Smiths 3100 User manual

Graseby 3100
Syringe Pump
Technical Service
Manual
Part Number 00SM-0131-7
August 2004
© 2004 Smiths Medical International Ltd.
Smiths Medical International Ltd.
Published by Smiths Medical International Limited.
All possible care has been taken in the preparation of this publication, but Smiths Medical Interna­tional Limited accepts no liability for any inaccuracies that may be found.
Smiths Medical International Limited reserves the right to make changes without notice both to this publication and to the product which it describes.
© Smiths Medical International Limited 2004
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 by any means without the prior permission of Smiths Medical International Limited.
SMITHS MEDICAL INTERNATIONAL LTD., COLONIAL WAY, WATFORD, HERTFORDSHIRE, UNITED KINGDOM, WD24 4LG
Address
TEL: (+44) (0)1923 246434 FAX: (+44) (0)1923 231595 WEB: www.smiths-medical.com
REGISTERED IN ENGLAND. COMPANY No. 362847.
Trademarks and acknowledgements Graseby and Smiths are registered trademarks of Smiths Group plc.
All other trademarks are acknowledged as the property of their respective owners.
Issue 7 (August 2004)
Page i
Issue Record
Smiths Medical International Ltd.
ISSUE RECORD
Issue No. Reason for change Pages affected Date
1
2
3
4 Reformatted revision All April 3 1995
4.1 Amendment to three pages iii, 6-4 and 8-1 Nov. 24 1995
4.2 Amendment to seven pages Cover, iii, vii, March 1996
4-8, 5-6, 7-8, 7-9
5.0 Reissue of entire Manual All Dec. 1999
6.0 Reissue of entire Manual All July 2000
6.1 Amendment to two pages ii and 5-11 August 2000
7.0 Reissue of entire manual All August 2004
Page ii
Issue 7 (August 2004)
Smiths Medical International Ltd.
Contents
CHAPTER 1 Page
INTRODUCTION, FEATURES and SPECIFICATION
Introduction .......................................................................................................... 1-1
Security cover ...................................................................................................... 1-2
Features .............................................................................................................. 1-2
Specification ........................................................................................................ 1-3
Brief history of Graseby bedside syringe pumps .................................................. 1-4
CHAPTER 2
CONFIGURATION MODE, DIAGNOSTICS MODE and OCCLUSION MEASUREMENT
Configuration mode ............................................................................................ 2-1
Calling up the Configuration mode .............................................................. 2-1
Syringe brand selection.............................................................................. 2-1
Language setting ....................................................................................... 2-2
Setting the AC voltage ......................................................................................... 2-2
Disassembly and assembly of casing ........................................................2-2
AC voltage and fuse adjustment ................................................................ 2-3
Contents
Diagnostic mode .................................................................................................. 2-3
Keying in the diagnostic mode ................................................................... 2-4
Occlusion measurements .................................................................................... 2-4
Thrust measurements ................................................................................ 2-4
Syringe stiction .......................................................................................... 2-4
Thrust checks ............................................................................................ 2-5
Thrust adjustments .................................................................................... 2-6
CHAPTER 3
FUNCTIONAL DESCRIPTIONS
Functional descriptions ....................................................................................... 3-1
Drive system ...................................................................................................... 3-1
Occlusion sensing system ................................................................................... 3-2
Clutch assembly and opto sensor .............................................................. 3-2
Occlusion detection ................................................................................... 3-2
Electro/mech. control system............................................................................... 3-2
Sensing (alarm) systems .................................................................................... 3-3
Syringe nearly empty ................................................................................. 3.3
End of infusion/occlusion ........................................................................... 3-3
AC power failure ........................................................................................ 3-3
Battery voltage low .................................................................................... 3-3
Self tests/pump malfunction ...................................................................... 3-3
Drive disengaged/syringe not fitted ............................................................ 3-3
Syringe size sensors ................................................................................. 3-3
Software ............................................................................................................. 3-4
Issue 7 (August 2004)
Page iii
Contents
Smiths Medical International Ltd.
CHAPTER 4
Page
CIRCUIT DESCRIPTIONS
Circuit descriptions ............................................................................................... 4-1
Main board circuit ................................................................................................. 4-1
Processor core circuit ................................................................................. 4-2
Motor interface circuit ................................................................................. 4-2
Power control circuit.................................................................................... 4-2
Sensors interface circuit ............................................................................. 4-2
Communications processor circuit .............................................................. 4-3
Regulator board circuit .......................................................................................... 4-3
Plug PL11 outputs ...................................................................................... 4-4
Setting RV1 ................................................................................................ 4-4
Syringe size sensors ............................................................................................ 4-5
Opto sensors ........................................................................................................ 4-5
CHAPTER 5
FAULT CODES, MAINTENANCE and REPAIR PROCEDURES
Fault codes ........................................................................................................... 5-1
Faults code, 0 to 92 .................................................................................... 5-1
Faults code, 100 to 112 .............................................................................. 5-2
Maintenance ......................................................................................................... 5-3
Cleaning ..................................................................................................... 5-3
Fuse renewal .............................................................................................. 5-3
Repair procedures ................................................................................................ 5-3
Main board renewal .................................................................................... 5-4
Regulator board renewal ............................................................................ 5-4
Opto sensors board renewal ...................................................................... 5-5
AC transformer renewal .............................................................................. 5-5
Plunger clamp and half nut assembly renewal............................................ 5-6
Pole clamp assembly renewal .................................................................... 5-6
Leadscrew assembly renewal..................................................................... 5-7
Motor and gearbox assembly renewal ........................................................ 5-8
Occlusion clutch and disc assembly renewal.............................................. 5-8
Membrane switch panel renewal ................................................................ 5-9
Super nut renewal .................................................................................... 5-10
Syringe size sensors board renewal ......................................................... 5-10
Plunger clamp repair ................................................................................. 5-11
Batteries. Checks and replacement........................................................... 5-11
Front and/or rear case repair ..................................................................... 5-11
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Issue 7 (August 2004)
Smiths Medical International Ltd.
CHAPTER 6
FUNCTIONAL TESTS
Functional tests .................................................................................................... 6-1
Plunger clamp alarm checks ................................................................................ 6-4
Ramp check procedures ............................................................................. 6-4
Linear accuracy .................................................................................................... 6-5
Test procedures .......................................................................................... 6-5
Plunger clamp alignment ...................................................................................... 6-5
Test procedures .......................................................................................... 6-5
CHAPTER 7
ILLUSTRATED PARTS LIST
General assembly ................................................................................................ 7-1
Plunger clamp assemblies .................................................................................... 7-6
Pole clamp assembly ........................................................................................... 7-7
Rotating pole clamp assembly .............................................................................. 7-8
Leadscrew assembly ............................................................................................ 7-9
Main board assembly ......................................................................................... 7-10
Regulator board assembly .................................................................................. 7-11
Contents
Page
CHAPTER 8
BRAUN PERFUSOR CONVERSION
Syringe conversion procedures ............................................................................ 8-1
Reselecting ‘various’ syringe brands .................................................................... 8-2
APPENDIX
Fitment of New Modified Size Sensor Flag .......................................................... A-1
Nearly empty flag .......................................................................................8-1
Spacer tube fitment .................................................................................... 8-1
Plunger clamp plate ................................................................................... 8-1
Braun Perfusor selection ............................................................................ 8-1
‘P’ label fitment .......................................................................................... 8-1
Mechanical procedures .............................................................................. 8-2
Programming procedures ..........................................................................8-2
Introduction ............................................................................................... A-2
Fitment of modified SSF ........................................................................... A-2
Final testing .............................................................................................. A-3
Setting the size sensor flag ....................................................................... A-4
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Page v
Figures and Tables
Smiths Medical International Ltd.
LIST OF FIGURES
Figure Page
1.1 General views of the 3100 pump ................................................................................ 1-1
2.1 Rear case screw fixing order ...................................................................................... 2-3
2.2 Thrust measuring set up ............................................................................................ 2-5
4.1 Overall block diagram ................................................................................................ 4-7
4.2 Main board block diagram .......................................................................................... 4-9
4.3 Processor core circuit diagram ................................................................................. 4-10
4.4 Motor interface circuit diagram ................................................................................. 4-11
4.5 Power control circuit diagram ................................................................................... 4-12
4.6 Sensors interface circuit diagram ............................................................................. 4-13
4.7 Communications processor circuit diagram .............................................................. 4-14
4.8 Regulator board circuit diagram ................................................................................ 4-15
4.9 Syringe size sensors circuit ..................................................................................... 4-17
4.10 Opto sensors circuit ................................................................................................. 4-17
4.11 Membrane switch panel circuit ................................................................................. 4-18
5.1 Half nut (obsolete)/ Super nut ................................................................................... 5-10
5.2 Strengthened rear case moulding ............................................................................. 5-11
6.1 Outline of dual ramp gauge ........................................................................................ 6-4
6.2 Size sensor flags ....................................................................................................... 6-4
6.3 Linear accuracy gauge ............................................................................................... 6-5
6.4 Taper gauge ............................................................................................................... 6-5
7.1 General assembly ...................................................................................................... 7-3
7.2 Plunger clamp assemblies ......................................................................................... 7-6
7.3a Pole clamp assembly ................................................................................................. 7-7
7.3b Rotating pole clamp assembly ................................................................................... 7-8
7.4 Leadscrew assembly ................................................................................................. 7-9
7.5 Main board assembly diagram ................................................................................. 7-11
7.6 Regulator board assembly ........................................................................................ 7-12
8.1 Braun Perfusor conversion: parts required .................................................................. 8-2
A.1 New modified Syringe Size Sensor flag...................................................................... A-1
A.2 Case fixing screw tightening order.............................................................................. A-3
A.3 Size Sensor Flag: general details ............................................................................... A-5
LIST OF TABLES
Table Page
4.1 Plug PL11 outputs ..................................................................................................... 4-4
4.1 Temperature/voltage range for setting RV1 ................................................................. 4-5
5.1 Main processor faults code ........................................................................................ 5-1
5.2 Slave processor faults code ....................................................................................... 5-2
5.3 Front case spares kit ............................................................................................... 5-12
5.4 Size Sensor Flag spares kit ..................................................................................... 5-12
5.5 Rear case spares kit ................................................................................................ 5-13
6.1 Functional testing of 3100 .......................................................................................... 6-1
A-1 3100 syringe size sensor gauge ................................................................................. A-5
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Issue 7 (August 2004)
Smiths Medical International Ltd.
Warnings and cautions
Introduction
This Technical Service Manual for the 3100 together with the Instruction Manual for the pump, contains all the informa­tion that is needed in order to operate, maintain and repair the pump. The contents of this Technical Service Manual is primarily intended to be read and used by suitably qualified personnel. Only qualified personnel should repair
and maintain the pump.
AC input power connecting socket/cable
The AC input power socket that connects to the rear of the pump has three connections (live, neutral and earth) provided by a 3-way power cable. As the casing is doubly insulated, the AC input connector situated on the pump only utilises two connections (live and neutral), there is no third earth pin. This method of AC input enables similar AC input sockets (if required) to that supplied by Smiths Medical International to be used.
Warnings and cautions
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.
WARNINGS
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.
not
4. WARNING: To avoid possible malfunction of the pump, do 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 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: 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.
not
13. WARNING: Do indicate a FAULT condition and the pump will fail to infuse. Incorrect performance of the pump can cause complications resulting in patient injury or death.
If the pump develops a fault then it must be referred to a suitably qualified engineer or returned to Smiths Medical in order to have the fault rectified.
14. WARNING: Failure to use the mains lead clamp 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.
use a faulty pump. If the pump develops a fault then an alarm will sound; the display will
Service Manual’s
maintenance schedule recommendations may result in
expose the pump to X- rays, gamma rays or
Issue 7 (August 2004)
Page vii
Warnings and cautions
15. 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.
16. WARNING: Use only the syringes and administration sets listed in the 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.
17. WARNING: The volume of fluid contained in the connecting tubing is a residual amount and will 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.
18. 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.
19. 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 actuator 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.
20. 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.
21. 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.
22. 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.
23. WARNING: When using a syringe smaller than 50/60 ml the occlusion pressure will increase as the diameter of the syringe decreases, i.e. the smaller the syringe the higher the pressure.
24. WARNING: The patient history is lost when the clock is reset.
25. WARNING: Only adequately qualified personnel should maintain and repair the pump.
26. WARNING: The pump must be disconnected from the AC power supply before the case is opened.
27. WARNING: The Configuration and Diagnostic mode must only be used by personnel who are adequately qualified and have previous training in the use of the pump.
28. WARNING: The safety and reliability of the pump may be compromised by the use of parts other than those specified in this Manual.
29. WARNING: When a new Syringe Size Sensor Flag has been fitted to the pump (see Appendix), then the pump must be tested using the new syringe size sensor gauges available from Smiths Medical (part number 0131-0202). Page 3 of the Appendix gives details of the Final Testing procedures.
30. WARNING: The pump must be set to display the brand and the size of syringe that is going to be used. Using a different brand or size of syringe to that being displayed could lead to the incorrect amount of drug being administered, that could result in injury or death.
31. WARNING: The internal pump batteries must be disposed of in accordance with the manufacturers instructions. Lead acid batteries must NOT be placed in the normal waste stream.
Smiths Medical International Ltd.
Specification
(Chapter 1).
not
be infused.
Page viii
Issue 7 (August 2004)
Smiths Medical International Ltd.
Warnings and cautions
CAUTIONS
Cautions tell you about dangerous conditions that can 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
2. CAUTION: When turning the pump on if screens similar to those illustrated are not displayed, do pump. Send the pump to a suitably qualified engineer or return it to Smiths Medical in order to have the fault rectified.
3. CAUTION: Do not use cleaning and disinfecting agents other than the approved ones specified here.
4. CAUTION: The pump must spills immediately, and do not allow fluid or residues to remain on the pump. Additionally, the pump is not designed to be autoclaved, steam-sterilised, ETO-sterilised or subjected to temperatures in excess of 45° C (113° F). Failure to observe this caution may cause serious damage to the pump.
5. CAUTION: During the removal and replacement of a pump's components, strict observance to Electro Static Discharge (ESD) rules must be observed at all times, i.e. an earthing strap must be worn. Failure to apply ESD protection may result in serious damage to the product and possible malfunction. Ensure that any replacement printed circuit board or other ESD sensitive items are stored in an anti-static container.
not
be carried out.
not
be immersed in any liquids or exposed to strong organic solvents. Wipe off
not
use the
Issue 7 (August 2004)
Page ix
Abbreviations
Smiths Medical International Ltd.
Abbreviations The following list shows the abbreviations that have been used at various places used throughout this Manual.
Abbreviation Full name
A to D Analogue to digital AC Alternating current C Capacitor or Centigrade COP Computer operating properly cm Centimetre cNm Centinewton meter csk Countersunk DC Direct current deg. Degrees dia. Diameter µg Micro gramme Fig. Figure g Gramme Hg Mercury symbol Hz Hertz IC Integrated circuit IM Instruction manual Kg Kilogram Khz Kilo Hertz KVO Keep vein open LCD Liquid crystal display LED Light emitting diode mA Milliampere mg Milligramme ml Millilitre mm Millimetre No. Number PCA Patient controlled analgesia PCB Printed circuit board Pl Plug R Resistor RAM Random access memory ROM Read only memory V Volts VFD Vacuum fluorescent display
Page x
Issue 7 (August 2004)
CHAPTER 1
INTRODUCTION, FEATURES and SPECIFICATION
Graseby 3100 Syringe Pump
Smiths Medical International Ltd.
CHAPTER 1
INTRODUCTION, FEATURES and SPECIFICATION
Introduction
Introduction
The 3100 syringe pump is microcomputer controlled and has been purpose developed for administering sterile liquids. All the controls are clearly marked and easy to use. The user is provided with a constant indication of the 3100’s operation; the dot matrix Vacuum Fluorescent Display (VFD) presents the display in any one of seven major
European languages.
The 3100 is a compact robust pump that can operate from a table top or a pole clamp.
The pump can be programmed by the user to work with a range of different makes of syringe and automatically senses the diameter of the syringe installed and hence its volume. The syringe sizes that the pump caters for are 20 ml, 30 ml and 50/60 ml.
Figure 1.1 General view of the 3100 pump
3100 Service Manual 1 — 1 Issue 7 (August 2004)
Introduction
Smiths Medical International Ltd.
Introduction
(contd.)
The 3100 is easily configured to dispense liquids at rates between 0.1 ml/hour and 199.9 ml/hour in increments of 0.1 ml. The pump keeps a running total of the volume of infused liquid even when the infusion has been stopped and then restarted.
The pump can be operated from AC power or from three internally fixed rechargeable batteries. When running on battery power, the pump gives more than three hours of continual use. The pump contains a battery recharging circuit and the batteries will be fully charged when the pump has been connected to the AC power for up to 14 hours (see Note below) - even when the pump is switched OFF.
Note:
The battery charging period may have to be slightly increased above 14 hours if the pump is infusing during the charging period.
Safety features have been built into both the software and the hardware. The pump carries out a self-testing routine each time it is switched on. The user is warned of incidents such as a power failure or an occlusion by both visual and audible alarms.
Two micro-controllers are installed in the pump and are used to combine the following facilities:
non-volatile Random Access Memory (RAM),
analogue to digital conversion,
communications circuitry, and
internal watchdog, COP (Computer Operating Properly).
Security cover
Features
The above facilities are usually provided by up to six separate silicon chips. The use of highly integrated micro-controllers greatly increases the reliability of the 3100.
The motor within the pump is under the direct control of the primary micro-controller. For added security, the primary micro-controller’s actions are monitored by the slave processor.
An optional security cover kit is available (part number 0131-0277). The kit includes all the items required to modify the pump, including comprehensive fitting instructions.
When fitted, the kit protects the syringe from tampering only; it provides no other security. It does not lockout the keypad or give audible or visual alarms when opened.
The main features of the 3100 are:
simple to use,
ergonomic styling,
easy to service,
AC powered or internal battery powered,
advanced safety features,
caters for different brands of syringe,
automatic syringe size sensing,
clear text display,
comprehensive range of alarms,
designed in consultation with users,
drip proof (IPX1)
state-of-the-art electronics, and
numerous Warnings accompanied by an audible and visual alarm, including a three minute nearly empty syringe warning,
all materials used in this product are latex free.
1 — 2
Issue 7 (August 2004)
3100 Service Manual
Smiths Medical International Ltd. Features
Specification
Graseby instruments are subject to continual development and may, therefore, differ from the following specification:
Dimensions: 325 mm (long) x 195 mm (high) x 115 mm (deep), with a pole
clamp, and the plunger clamp closed.
Weight: Not exceeding 3.5 kg including batteries and pole clamp.
Supply 220 V to 240 V AC at 50/60 Hz 15 VA or, voltage: 100 V to 120 V AC at 50/60 Hz 15 VA.
Battery type: Sealed lead acid, rechargeable (Cyclon, 3 off). The batteries should
be checked at least annually (see page 5-11).
Battery life: More than 3 hours of normal pump operation when the batteries are
fully charged. With the AC supply connected, up to 14 hours will be
required to fully recharge low voltage batteries.
Useable BD Plastipak ... Size 20; 30 or 50/60 ml. syringes: Braun Omnifix ... Size 20; 30 or 50/60 ml.
Monoject ... Size 20, 30/35 or 50/60 ml. Terumo ... Size 20; 30/35 or 50/60 ml. Injectomat 50 ml ... Size 50/60 ml. Braun Perfusor ... 50 ml (conversion kit required,
refer to Chapter 8).
Flow rate: 0.1 to 199.9 ml/hour in 0.1 ml increments.
Volume 0 to 999.9 ml in 0.1 ml increments. infused counter:
Adjustable 250 mm Hg to 600 mm Hg. occlusion pressure:
Temp. range: Operating conditions:
-5° to +40°C, 30 to 75% Rh, 700 to 1060 hPa.
Storage conditions:
-40° to +70°C, 30 to 90% Rh, 700 to 1060 hPa.
Drive +/– 2%. accuracy:
Design BS 5724 Part 1. standards: IEC 601 Part 1.
VFG 1046/I984.
Elec. safety: Class II; Type CF; Drip proof.
Language English, Dutch, French, German, Italian, Portugese and Spanish. versions:
3100 Service Manual 1 — 3 Issue 7 (August 2004)
Specification
Brief history of Graseby bedside syringe pumps
MS2000
The first Graseby bedside syringe pump was the MS2000. This was a basic syringe pump capable of infusions within the range of 0.1ml/hr to 99.9ml/hr. It had a totaliser, a limited infusion capability, a built in pole clamp and was designed for vertical operation. The MS2000 was powered by an AC supply or its internal DC batteries. This pump is no longer manufactured.
PCAS
The PCAS pump was developed from the MS2000 to satisfy the growing interest in Patient Controlled Analgesia (PCA). The PCAS was very similar to the MS2000 in both appearance and mechanical design, but utilised a different microprocessor with the capability of running the extra features required for PCA and was eventually replaced by the 3300 pump. A printer port was also incorporated. This pump is no longer manufactured.
3000
The first pump in the 3000 Series of syringe pumps was the 3000 itself. This pump was designed as a low-cost alternative to the MS2000 and satisfied the need for a horizontally mounted pump. The 3000 did not have an internal battery supply. This pump is no longer manufactured.
3100
The 3100 syringe pump was developed from the 3000. It is very similar mechanically but the electronic design is superior. Dual processors were incorporated along with a vacuum fluorescent text display and internal batteries. The maximum infusion rate was increased to 199.9 ml/hr and different syringe sizes were able to be used (automatically sensed). Extra software features, such as the intelligent ‘near end’ alarm, were also incorporated.
3300
The next bedside syringe pump to be developed was the 3300. This was similar in mechanical and electronic design to the 3100 but the features were specifically for the now more mature PCA market. A lockable syringe cover was added for security against drug theft, a four line LC display was added, and internal history recording with printout was also added. With the growth in PCA knowledge in the medical community, many more software features were incorporated into the 3300 to aid PCA administration.
3400
The 3400 was developed (again from the 3100) to satisfy the need for a high speed infusion pump for intravenous anaesthesia. Advances in micro-controller technology allowed the use of a single device to control all the pumps features. The maximum infusion rate was raised to 1200.0 ml/hr and bolusing facilities were also added. Later, an infusion rate calculation facility was added to the software.
Smiths Medical International Ltd.
A larger liquid crystal display was used on the 3400 with the ability to display text in different sizes, also ‘soft­keys’ were used to make the user interface simpler. The range of syringe sizes that could be used was also increased. For more advanced applications the pump could be controlled by a computer.
3200
The 3200 was developed as a high end general purpose syringe pump. In-line pressure sensing, intermittent infusion capabilities and computer interfacing were added. The In-line occlusion pressure monitoring made the pump particularly suitable for use in intensive care baby units. A large text vacuum fluorescent display was added and the range of increased syringe sizes of the 3400 remained.
3500
There are two versions of the 3500, as detailed below:
a Manually Controlled Infusion (MCI)
a MCI
The 3500 was developed from the 3400 and retains all the 3400 facilities. The ‘MCI TCI using the Diprivan drug. This version of the 3500 incorporates a Diprifusor module manufactured by Zeneca
Pharmaceuticals. A new main circuit board and new software allows the 3500 to interface with the Diprifusor module.
3150
The 3150 is very similar to the 3200 general purpose pump. The main difference being that the In-line pressure sensing system is not available on the 3150, i.e. the pressure transducer is not fitted.
plus
a Target Controlled Infusion (TCI) pump.
only
pump,
plus
TCI’ pump carries out a
1 — 4
Issue 7 (August 2004)
3100 Service Manual
CHAPTER 2
CONFIGURATION MODE, DIAGNOSTIC MODE,
and OCCLUSION MEASUREMENT
Graseby 3100 Syringe Pump
Smiths Medical International Ltd.
CHAPTER 2
CONFIGURATION MODE, DIAGNOSTIC MODE and OCCLUSION MEASUREMENT
Configuration mode
Configuration mode
Calling up the Configuration mode
Syringe brand selection
The Configuration mode allows both the syringe brand and the language required to be displayed and entered before using the pump.
CAUTION The Configuration mode procedures must only be undertaken by suitably qualified medical personnel.
1. When in the Set-up mode (refer to the 3100 Instruction Manual), simultaneously hold down ... either of the extreme right hand 0.1 arrow buttons (or ▼ ) and the PURGE button.
The display will show the following:
CONFIGURATION?
2. Within five seconds, press the START button to confirm that the Configuration mode is required. If the START button is not pressed within five seconds the pump will revert back to its Set-up mode.
Note:
The pump has been designed so that the Configuration mode will not be called up accidentally.
WARNING The 3100 must be set to operate with the selected syringe. Using the wrong selection could lead to the incorrect amount of drug being administered.
With the pump in its Configuration mode (as detailed above), complete the following procedures in order to select the syringe brand required.
1. Use either of the two extreme left hand 100 arrow buttons (or ) to display the last syringe brand that was used.
2. Use either of the two extreme right hand 0.1 arrow buttons (or ) in order to scroll to the syringe brand required (see below). The brand of syringe selected will be retained by the pump until the Configuration mode is called up again and a
different brand is selected.
BD Plastipak.
Terumo.
Braun Omnifix.
Monoject.
Injectomat 50 ml.
Note:
The Braun Perfusor 50 ml syringe can only be used when the pump has been converted to accept this particular syringe (see Chapter 8).
3. Press the STOP button in order to exit the Configuration mode.
3100 Service Manual Issue 7 (August 2004) 2 — 1
Configuration mode
Language setting With the pump in its Configuration mode (as detailed previously), complete the
following procedures to select the required language.
1. Use either of the two extreme left hand 100 arrow buttons (or ) to scroll and display the last language that was used.
2. Use either of the extreme right hand 0.1 arrow buttons (or ) in order to scroll and display the language required (see below). The language selected will be retained by the pump until the Configuration mode is called up again and a different language is selected:
English
Dutch
French
German
Italian
Portuguese
Spanish
3. To exit the Configuration mode, press the STOP button.
Smiths Medical International Ltd.
Setting the AC voltage
Disassembly and assembly of casing
WARNINGS
1. The following procedures must only be carried out by qualified technicians.
2.
ELECTRIC SHOCK HAZARD.
power supply before opening the casing.
CAUTION If the AC supply voltage settings are altered the label on the underside of the pump and also the AC fuse rating must be changed to indicate and cater for the new AC voltage.
The pump can be set to operate on a 100 to 120 V or a 220 to 240 V AC 50/60 Hz supply. To change the AC operating voltage settings (as fully detailed in the following sections) the pump casing has to be opened and two push-on connectors on the Regulator board have to be adjusted.
The AC supply fuse rating must also be changed.
Each time the case is taken apart, the Syringe size sensor tests (see page 6.1) must be completed.
1. Disconnect the AC power connector and using a scratch free flat surface, turn the pump over in order to gain access to its base.
2. Undo and retain the six screws that hold the casing halves together. One of the six screws is situated in a channel in the rear cover.
3. From the top of the pump carefully ease the casing halves apart, taking care not to put any strain on the internal connecting cable looms that form a hinge between the two halves.
The pump must be disconnected from the AC
4. Being careful not to trap any leads, assemble the casing by reversing steps (2) and (3) above. Ensure that the front and rear mating edges are equal and parallel. The screws should be tightened to a torque of between 70 and 75 cNm and in the order shown
2 — 2 Issue 7 (August 2004) 3100 Service Manual
Figure 2.1
.
Smiths Medical International Ltd.
Setting the AC voltage
AC voltage and fuse adjustment
GM0595-B
1
5
3
4
2
6
Rear view of pump
Figure 2.1 Rear case screw fixing order
1. Take the casing apart (see page 2-2).
2. Check/ alter the position of the two push-on connectors situated on the
Regulator board (these connectors are attached to a black and a grey wire). The alternative settings are as follows:
220-240 V 100-120 V
Grey: PL4 Grey: PL7 Black: PL8 Black: PL3
Diagnostic mode
3. Move the two blank insulated connectors so that they cover the two unused
alternative voltage terminals.
4. Remove the cover that is placed over fuse FS2. If required fit the correct
time delay fuse, as shown below:
T 50 mA for 220-240 V.
T 100 mA for 100-120 V.
5. Fit the fuse cover ensuring that the cover goes outside all of the spring
connectors.
6. Assemble the casing (see page 2-2).
7. If necessary stick a new voltage label over the existing label on the underside of
the pump. The new label must correctly specify the pump's present AC voltage.
The pump has a Diagnostic mode which enables the four following parameters to be checked:
the version of software that is installed in the Main processor,
the software Cyclic Redundancy Check (CRC),
the version of software that is installed in the Slave processor, and
the voltage from the power supply to the Main board, or with the AC removed will display the battery voltage.
The pump has been designed so that the Diagnostic mode has to be specifically keyed in. It will be very unlikely that this mode will appear on the display accidentally.
3100 Service Manual Issue 7 (August 2004) 2 — 3
Voltage and fuse adjustment
Smiths Medical International Ltd.
Keying in the diagnostic mode
Occlusion measurements
By carrying out the following procedures the pump will be transferred from its Set-up mode (refer to the 3100 Instruction Manual) to its Diagnostic mode:
1. Simultaneously press and hold down the following two buttons ... the ALARM
).
▼▼
▼▼
or
)
in
button and either the right hand up or down arrow button (0.1,
2. Within five seconds press the START button to confirm that the Diagnostic mode is required. If the START button is not pressed within five seconds the pump will revert back to its Set-up mode.
3. Press either the extreme left hand up or down arrow button (100, order to scroll through the four Diagnostic parameters listed above.
4. Press the STOP button to exit the Diagnostic mode.
The two most frequently used methods to measure the point at which an occlusion occurs are the thrust and pressure methods.
Currently, the occlusion is set at during manufacture by using a thrust measurement procedure. This method measures the plunger clamp thrust by using a set of weights (as described on the next page).
The occlusion pressure is obtained by measuring the pressure that occurs in the infusion line. This in-line method requires the use of a new syringe, infusion line and pressure gauge. Conversion between the two is achieved using the formulae below, taking into consideration syringe stiction.
The internal occlusion sensing system within the pump is always active.
or
Thrust measurements
Syringe stiction
The occlusion thrust checks must be carried out whenever the super nut assembly is dismantled.
Translation of the thrust depends on the syringe diameter and the stiction of the syringe. The formula for calculating the thrust is given below:
T = P x A +
732
where
: T = the thrust in kg,
P = the delivery pressure in mmHg, A = the cross sectional area of the syringe in cm2,
and
The occlusion thrust of the pump is factory set to be between two limits (i.e. a minimum and a maximum tolerance). The customer may reset the thrust for their own particular requirement. The thrust of a particular pump may, therefore, differ from the original factory set level.
The occlusion thrust of the 3100 pump is factory set at between
3.5 kg and 4.2 kg (471 mmHg and 565 mmHg).
Stiction for a syringe varies from brand to brand as well as from batch to batch. Stiction can be as low as 0.1 kg and as high as 2 kg. The stiction of some syringe brands has been found to be particularly high.
S = the syringe stiction in kg.
S
Stiction can also vary along the plunger travel and is usually lowest in small diameter syringes. Using a sample syringe and allowing for a safety margin for sticky syringes, adjustments can be made by measuring the thrust generated. If the stiction characteristics of a syringe are known then by using the formula given above the occlusion thrust can be set.
2 — 4 Issue 7 (August 2004) 3100 Service Manual
Smiths Medical International Ltd.
Occlusion thrust
Thrust checks
The following thrust checks detailed use the weights that correspond to the factory set occlusion threshold levels for a 3100 (i.e. 3.5 and 4.2 kg). If a different occlusion level setting is required, the weights must be adjusted accordingly.
The threshold level adjustment procedures are detailed on page 2-6.
1. Set the pump's plunger clamp to approximately midway along its support tube.
2. Remove the plunger from a BD 60 ml syringe and then saw the end off the
syringe. Place the modified syringe onto the pump so that it acts as a guide for the weight support rod and also position the size sensor flag (see
Figure 2-2
).
3. With the pump switched ON, set the infusion rate to 200 ml/hr.
4. Place the pump in a vertical position, with its left hand side uppermost (see
Figure 2-2
5. Place the weight support rod through the modified syringe and onto the pump's
plunger clamp.
6. Place a weight of 3.5 kg on top of the weight support and check that the pump
operates for at least 30 seconds and does not occlude (i.e. the alarm does not sound). Remove the weight.
7. Place a weight of 4.2 kg on top of the weight support and check that within 60
seconds the pump does occlude (i.e. the alarm sounds).
).
GM0241-A
MID-WAY POINT
WORK SURFACE
WEIGHTS
WEIGHT SUPPORT
1 0 . 0
m l / h r
SYRINGE BODY (MODIFIED)
SYRINGE BARREL CLAMP
SYRINGE SIZE SENSOR
G
S y r
r
in
a
g e
s e
P u
b
m
y
p
2
3
5
0
0
0
m
m
/ 6
l
l
0 m l
SYRINGE PLUNGER CLAMP
Figure 2.2 Thrust measuring set up
3100 Service Manual Issue 7 (August 2004) 2 — 5
Occlusion thrust
Thrust adjustments If the occlusion thrust requires adjustment, the following procedures must be
completed:
1. Switch the pump off and disconnect the AC supply.
2. Take the casing apart (see page 2-2).
3. If necessary rotate the leadscrew to reveal the grub screw that is located on the occlusion adjusting nut. Loosen the grub screw with a 1.5 mm hexagonal key.
4. Alter the setting of the occlusion adjusting nut as necessary. One full turn of the adjusting nut gives approximately 2.73 kg (369 mmHg) of adjustment.
Rotating the adjusting nut in order to decrease the tension on the leadscrew spring will decrease the pump's occlusion setting.
Rotating the adjusting nut in order to increase the tension on the leadscrew spring will increase the pump's occlusion setting.
5. Tighten the grub screw to a torque of 15 ± 2 cNm.
6. Temporarily assemble the two halves of the pump, being careful not to trap any leads.
7. Carry out a thrust check (see page 2-5).
Smiths Medical International Ltd.
8. In order to obtain the thrust required it may be necessary to repeat steps (2) to (7) above.
9. Finalise the Assembly of the pump casing (refer to page 2-2).
10. Carry out the tests listed below and fully detailed in the functional test procedures (see page 6-1 onwards):
Test 4 ... syringe size sensors,
Test 7 ... accuracy of infusion,
Test 9 ... plunger clamp alignment, and
Test 10 ... clamp open.
2 — 6 Issue 7 (August 2004) 3100 Service Manual
CHAPTER 3
FUNCTIONAL DESCRIPTIONS
Graseby 3100 Syringe Pump
Smiths Medical International Ltd.
CHAPTER 3
FUNCTIONAL DESCRIPTIONS
This Chapter explains how the 3100 operates. Reading this chapter will help a technician to rectify any possible faults that may occur within the pump.
The functional descriptions of the pump may divided into five separate areas, and each of these functional descriptions have been detailed separately in the descriptions that follow:
Drive system,
Occlusion sensing system,
Electro/mechanical control system,
Sensing (alarm) systems,
Software.
Functional descriptions
Drive system
The drive system comprises a stepper-motor working through a gearbox in order to rotate a leadscrew. A half nut/ super nut assembly engages onto the leadscrew; the assembly is also connected to a steel tube. The steel tube is connected to the plunger clamp. Thus the rotation of the leadscrew will move the plunger clamp and this movement will push ‘in’ the plunger on the syringe that is being used, as further described below.
As the stepper-motor spindle rotates the leadscrew rotates and the half nut/ super nut assembly travels to the left, along the leadscrew. The half nut/ super nut assembly pulls the outer of two steel tubes to the left. This outer tube travels over and along a support tube; the support tube is the length of the pump.
The pulses applied to the stepper-motor are derived from a microcomputer. The microcomputer and its associated software determines the speed of the stepper­motor. To ensure safe operation of the stepper-motor the microcomputer controls the stepper-motor directly.
A spring-loaded toggle mechanism is attached to the bottom of the half nut. This toggle mechanism enables the plunger clamp to be physically swung ‘in or out’ thus rotating the outer metal tube so that the half nut is either fully ‘engaged or disengaged’ (respectively) from the leadscrew.
When the plunger clamp is pushed ‘in’, the half nut/ super nut engages with the leadscrew and the pump's plunger clamp ‘grabs’ the end of the syringe. The syringe plunger slots into place behind a slotted pair of lips. These lips prevent the syringe plunger from moving forward in the event of negative pressure on the syringe.
A small push-button on the edge of the plunger clamp makes contact with the top of the syringe plunger. This push-button controls the operation of a lever which projects from the plunger clamp. When the push-button is pressed in, by coming into direct contact with the top of the syringe, the lever becomes free and is able to retract into the plunger clamp. This retraction takes place when the plunger clamp is physically swung into the forward operating position.
(contd.)
3100 Service Manual Issue 7 (August 2004) 3 — 1
Functional descriptions
Smiths Medical International Ltd.
Drive system (contd.)
If the push-button is not pressed ‘in’, the lever remains in its outward position thus preventing the plunger clamp from being moved. This in turn prevents the half nut from engaging on the leadscrew. This push-button system prevents the leadscrew from being engaged unless the top of the syringe is correctly positioned in the plunger clamp.
If the plunger clamp is accidentally knocked out of place during an infusion it will automatically and safely shut down and an alarm will sound.
The motor, gearbox, leadscrew and associated components are mounted on a glass reinforced polycarbonate casing. The strength of this casing enables a precise mechanical location to be achieved for the components. Both the inner and outer metal tubes are made of substantial material in order to eliminate all unwanted flexing.
Occlusion sensing system
Clutch assembly and opto-sensor
The occlusion sensing system consists of a clutch, spring mechanism, a rotating slotted disk and opto OPTO1 (see page 7.10). The clutch and spring mechanism comprise the back pressure system. The rotating slotted disc and OPTO1 comprise the rotation detector. The clutch, slotted disc and OPTO1 are located at the left hand end of the leadscrew, underneath the opto sensor board. The spring is located at the right hand end of the leadscrew.
Occlusion detection
Electro/mech. control system
The clutch is held engaged by the spring with a pressure sufficient to overcome any resistance from the syringe plunger and the normal back pressure from the infusion line. The rotation detector will generate an output that comprises a continuous set of pulses when the leadscrew rotates.
If there is an occlusion in the line then the back pressure will rise as the pump attempts to force fluid through the line. When there is sufficient pressure to overcome the spring pressure (factory set at 500 mm Hg) then the leadscrew moves to the right, losing contact with the clutch. The rotation detector no longer generates an output, which results in an occlusion alarm.
This method of occlusion detection is extremely sensitive as it is the lack of pressure on the clutch that generates the alarm, rather than the detection of the movement of the leadscrew as used in traditional designs. UK patent number 2249
497.
The microcomputer produces the pulse train for the stepper-motor in order to produce a set flow rate. The rotation of the leadscrew slotted disc (described above) is monitored by the movement of the slots and detected by the opto-sensor. If the appropriate pulses are ‘not’ detected by the opto-sensor then an alarm signal is generated.
Brief mechanical characteristics of the system are:
motor step angle ... 15 degrees,
gearbox reduction angle ... 210:1,
number of motor steps per 5,040 at all times,
revolution of leadscrew ...
leadscrew pitch ... 5 mm, and
syringe characteristics ... 1 ml/ 1.8 mm (BD 60 ml syringe).
3 — 2 Issue 7 (August 2004) 3100 Service Manual
Smiths Medical International Ltd.
Functional descriptions
Sensing (alarm) systems
Syringe nearly empty
End of infusion/ occlusion
AC power failure
Battery voltage low
In addition to the occlusion sensing system (see page 3-2) the following sensing systems are also operative within the 3100.
A metal flag protrudes from the left hand side of the half nut (in parallel with the leadscrew), this is the nearly empty flag. When this flag deactivates OPTO 0 (see
Figures 4.10
slotted disc is still rotating, then the processor makes a calculation that depends on the infusion rate, and issues an alarm three minutes before the end of the infusion.
Also, when the processor detects that OPTO 0 is deactivated, and the slotted disc has also stopped rotating, then a OCCLUSION alarm is generated.
Although the above condition has been termed an alarm state, the same conditions will occur when the syringe reaches the end of its travel at the end of a perfectly normal infusion.
If the slotted disc stops rotating and the nearly-empty flag has not moved a sufficient distance to the left to deactivate OPTO 0 then the alarm condition will be that of occlusion (see page 3-2).
The sensing system is able to detect an AC power failure. The pump will continue to run after a power failure for a period of three hours or more, by automatically switching over to its internal battery supply.
The sensing system also monitors the output of the batteries and registers an alarm if the voltage of the batteries drops below 5.75 V.
and
7.5
) that is situated at the left hand side of the leadscrew, and the
Self tests/ pump malfunction
Drive disengaged/ syringe not fitted
Syringe size sensors
If the voltage falls below 5.4 V the pump will turn itself off after an initial warning period.
Various ‘self tests’ are carried out on the pump when it is first switched on. In addition to the self tests the rotation of the slotted disc at the end of the leadscrew is monitored to ensure that the drive mechanism is operating correctly. The software continually checks itself for the validity of calculations.
The drive system is designed so that it is only engaged when the top of the syringe is correctly positioned in the plunger clamp. If the plunger clamp is knocked out of place during an infusion the drive will automatically stop (the disengagement of the half nut is detected by an opto-sensor). Also, trying to operate the 3100 without a syringe or with a syringe incorrectly fitted will cause the pump to go into an alarm state.
The pump has a syringe size sensor flag which rests on the barrel of the loaded syringe in order to measure its diameter. This spring retained sensor flag moves up and down in a bottom case groove. The bottom of the flag moves in-and-out between two opto sensors (depending upon the diameter of the syringe) and this action results in four sensor conditions being available:
top opto sensed ... no syringe,
neither opto sensed ... 20 ml syringe,
bottom opto sensed ... 30 ml syringe,
both opto's sensed ... 50 ml syringe.
3100 Service Manual Issue 7 (August 2004) 3 — 3
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