Evaluation: ICU Medical/Q Core Medical Sapphire Epidural Patient-Controlled Epidural Analgesic Infusion Pump
June 18, 2020 | 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)
- Pump