Evaluation: ICU Medical/Q Core Medical Sapphire Epidural Patient-Controlled Epidural Analgesic Infusion Pump

April 5, 2017 | Evaluations & Guidance

Preview

  • The Sapphire Epidural is a patient-controlled epidural analgesic (PCEA) infusion pump. PCEA pumps allow patients to self-administer doses of pain-relieving medication within the limits prescribed by a physician. Patients can activate the delivery of solutions by pressing a pendant button on a cord connected to the pump or a button directly on the pump. This device is used for epidural infusion therapies.
  • The Sapphire Epidural pump can be used in other modes for other clinical applications beyond PCEA, including continuous, secondary, multistep, intermittent, epidural intermittent, total parenteral nutrition (TPN), and patient-controlled analgesic (PCA) applications
  • The pump is normally connected to an IV pole with a clamp (mini cradle) and a lockbox.
  • Major device components and software features:

    • Pump
      • Medication container (bag )—Up to 500 mL supported by the largest lockbox
      • Administration set—Proprietary consumable administration set; various sets options are available; all are non-DEHP
      • Operational range
        • Flow rate: i) Continuous rate: 0.1-99 mL/hr ii) Bolus: Up to 600 mL/hr
        • Volume to be infused (VTBI): 0.1-9,999 mL
      • Infusion modes
        • Continuous infusion
        • PCEA dose only
        • Continuous and PCEA dose
        • Loading dose
        • Priming mode
        • Clinician bolus
        • Programmable intermittent epidural bolus (PIEB) mode
        • General (i.e., basic) mode: Infusion mode without any drug-specific limits
        • PreSet programs: Custom dosing protocols with default values. These cannot be configured through the DLE but rather must be configured separately for each pump through the user interface.
      • User controls: Resistive touchscreen; can be operated with dry, wet, or gloved hands
      • Display: 6.35 × 5.1 cm (2.5 × 2 in)
      • Weight with battery, lockbox 250 mL, and pole mount (mini cradle): 1.7 kg
      • Dimensions (H × W × D): 143 × 96 × 49 mm (5.63 × 3.78 × 1.93 in)
      • Battery life: 24 hr at 125 mL/hr (with a fully charged battery, and backlight off)
      • Wireless connection: Not available
    • Patient pendant
      • Used to request PCA doses
      • Indicators: Audible only
      • Patient handle can be configured to:
        • Audible alarm for every request
        • No audible alarm for every request
        • Audible alarm for a successful request (i.e., when dose was delivered)
    *Figure 2.**The Sapphire patient pendant. *...

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