Omnifuse Technical Service Manual Issue C March 2005

Omnifuse™ Syringe Pump

Smiths Medical

Warnings and Cautions The following warnings and cautions appear in this manual.

Warnings Warnings tell you about dangerous conditions (i.e. those capable of causing death or serious injury to the user or patient) that can occur if the instructions in this manual are not obeyed. 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 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 anaesthetics, oxygen-enriched or explosive atmospheres. The use of the device in such atmospheres may lead to explosion or fire.

4.

WARNING: To avoid possible malfunction of the pump, do not expose the pump to Xrays, 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 user injury.

6.

WARNING: In order to ensure that the intended infusion is performed, data must be entered correctly. Likewise 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 user injury.

7.

WARNING: Failure to respond promptly to an alarm may result in patient injury or death.

8.

WARNING: Failure to follow the Service Manual’s maintenance schedule recommendations may result in compromised function of the product and lead to patient injury or death.

9.

WARNING: It is essential that clinical staff remain within visual and audible range of the pump so that critical alarms can be seen or heard and responded to.

10. 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 user injury. 11. 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. 12. WARNING: Smiths Medical MD, Inc. 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.

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13. WARNING: Do not use a faulty pump. If the pump detects a fault when it is first turned on, or if it develops a fault during operation, a continuous system alarm will sound. The LCD screen will also display a message explaining what has happened and stating that the pump must be referred to a suitably qualified engineer or returned to Smiths Medical to have the fault rectified. In this event, switch the pump off at once and disconnect it from the mains. 14. 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. 15. WARNING: Failure to use the mains lead retainer means that the pump may be accidentally or erroneously disconnected from the mains. Although there is battery backup in case this happens, the battery may not be sufficiently charged. Consequently there is a risk of the pump not functioning, which could lead to patient injury or death. 16. 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. 17. 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. 18. WARNING: If an occlusion alarm occurs, immediately clamp the line to eliminate the possibility of a bolus being delivered to the patient. Inspect the fluid pathway for kinks, clogged catheter, etc. to remove any occlusion before restarting the infusion. An unintentional bolus of medication can result in patient injury or death. 19. WARNING: Use only the syringes and administration sets listed in the Specifications and Standards section of this manual. Failure to do so may result in an inaccurate delivery. Smiths 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. 20. WARNING: When using the In-Line Occlusion Sensing option, use only a Smiths Medical MD, Inc. or Smiths Medical-approved extension set (part number 0130-0041). Smiths Medical Ltd. 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. 21. WARNING: The volume of fluid contained in the connecting tubing is a residual amount and will not be infused. Hence this extra volume of fluid must be allowed for when initially filling the syringe and purging the system. Under-delivery of medication can cause complications resulting in patient injury or death. 22. 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. 23. WARNING: 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. 24. WARNING: For safe operation of the pump the syringe must be correctly loaded. Ensure that the plunger of the syringe is properly aligned with the middle of the pusher (firsttouch sensor) before closing the barrel clamp to start the load process. Failure to do so may result in inaccurate delivery, resulting in patient injury or death. 25. WARNING: The user should ensure that their fingers are not in the path of the pusher during syringe loading or unloading. Failure to do so may result in patient or user finger injury. 26. 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.

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27. WARNING: If you program an infusion to run at less than 0.5ml/h, there may be a significant delay between pressing the Start keyT and the start of fluid delivery. To reduce the startup time of an infusion, always use the purge facility to prime the line before connecting it to the patient and pressing the Start key. 28. 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. 29. WARNING: Where the bolus function is not required, this function should be disabled to prevent inappropriate use. Failure to observe this precaution may result in patient injury or death. 30. 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. 31. WARNING : 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™ syringe pump and harm the operator or the patient. As a result, the operator or patient may suffer direct injury, or the Omnifuse™ syringe pump may fail to operate correctly, leading to patient injury or death. 32. 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. 33. WARNING: When the Omnifuse™ syringe 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. 34. WARNING: The lockable cover’s safety-software interlocks are switched on by closing the syringe cover, not by turning the key in the lock. This means that it is perfectly possible to start an infusion with the cover closed but not locked - particularly if the pump is lying on a table so that the cover does not fall open under its own weight. Always ensure that the cover is locked before starting an infusion. 35. WARNING: When the Omnifuse™ syringe pump is fitted with an in-line occlusion sensor, the sensor, sensing disc and associated pressure sensing software should always be used in accordance with local protocol. The sensor can offer reduced time to an occlusion alarm only if the sensing disc is inserted and the sensing software is enabled. Failure to enable the in-line sensing software may result in an unacceptably slow time to occlusion alarm, resulting in patient injury or death. 36. WARNING: The Omnifuse™ syringe pump must be maintained, serviced and repaired only by properly trained and qualified technicians who have completed a Smiths Medical service training course. If any other personnel carry out such work it may result in inaccurate operation of the pump thereafter, leading to incorrect infusions and possibly causing injury or death to patients. 37. WARNING: Always disconnect the pump from the mains power supply before opening the case. 38. WARNING: While working on the pump, be careful not to get your fingers trapped in the pusher drive mechanism. The drive motor is powerful enough for you to be injured by it. 39. WARNING: It may appear that only the command wheel has been lost or damaged without affecting the optical encoder, and that repair only requires push-fitting a new wheel onto the encoder spindle. BEWARE! The encoder may also have been damaged without user knowledge, resulting in inaccurate infusions and possible injury or death to patients. Always run the Technician software Check Command Wheel test afterwards

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(see Chapter 5) even if a new command wheel has been fitted without opening the pump case. 40. WARNING: DO NOT ATTEMPT TO REPAIR THE PUSHER BLOCK. Because of the delicate calibration of the internal pressure sensor, the block is supplied as a factory-sealed unit. Any attempt to open it will invalidate the warranty. Using the pump later may produce incorrect infusions, possibly resulting in patient injury or death. If the pusher block malfunctions, always replace the complete pusher drive assembly. 41. WARNING: The pump must correctly display the brand and the size of syringe that is to be used. Using a different brand or size of syringe to that displayed could lead to the incorrect amount of drug being administered, resulting in injury or death to the patient. When a new syringe-size sensor flag has been fitted, the pump must be carefully tested using the Technician software with the Smiths Medical syringe-size sensor gauge set (part number 0151-0259). 42. WARNING: The Technician software tests can be run either individually, in any order to isolate and correct a specific fault, or as a complete suite. However, if a pump case is opened for any reason, Smiths Medical MD, Inc. may invalidate the agreed warranty. Failure to run all Functional and Calibration tests after closing the pump case may result in incorrect operation, leading to inaccurate infusions that may cause injury or death to patients. 43. WARNING: While Smiths Medical 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 the controlling device) is fit for its intended purpose. 44. WARNING: The assessment for the suitability of any software/ firmware in the clinical environment to control or receive data from the pump lies with the user of the equipment. Any connecting analogue and digital components are required to meet BS EN6009501:2002 / IEC 60950-1 (2001-10) for data processing and BSEN60601-1:1990 for medical devices. 45. WARNING: Any person connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard BS EN606010101:2001 / EIC 60601-1-1 (2000-12). Failure to do so may result in the compromised function of the product, patient injury or user injury.

Cautions Cautions tell you about dangerous conditions that may occur and cause damage to the pump if you do not obey all instructions in this manual.

Service Manual

1.

CAUTION: Refer all service, repair and calibrations to qualified technical personnel only. 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; 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 to the right. 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 dropping the pump and causing 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; do not allow fluid or residues to remain on the pump. Note that 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.

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7.

CAUTION: Correct battery management as described in this manual is essential for ensuring that the pump can operate on backup batteries for the time specified.

8.

CAUTION: Dispose of batteries strictly in accordance with the manufacturer's instructions and with local regulations concerning disposal. Lead-acid batteries must not be included with normal waste.

9.

CAUTION: Do not use Loctite 222 adhesive on the pump since it will damage the plastic of the case.

10. CAUTION: Do not switch the pump back on after a System Fault if the screen message specifically says not to. Switching the pump on again may destroy important diagnostic information needed by the Smiths Medical Customer Support Engineers. 11.

CAUTION: Replacing the main PCB and installing the lockable cover or in-line sensor as upgrades must only be performed by Smiths Medical Customer Support Engineers as the pump software must also be reconfigured.

12. CAUTION: Electro-Static Discharge (ESD) precautions conforming to BSEN 100015-4 (1994) must be strictly observed at all times when removing and handling any of the pump's components. Failure to take such precautions may result in serious damage to the pump and possible malfunction later. Ensure that an earthing wrist-strap is worn at all times when handling or working near static-sensitive components like printed circuit boards (PCBs). Ensure that any ESD-sensitive components are stored in an anti-static bag or other such container while not fitted. 13. CAUTION: If the main PCB is replaced, the pump must be reprogrammed by Smiths Medical engineers at the factory. 14. CAUTION: Lubricants must not be applied to any part of the pump unless specified by Smiths Medical MD, Inc. If the leadscrew runs jerkily or noisily, a smear of silicone grease (Smiths Medical MD, Inc. part number 6835-2006) may be applied to the leadscrew using a cotton bud. The screw must be run five times in each direction to spread the lubricant.

Associated manuals and software This manual should be read in conjunction with the following Smiths Medical MD, Inc. publications and software: Title

Part Number

Omnifuse™ Syringe Pump Instruction Manual

0151-0839

Omnifuse™ PCA Syringe Pump Instruction Manual

0153-0082

Omnifuse™ Syringe Pump Technical User Manual

0151-0840

Omnifuse™ PCA Syringe Pump Technical User Manual

0153-0083

Omnifuse™ Syringe Quick Reference Guide

0151-0843

Omnifuse™ PCA Syringe Quick Reference Guide

0153-0080

Omnifuse™ Technician PC Software

0151-0266

Omnifuse™ Drug Protocol Management System

0153-0084

Service engineers must be familiar with the contents of the publications and the operation of the software before attempting any of the procedures in this manual.

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Glossary The following acronyms are used in this manual: Abbreviation

Service Manual

Meaning

ADC

Analog-to-Digital Convertor

BME

Bio-Medical Engineering/ Engineer

CRC

Cyclic Redundancy Check

DVM

Digital Volt Meter

EOT

End of travel

FMS

Force Measurement Systems Ltd.

ID

Identification

KVO

Keep Vein Open

LCD

Liquid Crystal Display

LED

Light Emitting Diode

LSE

Leadscrew Encoder

MRI

Magnetic Resonance Imaging

PC

Personal Computer

PCA

Patient Controlled Analgesia

PCB

Printed Circuit Board

POST

Power-On Self-Test

PSU

Power Supply Unit

RAM

Random Access Memory

ROM

Read-Only Memory

TP

Test Point

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Document History ISSUE RECORD Issue No.

Event

Date

Issue A

Document published

November 2001

Issue B

PCA added; Phase IV update

February 2004

Issue C

Corporate name change

March 2005

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Omnifuse™ Contents Warnings and Cautions ... iii Warnings ... iii Cautions ... vi Associated manuals and software ... vii Glossary ... viii Document History ... ix

Chapter 1 – Introduction Scope of this manual ...1 - 1 Who should read this manual ... 1 - 2 Related manuals ... 1 - 2 Omnifuse™ ... 1 - 2 Omnifuse™ PCA ... 1 - 2 Product Overview ... 1 - 3 System description ... 1 - 3 Infusion modes ... 1 - 3 Controlling the pump ... 1 - 3 Technician Software ... 1 - 4 Patient Controlled Analgesia (PCA) ... 1 - 4 Cable and wrist strap ... 1 - 4 Connection to pump ... 1 - 4 Patient demand button and handset light ... 1 - 4 Safety features ... 1 - 4 Protocols ... 1 - 5 Operation ... 1 - 5 The drive mechanism ... 1 - 5 The pusher ... 1 - 5 The sensors ... 1 - 5 Independant Battery Monitor ... 1 - 6 System self-tests ... 1 - 6

Interconnections ...1 - 7 Power Supply Unit PCB ... 1 - 7 Main PCB ... 1 - 8

Chapter 2 – Maintenance Procedures Annual maintenance ...2 - 1 Preventive maintenance ...2 - 1 Care and replacement of batteries ... 2 - 1 Battery replacement ... 2 - 2

Tools and equipment ...2 - 4 Consumable Items ...2 - 5

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Cleaning ... 2 - 5 Disinfectants ... 2 - 5

Technician Software ... 2 - 6 Before using the Technician software ... 2 - 7 Saving pump configurations ... 2 - 7 Download the pump's history ... 2 - 7 Return pumps to Smiths Medical International Ltd. ... 2 - 7

Acceptance Tests ... 2 - 8

Chapter 3 – Fault Diagnosis Power supply ... 3 - 1 Battery ... 3 - 2 Main PCB ... 3 - 2 Keypad/ display ... 3 - 3 Command wheel/ optical encoder ... 3 - 3 Drive mechanism ... 3 - 3 Occlusion sensing ... 3 - 4 Syringe-size sensing ... 3 - 4 Syringe load / unload ... 3 - 5 Optical interface ... 3 - 5 Sounder ... 3 - 5 PCA handset (if fitted) ... 3 - 5

System faults ... 3 - 6

Chapter 4 – Disassembly and Reassembly Tools required ... 4 - 1 Parts Replacement ... 4 - 1 Items to be replaced at each disassembly ... 4 - 2 Safety Precautions ... 4 - 2 Open the pump case ... 4 - 3 Replacing PCBs ... 4 - 4 Power supply PCB ... 4 - 4 Display PCB ... 4 - 5 Independent Battery Monitor (IBM) PCB ... 4 - 5 Optical interface PCB ... 4 - 6 Optical encoder and/ or command wheel ... 4 - 8 Optical encoder ... 4 - 8 Command wheel ... 4 - 9 Sounder ... 4 - 9 Keypad ... 4 - 10 Upper case (standard version) ... 4 - 10 Remove components from the upper case ... 4 - 10 Assemble a standard upper case ... 4 - 10 Upper case (locking version) ... 4 - 11

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Remove components from a locking upper case ... 4 - 12 Assemble a locking upper case ... 4 - 13

Lower case ...4 - 13 Remove components from a lower case ... 4 - 14 Assemble lower case ... 4 - 15 Pole clamp ... 4 - 20 Remove the pole clamp ... 4 - 20 Assemble and secure the pole clamp ... 4 - 20

Pusher Drive Assembly ...4 - 21 Pusher drive assembly removal ... 4 - 21 Install pusher drive assembly ... 4 - 22 Repair the syringe barrel clamp mechanism ... 4 - 24 Syringe size sensor ... 4 - 24 Syringe size sensor flag ... 4 - 24 Barrel clamp spring arm ... 4 - 25 Syringe ear clamp sensor ... 4 - 26 Replace the ear clamp sensor flag ... 4 - 27 In-line occlusion sensor (replacement only) ... 4 - 27 Close the pump case ... 4 - 29

Chapter 5 – Test and Calibration Test sequence ...5 - 1 Basic tests ... 5 - 1 Functional tests ... 5 - 1 Calibration tests ... 5 - 2

Logging repairs and part replacement ...5 - 2 Critical parts ... 5 - 2 Test Equipment ... 5 - 5

Test and Calibration Procedures ...5 - 6 Basic tests ... 5 - 6 Functional tests ... 5 - 6 Calibration tests ... 5 - 8

Chapter 6 – Parts Lists Supply of Spare Parts ...6 - 1 Fitting Spare Parts ...6 - 1 Main PCB ...6 - 1 Service spares kit ...6 - 9 Software ...6 - 10

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Chapter 7 – Specifications and Standards Omnifuse™ ... 7 - 1 English/ Australian/ Canadian (English) ... 7 - 1 French ... 7 - 1 Dutch ... 7 - 1 Omnifuse™ PCA ... 7 - 1 English/ Australian/ Canadian (English) ... 7 - 1 French ... 7 - 1 Dutch ... 7 - 1

Chapter 8 – Serial Communications Protocol Introduction ... 8 - 1 Organisation of this chapter ... 8 - 1 Safety Considerations ... 8 - 1 Bad Command received ... 8 - 2 Pump Control fields and acceptable states ... 8 - 3

Serial interface ... 8 - 3 RS232 interface ... 8 - 3 Channel Specification ... 8 - 3

MESSAGE FORMAT ... 8 - 4 Message Assembly ... 8 - 6 Communications Link Control ... 8 - 6 Connection ... 8 - 6 Disconnection ... 8 - 6 Pump delay response ... 8 - 7 Error Handling ... 8 - 8 Bad message received or Connection failure ... 8 - 8

Enumerated Data ... 8 - 9 Infusion modes ( 30 – 3F ) ... 8 - 10 Infusion units ( 40 – 4F ) ... 8 - 10 Message Errors and General Message Responses ( 50 – 8F ) ... 8 - 11 Mass Units Programming ( 90 – 9F ) ... 8 - 12 History storage ( A0 – BF ) ... 8 - 13

Data formats and ranges ... 8 - 14 Parameter Data ... 8 - 14 Textual Data ... 8 - 15

Commands and Responses ... 8 - 17 Network messages ... 8 - 17 Generic Information ... 8 - 18 Infusion Device Commands ... 8 - 24 Infusion Device Command Usage ... 8 - 24 Infusion Device Commands Definition ... 8 - 26 General Commands ... 8 - 35 Infusion Control Commands ... 8 - 38

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History Commands ...8 - 41 Configuration Commands ...8 - 44 Technician Commands ...8 - 63

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Syringe Pump PCA Pump

Chapter 1 Introduction

Smiths Medical

Omnifuse™ Syringe Pump

Chapter 1 – Introduction This chapter briefly describes the Omnifuse™ syringe pump and its operating capabilities. For more detailed information of the pump’s capability, refer to the manuals listed below. Description The standard Omnifuse™ syringe pump (Phase 3 and Phase 4) has no In-line occlusion sensing capability or Lockable cover. Omnifuse™ syringe 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 variants, if it is returned to Smiths Medical. The three variants are: • Omnifuse™ syringe pump with In-line Occlusion Sensing • Omnifuse™ syringe pump with Lockable Cover, and • Omnifuse™ syringe pump 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 in-line occlusion sensor. 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™ syringe pump 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™ syringe pump is also available as a pump fitted with both the In-line sensor and the Lockable cover. Note: Technician Software - The pump may only be tested or calibrated using the Omnifuse™ Technician Software, (part number 01510266).

Scope of this manual This manual gives instructions for the service, repair and routine maintenance of the Omnifuse™ syringe pump and Omnifuse™ PCA syringe pumps. The service manual is for use by qualified technicians e.g. customer biomedical engineers (BMEs) who may be required to service, repair and calibrate the pump and run acceptance tests after work has been completed. The manual contains: • an overview of pump operation, •

instructions for using this manual with the Technician software,

•

a list of the tools and equipment required for servicing the pump,

•

a list of acceptance tests,

•

regular and preventive maintenance procedures, care of batteries etc,

•

fault finding and troubleshooting procedures,

•

service, repair and replace specific assemblies procedures,

•

test and calibration procedures after major servicing or repair,

•

an illustrated list of spare parts and accessories, and

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•

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serial communications protocol.

Who should read this manual This manual is for use only by suitably qualified personnel i.e. a qualified customer technician or BMEs who may be required to service or repair the Omnifuse™ syringe pump and calibrate and run acceptance tests when maintenance work has been completed. Smiths Medical recommend that users of this manual should have attended a recognised Omnifuse™ syringe pump training course.

Related manuals When operating instructions, specification, standards or trumpet curve information is required, refer to the appropriate manual(s) in the following list: Omnifuse™ Syringe Pump • Omnifuse™ syringe pump Instruction Manual, part number 0151-0839 •

Omnifuse™ syringe pump Quick Reference Guide, part number 0151-0843

•

Omnifuse™ syringe pump Technical User Manual, part number 0151-0840

Omnifuse™ PCA Syringe Pump • Omnifuse™ PCA Syringe Pump Quick Reference Guide, part number 0153-0080 •

Omnifuse™ PCA Syringe PumpTechnical User Manual, part number 0153-0083

•

Omnifuse™ PCA Syringe Pump Instruction Manual, part number 0153-0082

This manual is used in conjunction with Omnifuse™ Technician software (part number 0151-0266). Drug protocols are set-up using the Omnifuse™ Drug Protocol Management System (part number 0153-0084). Both programs are supplied on CD-ROMs. Omnistack™ Omnifuse™ Syringe Pump Stacking System Instruction Manual, part number 01560084. WARNING:

1 - 2

The Omnifuse™ syringe pump must be maintained, serviced and repaired only by properly trained and qualified technicians who have completed a Smiths Medical service training course. If any other personnel carry out such work, it may result in inaccurate operation of the pump thereafter, leading to incorrect infusions and possibly causing injury or death to patients.

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Product Overview System description The Omnifuse™ syringe pump is used to administer drugs or other parenteral fluids. Designed to be as compact and damage-resistant as possible - including a high degree of waterproofing against spillage - the pump operates either above the patient, clamped obliquely to an intravenous (IV) pole mounting, or lying face upwards on a table. Up to four pumps may be mounted on the Graseby Omnistack® pump stacking system. The Omnifuse™ syringe pump normally runs from the AC mains supply. It also has a set of three internal rechargeable lead-acid backup batteries. When fully charged, the pump can operate for up to 10 hours in the event of a power cut or while a patient is being moved. Three variants of the pump are available: •

with In-line occlusion sensing,

•

with a Lockable cover, or

•

with In-line occlusion sensing and Lockable cover.

Standard pumps can be upgraded to included either or both options. Infusion modes The standard pump can infuse in either Continuous, Preset-Volume or Preset-Time (not PCA) modes. The pump provides Intermittent and Circadian Rhythm infusions (not PCA), plus programming of infusions in mass units. Delivery rates in the Continuous mode range from 0.1 to 100 millilitres per hour in 0.1 ml increments and 101 to 800 millilitres per hour in 1 ml increments. Maximum infusion pressure is approximately 1250 mm Hg, and volumetric infusion accuracy is ±2% over the 2nd hour of infusion at 1 ml/h and at 5 ml/h with a Braun Omnifix 50 ml syringe and 150 cm extension set. Bolus can be administered either manually or as a preset volume at rates from 0.1 to 800 ml/h depending on syringe size. When the pump detects a nearly-empty syringe, it can infuse at a Keep Vein Open (KVO) rate. This can be set between 0.05 and 2 ml/h or turned off by setting it to zero. The pump accepts syringes of 2 ml, 5 ml, 10 ml, 20 ml, 30 ml and 50/60 ml capacities (see either Technical User Manual or Instruction manual, Specifications and Standards). A clamping sensor detects syringe size at loading and suggests the most likely brand from among the pump's library of syringe types. Syringes can be purged at rates from 50 to 800 ml/h (depending on syringe size) before an infusion starts. Users may define a syringe type of their own using the Configure feature on the Omnifuse™ Syringe Pump Technician PC Software. Controlling the pump The pump features an easily viewable LCD display which, together with an array of LEDs and sound signals, allows the pump’s operation to be monitored from anywhere within sight and hearing range. The pump is controlled via a soft-touch keypad and a rotary command wheel that allows the user to select options from a succession of screen menus. The pump can be factory-programmed to operate in one of a many languages. Whatever its primary operating language, each pump also allows technicians the option of viewing displays in English. Authorised personnel can set-up and configure a pump using password protected Configuration and Technician menus.

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Technician Software RS232 interface allows the pump to be connected to a PC where it can be controlled remotely using the Omnifuse™ Syringe Pump Technician software.

Note: Only the correct RS232 cable, part number 0053-0738 may be used. The Technician software enables authorised personnel to: •

set-up and print the pump labels,

•

add comments to the Repair Log,

•

select the communication port,

•

view or change pump parameters,

•

view or change a user defined syringe parameter,

•

review the pump history,

•

calibrate settings, and

•

run tests, record results and record replacement of critical parts.

Help screens describe the procedures. Patient Controlled Analgesia (PCA) The Omnifuse™ PCA syringe pump is designed for Patient Controlled Analgesia and is supplied with a patient handset and lockable cover. It can be used for a variety of PCA infusions which can be set up in the pump as protocols. It has a purple Command wheel, LCD surround and keypad. Cable and wrist strap The handset is connected to the pump by a purple cable which matches the pump and can be distinguished from any other cables. Connection to pump To connect the handset, the plug on the cable is pushed firmly into the socket on the left hand side of the pump. Patient demand button and handset light The handset button is used by the patient to demand a PCA dose. The light around the button can be set to switch on and off in one of three ways: •

on all the time, so the handset is easy to locate, even in the dark,

•

on only when the patient’s next PCA dose is available, or

•

off all the time.

Safety features Safety is designed into the pump and its software. Self-test routines check the pump when it is switched on. The mode, volume and duration of infusions, the syringe type being used and (optionally) the drug being administered are displayed for confirmation at each stage of an infusion. Levels of access to the pump can be configured from very restrictive - effectively a single type of infusion with the syringe under a locked cover up to the most flexible, with clinicians able to choose from and combine a wide range of infusion modes, drug types and delivery options. Users are warned of incidents like occlusions or power failure by both visible and audible alarms. In addition to standard occlusion sensing measured against the syringe plunger, optional in-line pressure sensing is available. With either type of sensing, it is possible to adjust the trigger pressure either to block out unwanted occlusion alarms or increase sensitivity e.g. in neo-natal units. The pump stores a historical database of its own operation as each event takes place. It records the 3,000 most recent events, logging them by date and time.

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Service Manual

Smiths Medical

Omnifuse™ Syringe Pump

The pump's history can be viewed either via the display, or in detail using the Omnifuse™ Syringe Pump Technician software package and a PC. Protocols The Omnifuse™ Syringe Pump Protocol Management System enables relevant hospital protocols to be pre-loaded in the pump. One-off infusions can also be set up using the User Programmed feature. Operation The Omnifuse™ syringe pump is built around an electric stepper motor driving a leadscrew. The leadscrew moves the pusher block that depresses the syringe plunger. The volume of fluid infused over a given period is thus a function of the syringe barrel diameter and the distance that the pusher travels to press in the plunger. This means that the accuracy of the dose being administered is crucially dependent on (i) the accuracy of the motor/leadscrew mechanism, (ii) the pump correctly sensing what size of syringe has been loaded into it, and (iii) the physical characteristics of the syringe itself. The drive mechanism The stepper motor rotates the leadscrew within a nut fixed into the left-hand end of the pusher tube. The pusher block is fixed to the right-hand end of the tube, and as the leadscrew rotates the tube and pusher block slide along a guide rail on the drive chassis. When the motor turns anti-clockwise the leadscrew pulls the pusher block to the left so that it can engage with the head of the syringe plunger. The syringe ear clamp closes to hold the syringe in place and the pusher block then starts to press in the plunger. When the motor rotates clockwise the pusher block disengages from the plunger, then moves rightwards to its limit of travel and opens the ear clamp so that the syringe can be unloaded. The microcomputer controls the speed of the motor and thus the distance travelled by the pusher in a given time. It does this by providing the motor with a pulse train calculated to produce the desired flow rate. The number of actual rotations is monitored by an opto sensor viewing a slotted disc on the motor end of the leadscrew. An alarm is generated if the sensor does not detect exactly the number of pulses that the microcomputer expects during a complete or partial revolution of the leadscrew. The pusher When the pusher block makes contact with the head of a syringe plunger, a pair of clamps engage to grip the head. Meanwhile the ear clamp closes to hold the syringe ear. If the plunger is accidentally dislodged during an infusion the pump immediately stops infusing and an alarm sounds. The sensors In addition to the leadscrew rotation sensor, the following sensors interact with the microcomputer to monitor and control the operation of the Omnifuse™ syringe pump. Syringe size sensor - The system for detecting the size of the syringe loaded into the pump consists of a spring-loaded, manually operated clamp that closes onto the syringe barrel. As the clamp rotates, a flag on its swivelling end interacts with an opto sensor to report the clamp's final resting point as one of seven positions corresponding to seven possible syringe capacities between 2 ml and 50/60 ml. If a syringe does not correspond to one of these capacities or has been incorrectly loaded an INVALID SYRINGE alarm is given. Occlusion sensor - When the pusher block contacts the plunger head during loading, a first-touch sensor inside the block signals to the microcomputer that a syringe is present. The clamp arms then close to grip the head of the plunger. If in-line occlusion sensing has not been installed (or has been disabled in the Configuration menu) a strain-beam pressure sensor inside the pusher block monitors the pressure on the plunger head throughout the infusion. The microcomputer gives an occlusion alarm if this pressure rises above a preset level.

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