DEVICE: Nimbus (00817170020000)

A battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.

A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting.