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Table 14� Guidance and manufacturer’s declaration – emissions and equipment and systems that are not life-supporting ������������������������������������������������������������������������������������������������������������������������������������������������ 64 PATIENT COUNSELING INFORMATION ������������������������������������������������������������������������������������������������������������������������ 65 SERVICE AND WARRANTY ������������������������������������������������������������������������������������������������������������������������������������������� 65 WARRANTY ������������������������������������������������������������������������������������������������������������������������������������������������������������ 65 OBTAINING WARRANTY SERVICE FROM BOSTON SCIENTIFIC CORPORATION ��������������������������������������������������������� 65 SYMBOL DEFINITIONS ������������������������������������������������������������������������������������������������������������������������������������������������� 65 Black (K) ∆E ≤5.0...
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician� Introduction This User’s Manual describes how to use, maintain, and troubleshoot the StoneSmart Connect Console� Device Description The LithoVue Elite System is a digital flexible ureteroscope system that consists of the LithoVue Elite Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable) and the StoneSmart Connect Console�...
ESSENTIAL PERFORMANCE LithoVue Elite System performance determined to be essential by Boston Scientific for electromagnetic compatibility testing, as per IEC 60601-1-2, is defined as follows� • Provide optical performance (Latency, Resolution and Framerate) that allows visualization of organs, cavities, and canals in the urinary tract�...
Clinical Benefit Statement The LithoVue Elite System is a supportive device to endoscopic diagnosis and treatments and contributes to procedural benefits by enabling navigation to and visualization of the organs, cavities, and canals in the urinary tract via transurethral or percutaneous access routes� It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract�...
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In addition, any person who connects additional equipment to the analog and digital interfaces installed by Boston Scientific is configuring a medical electrical system and is therefore responsible for ensuring that it complies with the requirements of the system standard IEC 60601-1� If in doubt, consult the technical services department or your authorized representative�...
• When the pressure limit set for the procedure is exceeded, before continuing to irrigate, exercise clinical judgment as the clinical implication of intrarenal pressure measurements may vary depending upon a variety of patient and procedural factors� • Patients on anticoagulants or with coagulopathies should be managed appropriately� •...
(dirty or bent connector pins), or image degradation on the touch screen� Contact Boston Scientific for service using the information found in “SERVICE AND WARRANTY “section�...
OPERATING MODES The Console contains a standard operating mode and a service mode� There is no administrative mode that contains administrator privileges� Standard Mode Standard mode is the default mode that the Console enters upon boots up� There is no login or user credentials required for this mode, however system access is limited to the following functions: 1�...
INTERFACES Table 1. Description of the Interfaces and their Function Interface Function USB Ports (3 Total) Download Session Data (Images, Video, Pressure Data) � Upload signed software Images for upgrading the Console� Ethernet (RJ45) Connector Disabled Network Switch There are 4 ports on this switch that allow the Console to interface with authorized BSC StoneSmart devices�...
For complaints related to cyber security, please use the following link: (https://www�bostonscientific�com/en-US/ customer-service/product-security/responsible-disclosure�html)� It is important that use is discontinued and immediately notify Boston Scientific upon finding malware infections, data breaches (unauthorized access/tampering/loss), cybersecurity attacks, or vulnerabilities in the Console� Please see “SPECIFICATIONS AND DEVICE COMPATIBILITY”...
Europe, Middle East, North Africa Technical Assistance Center Countries Contact Number Email European Toll-free number 00800 5555 7707 Laser products - Note: Don’t replace 00 by + but CELaserSupportEU@bsci�com dial as documented above Other products - CEtechsupportEMEA@bsci�com Europe general Tel: +31 45 546 7707 Fax: +31 45 546 7805 Austria +43 16 08 10 37...
The Console is shipped non-sterile� Before use, inspect the contents for any damage or defects� Do not Use if package is damaged or unintentionally opened before use� Do not use if labeling is incomplete or illegible� Do not use potentially defective components� If components appear to be damaged, contact your Boston Scientific representative� Handling and Storage The following instructions provide information for proper movement and storage of the Console�...
• External video source should be connected to the Console via shielded DVI input cable with maximum length of 2 m� Console has been tested by Boston Scientific with DVI input cable Lindy International 36202� The use of accessories and cables other than those specified or supplied as spare parts from Boston Scientific may result in increased emissions or decreased immunity of the LithoVue Elite System�...
SYSTEM INTEGRATION Connecting to an External Monitor The Console is intended to be connected to an external monitor for viewing of the live image and pressure readings� To connect, ensure the external monitor meets intended specifications� Use one of the provided video cables and connect to the applicable port on the back panel of the Console and to the monitor through a DVI, HDMI, or DisplayPort input port�...
LithoVue Elite 16 FEB 21 10:20 AM Figure 5. Home Menu The current date and time are displayed on the home screen with the date format: DD-MMM-YY� Light on/off Button When the Console is turned on and a new LithoVue Elite Ureteroscope is connected, the system will default to Light On.
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Table 8.1. Connected Device Icon status (Fluid Management) Fluid Management Connection State Fluid Management Icon Fluid Management Icon Graphics Color 1� No external device connected Gray 2� Connection to external device is Good Green 3� Connection to external device is in process or White attempting to be re-established 4�...
Pressure Sensor Re-Initialization Button (when using a pressure enabled ureteroscope) This button allows a user to perform a re-initialization of the connected LithoVue Elite ureteroscope at any point by pressing the button� LithoVue Elite 16 FEB 21 10:20 AM Figure 6. Pressure Sensor Re-Initialization Button External Viewing Screen Selection These buttons allow the user to display either the Console display or an external connected video signal on the connected external viewing screen�...
Video and Camera Capture Buttons These buttons allow for the capture of video and camera images during the procedure� LithoVue Elite 16 FEB 21 10:20 AM Figure 8. Video and Camera Capture Buttons LithoVue Elite Ureteroscope Button Enable The buttons on the connected LithoVue Elite Ureteroscope may be enabled or disabled during a procedure by clicking on this button�...
FILE MANAGEMENT MENU Stored images and videos are organized by session and arranged by date and time of the procedure start (the ureteroscope connection time)� The format of the date: DD-MMM-YY� The session is the connection of the scope and all files associated with the use of that scope during that use timeframe�...
SETTINGS MENU PRESSURE LithoVue Elite LIMIT mmHg 16 MAY 19 10:20 AM PRESSURE RECORDING PRESSURE mmHg cmH20 UNITS BUTTONS EXTERNAL SCREEN TIME/LANGUAGE Figure 11. Settings Menu Pressure Alarm Limit The pressure alarm limit can be changed during a procedure by using the + and – arrows to move the limit up or down� The pressure alarm limit may be set between 5 mmHg and 300 mmHg or between 5 cmH20 and 410 cmH20�...
TOOLS MENU Software Version The current software version is displayed in the upper right corner of this screen, for reference only� SOFTWARE VERSION 01.00.00 LithoVue Elite 22 MAR 21 Preventative Maintenance Due: 12 MAR 22 08:25 AM UPDATE DEVICE SOFTWARE SECURE DELETE DISABLE RECORDING Figure 12.
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Secure Delete The “Secure Delete” button will permanently delete the data (files, images, video, and pressure data) of all sessions that are stored on the device hard drive� This action is unrecoverable� SOFTWARE VERSION 0.33.00.00_0x79_0x2 LithoVue Elite 11 SEP 20 Preventative Maintenance Due: 01 SEP 21 08:26 AM UPDATE DEVICE SOFTWARE...
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Secure Delete Restart required� Restart required to re-enable file saving functionality� SOFTWARE VERSION PY_LVSW_2.3p LithoVue Elite 11 SEP 20 08:26 AM Secure Delete Complete! Manual Restart Required to Save New Files. SECURE DELETE DISABLE RECORDING Figure 16. Secure Delete Restart Message Disable Recording This option allows users to permanently disable all recordings, including image capture, video capture, and pressure data recording�...
SOFTWARE VERSION PY_LVSW_2.3p LithoVue Elite 16 MAY 19 10:20 AM Are you sure you want to Permanently Disable Recording Capability? THIS IS IRREVERSIBLE! CANCEL CONTNUE CANCEL CONTNUE Figure 18. Disable Recording Confirmation EXTERNAL VIEWING SCREEN External Viewing Screen Features Time Remaining Indicator The LithoVue Elite Ureteroscope is a single-use device�...
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Video recording timer A time indicator appears above the live image when a video recording has been initiated� The elapsed time of the video will display while the video recording is ongoing� After the video is stopped, the timer will remain temporarily showing the total elapsed time of the recording�...
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22 MAR 21 LithoVue Elite 08 : 30 AM 00 : 00 : 00 mmHg Figure 20. Pressure Display Note: the system can measure pressure values between -30 mmHg to 300 mmHg and between -41 cmH20 to 408 cmH20� Measured pressure values outside of this range will not be displayed� Pressure Alarm The Console contains a visual alarm that notifies the operator when the intraluminal pressure reaches and/or exceeds the operator’s set pressure limit�...
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22 MAR 21 LithoVue Elite 08 : 30 AM 00 : 00 : 00 mmHg mmHg Figure 21. Pressure and Pressure Limit Display In the event that the intraluminal pressure exceeds the set pressure limit, a visible alarm will be shown adjacent to the actual pressure reading on the external monitor�...
This alarm is a visual notification to alert the operator that the intraluminal pressure has exceeded the set limit� The delay from when the intraluminal pressure is exceeded to when the alarm is displayed on the external monitor is less than 5 seconds�...
SYSTEM CONFIGURATION Adjusting the Pressure Alarm Limit The pressure alarm limit may be adjusted at any time during or outside of a session� To adjust the alarm limit, use to + and – buttons to adjust the value up or down� Warning: When considering the pressure readings, exercise clinical judgment to inform treatment decisions as the clinical implication of intrarenal pressure measurements is not yet well-understood and may vary depending upon the individual scenario�...
Configuring pressure units The pressure may be displayed in either mmHg or cmH20� In order to program the buttons, enter the Settings menu on the Console and toggle to the desired units� Warning: To prevent the risk of misinterpretation of pressure data, ensure that the intended unit of pressure is selected PRESSURE LithoVue Elite...
PRESSURE LithoVue Elite LIMIT mmHg 16 MAY 19 10:20 AM PRESSURE RECORDING PRESSURE mmHg cmH20 UNITS BUTTONS EXTERNAL SCREEN TIME/LANGUAGE Figure 27. Pressure Recording Setting the time and language In order to adjust the time and language, enter the Settings menu on the Console and click the “Time/Language” button� LithoVue 12 hr TIME...
Time and Language from Settings Menu Time and clock setting (12 or 24 hour format), date, and language may be set in the Time/Language menu� SYSTEM OPERATION Note: In the unlikely event a console failure results in a lost or compromised image during surgery, an alternate device (such as a non-digital scope) should be readily available if immediate visualization is necessary to continue the procedure�...
06 MAY 19 LithoVue 00 : 00 : 00 Elite 10:20 AM Figure 30. External Display Screen – No Scope Connected 06 MAY 19 LithoVue 00 : 00 : 00 Elite 10:20 AM Figure 31. External Display Screen – Scope Connected To connect the LithoVue Elite Ureteroscope, follow the instructions in the LithoVue Elite Single-Use Digital Flexible Ureteroscope Instructions for Use to remove the blue LithoVue Elite Ureteroscope umbilicus from the packaging and connect it to the Console receptacle�...
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Performing initialization Follow the instructions on the screen to prepare the pressure sensor for the initialization step: 1� Hold the end of the LithoVue Elite Ureteroscope at the distal tip, ensuring that fingers are at least 3 cm from the tip� 2�...
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5� The initialization will take at least 10 seconds, during which the distal tip should remain submerged in saline to the white tip� The process may take up to 40 seconds to ensure the most accurate zero value� LithoVue Elite 27 JAN 21 05:07 AM VERIFYING PRESSURE SENSOR.
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6� An initialization success message will confirm that initialization has succeeded, and the pressure sensor is ready for use� LithoVue Elite 07 APR 21 PRESSURE SENSOR INITIALIZATION SUCCESFUL. 09:42 AM CONFIRM ZERO READING, THEN SET YOUR PRESSURE ALARM LIMIT. mmHg CONTINUE Figure 36.
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7� In the case of a failed initialization, please retry or continue to use the scope in image-only mode� LithoVue Elite 07 APR 21 09:50 PM PRESSURE SENSOR ERROR BOX PRESSURE SCOPE PRESSURE RETRY CONTINUE Figure 38. Console Screen – Pressure Sensor Verification Error (Ureteroscope Reading High) LithoVue Elite 03 AUG 20...
27 JAN 21 LithoVue Elite 05 : 07 PM 00:00:00 PRESSURE SENSOR ERROR! Pressure Sensor Initialization Required Figure 40. External Display Screen – Pressure Sensor Verification (Fail) External Display Note: In order to confirm the pressure sensor zero value, place the distal tip into saline to the white ring and check the pressure reading�...
LithoVue Elite 07 APR 21 09:42 PM PRESSURE SENSOR INITIALIZATION SUCCESFUL. CONFIRM ZERO READING, THEN SET YOUR PRESSURE ALARM LIMIT. mmHg CONTINUE Figure 41. Setting Pressure Alarm Limit This value must be confirmed for each procedure and may be changed after scope initialization by adjusting the Pressure Alarm Limit within the Console options menu�...
LithoVue Elite 16 FEB 21 10:20 AM Figure 42. Adjusting the brightness of a Video Note: adjustments in brightness may not be apparent in certain specific settings Using the LithoVue Elite Ureteroscope During the Procedure. 1� Confirm that the LithoVue Elite Ureteroscope is functioning properly by following the “Inspection and Operational Checks”...
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Switching between video sources The video source for the external display may be switched at any time between the LithoVue Elite Ureteroscope image and the connected DVI input image� To switch, select the desired video source� The selected source will be highlighted in blue�...
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Note: If the pressure sensor is articulated into tissue with high force, resulting on direct tissue contact and pressure on the pressure sensor, for a duration of longer than two seconds, reinitialization of the pressure sensor may be required in order to ensure that the pressure sensor is still calibrated appropriately and is not damaged� In this case, the Console will show an error screen with error code “3009�”...
LithoVue Elite 16 FEB 21 10:20 AM Figure 46. Video and Camera Buttons Taking photos and videos using Console interface In order to take images and video from the Console, utilize the buttons on the Console home screen� AFTER PROCEDURE Detaching LithoVue Elite Ureteroscope The session will automatically terminate when the LithoVue Elite Ureteroscope is detached from the Console�...
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1.2 MB LithoVue 4.4GB Elite 16 MAY 19 23/02/18 10:20 PM 09:20 25 min 09:20 25 min 09:20 25 min 23/02/18 09:20 25 min 09:20 25 min SELECT ALL Figure 47. Select Session Insert a USB device into either of the two USB ports on the front of the Console and select the export button to copy all selected session data to the USB�...
LithoVue Elite System to avoid any possible hazards due to device incompatibility� If the instructions are unclear, contact Boston Scientific for assistance, using the information found in “SERVICE AND WARRANTY” section� Keep this User’s Manual in an accessible location�...
(dirty or bent connector pins), or image degradation on the touch screen� Contact Boston Scientific for service using the information found in “SERVICE AND WARRANTY “section�...
• Console Warning: Do not open the Console housing� The Console has no serviceable components� Contact Boston Scientific for repair or service using the information found in “SERVICE AND WARRANTY” section� • Power Adaptor and Power Cord In the event of a failure of the Power Adaptor or Power Cord, replacement components can be ordered from Boston Scientific�...
If unsure of the national regulations in your country, please contact your local Boston Scientific representative� It is not necessary that technical and safety inspections be performed by Boston Scientific personnel� However, technical and safety inspections of the...
C� Dispose of the LithoVue Elite Ureteroscope in accordance with hospital, administrative and/or local government policy and use another scope to complete the procedure� If the image issues still do not resolve after connection of a new LithoVue Elite Ureteroscope, contact Boston Scientific using the information found in “SERVICE AND WARRANTY” section�...
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Articulation Lever Articulation Section Handle Buttons Cable and Plug Distal Tip Accessory Access Port Irrigation Port Strain Relief Flexible Shaft Figure 50. LithoVue Elite Ureteroscope B� Advance the guidewire slowly, observing the live video image for initial entry of the guidewire into the field of view�...
If the Console fails to start, have biomedical personnel verify correct functioning of the hospital’s electrical outlet and restart the Console� If the Console fails to start after the hospital’s electrical outlet has been verified, contact Boston Scientific using the information found in “SERVICE AND WARRANTY” section for Console service�...
1� Press the Power button until the Console shuts down� 2� Press the Power button to restart the Console� 3� If the Console fails to start, contact Boston Scientific using the information found in “SERVICE AND WARRANTY” section for Console service�...
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Table 11. LithoVue Elite System Troubleshooting Chart User Message Possible Cause Corrective Action LithoVue Elite Ureteroscope Disconnected icon is Ureteroscope Cable is Remove the LithoVue Elite displayed in video field� not properly or fully Ureteroscope� Ensure the inserted into the cable connection terminals are 06 MAY 19 LithoVue...
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Console internal Reboot the Console� If the hardware problem still exists, contact communication failure� Boston Scientific for support� LithoVue Elite Ureteroscope Use Time Exceeded LithoVue Elite Dispose of the LithoVue Elite icon is displayed in the video field� Ureteroscope use time Ureteroscope and replace with a exceeded�...
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Power Button� Press the Power Button to restart the Console� If problem reoccurs, contact Boston Scientific using the information found in “SERVICE AND WARRANTY” section� Console touch panel is unresponsive or Touch panel has water Ensure that touch panel is clean intermittently responsive.
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LithoVue Elite pressure� A pressure controller Ureteroscope� such as the Boston Scientific Single Action Pumping System can be used to help regulate irrigation pressures� Problems with secondary display (poor video...
If problems occur that cannot be resolved using the troubleshooting instructions above, contact BSC using the information found in “SERVICE AND WARRANTY” section for service including the displayed error code, if applicable. ELECTROMAGNETIC COMPATIBILITY (EMC) REQUIREMENTS Guidance and Manufacturer’s Declaration-Electromagnetic Emissions The LithoVue Elite System is intended for use in the electromagnetic environment specified below (Table 12)�...
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment (Guidance) Voltage dips, short 0 % UT; 0�5 cycle 0 % UT; 0�5 cycle Mains power quality interruptions and At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°, should be that of a typical voltage variations on 180°, 225°, 180°, 225°,...
All transportation and insurance charges and risk of loss are the responsibility of the customer and must be prepaid� A purchase order must be issued to Boston Scientific Corporation to cover all transportation and insurance charges for return shipment after service�...
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Contents USB Connection DVI input DisplayPort Ureteroscope CAUTION. Attention: Consult ACCOMPANYING DOCUMENTS. Ethernet DVI output Separate Collection Non-Ionizing Electromagnetic Radiation Black (K) ∆E ≤5.0...
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