Alaris BDDF00628_en Alari PK Plus Syringe Pump MK4 Model: 8005TIG03 Directions for Use

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Page 1

Alaris™ PK Plus Syringe

Directions For Use

Pump MK4

Model: 8005TIG03

Page 2

Alaris™ PK Plus Syringe Pump

Contents

Introduction ..............................................................................................2

About This Manual ........................................................................................3

TCI Overview ..............................................................................................4

Creating a Data Set ........................................................................................7

Features of the Pump ......................................................................................8

Controls and Indicators ...................................................................................9

Symbol Definitions .......................................................................................10

Main Display Features ....................................................................................11

Operating Precautions ...................................................................................13

Getting Started ..........................................................................................16

Syringe Loading ..........................................................................................18

Starting the Pump ........................................................................................21

Basic Features ............................................................................................23

Operations During Use ...................................................................................25

Alarms and Warnings .....................................................................................27

Prompts .................................................................................................31

Configured Options ......................................................................................32

Specifications ............................................................................................37

Recognised Syringes .....................................................................................40

Associated Products ......................................................................................41

Compatible Extension Sets ...............................................................................42

Maintenance .............................................................................................45

Occlusion Pressure Limits ................................................................................47

IrDA, RS232 and Nurse call Specification ..................................................................48

Trumpet Curves and Start-up Curves .....................................................................50

Profiles from TCI Mode ...................................................................................51

Products and Spare Parts .................................................................................54

Document History ........................................................................................55

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Alaris™ PK Plus Syringe Pump

Introduction

This Directions for use can be used with the Alaris™ PK Plus Syringe Pump MK4.

The Pumps can be identified as MK4 version by the MK4 on

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.

3. Total Intravenous Anaesthesia (TIVA) with TCI predictions mode.

4. TCI Mode

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.

the label on the rear case, see image right, or by verifying the software version as 3.4.x or above on power up.

– In this mode the user is able to select the infusion rate and administer bolus doses as required.

– 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.

• 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.

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 postplacement 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.

BD 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.

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Alaris™ PK Plus Syringe Pump

About This Manual

BD cannot guarantee the continued system accuracy with other manufacturer’s syringes as identified in the

‘Recognised Syringes’ table. Manufacturers may change syringe specification significant to system accuracy without prior notification.

Indications

The Alaris PK Plus Syringe Pump is indicated for the administration of drugs for anaesthesia

Contraindications

The Alaris PK Plus Syringe Pumps are contraindicated for:

• enteral therapies

• epidural infusion therapies

About This Manual

The user must be thoroughly familiar with the Alaris PK Plus 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.

Keep this Manual for future reference during the Pump’s operational life.

It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your BD products. These documents are referenced on bd.com. Paper copies of the Directions For Use can be obtained free of charge by contacting your local BD representative. An estimated delivery time will be provided when the order is placed.

Conventions used in this manual

BOLD Used for Display names, software commands, controls and indicators referenced in this manual, for

example, Battery Indicator, PURGE, ON/OFF button.

'Single quotes' Used to indicate cross-references made to another section of this manual.

Italics Used to refer to other documents or manuals and also used for emphasis.

Warning symbol. A warning is 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 Pump.

Caution symbol. A caution is a statement that alerts the User to the possibility of a problem with the Pump

associated with its use or misuse. Such problems may include Pump malfunction, Pump failure, damage to the Pump or damage to other property. The caution statement includes the precaution(s) that should be taken to avoid the hazard.

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Alaris™ PK Plus Syringe Pump

TCI Overview

The dose-response relationship can be divided into three parts: the relationship between administered dose and plasma concentration (the pharmacokinetic phase), the relationship between effect organ concentration and clinical effect (the pharmacodynamic phase) and the coupling between pharmacokinetics and dynamics. The ultimate goal when administering a particular dose of a drug is to obtain the desired clinical effect, for which a specific therapeutic concentration of the drug at the site of action (the receptor) is necessary.

Fig. 1: Schematic representation of the pharmacokinetic and dynamic processes determining the relationship between administered dose and resulting effect intensity of a drug. Pharmacokinetic factors such as distribution, metabolism, and/or excretion determine the relationship between drug dose and drug-concentration in the plasma and bio-phase (effect-site). In the bio-phase the drug interacts with the receptor resulting in the pharmacological effect.

Until recently, when intravenous anaesthetic agents were used for induction or maintenance of anaesthesia, they were administered either manually (by hand) or by simple infusion pumps (the anaesthetist calculated the infusion according to the body weight of the patient). Inline measurement of concentrations is not possible, and the polyexponential equations required to predict the concentrations requires vast computer processing power. Based on the pioneering work of Kruger-Thiemer2 and Schwilden et al.3, the TCI concept was developed during the 1980’s and early 1990’s, as advances in computer technology made inline predictions of drug concentrations feasible.

The pharmacokinetic behaviour of most anaesthetic drugs can be described mathematically with a 3-compartment model: usually a central compartment (V1), a vessel-rich compartment (V2) and a vessel-poor compartment (V3) are described. Transfer of drug between different compartments (distribution) is described by rate constants (k12, k21, k31 and k13) or clearances. Drug metabolism is described by the rate constant k10 (Fig. 2). The aim of TCI techniques is to use pharmacokinetic modelling to calculate the infusion rates required to achieve a desired plasma concentration. Thus, instead of specifying an infusion rate, the user specifies a "target" concentration, based on clinical judgement. When a concentration in the plasma compartment is targeted, this is called "open-loop plasma targeted TCI". When a certain concentration at the effect compartment is targeted, then this is called "open-loop effect-site targeted TCI".

Fig. 2: Schematic representation of the three compartment model used for target-controlled infusions.

For anaesthetic agents the effect-site (or bio-phase) is not the plasma4 but the brain, where concentrations cannot be directly measured. Until the early 1990’s it was considered that blood-brain equilibration was virtually instantaneous. Early TCI systems were thus all plasma-targeted. For many drugs the relationship between plasma concentration and clinical effect was described, usually in terms of the Cp50 or Cp95 (the concentrations required to elicit a specified clinical effect in 50 or 95% of patients respectively). For an example see Ausems et al.

During the 1990’s it was increasingly appreciated that after a change in plasma concentration there is a temporal delay in equilibration between the plasma and effect-site concentrations. The clinical effect changes in parallel with the effect-site concentration, and so for most drugs the rate of drug transfer into and from the site of action can be characterized by the time-course of drug effect

6,7

. This means that the effect can be transferred to concentrations, thereby resulting in a quantitative approach. The concentration at the site of action is called "the effect-site concentration" and the corresponding compartment8 (see Fig. 3) is called "the effect-site compartment". Because the actual amount of drug entering the brain is very small, the effect-site compartment can be regarded as having no volume, the rate constant k1e can be ignored and the rate constant keo can be used to describe the rate of equilibration between the plasma and effect-site compartments.

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Alaris™ PK Plus Syringe Pump

Input

TCI Overview

Knowledge of the keo for various agents has made targeting of the effect-site possible. With effect-site targeting the TCI system first calculates the necessary plasma concentration profile required to achieve the effect-site target as rapidly as possible, and then calculates the infusion rates required to achieve that plasma concentration profile (Fig 3). Effect Site vs Plasma Concentration will generate a larger induction dose followed by a pause in the infusion to allow plasma to equilibrate with effect site concentration.

cl2

Peripheral

Compartment

Effect

Compartment

Fig. 3: Schematic representation of the concentration-effect relationship.

V1 V3

Central

Compartment

Clearance cl1

cl3

Peripheral

Compartment

TCI infusion pumps can provide optimal control of anaesthesia when the three elements mentioned above have been accurately modelled and described. Firstly, the model that controls the Pump has to work accurately (The models used in the Alaris PK Plus Syringe Pump are well-validated and accepted). Secondly, the pharmacokinetic parameter set of a particular drug used by the computer model should match the pharmacokinetics of the patient (it should be remembered that the models described in the literature are based on "population" data, and apply to an "average" patient. They do not take account of the inter-patient pharmacokinetic variability). Thirdly, the pharmacodynamics of the administered drug should be well understood to enable the user to select the plasma or effect-site concentration needed for the required effect (with most anaesthetic agents there is broad inter-patient pharmacodynamic variability, and so the user needs to match knowledge of the general population pharmacodynamic data with careful observation of the individual patient to ascertain that individual’s sensitivity to the drug, to enable titration to effect if necessary).

Note: Specific model parameters are available in the "TCI Overview" section or directly on the Pump via the information key when

selecting drugs. Users should refer to the drug- prescribing information to verify that TCI mode is authorised in their respective countries.

References :

1. Danhof M: Does variability explain (all) variability in drug effects ?, Topics in pharmaceutical science. Edited by Breimer DD, Crommelin DJA, Midha KK. Noordwijk, Amsterdam Med. Press BV, 1989, pp 573-586

2. Kruger-Theimer E: Continuous intravenous infusion and multicompartment accumulation. Eur J Pharmacol 1968; 4: 317-324

3. Schwilden H: A general method for calculating the dosage scheme in linear pharmacokinetics. Eur J Clin Pharmacol 1981; 20: 379-86

4. Shafer SL: Towards optimal intravenous dosing strategies. Seminars in Anesthesia 1993; 12: 222-234

5. Ausems ME, Hug CC, Jr., Stanski DR, Burm AG: Plasma concentrations of alfentanil required to supplement nitrous oxide anesthesia for general surgery. Anesthesiology 1986; 65: 362-73

6. Schnider TW, Minto CF, Stanski DR: The effect compartment concept in pharmacodynamic modelling. Anaesthetic Pharmacology Review 1994; 2: 204-213

7. Shafer SL: Principles of pharmacokinetics and pharmacodynamics., Principles and practice of anesthesiology. 2nd Edition. Edited by Longnecker DE, Tinker JH, Morgan GE. New York, Mosby-Year Book, 1998, pp 1159- 1210

8. Shafer SL, Gregg KM: Algorithms to rapidly achieve and maintain stable drug concentrations at the site of drug effect with a computer-controlled infusion pump. J Pharmacokinet Biopharm 1992; 20: 147-69

TCI Precautions

When first starting the infusion the pharmacokinetic / pharmacodynamic models within the Alaris PK Plus Syringe Pump are reset to zero. Therefore, for any reason, if the Pump is switched off during the surgical procedure all current pharmacokinetic / pharmacodynamic model information will be lost. Under such circumstances switching the Pump off and on and restarting the infusion whilst the patient contains a significant residual drug dose could result in an over-infusion and, therefore, the Pump should not be restarted in TCI mode.

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Pharmacokinetic models in Alaris PK Plus Syringe Pump and their parameters

Drug: Diprivan Model: Marsh (weight adjusted) Age Limit: 16 years upwards Unit of Plasma Concentration: µg/ml Max. Plasma Concentration: 15 µg/ml Vc = 0.228 x mass (litres x kg-1) k10 = 0.119 minutes k12 = 0.112 minutes k13 = 0.0419 minutes k21 = 0.055 minutes k31 = 0.0033 minutes keo = 0.26 minutes Reference from the literature: Marsh et al.: Brit J Anaesth 1991, 67, 41-48

Drug : Remifentanil Model: Minto Age Limit: 12 years upwards Unit of Plasma Concentration: ng/ml Max. Plasma concentration: 20 ng/ml Vc = 5.1 - 0.0201 x (age-40) + 0.072 x (lbm-55)

V2 = 9.82 - 0.0811 x (age-40) + 0.108 x (lbm-55) V3 = 5.42 cl1 = 2.6 - 0.0162 x (age - 40) + 0.0191 x (lbm - 55) cl2 = 2.05 - 0.0301 x (age - 40) cl3 = 0.076 - 0.00113 x (age - 40) k10 = cl1 / Vc k12 = cl2 / Vc k13 = cl3 / Vc k21 = cl2 / V2 k31 = cl3 / V3 keo = 0.595 - 0.007 x (age - 40) Reference from the literature : Minto et al.: Anesthesiology 1997, 86, 10 - 33

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Alaris™ PK Plus Syringe Pump

TCI Overview

Drug : Sufentanil Model: Gepts (not weight adjusted) Age Limit: 12 years upwards Unit of Plasma Concentration: ng/ml Max. Plasma concentration: 2 ng/ml Vc = 14.3 l k10 = 0.0645 minutes k12 = 0.1086 minutes k13 = 0.0229 minutes k21 = 0.0245 minutes k31 = 0.0013 minutes

-1

Reference from the literature : Gepts et al.: Anesthesiology 1995, 83, 1194-1204

Additional : keo calculated with time to peak effect 5.6 minutes (keo = 0.17559 minutes-1) (reference: Shafer et al Anesthesiology. 1991 Jan;74(1):53-

63)

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Alaris™ PK Plus Syringe Pump

Creating a Data Set

To fully utilise the Alaris PK Plus Syringe Pump a Data Set will need to be developed, reviewed, approved, released, uploaded and verified according to the following process. Refer to the Alaris PK Editor Software Directions for Use (1000CH00016) for further details and operating precautions.

1. Create Master Lists (Using Alaris PK Editor Software)

• Master Drugs* A list of drug names and standard concentrations. These may be for TIVA use or may have an associated PK/PD model for TCI use.

• Alaris PK Syringe Library Configure syringes enabled for use

2. Create Profile (Using Alaris PK Editor Software)

• Profile Drugs* Drugs and concentrations for this profile with defaults, minimum and maximum limits and targets and occlusion level.

• Pump Configuration** Pump configuration settings and general options.

3. Review, Approve and Release (Using Alaris PK Editor Software)

• Review and Approve Entire Data Set Report to be printed, reviewed and signed as proof of approval by an authorised person according to Hospital protocol. Signed printout to be kept safe for use during verification procedure.

• Release Data Set status to be promoted to Released (password is required).

4. Upload Data Set to Alaris PK Plus Syringe Pump (Using Alaris PK Editor Transfer Tool)

5. Verify Data Set Upload

• First or Individual Pump Verification On completion of upload record CRC (Cyclic Redundancy Check) number shown on the Alaris PK Plus Syringe Pump.

Download the Data Set from the Pump using the Alaris PK Verification Tool.

Compare Data Set downloaded with the approved signed Data Set printout. Reviewer should sign the printout and also record the CRC number on the printout as record.

• Subsequent Pump Verification On subsequent uploads of the Data Set compare CRC number on the Pump with CRC number recorded on First Pump Verification.

6. Switch the Pump on and verify that the start-up splash screen displays the correct data set name and version. The Pump is now ready to use.

*Drug parameters have to be in accordance to local protocols and prescribed information.

Data set transfers should only be performed by qualified technical personnel.

** See important note in Configured Options section.

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Features of the Pump

Alaris™ PK Plus Syringe Pump

Features of the Pump

ON/OFF

RUN

Display

Release lever for MDI

High visibility Alarm Indicator

PURGE/BOLUS

MUTE

PRESSURE

OPTION

Finger Grips

Extension set hook

Rating Plate (see Symbol Definitions for an explanation of the symbols used)

Release lever for Rotating Cam

HOLD

Shelf for chevron keys and softkeys

Syringe Clamp

(

)

Positive Plunger Grippers

Rotating Cam to lock on to horizontal rectangular bars

Carrying Handle

IR Communications port

Potential Equalisation (PE) connector

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Folded Pole Clamp

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RS232 Connector

Extension set hook

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Controls and Indicators

Controls:

Symbol Description

ON/OFF button - Press once to switch the Pump on. Press and hold down for 3 seconds to switch the

Pump off.

Note: Pump can only be switched off at specific stages of operation, see 'Power Down Sequence'

section in Configured Options for further details.

Note: Logs are maintained for power down events including when the pump is powered down or

unexpected power loss.

Alaris™ PK Plus Syringe Pump

Controls and Indicators

b h

RUN button - Press to start the infusion. The green LED will flash during infusion.

HOLD button - Press to put the infusion on hold. The amber LED will be lit while on hold.

MUTE button - Press to silence alarm for two minutes. To re-enable the alarm audio press the MUTE

button a second time.

Note: Attention alarm only:

– The two minutes silence can be configured using the Alaris PK Editor Software. – when not in alarm press and hold until four audible beeps are sounded for 60 minutes silence

PURGE/BOLUS button - Press to access PURGE or BOLUS softkeys. Press and hold down softkey to operate.

PURGE the extension set during set up.

• Pump is on hold

• Extension set must not be connected to the patient

• Volume Infused (VI) is not added

BOLUS - fluid or drug delivered at an accelerated rate.

• Pump is infusing

• Extension set is connected to the patient

• VI is added

OPTION button - Press to access optional features, see 'Basic Features' section.

PRESSURE button - Use this button to display the pumping pressure and alarm level.

CHEVRON keys - Double or single for faster/slower increase or decrease of values shown on display.

BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display.

Indicators:

Symbol Description

BATTERY indicator - When illuminated the Pump is running on the internal battery. When flashing the

battery power is low with less than 30 minutes of use remaining.

AC POWER indicator - When illuminated the Pump is connected to an AC Power Supply and the battery is being charged.

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Symbol Definitions

Labelling Symbols:

Symbol Description

Consult accompanying documents.

Alaris™ PK Plus Syringe Pump

Symbol Definitions

IP32

Potential Equalisation (PE) Connector

RS232/Nurse call Connector

Defibrillation-proof type CF applied part (Degree of protection against electrical shock)

Protected against direct sprays of water up to 15° from vertical and protected against solid objects greater than

2.5mm.

Note: IP33 applies if AC power cable retainer kit, part number 1000SP01294, is fitted.

Alternating Current

Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.

Date of Manufacture

Manufacturer

Not for Municipal Waste

Fuse Rating

0°C



+40°C

Protective Earth; Protective Ground

Operating Temperature Range - Pump can be used between 0 and 40 degrees centigrade.

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Main Display Features

CONFIRM TIME

BMI 21.6

TIVA Mode

Pump Status

Drug Name and Concentration

Alaris™ PK Plus Syringe Pump

Main Display Features

Pressure Information

Flow Rate and Dose Rate

Dose and Volume Infused

TCI Mode

Pump Status

Plasma Concentration

Plasma Target

Initial Induction Dose

Initial Induction Rate

Initial Induction Volume

TCI Mode - MORE Information Screen

Selecting the MORE softkey will display the following additional information:

Drug Name and Model

Drug Name and Concentration

Induction

Duration

Time of Induction

Operations During Use

Pause Before

Maintenance

Initial Maintenance Rate

Volume and Dose InfusedElapsed Time

Patient Parameters Time to End of Infusion

at Current Rate

Press the BACK softkey to return to the TCI screen. The display will automatically revert to the TCI screen after approximately 20 seconds.

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Decrement Time

Decrement Concentration

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Screen Icons

Symbol Description

Alaris™ PK Plus Syringe Pump

Main Display Features

TIME REMAINING DISPLAY icon - Indicates time before syringe will require replacing.

BATTERY icon - Indicates battery charge level to highlight when the battery will require recharging or re-

connection to AC power supply.

Note: This can be enabled/disabled with the Alaris Editor software

Induction Phase Dose (Displayed on protocol confirmation screen)

Duration of Induction Phase (Displayed on protocol confirmation screen)

Duration of Hands Free Bolus (Displayed in bolus set-up screen)

Maintenance Phase Dose Rate (Displayed on protocol confirmation screen)

SOFT ALERT - Indicates the Pump is running at a rate above (pointing up) or below (pointing down) a Soft

Alert. (Number of arrows vary depending on drug name length)

LIMIT WARNING - Indicates the setting entered is under or exceeds a Soft Alert or setting entered is not permitted as it exceeds a Hard Limit.

DOWN MODE - Infusion status indicating that the target concentration is below current concentration.

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Operating Precautions

Disposable Syringes and Extension Sets

• The Pump has been calibrated for use with single-use disposable syringes. To best ensure correct and accurate operation, only use 3 piece Luer lock versions of the syringe make specified on the Pump or described in this manual. Use of non-specified syringes or extension sets may impair the operation of the Pump and the accuracy of the infusion.

• Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the Pump, or if it is removed from the Pump before the extension set is properly isolated from the patient. Isolation may include closing a tap in the patient line or activating a flow stop clamp.

• Secure the extension set to the Pump using the extension set hook at the rear of the Pump. This provides protection against accidental dislodging of the syringe from the Pump.

• When combining several apparatus and/or instruments with extension sets and other tubing, for example via a 3-way tap, the performance of the Pump may be impacted and should be monitored closely.

• Always clamp or otherwise isolate the patient line before unclamping or removing a syringe from the Pump. Failure to do so may result in unintended administration.

Mounting the Pump

• When more than one pump is being used on a patient, those containing high risk, critical medications must be positioned as close to the patient's heart level as possible to avoid the risk of variations in flow or siphoning.

• Raising a Pump whilst infusing may result in a bolus of the infusate, whereas lowering a Pump whilst infusing may result in a delay in the infusion (an underinfusion).

• Do not mount the Pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe. To protect against the introduction of air the user should regularly monitor the progress of the infusion, syringe, extension line and patient connections and follow the priming procedure specified herein.

Operating Environment

• Intended environments include intensive care and operating rooms. The pump may be used in an ambulance environment. Ensure that the Pump is appropriately attached using the provided pole clamp. The pump is designed to withstand possible bumps and vibrations whilst being used in an ambulance, complying with the standard EN 1789. If the Pump is dropped or experiences any severe physical disturbances, arrange a thorough inspection by Qualified Service Personnel as soon as is practically possible. The Pump may be used as long as the temperature is within the specified range as stated in the 'Specifications' section and on the Pump label.

• When using any infusion pump in conjunction with other pumps or devices requiring vascular access, extra care is necessary. Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the infusion system by such pumps. Typical examples of those pumps are used during dialysis, bypass or cardiac assist applications.

• The Pump is suitable for use in hospital and clinical environments other than domestic establishments that have access to single phase AC power supply.

• The Pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.

Operating Pressure

• This is a positive pressure Pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system.

• The pumping pressure alarm system is not designed to provide protection against, or detection of, IV complications which can occur.

Alarm Conditions

• Several alarm conditions detected by this Pump will stop the infusion and generate visual and audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating.

• Alarm tone settings are preserved in the case of power loss, however some system faults will result in loss of alarm settings. The new alarm tone settings will be stored when powering down from tech mode after a change. The settings will be lost if a cold-start is performed, but should be saved for faults that don't require a cold start.

Alaris™ PK Plus Syringe Pump

Operating Precautions

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Alaris™ PK Plus Syringe Pump

Operating Precautions

Hazards

• An explosion hazard exists if the Pump is used in the presence of flammable anaesthetics. Exercise care to locate the Pump away from any such hazardous sources.

• Dangerous Voltage: An electrical shock hazard exists if the Pump’s casing is opened or removed. Refer all servicing to Qualified Service Personnel.

• When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement is in doubt, the Pump should be operated from the battery.

• Do not open the RS232/Nurse Call protective covering when not in use. Electrostatic discharge (ESD) precautions are required when connecting RS232/Nurse Call. Touching the pins of the connectors may result in ESD protection failure. It is recommended that all actions must be taken by appropriately trained personnel..

• If the Pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by Qualified Service Personnel. When transporting or storing the Pump, use original packaging where possible, and adhere to temperature, humidity and pressure ranges stated in the 'Specifications' section and on the outer packaging.

• The embedded Pump software incorporates limits and Pump configuration parameters. Qualified personnel must ensure the appropriateness of the limits, the compatibility of the drugs, and the performance of each Pump, as part of the overall infusion. Potential hazards include drug interactions, and inappropriate delivery rates and pressure alarms.

• Alaris Syringe Pumps should not be modified or altered in any way, except where explicitly directed or authorised by BD. Any use of Alaris Syringe Pumps which have been altered or modified otherwise than in strict application of directions provided by BD, is at your sole risk, and BD does not provide any warranty for or endorsement on any Alaris Syringe Pump that has been so modified or altered. BD product warranty shall not apply in the event the Alaris Syringe Pump has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of unauthorised modification or alteration of the Alaris Syringe Pump.

• All pumps in a single care area should be configured with the same alarm tones to avoid User confusion.

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Alaris™ PK Plus Syringe Pump

Operating Precautions

Electromagnetic Compatibility and Interference

• The Pump is protected against the effects of external interference, including high energy radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to remain safe when unreasonable levels of interference are encountered.

• Therapeutic Radiation Equipment: Do not use the Pump in the vicinity of any Therapeutic Radiation Equipment. Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator, may severely affect functioning of the Pump. Please consult manufacturer’s recommendations for safe distance and other precautionary requirements. For further information, please contact your local BD representative.

• Magnetic Resonance Imaging (MRI): The Pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices. Therefore, the Pump is not considered an MRI compatible pump as such. If use of the Pump within an MRI environment is unavoidable, then BD highly recommends securing the Pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the Pump; or MRI image distortion. This safe distance should be established in accordance with the manufacturer's recommendations regarding electromagnetic interference (EMI). For further information, please refer to the product Technical Service Manual (TSM). Alternatively, contact your local BD representative for further guidance.

• Accessories: Do not use any non-recommended accessory with the Pump. The Pump is tested and compliant with the relevant EMC claims only with the recommended accessories. Use of any accessory, transducer or cable other than those specified by BD may result in increased emissions or decreased pump immunity.

• This Pump is a CISPR 11 Group 1 Class A device and uses RF energy only for its internal function in the normal product offering. Therefore, its RF emissions are very low and are not likely to cause any interference with the nearby electronic equipment. However, this Pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC/EN60601-1-2 and IEC/EN60601-2-

24. If the Pump interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation.

• In some circumstances the Pump may be affected by an electrostatic discharge through air at levels close to or above 15kv; or by radio frequency radiation close to or above 10v/m. If the Pump is affected by this external interference the Pump will remain in a safe mode; the Pump will duly stop the infusion and alert the user by generating a combination of visual and audible alarms. Should any encountered alarm condition persist even after user intervention, it is recommended to replace that particular Pump and quarantine the Pump for the attention of Qualified Service Personnel. (Consult Technical Service Manual for further information).

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Alaris™ PK Plus Syringe Pump

Getting Started

Initial Set-up

Before operating the Pump read this Directions For Use manual carefully.

1. Check that the Pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC Power Supply.

2. Items supplied are:

• Alaris PK Plus Syringe Pump

• User Support CD (Directions For Use)

• Electronic Instructions For Use Insert

• AC Power Cable (as requested)

• Protective Packaging

3. Connect the Pump to the AC Power Supply for at least 2½ hours to ensure that the internal battery is charged (verify that the S is lit).

Language Selection

1. On initial start-up the Pump will display the Select Language screen.

2. Select the required language from the list displayed using the f keys.

3. Press the OK softkey to confirm your selection.

• The Pump will automatically operate from its internal battery if the Pump is switched on without being connected to the AC Power Supply.

• Should the Pump fail to perform correctly, replace in its original protective packaging, where possible and contact Qualified Service Personnel for investigation.

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Do not mount the Pump with the AC power inlet or the syringe pointing upwards. This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe.

Pole Clamp Installation

Alaris™ PK Plus Syringe Pump

Getting Started

The pole clamp is fitted to the rear of the Pump and will provide secure fixing to vertical I.V. poles of a diameter between 15 and 40 mm.

1. Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole.

2. Place Pump around pole and tighten screw until the clamp is secured to the pole.

Ensure the pole clamp is folded away and stored

within the recessed area at the rear of the Pump before connecting to a Docking Station/Workstation* or when not in use.

Never mount the Pump such that the I.V. infusion stand becomes top heavy or unstable.

Prior to each use, check the pole clamp:

• does not show any signs of excessive wear,

• does not show any signs of excessively loose movement in the extended, mountable position.

If these signs are observed, the Pumps should be taken out of service for examination by Qualified Service Personnel.

Recessed area

Docking Station/Workstation* or Equipment Rail Installation

The rotating cam can be fitted to the rectangular bar on the Docking Station/Workstation* or the equipment rail measuring 10 by 25mm.

1. Align the rotating cam on the rear of the Pump with the rectangular bar on the Docking Station/Workstation* or the equipment rail.

2. Hold the Pump horizontally, push the Pump firmly onto the rectangular bar or equipment rail.

3. The Pump should click into position when fitted to the bar.

4. Ensure that the Pump is positioned securely. Verify Pump is secure by gently pulling the Pump away from the Docking Station/ Workstation* without using the release lever. When the Pump is securely attached, it should not come off the Docking Station/ Workstation*.

5. To release, push the release lever and pull the Pump forwards.

Pump may fall off the Docking Station/Workstation* if not properly mounted which could result in user and/ or patient harm.

Rectangular bar

* Alaris Gateway Workstation and Alaris DS Docking Station

BDDF00628 Issue 3

Release lever (push to release)

Rotating cam

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Alaris™ PK Plus Syringe Pump

Syringe Loading

Prepare Syringe and Administration Set

To decrease potential start-up delays, delivery inaccuracies and delayed generation of occlusion alarms each time a new syringe is loaded:

• Use smallest syringe size possible, for example, if infusing 9 ml of fluid, use a 10 ml syringe.

• Use the PURGE SYRINGE or PURGE option on the Pump to decrease the delay in the start of the infusion, see Starting the Pump section.

Use the smallest compatible syringe size necessary to deliver the fluid or medication; this is especially important when infusing high risk or life-sustaining medications at low infusion rates, especially flow rates < 0.5 ml/h.

Purge the Pump system before starting an infusion or after replacing a near-empty syringe with a replacement syringe. When Purging ensure that the extension set is not connected to the patient.

Practice Recommendations:

• Tubing internal diameter: Smallbore or microbore tubing is recommended when infusing at low rates

• Filters: Internal volume, dead space, of in-line filters should be minimized

• Connection sites: Critical drugs should be connected as close to the vascular access site as possible

Positioning of Pump

Ensure that the Pump is as close to level of patient’s heart as possible.

Patient’s heart level should be in line with the middle of the Pump.

w w

Adjusting the Pump's height relative to the patient's heart level can lead to temporary increases or decreases in fluid delivery

If using multiple syringe pumps and it is not clinically feasible to have all Pumps level with the patient’s heart, place the high risk or life-sustaining medications as close to the patient’s heart level as possible.

When infusing multiple high risk or life-sustaining medications, consider placing the Pumps infusing at the lowest rates as close to the level of the patient’s heart as possible.

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Loading and Confirming a Syringe

To securely load and confirm a syringe carefully follow the steps below. An incorrect loading of a syringe may result in misidentification of the syringe type and size. If then confirmed, this may lead to significant inaccuracy of the infusion rate and may also affect Pump performance.

Only use a syringe of the type stated on the Pump or in this manual. Using an incorrect syringe could adversely affect the accuracy of the infusion rate and may also affect Pump performance.

When drawing fluid into the syringe, draw enough to compensate for any 'dead space' volume in the extension set and syringe at the end of infusion as this cannot be fully infused.

Alaris™ PK Plus Syringe Pump

Syringe Loading

Syringe Barrel

Barrel Flange

Plunger Grippers

Syringe Clamp

Plunger Flange



Plunger



Finger Grips

Plunger Holder

Syringe Flange Clamp

Place the Pump on a stable horizontal surface or secure as described previously.

Prepare, load and prime the single-use disposable syringe and extension set using standard aseptic techniques.

1. Squeeze the finger grips together on the plunger holder and slide the mechanism to the right.

2. Pull the syringe clamp forward and down.

3. Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange clamp.

To ensure the syringe is loaded correctly, place the barrel flange in the space

between the syringe clamp and the syringe flange clamp. This is correct if the syringe remains in position before the syringe clamp is closed.

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Alaris™ PK Plus Syringe Pump

Syringe Loading

4. Lift the syringe clamp until it locks against the syringe barrel.

5. Squeeze the finger grips on the plunger holder and slide the mechanism to the left until it reaches the plunger end.

6. Release the finger grips. Ensure that the plunger grippers are securing the plunger in place and the finger grip returns to its original position.

7. Ensure that the syringe type and size match those displayed on the Pump then press CONFIRM. If required, the make of syringe can be changed by pressing the TYPE softkey.

ON HOLD

Note: If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the extension set can be

purged as required, however ensure that the extension set is not connected to the patient during this process.

BD recommends limiting the number of configured syringe types and sizes available for selection on the Pump.

Secure the extension set using the extension set hook at the rear of the Pump. This provides protection against accidental dislodging of the syringe from the Pump.

Ensure that both plunger grippers are fully locked onto the plunger flange and the upper finger grip has returned to its original position.

IVAC 50

CONFIRM

TYPE

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Alaris™ PK Plus Syringe Pump

Starting the Pump

When operating the Pump, the User should position themselves at a distance of 0.5 metres from the display.

1. Connect the Pump to an AC Power Supply using the AC power cable.

2. Press the a button.

• The Pump will run a short self-test.

Two beeps are activated during this self-test and the red alarm beacon illuminates and then clears. No action is required during this self-test.

• Check the display test pattern and ensure that no coloured rows are missing.

• Finally check that the displayed time and date are correct. Note: A warning - REPAIRING LOGS, may be displayed if event log information was not completely stored at the previous power

down. This is for information only, the Pump will continue to power up as normal.

3. CONFIRM PROFILE a) NO will display select profile screen

– Select profile. – Press OK to confirm.

b) YES will display the TCI MODE screen.

4. The TCI MODE selection is displayed - Answering YES selects the TCI Mode, NO will enter TIVA MODE.

The Alaris PK Plus Syringe Pump allows the user to select a TCI or TIVA mode of operation. The user may, at any time, switch mode by stopping the infusion and selecting the appropriate mode from the options menu. When in TIVA mode, if a drug with an associated model has been selected, the current plasma and effect site concentration will be displayed. This will demonstrate to the user unfamiliar with TCI, the Pharmacokinetics and Pharmacodynamics of the drug while still using TIVA mode.

TIVA Mode (with or without prediction)

1. A list of available drugs and models will be displayed. Use the f keys to select the required drug and press the OK softkey. If the drug has an associated model, an INFO softkey will be displayed. Pressing the INFO softkey will show more information on the selection. The ml/h option allows infusions without doserate calculation.

2. CONCENTRATION - a) Select Concentration required and OK to confirm (Only required if more than one concentration is available). b) Press the OK softkey to confirm Concentration or press the MODIFY softkey to change Drug amount and diluent volume.

3. WEIGHT - adjust the patient weight using the f keys, press the OK softkey to confirm.

4. The remaining patient parameters for the selected drug must be entered using the f keys and press the OK softkey to confirm. The required parameters may include the following depending on the model:

• AGE

• HEIGHT

• GENDER

• LBM and BMI (Lean Body Mass and Body Mass Index. This is for information only and is not an adjustable parameter).

5. The CONFIRM drug setup screen shows the initial infusion parameters for the drug. Press the OK softkey to accept or MODIFY to change the drug setup.

6. INDUCTION - Using the f keys, enter the induction dose amount per kg of patient weight (if required for dosing). Press the OK softkey to enter. The Induction feature may be disabled reducing the dose to zero until OFF is displayed and press OK softkey to confirm.

7. TIME - Enter the induction time in seconds over which the induction dose will be delivered. Press the OK softkey to enter.

8. MAINTENANCE - Set the maintenance dose rate in the drug protocol units. Press the OK softkey to enter.

Prime the extension set.

9. Load the syringe according to the procedure in this manual.

10. Check that the syringe type and size being used matches the display. If required, the make of syringe can be changed by pressing the TYPE button. Press CONFIRM when the correct type and size are shown.

11. Purge (if required) - Press the i button and then press and hold the PURGE softkey until the fluid flows and the purging of the extension set is complete. Release the softkey. The volume used during purging will be displayed.

12. Connect the extension set to the patient access device.

13. Press the b button to commence operation. INFUSING will be displayed. The amber stop light will be replaced by the flashing green start light to indicate that the Pump is in operation. If the infusion rate exceeds the Soft Alerts then check infusion setting, to continue with infusion at set target press the b button and then confirm OVERRIDE LIMIT by pressing the YES softkey. If

OVERRIDE LIMIT is not required press the NO softkey and adjust target concentration to be within the Soft Alerts.

If a model has been selected, the VOLUME softkey will be replaced by a Ce/Cp softkey. This will allow the user access

to screens showing predicted target concentrations. In this mode of operation the volume may never be cleared.

14. Press the h button to halt the operation. ON HOLD will be displayed. The amber stop light will replace the green start light.

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Alaris™ PK Plus Syringe Pump

Starting the Pump

TCI Mode

1. A list of available drugs and models will be displayed. Use the f keys to select the required drug and associated model and

press the OK softkey. Pressing the INFO key will show more information on the selection.

3. AGE - adjust the patient age using the f keys, press the OK softkey to confirm.

4. The remaining patient parameters for the selected drug must be entered using the f keys and press the OK softkey to

confirm. The required parameters may include the following depending on the model:

• HEIGHT

• GENDER

5. WEIGHT - adjust the patient weight using the f keys, press the OK softkey to confirm. A permissible weight range,

calculated using the models LBM limitations, is displayed.

• LBM and BMI (Lean Body Mass and Body Mass Index. This is for information only and is not an adjustable parameter).

6. If configuration allows, select Plasma targeting or Effect Site targeting.

Prime the extension set.

7. Load the syringe according to the procedure in this manual.

8. Check that the syringe type and size being used matches the display. If required, the syringe brand or type can be changed by

pressing the TYPE softkey. Press the CONFIRM softkey when the correct type and size are shown.

9. The CONFIRM induction screen shows the initial infusion parameters for the drug and model selected. The screen will show blank

data until the syringe has been loaded and confirmed.

10. When a slower titration is required the induction time may be increased in Plasma Targeting (Cpt) only. Press the TIME softkey and

cap the maximum induction rate or doserate to increase the desired induction time. The cap rate will be cleared when first titration occurs.

11. Target Concentration (Cpt or Cet) - Adjust the Target Concentration if necessary using the f keys. Confirm the Target

Concentration and Initial Infusion predicted parameters. On confirmation, if the Target Concentration exceeds any limits, a warning will be displayed.

Infusion cannot be started until confirmation has been made.

Initial infusion parameters may fluctuate from the displayed predicted values as a result of real time recalculation.

If the induction time is greater than 10s the flow rate may decrease on the last 10s period to adjust the dose to be administered.

Maintenance flow rate will decrease over time for a fixed target.

12. Purge (if required) - Press the i button and then press and hold the PURGE softkey until the fluid flows and the purging of the IV

infusion set is complete. Release the softkey. The volume used during purging will be displayed.

13. Connect the extension set to the patient access device.

14. Press the b button to commence operation. INFUSING will be displayed. The amber stop light will be replaced by the flashing

green start light to indicate that the Pump is in operation. If the infusion rate exceeds the Soft Alerts then check infusion setting, to continue with infusion at set target press the b button and then confirm OVERRIDE LIMIT by pressing the YES softkey. If

OVERRIDE LIMIT is not required press the NO softkey and adjust target concentration to be within the Soft Alerts.

If Target Concentration running exceeds the Soft Alerts then the display will cycle between Drug Name and Up

15. Pressing the h button during infusion will maintain the current Plasma or Effect site.

16. Press the h button to halt the operation. ON HOLD will be displayed. The amber stop light will replace the green start light.

Flow Rate and

Dose Rate

* The Ce value will not be displayed if there is no k41 (keo) defined for the selected model.

arrows.

Effect Site

Concentration*

Decrement Time

Drug Name and

Concentration

Actual Time

BDDF00628 Issue 3

Plasma Concentration

Prediction

Effect Site Prediction

Trend Time

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Alaris™ PK Plus Syringe Pump

Basic Features

Bolus Infusion

BOLUS is disabled in TCI mode.

Bolus Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic purposes. The Pump

should always be infusing and always attached to the patient. (Drugs given by an IV bolus could achieve immediate and high drug concentration levels.)

Bolus can be used at the start of an infusion or during an infusion.

The bolus feature can be configured to:

a) BOLUS Disabled b) BOLUS Enabled

• Hands-On

• Hands-Free

BOLUS Disabled

If configured to Disabled, pressing the i button will have no effect and the Pump will continue to infuse at the set rate.

A Hands-On bolus and Hands-Free bolus cannot be administered if the feature is disabled for the selected Profile or

specific drug. During BOLUS the pressure limit alarm is temporarily increased to the maximum level.

BOLUS Enabled - Hands-On

In Hands-On Bolus, press and hold the (flashing) BOLUS softkey to deliver the required bolus. The bolus rate can be adjusted. The bolus volume is limited in the configuration.

1. During infusion press the i button once to display the bolus screen.

2. Use the f keys to adjust the bolus rate if required.

3. To deliver the bolus press and hold the BOLUS softkey. During the bolus, the volume being infused is displayed. When the desired

bolus volume has been delivered or the bolus volume limit is reached, release the softkey. The bolus volume is added to the total volume infused.

BOLUS Enabled - Hands-Free

The Hands-Free Bolus is delivered with a single press of the (flashing) BOLUS softkey. The bolus rate and bolus volume are set by drug profile in the data set and can be changed within limits set by the data set.

1. During infusion press the i button to display the Hands-Free bolus selection screen.

2. Use the f keys to set the bolus volume/dose required; if necessary use the RAT E softkey and the f keys to adjust

the bolus delivery rate. Note: Rate may be restricted by the syringe size and the CAP BOLUS RATE.

3. Press the flashing BOLUS softkey once to begin the delivery of the preset bolus. The display will show the bolus being delivered, the

bolus counting down and revert to main infusion display upon completion of the bolus.

4. To terminate a bolus being delivered press STOP softkey. This will stop the bolus and continue infusing at the set rate. Press the h

button to stop the bolus delivery and place the Pump on hold.

5. If the bolus volume reaches the set bolus volume the bolus will stop and the Pump will revert to infuse at the set infusion rate and

continue infusing.

If the Hands-Free bolus option is active, then this feature will be cancelled following any interruption in delivery, e.g.

occlusion, even if the bolus delivery is incomplete.

Any Hands Free Bolus dose setting which exceeds or is under a Soft Alert must be confirmed before operation can be continued. This is not applicable in TCI mode.

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Alaris™ PK Plus Syringe Pump

Basic Features

Purge

The i button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe.

1. Press the i button when the Pump is not infusing. Ensure that the extension set is not connected to the patient.

2. Press and hold the PURGE softkey until fluid flows and the purging of the extension set is complete. The volume used during purging will be displayed, but it is not added to the volume infused.

3. When purging is complete release the PURGE softkey. Press the QUIT softkey to exit back to the main display.

During PURGE the pressure limit alarms are temporarily increased to their maximum level.

Pressure Level

1. To check and adjust the pressure level press the e button. A bar graph will be displayed showing the pressure alarm level and the current pressure level.

2. Press the f keys to increase or decrease the alarm level. The new level will be indicated on the display.

3. Press OK to exit the screen.

During PURGE, BOLUS and INDUCTION the pressure limit alarms are temporarily increased to their maximum level.

For TCI operation a threshold rate may be set above which the pressure limit alarms are temporarily increased to their maximum level.

Rate Titration

Note: This is not applicable in TCI mode.

If Rate Titration is enabled the rate can be adjusted while infusing:

1. Select the new rate using the f keys.

2. The message < START TO CONFIRM > will display on screen, titration callback tone will sound and Pump continues to infuse at the original rate.

3. Press the b button to confirm the new infusion rate and start infusing at the new rate.

If Rate Titration is disabled the rate can only be adjusted whilst on hold:

1. Press the h button to put the Pump on hold.

2. Select the new rate using the f keys.

3. Press the b button to start infusing at the new rate.

Clear Volume

Note: Clear Volume is not permitted in TCI mode or predictive TIVA mode.

This option enables the volume infused to be cleared.

1. Press the VOLUME softkey to display the CLEAR VOLUME option.

2. Press the YES softkey to clear the volume. Press the NO softkey to retain the volume. Note: Selecting YES resets the volume infused in the 24H LOG option.

Concentration Target Titration

Note: This only applies to TCI mode.

Concentration Target Titration allows the rate to be adjusted while infusing:

1. Select the new target using the f keys.

• The Pump status is shown as TITRATE and the Pump continues to infuse at the original concentration target.

2. Press the b button to confirm the new concentration target and start infusing at the new rate. If the new concentration target setting exceeds or is under a Soft Alert, confirmation is required before infusion can resume.

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Operations During Use

End of Operation

This option will only appear in the options menu when the infusion has been stopped.

1. Press the d button to access the options menu.

2. Select the END OF OPERATION option using the f keys.

3. Press the OK softkey indicated on the screen. Note: Selecting this option will reset parameters for a new patient.

TCI Mode

When the Pump is on hold in predictive TIVA mode, the user is able to switch from TIVA to TCI mode.

1. Press the d button to access the options menu.

2. Using the f keys, select the TCI MODE.

3. Press the OK softkey indicated on the screen. A confirmation screen will be displayed. Note: When the mode is changed to TCI mode, the initial target will be set to zero.

TIVA Mode

When the Pump is on hold in TCI mode, the user is able to switch from TCI to predictive TIVA mode.

1. Press the d button to access the options menu.

2. Using the f keys, select the TIVA MODE.

3. Press the OK softkey indicated on the screen. A confirmation screen will be displayed. Note: When the mode is changed to predictive TIVA mode, the initial doserate will be set to zero.

Alaris™ PK Plus Syringe Pump

Operations During Use

DECREMENT CONC.

In TCI mode only:

1. Press the d button to access the options menu.

2. Select DECREMENT CONC.

3. Select the required DECREMENT CONC and press the OK softkey to exit.

Trend Size

The user is able to select the Trend Size of the Concentration Prediction graph.

1. Press the d button to access the options menu.

2. Using the f keys, select TREND SIZE.

3. Using the f keys, select the required TREND SIZE option (5 Mins, 15 Mins, 30 Mins or 60 Mins).

4. Press the SELECT softkey indicated on the screen.

5. Press the RESIZE softkey to rescale the vertical axis of the graph. The initial displays calculates the scale so the peak value fills graph. If the trend is downward the graph only fills lower part and the RESIZE option forces it to rescale.

Text/Graph Display

When in TCI mode, the user is able to select a numerical or graphical display.

1. Press the d button to access the options menu.

2. Using the f keys, select the display mode (TEXT or GRAPH DISPLAY). The options menu shows the available display mode option.

3. Press the OK softkey indicated on the screen.

Dosing Summary

1. Press the d button to access the options menu.

2. Select the DOSING SUMMARY option using the f keys and press the OK softkey.

3. Press the QUIT softkey to exit the menu.

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Alaris™ PK Plus Syringe Pump

Operations During Use

24 Hour Log

This option allows the 24 hour log of volume infused to be reviewed.

1. Press the d button to access the options menu.

2. Select the 24H LOG option using the f keys and press the OK softkey. The display shows the hourly volume infused. The volume infused shown in brackets is the total volume infused since the volume was

last cleared. See example below:

07:48 - 08:00 4.34ml (4.34ml)

08:00 - 09:00 2.10ml (6.44ml)

09:00 - 10:00 2.10ml (8.54ml)

VOLUME CLEARED

3. Press the QUIT softkey to exit the log.

Event Log

This option allows the event log to be reviewed. It can be enabled/disabled.

1. Press the d button to access the options menu.

2. Select the EVENT LOG option using the f keys and press the OK softkey.

3. Scroll through the log using the f keys. Press the QUIT softkey to exit the log.

Note: When the event log reaches full capacity, the oldest events will be overwritten by the most recent events.

Data Set Details

To review currently selected data set information:

1. Press the d button to access the options menu.

2. Select DATA SET DETAILS.

3. Review the information and press the QUIT softkey to exit.

SET BY DOSERATE/SET BY ml/h (TIVA mode only)

To set doserate to flowrate in precise increments, it may be necessary to switch between the rate adjust options SET BY DOSERATE and SET BY ml/h. An arrow to the left of the rate display shows the rate changed when the f keys are used to increase/decrease the

infusion rate.

To precisely set a doserate, the arrow must be pointing to the doserate (mg/kg/h); the flowrate will be calculated from the doserate. To precisely set a flowrate, the arrow must be pointing to the flowrate (ml/h); the doserate will be calculated from the flowrate.

Selecting the SET BY ml/h option:

1. Whilst the Pump is infusing, press the d button to access the options menu.

2. Select the SET BY ml/h option using the f keys and press the OK softkey indicated on the screen. This will select the

SET BY FLOWRATE option, the arrow on the display will automatically select the flowrate, the flowrate can be adjusted if required.

Selecting the SET BY DOSERATE option:

1. Whilst the Pump is infusing, press the d button to access the options menu.

2. Select the SET BY DOSERATE option using the f keys and press the OK softkey indicated on the screen. This will select the

SET BY DOSERATE option, the arrow on the display will automatically select the doserate, the doserate can be adjusted if required.

EFFECT SITE TCI

When in PLASMA TCI mode the user is able to switch to EFFECT SITE TCI mode if the configuration permits:

1. Press the d button to access the options menu.

2. Select EFFECT SITE TCI using the f keys.

3. Press the OK softkey indicated on the screen. A confirmation screen will be displayed.

PLASMA TCI

When in EFFECT SITE TCI mode the user is able to switch to PLASMA TCI mode if the configuration permits:

1. Press the d button to access the options menu.

2. Select PLASMA TCI using the f keys.

3. Press the OK softkey indicated on the screen. A confirmation screen will be displayed.

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Alaris™ PK Plus Syringe Pump

Priority

Alarms and Warnings

Alarms are indicated by a combination of an audible alarm, alarm indicator and a descriptive message in the display.

1. First press the R button to silence the alarm for a maximum of 2 minutes, then check the display for an alarm message. Press CANCEL to cancel the alarm message.

2. If the infusion has stopped, rectify the cause of the alarm then press the b button to resume the infusion.

If the Pump initiates a safety processor alarm condition (an audible high pitched continuous shrill accompanied with a red alarm indicator) and there is no error message displayed on the Pump, remove the Pump from service for examination by Qualified Service Personnel.

Infusion will stop for all high priority alarms.

The default alarm system is ORIGINAL ALARMS (ISO60601-1-8 2nd Edition alarms). 3RD EDITION ALARMS

Original Alarms

(ISO60601-1-8 3rd Edition alarms) are also installed. To change the Pump alarm system from ORIGINAL ALARMS to 3RD EDITION ALARMS please refer to the Technical Service Manual. Please note that this change should only be performed by Qualified Service Personnel.

Display Alarm

DRIVE DISENGAGED High The drive system has been disengaged during operation. Check the finger grips

OCCLUSION High Excessive pressure measured at the syringe plunger exceeding the alarm

CHECK SYRINGE High Incorrect size of syringe has been fitted, the syringe has not been positioned

Error Code and Message High The alarm system has detected an internal malfunction. Note the malfunction

BATTERY EMPTY High The internal battery is exhausted. Connect the Pump to the AC Power Supply.

END OF INFUSION High The Pump has reached the end of the infusion and the Pump has stopped

COMMS. TIMEOUT High While being controlled remotely, the Pump does not receive a message during the

UNACHIEVABLE RATE STOP High The infusion rate specified is not achievable with the current setup. Cancel the

BATTERY LOW Medium Battery charge low with 30 minutes operation remaining. Battery indicator will

END OF INFUSION Medium The Pump has reached the end of the infusion and the Pump continues to infuse

Description and Troubleshooting Guide

and the position of the syringe.

limit. Identify and remove the cause of the blockage in the drive, syringe, or administration system before restarting the infusion.

correctly or has been disturbed during operation. Check the syringe location and the position.

A CHECK SYRINGE alarm may indicate the incorrect size of syringe has been fitted; the syringe has not been positioned correctly, or has been disturbed during operation, for example, the user opens the syringe clamp, or If the syringe plunger loses contact with the plunger button.

If there is no identifiable cause for the CHECK SYRINGE alarm(s) then the pump should be removed from clinical use and examined by Qualified Service Personnel in accordance with the Alaris Syringe Pump Technical Service Manual.

code. Remove Pump from service for examination by Qualified Service Personnel.

infusing. A pre-set volume will remain in the syringe to minimise the risk of the infusion of air bubbles into the set. This value can be configured.

defined timeout period. Attempt to re-establish connection to resolve this alarm condition and restart the infusion.

alarm message and reprogram the infusion with an achievable rate.

flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted. Reconnect to the AC Power Supply to continue operation and charge the internal battery. Optional* reminder signals may sound, they are auditory signals that have four beeps that occur every ten minutes once the Low Battery alarm is cancelled.

at KVO or set rate if lower.

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Alaris™ PK Plus Syringe Pump

Priority

Alarms and Warnings

Display Alarm

TITRATION NOT CONFIRMED Medium The infusion rate has been changed, but has not been confirmed and after five

AC POWER FAIL Medium AC Power has been disconnected and the Pump is operating on battery power, if

NEAR END OF INFUSION Medium The Pump is nearing the end of the infusion. This value can be configured.

ATTENTION Low Three beeps will sound if the Pump has been left on for more than 2 minutes*

Description and Troubleshooting Guide

seconds of no activity the User will be notified by an auditory cue. The infusion has not been confirmed and two minutes has expired without any operation, a medium priority alarm will be generated. Press the R button to silence the alarm, then press the CANCEL softkey to clear this message. Check infusion rate and confirm by pressing the b button or press the h button to revert to the previous rate. Press the b button to start infusion. (This alarm only occurs if rate titration is enabled).

this occurs when the Pump is infusing the message INFUSION CONTINUES will be displayed. Reconnect AC Power Supply or press the R button to silence the alarm and continue with battery operation. The alarm will automatically cancel if the AC Power Supply is reconnected.

Optional* reminder signals may sound, they are auditory signals that have four beeps that occur every ten minutes once the NEOI alarm is cancelled. This reminder signal will not occur for a continuous infusion in which the NEOI alarm is set for less than ten minutes.

(referred to as CALLBACK in the log) without starting the operation. Press the

R button to silence the alarm for a further two minutes. Alternatively press

and hold down the R button and wait for four beeps in succession, this will put the alarm on standby for 60 minutes.

*Configurable option.

Note: The audio sound pressure level is at least 45 dB depending on configuration of the alarm sound level.

Setting the alarm sound pressure level lower than the ambient sound pressure level can impede User recognition of alarm conditions.

Alarm Priority Level Indicators

Priority Audio Indicator Visual Indicator (Beacon)

HIGH One urgent tone pulse followed by one second pause Flashing Red

MEDIUM One warning tone pulse followed by one second pause Flashing Amber

LOW Three attention tone pulse followed by a three second pause Flashing Amber

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3rd Edition Alarms