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The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The KARL STORZ Flexible Video-Uretero-Renoscope (PNs 11278VSE, 11278VSUE) is a video endoscope used for visualization within the upper urinary tract (ureters) and kidneys. The endoscope includes a luer with two ports to allow access for instrumentation, as well as irrigation. The Flexible Video-Uretero-Renoscope models 11278VSE and 11278VSUE differ only in the direction of the distal tip deflection. With 11278VSUE when the control lever is pushed forward towards the distal tip, the distal tip deflects down and with 11278VSE the deflection is opposite.

The Disposable Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via trans-urethral or percutaneous access routes. It can also be used in conjunction with endoscopic instruments via its working channel to perform various diagnostic and therapeutic procedures in the urinary tract. Images Systems (Camera-Controlled Unit) is intended to provide power to and receive, process, display, and output recordings of images from compatible visualization devices, the intended medical indication will be defined by the connected visualization devices.

The Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope. It contains a miniature CMOS camera, light-emitting diodes (LED) illumination module at the tip and an EEPROM in the handle to store use time. The tip of the U-Scope has a bending portion with 270° ± 15° bidirectional bend angle in the bending section. The U-Scope connects to the I through a separate electrical connector for sending image data and receiving LED power. The U-Scope has an inner working channel no less than 1.20mm for the infusion fluid and instrument passage with two access ports. The insertion tube distal tip OD is available in two size configurations: Flexible Ureteroscope (2.8/1.2) and Flexible Ureteroscope (2.5/1.2). Apart from the size, the endoscopes share a similar design and working length of the ureteroscope is 670 mm. The Luer Port working lumen ID is 1.35mm and irrigation lumen ID is 1.3mm that is used for irrigation connection and accessory device access. The reusable Images System (Camera-Controlled Unit) contains most electronics, including a power on/off button, touch screen, video processor, LCD, power management electronics and microcontrollers. The system includes the necessary hardware, software, and firmware to drive the endoscope CMOS camera and light-emitting diodes (LED), adjust live view images, capture images, save images to an external source, capture videos, save videos to an external source, manage saved image and files, and manage saved video files. The reusable Images System (Camera-Controlled Unit) has connectors for attaching and detaching the endoscope, external monitor, external memory, and DC power supply. The LCD has a touchscreen function for user interaction with the GUI to control the CCU functions. The display unit has a VESA mount incorporated into the rear of the enclosure for attachment to a cart or any existing customer mounting bracket that adheres to the same standard mounting pattern. Both the reusable Images System (Camera-Controlled Unit) and the single-use Flexible Ureteroscope together complete the "Ureteroscope System" enabling a Flexible Ureteroscopy procedure to take place.

The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.

The Single-use Flexible Ureteroscope is intended to be used with Vathin Digital Video Monitor. During diagnosis and treatment, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display. The Single-use Flexible Ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. It is for use in professional Healthcare Facility Environment.

The F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit are indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The F88 URE-SD Flexible Ureteroscope, Standard Deflection and the F88 URE-RD Flexible Ureteroscope, Reverse Deflection (both also collectively referred to as the "F88 URE-SD/RD Flexible Ureteroscope") is a handheld flexible ureteroscope with a flexible insertion portion length of 670 mm and a maximum outer diameter of 3.05 mm. The device includes a working channel of 1.2 mm diameter for the insertion of various compatible flexible instruments and irrigation systems. The distal tip is equipped with a CMOS imaging sensor and an LED light source for live videos. The control body has a deflection lever to deflect the distal tip up to at least 270° in the up or down directions for navigation and access to targeted areas. The push buttons can be programmed to perform functions such as white balance, brightness, picture, record, zoom and to provide access to the setup menu. The standard deflection (SD) and reverse deflection (RD) models are functionally identical, with one primary difference: the direction of the distal tip deflection in response to the deflection lever's movement. When the deflection lever of the standard model moves upward, the distal tip deflects upward. In the reverse model, when the deflection lever moves upward, the distal tip deflects downward. The model is selected depending on the handling preference of the user. The F88 URE-SD/RD Flexible Ureteroscope is a reusable device. The F88 URE-SD/RD Flexible Ureteroscope is compatible for use with the F88 Flexible Camera Control Unit (FCCU) and several accessories, listed below: - Single Luer Stopcock - Vent Cap with Sterilization Card - Manual Leak Tester - Luer Port Cleaning Brush - Cleaning Brush - URE Working Channel Cleaning Brush The F88 Flexible Camera Control Unit (FCCU) or F88 flexible camera console is a device that processes and produces live video images during endoscopic procedures. It is used together with the F88 URE-SD/RD Flexible Ureteroscope and compatible surgical display monitors to form the F88 Flexible Camera System.

The LumiRex Single-Use Digital Flexible Ureteroscope is a single-use video endoscope designed for use with Contra Healthcare Solutions video processors, urology accessories, and other ancillary equipment used in urology and urological procedures.

The LumiRex Single-Use Ureteroscope is a flexible video-based medical device designed for insertion through the urethra into the urinary tract. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the urinary tract and interior of the kidney. The ureteroscope also features a working channel that allows for installation of fluids, the passage of various instruments, such as biopsy forceps, cytology brushes, biopsy brushes, and stone retrieval baskets to facilitate urology and ureteroscopy procedures. The ureteroscope can be used wired or wireless through a Wireless Scope Adapter or Wired Scope Adapter. The adapters transmit images from the ureteroscope to the Video Processor Unit where the user can view the image from the ureteroscope, control the LED, and save and export images from the ureteroscope onto USB removable media.

The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Flexible Ureterorenoscope (Model: US27F-12-EU; US27F-12-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, optical fibers for transmitting illumination from the LED inside the Handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Mechanism of action: The light emitted from the distal tip of the Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope. Flexible Ureterorenoscope has the following physical and performance characteristics: - Maneuverable tip controlled by the user - Flexible insertion cord - Camera at the distal tip - LED in the handle and transmitted to the distal tip by optical fibers - Sterilized by Ethylene Oxide - For single use

This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra. bladder, ureter and renal pelvis. This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis. This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis. The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two different treatment section (with or without suction section). The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section. The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years. The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases. Endoscope Imaging Processor (ZSR-EOS10) : Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.

Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube. Electronic Endoscope Imaging Processor (ZSR-EOS10) Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components. The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.

The Digital Video Processor is designed to be used with Vathin medical endoscopes, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The Digital Video Processor is used in conjunction with Vathin endoscopes, and other accessories for endoscopic image processing during endoscopic diagnostic and therapeutic procedures. When used, it receives and processes image signals from a digital endoscope and transfers these signals to a connected monitor.

As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.

The Single-Use Digital Flexible Ureteroscope (Model: PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) is an endoscope which is used with the Monitor for Single-Use Endoscopy (Model:P1-D) produced by ENDOSO LIFE TECHNOLOGY for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The Single-Use Digital Flexible Ureteroscope is integrated with a working channel which allowing the use of flexible endoscopic accessories (e.g. stone basket, forceps, laser fibers for lithotripsy, etc.). The insertion portion of the endoscope is flexible, and the shape changes corresponding to the shape of the cavity. Anatomical images are captured by a CMOS chip at the distal end of the endoscope and the electronic signals are transmitted to the Monitor. Then, the resulting picture images are sent to and shown on a visual display.