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Introduction
The Alaris® PK Syringe Pump (herein after 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 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 Use:
The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use (DFU)
including general wards, critical and intensive care, neonatal, outpatients clinics, operating rooms and accident and emergency rooms.
The Alaris® PK Syringe Pump is compatible with a wide range of standard single use, 3 piece Luer-lock syringes. It accepts syringe sizes from
5ml to 50ml. Specifications are available in the relevant section.
Use of the Alaris® PK Syringe Pump
DOES NOT
limit the responsibility of the anaesthetist for drugs administration. It is important that users
operating the Alaris® PK 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.
Cardinal Health 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 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.
The Asena® brand name has been recently changed to the Alaris® brand name. This change in brand name has no effect on the intended use
or functionality of the product. Recommended disposable products for use with this product may refer to either the Asena® brand name or
Alaris® brand name and both types are suitable for use with this infusion pump.
About This Manual
The user must be thoroughly familiar with the Alaris® PK Syringe Pump described in this manual prior to use.
All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump. These
settings and values are for illustrative use only. Where stated, a minimum infusion rate refers to a nominal rate of 1.0ml/h, and an
intermediate infusion rate refers to a nominal rate of 5.0ml/h. The complete range of infusion rates, settings and values are shown in the
Specifications section.