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FSE-054-EN-5.0 Fuse 1G Gastroscope with FuseBox

1. H us FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601 1 E364813 CAN USA C22 2 No 601 1 IEC60601 2 18 Medical Electrical Equipment a WITH RESPECT TO ELECTRICAL SHOCK c us FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH AAMI ES60601 1 E363751 CAN CSA C22 2 No 60601 1 08 IEC60601 2 18 e This product was designed and manufactured to meet all safety requirements applicable to electronic medical equipment However anyone operating the system must be fully aware of the potential safety hazards It should be operated and maintained in strict compliance with the safety precautions and operating instructions contained herein e This product must be installed maintained and serviced by EndoChoice qualified service personnel Operation and maintenance must be done in strict compliance with the operation instructions contained in the manual e The system is not to be modified in any way Any attempt to disassemble repair or modify this device by anyone other than an EndoChoice authorized service technician presents risk to the patient or operator and may result in equipment damage Equipment that has been disassembled repaired altered changed or modified by persons other than EndoChoice s own authorized service personnel is excluded from EndoChoice s warranty and is not warranted by EndoChoice in any way e Where applicable follow the official standards on the applicability of gastroscopy and gastroscopic tre
2. Endoscope Reprocessing Manual for reprocessing steps for these products In this document the Fuse 1G Gastroscope may be referred to as the gastroscope and the camera head may be referred to as the Distal Tip or Distal End The FuseBox serves as a control platform for the Fuse 1G Gastroscope The FuseBox is responsible for image processing transferring video signals from the gastroscope pneumatic control and control of various external accessories that interface with the system The Fuse 1G Gastroscope is an adult sized wide field of view video gastroscope lt has a 9 8mm Insertion Tube a large 2 8mm channel it also incorporates a dedicated forward water jet feature The Fuse system features multiple viewing options 160 standard and 245 wide The wide 2459 mode includes the 160 standard front field of view The operator can change the viewing mode from 160 to 245 or 245 to 160 by selecting the appropriate monitors using the FuseBox interface 12 QQENDCCHOICE FSE 054 EN 6 0 System Components CHAPTER 3 System Components 3 1 Fuse 1G Gastroscope 3 1 1 Packaged components The Fuse 1G Gastroscope and the gastroscope s accessories come packaged in a portable case and an accessories box Open the packaging and carefully remove the gastroscope and the gastroscope accessories Verify that all of the following items are included in the packaging Item Name of Item i F
3. 2 Confirm that water exits from both nozzles in the Distal Tip It may take a few seconds for the water to reach the Distal Tip Fuse 1G Gastroscope with FuseBox Processor User Manual 41 Preparing and Inspecting the System 1 Fill a cup with sterile water 2 Immerse the Distal Tip in the cup of sterile water 3 Press on the Suction Reusable Scope Valve va b 4 Confirm that the water level in the cup recedes N WARNING e Insufficient suction may cause loss of clear endoscopic image during the procedure Use of the device without clear image quality can result in patient injury If you are using an auxiliary water mechanism perform the following test Otherwise verify that the auxiliary water cap is tightly closed 1 Confirm that the auxiliary water pump is connected Operate the auxiliary water pump Confirm that water is forced out of the auxiliary water opening in the Distal Tip 1 Confirm that the system is turned ON and that the system light is ON 2 From the FuseBox Main screen press on the XLUM icon 3 Confirm that light on the Distal Tip blinks for seven 7 seconds CAUTION m Avoid looking directly at the Distal Tip when the light is ON as this could cause temporary blindness due to the illumination The following five tests apply to all active monitor screens 42 JENDCCHOICE FSE 054 EN 6 0 Preparing and Inspecting the System The following functionality is used with th
4. Do not use the Fuse 1G Gastroscope if it appears damaged or has missing parts Using an instrument that is damaged or incomplete may compromise the patient or operator s safety and may result in equipment damage or personal injury If the Fuse 1G Gastroscope appears damaged or has missing parts contact your EndoChoice representative before using the device The gastroscope was not cleaned and high level disinfected before shipping therefore it MUST be cleaned and high level disinfected prior to its first use Refer to the Fuse Endoscope Reprocessing Manual for the validated cleaning and high level disinfection procedures for this device Failure to clean and high level disinfect the device will increase the risk of patient infection Wear personal protective equipment such as protective gloves eyewear and facemask to ensure user safety Failure to do so could lead to infection control risk The following table illustrates the preparation and inspection process for the Fuse 1G Gastroscope Before each use it is the operator s responsibility to prepare and inspect all equipment accessories to be used in conjunction with the Fuse 1G Gastroscope as per their respective instructions for use Should any irregularities occur refer to Chapter 8 Troubleshooting Table 2 FUSE System Preparation and Inspection Process Step Section Description 1 4 3 1 Reprocess the endoscope system before use 2 4 3 2 Inspect the en
5. In addition to the inspection before each procedure it is highly recommended that the person in charge of medical equipment maintenance inspect the items periodically Do not use the endoscope or ancillary equipment if any irregularity is suspected Follow the procedures in Chapter 8 Troubleshooting to resolve the issue If you are unable to resolve the issue contact EndoChoice see Support on page 1 The system does not contain any user serviceable parts Do not modify or attempt to repair it patient or operator injury and or equipment damage may result Disassembly of the Fuse 1G Gastroscope with FuseBox Processor is performed in the opposite order of the assembly Refer to Chapters 3 and 4 CAUTION Be careful not to flip the water bottle while the system is connected to avoid equipment damage Handle the system with care when disconnecting the gastroscope from the FuseBox to ensure the connectors and cables are not damaged or that the FuseBox is not displaced Dispose of the single use items according to the manufacturer instructions for use If the system is located on a mobile workstation carefully move the system to its storage location Fuse 1G Gastroscope with FuseBox Processor User Manual 61 Storage and Handling The Distal Tip of the endoscope contains highly vulnerable optical end electrical components Avoid any mechanical damage to the tip during transport CAUTION m Do not store the endo
6. such as monitors printer etc should be medical grade only Follow the warnings and cautions given below when handling this endoscope This information is to be supplemented by the warnings and cautions provided in each chapter N WARNING Following endoscope use clean reprocess and store it according to the instructions found in the endoscope s companion Fuse Endoscope Reprocessing Manual Using instruments that have either been improperly or incompletely reprocessed or stored may cause cross contamination or infection Before endoscopy remove any metallic objects watch glasses necklace etc from the patient Performing high frequency cauterization treatment while the patient is wearing metallic objects may cause burns on the patient in areas around a metallic object Do not strike hit or drop the endoscope s Distal End Bending Section Insertion Tube Umbilical Tube Control Handle or endoscope Connector Also do not bend pull or twist the endoscope s Distal End Insertion Tube Bending Section Control Handle Umbilical Tube or endoscope Connector with excessive force The endoscope may be damaged and could cause patient injury burns bleeding and or perforations Never perform angulation control forcibly or abruptly Never forcefully pull twist or rotate the angulated Bending Section Patient injury bleeding and or perforation may result due to unintended retroflexion of the Bending Section It may a
7. Authorized Representative MedNet GmbH BorkstraBe 10 48163 Munster Germany Tel 49 251 32266 0 Email info medneteurope com FSE 054 EN 6 0
8. Processor User Manual 67 Troubleshooting Guidance and Manufacturer s Declaration Electromagnetic Immunity The Fuse 1G Gastroscope is intended to be used in the electromagnetic environment specified below The user and the medical staff should ensure that it is used only in these environments Level Electrostatic discharge ESD IEC 61000 4 2 2008 Electrical fast transient burst IEC 61000 4 4 2004 Surge IEC 61000 4 5 2005 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 2004 ENDCCHOICE Contact Discharge 6 kV Air Discharge 8 kV 2 kV Power supply lines 1 kV Input output lines Differential mode 1 kV Common Mode 2 kV lt 5 Ur gt 95 dip in Ur For 0 5 cycle 40 Ur 60 dip in Ur For 5 cycles 70 Ur 30 dip in Ur For 25 cycles lt 5 Ur gt 95 dip in Ur For 5 seconds Same as left Same as left Same as left Same as left Floors should by be made of wood concrete or ceramic tile that produces limited static If the floors are covered with synthetic material that tends to produce static the relative humidity should be at minimum 30 Mains power quality should be that of a typical commercial original condition feeding the facilities or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality shoul
9. clear image N WARNING Ensure the endoscope is clean before white balancing Cross contamination can be caused if the white balance cap is soiled inside Note Ensure to adjust the white balance every time an endoscope is used to achieve accurate color e While adjusting white balance avoid exposing the distal tip to external light as this may compromise white balance adjustment e If the cap is visibly dirty proper white balance adjustment cannot be performed White balance Cap handling If the white balance cap becomes soiled perform the following cleaning procedure immediately after use e Use a soft clean lint free cloth to wipe the inside of the cap to avoid damaging its surface e If the white balance cap cannot be cleaned or the color of the inside of the white balance cap is no longer white replace the white balance cap e To remove dust dirt and other non patient debris wipe using a soft lint free cloth moistened with 70 ethyl or isopropyl alcohol e If the equipment becomes soiled with blood or other potentially infectious materials first wipe off all gross debris using detergent Then decontaminate the equipment using a surface disinfectant e Ensure that the equipment is completely dry before use 38 MENDCCHOICE FSE 054 EN 6 0 Preparing and Inspecting the System White balance Cap Storage Store the White Balance Cap at room temperature in a clean dry well ventilated environment Fuse 1G Ga
10. is an endoscopic platform indicated to provide visualization and therapeutic access to the upper intestinal tract in the adult population The Fuse system is a wide field of view endoscopic system The Fuse 1G Gastroscope must be used in conjunction with the FuseBox The following table provides catalog and model numbers for the Fuse 1G Gastroscope and FuseBox Table 1 Fuse 1G Gastroscope System Catalog Numbers Catalog Number Description FSG 2500 ST Fuse 1G Gastroscope FSP 100 FuseBox Processor FSR 2004 White Balance Cap FusePanel Image Management System FusePanel e Keyboard FSA 2015 e Video Capture Device e Remote Control Cable e USB Extension Cord SFU 458 Air Water Reusable Scope Valve SFU 463 Suction Reusable Scope Valve Endoscope Reprocessing Adaptor Kit e Air Water Suction Cleaning Adapter e Working Channel Cleaning Adaptor FSR 3300 KT l e Soaking Cap also available separately see below e Water Jet Connector Tube Assembly e Cleaning Plugs HPP 2313 10 Valve O Rings FSA 4240 Auxiliary Water Port Cap SIT 470 100 Water Jet Connector Disposable SBC 460 10 Seal Biopsy Valve Reusable SBC 365 100 Seal Biopsy Valve Disposable SCT 468 Water Bottle Cap and Tubing Set Reusable SCT 466 Water Bottle Cap and Tubing Set Disposable Fuse 1G Gastroscope with FuseBox Processor User Manual 11 System Overview FSR 2000 Endoscope Leak Tester FSR 2001 Soaking Cap See the Fuse
11. larger ENDCCHOICE FSE 054 EN 6 0 TroubleshootingAppendix Guidance and Manufacturer s Declaration Electromagnetic Emission The Fuse 1G Gastroscope System is intended to be used in the electromagnetic environment specified below The user and the medical staff should ensure that it is used only in these environments EMC applied standard IEC 60601 1 2 2007 3 edition Electromagnetic Environment Class A limit Emission Standard Radiated Emission CISPR 11 2009 AM A1 2010 Frequency range 30 MHz to 1000 MHz Conducted emission CISPR 11 2009 AM A1 2010 Frequency range 150 KHz to 30 MHz Harmonic Emissions IEC 61000 3 2 2005 Voltage fluctuations flicker emissions IEC 61000 3 3 2008 Class A limit The Fuse 1G Gastroscope System uses RF Radio Frequency energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment The Fuse 1G Gastroscope System RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Fuse 1G Gastroscope System harmonic emissions are low and are not likely to cause any problem in the typical commercial power supply connected to this instrument The Fuse 1G Gastroscope System stabilizes its own radio variability and has no effect such as flickering of a lighting apparatus Fuse 1G Gastroscope with FuseBox
12. s insertion section Insertion section damage may result Do not hit or impact the Distal End of the insertion section especially the objective lens surface at the Distal End and side Damage may affect the image Do not twist squeeze or bend the Bending Section with your hands Equipment damage may result Electromagnetic interference may occur on this endoscope near portable and mobile RF Radio Frequency communications equipment such as cellular phones Check electromagnetic interference from other equipment prior to use Shielding or relocation of the device may be necessary if interference occurs If there is a change in lighting quality during the procedure or if the image dims during the procedure tissue or debris might have adhered to the Distal End Slowly extract the endoscope to avoid an increase in temperature The multiple portable socket outlet power strip used with the Fuse system shall only be used for powering equipment which forms a part of the Fuse system Maximum load on the U S power strip EDSB 486 is 12A 120V Maximum load on the international power strip FSA 2064 is 10A 250V Do not connect any non medical equipment supplied with the Fuse system such as the printer directly to the wall outlet when the system is supplied via a power strip with a separating transformer Connect supplied non medical Fuse system equipment to the isolation transformer only A power cable is supplied with the syst
13. that exceeds its noise level electromagnetic interference may occur on this instrument Electromagnetic interference may occur on this instrument near a high frequency electrosurgical equipment and or other equipment marked with the following symbol Fuse 1G Gastroscope with FuseBox Processor User Manual 69 Troubleshooting This section provides recommended separation distances between portable and mobile RF communications equipment and the Fuse 1G Gastroscope Separation Distance according to Frequency of Transmitter m The Fuse 1G Gastroscope is intended for use in the electromagnetic environment specified below The user and the medical staff should ensure that it is used only in these environments Rated maximum output 0 15 80 MHz 80 800 MHz 800 2500 MHz power of transmitter P W d 1 2 P d 1 2 P d 2 3 P 0 001 0 12 0 12 0 23 0 1 0 73 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption of and reflection of structures objects and people 70 QENDCCHOICE FSE 054 EN 6 0 TroubleshootingAppendix Limited Warranty a EndoChoice warrants that the Fuse endoscope s FuseBox and FuseCart products shall be free from defects in material and workmanship for a period of two years from the date of shipment all other EndoChoice products shall be free from defects
14. the use of the device if such use is not in strict compliance with instructions and safety precautions contained in the relevant operating manuals and in all supplements thereto in all product labels and according to all terms of warranty and sale of this device or in any change not authorized by EndoChoice Inc WARNING e User provided ancillary equipment and or accessories are NOT validated or warranted by EndoChoice Inc The use of such user provided items is the sole responsibility of the party using such items ual C we Ec re EndoChoice Innovation Center Ltd European Authorized Representative 2 Hatochen Street MedNet GmbH Caesarea 38900 Israel BorkstraBe 10 Tel 972 4 632 7731 48163 Munster Germany Fax 972 4 632 7734 Tel 49 251 32266 0 Email info EndoChoice com Email info medneteurope com ENDCCHOICE FSE 054 EN 6 0 Contents CONTON ee erneuern iii Safety Information Please Read Prior to Use cscsscscecsecscsceccccccscsceccecsces 1 Weigle Balke aA e ee ee 1 SUO eee E E E AOEEEREREN GENRE INEERHRRUENENER AGOR 1 Summary of instrument symbols 22u00sss222000000nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenennnen 2 Safety Guidelines please read prior tO use umsssnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnn 3 User Qualification please read prior tO use 222444444444nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 4 Warnings and Cations uns era 4 26 182 Est
15. tr enn nnn te ern err Cremer 65 Compatible accessories un en ee ee re 65 BIMCANTONMAUOMIN ee ee ea ee ERR 67 Compliance information and recommended electromagnetic emission 67 Compliance information and recommended electromagnetic immunity 68 Cautions and recommended electromagnetic environment cccccseeeeeeeeeeees 69 Recommended separation distance ccccccssesecceceseeeeeeeeeeeeeeesueeeeeesseeeeeseeas 70 Fuse 1G Gastroscope with FuseBox Processor User Manual V Contents vi Warranty ENDCCHOICE FSE 054 EN 6 0 Safety Information Please Read Prior to Use This manual provides information required to enable you to use the Fuse 1G Gastroscope with FuseBox Processor system Read this manual thoroughly before using the device and ensure that you understand the proper use of and care for the device If you have any questions or comments regarding the use of the device please contact EndoChoice Inc Note that the complete instruction manual set for this endoscope also includes the companion Fuse Endoscope Reprocessing Manual The following conventions are used in this manual Symbol Description A warning is a statement that alerts indicates a potentially hazardous situation associated with N WARN NG the use or misuse of the device which if not avoided could result in serious injury or death A caution is a statement that alerts indicate
16. 112 y orrs a E E E a 5 Electric interference Safety ccccccccccsscccceeeeecceescecseueeeceaueeeseseeeeeseeseeeeesseseesseneeeens 6 Fire and explosion safety ccccccccssseceecceeeeeceeceeeeeeeceeueeeeesuseceesseeeeeesssaeeeeesseneeeesaas 7 Operation environment uuneeesenneesnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnen nennen 7 Reprocessing sesers enen conde anne a Ena E tan under ernennen een ernennen 7 CHAPTER 1 Regulatory Information cccccccscscsccccscsccccccscsceccccscscececcccnces 9 1 1 Intended USE erneuern 9 2 WISP Re UA ONS ee een 9 o LECO epee enero ee en 9 CHAPTER System Overview een 11 CHAPTER 3 System Components 13 3 1 Fu use 1G GaSiOSCO DC 2 een 13 3 1 1 Packaged components ccccccssseeeccceeeeeeecceeeeeeeseeeeeesseaeeeeessaeeeess 13 3 1 2 Gastroscope general VIEW ccccccccsssseeceeeeeeeeeeeeeeeeeeeeeaeeeeseeeesenaas 15 3 1 3 GastrOSCOPe interface uuuusssnnnnnnnnnnneennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 16 3 1 4 Gastroscope internal Channels c cccecccccceeeeeeeseeeeeeeeeeeeeseeseeeeeesaas 18 32 GO nee een Een ee ee ee ee 19 3 2 1 Packaged components cccccccseeeceeeceeeeeeeeeeeeeeeeeeeeeeeeeseaseeeeesaaeeeees 19 3 2 2 FuseBox front panel interface ccccccccccceececeeeeceeeeeseeeseeeeseeeeeaes 20 3 2 3 FuseBox back panel interface ccccccccceeeeceeeeeeeee
17. Bottle 1 Prepare for use per manufacturer instruction for use 2 Fill the water bottle with sterile water or the prescribed solution 3 Fasten the cap with tube assembly onto the bottle by screwing it until tight Do not over tighten 4 Connect the tube to the Air Water Bottle Port on the Fuse endoscope N WARNING Improper handling of the Reusable Water Bottle may pose an infection control risk or degrade or prevent correct device function Observe the following warnings when using the water bottle o Refer to the instructions for use Failure to follow instructions for use may result in contamination degraded performance or loss of functionality o Prior to use inspect the water bottle package and the product itself for signs of damage or tampering If tampering or damage exists do not use Do not use if the Sterile package is not sealed and or the date has expired o Do not store the water bottle outside of its package remove the packing immediately before use Fuse 1G Gastroscope with FuseBox Processor User Manual 33 Preparing and Inspecting the System O O Do not use the water bottle for a longer period of time than recommended by the manufacturer Use only sterile water or the prescribed solution to avoid bio contamination Disposable Water Bottle Cap a a a a Prepare for use per manufacturer instruction for use Remove the cap from the bottle of sterile water provided by solutions manufactu
18. User Manual Fuse 1G Gastroscope with FuseBox Processor Part Number FSE 054 EN 6 0 Released March 2014 This manual includes all operating instructions for the Fuse 1G Gastroscope and FuseBox Processor Please refer to the companion Fuse Endoscope Reprocessing Manual for complete reprocessing instructions Onl F y Caution Federal U S law restricts this device to sale by or on the order of a physician EndoChoice Inc 11810 Wills Road Alpharetta GA 30009 Tel 888 682 3636 Fax 866 567 8218 customercare endochoice com www endochoice com IMPORTANT Read this User Manual in its entirety prior to using the Fuse 1G Gastroscope 2014 EndoChoice Inc ALL RIGHTS RESERVED EndoChoice Inc reserves the right to alter the equipment specifications and descriptions in this publication without prior notice No part of this publication shall be deemed to be part of any contract or warranty unless specifically incorporated by reference into such contract or warranty The information contained herein is merely descriptive in nature and does not constitute a binding offer for the sale of the product described herein Neither EndoChoice Inc nor its agent make any representations for fitness for any purpose other than specifically mentioned in this manual DISCLAIMER EndoChoice Inc shall not be obligated in any manner in respect to bodily injury and or property damage arising from
19. a _ s Se u g Ea 1 E Bi wia u u wWw_ 1 Pua ie ee 17 Q aaa aTa fr rw Gc ae DW Ee l E a sa J u I We wit EE Gyre iw iw gt The following system functions performed using the numbered buttons located on the endoscope Control Handle apply to all active monitor screens Capture image The capture image function stores a still image to an external drive e To use the capture function press the Capture button on the endoscope Control Handle marked as button 1 Capture 1 Fuse 1G Gastroscope with FuseBox Processor User Manual 53 Understanding the FuseBox System Screens and Functions a The endoscopic video can be recorded in real time Recording using the endoscope Control Handle 1 Prior to procedure verify that the FusePanel is connected to the system via the appropriate ports on the FuseBox back panel 2 To begin recording press the Record button marked as button 2 on the endoscope Control Handle 3 To stop recording press the Record button 2 again Record 2 54 DENDCCHOICE FSE 054 EN 6 0 Understanding the FuseBox System Screens and Functions The Timer function allows procedure time to be displayed on screen from the Control Handle Timer captures and displays three increments of time Insertion Time Withdrawal Time and Total Time To use Timer 1 Press the Timer button marked as button 3 once to start the clock 2 Press the Timer button ag
20. ain to set your first Mark such as Insertion Time 3 Press the Timer button a third time to set your second Mark such as Withdrawal Time 4 Pressing the Timer button a fourth time stops the Timer freezing all three values total time Mark 1 and Mark 2 on the screen 5 Pressing the Timer button a fifth time clears times from the screen Start starts the timer Mark marks the first and second durations Stop stops the timer Reset resets the timer back to 00 00 00 Display ON displays the timer information on the LEFT monitor Fuse 1G Gastroscope with FuseBox Processor User Manual 55 Understanding the FuseBox System Screens and Functions The Zoom function allows magnification of the endoscopic image during procedure Per the operator preference Zoom can be applied on the endoscopic image or ona frozen image The zoom function magnifies both image views To operate the Zoom function 1 Press the Zoom button marked as button 4 on the endoscope Control Handle Each press of the zoom button toggles through one of the 6 Zoom levels OFF X 1 2 X 1 4 X 1 6 X 1 8 X 2 0 m m Faal avi aN aa ae ee or OO sO ee Ct Oa CAO j TA TY Od CCLEC CIK Ya m la le w W Gee Ye I amp aw Ww SE Gy ww BEE EQUA Ue Ww The freeze function creates a still image that is displayed on the screen but not recorded The freeze function freezes both image views Freeze the image using t
21. ally rigid Visually confirm that all the markings on the Insertion Tube are clearly visible Visually inspect the two objective lenses located at the front and the left side of the Distal Tip for scratches cracks stains openings around the lens or other irregularities Visually inspect the two air water nozzles located at the front and the left side of the Distal Tip for abnormal swelling dents blocks scratches stains missing parts or other irregularities Using both hands gently bend the Insertion Tube not the Bending Section near the Distal Tip of the endoscope into a semicircle Then moving your hands confirm that the entire Insertion Tube can be smoothly bent to form a semicircle and that the Insertion Tube is flexible Gently hold your finger in the middle of the Bending Section Gently push and pull with your other hand the Insertion Tube to ensure that the joint between the Bending Section and the Insertion Tube is not loose Wipe dry the endoscope connector including the electrical contacts using sterile clean lint free cloths Also confirm that the electrical contacts are completely dry and clean Fuse 1G Gastroscope with FuseBox Processor User Manual 2 Preparing and Inspecting the System Af m f m um za a a Lia a u oe eee aa Z 12 4 LL QOQNNnHALT THA CLICTINN ALlL W m ad Fro Ole ic Qo u IG gt u oh OS 9 Ga IWW Poa ww Wi i Www FEE eSUEWEIWE ES GHEE WY Push the Suction Re
22. any internal changes removals attachments or additions to the product or components thereof Defective parts replaced by EndoChoice shall be returned to the designated EndoChoice facility at EndoChoice s expense Title and risk of loss with respect to such parts shall pass to EndoChoice upon delivery to EndoChoice s facility Products or parts thereof may be returned for repair replacement or adjustment only with EndoChoice s prior written consent or in accordance with the FuseCare Global Service Program terms No credit allowances will be given or replacements shipped unless defects are verified by EndoChoice or EndoChoice s authorized personnel TO THE EXTENT ALLOWABLE BY APPLICABLE LAW THE FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES GUARANTEES PROMISES OR REPRESENTATIONS OF QUALITY OR PERFORMANCE WHETHER WRITTEN ORAL OR IMPLIED AND ALL OTHER WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY SATISFACTORINESS FITNESS FOR ANY PARTICULAR PURPOSE OR USAGE OF TRADE ARE HEREBY DISCLAIMED THE REMEDIES STATED HEREIN CONSTITUTE THE EXCLUSIVE REMEDIES AND ENDOCHOICE S ENTIRE LIABILITY FOR ANY BREACH OF WARRANTY Fuse 1G Gastroscope with FuseBox Processor User Manual 71 Troubleshooting CE u EndoChoice Innovation Center Ltd 2 Hatochen Street Caesarea 38900 Israel Tel 972 4 632 7731 Fax 972 4 632 7734 Email info EndoChoice com 72 ENDCCHOICE Ec rer European
23. atment that are defined by the hospital s administrators or other official institutions such as academic societies on endoscopy Before starting gastroscopy and gastroscopic treatment thoroughly evaluate its properties purposes effects and possible risks their nature extent and probability e Procedures and treatment should only be performed when the potential benefits outweigh the risks Immediately stop the procedure if the patient risks exceed the potential benefits e Do not use the system if unsafe conditions exist In the event of hardware failure that could potentially cause hazardous conditions smoke fire etc turn the power off and unplug the power cord e Inthe event of product malfunction discontinue operation and contact an authorized service person immediately Fuse 1G Gastroscope with FuseBox Processor User Manual 3 Safety Information Please Read Prior to Use The Fuse 1G Gastroscope should only be used by a physician who is well trained and capable of performing the planned gastroscopy and gastroscopic treatment This manual does not explain or discuss endoscopic procedures The manufacturer or vendor of the equipment makes no claim that the act of reading this manual renders the reader qualified to operate the system It is important that this manual remain available studied carefully and reviewed periodically by the authorized operators All external components connected to the Fuse system
24. ce Pump Control Light Control Diaphragm Pump System Components Details Up Down 210 120 Left Right 120 105 cm Value 115 V 230 V 50 Hz 60 Hz 10 300 W Fuse 1G Gastroscope Fuse 1C Colonoscope 3 x Y C 3 x Composite NTSC 3 x DVI Activation via Front Panel Off Low Medium High Light ON OFF 14 5 kg 350 mm x 170 mm x 450 mm Class Type BF 45 kPa 1 25 cm s Fuse 1G Gastroscope with FuseBox Processor User Manual 23 System Components 24 Environment Value Operating Conditions Temperature 5C 41F 40C 104F Relative Humidity Uncontrolled 85 RH Transportation and Storage Conditions Temperature 29C 20F 38C 100F Relative Humidity Uncontrolled 85 RH ENDCCHOICE FSE 054 EN 6 0 Preparing and Inspecting the System CHAPTER 4 Preparing and Inspecting the System This chapter provides an overview of the system s setup and instructions for system preparation and inspection 4 1 Overview system connection chart Monitors FusePanel FuseBox Printer Fuse Endoscopic Optional Endoscope Tools Auxiliary Suction Water Water Source Bottle Supply Fuse 1G Gastroscope with FuseBox Processor User Manual 25 Preparing and Inspecting the System A WARNING The Fuse 1G Gastroscope must be inspected for device integrity before use
25. ceeseeeseeeesseueeessageeessaes 31 Connect Fuse 1G Gastroscope and ancillary equipment to the FuseBox 32 4 5 1 Connect the Fuse 1G GastrOSCOpe ccccccccsseeseeeeeeeeeeeeeeeeeeeeeeeaes 33 4 5 2 Connect the water bottle u444444404eennnnnnnnnnnnnnnnnnnnnnnnnnen nn 33 4 5 3 Connect the water jet connector to the auxiliary water port 34 4 5 4 Connect the irrigation tubing to the water jet connector 34 4 5 5 Connect the suction SOUfte anu ea 35 4 5 6 Connect the auxiliary water supply jet uus222440000B0e nennen nnennnnee nenn 36 Inspect the Fuse 1G Gastroscope functions 2 002220002000 nenn enenne nennen 37 4 6 1 Test the angulation mechanism us 44004ennn nennen nennen nenne nennen 37 4 6 2 Turn the FuseBox system on nuueensnnenennennnnnnnennonenne nenne nnnnnnenne nennen 37 4 6 3 Test the video signal and white balance u00444400BR ernennen 38 4 6 4 Test the insufflation MECHANISM 444444044n nenn nnnnnnnennnnnnne nen 40 4 6 5 Test the irrigation MECHANISM cccccseeeceseeeeeeseeeeecseeeeeseeeeeeseneeesaaes 41 4 6 6 Test the suction mechanism ccccceeeeeeeeeeeeeeeeeeeeeaeeeeeeesaaeeeeeesaaeeeees 42 4 6 7 Test the auxiliary water MECNANISM cccceeceecseeeeeceeeeeeseeeeeeseeeeeeaaes 42 4 6 8 Test the XLUM blinking mode cceeecccecceeeeeeeeseee
26. d be that of a typical commercial or hospital environment If the user of this instrument requires continued operation during power mains interruptions it is recommended that this instrument be powered from an uninterruptible power supply or battery FSE 054 EN 6 0 TroubleshootingAppendix Level Power 3V m Same asleft Itis recommended to Frequency use this instrument while 50 60Hz maintaining enough distance from any Magnetic field equipment that operates IEC 61000 4 with high current 8 2009 This section provides cautions and recommendations for electromagnetic environments in regards to portable and mobile RF communications equipment such as cellular phones Guidance and Manufacturer s Declaration Electromagnetic Immunity The Fuse 1G Gastroscope is intended to be used in the electromagnetic environment specified below The user and the medical staff should ensure that it is used only in these environments Immunity Test IEC 60601 1 2 test Compliance level Level Radiated RF 3V m Conditions not written in report recommend d 1 2VP _80MHz 800 MHz d 2 3VP _800MHz 2500 MHz IEC 61000 4 3 2006 80 2500MHz Amendment A1 2007 Amendment A2 2010 Conducted RF 3Vams Conditions not written in report recommend d 1 2 P IEC 61000 4 6 2003 0 15 80MHz Amendment A1 2004 80 A M by 1Khz Amendment A2 2006 This instrument complies with the IEC 60601 1 2 2001 However under electromagnetic environment
27. doscope 3 4 3 3 Inspect the accessories and connect to the endoscope 4 4 3 4 Set up the FuseBox system 5 4 5 Connect the endoscope and accessories to the FuseBox 6 0 Inspect system functionality Spare Backup Equipment Preparation of another gastroscope related accessories and backup generator is recommended to avoid unexpected procedure termination interruption due to equipment failure or malfunction 26 QENDCCHOICE FSE 054 EN 6 0 Preparing and Inspecting the System Refer to the Fuse Endoscope Reprocessing Manual for detailed instructions Visually inspect the Control Handle for excessive scratching deformation loose parts missing parts or other irregularities Visually inspect the Insertion Tube section specifically the section interfacing with the Control Handle for bends twists or other irregularities Visually inspect the external surface of the entire insertion section including the Bending Section and the Distal End for dents swelling scratches holes bends adhesion of foreign bodies missing parts protruding objects or other irregularities Holding the control section with one hand carefully run your other hand back and forth over the entire length of the insertion section Confirm that no rough surfaces sharp edges objects or metallic wire protrude from the outer surface of the insertion section nor from any endoscopically used accessories Also confirm that the Insertion Tube is not abnorm
28. e FusePanel Make sure the FusePanel is connected to the FuseBox for this test 1 Confirm that the FusePanel is properly connected and turned ON 2 Press the Capture 1 button on the endoscope 3 Animage capture thumbnail will appear at the bottom of the FusePanel screen The following video recording functionality is used with the FusePanel only Make sure the FusePanel is connected to the FuseBox for this test Confirm that FusePanel is properly connected and turned on To start the video recording press on the Record 2 button on the endoscope A red REC icon will flash in the upper right corner of the FusePanel screen To stop the video recording press on the Record 2 button on the endoscope A thumbnail of the video recording will appear at the bottom of the FusePanel A en screen 1 Press the Timer 3 button on the endoscope Confirm that the digital time appears on the Left monitor display Press the Timer 3 button three more times in sequence to test display of Insertion Time Withdrawal Time and Total time 4 Press the Timer 3 button one final time to reset 1 Press on the Zoom 4 button on the endoscope 2 Confirm that the endoscopic image zooms in by verifying that the zoom magnification OFF X 1 2 X 1 4 X 1 6 X 1 8 X 2 0 appears in the center monitor display 3 Press on the Zoom 4 button five 5 more times to cycle through all zoom levels 4 Con
29. e indicates a level of 5 e The range available is 5 to 5 Use the UP DOWN arrows to increase or decrease the blue color level of all active monitors PIG GVE e The image shown above indicates a level of 3 e The range available is 5 to 5 Use the UP DOWN arrows to increase or decrease the brightness level of all active monitors Phgnigss e _ The image shown above indicates a level of 5 e The range available is 5 to 5 Fuse 1G Gastroscope with FuseBox Processor User Manual 47 Understanding the FuseBox System Screens and Functions The LED Intensity screen allows adjustment of the LED Label name Function Use the slider to increase or decrease the light LED Intensity slider 7 intensity level of the Distal Tip 48 ENDCCHOICE FSE 054 EN 6 0 Understanding the FuseBox System Screens and Functions The System Information Scope Information screen displays the current system configuration Press the Setup icon three times to access this screen x z AA System Information Scope Information MCU S N 0000000 Scope S N 0000000 Revision A01 Type Gastroscope FPGA Ver 0 00 Handle Ver AA 12 2010 DSP Ver 0 00 SW Ver 00 00 0000 X Setup Light Timer XLUM No modifications can be made through this screen Label name Function Displays the FuseBox configuration TM PUSERO yM e Serial number Information l e _ Software version Displays the endoscope s information when c
30. e temporary blindness due to the illumination 1 Setup the 3 FuseView monitors on the monitor stand or properly secured bracket system For monitor operation refer to the monitor instructions for use 2 Locate the monitor cable bundle 3 Connect the FuseBox to the monitors using the cables 4 Select the appropriate video input on the monitor refer to the monitor instructions for use By default upon startup the letters for the Left L Center C and Right R views are displayed on the corresponding monitors Depending on the operator s needs the Left monitor may be turned ON and OFF the Center monitor always remains ON Use the FuseBox to configure the monitors following these steps 1 From the FuseBox Main screen press the SETUP icon four times This will take you to the Monitor Selection screen By default all monitors are ON 2 Press the ON OFF icon corresponding to the Left monitor to toggle its display ON OFF If the FuseBox is connected to the monitors each monitor will go blank as it is turned OFF 30 NDENDCCHOICE FSE 054 EN 6 0 Preparing and Inspecting the System There are two paths that connect the FusePanel to the FuseBox e Video cable path x3 e Remote trigger path x3 Consult the Connecting Cables section of the FusePanel User Guide to learn how to connect these paths Fuse 1G Gastroscope with FuseBox Processor User Manual 31 Prepari
31. ection the Bending Section moves RIGHT When this knob is turned in the L direction the Bending Section moves LEFT When this knob is turned in the U direction the Bending Section moves UP When this knob is turned in the D direction the Bending Section moves DOWN Moving this lock counter clockwise locks the Up Down angulation Moving the lock in the opposite direction disengages the Up Down angulation brake Contains five 5 auxiliary buttons with textural numerals 1 Capture Print image 2 Record Stop recording image 3 Timer 4 Zoom toggles through 6 zoom levels 5 Freeze Release unfreeze image Attach the Suction Reusable Scope Valve to this opening Attach the Air Water Reusable Scope Valve to this opening Attach the Biopsy Valve to this opening Fuse 1G Gastroscope with FuseBox Processor User Manual 17 System Components 3 1 4 Gastroscope internal channels 2 3 gt Item Name of Item 1 Air Water Nozzles 2 Air Channel 3 Water Channel 4 Suction Working Channel 5 Biopsy Port 6 Air Water Reusable Scope Valve 7 Suction Reusable Scope Valve 8 Suction Channel 9 Air Channel 10 Water Channel 11 Auxiliary Water Channel 12 Water Bottle 18 DENDCCHOICE FSE 054 EN 6 0 System Components 3 2 FuseBox 3 2 1 Packaged components Carefully remove the FuseBox from its packaging Verify that the following items are available Item Name of Item Funct
32. ed will hold in the set position Before moving on to the next step be sure the brakes are unlocked Unlocked position 45 angle 3 Rotate the Up Down angulation knob and verify that the bending area moves smoothly and through the full range of up down movement 4 Rotate the Left Right angulation knob and verify that the bending area moves smoothly and through the full range of left right movement If the FuseBox system has not yet been turned on follow these steps 1 Press the ON OFF button on the back of the FuseBox Fuse 1G Gastroscope with FuseBox Processor User Manual 3 Preparing and Inspecting the System 2 Press the round ON OFF button on the lower left hand side of the FuseBox front panel The ON OFF button illuminates green when the system is ON 3 Turn the Distal Tip light ON by pressing the LED button in the front panel CAUTION m Avoid looking directly at the Distal Tip when the light is ON as this could cause temporary blindness due to the illumination 1 Place the Distal Tip inside the White Balance Cup Note that the LEDs are currently white 2 Perform white balance test by pressing the WHITE BALANCE button on the FuseBox Continue pressing the WHITE BALANCE button until the white light blinks The white balance button will indicate white balance operation by blinking The white balance LED will turn from white to blue 3 Verify that the Center and Left video screens display a
33. eeeeeeeeeesseeeeeees 21 33 TODS CII ANOS See einen 22 3 3 1 Fuse 1G Gastroscope nu een 22 oe PEBE A aE a 23 3 329 SEINVIONMERL scriescene see 24 CHAPTER4 Preparing and Inspecting the System scsscscssscsscscsceccecnces 25 Fuse 1G Gastroscope with FuseBox Processor User Manual iii Contents 4 1 4 2 4 3 4 4 4 5 4 6 Overview system connection CNAMt ce ceeececcececeeeeeeeeeeeeeeeaeeeeeeeeeeesseaaeeeeeeees 25 Preparation and inspection workflow ccccsecccceeeeeeceeeeeeseeeeeeeeeeeeseeeeeseneeesaees 26 Prepare the Fuse 1G GastrOSCOpe ennenneensnnennnennnnnnnnnnnnnnnnn nennen nnennn nennen 27 4 3 1 Reprocess the Fuse 1G Gastroscope prior tO USE ccceeeeeeeeee ee 27 4 3 2 Inspect the Fuse 1G Gastroscope prior tO USe enuuenseessnesnneenenenenenn 27 4 3 3 Connect the suction air water and biopsy VaIVe S ccccseeseeeeeseeeeees 28 4 3 4 Connecting the reusable suction and air water scope valves 29 Set up the FUSEBOX system cccccccssseeeceeseeceeeseecceseeeseaseesseneeesseeeesseneeeess 30 4 4 1 Connect the FuseBox to a power SUPDIY cccceeceeseeeeeeeeeeeeeeeees 30 4 4 2 Connect the FUSeVieW monitors nuuuussnenseennennnenennnnnennnn nenne nennen 30 4 4 3 Select monitor display MOE ccccccseeeeeccceeeeeeeeeceeeeseeeeeeeeeeeeeeeaaas 30 4 4 4 Connect FusePanel 0 0 ccccceccccsesecccessceccsesee
34. eeeeeseaeeeeeesaaeeees 42 4 6 9 Test the Capture function uueesssssssssnnneeeennnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnn 43 4 6 10 Test the Record fUNCtION ccceccceeeeeeeeee eee eeeeeeeeaeeeeeeesaaeeeeesaaneeees 43 4 6 11 Test the Timer function cecceceeeseeeeceeeseeeeeseaaeeeesseaseeeessaaneeees 43 4 6 12 Test the Zoom function euesssssesnennennnnnnnnnnnennonnannennonnnnnennennannennennan en 43 4 6 13 Test the Freeze Release function 22 ceseeeeeeeeeeeeseeeeeeeeeseeeeeees 43 CHAPTERS Understanding the FuseBox System Screens and Functions 45 9 1 iv QDENDCCHOICE User Screens uanannsnanananennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnenennenn 45 5 1 1 Navigaing me GU csse E 45 5 1 2 FuseBox main ScheeN case 45 FSE 054 EN 6 0 Contents 5 1 3 Setup screen 1 image settings 22uuuessennnnnnnnnnenennnnnnnnnnnennnnnnnnnnnnnn 47 5 1 4 Setup screen 2 LED intensity uuuuusunnsesnnnnnnnnnnnnnnnnnnnnnnnnennnnennnnnnnn 48 5 1 5 Setup screen 3 system scope information cccceessseeeeeeeeeeeeees 49 5 1 6 Setup screen 4 monitor selection 1 2 3 monitors 50 9 457 EIOHL MOderzEr nr eed ee 51 91 8 WANA asien 52 5 1 9 XLUM Distal Tip LED blinking mode ccccccccececceeeeeeeseeeseeseeeeeaees 52 52 SYSIEHILTIURCIONS Eee ae 53 9 2 1 Capture Image anne nee eine 53 922 Videorecord
35. em to provide the appropriate electrical grounding To minimize the potential for electrical shock the power cable must be plugged into an approved grounded electrical outlet Do not use an adapter to plug the system into an ungrounded outlet Do not operate the system if damaged wires or open leads are detected Fuse 1G Gastroscope with FuseBox Processor User Manual 5 Safety Information Please Read Prior to Use e Do not remove or open system covers The operator should never open the panels of the system Only qualified personnel are authorized to maintain and service the system e Be sure to install the Fuse system equipment in one of the recommended combinations for optimal use If combinations other than those shown throughout this and other Fuse manuals are used optimal operation cannot be assured WARNING e Do not place a power strip on the floor e Donot connect an additional power strip to the system e Do not connect items which are not specified as part of the Fuse system Using incompatible equipment can result in patient or operator injury and or equipment damage and will increase the leakage current CAUTION m The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Consideration relating to the choice shall include 1 use of the accessory in the PATIENT VICINITY and 2 evidence that the
36. firm that the endoscopic image returns to normal view The following functionality is used with the FusePanel Make sure the FusePanel is connected to the FuseBox for this test 1 Press the Freeze 5 button on the endoscope 2 Confirm that the endoscopic images freeze 3 During Freeze the live endoscopic image appears in a small picture in picture 4 Press on the Freeze 5 button again 5 Confirm that the endoscopic images return picture in picture disappears This page intentionally left blank Fuse 1G Gastroscope with FuseBox Processor User Manual 43 Preparing and Inspecting the System 44 DENDCCHOICE FSE 054 EN 6 0 Understanding the FuseBox System Screens and Functions This chapter provides descriptions and functionality of the FuseBox system touch screen user interface Icon Icon name Function Back icon Use this icon to move backward one screen Use this icon to go directly to the system s main screen Main screen icon Touch these numerals to move to the desired Setup screen Alternative to pressing the Setup icon to reach the Setup screens 1 Image Settings 2 LED Intensity 3 System Information 4 Monitor Selection Setup Screen Navigation icons The FuseBox system uses a touch screen user interface Fuse 1G Gastroscope with FuseBox Processor User Manual 45 Understanding the FuseBox System Screens and Functions 46 Label Icon name T
37. foration Patient safety in gastroscopic examinations and gastroscopic treatment can be obtained through appropriate handling by the physician and the medical facility Examples of improper handling are listed below N WARNING Over insufflating the lumen may cause patient pain injury bleeding and or perforation Do not excessively inflate air or a nonflammable gas into the patient This could cause gas embolism Applying suction with the Distal End in prolonged contact with the mucosal surface with higher suction pressure than required or with a prolonged suction time may cause bleeding and or lesions Inserting or withdrawing the endoscope feeding air applying suction or operating the Bending Section without a clear image may cause patient injury bleeding and or perforation Fuse 1G Gastroscope with FuseBox Processor User Manual 57 Performing the Procedure e Using the endoscope with no image If the endoscope image disappears unexpectedly during an examination immediately stop using the endoscope and withdraw it Inserting the endoscope using endoscopic tools performing suction feeding air or performing angulation control under these conditions could result in patient injury bleeding and or perforation If the intestines contain a flammable gas replace with air or a nonflammable gas such as CO before performing high frequency treatment WARNING e Performing treatment while the intestines are filled wit
38. h a flammable gas could result in an explosion fire and or serious injury NOTE Using CO2 during endoscopic examinations may reduce post examination pain Recommend the use of a bite block of at least 38 French or greater 1 Confirm that the angulation brakes are not in the locked position 2 Slowly and gently insert the gastroscope Insertion Tube while viewing the gastroscopic image 3 Operate the angulation controls to guide the Distal Tip for insertion and examination N WARNING 58 e Do not force the endoscope Insertion Tube Serious injury may result from use of excessive force CAUTION m Do not apply petroleum based materials lubricants on the Distal Tip as they may accelerate the degradation ofthe Bending Section m fthe image dims during the procedure tissue or debris might have adhered to the Distal End which may cause the temperature to rise Slowly extract the gastroscope to avoid patient and or operator burn injury CAUTION Failure to observe the following cautions may cause device damage or patient injury m Make sure the endoscopic devices accessories diameter is suitable for the work channel ENDCCHOICE FSE 054 EN 6 0 Performing the Procedure Do not open or attempt to articulate endoscopic devices accessories inside the work channel Open tools can cause damage to the channel Do not use endoscopic devices accessories if the field of vision is not clear Take care not to tear the Bio
39. hat suctions at rates up to 30L min j SCT 466 Hydra Water Bottle Cap and Tubing Set by EndoChoice Fuse 1G FuseBox Water bottle cap SCT 467 Hydra Water Bottle Cap Disposable and Tubing Set with CO2 by EndoChoice Fuse 1G Biopsy cap SBC 460 10 Seal Reusable Biopsy Reusable Valve by EndoChoice Fuse 1G Valve cleaning SBB 119 50 HedgeHog Valve Disposable brush Brush by EndoChoice Sterile SBS 227 50 HedgeHog Single End Channel Brush by EndoChoice SBD 228 50 HedgeHog Double End Channel Brush by EndoChoice SBD 289 50 HedgeHog Dual End Cleaning brush Channel Valve Brush by Fuse 1G suited for 2 8 EndoChoice Disposable Sterile mm channels SBD 291 50 HedgeHog Sweeper by EndoChoice SBD 371 50 HedgeHog Sweeper Bundle by EndoChoice SBD 382 50 HedgeHog Double Bundle by EndoChoice Auxiliary water pump tube set Disposable TM au Sterile Fuse 1G Gastroscope with FuseBox Processor User Manual 65 Troubleshooting 66 Fuse System component name Fuse 1G Recommended compatible accessory to be used Bite block Recommended accessory SBT 114 100 Blox Bite Block with Dental Retention by EndoChoice SBT 321 100 Blox without Dental Disposable Retention by EndoChoice Sterile SBP 236 40 Blox Pediatric Bite Block by EndoChoice All of the HedgeHog brush products listed above are used in channels 2 mm and
40. he FuseBox hardware These objects may prevent proper cooling of the electronic equipment The system should not be exposed to a wet or humid environment When positioning the system make sure that the main plug and socket are accessible Avoid exposing the system to direct sunlight or other heat sources The Fuse 1G Gastroscope is a flexible semi critical device that contacts intact mucus membranes or non intact skin Therefore as with any other flexible endoscopes it must be reprocessed to be free from all microorganisms before use The FDA recommends reprocessing by thoroughly cleaning this device and then by performing appropriate disinfection Validated procedures for reprocessing this device are provided in the Fuse Endoscope Reprocessing Manual The Fuse 1G Gastroscope was not reprocessed before shipment Before first time use reprocess the device according to the instruction provided in the companion Fuse Endoscope Reprocessing Manual After use reprocess and store according to the Fuse Endoscope Reprocessing Manual Improper and or incomplete reprocessing or storage can create an infection control risk cause equipment damage or reduce performance Fuse 1G Gastroscope with FuseBox Processor User Manual 7 Safety Information Please Read Prior to Use This page intentionally left blank 8 ENDCCHOICE FSE 054 EN 6 0 Regulatory Information The Fuse system is intended for d
41. he System e Connect the suction source to the Suction Port on the Main Connector N WARNING e Applying suction with the Distal End with higher suction pressure than required may cause bleeding and or lesions Fuse 1G Gastroscope with FuseBox Processor User Manual 35 Preparing and Inspecting the System 1 Prepare the auxiliary water supply system per manufacturer s instructions for use 2 Unscrew the Auxiliary Water Supply Port Cap on the Fuse 1G Gastroscope a 3 Connect the Water Jet Connector to the Auxiliary Water Supply Port 4 Connect the Auxiliary Water Supply Tube to the Water Jet Connector i 5 Replace the Auxiliary Water Supply Port Cap on the Fuse 1G Gastroscope after 4 WARNING e f an auxiliary water source is not used ensure that the Auxiliary Water Supply Port is use closed Failure to do so could result in infection control risk such as retrograde flow of patient material to the Auxiliary Water Supply Port 36 MENDCCHOICE FSE 054 EN 6 0 Preparing and Inspecting the System 1 Hold the gastroscope with the controls resting in the palm of your hand so that the angulation control knobs are facing you 2 Confirm that the brakes are not locked When the Up Down brake handle points upward the brake is locked When the brake handle points 45 to the right the brake is not locked When the Left Right brake labeled F gt RL is near the R mark the Distal Tip is lock
42. he endoscope Control Handle 1 Press the Freeze Release button marked as button 5 2 To release the image press button 5 again Freeze Release 5 56 DENDCCHOICE FSE 054 EN 6 0 Performing the Procedure N WARNING The Fuse 1G Gastroscope should only be used by a physician It is the responsibility of the personnel using this equipment to be well trained in the use of clinical endoscopy techniques This manual only provides basic instructions and precautions related to the operation of this equipment The gastroscope and its reusable accessories MUST be reprocessed prior to use Refer to the Fuse Endoscope Reprocessing Manual for complete reprocessing instructions Failure to do so may pose an infection control risk In case of instrument failure malfunction during a procedure it is recommended to always keep a spare gastroscope system in the room ready for use Perform all device inspections described in these instructions prior to use Do not use the Fuse 1G Gastroscope if it is not functioning correctly Using an impaired or damaged device may result in patient injury Wear personal protective equipment to guard against dangerous chemicals and potentially infectious materials during use of the device Do not use the gastroscope if the markings are not clearly visible Insertion and manipulation of the endoscope without visibility of the markings may cause patient pain injury bleeding and or per
43. his icon to activate the Light Fuse 1G Gastroscope with FuseBox Processor User Manual 51 Understanding the FuseBox System Screens and Functions The Timer allows the user to record elapsed time between events during the procedure Each press of the scope button affects the timer as follows e Click 1 Starts Total Procedure Time green timer e Click 2 Freezes marks the moment of total insertion time and begins timer for withdrawal starting at 00 00 e Click 3 Stops all timers e Click 4 Resets all timers KA Total Procedure Time Timer Display ON Insertion Time Withdrawal Time X Setup Light O Timer XLUM Icon name Function Timer Use this icon to record procedure time The position of the Distal Tip may be determined from outside the patient s body by using the XLUM Trans illumination mode XLUM mode can be activated by pressing the XLUM icon located on the far right of the Main screen When in XLUM mode the Distal Tip light is set to cycle between maximum and minimum light intensity blinking Pressing the XLUM icon activates only the Distal Tip light No additional screen will appear on the FuseBox when using this mode 52 MENDCCHOICE FSE 054 EN 6 0 Understanding the FuseBox System Screens and Functions Icon name Function Use this icon to activate the XLUM mode XLUN mode activation XLUM mode automatically deactivates after seven 7 seconds Ca i a E
44. iagnostic visualization of the digestive tract The system also provides access for therapeutic interventions using standard endoscopy tools The Fuse system consists of EndoChoice camera heads endoscopes video system light source and other ancillary equipment The Fuse 1G Gastroscope in conjunction with the FuseBox processor is indicated for use within the upper digestive tract including the esophagus stomach and duodenum CAUTION m Federal U S law restricts this device to sale by or on the order of a physician wal C owe Ec REP EndoChoice Innovation Center Ltd 2 Hatochen Street MEDNET GmbH Caesarea 38900 Israel BorkStraBe 10 Tel 972 4 632 7731 Munster Germany 48163 Fax 972 4 632 7734 Tel 49 251 32266 0 Email info EndoChoice com Email info medneteurope com This device complies with the requirements of Directive 93 42 EEC concerning medical devices Classification Class Ila In the European Union the following symbol indicates that when the last user wishes to discard this product it must be sent to appropriate facilities for recovery and recycling Contact your local EndoChoice representative for additional information on the collection and recovery programs available for this product Fuse 1G Gastroscope with FuseBox Processor User Manual Regulatory Information This page intentionally left blank 10 JENDCCHOICE FSE 054 EN 6 0 System Overview The Fuse system
45. in material and workmanship for a period of one year from the date of shipment as applicable the Warranty Remedy Period If a nonconformity is discovered in a product during the Warranty Remedy Period under normal and proper use then EndoChoice shall at its option either repair or replace any allegedly defective part or parts at its expense It is a condition precedent to EndoChoice s undertakings that written notice of such nonconformity is provided to EndoChoice promptly after such discovery but in no event later than ten 10 business days thereafter and within the applicable Warranty Remedy Period Such notice shall describe the full extent and nature of the problem EndoChoice shall have no obligation hereunder with respect to any product that i has been improperly stored installed operated or maintained or has otherwise been used in a manner contrary to the instructions for use ii has been repaired or altered not in accordance with the instructions for use ili has been subject to misuse unauthorized use negligence accident including fire water explosion smoke vandalism etc moisture intrusion during cleaning or any other cause beyond EndoChoice s control or iv has failed as a result of ordinary wear and tear Without derogating from the above the warranty for the products is void if at any time anyone other than EndoChoice s authorized personnel removes a product casing and or attempts to make or makes
46. ing ee ee ee ee 54 923 MNE seele 55 924 ZOOMA r a E a a eee 56 5 2 5 Freeze Release IMAGES inier nei 56 CHAPTER 6 Performing the Procedure cccscsssccscscecsccscsceccccscscscescccnces 57 Git Important sale INFOMMAUNON ssie a E AE 57 6 1 1 Examples of improper handling 0 224004404000080nnennnnnn nennen 57 6 1 2 Using nonflammable gases cccccccccsseeeeeecaeeeeeeeceeeeeeeeseaeeeeeesaeeeeees 58 6 2 Inserting the gastroscope an Eee 58 6 3 Using endoscopic devices and accessories uusssnssennennnenennennnnnnnne nennen 58 6 3 1 Using endoscopic accessories ccccseecceceeeceeceeeeeceeeceeceeeeeseueeeesaees 59 6 3 2 Using electrosurgical accessories uuuueessnnnssnnnnneennnnnnnnnnnennnnnennnnnnnnn 59 6 4 Withdrawing the gastroscope 22uss0nn0nnnnnennnnnnnnennnnnnnnonnnnnennnnnnnnennennnnnennennen 60 CHAPTER 7 Storage and Handling cscsccccscscecsccscsceccccscsceccccecscsceececsces 61 71 OENGO aaa a Ce eee ee 61 1 2 DISaSSEMDV nee ee 61 AS WANS DOM ANON stake eee eee ie ei cl ae eee re 61 TA STOR AGC cei oes ee sens sada enal AO 62 CHAPTER 8 Troubleshooting ccsccccscscsccscscsccccccscsccccccscsceccccscscsccececnces 63 8 1 Troubleshooting the Fuse 1G Gastroscope cccccceeccceeeeeeeeeeseeeeeeeeesaeees 63 8 2 Withdrawal of the gastroscope with NO image ccseeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeees 64 ADDENAN arena RDE On
47. ion 1 FuseBox The control platform for the Fuse 1G Gastroscope 2 AC Cable power cable Provides power to the FuseBox 3 White Balance Cap Proprietary white balance tool 4 User Manual Flash Provides information and instructions for using the drive FuseBox Fuse 1G Gastroscope with FuseBox Processor User Manual 19 System Components 3 2 2 FuseBox front panel interface 20 Item np np np ENDCCHOICE Name of Item ON OFF Button Main Connecter Socket White Balance Button Air Flow Button LED Button System Main Screen Water Bottle Holder Reusable Water Bottle White Balance Cap Setup Light OTimer YXLUM _ u Function Turns the system ON OFF Connect the gastroscope to this opening Perform white balance by pressing and holding for longer than 2 seconds Controls the operation of the pump Pressing the pump level button toggles the pump operation level There are three LEDs on each side of the button The LEDs indicate the following e NoLeEDs lit Pump is OFF e Bottom LEDs lit Pump is operating at a low level e Middle and bottom LEDs lit Pump is operating at a medium level e All LEDs lit Pump is operating at a high level llluminates the Distal Tip LEDs Toggles between ON OFF User interface touch screen Mounts on side of FuseBox or on the side of the FuseCart using hardware provided Not pictured Mounts on Water Bottle h
48. lowing all applicable national and local laws and guidelines To connect the Suction Reusable Scope Valve perform the following steps 7 Grasp the Suction Reusable Scope Valve at its widest point To remove the valve pull gently upward while twisting The valve will slip out when the channel aligns with its slot in the Suction Port Replace the valve by pushing gently into the section port and twisting When the channels align the valve will slip into place Test to make sure the valve is securely seated To connect the Air Water Reusable Scope Valve perform the following steps gn 3008 o E Grasp the Air Water Reusable Scope Valve at its widest point Pull gently to remove the valve Replace the valve by re inserting the valve into the air water port Test to make sure the valve is securely seated Fuse 1G Gastroscope with FuseBox Processor User Manual 29 Preparing and Inspecting the System Use the following steps to set up the FuseBox Connect the power cable to the FuseBox back panel Plug the FuseBox power cable into the power supply On the back panel of the FuseBox switch the power button ON a On the front panel of the FuseBox in the lower left hand corner press the ON OFF button The ON OFF button illuminates green when the system is ON CAUTION m Ifthe FuseBox is already connected to the endoscope avoid looking directly at the Distal Tip when the device is ON as this could caus
49. lso become impossible to straighten the Bending Section during an examination Never insert or withdraw the endoscope s insertion section while the Bending Section is locked in position Patient injury bleeding and or perforation may result Never operate the Bending Section feed air or perform suction insert or withdraw the endoscope s insertion section or use accessories without viewing the endoscopic image or while there is no image Patient injury bleeding and or perforation may result Never insert or withdraw the insertion section abruptly or with excessive force Patient injury bleeding and or perforation may result 4 ENDCCHOICE FSE 054 EN 6 0 Safety Information Please Read Prior to Use If it is difficult to insert the endoscope do not forcibly insert the endoscope stop the endoscopy Forcible insertion can result in patient injury bleeding and or perforation The temperature of the endoscope s Distal Tip may exceed 41 C 106 F due to endoscopic illumination As surface temperatures over 41 C 106 F may cause mucosal burns always maintain a distance suitable for adequate viewing while using the minimum illumination level for the minimum length of time Do not use stationary viewing in close proximity to the mucous membrane or leave the Distal Tip of the endoscope close to the mucous membrane for an extended length of time without necessity CAUTION Do not attempt to manually bend the endoscope
50. ng and Inspecting the System 4 5 Connect Fuse 1G Gastroscope and ancillary equipment to the FuseBox 32 Item ENDCCHOICE Description Fuse 1G Gastroscope to FuseBox Fuse 1G Gastroscope to Air Water Supply Port Cap Fuse 1G Gastroscope to Suction source Fuse 1G Gastroscope to Auxiliary water supply FSE 054 EN 6 0 Preparing and Inspecting the System RNING Prior to connecting the gastroscope connector to the FuseBox confirm that the gastroscope electric connector and the electrical contacts are completely dry and clean If the gastroscope is used with the electrical contacts wet and or dirty the gastroscope and the FuseBox may malfunction Failure to follow the instruction listed below can result in unexpected image loss which may pose patient injury CAUTION Do not bend hit pull or twist the insertion section Bending Section umbilical and gastroscope Main Connector Do not pull the video cable or any connections during an examination The following video connection procedure order is highly recommended to ensure device function Ensure the FuseBox is in a stable and secure location hold it steady while connecting the endoscope and cables e Plug the endoscope Main Connector into the FuseBox Audibly confirm that it clicks into place Follow the instructions for one of the following Reusable Water Boitle or Disposable Water Bottle Cap Reusable Water
51. nnel Auxiliary water functionality e Verify that the pump is turned on e Verify that the auxiliary water supply is tightly connected Angulation functionality e Verify that the brakes are not locked Unexpected resistance when e Ifthe brakes are not locked and you still turning angulation knobs experience resistance do not use the endoscope Contact an EndoChoice representative for further instructions Fuse 1G Gastroscope with FuseBox Processor User Manual 63 Troubleshooting Problem with N WARNING Possible Solutions e If there is unexpected resistance when turning the angulation knobs during a procedure immediately stop the procedure and remove the gastroscope by unlocking the brakes straightening out the gastroscope and carefully removing the gastroscope Continued use of the device may cause patient injury or damage the device Does not reach full range of motion No video signal System does not turn on Pump button does not react Image not clear Do not use the endoscope Contact your EndoChoice representative for further instructions Verify that the system is turned on Verify that the video cables from the FuseBox to the monitors are securely connected Verify clean electrical contacts Verify that the monitors are turned on Verify the video selection on the monitor If the issue is still not resolved do not use the endoscope Contact your EndoChoice representative for further i
52. nstructions If the video signal is lost during a procedure and cannot be restored refer to section 8 2 Withdrawal of the gastroscope with no image Verify that the power back power button is on Verify that the system is connected to a source of electricity Press the ON OFF button until you hear a click Verify that the system is turned on Feed water to remove mucus debris from lens at the Distal Tip When the image disappears and cannot be restored use the following steps 1 Turn OFF the FuseBox and then restart the system If the image is not restored use the following steps Pak wm force 64 MENDCCHOICE Release the angulation knob break Turn the Up Down and Right Left angulation knobs to their natural position Turn the FuseBox and suction source OFF Slowly remove the endoscopic accessory if applicable Release the knobs and slowly withdraw the endoscope do not apply any excessive FSE 054 EN 6 0 TroubleshootingAppendix The following table outlines compatible accessories to be used with the Fuse 1G Table 3 Fuse 1G Accessories Compatibility Fuse Recommended Recommended accessory System compatible component accessory to be name used Fuse 1G Auxiliary water Any product compatible with the Reusable pump Fuse system SIT 355 10 Hydra Disposable Irrigation Tubing System by EndoChoice l Use a suction pump with a tube set Fuse 1 Reusable nn J a ompam t
53. older applied to side of FuseBox or on the side of the FuseCart using the hardware provided Not pictured Used to conduct the white balance test Magnetically mounts to the side of the FuseBox Not pictured FSE 054 EN 6 0 System Components IICC FUSCI 11 EEE o etsteieietete Omoanoc 0 9 0 90 9 9 0 E PE PEDE PE PE PE EEE A este u LPE PE PE DE DE Ppa 955 5 e205 e bd hd bed ba be be be be DPI PA PE PA PA PE DS PA PE PE PE PE PAI L a E E E d 7 6 5 4 3 Item Name of Item Function 1 ON OFF Main Power Button Switch ON OFF the power supply to the FuseBox 2 Power Socket Connects the power cord to supply the AC power 3 O OE Connects video signal to a monitor Y C Composite DVI YPbPr 4 oe Connects video signal to a monitor Y C Composite DVI YPbPr 5 On Connects video signal to a monitor Y C Composite DVI YPbPr Video In j Allows AUX video input R for f a Y C Composite DVI YPbPr ows AUX video input Reserved for future versions 7 I O Port RS232 Ports Reserved for future versions e USB Keyboard mouse and external drive 8 USB and Ethernet Ports connection Ethernet Reserved for future versions 9 Audio Ports Reserved for future versions When connected to a potential equalization terminal of 10 Equipotential Pin another device the electrical potentials of the devices are equalized 11 Remote Control Ports Allows remote device c
54. onnected Scope Information e Endoscope type e Endoscope serial number Endoscope version Fuse 1G Gastroscope with FuseBox Processor User Manual 49 Understanding the FuseBox System Screens and Functions tian 41_9_9 manit A Ke uUon 1I Z 8 MONITOLS The Monitor Selection screen allows the user to turn ON OFF the Left and Right monitors in order to switch between the standard and wide views Monitor ID Display OFF X Setup Plight Timer XXLUM Label name Function Allows combinations of the desired monitors Press the ON OFF icon to toggle between ON OFF ON OFF views for the Left monitor The Right monitor is not available in gastroscope mode The Center monitor is always ON Used to display the letters L and C on the Left and Monitor ID Displa pray Center monitors if desired NOTE the center screen cannot be turned OFF 50 ENDOCHOICE FSE 054 EN 6 0 Understanding the FuseBox System Screens and Functions 5 1 7 Light mode Use the Light mode when additional light is required in a low light environment Light mode can be activated by pressing the Light icon located on the Main screen During Light mode the screen on the FuseBox illuminates to maximum intensity allowing the user to use the FuseBox as a local illumination source This may be useful when observing the content of an attached polyp trap in a low light environment Icon name Function Light activation Use t
55. onnection FusePanel Fuse 1G Gastroscope with FuseBox Processor User Manual 21 System Components 3 3 Specifications 3 3 1 Fuse 1G Gastroscope Function Feature Optical System Insertion Tube Working Channel 22 QENDCCHOICE Description Field of view Direction of view Depth of field Distal End outer diameter Distal End Right side view shown Insertion Tube outer diameter Working Channel inner diameter Details Standard view 160 Wide view 245 Front and side views side views shown here are pictured as its RIGHT side 3 0 100 mm 10 5 mm FRONT VIEW 1 Air Water front nozzle 2 LED cover 3 Front lens 4 Jet auxiliary water channel opening 5 Working channel opening SIDE VIEW 1 LED cover 2 Side lens 3 Air Water side nozzle 9 8mm 2 8mm FSE 054 EN 6 0 Function Feature Description Direction from which endoscope accessories enter the endoscopic image Bending Section Angulation range Working length Degree of protection Type BF applied part against electric shock Function Power Scope Compatibility Video Signals Control Signals Weight Dimensions Electrical class amp Electrical type Air Pump Type Max Pressure Irrigation flow Rate when connected to Fuse 1G Gastroscope Feature Voltage Frequency Voltage Fluctuation Max Power Analog Video Output Digital Video Output White Balan
56. psy Valve when inserting or extracting the endoscopic devices accessories Make sure that there is enough distance between the endoscopic devices accessories and the Distal Tip Always use the instrument according to the manufacturer s instructions for use Never operate an electrosurgical tool while the working element is in the work channel Never use an electrosurgical tool if the field of vision is not clear Make sure that there is enough distance between the electrosurgical tool and the Distal Tip and that it is correctly positioned for the procedure before activating the power When performing electrosurgical procedures do not use any accessories or tools that are not specifically designed for electrosurgical procedures during endoscopy When using high frequency surgical equipment do not exceed the following ratings Accessory Intended Use Mode Maximum rated recurring peak voltage Spray Coag VPK 3800V Cut VPK 840V Soft Coag VPK 200V WARNING Patient leakage currents may be additive when endoscopes are used with energized endoscopically used accessories 1 Open the Biopsy Valve 2 Verify the mechanical integrity of the Biopsy Valve 3 Gently push the endoscopic devices accessories through the Biopsy Port into the working channel and out through the Distal Tip 4 Operate the endoscopic devices accessories according to the manufacturer s instructions 5 Gently pull the endoscopic devices accessories out of the wo
57. rer Remove the Disposable Water Bottle Cap from its packaging Insert the narrow tube of the water bottle cap assembly into the bottle of water Screw the water bottle cap into place Place the water bottle assembled into the disposable water bottle holder Connect the tube to the Air Water Bottle Port on the Fuse endoscope N WARNING e Improper handling of the disposable water bottle cap may pose an infection control risk or degrade or prevent correct device function Observe the following warnings when using the disposable water bottle cap O Refer to the instructions for use Failure to follow instructions for use may result in contamination degraded performance or loss of functionality Prior to use inspect the water bottle cap package and the product itself for signs of damage or tampering If tampering or damage exists do not use Do not use if the sterile package is not sealed and or the date has expired Do not store the water bottle cap outside of its package remove the packing immediately before use Do not use the water bottle cap for a longer period of time than recommended by the manufacturer Use only sterile water or the prescribed solution to avoid bio contamination Open the sterile pouch and attach the disposable Water Jet Connector to the Auxiliary Water Port on the endoscope Prepare for use per manufacturer instruction for use 34 QEND AnHOICE FSE 054 EN 6 0 Preparing and Inspecting t
58. rking channel 6 When the endoscopic devices accessories is removed close the biopsy valve 1 Open the Biopsy Valve 2 Gently push the electrosurgical tool through the Biopsy Port into the working channel and out through the Distal Tip Fuse 1G Gastroscope with FuseBox Processor User Manual 59 Performing the Procedure 3 After performing the procedure gently pull the electrosurgical tool out of the working channel 4 When the electrosurgical tool is removed close the Biopsy Valve Slowly and gently withdraw the gastroscope Insertion Tube while viewing the gastroscopic image CAUTION m Make sure that the angulation brakes are not in the locked position m Reprocess the gastroscope after the procedure as described in the companion Fuse Endoscope Reprocessing Manual with the gastroscope model listed on the cover 60 QENDCCHOICE FSE 054 EN 6 0 Storage and Handling N WARNING The endoscope and its parts must be reprocessed prior to use Refer to the Fuse Endoscope Reprocessing Manual for complete reprocessing instructions Failure to properly reprocess the device may pose an infection risk This product must be installed maintained and serviced by EndoChoice personnel The probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and or the total operating hours increase The product and ancillary equipment must be inspected before each use
59. rocessor User Manual 15 System Components 3 1 3 Gastroscope interface 45 16 Item ENDCCHOICE Name of Item Leak Tester Port Suction Port Grounding S cord port Air Water Bottle Port Auxiliary Water Supply Port Left Right Angulation Knob Brake 6 789 13 Fuse 1C Colonoscope pictured Function Connects the Leak Tester to the gastroscope Connects the suction source to the gastroscope Connect the gastroscope with the electrosurgical unit via the S cord The S cord conducts leak current from the gastroscope to the electrosurgical unit To connect the S cord refer to the instruction manual for the electrosurgical unit Connects the Air Water bottle to the gastroscope Connects the auxiliary water supply tube to the gastroscope This threaded port is also referred to as the water jet connector When an auxiliary water supply is not connected make sure the cap is on When this knob is turned so that the F gt RL is near the L mark the Distal Tip is unlocked When this knob is turned so that the F gt RL is near the R mark the Distal Tip is locked will hold in the set position FSE 054 EN 6 0 Item Name of Item Left Right Angulation Control Knob Up Down Angulation Control Knob Up Down Angulation Knob Brake Auxiliary Button Housing Suction Opening Air Water Opening Biopsy Port System Components Function When this knob is turned in the R dir
60. s a potentially hazardous situation associated with its use or misuse which may if not avoided CAUTION nz i result in minor or moderate injury It may also be used to alert against unsafe practices or potential equipment damage An informational note provides additional information of interest to the user Outside the United States United States EndoChoice GmbH Otto Hahn Str 11 25337 Elmshorn Germany EndoChoice Inc 11810 Wills Rd Alpharetta GA 30009 888 682 ENDO 3636 Phone 49 0 4121 649390 Ph ze A 866 567 8218 Fax 49 0 4121 649383 Fax Fuse 1G Gastroscope with FuseBox Processor User Manual 1 Safety Information Please Read Prior to Use 2 slaplEerceb gt oggli oN m m E Lp S Bu O ag ep ENDCCHOICE Description Serial number Consult instructions for use Attention see instructions Shock protection type BF Power button Equipotentiality Manufactured by Catalog number Must not be disposed of as unsorted municipal waste but should be collected separately Number of units CE Mark Class Ila European Representative Federal US law restricts this device for sale by or on the order of a physician Non sterile Manufacturing date Manufactured according to Restriction of Hazardous Substances Directive FSE 054 EN 6 0 Safety Information Please Read Prior to Use Medical Electrical Equipment SE WITH RESPECT TO ELECTRICAL SHOCK
61. safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601 1 and or IEC 60601 1 1 harmonized national standard Refer to the Appendix for a list of compatible accessories This equipment generates and can radiate radio frequency energy The equipment may cause radio frequency interference to other medical and non medical devices as well as to radio communications To provide reasonable protection against such interference the system complies with the IEC60601 1 2 standard If the device is suspected of interfering with other nearby electrical equipment power down the device to see if the interference is eliminated If the endoscope system is determined to be the source of interference additional shielding or relocation of the device or neighboring equipment may be necessary Use of improperly shielded and grounded cables may result in the equipment causing radio frequency interference in violation of the local regulations The manufacturer is not responsible for any interference caused by using cables other than those recommended or by unauthorized changes or modifications to this equipment Do not use devices that intentionally transmit RF signals cellular phones transceivers or radio controlled products in the vicinity of this equipment as it may cause performance outside the published specifications Keep the power of these types of devices turned off when located near this equipment The medical s
62. scope in its transport case Routine storage in a non ventilated humid environment may result in contamination and or damage the device Refer to the Fuse Endoscope Reprocessing Manual for storage between usage instructions 62 MENDCCHOICE FSE 054 EN 6 0 Troubleshooting This table provides a list of common potential problems you may experience and possible solutions to these problems Ifthe problem persists do not use the endoscope and contact your EndoChoice representative Problem with Possible Solutions Air Water functionality e Remove and inspect the Air Water Reusable Scope Valves Verify that there are no blockages in the button e Verify that the air water tube is connected correctly e Verify that the system is turned on e Verify that the pump is turned on e _ Verify that the water bottle is tightly closed e If the above options do not resolve the problem try using a new Air Water Reusable Scope Valve Suction functionality e _ Remove and inspect the Suction Reusable Scope Valve Verify that there are no blockages in the valve e _ Verify that the suction tube is connected correctly e _ Verify that the suction pump is turned on e Verify that the Biopsy Valve is closed and attached correctly e _ Ifthe above options do not resolve the problem irrigate the channel with sterile water If irrigating does not resolve the problem push a biopsy forceps through the channel to clean the cha
63. stroscope with FuseBox Processor User Manual 39 Preparing and Inspecting the System 1 Filla cup to a minimum of 75 total volume with sterile water 2 Immerse the Distal Tip of the gastroscope to a depth of 10 15 cm in the sterile water 3 Cover the hole of the Air Water Reusable Scope Valve with your finger 40 ENDCCHOICE FSE 054 EN 6 0 Preparing and Inspecting the System 4 Confirm that air bubbles are continuously emitted from both air water nozzles 5 Uncover the hole in the Air Water Reusable Scope Valve and verify that no air bubbles are being emitted from the nozzles N WARNING e Failure to check correct insufflation function can result in patient injury If a stream of air bubbles is emitted from either of the two air water nozzles while the Distal Tip is submerged in 10 15 cm or more even though the Air Water Reusable Scope Valve is not being operated an irregularity in the air feeding function potentially exists Refer to Chapter 8 Troubleshooting Over insufflation can cause patient pain injury bleeding and or perforation When the Distal Tip is immersed less than 10 cm below the surface of the sterile water a small amount of air bubbles may be emitted from the air water nozzles even when the Air Water Reusable Scope Valve is not being operated This does not indicate a malfunction 4 6 5 Test the irrigation mechanism 1 Remove the Distal Tip from the cup and press the Air Water Reusable Scope Valve
64. taff in charge of this equipment is required to instruct technicians and other people who may be around this equipment to fully comply with the above requirement 6 ENDCCHOICE FSE 054 EN 6 0 Safety Information Please Read Prior to Use Conductive fluids that drain into the active circuit components of the system may cause short circuits potentially resulting in electrical fire Do not block the ventilation ports of the electronic equipment Always maintain a minimum 6 inch 15 cm clearance around the ventilation ports to prevent overheating and damage to the electronic hardware To avoid electric shocks and burns potentially caused by application of the wrong type of fire extinguisher ensure that the fire extinguisher at the site has been approved for use on electrically induced fires Do not operate the equipment in the presence of flammable or explosive liquids vapors or gases such as flammable anesthetic oxygen or nitrous oxide Do not plug in or turn on the system if hazardous substances are detected in the environment If flammable substances are detected after the system has been turned on do not attempt to turn off the system or unplug it Evacuate and ventilate the area before turning the system off Do not operate in the presence of explosive gas concentrations in the area of use of high frequency endoscopically used accessories See also Section 6 1 2 Using nonflammable gases Do not place any object on top of t
65. us or air from the patient Connects the cleaning apparatus to the water jet port Used to close the Water Jet Port when it is not in use Not pictured Provides information and instructions for using and maintaining the Fuse 1G Gastroscope with FuseBox Processor FSE 054 EN 6 0 System Components Item Name of Item Function 1 Insertion Tube The Insertion Tube is the main shaft of the gastroscope and contains the working channel air water channel and video cable The Insertion Tube has markings to indicate the gastroscope s location within the upper Gl tract 2 Main Connector The Main Connector connects the gastroscope to the FuseBox The Main Connector contains the video socket S cord connector auxiliary water port Air Water Bottle Port and leak tester connector 3 Umbilical Tube The Umbilical Tube is a hollow tube that connects the gastroscope s FuseBox connector to the Control Handle and contains the suction and air water channels and the video cable 4 Distal Tip The Distal Tip contains the video assembly light sources work channel outlet and air water outlets 5 Bending Section The Bending Section enables angulation of the tip of the gastroscope The Bending Section s movement is controlled by the angulation knobs 6 Control Handle The Control Handle contains the angulation knobs angulation brakes Suction Opening air water opening and Biopsy Port Fuse 1G Gastroscope with FuseBox P
66. usable Scope Valve into the Suction Opening of the gastroscope 1 and turn until you feel it drop into position Visually confirm the valve is seated properly Push the Air Water Reusable Scope Valve into the air water opening until it is 2 securely in place Visually confirm the valve is seated properly Attach the flat end of a Biopsy Valve onto the Biopsy Port and twist the cap clockwise 3 to ensure that it is on tightly Verify that the Biopsy Valve is closed WARNING Improper handling of the Biopsy Valve may pose an infection control risk or degrade or prevent correct device function Observe the following warnings when using the Biopsy Valve 28 QENDCCHOICE FSE 054 EN 6 0 Preparing and Inspecting the System Refer to the manufacturer instructions for use for the Biopsy Valve Failure to follow instructions for use can result in patient infection device contamination degraded performance or loss of functionality Prior to use inspect the Biopsy Valve package and the product itself for signs of damage or tampering If tampering or damage exists to the cap or its package do not use If the Biopsy Valve is not properly connected to the Biopsy Port it can cause patient debris to leak or spray and can reduce the efficacy of the gastroscope suction system To avoid any leaks verify that the Biopsy Valve is properly closed After use discard Biopsy Valves according to the manufacturer instructions fol
67. use 1G Gastroscope 5 Working Channel Cleaning Adapter 3 Endoscope Case 4 Soaking Cap 5 Air Water Channel Cleaning Adaptor 6 Leak Tester Function Gastroscope Enables cleaning the working channel adaptor and accompanying silicone tube are attached to the Biopsy Port Case that houses the gastroscope upon delivery Used during the leak test and cleaning process Enables cleaning of the Air Water and working channels and is attached to the Air Water and Suction Ports Used to test for leaks in the gastroscope and is attached to the Leak Tester Port on the Main Connector Fuse 1G Gastroscope with FuseBox Processor User Manual 13 System Components 14 10 11 np 12 ENDCCHOICE Spare O Ring Set Biopsy Valve Air Water Reusable Scope Valve Suction Reusable Scope Valve Water Jet Cleaning Adaptor Water Jet Cap Fuse 1G Gastroscope with FuseBox Processor User Manual and Reprocessing Manual Used for O Ring replacement in the valves The cap is attached to the Biopsy Port Instruments are inserted through the Biopsy Valve into the work channel Covering the hole on top of the valve enables insufflation pressurized air delivered to the Distal Tip Depressing the valve enables water to pass to the Distal Tip for lens washing Y 4 i Depressing the valve creates negative pressure in the work channel activates suction to remove fluids debris flat
68. ype Scope S N Setup Light Timer XLUM ENDCCHOICE Function Displays the type of endoscope attached to the FuseBox Displays the serial number of the endoscope attached to the FuseBox Pressing this icon multiple times cycles through to the various setup screens in the following order e _ Image Settings LED Intensity e _ System Information Scope Information e _ Monitor Selection Turns the FuseBox touch screen light ON OFF When on the entire screen acts as a local illumination source useful in a low light environment Displays the Timer screen which can be used like a stopwatch to mark the duration of a procedure Operates the XLUM mode trans illumination function Distal Tip blinking Enables the operator to determine the position of the scope from outside the body FSE 054 EN 6 0 Understanding the FuseBox System Screens and Functions fal 4 5 ATI ara 71 ua a FA a N y q F An E f Y En Wott ID SCI iu itl aus L w Ww AS aw L Sn r tF Press the Setup icon one time to access this screen The Image Settings screen appears as below and contains settings for red and blue colors and for brightness The settings modified via this screen affect all active views 1 2 3 G Image Settings Red Level Blue Level rN A T Label name Function Use the UP DOWN arrows to increase or decrease the red color level of all active monitors REO EVE e The image shown abov

FSE-054-EN-5.0 Fuse 1G Gastroscope with FuseBox

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