Alaris PK Plus Syringe Pump MK4 Directions for Use Issue 2 2020

Alaris™ PK Plus Syringe Pump 

Contents

Page

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 Contact Us... 56

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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 3.4.x 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 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

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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.

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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.

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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

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.1

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.5 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 effect6,7. 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 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. Input

V2

Peripheral Compartment

Effect Compartment

cl2

cl3

k21

k13

k12

keo

V1

Central Compartment

k31

V3

Peripheral Compartment

k10

Clearance cl1 Fig. 3: Schematic representation of the concentration-effect relationship.

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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Alaris™ PK Plus Syringe Pump TCI Overview

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-1 k12 = 0.112 minutes-1 k13 = 0.0419 minutes-1 k21 = 0.055 minutes-1 k31 = 0.0033 minutes-1 keo = 0.26 minutes-1 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 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-1 k12 = 0.1086 minutes-1 k13 = 0.0229 minutes-1 k21 = 0.0245 minutes-1 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):5363)

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Alaris™ PK Plus Syringe Pump Creating a Data Set

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.

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*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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Alaris™ PK Plus Syringe Pump

Features of the Pump

Features of the Pump ON/OFF

Release lever for MDI

Display

RUN

High visibility Alarm Indicator

PURGE/BOLUS

MUTE PRESSURE OPTION

Finger Grips Extension set hook HOLD Rating Plate (see Symbol Definitions for an explanation of the symbols used)

Shelf for chevron keys and softkeys

Positive Plunger Grippers

Syringe Clamp

Release lever for Rotating Cam

Medic

Rotating Cam to lock on to horizontal rectangular bars Carrying Handle

al Dev ice Int erface

(MDI)

IR Communications port

Potential Equalisation (PE) connector BDDF00628 Issue 2

Folded Pole Clamp

RS232 Connector

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Extension set hook

Alaris™ PK Plus Syringe Pump Controls and Indicators

Controls and Indicators Controls: Symbol

Description

a

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.

b h R

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.

i

• 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

d e f

g

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

j S

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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Alaris™ PK Plus Syringe Pump

Symbol Definitions

Symbol Definitions Labelling Symbols: Symbol

Description Consult accompanying documents.

x y l

Potential Equalisation (PE) Connector RS232/Nurse call Connector Defibrillation-proof type CF applied part (Degree of protection against electrical shock)

IP32

Protected against direct sprays of water up to 15° from vertical and protected against solid objects greater than 2.5mm.

r

Alternating Current

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

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

T t U W

Date of Manufacture Manufacturer Not for Municipal Waste Fuse Rating

+40°C



0°C

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

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Alaris™ PK Plus Syringe Pump Main Display Features

Main Display Features TIVA Mode Drug Name and Concentration

Pump Status

Flow Rate and Dose Rate

Pressure Information

Dose and Volume Infused

Operations During Use

TCI Mode Drug Name and Concentration

Pump Status

CONFIRM

Plasma Concentration

Plasma Target

Initial Induction Dose

Induction

Pause Before

Duration

Maintenance

TIME

Initial Induction Initial Induction Rate Volume

Time of Induction

Initial Maintenance Rate

TCI Mode - MORE Information Screen Selecting the MORE softkey will display the following additional information: Drug Name and Model

BMI

Patient Parameters

Elapsed Time

Volume and Dose Infused

21.6

Time to End of Infusion at Current Rate

Decrement Time

Decrement Concentration

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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Alaris™ PK Plus Syringe Pump Main Display Features

Screen Icons Symbol

Description

l N

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 reconnection to AC power supply. Note: This can be enabled/disabled with the Alaris Editor software

C

Induction Phase Dose (Displayed on protocol confirmation screen)

D

Duration of Induction Phase (Displayed on protocol confirmation screen)

E

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

F

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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Alaris™ PK Plus Syringe Pump

Operating Precautions

Operating Precautions Disposable Syringes and Extension Sets

m

•

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.

n

•

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.

o

•

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

I

•

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

J

•

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.

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Alaris™ PK Plus Syringe Pump

Operating Precautions

Hazards

A V

•

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.

L

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Alaris™ PK Plus Syringe Pump

Operating Precautions

Electromagnetic Compatibility and Interference

M

•

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/EN60601-224. 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).

MR

K

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Alaris™ PK Plus Syringe Pump Getting Started

Getting Started Initial Set-up

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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.

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• 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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Alaris™ PK Plus Syringe Pump Getting Started

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 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.

Recessed area

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.

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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.

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

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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.

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

Release lever (push to release) Rotating cam

* Alaris Gateway Workstation and Alaris DS Docking Station

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Alaris™ PK Plus Syringe Pump Syringe Loading

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.

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

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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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Alaris™ PK Plus Syringe Pump Syringe Loading

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.

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Finger Grips Plunger Grippers

Plunger Flange

Plunger

Plunger Holder

Syringe Barrel Barrel Flange Syringe Clamp

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.

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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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