Intended Use
BD Alaris
TM
System with Guardrails
TM
Suite MX User Manual 3
Intended Use
The Alaris™ system with Guardrails suite MX is intended for use in professional healthcare facilities that
utilize infusion devices for the delivery of fluids, medications, blood, and blood products. The Alaris
system with Guardrails suite MX is intended to provide trained healthcare caregivers a way to automate the
programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter
infusion data.
All data entry and validation of infusion parameters is performed by the trained hea
lthca
re professional
according to a physician's order. The Alaris system with Guardrails suite MX is an interoperable system
capable of communicating and exchanging data accurately, effectively, securely, and consistently with
different information technology systems, software applications, and networks, in various settings; and
exchanging data such that the clinical or operational purpose and meaning of the data are preserved and
unaltered.
Essential Performance
The BD Alaris
TM
pump module, Alaris
TM
pump module, Alaris
TM
syringe module, and Alaris
TM
PCA
module are designed to accurately deliver the programmed amount of the medication or fluid over the
programmed time period. The pump module, syringe module, and PCA module ensure that an infusion is
not being inadvertently delivered when the user expects the system to be in a paused, stopped, or off
condition. The pump module, syringe module, and PCA module employ measurement systems to detect
and alarm for conditions adverse to safe administration of fluid. These include measurements of proper
infusion set loading (free flow detection), pressure (occlusion detection), and air-in-line detection.
The Alaris
TM
EtCO
2
and Alaris
TM
SpO
2
modules will monitor and alarm when a patient’s physiological
condition is out of range.
The Alaris system will alarm when the monitoring modules (SpO
2
and/or EtCO
2
modules) are unable to
detect patient vitals.
Warnings, Cautions, and Notes
Product-specific warnings and cautions, covered in the applicable sections of this user manual, provide
information needed to safely and effectively use the system.
NOTE:
Notes contain supplementary information or emphasize a point or procedure
.
A statement that alerts the user to the possibility of injury, death, or other serious adverse
reactions associated with the use or misuse of the device.
A statement that alerts the user to the possibility of a problem with the device associated with the
use or misuse of the device.
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