Search Results

Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for the central control of integrated medical devices and accessories in one central location within the operating room. In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp, OR-camera, ORtable, insufflator, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The connected devices (Richard Wolf or third party) can be control terminals (with touch screen), or the control mechanism on actual device.

The core nova (complete operating room endoscopy nova) by Richard Wolf is a networkbased integrated operating room accessory that provides central control to various Richard Wolf devices and third party devices. This control allows the user to control device settings from the sterile area. Richard Wolf's core nova is comprised of core.browser, core.connect with driver, IR Transceiver, an optional core.media, and an optional server core.portal.

The ENDOCAM® Logic HD Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic HD Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.

The Richard Wolf ENDOCAMB Logic HD Camera System 5525 is an endoscopic camera system for rigid and flexible endoscopes (e.g. Arthroscopes, Bronchoscopes, Hosteroscopes. Laparoscopes, Ureteroscopes, etc.). The Richard Wolf ENDOCAM® Logic HD Camera System 5525 allows the doctor to visualize the image of natural and artificial cavities through the endoscope by projecting images to a monitor for visual display and data storage during endoscopic diagnostic and therapeutic surgical procedures. The Richard Wolf ENDOCAM® Logic HD Camera System 5525 consists of: - ENDOCAM® Logic HD Controller(s) - ENDOCAM & Logic HD Camera Head(s), and - Objective Lens (Coupler). Devices are used in conjunction with other ancillary equipment such as endoscopes, light source, monitors, printers, recorders, required cabling, etc. The Richard Wolf ENDOCAM® Logic HD Camera Head(s) use ICCD or 3CCD imaging systems to provide high definition (HD) visualization and quality images. The Richard Wolf ENDOCAM® Logic HD Camera Head cable connects to the ENDOCAM® Logic HD Controller, the ENDOCAM® Logic HD Controller relays the image from the endoscope with/without the use of an objective lens (coupler) to a video monitor; projection can be either analog or digital at the user's preference. The Richard Wolf ENDOCAM® Logic HD Controller(s) is equipped with pre-programmed presets which can be selected via touch-screen, remote control, and/or keyboard. Self-made adjustments can be stored and individually named by user. Patient data and endoscopic images can be printed or stored directly onto USB flash drive. The Richard Wolf ENDOCAM® Logic HD Camera System 5525 is compatible and can be integrated with the Richard Wolf RiwoNet / Core operating room system. Devices included in the Richard Wolf ENDOCAM® Logic HD Camera System 5525 are reusable and do not require sterilization before use because there is no direct patient contact. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use Manual: these instructions were developed by Richard Wolf using standards outlined in ANSI / AAMI ST:2004/(R) 2010 and FDA's Guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. Office of Device Evaluation April 1996. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

The ENDOLIGHT LED Light Source Projector is intended to illuminate the surgical site during minimally invasive surgical procedures by producing light that is transmitted from the light source through fiber optic cable and a scope.

The ENDOLIGHT LED Light Source is a fiber optic light source utilizing a single, solid state, high power, white light emitting diode (LED) to produce visible light that used to illuminate surgical sites during minimally invasive surgical procedures. The light from the ENDOLIGHT LED Light Source is transmitted through an optical cable and a scope. ENDOLIGHT LED 1.1 and 1.2 are comprised of light source and power supply cord. The units consist of aforementioned LED, cooling fan, light port, and protective housing. ENDOLIGHT LED 1.1 and 1.2 are portable and are very similar in design, format, and functionality to other LED light sources including the predicate devices. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

The KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).

The KeyPort AR System is a reusable device used for creating and maintaining an artificial access port to body cavities including the necessary pneumoperitoneum. The KeyPort AR System allows multiple instruments and /or camera access during minimally invasive procedures, which include anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision). This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons. The KeyPort AR System is comprised of KeyPort silicone sealing insert (1), KeyPort AR trocar sleeve (2), and KeyPort trocar (3). The KeyPort AR System is used in conjunction with CO2 insufflator, Pump for smoke gas evacuation, and required instruments which are selected in accordance with the indications as well as the surgeon's requirements. Unless otherwise specified, all components of the KeyPort AR System are reusable and require sterilization before use. Methods of cleaning, disinfection, and sterilization are detailed in Instruction Manual GA-B 253-2 USA.

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stones, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as: Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is comprised of a Holmium YAG laser base unit with integrated cooling unit and system specific laser fibers. The laser system base contains the switching elements and interfaces, the display unit, the fiber connection point, components inside the laser system, and software. For a safe operation, essential functions and components are monitored automatically. The MegaPulse Laser system is designed with automated fiber recognition to ensure only permissible parameters are used. A warning message appears on the touch screen monitor and is accompanied by a signal should a fault or error occur. The MegaPulse Laser Fibers are intended to be used in with MegaPulse Laser System to deliver laser energy. The laser fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to provide access to the surgical procedure site. The laser fiber works on the principle of internal reflection. Laser energy is focused into the fiber at the proximal end and it travels the length of the fiber by means of total reflection. The fiber contains the laser beam and channels the laser energy from the proximal end of the fiber to its distal end. The laser fibers are single-use sterile packaged. They are similar if not equivalent in design and performance to other legally marketed laser fibers with an integrated fiber identification system designed to work only with the MegaPulse laser system base.

Intended use: In conjunction with a motorized handle (c.g. Power Stick M5/3), the POWER DRIVE ART1 2304 serves as a drive unit for Richard Wolf rotary blades/abraders for the removal of tissue during endoscopic intervention. Simultaneous evacuation (suction) allows continuous removal of the ablated tissue. In conjunction with Power Drill M1, bones can be severed or machined. Indications and field of use: The product is used in conjunction with endoscopic accessories for the following purposes: - . In arthroscopy, e.g. resection of the meniscus, for removing soft tissue as well as intraarticular severing or abrasion of bone tissue (e.g. ACL or shoulder applications). - In theracte surgery, e.g. for the removal of hematomas. . - In sinus surgery, e.g. for the removal of polyps. - . In spinal surgery (arthroscopic microdiskectomy (AMD) for removing degenerated tissue.

The POWER DRIVE ART1 2304 is an enhanced version of our POWER CONTROL 2303, cleared in K030082. The new device has new electronics, new software, additional motor handles, tools and tool holders such as rotary blades/ abraders, saws, sagittal and reciprocal saw attachments, drill chucks, drills and surgical wires. The POWER DRIVE ART1 2304, consisting of: generator, motor handles, tools (such as rotary blades/ abraders, sagittal and reciprocal saws, drills and surgical wires) and tool holders (such as sagittal and reciprocal saw attachments and drill chucks). Additional features are new motor handles, some with integrated keypad as well as automatic tool recognition with the new rotary blades and abraders (via RFID technology) and a touch screen for user control. Multiple use devices are not provided sterile; they must be startlized per their instruction before each use. Single use devices are provided sterife and designed for only one use on or in-a single patient. Via the integrated CAN-BUS interface, the POWER CONTROL 2304 can be integrated into the R. Wolf RIWO NET SYSTEM with remote control, speech control, and touch-screen monitor.

Intended Use: The 3 CCD HD ENDOCAM 5550 has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. In conjunction with video recorders, video printers and other video devices it can be used for recording and storing video images. Indications and field of Use: The 3 CCD Endocam is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, gynecologic, laparoscopic, urologic, sinuscopic, plastic, and as an accessory for microscopic surgery.

The 3 CCD HD Endocam 5550 consists of a camera control unit and a connectable camera head. The camera head connects to an endoscope for High Definition visualization during minimally invasive surgical procedures. The camera controller provides outputs for video monitoring, video recording, and connecting to the RWMIC-NET Operating Room Control System.

The "The View MD Office System" is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures

The View MD Office System is a 50 watt light source, 1 CCD camera, and LCD Monitor with image capture combined into a compact unit.

S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. For Urology: Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract. For Gynecology: Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation. Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

The bipolar S-line Resectoscopes with electrodes have a design similar to the traditional monopolar resectoscopes, but with an additional pin for the neutral pole at the working element. The HF bipolar connection cables have a standard resectoscope connector and in addition a neutral connection to the neutral pin at the neutral pin at the S-line working element and on unit side plugs for connection to bipolar generators.