Chapter 1. Introduction
10
Hospira GemStar System Operating Manual
Indications for Use
Physicians or certified, licensed healthcare professionals should always oversee
infusions. Healthcare professionals should always supervise pump users and instruct
users in pump operation and troubleshooting. Instruction should include how to
prevent intravenous (I.V.) related complications, including how to prevent accidental
infusion of air.
The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural
infusion and parenteral administration of general I.V. fluids, medications, nutritional
fluids, and blood/blood products. The epidural route is recommended to provide
anesthesia or administer analgesia for periods up to 96 hours.
Intended parenteral administrations include but are not limited to: intravenous (within
a vein), arterial, subcutaneous (tissue just below the skin), regional (located to specific
areas of the body) and epidural analgesia, intrathecal analgesia, intraspinal analgesia,
combined spinal-epidural analgesia, short term epidural infusion, intraspinal (within
the spinal canal), intrathecal (within the subarachnoid or subdural space),
intraoperative sites (soft tissue, body cavity or surgical wounds), intraarticular (within
a joint), intraperitoneal (within the peritoneal cavity), and intracerebroventricular
infusions. The indications for use include hospital, homecare and ambulatory
environments. The system has also been qualified for use in rotary wing aircrafts (e.g.,
helicopters). The pump must be used with sterile, dedicated, GemStar administration
sets.
For epidural use, the administration of drugs is restricted to those anesthetic and
analgesic drugs approved for continuous epidural administration: e.g., Chloroprocaine
Hydrochloride USP, Lidocaine Hydrochloride USP, and Morphine Sulfate Injection
USP (Preservative Free).
d
Note: Epidural administration of anesthetics is recommended in the continuous
mode only. Epidural administration of analgesics may be delivered by continuous,
bolus, or continuous with bolus.
WARNING: Delayed respiratory depression following continuous
epidural administration of preservative-free morphine
sulfate has been reported.
Summary of Contents for GemStar Series
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