Graseby Omnifuse User Manual

Syringe Pump
Instruction
Manual
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: +44 (0)1923 246434 Facsimile: +44 (0)1923 231595
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.
Graseby Medical Ltd.
Using this manual
Read the first three chapters of this manual for an overview of the Omnifuse pump and to find out how to program the pump for a basic infusion.
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 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 and loading or changing a syringe. It also covers the care and maintenance of the pump.
Chapter 3, Programming the pump
This chapter describes how to program the Omnifuse pump for a Continuous infusion. It explains how to use the pump features designed for the clinical environment, for example, setting the occlusion alarm, viewing and resetting totals, purging the line, using Sleep mode, and giving a bolus.
Read the remaining chapters for details on programming and running other types of infusion and to find out how to use the pump variants.
Chapter 4, Specialised infusions
This chapter explains how to program using Mass Units, and describes how to use the Preset Time, Preset Volume, Intermittent and Circadian Rhythm infusion modes on the Omnifuse.
Chapter 5, Protocols
This chapter explains how to program the Omnifuse by selecting from a menu of Drug Protocols.
Chapter 6, In-line occlusion sensing
This chapter explains how to use an Omnifuse pump variant with an In-line occlusion sensor.
Chapter 7, Lockable cover
This chapter explains how to use the Omnifuse pump variant with a Lockable cover.
Chapter 8, Troubleshooting
This chapter explains the warnings and alarms that may be displayed by the Omnifuse.
Specifications and Standards
This lists the specifications for the Omnifuse pump and the standards with which it complies.
Index
At the end of the manual is an index which provides a list of key words, and cross-references these to the relevant pages in the manual.
Using this manual
Omnifuse Instruction Manual
Warnings/Cautions
Warnings/Cautions
Warnings
Graseby Medical Ltd.
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 on the 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 must only be changed 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 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) machine s 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 with in 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 Mai nt e nan ce 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.
expose the pump to X- rays,
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.
Omnifuse Instruction Manual
Graseby Medical Ltd.
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: When using the In-line Occlusion Sensing option, use only a Graseby Medical or Graseby Medical-approved extension set (part number 0130-0041). Graseby Medical does not guarantee performance of the pump if unapproved extension sets are used. Failure to observe this warning may lead to compromised performance of the pump, resulting in patient injury or death.
19. WARNING: The volume of fluid contained in the connecting tubing is a residual amount and will not 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.
20. 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.
21. WARNING: For safe operation of the pump, 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.
22. 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.
be infused. Allowance must be
23. 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.
24. 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.
25. 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.
26. 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.
27. 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 over­infusion leading to patient injury or death.
28. WARNING: When the Omnifuse pump is fitted with a Lockable cover, the cover and associated security software should always be used in accordance with local protocol. The Lockable cover protects the syringe and its contents from tampering; the security software ensures that the infusion parameters are not interfered with. Failure to use the security software together with the Lockable cover could result in an inaccurate delivery leading to patient injury or death.
Warnings/Cautions
Omnifuse Instruction Manual
Warnings/Cautions
Cautions
Graseby Medical Ltd.
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
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
W
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.
be carried out.
to move the pusher. Failure to observe
5. CAUTION: Do not use cleaning and disinfecting agents other than the approved ones specified here.
6. CAUTION: The pump must not 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, EtO­sterilised 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: Failure to use the mains lead retainer means that the pump may be accidentally disconnected from the AC mains supply.
8. 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 back­pressures that may be encountered in certain clinical applications.
be immersed in
Omnifuse Instruction Manual
Graseby Medical Ltd.
Contents
Chapter 1 - Introduction
Introduction to the Omnifuse pump ...................................................... 1 - 1
Omnifuse pump features ................................................................................1 - 1
Omnifuse pump variants .................................................................................1 - 4
PC software ..............................................................................................1 - 5
Omnistack pump stacking system .........................................................1 - 6
Chapter 2 - Basics
Parts of the Omnifuse pump ...................................................................2 - 1
Rear of the pump ...........................................................................................2 - 1
Front of the pump ...........................................................................................2 - 2
The Command wheel, keypad and LEDs .......................................................2 - 3
Switching the pump on and off ............................................................... 2 - 4
Switching on and power-up tests ................................................ .. ..................2 - 4
Switching off ...................................................................................................2 - 5
Using the pump on batteries ............. ................................. ... ..........................2 - 6
Recharging the batteries ........................................ ... ................................. ... .2 - 7
Omnifuse screen, icons and indicators .................................................2 - 8
Icons on the pump screen ..............................................................................2 - 8
Screen icons ...................................................................................................2 - 9
Pump indicators .................. .. ..........................................................................2 - 10
Sounds on the Omnifuse ................................................................................2 - 11
Setting the alarm volume ................................................................................2 - 11
Loading and unloading a syringe ...........................................................2 - 12
When to load the syringe ....................... ... ... ...................................................2 - 12
Syringe brand and size ...................................................................................2 - 13
Replacing a syringe during an infusion ...........................................................2 - 13
Warnings and Cautions concerning syringes .................................................2 - 14
How to load a syringe ................................................... ..................................2 - 15
How to unload a syringe .................................................................................2 - 16
How to change the brand of syringe ...............................................................2 - 17
Care and maintenance .............................................................................2 - 18
Carrying the pump ............................................ ... ... .................................... ... .2 - 18
Positioning the pump for use ...................................................... .. ..................2 - 18
Using the pole clamp ................................................. .................................... .2 - 19
Cleaning and care of the pump ......................................................................2 - 20
Contents
Omnifuse Instruction Manual i
Graseby Medical Ltd.
Chapter 3 - Programming the pump
Continuous infusion in ml per hour .......................................................3 - 1
Changing the rate while running ....................................................................3 - 2
Ending a Continuous infusion ........................................................................ 3 - 2
Occlusion pressure and alarms ..............................................................3 - 3
How to set or change the occlusion alarm level .............................................3 - 4
Monitoring the dry-side pressure .......................... .................................. ... ..... 3 - 5
The Totaliser ............................................................................................. 3 - 6
About the cumulative total ..............................................................................3 - 6
How to view and reset the cumulative total ....................................................3 - 7
Hourly total and Shift total ...................... ..................................... ... .. ..............3 - 8
Purging the line ........................................................................................3 - 10
Sleep mode ...............................................................................................3 - 11
How to use SLEEP mode .............................................................................. 3 - 11
While the pump is asleep ................................................... ............................3 - 11
Contents
Waking the pump up ................................................................................. ... ..3 - 12
Omnifuse bolus feature ...........................................................................3 - 13
Types of bolus delivery methods ...................................................................3 - 13
Default rate for bolus ...................................................................................... 3 - 13
Bolus beep ............................................. ........................................................3 - 13
Quitting the Bolus screen ...............................................................................3 - 14
Bolus and TOTAL ............................................................................ ..............3 - 14
How to give a hands-on bolus ........................................................................3 - 15
How to give a pre-set bolus ............................................. .. ............................3 - 16
Graphics ....................................................................................................3 - 17
Accessing the Graphics screen ............................................ ... ... ...................3 - 17
Viewing infusion data as a graph ...................................................................3 - 18
Graph icons .................................................................................................... 3 - 18
How to view an Infusion Profile graph and text .............................................. 3 - 19
Chapter 4 - Specialised infusions
Mass units and special infusion modes .................................................4 - 1
Setting up the mass units and extra modes ...................................................4 - 1
Programming using mass units ..............................................................4 - 2
Setting up a Continuous infusion in mg/h ................................... ... ................4 - 3
Setting up a Continuous infusion in µg/kg/min ............................................... 4 - 4
Setting up a Continuous infusion with user mix drug concentration ............. ..4 - 5
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How to change the infusion mode .......................................................... 4 - 7
The Review screen ...................................................................................4 - 8
Preset Volume infusion ........................................................................... 4 - 9
Changing the rate while running - Preset Volume ..........................................4 - 10
Checking the totals - Preset Volume ..............................................................4 - 11
Giving a bolus - Preset Volume ......................................................................4 - 11
Ending a Preset Volume infusion ......................................... ... .......................4 - 11
Preset Time infusion ................................................................................4 - 12
Changing the rate while running - Preset Time ..............................................4 - 13
Giving a bolus - Preset Time ..........................................................................4 - 14
Checking the totals - Preset Time ..................................................................4 - 14
Ending a Preset Time infusion ...................................................... ..................4 - 14
Intermittent infusion ................................................................................4 - 15
Programming an Intermittent infusion ............................................................4 - 16
Starting an Intermittent infusion .....................................................................4 - 17
Background rates and KVO rate .....................................................................4 - 18
Circadian Rhythm infusion .....................................................................4 - 19
Setting up and running a Circadian Rhythm infusion ......................................4 - 20
Chapter 5 - Drug Protocols
About Omnifuse Drug Protocols ............................................................5 - 1
Programming using a protocol ......................................................... ...............5 - 1
Selecting a protocol .................................................................................5 - 2
Programming the pump without a protocol .............................. .......................5 - 3
...................................................................................................................5 - 4
Chapter 6 - In-line occlusion sensing
In-line Occlusion Sensing .......................................................................6 - 1
In-line pressure ..................... ..................................... ... ..................................6 - 1
Using the In-line pressure sensor ..........................................................6 - 2
Monitoring In-line pressure .....................................................................6 - 3
How to view a Pressure Trend graph .............................................................6 - 4
In-line sensor warning messages ...................................................................6 - 6
Omnifuse Instruction Manual iii
Contents
Graseby Medical Ltd.
Chapter 7 - Lockable cover
Introduction .............................................................................................. 7 - 1
Features of the Lockable cover .............................................................. ... ... ..7 - 1
About the security software ....................................................................7 - 2
Infusions with the cover and security software ...............................................7 - 3
Removing and replacing the cover .........................................................7 - 5
Chapter 8 - Troubleshooting
Introduction .............................................................................................. 8 - 1
Format of Omnifuse Alarms and Warnings ....................................................8 - 1
How to handle Alarms .................... ... ... .................................... ......................8 - 1
How to handle Warnings ........................ ... ..................................... .. ..............8 - 2
How to handle System faults ................................................ ... ... ...................8 - 3
Alarms .......................................................................................................8 - 4
Warnings ...................................................................................................8 - 6
Contents
One-off warnings ........................................................ ... ... ..............................8 - 6
Repeated warnings ........................................................................................ 8 - 11
Specification
Specification ........................... ................................................................. . S - 1
Standards ............................. ................................... ................................. .S - 7
Startup curves ........ ... ....................................................................... ... .... . S - 8
Trumpet curves ........................................................................................ S - 9
Index
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Chapter 1
Introduction
Graseby Medical Ltd. Introduction to the Omnifuse pump
Introduction to the Omnifuse pump
The Omnifuse is part of the wide range of Graseby pumps. Omnifuse syringe pumps have been designed to meet the growing needs of the clinical environment. They are suitable for the administration of drugs or other parenteral fluids by or under the supervision of healthcare professionals such as physicians and nurses.
Omnifuse pump features
The features on the Omnifuse pump can be tailored to suit individual hospital and clinical requirements.
The pump offers a Continuous infusion mode as well as other modes for specialised infusions: Preset Volume, Preset Time, Intermittent and Circadian Rhythm.
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 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. 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.
Carefully read the entire contents of this manual before using the pump.
This Instruction Manual describes the features of the standard Omnifuse pump, explains how to use the pump and also describes the pump variants.
The pump has a green Command wheel, LCD surround and keypad.
Safety and security
Many safety features have been incorporated into the Omnifuse 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 history of 3000 of the pump’s most recent events or actions, stamped with their date and time can be viewed on the pump screen, or transferred to a PC.
Introduction
Omnifuse Instruction Manual 1 – 1
Introduction to the Omnifuse pump Graseby Medical Ltd.
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
Introduction
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.
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.
Pump configuration
The features required for a particular clinical application must be configured on the pump, by a qualified technician, prior to use in the clinical area.
The technician uses Graseby Omnifuse Technician PC software to enable features on the Configuration menu, then transfers this information to the pump. Alternatively, the technician accesses the Configuration menu directly on the pump, using a special password. Once the Omnifuse has been configured for use, it can be programmed with specific infusion settings according to the clinical requirements of the patient and medication.
In addition to the Configuration menu, there is a Technician menu giving access to information about the use of the pump. This menu is normally accessed using PC software but may be accessed directly on the pump, using a special technician’s password. For more details about Configuration and Technician menus, read the Omnifuse Technical User Manual.
Syringes
On the Omnifuse, the syringe can be loaded as a one-handed operation. Syringes of 2 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 that are available on the pump’s menu depend on which have been configured for use.
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Graseby Medical Ltd. Introduction to the Omnifuse pump
Bolus features
The Omnifuse pump may be configured to offer one or two methods for administering a bolus: a hands-on and/or a pre-set bolus. The maximum bolus rate can be set up to 800 ml/h although this also depends on how the pump has been set up and the size of syringe in use.
If no bolus is needed for the clinical area, then the bolus feature can be turned off.
Mass Units
A wide range of mass units can be configured for use on the Omnifuse. The pump can be programmed to give a dose of medication which is expressed as a mass unit, rather than volume to be infused over a period of time.
Protocols
The pump can offer the clinical user a selection of protocols. Before the pump is used, the hospital/community protocols relevant to the clinical area must be loaded into the pump. This is done using the Omnifuse Drug Protocol Management System.
Power
The Omnifuse 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, is used to transfer the pump hi sto ry to a PC and is also used to control the pump externally.
Introduction
With Protocols in use, 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.
Graphics
This feature allows you to view the progress of the infusion in graphic form as an infusion profile.
Omnifuse Instruction Manual 1 – 3
Introduction to the Omnifuse pump Graseby Medical Ltd.
Omnifuse pump variants
The standard Omnifuse has no In-line occlusion sensing capability or Lockable cover. Three Omnifuse pump variants are available for use in environments where In-line Occlusion Sensing or a Lockable cover are required.
The variants can be specified when the pump is purchased, or the standard pump can be upgraded to one of the
Introduction
variants, if it is returned to Graseby Medical. The three variants are:
• Omnifuse with In-line Occlusion Sensing
• Omnifuse with Lockable Cover
• Omnifuse with In-line Occlusion Sensing and Lockable Cover.
In-line Occlusion Sensing
For clinical applications where occlusion pressure needs to be monitored very precisely, for example in a Neonatal unit, the pump should be ordered with an in­line occlusion sensor.
This is used with a special extension set, which includes a pressure sensing disc, to monitor occlusion pressure in the infusion line while the pump is infusing.
Lockable Cover
The Lockable cover pump variant may be used in clinical areas where it is necessary to prevent the syringe from being removed and to prevent any change to the flow rate for the infusion.
The Lockable cover prevents physical access to the syringe except by an authorised person with a key. The cover can be used with the Omnifuse’s Security software enabled, which locks the keypad once the infusion is started. This prevents accidental changes to the infusion rate, or access to the bolus feature.
In-line Occlusion Sensing and Lockable Cover
The Omnifuse is also available as a pump fitted with both the In-line sensor and the Lockable cover.
If required, an infusion can be started without the in-line sensor, in which case the pump reverts to the standard dry­side occlusion sensing.
With In-line sensing in use, the Graph hotspot offers a choice of infusion profile graph or a pressure trend graph.
1 – 4 Omnifuse Instruction Manual
Graseby Medical Ltd. PC software
PC software
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 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.
Graseby Omnifuse Technician PC Software
This software package is supplied with the Service Manual. It is required for technical maintenance and servicing an Omnifuse 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
Omnifuse Instruction Manual 1 – 5
Omnistack pump stacking system Graseby Medical Ltd.
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.
Introduction
For full details on how to use the Omnistack, see the Omnistack Instruction Manual.
The part numbers for the Omnistack stacking system, pole and wheelbase are listed in the Accessories section of the Specification at the back of this manual.
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Chapter 2
Basics
Parts of the Omnifuse pump 1 Switching the pump on and off 4 Omnifuse screen, icons and indicators 8 Loading and unloading a syringe 12 Care and maintenance 18
Page
Graseby Medical Ltd. Parts of the Omnifuse pump
Parts of the Omnifuse pump
This section shows the main external features of the standard Omnifuse pump. It has no In-line occlusion Sensor or Lockable cover.
Rear of the pump
For information on in-line occlusion sensing on the Omnifuse, see In-line occlusion sensing, Chapter 6 or for details on the Lockable cover, see Lockable cover, Chapter 7.
Basics
Omnifuse Instruction Manual 2 – 1
Parts of the Omnifuse pump Graseby Medical Ltd.
Front of the pump
Basics
This illustration shows the main external features on the
front of the Omnifuse pump.
2 – 2 Omnifuse Instruction Manual
Graseby Medical Ltd. Parts of the Omnifuse pump
The Command wheel, keypad and LEDs
Command wheel
You enter commands into the pump with a multi-function Command wheel.
You can turn the wheel freely, either clockwise or counter-clockwise.
If you press the wheel down, you will feel a positive click.
Keypad
Next to the Command wheel is the keypad where you will find the:
On/Off key
S
Start key (Green)
T
Stop key (Red).
U
The numeric keypad is for entering numbers. It includes a Cancel key and Decimal point key.
On the right of the keypad is:
Alarm Silence key (Red)
V
Syringe Load key (Blue).
W
• Turn the wheel in either direction to highlight items on the screen such as hotspots
• Press the wheel to select, accept or confirm the parameters or action.
Basics
LEDs
The pump has three LEDs:
Infusion LED - This is green, or amber. It is lit or flashes when an infusion is running. For full details, see Pump indicators‚ page 2 - 10.
Mains LED - This is yellow. It is lit when the pump is connected to the AC mains supply and goes out if the pump is operating on batteries.
Alarm LED - This flashes red when the pump is sounding the alarm.
Omnifuse Instruction Manual 2 – 3
Switching the pump on and off Graseby Medical Ltd.
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Switching the pump on and off
Before you switch the pump on, visually check for damage to any part of the pump or its connectors.
Plug it in to an AC mains supply if possible. If necessary the pump can be run on its internal batteries see Using the pump on batteries‚ page 2 - 6.
Switching on and power-up tests
To switch on, press On/Off S. The initial screen shows:
The pump continues with its self test:
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Service due message
The pump checks its service due date at the end of the power-up tests. If a service is due, you will see a message, for example:
The pump can still be used. To continue with your setup, simply press the Command wheel. If however you wish the pump to be serviced, switch off.
The pump will display the service due message when you next switch it on.
Faulty pump
If the pump discovers a fault during the
The Pump ID and Location shown on this screen are set up in the Technician menu described in the Omnifuse Technical
User Manual.
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.
2 – 4 Omnifuse Instruction Manual
power-up tests, it displays a message. Do not use the pump, but return it to a qualified service engineer. For more details, see Troubleshooting, Chapter 8.
ARNING: Do not use a faulty pump. If the
pump detects a fault, a continuous alarm will
ound and the screen will display a System Fault message. If this happens, switch the pump off, disconnect it from the mains and
ake it to a suitably qualified engineer.
Incorrect performance of the pump can
ause complications resulting in patient injury or death.
Graseby Medical Ltd. Switching the pump on and off
Power-up tests completed
When the power-up tests are complete, the screen shows the first of the syringe loading instructions.
For example:
The pump is now ready for you to load the syringe, as described on page 2 - 12.
Switching off
Before you can switch off, the pump must be stopped. If an infusion is running:
• Press and hold the Stop
The screen displays:
U
key.
Basics
To switch off the pump:
• Press the On/Off key down for two seconds.
As the pump switches off, the screen displays:
Ensure that the pump is connected to the AC mains to keep the batteries charged and ready for use next time.
Omnifuse Instruction Manual 2 – 5
and hold it
S
Switching the pump on and off Graseby Medical Ltd.
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Using the pump on batteries
In everyday use, the Omnifuse pump should be connected to a suitable AC mains supply, not used on batteries.
This way, the batteries are kept fully charged, available for use in an emergency.
• The yellow Mains LED is only lit when the pump is connected to the AC mains supply
• The battery icon P is shown on the screen when the pump is running on batteries
• The battery icon is displayed when the pump is connected to the AC mains supply, to show that the batteries are being charged. When
Basics
the batteries are charged, the icon disappears.
Pump with patient in transit
If a mains supply is unavailable - for example, if the pump is infusing a patient in transit - you can start or continue an infusion with the pump running on batteries.
Mains lead retainer
The mains lead is held in the pump with a retainer. This is so that it cannot be pulled out accidentally.
CAUTION: Failure to use the mains lead retainer means that the pump may be accidentally disconnected from the AC mains supply.
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 o death.
Mains supply failure
If the AC mains supply fails or if the pump is disconnected from the mains, it automatically switches to its internal batteries.
If the pump is infusing, the infusion continues without interruption. This message is displayed:
• The yellow Mains LED goes out and
the battery icon P is shown on the screen when the pump is running on batteries.
The pump will display a warning message approximately 30 minutes before battery power runs out.
When the pump is reconnected to the main supply, or mains power resumes, the pump automatically switches back to the AC mains supply.
Note: When the pump is being used on battery, an independent battery monitor is active. This provides an additional check on the battery condition.
If the pump’s alarm sounds but no message is displayed on the screen, the independent battery monitor has detected a problem.
The alarm cannot be silenced and the pump cannot be used. It must be taken to a qualified technician for repair.
2 – 6 Omnifuse Instruction Manual
Graseby Medical Ltd. Switching the pump on and off
Recharging the batteries
While the pump is switched off, you should leave it connected to the AC mains supply so that the batteries are always kept fully charged.
Recharging can take up to 10 hours if the batteries are completely flat.
While the pump is running on the mains supply, the battery icon P is displayed to show that the batteries are being charged. The battery icon disappears once the batteries are fully charged.
Battery life
As a rough guide, an Omnifuse pump can operate on battery power for up to 10 hours at a continuous infusion rate of 5 ml/h with the batteries starting from fully charged. This period includes four syringe load/unload cycles.
To ensure that the batteries perform as specified they must always be fully charged. The batteries must not be left partially charged for extended periods, for example when the pump is in store.
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.
Omnifuse Instruction Manual 2 – 7
Basics
Omnifuse screen, icons and indicators Graseby Medical Ltd.
Omnifuse screen, icons and indicators
Moving around the screen
To move around on the screen you turn the Command wheel in either direction. The highlighting shows you where you are.
As well as the main command on the screen, you can see:
•The message line
• Hotspots
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•Icons.
Message line
This gives you more details about the command on the screen, or shows the status of the infusion, or shows you a warning or alarm message reminder.
Hotspots
A hotspot is an action word on the bottom line of the screen. The hotspots you can see are relevant to whatever the pump is doing. The most common hotspot is CONFIRM.
In many cases, the hotspot you need is automatically highlighted on the screen, so you can just press the Command wheel.
If the relevant hotspot is not highlighted, turn the Command wheel to highlight it, then press the Command wheel.
When you press the wheel, the pump will carry out the command. In this example, if you press the Command wheel with
SKIP highlighted, the pump will skip the
syringe load process.
Icons on the pump screen
This example screen illustrates where the Omnifuse screen icons appear:
Some icons are displayed on the screen all the time, others only appear in special circumstances.
The table on page 2 - 9 shows all the icons that may appear.
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Graseby Medical Ltd. Omnifuse screen, icons and indicators
Screen icons
Icon Name Description
Info Displays settings and parameters for the
H
Help Displays a screen of help information relating
T
current infusion.
to the current state of the pump.
C Occlusion Level
(Dry-side)
Battery level This is displayed as a static icon when the
P
Hold (Graph) This appears when the pump is displaying the
I
Return (Graph) This is displayed when the pump is holding
F
Occlusion Level (In-line)
The position of the vertical line shows the level at which the occlusion alarm pressure has been set, from Level 1 on the left to Level 5 on the right. When the pump is running the icon fills from left to right to show the current pressure. You use this icon to set the alarm pressure level, see How to set or change the occlusion alarm level‚ page 3 - 4.
This replaces the dry-side occlusion level icon when the sensor is use on an Omnifuse with In-line occlusion sensing, see In-line occlusion sensing, Chapter 6.
pump is running on batteries, or as a flashing icon when the pump is connected to the AC mains supply and the batteries are charging.
Graph screen. Select this icon to hold the screen. While the screen is on hold, the icon changes to the return icon shown below.
the Graph screen. Select this icon to return to the running screen, or previous graph screen.
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Zoom (Graph) This is displayed during long infusions, when
J
Omnifuse Instruction Manual 2 – 9
the graph display can be zoomed to show more detail for a particular hour.
Omnifuse screen, icons and indicators Graseby Medical Ltd.
Pump indicators
There are three LEDs or indicators on the front of the pump, positioned above the numeric keypad.
Infusion indicator
The Infusion indicator shows whether or not the pump is infusing, and changes colour when the syringe is nearly empty. See details in the table below.
Basics
Infusion LED Shows ...
Flashing Medication being
delivered.
Steady Infusion suspended -
Stop key pressed.
LED Colour Shows ...
T
Mains indicator
The yellow Mains indicator is lit when the pump is connected to the AC mains supply.
Alarm indicator
The red Alarm indicator flashes when the pump sounds the alarm.
was
Green Syringe is full.
Amber Syringe is nearly
empty.
2 – 10 Omnifuse Instruction Manual
Graseby Medical Ltd. Omnifuse screen, icons and indicators
Sounds on the Omnifuse
This table describes the sounds that you may hear from the Omnifuse pump and tells you what action is required if you hear them.
Sound Occurs when... What you should do Beep You press a key or the
Command wheel.
Double beep The pump requires
your attention.
Alarm The pump has
discovered an operating problem, for example the syringe is empty or there is an occlusion.
Continuous System Alarm
The pump has detected an internal error.
For more details on pump warnings and alarms, see Troubleshooting, Chapter 8.
If the beep is too soft or too loud, call a technician to change it for you via the Key Beep Volume parameter in the Configuration menu.
Read the message on the screen, then carry out the suggested action.
Read the message on the screen, then press the Alarm Silence key
and carry out the suggested
V
action.
Read the message on the screen. Pressing Alarm Silence V will have no effect. Switch off the pump and hand it over to a qualified technician for servicing.
Basics
Setting the alarm volume
The volume of the alarm on the Omnifuse can be set to one of three levels:
• 1 - Soft
•2 - Medium
•3-Loud.
Provided the pump is not infusing and the cover is open, you can adjust the volume to suit the operating environment.
Omnifuse Instruction Manual 2 – 11
To adjust the alarm volume:
• Press and hold the Alarm Silence V key and at the same time press the 1, 2 or 3 key on the keypad.
As you press a number, the pump demonstrates the volume of the alarm at your chosen level.
The last number you press sets the volume that the pump will use for the alarm, until set to a different volume.
Loading and unloading a syringe Graseby Medical Ltd.
Loading and unloading a syringe
The pump is designed to make loading a syringe a one-handed operation. There are three components that secure the syringe:
• The syringe ear slot
• The barrel clamp
• The pusher.
The syringe is placed in the trough at the front of the pump. The ear or flange of the syringe should be placed into the syringe ear slot. The barrel clamp is lowered by hand onto the syringe.
The sections on the following pages provide full details on loading/unloading a syringe.
Basics
When to load the syringe
When you turn the pump on, you see the screen below, unless a syringe is already loaded:
Please note that Warnings relating to syringe loading and unloading are listed on page 2 - 14.
When to skip loading
If the syringe is not yet ready, or if someone else is preparing the syringe while you program the pump, you can skip loading. The SKIP hotspot allows you to go ahead with programming the pump and load the syringe later on.
If a syringe is already loaded you will only be asked to confirm the brand and size.
Please read Warnings and Cautions concerning syringes, on page 2 - 14.
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