598_volumetric_pump_directions_for_use_issue_2.pdf
Page 1
IVAC®598 Volumetric
Pump
s
Directions For Use
en
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
1000DF00645 Issue 2
1/26
Page 3
IVAC® 598 Volumetric Pump
Introduction
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
1000DF00645 Issue 2
2/26
Page 4
IVAC® 598 Volumetric Pump
About This Manual
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.
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 Pump.
1000DF00645 Issue 2
3/26
Page 5
IVAC® 598 Volumetric Pump
Features of the Pump
Features of the Pump
Main Display
Display
Indicators
VTBI
VOL
ml
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
1000DF00645 Issue 2
4/26
Page 6
IVAC® 598 Volumetric Pump
Controls and Indicators
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.
ml
(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.
1000DF00645 Issue 2
5/26
Page 7
IVAC® 598 Volumetric Pump
Symbol Definitions
Symbol Definitions
Labelling Symbols:
Symbol
w
x
k
IPX1
r
s
T
t
U
W
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
6/26
Page 8
IVAC® 598 Volumetric Pump
Operating Precautions
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.
2.
Spike the
container
3.
4.
Fill drip
chamber to
fill line
Open the air vent
to allow pressure
equalisation - ready
for infusion
5.
Prime the set by
opening / closing the
roller clamp
1.
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.
1000DF00645 Issue 2
7/26
Page 9
IVAC® 598 Volumetric Pump
Operating Precautions
Hazards
B
A
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.
d
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
M
The Pump is protected against the effects of external interference, including high energy radio frequency
emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and
cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to remain safe
when 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
8/26
Page 10
IVAC® 598 Volumetric Pump
Getting Started
Getting Started
Initial Set-up
A
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).
A
A
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.
A
Never mount the pump such that the infusion stand
becomes top heavy or unstable.
1000DF00645 Issue 2
9/26
Page 11
IVAC® 598 Volumetric Pump
Loading an Infusion Set
Loading an Infusion Set
A
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
10/26
Page 12
IVAC® 598 Volumetric Pump
Starting the Infusion
Starting the Infusion
A
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
1.
2.
3.
4.
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.
1000DF00645 Issue 2
11/26
Page 13
IVAC® 598 Volumetric Pump
Basic Features
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
1.
2.
3.
4.
5.
6.
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'.
A
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
1.
2.
3.
4.
5.
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'.
A
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
12/26
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.
A
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
13/26
Page 15
IVAC® 598 Volumetric Pump
Alarms and Display Messages
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)
Flow Sensor Operation (Optional)
A
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.
A
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
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).
A
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
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.
A
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.
A
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
19/26
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)
A
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.
A
The plug of the flow sensor must not be immersed in water as damage will occur.
1000DF00645 Issue 2
20/26
Page 22
IVAC® 598 Volumetric Pump
CareFusion Dedicated Infusion Sets
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.
A
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
• 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
• Length: 260cm
• 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
• No Filter
• Length: 270cm
• Length: 260cm
• 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
• 15 Micron Filter
• Length: 255cm
• Length: 255cm
• Length: 265cm
• Length: 260cm
G59903
G59394
G59016
• 15 Micron Filter
• 15 Micron Filter
• 15 Micron Filter
• Length: 250cm
• Length: 270cm
• Length: 275cm
G59953
G59643
• 15 Micron Filter
• 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
• 200 Micron Filter
• Length: 255cm
• Length: 270cm
• Length: 255cm
Blood Transfusion sets
G59980
G59895
• 200 Micron Filter
• 200 Micron Filter
• Length: 250cm
• Length: 255cm
Please note these drawings are not to scale
1000DF00645 Issue 2
21/26
Page 23
IVAC® 598 Volumetric Pump
Trumpet and Flow Rate Curves
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
1.8
1.6
1.6
Flow Rate (ml/h)
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
0.0
0
20
40
60
80
100
120
1320
30.0
30.0
25.0
25.0
20.0
15.0
10.0
5.0
0.0
A
A
A
A
-5.0
-10.0
-15.0
-20.0
-25.0
-30.0
2
7
12
17
22
27
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
32
Observation Window (Minutes)
D Minimum Rate Error G Maximum Rate Error A Overall Mean Error
2
7
12
17
22
27
32
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 (%)
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
0
20
40
60
80
100
120
0
20
Time (minutes)
1000DF00645 Issue 2
40
60
80
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 (%)
Flow Rate Error (%)
10.0
5.0
0.0
A
A
A
-5.0
-10.0
2
7
12
17
22
27
32
5.0
0.0
-5.0
-10.0
2
37
Observation Window (Minutes)
7
12
17
22
27
32
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)
1
1
0.8
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
0
0
0
20
40
60
80
100
120
0
10
10
8
8
6
6
4
2
0
-2
D
A
G
D
A
G
D
A
G
D
A
G
D
A
G
-4
-6
14
18
22
26
30
D Minimum Rate Error G Maximum Rate Error A Overall Mean Error
G
A
D
G
A
D
G
A
D
120
G
A
D
G
A
D
-6
2
6
10
14
18
22
26
Observation Window (Minutes)
30
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
10
80
0
-2
-10
Observation Window (Minutes)
60
2
-10
6
40
4
-8
2
20
Time (minutes)
Trumpet Graph at 999ml/h (24 Hour)
Flow Rate Error (%)
Flow Rate Error (%)
Time (minutes)
Trumpet Graph at 999ml/h (Initial Period)
23/26
Page 25
IVAC® 598 Volumetric Pump
Spare Parts
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