Graseby omnifuse User manual

Instruction
Manual
PCA Syringe Pump

Published by Graseby Medical Limited.
All possible care has been taken in the preparation of this publication, but
Graseby Medical Limited accepts no liability for any inaccuracies that may be
found.
Graseby Medical reserves the right to make changes without notice both to this
publication and to the product which it describes.
Copyright © 2004 Graseby Medical Limited
No part of this publication may be reproduced, transmitted, transcribed, or stored
in a retrieval system or translated into any human or computer language in any
form or by any means without the prior permission of Graseby Medical Limited.
GRASEBY MEDICAL LIMITED
Colonial Way,
Watford,
Hertfordshire,
United Kingdom,
WD24 4LG
Telephone: [phone]
Facsimile: [phone]
http://www.smiths-medical.com
Registered in England. Company number 995550
Trademarks and acknowledgements:
“Graseby”; “Smiths”; “omnifuse”; “omnistack”; and “Flo-Safer” are all
trademarks of the Smiths Group plc.
All other trademarks are acknowledged as the property of their respective owners.

Using this manual
Graseby Medical Ltd.
Omnifuse PCA Instruction Manual
Using this manual
This manual covers all aspects of using
the Omnifuse PCA pump:
Warnings and Cautions
This gives a list of Warnings and
Cautions which you must be aware of
before using the pump. These are
repeated on the relevant pages in the
manual.
Table of Contents
Use the table of contents to see the
structure of the manual and the
headings in the order in which they
appear.
Chapter 1, Introduction
This introduces the Omnifuse PCA
pump. It provides a high-level
description of the features of the pump.
Chapter 2, Basics
This chapter covers the external features
of the pump, and contains detailed
explanations of the techniques for using
the pump, for example, switching on,
loading or changing a syringe and
operating the patient handset. It also
covers the care and maintenance of the
pump.
Chapter 3, PCA Programming
This chapter describes how to program
the Omnifuse PCA pump. It explains
how to use the special pump features
designed for the PCA environment.
Chapter 4, Troubleshooting
This chapter gives you a list of the
warnings and alarms that may be
displayed by the Omnifuse, and tells you
how to handle them.
Specifications and Standards
This lists the specifications for the
Omnifuse PCA pump and the standards
with which it complies.
Index
At the end of the manual is an index
which provides an alphabetical list of key
words, and cross-references these to the
relevant pages in the manual.

Graseby Medical Ltd.
Omnifuse PCA Instruction Manual
Warnings/Cautions
Warnings/Cautions
Warnings
Warnings tell you about dangerous
conditions that could lead to death or
serious injury to the user or patient, that
can occur if you do not obey all of the
instructions in this manual.
1. WARNING: To avoid over- or under- infusion,
always verify that the brand and size of the
loaded syringe are the same as the brand and
size displayed onthe screen before starting an
infusion. Failure to do so may result in an
inaccurate delivery of medication, resulting in
patient injury or death.
2. WARNING: To avoid incorrect or inappropriate
configuration of the pump, the Configuration
menu must only be selected by qualified
persons or authorised personnel. Incorrect
pump configuration could lead to
inappropriate infusion resulting in patient
injury or death.
3. WARNING: This equipment is not suitable for
use in the presence of flammable anaesthetic
mixtures with air, oxygen, or nitrous oxide.
The use of the device in presence of such
mixtures may lead to explosion or fire.
4. WARNING: To avoid possible malfunction of
the pump, do not expose the pump to X- rays,
gamma rays or ionizing radiation, or to the RF
interference or strong electric/magnetic fields
emitted (for example) by diathermy equipment
or mobile telephones. If the pump is used in
the presence of, or in combination with
Magnetic Resonance Imaging (MRI) machines
it must be protected from the magnetic field
emitted by such equipment. Malfunction of the
pump can cause incorrect infusion or loss of
infusion resulting in patient injury or death.
5. WARNING: Operation of the pump outside the
temperature limits defined in the specification
may result in erroneous operation. Ensure that
the temperature is within the specified limits.
Failure to do so may result in patient injury or
death.
6. WARNING: In order to ensure that the
intended infusion is performed, data must be
entered correctly. Before confirming any
displayed data the user should ensure that it
is correct. Failure to do so may result in
compromised function of the product, patient
injury or death.
7. WARNING: Failure to follow the Maintenance
Procedures described in Chapter 2 of the
Omnifuse Service Manual may result in
compromised function of the product and lead
to patient injury or death.
8. WARNING: It is essential that clinical staff
remain within visual and audible range of the
pump so that they can respond promptly to
critical alarms. Failure to respond promptly to
an alarm may result in patient injury or death.
9. WARNING: The user should ensure that the
performance offered by the pump is fit for the
intended purpose. Failure to do so may result
in compromised function of the product,
patient injury or death.
10. WARNING: When the pump is carrying out an
infusion, to ensure that electrical safety is
maintained only items of equipment that
conform to EN60950 are to be connected to
the RS232 connector situated at the base of
the pump, otherwise patient safety may be
compromised.
11. WARNING: While Graseby Medical Limited
have taken all reasonable steps to ensure that
the pump operates correctly while under
remote control, it is the responsibility of the
person who designs and implements the
controlling device to ensure that the resulting
system (pump and controlling device) is fit for
its intended purpose. Failure to do so may
result in compromised function of the product,
patient injury or user injury.
12. WARNING: Do not use a faulty pump. If the
pump detects a fault, a continuous alarm will
sound and the screen will display a System
Fault message. If this happens, switch the
pump off, disconnect it from the mains and
take it to a suitably qualified engineer.
Incorrect performance of the pump can cause
complications resulting in patient injury or
death.
13. WARNING: Failure to use the mains lead
supplied with the pump will compromise the
pump’s ability to resist fluid ingress, resulting
in possible user or patient injury or death.
14. WARNING: Correct management of battery
charging is essential to ensure that the pump
can operate on batteries for the time specified.
Failure to do so may lead to impaired
functioning of the pump, resulting in patient
injury or death.
15. WARNING: The occlusion alarm level must be
checked before starting an infusion to ensure
that it is appropriate for that infusion. Failure
to do so may result in an unacceptably slow
time to occlusion alarm, resulting in patient
injury or death.

Warnings/Cautions
Graseby Medical Ltd.
Omnifuse PCA Instruction Manual
16. WARNING: If an occlusion alarm occurs,
immediately clamp the line to eliminate the
possibility of a bolus being delivered to the
patient. Then inspect the fluid pathway for
kinks, clogged catheter, etc. in order to
remove the occlusion prior to restarting the
infusion. An unintentional bolus of medication
can result in patient injury or death.
17. WARNING: Use only the syringes and
administration sets listed in Specifications
and Standards at the end of this manual.
Failure to do so may result in an inaccurate
delivery. Graseby Medical does not guarantee
performance of the pump if syringes other
than those listed are used. Incorrect function
or performance of the pump can cause
complications resulting in patient injury or
death.
18. WARNING: The volume of fluid contained in
the connecting tubing is a residual amount
and will not be infused. Allowance must be
made for this extra volume of fluid when
initially filling the syringe and purging the
system. Under-delivery of medication can
cause complications resulting in patient injury
or death.
19. WARNING: To avoid patient embolism, ensure
that the patient tubing is purged of all air
bubbles before administering any medication.
The pump provides a purge facility to assist
with this process. The presence of air within
the medication can result in complications
leading to patient injury or death.
20. WARNING: For safe operation of thepump, the
syringe must be correctly loaded. Ensure that
the syringe plunger is properly aligned before
closing the barrel clamp. Failure to do so may
result in inaccurate delivery, resulting in
patient injury or death.
21. WARNING: Ensure that your fingers are not in
the path of the pusher during syringe loading
or unloading. Failure to do so may result in
user injury.
22. WARNING: To avoid syphoning of the syringe
contents (free flow), ensure that the syringe is
correctly loaded into the pump, that the
syringe plunger is properly engaged by the
pump’s pusher block and that the pump is
placed not more than 80cm above the infusion
site. Syphoning can result in over-infusion
leading to patient injury or death.
23. WARNING: To avoid over-infusion, do not
purge the infusion line when the
administration set is connected to the patient.
Over-infusion of medication can result in
patient injury or death.
24. WARNING: To avoid the pump becoming
detached from an IV pole always make sure
that the pump is securely fixed to the pole.
Always check the security and stability of the
assembly with the pump mounted.
If no IV pole is used make sure that the pump
is completely stable on a horizontal surface.
Failure to observe this warning may cause
damage to the Omnifuse pump and harm the
user or the patient. As a result, the user or
patient may suffer direct injury, or the
Omnifuse pump may fail to operate correctly,
leading to patient injury or death.
25. WARNING: Following a significant liquid spill
onto the pump, it should be wiped dry and
inspected by service personnel before being
returned to service. Failure to do so may result
in compromised functioning of the pump,
leading to patient or user injury or death.
26. WARNING: To avoid syphoning of the syringe
contents (free flow), ensure that the patient
line is clamped before loading or unloading
the syringe. Syphoning can result in over-
infusion leading to patient injury or death.

Graseby Medical Ltd.
Omnifuse PCA Instruction Manual
Warnings/Cautions
Cautions
Cautions tell you about dangerous
conditions that may occur and cause
damage to the pump if you do not obey all
of the instructions in this manual.
1. CAUTION: Refer all service, repair and
calibrations only to qualified technical
personnel. Unauthorised modifications to the
pump must not be carried out.
2. CAUTION: When turning the pump on, if
screens similar to those illustrated are not
displayed do not use the pump, and send the
pump to authorised service personnel.
3. CAUTION: Do not attempt to move the pump’s
pusher by hand. Always use the syringe Load
key Wto move the pusher. Failure to observe
this caution may cause mechanical damage to
the pump.
4. CAUTION: Never carry the pump except by the
handle. Failure to do so may result in damage
to the case, or you may drop the pump and
cause it internal damage.
5. CAUTION: Do not use cleaning and
disinfecting agents other than the approved
ones specified here.
6. CAUTION: The pump must not be immersed in
any liquids or exposed to strong organic
solvents. Wipe off spills immediately, and do
not allow fluid or residues to remain on the
pump. Additionally, the pump is not designed
to be autoclaved, steam-sterilised, EtO-
sterilised or subjected to temperatures in
excess of 45°C (113° F). Failure to observe this
caution may cause serious damage to the
pump.
7. CAUTION: Users should bear in mind that the
syringe-ear clamp is for location only and may
not be powerful enough to hold the syringe in
place against the powerful negative back-
pressures that may be encountered in certain
clinical applications.
8. CAUTION: Failure to use the mains lead
retainer means that the pump may be
accidentally disconnected from the mains.

Contents
Graseby Medical Ltd.
Omnifuse PCA Instruction Manual i
Contents
Chapter 1 - Introduction
Introduction to the Omnifuse PCA .........................................................1 - 1
PC software options ................................................................................1 - 4
Omnistack pump stacking system .........................................................1 - 4
Chapter 2 - Basics
Parts of the Omnifuse PCA pump ..........................................................2 - 1
Rear of the pump ...........................................................................................2 - 1
Lockable cover ...............................................................................................2 - 1
Front of the pump ...........................................................................................2 - 2
PCA Handset ..................................................................................................2 - 3
The Command wheel, keypad and LEDs .......................................................2 - 4
Switching the pump on and off ...............................................................2 - 5
Switching on and power-up tests ....................................................................2 - 5
Switching off ...................................................................................................2 - 6
Using the pump on batteries ...........................................................................2 - 7
Recharging the batteries ................................................................................2 - 8
Omnifuse screen, icons and indicators .................................................2 - 9
Icons on the pump screen ..............................................................................2 - 9
Screen icons ...................................................................................................2 - 10
Pump indicators ..............................................................................................2 - 11
Sounds on the Omnifuse ................................................................................2 - 12
Setting the alarm volume ................................................................................2 - 12
Loading and unloading a syringe ...........................................................2 - 13
When to load the syringe ................................................................................2 - 13
Syringe brand and size ...................................................................................2 - 14
Replacing a syringe during an infusion ...........................................................2 - 14
Warnings and Cautions concerning syringes .................................................2 - 15
How to load a syringe .....................................................................................2 - 16
How to unload a syringe .................................................................................2 - 17
How to change the brand of syringe ...............................................................2 - 18
Care and Maintenance .............................................................................2 - 19
Carrying the pump ..........................................................................................2 - 19
Positioning the pump for use ..........................................................................2 - 19
Using the pole clamp ......................................................................................2 - 20

Graseby Medical Ltd.
ii Omnifuse PCA Instruction Manual
Contents
Locking pole clamp ........................................................................................ 2 - 20
Cleaning and care of the pump ...................................................................... 2 - 21
Removing and replacing the lockable cover .................................................. 2 - 22
Chapter 3 - PCA Programming
Programming the Omnifuse PCA ...........................................................3 - 1
Programming with protocols ........................................................................... 3 - 1
Programming without protocols ...................................................................... 3 - 1
Overview of how the pump works with a protocol ..........................................3 - 2
PCA infusion features .................................................................................... 3 - 3
Selecting a PCA protocol ............................................................................... 3 - 4
Reviewing settings and starting the infusion .................................................. 3 - 5
PCA Totaliser ............................................................................................3 - 6
How to view and reset the cumulative total ....................................................3 - 6
Hourly total and Shift total .............................................................................. 3 - 8
Purging the line .......................................................................................3 - 10
Occlusion pressure and alarms ..............................................................3 - 11
How to set or change the occlusion alarm level ............................................. 3 - 12
Monitoring the pressure ................................................................................. 3 - 12
Using the Omnifuse Sleep mode ............................................................3 - 13
Using SLEEP mode ....................................................................................... 3 - 13
While the pump is asleep ...............................................................................3 - 13
Waking the pump up ......................................................................................3 - 14
Giving a clinician override bolus ............................................................3 - 15
PCA Infusion Graph features ..................................................................3 - 17
Graph icons .................................................................................................... 3 - 17
Graph annotation ........................................................................................... 3 - 18
Viewing a PCA infusion profile graph and text ............................................... 3 - 19
PCA Charting ............................................................................................3 - 21
Entering pain, nausea and sedation scores ................................................... 3 - 21
Viewing pain, nausea and sedation graphs ................................................... 3 - 23
User Programmed infusions ...................................................................3 - 24
Programming steps ........................................................................................ 3 - 24
User programming screens ............................................................................ 3 - 26
Reviewing User Programmed settings ........................................................... 3 - 29
Starting a User Programmed infusion ............................................................ 3 - 30
Ending an infusion ......................................................................................... 3 - 31

Contents
Graseby Medical Ltd.
Omnifuse PCA Instruction Manual iii
Chapter 4 - Troubleshooting
Introduction ..............................................................................................4 - 1
Format of Omnifuse PCA Alarms and Warnings ............................................4 - 1
How to handle Alarms ....................................................................................4 - 1
How to handle Warnings ................................................................................4 - 2
How to handle System faults ..........................................................................4 - 3
Alarms .......................................................................................................4 - 4
Warnings ...................................................................................................4 - 6
One-off warnings ............................................................................................4 - 6
Repeated warnings .........................................................................................4 - 12
Specification
Specifications ...........................................................................................S - 1
Standards ..................................................................................................S - 8
Startup curves ................................................................................................S - 9
Trumpet curves ...............................................................................................S - 10

Graseby Medical Ltd.
iv Omnifuse PCA Instruction Manual
Contents

Chapter 1
Introduction Page
Introduction to the Omnifuse PCA 1
PC software options 4
Omnistack pump stacking system 5

Introduction
Graseby Medical Ltd. Introduction to the Omnifuse PCA
Omnifuse PCA Instruction Manual 1 – 1
Introduction to the Omnifuse PCA
The Omnifuse PCA pump is designed for
Patient Controlled Analgesia and is
supplied with a patient handset and
lockable cover. It has a purple Command
wheel, LCD surround and keypad.
The features on the Omnifuse PCA pump
can be tailored to suit individual hospital
and clinical requirements. The pump can
be programmed for a patient bolus, with
or without a loading dose or background
infusion. A clinician’s override bolus is
also available.
The clear messages on the screen guide
you through an intuitive programming
and running sequence, with further
information available from on-screen
help explaining how to use a feature or
follow a prompt.
The Omnifuse PCA pump can be run
directly from the AC mains supply or,
when necessary, from its own
rechargeable backup batteries.
The pump has been designed to be simple
to use, with a minimum of physical
controls. Most actions are performed by
choosing options from the screen with
the Command wheel which you turn and
then press. There is a keypad for entry of
numerical data, for stopping and starting
the pump and for switching it on and off.
Safety and security
Many safety features are incorporated
into the Omnifuse PCA pump:
• Self-test routines run each time the
pump is switched on to check it is
working correctly.
• Continual checks are also made
while the pump is running;
especially during an infusion.
• A wide range of audible and visual
alarms and warnings, including the
LCD screen flashing.
• Each infusion setting must be
reviewed and confirmed before an
infusion can start.
• Occlusion pressure is monitored as a
standard feature. The dry-side
pressure level is displayed while the
pump is running. The occlusion
alarm level setting is adjustable but
may be locked to restrict the upper
level if required.
• A lockable cover and security
software controls access to the
syringe. The pump can only be
programmed if the cover is open and
an infusion can only be started when
the cover is shut.
• A history of the last 3000 of the
pump’s events or actions, stamped
with the date and time can be viewed
on the pump screen, or transferred to
a PC to be analysed in more detail.
Carefully read the entire contents of
this manual before using the pump.

Introduction to the Omnifuse PCA Graseby Medical Ltd.
1 – 2 Omnifuse PCA Instruction Manual
Introduction
Performance
Below is a summary of PCA features of
the pump and the relevant parameter
range:
At the back of this manual is a detailed
specification covering all aspects of the
pump performance.
User interface
The screen and controls on the pump are
easy to use.
• All the information for programming
and running infusions is shown on
the LCD screen (Liquid Crystal
Display).
• Next to the screen is a multi-function
Command wheel which you turn and
press to select items and enter
information.
• The pump has a numeric keypad for
entry of data such as bolus dose.
• An Infusion LED flashes to show
that the pump is infusing and
changes colour if the syringe nears
empty. A yellow LED is lit when the
pump is connected to the AC mains
supply.
• While you program the pump and
during an infusion, the screen shows
instructions on a message line. Help
and information icons lead to more
detailed information.
• Status icons show the battery level
and occlusion pressure level.
• A special feature lets you program
the pump ready for an infusion, then
leave it ‘asleep’ until it is needed.
• The pump totaliser shows totals for
the infusion and totals since last
reset. A shift totals feature is also
available.
•
Pump feature Range
Dose Range 0.1 µg (mcg) - 99.9mg
Dose Duration 5 seconds - 99.59 minutes
Clinician Override Dose Range 0.1 µg (mcg) - 99.9 mg
Loading Dose Range 0.1 µg (mcg) - 99.9 mg
Background (Dose) Rate Range 0.1 µg (mcg)/hour - 500 mg/hour
Background Rate Ranges (with bolus) 0.1 - 20 ml/hour
Background Rate Range (no boluses) 0.1 - 800 ml/hour
Bolus Rate Range 0.1 - 800 ml/hour
Bolus Duration Range (timed) 1 second - 99 hours 99 mins
Dose Limit Range by Mass 0.1 µ(mcg) - 99.9 mg
Dose Limit Range by Volume 1 - 999.9 ml
Dose Limit Range by Demands 1 - 999 demands
Dose Limit Period 1 - 8 hours or infusion time

Introduction
Graseby Medical Ltd. Introduction to the Omnifuse PCA
Omnifuse PCA Instruction Manual 1 – 3
Administration sets
Graseby medical have a wide range of
Flo-Safer™ administration sets that
may be used for specific infusion
therapies. These are listed in the
Specification at the end of this manual.
Syringes
On the Omnifuse PCA, the syringe can
be loaded as a one-handed operation.
Syringes of 2 ml to 60 ml capacity can be
used with the pump.
The syringe type and size are confirmed
as the first step in programming an
infusion. The syringe types available on
the pump’s menu depend on which have
been configured for use.
Bolus
The Omnifuse PCA pump offers a PCA
bolus, activated by a press on the
patient’s handset. The rate and size of
the dose and the lockout time between
doses depends on the drug protocol or
programmed infusion in use on the
pump. The pump’s maximum PCA bolus
rate is 800 ml/h.
In addition to the PCA bolus, the
Omnifuse PCA can be configured to offer
a Clinician Bolus. You need to use a
special password to access this feature
which overrides the PCA lockout time.
The dose and rate for the clinician bolus
shown on the screen are the same as the
PCA bolus, but can be altered if
necessary before giving the bolus.
The PCA pump can also be programmed
to deliver a loading dose when required.
Charts - Pain, nausea and sedation
scoring
You can use the Omnifuse PCA to collect
patient monitoring scores regarding
pain, nausea and sedation. This
information can then be viewed as a
chart on the screen, or transferred to a
PC for viewing.
Protocols
The Protocol feature is an integral part of
the Omnifuse PCA. It ensures the safe
programming and use of the Omnifuse
for a PCA environment.
Before the pump is used, the hospital/
community protocols relevant to the
clinical area can be configured in the
pump. This is done using the Omnifuse
Drug Protocol Management System.
Depending on the clinical area, there
may be just one protocol reflecting a
specific drug regime, or there may be a
choice of protocols.
For example, a protocol can be loaded
into the pump so it can be used for the
administration of 1 mg of analgesia with
a lockout time of 5 minutes. When the
pump is switched on for use, this protocol
will be available, and all the user in the
clinical area needs to do to set up the
pump for a patient is to load the syringe,
select the protocol and confirm the
parameters displayed on the screen.
The Omnifuse PCA can also offer a User
Programmed option to enable the pain
specialist to enter one-off infusion
settings suitable for a particular patient.

Introduction to the Omnifuse PCA Graseby Medical Ltd.
1 – 4 Omnifuse PCA Instruction Manual
Introduction
Mass Units
The Omnifuse PCA can be set up to allow
the clinical user to enter a dose of
medication expressed as a mass, rather
than a volume to be infused over a period
of time.
Graphics
The pump can display a graph to show
the profile of the infusion, the pain,
nausea and sedation scores entered for
the patient.
Locking pole clamp
An optional locking pole clamp can be
used with the Omnifuse PCA. Once
locked onto an IV pole, the pump can
only be moved by an authorised person
with a key.
Power
The Omnifuse PCA is normally run from
the AC mains supply. However, it
switches automatically to internal
rechargeable batteries in the event of a
power cut or if it is disconnected from the
mains. On fully charged batteries, the
pump may be run for up to 10 hours
depending on the infusion rate.
External communications
The pump has an RS232 serial cable
connector with PC interface protocol.
This is used for configuring the pump
from a PC, used to transfer the pump
history to a PC and is also used to control
the pump externally.
PC software options
With a PC linked to the pump by RS232
cable you can transfer information
between the pump and PC. Two software
packages are available on CD-ROM from
Graseby Medical Ltd. for use with the
Omnifuse PCA pump.
Omnifuse Drug Protocol
Management System
The Protocol support software package is
used to design and create Protocols and
download them for use on the Omnifuse
PCA.
Graseby Omnifuse Technician PC
Software
This software package is required for
technical maintenance and servicing an
Omnifuse PCA pump, as well as pump
configuration.
The Technician PC software is used to:
• Perform service tests and calibration
on the pump.
• Set parameters and enable or disable
options that would otherwise be
changed using the pump’s own
Configuration menu.
• Download and examine the pump’s
history database.
• Keep a service database for pumps.
• Store configurations and settings
from the pump and restore them
later.

Introduction
Graseby Medical Ltd. Omnistack pump stacking system
Omnifuse PCA Instruction Manual 1 – 5
Omnistack pump stacking system
The Omnistack is a multi-pump stacking
system designed for mounting Omnifuse
syringe pumps.
Up to four Omnifuse pumps can be
mounted on an Omnistack, powered from
a single mains inlet.
The Omnistack can be clamped to the
Graseby wheelbase, or to a suitable
pylon. The Omnistack must not be used
with a standard IV pole.
For full details on how to use the
Omnistack, see the Omnistack
Instruction Manual.
The part numbers for the Omnistack
stacking system are listed in the
Accessories section of the Specification at
the back of this manual.
Note: An Omnifuse PCA pump fitted
with the optional Locking Pole Clamp
cannot be mounted in an Omnistack
stacking system.

Omnistack pump stacking system Graseby Medical Ltd.
1 – 6 Omnifuse PCA Instruction Manual
Introduction

Chapter 2
Basics Page
Parts of the Omnifuse PCA pump 1
Switching the pump on and off 5
Omnifuse screen, icons and indicators 9
Loading and unloading a syringe 13
Care and Maintenance 19