System Safety Checks - CME BodyGuard 545 Color Vision Directions For Use Manual

System Safety Checks

The following details outline the safety checks designed into the BodyGuard 545
pump to minimize the possibility of under or over infusions.
TM
Color Vision
Free Flow Protection
The system's customized IV lines are equipped with a check valve that prevents free
flow towards the patient when the IV line is not attached to the pump. When the
pump is attached to the IV line and delivering fluid, the pressure delivered by the
pump opens the valve. The valve is also one way valve preventing fluids flow from
the patient to the administration line.
Post Occlusion Bolus Reduction System
During an occlusion, pressure in the downstream section of the line can build up to
1100mmHg (depending on user defined settings). When the pump alarms the user
will check the line and attempt to clear the occlusion. In the absence of Post
Occlusion Bolus Reduction System the pressure build up could cause a surge of
fluid into the patient. This feature works by reversing the operation of the motor until
pressure in the downstream line is returned to neutral (usually within 15 seconds).
Unintended Bolus
An unintended bolus is the volume of fluid that can be potentially delivered to the patient
once an occlusion blockage in the administration line is resolved. The following table
shows the potential unintended bolus volume under the specified conditions.
Intermediate Rate
25ml/h
An occlusion may pressurize the infusion tubing, which can result in an unintended
bolus of drug when the occlusion is cleared. In order to prevent this potentiall bolus,
disconnect the tubing or relieve the excess pressure through a stopcock, if present. The
clinician should weigh the relative risks of disconnection with the risks of an unintended
bolus of drug.
Air-in-Line Detection
To improve the detection of air in the IV line, the BodyGuard 545 Color Vision™ system
utilizes an air-in-line accumulation system in addition to the standard single bubble
detection. This feature monitors the volume of air that passes through the IV line by
accumulating the volume of individual bubbles within a 15 minute period. This limit is not
configurable. Although an individual bubble may not exceed the pre-programmed
threshold, if the cumulative volume of smaller bubbles exceeds 1ml (+/- 50%) within a
15 minute period an air-in-line alarm is initiated. This accumulation feature is particularly
useful with infusions for patients who are highly sensitive to air (i.e. infants, neonates,
children) or when infusing products that create significant volumes of small air bubbles.
BodyGuard 545 Color Vision™ Directions For Use
Occlusion Pressure
250mmHg (minimum)
1100mmHg (maximum)
Unintended Bolus Volume
≤0.5ml
1 - Introduction
12