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The TRANBERG®|Thermoguide Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery, for a wavelength of 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton resonancefrequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time. The TRANBERG®|Thermoguide Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of analysis using the TRANBERG®|Thermoguide Therapy System.

The TRANBERG®|Thermoguide Therapy System is indicated for use in an MRI suite to perform soft tissue ablations under MRI guidance, it consists of three parts: - 1) TRANBERG®|Mobile Laser Unit, cleared by K142216. - 2) TRANBERG®|Laser applicator and introducer, cleared by K201466. - 3) TRANBERG®|Thermoguide Workstation, article no. 1100-01, new in this submission. The TRANBERG® Mobile Laser Unit includes a laser generator that operates at the wavelength of 1064nm, a continuous wave. The generated laser light is locally applied by means of a single use applicator kit (TRANBERG®)Laser applicator and introducer, cleared by K201466) through a minimally invasive surgical or percutaneous procedure. The energy from the laser generator is transmitted to tissue through the TRANBERG® Laser applicator and absorbed by the tissue surrounding the laser applicator, resulting in increased tissue temperature that necrotizes or coagulates soft tissue. The TRANBERG® Laser applicator is a 12m long optical fiber that allows the laser generator to be placed in the MRI control room. A workstation with software (TRANBERG®)Thermoguide Workstation) is used to extract temperature maps from magnetic resonance (MR) images and to calculate the thermal dose in treated tissue. Algorithms used in the system to calculate temperature maps and thermal dose in tissue are well established and described in scientific literature. The TRANBERG® Mobile Laser Unit has safety systems to prevent the use of a malfunctioning unit, including self-testing at startup and continuous monitoring of software and components that are critical for the unit and laser emission to function optimally. All laser safety requirements are met according to IEC 60601-2-22:2019. The TRANBERG® Laser applicator utilizes an RFID tag which limits the maximum power and time (per applicator type) that can be used. It also ensures that an expired fiber, a reused fiber, or a fiber programmed for a different use cannot be used as a treatment fiber. The TRANBERG®|Thermoguide Workstation has an interface for control of the TRANBERG®|Mobile Laser Unit output through the computer interface port of the laser control). It controls power and time settings on the laser unit, and it can start and stop the laser control and safety as per medical laser equipment requirements are managed by the TRANBERG®|Mobile Laser Unit. Mandatory conditions must be satisfied to enable the laser unit and run a treatment. When one of more of these conditions are not met, the laser will not allow emitting laser radiation until all conditions are fulfilled: - Real time images from the scanner are received at least every 5s. If Thermoguide Workstation detects update rates longer than 5s the laser emission is automatically interrupted. - Laser unit enabled and the connection is verified, any loss of communication within 1.5s between the Laser unit and Thermoquide workstation or data incoherency automatically stops the laser emission. - The use of the RFID tag is a mandatory condition to run a treatment and limits the maximum power and time (per applicator type). - Laser Applicator type confirmed and received by TRANBERG®Thermoguide Workstation, the information is read on the RFID tag belonging to the fiber. - Minimum 1 ROI (monitoring or guard) has been set. - Baseline temperature (e.g., core body temperature) is set and confirmed - B0 drift compensation: Reference baseline ROI is set and confirmed - Placement of the High temperature guard ROI. - Test dose successful and confirmed Safety guard functionality: TRANBERG®Thermoguide Workstation can be used to prescribe limits for the temperature at certain points (ROIs) in the image which can, in turn, be used to deactivate the laser if the limits are reached.

The TRANBERG® Laser Applicator is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology, for wavelengths 980nm through 1064nm.

The TRANBERG® Laser Applicator is used to transfer laser energy from the laser unit to the location for the treatment. The laser Applicator is designed with a core of 550 μm. The fiber length is 3 and 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The Laser Applicator is used with an introducer and both (fiber and introducer), are delivered sterile and for single use only. The introducer consists of an introducer stylet and introducer catheter with a fiber lock.

The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended for use by trained technical personnel.

The Thermidas IR System consists of an off-the-shelf thermal imaging camera, a mount for the camera and a Windows workstation running the Thermidas Imager software. The Thermidas IR System is a non-invasive medical device which uses infrared radiation naturally emitted by the patient, which senses variations in temperature. The captured data is processed by software producing a quantitative image on the computer screen. The medical professional can use the image to review, analyze, investigate, and quantify the temperature of the objects that are imaged.

The Thermi Temperature Controlled Radiofrequency (RF) System (generator, electrodes/hanpieces and accessories) are indicated: - for use in dermatological and general surgical procedures for electrocoagulation and hemostasis - to create lesions in nervous tissue

The Thermi Temperature Controlled Radiofrequency (RF) System consists of a RF generator with integral temperature and impedance feedback, automatically adjusting energy delivery to maintain set temperature and percutaneous and transcutaneous electrodes accessories that deliver the RF to the targeted location on the patient's anatomy when use with Thermi RF generator. It is operating with set temperature range between 35-90° C that allows the physician to control treatment temperature to achieve the desired clinical outcome. The Thermi RF System consist of: - 1. RF Generator - 2. Percutaneous electrodes - 3. Disposable and re-usable transcutaneous electrodes/handpieces - 4. Foot pedal - 5. Power cord Thermi RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue.

The TRANBERG CLS/Diffusor Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery. neurosurgery, pulmonology, radiology, and urology, for wavelengths 980mm through 1064nm.

The TRANBERG45| Diffusor Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The diffusor laser fiber is designed with a core of 550 µm. The fiber length is 3 to 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The TRANBERGCS|Diffusor Laser fiber is delivered sterile and for single use only.

The Thermi Injectable RF® Electrodes used with the Thermi RF Generator System are indicated: - *for use in dermatological and general surgical procedures for electrocoagulation and hemostasis - * to create lesions in nervous tissue when used in combination with Thermi RF Generator.

The Thermi Injectable RF® Electrodes are designed to provide finely-controlled radiofrequency (RF) energy in combination with the Thermi RF Generator. They are not intended to function with other RF generators or other non-Thermi branded products. The Injectable RF® Electrodes are a combination of a RF electrode and a RF cannula to allow percutaneous application of RF energy. The RF electrode delivers the RF signal from the generator to the active tip of the cannula. The device utilizes an insulated shaft along the outside of the cannula to avoid transition of the RF signal outside of the tip area. From the active tip, the RF signal causes the tissue molecules to vibrate resulting in the formation of heat. The heated area is a function of the active tip size (length, gauge). The device is offered in different sizes to accommodate multiple anatomies and desired heating areas. The device connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit. The Injectable RF® Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the Thermi Injectable RF® Electrodes range from 5 cm to 20 cm. The cannula portion is coated with an insulation layer such that only the tip will transmit the RF signal and ablate the tissue. The tip exposures available for the Thermi Injectable RF® Electrodes range from 5 mm to 10 mm. The diameters available for the Thermi Injectable RF® Electrodes range from 16 GA to 20 GA. The cannula electrodes have a blunt tip. All the RF electrodes have a 264 cm long silicone cable. The disposable cannula electrode is provided sterile in a sealed tray for single use only.

The Thermi RF accessories used with the Thermi RF Generator System are indicated: - * for use in dermatological and general surgical procedures for electrocoagulation and hemostasis - * to create lesions in nervous tissue when used in combination with Thermi RF Generator.

The Thermi RF Accessories (electrodes, cannula, adapter cable) are designed to provide finely-controlled radiofrequency (RF) energy in combination with the predicate device Thermi RF Generator (K130689).

The TRANBERG CLS Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology, at a wavelength of 1064nm.

The TRANBERG CLS Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The laser fiber is an optical fiber with a core of 550 mic and radial diffusor. The length is 3m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The material in contact with human tissue is biocompatible. The TRANBERG CLS Laser fiber is delivered sterile and for single use only.

The Tranberg 65 Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The TRANBERGCSS|Thermal Therapy System consists of three parts: - TRANBERGCSS|Mobile Laser - TRANBERGCLS|Temperature Sensor ● - Applicator Kit (The Applicator kit is not included) The mobile laser unit is provided with a laser generator operating at the wavelength 1064 nm. The generated laser light is locally applied by means of a single use applicator kit through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature. Tissue heating and lesion formation is controlled by a tissue temperature feedback system integrated into the TRANBERGCS | Thermal Therapy System.

The Enthermics Medical Systems DC Series Fluid Warming Cabinets are designed to safely store and warm irrigation fluids and injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.

The DC Series Fluid Warming Cabinets are single cavity warming cabinets intended to heat either irrigation fluids (set point range of 90°F to 150°F) or injection fluids (set point range of 90°F to 110°F). The cabinets consist of powder coated steel exterior panels, and stainless steel cavity panels. The exterior also consists of ABS plastic panels. The heating system of the device includes three or more independent, fully insulated, electrothermal arrays mounted on the outside of the cavity. The device includes an over temperature alarm which provides an audible and visual indication that the cavity temperature has exceeded the set temperature by 10°F. Additional thermal reset switches are present the shut off power to the heating array or unit in the event of an over temperature array or cavity respectively.