HurriChem Nebulizer

The HurriChem™ is intended for the minimally invasive administration of aerosolized liquids. Warnings: Read the IFU. Failure to read IFU could result in harmful effects to the user, patient, and/or product. The HurriChem™ is sterile. Inspect the device & packaging carefully, do not use if the package is damaged or the expiration date has passed. Device should only be used by a trained physician. The HurriChem™ should only be operated to a maximum pressure of 300 psi and used with a liquid injector system capable of delivering flow of .5 ml to 1 ml/second. Flow rate of .7 ml/sec recommended for proper aerosolization and should not exceed a pressure of 300 psi or greater. If combined with other equipment, also follow the warnings and cautions of the other device. Follow hospital internal guidelines for handling and disposal of any contaminated materials, products, and pharmaceuticals. Designed for single use only; do not re-sterilize to avoid risk of material damage, microbiological contamination, or infection.. Do not modify, as product may not work as intended if altered. Use only with supplied high-pressure tubing. Ensure the integrity of the pneumoperitoneum prior to insertion. Any medicinal substances used with the device are at the discretion of the physician. Off-label use is not promoted. Cautions: Ensure the high-pressure tubing is connected properly and securely to both the HurriChem™ and any injector pump or manual syringe. Store in a dry and clean environment. Maintain sterility of the components after removing from the packaging. When using a camera cover over the system, contain the entire length of the assembled device within the cover. Insert the device through a trocar/port under direct visualization to avoid unintended contact/damage to internal tissue. The device requires a 10 to 12mm port for access. The access port must maintain a secure fix on the abdominal wall throughout the use of the device. Luer lock connections should be ISO 594-2 compliant. A Closed Aerosol Waste System (CAWS) should be used to remove pressure and aerosolized pharmaceuticals from the insufflated area. The HurriChem™ device should be operated in a direct flow operating room only. Use remote operation of the injection system to avoid unintended exposure to aerosolized solutions. Prevent unintended exposure or inhalation of aerosolized solutions by the patient and users. Contraindications: The HurriChem™ is not indicated for use in any other areas other than the intraperitoneal area, during laparoscopic operations. Do not use pharmaceutical or liquid solutions that are contraindicated for contact with medical grade stainless steel. Bibliography: Alyami M, Hubner M, Grass F, et al. Pressurised intraperitoneal aerosol chemotherapy: rationale, evidence, and potential indications. Lancet Oncol. 2019;20(7):e368-e377. doi:10.1016/S1470-2045(19)30318-3