598 Volumetric Pump Directions for Use Issue 2

Directions for Use

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File Name: 598_volumetric_pump_directions_for_use_issue_2.pdf

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Page 1

IVAC®598 Volumetric

Pump

Directions For Use

Page 2

IVAC® 598 Volumetric Pump

Contents

Page

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

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

Features of the Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Symbol Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Loading an Infusion Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Starting the Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Basic Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Alarms and Display Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Flow Sensor Operation (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

CareFusion Dedicated Infusion Sets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Trumpet and Flow Rate Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Service Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Document History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

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Page 3

IVAC® 598 Volumetric Pump

Introduction

This Directions For Use applies to the IVAC® 598 Volumetric Pump.

The IVAC® 598 Volumetric Pump (hereinafter referred to as Pump) is a small lightweight volumetric infusion pump that provides accurate

and reliable infusions over a range of rates.

The IVAC® 598 Volumetric Pump automatically regulates the infusion rate of intravenous solutions. The microprocessor-based pump

uses a linear peristaltic, volume displacement mechanism to regulate fluid flow at the desired rate. The pump's many features include:

•

Easy setup and operation:

Advisory prompts to assist in setup and operation.

Quick start mode.

Diagnostic alarm messages to simplify operation and troubleshooting.

Easy viewing of rate and Volume To Be Infused (VTBI) settings.

Wide range of infusion rates: 1 to 999 ml/h in 1 ml/h increments.

Volumetric rate entry.

Volume To Be Infused capability with automatic switchover to the Keep Vein Open (KVO) rate.

Integral ultrasonic air in line detection.

Detection of upstream/downstream occlusions.

Low occlusion pressures (nominal 6 to 8 psi).

Lightweight and portable with self-contained rechargeable battery.

Automatic flow shutoff with activation of audible and visible alarms.

Audible and visible low battery alert about one hour before battery alarm.

Optional flow sensor (Model 192).

Optional remote computer monitoring capability.

Intended Purpose

The IVAC® 598 infusion pump is intended for use by medical staff for purposes of controlling infusion rate and volume.

Conditions of Use

The Pump should only be operated by a clinician competent in use of automated infusion pumps and post-placement management of

intravenous catheters. Only CareFusion dedicated infusion sets should be used.

Indications

The IVAC® 598 infusion pump is indicated for infusion of therapeutics including:

•

analgesics

antimicrobials

blood products

chemotherapy

nutrition

Contraindications

The IVAC® 598 Infusion Pump is contraindicated for enteral feeding, extracorporeal circulation of blood and for diagnostic uses

including:

•

angiography

urodynamics

cavernosometry

cavernosongraphy

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Page 4

IVAC® 598 Volumetric Pump

About This Manual

Users are advised to read, to understand this manual and to be thoroughly familiar with the Pump 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 Pump. These

settings and values are for illustrative use only. The complete range of infusion rates, settings and values are shown in the 'Specifications'

section.

Conventions used in this manual

BOLD

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

example, AC Power Indicator, HOLD, ON/OFF switch.

'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.

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 Pump.

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Page 5

IVAC® 598 Volumetric Pump

Features of the Pump

Main Display

Display

Indicators

VTBI

VOL

KVO

RATE

ml/hr

CLEAR

VOL

Keyboard

READ

VOL

Door

VOL

TO BE

INF

RUN/

HOLD

CAM Follower

Assembly

ON /

OFF

CAM Follower

Assembly Latch

AC power

Indicator

Air-In-Line

Sensor

Model 598

Vo l u m e t r i c P u m p

Pole Clamp

PE Connector

Test Connector Cover

AC Power

Connector

Flow Sensor

Connector

Fuse Holders

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Page 6

IVAC® 598 Volumetric Pump

Controls and Indicators

Controls:

Symbol

Description

ON/OFF switch - Press once to switch the pump ON. Press and hold down for approximately 3 seconds

to switch the pump OFF.

RUN/HOLD switch - Starts and stops pump infusions. Silences/cancels alarms.

VOLUME TO BE INFUSED switch - Sets value of Volume To Be Infused (VTBI).

CLEAR VOLUME switch - Resets volume infused value to zero.

READ VOLUME switch - Displays volume infused value.

CHEVRON switches - Double chevrons/single chevrons for faster/slower increase or decrease of infusion

rate and volume values.

Indicators:

Symbol

Description

AC POWER indicator - When illuminated the pump is connected to an AC power supply and the battery

is being charged.

VTBI

The value displayed is the Volume To Be Infused.

KVO

The pump is infusing at the Keep Vein Open rate of 5ml/h (or current rate, whichever is less).

VOL

The value displayed is the volume infused.

RATE

The value displayed is the current infusion rate.

(Millilitres) The value displayed is the Volume To Be Infused or volume infused value.

ml/hr

(Millilitres / hour) The value displayed is the infusion rate.

Infusion indicator. Three horizontal bars in the left-hand display position flash sequentially when the

pump is infusing.

Infusion indicator with Flow Sensor in use. Upper two horizontal bars convert to a square when a drop is

detected by the flow sensor in the drip chamber.

Flashing Display

When the pump is operating on battery power, the Display flashes on/off.

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Page 7

IVAC® 598 Volumetric Pump

Symbol Definitions

Labelling Symbols:

Symbol

IPX1

EC REP

Description

Attention (Consult accompanying documents)

Potential Equalisation (PE) Connector

Type CF applied part. (Degree of protection against electrical shock)

Protected against vertically falling drops of water

Alternating Current

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

Date of Manufacture

Manufacturer

Not for Municipal Waste

Fuse Rating

Authorised Representative in the European Community

1000DF00645 Issue 2

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Page 8

IVAC® 598 Volumetric Pump

Operating Precautions

Disposable Infusion Sets

To ensure correct and accurate operation, only use CareFusion dedicated infusion sets described in this

Directions For Use.

It is recommended that infusion sets are changed according to the instructions in the 'Changing the Infusion

Set' section. Carefully read the Directions For Use supplied with the infusion set prior to use.

Use of non-specified infusion sets may impair the operation of the pump and the accuracy of the infusion.

When combining several apparatus and/or instruments with infusion sets and other tubing, for example via

a 3-way tap or multiple infusion, the performance of the pump may be affected and should be monitored

closely.

Uncontrolled flow may result if the infusion set is not properly isolated from the patient i.e. closing a tap in

the set or activating an in-line clamp / roller clamp.

The infusion set may be fitted with an in-line clamp, which can be used to occlude tubing in case it is required

to stop fluid flow.

The IVAC® 598 Volumetric Pump is a positive pressure pump, which should use infusion sets fitted with luer

lock fittings or equivalent locking connectors.

To infuse from a burette, close the roller clamp above the burette and open the clamp on the vent on top of

the burette.

Discard infusion set if the packaging is not intact or the protector cap is detached. Ensure sets are not kinked

as this may occlude the tubing.

Using Collapsible Bags, Glass Bottles and Semi Rigid Containers

It is recommended that the air vent be opened on the IVAC® 598 Volumetric Pump set if using glass bottles

or semi-rigid containers, to reduce the partial vacuum formed as the fluid is infused from the container.

This action will ensure the pump can maintain volumetric accuracy whilst the container empties. The action

of opening the air vent for semi-rigid containers should take place after the spiking of the container and

priming of the drip chamber.

Steps for the Collapsible bags

Steps for Semi-rigid containers

Follow steps 1 to 3 as shown for

the semi-rigid containers, however

do not open vent as in step 4, but

prime the set as per step 5. Ensure

the bag outlet is fully pierced

before filling the drip chamber.

Spike the

container

Fill drip

chamber to

fill line

Open the air vent

to allow pressure

equalisation - ready

for infusion

Prime the set by

opening / closing the

roller clamp

Close the roller

clamp

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 fluid channels of 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 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 CareFusion for further information). Mains power quality should

be that of a typical commercial or hospital environment.

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

The pumping pressure alarm system is not designed to provide protection against, or detection of,

extravasation or tissuing 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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Page 9

IVAC® 598 Volumetric Pump

Operating Precautions

Hazards

An explosion hazard exists if the Pump is used in the presence of flammable anaesthetics. Exercise care to

locate the Pump away from any such hazardous sources.

Dangerous Voltage: An electrical shock hazard exists if the Pump’s casing is opened or removed. Refer all

servicing to qualified service personnel.

The IVAC® 598 Volumetric Pump is a Class I device, therefore must be earthed when connected to an AC

power supply.

The Pump also has an internal power source.

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.

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 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.

Electromagnetic Compatibility and Interference

The Pump is protected against the effects of external interference, including high energy radio frequency

emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and

cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to remain safe

when abnormally high 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 CareFusion

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. If use of the Pump within an MRI environment is unavoidable, then CareFusion

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 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.

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 CareFusion 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, the Pump emits a certain level of electromagnetic radiation which is

within the levels specified by IEC/EN60601-1-2. 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.

1000DF00645 Issue 2

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Page 10

IVAC® 598 Volumetric Pump

Getting Started

Initial Set-up

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

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

supply.

2. Items supplied are:

• IVAC® 598 Volumetric Pump

• User Support CD (Directions For Use)

• AC Power Cable (as requested)

• Protective Packaging

3. Connect the Pump to the AC power supply for at least 6 hours to ensure that the internal battery is charged (verify that the AC Mains

indicator is lit).

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 a

qualified service engineer for investigation.

Pole Clamp Installation

A pole clamp is fitted to the rear of the pump and will provide secure

fixing to vertical I.V. poles of a diameter between 12 and 26 mm.

Pole Clamp

1. 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.

Never mount the pump such that the infusion stand

becomes top heavy or unstable.

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Page 11

IVAC® 598 Volumetric Pump

Loading an Infusion Set

Ensure the appropriate infusion set for the fluid/drug to be infused has been selected.

Follow the instructions supplied with the individual infusion set.

Only use IVAC® 598 Volumetric Pump infusion sets, (Refer to 'Infusion Sets' section of the DFU)

Position the fluid container to avoid spillage onto the pump.

Ensure that the tubing is inserted completely into the top set retainer through to the tubing guide avoiding any

slack.

1. Prime the IV infusion set slowly and close the roller clamp.

2. Open the door.

Top set retainer

3. Load the primed IV infusion set:

• Open the latch

• Load the upper tubing segment into the top set retainer

• Insert lower tubing segment into the Air-In-Line Sensor

• Close the latch, ensuring the set is enclosed

4. Close the door.

5. Open the roller clamp. Ensure no fluid flows.

Primed IV

Infusion Set

Latch

(shown open)

Air-In-Line Sensor

Lower Tubing

Segment

1000DF00645 Issue 2

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Page 12

IVAC® 598 Volumetric Pump

Starting the Infusion

Prime and load the set (refer to 'Loading an Infusion Set')

1. Ensure the pump is connected to an AC power supply (also operates from battery).

2. Connect flow sensor, if required. (See 'Flow Sensor Operation')

3. Press the ON/OFF switch to power on the pump. The pump will power up and the rate and ml/hr indicators will light. The display will

show rate alternating with the rate value.

4. Use the chevron switches (I, J, L and K) to set or change the infusion rate.

5. To read the total infused volume press and hold the READ VOL switch. To clear the total infused volume, press and hold the

CLEAR VOL switch until the display reads 0000 (four zeros).

6. Press VOL TO BE INF if required. The VTBI and ml indicators will light. The display will alternate between VTBI and the current VTBI value.

When operating the pump without a flow sensor, a VTBI must be entered. This value is independent of any volume already infused. If the VTBI is

at 0000 and the RUN/HOLD switch is pressed, the prompt VTBI will be displayed. When operating the pump with a flow sensor, and a VTBI is not

desired, press the L switch until OFF is displayed.

7. Use the chevron switches (I, J, L and K) to set VTBI.

8. Connect the infusion set to the patient access device.

9. Press RUN/HOLD to start infusion. The run indicator will appear when the pump mechanism begins to operate.

Changing the Infusion Rate

1. Press the RUN/HOLD switch to place the pump on hold.

2. Adjust rate by using the chevron switches.

3. Restart the pump by pressing the RUN/HOLD switch.

Clearing Total Volume Infused

1. Press the RUN/HOLD switch to place the pump on hold.

2. Press and hold CLEAR VOL for 2 seconds, until display shows 0000.

3. Restart the pump by pressing the RUN/HOLD switch.

Changing the Volume To Be Infused

Press the RUN/HOLD switch to place the pump on hold.

Press the VOL TO BE INF switch.

Set new volume by pressing the chevron switches. OFF can also be selected when a flow sensor is in use, see Notes below.

Restart the pump by pressing the RUN/HOLD switch.

Notes:

• Without a flow sensor in use, a VTBI value must be entered, otherwise, the pump displays VTBI when the pump is restarted.

• With a flow sensor in use, a VTBI value isn't required and OFF can be selected if required.

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Page 13

IVAC® 598 Volumetric Pump

Basic Features

KVO (Keep Vein Open) Rate

When using a flow sensor and the solution container empties, the pump will alarm and FLO will be displayed.

When not using a flow sensor and the pump has counted down to zero from the preset volume-to-be-infused value, it automatically

switches to a 5 ml/h KVO rate, (or current rate, whichever is less), lights the KVO indicator, and produces two audible beeps every 5

seconds.

1. To exit the KVO mode, press the RUN/HOLD switch to place the pump on hold.

2. Press the VTBI switch. Set the VTBI to a value greater than zero.

3. Press RUN/HOLD to continue pump operation.

Changing the Infusion Set

Press RUN/HOLD switch to place the pump on hold.

Close in-line clamp and ensure the access to the patient is isolated.

Disconnect the infusion set from the patient.

Open pump door and remove infusion set from the pump and discard the set and fluid container according to hospital protocol.

Prepare the new infusion set, load infusion set into pump and close the door, see 'Loading the Infusion Set'.

Restart infusion, see 'Starting the Infusion'.

When changing the infusion set or the fluid container use aseptic technique according to hospital protocol.

It is recommended that infusion sets are changed in accordance with the Directions For Use.

Carefully read the Directions For Use supplied with the infusion set prior to use.

The set change interval is 24 hours.

Changing the Fluid Container

Press RUN/HOLD switch to place the pump on hold.

Remove bag spike on infusion set from empty / used container. Discard empty / used container according to hospital protocol.

Insert spike into new container.

Squeeze the drip chamber approximately half full or up to fill line (if the drip chamber is marked) with fluid.

Restart infusion, see 'Starting the Infusion'.

When changing the infusion set or the fluid container use aseptic technique according to hospital protocol.

It is recommended that infusion sets are changed in accordance with the Directions For Use.

Carefully read the Directions For Use supplied with the infusion set prior to use.

1000DF00645 Issue 2

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Page 14

IVAC® 598 Volumetric Pump

Basic Features

SmartSite® Needle-Free System Instructions

SmartSite® Needle-Free Valve is designed to permit safe gravity flow and automated flow, injection and aspiration of fluids without the

use of needles by utilising luer lock and luer slip connectors.

Precautions:

Discard if packaging is not intact or protector caps are unattached.

If Needle-Free Valve is accessed by a needle in an emergency the valve will be damaged causing leakage. Replace

Needle-Free Valve immediately.

Needle-Free Valve contraindicated for blunt cannula system.

DO NOT leave slip luer syringes unattended.

DIRECTIONS - Use Aseptic Technique

1. Prior to every access, swab top of Needle-Free Valve port with 70% Isopropyl alcohol (1-2

seconds) and allow to dry (approximately 30 seconds).

NOTE: Dry time is dependent on temperature, humidity, ventilation of the area.

2. Prime valve port. If applicable, attach syringe to Needle-Free Valve port and aspirate

minuscule air bubbles.

3. When used with administration sets always refer to individual set directions for use as

change interval may vary according to clinical application (e.g. infusions of blood, blood

products, and lipid emulsions).

NOTE: During use of Needle-Free Valve port, fluid may be observed between the housing

and blue piston. This fluid does not enter the fluid path and requires no action.

NOTE: For product questions or needle-free valve educational materials, contact your

CareFusion representative. Consult facility protocols. Consult other organizations

that publish guidelines useful in developing facility protocols.

1000DF00645 Issue 2

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Page 15

IVAC® 598 Volumetric Pump

Alarms and Display Messages

If the pump sounds an alarm, note the alarm message and press the RUN/HOLD switch to place the pump on hold and silence the alarm.

Use the following guide to eliminate the cause of the alarm.

After correcting the condition, press the RUN/HOLD switch again to restart the infusion.

Displays Flashing Message with Audible Alarm

Display

Cause

Action

FLO

Upstream Occlusion

Check the tubing, clamp and container for probable causes and

correct. (Repeated alarms may indicate pump mechanism requires

cleaning. Refer to the 'Cleaning and Storage' section of this DFU.)

FLO.1

Too few or no drops

The flow sensor has detected no or insufficient flow. Check tubing,

clamp, container and flow sensor for probable causes and correct.

FLO.2

Drip chamber problem.

Abnormal drops detected. Drip chamber fogged or overfilled. Shake

drip chamber to clear sidewalls; reduce fluid level in drip chamber. Plug

flow sensor into connector on rear of instrument.

FLO.3

Too many drops.

Flow sensor disconnected while pump in

operation.

Possible faulty flow sensor.

Flow detected in excess of the set rate. Flow detected while the pump is on

hold or in the start up mode.

Check that the set tubing is completely installed in the mechanism, that the

mechanism pinches off the tubing and that the drip chamber is not swinging

excessively or overfilled.

OCCL

Downstream occlusion.

Check for kinked tubing, clogged filter. (Repeated alarms may indicate

pump mechanism requires cleaning. Refer to the 'Cleaning and

Storage' section of this DFU.)

rELOAd

Set adapter improperly loaded into air

detector.

Reload adapter into air detector. Press firmly until flush.

rELOAd

- - - - Air

Air detector senses air in tubing,

Ensure air detector is clean. Reload set adapter into air detector. Press

firmly until flush.

Air

Air detector senses air in tubing or set

adapter dislodged from air detector.

Remove air according to hospital protocol. Ensure air detector is clean.

Door

Door opened during infusion or upon

entering run mode.

Check set for proper installation. Close door and re-start pump.

BATT

Battery has insufficient charge to

operate pump

Plug power cord into an AC outlet. Pump will be operable immediately.

HoLD

Two minutes have elapsed since pump

Press RUN/HOLD switch once to silence alarm, and again to restart pump.

was placed on hold or into start-up mode,

or a switch may be stuck. If the pump is in

start-up mode and on battery power, it will

automatically power-off if left in this alarm

for 3 minutes.

KVO005

Pump is in KVO mode.

Set the VTBI value to a non-zero value.

ERR (followed by a

Possible pump malfunction.

Cycle power off, then on. If problem persists, do not use pump. Contact

qualified service personnel.

ERR n

Pump mechanism requires cleaning.

Refer to the 'Cleaning and Storage' section of this DFU.

- or Set adapter improperly loaded into air

detector.

or less

(two beeps)

letter or number)

Momentary display Pump has automatically shut off due

that disappears

to low battery charge.

shortly after

power-up.

1000DF00645 Issue 2

Plug the power cord into an AC outlet. The pump will be operable after

several seconds.

14/26

Page 16

IVAC® 598 Volumetric Pump

Alarms and Display Messages

Alternating Messages

Display

Cause

Action

bat.

Battery charge low with

approximately 1 hour of operation

remaining.

Plug the power cord into an AC outlet.

Pump has been placed on hold. This

is not an alarm condition.

Press RUN/HOLD switch once to restart infusion.

Rate (alternating with

Pump is in rate setting mode. This is

not an alarm condition.

Press RUN/HOLD or VOL TO BE INF switch to advance to VTBI

setting mode.

VtBI (alternating with

Pump is in VTBI setting mode. This is not

an alarm condition.

Press RUN/HOLD switch once to start infusion.

Display

Cause

Action

set vtbi

VTBI value is at zero.

Set the VTBI value to a non-zero value or operate the pump with a

flow sensor and set VTBI to OFF.

Set rate

Rate set to zero.

Enter a non-zero rate.

(alternating with rate

display, pump continues

to run)

HOLD

(alternating with rate

value)

rate value)

VTBI value)

Prompts

1000DF00645 Issue 2

15/26

Page 17

IVAC® 598 Volumetric Pump

Flow Sensor Operation (Optional)

The flow sensor automatically detects drops falling in the drip chamber. The flow sensor will cause the pump to

alarm if a significant deviation from the infusion rate occurs. The flow sensor will also be able to detect empty

containers. For this reason we recommend use of a flow sensor wherever possible.

IVAC® Flow Sensor Model 192

Pull back handles

Handles

Flanges

Drip chamber

1. Plug the flow sensor into the flow sensor interface located on the top rear part of the pump.

2. Attach the IVAC® Flow Sensor Model 192 to the drip chamber of the infusion set, by pulling back the handles. Refer to the illustration

above.

3. Proceed with load, priming, and set-up instructions as described in section 'Getting Started'.

NOTE: Ensure drip chamber is half full and upright.

Always attach the flow sensor before you start an infusion .

Avoid using the flow sensor in direct sunlight.

Always ensure lens is clean.

1000DF00645 Issue 2

16/26

Page 18

IVAC® 598 Volumetric Pump

Specifications

Electrical Protection

Class I, Type CF.

Electrical/Mechanical Safety

Complies with IEC/EN60601-1 and IEC/EN60601-2-24.

Electro Magnetic Compatibility (EMC)

Complies with IEC/EN60601-1-2 and IEC/EN60601-2-24.

Electrical Safety

IEC/EN60601-1;

Earth Leakage Current (Normal Condition) Maximum 100µA rms (ungrounded) at 220V rms.

Classification

Continuous mode of operation, Portable Equipment.

AC Power Supply 220 to 240V AC; 50/60 Hz; 0.07A; 3-wire grounded system.

Fuse Type 2 X T63 mA 250V.

Dimensions 133mm (w) x 193mm (h) x 184mm (d). Weight: approx. 2.7kg (excluding power cable).

Protection against fluid ingress IPX1 - Protected against vertically falling drops of water.

Environmental Specifications

Condition

Operating

Transport and Storage

Temperature

+10°C to +40°C

-40°C to +70°C

Humidity

30% to 75% non-condensing

0% to 100%

Atmospheric Pressure

700hPa - 1060 hPa

500hPa - 1060hPa

System Accuracy:

±5% under specified conditions.

Note: Accuracy specified under the following conditions:

Head height: 30"/76.2cm.

Test solution: distilled water.

Environmental: ambient temperature.

Back pressure: 20 gauge needle.

Infusion Set: Model 59073 (59073 has been superseded by G59073, which is identical to the previous infusion set).

Use of high viscosity liquids or non CareFusion branded sets may adversely affect accuracy

Starting the Infusion / Set-up

Infusion Parameter

Range

Infusion Rate

1 - 999ml/h in steps of 1ml/h

VTBI

(0 - OFF), 1 - 9999ml in 1ml increments

VI (Total)

0 - 9999ml

KVO rate

5 ml/h or current set rate if less than 5 ml/h in primary operation

Battery Specifications

Rechargeable Sealed Lead Acid. Automatically charges when the pump is connected to AC power.

Battery Life - 6 hours @ 125ml/h.

Battery Charging - 24 hours.

Alarm Conditions

Alarm conditions cause the pump to display specific alarm messages, sound an audible alarm, and except for the low battery and KVO

mode alerts, cease operation. Alarm and display messages include: FLO, door, hold, bat., batt., OCCL, RELOAD, Air and Err.

(See the 'Alarms and Display Messages' section of this DFU for message descriptions.).

1000DF00645 Issue 2

17/26

Page 19

IVAC® 598 Volumetric Pump

Specifications

Memory Retention

At 25°C, the electronic memory of the pump will be retained for a minimum of 6 months when not powered up.

Air Sensor

Integral Ultrasonic Sensor.

Maximum time for activation of occlusion alarm

Time to alarm at 1ml/h is nominally 35 minutes.

Time to alarm at 100ml/h is nominally 0.31 minutes.

Air in Line Accuracy

100 µl ±50 µl.

Maximum Occlusion Alarm Pressure:

775 mmHg; Nominal: 310 mmHg to 413 mmHg.

Post Occlusion Bolus:

Bolus volume generated at 1 ml/h when the occlusion alarm threshold is reached 0 5 ml.

Bolus volume generated at 100 ml/h when the occlusion alarm threshold is reached <0.5 ml.

Critical Volume

25 ml at 999 ml/h is maximum incremental volume which can occur in case of single point failure.

1000DF00645 Issue 2

18/26

Page 20

IVAC® 598 Volumetric Pump

Maintenance

Routine Maintenance Procedures

To ensure that this pump remains in good operating condition, it is important to keep it clean and carry out the routine maintenance

procedures described below. All servicing should only be performed by a qualified service engineer with reference to the Technical

Service Manual (TSM).

Circuit diagrams and components parts lists and all other servicing information which will assist the qualified service engineer in

performing repair of the parts designated as repairable are available upon request from CareFusion.

Refer to the Technical Service Manual for the access code for technical service.

Interval

Routine Maintenance Procedure

As per Hospital Policy

Thoroughly clean external surfaces of the Pump before and after prolonged period of

storage.

1. Inspect AC power supply plug and cable for damage.

2. Perform functional tests as outlined in the Technical Service Manual.

At least once per year

3. Operate the pump on battery power until the battery low alarm then charge the battery

(Refer to TSM for identification of parts) to confirm battery operation and charging.

4. Inspect mechanism for damage or excessive wear. Clean and lubricate the mechanism as

outlined in the Technical Service Manual.

If the pump is dropped, damaged, subjected to excessive moisture or high temperature, immediately take it out of

service for examination by a qualified service engineer.

All preventative and corrective maintenance and all such activities shall be performed at a compliant work place

in accordance with the information supplied. CareFusion will not be responsible should any of these actions

be performed outside the instructions or information supplied by CareFusion. For Preventative and Corrective

Maintenance instructions please refer to the Technical Service Manual (TSM).

All preventative and corrective maintenance and all such activities should be performed by a qualified service

engineer only, with reference to the TSM.

Please refer to Technical Service Manual for calibration procedures. The units of measurement used in the

calibration procedure are standard SI units (The International System of Units).

Battery Operation

The internal rechargeable battery allows continued operation when the AC power is unavailable, for example during patient transfer or

AC power failure. A fully charged battery will provide a minimum of 6 hours of operation at 125ml/h infusion rate. When connected to

the AC power supply for 24 hours, (whether the pump is in use or not) a battery pack will be fully charged.

The battery is maintenance free, sealed Lead Acid and requires no routine servicing. However, to achieve optimum operation, ensure

that the battery is fully recharged after full discharge, before storage, and at regular 3 month intervals during storage.

Charge retention will eventually degrade. Where retention is critical the internal battery should be replaced every 3 years.

It is recommended that only a qualified service engineer replaces the battery. For further information regarding the replacement of

batteries refer to the Technical Service Manual.

Disposal

Information on Disposal for Users of Waste Electrical & Electronic Equipment

This U symbol on the product and/or accompanying documents means that used electrical and electronic products should not be

mixed with household waste.

If you wish to discard electrical and electronic equipment, please contact your CareFusion affiliate office or distributor for further

information.

Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and

the environment which could otherwise arise from inappropriate waste handling.

Information on Disposal in Countries outside the European Union

This symbol is only valid in the European Union. The product should be disposed of taking environmental factors into consideration.

To ensure no risk or hazard, remove the internal rechargeable battery and the Nickel Metal Hydride battery from the control board and

dispose of as outlined by the local country regulations. All other components can be safely disposed of as per local regulations.

1000DF00645 Issue 2

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Page 21

IVAC® 598 Volumetric Pump

Maintenance

Cleaning and Storage

Before the transfer of the Pump to a new patient and periodically during the use, clean the Pump by wiping over with a lint-free cloth

lightly dampened with warm water and a standard disinfectant / detergent solution.

Do not use the following disinfectant types:

• Disinfectants which are known to be corrosive to metals must not be used, these include:

• NaDcc (such as Presept),

• Hypochlorites (such as Chlorasol),

• Aldehydes (such as Cidex),

• Cationic Surfactants (such as Benzalkonium Chloride).

• Use of Iodine (such as Betadine) will cause surface discoloration.

• Concentrated Isopropyl alcohol based cleaners will degrade plastic parts.

Recommended cleaners are:

Brand

Concentration

Hibiscrub

20% (v/v)

Virkon

1% (w/v)

The following products were tested and are acceptable for use on the Pump if used in accordance with the specified manufacturer’s

guidelines.

•

Warm soapy water

Mild detergent in water (e.g. Young’s Hospec)

70% Isopropyl Alcohol in water

Chlor-Clean

Clinell Sporicidal wipes

Hibiscrub

TriGene Advance

Tristel Fuse sachets

Tristel Trio wipes system

Tuffie 5 wipe

Virkon Disinfectant

Virusolve+ (Ready To Use)

Virusolve+ (Wipes)

Before cleaning always switch off and disconnect from the AC power supply. Never allow liquid to enter the casing

and avoid excess fluid build up on the Pump. Do not use aggressive cleaning agents as these may damage the

exterior surface of the Pump. Do not steam autoclave, ethylene oxide sterilise or immerse this Pump in any fluid.

If the Pump has visible cracks or damage to the case do not clean and immediately take out of service for

examination by a qualified service engineer.

The infusion set is a disposable single use item and should be discarded after use according to hospital protocol.

If the Pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged. Store in a clean, dry

atmosphere at room temperature and, if available, employ the original packaging for protection.

Once every 3 months during storage, carry out functional tests as described in the Technical Service Manual and ensure that the internal

battery is fully charged.

Cleaning the Flow Sensor: Before the transfer of the flow sensor to a new infusion set and periodically during use, clean the flow sensor by wiping over with a lintfree cloth lightly dampened with warm water and a standard disinfectant / detergent solution. Ensure the connector does not get wet.

Dry flow sensor before use.

To aid cleaning of flow sensors which have been heavily soiled, contaminated or if the handle operation is not free moving, then the flow

sensor may be immersed and soaked in clean soapy water (see A). The inside of the spring mechanism can be cleaned by activating it

whilst submerged in the water.

After cleaning, the sensor should be allowed to dry fully prior to use.

The plug of the flow sensor must not be immersed in water as damage will occur.

1000DF00645 Issue 2

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Page 22

IVAC® 598 Volumetric Pump

CareFusion Dedicated Infusion Sets

The IVAC® 598 Volumetric Pump uses standard, single-use, disposable infusion sets. The user is responsible for verifying the suitability of

a product used, if it is not recommended by CareFusion.

For availability please contact your local CareFusion representative because new sets are continuously being

developed for our customers.

It is recommended that infusion sets are changed according to the instructions in the 'Changing the Infusion Set'

section. Carefully read the Directions For Use supplied with the infusion set prior to use.

Standard infusion sets

G59033E

G59123E

G59027E

G59073

• 2 SmartSite® Needle-Free Valve Ports

• 3 SmartSite® Needle-Free Valve Ports

• No Filter

• 15 Micron Filter & 0.2 Micron In Line

Filter

• 15 Micron Filter & 1.2 Micron In Line Filter • No Filter

• Length: 260cm

G59093

G59103E

G59173E

G59273E

• 15 Micron Filter

• 2 SmartSite® Needle-Free Valve Ports

• 1 SmartSite® Needle-Free Valve Port

• 2 SmartSite® Needle-Free Valve Ports

• Length: 260cm

• 1 Burette (150ml)

• No Filter

• Length: 270cm

• Length: 260cm

G59293E

G59593

G59693E

G59793E

• 2 SmartSite® Needle-Free Valve Ports

• 15 Micron Filter

• 1 SmartSite® Needle-Free Valve Port

• 2 SmartSite® Needle-Free Valve Ports

• No Filter

• Length: 270cm

• 15 Micron Filter

• Length: 255cm

• Length: 265cm

• Length: 260cm

G59903

G59394

G59016

• 15 Micron Filter

• Length: 250cm

• Length: 270cm

• Length: 275cm

G59953

G59643

• 15 Micron Filter

• Low Sorbing Infusion Set

• Opaque white PVC Infusion Set

• Length: 260cm

• Length: 250cm

G59024

G59393E

G59893E

G59894

• 200 Micron Filter

• 2 SmartSite® Needle-Free Valve Ports

• 1 SmartSite® Needle-Free Valve Port

• 200 Micron Filter

• Length: 295cm

• 200 Micron Filter

• Length: 255cm

• Length: 270cm

• Length: 255cm

Blood Transfusion sets

G59980

G59895

• 200 Micron Filter

• Length: 250cm

• Length: 255cm

Please note these drawings are not to scale

1000DF00645 Issue 2

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Page 23

IVAC® 598 Volumetric Pump

Trumpet and Flow Rate Curves

In this pump, as with all infusion systems, the action of the pumping mechanism and variations cause short-term fluctuations in rate

accuracy.

The following curves show typical performance of the system in two ways: 1) the accuracy of fluid delivery over various time periods is

measured (trumpet curves), and 2) the delay in onset of fluid flow when infusion commences (start-up curves).

Trumpet curves are named for their characteristic shape. They display discrete data averaged over particular time periods or

'observation windows', not continuous data versus operating time. Over long observation windows, short term fluctuations have little

effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short term fluctuations have

greater effects as represented by the "mouth" of the trumpet.

Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short

term fluctuations in rate accuracy may have clinical impact depending on the half-life of the drug being infused and the degree of inter

vascular integration, the clinical effect cannot be determined from the trumpet curves alone.

The start-up curves represent continuous flow versus operating time for two hours from the start of the infusion. They exhibit the delay

in onset of delivery due to mechanical compliance and provide a visual representation of uniformity. Trumpet curves are derived from

the second hour of this data. Tests performed per IEC/EN60601-2-24 standard.

Start-up Graph at 1.0ml/h (24 hour)

2.0

1.8

1.6

Flow Rate (ml/h)

Start-up Graph at 1.0ml/h (Initial Period)

2.0

1.4

1.2

1.0

0.8

0.6

0.4

0.2

1.4

1.2

1.0

0.8

0.6

0.4

0.2

0.0

100

120

1320

30.0

25.0

20.0

15.0

10.0

5.0

0.0

-5.0

-10.0

-15.0

-20.0

-25.0

-30.0

1360

1380

1400

1420

1440

20.0

15.0

10.0

5.0

0.0

-5.0

-10.0

-15.0

-20.0

-25.0

-30.0

Observation Window (Minutes)

D Minimum Rate Error G Maximum Rate Error A Overall Mean Error

Observation Window (Minutes)

D Minimum Rate Error G Maximum Rate Error A Overall Mean Error

Start-up Graph at 100ml/h (Initial Period)

Start-up Graph at 100ml/h (24 hour)

100.0

Flow Rate (ml/h)

100.0

Flow Rate (ml/h)

1340

Time (minutes)

Trumpet Graph at 1.0ml/h (24 Hour)

Flow Rate Error (%)

Time (minutes)

Trumpet Graph at 1.0ml/h (Initial Period)

80.0

60.0

40.0

20.0

0.0

80.0

60.0

40.0

20.0

0.0

100

120

Time (minutes)

1000DF00645 Issue 2

Time (minutes)

22/26

100

120

Page 24

IVAC® 598 Volumetric Pump

Trumpet and Flow Rate Curves

Trumpet Graph at 100ml/h (Initial Period)

Trumpet Graph at 100ml/h (24 Hour)

10.0

Flow Rate Error (%)

10.0

5.0

0.0

-5.0

-10.0

5.0

0.0

-5.0

-10.0

Observation Window (Minutes)

D Minimum Rate Error G Maximum Rate Error A Overall Mean Error

Start-up Graph at 999ml/h (Initial Period)

Start-up Graph at 999ml/h (24 hour)

0.8

Flow Rate (ll/h)

Flow Rate (l/h)

D Minimum Rate Error G Maximum Rate Error A Overall Mean Error

0.6

0.4

0.2

0.6

0.4

0.2

100

120

-2

-4

-6

D Minimum Rate Error G Maximum Rate Error A Overall Mean Error

120

-6

Observation Window (Minutes)

D Minimum Rate Error G Maximum Rate Error A Overall Mean Error

Note: The typical flow rate and trumpet curves are achieved using a recommended infusion set.

1000DF00645 Issue 2

100

-4

-8

-2

-10

Observation Window (Minutes)

-10

-8

Time (minutes)

Trumpet Graph at 999ml/h (24 Hour)

Flow Rate Error (%)

Time (minutes)

Trumpet Graph at 999ml/h (Initial Period)

23/26

Page 25

IVAC® 598 Volumetric Pump

Spare Parts

A comprehensive list of spare parts for this pump is included within the Technical Service Manual.

The Technical Service Manual (1000SM00016) is available in electronic format on the World Wide Web at :http://www.carefusion.com/alaris-intl/

A username and password are required to access our manuals. Please contact a local customer services representative to obtain login

details.

1000DF00645 Issue 2

24/26

IVAC Corporation

Infusion Pumps

598 Volumetric Pump Directions for Use Issue 2

IVAC Corporation

Infusion Pumps

598 Volumetric Pump Directions for Use Issue 2

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