feed in 5 ml of water Check the amount of water to be fed before use Note If water cannot be discharged or little water is discharged from the balloon refer to Chapter 5 Troubleshooting Chapter 5 Trou...

Страница 69: ...Attach a syringe to the balloon attachment tool and then suck air out of the balloon 6 Insert the distal end of the ultrasonic endoscope into the balloon attachment tool until the balloon ring fits f...

Страница 70: ...alve fully to suck out all sterile water inside of the balloon Note If water cannot be discharged or little water is discharged from the balloon refer to Chapter 5 Troubleshooting Chapter 5 Troublesho...

Страница 71: ...se the puncture needle if the expiration date has expired 2 Inspect the puncture needle according to its operation manual Note If the inspection result shows any abnormality do not use the puncture ne...

Страница 72: ...g so 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...

Страница 73: ...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 74: ...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 75: ...the light source Patient s blood adhering to light guide at the distal end of the ultrasonic endoscope may be coagulated by the energy of illumination For details on how to use the light save function...

Страница 76: ...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 un...

Страница 77: ...ess 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 of the ultrasonic endoscope into the oral cavit...

Страница 78: ...he up down and left right angulation knobs Note Never insert or withdraw the ultrasonic endoscope forcibly Note In case that the bending section does not return or cannot be pulled out easily because...

Страница 79: ...or 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...

Страница 80: ...ischarged from the balloon refer to Chapter 5 Troubleshooting Chapter 5 Troubleshooting 1 Feed a small amount of sterile water to the affected area before using the balloon 2 Turn the up down and left...

Страница 81: ...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 82: ...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 83: ...rt the puncture needle into the instrument channel inlet while the bending section of the ultrasonic endoscope is bent Do not insert a bent puncture needle into the instrument channel inlet Stop punct...

Страница 84: ...e Note Do not move or angulate the ultrasonic endoscope with the puncture needle protruding from the instrument channel outlet Before moving or angulating the ultrasonic endoscope be sure to pull the...

Страница 85: ...k the area to be punctured by observing the ultrasonic image Color Doppler Power Doppler Mode 5 Check that there is no blood vessel around the puncture guiding line by observing the ultrasonic image a...

Страница 86: ...pe is angulated with the puncture needle inserted 9 Perform puncture Note The puncture guiding line is only meant as a guide Check the actual part to be punctured on the ultrasonic image Note The punc...

Страница 87: ...ncture store the inner needle in the outer syringe and then pull out the puncture needle slowly 11 Push out the collected tissue using the syringe or wire Chapter 4 Method of Use 87 EG580UT_E2 50_202B...

Страница 88: ...stand 4 If the balloon is attached 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 WB2...

Страница 89: ...02B1262575D 6 Slowly pull out the ultrasonic endoscope 7 Press the Lamp button on the light source to turn off the lamp Chapter 4 Method of Use 89 EG580UT_E2 50_202B1262575D indb 89 2016 07 05 9 28 55...

Страница 90: ...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 91: ...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 92: ...he 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...

Страница 93: ...straighten 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...

Страница 94: ...charge 3 The video signal cable has shorted out or broken 1 2 3 If the problem occurred during puncture stop puncture and remove the puncture needle from the ultrasonic endoscope Then reset Note the p...

Страница 95: ...much sterile water 6 Water tank is empty 7 Water tank is not connected 8 Clogged nozzle or channel 1 Switch on the pump 2 Replace with a new air water button 3 Push in the air water button firmly 4 C...

Страница 96: ...cannot be supplied to or discharged from the balloon 1 The suction pump is turned OFF 2 The suction tube is not attached properly 3 The suction tube is not connected 4 The suction valve is damaged 5 T...

Страница 97: ...ltrasonic endoscope and endotherapy device together Note Use an endotherapy device with an appropriate size Endotherapy device such as biopsy forceps cannot be closed An abnormality occurs in the endo...

Страница 98: ...puncture immediately stop puncture and remove the puncture needle from the ultrasonic endoscope Then immediately stop using the ultrasonic endoscope Do not forcibly withdraw the ultrasonic endoscope...

Страница 99: ...n knob counterclockwise to adjust the brightness of the ultrasonic image 2 Press the STC key to set the STC level closer to the center value The image disappears during ultrasonic diagnosis The US con...

Страница 100: ...o 100 mm Field of view 140 Distal end diameter 13 9 mm Maximum diameter of insertion portion 15 0 mm Insertion tube diameter 12 4 mm Flex Note 1 10 5 N Bending capability UP DOWN 150 150 LEFT RIGHT 12...

Страница 101: ...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 Operating Env...

Страница 102: ...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 Supplies...

Страница 103: ...hannel diameter is guaranteed Compatible Endotherapy Devices Name Model Biopsy forceps Fenestrated Fenestrated with needle Slotted hole Alligator Grasping forceps Three prong V shape Basket High frequ...

Страница 104: ...irection of Forceps Medical Device Directive This product complies with the requirements of European Directive 93 42 EEC Classification Class II a 104 Main Specification EG580UT_E2 50_202B1262575D ind...

Страница 105: ...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 106: ...er 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 107: ...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 108: ...is 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 i...

Страница 109: ...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 110: ...ulation 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 49 Printer 33 Puncture 83 S S connector 34 Storage envi...

Страница 111: ...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 112: ...5 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 EG580UT_E2 50_202B1262575D ind...

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