Graseby MS16A and MS26 Syringe Driver Instruction Manual June 2002

MS 16A Syringe Driver MS 26 Syringe Driver

Instruction Manual Please make sure the Instruction Manual is given to the person who will be responsible for using the Syringe Driver.

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. 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: Fax: Web:

(+44) (0)1923 246434 (+44) (0)1923 231595 www.graseby.co.uk

Registered in England. Company number 995550

Trademarks and acknowledgements: Graseby and Smiths are registered trademarks of the Smiths Group plc. All other trademarks are acknowledged as the property of their respective owners.

MS 16A and MS 26 Instruction Manual

Contents 1 Instructions - for the MS 16A and MS 26 Syringe Drivers Introduction ... 3 What is a Syringe Driver? ... 3 What are the differences between an MS 16A and an MS 26? ... 4 Why are there two models? ... 4 How to use the Syringe Driver ... 5 Do’s and Don’ts ... 5 Fitting the battery ... 6 What the controls do ... 7 What the symbols on the Syringe Driver mean ... 8 Selecting a syringe ... 9 Identifying the Syringe Driver model, MS 16A or MS 26 .. 9 Setting the correct rate for the MS 16A ... 10 Setting the correct rate for the MS 26 ... 12 Fitting the syringe ... 14 Fitting the Cover ... 15 Starting the Syringe Driver ... 17 During the administration ... 18 How to use the Boost Dose on the MS 26 ... 18 Stopping the Syringe Driver ... 19 Alarms ... 19 Accessories ... 20 Care and Maintenance ... 21 Battery replacement ... 21 Cleaning ... 21 Storage ... 21 Servicing ... 22 Disposal ... 22 Troubleshooting ... 22 2 Guide to subcutaneous analgesia Parenteral administration of drugs ... 24 Drugs commonly administered using syringe drivers ... 24 What is needed for a subcutaneous infusion with the Syringe Driver? ... 25 Selection of a suitable infusion site ... 26 Inserting the Subcutaneous Needle ... 27 Observation during treatment ... 27 3 Technical and Performance Specification ... 28

1

MS 16A and MS 26 Instruction Manual

The MS 16A HOURLY RATE Syringe Driver

The MS 26 DAILY RATE Syringe Driver 2

MS 16A and MS 26 Instruction Manual

1

Instructions - for the MS 16A and MS 26 Syringe Drivers

Introduction In this manual you will find instructions on how to use the Syringe Driver safely, care for it and what to do if it should go wrong. Please take time to read all the information before you start to use the Syringe Driver and follow all the warnings printed in bold type. The Syringe Driver is a medical device and has been carefully designed and made to achieve a high level of safety protection. In making a decision whether the Syringe Driver is a suitable aid for a particular treatment the performance specification should be considered. Used wrongly this medical device can pose a serious risk to human life. It should therefore only be used under the supervision of a medical professional. Please make sure the Instruction Manual is given to the person who will be responsible for using the Syringe Driver.

What is a Syringe Driver? A syringe driver is a power driven device for pushing the plunger of a syringe forward at an accurately controlled rate. It is an aid in administering medicinal preparations in liquid form over much longer periods than could be achieved by injecting by hand. Besides the syringe driver all that is usually required is a suitable sterile syringe along with a sterile pathway to deliver the medication to the patient. The MS 16A and MS 26 are battery powered ambulatory syringe drivers, so they can be carried around by patients whilst they are undergoing treatment. These Syringe Drivers are suitable for administering medication intravenously (IV) or subcutaneously. For more information on subcutaneous infusion therapy see the section Guide to subcutaneous analgesia.

3

MS 16A and MS 26 Instruction Manual

What are the differences between an MS 16A and an MS 26? It is most important to be familiar with what the differences are. The most visible difference is the colour; the MS 16A has a blue label and the MS 26 a green one. The table shows all the main differences: MS 16A HOURLY RATE Syringe Driver

MS 26 DAILY RATE Syringe Driver

Rate range

0 - 99 mm per hour

0 - 99 mm per 24 hours

Indicator lamp flashes every

1 second

25 seconds

Motor turns every

(420 ÷ rate set) seconds

(168 ÷ rate set) minutes

Test time

5 seconds

10 seconds

Boost

NO

YES

Label colour

Blue

Green

Feature

Why are there two models? The MS 16A is intended for administrations lasting between 30 minutes and 24 hours. The rate setting is in millimetres (mm) of syringe plunger movement every hour. The MS 16A is known as the HOURLY RATE Syringe Driver. For slower infusions, the MS 26 is intended for administrations over periods of 1 day and longer. The rate setting is in millimetres (mm) of syringe plunger movement every 24 hours. The MS 26 is known as the DAILY RATE Syringe Driver. At the slowest setting, of 01, the MS 26 would take 60 days to move the actuator over the full length of travel. The MS 26 can also be used to give manually administered boost doses during the administration.

4

MS 16A and MS 26 Instruction Manual

How to use the Syringe Driver Do’s and Don’ts DO -

check the battery daily.

DO -

avoid using mobile telephones close, nearer than 1 metre, to the Syringe Driver. Although there have been no confirmed reports of mobile telephones interfering with the operation of the Syringe Driver, following this advice will help reduce any risk.

DON’T -

use the Syringe Driver without understanding these instructions.

DON’T -

get it wet. It is not waterproof and the performance will be affected.

DON’T -

take it from a cool place and put it into a warm, very humid one (e.g. an incubator) or take it from there into a cooler one. Condensation will form and the inside will get wet.

DON’T -

open it up to look inside. The performance will be affected.

DON’T -

use it in or near strong magnetic fields, Nuclear Magnetic Resonance (NMR) scanners for example. They may stop it.

DON’T -

use it in the presence of flammable anaesthetic gases or in an oxygen enriched atmosphere. It may increase the risk of a fire or explosion.

DON’T -

use it outside its temperature range. The performance will be affected.

DON’T -

wipe it with organic cleaning solvents or strong disinfectants. The plastic case may be damaged.

5

MS 16A and MS 26 Instruction Manual

Fitting the battery Always fit a 9 volt (9 V) ‘alkaline’ battery. These batteries can be identified by the international code 6LR61 marked on them or on their packaging. They are available from most retail outlets selling batteries. A recommended battery of this type is the DURACELL MN1604. Be careful when selecting a battery as some brands may not fit properly, if possible try the battery in the battery compartment first. Never try to force in a battery which is too large as this may damage the battery contacts. Batteries of the ‘zinc-carbon’ type (marked 6F22 or 6R61), for example a PP3, are not recommended. They perform poorly with the Syringe Driver needing to be replaced more often.

_

+

To fit the battery, slide off the cover at the back of the Syringe Driver and push the battery in. The label in the battery compartment shows which way round to put it. Accidentally putting it in the wrong way round will not do any harm. Slide the cover on again until it latches shut.

GM0305-A

The alarm will sound for about 15 seconds after the battery is fitted.

6

MS 16A and MS 26 Instruction Manual

What the controls do Rate setting switches These are the two switches that set the rate (speed) at which the syringe plunger will be pushed forwards. This is the distance, in mm, that the plunger will move in one hour on an MS 16A and in one day on an MS 26. There is one switch for the ‘tens’ and one for the ‘units’ of the rate value. Values from 0 to 99 can be set.

0 9 mm PER GM0307-A

The numbers set appear in the windows next to each switch. The switches can be turned with the key supplied or with a small screwdriver with a flat blade.

START/TEST button (MS 16A)

START/TEST

Pressing and holding this button down tests the safety system. Releasing it starts the MS 16A.

50

60mm

GM0418-A

START/BOOST button (MS 26) Pressing and holding this button down tests the safety system and allows a boost dose to be administered by counting the sound bleeps. Releasing it starts the MS 26.

START/BOOST 1 bleep = 0.23 mm

50

60mm

GM0311-A

Actuator release button Pressing and holding this button down releases the actuator so it can be moved backwards or forwards by hand.

GM0310-A

7

MS 16A and MS 26 Instruction Manual

What the symbols on the Syringe Driver mean An electrical safety classification in the international safety standard for medical electrical equipment, Type BF. If the equipment is used as intended there is no risk of a serious electric shock. But it is not suitable for direct connection to the heart.

Refer to the accompanying instructions on how to use the equipment. The instructions are all in this manual.

The CE mark demonstrates that the Syringe Driver conforms to the requirements in the European Council Directive 93/42/EEC concerning medical devices. The number 0473 identifies the Notified Body under which the Quality Systems operated within Graseby Medical Ltd. are assessed.

8

MS 16A and MS 26 Instruction Manual

Selecting a syringe Most of the small sterile plastic syringes available, from 2 ml up to 35 ml capacity, can be used. Syringes with a Luer lock nozzle are best because they offer more security against accidental disconnection of the infusion line. Choose a syringe brand and size that fits properly onto the Syringe Driver. The adjustable strap must fit round it to hold it firmly, the finger grip and the plunger push-button must fit in the retaining slots in the case and actuator.

GM0308-A

GM0467-A

With some of the larger sizes it may not be possible to fill them to their full capacity but they can still be used as long as they fit on properly.

Identifying the Syringe Driver model, MS 16A or MS 26 The MS 16A is the HOURLY RATE model with the rate in mm per 1 h and has a BLUE label. The MS 26 is the DAILY RATE model with the rate in mm per 24 h and has a GREEN label.

9

MS 16A and MS 26 Instruction Manual

Setting the correct rate for the MS 16A 1.

Fill the syringe with the required volume of medication.

2.

Connect and fill the infusion line. Make sure the connection is secure and the air is expelled.

3.

Measure the distance, in millimetres (mm), from the empty (0) line on the syringe’s scale up to the line where the plunger piston is. There is a ‘mm’ scale on the front of the MS 16A for this.

mm

GM0313-A

4.

Divide this distance, measured in mm, by the time in hours (h) all the medication in the syringe needs to be administered in. The answer is the rate to set in the rate windows. Distance in mm ÷ Time in hours = Rate in mm per 1 h

0

10

10

20

30

40

50

60

mm

MS 16A and MS 26 Instruction Manual

Here is an example: A syringe is to be used to administer 8 ml of medication over 12 hours. With this syringe filled to the 8 ml line the plunger travel measures 48 mm. 48 mm ÷ 12 hours = 4 mm per 1 h Set the rate switches to 04

0 GM0314-B

4

mm PER

1

h

Each switch must be moved until all of the number can be seen in the window. In this example, every hour the syringe plunger will move forwards 4 mm, administering about 0.67 ml of the medication and after 12 hours the syringe will have emptied. Remember that for rates up to 9 the left-hand ‘tens’ number must be set at 0. If the result of the division is not a whole number select the nearest whole number for the rate. REMEMBER THAT YOU HAVE TO SET THE RATE IN MILLIMETRES (mm) NOT MILLILITRES (ml).

11

MS 16A and MS 26 Instruction Manual

Setting the correct rate for the MS 26 1.

Fill the syringe with the required volume of medication.

2.

Connect and fill the infusion line. Make sure the connection is secure and the air is expelled.

3.

Measure the distance, in millimetres (mm), from the empty (0) line on the syringe’s scale up to the line where the plunger piston is. There is a ‘mm’ scale on the front of the MS 26 for this.

mm

GM0313-A

4.

Divide this distance, measured in mm, by the time in days (24 hour (h) periods) all the medication in the syringe needs to be administered in. The answer is the rate to set in the rate windows. Distance in mm ÷ Time in days = Rate in mm per 24 h

0

12

10

20

30

40

50

60

mm

MS 16A and MS 26 Instruction Manual

Here is an example: A syringe is to be used to administer 8 ml of medication over 2 days. With this syringe filled to the 8 ml line the plunger travel measures 48 mm. 48 mm ÷ 2 days = 24 mm per 24 h Set the rate switches to 24

Each switch must be moved until all of the number can be seen in the window. In this example, every 24 hours the syringe plunger will move forwards 24 mm, administering about 4 ml of the medication and after 48 hours the syringe will have emptied. Remember that for rates up to 9 the left-hand ‘tens’ number must be set at 0. If the result of the division is not a whole number select the nearest whole number for the rate. REMEMBER THAT YOU HAVE TO SET THE RATE IN MILLIMETRES (mm) NOT MILLILITRES (ml).

13

MS 16A and MS 26 Instruction Manual

Notes on setting up your Syringe Drivers An alternative method may be used to set up the MS16A or MS26 Syringe Driver, if a specific policy has been devised as part of your hospital/community protocol. The alternative method involves first measuring the volume in the syringe, then priming the line. Warning:

If you measure first, then prime the line, the infusion will finish early. You should therefore only use this method when your hospital has devised this protocol for a specific clinical area.

Fitting the syringe 1.

Put the syringe on top of the Syringe Driver, with its barrel in the shallow V-shaped recess. The finger grip on the syringe barrel must be in the slot in the case.

GM0419-A

14

MS 16A and MS 26 Instruction Manual

2. Move the actuator up to the syringe plunger, by pressing and holding in the button on the side, and sliding it along. The pushbutton on the plunger of the syringe must be fitted in the slot in the actuator. Be careful not to push the plunger forwards.

GM0467-A

Older versions did not have the slot in the actuator for the syringe plunger push-button. A small metal screw-clamp was supplied and this must be fitted through the hole in the actuator and used to hold the plunger push-button. The actuator can be replaced by the latest type and it is recommended that this is done the next time the Syringe Driver is overhauled. 3.

Put the rubber securing strap over the syringe barrel and pull it tight. Hook and then press it into the groove in the side of the case.

GM0309-A

WARNING: Risk of uncontrolled flow into the patient. Only use the Syringe Driver if the syringe can be secured as described. If the selected syringe does not fit, try another brand of syringe with the same capacity. Caution, the rate setting used may need to be changed so the dose is administered in the same time. Recalculate the correct rate to use.

15

MS 16A and MS 26 Instruction Manual

Fitting the Cover The clear Cover is supplied to protect the Syringe Driver with a syringe fitted. If the Syringe Driver is to be put in a holster then this Cover must be used. Slide the Syringe Driver into one of the open ends of the Cover with the front facing the side of the Cover with the hole in it. NEVER PUT THE SYRINGE DRIVER IN FACING THE OTHER WAY.

2.

Push the Syringe Driver in until the START button lines up with the hole. The peg on the inside back of the Cover goes into the hole in the middle of the back of the Syringe Driver. It is now held in the Cover.

3.

The START button can be pressed through the hole in the Cover when needed.

4.

If the Syringe Driver is to be carried then the Holster can be used. Keeping the syringe nozzle uppermost, slide the Syringe Driver with its Cover into the Holster. Fasten the tape across the top to hold everything in. Make sure the infusionline is not trapped anywhere.

mm PER

1.

GM0316-A

5.

16

To get the Syringe Driver out of the Cover, hold the Cover without squeezing it and press firmly on either end of the Syringe Driver until it pops out.

MS 16A and MS 26 Instruction Manual

Starting the Syringe Driver Before starting the administration going through this checklist will help to make sure everything has been set up correctly:

! Correct Syringe Driver is being used. MS 16A or MS 26. ! Correct brand and size of syringe is fitted. ! Syringe is fitted securely. ! Syringe is filled with correct volume. ! Rate set is correct - check numbers showing in windows. ! Cover is fitted correctly (if needed). Everything should now be ready to start. Always start the Syringe Driver like this to check the safety system and alarm are working. 1.

Press and hold down the START button. The motor will turn and stop after: 5 seconds for an MS 16A

10 seconds for an MS 26

Then the alarm will sound. This will continue for about 15 seconds longer if the button is not released. WARNING: Do not use the Syringe Driver if the motor does not stop and/or the alarm does not sound. Refer to the section on servicing for advice on what to do if this happens. 2.

Releasing the button starts the Syringe Driver. The indicator lamp will begin to flash: once a second on the MS 16A

5

once every 25 seconds on the MS 26

5

mm PER GMO312-A

Tip: If the lamp does not flash try replacing the battery. Caution: The patient will receive a small amount of medication as the syringe plunger is pushed forwards during the safety check. If this is undesirable the final patient connection can be left until the START button has been released. 17