Graseby 3100 Syringe Pump Instruction Manual March 2002

Graseby 3100 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 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. 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. 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.

Graseby 3100

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Syringe pump 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. 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 3100 Syringe pump and harm the operator or the patient. As a result, the operator or patient may suffer direct injury, or the 3100 Syringe pump may fail to operate correctly, leading to patient injury or death.

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Graseby 3100

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, 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: 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 3100

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

Page

Contents

Graseby 3100

1.

Switch On ... 3

2.

Loading the Syringe ... 5

3.

Setting the Infusion Rate ... 7

4.

Purging the Infusion Line ... 8

5.

Starting the Infusion ... 8

6.

Using the Totalizer ... 8

7.

Stopping the Infusion ... 8

8.

Switch Off ... 9

9.

Alarms ... 9-16

10.

Battery Operation ... 16

11.

Positioning the pump for use ... 17

12.

Care of the Pump ... 18

13.

Standards ... 20

14.

Specification... 22

1

Syringe pump Introduction

Thank you for choosing a Graseby 3100 Syringe Pump. This Instruction Manual contains important information on operating and looking after your pump. So that you are completely familiar with all of the pump’s features please take the time to read this manual before switching the pump on. It is important that all users of the 3100 Syringe Pump should be trained in how to use the pump. The Graseby 3100 Syringe Pump is micro-computer controlled and developed by Graseby Medical Ltd for the administration of sterile liquids. This compact, robust unit is designed to sit on a table top or to be mounted on a pole clamp. (Part No. 0131-0129). It caters for 20, 30, 50 and 60ml syringes. All the controls are clear and easy to use. The pump incorporates a dot matrix VFD display that provides the user with a constant indication of the pump’s operation. The pump can be programmed by the user to work with one of a range of makes of syringe and automatically senses the syringe size. It can easily be set to dispense liquids at rates of 0.1 to 199.9ml/hr (with a 50/60ml syringe) in steps of 0.1ml. The pump keeps a running total of the volume of liquid infused, even when the infusion is stopped and restarted (or switched off). Safety features have been built into the pump and its software. The Graseby 3100 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 unit can be run from mains power, or from internal rechargeable batteries which give three to four hours of use. Designed in consultation with users, key features are: • Simple to use • Ergonomic styling • Simple to service • Battery or mains power • 3 minute near empty warning alarm • Drip proof • Purge facility • Automatic syringe size sensing

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• Clear text display • Comprehensive range of alarms, including the detection of an incorrectly placed syringe. • Advanced safety features • Caters for different makes of syringe

Graseby 3100

Syringe pump The Graseby 3100 pump

Diagram 1.

1. Switch On

Connect to AC power. For battery operation refer to section 9. Insert the AC power lead into the rear of the pump. Secure the mains lead with the clamp as shown in Diagram 2, to prevent it from being accidentally pulled out of the pump.

Diagram 2. The Mains Lead Clamp Connect the pump to the AC power supply. Graseby 3100

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Syringe pump 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.

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Graseby 3100

Syringe pump 2. Loading the Syringe

2.1 Syringe Brand When the pump is switched on (Section 1) the display will briefly indicate which syringe brand the pump is calibrated for. 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. Refer to a qualified technician or Graseby Medical to re-calibrate the pump to accept any of the following syringe brands and sizes: Syringe brand

Syringe sizes suitable

BD BRAUN OMNIFIX TERUMO MONOJECT FRESENIUS

20ml, 30/35ml, 50/60ml 20ml, 30/35ml, 50/60ml 20 ml, 50/60 ml, 50/60 ml 20 ml, 50/60 ml 50ml only

2.2

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 Prime Syringe Fill and prime the syringe and catheter in the normal way, ensuring all the air is expelled.

Graseby 3100

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Syringe pump 2.3

Insert Syringe Carefully swing the syringe plunger clamp away from the body of the pump, until it clicks. Slide the syringe 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. 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. 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. Lower the syringe barrel clamp onto the syringe. Slide the syringe 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 syringe plunger clamp (see diagram). Check: Syringe brand corresponds to syringe brand in use

Check: Syringe ears located in groove

Check: Syringe size sensor is located on top of syringe

Check: Plunger clamp is flush with syringe plunger then lower over plunger Check: Syringe size indicator lamp corresponds to the size of syringe you are using

BD

GM0751-A

Diagram. 3. Inserting the Syringe The syringes being used are disposable types for single-use only. 6

Graseby 3100

Syringe pump 3. Set Infusion Rate

3.1

Infusion Rate Memory After switch on, the pump will display the ml/hr infusion rate used last time the pump was run. Note: not the last rate set. It is possible to set the pump at 0.0ml/hr. Of course the pump will not run at this rate. The rate invalid alarm will sound if the START button is pressed.

3.2

Setting the ml/hr Infusion Rate If the memorised rate is not required then the rate can be altered by pressing the arrowed keys underneath the display. To facilitate ease of setting up, the buttons are arranged in pairs of up and down keys for hundreds, tens, units and tenths of the ml/hr infusion rate. The infusion rate can be set to between 0.1ml/hr to 199.9ml/hr in steps of 0.1ml/hr. For applications where flow uniformity is a concern, rates of 1.0ml/hr or above are recommended.

3.3

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, the higher the infusion rate the faster the start-up time. The typical start-up times for the Graseby 3100 are (using 50/60ml BD syringes):at 5ml/hr = 3 minutes at 1ml/hr =15 minutes (independant test data) 1

3.4

Accuracy The volumetric accuracy of the Graseby 3100 is +or- 2%. 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. 1 See MDA evaluation 149 (2/1993)

Graseby 3100

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Syringe pump 4. Purging (disconnect tubing from patient)

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. 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. For safety reasons the purge facility cannot be used whilst the pump is infusing. Press the PURGE key, the display will show the message “PRESS AGAIN” . Press the PURGE key immediately and hold it depressed. Whilst running in the purge mode the ALARM lamp and START lamp will flash and the display will show the total fluid quantity delivered since the PURGE button was pressed. Maximum purge volume is 2ml for all syringe sizes. Purge speed is 199.9ml/hr (50/60ml syringes), 100ml/hr (30ml syringes) and 60ml/hr (20ml syringes).

5. Starting the Infusion

Press START to begin the infusion at the set ml/hr rate. The brand and size of the syringe will be displayed briefly, followed by the infusion rate. During the infusion the green START lamp will flash. In addition, the “pump running” indicator arrows on the display will flash. If anything occurs to disrupt the infusion the pump will alarm. See Section 9; Alarms.

6. Using the Totalizer

This tells you how much drug has been infused by the pump. The totalizer can be accessed when the pump is running or when the pump is stopped. Press the display totalizer key. For a few seconds the display will show “TOTAL :XXX.X ML”. If you wish to reset the totalizer, press the reset totalizer key when the total is displayed. It is not possible to reset the totalizer without first accessing the display totalizer program. The totalizer can only be reset when the pump is stopped.

7. Stopping the Infusion

8

Press the STOP button to stop the infusion. The yellow stop lamp will illuminate and the pump running indicators in the display will disappear. Graseby 3100

Syringe pump 8. Switch Off

8

Switch Off Stop the infusion (Section 7). Press the OFF button to switch the pump off. The pump is now in “sleep” mode. The AC power indicator lamp will remain illuminated if the pump is connected to AC power. Disconnect from the AC power supply if the pump is not going to be used for any length of time; the AC power indicator lamp will then extinguish. To return to “set-up” mode whilst the unit is in “sleep” mode, press the ON button. To conserve battery life it is recommended to run the pump connected to the AC power supply. Note that running the pump on AC power automatically charges the batteries. For notes on battery operation see Section 10. There are several alarm states, each accompanied by a descriptive message on the display, an audible alarm and a flashing red alarm light. If the pump was infusing at the time of the alarm then the pump will have stopped automatically (except for the low battery and nearly empty alarm). To silence the alarm press the button with the “cross bell” symbol. Set out below and on the following pages are the alarm messages and an explanation of their meaning.

9. Alarms

9.1

Syringe Plunger Clamp Disengaged ALARM

CLAMP OPEN AC

ALARM TYPE - 2 second quiet alarm. CAUSE

The syringe plunger clamp has not been correctly located over the syringe plunger. The clamp is not correctly engaged onto the drive mechanism.

ACTION

Reposition the clamp on the syringe plunger. Ensure that the syringe plunger crosspiece is correctly placed within the plunger clamp.

WARNING: Failure to respond promptly to an alarm may result in patient injury or death. 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. Graseby 3100

9

Syringe pump 9.2

Syringe Invalid ALARM

SYRINGE INVALID AC

ALARM TYPE - 2 second quiet alarm. CAUSE

The syringe size sensor does not detect a syringe in the syringe trough. Syringe size is too small.

ACTION Ensure syringe size is appropriate i.e. 20ml, 30/35ml or 50/60ml. Reposition the syringe barrel on the syringe trough. 9.3

Rate Invalid ALARM

RATE INVALID AC

ALARM TYPE - 2 second quiet alarm. CAUSE

The START button has been pressed with the infusion rate set to 00.0ml/hr. The START button has been pressed with too high an infusion rate set for the syringe size in use (above 60ml/hr for a 20ml syringe, above 100ml/hr for a 30ml syringe).

ACTION Set desired infusion rate then press the START button.

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Graseby 3100

Syringe pump 9.4

Occlusion

ALARM

OCCLUSION AC

ALARM TYPE - Pulsing loud alarm (silenceable) CAUSE

There is a pressure build-up on the syringe plunger clamp, probably because of a blocked infusion line. The infusion has stopped.

ACTION

Silence the alarm.

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. Press START to restart the infusion when the occlusion has been cleared. 9.4.1

The Occlusion Sensing System The Graseby 3100 has a sensitive, internal occlusion pressure detector which detects the pressure build-up on the syringe plunger clamp most often caused by a blocked infusion line. This system detects an occlusion between 3.5 and 4.2. kg. For BD 50/60ml syringes this is equivalent to about 500 mmHg. Note that for other brands and sizes of syringe this will vary considerably. The factory set occlusion pressure is 500 mmHg.

9.4.2

Time to alarm following occlusion The time to alarm following occlusion is due to a number of factors which include the compliance in the syringe and infusion line and largely the infusion rate. Independent tests show that under normal conditions, using a non compliant infusion line, e.g. Vygon Lectrocath 100cm infusion line, the time to alarm following occlusion at 1.0 ml/hr is approximately 27 minutes at the factory occlusion pressure setting of about 500 mmHg. This time can be reduced by reducing the internal occlusion pressure. A lower pressure will

Graseby 3100

11

Syringe pump give a shorter time to alarm but there may be an increase in false alarms below the 250mmHg setting. For neontal use we recommend reducing this pressure to below the 250mmHg setting. The maximum time to alarm following occlusion will occur at the lowest settable infusion rate of 0.1ml/hr. At rates as low as this the time to alarm is likely to be 10hrs. 9.5

The Nearly Empty Alarm System The Graseby 3100 Syringe Pump has a unique intelligent Nearly Empty Alarm System. One of two messages is displayed. ALARM

<3 mins to END

NB This alarm only operates at infusion rates at or below 100ml/hr.

AC

ALARM TYPE - Intermittent quiet alarm. CAUSE

The syringe is nearly empty, there are less than 3 minutes before the syringe enters the KVO mode (Section 9.6). The pump is continuing to infuse at the set rate.

ACTION

This alarm can be silenced. If you wish to continue infusing fill, prime and reload the next syringe (Section 2.2). If not, stop the infusion when the end of infusion alarm sounds (Section 9.6/9.7).

ALARM

NEARLY EMPTY AC

NB This alarm only operates at infusion rates above 100ml/hr. OR when a syringe is loaded with approximately 2.5cm or less fluid remaining in the syringe.

ALARM TYPE - Intermittent quiet alarm.

12

CAUSE

The syringe is nearly empty. The pump is continuing to infuse at the set rate.

ACTION

This alarm can be silenced. If you wish to continue infusing fill, prime and reload the next syringe (Section 2.2). If not, stop the infusion when the SYRINGE EMPTY alarm sounds (Section 9.7). Graseby 3100

Syringe pump 9.6

Infusion Ended (KVO mode) ALARM

END (KVO = .5)

NB This alarm only operates at infusion rates at or below 100ml/hr.

AC

ALARM TYPE - Pulsing loud alarm (silenceable) CAUSE

The infusion has stopped. The pump is running at a rate of 0.5ml/hr or less, if set rate is less, to keep the vein open.

ACTION Press the alarm silence key to silence the audible alarm. If you wish to continue the infusion fill, prime and reload the next syringe (Section 2.2). You may infuse the small amount of drug left in the syringe at the set infusion rate by stopping and re-starting the pump. If you do not wish to continue infusing press the STOP button to end the infusion. 9.7

Empty/Occlusion ALARM

EMPTY/OCCLUSION AC

ALARM TYPE - Pulsing loud alarm (silenceable) CAUSE

The syringe is empty and the infusion is complete. The pump has stopped infusing or an occlusion has occured within the nearly empty zone (e.g. the last 13ml of a 50/60ml BD syringe).

ACTION Press the alarm silence key to silence the audible alarm.Prepare, prime and load a new syringe or switch off the pump.

Graseby 3100

13

Syringe pump 9.8

Not Infusing ALARM

NOT INFUSING AC

ALARM TYPE - Intermittent quiet alarm (silenceable) CAUSE

The pump has been switched on but the START button has not been pressed.

CAUSE

The infusion may have been stopped (or completed) and the user has neglected to press the START button again (or switch the pump off).

ACTION Press START to commence infusion or switch pump off.

9.9

AC Power Failure ALARM

AC MAINS FAIL AC

ALARM TYPE - Intermittent quiet alarm (silenceable) CAUSE

AC power supply has been interrupted. The pump will continue to run on its internal batteries. A fully charged pump will operate for more than 3 hours.

ACTION This alarm can be silenced to continue running the pump on batteries. Reconnect to AC power if possible.

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Graseby 3100