Graseby 500 Manuale utente

Graseby Instruction Manuals

This publication has been compiled and approved by Graseby

Medical Ltd for use with their respective products. It is supplied

in this format to permit users to access the text and illustrations

for their own use e.g. training and educational purposes.

Users of the equipment must ensure that they have read and

understood the contents of the complete manual including the

warnings and cautions and have been trained in the correct use

of the product.

Graseby Medical Ltd cannot be held responsible for the

accuracy and any resulting incident arising from information

that has been extracted from this manual and compiled into the

users documentation.

These manuals are subject to revision and it is the users

responsibility to ensure that the correct version of manual/

text/illustration is used in conjunction with the equipment.

Instruction

Manual

Model 500

and Micro 505

Volumetric

Infusion

Pump

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.

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

Facsimile: +44 (0)1923 231595

http://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.

Volumetric Infusion Pumps

Graseby Medical Ltd.

Warnings and Cautions

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:You 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.

2. WARNING: Do not use a faulty pump.If the

pump detects a fault when it is first turned on,

or if it develops a fault during operation then a

continuous system alarm sounds.The pump

must be referred to a suitably qualified

technician orreturnedto Graseby Medicalin

order to have the fault rectified.

3. WARNING: Before using the pump,it should be

inspected for physical damage.The pump

should not be used if damage is evident, and

should be returned to service personnel for

repair before being returned to use. Failure to

do so may result in compromised function of

the product,patient injury or user injury.

4. WARNING: Do not use the pump if you detect

any cracks, chips and loose or bent parts, or

if the buttons do not move in and out freely

when they are pressed. Failure to do so could

cause inadvertent disconnection of the pumps.

5. WARNING: Do not push or pull on the pumps,

or the IV pole may tip over or the pumps fall

to the floor. Do not try to remove modular

connected pumps from the IV pole whilst they

are joined together.Either of these could

cause the administration set to separate from

the fluid container thus spilling the

medication, or the pumps themselves could be

damaged.

6. WARNING:Correct entry of data is essential in

order to ensure that the intended infusion is

performed. Before confirming any displayed

data when setting up an infusion, you 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: Dose-rate calculation requires

care in entering data. Refer to specific product

drug labelling for information on appropriate

administration techniques and dosages.

Entering incorrect data may result in patient

injury or death.

8. WARNING:When delivering drugs in the

epidural space, use only those medications

specifically indicated for epidural use.

Epidural administration of other drugs could

result in serious patient injury or death.

9. WARNING:The use of administration sets

incorporating injection sites could lead to an

improper or inappropriate infusion resulting in

serious patient injury or death.

10. WARNING:Failure to clearly identify the pump

and administration sets could lead to an

improper or inappropriate infusion resulting in

serious patient injury or death.

11. WARNING: Remove any air to prevent air

embolism.The presence of air within the

infusion can result in complications resulting

in patient injury or death.

12. WARNING: To avoid over infusion,do not

prime the infusion line when the admini-

stration set is connected to the patient. Over

infusion can result in patient injury or death.

13. WARNING:The Occlusion alarm level must be

checked before starting an infusion to ensure

that it is appropriate for the infusion. Failure

to do so may result in an unacceptably slow

time to Occlusion alarm, resulting in patient

injury or death.

14. WARNING:Prior to starting an infusion,

inspect the fluid path for kinks, a closed clamp

or other obstructions. Failure to do so may

result in the infusion not being delivered

correctly, resulting in patient injury or death.

15. WARNING:If using a blood pressure cuff above

the patient’s venipuncture site take extra care

in setting the Occlusion alarm pressures.

Failure to do so may result in unnecessary

Occlusion alarms, resulting in patient injury

or death.

16. WARNING:The Occlusion detection system

measures downline pressure in the admini-

stration set, but does not detect infiltration. In

accordance with local protocol, you must

periodically inspect the patient’s infusion site

for signs of infiltration. Failure to do so may

result in an unacceptably slow time to

Occlusion resulting in patient injury or death.

17. WARNING:If an Occlusion alarm occurs,

immediately clamp the line to the patient.Then

inspect the fluid pathway to determine what

has caused the obstruction. An unintentional

bolus of medication can result in patient injury

or death.

Warnings

Volumetric Infusion Pumps

Warnings and Cautions

Graseby Medical Ltd.

18. WARNING:Do not run parallel infusion lines

below the pump. Delivering a Secondary

infusion means running a second line

above

the pump. Failure to do so may result in an

inaccurate delivery of medication, resulting in

patient injury or death.

19. WARNING:Check the Secondary set carefully,

since an occlusion above the pump on the

Secondary line could cause the Primary fluid

to be delivered instead of the Secondary

infusion. Administering the wrong medication

may cause serious patient injury or death.

20. WARNING:The Secondary volume to be infused

must match the amount of fluid in the

secondary container.Primary flow resumes

when the secondary container is empty. If the

volumes do not correspond, the wrong infusion

may be delivered which could cause serious

patient injury or death.

21. WARNING: Correct management of battery

charging, as described in this documentation

is essential to ensure that the pump can

operate on battery for the time specified.

Failure to do so may result in compromised

function of the product or patient injury.

22. WARNING:If a backup alarm sounds,the pump

should be immediately removed from the

patient and sent to be repaired by a Graseby

Medical qualified technician. Failure to do so

may cause patient injury or death.

23. WARNING:Failure to use the power cord

retainer means that the pump may be

accidentally or erroneously disconnected from

the mains. Although there is a battery backup

in case this happens, the battery may not be

charged sufficiently.Consequently, there is a

risk of the pump not functioning which could

lead to patient injury or death.

24. WARNING:Donot open thepump housing.

Refer all service faults only to qualified

technical personnel. Opening the pump

housing may cause electric shock leading to

patient or user injury or death.

25. 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 back of the

pump, otherwise patient safety may be

compromised.

26. WARNING:While Graseby Medical Limited

have taken all reasonable steps to ensure that

the pump operates correctly while under

remote control, it is the responsibility of the

person who designs and implements the

controlling device to ensure that the resulting

system (pump and controlling device) is fit for

its intended purpose. Failure to do so may

result in compromised function of the product,

patient injury or user injury.

27. WARNING:Use only Graseby Medical

administration sets with this product. Failure

to do so may result in compromised system

accuracy leading to complications resulting in

patient injury or death.

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: Do not autoclave, steam sterilize,

ETO sterilise or subject the pump to

temperatures in excess of 55° C (131° F).

Excessive temperatures may cause damage to

thepump.

3. CAUTION:To prevent serious damage to the

pump it must not be immersed in any liquids or

exposed to strong organic solvents.Wipe off

spills immediately. Do not allow fluid or

residues to remain on the pump.Additionally,

Cautions the pump is not designed to allow it to be

sterilised. Failure to observe these cautions

may cause internal damage to the pump.

4. CAUTION: Carry out periodic cleaning

following the detailed instructions in the

Volumetric Infusion Pumps Service Manual

. Do

not use unapproved cleaning agents.

5. CAUTION:When turning the pump on, if

screens similar to those illustrated are not

displayed, do not use the pump, and send the

pump to authorised service personnel.

6. CAUTION: Only carry the pump by the handle.

Failure to do so may result in damage to the

pump, or the pump may be dropped which

could cause internal damage to the pump.

7 CAUTION:The backlight has a limited life and

may,if used constantly, cause the light to dim.

Eventually the message display may then need

to be replaced.To preserve the life of the

message display,you should only turn on the

Message Display Light as described here if it

is specifically required. Misuse of this feature

could lead to both battery and LCD depletion.

Volumetric Infusion Pump Instruction Manual

Graseby Medical Ltd.

Contents

New features of version 0.71 software..............................................................v

Chapter 1 - Introduction

Introduction to the 500/505 pumps .............................................................1 - 1

Model 500 Volumetric pump...............................................................................1 - 1

Micro 505 Volumetric pump................................................................................1 - 1

Epidural administration ......................................................................................1 - 2

Pump features ....................................................................................................1 - 3

Chapter 2 - Operating the pump

Introduction..................................................................................................2 - 1

Who should read this chapter ............................................................................2 - 1

What this chapter covers ....................................................................................2 - 1

Front of the pump ........................................................................................2 - 2

Indicators and displays.......................................................................................2 - 2

Programming keys .............................................................................................2 - 3

Rear of the pump .........................................................................................2 - 4

Connecting the pumps to an IV pole ..........................................................2 - 5

Switching on .......................................................................................................2 - 7

Switching the pump on and off...................................................................2 - 7

Switching off .......................................................................................................2 - 8

Using the pump on battery .................................................................................2 - 8

Sounds on theVolumetric ......................................................................... 2 - 10

Audio alarm ......................................................................................................2 - 10

Quiet Pump mode.............................................................................................2 - 11

Alarms and computer control ...........................................................................2 - 11

Types of infusion ....................................................................................... 2 - 12

Primary .............................................................................................................2 - 12

Primary and Secondary....................................................................................2 - 13

Primary and Bolus ............................................................................................2 - 14

Ending a Secondary infusion ...........................................................................2 - 14

Volumetric Infusion Pump Instruction Manual

Contents

Graseby Medical Ltd.

The effect of Options settings on infusions ............................................. 2 - 15

Infusing with Rate and VTBI limits enabled......................................................2 - 15

Setting up a Primary Infusion ................................................................... 2 - 16

Prepare the solution .........................................................................................2 - 16

Prime the administration set - Example ...........................................................2 - 17

Load the cassette into the pump ......................................................................2 - 18

Setting the Occlusion Alarm .............................................................................2 - 18

Primary infusion 5 or 6-Step Setup ..................................................................2 - 19

During the infusion ....................................................................................2 - 20

If the infusion will not start running...................................................................2 - 20

Infusion information displays............................................................................2 - 21

Running Rate Change (Rate titration) .............................................................2 - 21

Security on the pump........................................................................................2 - 22

Display the Drug Label.....................................................................................2 - 23

Stop the infusion...............................................................................................2 - 23

If an occlusion is detected ................................................................................2 - 23

Change the Occlusion alarm setting ................................................................2 - 24

Ending the Primary infusion ..................................................................... 2 - 25

KVO infusion.....................................................................................................2 - 25

About Secondary Infusions ....................................................................... 2 - 26

Setting up a Secondary infusion ......................................................................2 - 26

Lower the Primary solution container ..............................................................2 - 27

Prime the Secondary administration set ..........................................................2 - 27

Connect the Secondary to the Primary administration set...............................2 - 28

About the Secondary Volume to be Infused .....................................................2 - 28

Program the Secondary infusion......................................................................2 - 29

Secondary infusion - Bolus enabled ................................................................2 - 30

Running a Bolus infusion.......................................................................... 2 - 31

Ending a Secondary infusion ...........................................................................2 - 32

Ending a Bolus infusion ...................................................................................2 - 32

Checking infusion totals............................................................................ 2 - 33

Total Volume infused ........................................................................................2 - 33

Primary totals ....................................................................................................2 - 34

Secondary totals...............................................................................................2 - 34

Bolus totals .......................................................................................................2 - 34

Re-running infusions at the same rate.............................................................2 - 35

Volumetric Infusion Pump Instruction Manual

Graseby Medical Ltd.

iii

Contents

Chapter 3 - Options

Introduction..................................................................................................3 - 1

Options available................................................................................................3 - 1

Using options......................................................................................................3 - 2

1. Standard Message...................................................................................3 - 3

2. Time Remaining......................................................................................3 - 3

3. Message Display Light............................................................................3 - 4

Turning the light on and off.................................................................................3 - 4

4. BatteryTest ..............................................................................................3 - 5

Using the Battery Test option..............................................................................3 - 5

5. Quick Rate Change .................................................................................3 - 7

Performing Quick Rate Changes........................................................................3 - 7

6. RateTaper ................................................................................................3 - 8

To enter Rate Taper ............................................................................................3 - 9

To exit Rate Taper ...............................................................................................3 - 9

To program a Rate Taper by ‘Total Time’ ..........................................................3 - 10

To program a Rate Taper by ‘Maximum Rate’ ..................................................3 - 12

Using the ‘End Early’ feature ............................................................................3 - 14

Resuming, restarting or reprogramming the Rate Taper .................................3 - 15

Programming or reprogramming the Rate Taper with Limits set .....................3 - 16

7. Volume OverTime (VOT)....................................................................... 3 - 17

To use Volume Over Time .................................................................................3 - 18

8. Dose-Rate Calculation........................................................................... 3 - 19

Dose-Rate Calculation Recovery ....................................................................3 - 19

To enter or exit Dose-Rate Calculation ............................................................3 - 20

Dose-Rate Calculation steps ...........................................................................3 - 20

Dose-Rate Calculation programming example ...............................................3 - 23

Changing the dosing rate without stopping the infusion .................................3 - 25

Changing the infusion rate without stopping the infusion ...............................3 - 26

Dose or rate change alarms.............................................................................3 - 27

Programming or reprogramming Dose-Rate Calculation with Limits set........3 - 28

Setting Rate andVTBI limits...................................................................... 3 - 29

Minimum and Maximum Infusion Rates...........................................................3 - 29

To set the minimum and maximum infusion rate..............................................3 - 30

MaximumVTBI..................................................................................................3 - 31

Volumetric Infusion Pump Instruction Manual

Contents

Graseby Medical Ltd.

To set the maximum infusion volume ...............................................................3 - 31

Programming and running infusions with limits...............................................3 - 32

KVO rate...................................................................................................... 3 - 33

Setting a KVO rate ............................................................................................3 - 33

Drug Label .................................................................................................. 3 - 34

Drug Library......................................................................................................3 - 34

Checking the current drug label.......................................................................3 - 35

Selecting a new drug label...............................................................................3 - 35

Clearing the drug label.....................................................................................3 - 36

Chapter 4 - Troubleshooting

Introduction..................................................................................................4 - 1

What’s in this chapter..........................................................................................4 - 1

Who should read this chapter ............................................................................4 - 1

Handling problems with the pump .............................................................4 - 2

Pump Messages ...........................................................................................4 - 3

Pump will not switch on ......................................................................................4 - 3

Programming Messages with alarms.................................................................4 - 3

Warning Messages with alarms .........................................................................4 - 3

Warning Messages with no alarms ....................................................................4 - 7

InstrumentCare............................................................................................4 - 8

Specifications/Standards

Specifications.............................................................................................. S - 1

Standards .................................................................................................... S - 9

Trumpet curves ......................................................................................... S - 10

Appendix

Nurse-CallFeature....................................................................................... A - 1

Index

Volumetric Infusion Pump Instruction Manual

Graseby Medical Ltd.

Contents

The information in this section is

intended for technicians and clinicians

already familiar with earlier versions

of the Graseby 500/505 volumetric

pump. It summarises the changes to

the pump that appear with version 0.71

of the pump software:

• new menu,

• new options,

• new features that the menu and

options provide.

To find out the software version of a

particular pump, check the instructions

label on the right side of the pump. If

there are more than eight options

listed, then the software version is 0.71

or later.

For full details on how to use the pump

see the VolumetricInstruction Manual.

For information on configuring the

pump, see the Technical User Manual,

and for more detailed technical

information, obtain a copy of the

VolumetricServiceManual.

New Menu

A Technician Menu has been introduced,

to simplify the configuration of each

pump. Some of the items on the

Technician Menu affect how the pump

behaves; others control the options that

appear to the pump user when they

press the Options button to show the

Options menu. The configurable items

on the new Technician Menu are shown

on page 12 of the Technical User

Manual.

If the Technician Menu settings are left

at their factory defaults, the pump

behaves as the previous version of the

pump.

New features of version 0.71 software

New Options

The new options (and some of the

previous options) can be enabled on the

Technician Menu. This means that they

can appear when appropriate, but can

be disabled if not required. On the

instruction label on the pump, Options

numbered 1 to 8 are the ones that

appeared in previous versions of the

pump software. The additional new

options shown on the label are:

• Primary infusion Minimum

• Primary infusion Maximum

• Primary Max Volume to be infused

• Secondary/Bolus Minimum

• Secondary/Bolus Maximum

• Secondary/Bolus Max Volume to be

infused

• KVO Rate

• Drug Library to allow selection and

display of a drug label.

New features

The new menu and new options in

version 0.71 software provide a number

of new features. These fall into the

following broad areas:

• Infusion mode features

• Safety features

• Display features

• Servicing features.

Infusion mode features

Using the Technician Menu, the pump

can be configured:

• to stop at the end of a Secondary

infusion, or to continue infusing and

automatically switch to the

programmed Primary rate;

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