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897N200877B

Appendix-1

Appendix

This chapter describes main specifications, related equipment used in combination with this
product, electromagnetic compatibility (EMC), etc.

Main Specification

♦

Classification of Medical Electrical Equipment

1. Type of protection against electric shock:

Class I equipment (power supply: protected ground fault receptacle)

2. Degree of protection 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.

Note

Use in combination with the processor EP-6000 or with the processor VP-7000/

VP-4450HD/VP-3500HD and the light source BL-7000/XL-4450.

♦

Electromagnetic Compatibility (EMC) Related Standard

This product has been tested and confirmed to comply with the limits for medical devices
defined in EN 60601-1-2

*1

.

These limits are designed to provide reasonable protection against harmful electromagnetic
interference in a typical installation at professional healthcare facilities such as hospitals and
clinics.
There is no guarantee that interference will not occur in a particular installation.

*1 The leftmost alphanumeric character of the serial numbers of this product that complies

with the requirements of EN 60601-1-2:2015 is 2 or higher or any of J to Z.

If the serial number is other than any of those above, this product complies with the

requirements of EN 60601-1-2:2007.

♦

Applied Part

Insertion portion

Appendix

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Содержание ED-580XT

Страница 1: ...ON MANUAL Duodenoscope ED 580XT This Operation Manual provides details on how to prepare and operate the endoscope and describes cautions to be observed Please read this manual thoroughly before opera...

Страница 2: ...ii 897N200877B ED580XT_E2 30_897N200877B indb 2 2018 09 20 15 50 15...

Страница 3: ...rs depending on the type of endoscope and accessories to be used Chapter 4 Preparation and Inspection This chapter describes the inspection and preparation methods to be performed before using the end...

Страница 4: ...3 Disposal 1 4 1 6 For Safe Operation 1 4 1 7 Maintenance 1 4 1 8 Symbols 1 5 1 9 Precautions for Transportation 1 6 1 10 Precautions Against Electric Shock 1 6 1 11 Electromagnetic Compatibility EMC...

Страница 5: ...ion and Inspection 4 1 4 1 Preparation of the Equipment 4 2 Endoscope 4 2 Accessories 4 2 Related Equipment Essential 4 3 Related Equipment To be Prepared when Necessary 4 3 Personal Protective Equipm...

Страница 6: ...tion 4 28 4 7 4 Inspecting Suction Function 4 29 4 7 5 Inspecting Instrument Channel 4 29 Chapter 5 How to Use 5 1 5 1 Preparation 5 3 5 1 1 Preparing Related Equipment 5 3 5 1 2 Pretreatment of Patie...

Страница 7: ...riginal Position 6 9 6 4 Returning Endoscope for Repair 6 11 Chapter 7 Service 7 1 7 1 Service 7 1 7 2 After Sales Service 7 1 Repairs during the warranty period 7 1 Repairs after the warranty period...

Страница 8: ...ir Leak Tester Appendix 6 Mouthpiece Appendix 6 Compatible Endotherapy Devices Appendix 6 Medical Device Directive Appendix 6 Electromagnetic Compatibility EMC Information Appendix 7 Disposal of Elect...

Страница 9: ...fter reading this manual store it close to this product for future reference to keep this product in optimum working condition If you have any questions or comments about any information in this manua...

Страница 10: ...pe Endoscope Reprocessing Manual Endoscope Operation Manual Model ED 580XT This manual provides necessary information for using the endoscope such as the equipment overview operation procedures and pr...

Страница 11: ...products whose life expectancy is limited and which require replacement once they show signs of wear or irregularity Such parts and products cannot be repaired or refurbished and should be replaced a...

Страница 12: ...897N200877B 4 Introduction ED580XT_E2 30_897N200877B indb 4 2018 09 20 15 50 16...

Страница 13: ...uct for any other purposes WARNING Never use this product for any other purposes It may cause severe harm to patient and or end users 1 2 Applicability of Endoscopy and Endoscopic Treatment Proper cli...

Страница 14: ...tion of Modification and Improper Repair Do not modify this product or its components and do not disassemble repair or in any other way reverse engineer these products Even if you find a defect do not...

Страница 15: ...especially variant Creutzfeldt Jakob disease use it exclusively for a patient with the same disease or properly discard this product after use Since the cleaning disinfection and sterilization method...

Страница 16: ...mediately stop treatment and withdraw the endotherapy device together with the endoscope Use back up equipment to complete the procedure as necessary 1 7 Maintenance WARNING Deterioration or degradati...

Страница 17: ...cture Manufacturer Authorised representative in the European Community Blue Refer to instructions for use Temperature limitation Keep dry Non sterile CE marking Type BF applied part WEEE marking Humid...

Страница 18: ...ortion or the boot is grasped it may damage the endoscope When transporting a reprocessed endoscope do not coil the insertion tube or the LG flexible portion of the endoscope with a small diameter Doi...

Страница 19: ...n or inversion of the viewing image Noise may appear on the monitor of this product due to the effect of electromagnetic interference In this case turn off the device emitting the electromagnetic wave...

Страница 20: ...electromagnetic waves Doing so may cause malfunction of this product If this product is used in combination with an electrosurgical unit follow the instructions provided in the operation manuals of t...

Страница 21: ...n does not return to its neutral position causing patient injury If water leaks from the forceps valve or suction valve during the inspection of the suction function replace it with a new one already...

Страница 22: ...an create a risk of infection Use a reprocessed forceps valve air water valve suction valve mouthpiece and distal end cap Insufficient reprocessing could be a source of infection Ensure that the force...

Страница 23: ...t sneezes or moves abruptly during the procedure malfunction of the endoscope and patient bleeding or trauma may occur Depending on the degree of malfunction safe endoscope withdrawal may be difficult...

Страница 24: ...k fluids adhere to or clog the suction valve suction may not stop causing damage to mucous membrane When injecting fluids by attaching a syringe to the forceps valve open the lid of the forceps valve...

Страница 25: ...endoscope may exceed 41 C Do not allow the distal end to remain in contact with the same site for an extended period of time It may cause burn injury Do not use a mouthpiece that is damaged deformed...

Страница 26: ...lve It may impair the functionality of the valve or may clog the channel diminishing functionality of air water supply Slowly insert the air water valve straight into the air water valve cylinder of t...

Страница 27: ...rmality loss of image dark image bright image etc is found in the endoscopic image the imaging section may malfunction If this happens stop the treatment immediately and slowly pull out the endoscope...

Страница 28: ...ction control risks to patient or operator Wear protective clothing when detaching the distal end cap from the distal end of the endoscope Otherwise it may pose an infection risk Firmly connect the su...

Страница 29: ...ocessor or the LG connector connected to the light source does not hit the bed Otherwise the endoscope s video connector and LG connector processor and light source may malfunction With regard to the...

Страница 30: ...of the electrosurgical unit Energize the electrosurgical unit after bringing the tip of the endotherapy device into the field of view When the high frequency endotherapy device or energizing part mak...

Страница 31: ...thing is wet when performing high frequency treatment Doing so may cause thermal injury 1 13 2 Precautions for Endotherapy Device and Syringe WARNING When inserting an endotherapy device into the endo...

Страница 32: ...897N200877B 1 20 Chapter 1 Precautions ED580XT_E2 30_897N200877B indb 20 2018 09 20 15 50 17...

Страница 33: ...oduct 2 1 Checking Package Contents Check the endoscope and other components in the package against the items shown in the figures below Inspect the endoscope and each component for damage If the endo...

Страница 34: ...brush WB11003DV 3 Ventilation Adapter AD 7 1 Suction Channel Brush WB7025DC 3 Operation Manual 1 Reprocessing Manual 1 Forceps Valve 1 FOV DV7 11 Injection Tube WA 007 Cylinder Adapter WA 010 Syringe...

Страница 35: ...897N200877B 2 3 Chapter 2 Product Overview ED580XT_E2 30_897N200877B indb 3 2018 09 20 15 50 17...

Страница 36: ...following parts LG Flexible Portion 4 Light Guide Cover Glass 2 Air Guide Port 5 Water Supply Connector 6 Ventilation Connector 8 Lock Handle 9 Waterproof Cap 3 Light Guide Prong 1 Suction Connector...

Страница 37: ...Scope Switches 1 to 3 20 Suction Valve Cylinder 19 Suction Valve 18 Air Water Valve 16 Instrument Channel Inlet 15 Forceps Valve Boot 24 Bending Section 23 Insertion Tube 25 Distal End 17 Air Water V...

Страница 38: ...s to the air leak tester or ventilation adapter 7 S Connector Accepts the S cord when using an electrosurgical unit Video Connector The video connector is connected to the processor No Name Function 8...

Страница 39: ...ly Moving this lock in the direction opposite to F locks the right left movement and maintains the right left angle of the bending section 13 Left Right Angulation Knob Angulates the bending section t...

Страница 40: ...oot This portion connects the control portion and the insertion portion Insertion Portion Applied Part The insertion portion contains various components of the angulation system internal channels opti...

Страница 41: ...r or water onto the objective lens with the air water valve operation 3 Instrument Channel Outlet Endotherapy devices exit from this opening when inserted from the instrument channel inlet During oper...

Страница 42: ...the labels are affixed on this product are shown below 2 4 1 Location of Labels Control Portion Model Label Instrument Channel Diameter Label LG Connector LG Connector Label Label for the Serial Numb...

Страница 43: ...w Related equipment is optional WARNING Use this product only in combination with related equipment described in this manual Otherwise it is unable to ensure its functionality and may cause severe har...

Страница 44: ...Regulator GW 100 Water Tank WT 2 WT 4 Water Tank WT 04G Monitor Printer Video Recorder Cart Data Keyboard Foot Switch Suction Unit 1 1 Use a suction unit which complies with EN 60601 1 IEC 60601 1 an...

Страница 45: ...en discontinued or not marketed depending on the country or region For details on the devices used in combination with this product contact your local FUJIFILM dealer Endoscope ED 580XT Gas Water Valv...

Страница 46: ...0 Endoscopic CO2 Regulator GW 100 Water Tank WT 2 WT 4 Water Tank WT 04G Monitor Printer Video Recorder Cart Data Keyboard Foot Switch Suction Unit 1 1 Use a suction unit which complies with EN 60601...

Страница 47: ...en discontinued or not marketed depending on the country or region For details on the devices used in combination with this product contact your local FUJIFILM dealer Endoscope ED 580XT Gas Water Valv...

Страница 48: ...897N200877B 2 16 Chapter 2 Product Overview ED580XT_E2 30_897N200877B indb 16 2018 09 20 15 50 19...

Страница 49: ...ter describes the workflow of endoscopy which differs depending on the type of endoscope and accessories to be used Have an understanding about the workflow and read the relevant sections thoroughly b...

Страница 50: ...ing Water Tank 4 6 4 Attaching Suction Unit 4 7 1 Inspecting Endoscopic Images 4 7 2 Inspecting Scope Switch 4 7 3 Inspecting Air Water Supply Function 4 7 4 Inspecting Suction Function 4 7 5 Inspecti...

Страница 51: ...ion 5 2 2 Observing Endoscopic Image 5 2 3 Operating Scope Switch 5 2 4 Bending Operation 5 2 5 Operating Air Water Valve 5 2 6 Operating Suction Valve 5 5 Treatment 5 3 Injecting Fluids from Instrume...

Страница 52: ...897N200877B 3 4 Chapter 3 Workflow ED580XT_E2 30_897N200877B indb 4 2018 09 20 15 50 19...

Страница 53: ...e Reprocessing Manual Inadequate reprocessing or storage may cause infection Make sure to inspect the endoscope and accessories before use according to the procedures provided in this manual Do not us...

Страница 54: ...operation manual of related equipment and personal protective equipment Endoscope Note Prepare the endoscope that has been reprocessed as per instructions provided in the Reprocessing Manual Accessori...

Страница 55: ...ces described here products that can be used in combination with this product may be added In addition the devices described here may have already been discontinued or not marketed depending on the co...

Страница 56: ...t and Waterproof Gloves 2 1 It is also recommended to use shoes that can be disinfected and or a single use shoes cover 2 Chemical resistant and waterproof gloves are recommended to be long enough to...

Страница 57: ...CAUTION When transporting a reprocessed endoscope firmly grasp the control portion and LG connector If only the LG flexible portion or the boot is grasped it may damage the endoscope When transportin...

Страница 58: ...cibly twist or bend the insertion tube of the endoscope It could damage the endoscope 1 Visually inspect the boot and the insertion portion near the boot for bends twists swelling or other irregularit...

Страница 59: ...lens is free from scratches cracks or disengagement The areas around the objective lens are free from cracks or gaps The light guides are free from scratches cracks or disengagement The areas around...

Страница 60: ...ned it may cause malfunction of the endoscope Inspection for Smooth Operation 1 Straighten the bending section 2 Turn the up down and left right angulation locks in the direction of F Free until they...

Страница 61: ...f F Free the rotation of the up down or left right angulation knob becomes harder and even when fully locked the angulation knob and the distal bending section still can be moved 2 Turn the up down an...

Страница 62: ...and even when fully locked the angulation knob and the distal bending section still can be moved 2 Turn the left right angulation knob in the directions of L and R until it stops Confirm that the angl...

Страница 63: ...ragments is connected it may cause malfunction or failure of the devices Do not touch the light guide cover glass A dirty light guide cover glass may result in the reduction of light intensity 1 Visua...

Страница 64: ...4 3 7 Inspecting Video Connector 1 Visually and manually inspect the video connector for abnormalities such as dirt on the pin broken or bent pin excessive scratches dents deformation or loose parts...

Страница 65: ...sign of abnormality or irregularity replace the forceps valve with a new one already reprocessed Use of an abnormal forceps valve may cause the leakage of body fluid posing an infection risk Ensure t...

Страница 66: ...hen attaching the suction valve to the suction valve cylinder of the endoscope align the recessed and projecting portions and slowly insert the suction valve straight into the suction valve cylinder o...

Страница 67: ...r to prevent an error in attachment Bulge Rotation Metal Ridges Holes Orange marking Suction Valve Cylinder Top View Suction Valve Bottom View Orange marking 1 Attach the suction valve to the endoscop...

Страница 68: ...water valve It may impair the functionality of the valve or may clog the channel diminishing functionality of air water supply Preparation The air water valve is not reprocessed before shipping from...

Страница 69: ...rking Check the marking on the air water valve and that on the air water valve cylinder to prevent an error in attachment Bulge Blue marking Blue marking 1 Attach the air water valve to the endoscope...

Страница 70: ...Attach the distal end cap before inserting the endoscope Not doing so may cause injury to tissues in the body cavity bleeding and or perforation CAUTION Do not hold the bending portion tightly when at...

Страница 71: ...oove of the distal end is hidden completely 3 Embed the distal end cap into the installation groove by pushing the edge of the cap with one s finger 4 4 Make sure that the distal end cap is attached t...

Страница 72: ...ided in the operation manual of the water tank If the amount of sterile water in the water tank exceeds the limit the air water supply function may be disabled or it may cause equipment failure due to...

Страница 73: ...e water on the cart or light source Note The water in the water tank should be changed at least daily using sterile water Use a reprocessed water tank FUJIFILM water tanks must be reprocessed at least...

Страница 74: ...light source Light leaking from the connecting part may cause damage to the eyes Immediately after detaching the LG connector from the light source do not touch the light guide prong with hands since...

Страница 75: ...lign the index on the video connector and that on the 500 system connector socket of the processor and insert the video connector into the processor 2 Rotate the lock handle clockwise while pressing t...

Страница 76: ...nt causing equipment failure 1 2 1 Align the pin of the water supply connector of the endoscope to the groove in the connector of the water tank 2 Insert the connector of the water tank straight into...

Страница 77: ...on tube from the suction unit to the suction connector on the LG connector If the suction tube is not attached properly body fluid may drip from the tube and come into contact with related equipment c...

Страница 78: ...ecome hot causing burn injury to the patient or end user Turn off the light of the light source except during an inspection or procedure etc when necessary If the light of the light source is left on...

Страница 79: ...egularities 4 7 2 Inspecting Scope Switch Scope Switch 3 Scope Switch 4 Scope Switch 2 Scope Switch 1 1 Confirm that the assigned function is executed by pressing each scope switch Note Use the proces...

Страница 80: ...zzle even when the hole in the air water valve is not covered This does not indicate a malfunction 4 Cover the center hole of the air water valve with your finger and be sure that air comes out of the...

Страница 81: ...forceps valve has been properly attached to the instrument channel inlet of the endoscope If it is not attached properly water cannot be aspirated 3 Release the suction valve Confirm that suction stop...

Страница 82: ...897N200877B 4 30 Chapter 4 Preparation and Inspection ED580XT_E2 30_897N200877B indb 30 2018 09 20 15 50 23...

Страница 83: ...and shoe covers during a procedure as well as during reprocessing to protect your eye and skin and to prevent infection Not doing so may cause infection Do not supply an excessive amount of air or gas...

Страница 84: ...urce from accidental impact damage During the operation of an electric bed etc ensure that the video connector connected to the processor or the LG connector connected to the light source does not hit...

Страница 85: ...s instructions including specific reprocessing recommendations CAUTION Do not use a mouthpiece that is damaged deformed or reveals other irregularities Doing so may cause injury in the oral cavity and...

Страница 86: ...tal end cap is not attached securely the distal end cap may fall off during use Use this product in combination with the distal end cap DC 07D If another type of distal end cap is used in combination...

Страница 87: ...eps elevator 4 When necessary wipe the objective lens and light guides with sterile gauze moistened with alcohol Note Use lint free sterile gauze to prevent fibers from entering the air water nozzle 5...

Страница 88: ...not allow the distal end to remain in contact with the same site for an extended period of time It may cause burn injury Note In cases with bleeding use the light save function of the light source Pat...

Страница 89: ...t difficult to withdraw the endoscope If the bending section does not return to its neutral position during a procedure do not withdraw the endoscope forcibly Consult your local FUJIFILM dealer If the...

Страница 90: ...ght angulation locks the bending angle at the distal end may change due to advancement or withdrawal of the endoscope or insertion of an endotherapy device into the instrument channel Locking of Up Do...

Страница 91: ...et of the processor 2 1 When the hole in the air water valve is covered with one s finger air is supplied to the air water nozzle in the distal end 2 When the air water valve is pressed water is suppl...

Страница 92: ...ls or thick fluids If the suction valve does not return to its original position stop aspiration immediately and slowly withdraw the endoscope If any solid materials or thick fluids adhere to or clog...

Страница 93: ...r When the lid of the forceps valve needs to be opened during a procedure place a piece of gauze etc over it to prevent leakage Otherwise body fluids may leak or splash from the forceps valve posing a...

Страница 94: ...f it is inserted quickly 1 Angulate the bending section so that the duodenal papilla aperture comes to the center of the field of view 2 Connect a sterile syringe filled with contrast agent to the inl...

Страница 95: ...lation tube to the papilla opening and insert the cannulation tube into the common bile duct or the pancreatic duct through the papilla opening Note To move the tip of the cannulation tube to the papi...

Страница 96: ...g so may cause injury to tissues in the body cavity bleeding and or perforation When inserting an endotherapy device into the endoscope or when injecting fluids by attaching a syringe to the instrumen...

Страница 97: ...the holding force If an accessory cannot be advanced or meets resistance at the scope distal tip make sure that the forceps elevator is lowered so as not to impede or restrict movement of the accesso...

Страница 98: ...the electrosurgical unit and high frequency endotherapy device If the output power is inappropriate it may cause injury to tissues in the body cavity thermal injury bleeding or perforation Wear chemic...

Страница 99: ...conductive parts such as a metal part of the bed It could cause thermal injury to a patient due to energization via vomitus or body fluids While performing high frequency treatment ensure that the end...

Страница 100: ...ON Lower the forceps elevator before withdrawing the endoscope Not doing so may cause patient injury 1 Prior to withdrawal press the suction valve to apply suction to remove insufflated air or CO2 gas...

Страница 101: ...o any reason or condition including loss of image power interruption water droplets or dirt debris adhering to the objective lens etc Doing so may cause injury to tissues in the body cavity bleeding a...

Страница 102: ...ccessories as per instructions provided in the Reprocessing Manual Reprocessing Manual WARNING Immediately upon completion of the procedure it is imperative that pre cleaning is performed as per instr...

Страница 103: ...of Endoscope with Abnormality WARNING Make sure to inspect the endoscope and accessories before use according to the procedures provided in this manual Do not use the equipment that shows any signs of...

Страница 104: ...und MIN Set the brightness level around 0 Operation manual of the light source The iris mode is set to PEAK Set iris mode to AVE Operation manual of the processor Moisture or foreign matter such as du...

Страница 105: ...em Cause Remedy The intended function is not executed even if the scope switch is pressed The intended function is not assigned to the scope switch Assign the function to the scope switch as per instr...

Страница 106: ...ss the air water nozzle or air water channel according to the instructions given in the Reprocessing Manual Low air water supply amount Foreign matters have adhered to the air water channel Reprocess...

Страница 107: ...ct your local FUJIFILM dealer Fluid leaks from forceps valve during suction The forceps valve is not attached correctly Attach the forceps valve properly and close the lid The forceps valve is damaged...

Страница 108: ...tor lever to raise the forceps elevator attach a syringe to the forceps valve and flush clean water to push out the foreign matter An abnormality occurs in the endotherapy device Withdraw the tip of t...

Страница 109: ...therapy device together If the treatment is not stopped or the endotherapy device is forcibly pulled out it may cause injury to tissues in the patient s body cavity bleeding and or perforation During...

Страница 110: ...ice slowly withdraw the endotherapy device from the endoscope 3 Turn the up down and left right angulation locks in the direction of F Free until they stop to unlock the up down and left right angulat...

Страница 111: ...device slowly withdraw the endotherapy device from the endoscope 4 Aspirate accumulated air or CO2 gas by pressing the suction valve 5 Turn off the suction pump 6 Turn the up down and left right angu...

Страница 112: ...basin filled with sterile water 16 Aspirate air with the syringe While pressing the suction valve inject air into instrument suction channel until the sterile water inside the channel is discharged c...

Страница 113: ...uct is returned for repair Be sure to reprocess this product before returning for repair If a product which is not reprocessed is returned it can create a risk of infection to users service personnel...

Страница 114: ...897N200877B 6 12 Chapter 6 Troubleshooting ED580XT_E2 30_897N200877B indb 12 2018 09 20 15 50 25...

Страница 115: ...information Model name Serial number Description of failure Provide as much details as possible Date of purchase Reprocessing method Automated Endoscope Reprocessor disinfectant solution etc Repairs d...

Страница 116: ...897N200877B 7 2 Chapter 7 Service ED580XT_E2 30_897N200877B indb 2 2018 09 20 15 50 25...

Страница 117: ...ce BL 7000 XL 4450 Electromagnetic Compatibility EMC Related Standard This product has been tested and confirmed to comply with the limits for medical devices defined in EN 60601 1 2 1 These limits ar...

Страница 118: ...nsertion portion mm 1 14 9 Minimum diameter of instrument channel mm 2 4 2 Bending capability Up Down 120 90 Left Right 90 110 Working length mm 3 1250 Total length mm 1550 Insertion route Peroral 1 T...

Страница 119: ...no dew condensation Pressure 70 to 106 kPa within range of atmospheric pressure Storage Environment Temperature 20 to 60 C Humidity 10 to 85 RH no dew condensation Pressure 70 to 106 kPa within range...

Страница 120: ...or refurbished and should be replaced after any irregularity is observed Name Model Forceps valve FOV DV7 1 Air water valve AW 603 Suction valve SB 605 Suction channel brush WB7025DC 1 Cylinder inlet...

Страница 121: ...BL 7000 XL 4450 Note For details on the monitors printers and video recorders that can be used in combination with this product refer to the operation manual of the processor and light source Water T...

Страница 122: ...e MPC ST Compatible Endotherapy Devices Endotherapy devices have a use by date If any deterioration or abnormality is found in them they need to be replaced Endotherapy devices cannot be repaired or r...

Страница 123: ...rocessor VP 7000 VP 4450HD VP 3500HD and the light source BL 7000 XL 4450 Electromagnetic Emission Compliance Information and Guidance Table 1 Guidance and Manufacturer Declaration Electromagnetic Emi...

Страница 124: ...lity should be that of a typical commercial or hospital environment Surge IEC EN 61000 4 5 0 5 kV 1 0 kV line to line 0 5 kV 1 0 kV 2 0 kV line to earth 0 5 kV 1 0 kV line to line 0 5 kV 1 0 kV 2 0 kV...

Страница 125: ...W according to the transmitter manufacturer and d is the recommended separation distance in meters m The electric field intensity from a fixed RF transmitter determined by an electromagnetic field stu...

Страница 126: ...onsidered If the measured field strength in the location in which this product is used exceeds the applicable RF compliance level above this product should be observed to verify normal operation If ab...

Страница 127: ...aximum output power of transmitter P W Separation distance related to frequency of the transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 GHz d 2 3 P 0 01 0 12 0 12 0 23...

Страница 128: ...uency energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electric equipment Radiated emissions CISPR11 EN 55011 Class...

Страница 129: ...C EN 61000 4 5 0 5 kV 1 0 kV line to line 0 5 kV 1 0 kV 2 0 kV line to earth 0 5 kV 1 0 kV line to line 0 5 kV 1 0 kV 2 0 kV line to earth Main power quality should be that of a typical commercial or...

Страница 130: ...m The electric field intensity from a fixed RF transmitter determined by an electromagnetic field studya should be lower than the compliance level in each frequency rangeb Interference may occur near...

Страница 131: ...aximum output power of transmitter P W Separation distance related to frequency of the transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23...

Страница 132: ...r the recycling of electrical 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...

Страница 133: ...ect Cable 2 4 L Label for the Serial Number 2 10 Label for the Year of Manufacture 2 10 Left Right Angulation Knob 2 5 Left Right Angulation Lock 2 5 LG Connector 2 4 LG Connector Label 2 10 LG Flexib...

Страница 134: ...897N200877B Appendix 18 Appendix ED580XT_E2 30_897N200877B indb 18 2018 09 20 15 50 27...

Страница 135: ...ve 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 Asia Paci...

Страница 136: ...ny FUJIFILM Corporation 26 30 Nishiazabu 2 chome Minato ku Tokyo 106 8620 Japan EU Importer FUJIFILM Europe B V Oudenstaart 1 5047 TK Tilburg The Netherlands Imported to Australia by FUJIFILM Australi...

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