Graseby 3150 Syringe Pump Instruction Manual March 2002

Graseby 3150 Syringe Pump

Instruction Manual

Published by Graseby Medical Limited. All possible care has been taken in the preparation of this publication, but Graseby Medical Limited accepts no liability for any inaccuracies that may be found. Graseby Medical reserves the right to make changes without notice both to this publication and to the product which it describes. Graseby Medical seek to constantly improve their products, therefore, the specification of the 3150 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 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. All other trademarks are acknowledged as the property of their respective owners.

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.

Graseby 3150

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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 and administration sets listed in the Specification at the end of this manual. Failure to do so may result in an inaccurate delivery. Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used. Incorrect function or performance of the pump can cause complications resulting in patient injury or death. 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.

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Graseby 3150

Syringe pump 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 3150 Syringe pump and harm the operator or the patient. As a result, the operator or patient may suffer direct injury, or the 3150 Syringe pump may fail to operate correctly, leading to patient injury or death. 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 instructins 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.

U.S.A. and Canada

Graseby 3150

Federal law in the U.S.A. and Canada restricts this device to sale by or on the order of a licensed Medical Practioner.

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Syringe pump CONTENTS Section

Graseby 3150

Page

1.

Switching on ... 5

2.

Loading the syringe ... 6

3.

Infusion settings ... 8

4.

Starting the infusion ... 15

5.

Giving a bolus infusion ... 16

6.

Total volume infused counter ... 16

7.

History recall ... 17

8.

Stopping the infusion ... 18

9.

Switching off ... 19

10.

Intermittent infusion mode ... 20

11.

PC or printer connection ... 24

12.

Built in clock ... 27

13.

Alarms, cause and action ... 28

14.

Battery operation ... 43

15.

Placement of pump ... 44

16.

Configuration mode ... 45

17.

Care of the pump ... 49

18.

Standards ... 51

19.

Specifications ... 53

Page 1

Syringe pump

INTRODUCTION

Thank you for choosing a Graseby 3150 bedside syringe infusion pump. This Instruction Manual contains important information on operating and looking after your pump. To ensure that you are completely familiar with all of the pump’s features, please take time in reading this Manual before switching on. It is important that all users of the 3150 have received the correct training in how to use the pump. The Graseby 3150 is a microcomputer controlled pump developed for administration of sterile liquids. This compact, robust pump is designed to sit on a table top or to be mounted on an IntraVenous (IV) pole or bed rail, and is able to operate with 5, 10, 20, 30, 35, 50 and 60 ml syringes. All the controls are clear and easy to use. A dot matrix fluorescent display provides the user with a constant indication of the pump’s operation. The pump can be adjusted by the user to work with a range of types of syringe and automatically senses the syringe size. The pump can be set to dispense liquids at rates of 0.05 to 200.0 ml/h , in steps of 0.01 ml/h between 0.05 - 1.0 ml/h, and in steps of 0.1 ml/h between 1.0 - 200 ml/h. A variety of mass unit infusion rates (e.g. mg/kg/h) are offered in addition to the usual ml/h infusion rate. Occlusion sensing is monitored by the adjustable internal occlusion sensing mechanism. The pump keeps a running total of the volume of liquid infused, even when the infusion is stopped and restarted. This totaliser is time and date stamped to simplify charting of infusion data. Safety features have been built into the pump and its software. The pump carries out self testing routines every time it is switched on. Users are warned of such incidents as occlusion or power failure by both visible and audible alarms. The pump can be run from the power supply, or from internal rechargeable batteries which give more than three hours of use. The flexibility of the pump is maintained by the use of a configuration program which allows customising of the pump's features to the users own requirements, thus removing unnecessary programming steps.

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Graseby 3150

Syringe pump

FEATURES

Graseby 3150

The main features of the 3150 are shown below: -

0.05 to 200.0 ml/h infusion rates may be selected.

-

Automatic syringe size sensing for 5, 10, 20, 30/35 or 50/60 ml syringes.

-

Can be configured to accept syringe types from most manufacturers.

-

Continuous, preset or intermittent infusion modes may be selected.

-

State-of-the-art electronics.

-

Infusion in either ml/h or in mass units ( e.g. mg/kg/h).

-

AC supply or battery operated (the batteries are rechargeable).

-

RS232 printer or PC connection available.

-

History log of up to 1,500 events.

-

Configuration mode for selecting the numerous options.

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Syringe pump

The 3150 Syringe pump

Figure 1 Front view of pump The 3150 is the first of a new generation of syringe pumps which can be customised to fit each hospital unit's exact requirements. It has a large range of features not found on other syringe pumps and can be made to function in a simple or sophisticated manner in order to meet today’s infusion requirements, with provision for tomorrow’s needs. The Configuration options available to the user are detailed in Section 16. For battery operation refer to Section 14.

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Graseby 3150

Syringe pump 1. Switching on

Insert the power supply lead into the rear of the pump and secure the lead with the clamp as shown in Figure 2, this action will prevent the lead from being accidentally pulled out of the pump.

Figure 2 Power lead clamp Connect the pump to the power supply. The AC power indicator lamp will illuminate. Press the ON key to switch on the pump. A brief self-test procedure will then be performed, during which a bleep will be heard. The pump is now in ‘set-up’ mode, ready for an infusion rate to be set. In the unlikely event of a fault being detected during the selftest procedure a continuous audible alarm will sound and a fault code will be displayed. 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. 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.

Graseby 3150

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Syringe pump

2. Loading the syringe

2.1

Syringe brand When the pump is switched ON the display will briefly indicate which syringe brand the pump is calibrated for. 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. Syringe brand BD PLASTIPAK BD PLASTIPAK (A)* BRAUN OMNIFIX BRAUN PERFUSOR IMS PUMPJET INJECTOMAT MONOJECT TERUMO

Syringe sizes available 5ml, 10ml, 20ml, 30/35ml, 50/60ml. 5ml, 10ml, 20ml, 30/35ml, 50/60ml. 5ml, 10ml, 20ml, 30/35ml, 50/60ml. 50ml, optional (see TSM, Appendix). 30ml only. 10ml and 50ml. 5ml, 10ml, 20ml, 30/35ml, 50/60ml. 5ml, 10ml, 20ml, 30/35ml, 50/60ml.

* The BD Plastipak (A) syringe selection is there to accommodate the American manufactured 10 ml syringe, which is slightly different in length to the European version. All other syringe sizes in the BD Plastipak (A) selection are identical to the standard BD Plastipak syringe.

If a syringe size smaller than 50/60 ml is going to be used for an infusion the following WARNING must be observed. 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 WARNING: Use only the syringes and administration sets listed in the Specification at the end of this manual. Failure to do so may result in an inaccurate delivery. Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used. Incorrect function or performance of the pump can cause complications resulting in patient injury or death. 2.2

Page 6

Priming the syringe Fill the syringe in the normal way, ensuring that all the air is expelled.

Graseby 3150

Syringe pump 2.3

Inserting the syringe Swing the syringe plunger clamp away from the body of the pump, until it clicks and then slide the plunger clamp fully to the right. Pull the syringe barrel clamp upwards and insert the primed syringe into the syringe trough. Ensure at the same time that the ear of the syringe is located in the groove and pushed fully to the left. The syringe size sensor should rest on the syringe barrel and the syringe size indicator lamp should indicate the syringe size. Lower the syringe barrel clamp onto the syringe. Slide the plunger clamp to the left until it is touching the plunger. Swing the clamp back until it clicks over the syringe plunger. Ensure the plunger cross piece is correctly placed within the slot in the actuator clamp. 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 overinfusion leading to patient injury or death.

Note:

Figure 3

Pre-infusion checks

The syringes are disposable types for single-use only. Graseby 3150

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Syringe pump

3. Infusion settings

3.1

Settings memory Turn the pump ON. After the SELF TEST has completed the pump will enter one of its three infusion modes, according to the mode in which it was last used. The following explanation assumes that the pump powers up in the CONTINUOUS mode (the following sections give details of the other two pump modes).

3.2

Setting the ml/h infusion rate If the previous ml/h rate is not the rate required then it can be altered by pressing the arrow keys underneath the display. The infusion rate can be set between 0.05 ml/h and 200 ml/h. The settings will increase by 0.01 ml/h between 0.05 and 1.0 ml/h, and 0.1 ml/h between 1.0 and 200 ml/h. The rate will change more rapidly if the arrow key is kept depressed. It is advised that smaller size syringes should be used for low flow rates.

3.3

Confirming the continuous infusion mode It may be necessary to confirm the continuous mode at this point, if so, press ENTER and confirm/set the display to:

INFUSION MODE = CONTINUOUS 3.4

Selecting a mass unit infusion rate A mass unit infusion can only be given for CONTINUOUS infusions. If an INTERMITTENT or PRESET infusion is selected the infusion units will become ml/h. When the CONTINUOUS mode is selected and the use of mass units is allowed (via the Configuration mode) the numerical values and units that are shown in the following sections (e.g. infusion units, patient weight, etc.) will be as previously selected.

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Graseby 3150

Syringe pump 3.4.1

Press the ENTER key. The display will show which infusion units are being used and will be similar to the following display:

INFUSION UNITS = ml/h 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. Select the required mass unit (see below) by pressing the arrow keys. The mass unit options available will be any or all of the following: 3. mg/kg/min 1. mg/kg/h 2. µg/kg/h 4. µg/kg/min 5. mg/h 6. µg/h. When the required mass units are shown on the display, press ENTER to confirm the selection. 3.4.2

Patient body weight (options 1 to 4 above only) The display will show the previous patient's weight:

PATIENT BODY WEIGHT = 40.00 Kg

(Range = 0.4 - 200.0 kg)

Change the weight to that of the current patient using the arrow keys and confirm by pressing the ENTER key. 3.4.3

Enter drug mass

DRUG MASS = 3.0 mg

(Range = 1µg - 999.0 mg)

The display will show the mass of drug used in the previous infusion. Use the arrow keys to change this to the mass of drug that was used to make up the present infusate.

Graseby 3150

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Syringe pump

3.4.4

Press ENTER to confirm the desired drug mass. Drug volume

DRUG VOLUME = 2 ml (CONC’N = 1.5 mg/ml)

(Range = 1ml - 60ml)

The display will show the volume of fluid that was added to the drug mass to make up the infusate. The resultant drug concentration is shown in brackets. Use the arrow keys to change the desired drug volume. Press ENTER to confirm the desired drug volume. 3.4.5

Infusion rate

(Range = 0.01 - 999.0)

INFUSION RATE = 1.0 mg/kg/h Use the arrow keys to change the infusion rate to the desired setting (refer to section 18 for range of infusion rates). Press ENTER to confirm.

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Graseby 3150

Syringe pump 3.5

End of menu

END OF MENU PRESS START TO RUN Pressing the green START key will commence running the infusion. 3.6

Infusing options One of the following displays will be shown, depending on which option has been selected in the pump configuration mode: i) Normal mass unit Infusion display.

1.0 mg/kg/h ii) SHOW RATE IN ml/h WHILE INFUSING, selected in configuration mode.

25.4 ml/h (M) At any time during the infusion, the entered parameters (i.e. the patient weight, mass and volume) can be viewed by sequentially pressing the ENTER key. The pump will be in its standby mode allowing you to step through (but not change) the settings.

Graseby 3150

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Syringe pump 3.7

Giving a preset volume infusion (if configured) Whilst in the standby (not infusing) mode press the ENTER key until the display shown below appears:

INFUSION MODE = CONTINUOUS INFUSION Press the arrow keys to change to:

INFUSION MODE= PRESET VOLUME Press the ENTER key to confirm your selection. The pump will prompt you to enter the desired infusion rate:

INFUSION RATE = 12 ml/h Select the desired rate with the arrow keys and press ENTER to confirm. The INFUSION MODE display will again appear. Press ENTER and the display shown below will appear:

PRESET VOLUME = 12.5 ml

(Range = 0.2 - 99.9 ml)

Enter the desired PRESET VOLUME to be infused.

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Graseby 3150

Syringe pump Pressing ENTER once more reaches the end of the menu:

END OF MENU PRESS START TO RUN

Press START to commence the Infusion. The screen will display the Infusion rate and the preset volume remaining:

5.1 ml/h 13.4 ml REMAINING

When the preset volume has been infused the pump will alarm and enter Keep Vein Open (KVO) mode, infusing at 0.5 ml/h (or less if set rate is less, see section 13.3.3). Pressing the STOP key will suspend the infusion, thus allowing the syringe to be changed.

INFUSION SUSPENDED CHANGE SYRINGE ? Press START to continue the infusion. Press STOP to reprogram the infusion. 3.8

Adjusting the infusion rate whilst infusing (if configured) The pump has the option of adjusting the infusion rate without stopping the infusion; this allows titration of the drug dose to its physiological effect on the patient.

Graseby 3150

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Syringe pump If this option has been selected pressing the ENTER key will display the infusion rate, as shown below:

NEW INFUSION RATE = 12.3 ml/h Use the arrow keys to change the displayed infusion rate to the new, desired level and press the START key to confirm and action this new infusion rate. 3.9

Maximum infusion rates for different syringe sizes The maximum infusion rates for the range of syringe sizes are as follows: Max. infusion rate Syringe size 200 ml/h 50/60 ml 100 ml/h 30/35 ml 60 ml/h 20 ml 45 ml/h 10 ml 30 ml/h 5 ml The maximum infusion rates also apply to the purge and bolus infusions. Note: The pump can have a set maximum allowable infusion rate via the pump’s configuration program. If the maximum allowable infusion rate is exceeded an alarm message is shown briefly when the START key is pressed and the pump will not infuse (see section 13.1.3).

3.10

Start-up time The time taken for a syringe pump to achieve the set infusion rate after being started is known as the start-up time. The start-up time is dependant on the infusion rate and the syringe size. The higher the infusion rate the faster the start-up time. Smaller syringes give better results at any given flow rate. Typical start-up times for the pump, using a 50 ml syringe are three minutes at 5 ml/h and 15 minutes at 1 ml/h (independant test data)1.

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Graseby 3150