Alaris PK User manual

Name: Alaris PK
Brand: Alaris
SKU: 6512478
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Alaris®PK Syringe Pump

Directions For Use - English

Contents

Page

 Introduction .......................................................................................................................................... 2

 About This Manual ................................................................................................................................ 2

 TCI Overview .......................................................................................................................................... 3

 Creating a Data Set ............................................................................................................................... 6

 Features of the Alaris® PK Syringe Pump ............................................................................................ 7

 Controls & Indicators ............................................................................................................................ 8

 Symbol Definitions ................................................................................................................................ 9

 Main Display Features ........................................................................................................................... 10

 Operating Precautions .......................................................................................................................... 12

 Getting Started ...................................................................................................................................... 14

 Basic Features ........................................................................................................................................ 19

 Operations During Use ......................................................................................................................... 21

 Alarms and Warnings ............................................................................................................................ 23

 Prompts .................................................................................................................................................. 24

 Configured Options ............................................................................................................................... 25

 Specifications......................................................................................................................................... 29

 Compatible Syringes ............................................................................................................................ 30

 Associated Products ............................................................................................................................. 30

 Compatible Extension Sets .................................................................................................................. 31

 Maintenance .......................................................................................................................................... 32

 Occlusion Pressure Limits .................................................................................................................... 34

 IrDA, RS232 and Nurse Call Specification ........................................................................................... 35

 Trumpet Curves & Start-up Curves ...................................................................................................... 36

 Profiles From TCI Mode ......................................................................................................................... 37

 Products and Spare Parts ..................................................................................................................... 40

 Service Contacts ................................................................................................................................... 41

 Document History ................................................................................................................................ 41

 Warranty ................................................................................................................................................. 42

 Index ....................................................................................................................................................... 43

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Introduction

The Alaris® PK Syringe Pump (herein after referred to as "pump") provides the user with an infusion tool for the administration of drugs for anaesthesia. The embedded software within the pump is loaded with three compartment pharmacokinetic predictive models and has 4 modes of operation:

1) Continuous infusion (ml/h)

2) Total Intravenous Anaesthesia ( TIVA) mode. In this mode the user is able to select the infusion rate and administer bolus doses as required.

3) Total Intravenous Anaesthesia ( TIVA) with TCI predictions mode. In this mode the user is able to select the infusion rate and administer bolus doses as required. The pharmacokinetic model is used to

estimate the plasma and effect site concentration.

4) TCI Mode  Plasma target-controlled infusion ( TCI). In this mode the user selects the desired (target) plasma drug concentration, and the pharmacokinetic model is used to calculate the

infusion rates required to achieve that concentration. A graphic display shows the trajectory of the estimated plasma and effect site drug concentration over time.

 Effect Site target-controlled infusion ( TCI). In this mode the user sets the desired effect site target concentration and the pharmacodynamic model is used to calculate the

infusion rates required to achieve that concentration. A graphic display shows the trajectory of the estimated effect site and plasma

concentration over time. The Alaris® PK Syringe Pump has a user friendly interface that displays the infusion rate, the total drug dose delivered, and the estimated plasma and effect-site concentrations to enable the user to follow the drug prescription information from the relevant country.

Intended Use:

The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use (DFU) including general wards, critical and intensive care, neonatal, outpatients clinics, operating rooms and accident and emergency rooms.

The Alaris® PK Syringe Pump is compatible with a wide range of standard single use, 3 piece Luer-lock syringes. It accepts syringe sizes from 5ml to 50ml. Specifications are available in the relevant section.

Use of the Alaris® PK Syringe Pump DOES NOT limit the responsibility of the anaesthetist for drugs administration. It is important that users operating the Alaris® PK Syringe Pump are fully aware of the available literature for any model used in association with a drug and that they refer to the prescribed information for rate and dosing limits. Pharmacokinetic and Pharmacodynamic Interactions among anaesthetic drugs are known, but are not taken into account in the calculation of the plasma and effect site concentrations.

The user should be appropriately trained in the use of the pump and should follow the recommendations of this Direction For Use (DFU).

In particular, the user must be aware that starting the pump in a TCI mode will result in the automatic infusion of a pre-calculated bolus dose followed by an infusion to achieve the selected target concentration. The initial parameter calculations are displayed on screen prior to starting the infusion. It is thus essential that the user verifies that the patient characteristics and the selected infusion rate or target concentration conform with the drug prescribing information of the relevant country.

Cardinal Health has verified the accuracy of the mathematical model implementation as well as pump delivery accuracy - (specification and accuracy of pump - delivery are available in 'Profiles from TCI Mode' section).

Different drugs are associated with dedicated models – each model consists of a set of standard pharmacokinetic parameters which can be selected and used by the embedded 3 compartment model used in the Alaris® PK Syringe Pump (where use of that drug in TCI mode is authorised);

Diprivan from ASTRA-ZENECA is the only recommended Propofol formulation to be used in TCI mode as per prescribing information. This pump includes the “Marsh” model for the calculation of the Diprivan infusion rates, and plasma and effect-site concentrations.

When Remifentanil and Sufentanil are used in TCI mode, – the “Minto” and “Gepts” models respectively – are used to calculate the required infusion rates.

The Asena® brand name has been recently changed to the Alaris® brand name. This change in brand name has no effect on the intended use or functionality of the product. Recommended disposable products for use with this product may refer to either the Asena® brand name or Alaris® brand name and both types are suitable for use with this infusion pump.

About This Manual

The user must be thoroughly familiar with the Alaris® PK Syringe Pump described in this manual prior to use.

All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump. These settings and values are for illustrative use only. Where stated, a minimum infusion rate refers to a nominal rate of 1.0ml/h, and an intermediate infusion rate refers to a nominal rate of 5.0ml/h. The complete range of infusion rates, settings and values are shown in the Specifications section.

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T C I O v e r v i e w

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 (k 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”.

, k21, k31 and k13) or clearances. Drug metabolism is described by the

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 plasmatargeted. 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 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.

Knowledge of the k

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.

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

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TCI Overview (continued)

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 Syringe Pump are wellvalidated 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 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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TCI Overview (continued)

Pharmacokinetic models in Alaris® PK 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

= 0.119 min

k12 = 0.112 min k13 = 0.0419 min k21 = 0.055 min k31 = 0.0033 min Keo = 0.26 min

-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 CL

= 2.6 - 0.0162 x (age - 40) + 0.0191 x (lbm - 55)

= 2.05 - 0.0301 x (age - 40)

= 0.076 - 0.00113 x (age - 40)

k10 = Cl1 / Vc k12 = Cl2 / Vc k13 = Cl3 / Vc

= 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

-1

)

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 k

= 0.0645 min

k12 = 0.1086 min k13 = 0.0229 min k21 = 0.0245 min k31 = 0.0013 min

-1

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

Additional : k

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

63)

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Creating a Data Set

To fully utilise the Alaris® PK 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)

Drug Library* Drugs and concentrations for this profile with defaults, minimum & maximum limits and targets and

occlusion level.

Configuration** Instrument 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 Syringe Pump (Using Alaris® PK Editor Transfer Tool)

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

5. Verify Data Set Upload

First or Individual Instrument Verification

On completion of upload record CRC (Cyclic Redundancy Check) number shown on the Alaris® PK

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 Instruments Verification

On subsequent uploads of the Data Set compare CRC number on the instrument with CRC number

recorded on First Instrument Verification.

* Note: Drug parameters have to be in accordance to local regulation and prescribed information.

** See important note in Configured Options section.

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Features of the Alaris® PK Syringe 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

Syringe Clamp

keys and softkeys

(

)

Positive Plunger

Grippers

Rotating Cam to

lock on to horizontal

rectangular bars

Carrying

Handle

IR Communications

Potential

Equalisation

(PE) connector

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Folded Pole

Clamp

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RS232

Connector

Extension set

hook

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.

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 2 minutes (configurable). Press and hold until 3 beeps are heard for 15 minutes silence.

PURGE/ BOLUS button - Press to access PURGE or BOLUS soft keys. Press and hold down soft key to operate.

PURGE the extension set during set up.

 Pump is on hold

 Extension set is not 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

Controls & Indicators

OPTION button - Press to access optional features (see Basic Features).

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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Labelling Symbols:

Symbol Description

Attention (Consult accompanying documents)

Potential Equalisation (PE) Connector

RS232/Nurse call Connector (Optional)

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



Symbol Definitions

s T

Protected against vertically falling drops of water

Alternating Current

Device complies with the requirements of the EC Directive 93/42/EEC. Registered with the CE Mark.

Date of Manufacture

Manufacturer

Not for Municipal Waste

Important information

Fuse Rating

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TIVA Mode

Pump Status

Main Display Features

Drug Name and Concentration

Pressure Information

Flow Rate and Dose Rate

TCI Mode

Pump Status

Plasma Concentration

Plasma Target

Initial Induction Dose

TCI Mode - MORE information screen

Dose and Volume Infused

CONFIRM TIME

Initial Induction Rate

Drug Name and Concentration

Initial Induction Volume

Induction Duration

Time of Induction

Operations During Use

Pause Before Maintenance

Initial Maintenance Rate

Selecting the MORE softkey will display the following additional information:

Drug Name and Model

BMI 21.6

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.

Decrement Time

Decrement Concentration

Volume and Dose InfusedElapsed Time

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Screen Icons:

Symbol Description

Main Display Features (continued)

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.

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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G H

Operating Precautions

Disposable Syringes and Extension Sets

• This Alaris® PK Syringe Pump has been calibrated for use with single-use disposable syringes. To 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.

Mounting the Pump

• The pump must be mounted within 1.0m above or below the patient’s heart. The most accurate pressure

monitoring in the extension set is achieved when the pump is positioned close to the patients heart level.

• 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

• When using any infusion pump in conjunction with other pumps or devices requiring vascular access,

extra care is advised. Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the local vascular system by such pumps. Typical examples of those pumps are used during dialysis, bypass or cardiac assist applications.

• This pump is suitable for use in Hospital and clinical environments other than domestic establishments

and those directly connected to the public single phase AC mains power supply network that supplies

buildings used for domestic purposes. However, it may be used in domestic establishments under the supervision of Medical professionals with additional necessary appropriate measures. (Consult

Technical Service Manual, appropriately trained technical personnel or Cardinal Health for further information).

• This 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.

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Operating Precautions (continued)

Electromagnetic Compatibility & Interference

• This 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.

• 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 appropriately trained technical personnel. (Consult Technical Service Manual for further information).

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 this 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 a qualified service engineer. 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.

Latex Content

• The Alaris® PK Syringe Pump does not contain any Latex.

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