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The CompuFlo® Epidural Computer Control Anesthesia System is intended for use with an epidural needle for the real-time verification of needle placement in the lumbar or thoracic epidural space, inclusive of cervicothoracic junction (CTJ). It is intended for patients over age of 18 who are required to have epidural needle or catheter placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider (HCP). The CathCheck is an additional feature for clinicians to use to assess proper catheter placement inside the epidural space by evaluating a pulsatile waveform. The CathCheck function utilizes the same technology as the CompuFlo® Epidural Computer Control Anesthesia System and should only be used in conjunction with standard clinical assessment practice. Once the Health Care Provider verifies the epidural needle or catheter placement in the epidural space, the HCP continues with the medical procedure.

The device consists of: (1) the primary unit, (2) a pneumatic foot pedal control, (3) an AC power cord and (4) single-use disposable kit, which can include an external in-line fluid pressure sensor, a 20 mL plastic syringe, plastic tubing and an ID Adapter. Operation of the device is allowed when powered by the AC mains or by the internal battery source. The epidural needle and solution is not supplied in the disposable Kit

The CompuFlo® Epidural Computer Controlled Anesthesia System is intended for use with an epidural needle for the real-time verification of needle tip placement in the lumbar epidural space in patients over age of 18 who are required to have epidural needle placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider. Once Health Care Provider verifies the epidural needle placement in the lumbar epidural space, CompuFlo® Epidural Computer Controlled Anesthesia System is disconnected and the HCP continues with the medical procedure.

The device consists of: (1) the primary unit, (2) a pneumatic foot pedal control, (3) an AC power cord and (4) single-use disposable kit, which include an external in-line fluid pressure sensor, a 20 mL plastic syringe, plastic tubing and an ID Adapter. Operation of the device is allowed when powered by the AC mains or by the internal battery source. The epidural needle and solution is not supplied in the disposable Kit.

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

The CompuDent STA™ Syringe is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible and visible status indicators of injection rate, amount of anesthetic remaining in the carpule, and pressure at the tip of the needle. It is substantially equivalent to the company's currently marketed CompuDent™ computer controlled syringe.

The CompuFlo is intended for use in delivering medication and other fluids in a controlled manner. The CompuFlo is indicated for use in adults for the continuous or intermittent delivery of medications and other fluids through intravenous, intra-arterial, subcutaneous, epidural and enteral routes.

The CompuFlo unit consists of a motor-driven piston syringe pump with an internal pressure transducer, an external pressure transducer (Meritrans™ Disposable Pressure Transducer (K920977)), a syringe retainer, a computer processor, a liquid crystal display (LCD), and a power supply. All but the external pressure transducer are contained in a plastic cabinet. A foot pedal and power cord are also included. The unit operates with a variety of user-provided disposable supplies, including Luer Lock plastic piston syringes, plastic syringe tubing, and needles.