Graseby 3500 Syringe Pump Instruction Manual Aug 2002

Graseby 3500 Anæsthesia Syringe Pump with optional TCI

Instruction Manual

Published by Graseby Medical Limited. All possible care has been taken in the preparation of this publication, but Graseby Medical Limited accepts no liability for any inaccuracies that may be found. Graseby Medical reserves the right to make changes without notice both to this publication and to the product which it describes. Graseby Medical seeks constantly to improve their products, therefore, the specification for the 3500 pump is subject to change. Copyright © 2002 Graseby Medical Limited. No part of this publication may be reproduced, transmitted, transcribed, or stored in a retrieval system or translated into any human or computer language in any form or by any means without the prior permission of Graseby Medical Limited. GRASEBY MEDICAL LIMITED, Colonial Way, Watford, Hertfordshire, United Kingdom, WD24 4LG TELEPHONE: (+44) (0)1923 246434. FAX: (+44) (0)1923 231595. http://www.graseby.co.uk REGISTERED IN ENGLAND. COMPANY No. 995550

Trademarks and acknowledgements: “Graseby”; “Smiths”; and “Flo-Safer” are all trademarks of Smiths Group plc. Zeneca Trademark ‘DiprifusorTM’ (Target Controlled Infusion...TCI, Software/ Subsystem/System) and the stylized D with arrow logo are trademarks, the property of Zeneca Limited (Astra Zeneca). All other trademarks are acknowledged as the property of their respective owners.

Anaesthesia Syringe Pump Warnings

Warnings tell you about dangerous conditions that could lead to death or serious injury to the user or patient that can occur if you do not obey all of the instructions in this manual. 1. 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 X- rays, gamma rays or ionizing radiation, or to the RF interference or strong electric/magnetic fields emitted (for example) by diathermy equipment or mobile telephones. If the pump is used in the presence of, or in combination with Magnetic Resonance Imaging (MRI) machines it must be protected from the magnetic field emitted by such equipment. Malfunction of the pump can cause incorrect infusion or loss of infusion resulting in patient injury or death. 5. 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.

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Anaesthesia Syringe Pump 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. 13. WARNING: Do not use a faulty pump. If the pump develops a fault then an alarm will sound; the display will 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 Graseby 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. 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 listed on page 7-3. Failure to do so may result in an inaccurate delivery. Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used. Incorrect function or performance of the pump can cause complications resulting in patient injury or death. 17. 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. 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. 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 3500 pump and harm the operator or the patient. As a result, the operator or patient may suffer direct injury, or the 3500 pump may fail to operate correctly, leading to patient injury or death.

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Anaesthesia Syringe Pump 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

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 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 a suitably qualified engineer or return it to Graseby 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 not be immersed in any liquids or exposed to strong organic solvents. Wipe off spills immediately, and do not allow fluid or residues to remain on the pump. Additionally, the pump is not designed to be autoclaved, steam-sterilised, ETOsterilised or subjected to temperatures in excess of 45° C (113° F). Failure to observe this caution may cause serious damage to the pump. 5. CAUTION: If the pump is used in close proximity to a fluid bag(s), it should where possible, not be mounted directly underneath the fluid bag(s). This is to minimise the possible risk of damage to the pump from fluid ingress should the bag rupture or leak during use.

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Anaesthesia Syringe Pump

List of Contents

Page For the attention of U.S.A. and Canadian users ... ix

CHAPTER 1 INTRODUCTION, OVERVIEW AND FEATURES Introduction ... 1-1 Overview of 3500 ... 1-2 Features ... 1-6

CHAPTER 2 SWITCHING ON/OFF AND LOADING A SYRINGE Operational keys ... 2-1 Switching the pump on ... 2-2 Set-up mode ... 2-2 Switching the pump off ... 2-5 Loading a syringe ... 2-5 Syringe sizes and maximum rates (Normal mode) ... 2-8 Purging the system ... 2-9 Positioning the pump for use ... 2-10

CHAPTER 3 USING THE PUMP FOR A TCI INFUSION Introduction ... 3-1 Parameters for set-up mode ... 3-3 Parameter value invalid ... 3-4 Start-up mode ... 3-6 Tag erasure ... 3-7 Tag unrecognised ... 3-7

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Anaesthesia Syringe Pump Page

Contents (contd.)

Suspending and then stopping an infusion ... 3-8 Changing the target value ... 3-9 TCI totaliser ... 3-10 INFO sequence ... 3-11 Alarm during TCI ... 3-14 Guidance on the administration of Diprivan ... 3-15

CHAPTER 4 USING THE PUMP FOR A NORMAL INFUSION Switching on ... 4-1 Set-up mode for ml/h ... 4-1 Set-up mode for mass units ... 4-4 Stopping a normal infusion ... 4-7 Normal infusion start up time ... 4-8 Changing the rate while infusing ... 4-8 Totaliser access and resetting procedures ... 4-9 Hands on bolus procedures ... 4-10 Hands free bolus procedures ... 4-12

CHAPTER 5 ALARMS Introduction ... 5-1 Urgent alarms ... 5-2 Quiet alarms ... 5-9 Soft alarms ... 5-12 TCI alarms ... 5-16

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Anaesthesia Syringe Pump

CHAPTER 6 PUMP CONFIGURATION Configuration mode ... 6-1 Configuration settings available ... 6-3 Setting the date and time ... 6-5

CHAPTER 7 STANDARDS AND SPECIFICATION Standards ... 7-1 Specification ... 7-3 Cleaning and maintenance ... 7-5

List of Figures

Figure 1.1 1.2 1.3 2.1 2.2 2.3

Front view of the 3500 with Diprifusor ... 1-3 Front view of the standard pump ... 1-3 Cable clamp ... 1-5 Checks to ensure syringe is loaded corrected ... 2-6 Plunger clamp and release buttons ... 2-7 Diprifusor syringe ... 2-7

Index

Index: rear of manual ... Index 1

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Anaesthesia Syringe Pump Abbreviations used The following abbreviations have been used within this Manual. Abbrev.

Full name

Abbrev.

Full name

AC Ccalc Ctarget cm DC FDA h Hg hPa kg kPa KVO LCD

Alternating current Current calculated plasma concentration Target plasma concentration Centimetre Direct current FOOD AND DRUG ADMINISTRATION Hour Mercury Hectopascal Kilogram Kilopascal Keep vein open Liquid crystal display

LED Max. mg min. ml mm PC PFS psi TCI µg V

Light emitting diode Maximum Milligram Minutes Millilitre Millimetre Personal computer Pre filled syringe Pounds per square inch Target controlled infusion Microgram Volts

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Anaesthesia Syringe Pump For the attention of U.S.A. and Canadian users Federal law in the U.S.A. and Canada restricts this device to sale by or on the order of a licensed Medical Practioner.

Application information required by the FDA For Epidural Applications please note: 1.

The device can be used for analgesic infusion.

2.

Infusion may be short-term (up to 96 hours), or long-term in accordance with the catheter and drug labelling.

3.

Use only catheters indicated for epidural administration.

4.

Infusion sets with Y-connection sites should not be used for epidural applications.

5.

The device must be used to administer only those analgesics which are approved for epidural administration as indicated on the drug labelling.

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Anaesthesia Syringe Pump

CHAPTER 1 Introduction

INTRODUCTION, OVERVIEW AND FEATURES The 3500 anaesthesia syringe pump is based on a micro-controller design which has been developed by Graseby Medical for the administration of intravenous anaesthetics in the anaesthetic room or operating theatre. There are two versions of the pump, as follows: •

a standard 3500 (Fig. 1.2) for administration of manually controlled infusions.

•

a 3500 with the Zeneca Diprifusor (Fig. 1.1) for administration of either manually controlled infusions or target controlled infusions (TCI).

The two pumps may be distinguished by looking at the front panel markings. The TCI pump has a front panel that shows the Diprifusor brand name and the ‘Diprivan’ logo as shown below:

The standard 3500 does not have this front panel logo. This Instruction Manual covers both versions of the pump. The TCI pump can be used in both ‘TCI mode’ (for administration of target controlled infusions) or ‘Normal mode’ for manually controlled infusions. The standard 3500 operates in normal mode only. TCI mode

In this mode the 3500 uses a Zeneca Prefilled Syringe (PFS) for TCI. During a TCI, the infusion rate will be controlled by the Diprifusor module in order to achieve and then maintain a desired Target Plasma Concentration. A tag on the PFS ear allows positive identification of the Diprivan drug when the pump is being used in TCI mode.

Normal mode

In this mode the 3500 may be used to perform a manually controlled infusion and/or bolus using an appropriate brand of syringe. A manual infusion entails setting the required infusion rate and, if appropriate, the drug concentration and patient weight.

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Anaesthesia Syringe Pump Overview of 3500 Introduction

This compact and robust pump is able to sit on either a bedside table-top or to be attached to a bedside pole mount. All the controls are clear and easy to use. A front panel Liquid Crystal Display (LCD) provides the user with a constant visual indication of the pump’s activities. The syringe sits in a trough on top of the pump.

‘Diprifusor’ target controlled infusion (TCI mode)

Syringe size (Normal mode)

Syringe brand (Normal mode)

Continuous infusion rates

This pump incorporates the Diprifusor subsystem developed by Zeneca Pharmaceuticals for the administration of Diprivan by TCI. Electronically tagged pre-filled syringes of Diprivan (1% or 2%) are required for the operation of the Diprifusor TCI system. See also the section of the Manual produced by Zeneca as Guidance on the administration of Diprivan by target controlled infusion, (page 3-20). The 3500 accepts the following sizes of syringe - 5, 10, 20, 30/35, and 50/60 ml - and automatically senses and displays the size of syringe that is fitted to the pump. The pump can be configured to work with a syringe of any one of a range of manufacturers brands (see page 7-3). The brand of syringe being used is not automatically sensed by the pump. The user is required to observe from the display that the brand of syringe for which the pump is configured corresponds to the brand that is being used. The 3500 can be programmed to infuse at continuous (maintenance) rates of 0.1 to 400 ml/h in steps of 0.1 ml/h.

(Normal mode)

Dose rate calculations (i.e. weight/drug concentration) are also possible, allowing an infusion rate to be programmed in a range of units (e.g. mg/kg/h; mg/min etc.).

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Anaesthesia Syringe Pump

Figure 1.1 Front view of the 3500 with Diprifusor

Figure 1.2 Front view of the standard 3500

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Anaesthesia Syringe Pump Bolus infusion (Normal mode only)

The bolus infusion rate can be adjusted from 0.1 ml/h to 1200 ml/h in steps of 0.1 ml/h and the bolus infusion audible alarm can be silenced (e.g. for operating theatre use). ‘Hands Free’ bolus By presetting the dose and rate/duration a Hands Free bolus can be administered by just pressing and releasing the BOLUS button, thus leaving the hands free (see page 4-14). ‘Hands On’ bolus The Hands On bolus is delivered by presetting the rate and then keeping the BOLUS button pressed while the required bolus is delivered (see page 4-11).

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Total volume infused

The pump records the volume ( and mass if infusing in mass units) of liquid infused, adding it to the stored total already infused. The stored total may be displayed on request and may be cleared in preparation for a new infusion.

Configuration mode

The configuration mode (see page 6-1) allows a trained person to configure the pump.

Diagnostic mode

The diagnostic mode allows a trained person to view numerous parameters of the pump (e.g. software version, total hours of operation since manufacture, etc.). The Technical Service Manual, part number 00SM-0138 details the diagnostic mode. The diagnostic details are not contained in this manual.

Safety features

Safety features have been built into the pump’s hardware and software including a set of self-tests which run each time the pump is switched on. Also, audible and visual alarms are activated for various incidents which include Clamp Open, Syringe Invalid; Rate Invalid; Review Settings (see Chapter 5).

Operating position

The pump must be operated in a horizontal position. The adjustable rotating pole clamp enables the pump to be positioned horizontally when a non-vertical IV pole is used.

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Anaesthesia Syringe Pump AC supply and connector

The pump is able to run on AC power supplies between 100 V AC and 240 V AC at 50/60 Hertz. Push the plug into the pump before switching on the AC power. Locate the AC cable under the cable clamp (see Fig. 1.3) this prevents the connector from being accidentally pulled out of the pump. The AC supply LED will be illuminated.

Figure 1.3 Cable clamp 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.

Battery operation

When an AC supply is not available, e.g. during a power failure or patient transport, the pump may be run from its internal batteries. When fully charged they will power the pump for a minimum of 10 hours under normal conditions. (see page 7-3) The batteries will be fully charged when the pump has been connected to an AC supply (AC LED on) for a minimum of 10 hours (whether the pump is turned on or off). Battery operation is indicated by the following: • the AC LED is not illuminated. • the message... ON BATTERY will be permanently displayed in the top left hand corner of the display. When on battery power the display backlight will come on when a button/key is pressed and will remain on for two minutes after the last key button is pressed. 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.

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Anaesthesia Syringe Pump Features

The major features of the pump are as follows: • ability to run target controlled infusions (3500 with Diprifusor). The TCI module incorporated within the pump recognizes the tagged Diprivan pre- filled syringe, and the pump will only carry out a TCI infusion when the PFS syringe is detected. • fast infusion rate for specific applications, • AC supply with battery backup (the batteries are rechargeable). • bolus facility, • large text display, • infusion totaliser, • mass units calculation, • ability to use different syringe sizes (with automatic detection), • intelligent near empty alarm system, • the pump is configurable to display messages in different languages.

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CHAPTER 2 SWITCHING ON/OFF AND LOADING A SYRINGE Operational keys

The actions that take place when the various keys on the pump are pressed are listed below. Any active key pressed will be accompanied by a short beep, unless disabled from within the configuration mode.

Operational buttons and keys Button

Action

ON

Power on.

OFF

Power off (unless infusing).

START

Starts an infusion. Also used to confirm diagnostics/configuration/set date & time modes.

STOP

Stops the infusion. Silences the alarm.

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BOLUS

Performs the bolus infusion (multiple button press is required). Disabled if in TCI mode.

Key

Action

0 to 9 and decimal point

Used to set parameter values.

Cancel

Used to clear the parameter value entered.

Four soft keys (▲)

Software programmable functions, dependent on current mode.

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Anaesthesia Syringe Pump Switching the pump on Self test sequence

Pressing the ON button will switch the pump on and 2 short beeps will be heard (confirming hardware and software functionality through self-testing). During the self-test all the LEDs will be illuminated (if the pump is operating on batteries the AC LED will not be illuminated). The following display will appear during self test: TESTING ... When the self-test has been completed the START and ALARM LEDs will be switched off. WARNING: Do not use a faulty pump. If the pump develops a fault then an alarm will sound; the display will 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 Graseby Medical in order to have the fault rectified.

Set-up mode

If the pump is working correctly the self-test mode will exit to the set-up mode. A standard 3500 will enter it’s Normal mode set-up (see page 4-1). A 3500 with Diprifusor may enter Normal mode set-up , TCI mode set-up, or the select mode set-up depending on the configuration mode selected (i.e. MODE = NORMAL/TCI/BOTH).

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Anaesthesia Syringe Pump Select mode

The following screen is displayed:

SELECT MODE ... TCI

NORMAL

▲ ) will enter the Normal mode set-up. Pressing the NORMAL soft key (▲ ▲ ) will enter the TCI mode set-up. Pressing the TCI soft key (▲ If a key is not pressed within two minutes the pump will switch off. The STOP LED will not be illuminated while the select mode screen is displayed.

Normal mode setup

A screen similar to the one shown below will be displayed: BD PLASTIPAK 60 RATE =

0 . 07 mg/kg/mn UNITS

(315.0 ml/h) ENTER PURGE

TOTAL

This is the first display for the Normal mode set-up for a mass units infusion with mg/kg/mn selected (see page 4-4).

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