BD Alaris PK Manual De Instrucciones página 5

By measuring the volume from the flow rate profile delivered from the Pump and then introducing this into a reverse
pharmacokinetic model, the predicted plasma (or effect) concentration can be calculated from the flow rate . These are
illustrated on pages 5-6, showing the typical performance of the system against changes in the target plasma (or effect)
concentration for a typical, idealised profile . For the same targeted profile, the deviation of the predicted plasmatic
(or effect) concentration (back calculated from the volume collected) from the expected Ideal plasma (or effect)
concentration, results from the volumetric inaccuracy of the system (Pump and syringe) . The Pump will track the predicted
plasma (or effect) concentration to within ±5%
Flow rate inaccuracies and start-up delays may decrease the accuracy of the predicted plasma (or effect) concentration
particularly where high syringe drug concentrations are used in conjunction with large sizes of syringes and low target
plasma (or effect) concentrations as the syringe plunger motion over time (proportional to the flow rate accuracy) will be
significantly reduced .
For a given drug concentration, the volumetric error is proportional to the dose rate error . Knowledge of the
Note:
system accuracy over different time intervals may be of interest when assessing the impact of administering
short-half life drugs . In these circumstances, short-term fluctuation in the infusion rate could have a clinical
impact that cannot be determined from the performance profiles shown in Figures below . In general, the
volumetric error will increase with small induction and maintenance rates, which may occur with large volume
syringes, high syringe concentrations, low patient weights and low target (plasma or effect) concentrations . For
applications where system accuracy is important, maintenance rates less than 1 .0ml/h are not recommended;
syringe sizes, drug concentrations / dilutions and target (plasma or effect) concentrations should be selected
accordingly to ensure the maintenance rate exceeds this lower limit .
Note:
1
IEC 60601-2-24: Particular requirements for the basic safety and essential performance of infusion pumps and
controllers;
2
95% Confidence / 95% Population.
2
of that calculated by pharmacokinetic model over a one hour period .
BDDF00869 Issue 1
Alaris™ PK/PK Plus Syringe Pump
Propofol-Schnider Model
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