Graseby 3400 Technical Service Manual Issue 6 July 2000

SIMS Graseby Ltd.

Copyright and address

Published by SIMS Graseby Limited. All possible care has been taken in the preparation of this publication, but SIMS Graseby Limited accepts no liability for any inaccuracies that may be found. SIMS Graseby reserves the right to make changes without notice both to this publication and to the product which it describes. ©

SIMS Graseby Limited 1999

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 SIMS Graseby Limited.

SIMS GRASEBY LIMITED, COLONIAL WAY, WATFORD, HERTFORDSHIRE, UNITED KINGDOM, WD2 4LG TEL: (+44) (0)1923 246434 FAX: (+44) (0)1923 231595 REGISTERED IN ENGLAND. COMPANY No. 995550

3400 Service Manual

Issue 6 (July 00)

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SIMS Graseby Ltd.

ISSUE RECORD Reason for change

Pages affected

Date

Initial issues

A ll

91 to 93

5

Reissue

All

Dec 99

6

Reissue

All

July 00

6.1

Amendment to three pages

ii, x and 5-10

August 00

6.2

Amendment to two pages

ii and 7-15

Feb 01

Issue No. 1 to 4

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Issue 6.2 (Feb 01)

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Contents

LIST OF CONTENTS Page General ... x Warnings and caution ... x Abbreviations used ... xi

CHAPTER 1 INTRODUCTION, FEATURES, CLASSIFICATION AND SPECIFICATION Introduction ... 1-1 General information ... 1-1 Features ... 1-3 Classification ... 1-3 Specification ... 1-4 Brief history of Graseby bedside syringe pumps ... 1-5

CHAPTER 2 CONFIGURATION & DIAGNOSTIC MODE, AND THRUST ADJUSTMENTS Configuration mode ... 2-1 Calling up the configuration mode ... 2-2 Changing an option ... 2-2 Moving to the next parameter ... 2-2

Configuration parameters and settings that are available Syringe brands ... 2-2 Display language ... 2-3 Bolus beep ... 2-3 Preset bolus dose ... 2-3 Mass units ... 2-3 LCD contrast ... 2-3 Baud rate ... 2-3 Max rate ... 2-3 Diagnostic mode ... 2-4 Calling up the Diagnostic mode ... 2-4 Moving to the next parameter ... 2-4 Diagnostic displays ... 2-4 Exiting from the Diagnostic mode ... 2-5

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Contents

SIMS Graseby Ltd.

CHAPTER 2 (contd.) Page Disassembly and assembly of casing ... 2-5 Taking the casing apart ... 2-5 Assembly ... 2-5 Occlusion measurements ... 2-6 Thrust measurements ... 2-6 Syringe stiction ... 2-6 Thrust checks ... 2-7 Thrust adjustments ... 2-8

CHAPTER 3 FUNCTIONAL DESCRIPTIONS Introduction ... 3-1 Drive system ... 3-1 DC motor and leadscrew ... 3-1 Processor ... 3-1 Toggle mechanism ... 3-1 Plunger clamp ... 3-1 Occlusion sensing system ... 3-2 Clutch assembly and opto-sensor ... 3-2 Occlusion detection ... 3-2 Electro/mechanical control system ... 3-2 Motor speed ... 3-2 Motor rotation ... 3-2 Mechanical characteristics ... 3-2 Sensing (alarm) systems ... 3-3 Introduction ... 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, or syringe not fitted ... 3-3 Syringe sizing system ... 3-3 Software ... 3-4 Design methods ... 3-4 Self tests ... 3-4

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Contents

CHAPTER 4 CIRCUIT DESCRIPTIONS Page Introduction ... 4-1 Main board circuit ... 4-2 Sub-circuits ... 4-2 Processor core circuit ... 4-2 Description ... 4-2 Motor interface circuit description ... 4-3 Introduction ... 4-3 Motor current control ... 4-3 Transients; suppression ... 4-3 Motor speed control ... 4-3 Power control circuit ... 4-4 Logic circuit supply; Vcc ... 4-4 RAM and clock supply ... 4-4 Sensors interface circuit ... 4-4 Introduction ... 4-4 Circuit description ... 4-4 RS232 Interface circuit ... 4-5 Circuit description ... 4-5 Input/output circuit ... 4-5 Front panel interface ... 4-5 LED illumination ... 4-6 Real time clock ... 4-6 Liquid crystal display ... 4-6 Sounder ... 4-6 Regulator board circuit ... 4-7 Introduction ... 4-7 Live circuit and T1 primary description ... 4-7 T1 secondary ... 4-7 Batteries circuit ... 4-7 Overvoltage protection ... 4-8 Plug PL11 outputs ... 4-8 Setting RV1 ... 4-8 Size sensors and board ... 4-9 Opto sensors and board ... 4-9 Umbilical board connections ... 4-9 Umbilical cable connector ... 4-9

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Contents

SIMS Graseby Ltd.

CHAPTER 5 FAULT CODES, CLEANING AND REPAIRS Page Fault codes ... 5-1 Cleaning ... 5-3 Repair procedures ... 5-3 Introduction ... 5-3 Renewal of fuses ... 5-3 Regulator board renewal ... 5-4 Main board renewal ... 5-4 Displacement of the Umbilical board tray ... 5-4 Umbilical board renewal ... 5-5 Opto sensors board renewal ... 5-5 Plunger clamp and super nut assembly renewal ... 5-5 Pole clamp renewal ... 5-6 Leadscrew assembly renewal... 5-6 Removal ... 5-6 Renewal ... 5-7 Releasing the spring pressure ... 5-7 Case assy and checks ... 5-7 Motor and gearbox assembly renewal ... 5-7 Occlusion clutch and disc assy renewal ... 5-7 Membrane switch panel renewal ... 5-8 Super nut renewal ... 5-8 Syringe size sensor board renewal ... 5-9 Plunger clamp repair ... 5-10 Batteries. Checks and replacement ... 5-10 Front and/or rear case repair ... 5-10

CHAPTER 6 FUNCTIONAL TESTS Introduction ... 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

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Contents

CHAPTER 7

Page

ILLUSTRATED PARTS LISTS General assembly ... 7-1 Plunger clamp and half nut assemblies ... 7-6 Pole clamp assembly: non-rotating ... 7-7 Pole clamp assembly: rotating ... 7-8 Leadscrew assembly ... 7-9 Opto sensors board assembly ... 7-10 Size sensors board assembly ... 7-11 Main board assembly ... 7-12 Regulator board assembly ... 7-15 Distribution board assembly ... 7-17

CHAPTER 8 BRAUN PERFUSOR CONVERSION Syringe conversion procedures ... 8-1 Introduction ... 8-1 Nearly empty flag conversion ... 8-1 Spacer tube fitment ... 8-1 Plunger clamp plate fitment ... 8-1 Reassembling case ... 8-1 Braun Perfusor selection ... 8-1 ‘P’ label fitment ... 8-1 Selecting ‘various’ syringe brands ... 8-2 Mechanical procedures ... 8-2 Programming procedures ... 8-2

APPENDIX FITMENT OF NEW MODIFIED SIZE SENSOR FLAG ... rear of manual Introduction ... A-1 Warnings ... A-2 Caution ... A-2 Opening the case ... A-2 Removal of old SSF ... A-2 Reassembly ... A-3 Final testing ... A-3 Setting the Size Sensor Flag ... A-4

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Contents

SIMS Graseby Ltd.

LIST OF FIGURES Figure

Page viii

Page

1.1

Front view of the 3400 pump ... 1-2

2.1

Thrust measuring set up ... 2-7

4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 4.21 4.22

Overall block diagram of the 3400 system ... 4-10 Main board block diagram ... 4-11 Processor core circuit diagram ... 4-12 Motor interface circuit diagram ... 4-13 Power control circuit diagram... 4-14 Sensors interface circuit diagram ... 4-15 Communications (RS232) circuit diagram ... 4-16 Main board input/output interface circuit diagram ... 4-17 Umbilical cable connections diagram ... 4-18 Umbilical board connections diagram ... 4-19 Regulator circuit diagram (overview) ... 4-21 Regulator live circuit diagram ... 4-22 Regulator isolated circuit diagram ... 4-23 Main board: layout of components ... 4-24 Regulator board: layout of components ... 4-25 Syringe size sensors circuit diagram ... 4-26 Syringe size sensors board: layout of components ... 4-26 Opto sensors circuit diagram ... 4-27 Opto sensors board: layout of components ... 4-27 Umbilical board: layout of components ... 4-28 Membrane switch panel ... 4-29 Internal ribbon cable and ‘D’ connector connections ... 4-30

7.1 7.2 7.3a 7.3b 7.4 7.5 7.6 7.7 7.8 7.9

General assembly ... 7-3 Plunger clamp and half nut assembly ... 7-6 Pole clamp assembly: non-rotating ... 7-7 Pole clamp assembly: rotating ... 7-8 Leadscrew assembly ... 7-9 Opto sensors board assembly ... 7-10 Size sensors board assembly ... 7-11 Main board assembly ... 7-13 Regulator board assembly ... 7-16 Distribution board assembly ... 7-17

8.1

Braun Perfusor conversion: parts required ... 8-2

A.1 A.2 A.3

New modified Size Sensor Flag ... A-1 Order of tightening the case screws ... A-3 Size Sensor Flag: general details ... A-4

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Contents

LIST OF TABLES Table

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Page

2.1

Syringe size and max. auto. continuous infusion rate ... 2-3

4.1 4.2

RS232 ‘D’ connector connections ... 4-5 Temperature/voltage range for setting RV1 ... 4-8

5.1 5.2 5.2 5.4

Diagnostic fault codes ... 5-1 Front case spares kit... 5-11 Size Sensor Flag spares kit ... 5-11 Rear case spares kit ... 5-11

6.1

Functional tests ... 6-1

7.1 7.2 7.3a 7.3b 7.4 7.5 7.6 7.7 7.8 7.9

General assembly ... 7-1 Plunger clamp and half nut assembly ... 7-6 Pole clamp assembly: non-rotating ... 7-7 Pole clamp assembly: rotating ... 7-8 Leadscrew assembly ... 7-9 Opto sensors board assembly ... 7-10 Size sensors board assembly ... 7-11 Main board assembly ... 7-12 Regulator board assembly ... 7-15 Distribution board assembly ... 7-17

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Warnings and cautions General

SIMS Graseby Ltd.

This Technical Service Manual (TSM) together with the Instruction Manual for the 3400, contains the information that is required in order to carry out the following actions to the pump: • • •

operation, maintenance, repair.

The TSM is primarily intended to be read and used by suitably qualified personnel. Warnings and cautions are given throughout this manual and are repeated below.

Warnings

Only qualified personnel should maintain and repair the pump. The pump's Configuration or Diagnostic mode must only be used by personnel who have been adequately trained in how to use the pump and have been assigned to enter these modes. The pump must be disconnected from the AC power supply prior to opening the casing. During the setting of RV1 dangerous AC voltages may be present when the case is open. Do not immerse the pump in any liquids. Immediately wipe off any liquid accidentally spilt on the pump. The safety and reliability of the pump may be compromised by the use of parts other than those specified in this Manual. The pump must be set to display the brand and size of syringe that is going to be used. Using a different brand or size of syringe to the one that is going to be used could lead to the incorrect amount of drug being administered, resulting in injury or death. When a new Size Sensor Flag has been fitted, then the pump must be tested using the Syringe Size sensor Gauges available from SIMS Graseby (Part No. 0131- 0202). The Appendix, Page 3 gives details of the Final Testing procedures required. Only items of equipment that conform to EN60950 may be connected to the 9-pin RS232 connector that is situated at the rear of the pump. This conformity will prevent the safety of the patient being compromised. When using a syringe smaller than 50/60 ml on a pump the occlusion pressure will increase as the diameter of the syringe decreases, i.e. the smaller the syringe the higher the pressure. 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.

Cautions

As with all computer electronic equipment, high powered electromagnetic radiation, such as from diathermy eqipment in close proximity, can affect the operation of the pump, although no hazard will be caused. The pump is not suitable for use in the presence of flammable anaesthetics mixture with air, with oxygen or nitrous oxide. The Printed Circuit Boards (PCB) contained in the pump are electrostatically sensitive. Use an earthing strap when handling a PCB to avoid electrostatic damage to the components situated on the PCB. Ensure that replacement PCB are stored in anti-static containers.

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Abbreviations

Abbreviations used

The following list shows the abbreviations that have been used at various places throughout this Manual.

3400 Service Manual

Abbreviation

Full name

A A to D AC C °C CPU cm csk CRC DC Fig. g Hg Hz IC kg KVO LED MCI mA mg ml mm PCA PCB PL PWM PFS R R.F. RAM ROM V

Ampere Analogue to Digital Alternating Current Capacitor Degrees Celsius Central Processing Unit Centimetre Counter-sunk Cyclic Redundancy Check Direct Current Figure Gram Mercury Hertz Integrated Circuit Kilogram Keep Vein Open Light Emitting Diode Manually Controlled Infusion Milliampere Milligram Millilitre Millimetre Patient Controlled Analgesia Printed Circuit Board Plug Pulse Width Modulation Prefilled syringe Resistor Radio Frequency Random Access Memory Read Only Memory Volts

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CHAPTER 1 INTRODUCTION, FEATURES, CLASSIFICATION AND SPECIFICATION

3400 ANAESTHESIA SYRINGE PUMP

SIMS Graseby Ltd.

Introduction

CHAPTER 1 INTRODUCTION, FEATURES, CLASSIFICATION AND SPECIFICATION Introduction

The 3400 anaesthesia syringe pump (Fig. 1.1) is based on a micro-controller design and has been purpose developed by Graseby for the administration of anaesthetics, mainly in a hospital operating theatre. The pump allows a Manually Controlled Infusion, and/or a bolus to be infused using the normal brands of syringe. The infusion entails presetting into the pump both the required infusion rate and the dose of the drug that is going to be used. The pump can be configured by a suitably qualified person to work with any one of several selected brands of syringe, plus, when converted, the Braun Perfusor syringe. The particular brand of syringe selected will be displayed. The diameter of the syringe installed is automatically sensed by the pump and from this dimension and knowing the syringe brand the pump is able to calculate and display the following syringe sizes: 5; 10; 20; 30 and 60 millilitres. The pump is a compact robust unit that is able to function either sitting on a table top or mounted on an IV pole via the pumps pole clamp.

General information

The pump can be configured to: •

deliver a volume or mass unit, manual controlled infusion, or

•

a volume or mass unit bolus infusion.

A running total of the volume of liquid that has been infused is stored in the pump’s totaliser, and will remain available for display even though the infusion may have been stopped and then restarted. The totaliser can be set to zero when required. The pump can be operated from AC power or from internal rechargeable batteries. When functioning on fully charged batteries, and under normal conditions, the pump gives more than ten hours of continual use. The AC power can vary between 100 V and 250 V and 50 to 60 Hz, thus allowing the pump to be used anywhere in the world without adjustment. A battery charging circuit within the pump keeps the batteries charged. The batteries are fully charged when the AC power has been connected to the pump for 14 hours, even though the pump itself may be switched off. Numerous safety features have been built into both the software and the hardware, and the user is warned of such incidents as a power failure or an occlusion by both visible and audible alarms. The pump carries out a self-testing routine each time it is switched on.

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Figure 1.1 Front view of the 3400 pump

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Features

SIMS Graseby Ltd.

Features

Classification

Insulation

The main features of the 3400 are as follows: •

simple to use and easy to service,

•

ergonomic styling,

•

AC powered or internal battery powered,

•

advanced safety features,

•

a selection from several brands of syringe can be made, also the pump may be converted to work with the Braun Perfusor 50 ml syringe,

•

automatic syringe size sensing,

•

a clear text display,

•

a comprehensive range of alarms. For example the pump gives a Syringe Invalid alarm; a syringe Nearly Empty alarm; etc.,

•

designed in consultation with users.

The following classification information applies to the 3400, and is to the IEC 601-1:1988 requirement. The pump is a Class II (double insulated) device. Also classified as internally powered equipment. Type CF (Cardiac Floating) insulation on all inputs.

Fluid ingress

IPX1. In the normal operating position the pump is protected against drops of water falling vertically onto it. It is not safe to use the pump in more severe wet conditions.

Safety (Caution)

The pump is not suitable for use in the presence of inflammable anaesthetics mixture with air, with oxygen or nitrous oxide. As with all computer electronic equipment, high powered electromagnetic radiation, such as diathermy equipment in close proximity, can affect operation, although no hazard will be caused.

Mode of operation

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Continuous.

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Specification

SIMS Graseby Ltd.

Specification

Graseby pumps are subject to continual development and the 3400 may, therefore, differ slightly from the following specification: Dimensions:

325 mm (long) x 195 mm (high) x 115 mm (deep) with the pole clamp fitted and the plunger clamp closed.

Weight:

3.5 kg including batteries and pole clamp.

AC supply:

100 to 240 V, 50/60 Hz, 40 VA. The power supply uses Primary Switching in order to utilise the AC supplies of most countries.

Battery type:

Sealed lead acid, rechargeable (Cyclon, 3 off). SIMS Graseby recommend that the batteries are checked at least annually (see page 5-10).

Battery life:

More than 10 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.

Syringe brands:

BD Plastipak Terumo Braun Omnifix Sherwood Monoject IMS Pump-jet 30 Fresenius Injectomat Braun Perfusor

Flow rate:

Continuous; 0.1 to 400 ml/h in 0.1 ml increments. Mass units; mg/kg/h etc. Bolus; 0.1 to 1200 ml/h in 0.1 ml increments.

Totaliser:

0 to 999.9 ml in 0.1 ml increments.

Adjustable occlusion pressure:

1.85 kg (250 mm Hg) to 7.42 kg (1000 mm Hg).

Temperature range:

Operating conditions: +5° to +40°C, 30 to 75% Rh, 700 to 1060 hPa.

5;10; 20; 30/35 or 50/60 ml. 5; 10; 20; 30/35 or 50/60 ml. 5;10; 20; 30/35 or 50/60 ml. 5; 10; 20; 30/35 or 50/60 ml. 30 ml (prefilled). 50 ml. 50 ml (conversion kit required, refer to Chapter 8).

Storage conditions: -40° to +70°C, 30 to 90% Rh, 700 to 1060 hPa.

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Drive accuracy:

± 2% when measured over a complete syringe.

Design standards:

IEC 601-1.

Elec. safety:

Class II; Type CF.

Languages available:

Selectable via the configuration mode (see page 2-2).

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Development of 3000 series

Brief history of SIMS 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 by SIMS Graseby.

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 micro-processor 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 by SIMS Graseby.

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 by SIMS Graseby.

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. This is the only pump in the 3000 Series that is not fitted with an RS232 connector.

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 (1500 events) 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. A larger liquid crystal display was used on the 3400 with the ability to display text in different sizes, also ‘soft-keys’ 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. (contd.)

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Development of 3000 series

SIMS Graseby Ltd.

Brief history (contd.) 3200 The 3200 was developed as a general purpose syringe pump. Wet-side pressure sensing, intermittent infusion capabilities, and computer interfacing were added. The wet-side 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 increased syringe size range of the 3400 remained. A DC input supply (10 V to 28 V DC) version of the 3200 is also manufactured by SIMS Graseby. This variant is primarily intended for use in an aviation environment. 3500 There are two versions of the 3500, as follows: 1. A Manually Controlled Infusion (MCI) only pump. 2. An MCI plus a Target Controlled Infusion (TCI) pump. The 3500 was developed from the 3400 and retains all the 3400 facilities. The ‘MCI plus TCI’ pump carries out a 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. A 3500 non- TCI pump can be converted to become a 3500 MCI plus TCI pump. 3150 The 3150 is very similar to the 3200 general purpose pump. The main difference being that the In-line (wet-side) pressure sensing system in not available on the 3150, i.e. the pressure transducer is not fitted.

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3400 Service Manual

CHAPTER 2 CONFIGURATION & DIAGNOSTICS MODE, AND THRUST ADJUSTMENTS

3400 ANAESTHESIA SYRINGE PUMP