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The Halo Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. The device is intended for subcutaneous, perineural, epidural and intravenous infusion. The device is intended for 240 hours or 1500mL of infusion, whichever limit is reached first.

The Halo Ambulatory Infusion System includes Halo Ambulatory Infusion Pump ("Halo Pump'') and Halo Administration Set. The system provides measured drug / fluid therapy for subcutaneous, perineural, evidural and intravenous delivery to patient under the direction or supervision of physician or other certified health care professional. The design philosophy was "Simplicity = Safety". Verification and validation data have demonstrated that this is a simple, safe and reliable infusion device for patient in the clinical and non-clinical environments, including but not limited to hospital, homecare, and outpatient settings. Halo Ambulatory Infusion Pump: The Halo Ambulatory Infusion Pump ("Halo Pump") has a microprocessor controlled motor that drives a mechanical pumping mechanism to deliver fluid at a controlled rate, same as the CADD-Legacy PCA 6300 Ambulatory Infusion Pump (K982839) and ambIT Continuous Ambulatory Infusion Pump (K033325). The Halo Pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for Halo Pump components are widely used in the medical industry. The Halo Pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA). Halo Administration Set: The Halo Administration Set is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient. The Halo Administration Set can be used with Halo Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets(K120685), which can be used with Z-800 Infusion Pump or gravity infusion.