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Alaris™ PK Plus Syringe Pump
Introduction
Introduction
This Directions for use can be used with the Alaris™ PK Plus Syringe Pump MK4.
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The Pumps can be identified as MK4 version by the MK4 on
the label on the rear case, see image right, or by verifying the
software version as 3.3.0 or above on power up.
The Alaris PK Plus Syringe Pump (hereinafter referred to as Pump) provides the user with an infusion tool for the administration of drugs
for anaesthesia. The embedded software within the Pump is loaded with three compartment pharmacokinetic predictive models and
has 4 modes of operation:
1. Continuous infusion (ml/h)
2. Total Intravenous Anaesthesia (TIVA) mode.
– In this mode the user is able to select the infusion rate and administer bolus doses as required.
3. Total Intravenous Anaesthesia (TIVA) with TCI predictions mode.
– In this mode the user is able to select the infusion rate and administer bolus doses as required. The pharmacokinetic model is
used to estimate the plasma and effect site concentration.
4. TCI Mode
• Plasma target-controlled infusion (TCI).
– In this mode the user selects the desired (target) plasma drug concentration, and the pharmacokinetic model is used to
calculate the infusion rates required to achieve that concentration. A graphic display shows the trajectory of the estimated
plasma and effect site drug concentration over time.
• Effect Site target-controlled infusion (TCI).
– In this mode the user sets the desired effect site target concentration and the pharmacodynamic model is used to calculate
the infusion rates required to achieve that concentration. A graphic display shows the trajectory of the estimated effect site
and plasma concentration over time.
The Alaris PK Plus Syringe Pump has a user friendly interface that displays the infusion rate, the total drug dose delivered, and the
estimated plasma and effect-site concentrations to enable the user to follow the drug prescription information from the relevant
country.
Intended Purpose
The Alaris PK Plus Syringe Pump is intended for use by medical staff for purposes of controlling infusion rate and volume.
Conditions of Use
The Alaris PK Plus Syringe Pump should only be operated by a clinician competent in use of automated syringe pumps and post-
placement management of intravenous catheters.
Use of the Alaris PK Plus Syringe Pump does not limit the responsibility of the anaesthetist for drugs administration. It is important that
users operating the Alaris PK Plus Syringe Pump are fully aware of the available literature for any model used in association with a drug
and that they refer to the prescribed information for rate and dosing limits. Pharmacokinetic and Pharmacodynamic Interactions among
anaesthetic drugs are known, but are not taken into account in the calculation of the plasma and effect site concentrations.
The user should be appropriately trained in the use of the Pump and should follow the recommendations of this Direction For Use
(DFU).
In particular, the user must be aware that starting the Pump in a TCI mode will result in the automatic infusion of a pre-calculated bolus
dose followed by an infusion to achieve the selected target concentration. The initial parameter calculations are displayed on screen
prior to starting the infusion. It is thus essential that the user verifies that the patient characteristics and the selected infusion rate or
target concentration conform with the drug prescribing information of the relevant country.
CareFusion has verified the accuracy of the mathematical model implementation as well as pump delivery accuracy - (specification and
accuracy of pump - delivery are available in 'Profiles from TCI Mode' section).
Different drugs are associated with dedicated models – each model consists of a set of standard pharmacokinetic parameters which can
be selected and used by the embedded 3 compartment model used in the Alaris PK Plus Syringe Pump (where use of that drug in TCI
mode is authorised);
Diprivan from ASTRA-ZENECA is the only recommended Propofol formulation to be used in TCI mode as per prescribing information.
This Pump includes the Marsh model for the calculation of the Diprivan infusion rates, and plasma and effect-site concentrations.
When Remifentanil and Sufentanil are used in TCI mode, – the Minto and Gepts models respectively – are used to calculate the required
infusion rates.
