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EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 are used for endoscopic diagnosis and treatment within the respiratory organs. These endoscopes consist of three parts: the control section, the insertion section, and the connector section.

a. Endoscope Model EB-710P Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes. b. Processor EP-8000 The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It is used for endoscopic observation, diagnosis and treatment.

a. Endoscope Model EB-710P FUJIFILM Endoscope Model EB-710P is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion portion is flexible and contains glass fiber bundles, several channels, and a complementary metal-oxide semiconductor (CMOS) image sensor in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart. b. Processor EP-8000 FUJIFILM Video Processor EP-8000 is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. FUJIFILM Video Processor EP-8000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor employs fiber bundles to transmit light from four LED lamps (Violet, Blue, Green, and Amber), with a total power of 79.2W lamps, to the body cavity. The device is AC operated at a power setting of 100-240V/50-60Hz/ 3.0-1.5A. The processor is housed in a steel-polycarbonate case measuring 395×210×515mm

The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade).

The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade). The Balloon Catheter is inserted into the instrument channel of compatible bronchoscopes and advanced to the target area, where medical fluid or saline solution are injected, or the balloon is inflated to allow for hemostasis (tamponade). When the procedure is completed, the balloon is deflated, and the catheter is removed from the patient. The Balloon Catheter is provided sterile and is constructed of a natural rubber latex inflatable balloon, polyethylene tube, branch, irrigation port, air feed cap, and stopcock. The inflatable balloon has a maximum diameter of O 11 mm after inflation.

The DISPOSABLE BIOPSY FORCEPS FB-211D/221D/231D/241D are intended to be used to collect tissue within the tracheobronchial tree in combination with a bronchoscope

The Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, and FB-241D (also known as "EndoJaw") have been designed to collect tissue within the tracheobronchial tree in combination with a flexible bronchoscope. The Disposable Biopsy Forceps are inserted into the channel of a bronchoscope to collect tissue by biting the surface of the lesion with a pair of forceps located at the distal end of the device. The Disposable Biopsy Forceps are withdrawn from the channel and the tissue sample is collected. The Disposable Biopsy Forceps consists of a handle and an insertion portion. The handle consists of a handle body and slider. The insertion portion consists of a sheath, metallic coil (operating wire), cups, and forceps cap. The slider is connected to the operating wire in the insertion portion and the cups are opened/closed by advancing/retreating the slider with the function of the connection parts. The subject device is available in multiple distal end cup shapes; FB-211D – Alligator jaw-step, FB-221D – Alligator jaw-step with needle, FB-231D – Oval type, and FB-241D – Oval type with needle.

The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

The Bronchoscope System comprises two components: (1) a Portable Video Processor (model: EA101) and (2) a compatible Flexible Bronchoscope (model: BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US). The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope. The Portable Video Processor consists a 13.3" LCD touch screen. It is powered through a Lithium-ion battery or a separate power adaptor. The Flexible Bronchoscope has following physical and performance characteristics: - Maneuverable tip controlled by the user - Flexible insertion cord - CMOS Camera and LED light source at the distal tip - Sterilized by Ethylene Oxide - For single use Portable Video Processor has following physical and performance characteristics: - Displays the image from the Flexible Bronchoscope on the built-in screen. - Can be connected to an external monitor. - Non-sterile Reusable device.

The Insighters(TM) Single-use Bronchoscope System provides images for the observation, diagnosis and treatment of trachea, bronchus and lung area. It is indicated for diseases of the trachea and bronchi other than contraindications. The Insighters(TM) Single-use Bronchoscope System is generally in-hospital use. The Insighters(TM) Single-use Bronchoscope System is for use by trained clinicians/physicians only.

The Single-use Flexible Video Bronchoscope (Insighters™ Single-use Bronchoscope System) consists of an Single-use Bronchoscope (iS-B12A/ iS-B22A/iS-B26A) and an Insight Workstation(iS-PF1) which is a compatible displaying unit. The Single-use Bronchoscope consists of an insertion part (including the head end part, a bending part, and Main Hose part) and an operation part (including an electrical interface, a suction interface, a suction button, and clamp channel interface). It comes in 3 models: iS-B12A, iS-B22A, iS-B26A. The differences among the different models are only in size. This product is sterilized by ethylene oxide, single use, disposable, body orifices invasive and short-term use device. The Insighters™ Insight Workstation (iS-PF1) consists of a display host and accessories: Power adaptor (model PH50-12), Connection Cable. The Insight workstation supports connection with Single-use bronchoscope by Connection Cable. It can supply power and processes the images for medical electronic endoscope. It is a reusable monitor and no contact with the patient. The Insighters™ Single-use Bronchoscope System is to provide images for the observation, diagnosis and treatment of trachea, bronchus and lung area. This product is a portable electronic endoscope. It has the characteristics of clear image, small size, light weight, easy to carry, flexible operation, easy to learn and use, etc. This product contains a working channel, which is convenient for use after insertion of endoscopic accessories. The applied part of this product is the insertion part of the Single-use Bronchoscope. Single use application of this product minimises the risk of cross-contamination of the patient.

The LumiRex Bronchoscope is a single-use flexible endoscope designed to be used with Contra Healthcare Solutions video processors, endotherapy accessories, and ancillary equipment for endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment.

The LumiRex Single-Use Bronchoscope is a flexible video-based medical device designed for insertion through the mouth or nose into the trachea and bronchial tubes. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the airways. The bronchoscope also features a working channel that allows for the passage of various instruments, such as biopsy forceps, brushes, and suction devices, facilitating endoscopic procedures. The device is available in different diameters to accommodate a range of patient anatomies and clinical needs. The Bronchoscope can be used wired or wireless through a Wired Scope Adapter or Wireless Scope Adapter. The adapters transmit images from the bronchoscope to the Video Processor Unit where the user can view the image from the bronchoscope, control the LED, and save and export images from the bronchoscope onto USB removable media.

The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment. The Single-use Broncho Videoscope 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 respiratory system such as trachea, bronchi, and lungs. The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or within the field of view from the body cavity. The 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, Broncho Videoscope System, is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor or Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Single-use Broncho Videoscope is a single use in conjunction with Full HD Visualization Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi and lungs. The Single-use Broncho Videoscope has six models, which are available in three kinds of outer diameter of insertion section (02.8mm and 05.6mm), one working length (600mm), two different material of the insertion (Nylon and PEEK) and two plug types (Square type and round type). The six models with round type have been cleared in K210739. The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, they have and the difference is only on the image adjustment functions. 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.

The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging Processor is a reusable monitor. The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope 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 of the Electronic Endoscope Imaging Processor via the encoding circuit. The Electronic Endoscope Imaging Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Electronic Endoscope Imaging Processor also controls the brightness of the LEDs on the endoscope. The optical components and their arrangement at the distal tip for all models of the Single-use Bronchoscope are identical. The Single-use Bronchoscope is single-use medical devices that are sterilized with ethylene oxide and intended for use in adults. This product is accompanied by an electronic endoscopic image processor, which supports the use of medical monitors. The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor.