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Boston Scientific EKOS Control System 4.0, Руководство пользователя

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Boston Scientific EKOS Control System 4.0 Скачать руководство пользователя страница 53

Bost

on Scientific (Mast

er Br

and,

 Spir

al Bound Manual T

empla

te

, 8

.5in x 11in Global,

 923100

58G),

 IFU

, MB,

 CU4,

 en,

 5

1011236

-001A

Black (K) ∆E ≤5.0

Black (K) ∆E ≤5.0

53

Symbol

Description

Disables channel when pressed� 
Disable button may be green, yellow or red�

Displays the current runtime for the channel� Runtime is the length of time a device has delivered 
ultrasound therapy on a channel� Time is displayed in Hours:Minutes:Seconds�

Ultrasound therapy is ON�

When audio alert tone is on, the alert icon displays�

When the audio alert tone is silenced, the alert icon is crossed-out indicating audio is silenced�

Decrease screen brightness�

Increase screen brightness�

Decrease audible tone�

Increase audible tone�

Connector Interface Cable:

Used to connect the Infusion Catheter and Ultrasonic Core to the Control Unit�

Infusion Catheter:

The device Infusion Catheter connects to the Connector Interface Cable�

Ultrasonic Core:

The device Ultrasonic Core connects to the Connector Interface Cable�

US

Canadian Standards Association 
Certification for the United States

Equipotential Terminal

The terminal marked with this symbol is the equipotential terminal� It can be connected to a locally 
available external equipotential line to prevent danger caused by the difference in the potentials between 
this device and the other devices�

Содержание EKOS Control System 4.0

Страница 1: ...Boston Scientific Master Brand Spiral Bound Manual Template 8 5in x 11in Global 92310058G IFU MB CU4 en 51011236 001A Black K E 5 0 EKOS Control System 4 0 Console User s Manual 2 CV03 ...

Страница 2: ...Unit 9 Table 3 10 Side View 10 Figure 4 Side View of Control Unit 10 Screen Layout Prior to Connection 10 Figure 5 Example Screen Prior to Connection 11 Table 4 11 Screen Layout During Ultrasound Therapy 12 Figure 6 Example Screen During Ultrasound Therapy 12 Table 5 12 Color Coding Glossary 13 Table 6 13 User Information 13 INTENDED USE 13 INDICATIONS FOR USE 13 Clinical Benefit Statement 13 Summ...

Страница 3: ...e Battery 24 AC Power Battery Status Indicator 24 Table 11 25 Figure 12 Screen with AC Power Battery Status 25 Battery Gauge 26 Table 12 26 Low Battery Notification 26 Figure 13 Low Battery Message 26 Critically Low Battery 27 Figure 14 Critically Low Battery 27 Battery Error 27 Figure 15 Battery Error Message 28 Battery Charging Indicator Control Unit Turned Off 28 Figure 16 Charging Indicator on...

Страница 4: ...go Screen Shutting Down 37 INFORMATION TO BRIEF THE PATIENT 37 SYSTEM INFORMATION 37 Figure 34 System Information Screen 37 Table 15 38 TROUBLESHOOTING 38 Power Graph 38 Reading the Power Graph 38 Figure 35 Power Graph Menu Tab 38 Screen Layout Power Graph 38 Figure 36 Screen Layout Power Graph 39 Table 16 39 Example Power Graphs 40 Figure 37 Example Two Channel Power Graph 40 Figure 38 Example Tw...

Страница 5: ...age 48 Figure 45 Channel A and B Messages 48 INFUSION STAND 49 Selecting the Appropriate Infusion Stand 49 Table 21 49 Attaching the Control Unit to an Infusion Stand 50 Figure 46 Pole Inside Bracket 50 Figure 47 Turn Knob 50 Figure 48 Secure 51 SYMBOLS AND INDICATORS 51 Table 22 51 SPECIFICATIONS 54 Table 23 54 Table 24 Ordering Information 54 WARRANTY 54 SYMBOL DEFINITIONS 54 ...

Страница 6: ...om henceforth will be referred to as the EKOS Device The EKOS Device is a single use sterile device consisting of a multi lumen Infusion Catheter and an Ultrasonic Core that contains multiple transducers The Infusion Catheter delivers the specified solutions to the target area while the transducers simultaneously deliver ultrasound therapy to the same location See the EKOS Device Instructions for ...

Страница 7: ...tissue surrounding the treatment zone within the patient s vasculature The ultrasound acts locally to increase the dispersion of the delivered solutions into the treatment region In addition to generating the prescribed ultrasound therapy profile the Control Unit continually monitors output power and temperature of the EKOS Device The system has safeguards to prevent deviation of these parameters ...

Страница 8: ...Note When audio alert tone is ON the alert icon displays on the screen When the audio alert tone is silenced the alert icon is crossed out indicating audio silenced AC Power Battery Charging Indicator Illuminates when the Control Unit is OFF indicating battery charge status Note this icon is not visible when the Control Unit is ON When the Control Unit is connected to AC power Steady green indicat...

Страница 9: ... up to two devices at the same time Start Ultrasound Start Button Starts energy transmission for a specific channel when pressed Stop Ultrasound Stop Button Stops energy transmission for a specific channel when pressed Connector Interface Cable Receptacle For connecting the Connector Interface Cable s to the Control Unit Display Touch Screen Shows ultrasound and battery information and other messa...

Страница 10: ...e to prevent danger caused by the difference in the potentials between this device and other devices Side View A B Connector Interface Cable Attached for Storage Connector Interface Cable Attachment Bracket Attachment Bolt Figure 4 Side View of Control Unit Screen Layout Prior to Connection When the Control Unit is on the display touch screen provides helpful messages to guide the operator through...

Страница 11: ...aph Tab Displays a line graph that shows the percentage of the maximum average power delivered for each channel Settings Tab Displays a configuration menu for setting alert tone volume screen brightness and language AC Power Battery Status Indicator Provides AC power and battery charge information when the Control Unit is turned ON Disable Button Disables channel when X icon is pressed Disable but...

Страница 12: ...he current AC power battery status see Figure 6 Menu Tabs Channel A Message Area Channel B Message Area AC Power Battery Status Figure 6 Example Screen During Ultrasound Therapy Table 5 Item Description A B Channel Identifier Indicates channel A or channel B Note Messages and information associated with Channel A are provided in the message area on the left side of the display messages and informa...

Страница 13: ...bolytics into the pulmonary and or peripheral vasculature of adults INDICATIONS FOR USE See EKOS Device Instructions for use for detailed information on indications for EKOS Devices Clinical Benefit Statement The EKOS Endovascular System is intended to facilitate the administration of physician specified fluids including thrombolytics and deliver ultrasound to the peripheral vasculature or the pul...

Страница 14: ... then used to continue therapy vascular injury or burns could occur Avoid spilling fluids on the cables and Control Unit Do not immerse any portion of the cables or Control Unit in water or other fluids as this may cause the equipment to perform inaccurately or fail which could result in vascular injury electric shock or fire The Control Unit is designed for use with the EKOS Device approved cable...

Страница 15: ...gned to be operated by medical personnel who have knowledge of endovascular interventional procedures and who are responsible for direct patient care in the areas of the hospital where the unit is used Optional in service training from an authorized EKOS or Boston Scientific trainer is available This document provides instructions for operating the Control Unit as well as configuration maintenance...

Страница 16: ...een the equipment Connect this equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer for help If the Control Unit must be used directly adjacent to other equipment observe the function of the Control Unit to verify normal operation in that configuration If this equipment is adversely affected by interference from other devices ...

Страница 17: ... Guidance and manufacturer s declaration electromagnetic immunity The Control Unit is intended for use in the electromagnetic environment specified below The customer or the user of the Control Unit should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 k...

Страница 18: ... 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipm...

Страница 19: ...ic propagation is affected by absorption and reflection from structures objects and people HOW SUPPLIED This product is supplied non sterile and is intended for multiple use Device Details Do not use if package is damaged or unintentionally opened before use Do not use if labeling is incomplete or illegible Cleaning the Control Unit Warning The reusable Connector Interface Cable and Control Unit a...

Страница 20: ...he Control Unit should be plugged into a hospital grade outlet to ensure the battery is recharged fully Failure to plug in the AC power after use could result in the battery not being fully charged and delay of ultrasound therapy 3 An AC power Battery Charging Indicator on the front of the Control Unit illuminates when the unit is turned OFF For more information about the power and charging see Po...

Страница 21: ...or damage prior to use If damaged e g exposed wires do not use and replace immediately Warning Ensure all connectors are dry before connecting the Connector Interface Cable to the Control Unit or the Connector Interface Cable to the EKOS Device If connectors do become wet thoroughly dry prior to use Fluid in the connectors may affect sensor accuracy and result in vascular injury Warning Connect sy...

Страница 22: ...tap the left circle until the desired brightness is achieved Note The minimum setting reduces the brightness but does not completely darken the display Selecting Language 1 To view the list of available languages press the Select button 2 From the list of languages tap the desired language to highlight the selected language see Figure 8 If the desired language is not visible on the screen use the ...

Страница 23: ...pital grade outlet Warning Connect the Control Unit only to a properly grounded hospital grade outlet using the specified power cord Use of a non hospital grade outlet could result in electric shock or burn Use of a non specified power cord could result in increased electromagnetic interference EMI emissions or decreased immunity to EMI from other sources 3 Press the Power button on the front of t...

Страница 24: ...Charging the Battery The Control Unit operates on AC power or an internal lithium ion battery Important battery information During use the Control Unit should be plugged into a hospital grade outlet When disconnected from an outlet the Control Unit automatically operates on battery power The battery is intended to only power the Control Unit during patient transport or for short periods when AC po...

Страница 25: ... to AC power and battery is charging Connected to AC power and battery is fully charged If the battery is defective the battery icon is red with an X The battery charge level shown in is displayed in the upper right corner of the display next to the AC power battery status indicator see Figure 12 AC Power Battery Status Figure 12 Screen with AC Power Battery Status CMYK ...

Страница 26: ...tification If the Control Unit is operating on battery power and the battery charge level is 15 or less a low battery message with an alert icon displays and an audible alert sounds The percentage of remaining charge and the battery gauge with a red bar in the upper right corner of the display indicates the level of battery charge Connect to AC power to continue to use the Control Unit The message...

Страница 27: ...annel where it left off Battery Error During operation on AC power if the internal battery cannot provide power to the Control Unit a battery error message with an alert icon displays The red battery gauge with an X indicates the battery is defective Even with a battery error the Control Unit can continue to operate as long as it is connected to AC power Do not attempt to open the Control Unit and...

Страница 28: ...arging Indicator on Control Panel The charging indicator on the front of the Control Unit changes color to indicate the charging status If the battery reaches a critically low state the Control Unit enters battery saving mode and the charging indicator is not illuminated Table 13 Control Unit Turned Off AC Connected Indicator Description Steady green indicates Control Unit is connected to AC power...

Страница 29: ...will bring the Control Unit out of its low power battery saving mode Starting Ultrasound The sterile disposable EKOS Device is sold separately Carefully read the Instructions for Use that is provided with the device for a complete description instructions warnings cautions and specifications specific to the EKOS Device The Instructions for Use packaged with the EKOS Device may still reference the ...

Страница 30: ...matically activated and a connect device cables message is displayed see Figure 20 2 Connect the Connector Interface Cable to the channel A or B receptacles on the front panel of the Control Unit by inserting the Connector Interface Cable until a click is heard Note The Connector Interface Cable can be used in either channel A or B If providing ultrasound therapy to two devices connect one Connect...

Страница 31: ...ce Cable see Figure 20 Figure 20 Connect Device Cables Screen 3 Connect the Ultrasonic Core to the Connector Interface Cable see Figure 21 4 Connect the Infusion Catheter to the Connector Interface Cable see Figure 21 Ultrasonic Core A B Infusion Catheter Figure 21 Connect Device Cables Diagram If the device is not properly connected a connect message displays indicating the specific device cable ...

Страница 32: ...nce the device is properly connected a ready message displays indicating the Control Unit is ready see Figure 24 Figure 24 Ready Screen 5 Turn on the drug and coolant pumps and set the specified flow rate per the physician s orders and within the flow rates specified in the EKOS Device Instructions for Use 6 Secure the housing end of the Connector Interface Cable near the patient using standard ho...

Страница 33: ...OFF the ultrasound before removing the Ultrasonic Core from the Infusion Catheter otherwise overheating of the device may occur potentially causing damage to the device burns and or interruption of therapy If the device is damaged in this manner and then used to continue therapy vascular injury or burns could occur Note If the Start button is not pressed within 5 minutes of successfully connecting...

Страница 34: ...sume when the ultrasound therapy is started again If the device cables are disconnected e g patient transport and re connected the channel timer will resume when ultrasound therapy is started again It is strongly recommended that devices be reconnected to the same channel they started on to ensure the total runtime displayed for the channel reflects the total runtime for the device Note During nor...

Страница 35: ... 4 Use the carrying handle the EKOS CU 4 0 Cart or an infusion stand to transport the Control Unit with the patient Ensure the Control Unit is securely attached to the EKOS CU 4 0 Cart or infusion stand Transport by holding the pole in the middle or using the provided handle if available to ensure the best control Do not allow the EKOS CU 4 0 Cart or infusion stand to tip Secure patient cables to ...

Страница 36: ... in use see Figure 30 Figure 30 Ready Screen Showing Disable Button Press the Disable icon on the confirmation screen and the channel becomes inactive see Figure 31 and Figure 32 Figure 31 Disable Confirmation Screen Figure 32 Disabled Ready to Activate Screen 3 Disconnect the Infusion Catheter and Ultrasonic Core from the Connector Interface Cable 4 Press and hold the Power button for 3 seconds t...

Страница 37: ...ant local regulatory authority INFORMATION TO BRIEF THE PATIENT The physician should consider the following points while counseling the patient on the use of the EKOS Endovascular System in association with the interventional procedure Discuss the risks and benefits including review of potential adverse events listed in the EKOS Device IFU both for EKOS Endovascular System and for other interventi...

Страница 38: ...ultrasound therapy should always be made using other clinical diagnostic tools e g fluoroscopy An incorrect diagnosis could result in prolonged therapy or inadequate therapy Reading the Power Graph 1 To view the power graph press the Graph tab on the display see Figure 35 Figure 35 Power Graph Menu Tab 2 The power graph displays the power information for each channel with a 6 hour 12 hour or 24 ho...

Страница 39: ...indicates ultrasound is ready to start or currently running Yellow icon indicates further steps are required to start the ultrasound Red icon indicates there is an error detected and ultrasound is not running Black icon indicates the channel is not active 80 Power 73 Power Percentage of the maximum average power currently being delivered Note 0 indicates ultrasound is NOT currently being delivered...

Страница 40: ...r both devices then the device connected to channel B was replaced with a new device The new device was connected to channel B on the Control Unit and ultrasound therapy was restarted Figure 38 Example Two Channel Power Graph Device Changed Note If therapy is stopped for both devices and the devices disconnected from the Control Unit it is important to reconnect the devices to the same channel the...

Страница 41: ...lowing the onscreen instructions turning the Control Unit off and back on or by following the troubleshooting steps below note the associated issue and or error code in parentheses at the end of the message and call the phone number listed in the For Support section on the back of the cover page System Errors A system error affects both channels and stops ultrasound therapy on both channels System...

Страница 42: ...me The details of the event or problem Table 17 For Support In the US 888 EKOSHELP 888 356 7435 Outside the US Contact your local Boston Scientific representative or call 1 425 415 3100 Table 18 Message Description Error Code Possible Cause Troubleshooting Step Unrecoverable Control Unit error E007 System failure 1 Press the Power button for 10 or more seconds to turn off the Control Unit 2 Let th...

Страница 43: ...perature 3 When the message disappears press Start to resume ultrasound 4 If the error persists press the Power button to turn off the Control Unit 5 Let the Control Unit Sit for 30 seconds 6 Use the Power button to turn on the Control Unit 7 If the error persists please call the phone number listed in the For Support section Device cables are crossed E006 Device cables are cross connected between...

Страница 44: ...cal emergencies Boston Scientific provides assistance only for technical issues involving the operation of the EKOS Control System 4 0 Use this contact information for assistance in Control Unit problems where the Control Unit requires attention to prevent compromising patient or user well being in future operations Obtain pertinent information before calling including the following The EKOS Contr...

Страница 45: ...ber listed in the For Support section E316 E317 E318 E319 E326 E327 E328 E329 E330 Channel error In rare circumstances error code E319 may also be presented due to a software anomaly 1 Press the Power button to turn off the Control Unit 2 Let the Control Unit sit for 30 seconds 3 Use the Power button to turn on the Control Unit 4 If the error persists please call the phone number listed in the For...

Страница 46: ...Control Unit 7 Let the Control Unit sit for 30 seconds 8 Use the Power button to turn on the Control Unit 9 If the error persists please call the phone number listed in the For Support section The Infusion Catheter and Ultrasonic Core are not compatible E304 The Infusion Catheter and Ultrasonic Core connected to the Control Unit are not compatible either catheter zone length and ultrasound zone le...

Страница 47: ...roubleshoot the issue with the original CIC Check the device connectors E311 Poor connection of the Infusion Catheter and Ultrasonic Core Infusion Catheter and Ultrasonic Core Connectors are wet at the connection site 1 Disconnect the Infusion Catheter and Ultrasonic Core from the Connector Interface Cable 2 Inspect for fluid or damage to the pins 3 Dry the Infusion Catheter and Ultrasonic Core co...

Страница 48: ...eeds to be connected when ultrasound therapy needs to be started or when a confirmation is needed Channel messages can occur for both channels at the same time When a channel message occurs read the message and follow the instructions for troubleshooting steps to take See Figure 44 and Figure 45 below for examples of a channel message Figure 44 Channel A Message Figure 45 Channel A and B Messages ...

Страница 49: ... these Instructions for Use to ensure the Control Unit is securely attached to infusion stand Attach the Control Unit and infusion pumps to a position on the infusion stand such that the combined weight of the infusion pumps and Control Unit is as low as practical When transporting the infusion stand hold the pole in the middle or use the handle if available to ensure the best control Always evalu...

Страница 50: ... Control Unit on the infusion stand Ensure The infusion pumps and Control Unit are positioned as low as practical on the pole Access to the infusion pumps is not blocked when the Control Unit is attached 2 Place the pole inside the mounting bracket that is located on the back of the Control Unit see Figure 46 Figure 46 Pole Inside Bracket 3 Turn the knob clockwise until it is tight see Figure 47 F...

Страница 51: ... the button when audio is silenced turns on the audio alert tone Steady green indicates Control Unit is connected to AC power and battery is fully charged Steady yellow indicates Control Unit is connected to AC power and battery is charging Blinking Blinking red once per second indicates Control Unit is connected to AC power and has a battery error Blinking red once every 10 seconds indicates Cont...

Страница 52: ...nel i Information Tab Displays Control Unit model number and software version Connector Interface Cable and device information and the EKOS help line phone number Graph Tab Displays a line graph that shows the percentage of the maximum average power delivered for each channel Settings Tab Displays a configuration menu for setting audible alert volume screen brightness and language Connected to AC ...

Страница 53: ...out indicating audio is silenced Decrease screen brightness Increase screen brightness Decrease audible tone Increase audible tone Connector Interface Cable Used to connect the Infusion Catheter and Ultrasonic Core to the Control Unit Infusion Catheter The device Infusion Catheter connects to the Connector Interface Cable Ultrasonic Core The device Ultrasonic Core connects to the Connector Interfa...

Страница 54: ...maximum Physical Dimensions 4 0 in x 10 5 in x 8 3 in 10 2 cm x 26 7 cm x 21 1 cm H x W x D Environmental Conditions Operating Humidity 30 to 75 non condensing Operating Temperature 15 C to 40 C Operating Atmospheric Pressure 73 kPa to 111 kPa External Storage Transport Humidity 10 to 90 non condensing External Storage Transport Temperature 20 C to 60 C External Storage Transport Atmospheric Press...

Страница 55: ...ie Gebrauchsanweisung für dieses Produkt ist in elektronischer Form über das Internet verfügbar Die Gebrauchsanweisung im Adobe Portable Document Format PDF finden Sie auf www IFU BSCI com Halten Sie das Produktetikett zur Referenz bereit Wenn Sie Probleme haben die Gebrauchsanweisung online aufzurufen oder wenn Sie eine gedruckte Kopie der Gebrauchsanweisung wünschen wenden Sie sich bitte an den ...

Страница 56: ...sem qualquer custo que deverá ser recebida no prazo de sete dias BRUKSANVISNING sv Bruksanvisningen till denna produkt tillhandahålls i elektronisk form via internet Gå in på www IFU BSCI com för att få tillgång till bruksanvisningen i PDF format Adobe Portable Document Format Glöm inte att ha produktetiketten tillgänglig som referens Omduharsvårtattfåtillgångtillbruksanvisningenonlineellerföredra...

Страница 57: ...önderilecektir ve bunun yedi gün içinde ulaşması gerekir INSTRUÇÕES DE USO pt BRA As instruções de uso deste produto são fornecidas em formato eletrônico pela Internet Acesse www IFU BSCI com para acessar as instruções de uso no formato de documento portátil PDF da Adobe e verifique se a etiqueta do produto está disponível para referência Em caso de dificuldade para acessar as instruções de uso on...

Страница 58: ...ste trebali dobiti u roku od sedam dana KASUTUSJUHISED et Selle toote kasutusjuhised on saadaval elektroonilisel kujul internetis Adobe porditavas dokumendivormingus PDF kasutusjuhendi hankimiseks külastage veebilehte www IFU BSCI com ja veenduge et teil oleks andmete esitamiseks olemas tootesilt Kui teil on kasutusjuhistele internetis ligipääsemisega probleeme või eelistate paberkoopiat võtke pal...

Страница 59: ...la prispeti v sedmih dneh PETUNJUK PENGGUNAAN id Petunjuk Penggunaan IFU untuk produk ini disediakan dalam bentuk elektronik lewat Internet Kunjungi www IFU BSCI com untuk mengakses IFU dalam Portable Document Format PDF Adobe dan pastikan Anda menyiapkan label produk untuk rujukan Jika Anda kesulitan mengakses IFU secara online atau lebih suka menerima salinan cetak silakan hubungi Layanan Pelang...

Страница 60: ...eiligheidsteken Volg de instructies voor gebruik sinal de segurança azul Siga as Instruções de Utilização Electrostatic Sensitive Device Dispositivo sensible a la electrostática Dispositif sensible aux décharges électrostatiques Elektrostatisch empfindliches Gerät Dispositivo sensibile all energia elettrostatica Voor elektrostatische energie gevoelig hulpmiddel Dispositivo Sensível a Descarga Eletr...

Страница 61: ...r Service 1 888 272 1001 Manufacturer Boston Scientific Limited Ballybrit Business Park Galway IRELAND Authorized Representative in the European Community Recyclable Package Boston Scientific Australia Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 Australian Sponsor Address Do not use if package is damaged Para obtener información de contacto de Boston Sc...

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