Graseby MS18 Driver Instruction Manual June 2002

MS 18 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 18 Instruction Manual

Contents 1 Instructions - for the MS 18 Syringe Driver Introduction ... 2 What is a Syringe Driver? ... 3 The MS 18 Syringe Driver ... 3 How to use the Syringe Driver ... 4 Do’s and Don’ts ... 4 Fitting the battery ... 5 What the controls do ... 6 What the symbols on the Syringe Driver mean ... 6 Selecting a syringe ... 7 Calculating the administration time ... 8 Fitting the syringe ... 10 Fitting the Cover ... 11 Starting the Syringe Driver ... 13 During the administration ... 14 Stopping the Syringe Driver ... 14 Accessories ... 15 Care and Maintenance ... 16 Battery replacement ... 16 Cleaning ... 16 Storage ... 16 Servicing ... 17 Disposal ... 17 Troubleshooting ... 18 2 Technical and Performance Specification ... 19

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MS 18 Instruction Manual

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Instructions for the MS 18 Syringe Driver

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.

The MS 18 FIXED RATE Syringe Driver 2

MS 18 Instruction Manual

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 18 is a battery powered ambulatory syringe driver, so it can be carried around by patients whilst they are undergoing treatment. The Syringe Driver is suitable for administering medication intravenously (IV) or subcutaneously.

The MS 18 Syringe Driver The MS 18 Syringe Driver pushes the plunger of a syringe forward at a fixed rate of 5 millimetres every hour. The MS 18 is known as the FIXED RATE Syringe Driver and is intended for administrations lasting 10 to 12 hours. The table shows the main features:

Feature Rate

MS 18 FIXED RATE Syringe Driver 5 mm per hour

Indicator lamp flashes every

2 seconds

Motor turns every

84 seconds

Test time

5 seconds

Boost

NO

Label colour

Silver

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MS 18 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.

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MS 18 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

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MS 18 Instruction Manual

What the controls do START/TEST button

START/TEST

Pressing and holding this button down tests the safety system. Releasing it starts the MS 18.

50

60mm

GM0819-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

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.

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MS 18 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.

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MS 18 Instruction Manual

Calculating the administration time 1.

Fill the syringe with the required volume of medication.

Tip: Allow for the small volume needed to fill the line or set when filling the syringe. Usually 1 to 2 ml is sufficient. 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 18 for this.

mm

GM0313-A

4.

Divide this distance, measured in mm, by five. The answer is the time it will take for the syringe to empty. Distance in mm ÷ 5 = Administration time in hours (h)

0

8

10

20

30

40

50

60

mm

MS 18 Instruction Manual

These examples show syringes with their plungers in different positions and how long the Syringe Driver will take, in hours (h), to empty each syringe. 20 mm 4h

50 mm 10 h

60 mm 12 h GM0821-A

5

GM0820-B

mm PER

1

h

REMEMBER THAT YOU HAVE TO MEASURE IN MILLIMETRES (mm) NOT MILLILITRES (ml).

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MS 18 Instruction Manual

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

2.

Move the actuator up to the syringe plunger, by pressing and holding in the button on the side, and sliding it along. The push-button 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 pushbutton. 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.

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MS 18 Instruction Manual

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, remeasure the plunger position to make sure the dose is going to be administered in the same time.

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. 1.

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.

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MS 18 Instruction Manual

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 infusion line is not trapped anywhere.

mm PER

2.

GM0316-A

5.

12

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 18 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 18 „ Correct brand and size of syringe is fitted. „ Syringe is fitted securely. „ Syringe is filled with correct volume. „ 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 is working. 1.

Press and hold down the START button. The motor will turn and stop after 5 seconds.

WARNING: Do not use the Syringe Driver if the motor does not stop. 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 every 2 seconds

5

mm PER GMO822-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.

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MS 18 Instruction Manual

During the administration It is recommended that procedures are established for regular checks on the progress of the administration. Patients, relatives or other carers, as well as medical staff, should be made aware of a few simple checks that can be made. These are to confirm:

„ the volume is being delivered as expected. „ the indicator lamp is flashing (the battery is not exhausted). „ the Syringe Driver is in good condition. Also that they know what to do and who to contact in an emergency

Stopping the Syringe Driver When the syringe is empty the Syringe Driver will stop automatically; the indicator lamp will stop flashing. There is no OFF switch to stop the Syringe Driver before the syringe is empty. To stop it, take out the battery. WARNING: Risk of the remaining medication flowing out into the patient. Never take a syringe that is not empty off the Syringe Driver and leave it connected to the patient, unless the infusion line is clamped off.

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MS 18 Instruction Manual

Accessories These accessories are supplied along with the Syringe Driver: Cover 0105-0529

A clear rigid plastic cover to put over the Syringe Driver and syringe to protect them.

Holster 0105-0027

A washable soft fabric holster for carrying the Syringe Driver (with Cover) whilst it is administering the medication.

These are the optional accessories which can be ordered: Belt holster 0105-0082

A leather holster for attaching to a belt as an alternative to the soft fabric type. The Cover still needs to be used with this holster.

Base 0105-0108

This provides a secure base to stand the Syringe Driver on a flat surface. The Cover is not used with this accessory.

Instructions 0112-0031

Extra copies of this manual can be ordered by quoting this number.

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MS 18 Instruction Manual

Care and Maintenance When used as described in these instructions the Syringe Driver does not require any routine maintenance apart from replacing the battery and occasional cleaning. It is recommended that the performance of the Syringe Driver is checked annually. If the Syringe Driver is damaged in any way the performance must always be checked before it is used again. See the section on servicing for further information.

Battery replacement Slide off the cover at the back of the Syringe Driver and gently tap out the battery. Always fit a fresh 9 volt (9 V) ‘alkaline’ battery of the correct type, IEC 6LR61. For example a DURACELL MN1604. Slide the cover on, holding the battery down.

Cleaning The outside surfaces can be cleaned by wiping them with a soft cloth either dampened with a solution of mild detergent or disinfectant, in water. The threads of the screw the actuator moves along can be cleaned with a small stiff bristled brush. A toothbrush is ideal. Cleaning with organic solvents, e.g. surgical spirit, or abrasive cleaners, may damage some of the plastic parts. WARNING: Risk of change in device performance. Never dip or immerse the Syringe Driver in any liquid or try to sterilize it with steam or gas. It is not completely sealed.

Storage If you are going to store the Syringe Driver for some time, remove the battery; then put it in a warm dry place.

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MS 18 Instruction Manual

Servicing The Syringe Driver must be repaired by either Graseby Medical’s service organisation, its appointed representatives or appropriately trained technicians who have access to the correct technical manuals, service bulletins and approved replacement parts. WARNING: Risk of change in device performance. Always use the appropriate parts and procedures for repair and testing as advised by Graseby Medical and published in its literature. For after-sales service or advice on how to use the Syringe Driver you can contact customer services at the address on the backcover of the manual. It will help to quote the Syringe Driver’s serial number. This is on the label inside the battery compartment.

Disposal When the time comes to dispose of the Syringe Driver, accessories or packaging do so in the best way to minimise any negative impact on the environment. You may be able to use special recycling or disposal schemes. To find out about these contact your local waste disposal service. Separate any parts of the equipment where arrangements can be made for their recovery, either by recycling or energy recovery. Important: existing national or local regulations concerning waste disposal must take precedence over the above advice.

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