StoneSmart Connect Console Users Manual

TABLE OF CONTENTS Introduction... 6 Device Description... 6 Figure 1. LithoVue Elite System... 6 Contents... 6 Operating Principle... 7 User Information... 7 Intended Patient Population... 7 INTENDED USE/INDICATION FOR USE... 7 ESSENTIAL PERFORMANCE... 7 Clinical Benefit Statement... 8 CONTRAINDICATIONS... 8 WARNINGS... 8 PRECAUTIONS... 10 ADVERSE EVENTS... 11 OPERATING MODES...12 Standard Mode...12 Service Mode...12 INTERFACES...13 Table 1. Description of the Interfaces and their Function...13 Session Data...13 Table 2. Session Data...13 Physical Controls...14 Contact Information...14 CYBERSECURITY INFORMATION...14 Obtaining Technical Assistance...14 United States Technical Assistance Center...14 Europe, Middle East, North Africa Technical Assistance Center...15 Central and South America Technical Assistance Center...15 Asia, Pacific Contact Information...15 HOW SUPPLIED...16 Device Details...16 Handling and Storage...16 Table 3. Transportation, use, and storage environmental limits...16

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Security Features...14

SPECIFICATIONS AND DEVICE COMPATIBILITY...16 Electrical...16 Table 4.1. Power Adaptor and Power Cord Specifications...16 Physical (nominal)...17 Table 4.2. Console...17 Illumination Output (nominal)...17 Table 4.3. LithoVue Elite Ureteroscope...17 Medical Electrical Classifications...17 Table 5. Medical Electrical Classifications...17 LithoVue Elite Ureteroscope Fluid Compatibility...17 Console - Accessory Compatibility...17 Software Information... 18 OPERATIONAL INSTRUCTIONS... 18 LithoVue Elite System Features and User Interface... 18 Console Front Panel Features... 18 Figure 2. Console Front Panel... 18 Table 6. Front Plan Features... 18 Console Rear Panel Features...19 Figure 3. Console Rear Panel...19 Table 7. Rear Panel Features...19 SYSTEM INTEGRATION... 20 Connecting to an External Monitor... 20 Connecting a DVI Video Passthrough Device... 20 CONSOLE OPERATING SCREEN FEATURES... 20 BSC (MB Perfect Bound Manual Template 8.5 x 11 Global, 92310056L), eManual, MB, StoneSmart Connect, en, 51055235-01B

Initial Power Up Screen and Navigation Panel... 20 Figure 4. Navigation Panel... 20 Figure 5. Home Menu...21 Light on/off Button...21 Image Brightness control Buttons...21 Image Brightness Scale...21 Fluid Management Connection indicator...21 Table 8.1. Connected Device Icon status (Fluid Management)... 22 Table 8.2. Laser Connection indicator... 22 Pressure Sensor Re-Initialization Button (when using a pressure enabled ureteroscope)... 23 Figure 6. Pressure Sensor Re-Initialization Button... 23 External Viewing Screen Selection... 23 Figure 7. External Viewing Screen... 23 2

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Video and Camera Capture Buttons... 24 Figure 8. Video and Camera Capture Buttons... 24 Figure 9. LithoVue Elite Ureteroscope Button Enable... 24 FILE MANAGEMENT MENU... 25 Figure 10. File Management Screen... 25 SETTINGS MENU... 26 Figure 11. Settings Menu... 26 TOOLS MENU... 27 Figure 12. Software Version... 27 Figure 13. Preventative Maintenance Date... 27 Figure 14. Secure Delete... 28 Figure 15. Secure Delete Confirmation... 28 Figure 16. Secure Delete Restart Message... 29 Figure 17. Disable Recording... 29 Figure 18. Disable Recording Confirmation... 30 EXTERNAL VIEWING SCREEN... 30 Table 9. Time Remaining... 30 Figure 19. Image Capture and Video Recording Screen...31 Figure 20. Pressure Display... 32 Figure 21. Pressure and Pressure Limit Display... 33 Figure 22. Pressure Alarm... 33 Table 10. Alarm Flashing Parameter... 33 Programmable Buttons... 34 Figure 24. Date and Time... 34 SYSTEM CONFIGURATION... 35 Adjusting the Pressure Alarm Limit... 35 Programming the LithoVue Elite Ureteroscope Buttons... 35 Figure 25. Programming the Buttons... 35 Configuring pressure units... 36 Figure 26. Configuring pressure units... 36 Turning pressure recording on/off... 36 Figure 27. Pressure Recording...37 Setting the time and language...37 Figure 28. Time and Date...37

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Figure 23. Programmable Buttons above Pressure Display... 34

SYSTEM OPERATION... 38 Starting the Console... 38 Figure 29. Boot Screen... 38 CONNECTING THE LITHOVUE ELITE URETEROSCOPE PRESSURE SENSOR... 38 Figure 30. External Display Screen – No Scope Connected... 39 Figure 31. External Display Screen – Scope Connected... 39 INITIALIZING THE LITHOVUE ELITE URETEROSCOPE PRESSURE SENSOR... 39 Figure 32. Console Screen – Pressure Sensor Initialization...40 Figure 33. External Display Screen – Pressure Sensor Initialization...40 Figure 34. Console Screen – Verifying Pressure Sensor...41 Figure 35. External Display Screen – Verifying Pressure Sensor...41 Figure 36. Console Screen – Pressure Alarm Setting (Initial)... 42 Figure 37. External Display Screen – Pressure Sensor Verification (Pass)... 42 Figure 38. Console Screen – Pressure Sensor Verification Error (Ureteroscope Reading High)... 43 Figure 39. Console Screen – Pressure Sensor Verification Error (Stability)... 43 Figure 40. External Display Screen – Pressure Sensor Verification (Fail)... 44 External Display... 44 Figure 41. Setting Pressure Alarm Limit... 45 DURING PROCEDURE... 45 Figure 42. Adjusting the brightness of a Video... 46 Using the LithoVue Elite Ureteroscope During the Procedure... 46 Figure 43. Switching between Video Sources... 47 Figure 44. Re-initializing the pressure sensor... 47 BSC (MB Perfect Bound Manual Template 8.5 x 11 Global, 92310056L), eManual, MB, StoneSmart Connect, en, 51055235-01B

Figure 45. Enabling the Handle Buttons...48 Figure 46. Video and Camera Buttons... 49 AFTER PROCEDURE... 49 Figure 47. Select Session...50 Figure 48. Transferring Files...50 Figure 49. Powering off...51 DISPOSAL...51 INSTALLATION, CALIBRATION AND SERVICING...51 Additional Items For Safe Use...51 Cleaning and Disinfection Instructions... 52 Maintenance, Service and Replacement Parts... 53 Safety Measurements... 54 Annual PM Required... 54

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TROUBLESHOOTING... 54 Isolating The Console From The Mains Power Supply... 54 Loss of Image... 55 Loss of Articulation Control on the LithoVue Elite Ureteroscope... 55 Figure 50. LithoVue Elite Ureteroscope... 56 Console Power Loss...57 Pressure Sensor Troubleshooting...57 Figure 51. The Re-initialize button...57 Console Becomes Non-Operational... 58 Table 11. LithoVue Elite System Troubleshooting Chart... 59 ELECTROMAGNETIC COMPATIBILITY (EMC) REQUIREMENTS... 63 Guidance and Manufacturer’s Declaration-Electromagnetic Emissions... 63 Table 12. Acceptable environment for operation of the Console... 63 Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems... 63 Table 13. Electromagnetic Environment... 63 GUIDANCE AND MANUFACTURER’S DECLARATION – EMISSIONS AND EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING... 64 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

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SYMBOL DEFINITIONS... 65

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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. The StoneSmart Connect Console is referred to as the Console and the LithoVue Elite Single-Use Digital Flexible Ureteroscope is referred to as the LithoVue Elite Ureteroscope in these instructions. The LithoVue Elite Ureteroscope connects to the Console via the Connector Cable Plug Receptacle (hereafter referred to as Console Receptacle) on the front of the Console (see Figure 1). The LithoVue Elite System is designed to allow physicians to access, visualize, and perform procedures in the urinary tract, using appropriate accessory devices (e.g., baskets, laser fibers, and forceps). The system can optionally support pressure monitoring when used with a ureteroscope with a pressure sensor.

Figure 1. LithoVue Elite System Contents • StoneSmart Connect Console • Power Adaptor • Power Cord • DisplayPort Cable • DVI Cable • DVI to HDMI Cable

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INTENDED USE/INDICATION FOR USE The LithoVue Elite Digital Flexible Ureteroscope System is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) 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. 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. • Monitor accurate intraluminal pressure in ureter and kidney. • Protect against unintentional activation of the ureteroscope button functionality due to electromagnetic interference (EMI). For measurements related to safety, please consult the “Safety Measurements” section of this manual. For preventative maintenance (PM), please consult the “Annual PM Required” section of this manual. 7

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Operating Principle The Console does the following: • Provides power for the illuminating LED, image sensor, and pressure sensor hardware in the LithoVue Elite Ureteroscope. • Receives video and pressure signals from the LithoVue Elite Ureteroscope and processes the images and pressure readings. The Console outputs the video and pressure information to an external video display. • Provides illumination control. The illumination provided by the LithoVue Elite Ureteroscope is adjusted automatically by the system to ensure adequate light levels at the treatment site. Additionally, the user may also turn the illumination on/off and adjust the illumination levels using the controls provided on the Console. • Provides the ability to program the handle buttons on the LithoVue Elite Ureteroscope. • Provides the user interface. User Information Read the entire Console User’s Manual and the LithoVue Elite Single-Use Digital Flexible Ureteroscope Instructions for Use before using the LithoVue Elite System. Study labeling thoroughly for safe handling and storage. Use the LithoVue Elite System as intended. The Console should only be assembled and installed by a trained biomedical technician. The Console is designed to be placed outside the sterile field during clinical use. Cleaning and disinfection are required only when the Console becomes contaminated during use. If contamination of the Console occurs, refer to the cleaning and disinfection instructions found in “Cleaning and Disinfection Instructions” section. Only physicians who have ureteroscopic, diagnostic, and therapeutic training should use the LithoVue Elite System. A thorough understanding of the techniques, principles, clinical applications, and risks associated with endoscopic urinary tract procedures is necessary before using this device. This includes but is not limited to devices used in laser lithotripsy, administration of irrigation/contrast, and use of procedural accessories such as baskets/forceps, access sheaths, renal sheaths, guidewires, and antiretropulsion devices. Nursing support staff should have reasonable experience with common medical equipment and urology procedures. Intended Patient Population This product is intended for patients indicated for flexible ureteroscopy or percutaneous procedures. Age, weight, gender and language should have no bearing on the physician using this technology as long as the patient is indicated for the procedure.

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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CONTRAINDICATIONS Contraindications for this device are those specific to urinary tract endoscopy. Diagnostic or therapeutic ureteroscopy is contraindicated in people with an untreated urinary tract infection. Contraindications associated with therapeutic ureteroscopy (e.g., lithotripsy, endopyelotomy, tumor therapy) are more numerous and can mirror those associated with the corresponding open surgical interventions. Consideration should be given to the contraindications for those procedures. WARNINGS • Do not use the LithoVue Elite System in the presence of flammable fluids and gases such as alcohol or oxygen. Doing so can result in fire and burns to the operator and patient. • Consult the operating manuals of all electromedical energy sources used with endoscopic instruments for appropriate instructions, warnings, and cautions prior to use. Such sources of energy include electrical, electrohydraulic, electrosurgical, heat, hydraulic, laser, light, pressure, sound, ultrasound, and vacuum. • Do not insert or advance the LithoVue Elite Ureteroscope unless there is a clear, live endoscopic view of the lumen through which the ureteroscope is being advanced (or confirm with visualization by other imaging modalities). Doing so can cause patient injury such as perforation, avulsion, hemorrhage, or urothelial damage. • In the event that the live endoscopic image is lost, do not advance or insert the LithoVue Elite Ureteroscope and do not insert, advance or actuate accessories. Doing so can cause accessory damage or patient injury such as perforation, avulsion, hemorrhage, or urothelial damage. • Do not use excessive force when advancing or withdrawing the LithoVue Elite Ureteroscope. Doing so can cause patient injury such as perforation, hemorrhage or urothelial damage, or damage to the LithoVue Elite Ureteroscope. If resistance is felt during advancement or withdrawal of the LithoVue Elite Ureteroscope, investigate the source of resistance and take remedial action (e.g., fluoroscopy, contrast injection). • Do not force the distal tip of the LithoVue Elite Ureteroscope against the sidewall of the ureter or renal pelvis. Doing so can cause patient injury such as perforation, avulsion, hemorrhage, or urothelial damage. • Do not use excessive force when advancing or withdrawing an accessory within the LithoVue Elite Ureteroscope. Doing so can cause patient injury such as perforation, avulsion, hemorrhage, urothelial damage or damage to the LithoVue Elite Ureteroscope. • When inserting or using accessories, maintain continuous visualization of the distal tip. Ensure the distance between the distal tip of the LithoVue Elite Ureteroscope and the object in view is greater than the LithoVue Elite Ureteroscope’s minimum visible distance. Failure to do so may result in accessory damage or patient injury such as perforation, hemorrhage or urothelial damage. • The distal tip of the LithoVue Elite Ureteroscope should be straight when inserting and withdrawing accessories. Follow the accessory instructions for use regarding inserting accessories into a flexible ureteroscope. Some accessories may be inserted or withdrawn in a ureteroscope with a deflected distal tip, some accessories should be inserted or withdrawn in a straightened distal tip. Failure to follow the accessory instructions for use may result in patient injury such as avulsion, perforation, stenosis, additional intervention, and an unretrieved device fragment, or accessory and ureteroscope damage or malfunction. • The LithoVue Elite System has been tested and shown to be compatible with laser lithotripsy devices. The LithoVue Elite System is not intended to be used with High Frequency Surgical Equipment. The use of other 8

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energized procedural devices may cause loss of image, device damage, or patient injury such as burn, erectile dysfunction, hematoma, hemorrhage, nerve injury, perforation, reflux (genitourinary), restenosis, stenosis, and urinary retention. Do not initiate laser firing while a laser fiber distal tip is still within the ureteroscope working channel or withdraw a laser fiber’s distal tip back into the ureteroscope working channel while the laser is firing. Doing so may cause patient injury such as perforation and stenosis, and/or ureteroscope damage. Do not look directly into the light emitted from the LithoVue Elite Ureteroscope. Doing so can result in eye injury. Do not open the handle of the LithoVue Elite Ureteroscope. Doing so can damage the waterproof seals and result in risk of electric shock. The LithoVue Elite Ureteroscope is a single-use device, and there are no serviceable parts. Do not repair damaged or non-operating LithoVue Elite Ureteroscopes. Do not use the LithoVue Elite Ureteroscope if damage is discovered or suspected. Do not excessively bend the flexible shaft or the articulating section of the LithoVue Elite Ureteroscope as this may break or kink the shaft. If damage to the LithoVue Elite Ureteroscope occurs or it stops functioning during a procedure, stop using the LithoVue Elite Ureteroscope immediately. See “TROUBLESHOOTING” section for more information. Continue the procedure with a new LithoVue Elite Ureteroscope, as appropriate. No modification of this equipment is allowed. Do not attempt to repair or alter any components/parts of the Console. The Console contains no operator serviceable components. All repairs and servicing are to be performed only by authorized Boston Scientific service personnel. See “SERVICE AND WARRANTY” section for additional information. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Prior to installation, ensure that the selected hospital’s electrical outlet has a proper ground connection and complies with the information listed on the label located on the rear of the Console. The use of accessories, a power supply and/or cables other than those specified or supplied as spare parts from Boston Scientific may increase electromagnetic emissions or decrease immunity of the LithoVue Elite System. When the LithoVue Elite System is used with other electrical medical equipment, the applied parts must be Type BF or Type CF applied parts. Components added to the system by the user must be certified to the respective IEC standards (IEC 60601-1 for medical equipment, IEC 60950 for data processing equipment, and IEC 60065 for A/V equipment) or other country equivalent. 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. The use of component equipment not complying with IEC standards may lead to a reduced level of safety of the resulting capital. Power cords are considered part of the medical electrical system and must be compliant with the system. Use of the LithoVue Elite System adjacent to or stacked with other electrical equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. If the Console stops functioning during a procedure, follow the procedure described in “TROUBLESHOOTING” section. Using a Console contaminated with patient fluids can expose the operator or secondarily, the patient through clinician contact, to bio-hazardous materials. To prevent exposure to potentially bio-hazardous materials, visually inspect, clean and disinfect the Console during and between uses using the cleaning procedure described in the “Cleaning and Disinfection Instructions” section. When considering the pressure readings, exercise clinical judgment as the clinical implication of intrarenal pressure measurements may vary depending upon a variety of patient and procedural factors.

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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. To ensure satisfactory performance, perform the prescribed inspections and operational checks on the LithoVue Elite Ureteroscope described in the LithoVue Elite Single-Use Digital Flexible Ureteroscope Instructions for Use before use. Failure to perform inspection and operational checks may result in patient injury such as burn, perforation, tissue damage, avulsion, and stenosis, and/or damage to the device and accessories. Additionally, verify the Console is properly installed. See the “INSTALLATION, CALIBRATION AND SERVICING” section for more information. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no close than 30 cm (12 inches) to any part of the LithoVue Elite System, including cables specified by the manufacture. Otherwise, degradation of the performance of this equipment could result.

PRECAUTIONS • Only use the LithoVue Elite Ureteroscope in conjunction with the Console. Connection to other controller or workstation devices may cause device or property damage or operator injury. • The LithoVue Elite Ureteroscope is not compatible with the LithoVue System Workstation. • Only physicians with adequate ureteroscopic training should perform procedures with the LithoVue Elite Ureteroscope. Consult the medical literature regarding techniques, complications, and hazards prior to any procedure. • Use the LithoVue Elite Ureteroscope with caution in patients who have undergone previous urinary tract reconstructive surgery or with known strictures. These conditions may prevent passage of the flexible ureteroscope shaft. • Failure to thoroughly understand and follow all instructions, cautions and warnings provided in this User’s Manual and the LithoVue Elite Ureteroscope Instructions for Use may result in injury to the patient and/or user, and/or may result in damage to, or malfunction of, this equipment. Additionally, damage to other equipment or property may result. Follow all instructions, cautions and warnings provided with all products and equipment to be used in conjunction with the LithoVue Elite System to avoid any possible hazards due to device incompatibility. • The illumination contained within the LithoVue Elite Ureteroscope handle may cause the ureteroscope to overheat, resulting in possible user harm such as burn, discomfort, pain and tissue damage. Therefore, if the ureteroscope is not to be used immediately for a procedure, it is recommended that the light be turned off until needed. • When using the LithoVue Elite Ureteroscope with a laser lithotripsy device, all personnel within the treatment room shall wear protective laser eyewear in accordance with the laser manufacturer’s instructions for use. • Do not use accessories that fail to meet the compatibility requirements of the LithoVue Elite Ureteroscope as stated in the LithoVue Elite Single-Use Digital Flexible Ureteroscope Instructions for Use. Doing so may cause damage to the LithoVue Elite Ureteroscope, Console and/or accessory. • Verify ground isolation when setting up and using accessories from different manufacturers. Failure to do so can result in user/patient injury such as electric shock, tissue damage, additional intervention, and prolonged procedure, and accessory malfunction leading to patient injury. • Prior to use of a cardiac defibrillator, remove the ureteroscope from the patient. Failure to remove the ureteroscope from a patient during use of a cardiac defibrillator could result in patient injury such as electric shock, or damage to the system due to the discharge of the cardiac defibrillator. • The LithoVue Elite Ureteroscope features a strain relief at the transition from the handle to the shaft. The strain relief protects the device during use. To prevent damage to the shaft and/or light fiber, do not bend the shaft sharply. • Use only those fluids/lubricants recommended in the “Fluid Compatibility” section of the LithoVue Elite Single-Use Digital Flexible Ureteroscope Instructions for Use.

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The LithoVue Elite Ureteroscope Connector Cable (hereafter referred to as Ureteroscope Cable) should connect to the Console Receptacle easily. If the Ureteroscope Cable does not connect, verify that the arrows on the Ureteroscope Cable and the Console Receptacle line up and that the Console Receptacle is not damaged. Forcing the Ureteroscope Cable into the Console Receptacle may damage the Ureteroscope and/or Console. Do not insert a wet, contaminated, or damaged Ureteroscope Cable plug into the Console Receptacle as poor video performance or damage to the system may result. Do not remove the Ureteroscope Cable from the Console by pulling on the cable as poor video performance or damage to the system may result. Slide the locking collar on the Ureteroscope Cable’s plug toward the cable and pull the plug out to remove the cable. Placing the Console near other medical electrical equipment may result in electromagnetic interference (EMI) which may degrade the video image. Additionally, EMI from the Console may interfere with other equipment in the operating room. Verify that all electrical equipment is working properly before starting the procedure. Failure to do so may result in the equipment not working properly resulting in either a delay of the procedure or an adverse event. Spilling liquids on the Console can damage it or cause it to shut down. Do not place liquids above or near the Console. Inspect all cables and cords (cuts in insulation, fraying or broken wires, dirty or bent connector pins). Replace if damaged. Inspect the console enclosure to verify that there are no unacceptable damages to the console enclosure (e.g., chips, dents, scratches, or marks), degraded labels, connectors with signs of damage or excessive wear (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. Power down the Console when not in use (i.e., at the end of a procedure). Do not power down the Console by unplugging the power cord from the hospital’s electrical outlet until after the power button is pressed and power down is complete. Doing so may cause damage to the system or present electrical energy exposure to the user.

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ADVERSE EVENTS Possible complications include, but may not be limited to: • Avulsion • Bleeding • Burn • Discomfort • Extravasation • Fever • Hematoma • Infection • Inflammation • Laceration • Pain • Perforation (ureter, renal pelvis, or bladder) • Sepsis • Stenosis/Stricture • Ureteral reflux • Urinoma • Urothelial damage. 11

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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. Delete the following data from the Solid State Drive (SSD) A. Session Images B. Session Video C. Session Pressure Data 2. Download the following data to a USB storage device A. Session Images B. Session Video C. Session Pressure Data 3. Change the following configuration information A. Time B. Date C. Language D. Pressure Units 4. LED Brightness 5. Enable/Disable Pressure Recording 6. Connect and use a LithoVue Elite Ureteroscope 7. Connect a secondary scope via the DVI In Port 8. Upgrade the Console software using a thumb drive containing signed software images. To protect against unauthorized use, it is always advised that the Console be stored in a secure location. Service Mode Controls have been implemented to limit the access to BSC Service mode to BSC service personnel. Mode is used by the BSC service personnel to perform the following functions: 1. Download service logs for debugging 2. Upgrade the Console software using a thumb drive containing signed software images 3. Calibrate the Console pressure sensors. The authorized service personnel will not have root access in this mode.

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INTERFACES Table 1. Description of the Interfaces and their Function Interface Function USB Ports (3 Total) Download Session Data (Images, Video, Pressure Data)1. Upload signed software Images for upgrading the Console. Ethernet (RJ45) Connector Disabled2 Network Switch There are 4 ports on this switch that allow the Console to interface with authorized BSC StoneSmart devices. To use these ports, the user will need to install a small form-factor pluggable (SFP) module in each port that they wish to use. The Console will be shipped without any SFP’s and thus the network switch will not be readily useable. The Console connects with authorized BSC StoneSmart devices using a certificate-based authentication. Console Operating Screen Allows the user to: Configure the Console Capture images and video Save data to USB Update the Console software. Ureteroscope Connector Allows a BSC authorized Ureteroscope to be connected to the Console3. DVI In Allows a secondary scope to be connected to the Console. The image from this scope will be displayed via the DVI Out and DisplayPort when selected via the touch panel. DVI Out Allows the image from a LithoVue Elite Ureteroscope or a secondary scope to be displayed on an external monitor. It will also display pressure data from a pressure sensor equipped LithoVue Elite Ureteroscope that has been properly initialized. DisplayPort Allows the image from a LithoVue Elite Ureteroscope or a secondary scope to be displayed on an external monitor. It will also display pressure data from a pressure sensor equipped LithoVue Elite Ureteroscope that has been properly initialized. 1. The session data is unencrypted when it is transferred from the Console to the USB storage device.

3. User’s must only connect BSC authorized Ureteroscopes to this connector.

Session Data The session data consists of the following: Table 2. Session Data Session Data 1 Images 2

Video

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Pressure data

These are time stamped images of the patient’s kidneys, ureter, and bladder that are taken during the procedure by a LithoVue Elite Ureteroscope. These are timestamped videos of the patient’s kidneys, ureter, and bladder that are taken during the procedure by a LithoVue Elite Ureteroscope. These are pressure values taken during the procedure as measured by a pressure sensor equipped LithoVue Elite Ureteroscope.

The session data contains no patient identifiable information only a timestamp and the actual physiological data. Session data remains encrypted within the Console’s solid-state drive (SSD) until it is manually deleted through deletion of the session data or use of the Secure Delete Functionality. When downloading session data, it is recommended that a FIPS 140-2 certified USB storage device be used. It is important to note that the Console is not intended as a long-term 13

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2. The user must not connect any devices to this ethernet port. This device does not need to be connected to the Hospital LAN and will not respond to inventory and vulnerability scans.

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repository of session data. Once the SSD becomes full, the user is required to delete or download session data prior to beginning a session. Users should routinely download session data that they wish to save. Security Features The Console contains the following security features: 1. Secure boot – to ensure the integrity of the software and firmware at startup is guaranteed. 2. Digital Signature Validation – to ensure that the device only accepts BSC-authorized software and firmware images and rejects any attempts to install unauthorized software. 3. Certificate-based authentication of Service users (Service Mode). 4. Certificate-based authentication of BSC approved devices that connect via the network switch. Physical Controls Maintain good physical controls over the Console. Having a secure physical environment prevents access to the internals of the Console. USB devices connected to the Console should be controlled to limit the introduction of malware. Appropriate precautions should be taken to secure the Console from unauthorized access. Contact Information For information on known vulnerabilities in the Console and mitigations please routinely monitor the BSC Product Security website (https://www.bostonscientific.com/en-US/customer-service/product-security/product-securityinformation.html) CYBERSECURITY INFORMATION Only use consoles obtained from Boston Scientific. Refrain from using consoles obtained from unauthorized third parties. To request inventory or additional product details, please access the following website: https://www.bostonscientific.com/en-US/customer-service/ordering.html Or call 1- (888) 272-1001 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” section to locate the model and serial number located on the Console. This will be required when registering a complaint. To request the latest cybersecurity documentation please contact the BSC Technical Assistance Center as detailed below. Obtaining Technical Assistance For technical information and assistance contact: United States Technical Assistance Center Countries Contact Number United States, Puerto Rico and Tel: +1.800.949.6708 Caribbean Islands

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Email Laser products [email protected] Other products [email protected]

Central and South America Technical Assistance Center Countries Contact Number Argentina, Chile, Bolivia, Uruguay, +54 1170900232 Paraguay Brazil +55 1155459063 Colombia, Venezuela, Peru, Ecuador Mexico, Panama, Costa Rica, Guatemala, EL Salvador, Nicaragua Asia, Pacific Contact Information Countries ANZ

+57 16295045 +52 15559924100

APAC

Contact Number Tel: +61 1800.676133 option 5 +65.64.18.8878

China

Tel: +86 400.801.6908

Japan

Tel: +81.120.177.779 Fax: +81.45.444.2799

Email Laser products [email protected] Other products [email protected]

Email [email protected] [email protected] [email protected] [email protected] [email protected]

Email [email protected] Legacy - [email protected] Lasers - [email protected] [email protected] [email protected]

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Europe, Middle East, North Africa Technical Assistance Center Countries Contact Number European Toll-free number 00800 5555 7707 Note: Don’t replace 00 by + but dial as documented above Europe general Tel: +31 45 546 7707 Fax: +31 45 546 7805 Austria +43 16 08 10 37 Denmark +45 80 25 34 29 Czech Republic 0800 142942 Finland +358 800770055 France +33 139 304 971 Germany +49 815 126 86118 Italy +39 022 698 3218 Netherlands +31 45 5467707 Norway 0800 14236 Spain +34 917 619 999 Sweden +46 020790077 UK +44 1442 411 686

HOW SUPPLIED Device Details 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. • Store the Console in an area that is safe from impact or other accidental damage. • Confirm that storage area environment is within the limits provided in Table 3 “Transportation, Use and Storage Environmental Limits”. • Confirm that the storage area is free from risk of water leakage or splashes. Table 3. Transportation, use, and storage environmental limits Environmental Limits during Use Ambient temperature 10 °C to 35 °C Relative humidity 20 % to 85 % RH (non-condensing) Atmospheric pressure 700 hPa to 1060 hPa Environmental Limits during Transport and Storage Ambient temperature -29 °C to 60 °C Relative humidity 30 % to 85 % RH (non-condensing) Atmospheric pressure 500 hPa to 1060 hPa SPECIFICATIONS AND DEVICE COMPATIBILITY Electrical

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Caution: The Power Cords and Power Adaptor must be compatible with the LithoVue Elite System. A compatible Power Cord and Power Adaptor are provided with each Console for this purpose. The power plug is considered as the isolation means from the AC mains. Table 4.1. Power Adaptor and Power Cord Specifications Power Adaptor and Power Cord Specifications Power Adaptor External, Medical grade, DC Cord Length: 1.2 meters Input: AC, 100 V-240 V ~, 50 Hz-60 Hz, 2.2 A Output: 12 V DC, 13.33 A, 160 W North America Power Cord Length-3.0 meters Voltage Rating-125 VAC Current Rating-10 amps International Power Cords (EU, UK, Italy, Denmark, Length-2.5 meters Switzerland, Australia/New Zealand, China, South Voltage Rating-250 VAC Africa) Current Rating-10 amps Japan Power Cord Length-2.5 meters Voltage Rating-125 VAC Current Rating-12 amps

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Physical (nominal) Table 4.2. Console Console Physical Specifications Height Width Depth Weight LCD Panel

4.83 in 16.43 in 12.15 in 11.45 lbs Capacitive Touchscreen

Illumination Output (nominal) Table 4.3. LithoVue Elite Ureteroscope Illumination Output Type Wavelength

LED 375 nm - 800 nm

Medical Electrical Classifications The LithoVue Elite System meets the requirements of the following standards: IEC 60601-1 and CAN/CSA- C22.2 No. 60601-1. Table 5. Medical Electrical Classifications Medical Electrical Classifications Type of Protection Against Electric Shock Degree of Protection Against Electric Shock Degree of Protection Against Ingress of Liquids, Console Degree of Protection Against Ingress of Liquids, LithoVue Elite Ureteroscope Mode of Operation Suitability for use in oxygen rich environments

Class 1 equipment Type BF Applied Part (LithoVue Elite Ureteroscope) IP21 IPX2

Installation and Use

LithoVue Elite Ureteroscope Fluid Compatibility The LithoVue Elite Ureteroscope is known to withstand exposure to the following procedural fluids: blood, urine, saline, contrast media and water-based lubricants. Console - Accessory Compatibility Note: All attached equipment must comply with applicable electrical safety standards. Proper system functioning must be verified before use. • • •

•

The Console is ONLY compatible with the LithoVue Elite Ureteroscope. Accessories supplied with the Console have been verified to comply with applicable standards. Medical Grade video monitor with standard video signal inputs (at a minimum DVI 1.0 or Display Port 1.0 or 1.1 or HDMI) and a minimum resolution of 1920 x 1080 at an aspect ratio of 16:9. Console has been tested by Boston Scientific with Sony Monitor LMD-2765MD and LG Monitors LG 27HJ713C-B and LG 27HJ712C-W. Video monitors included in console testing are considered supportive equipment and not part of the LithoVue Elite system. 17

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Continuous Operation Equipment not suitable for use in the presence of flammable mixtures Portable Equipment

•

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. Software Information The software revision level is controlled by Boston Scientific. The current revision level is provided within the Tool menu on the Console display. OPERATIONAL INSTRUCTIONS LithoVue Elite System Features and User Interface Console Front Panel Features 2

USB Connection

StoneSmartTM Connect

USB Connection

Ureteroscope

1

3

4

Figure 2. Console Front Panel

BSC (MB Perfect Bound Manual Template 8.5 x 11 Global, 92310056L), eManual, MB, StoneSmart Connect, en, 51055235-01B

The front panel includes the features listed in Table 6. Table 6. Front Plan Features Front Panel Features 1 Power Button

2

Two USB Ports

3

Console Receptacle

4

Display

Description When the Console is connected to a power source, pushing the front panel Power Button powers up the Console. When the Console is powered on, another press of the Power Button will power the system down. The Power Button illuminates green when the Console is powered on. These ports may be used for transferring saved images, videos, and pressure recordings to a USB media device. The LithoVue Elite Ureteroscope Cable plugs into the receptacle on the front of the Console. Color liquid crystal touchscreen display (LCD) provides the graphical user interface (GUI). The user interacts with the system via the touchsensitive controls on the screen. Buttons on the main operating screen are activated with a finger press.

Note: The Console GUI has been demonstrated to function with gloves. 18

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Console Rear Panel Features

3

1

1

2

3

4

StoneSmartTM Connect Console

Consola, Console, Konsole, Console, console, Konsol, Κονσόλα, Consola, Konsol, Konzol, Konzole, Konsola, Konsoll, Konsol, Konsoli, Consolă, Konzola, Конзола, Konzola, Juhtpult, Vadības pults, Valdymo pultas, Konzola

Ethernet

5 Ethernet

DVI output

DisplayPort 12V --- 13.33A

DVI input

USB Connection

2

4

5

6

7 8

Figure 3. Console Rear Panel The rear panel includes the features listed in Table 7:

2 3 4

5 6

7

8

Description Ground connection for other devices to ensure common potential between devices. Power Adaptor Connector Accepts the DC out plug from the Power Adaptor supplied with Console. Network Switches (4X) Ethernet RJ-45 connectors allows connection of up to 4 BSC compatible devices. Ports are secured so only BSC approved devices will function. Ethernet Port (standalone) This port is not active and is only included for future implementation. USB 3.0 Port Used for transfer of locally stored data to USB pen drives, software upgrades or implementation of a Manufacturing Test Interface used during Console manufacturing acceptance testing. Labeling Information Product, Manufacturer, and Regulatory information. DisplayPort Out Video output port that allows DP connection to an external video display. For more information regarding compatible monitors see the “Console - Accessory Compatibility” section. DVI Out Port Video output port that allows DVI connection to an external video display or a DVI Switcher. For more information regarding compatible monitors and DVI Switchers, see the “Console - Accessory Compatibility” section. DVI In Port Video input port that allows connection of an external video source (For e.g. from a Cystoscope system, Nephroscope system). This feature will allow quick switching between internal and external video sources on a connected external video display.

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Table 7. Rear Panel Features Feature 1 Equipotential Connection