Enteral Plus Syringe Pump MK4 Directions for Use Issue 2

Alaris™ Enteral Plus Syringe Pump MK4 

Contents

Page

Introduction... 2 About This Manual... 3 Features of the Alaris Enteral Plus Syringe Pump... 4 Controls and Indicators... 5 Symbol Definitions... 6 Main Display Features... 7 Operating Precautions... 8 Getting Started... 11 Loading and Confirming a Syringe... 13 Starting the Alaris Enteral Plus Syringe Pump... 15 Basic Features... 16 Alarms and Warnings... 19 Configured Options... 21 Specifications... 23 Recognised Syringe Types... 25 Associated Products... 26 Maintenance... 27 IrDA, RS232 and Nurse call Specification... 29 Occlusion Pressure Limits... 31 Trumpet Curves and Start-up Curves... 32 Spare Parts... 33 Service Contacts... 34

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Alaris™ Enteral Plus Syringe Pump MK4 Introduction

Introduction This Directions For Use applies to Alaris™ Enteral 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 4.4.X or above on power up.

The Alaris Enteral Plus Syringe Pump functions with a wide range of standard, single-use, disposable enteral syringes together with the appropriate enteral Administration sets. The Alaris Enteral Plus Syringe Pump accepts syringe sizes from 5ml to 50/60ml. A list of recognised syringes can be found in the Recognised Syringes section of this manual.

Intended Purpose The Alaris Enteral Plus Syringe Pump is intended exclusively for enteral administration.

Conditions of Use The Alaris Enteral Plus Syringe Pump should only be operated by a clinician competent in use of automated enteral pumps and postplacement management of enteral catheters. Only enteral syringes and catheters should be used.

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Wrong route errors can be life threatening. Connectors used on enteral feeding systems should be incompatible with other medical device connectors (especially those used for intravenous or other parenteral routes). CareFusion recommends use of enteral catheters and enteral giving sets meeting European Standard EN 1615:2000. Three-way taps and syringe tip adaptors should not be used in enteral feeding systems.

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CareFusion cannot guarantee the continued system accuracy with other manufacturer’s enteral syringes as identified in the ‘Recognised Syringe Types’ table. Manufacturers may change syringe specification significant to system accuracy without prior notification.

Indications The Alaris Enteral Plus Syringe Pump is specifically indicated for the delivery of enteral therapies via Nasogastric, Orogastric or Gastrostomy (e.g. PEG - Percutaneous Endoscopic Gastrostomy) routes.

Contraindications The Alaris Enteral Plus Syringe Pump is contraindicated for: • intravascular infusion therapies • subcutaneous infusion therapies • intrathecal and epidural infusion therapies

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Alaris™ Enteral Plus Syringe Pump MK4 About This Manual

About This Manual Users are advised to read, to understand this manual and to be thoroughly familiar with the Alaris Enteral Plus Syringe Pumps prior to operating. All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the Alaris Enteral Plus Syringe Pump. These settings and values are for illustrative use only. Where stated, a minimum delivery rate refers to a nominal rate of 1.0ml/h, and an intermediate delivery rate refers to a nominal rate of 5.0ml/h. The complete range of delivery rates, settings and values are shown in the 'Specifications' section.

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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 CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.

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.

A

Important Information: Wherever this symbol is shown an Important note is found. These notes highlight an aspect of use that is important for the user to be aware of when operating the Alaris Enteral Plus Syringe Pump.

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Alaris™ Enteral Plus Syringe Pump MK4 Features of the Alaris Enteral Plus Syringe Pump

Features of the Alaris Enteral Plus Syringe Pump ON/OFF

Release lever for MDI

Display

RUN

High visibility Alarm Indicator

PURGE/BOLUS

MUTE PRESSURE OPTION

Finger Grips 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 1000DF01026 Issue 2

Folded Pole Clamp

RS232 Connector

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Hook

Alaris™ Enteral Plus Syringe Pump MK4 Controls and Indicators

Controls and Indicators Controls: Symbol

Description

a b h R

ON/OFF button - Press once to switch the Alaris Enteral Plus Syringe Pump on. Press and hold down for 3 seconds to switch the Alaris Enteral Plus Syringe Pump off. RUN button - Press to start feeding. The green LED will flash during delivery. HOLD button - Press to put the delivery 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: Callback alarm - When not in alarm press and hold until four audible beeps are sounded for 15 minutes silence PURGE/BOLUS button - Press to access PURGE or BOLUS soft keys. Press and hold down soft key to operate. PURGE - primes the feeding tube during initial set up.

i

• Alaris Enteral Plus Syringe Pump is on hold • Administration set must not be connected to the patient • Volume Delivered is not added to total volume delivered BOLUS - fluid or drug delivered at an accelerated rate. • Alaris Enteral Plus Syringe Pump is delivering • Administration set should be connected to the patient • Volume Delivered is added to total volume delivered

d e f

g

OPTION button - Press to access optional features, see 'Basic Features' section. PRESSURE button - Use this button to display the Alaris Enteral Plus Syringe 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 Alaris Enteral Plus Syringe 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 Alaris Enteral Plus Syringe Pump is connected to an AC power supply and the battery is being charged.

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Alaris™ Enteral Plus Syringe Pump MK4 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

s T t U W +40°C

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. Date of Manufacture Manufacturer Not for Municipal Waste Fuse Rating



Operating Temperature Range - Alaris Enteral Plus Syringe Pump can be used between 0 and 40 degrees centigrade.

EC REP

Authorised Representative in the European Community

0°C

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Alaris™ Enteral Plus Syringe Pump MK4 Main Display Features

Main Display Features Pressure Information

Syringe type fitted

Status

ON HOLD

+

00

ADJUST

PENTA ENTERAL

VOLUME

0.00ml 00h 00m 00s

-

VOLUME

Volume Delivered

Delivery Rate

60

VTBD

Volume Delivered Option

VTBD Option

Screen Icons Symbol

Description

z

Time remaining display icon - Indicates time before syringe will require replacement.

N

BATTERY icon - Indicates battery charge level to highlight when the battery will require recharging or re-connection to AC power supply.

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Alaris™ Enteral Plus Syringe Pump MK4 Operating Precautions

Operating Precautions Disposable Syringes and Administration Sets •

•

n

•

•

•

The Alaris Enteral Plus Syringe Pump has been calibrated for use with single-use enteral syringes. To ensure correct and accurate operation, only use the brand, model and size of enteral syringes described in this manual. Use of non recognised enteral syringe types may impair the operation of the Alaris Enteral Plus Syringe Pump and the accuracy of the delivery. Users are advised to re-evaluate syringe performance periodically as the syringe manufacturer may change specifications significant to accuracy without notice. Users concerned about any observed change in performance are advised to contact their local CareFusion representative. Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the Alaris Enteral Plus Syringe Pump, or if it is removed from the Alaris Enteral Plus Syringe Pump before the administration set is properly isolated from the patient. Isolation may include closing a tap in the patient line or activating a flow stop clamp. The user must be thoroughly familiar with instructions in this Directions For Use and understand how to load and confirm the syringe on the Alaris Enteral Plus Syringe Pump. Incorrect syringe loading may result in misidentification of the syringe brand/model and size which may lead to significant inaccuracy of the delivery rate and may also affect Alaris Enteral Plus Syringe Pump performance. Secure the feeding tube to the Alaris Enteral Plus Syringe Pump using the hook at the rear of the Alaris Enteral Plus Syringe Pump. This provides protection against accidental dislodging of the syringe from the Alaris Enteral Plus Syringe Pump.

Operating Environment •

•

•

Intended environments include general wards, neonatal wards, paediatric wards, critical and intensive care, operating rooms, accident and emergency rooms. Ensure that the Alaris Enteral Plus Syringe Pump is appropriately attached using the provided pole clamp. If the Alaris Enteral Plus Syringe Pump is dropped or experiences any severe physical disturbances, remove it from service and arrange a thorough inspection by appropriately trained technical personnel as soon as is practically possible. The Alaris Enteral Plus Syringe Pump is suitable for use in hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC 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, Qualified Service Personnel or CareFusion for further information). The Alaris Enteral Plus Syringe 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 accurate fluid administration.

Alarm Conditions

J

•

Several alarm conditions detected by the Alaris Enteral Plus Syringe Pump will stop the delivery and generate visual and audible alarms. Users are to remain vigilant during delivery to ensure that the therapy is progressing correctly and no alarms are operating.

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Alaris™ Enteral Plus Syringe Pump MK4 Operating Precautions

Hazards

A V

•

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

•

Dangerous Voltage: An electrical shock hazard exists if the Alaris Enteral Plus Syringe 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 Alaris Enteral Plus Syringe 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 Alaris Enteral Plus Syringe 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 Alaris Enteral Plus Syringe Pump, use original packaging where possible, and observe to temperature, humidity and pressure ranges stated in the 'Specifications' section and on the outer packaging. Warning: Alaris Enteral Plus Syringe Pumps should not be modified or altered in any way, except where explicitly directed or authorised by CareFusion. Any use of Alaris Enteral Plus Syringe Pumps which have been altered or modified otherwise than in strict application of directions provided by CareFusion, is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any Alaris Enteral Plus Syringe Pump that has been so modified or altered. CareFusion product warranty shall not apply in the event the Alaris Enteral Plus 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 Enteral Plus Syringe Pump.

•

•

L •

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Alaris™ Enteral Plus Syringe Pump MK4 Operating Precautions

Electromagnetic Compatibility and Interference

M

•

•

•

MR •

Accessories: Do not use any non-recommended accessory with the Alaris Enteral Plus Syringe Pump. The Alaris Enteral Plus Syringe 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 CareFusion may result in increased emissions or decreased Alaris Enteral Plus Syringe Pump immunity.

•

This Alaris Enteral Plus Syringe 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, the Alaris Enteral Plus Syringe Pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC/ EN60601-1-2. If the Alaris Enteral Plus Syringe Pump interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation. In some circumstances the Alaris Enteral Plus Syringe 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 Alaris Enteral Plus Syringe Pump is affected by this external interference the Alaris Enteral Plus Syringe Pump will remain in a safe mode; the Alaris Enteral Plus Syringe Pump will stop the delivery and alert the user by generating a combination of visual and audible alarms. Should any alarm condition persist after user intervention, it is recommended to remove the Alaris Enteral Plus Syringe Pump from service. (Consult Technical Service Manual for further information).

•

K

The Alaris Enteral Plus Syringe 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 abnormally high levels of interference are encountered. Therapeutic Radiation Equipment: Do not use the Alaris Enteral Plus Syringe 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 Alaris Enteral Plus Syringe Pump. Please consult manufacturer’s recommendations for safe distance and other precautionary requirements. For further information, please contact your local CareFusion representative. Magnetic Resonance Imaging (MRI): The Alaris Enteral Plus Syringe Pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices. Therefore, the Alaris Enteral Plus Syringe Pump is not considered an MRI compatible pump. If use of the Alaris Enteral Plus Syringe Pump within an MRI environment is unavoidable, then CareFusion highly recommends securing the Alaris Enteral Plus Syringe Pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the Alaris Enteral Plus Syringe Pump; or MRI image distortion. This safe distance should be established in accordance with the manufacturers’ recommendations regarding electromagnetic interference (EMI). For further information, please refer to the product Technical Service Manual (TSM). Alternatively, contact your local CareFusion representative for further guidance.

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Alaris™ Enteral Plus Syringe Pump MK4 Getting Started

Getting Started Initial Set-up

A

Before operating the Alaris Enteral Plus Syringe Pump read this Directions For Use manual carefully.

1. Check that the Alaris Enteral Plus Syringe 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 Enteral Plus Syringe Pump • User Support CD (Directions For Use) • AC Power Cable (as requested) • Protective Packaging 3. Connect the Alaris Enteral Plus Syringe 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 Alaris Enteral Plus Syringe 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.

A A

The Alaris Enteral Plus Syringe Pump will automatically operate from its internal battery if the Alaris Enteral Plus Syringe Pump is switched on without being connected to the AC power supply. Should an Alaris Enteral Plus Syringe Pump fail comissioning, replace in its original protective packaging, where possible and contact Qualified Service Personnel for investigation.

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Alaris™ Enteral Plus Syringe Pump MK4 Getting Started

A

Do not mount the Alaris Enteral Plus Syringe Pump with the AC power inlet pointing upwards. This could affect the electrical safety in the event of a fluid spill.

Pole Clamp Installation The pole clamp is fitted to the rear of the Alaris Enteral Plus Syringe Pump and will provide secure fixing to vertical drip poles of a diameter between 15 and 40 mm.

Recess

1. Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole. 2. Place Alaris Enteral Plus Syringe Pump around pole and tighten screw until the clamp is secured to the pole.

A

Ensure the pole clamp is folded away and stored within the recess at the rear of the Alaris Enteral Plus Syringe Pump before connecting to a Docking Station/ Workstation* or when not in use.

*

*

Never mount the Alaris Enteral Plus Syringe Pump such that the stand becomes top heavy or unstable.

A

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 Alaris Enteral Plus Syringe Pump with the rectangular bar on the Docking Station/ Workstation* or the equipment rail. 2. Hold the Alaris Enteral Plus Syringe Pump horizontally, push the Alaris Enteral Plus Syringe Pump firmly onto the rectangular bar or equipment rail. 3. The Alaris Enteral Plus Syringe Pump should click into position when fitted to the bar. 4. Ensure that the Alaris Enteral Plus Syringe Pump is positioned securely. 5. To release, push the release lever and pull the Alaris Enteral Plus Syringe Pump forwards. Rectangular bar

Release lever (push to release) Rotating cam

* Alaris Gateway Workstation and Alaris DS Docking Station

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Alaris™ Enteral Plus Syringe Pump MK4 Loading and Confirming a Syringe

Loading and Confirming a Syringe

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Warning: To securely load and confirm a syringe carefully follow the steps below. Loading a syringe incorrectly may result in misidentification of the syringe. If incorrectly confirmed, this may lead to significant inaccuracy of the delivery rate and may also affect Alaris Enteral Plus Syringe Pump performance. Only use a syringe of the brand/model stated on the Alaris Enteral Plus Syringe Pump display or in this manual. Using a non recognised enteral syringe type could adversely affect the accuracy of the delivery rate and may also affect Alaris Enteral Plus Syringe Pump performance. When drawing fluid into the syringe, draw enough to compensate for any 'dead space' volume in the feeding tube and syringe at the end of delivery as this cannot be fully administered.





Finger Grips Plunger Grippers

Plunger Flange

Plunger

Plunger Holder

Syringe Barrel Barrel Flange Syringe Clamp

Syringe Flange Clamp Place the Alaris Enteral Plus Syringe Pump on a stable horizontal surface or secure as described previously. Prepare, load and prime the single-use enteral syringe and administration set using standard 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.

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Alaris™ Enteral Plus Syringe Pump MK4 Loading and Confirming a Syringe 3. Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange clamp.

A

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.

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 Alaris Enteral Plus Syringe Pump display then press CONFIRM. If required, the make of syringe can be changed by pressing the TYPE softkey. ON HOLD

PENTA ENTERAL

CONFIRM

A

60

TYPE

Secure the feeding tube using the hook at the rear of the Alaris Enteral Plus Syringe Pump. This provides protection against accidental dislodging of the syringe from the Alaris Enteral Plus Syringe Pump. Ensure that both plunger grippers are fully locked onto the plunger flange and the upper finger grip has returned to its original position.

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Alaris™ Enteral Plus Syringe Pump MK4 Starting the Alaris Enteral Plus Syringe Pump

Starting the Alaris Enteral Plus Syringe Pump

A

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

1. Connect the Alaris Enteral Plus Syringe Pump to an AC power supply using the AC power cable. 2. Press the a button. • The Alaris Enteral Plus Syringe Pump will run a short self-test.

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Warning: 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 rows are missing. • Check that the displayed time and date are correct. • Finally check display shows the data set name and version number. 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 Alaris Enteral Plus Syringe Pump will continue to power up as normal. 3. CLEAR SETUP • Selecting NO will keep previous setup and go to step 8. • Selecting YES will clear previous setup and will go to step 4. 4. Load the syringe according to the procedure in this manual. 5. Ensure that the syringe type and size match those displayed on the Alaris Enteral Plus Syringe Pump then press CONFIRM. If required, the make of syringe can be changed by pressing the TYPE softkey. 6. Purge (if required) - Press the i button and then press and hold the PURGE softkey until fluid flows and the purging of the administration set is complete. Release the softkey. The volume used during purging will be displayed. 7. Check the rate shown if set and change the rate if necessary using the f keys. 8. Connect the administration set to the patient access device. 9. Press b to commence operation. • The amber stop light will be replaced by the flashing green start light to indicate that the Alaris Enteral Plus Syringe Pump is in operation. RUNNING will be displayed. 10. Press h to halt the operation. ON HOLD will be displayed. The amber stop light will replace the green start light.

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Alaris™ Enteral Plus Syringe Pump MK4 Basic Features

Basic Features Bolus Delivery Bolus Administering a controlled volume of fluid or drug at an increased rate. Bolus can be used at the start of a delivery or during feeding.

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

Hands-Free The Hands-Free Bolus is delivered with a single press of the (flashing) BOLUS softkey. 1. During delivery press the i button to display the Hands-Free bolus selection screen. 2. Press the YES softkey to go to Hands-Free selection bolus screen. 3. Use the f keys to set the bolus volume/dose required; If necessary use the RATE 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. 4. 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 delivery display upon completion of the bolus. 5. To terminate a bolus being delivered press STOP softkey. This will stop the bolus and continue delivery at the set rate. Press the h button to stop the bolus delivery and place the pump on hold. 6. If the bolus volume reaches the set bolus volume the bolus will stop and the pump will revert to deliver at the set delivery rate and continue delivery. 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 delivery press the i button once to display the bolus screen. 2. Press the HANDS ON softkey for Hands-On bolus. 3. Use the f keys to adjust the bolus rate if required. 4. To deliver the bolus press and hold the BOLUS softkey. During the bolus, the volume being delivered 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 delivered.

A

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. If the volume to be delivered (VTBD) is reached during a bolus, the VTBD complete alarm will sound. Press R to silence the alarm or CANCEL to acknowledge the alarm. See VTBD section for more details on VTBD operation.

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Alaris™ Enteral Plus Syringe Pump MK4 Basic Features

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

1. Press the i button when the Alaris Enteral Plus Syringe Pump is not delivering. Ensure that the administration set is not connected to the patient. 2. Press and hold the PURGE softkey until fluid flows and the purging of the administration set is complete. The volume used during purging will be displayed, but it is not added to the volume delivered. 3. When purging is complete release the PURGE softkey. Press the QUIT softkey to exit back to the main display. Note: When maximum purge volume is reached , the pump will return to the main display screen.

A

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

Volume to be Delivered (VTBD) This option allows a specific volume to be delivered to be set. Rate at the end of this VTBD can also be set, selecting from stop, KTO (Keep Tube Open), or continuous delivery at the set rate. 1. Press the VTBD softkey to select the volume to be infused option. 2. Enter the volume to be delivered using the f keys and press the OK softkey. 3. Select the rate at the end of the VTBD using the f keys to scroll through the on-screen choices. The default is stop. 4. Press the OK softkey to confirm and exit the VTBD menu. Note: When current VTBD has finished, no other delivery will be allowed unless a new VTBD is set or current VTBD is cleared.

Clear Volume This option enables the volume delivered 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 delivered in the 24H LOG option.

Set VTBD over Time This option allows a VTBD and delivery time to be specified. The rate necessary to deliver the required volume within the specified time is calculated and displayed. 1. Ensure the pump is on hold. Press the d button to access the options menu. 2. Select the SET VTBD OVER TIME option using the f keys and press the OK softkey. 3. Adjust the volume to be delivered using the f keys. When the desired volume has been reached press the OK softkey. 4. Enter the time over which the volume is to be delivered. The delivery rate will automatically be calculated. Press the OK softkey to enter the value. 5. Select the rate at VTBD end from the list using the f keys and press the OK softkey. The default is STOP.

24 Hour Log This option allows the 24 hour log of volume delivered 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 delivered. The volume delivered shown in brackets is the total volume delivered 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.

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Alaris™ Enteral Plus Syringe Pump MK4 Basic Features

Event Log This option allows the event log to be reviewed. 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 option using the f keys and press the OK softkey. 3. Review the information and then press the QUIT softkey.

A

The data set for the Alaris Enteral Plus Syringe Pump is factory set and can not be configured.

Pump Details To review Alaris Enteral Plus Syringe Pump information. 1. Press the d button to access the options menu. 2. Select PUMP DETAILS option using the f keys and press the OK softkey. 3. Review the information and then press the QUIT softkey. Note: The following information will be displayed: • SN • S/W

The serial number of the Alaris Enteral Plus Syringe Pump Software version of the Alaris Enteral Plus Syringe Pump

Adjust Alarm Volume To change the alarm volume. 1. Press the d button to access the options menu. 2. Select ADJUST ALARM VOLUME option using the f keys and press the OK softkey. Note: The Alaris Enteral Plus Syringe Pump will beep at the selected alarm volume setting. The user must assess whether the alarm volume setting is loud enough for the intended operating environment, and adjust appropriately. 3. Select alarm volume required and press the OK softkey.

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.

A

The interpretation of the pressure readings and occlusion alarms are the responsibility of the clinician and should include the clinical context in which the Alaris Enteral Plus Syringe Pump is being used.

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Alaris™ Enteral Plus Syringe Pump MK4 Alarms and Warnings

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 2 minutes, then check the display for an alarm message. Press CANCEL to cancel the alarm message. 2. If the delivery has stopped, rectify the cause of the alarm then press the b button to resume feeding.

A

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

A

Delivery will stop for all high priority alarms.

Display

Alarm Priority

Description and Troubleshooting Guide

DRIVE DISENGAGED

High

The drive system has been disengaged during operation. Check the finger grips and the position of the syringe.

OCCLUSION

High

Excessive pressure measured at the syringe plunger exceeding the alarm limit. Identify and remove the cause of the blockage in the drive, syringe, or administration system before restarting delivery.

CHECK SYRINGE

High

Incorrect size of syringe has been fitted, the syringe has not been positioned correctly or has been disturbed during operation. Check the syringe location and the position.

BATTERY LOW

Medium

Battery charge low with 30 minutes operation remaining. Reconnect to the AC power supply to charge the internal battery and continue operation. If action is not taken the battery indicator will flash for 30 minutes followed by a continuous audible alarm, red alarm indicator and message BATTERY EMPTY displayed, indicating that the battery is too low to operate the Alaris Enteral Plus Syringe Pump. *Optional reminder signals may sound. These auditory signals have four beeps that occur every ten minutes once the Low Battery alarm has been cancelled

BATTERY EMPTY

High

The internal battery is too low to operate the Alaris Enteral Plus Syringe Pump. Immediately connect the Alaris Enteral Plus Syringe Pump to the AC power supply and cycle the power to resume operation.

NEAR END OF DELIVERY

Low

The Alaris Enteral Plus Syringe Pump is nearing the end of the delivery. *Optional reminder signals may sound. These auditory signals have four beeps that occur every ten minutes once the Near End Of Delivery alarm has been cancelled.

END OF DELIVERY

High

The Alaris Enteral Plus Syringe Pump has reached the end of the delivery and the Alaris Enteral Plus Syringe Pump has stopped delivering. A pre-set volume will remain in the syringe.

VTBD DONE

High

The pre-set Volume To Be Delivered is complete and the Alaris Enteral Plus Syringe Pump has stopped delivering.

Medium

The pre-set Volume To Be Delivered is complete and the Alaris Enteral Plus Syringe Pump continues to deliver at set rate or at KTO rate.

Low

AC Power has been disconnected and the Alaris Enteral Plus Syringe Pump is operating on battery power. If this occurs when the Alaris Enteral Plus Syringe Pump is operating the message DELIVERY 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.

(STOP) VTBD DONE (KVO/CONTINUE) AC POWER FAIL

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