Omnifuse PCA Instruction Manual Jan 2004

PCA 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: Facsimile:

+44 (0)1923 246434 +44 (0)1923 231595

http://www.smiths-medical.com Registered in England. Company number 995550 Trademarks and acknowledgements: “Graseby”; “Smiths”; “omnifuse”; “omnistack”; trademarks of the Smiths Group plc.

and “Flo-Safer” are all

All other trademarks are acknowledged as the property of their respective owners.

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.

Omnifuse PCA Instruction Manual

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.

Using this manual

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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.

2.

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. 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.

6.

7.

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. 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. 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.

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 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. 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.

Omnifuse PCA Instruction Manual

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 overinfusion leading to patient injury or death.

Warnings/Cautions

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Graseby Medical Ltd.

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 W to 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, 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: 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.

8.

CAUTION: Failure to use the mains lead retainer means that the pump may be accidentally disconnected from the mains.

Omnifuse PCA Instruction Manual

Graseby Medical Ltd.

Contents 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

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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

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Omnifuse PCA Instruction Manual

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Chapter 4 - Troubleshooting Introduction ... 4 - 1

Contents

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

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Contents iv

Omnifuse PCA Instruction Manual

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

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Introduction to the Omnifuse PCA

Introduction to the Omnifuse PCA

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.

Carefully read the entire contents of this manual before using the pump.

Omnifuse PCA Instruction Manual

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.

1 – 1

Introduction

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.

Introduction to the Omnifuse PCA

Graseby Medical Ltd.

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.

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

User interface

• 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.

The screen and controls on the pump are easy to use.

Introduction

• 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. 1 – 2

• 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. •

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Introduction to the Omnifuse PCA

Administration sets

Charts - Pain, nausea and sedation scoring

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.

Omnifuse PCA Instruction Manual

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.

1 – 3

Introduction

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.

Introduction to the Omnifuse PCA

Graseby Medical Ltd.

Mass Units

Power

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.

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.

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.

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

Introduction

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.

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Omnifuse PCA Instruction Manual

Graseby Medical Ltd.

Omnistack pump stacking system

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.

Introduction

Note: An Omnifuse PCA pump fitted with the optional Locking Pole Clamp cannot be mounted in an Omnistack stacking system.

Omnifuse PCA Instruction Manual

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Omnistack pump stacking system

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Introduction 1 – 6

Omnifuse PCA Instruction Manual

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

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Parts of the Omnifuse PCA pump

Parts of the Omnifuse PCA pump Rear of the pump

The PCA pump is fitted with a lockable cover which must be opened, using a key, before you can program a PCA infusion. The cover must be shut and locked with a key before the infusion starts. The cover should only be removed for cleaning, see Removing and replacing the lockable cover‚ page 2 - 22.

Omnifuse PCA Instruction Manual

If an infusion is started, then suspended, the cover must be unlocked and opened then shut and locked before you can restart the infusion. This is to ensure that the infusion can only be started by an authorised person who has the key to the cover.

2 – 1

Basics

Lockable cover