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