HurriChem Device Kit (FDA approved use)

Intended purpose: The ThermaSolutions HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site. Warnings: Read the IFU in its entirety before operating the HurriChem™ Device Kit. Failure to read the instructions could result in harmful effects to the user, patient, and/or HurriChem™ Device Kit. The HurriChem™ Device Kit is STERILE. If the package is damaged, DO NOT use. Damaged packaging could compromise the sterility of the components. Replace with a new HurriChem™ Device Kit and notify customer service via the contact information in the IFU. HurriChem™ Device Kit should only be used by a physician who has been trained in the use of the device. The HurriChem™ Device Kit should only be operated to a maximum pressure of 300 psi. The HurriChem™ Device Kit should be used with a liquid injector system that is capable of delivering a flow rate of 30ml to 60 ml/minute. For proper aerosolization, it is recommended that the flow rate be 42 ml/min. Flow rates should not exceed a set point that results in pressure of 300psi or greater. If the HurriChem™ is combined with other equipment, the user should also follow the warnings and cautions of the other device. If using any pharmaceutical agents during the procedure please follow the hospital internal guidelines for handling and disposal of any contaminated materials or products, as well as complying with the labeled recommendations of the pharmaceutical manufacturer regarding appropriate protective clothing, handling, and disposal of any contaminated material or products. Inspect the device and sterile package carefully. Do not use if the sterile package and/or device is damaged or suspect. CONFIRM expiration date on device packaging. DO NOT use if the expiration date has been exceeded. The HurriChem™ is designed for SINGLE-USE only and should not be re-sterilized to avoid risk of biohazard/infection or device failure. DO NOT reuse the device. Reuse may result in device failure, microbiological contamination, or biohazard/infection. DO NOT modify. Product may not work as intended if altered. Only use the high-pressure tubing supplied in the HurriChem™. Prior to insertion into the trocar/port, ensure the integrity of the pneumoperitoneum. Any medicinal substances used with the device are at the discretion of the physician. Off-label use is not promoted. Do not use irrigation solutions that are contraindicated for use or contact with medical grade stainless steel. Cautions: Ensure the high-pressure tubing is connected properly and securely to both the HurriChem™ and any injector pump or manual syringe. Store the HurriChem™ in a dry and clean environment. Maintain the sterility of the components after removing from the packaging. When using a camera cover over the HurriChem™ and high-pressure tubing, be certain the entire length of the assembled device can be contained within the cover. Insertion of the HurriChem™ through a trocar/port should only be done under direct visualization to avoid unintended damage to internal tissue. Only use the HurriChem™ under direct visualization to ensure no unintended contact with tissue. The device requires insertion through a trocar or single lumen multi-port device with access for 10 to 12mm laparoscopic devices. The trocar or access port must be able to maintain a secure fix on the abdominal wall throughout the use of the device. Luer lock connections of the liquid injector syringe should be ISO 594-2 compliant. Precautions should be taken to prevent unintended exposure or inhalation of aerosolized solutions by the patient. Contraindications: The HurriChem™ Device Kit is not indicated for use in any other areas other than the intraperitoneal area, during laparoscopic operations. Do not use irrigation fluids that are contraindicated for use or contact with medical grade stainless steel.